,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32339032,SAFETY AND EFFICACY OF DDP4-INHIBITORS FOR MANAGEMENT OF HOSPITALIZED GENERAL MEDICINE AND SURGERY PATIENTS WITH TYPE 2 DIABETES.,"Background:  DPP4-inhibitors (DPP4-i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from three prospective studies using DPP4-i in general medicine and surgery patients with type 2 diabetes (T2D).  Research Design and Methods:  We combined data from three randomized studies comparing DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen. Medicine (n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with diet, oral agents or low-dose insulin therapy were included. Patients received DPP4-i alone (n=144), DPP4-i plus basal insulin (n=158) or basal bolus regimen (n=283). All groups received correctional doses with rapid-acting insulin for BG >140mg/dl. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications.  Results:  There were no differences in mean hospital daily BG among patients treated with DPP4-i alone (170±37 mg/dl), DPP4-i plus basal (172±42 mg/dl) or basal bolus (172±43 mg/dl), p=0.94; or in the percentage of BG readings within target of 70-180 mg/dl (63±32%, 60±31% and 64±28% respectively, p=0.42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP4-i alone (2%) compared to DPP4-i plus basal (9%) and basal bolus (10%), p=0.004.  Conclusion:  Treatment with DPP4-i alone or in combination with basal insulin is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin re gimen in general medicine and surgery patients with T2D.",2020,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"['general medicine and surgery patients with T2D', 'general medicine and surgery patients with type 2 diabetes (T2D', 'n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with']","['DPP4-i alone', 'correctional doses with rapid-acting insulin for BG >140mg/dl', 'DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen', ':  DPP4-inhibitors (DPP4-i', 'diet, oral agents or low-dose insulin therapy', 'DPP4-i plus basal insulin (n=158) or basal bolus regimen', 'DPP4-i', 'DPP4-i alone or in combination with basal insulin', 'Medicine']","['hypoglycemia and hospital complications', 'mean daily BG', 'mean hospital daily BG', 'length of stay or complications, but hypoglycemia', 'hypoglycemia']","[{'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0952002,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lorenzo-González', 'Affiliation': 'From: Department of Endocrinology and Nutrition, Hospital Universitario Nuestra Señora de La Candelaria, Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Atienza-Sánchez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Príncipe de Asturias, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes-Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Schoolf of Public Health, Emory University.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0481']
1,32340738,"The Effect of Soft Tissue Injury Cold Application Duration on Symptoms, Edema, Joint Mobility, and Patient Satisfaction: A Randomized Controlled Trial.","INTRODUCTION


The aim of this study was to determine the effect of cold application time on symptoms, edema, and patient satisfaction in soft tissue injuries.
METHODS


A randomized controlled trial was conducted with 105 patients who were treated with cold applications of different durations (10, 20, and 30 minutes). Interview-assisted data were collected on symptoms and patient satisfaction. Edema and range of motion were objectively measured in patients with an ankle injury. Data were analyzed using repeated-measures analysis of variance.
RESULTS


Pain reduction was greatest in the 20 minutes of cold application group (F = 46.35, P < 0.05). Symptoms of discomfort such as tingling (F = 65.93, P < 0.05), redness (F = 61.95, P < 0.05), itching (F = 36.49, P < 0.05), numbness (F = 57.94, P < 0.05), and burning (F = 55.40, P < 0.05) were more frequent in the group with 30 minutes of cold application. Both joint mobility (F = 45.28, P < 0.05) and patient satisfaction (F = 130.99, P < 0.05) were the highest in the group with 20 minutes of cold application.
DISCUSSION


Our findings suggest that a duration of 20 minutes for cold application for a soft tissue ankle injury is recommended to maximize pain control, joint mobility, and patient satisfaction while decreasing other symptoms of discomfort.",2020,"Both joint mobility (F = 45,283, P < 0.05) and patient satisfaction (F = 130,987, P < 0.05) were the highest in the group with 20 minutes of cold application.
","['105 patients who were treated with cold applications of\xa0different durations (10, 20, and 30\xa0minutes', 'patients with an ankle injury']",['Soft Tissue Injury Cold Application Duration'],"['Edema and range of motion', 'joint mobility', 'Symptoms, Edema, Joint Mobility, and Patient Satisfaction', 'numbness', 'patient satisfaction', 'Symptoms of discomfort such as tingling', 'itching', 'symptoms, edema, and patient satisfaction', 'Pain reduction', 'redness']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0085111', 'cui_str': 'Injury of ankle'}]","[{'cui': 'C0037578', 'cui_str': 'Soft tissue injury'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",,0.111752,"Both joint mobility (F = 45,283, P < 0.05) and patient satisfaction (F = 130,987, P < 0.05) were the highest in the group with 20 minutes of cold application.
","[{'ForeName': 'Senan', 'Initials': 'S', 'LastName': 'Mutlu', 'Affiliation': ''}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.02.017']
2,32367010,Exposure to direct-to-consumer advertising is associated with overestimation of benefits regarding ultrahypofractionated radiation therapy for prostate cancer.,"BACKGROUND


While direct-to-consumer (DTC) medical advertising can provide useful information, it also risks oversimplification and being misleading. For an abbreviated prostate cancer treatment regimen called ""ultrahypofractionation"" (UHF), advertising has been used for CyberKnife (CK), a common delivery system for stereotactic body radiation therapy. We hypothesized that those viewing an advertisement for CK versus factual information would have inaccurate impressions of effectiveness and safety.
METHODS


400 men aged 40-80 were randomly assigned to one of four arms: a de-identified CK advertisement, the same advertisement with disclaimers, scientific information obtained from review of contemporary peer-reviewed literature, and a control. Subjects answered questions regarding risks/benefits of CK and likelihood of pursuing CK versus other treatments. Regression analysis was performed to determine factors associated with CK preference.
RESULTS


400 men were included. Compared to controls, those who viewed any of the three interventions were more likely to pursue CK over other treatments (p < 0.01), with a greater increase in the advertisement groups. Respondents who viewed scientific information were less likely to agree CK is superior regarding impotence and urinary dysfunction. Disclaimers decreased positive impressions of CK's side effects, but not effectiveness. Both advertisement and advertisement with disclaimer respondents were more likely to consider CK superior.
CONCLUSIONS


DTC medical advertisements can be misleading and impact laypersons' impressions. In this case, viewing an advertisement created inaccurate impressions regarding effectiveness and safety of UHF for prostate cancer.",2020,"Compared to controls, those who viewed any of the three interventions were more likely to pursue CK over other treatments (p < 0.01), with a greater increase in the advertisement groups.","['400 men were included', '400 men aged 40-80', 'prostate cancer']","['abbreviated prostate cancer treatment regimen called ""ultrahypofractionation"" (UHF', 'CK advertisement, the same advertisement with disclaimers, scientific information obtained from review of contemporary peer-reviewed literature, and a control', 'ultrahypofractionated radiation therapy']",['pursue CK'],"[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1300683', 'cui_str': 'CyberKnife'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C1300683', 'cui_str': 'CyberKnife'}]",400.0,0.0324415,"Compared to controls, those who viewed any of the three interventions were more likely to pursue CK over other treatments (p < 0.01), with a greater increase in the advertisement groups.","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Caputo', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Columbia University Medical Center, 161 Fort Washington Avenue, 11th Floor, New York, NY, 10032, USA.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, NewYork-Presbyterian Lawrence Hospital, 55 Palmer Avenue, Bronxville, NY, 10708, USA.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Chiles', 'Affiliation': 'Columbia University Business School, 3022 Broadway, Rm 703, New York, NY, 10027, USA.'}, {'ForeName': 'Elias S', 'Initials': 'ES', 'LastName': 'Hyams', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Columbia University Medical Center, 161 Fort Washington Avenue, 11th Floor, New York, NY, 10032, USA. esh2157@cumc.columbia.edu.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0234-2']
3,32357897,Randomized control trial comparing an Alvarado Score-based management algorithm and current best practice in the evaluation of suspected appendicitis.,"BACKGROUND


An objective algorithm for the management of suspected appendicitis guided by the Alvarado Score had previously been proposed. This algorithm was expected to reduce computed tomography (CT) utilization without compromising the negative appendectomy rate. This study attempts to validate the proposed algorithm in a randomized control trial.
METHODS


A randomized control trial comparing the management of suspected acute appendicitis using the proposed algorithm compared to current best practice, with the rate of CT utilization as the primary outcome of interest. Secondary outcomes included the percentage of missed diagnosis, negative appendectomies, length of stay in days, and overall cost of stay in dollars.
RESULTS


One hundred sixty patients were randomized. Characteristics such as age, ethnic group, American Society of Anesthesiologist score, white cell count, and symptom duration were similar between the two groups. The overall CT utilization rate of the intervention arm and the usual care arm were similar (93.7% vs 92.5%, p = 0.999). There were no differences in terms of negative appendectomy rate, length of stay, and cost of stay between the intervention arm as compared to the usual care arm (p = 0.926, p = 0.705, and p = 0.886, respectively). Among patients evaluated with CT, 75% (112 out of 149) revealed diagnoses for the presenting symptoms.
CONCLUSION


The proposed AS-based management algorithm did not reduce the CT utilization rate. Outcomes such as missed diagnoses, negative appendectomy rates, length of stay, and cost of stay were also largely similar. CT utilization was prevalent as 93% of the study cohort was evaluated by CT scan.
TRIAL REGISTRATION


The study has been registered at ClinicalTrials.gov (NCT03324165, Registered October 27 2017).",2020,"There were no differences in terms of negative appendectomy rate, length of stay, and cost of stay between the intervention arm as compared to the usual care arm (p = 0.926, p = 0.705, and p = 0.886, respectively).","['suspected appendicitis', 'One hundred sixty patients were randomized']",['Alvarado Score-based management algorithm'],"['computed tomography (CT) utilization', 'missed diagnoses, negative appendectomy rates, length of stay, and cost of stay', 'overall CT utilization rate', 'CT utilization', 'negative appendectomy rate, length of stay, and cost of stay', 'percentage of missed diagnosis, negative appendectomies, length of stay in days, and overall cost of stay in dollars', 'CT utilization rate']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5197778', 'cui_str': 'Missing Diagnosis'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0562019', 'cui_str': 'dollar'}]",160.0,0.100051,"There were no differences in terms of negative appendectomy rate, length of stay, and cost of stay between the intervention arm as compared to the usual care arm (p = 0.926, p = 0.705, and p = 0.886, respectively).","[{'ForeName': 'Winson Jianhong', 'Initials': 'WJ', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Sengkang General Hospital, Singapore, Singapore. winson.tan.j.h@singhealth.com.sg.'}, {'ForeName': 'Sanchalika', 'Initials': 'S', 'LastName': 'Acharyya', 'Affiliation': 'Clinical Research & Innovation Office, Tan Tock Seng Hospital Singapore, Singapore, Singapore.'}, {'ForeName': 'Min Hoe', 'Initials': 'MH', 'LastName': 'Chew', 'Affiliation': 'Department of General Surgery, Sengkang General Hospital, Singapore, Singapore.'}, {'ForeName': 'Fung Joon', 'Initials': 'FJ', 'LastName': 'Foo', 'Affiliation': 'Department of General Surgery, Sengkang General Hospital, Singapore, Singapore.'}, {'ForeName': 'Weng Hoong', 'Initials': 'WH', 'LastName': 'Chan', 'Affiliation': 'Department of General Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Wai Keong', 'Initials': 'WK', 'LastName': 'Wong', 'Affiliation': 'Department of General Surgery, Sengkang General Hospital, Singapore, Singapore.'}, {'ForeName': 'London Lucien', 'Initials': 'LL', 'LastName': 'Ooi', 'Affiliation': 'Department of General Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Jeremy Chung Fai', 'Initials': 'JCF', 'LastName': 'Ng', 'Affiliation': 'Department of General Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hock Soo', 'Initials': 'HS', 'LastName': 'Ong', 'Affiliation': 'Department of General Surgery, Singapore General Hospital, Singapore, Singapore.'}]",World journal of emergency surgery : WJES,['10.1186/s13017-020-00309-0']
4,32363910,Provider experiences with three- and six-month antiretroviral therapy dispensing for stable clients in Zambia.,"Multi-month dispensing of antiretroviral therapy (ART) has been taken to scale in many settings in sub-Saharan Africa with the benefits of improved client satisfaction and decreased client costs. Six-month ART dispensing may further increase these benefits; however, data are lacking. Within a cluster-randomized trial of three- versus six-month dispensing in Malawi and Zambia, we performed a sub-study to explore Zambian provider experiences with multi-month dispensing. We conducted 18 in-depth interviews with clinical officers and nurses dispensing ART as part of INTERVAL in Zambia. Interview questions focused on provider perceptions of client acceptability, views on client sharing and selling of ART, and perceptions on provider workload and clinic efficiency, with a focus on differences between three- and six-month dispensing. Interviews were analyzed using inductive thematic analysis to identify key themes and patterns within the data. Providers perceived significant benefits of multi-month dispensing, with advantages of six-month over three-month dispensing related to a reduced burden on clients, and for reductions in their own workload and clinic congestion. Among nearly all providers, the six-month dispensing strategy was perceived as ideal. Further research is needed to quantify clinical outcomes of six-month dispensing and feasibility of scaling-up this intervention in resource-limited settings.Clinical Trial Number: NCT03101592.",2021,"Providers perceived significant benefits of multi-month dispensing, with advantages of six-month over three-month dispensing related to a reduced burden on clients, and for reductions in their own workload and clinic congestion.","['stable clients in Zambia', '18 in-depth interviews with clinical officers and nurses dispensing ART as part of INTERVAL in Zambia']","['three- and six-month antiretroviral therapy dispensing', 'antiretroviral therapy (ART']","['client acceptability, views on client sharing and selling of ART, and perceptions on provider workload and clinic efficiency']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237758', 'cui_str': 'Non-commissioned officer'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0441767,"Providers perceived significant benefits of multi-month dispensing, with advantages of six-month over three-month dispensing related to a reduced burden on clients, and for reductions in their own workload and clinic congestion.","[{'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Phiri', 'Affiliation': 'Partners in Hope Medical Center, Lilongwe, Malawi.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'McBride', 'Affiliation': 'Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Zumbe', 'Initials': 'Z', 'LastName': 'Siwale', 'Affiliation': 'Right to Care, EQUIP, Lusaka, Zambia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hubbard', 'Affiliation': 'Partners in Hope Medical Center, Lilongwe, Malawi.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Bardon', 'Affiliation': 'School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Corrina', 'Initials': 'C', 'LastName': 'Moucheraud', 'Affiliation': 'Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Mwiza', 'Initials': 'M', 'LastName': 'Haambokoma', 'Affiliation': 'Right to Care, EQUIP, Lusaka, Zambia.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Pisa', 'Affiliation': 'Right to Care, EQUIP, Centurion, South Africa.'}, {'ForeName': 'Crispin', 'Initials': 'C', 'LastName': 'Moyo', 'Affiliation': 'Right to Care, EQUIP, Lusaka, Zambia.'}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Partners in Hope Medical Center, Lilongwe, Malawi.'}]",AIDS care,['10.1080/09540121.2020.1755010']
5,32367738,"Positive effect of a new supplementation of vitamin D 3  with myo-inositol, folic acid and melatonin on IVF outcomes: a prospective randomized and controlled pilot study.","To assess whether oral supplementation of vitamin D 3 , myo-inositol, folic acid and melatonin affects IVF outcomes. One hundred and twenty consecutive infertile women attending IVF treatment were 1:1 randomly distributed in two groups. Women in group A (control) were assigned to receive myo-inositol, alpha-lactalbumin and folic acid in the morning, and myo-inositol, folic acid and melatonin in the evening. Women in group B (treated) were assigned to receive analogous treatment, with the addition of cholecalciferol (vitamin D 3 ) in the evening from the early beginning of the luteal phase. 50 patients in group A and 50 in group B underwent blastocyst transfer and were considered in the statistical analysis. Vitamin D 3  levels significantly increased after 45 days of treatment: 33.2 ng/ml in group B Vs. 24.3 ng/ml in group A ( p  < .0001). The implantation rate increased as well: 37.1% in group B Vs. 19.2% in group A ( p  < .0151). Overall, the results indicate that increased vitamin D 3  levels positively correlate with the implantation rate in IVF. Because of the low number of participants, these findings need to be confirmed with larger cohorts of patients.",2021,Vitamin D 3  levels significantly increased after 45 days of treatment: 33.2 ng/ml in group B Vs.,['One hundred and twenty consecutive infertile women attending IVF treatment'],"['myo-inositol, alpha-lactalbumin and folic acid in the morning, and myo-inositol, folic acid and melatonin in the evening', 'vitamin D 3 , myo-inositol, folic acid and melatonin', 'vitamin D 3  with myo-inositol, folic acid and melatonin', 'cholecalciferol (vitamin D 3 ']","['implantation rate', 'IVF outcomes', 'Vitamin D 3  levels']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0002287', 'cui_str': 'Alpha-lactalbumin'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",120.0,0.139163,Vitamin D 3  levels significantly increased after 45 days of treatment: 33.2 ng/ml in group B Vs.,"[{'ForeName': 'Maria Salomé', 'Initials': 'MS', 'LastName': 'Bezerra Espinola', 'Affiliation': 'System Biology Group, University of Rome, Alma Res Fertility Center, Rome, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Bilotta', 'Affiliation': 'Alma Res Fertility Center, Rome, Italy.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Aragona', 'Affiliation': 'cSystem Biology Group, University of Rome, Alma Res Fertility Center, Rome, Italy.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1760820']
6,32370147,Water Consumption during a School Day and Children's Short-Term Cognitive Performance: The CogniDROP Randomized Intervention Trial.,"There is still little research examining the relationship between water consumption in school and specific cognitive performance. The aim of this cluster-randomized intervention CogniDROP trial was to investigate the short-term effects of drinking water during the morning on executive functions. The participants were from the 5 th  and 6 th  grade of a comprehensive school in Germany (14 classes,  n  = 250, 61.6% boys). The classes were randomly divided into an intervention group (an education on healthy drinking behavior and a promotion of water consumption) and a control group. A battery of computerized tasks (Switch Task, 2-Back Task, Corsi Block-Tapping Task and Flanker Task) was used to test executive functions. Urine color and thirst were evaluated to check the hydration level. Physical activity over the past 24 h was measured using GT3X ActiGraph. A non-linear relationship was observed between the amount of drinking water and executive performance. Consuming water up to 1000 mL (or up to 50% of Total Water Intake) had benefits during memory tasks. Urine color and number of steps on the study day correlated with water consumed. The results suggest that a water-friendly environment supports school-aged children in adequate water intake resulting in better cognitive performance, especially short-term memory.",2020,"The results suggest that a water-friendly environment supports school-aged children in adequate water intake resulting in better cognitive performance, especially short-term memory.","[""Water Consumption during a School Day and Children's Short-Term Cognitive Performance"", 'participants were from the 5 th  and 6 th  grade of a comprehensive school in Germany (14 classes,  n  = 250, 61.6% boys']","['intervention group (an education on healthy drinking behavior and a promotion of water consumption) and a control group', 'computerized tasks (Switch Task, 2-Back Task, Corsi Block-Tapping Task and Flanker Task']","['executive functions', 'Physical activity', 'Urine color and number of steps', 'drinking water and executive performance']","[{'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0557796', 'cui_str': 'Comprehensive school'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0278030', 'cui_str': 'Color of urine'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",,0.0274991,"The results suggest that a water-friendly environment supports school-aged children in adequate water intake resulting in better cognitive performance, especially short-term memory.","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Drozdowska', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University Bochum, 44791 Bochum, Germany.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Falkenstein', 'Affiliation': 'Institute for Work, Learning and Ageing (ALA), 44805 Bochum, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Jendrusch', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Platen', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Luecke', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University Bochum, 44791 Bochum, Germany.""}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Kersting', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University Bochum, 44791 Bochum, Germany.""}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Jansen', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University Bochum, 44791 Bochum, Germany.""}]",Nutrients,['10.3390/nu12051297']
7,32372561,"Local Administration of Methylcobalamin for Subacute Ophthalmic Herpetic Neuralgia: A Randomized, Phase III Clinical Trial.","OBJECTIVES


The ophthalmic branch of the trigeminal nerve is one of the most frequently involved sites of postherpetic neuralgia. A single-center randomized controlled study was conducted to evaluate the efficacy of local methylcobalamin injection for subacute ophthalmic herpetic neuralgia (SOHN).
METHODS


One hundred and five patients with a pain score of 4 or greater were randomized to receive a combination of methylcobalamin and lidocaine via local injection (LM group, n = 35), intramuscular methylcobalamin and local lidocaine injection (IM group, n = 35), and oral methylcobalamin tablet and lidocaine local injection (OM group, n = 35) for 4 weeks. Multilevel mixed modeling was employed to examine treatment responses.
RESULTS


Pain scores were reduced in all groups, but this reduction was significantly greater in the LM group (6.7 at baseline vs. 2.8 at endpoint) when compared with systemic administration (IM group 6.8 vs. 4.9, OM group 6.7 vs. 5.1). Clinically relevant reduction of pain (>30%) was seen in 91% of patients in the LM group, a significantly greater proportion than in the systemic groups (66% IM group, 57% OM group). Analgesic use reduced significantly in the LM group (94% at baseline vs. 6% at endpoint) but not in systemic groups (IM group 97% vs. 86%, OM group 94% vs. 80%). Health-related quality of life was higher in the LM group than in the systemic groups. In mixed modelling, increased age was associated with a lower response to methylcobalamin.
CONCLUSIONS


This study indicates that local injection of methylcobalamin produces significant pain relief from SOHN and is superior to systemic administration.",2020,"RESULTS


Pain scores were reduced in all groups but this reduction was significantly greater in patients who received local methylcobalamin (6.7 at baseline vs 2.8 at endpoint) when compared with systemic administration (intramuscular 6.8 vs 4.9, oral 6.7 vs 5.1).","['Subacute Ophthalmic Herpetic Neuralgia', 'subacute ophthalmic herpetic neuralgia (SOHN', 'One hundred and five patients with a pain score of 4 or greater']","['Methylcobalamin', 'methylcobalamin', 'methylcobalamin and lidocaine via local injection (LM, N=35), intramuscular methylcobalamin and local lidocaine injection (IM, N=35), and oral methylcobalamin tablet and lidocaine local injection', 'local methylcobalamin injection']","['pain relief', 'Health-related Quality of Life', 'Analgesic', 'pain', 'Pain scores']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",105.0,0.131465,"RESULTS


Pain scores were reduced in all groups but this reduction was significantly greater in patients who received local methylcobalamin (6.7 at baseline vs 2.8 at endpoint) when compared with systemic administration (intramuscular 6.8 vs 4.9, oral 6.7 vs 5.1).","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Chao Sheng', 'Initials': 'CS', 'LastName': 'Zhou', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei Zhen', 'Initials': 'WZ', 'LastName': 'Tang', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Li Dong', 'Initials': 'LD', 'LastName': 'Wang', 'Affiliation': ""Rehabilitation Medicine Department, Chongming Branch of Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Kai Hua', 'Initials': 'KH', 'LastName': 'Ding', 'Affiliation': ""Rehabilitation Medicine Department, Chongming Branch of Shanghai Tenth People's Hospital, Shanghai, China.""}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12909']
8,32173035,Body coordination during sit-to-stand in blind and sighted female children.,"Detecting coordination pattern and coordination variability help us to find how joints organize collaboratively to perform sit-to-stand (STS) under restricted visual input. This experiment aimed to compare the coordination of the trunk, hip, knee, and ankle and its variability between individuals with long- and short-term restricted visual input during STS. Forty-five female children participated in this study, including fifteen congenitally blind (CB) children and 30 healthy children. The healthy children were divided randomly into two groups: one group in which the participants were instructed to keep their eyes open (EO) and another to keep their eyes closed (EC) for 20 min before the test. In the standing phase, CB children had a decreased ankle-knee vector angle on the nondominant (ND) side compared to that of healthy children. In the sagittal plane, a small coefficient-of-correspondences (CoC) was observed at seat-off (hip-trunk CoC on the dominant (D) side and ankle-hip CoC on the ND side) and in the preparation phase (ankle-hip CoC on the ND side and bilateral hip CoC). In the frontal plane (at the end: ankle-knee, in the standing phase: bilateral hip) a high CoC was observed (in the standing phase: knee-trunk CoC on the D side). The EC group had smaller CoCs at initiation event (knee-trunk and bilateral knee CoCs on both sides), the end event (ankle-knee and ankle-hip CoCs on the ND side), and in the standing phase (bilateral hip CoC) in the frontal plane than the other groups. The findings reveal that vector and CoC variables are altered because of long- and short-term restricted visual data and should be a focus in rehabilitation programs.",2020,"The EC group had smaller CoCs at initiation event (knee-trunk and bilateral knee CoCs on both sides), the end event (ankle-knee and ankle-hip CoCs on the ND side), and in the standing phase (bilateral hip CoC) in the frontal plane than the other groups.","['Forty-five female children participated in this study, including fifteen congenitally blind (CB) children and 30 healthy children', 'individuals with long- and short-term restricted visual input during STS', 'healthy children', 'sighted female children']",['keep their eyes open (EO) and another to keep their eyes closed (EC'],"['ankle-knee vector angle', 'Body coordination']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0870604', 'cui_str': 'Female child (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}]",45.0,0.0176329,"The EC group had smaller CoCs at initiation event (knee-trunk and bilateral knee CoCs on both sides), the end event (ankle-knee and ankle-hip CoCs on the ND side), and in the standing phase (bilateral hip CoC) in the frontal plane than the other groups.","[{'ForeName': 'Mozhgan Faraji', 'Initials': 'MF', 'LastName': 'Aylar', 'Affiliation': 'Faculty of Engineering, Electrical Engineering Department, Imam Reza International University, Mashhad, Iran. Electronic address: mf.aylar@protonmail.com.'}, {'ForeName': 'Valdeci Carlos', 'Initials': 'VC', 'LastName': 'Dionisio', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'AmirAli', 'Initials': 'A', 'LastName': 'Jafarnezhadgero', 'Affiliation': 'Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Ali Zolfaghari', 'Initials': 'AZ', 'LastName': 'Parikhani', 'Affiliation': 'Department of Business Administration, Faculty of Management, University of Applied Science and Technology (UAST), Tehran, Iran.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2020.109708']
9,32374710,Effects of a Communication Intervention Randomized Controlled Trial to Enable Goals-of-Care Discussions.,"PURPOSE


Patients with advanced cancer often have a poor understanding of cancer incurability, which correlates with more aggressive treatment near the end of life (EOL). We sought to determine whether training oncologists to elicit patient values for goals-of-care (GoC) discussions will increase and improve these discussions. We explored its impact on use of aggressive care at EOL.
METHODS


We enrolled and used block randomization to assign 92% of solid tumor oncologists to 2-hour communication skills training and four coaching sessions. We surveyed 265 patient with newly diagnosed advanced cancer with < 2-year life expectancy at baseline and 6 months. We assessed prevalence and quality of GoC communication, change in communication skills, and use of aggressive care in the last month of life.
RESULTS


Intervention (INT) oncologists' (n = 11) skill to elicit patient values increased (27%-55%), while usual care (UC) oncologists' (n = 11) skill did not (9%-0%;  P  = .01). Forty-eight percent (n = 74) INT  v  51% (n = 56) UC patients reported a GoC discussion ( P  = .61). There was no difference in the prevalence or quality of GoC communication between groups (global odds ratio, 0.84; 95% CI, 0.57 to 1.23). Within 6 months, there was no difference in deaths (18 INT  v  16 UC;  P  = .51), mean hospitalizations (0.47 INT  v  0.42 UC;  P  = .63), intensive care unit admissions (5% INT  v  9% UC;  P  = .65), or chemotherapy (26% INT  v  16% UC;  P  = .39).
CONCLUSION


Use of a coaching model focused on teaching oncologists to elicit patient values improved that skill but did not increase prevalence or quality of GoC discussions among patients with advanced cancer. There was no impact on high care utilization at EOL.",2020,"There was no difference in the prevalence or quality of GoC communication between groups (global odds ratio, 0.84; 95% CI, 0.57 to 1.23).","['Forty-eight percent (n = 74', 'Patients with advanced cancer', '265 patient with newly diagnosed advanced cancer with < 2-year life expectancy at baseline and 6 months', 'patients with advanced cancer']",[],"['prevalence or quality of GoC discussions', 'prevalence and quality of GoC communication, change in communication skills, and use of aggressive care', 'mean hospitalizations', 'prevalence or quality of GoC communication', 'deaths', 'intensive care unit admissions']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.0728591,"There was no difference in the prevalence or quality of GoC communication between groups (global odds ratio, 0.84; 95% CI, 0.57 to 1.23).","[{'ForeName': 'Nina A', 'Initials': 'NA', 'LastName': 'Bickell', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Back', 'Affiliation': 'Center of Excellence in Palliative Care, University of Washington, Seattle, WA.'}, {'ForeName': 'Kerin', 'Initials': 'K', 'LastName': 'Adelson', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Gonsky', 'Affiliation': 'Kings County Hospital Center, Brooklyn, NY.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Egorova', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Sofya', 'Initials': 'S', 'LastName': 'Pintova', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Jenny J', 'Initials': 'JJ', 'LastName': 'Lin', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kozuch', 'Affiliation': 'Mount Sinai Beth Israel Comprehensive Cancer Center West, New York, NY.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Bagiella', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Cardinale B', 'Initials': 'CB', 'LastName': 'Smith', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",JCO oncology practice,['10.1200/OP.20.00040']
10,32379487,A Randomized Sham-controlled Trial of 1-Hz and 10-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) of the Right Dorsolateral Prefrontal Cortex in Civilian Post-traumatic Stress Disorder: Un essai randomisé contrôlé simulé de stimulation magnétique transcrânienne repetitive (SMTr) de 1 Hz et 10 Hz du cortex préfrontal dorsolatéral droit dans le trouble de stress post-traumatique chez des civils.,"OBJECTIVE


Despite effective psychological and pharmacological treatments, there is a large unmet burden of illness in post-traumatic stress disorder (PTSD). Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention and a putative treatment strategy for PTSD. The evidence base to date suggests that rTMS targeting the dorsolateral prefrontal cortex (DLPFC), in particular the right DLPFC, leads to improvements in PTSD symptoms. However, optimal stimulation parameters have yet to be determined. In this study, we examine the efficacy of high- and low-frequency rTMS of the right DLPFC using a randomized, double-blind, sham-controlled design in civilian PTSD.
METHODS


We conducted a 2-week single-site randomized sham-controlled trial of rTMS targeting the right DLPFC. We recruited civilians aged 19 to 70 with PTSD and randomized subjects with allocation concealment to daily 1-Hz rTMS, 10-Hz rTMS, or sham rTMS. The primary outcome was improvement in Clinician Administered PTSD Scale-IV (CAPS-IV). Secondary outcomes included change in depressive and anxiety symptoms.
RESULTS


We recruited 31 civilians with PTSD. One 1-Hz-treated patient developed transient suicidal ideation. Analyses revealed significant improvement in CAPS-IV symptoms in the 1-Hz group relative to sham (Hedges'  g  = -1.07) but not in the 10-Hz group. This was not attributable to changes in anxious or depressive symptomatology. Ten-Hz stimulation appeared to improve depressive symptoms compared to sham.
CONCLUSION


Low-frequency rTMS is efficacious in the treatment of civilian PTSD. Our data suggest that high-frequency rTMS of the right DLPFC is worthy of additional investigation for the treatment of depressive symptoms comorbid with PTSD.",2020,Analyses revealed significant improvement in CAPS-IV symptoms in the 1-Hz group relative to sham (Hedges'  g  = -1.07) but not in the 10-Hz group.,"['We recruited civilians aged 19 to 70 with PTSD and randomized subjects with', '31 civilians with PTSD', 'Civilian Post-traumatic Stress Disorder']","['allocation concealment to daily 1-Hz rTMS, 10-Hz rTMS, or sham rTMS', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', '1-Hz and 10-Hz Repetitive Transcranial Magnetic Stimulation (rTMS']","['CAPS-IV symptoms', 'anxious or depressive symptomatology', 'Clinician Administered PTSD Scale-IV (CAPS-IV', 'change in depressive and anxiety symptoms', 'transient suicidal ideation', 'depressive symptoms']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.283303,Analyses revealed significant improvement in CAPS-IV symptoms in the 1-Hz group relative to sham (Hedges'  g  = -1.07) but not in the 10-Hz group.,"[{'ForeName': 'Kawai', 'Initials': 'K', 'LastName': 'Leong', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Ong', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Zwicker', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': '380154Vancouver General Hospital, British Columbia, Canada.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'McGirr', 'Affiliation': 'Department of Psychiatry, 2129University of Calgary, Alberta, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720923064']
11,32115328,Intraoperative Surgeon Administered Adductor Canal Blockade Is Not Inferior to Anesthesiologist Administered Adductor Canal Blockade: A Prospective Randomized Trial.,"BACKGROUND


Controlling postoperative pain and reducing opioid requirements after total knee arthroplasty remain a challenge, particularly in an era stressing rapid recovery protocols and early discharge. A single-shot adductor canal blockade (ACB) has been shown to be effective in decreasing postoperative pain. The purpose of the present study is to compare the efficacy of an anesthesiologist administered ACB and a surgeon administered intraoperative ACB.
METHODS


Patients undergoing primary total knee arthroplasty were prospectively randomized to receive either an anesthesiologist administered (group 1) or surgeon administered (group 2) ACB using 15 mL of ropivacaine 0.5%. Primary outcomes were pain visual analog scale, range of motion, and opioid consumption.
RESULTS


Thirty-four patients were randomized to group 1 and 29 to group 2. Opioid equivalents consumed were equal on postoperative day (POD) 0, 1, and 2. Patients in group 1 had statistically less pain on POD 0, but this did not reach clinical significance and there was no difference in pain on POD 1 or 2. Patients in group 1 had significantly increased active flexion POD 1, but there was no difference in active flexion on POD 0 or 6 weeks postop. There was no difference in patient satisfaction with pain control or short-term functional outcomes.
CONCLUSION


Surgeon administered ACB is not inferior to anesthesiologist administered ACB with respect to pain, opioid consumption, range of motion, patient satisfaction, or short-term functional outcomes. Surgeon administered ACB is an effective alternative to anesthesiologist administered ACB.",2020,"CONCLUSION


Surgeon administered ACB is not inferior to anesthesiologist administered ACB with respect to pain, opioid consumption, range of motion, patient satisfaction, or short-term functional outcomes.","['Patients undergoing primary total knee arthroplasty', 'Thirty-four patients']","['single-shot adductor canal blockade (ACB', 'Intraoperative Surgeon Administered Adductor Canal Blockade', 'ACB', 'ropivacaine', 'anesthesiologist administered (group 1) or surgeon administered (group 2) ACB']","['pain visual analog scale, range of motion, and opioid consumption', 'active flexion', 'pain on POD 0', 'patient satisfaction with pain control or short-term functional outcomes', 'active flexion POD', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",34.0,0.187556,"CONCLUSION


Surgeon administered ACB is not inferior to anesthesiologist administered ACB with respect to pain, opioid consumption, range of motion, patient satisfaction, or short-term functional outcomes.","[{'ForeName': 'Max R', 'Initials': 'MR', 'LastName': 'Greenky', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA.'}, {'ForeName': 'Mikayla E', 'Initials': 'ME', 'LastName': 'McGrath', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Levicoff', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Good', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Department of Anesthesiology, Bryn Mawr Hospital, Main Line Health, Bryn Mawr, PA.'}, {'ForeName': 'Asim M', 'Initials': 'AM', 'LastName': 'Makhdom', 'Affiliation': 'Department of Orthopaedic Surgery, Foothills Medical Group, Bradford, PA.'}, {'ForeName': 'Jess H', 'Initials': 'JH', 'LastName': 'Lonner', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.02.011']
12,32178849,Positioning and baby devices impact infant spinal muscle activity.,"Infant positioning in daily life, particularly in relation to active neck and back muscles, may affect spinal development, psychosocial progression, and motor milestone achievement. Yet the impact of infant body position on muscle activity is unknown. The objective of this study was to evaluate neck and back muscle activity of healthy infants in common positions and baby devices. Healthy full-term infants (n = 22, 2-6 months) participated in this experimental study. Daily sleep and positioning were reported by caregivers. Cervical paraspinal and erector spinae muscle activity was measured using surface electromyography (EMG) in five positions: lying prone, lying supine, held in-arms, held in a baby carrier, and buckled into a car seat. Mean filtered EMG signal and time that muscles were active were calculated. Paired t-tests were used to compare positions to the prone condition. Caregivers reported that infants spent 12% of daily awake time prone, 43% in supine-lying baby gear, and 44% held in-arms or upright in a baby carrier. Infants exhibited highest erector spinae activity when prone, and lowest cervical paraspinal muscle activity in the car seat. No differences were found between in-arms carrying and babywearing. This first evaluation of the muscle activity of healthy infants supports the importance of prone time in infants' early spinal development because it promotes neck and back muscle activity. Carrying babies in-arms or in baby carriers may also be beneficial to neck muscle development, while prolonged time spent in car seats or containment devices may be detrimental to spinal development.",2020,"Infants exhibited highest erector spinae activity when prone, and lowest cervical paraspinal muscle activity in the car seat.","['healthy infants in common positions and baby devices', 'healthy infants', 'Healthy full-term infants (n\xa0']",[],"['Cervical paraspinal and erector spinae muscle activity', 'Daily sleep and positioning', 'Mean filtered EMG signal and time that muscles', 'highest erector spinae activity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]",[],"[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0442145', 'cui_str': 'Paraspinal (qualifier value)'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0390754,"Infants exhibited highest erector spinae activity when prone, and lowest cervical paraspinal muscle activity in the car seat.","[{'ForeName': 'Safeer F', 'Initials': 'SF', 'LastName': 'Siddicky', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, United States.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Bumpass', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, United States.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, United States.'}, {'ForeName': 'Stewart A', 'Initials': 'SA', 'LastName': 'Tackett', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, United States.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'McCarthy', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, United States.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Mannen', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, United States. Electronic address: erinmannen@gmail.com.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2020.109741']
13,32171078,"Triple artemisinin-based combination therapies versus artemisinin-based combination therapies for uncomplicated Plasmodium falciparum malaria: a multicentre, open-label, randomised clinical trial.","BACKGROUND


Artemisinin and partner-drug resistance in Plasmodium falciparum are major threats to malaria control and elimination. Triple artemisinin-based combination therapies (TACTs), which combine existing co-formulated ACTs with a second partner drug that is slowly eliminated, might provide effective treatment and delay emergence of antimalarial drug resistance.
METHODS


In this multicentre, open-label, randomised trial, we recruited patients with uncomplicated P falciparum malaria at 18 hospitals and health clinics in eight countries. Eligible patients were aged 2-65 years, with acute, uncomplicated P falciparum malaria alone or mixed with non-falciparum species, and a temperature of 37·5°C or higher, or a history of fever in the past 24 h. Patients were randomly assigned (1:1) to one of two treatments using block randomisation, depending on their location: in Thailand, Cambodia, Vietnam, and Myanmar patients were assigned to either dihydroartemisinin-piperaquine or dihydroartemisinin-piperaquine plus mefloquine; at three sites in Cambodia they were assigned to either artesunate-mefloquine or dihydroartemisinin-piperaquine plus mefloquine; and in Laos, Myanmar, Bangladesh, India, and the Democratic Republic of the Congo they were assigned to either artemether-lumefantrine or artemether-lumefantrine plus amodiaquine. All drugs were administered orally and doses varied by drug combination and site. Patients were followed-up weekly for 42 days. The primary endpoint was efficacy, defined by 42-day PCR-corrected adequate clinical and parasitological response. Primary analysis was by intention to treat. A detailed assessment of safety and tolerability of the study drugs was done in all patients randomly assigned to treatment. This study is registered at ClinicalTrials.gov, NCT02453308, and is complete.
FINDINGS


Between Aug 7, 2015, and Feb 8, 2018, 1100 patients were given either dihydroartemisinin-piperaquine (183 [17%]), dihydroartemisinin-piperaquine plus mefloquine (269 [24%]), artesunate-mefloquine (73 [7%]), artemether-lumefantrine (289 [26%]), or artemether-lumefantrine plus amodiaquine (286 [26%]). The median age was 23 years (IQR 13 to 34) and 854 (78%) of 1100 patients were male. In Cambodia, Thailand, and Vietnam the 42-day PCR-corrected efficacy after dihydroartemisinin-piperaquine plus mefloquine was 98% (149 of 152; 95% CI 94 to 100) and after dihydroartemisinin-piperaquine was 48% (67 of 141; 95% CI 39 to 56; risk difference 51%, 95% CI 42 to 59; p<0·0001). Efficacy of dihydroartemisinin-piperaquine plus mefloquine in the three sites in Myanmar was 91% (42 of 46; 95% CI 79 to 98) versus 100% (42 of 42; 95% CI 92 to 100) after dihydroartemisinin-piperaquine (risk difference 9%, 95% CI 1 to 17; p=0·12). The 42-day PCR corrected efficacy of dihydroartemisinin-piperaquine plus mefloquine (96% [68 of 71; 95% CI 88 to 99]) was non-inferior to that of artesunate-mefloquine (95% [69 of 73; 95% CI 87 to 99]) in three sites in Cambodia (risk difference 1%; 95% CI -6 to 8; p=1·00). The overall 42-day PCR-corrected efficacy of artemether-lumefantrine plus amodiaquine (98% [281 of 286; 95% CI 97 to 99]) was similar to that of artemether-lumefantrine (97% [279 of 289; 95% CI 94 to 98]; risk difference 2%, 95% CI -1 to 4; p=0·30). Both TACTs were well tolerated, although early vomiting (within 1 h) was more frequent after dihydroartemisinin-piperaquine plus mefloquine (30 [3·8%] of 794) than after dihydroartemisinin-piperaquine (eight [1·5%] of 543; p=0·012). Vomiting after artemether-lumefantrine plus amodiaquine (22 [1·3%] of 1703) and artemether-lumefantrine (11 [0·6%] of 1721) was infrequent. Adding amodiaquine to artemether-lumefantrine extended the electrocardiogram corrected QT interval (mean increase at 52 h compared with baseline of 8·8 ms [SD 18·6] vs 0·9 ms [16·1]; p<0·01) but adding mefloquine to dihydroartemisinin-piperaquine did not (mean increase of 22·1 ms [SD 19·2] for dihydroartemisinin-piperaquine vs 20·8 ms [SD 17·8] for dihydroartemisinin-piperaquine plus mefloquine; p=0·50).
INTERPRETATION


Dihydroartemisinin-piperaquine plus mefloquine and artemether-lumefantrine plus amodiaquine TACTs are efficacious, well tolerated, and safe treatments of uncomplicated P falciparum malaria, including in areas with artemisinin and ACT partner-drug resistance.
FUNDING


UK Department for International Development, Wellcome Trust, Bill & Melinda Gates Foundation, UK Medical Research Council, and US National Institutes of Health.",2020,"Both TACTs were well tolerated, although early vomiting (within 1 h) was more frequent after dihydroartemisinin-piperaquine plus mefloquine (30 [3·8%] of 794) than after dihydroartemisinin-piperaquine (eight [1·5%] of 543; p=0·012).","['patients with uncomplicated P falciparum malaria at 18 hospitals and health clinics in eight countries', 'The median age was 23 years (IQR 13 to 34) and 854 (78%) of 1100 patients were male', 'Eligible patients were aged 2-65 years, with acute, uncomplicated P falciparum malaria alone or mixed with non-falciparum species, and a temperature of 37·5°C or higher, or a history of fever in the past 24 h. Patients', 'uncomplicated Plasmodium falciparum malaria', '1100 patients were given either']","['lumefantrine plus amodiaquine', 'artesunate-mefloquine', 'artemether-lumefantrine plus amodiaquine', 'mefloquine', 'dihydroartemisinin-piperaquine plus mefloquine', 'artesunate-mefloquine or dihydroartemisinin-piperaquine plus mefloquine; and in Laos, Myanmar, Bangladesh, India, and the Democratic Republic of the Congo they were assigned to either artemether-lumefantrine or artemether-lumefantrine plus amodiaquine', 'Triple artemisinin-based combination therapies (TACTs', 'amodiaquine', 'Triple artemisinin-based combination therapies versus artemisinin-based combination therapies', 'dihydroartemisinin-piperaquine or dihydroartemisinin-piperaquine plus mefloquine', 'dihydroartemisinin-piperaquine', 'artemether-lumefantrine', 'mefloquine and artemether-lumefantrine plus amodiaquine TACTs']","['42-day PCR corrected efficacy', 'overall 42-day PCR-corrected efficacy', 'tolerated', 'safety and tolerability', 'Vomiting', 'early vomiting', 'electrocardiogram corrected QT interval', 'efficacy, defined by 42-day PCR-corrected adequate clinical and parasitological response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0531104', 'cui_str': 'lumefantrine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0936150', 'cui_str': 'artemether / lumefantrine'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0023034', 'cui_str': 'Laos'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0618927', 'cui_str': 'TACT'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic (qualifier value)'}]",1100.0,0.288372,"Both TACTs were well tolerated, although early vomiting (within 1 h) was more frequent after dihydroartemisinin-piperaquine plus mefloquine (30 [3·8%] of 794) than after dihydroartemisinin-piperaquine (eight [1·5%] of 543; p=0·012).","[{'ForeName': 'Rob W', 'Initials': 'RW', 'LastName': 'van der Pluijm', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rupam', 'Initials': 'R', 'LastName': 'Tripura', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Hoglund', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Pyae Phyo', 'Affiliation': 'Myanmar-Oxford Clinical Research Unit, Yangon, Myanmar.'}, {'ForeName': 'Dysoley', 'Initials': 'D', 'LastName': 'Lek', 'Affiliation': 'National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia; School of Public Health, National Institute of Public Health, Phnom Penh, Cambodia.'}, {'ForeName': 'Akhter', 'Initials': 'A', 'LastName': 'Ul Islam', 'Affiliation': ""Ramu Upazila Health Complex, Cox's Bazar, Bangladesh.""}, {'ForeName': 'Anupkumar R', 'Initials': 'AR', 'LastName': 'Anvikar', 'Affiliation': 'National Institute of Malaria Research, Indian Council of Medical Research, New Delhi, India.'}, {'ForeName': 'Parthasarathi', 'Initials': 'P', 'LastName': 'Satpathi', 'Affiliation': 'Midnapore Medical College, Midnapur, India.'}, {'ForeName': 'Sanghamitra', 'Initials': 'S', 'LastName': 'Satpathi', 'Affiliation': 'Ispat General Hospital, Rourkela, India.'}, {'ForeName': 'Prativa Kumari', 'Initials': 'PK', 'LastName': 'Behera', 'Affiliation': 'Ispat General Hospital, Rourkela, India.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Tripura', 'Affiliation': 'Agartala Medical College, Tripura, India.'}, {'ForeName': 'Subrata', 'Initials': 'S', 'LastName': 'Baidya', 'Affiliation': 'Agartala Medical College, Tripura, India.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Onyamboko', 'Affiliation': 'Kinshasa Mahidol Oxford Research Unit (KIMORU), Kinshasa, Democratic Republic of the Congo; Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Nguyen Hoang', 'Initials': 'NH', 'LastName': 'Chau', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Yok', 'Initials': 'Y', 'LastName': 'Sovann', 'Affiliation': 'Pailin Provincial Health Department, Pailin, Cambodia.'}, {'ForeName': 'Seila', 'Initials': 'S', 'LastName': 'Suon', 'Affiliation': 'National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sokunthea', 'Initials': 'S', 'LastName': 'Sreng', 'Affiliation': 'National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sivanna', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Sampov Meas Referral Hospital, Pursat, Cambodia.'}, {'ForeName': 'Savuth', 'Initials': 'S', 'LastName': 'Oun', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Sovannary', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Chanaki', 'Initials': 'C', 'LastName': 'Amaratunga', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Kitipumi', 'Initials': 'K', 'LastName': 'Chutasmit', 'Affiliation': 'Phu Sing hospital, Phu Sing, Sisaket, Thailand.'}, {'ForeName': 'Chalermpon', 'Initials': 'C', 'LastName': 'Saelow', 'Affiliation': 'Phu Sing hospital, Phu Sing, Sisaket, Thailand.'}, {'ForeName': 'Ratchadaporn', 'Initials': 'R', 'LastName': 'Runcharern', 'Affiliation': 'Khun Han Hospital, Khun Han, Sisaket, Thailand.'}, {'ForeName': 'Weerayuth', 'Initials': 'W', 'LastName': 'Kaewmok', 'Affiliation': 'Khun Han Hospital, Khun Han, Sisaket, Thailand.'}, {'ForeName': 'Nhu Thi', 'Initials': 'NT', 'LastName': 'Hoa', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ngo Viet', 'Initials': 'NV', 'LastName': 'Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Borimas', 'Initials': 'B', 'LastName': 'Hanboonkunupakarn', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Callery', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Akshaya Kumar', 'Initials': 'AK', 'LastName': 'Mohanty', 'Affiliation': 'Infectious Disease Biology Unit, IGH, Rourkela Research Unit of ILS, Bhubeneswar, DBT, Rourkela, India.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Heaton', 'Affiliation': 'Myanmar-Oxford Clinical Research Unit, Yangon, Myanmar.'}, {'ForeName': 'Myo', 'Initials': 'M', 'LastName': 'Thant', 'Affiliation': 'Defence Services Medical Research Centre, Yangon, Myanmar.'}, {'ForeName': 'Kripasindhu', 'Initials': 'K', 'LastName': 'Gantait', 'Affiliation': 'Midnapore Medical College, Midnapur, India.'}, {'ForeName': 'Tarapada', 'Initials': 'T', 'LastName': 'Ghosh', 'Affiliation': 'Midnapore Medical College, Midnapur, India.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Amato', 'Affiliation': 'Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK; Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Pearson', 'Affiliation': 'Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK; Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Jacob', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Sónia', 'Initials': 'S', 'LastName': 'Gonçalves', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Waithira', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Woodrow', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Grobusch', 'Affiliation': 'Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'van Vugt', 'Affiliation': 'Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rick M', 'Initials': 'RM', 'LastName': 'Fairhurst', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA; AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Phaik Yeong', 'Initials': 'PY', 'LastName': 'Cheah', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Peto', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'von Seidlein', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Dhorda', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; WorldWide Antimalarial Resistance Network - Asia Regional Centre, Bangkok, Thailand.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Maude', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; The Open University, Milton Keynes, UK; Harvard T H Chan School of Public Health, Harvard University, Boston, MA USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Winterberg', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Thuy-Nhien', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dominic P', 'Initials': 'DP', 'LastName': 'Kwiatkowski', 'Affiliation': 'Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK; Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Imwong', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Podjanee', 'Initials': 'P', 'LastName': 'Jittamala', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Khin', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Research, Pyin Oo Lwin, Myanmar.'}, {'ForeName': 'Tin Maung', 'Initials': 'TM', 'LastName': 'Hlaing', 'Affiliation': 'Defence Services Medical Research Centre, Yangon, Myanmar.'}, {'ForeName': 'Kesinee', 'Initials': 'K', 'LastName': 'Chotivanich', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rekol', 'Initials': 'R', 'LastName': 'Huy', 'Affiliation': 'National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Fanello', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Kinshasa Mahidol Oxford Research Unit (KIMORU), Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ashley', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU), Vientiane, Laos.'}, {'ForeName': 'Mayfong', 'Initials': 'M', 'LastName': 'Mayxay', 'Affiliation': 'Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU), Vientiane, Laos; Institute of Research and Education Development (IRED), University of Health Sciences, Ministry of Health, Vientiane, Laos.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Newton', 'Affiliation': 'Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU), Vientiane, Laos.'}, {'ForeName': 'Tran Tinh', 'Initials': 'TT', 'LastName': 'Hien', 'Affiliation': 'Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Valecha', 'Affiliation': 'National Institute of Malaria Research, Indian Council of Medical Research, New Delhi, India.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Myanmar-Oxford Clinical Research Unit, Yangon, Myanmar.'}, {'ForeName': 'Sasithon', 'Initials': 'S', 'LastName': 'Pukrittayakamee', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; The Royal Society of Thailand, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'Malaria Research Group and Dev Care Foundation, Dhaka, Bangladesh.'}, {'ForeName': 'Olivo', 'Initials': 'O', 'LastName': 'Miotto', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK; Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Arjen M', 'Initials': 'AM', 'LastName': 'Dondorp', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK. Electronic address: arjen@tropmedres.ac.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30552-3']
14,32162450,The effect of mindfulness-based stress reduction on maternal anxiety and self-efficacy: A randomized controlled trial.,"OBJECTIVE


The aim of the study was to assess the effect of mindfulness-based stress reduction (MBSR) on anxiety and self-efficacy in coping with childbirth.
MATERIAL AND METHODS


This randomized controlled trial was conducted on 70 pregnant women in Abyek city of Qazvin province in Iran. The convenient sampling method was recruited. Samples were assigned to control and intervention groups using random blocks. In addition to routine care, individuals in the intervention group received 6 MBSR training sessions. The data gathering questionnaire in this study included mindfulness, Pregnancy-Related Anxiety Questionnaire, and self-efficacy in coping with childbirth questionnaire.
RESULTS


There was no statistically significant difference between the demographic characteristics in the control and intervention groups. The results of the analysis of variance (ANOVA) with repeated measures indicated the effect of time on the change in the total score of anxiety in the intervention group (p = .001). There was a significant difference between the two groups (p = .001). Also, the results of ANOVA with repeated measures showed that time had no impact on the score of self-efficacy in delivery coping (p = 0/1) and that there was no significant difference between the two groups in this respect (p = .6).
CONCLUSION


The result of this study showed that mindfulness reduces anxiety of pregnant mothers, and it is suggested that mindfulness programs be educated for healthcare providers and pregnant mothers to reduce maternal anxiety and improve pregnancy outcomes and delivery.",2020,There was no statistically significant difference between the demographic characteristics in the control and intervention groups.,"['70 pregnant women in Abyek city of Qazvin province in Iran', 'pregnant mothers']","['MBSR training sessions', 'mindfulness-based stress reduction', 'mindfulness-based stress reduction (MBSR']","['maternal anxiety and self-efficacy', 'score of self-efficacy in delivery coping', 'maternal anxiety', 'demographic characteristics', 'anxiety and self-efficacy', 'total score of anxiety']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",70.0,0.0521586,There was no statistically significant difference between the demographic characteristics in the control and intervention groups.,"[{'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Zarenejad', 'Affiliation': 'Student Research Committee, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Yazdkhasti', 'Affiliation': 'Social Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Rahimzadeh', 'Affiliation': 'Social Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mehdizadeh Tourzani', 'Affiliation': 'Reproductive health Department, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Esmaelzadeh-Saeieh', 'Affiliation': 'Social Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}]",Brain and behavior,['10.1002/brb3.1561']
15,32268257,Effects of auditovisual feedback on eye-hand coordination in children with cerebral palsy.,"BACKGROUND


Children with spastic hemiplegic cerebral palsy have deficits in eye-hand coordination. This limits manual actions performed with the affected hand, especially fine motor skills such as grasping and manipulation. Visual-motor integration, grasping skills, and visual perception are collectively involved in eye-hand coordination.
AIMS


We investigated the effects of augmented biofeedback training on eye-hand coordination in children with spastic hemiplegic cerebral palsy.
METHODS AND PROCEDURES


Forty-five spastic hemiplegic cerebral palsy children (5-8 years old) were included. Children were assigned randomly into three equal groups. One group received traditional physical therapy to facilitate visual-motor integration and grasping skills for 3 months. The second group received augmented biofeedback training. The third group received a combination of augmented biofeedback training and traditional physical therapy. Children were evaluated with the Peabody Developmental Motor Scale (2nd edition) (PDMS-2). Treatment sessions were conducted for 60 min, three times a week, for 3 consecutive months.
OUTCOMES AND RESULTS


Children that received augmented biofeedback training alongside traditional physical therapy had significantly improved scores in the Visual-Motor Integration and grasping subtests compared to children that received only one intervention.
CONCLUSIONS AND IMPLICATIONS


Augmented biofeedback training alongside physical therapy improved eye-hand coordination in children with spastic hemiplegic cerebral palsy.",2020,"OUTCOMES AND RESULTS


Children that received augmented biofeedback training alongside traditional physical therapy had significantly improved scores in the Visual-Motor Integration and grasping subtests compared to children that received only one intervention.
","['Children with spastic hemiplegic cerebral palsy', 'children with cerebral palsy', 'Forty-five spastic hemiplegic cerebral palsy children (5-8 years old', 'children with spastic hemiplegic cerebral palsy']","['traditional physical therapy', 'augmented biofeedback training', 'auditovisual feedback', 'combination of augmented biofeedback training and traditional physical therapy', 'biofeedback training alongside physical therapy', 'biofeedback training alongside traditional physical therapy']","['Visual-Motor Integration and grasping subtests', 'Visual-motor integration, grasping skills, and visual perception', 'Peabody Developmental Motor Scale (2nd edition) (PDMS-2']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]",,0.0112495,"OUTCOMES AND RESULTS


Children that received augmented biofeedback training alongside traditional physical therapy had significantly improved scores in the Visual-Motor Integration and grasping subtests compared to children that received only one intervention.
","[{'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Alwhaibi', 'Affiliation': 'Rehabilitation Sciences Department, College of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, P.O. Box 25058, Riyadh, 11466, Saudi Arabia. Electronic address: rmalwhaibi@pnu.edu.sa.'}, {'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Alsakhawi', 'Affiliation': 'Rehabilitation Sciences Department, College of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia; Pediartic Department, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Safaa', 'Initials': 'S', 'LastName': 'ElKholi', 'Affiliation': 'Rehabilitation Sciences Department, College of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia; Pediartic Department, Faculty of Physical Therapy, Cairo University, Egypt.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103635']
16,31917054,Comparison of Early-Stage and Late-Stage Periarticular Injection for Pain Relief After Total Hip Arthroplasty: A Double-Blind Randomized Controlled Trial.,"BACKGROUND


No randomized controlled trial has investigated a more optimal timing of periarticular injection for pain relief after total hip arthroplasty.
METHODS


The study included 140 patients, and these patients were randomly allocated to the early-stage (periarticular injection was performed just before arthrotomy, and placebo was injected after implantation) or late-stage (placebo was injected just before arthrotomy, and periarticular injection was performed after implantation) injection groups. Other perioperative interventions were similar in all participants. The prespecified primary outcome was postoperative pain score at the recovery room.
RESULTS


The visual analog scale score at the recovery room of the early-stage injection group was significantly lower than that of the late-stage injection group (30 ± 28 vs 46 ± 30 mm; 95% CI, -25 to -5 mm; P = .0022), and this difference reaches a minimal clinically important difference level of 10 mm. No differences were observed with regard to complication rate.
CONCLUSION


Early-stage periarticular injection during total hip arthroplasty provided better postoperative pain relief than late-stage periarticular injection without elevating complication rate.
LEVEL OF EVIDENCE


Level I, randomized controlled trial.",2020,"No differences were observed with regard to complication rate.
","['After Total Hip Arthroplasty', '140 patients']","['periarticular injection', 'early-stage (periarticular injection was performed just before arthrotomy, and placebo was injected after implantation) or late-stage (placebo']","['Pain Relief', 'pain relief', 'postoperative pain relief', 'complication rate', 'postoperative pain score at the recovery room', 'visual analog scale score']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0394854', 'cui_str': 'Periarticular injection (procedure)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0185160', 'cui_str': 'Arthrotomy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",140.0,0.677804,"No differences were observed with regard to complication rate.
","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kurosaka', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Ibaraki, Japan.'}, {'ForeName': 'Sachiyuki', 'Initials': 'S', 'LastName': 'Tsukada', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Ibaraki, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Ibaraki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Ibaraki, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Yoshiya', 'Affiliation': 'Department of Orthopaedic Surgery, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Hirasawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Ibaraki, Japan.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.12.020']
17,32382078,Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10 ng/mL.,"BACKGROUND


The ExoDx Prostate(IntelliScore) (EPI) test is a non-invasive risk assessment tool for detection of high-grade prostate cancer (HGPC) that informs whether to proceed with prostate biopsy. We sought to assess the impact of EPI on the decision to biopsy in a real-world clinical setting.
METHODS


We conducted a prospective, randomized, blinded, two-armed clinical utility study that enrolled 1094 patients with 72 urologists from 24 urology practices. Patients were considered for prostate biopsy at enrollment based on standard clinical criteria. All patients had an EPI test; however, patients were randomized into EPI vs. control arms where only the EPI arm received results for their biopsy decision.
RESULTS


In the EPI arm (N = 458), 93 patients received negative EPI scores of which 63% were recommended to defer biopsy by the urologist and 74% ultimately deferred. In contrast, 87% of patients with positive EPI scores were recommended to undergo biopsy with a 72% compliance rate to the urologist's recommendation. This led to detection of 30% more HGPC compared to the control arm, and we estimate that 49% fewer HGPC were missed due to deferrals compared to standard of care (SOC). Overall, 68% of urologists reported that the EPI test influenced their biopsy decision. The primary reason not to comply with EPI results was rising PSA.
CONCLUSION


To our knowledge this is the first report on a PC biomarker utility study with a blinded control arm. The study demonstrates that the EPI test influences the overall decision to defer or proceed with a biopsy and improves patient stratification.",2020,(EPI) test is a non-invasive risk assessment tool for detection of high-grade prostate cancer (HGPC) that informs whether to proceed with prostate biopsy.,"['men presenting for initial Biopsy with a PSA 2-10\u2009ng/mL', 'enrolled 1094 patients with 72 urologists from 24 urology practices']","['exosome based ExoDx Prostate(IntelliScore', 'EPI']",['negative EPI scores'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0260314', 'cui_str': 'Urologist'}, {'cui': 'C0042077', 'cui_str': 'Urology'}]","[{'cui': 'C2350332', 'cui_str': 'Exosomes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1094.0,0.103729,(EPI) test is a non-invasive risk assessment tool for detection of high-grade prostate cancer (HGPC) that informs whether to proceed with prostate biopsy.,"[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Tutrone', 'Affiliation': 'Chesapeake Urology Associates, Baltimore, MD, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Donovan', 'Affiliation': 'Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Phillipp', 'Initials': 'P', 'LastName': 'Torkler', 'Affiliation': 'Exosome Diagnostics GmbH, a Bio-Techne brand, Martinsried, Germany.'}, {'ForeName': 'Vasisht', 'Initials': 'V', 'LastName': 'Tadigotla', 'Affiliation': 'Exosome Diagnostics Inc, a Bio-Techne brand, Waltham, MA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'McLain', 'Affiliation': 'Exosome Diagnostics Inc, a Bio-Techne brand, Waltham, MA, USA.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Noerholm', 'Affiliation': 'Exosome Diagnostics GmbH, a Bio-Techne brand, Martinsried, Germany.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Skog', 'Affiliation': 'Exosome Diagnostics Inc, a Bio-Techne brand, Waltham, MA, USA. Johan.skog@bio-techne.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKiernan', 'Affiliation': 'Department of Urology, Columbia University Medical Center, New York, NY, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0237-z']
18,32398433,"High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial.","BACKGROUND


Over 6 million esophagogastroduodenoscopy (EGD) procedures are performed in the United States each year. Patients having anesthesia for advanced EGD procedures, such as interventional procedures, are at high risk for hypoxemia.
METHODS


Our primary study aim was to evaluate whether high-flow nasal cannula (HFNC) oxygen reduces the incidence of hypoxemia during anesthesia for advanced EGD. Secondarily, we studied whether HFNC oxygen reduces hypercarbia or hypotension. After obtaining written informed consent, adults having anesthesia for advanced EGD, expected to last longer than 15 minutes, were randomly assigned to receive HFNC oxygen or standard nasal cannula (SNC) oxygen. The primary outcome was occurrence of one or more hypoxemia events during anesthesia, defined by arterial oxygen saturation <92% for at least 15 consecutive seconds. Secondary outcomes were occurrence of one or more hypercarbia or hypotension events. A hypercarbia event was defined by a transcutaneous CO2 measurement 20 mm Hg or more above baseline, and a hypotension event was defined by a mean arterial blood pressure measurement 25% or more below baseline.
RESULTS


Two hundred seventy-one adult patients were enrolled and randomized, and 262 patients completed study procedures. Eight randomized patients did not complete study procedures due to changes in their anesthesia or endoscopy plan. One patient was excluded from analysis because their procedure was aborted after 1 minute. Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03). There was no difference in the incidence of hypercarbia or hypotension between the groups. The HR for hypercarbia with HFNC oxygen was 1.29 (95% CI, 0.89-1.88; P = .17), and the HR for hypotension was 1.25 (95% CI, 0.86-1.82; P = .25).
CONCLUSIONS


HFNC oxygen reduces the incidence of hypoxemia during anesthesia for advanced EGD and may offer an opportunity to enhance patient safety during these procedures.",2021,"Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03).","['adults having anesthesia for advanced EGD, expected to last longer than 15 minutes', 'Two hundred seventy-one adult patients were enrolled and randomized, and 262 patients completed study procedures', 'Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy']","['HFNC oxygen or standard nasal cannula (SNC) oxygen', 'High-Flow Nasal Cannula Oxygen', 'high-flow nasal cannula (HFNC) oxygen', 'HFNC oxygen']","['hypotension event', 'occurrence of one or more hypercarbia or hypotension events', 'occurrence of one or more hypoxemia events during anesthesia, defined by arterial oxygen saturation', 'incidence of hypoxemia', 'incidence of hypercarbia or hypotension', 'hypercarbia or hypotension', 'HR for hypotension']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",271.0,0.426427,"Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Mazzeffi', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Kendra M', 'Initials': 'KM', 'LastName': 'Petrick', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Greenwald', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Darwin', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Goldberg', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bigeleisen', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Chow', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Boyd', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Kaplowitz', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rock', 'Affiliation': 'From the Department of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004837']
19,32324902,Placebo effects in allergen immunotherapy-An EAACI Task Force Position Paper.,"The placebo (Latin ""I will please"") effect commonly occurs in clinical trials. The psychological and physiological factors associated with patients' expectations about a treatment's positive and negative effects have yet to be well characterized, although a functional prefrontal cortex and intense bidirectional communication between the central nervous system and the immune system appear to be prerequisites for a placebo effect. The use of placebo raises certain ethical issues, especially if patients in a placebo group are denied an effective treatment for a long period of time. The placebo effect appears to be relatively large (up to 77%, relative to pretreatment scores) in controlled clinical trials of allergen immunotherapy (AIT), such as the pivotal, double-blind, placebo-controlled (DBPC) randomized clinical trials currently required by regulatory authorities worldwide. The European Academy of Allergy and Clinical Immunology (EAACI) therefore initiated a Task Force, in order to better understand the placebo effect in AIT and its specific role in comorbidities, blinding issues, adherence, measurement time points, variability and the natural course of the disease. In this Position Paper, the EAACI Task Force highlights several important topics regarding the placebo effect in AIT such as a) regulatory aspects, b) neuroimmunological and psychological mechanisms, c) placebo effect sizes in AIT trials, d) methodological limitations in AIT trial design and e) potential solutions in future AIT trial design. In conclusion, this Position Paper aims to examine the methodological problem of placebo in AIT from different aspects and also to highlight unmet needs and possible solutions for future trials.",2021,"The placebo effect appears to be relatively large (up to 77%, relative to pre-treatment scores) in controlled clinical trials of allergen immunotherapy (AIT), such as the pivotal, double-blind, placebo-controlled (DBPC) randomized clinical trials currently required by regulatory authorities worldwide.",[],"['Placebo', 'placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.32427,"The placebo effect appears to be relatively large (up to 77%, relative to pre-treatment scores) in controlled clinical trials of allergen immunotherapy (AIT), such as the pivotal, double-blind, placebo-controlled (DBPC) randomized clinical trials currently required by regulatory authorities worldwide.","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Pfaar', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Agache', 'Affiliation': 'Transylvania University, Brasov, Romania.'}, {'ForeName': 'Karl-Christian', 'Initials': 'KC', 'LastName': 'Bergmann', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bindslev-Jensen', 'Affiliation': 'Department of Dermatology and Allergy Centre, Odense University Hospital, Odense Research Center for Anaphylaxis (ORCA), Odense, Denmark.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bousquet', 'Affiliation': 'MACVIA-France, Montpellier, France.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Creticos', 'Affiliation': 'Division of Allergy & Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Devillier', 'Affiliation': 'Department of Airway Diseases, Exhalomics, Hôpital Foch, Université Paris-Saclay, Suresnes, France.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hellings', 'Affiliation': 'Department of Otorhinolaryngology, University Hospitals of Leuven, Leuven, Belgium.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': 'Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Kleine-Tebbe', 'Affiliation': 'Allergy & Asthma Center Westend, Outpatient Clinic and Clinical Research Center, Berlin, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Klimek', 'Affiliation': 'Center for Rhinology and Allergology, Wiesbaden, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Jacobsen', 'Affiliation': 'ALC, Allergy Learning and Consulting, Copenhagen, Denmark.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Jutel', 'Affiliation': 'Department of Clinical Immunology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Muraro', 'Affiliation': 'Food Allergy Referral Centre, Padua University Hospital Padua, Padua, Italy.'}, {'ForeName': 'Nikolaos G', 'Initials': 'NG', 'LastName': 'Papadopoulos', 'Affiliation': 'Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester, UK.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Marburg, Germany.'}, {'ForeName': 'Glenis K', 'Initials': 'GK', 'LastName': 'Scadding', 'Affiliation': 'RNTNE Hospital, University College London Hospitals, London, UK.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Clinic Essen, Essen, Germany.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Shamji', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Sturm', 'Affiliation': 'Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Ree', 'Affiliation': 'Departments of Experimental Immunology and of Otorhinolaryngology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vidal', 'Affiliation': 'Department of Allergy and Faculty of Medicine, University of Santiago de Compostela, Santiago, Spain.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Vieths', 'Affiliation': 'Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wedi', 'Affiliation': 'Department of Dermatology and Allergy, Hannover Medical School, Comprehensive Allergy Center, Hannover, Germany.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Gerth van Wijk', 'Affiliation': 'Section of Allergology, Department of Internal Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Frew', 'Affiliation': 'Department of Respiratory Medicine, Royal Sussex County Hospital, University of Sussex and University of Brighton, Brighton, UK.'}]",Allergy,['10.1111/all.14331']
20,32320465,Phase 1 Safety and Immunogenicity Study of a Respiratory Syncytial Virus Vaccine With an Adenovirus 26 Vector Encoding Prefusion F (Ad26.RSV.preF) in Adults Aged ≥60 Years.,"BACKGROUND


Despite the high disease burden of respiratory syncytial virus (RSV) in older adults, there is no approved vaccine. We evaluated the experimental RSV vaccine, Ad26.RSV.preF, a replication-incompetent adenovirus 26 vector encoding the F protein stabilized in prefusion conformation.
METHODS


This phase 1 clinical trial was performed in healthy adults aged ≥60 years. Seventy-two participants received 1 or 2 intramuscular injections of low-dose (LD; 5 × 1010 vector particles) or high-dose (HD; 1 × 1011 vector particles) Ad26.RSV.preF vaccine or placebo, with approximately 12 months between doses and 2-year follow-up for safety and immunogenicity outcomes.
RESULTS


Solicited adverse events were reported by 44% of vaccine recipients and were transient and mild or moderate in intensity. No serious adverse events were related to vaccination. After the first vaccination, geometric mean titers for RSV-A2 neutralization increased from baseline (432 for LD and 512 for HD vaccine) to day 29 (1031 for LD and 1617 for HD). Pre-F-specific antibody geometric mean titers and median frequencies of F-specific interferon γ-secreting T cells also increased substantially from baseline. These immune responses were still maintained above baseline levels 2 years after immunization and could be boosted with a second immunization at 1 year.
CONCLUSIONS


Ad26.RSV.preF (LD and HD) had an acceptable safety profile and elicited sustained humoral and cellular immune responses after a single immunization in older adults.",2020,"These immune responses were still maintained above baseline levels 2 years post-immunization and could be boosted with a second immunization at 1 year.
","['healthy adults aged ≥60 years', 'older adults', 'adults 60 years and older']","['Ad26.RSV.preF (LD and HD', 'Ad26.RSV.preF 5x1010 vp (LD) or 1x1011 vp (HD) or placebo', 'Respiratory Syncytial Virus Vaccine with an Adenovirus 26 Vector Encoding Pre-Fusion F (Ad26.RSV.preF']",['geometric mean titers (GMTs) for RSV-A2 neutralization'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}]",,0.259988,"These immune responses were still maintained above baseline levels 2 years post-immunization and could be boosted with a second immunization at 1 year.
","[{'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Arangassery Rosemary', 'Initials': 'AR', 'LastName': 'Bastian', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Robert Allen', 'Initials': 'RA', 'LastName': 'Feldman', 'Affiliation': 'QPS Miami Research Associates, Miami, Florida, USA.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Omoruyi', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'de Paepe', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'van Zeeburg', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Godeaux', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Johannes P M', 'Initials': 'JPM', 'LastName': 'Langedijk', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Sadoff', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Callendret', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa193']
21,32308987,"Does the combination of photobiomodulation therapy (PBMT) and static magnetic fields (sMF) potentiate the effects of aerobic endurance training and decrease the loss of performance during detraining? A randomised, triple-blinded, placebo-controlled trial.","Background


Photobiomodulation (PBMT) is a therapy that uses non-ionising forms of light, including low-level lasers and light-emitting diodes (LEDs) that may be capable of modulating cellular activity. Some biological processes may also interact with static magnetic fields (sMF), leading to modulatory effects on cells. Previous studies have verified that the combination of PBMT and sMF (PBMT/sMF) enhances the performance of individuals during aerobic training programs. The detraining period can cause losses in aerobic capacity. However, there is no evidence of the existence of any recourse that can decrease the effects of detraining. We aimed to investigate the effects of PBMT/sMF application during training and detraining to assess the effectiveness of this treatment in reducing the effects of detraining.
Methods


Sixty male volunteers were randomly allocated into four groups- participants who received PBMT/sMF during the training and detraining (PBMT/sMF + PBMT/sMF); participants who received PBMT/sMF during the training and a placebo in the detraining (PBMT/sMF + Placebo); participants who received a placebo during the training and PBMT/sMF in the detraining (Placebo+PBMT/sMF); and participants who received a placebo during the training and detraining (Placebo+Placebo). Participants performed treadmill training over 12 weeks (3 sessions/week), followed by 4 weeks of detraining. PBMT/sMF was applied using a 12-diode emitter (four 905 nm super-pulsed lasers, four 875 nm light-emitting diodes (LEDs), four 640 nm LEDs, and a 35 mT magnetic field) at 17 sites on each lower limb (dosage: 30 J per site). The data were analysed by two-way repeated measures analysis of variance (ANOVA, time vs experimental group) with post-hoc Bonferroni correction.
Results


The percentage of change in time until exhaustion and in maximum oxygen consumption was higher in the PBMT/sMF + PBMT/sMF group than in the Placebo+Placebo group at all time-points ( p  < 0.05). Moreover, the percentage of decrease in body fat at the 16th week was higher in the PBMT/sMF + PBMT/sMF group than in the Placebo+Placebo group ( p  < 0.05).
Conclusions


PBMT/sMF can potentiate the effects of aerobic endurance training and decrease performance loss after a 4-week detraining period. Thus, it may prove to be an important tool for both amateur and high-performance athletes as well as people undergoing rehabilitation.
Trial registration


NCT03879226. Trial registered on 18 March 2019.",2020,The percentage of change in time until exhaustion and in maximum oxygen consumption was higher in the PBMT/sMF + PBMT/sMF group than in the Placebo+Placebo group at all time-points ( p  < 0.05).,['Methods\n\n\nSixty male volunteers'],"['photobiomodulation therapy (PBMT) and static magnetic fields (sMF', 'PBMT/sMF', 'aerobic endurance training', 'placebo', '\n\n\nPhotobiomodulation (PBMT', 'placebo during the training and PBMT/sMF in the detraining (Placebo+PBMT/sMF', 'Placebo+Placebo', 'placebo during the training and detraining (Placebo+Placebo', 'PBMT and sMF (PBMT/sMF', 'PBMT/sMF during the training and a placebo in the detraining (PBMT/sMF\u2009+\u2009Placebo', 'PBMT/sMF during the training and detraining (PBMT/sMF\u2009+\u2009PBMT/sMF', 'treadmill training']","['percentage of change in time until exhaustion and in maximum oxygen consumption', 'performance loss', 'body fat']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",60.0,0.167011,The percentage of change in time until exhaustion and in maximum oxygen consumption was higher in the PBMT/sMF + PBMT/sMF group than in the Placebo+Placebo group at all time-points ( p  < 0.05).,"[{'ForeName': 'Paulo Roberto Vicente', 'Initials': 'PRV', 'LastName': 'de Paiva', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Heliodora Leão', 'Initials': 'HL', 'LastName': 'Casalechi', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Shaiane Silva', 'Initials': 'SS', 'LastName': 'Tomazoni', 'Affiliation': '3Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Caroline Dos Santos Monteiro', 'Initials': 'CDSM', 'LastName': 'Machado', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Neide Firmo', 'Initials': 'NF', 'LastName': 'Ribeiro', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Amanda Lima', 'Initials': 'AL', 'LastName': 'Pereira', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Marcelo Ferreira Duarte', 'Initials': 'MFD', 'LastName': 'de Oliveira', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Marjury Nunes da Silva', 'Initials': 'MNDS', 'LastName': 'Alves', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Maiara Conceição', 'Initials': 'MC', 'LastName': 'Dos Santos', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Inti Ernesto Torrico', 'Initials': 'IET', 'LastName': 'Takara', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Eduardo Foschini', 'Initials': 'EF', 'LastName': 'Miranda', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Paulo de Tarso Camillo', 'Initials': 'PTC', 'LastName': 'de Carvalho', 'Affiliation': '2Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, São Paulo, SP Brazil.'}, {'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': '1Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00171-2']
22,32323014,Modified (Bai-Jiang style) vagus nerve-preserving versus conventional laparoscopic splenectomy and azygoportal disconnection: a randomized clinical trial.,"BACKGROUND


Digestive system complications are among the most important causes of postoperative poor quality of life after open and conventional laparoscopic splenectomy and azygoportal disconnection (CLSD). We firstly developed a modified vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection (MVLSD). In this study, we aimed to evaluate whether MVLSD is feasible and safe and to determine whether MVLSD can effectively eliminate postoperative digestive system complications, in comparison with CLSD.
METHOD


In this randomized controlled single-center study, 60 patients with cirrhosis were randomly assigned to undergo either CLSD (n = 30) or MVLSD (n = 30) between April and December 2018. The primary outcome was delayed gastric emptying (DGE). Endoscopic physicians were blinded to group assignments.
RESULTS


One patient who received MVLSD withdrew from the study. There were no significant differences in intraoperative blood loss, incidence of blood transfusion, time to off-bed activity, time to first flatus, and postoperative hospital stay between the two groups. Compared with CLSD, operation time and incidences of DGE, diarrhea, epigastric fullness, and overall postoperative complications were all significantly reduced in the MVLSD group (all P < 0.05). Compared with CLSD, MVLSD was associated with significantly increased weight and albumin levels at 1, 6, and 12 months postoperatively versus preoperative values (all P < 0.05). The curative effect of resolving gastroesophageal variceal bleeding was similar between the groups.
CONCLUSION


MVLSD is not only a technically feasible and safe procedure, it is also succinct and convenient. Furthermore, MVLSD effectively reduces postoperative digestive system complications, contributing to improved quality of life.",2021,"There were no significant differences in intraoperative blood loss, incidence of blood transfusion, time to off-bed activity, time to first flatus, and postoperative hospital stay between the two groups.",['60 patients with cirrhosis'],"['MVLSD', 'CLSD', 'modified vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection (MVLSD', 'Modified (Bai-Jiang style) vagus nerve-preserving versus conventional laparoscopic splenectomy and azygoportal disconnection', 'CLSD, MVLSD', 'conventional laparoscopic splenectomy and azygoportal disconnection (CLSD']","['weight and albumin levels', 'postoperative digestive system complications', 'quality of life', 'gastroesophageal variceal bleeding', 'intraoperative blood loss, incidence of blood transfusion, time to off-bed activity, time to first flatus, and postoperative hospital stay', 'delayed gastric emptying (DGE', 'operation time and incidences of DGE, diarrhea, epigastric fullness, and overall postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042276', 'cui_str': 'Vagus nerve structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0232570', 'cui_str': 'Epigastric fullness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",60.0,0.115353,"There were no significant differences in intraoperative blood loss, incidence of blood transfusion, time to off-bed activity, time to first flatus, and postoperative hospital stay between the two groups.","[{'ForeName': 'Dou-Sheng', 'Initials': 'DS', 'LastName': 'Bai', 'Affiliation': 'Department of Hepatobiliary Surgery, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, 225000, China.'}, {'ForeName': 'Sheng-Jie', 'Initials': 'SJ', 'LastName': 'Jin', 'Affiliation': 'Department of Hepatobiliary Surgery, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, 225000, China.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Qian', 'Affiliation': 'Department of Hepatobiliary Surgery, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, 225000, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, 225000, China.'}, {'ForeName': 'Bao-Huan', 'Initials': 'BH', 'LastName': 'Zhou', 'Affiliation': 'Department of Hepatobiliary Surgery, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, 225000, China.'}, {'ForeName': 'Guo-Qing', 'Initials': 'GQ', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatobiliary Surgery, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, 225000, China. jgqing2003@hotmail.com.'}]",Surgical endoscopy,['10.1007/s00464-020-07573-w']
23,32320797,Tiotropium Respimat Efficacy and Safety in Asthma: Relationship to Age.,"BACKGROUND


Data are limited on the differential response to long-acting bronchodilators in older versus younger adults with asthma.
OBJECTIVE


To determine whether the response to tiotropium Respimat differed in older versus younger patients with asthma.
METHODS


Post hoc analyses of 4 randomized, double-blind, placebo-controlled studies in adults with asthma were carried out. Two studies compared tiotropium Respimat 5 μg once daily with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting β 2 -agonist (ie, severe asthma). The other 2 evaluated tiotropium Respimat 2.5 or 5 μg once daily, salmeterol 50 μg twice daily, or placebo, all added to medium-dose ICS (moderate asthma). Data were analyzed in 2 pools: (1) severe and (2) moderate asthma. Efficacy end points: trough and peak FEV 1 ; trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage, all at week 24. One set of analyses was performed with age as a continuous covariate; the second was conducted in categories less than 40, 40 to 60, and more than 60 years, with treatment-by-age subgroup interaction P values obtained. Safety was analyzed in age categories.
RESULTS


Across the age categories, treatment-by-age subgroup interaction P values for trough FEV 1  were .13 and .77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the 2 continuum analyses. The other end points (including safety) were also not impacted by age.
CONCLUSIONS


Once-daily tiotropium Respimat add-on to ICS or ICS/long-acting β 2 -agonist therapy was effective and well tolerated in patients with asthma independent of age.",2020,"Across the age categories, treatment-by-age subgroup interaction p-values for trough FEV 1  were 0.13 and 0.77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the two continuum analyses.","['patients with asthma independent of age', 'older versus younger patients with asthma', 'asthma', 'older versus younger adults with asthma', 'adults with asthma']","['tiotropium Respimat 5μg once-daily (QD) with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting β 2 -agonist (LABA', 'placebo', 'Tiotropium', 'tiotropium 2.5 or 5μg QD, salmeterol 50μg twice-daily, or placebo', 'tiotropium Respimat', 'LABA therapy']","['Efficacy endpoints: trough and peak forced expiratory volume in 1 second (FEV 1 ); trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage', 'effective and well tolerated', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1.0,0.455248,"Across the age categories, treatment-by-age subgroup interaction p-values for trough FEV 1  were 0.13 and 0.77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the two continuum analyses.","[{'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Doherty', 'Affiliation': 'University of Kentucky, Lexington, Ky. Electronic address: dedohe0@email.uky.edu.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Moroni-Zentgraf', 'Affiliation': 'Boehringer Ingelheim Pty. Ltd., Sydney, NSW, Australia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Zaremba-Pechmann', 'Affiliation': 'Boehringer Ingelheim, Biberach an der Riss, Germany.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'University of Groningen, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, The Netherlands.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.04.013']
24,31537420,Surgical conditions with rocuronium versus suxamethonium in cesarean section: a randomized trial.,"BACKGROUND


Onset times and conditions for intubation after rocuronium versus suxamethonium at cesarean section have been evaluated, but no study thus far has examined the influence of these neuromuscular blocking drugs on the surgical conditions or their effect on the duration of surgery and the ease of fetal delivery. We aimed to compare the surgical conditions for delivery in parturients who received deep neuromuscular block with rocuronium with those who had induction with suxamethonium.
METHODS


Ninety patients undergoing cesarean section under general anesthesia were randomized to receive either rocuronium 0.6 mg/kg or suxamethonium 1 mg/kg for tracheal intubation and delivery. Times to delivery and the quality of surgical conditions, using a five-point Surgical Rating Scale for Delivery (SRSD) ranging from 1 (poor) to 5 (excellent), were evaluated.
RESULTS


The median SRSD (range) was found to be significantly better in the rocuronium group [4 (3-5) points vs 3 (2-4) points with suxamethonium (P <0.001)]. Whereas the mean (SD) induction-to-intubation interval was longer with rocuronium [106 (34) s vs 68 (32) s with suxamethonium (95% CI of the difference 24 to 52 s, P <0.001)], the incision-to-delivery interval was shorter in the rocuronium group [147 (68) s vs 196 (51) s with suxamethonium (95% CI of the difference -75 to -24 s, P <0.001)]. The mean induction-to-delivery intervals were similar [268 (73) s vs 276 (63) s, respectively].
CONCLUSIONS


Whereas the induction-to-delivery intervals were comparable, we found rocuronium superior to suxamethonium in allowing better surgical conditions for fetal delivery, which enabled an easier delivery and a shorter incision-to-delivery interval.",2020,The median SRSD (range) was found to be significantly better in the rocuronium group,"['cesarean section', 'Ninety patients undergoing cesarean section under general anesthesia', 'parturients who received deep neuromuscular block with rocuronium with those who had induction with suxamethonium']","['rocuronium', 'suxamethonium', 'rocuronium 0.6\u202fmg/kg or suxamethonium 1\u202fmg/kg for tracheal intubation and delivery']","['incision-to-delivery interval', 'median SRSD (range', 'mean (SD) induction-to-intubation interval', 'Times to delivery and the quality of surgical conditions, using a five-point Surgical Rating Scale for Delivery (SRSD', 'mean induction-to-delivery intervals']","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0222045'}]",90.0,0.220436,The median SRSD (range) was found to be significantly better in the rocuronium group,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bláha', 'Affiliation': 'Department of Anesthesiology, Resuscitation and Intensive Medicine, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nosková', 'Affiliation': 'Department of Anesthesiology, Resuscitation and Intensive Medicine, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hlinecká', 'Affiliation': 'Department of Gynecology and Obstetrics, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Krakovská', 'Affiliation': 'Neonatology, Department of Gynecology and Obstetrics, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Fundová', 'Affiliation': 'Department of Anesthesiology, Resuscitation and Intensive Medicine, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bartošová', 'Affiliation': 'Department of Anesthesiology, Resuscitation and Intensive Medicine, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Michálek', 'Affiliation': 'Department of Anesthesiology, Resuscitation and Intensive Medicine, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stříteský', 'Affiliation': 'Department of Anesthesiology, Resuscitation and Intensive Medicine, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic. Electronic address: martin.stritesky@vfn.cz.'}]",International journal of obstetric anesthesia,['10.1016/j.ijoa.2019.08.005']
25,22752690,Randomized phase II study of three doses of the integrin inhibitor cilengitide versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer.,"INTRODUCTION


This multicenter, open-label, phase II study was carried out to compare the efficacy and safety of cilengitide (EMD 121974), a selective inhibitor of the cell-surface integrins αVβ3 and αVβ5, with that of docetaxel in patients with advanced non-small-cell lung cancer (NSCLC).
METHODS


Patients (n = 140) with advanced NSCLC who had failed first-line chemotherapy were randomized to cilengitide 240, 400, or 600 mg/m(2) twice weekly, or docetaxel 75 mg/m(2) once every 3 weeks for eight cycles. Non-progressing patients could continue cilengitide for up to 1 year. The primary endpoint was progression-free survival (PFS). No statistical tests were performed since the study was exploratory in nature and the number of patients enrolled was relatively small.
RESULTS


Median PFS was 54, 63, 63, and 67 days for cilengitide 240, 400, and 600 mg/m(2), and docetaxel 75 mg/m(2), respectively. One-year survival rates were 13 %, 13 %, 29 %, and 27 %, respectively. The response rate (partial response only) with docetaxel was 15 %. No responses were reported in any cilengitide arm. The most frequent grade 3/4 treatment-related adverse events in the docetaxel group were leukopenia and neutropenia (experienced by 13 % of patients). Hematologic toxicity of this severity did not occur in cilengitide-treated patients.
CONCLUSION


With the highest dose of cilengitide (600 mg/m(2)), median PFS and 1-year survival were similar to those in patients treated with docetaxel 75 mg/m(2) and there were fewer grade 3/4 treatment-related adverse events.",2013,"One-year survival rates were 13 %, 13 %, 29 %, and 27 %, respectively.","['patients with advanced non-small-cell lung cancer', '140) with advanced NSCLC who had failed first-line chemotherapy', 'Patients (n\u2009', 'patients with advanced non-small-cell lung cancer (NSCLC']","['cilengitide', 'docetaxel', 'integrin inhibitor cilengitide versus docetaxel']","['median PFS and 1-year survival', 'efficacy and safety', 'response rate', 'survival rates', 'Hematologic toxicity', 'leukopenia and neutropenia', 'adverse events', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0971473', 'cui_str': 'Cilengitide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0218951,"One-year survival rates were 13 %, 13 %, 29 %, and 27 %, respectively.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Manegold', 'Affiliation': 'Medizinische Fakultät Mannheim der Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. Prof.Manegold@t-online.de'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': ''}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Cardenal', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schuette', 'Affiliation': ''}, {'ForeName': 'Penella J', 'Initials': 'PJ', 'LastName': 'Woll', 'Affiliation': ''}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Ulsperger', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kerber', 'Affiliation': ''}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Eckmayr', 'Affiliation': ''}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'von Pawel', 'Affiliation': ''}]",Investigational new drugs,['10.1007/s10637-012-9842-6']
26,32299284,Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs.,"Background Hospitals commonly provide a short-term supply of free P2Y 12  inhibitors at discharge after myocardial infarction, but it is unclear if these programs improve medication persistence and outcomes. The ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) trial randomized hospitals to usual care versus waived P2Y 12  inhibitor copayment costs for 1-year post-myocardial infarction. Whether the impact of this intervention differed between hospitals with and without pre-existing medication assistance programs is unknown. Methods and Results In this post hoc analysis of the ARTEMIS trial, we examined the associations of pre-study free medication programs and the randomized copayment voucher intervention with P2Y 12  inhibitor persistence (measured by pharmacy fills and patient report) and major adverse cardiovascular events using logistic regression models including a propensity score. Among 262 hospitals, 129 (49%) offered pre-study free medication assistance. One-year P2Y 12  inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively). The randomized copayment voucher intervention improved persistence, assessed by pharmacy fills, in both hospitals with (53.6% versus 44.0%, adjusted odds ratio 1.45, 95% CI, 1.20-1.75) and without (59.0% versus 48.3%, adjusted odds ratio 1.46, 95% CI, 1.25-1.70) free medication programs ( P interaction =0.71). Differences in patient-reported persistence were not significant after adjustment. Conclusions While hospitals commonly report the ability to provide free short-term P2Y 12  inhibitors, we did not find association of this with medication persistence or major adverse cardiovascular events among patients with insurance coverage for prescription medication enrolled in the ARTEMIS trial. An intervention that provided copayment assistance vouchers for 1 year was successful in improving medication persistence in hospitals with and without pre-existing short-term medication programs. Registration URL: https://www.clini​caltr​ials.gov/. Unique identifier: NCT02406677.",2020,"One-year P2Y 12  inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively).","['Hospitals', '262 hospitals, 129 (49%) offered pre-study free medication assistance', 'patients with insurance coverage for prescription medication enrolled']","['Copayment Reduction Intervention', 'Registration URL', 'usual care versus waived P2Y 12  inhibitor copayment costs']","['inhibitor persistence and major adverse cardiovascular events risks', 'Medication Persistence and Cardiovascular Events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}, {'cui': 'C2350288', 'cui_str': 'Medication Persistence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.178778,"One-year P2Y 12  inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively).","[{'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Doll', 'Affiliation': 'VA Puget Sound Health Care System Seattle WA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'Duke Clinical Research Institute Durham NC.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute Durham NC.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'University of California-Los Angeles CA.'}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences Brigham and Women's Hospital and Harvard Medical School Boston MA.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Fonseca', 'Affiliation': 'AstraZeneca Wilmington DE.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Bhalla', 'Affiliation': 'AstraZeneca Wilmington DE.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Eudicone', 'Affiliation': 'AstraZeneca Wilmington DE.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke University Durham NC.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Duke University Durham NC.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014975']
27,32306797,Pharmacodynamic Effects of Vorapaxar in Prior Myocardial Infarction Patients Treated With Potent Oral P2Y 12  Receptor Inhibitors With and Without Aspirin: Results of the VORA-PRATIC Study.,"Background Vorapaxar as an adjunct to dual antiplatelet therapy (DAPT) reduces thrombotic events in patients with prior myocardial infarction at the expense of increased bleeding. Withdrawal of aspirin has emerged as a bleeding reduction strategy. The pharmacodynamic effects of vorapaxar with potent P2Y 12  inhibitors as well as the impact of dropping aspirin is unexplored and represented the aim of the VORA-PRATIC (Vorapaxar Therapy in Patients With Prior Myocardial Infarction Treated With Newer Generation P2Y 12  Receptor Inhibitors Prasugrel and Ticagrelor) study. Methods and Results Post-myocardial infarction patients (n=130) on standard DAPT (aspirin+prasugrel or ticagrelor) were randomized to 1 of 3 arms: (1) triple therapy: aspirin+prasugrel/ticagrelor+vorapaxar; (2) dual therapy (drop aspirin): prasugrel/ticagrelor+vorapaxar; (3) DAPT: aspirin+prasugrel/ticagrelor. Pharmacodynamic assessments were performed at 3 time points (baseline and 7 and 30 days). Vorapaxar reduced CAT (collagen-ADP-TRAP)-induced platelet aggregation, a marker of platelet-mediated global thrombogenicity (triple therapy versus DAPT at 30 days: mean difference=-27; 95% CI,-35 to -19;  P <0.001; primary end point). This effect was attenuated but still significant in the absence of aspirin (dual therapy versus DAPT at 30 days: mean difference=-15; 95% CI,-23 to -7;  P <0.001; between-group comparisons,  P <0.05). Vorapaxar abolished TRAP-induced aggregation ( P <0.001), without affecting thrombin generation and clot strength. There were no differences in markers of P2Y 12  reactivity. Markers sensitive to aspirin-induced effects increased ( P <0.001) in the dual-therapy arm. Conclusions In post-myocardial infarction patients treated with potent P2Y 12  inhibitors, vorapaxar reduces platelet-driven global thrombogenicity, an effect that persisted, albeit attenuated, in the absence of aspirin and without affecting markers of P2Y 12  reactivity or clot kinetics. The clinical implications of these PD observations warrant future investigation. Registration URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT02545933.",2020,"Vorapaxar abolished TRAP-induced aggregation ( P <0.001), without affecting thrombin generation and clot strength.","['Patients', 'Prior Myocardial Infarction Patients Treated With Potent Oral P2Y 12  Receptor Inhibitors With and Without', 'patients with prior myocardial infarction']","['aspirin', 'Vorapaxar', 'dual antiplatelet therapy (DAPT', 'triple therapy: aspirin+prasugrel/ticagrelor+vorapaxar; (2) dual therapy (drop aspirin): prasugrel/ticagrelor+vorapaxar; (3) DAPT: aspirin+prasugrel/ticagrelor', 'standard DAPT (aspirin+prasugrel or ticagrelor', 'Aspirin']","['platelet-driven global thrombogenicity', 'thrombin generation and clot strength', 'Vorapaxar reduced CAT (collagen-ADP-TRAP)-induced platelet aggregation, a marker of platelet-mediated global thrombogenicity', 'thrombotic events', 'Vorapaxar abolished TRAP-induced aggregation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C1271704', 'cui_str': 'Collagen ADP'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C1268819', 'cui_str': 'Induced platelet aggregation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}]",,0.0571621,"Vorapaxar abolished TRAP-induced aggregation ( P <0.001), without affecting thrombin generation and clot strength.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Franchi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Rollini', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Faz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Jose Ramon', 'Initials': 'JR', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Malhar', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Maryuri', 'Initials': 'M', 'LastName': 'Briceno', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Wali', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Nawaz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Silva', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Zubair', 'Initials': 'Z', 'LastName': 'Shaikh', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Maaliki', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Kerolos', 'Initials': 'K', 'LastName': 'Fahmi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Latonya', 'Initials': 'L', 'LastName': 'Been', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Pineda', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Suryadevara', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Soffer', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Zenni', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Jennings', 'Affiliation': 'CirQuest Labs Memphis TN.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Bass', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.015865']
28,32243363,"Efficacy of photodynamic therapy and periodontal treatment in patients with gingivitis and fixed orthodontic appliances: Protocol of randomized, controlled, double-blind study.","It is known that the presence of orthodontic brackets predisposes for a change in the biofilm, facilitating the development of gingivits. The sites are difficult to access with a toothbrush and periodontal curette, worsening inflammation, in addition, a gingival hyperplasia is associated with poor hygiene. The objective of this study is to evaluate the impact of photodinamyc therapy (PDT) as an adjuvant treatment, considering clinical immunoregulatory and microbiological parameters. This randomized, controlled, double-blind clinical study will include 34 patients, both genders, having used fixed appliance for more than 12 months, with gingivitis. Participants will be divided into two groups: G1 (n = 17)- Scaling and Root Planing + PDT placebo and G2 (n = 17)- Scaling and Root Planing + PDT. In G2 the following dosimetric parameters will be used: methylene blue 0.005%, λ= 660 nanometers (nm), 9 Joules (J) per site, irradiance= 3.5Watts (W)/ centimeters (cm), radiant exposure= 318J/cm. All participants will receive oral hygiene guidance prior the curetes scaling. The clinical periodontal data to be analyzed are plaque index, gingival index and probing depth. Crevicular fluid, from 4 pre-determined sites and saliva, will be collected and analysed for IL-6, IL-1β, IL-8, TNF-α and IL-10 cytokines using ELISA (Enzyme immunoabsorption assay) method. Total Bacteria count will also be performed, by qPCR and Universal16SrRNA gene. All analysis will be realized using in the baseline (T0), 7 (T1) and 21 (T2) days after treatment. Oral health-related quality of life will be assessed using the OHIP-14 questionnaire at times T0 and T2. If sample distribution is normal, the Student T-test will be applied if it is not normal, the Mann-Whitney test will be used. The data will be presented in terms of ± PD and The significance level will be set at p < 0.05. Our results may improve quality of life and add data to establish a therapeutic alternative for gingivitis during the orthodontic treatment. Registration: clinicaltrials.gov NCT04037709. https://clinicaltrials.gov/ct2/show/NCT04037709 - Registered in July 2019.",2020,Oral health-related quality of life will be assessed using the OHIP-14 questionnaire at times T0 and T2.,"['34 patients, both genders, having used fixed appliance for more than 12 months, with gingivitis', 'patients with gingivitis and fixed orthodontic appliances']","['photodinamyc therapy (PDT', 'G1 (n\u200a=\u200a17)- Scaling and Root Planing + PDT placebo and G2 (n\u200a=\u200a17)- Scaling and Root Planing + PDT', 'https://clinicaltrials.gov/ct2/show/NCT04037709', 'photodynamic therapy and periodontal treatment']","['quality of life', 'Total Bacteria count', 'Oral health-related quality of life', 'plaque index, gingival index and probing depth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",34.0,0.202244,Oral health-related quality of life will be assessed using the OHIP-14 questionnaire at times T0 and T2.,"[{'ForeName': 'Ellen Perim', 'Initials': 'EP', 'LastName': 'Rosa', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Murakami-Malaquias-Silva', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Tânia Oppido', 'Initials': 'TO', 'LastName': 'Schalch', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Daniela Bezerra', 'Initials': 'DB', 'LastName': 'Teixeira', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Ricardo Fidos', 'Initials': 'RF', 'LastName': 'Horliana', 'Affiliation': 'Academic specialization student in Temporomandibular Disorder and Orofacial pain.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Tortamano', 'Affiliation': 'Department of Orthodontics, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Isabel Peixoto', 'Initials': 'IP', 'LastName': 'Tortamano', 'Affiliation': 'Department of Stomatology, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Inês Aparecida', 'Initials': 'IA', 'LastName': 'Buscariolo', 'Affiliation': 'Department of Stomatology, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Priscila Larcher', 'Initials': 'PL', 'LastName': 'Longo', 'Affiliation': 'Postgraduate Program of Aging Science -São Judas Tadeu University - São Paulo, SP, Brazil.'}, {'ForeName': 'Renata Matalon', 'Initials': 'RM', 'LastName': 'Negreiros', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}]",Medicine,['10.1097/MD.0000000000019429']
29,32293045,Evaluation of Fractional CO 2  Versus Long Pulsed Nd:YAG Lasers in Treatment of Hypertrophic Scars and Keloids: A Randomized Clinical Trial.,"BACKGROUND


Keloids and hypertrophic scars are challenging to both patients and physicians. They can be aesthetically disfiguring, functionally debilitating, and emotionally distressing. Lasers have introduced new mechanisms to improve scars both on aesthetic and symptomatic levels.
AIM OF WORK


Comparing the efficacy of fractional CO 2  laser, long-pulsed Nd:YAG laser and their combination in the treatment of hypertrophic scars and keloids on clinical, histopathological, and biochemical basis.
PATIENTS AND METHODS


Thirty patients with hypertrophic scars and keloids were enrolled in the study. Three scars in each patient were randomly assigned to treatment modalities (i) Fractional CO 2  , (ii) Nd:YAG laser, (iii) Combined CO 2  and Nd:YAG lasers. For each treatment area four sessions, 4-6 weeks apart were performed. Clinical evaluation was done before and 1 month following last session using the Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessment Scale (POSAS). Routine hematoxylin and eosin, Masson's trichrome, and Orcein stains were used to evaluate the appearance and pattern of dermal collagen and elastic fibers. Image analysis was used to quantitatively assess the density of collagen and elastic fibers. Biochemical evaluation of tissue level of transforming growth factor-β I (TGF-β I) and TGF-β III was performed using enzyme-linked immunosorbent assay studies.
RESULTS


Both VSS and POSAS showed significant improvement following treatment with the three used modalities. Collagen fibers showed significant improvement as regards appearance and pattern while it was insignificant as regards density. Elastic fibers density improvement was only significant in fractional CO 2  (treatment area A). Hypertrophic scars showed more significant improvement with fractional CO 2  laser, while in keloids there was no significant difference between the three modalities regarding improvement. Level of TGF-β I showed significant reduction after treatment in all treatment modalities, while TGF-β III levels showed insignificant elevation in all treatment modalities. Side effects were significantly higher in treatment area C (combined treatment).
CONCLUSION


Long pulsed Nd:YAG laser is effective and safe treatment of hypertrophic scars and keloids. Fractional CO 2  laser yields better improvement in hypertrophic scars, while in keloids both fractional CO 2  and Nd:YAG lasers achieve comparable improvement. Combination in the same session did not add significant additional benefit and the side effects profile was higher.
LIMITATIONS


small sample size and short follow-up period. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.",2020,"Hypertrophic scars showed more significant improvement with fractional CO 2  laser, while in keloids there was no significant difference between the three modalities regarding improvement.","['Hypertrophic Scars and Keloids', 'Thirty patients with hypertrophic scars and keloids were enrolled in the study']","['fractional CO 2  laser, long-pulsed Nd:YAG laser and their combination', 'Fractional CO 2  Versus Long Pulsed Nd:YAG Lasers', 'factor-β', 'Long pulsed Nd:YAG laser', 'transforming growth']","['density of collagen and elastic fibers', 'Side effects', 'Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessment Scale (POSAS', 'Elastic fibers density improvement', 'Hypertrophic scars', 'i) Fractional CO 2  , (ii) Nd:YAG laser, (iii', 'Level of TGF-β']","[{'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0230899', 'cui_str': 'Elastic fiber'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}]",30.0,0.0153531,"Hypertrophic scars showed more significant improvement with fractional CO 2  laser, while in keloids there was no significant difference between the three modalities regarding improvement.","[{'ForeName': 'Shereen O', 'Initials': 'SO', 'LastName': 'Tawfic', 'Affiliation': 'Department of Dermatology, Cairo University, Cairo, 11562, Egypt.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'El-Tawdy', 'Affiliation': 'Department of Dermatology, Cairo University, Cairo, 11562, Egypt.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Shalaby', 'Affiliation': 'Department of Dermatology, Cairo University, Cairo, 11562, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Foad', 'Affiliation': 'Department of Dermatology, Cairo University, Cairo, 11562, Egypt.'}, {'ForeName': 'Olfat', 'Initials': 'O', 'LastName': 'Shaker', 'Affiliation': 'Department of Biochemistry, Cairo University, Cairo, 11562, Egypt.'}, {'ForeName': 'Safinaz S', 'Initials': 'SS', 'LastName': 'Sayed', 'Affiliation': 'Department of Histology, Cairo University, Cairo, 11562, Egypt.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Metwally', 'Affiliation': 'Department of Dermatology, Cairo University, Cairo, 11562, Egypt.'}]",Lasers in surgery and medicine,['10.1002/lsm.23249']
30,32313142,Surrogate endpoints for overall survival for patients with metastatic hormone-sensitive prostate cancer in the CHAARTED trial.,"BACKGROUND


Metastasis-free survival has been shown to be a robust surrogate for overall survival (OS) in men with nonmetastatic prostate cancer (PC). However, this surrogate only holds true for a select subset of patients, and leaves those trials analyzing metastatic disease at a disadvantage. We aimed to identify the best surrogate for predicting OS in patients with metastatic hormone-sensitive PC.
METHODS


We analyzed data from the Chemohormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease trial in which patients were randomly assigned to receive either androgen deprivation therapy (ADT) or ADT plus docetaxel. PSA response, progression and development of castration-resistant PC (CRPC) within 6 and 12 months were investigated as potential OS surrogates, in accordance with the Prentice Criteria. The proportion the of treatment effect (PTE) was calculated for each surrogate and used to identify the best one.
RESULTS


Data from 790 patients were considered: 393 (49.7%) men received ADT alone, while 397 (50.3%) received combination therapy. Four intermediate clinical endpoints met the criteria for surrogacy: progression within 6 months (HR: 5.70; 95%CI: 4.26, 7.64; p < 0.001) and 12 months (HR: 7.09; 95%CI: 5.16, 9.76; p < 0.001) as well as development of CRPC within 6 (HR: 5.11; 95%CI: 3.81, 6.85; p < 0.001) and 12 months (HR: 6.24; 95%CI: 4.58, 8.51; p < 0.001). The PTE for the four surrogates were 88%, 52%, 80%, and 46%, respectively. The 2-year OS rates for patients who progressed within 6 months of randomization were 42 versus 89% for the patient population that did not progress that quickly.
CONCLUSIONS


Progression within 6 months following combination therapy emerged as the best surrogate for OS.",2020,"Four intermediate clinical endpoints met the criteria for surrogacy: progression within 6 months (HR: 5.70; 95%CI: 4.26, 7.64; p < 0.001) and 12 months (HR: 7.09; 95%CI: 5.16, 9.76; p < 0.001) as well as development of CRPC within 6 (HR: 5.11; 95%CI: 3.81, 6.85; p < 0.001) and 12 months (HR: 6.24; 95%CI: 4.58, 8.51; p < 0.001).","['patients with metastatic hormone-sensitive PC', 'patients with metastatic hormone-sensitive prostate cancer', 'men with nonmetastatic prostate cancer (PC', '790 patients were considered: 393 (49.7%) men received']","['androgen deprivation therapy (ADT) or ADT plus docetaxel', 'ADT', 'combination therapy']","['overall survival', 'PSA response, progression and development of castration-resistant PC (CRPC', 'overall survival (OS', '2-year OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517754', 'cui_str': '393'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",790.0,0.328565,"Four intermediate clinical endpoints met the criteria for surrogacy: progression within 6 months (HR: 5.70; 95%CI: 4.26, 7.64; p < 0.001) and 12 months (HR: 7.09; 95%CI: 5.16, 9.76; p < 0.001) as well as development of CRPC within 6 (HR: 5.11; 95%CI: 3.81, 6.85; p < 0.001) and 12 months (HR: 6.24; 95%CI: 4.58, 8.51; p < 0.001).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. a.martini.md@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pfail', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Montorsi', 'Affiliation': 'Department of Urology, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0231-5']
31,32302757,Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials.,"OBJECTIVE


Family navigation (FN), a care management strategy, helps families overcome systems and person-level barriers to care. We previously demonstrated FN's feasibility, acceptability, and potential efficacy for increasing access and reducing time to autism-related diagnostic services among low-income, minority children. In this paper, we describe modifications to FN in response to concerns raised in our first pilot randomized controlled trial (RCT), and then assess these modifications in a second pilot RCT.
METHODS


An advisory group recommended modifications to recruitment procedures and study conditions. Forty parent-child dyad participants with autism-related concerns were randomized to receive modified usual care (UC) or modified FN. We compared whether the first and second pilot RCTs differed in: participant enrollment, satisfaction with clinical care, and timely completion of the diagnostic assessment.
RESULTS


Recruitment improved under the modified protocol with significantly fewer potentially eligible families refusing (19.5% vs 4.8%, P < .05) or being excluded from study enrollment (43.6% vs 0%, P < .01). Comparing the first and second pilot RCTs, regardless of study arm, families in the second pilot were more likely to complete diagnostic assessment (UC: hazard ratio [HR] 3.41, 95% confidence intervals [CI 1.20, 9.68]; FN: HR 2.64, 95% CI [1.31, 5.30]) and report greater satisfaction with clinical care. In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
CONCLUSIONS


Easy-to-implement system-level enhancements improved study recruitment, satisfaction with care, and completion of a diagnostic assessment. With enhancement, FN continued to confer benefits to families.",2021,"In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
","['Children with Autism', '40 parent-child dyad participants with autism-related concerns', 'low-income, minority children']","['modified usual care (UC) or modified FN', 'Family Navigation (FN']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],,0.105002,"In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Boston University School of Medicine (E Feinberg, and S Broder-Fingert), Boston, Mass; Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass. Electronic address: emfeinbe@bu.edu.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Kuhn', 'Affiliation': 'Department of Pediatrics, Boston Medical Center (J Kuhn), Boston, Mass.'}, {'ForeName': 'Jenna Sandler', 'Initials': 'JS', 'LastName': 'Eilenberg', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Levinson', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Patts', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Sarabeth', 'Initials': 'S', 'LastName': 'Broder-Fingert', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Boston University School of Medicine (E Feinberg, and S Broder-Fingert), Boston, Mass.'}]",Academic pediatrics,['10.1016/j.acap.2020.04.007']
32,31667859,Do sluggish cognitive tempo symptoms improve with school-based ADHD interventions? Outcomes and predictors of change.,"BACKGROUND


Sluggish cognitive tempo (SCT) is a construct that includes symptoms of slowness, excessive daydreaming, and drowsiness. SCT is often comorbid with attention-deficit/hyperactivity disorder (ADHD), and SCT symptoms are associated with significant academic impairment above the influence of ADHD. Despite the overlap between ADHD and SCT and associated impairments, no studies have evaluated how evidence-based psychosocial interventions for adolescents with ADHD impact symptoms of SCT.
METHODS


This study examined whether SCT symptoms improved in a sample of 274 young adolescents with ADHD who were randomly assigned to an organizational skills intervention, homework completion intervention, or to a waitlist control. SCT intervention response was evaluated broadly in all participants and, specifically, for participants in the clinical range for SCT symptom severity at baseline. Change in ADHD symptoms of inattention, executive functioning, and motivation were examined as potential predictors of improvement in SCT.
RESULTS


The two intervention groups were collapsed together for analyses because there were no significant differences in change in SCT symptoms. Multilevel modeling results indicate that parent-reported SCT symptoms significantly decreased when comparing the intervention group to waitlist control (d = .410). For adolescents with parent-reported clinical levels of SCT, the decrease in symptoms was more pronounced (d = .517). Self-reported SCT symptoms produced null results, though effect size calculations showed small improvement for the full sample (d = .313) and for the high-SCT group (d = .384). Change in behavior regulation executive functioning (d = .247), metacognitive executive functioning (d = .346), and inattention (d = .230) predicted change in parent-reported SCT symptoms.
CONCLUSIONS


Although not specifically designed to decrease SCT symptoms, the ADHD interventions evaluated in this study resulted in significant improvements in parent-reported SCT with small to moderate effect sizes. Clinical implications and future directions are discussed, including development of interventions for adolescents with high levels of SCT.",2020,Multilevel modeling results indicate that parent-reported SCT symptoms significantly decreased when comparing the intervention group to waitlist control (d = .410).,"['adolescents with high levels of SCT', '274 young adolescents with ADHD', 'adolescents with ADHD impact symptoms of SCT']","['Sluggish cognitive tempo (SCT', 'organizational skills intervention, homework completion intervention, or to a waitlist control', 'SCT']","['SCT intervention response', 'behavior regulation executive functioning', 'metacognitive executive functioning ', 'Change in ADHD symptoms of inattention, executive functioning, and motivation', 'SCT symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424101', 'cui_str': 'Inattention (finding)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",274.0,0.037287,Multilevel modeling results indicate that parent-reported SCT symptoms significantly decreased when comparing the intervention group to waitlist control (d = .410).,"[{'ForeName': 'Zoe R', 'Initials': 'ZR', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Langberg', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13149']
33,31702058,Mentalization-based treatment in groups for adolescents with borderline personality disorder: a randomized controlled trial.,"BACKGROUND


Borderline personality disorder (BPD) typically onsets in adolescence and predicts later functional disability in adulthood. Highly structured evidence-based psychotherapeutic programs, including mentalization-based treatment (MBT), are first choice treatment. The efficacy of MBT for BPD has mainly been tested with adults, and no RCT has examined the effectiveness of MBT in groups (MBT-G) for adolescent BPD.
METHOD


A total of 112 adolescents (111 females) with BPD (106) or BPD symptoms ≥4 DSM-5 criteria (5) referred to child and adolescent psychiatric outpatient clinics were randomized to a 1-year MBT-G, consisting of three introductory, psychoeducative sessions, 37 weekly group sessions, five individual case formulation sessions, and six group sessions for caregivers, or treatment as usual (TAU) with at least 12 monthly individual sessions. The primary outcome was the score on the borderline personality features scale for children (BPFS-C); secondary outcomes included self-harm, depression, externalizing and internalizing symptoms (all self-report), caregiver reports, social functioning, and borderline symptoms rated by blinded clinicians. Outcome assessments were made at baseline, after 10, 20, and 30 weeks, and at end of treatment (EOT). The ClinicalTrials.gov identifier is NCT02068326.
RESULTS


At EOT, the primary outcome was 71.3 (SD = 15.0) in the MBT-G group and 71.3 (SD = 15.2) in the TAU group (adjusted mean difference 0.4 BPFS-C units in favor of MBT-G, 95% confidence interval -6.3 to 7.1, p = .91). No significant group differences were found in the secondary outcomes. 29% in both groups remitted. 29% of the MBT group completed less than half of the sessions compared with 7% of the control group.
CONCLUSIONS


There is no indication for superiority of either therapy method. The low remission rate points to the importance of continued research into early intervention. Specifically, retention problems need to be addressed.",2020,No significant group differences were found in the secondary outcomes.,"['adolescents with borderline personality disorder', 'Borderline personality disorder (BPD', '112 adolescents (111 females) with BPD (106) or BPD symptoms ≥4 DSM-5 criteria (5) referred to child and adolescent psychiatric outpatient clinics']","['mentalization-based treatment (MBT', 'MBT']","['score on the borderline personality features scale for children (BPFS-C); secondary outcomes included self-harm, depression, externalizing and internalizing symptoms (all self-report), caregiver reports, social functioning, and borderline symptoms rated by blinded clinicians']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C4704687', 'cui_str': 'Mentalization'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0222045'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",112.0,0.114428,No significant group differences were found in the secondary outcomes.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Beck', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Denmark.'}, {'ForeName': 'Sune', 'Initials': 'S', 'LastName': 'Bo', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Denmark.'}, {'ForeName': 'Mie Sedoc', 'Initials': 'MS', 'LastName': 'Jørgensen', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Denmark.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gondan', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Poulsen', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ole Jakob', 'Initials': 'OJ', 'LastName': 'Storebø', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fjellerad Andersen', 'Affiliation': 'Child and Adolescent Psychiatric Department, Region Zealand, Denmark.'}, {'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Folmo', 'Affiliation': 'Norwegian National Advisory Unit on Personality Psychiatry, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Sharp', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Pedersen', 'Affiliation': 'Child and Adolescent Psychiatric Department, Region Zealand, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Simonsen', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Denmark.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13152']
34,32303839,"Laparoscopic Heller myotomy or pneumatic dilatation in achalasia: results of a prospective, randomized study with at least a decade of follow-up.","BACKGROUND AND OBJECTIVES


The most efficient long-term treatment strategy for achalasia has yet to be established. This study compared the long-term results (≥ 10 years) after either pneumatic dilatations or laparoscopic myotomy using treatment failure as the primary outcome. Secondary objectives were; the frequency and degree of dysphagia and effects on health-related quality of life (QoL).
PATIENTS AND METHODS


Out of the 53 patients with achalasia who were initially randomized to either laparoscopic myotomy with a posterior partial fundoplication (LM) or repetitive pneumatic dilatation (PD), 43 remained for scrutiny after a median observation period of 170 months (LM; n = 20 and PD; n = 23).
RESULTS


At the follow-up of 60 months, 10 patients (36%) in the PD group and two patients (8%) in the LM group were classified as treatment failures (p = 0.016). At the latest follow-up time point (≥ 10 years), the corresponding numbers were 13 (57%) and 4 (20%), respectively. The Kaplan-Meier analysis of the cumulative incidence of treatment failure revealed a significant advantage of LM over the dilatation strategy (p = 0.036)). QoL assessed by the generic instrument PGWB and the more disease-specific instrument GSRS revealed scores which were similar in the two study groups with no obvious changes over time. Reflux was better controlled in the LM group (p = 0.02 regarding PPI consumption).
CONCLUSIONS


After more than a decade of follow-up, laparoscopic myotomy reinforces its superiority over repetitive pneumatic dilatation treatment strategy in the management of newly diagnosed achalasia.",2021,The Kaplan-Meier analysis of the cumulative incidence of treatment failure revealed a significant advantage of LM over the dilatation strategy (p = 0.036)).,"['achalasia', 'Out of the 53 patients with achalasia who were initially randomized to either']","['Laparoscopic Heller myotomy or pneumatic dilatation', 'laparoscopic myotomy with a posterior partial fundoplication (LM) or repetitive pneumatic dilatation (PD', 'pneumatic dilatations or laparoscopic myotomy']","['frequency and degree of dysphagia and effects on health-related quality of life (QoL', 'Reflux']","[{'cui': 'C0014848', 'cui_str': 'Achalasia of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C4505238', 'cui_str': 'Laparoscopic Heller Cardiomyotomy'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0185181', 'cui_str': 'Incision of muscle'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0701808', 'cui_str': 'Partial fundoplication'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}]",53.0,0.0987361,The Kaplan-Meier analysis of the cumulative incidence of treatment failure revealed a significant advantage of LM over the dilatation strategy (p = 0.036)).,"[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Sediqi', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden. ehsan_se@hotmail.com.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Tsoposidis', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Wallenius', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Axelsson', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lundell', 'Affiliation': 'Division of Surgery, CLINTEC, Department of Surgery, Karolinska Institutet at Karolinska University Hospital, Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Kostic', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Surgical endoscopy,['10.1007/s00464-020-07541-4']
35,32301853,Effect of Strength Training on Glycemic Control and Adiponectin in Diabetic Children.,"PURPOSE


This study aimed to examine the effect of isolated supervised progressive resistance training with duration of more than 32 wk on muscle strength, metabolic control and adiponectin.
METHOD


Twenty-one children with type 1 diabetes mellitus were separated into an intervention group (IG) (n = 11 age 11.0 ± 0.8) and a control group (CG) (n = 10 age 11.30 ± 0.7) without training to control for the effect of progressive resistance training on muscle strength, hemoglobin (HbA)1C and adiponectin. All parameters were assessed before and after a period of 32 wk. No attempt was made to change diet and the daily behaviors during the study in both groups.
RESULTS


After a period of 32 wk, upper and lower limb strength increased significantly (P < 0.05) in the IG, whereas no changes occurred in the CG. In the IG, HbA1C decreased significantly after 32 wk but not after 17 wk (P < 0.00), whereas HbA1C increased in the CG (P < 0.007). Adiponectin increased significantly (P < 0.000) only in the IG. Self-monitored blood glucose levels, measured before and after each session, showed a significant reduction (P < 0.00) of 26.5% ± 4.4% after each session. Effect size (ES) for the strength training on limb strength was medium (d = 0.464 to d = 0.661), the ES for strength training on HbA1C (d = -1.292) and the ES for strength training on adiponectin (d = 1.34) was large. There was no hypoglycemia as the result of training.
CONCLUSIONS


An isolated supervised progressive resistance training two times a week in children with type 1 diabetes mellitus must last at least 32 wk to get a significant decrease in blood glucose level HbA1C. In addition, exercise-induced increase in adiponectin improves insulin sensitivity.",2020,In the IG HbA1C decreased significantly after 32 weeks but not after 17 weeks (p<0.00) while HbA1C increased in the CG (p<0.007).,"['Diabetic Children', 'Twenty one children with Type 1 DM diabetes']","['control group (CG n = 10 age 11.30 ± 0.7) without training to control', 'Strength Training', 'isolated supervised progressive resistance training', 'progressive resistance training']","['hypoglycemia', 'HbA1C', 'blood glucose level HbA1C', 'adiponectin improves insulin sensitivity', 'limb strength', 'Glycemic Control and Adiponectin', 'Adiponectin', 'Self-monitored blood glucose levels', 'muscle strength, metabolic control and adiponectin']","[{'cui': 'C0425067', 'cui_str': 'Diabetic child'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",21.0,0.0111125,In the IG HbA1C decreased significantly after 32 weeks but not after 17 weeks (p<0.00) while HbA1C increased in the CG (p<0.007).,"[{'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Petschnig', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Danube Hospital Vienna, AUSTRIA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wagner', 'Affiliation': 'Department of Pediatric, Danube Hospital, Vienna, AUSTRIA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Robubi', 'Affiliation': 'Department of Chemistry, Danube Hospital, Vienna, AUSTRIA.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Baron', 'Affiliation': 'Institute of Sport Science, Department of Prevention-Rehabilitation and Science of Training, University of Vienna, Vienna, AUSTRIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002356']
36,32298697,Molecular profiling of allergen-specific antibody responses may enhance success of specific immunotherapy.,"BACKGROUND


House dust mites (HDMs) are among the most important allergen sources containing many different allergenic molecules. Analysis of patients from a double-blind, placebo-controlled allergen-specific immunotherapy (AIT) study indicated that patients may benefit from AIT to different extents depending on their molecular sensitization profiles.
OBJECTIVE


Our aim was to investigate in a real-life setting whether stratification of patients with HDM allergy according to molecular analysis may enhance AIT success.
METHODS


Serum and nasal secretion samples from patients with HDM allergy (n = 24) (at baseline, 7, 15, 33, and 52 weeks) who had received 1 year of treatment with a well-defined subcutaneous AIT form (Alutard SQ 510) were tested for IgE and IgG reactivity to 15 microarrayed HDM allergen molecules with ImmunoCAP Immuno-solid-phase Allergen Chip technology. IgG subclass levels to allergens and peptides were determined by ELISA, and IgG blocking was assessed by basophil activation. In vitro parameters were related to reduction of symptoms determined by combined symptom medication score and visual analog scale score.
RESULTS


Alutard SQ 510 induced protective IgG mainly against Dermatophagoides pteronyssinus (Der p) 1 and Der p 2 and to a lesser extent to Der p 23, but not to the other important allergens such as Der p 5, Der p 7, and Der p 21, showing better clinical efficacy in patients sensitized only to Der p 1 and/or Der p 2 as compared with patients having additional IgE specificities.
CONCLUSION


Stratification of patients with HDM allergy according to molecular sensitization profiles and molecular monitoring of AIT-induced IgG responses may enhance the success of AIT.",2020,induced protective IgG mainly against Der p 1 and Der p 2 and to a lower extent to Der,"['House dust mites (HDM', 'HDM allergic patients', 'Serum and nasal secretion samples from HDM allergic patients (n=24) (baseline, 7, 15, 33 and 52 weeks) who had received one year treatment with a well-defined subcutaneous AIT form (Alutard SQ 510']","['ImmunoCAP ISAC technology', 'placebo-controlled allergen-specific immunotherapy (AIT']","['reduction of symptoms determined by combined symptom medication score (CSMS) and visual analogue (VAS', 'clinical efficacy']","[{'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0524581', 'cui_str': 'House dust'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442825', 'cui_str': 'Well defined'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C4517800', 'cui_str': '510'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",510.0,0.0767799,induced protective IgG mainly against Der p 1 and Der p 2 and to a lower extent to Der,"[{'ForeName': 'Azahara', 'Initials': 'A', 'LastName': 'Rodríguez-Domínguez', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Berings', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rohrbach', 'Affiliation': 'Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Huey-Jy', 'Initials': 'HJ', 'LastName': 'Huang', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Curin', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Matricardi', 'Affiliation': 'Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Valenta', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria; NRC Institute of Immunology, Federal Biomedical Agency of Russia, Moscow; Department of Clinical Immunology and Allergy, Sechenov First State Medical University, Moscow, Russia; Karl Landsteiner University of Health Sciences, Krems, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Vrtala', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria. Electronic address: susanne.vrtala@meduniwien.ac.at.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.03.029']
37,32298853,Treatment Benefit with Omalizumab in Children by Indicators of Asthma Severity.,"BACKGROUND


Greater severity in childhood asthma negatively impacts functioning and quality of life. Omalizumab is effective in children aged 6 years or older with moderate to severe persistent asthma, but predicting responsiveness in severe disease requires further study.
OBJECTIVE


To assess response to omalizumab treatment among children using indicators of asthma severity.
METHODS


Post hoc analyses of randomized placebo-controlled studies of omalizumab (Inner-City Anti-IgE Therapy for Asthma [ICATA], IA05, and Preventative Omalizumab or Step-up Therapy for Fall Exacerbations [PROSE]) stratified by body mass index, eosinophil count, fractional exhaled nitric oxide levels, and baseline severity indicators (baseline percent predicted FEV 1 , previous hospitalizations, asthma exacerbations). Poisson regression analysis examined exacerbation rate reductions for body mass index, biomarkers, and severity indicators.
RESULTS


Children aged 6 to 11 years in IA05 (N = 576; 56% white, 17% black, 26% other/missing), ICATA (N = 237; 55% black, 43% Hispanic), and PROSE (N = 342; 59% black, 35% Hispanic) were included. Trends indicative of greater exacerbation rate change ([omalizumab - placebo]/placebo) were observed for low baseline lung function (IA05 percent predicted FEV 1 : <90%, 36% reduction, 95% CI, -53.3 to -13.5; ≥90%, 22% reduction, 95% CI, -52.1 to 27.5), previous hospitalizations (ICATA: 46% reduction with, 95% CI, -69.7 to -3.9; 24% reduction without, 95% CI, -48.1 to 10.3), frequent baseline exacerbations (IA05: ≥3, 42% reduction, 95% CI, -60.4 to -14.1; <3, 20% reduction, 95% CI, -45.2 to -15.9), and high baseline eosinophil count (IA05: ≥300 cells/μL, 39% reduction, 95% CI, -56.4 to -14.7; <300 cells/μL, 5% reduction, 95% CI, -40.6 to 52.1).
CONCLUSIONS


Omalizumab reduces exacerbations in children with moderate to severe persistent allergic asthma, and may provide greater benefit in children with more severe asthma subtypes.",2020,"Trends indicative of greater exacerbation rate change ([omalizumab-placebo]/placebo) were observed for low baseline lung function (IA05 ppFEV 1 : <90%, 36% reduction, 95%CI: -53.3,","['Children aged 6-11 years in IA05 (N=576', 'IA05: ≥300 cells/μL, 39% reduction, 95%CI: -56.4, -14.7; <300 cells/μL, 5% reduction, 95%CI: -40.6, 52.1', 'children using indicators of asthma severity', 'children with moderate-to-severe persistent allergic asthma', ' 56% White, 17% Black, 26% Other/Missing), ICATA (N=237; 55% Black, 43% Hispanic), and PROSE (N=342; 59% Black, 35% Hispanic', 'children aged ≥6 years with moderate-to-severe persistent asthma']","['Omalizumab', 'placebo', 'omalizumab']","['forced expiratory volume in 1 second [ppFEV 1 ], prior hospitalizations, asthma exacerbations', 'high baseline eosinophil count', 'body mass index (BMI), eosinophil count, fractional exhaled nitric oxide (FeNO) levels, and baseline severity indicators']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.524462,"Trends indicative of greater exacerbation rate change ([omalizumab-placebo]/placebo) were observed for low baseline lung function (IA05 ppFEV 1 : <90%, 36% reduction, 95%CI: -53.3,","[{'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Pediatric Asthma Research Program, Breathing Institute, Children's Hospital Colorado, and University of Colorado School of Medicine, Aurora, Colo. Electronic address: Stanley.Szefler@childrenscolorado.org.""}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'University of South Florida, Tampa, Fla.'}, {'ForeName': 'Tmirah', 'Initials': 'T', 'LastName': 'Haselkorn', 'Affiliation': 'EpiMetrix, Inc, Los Altos, Calif.'}, {'ForeName': 'Bongin', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ortiz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Kattan', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.033']
38,32221067,Evaluation of the effects of photobiomodulation on orthodontic movement of molar verticalization with mini-implant: A randomized double-blind protocol study.,"INTRODUCTION


Loss of a dental element can generate several repercussions in the stomatognathic system. According to the latest survey by the Ministry of Health, in 2010, Brazilian adults had, on average, 7 missing teeth. This loss may lead to movement of the adjacent teeth and the antagonist, which would make prosthetic rehabilitation harder to do. Anchoring systems, such as mini-implants, have been increasingly used as a treatment option because they act with heavy but controlled forces and without side effects. Recent studies have shown that photobiomodulation (PBM) can accelerate orthodontic movement in molar intrusion. The objective of this study will be to evaluate the effect of PBM on the acceleration of the orthodontic movement of molar verticalization and its effect on pain and inflammation of the periodontal tissues. PATIENT CONCERNS:: the concerns assessments will be done over the study using anamnesis interviews and specific questionnaire.
DIAGNOSIS


verticalization will be evaluated by clinical and radiographic analysis.
INTERVENTIONS


Thirty four healthy patients aged 30 to 60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element, will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM. The movements will occur with the aid of mini-implants and elastomeric chains ligatures. The PBM will occur with diode laser application, 808 nm, 100 mW, receiving 1J per point, 10 seconds, 10 points (5 per buccal and 5 per lingual) and radiant exposure of 25 J/cm. The orthodontic forces of verticalization (corresponding to any exchange of elastomeric ligation) will be applied every 30 days and the PBM will be applied immediately, 3 and 7 days of each month, for a period of 3 months. The crevicular gingival fluid (CGF) will be collected on the 1st, 3rd, and 7th days after the first activation, and then on the 3rd day of the following 2 months.
OUTCOMES


Interleukins IL1β, IL-6, IL-8, IL-10, and TNF-α will be analyzed by ELISA. Panoramic radiography will be performed at baseline and 90 afterwards to ascertain the amount (in degrees) of verticalization. To evaluate the pain, the Visual Analog Scale (VAS) will be used in all the consultations, and to evaluate the quality of life, the Oral Health Impact Profile (OHIP-14) questionnaire will be applied. Analgesics will be given and the quantity of drugs will be counted. If the data are normal, they will be submitted to Student t test. The data will be presented as means ± SD and the value of p will be defined as <0.05.
DISCUSSION


This protocol will determine the effectiveness of photobiomoduation regarding the orthodontic movement of molar verticalization.
ETHICS AND DISSEMINATION


This protocol received approval from the Human Research Ethics Committee of Universidade Nove de Julho (certificate number: 3 533 219). The data will be published in a peer-reviewed periodical.",2020,"OUTCOMES


Interleukins IL1β, IL-6, IL-8, IL-10, and TNF-α will be analyzed by ELISA.","['2010, Brazilian adults had, on average, 7 missing teeth', 'Thirty', 'four healthy patients aged 30 to 60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element']","['Panoramic radiography', 'PBM', 'G1 (control group) - verticalization by mini-implant + PBM simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM', 'photobiomodulation (PBM', 'photobiomodulation', 'molar verticalization with mini-implant']","['pain, the Visual Analog Scale (VAS', 'pain and inflammation of the periodontal tissues', 'quality of life, the Oral Health Impact Profile (OHIP-14) questionnaire', 'Interleukins IL1β, IL-6, IL-8, IL-10, and TNF-α will be analyzed by ELISA', 'crevicular gingival fluid (CGF']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0419104', 'cui_str': 'Oral rehabilitation (regime/therapy)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}]","[{'cui': 'C0034579', 'cui_str': 'Panoramic Radiography'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031104', 'cui_str': 'Tooth Supporting Structures'}, {'cui': 'C0034380'}, {'cui': 'C0029162'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]",34.0,0.0769534,"OUTCOMES


Interleukins IL1β, IL-6, IL-8, IL-10, and TNF-α will be analyzed by ELISA.","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Murakami-Malaquias-Silva', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Ellen Perim', 'Initials': 'EP', 'LastName': 'Rosa', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Paulo André', 'Initials': 'PA', 'LastName': 'Almeida', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Tânia Oppido', 'Initials': 'TO', 'LastName': 'Schalch', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Tenis', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Renata Matalon', 'Initials': 'RM', 'LastName': 'Negreiros', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Ricardo Fidos', 'Initials': 'RF', 'LastName': 'Horliana', 'Affiliation': 'Academic specialization student in Temporomandibular Disorder and Orofacial pain, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Aguinaldo Silva', 'Initials': 'AS', 'LastName': 'Garcez', 'Affiliation': 'São Leopoldo Mandic, School of Dentistry, Campinas.'}, {'ForeName': 'Marcella Ueda R', 'Initials': 'MUR', 'LastName': 'Fernandes', 'Affiliation': 'São Leopoldo Mandic, School of Dentistry, Campinas.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Tortamano', 'Affiliation': 'Coordinator of Graduation course.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}]",Medicine,['10.1097/MD.0000000000019430']
39,32147362,Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials.,"BACKGROUND & AIMS


Apoptosis signal-regulating kinase 1 (ASK1) plays a key role in hepatocyte injury, inflammation, and fibrosis in non-alcoholic steatohepatitis (NASH). We evaluated the safety and antifibrotic effect of selonsertib, a selective inhibitor of ASK1, in patients with advanced fibrosis due to NASH.
METHODS


We conducted 2 randomized, double-blind, placebo-controlled, phase III trials of selonsertib in patients with NASH and bridging fibrosis (F3, STELLAR-3) or compensated cirrhosis (F4, STELLAR-4). Patients were randomized 2:2:1 to receive selonsertib 18 mg, selonsertib 6 mg, or placebo once daily for 48 weeks. Liver biopsies were performed at screening and week 48 and non-invasive tests of fibrosis (NITs) were evaluated. The primary efficacy endpoint was the proportion of patients with ≥1-stage improvement in fibrosis without worsening of NASH at week 48. Additional endpoints included changes in NITs, progression to cirrhosis (in STELLAR-3), and liver-related clinical events.
RESULTS


Neither trial met the primary efficacy endpoint. In STELLAR-3, fibrosis improvement without worsening of NASH was observed in 10% (31/322, p = 0.49 vs. placebo), 12% (39/321, p = 0.93 vs. placebo), and 13% (21/159) of patients in the selonsertib 18 mg, selonsertib 6 mg, and placebo groups, respectively. In STELLAR-4, the primary endpoint was achieved in 14% (51/354; p = 0.56), 13% (45/351; p = 0.93), and 13% (22/172) of patients, respectively. Although selonsertib led to dose-dependent reductions in hepatic phospho-p38 expression indicative of pharmacodynamic activity, it had no significant effect on liver biochemistry, NITs, progression to cirrhosis, or adjudicated clinical events. The rates and types of adverse events were similar among selonsertib and placebo groups.
CONCLUSIONS


Forty-eight weeks of selonsertib monotherapy had no antifibrotic effect in patients with bridging fibrosis or compensated cirrhosis due to NASH.
LAY SUMMARY


Patients with non-alcoholic steatohepatitis (NASH) can develop scarring of the liver (fibrosis), including cirrhosis, which increases the risks of liver failure and liver cancer. We tested whether 48 weeks of treatment with selonsertib reduced fibrosis in patients with NASH and advanced liver scarring. We did not find that selonsertib reduced fibrosis in these patients.
TRIAL REGISTRATION DETAILS


Clinicaltrials.gov numbers NCT03053050 and NCT03053063.",2020,"Although selonsertib led to dose-dependent reductions in hepatic phospho-p38 expression indicative of pharmacodynamic activity, it had no significant effect on liver biochemistry, NITs, progression to cirrhosis, or adjudicated clinical events.","['patients with bridging fibrosis or compensated cirrhosis due to NASH', 'Patients with Bridging Fibrosis or Compensated Cirrhosis Due to NASH', 'patients with NASH and bridging fibrosis (F3, STELLAR-3) or compensated cirrhosis (F4, STELLAR-4', 'patients with advanced fibrosis due to NASH']","['selonsertib 18 mg, selonsertib 6 mg, or placebo', 'selonsertib monotherapy', 'placebo']","['changes in NITs, progression to cirrhosis (in STELLAR-3), and liver-related clinical events', 'STELLAR-3, fibrosis improvement without worsening of NASH', 'rates and types of adverse events', 'liver biochemistry, NITs, progression to cirrhosis', 'proportion of patients with ≥1-stage improvement in fibrosis without worsening of NASH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0334160', 'cui_str': 'Bridging fibrosis (morphologic abnormality)'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0562688', 'cui_str': 'Egg of order Phthiraptera (organism)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]",,0.317529,"Although selonsertib led to dose-dependent reductions in hepatic phospho-p38 expression indicative of pharmacodynamic activity, it had no significant effect on liver biochemistry, NITs, progression to cirrhosis, or adjudicated clinical events.","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX, USA. Electronic address: sharrison@pinnacleresearch.com.'}, {'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong, China.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Okanoue', 'Affiliation': 'Saiseikai Suita Hospital, Suita City, Osaka, Japan.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bzowej', 'Affiliation': 'Oschner Medical Center, New Orleans, LA, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Vuppalanchi', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Younes', 'Affiliation': 'Gastro One, Germantown, TN, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'The Institute for Liver Health, Chandler, AZ, USA.'}, {'ForeName': 'Shiv', 'Initials': 'S', 'LastName': 'Sarin', 'Affiliation': 'Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Caldwell', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, TX, USA.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Liver Institute of Virginia, Bon Secours Mercy Health, Richmond, VA, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Camargo', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Kersey', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Yanni', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'C Stephen', 'Initials': 'CS', 'LastName': 'Djedjos', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Nadege', 'Initials': 'N', 'LastName': 'Gunn', 'Affiliation': 'Pinnacle Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Aasim', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'GI Specialists of Georgia, Marietta, GA, USA.'}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK & Newcastle NIHR Biomedical Research Center, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Romero-Gomez', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Vienna, Austria.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, TX, USA.'}, {'ForeName': 'Zobair', 'Initials': 'Z', 'LastName': 'Younossi', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hepatology,['10.1016/j.jhep.2020.02.027']
40,30671535,Effects of high dose atorvastatin before elective percutaneous coronary intervention on highly sensitive troponin T and one year major cardiovascular events; a randomized clinical trial.,"Introduction


Some studies have demonstrated that post-PCI elevated cardiac enzymes are associated with worse outcomes. In this study, we aimed to determine if high-dose treatment with atorvastatin before planned elective PCI reduces PMI or MACE at 1-year median follow-up.
Material and methods


Eligible participants were randomly allocated to group A (80 mg atorvastatin 12 h and 40 mg 2 h before PCI) and group B (40 mg atorvastatin daily). Blood samples were obtained before and at 24 h after PCI to measure hsTnT. All patients were followed regarding MACE (combination of death, re-hospitalizations for ACS, and unplanned coronary revascularization) during one year after PCI.
Results


207 patients randomly assigned to Group A (n = 97) or group B (n = 110). The rate of PMI was lower in group A (5.2%) compared to group B (10.9%); despite near to 50% lower rate of PMI in group A, binary logistic regression showed no significant association between atorvastatin recapture and PMI. The occurrence of MACE in 97 patients of group A was 11 (11.3%), higher than 11 (10%) cases of 110 patients in group B. Cox proportional hazards regression model shows no significant difference in MACE of study groups.
Conclusion


Pretreatment of patients with stable angina who were planned to undergo an elective PCI with 120 mg of atorvastatin before the procedure confer them the same benefit in terms of PMI and MACE as 40 mg routine daily dosage of this statin does.",2019,"The occurrence of MACE in 97 patients of group A was 11 (11.3%), higher than 11 (10%) cases of 110 patients in group B. Cox proportional hazards regression model shows no significant difference in MACE of study groups.
",['patients with stable angina who were planned to undergo an elective PCI with 120\u202fmg of'],"['atorvastatin', 'atorvastatin 12\u202fh and 40\u202fmg 2\u202fh before PCI']","['Blood samples', 'rate of PMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",207.0,0.0383507,"The occurrence of MACE in 97 patients of group A was 11 (11.3%), higher than 11 (10%) cases of 110 patients in group B. Cox proportional hazards regression model shows no significant difference in MACE of study groups.
","[{'ForeName': 'HamidReza', 'Initials': 'H', 'LastName': 'Pourhosseini', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Lashkari', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Danesh', 'Initials': 'D', 'LastName': 'Soltani', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masih', 'Initials': 'M', 'LastName': 'Tajdini', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, North Kargar Ave., Tehran, Iran.'}]",International journal of cardiology. Heart & vasculature,['10.1016/j.ijcha.2018.12.003']
41,31656057,Diffusion of effects of the ASSIST school-based smoking prevention intervention to non-participating family members: a secondary analysis of a randomized controlled trial.,"AIMS


To investigate whether effects of the ASSIST (A Stop Smoking In Schools Trial) school-based smoking prevention intervention diffused from students to the people they lived with.
DESIGN


Secondary analysis of a cluster-randomized control trial (cRCT).
SETTING


England and Wales.
PARTICIPANTS


A total of 10 730 students aged 12-13 years in 59 schools assigned using stratified block randomization to the control (29 schools, 5372 students) or intervention (30 schools, 5358 students) condition.
INTERVENTION AND COMPARATOR


The ASSIST intervention involves 2 days of off-site training of influential students to encourage their peers not to smoke during a 10-week period. The control group continued with their usual education.
MEASUREMENTS


The outcomes were the proportion of students who self-reported living with a smoker and the smoking status of each resident family member/caregiver. Follow-up assessments were immediately after the intervention and at 1 and 2 years post-intervention.
FINDINGS


The odds ratio (OR) for living with a smoker in the intervention compared with the control groups was 0.86 [95% confidence interval (CI) = 0.72, 1.03] immediately after the intervention, OR = 0.84 (95% CI = 0.72, 0.97) at a 1-year follow-up and OR = 0.86 (95% CI = 0.75, 0.99) at 2-year follow-up. In a three-tier multi-level model with data from all three follow-ups, student-reported smoking by fathers (OR = 0.90, 95% CI = 0.80, 1.00), brothers (OR = 0.78, 95% CI = 0.67, 0.92) and sisters (OR = 0.80, 95% CI = 0.69, 0.92) was lower in the intervention compared with control group. Subgroup analyses by baseline smoking status suggested that these effects were more consistent with prevention of uptake than prompting cessation.
CONCLUSIONS


A Stop Smoking In Schools Trial (ASSIST) school-based smoking prevention intervention may have reduced the prevalence of smoking in people who lived with ASSIST-trained students. This indirect transmission is consistent with the predictions of diffusion of innovations theory which underpins the design of ASSIST.",2020,"The odds ratio for living with a smoker in the intervention compared with control group was 0.86 (95% confidence interval 0.72, 1.03) immediately after the intervention, 0.84 (0.72, 0.97) at a 1-year follow-up, and 0.86 (0.75, 0.99) at a 2-year follow-up.","['people who lived with ASSIST-trained students', '10,730 students aged 12-13 years in 59 schools assigned using stratified block randomisation to the control (29 schools, 5,372 students) or intervention (30 schools, 5,358 students) condition', 'non-participating family members', 'England and Wales', 'students to the people they lived with']","['ASSIST (A Stop Smoking', 'school-based smoking prevention intervention', 'ASSIST school-based smoking prevention intervention']","['odds ratio for living with a smoker', 'proportion of students who self-reported living with a smoker and the smoking status of each resident family member/caregiver']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1519385', 'cui_str': 'Smoking Prevention'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",,0.0670404,"The odds ratio for living with a smoker in the intervention compared with control group was 0.86 (95% confidence interval 0.72, 1.03) immediately after the intervention, 0.84 (0.72, 0.97) at a 1-year follow-up, and 0.86 (0.75, 0.99) at a 2-year follow-up.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Holliday', 'Affiliation': 'Nuffield Department of Population Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Daniel', 'Affiliation': 'School of Medicine, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14862']
42,31327292,"Long-term effects of participation in a prenatal exercise intervention on body weight, body mass index, and physical activity level: a 6-year follow-up study of a randomized controlled trial.","BACKGROUND


Growing evidence supports that physical activity and exercise during pregnancy is favorable for the mother, with persisting benefits in the postpartum period. However, there is scant knowledge of the effect of a prenatal exercise program on long-term health and lifestyle habits.
OBJECTIVES


This 6-year follow-up study of a randomized controlled trial had two aims: (1) compare body weight, weight retention and body mass index (BMI) in the intervention group and control group, and (2) evaluate effects on physical activity level and recreational exercise.
MATERIALS AND METHODS


Out of 105 participants initially randomized to either an intervention group,  n  = 52 (twice weekly group-exercises and physical activity counselling) or control group,  n  = 53 (standard prenatal care), 80 women (76.2%) participated in the present long-term follow-up study, performed in a general community in Oslo, Norway. Data were collected through a standardized telephone interview based on the baseline protocol and a modified Physical Activity and Pregnancy Questionnaire (PAPQ). Body weight at 6 years follow-up was self-reported (kg), and calculation of current BMI (kg/m 2 ) was based on self-reported weight and measured height at study inclusion. Investigators were unaware of the original randomization at the time of the interviews. Analyses of covariance were used to examine the difference in change in body weight and BMI between the groups. Even though the MET-values were not normally distributed, differences were examined using a two-sided independent sample  t -test due to large sample size ( n  ≥ 30).
RESULTS


At 6 years follow-up there were no differences in mean BMI (kg/m 2 ) (24.0 ± 3.8 versus 24.8 ± 4.0,  p  = .37), physical activity level (4167 ± 2638 versus 3925 ± 3075 MET-min/week,  p  = .67) or recreational exercise (630 ± 1290 versus 720 ± 1005 MET-min/week,  p  = .88) between the intervention and control group, respectively. Subgroup analysis of participants with high adherence during the intervention 6 years ago (≥24 prenatal exercise classes), showed a positive intervention effect at long-term follow up in body weight (kg) (62.8 ± 7.9 versus 70.8 ± 11.8,  p  = .03) and BMI (kg/m 2 ) (22.5 ± 3.1 versus 24.8 ± 4.0,  p  = .05), and none (versus 11 in the control group) had gained ≥5 kg compared to prepregnancy weight ( p  = .02).
CONCLUSIONS


Women who adhered to the original prenatal exercise intervention demonstrated significantly lower body weight and BMI at 6-year follow-up. Otherwise, no long-term intervention effect was observed.",2021,"At 6 years follow-up there were no differences in mean BMI (kg/m 2 ) (24.0 ± 3.8 versus 24.8 ± 4.0,  p  = .37), physical activity level (4167 ± 2638 versus 3925 ± 3075 MET-min/week,  ","['105 participants initially randomized to either an', '80 women (76.2%) participated in the present long-term follow-up study, performed in a general community in Oslo, Norway']","['intervention group,  n \u2009=\u200952 (twice weekly group-exercises and physical activity counselling) or control group,  n \u2009=\u200953 (standard prenatal care', 'prenatal exercise intervention', 'original prenatal exercise intervention', 'recreational exercise', 'prenatal exercise program']","['body weight, body mass index, and physical activity level', 'modified Physical Activity and Pregnancy Questionnaire (PAPQ', 'Body weight', 'physical activity level and recreational exercise', 'physical activity level', 'mean BMI', 'body weight and BMI', 'body weight, weight retention and body mass index (BMI']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",105.0,0.0943391,"At 6 years follow-up there were no differences in mean BMI (kg/m 2 ) (24.0 ± 3.8 versus 24.8 ± 4.0,  p  = .37), physical activity level (4167 ± 2638 versus 3925 ± 3075 MET-min/week,  ","[{'ForeName': 'Lene A H', 'Initials': 'LAH', 'LastName': 'Haakstad', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Iselin', 'Initials': 'I', 'LastName': 'Kissel', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Bø', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1636028']
43,32259647,The possible use of precision tinted lenses to improve social cognition in children with autism spectrum disorders.,"A masked randomised control design compared the effectiveness of precision ophthalmic tints in improving the recognition of emotion in Autism Spectrum Disorders (ASD). Fourteen children aged 10-14 with ASD and 14 control children matched on verbal and non-verbal IQ, wore spectacles with coloured lenses to complete two tasks that involved the observation of coloured video sequences in which social interactions were depicted. On one occasion (randomly first or second) the coloured lenses provided light of a colour that the child had one month previously selected as optimal for the clarity of text. On the other occasion the lenses differed in CIE UCS chromaticity by 0.077. Performance in the ASD group was superior in both social interaction tasks with the lenses that provided the optimal colour of light.",2020,A masked randomised control design compared the effectiveness of precision ophthalmic tints in improving the recognition of emotion in Autism Spectrum Disorders (ASD).,"['children with autism spectrum disorders', 'Fourteen children aged 10-14 with ASD and 14 control children matched on verbal and non-verbal IQ, wore spectacles with coloured lenses', 'Autism Spectrum Disorders (ASD']","['precision tinted lenses', 'precision ophthalmic tints']","['CIE UCS chromaticity', 'social cognition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]","[{'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0010214', 'cui_str': 'Countercurrent electrophoresis measurement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",14.0,0.0151303,A masked randomised control design compared the effectiveness of precision ophthalmic tints in improving the recognition of emotion in Autism Spectrum Disorders (ASD).,"[{'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Ludlow', 'Affiliation': 'University of Hertfordshire, School of Psychology and Sports Sciences, College Lane, Hatfield AL10 9AB, United Kingdom. Electronic address: a.ludlow@herts.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Giannadou', 'Affiliation': 'University of Sheffield, Department of Psychology, 1 Vicar Lane, Sheffield S1 2LT, United Kingdom. Electronic address: agiannadou1@sheffield.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Franklin', 'Affiliation': 'University of Sussex, School of Psychology, Falmer BN1 9QH, United Kingdom. Electronic address: Anna.Franklin@sussex.ac.uk.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Allen', 'Affiliation': 'Anglia Ruskin University, Department of Vision and Hearing Sciences & Vision and Eye Research Unit, Cambridgeshire CB1 1PT, United Kingdom. Electronic address: peter.allen@anglia.ac.uk.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Simmons', 'Affiliation': 'University of Glasgow, School of Psychology, 62 Hillhead Street, Glasgow G12 8QB, United Kingdom. Electronic address: David.Simmons@glasgow.ac.uk.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Wilkins', 'Affiliation': 'University of Essex, Department of Psychology, Wivenhoe Park, Colchester CO4 3SQ, United Kingdom. Electronic address: arnold@essex.ac.uk.'}]",Vision research,['10.1016/j.visres.2020.03.007']
44,32293044,Systemic Effects of Cryolipolysis in Central Obese Women: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


To investigate the adding effect of Cryolipolysis to a low-calorie diet program on lipid profile, liver enzymes, body mass index, waist-to-hip ratio, and volume reduction of subcutaneous fat tissue in central obese women.
STUDY DESIGN/MATERIALS AND METHODS


Sixty central obese women were randomly divided into two equal groups. Women in the control group received prescribed low-calorie diet regimen only, while women in the study group received three Cryolipolysis sessions plus the same dietary regimen for 3 months. Assessment of women in each group for weight, height to obtain the body mass index, waist-to-hip ratio, and abdominal subcutaneous fat thickness as well as evaluation of lipid profile and liver enzymes was done just before starting the treatment procedures and immediately after ending the study duration.
RESULTS


There were statistically significant improvements of waist-to-hip ratio, body mass index, total cholesterol, triglycerides, low- and high-density lipoprotein, as well as liver enzymes in favor of the study group (P < 0.001).
CONCLUSION


Women who underwent Cryolipolysis and diet program had better improvement in components of lipid profile and liver enzymes than women who were maintained over diet program alone. Measures to decrease waist circumference, associated with abdominal subcutaneous fat reduction, enhanced the systemic effects of Cryolipolysis. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.",2020,"There were statistically significant improvements of waist-to-hip ratio, body mass index, total cholesterol, triglycerides, low- and high-density lipoprotein, as well as liver enzymes in favor of the study group (P < 0.001).
","['Sixty central obese women', 'central obese women', 'Central Obese Women']","['Cryolipolysis sessions plus the same dietary regimen', 'Cryolipolysis and diet program', 'Cryolipolysis', 'low-calorie diet regimen']","['lipid profile and liver enzymes', 'lipid profile, liver enzymes, body mass index, waist-to-hip ratio', 'waist circumference', 'systemic effects of Cryolipolysis', 'waist-to-hip ratio, body mass index, total cholesterol, triglycerides, low- and high-density lipoprotein, as well as liver enzymes']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",,0.0357601,"There were statistically significant improvements of waist-to-hip ratio, body mass index, total cholesterol, triglycerides, low- and high-density lipoprotein, as well as liver enzymes in favor of the study group (P < 0.001).
","[{'ForeName': 'Nabil M', 'Initials': 'NM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Department of Physical Therapy, Basic Science, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed E', 'Initials': 'AE', 'LastName': 'Elerian', 'Affiliation': 'Department of Physical Therapy, Basic Science, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ayman M', 'Initials': 'AM', 'LastName': 'Elmakaky', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, South Valley University, Qena, Egypt.'}, {'ForeName': 'Dina M A', 'Initials': 'DMA', 'LastName': 'Alhamaky', 'Affiliation': 'Department of Physical Therapy for Musculoskeletal Disorders and Its Surgery, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}]",Lasers in surgery and medicine,['10.1002/lsm.23250']
45,32297054,Laparoscopically guided transversus abdominis plane block offers better pain relief after laparoscopic cholecystectomy: results of a triple blind randomized controlled trial.,"BACKGROUND


Transversus abdominis plane (TAP) block is a regional anaesthetic technique providing analgesia to the parietal peritoneum, muscles and skin of the anterior abdominal wall innervated by somatic nerves T6 to L1. We present the results of our randomized triple blind study comparing laparoscopically guided TAP block with the commonly used port site local anaesthetic infiltration for pain relief after laparoscopic cholecystectomy.
METHODS


A hundred patients with symptomatic gallstones planned for laparoscopic cholecystectomy were randomized into two groups of TAP block and port site infiltration. Group A received 4-quadrant TAP block with 10 ml of 0.25% bupivacaine at each of the four sites guided laparoscopically and port site infiltration with 10 ml of normal saline at each of the 4 ports for blinding the surgeon. Group B received port site infiltration with 0.25% bupivacaine, and infiltration with normal saline at TAP block sites for blinding the surgeon. Post-operative pain (at 3, 6, 24 h and 1-week post-operative) (VAS), time to return to activities of daily living and patient satisfaction (Capuzzo Score) were recorded by an observer blinded towards the groups of the patients.
RESULTS


The median VAS at 3, 6, 24 h, at discharge, and 1-week post-operative were lesser in Group A compared to Group B (p ≤ 0.001 for all). The median duration of hospital stay was also lesser in Group A compared to Group B (p = 0.48, not significant) as was the time to return to activities (p < 0.05). The median Capuzzo score was higher in Group A compared to Group B (p < 0.001).
CONCLUSION


This study shows that laparoscopically guided TAP block is a safe and easy-to-use technique. It reduces the severity of post-operative pain, helps in quick recovery, early discharge and improved patient satisfaction after laparoscopic cholecystectomy. Clinical Trials Registry of India 020227.",2021,"The median Capuzzo score was higher in Group A compared to Group B (p < 0.001).
","['after laparoscopic cholecystectomy', 'pain relief after laparoscopic cholecystectomy', 'A hundred patients with symptomatic gallstones planned for laparoscopic cholecystectomy']","['4-quadrant TAP block with 10\xa0ml of 0.25% bupivacaine', 'port site infiltration with 0.25% bupivacaine, and infiltration with normal saline at TAP block sites for blinding the surgeon', 'laparoscopically guided TAP block', 'guided laparoscopically and port site infiltration with 10\xa0ml of normal saline', 'Transversus abdominis plane (TAP) block', 'TAP block and port site infiltration', 'Laparoscopically guided transversus abdominis plane block']","['median VAS', 'median Capuzzo score', 'time to return to activities of daily living and patient satisfaction (Capuzzo Score', 'severity of post-operative pain, helps in quick recovery, early discharge and improved patient satisfaction', 'Post-operative pain', 'pain relief', 'time to return to activities', 'median duration of hospital stay']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.224121,"The median Capuzzo score was higher in Group A compared to Group B (p < 0.001).
","[{'ForeName': 'Anubhav', 'Initials': 'A', 'LastName': 'Vindal', 'Affiliation': 'Division of Minimal Access Surgery, Department of Surgery, Maulana Azad Medical College (University of Delhi), New Delhi, India. avindal.mamc@gmail.com.'}, {'ForeName': 'Hitesh', 'Initials': 'H', 'LastName': 'Sarda', 'Affiliation': 'Division of Minimal Access Surgery, Department of Surgery, Maulana Azad Medical College (University of Delhi), New Delhi, India.'}, {'ForeName': 'Pawanindra', 'Initials': 'P', 'LastName': 'Lal', 'Affiliation': 'Division of Minimal Access Surgery, Department of Surgery, Maulana Azad Medical College (University of Delhi), New Delhi, India.'}]",Surgical endoscopy,['10.1007/s00464-020-07558-9']
46,32280940,Safety and tolerability of injectable Rilpivirine LA in HPTN 076: A phase 2 HIV pre-exposure prophylaxis study in women.,"Background


Daily oral TDF/FTC is protective against HIV infection when used for pre-exposure prophylaxis (PrEP). However, daily adherence to oral PrEP is difficult for many; therefore, finding alternative PrEP strategies remains a priority. HPTN 076 evaluated the long-acting injectable form of rilpivirine (RPV), known as RPV LA for safety, pharmacokinetics and acceptability.
Methods


HPTN 076 (NTC 02165202) was a phase 2, double-blind, 2:1 randomized trial comparing the safety of 1200mg RPV LA (LA) to placebo (P). The study included a 28-day oral run-in phase of daily, self- administered oral RPV (25 mg), with directly observed oral dosing about six times. Of 136 enrolled sexually active, HIV-uninfected, low HIV-risk African (100) and US (36) adult women, injectable product was administered in two gluteal, intramuscular (IM) injections once every eight weeks to 122 participants following the oral run-in phase. A maximum of six injection time points occurred over a 48-week period. Acceptability, safety, tolerability and pharmacokinetic (PK) data were collected throughout the study. This paper includes primary endpoint data collected up to the week 52 post enrollment.
Findings


The median age of the enrolled population was 31 years (IQR: 25,38), median weight 75 kg (IQR: 64, 89), median body mass index (BMI) 30 (IQR: 27, 35), 46% married, 94% Black and 60% unemployed. A total of 122 (80 LA, 42 P) women received at least one injection and 98 (64 LA, 34 P) received all six injections. During the injection phase, three women withdrew from the study (2 LA, 1 P) and 16 women discontinued study product (10 LA, 6 P). Fourteen women (11 LA and 3 P) discontinued oral study product and did not enter the injection phase. Study product discontinuations were not significantly different between the two arms throughout. Of the product discontinuations in the injection phase, 8% in LA and 5% in P arm were due to adverse events (AEs), including one randomized to the P arm with prolonged QTc interval on EKG. The proportion of women who experienced Grade 2 or higher AEs during the injection phase as the primary outcome was not significantly different between the two arms [73.8%, 95% CI: (63.2%, 82.1%) for LA and 73.8%, 95% CI: (58.9%, 84.7%), p>0.99]. Transient Grade ≥2 liver abnormalities occurred in 14% of women in the LA arm compared with 12% in P arm. Three LA women (4%) developed Grade 3 injection site reactions compared with none in P arm. In participants who received at least 1 injection, the geometric mean of overall RPV trough concentrations (C trough ) was 62.2 ng/mL. In participants who received all six injections, the geometric mean of C Trough  through the injection phase and after the last injection were 72.8 ng/mL and 100.9 ng/mL, respectively. At week 52 (eight weeks after last injection), the geometric mean of RPV C trough  was 75.0 ng/mL. At the last injection visit (Week 44), 80 % of women who answered acceptability questions strongly agreed that they would think about using- and 68% that they would definitely use a PrEP injectable in the future.
Interpretation


RPV LA IM injections every eight weeks in African and US women were safe and acceptable. Overall, despite more injection site reactions and pain in the participants receiving RPV LA the injections were well tolerated. Data from this study support the further development of injectable PrEP agents.",2020,Transient Grade ≥2 liver abnormalities occurred in 14% of women in the LA arm compared with 12% in P arm.,"['HPTN 076', 'Fourteen women (11 LA and 3 P) discontinued oral study product and did not enter the injection phase', 'women', '136 enrolled sexually active, HIV-uninfected, low HIV-risk African (100) and US (36) adult women', 'The median age of the enrolled population was 31 years (IQR: 25,38), median weight 75 kg (IQR: 64, 89), median body mass index (BMI) 30 (IQR: 27, 35), 46% married, 94% Black and 60% unemployed']","['RPV LA (LA) to placebo (P', 'TDF/FTC', 'rilpivirine (RPV', 'injectable Rilpivirine LA', 'self- administered oral RPV']","['Grade 3 injection site reactions', 'geometric mean of overall RPV trough concentrations', 'tolerated', 'Safety and tolerability', 'geometric mean of RPV C trough', 'Transient Grade ≥2 liver abnormalities', 'injection site reactions and pain', 'safety, pharmacokinetics and acceptability', 'Acceptability, safety, tolerability and pharmacokinetic (PK) data']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}]","[{'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",14.0,0.319514,Transient Grade ≥2 liver abnormalities occurred in 14% of women in the LA arm compared with 12% in P arm.,"[{'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'E E', 'Initials': 'EE', 'LastName': 'Tolley', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Justman', 'Affiliation': 'ICAP at Columbia University, New York, NY, USA.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Mgodi', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chirenje', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Adeyeye', 'Affiliation': 'DAIDS/NIAID/NIH, Rockville, MD, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Farrior', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piwowar-Manning', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Eshelman', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Redinger', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Johnson and Johnson Global Public Health, Belgium.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Sista', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100303']
47,31776012,Selective local anesthesia versus corticosteroid infiltration on low back pain: a randomized clinical trial.,"ANTECEDENTS AND OBJECTIVE


Local infiltrations are second line therapy in the treatment of chronic low back pain, although their use is controversial in the literature. Our objective was to compare the effectiveness of 2 types of infiltration at the paravertebral lumbar level in two groups of patients diagnosed with low back pain: corticosteroids, and selective local anaesthetic administered using segmental neural therapy (SNT).
MATERIAL AND METHODS


Double-blind clinical trial in 55 patients diagnosed with low back pain in the neurosurgery department of the Hospital Central de la Defensa Gómez Ulla. Patients were randomised to 2 treatment groups to receive either paravertebral injections of corticosteroids or SNT. Outcomes were measured using a visual analogue scale, the Oswestry Disability Index, the Short Form-36, and patient satisfaction at the start of treatment (baseline) and at 3 and 12 months post intervention.
RESULTS


The combined treatment group showed a statistically significant improvement in Oswestry Disability Index at 3 months. The SNT group showed a statistically significant improvement in baseline visual analogue scale vs. visual analogue scale at 3 (1.398cm, p=0.001) and 12 months (0.791cm, p=0.007). No differences were observed in the remaining variables measured. The percentage of patients that would repeat the treatment was 81% and 83%, respectively.
CONCLUSIONS


Significant pain relief was achieved with SNT, and disability improved with the combined treatment. Although clinical improvement was limited, patients were satisfied. Local infiltrations should be considered as an alternative treatment for chronic low back pain.
CLINICAL TRIAL REGISTRATION


This clinical trial was registered at the European Union Clinical Trials Register with EUDRA-CT number 2015-001146-29.",2020,"The SNT group showed a statistically significant improvement in baseline visual analogue scale vs. visual analogue scale at 3 (1.398cm, p=0.001) and 12 months (0.791cm, p=0.007).","['low back pain', '55 patients diagnosed with low back pain in the neurosurgery department of the Hospital Central de la Defensa Gómez Ulla', 'patients diagnosed with low back pain']","['corticosteroids, and selective local anaesthetic administered using segmental neural therapy (SNT', 'paravertebral injections of corticosteroids or SNT', 'Selective local anesthesia versus corticosteroid infiltration']","['baseline visual analogue scale vs. visual analogue scale', 'pain relief', 'Oswestry Disability Index', 'visual analogue scale, the Oswestry Disability Index, the Short Form-36, and patient satisfaction']","[{'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0394673', 'cui_str': 'Scar infiltration (procedure)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",,0.231068,"The SNT group showed a statistically significant improvement in baseline visual analogue scale vs. visual analogue scale at 3 (1.398cm, p=0.001) and 12 months (0.791cm, p=0.007).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Valencia Moya', 'Affiliation': 'Servicio de Neurocirugía, Hospital Central de la Defensa Gómez Ulla, Madrid, España. Electronic address: avalmo1@oc.mde.es.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Navarro Suay', 'Affiliation': 'Servicio de Anestesia y Reanimación, Hospital Central de la Defensa Gómez Ulla, Madrid, España.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Fernández González', 'Affiliation': 'Servicio de Neurocirugía, Hospital Central de la Defensa Gómez Ulla, Madrid, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gutiérrez Ortega', 'Affiliation': 'Servicio de Medicina Preventiva, Hospital Central de la Defensa Gómez Ulla, Madrid, España.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Panadero Useros', 'Affiliation': 'Servicio de Neurocirugía, Hospital Central de la Defensa Gómez Ulla, Madrid, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mestre Moreiro', 'Affiliation': 'Servicio de Neurocirugía, Hospital Central de la Defensa Gómez Ulla, Madrid, España.'}]",Revista espanola de anestesiologia y reanimacion,['10.1016/j.redar.2019.08.005']
48,31968400,Comparison of Allen Carr's Easyway programme with a specialist behavioural and pharmacological smoking cessation support service: a randomized controlled trial.,"BACKGROUND AND AIMS


A combination of behavioural and pharmacological support is judged to be the optimal approach for assisting smoking cessation. Allen Carr's Easyway (ACE) is a single-session pharmacotherapy-free programme that has been in operation internationally for 38 years. We compared the effectiveness of ACE with specialist behavioural and pharmacological support delivered to the national standard in England.
DESIGN


A two-arm, parallel-group, single-blind, randomized controlled trial.
SETTING


London, UK, between February 2017 and May 2018.
PARTICIPANTS


A total of 620 participants (310 in ACE and 310 in the combined behavioural and pharmacological support condition) were included in the analysis. Adult (≥ 18 years) smokers wanting to quit were randomized in a 1 : 1 ratio. Mean age for the total sample was 40.8 years, with 53.4% being male. Participant baseline characteristics (ethnicity, educational level, number of previous quit attempts, nicotine dependence) were evenly balanced between treatment groups.
INTERVENTION AND COMPARATOR


The intervention was the ACE method of stopping smoking. This centres on a 4.5-6-hour session of group-based support, alongside subsequent text messages and top-up sessions if needed. It aims to make it easy to stop smoking by convincing smokers that smoking provides no benefits for them. The comparator was a specialist stop smoking service (SSS) providing behavioural and pharmacological support in accordance with national standards.
MEASUREMENTS


The primary outcome was self-reported continuous abstinence for 26 weeks from the quit/quit re-set date verified by exhaled breath carbon monoxide measurement < 10 parts per million (p.p.m.). Primary analysis was by intention to treat. Secondary outcomes were: use of pharmacotherapy, adverse events and continuous abstinence up to 4 and 12 weeks.
FINDINGS


A total of 468 participants attended treatment (255 ACE versus 213 SSS, P < 0.05). Of those who did attend treatment, 100 completed 6-month measures (23.7% ACE versus 20.7% SSS). Continuous abstinence to 26 weeks was 19.4% (60 of 310) in the ACE intervention and 14.8% (46 of 310) in the SSS intervention [risk difference for ACE versus SSS 4.5% (95% confidence interval (CI) = -1.4 to 10.4%, odds ratio (OR) = 1.38)]. The Bayes factor for superiority of the ACE condition was 1.24.
CONCLUSION


There was no clear evidence of a difference in the efficacies of the Allen Carr's Easyway (ACE) and specialist smoking cessation support involving behavioural support and pharmacotherapy.",2020,There was no clear evidence of a difference in the efficacies of the Allen Carr's Easyway (ACE) and specialist smoking cessation support involving behavioural support and pharmacotherapy.,"['Mean age for the total sample was 40.8\xa0years, with 53.4% being male', '468 participants attended treatment (255 ACE versus 213 SSS, P\xa0<\xa00.05', 'A total of 620 participants (310 in ACE and 310 in the combined behavioural and pharmacological support condition', 'London, UK, between February 2017 and May 2018', 'Adult (≥ 18\xa0years) smokers wanting to quit']","['ACE', 'specialist behavioural and pharmacological smoking cessation support service']","['Participant baseline characteristics (ethnicity, educational level, number of previous quit attempts, nicotine dependence', 'use of pharmacotherapy, adverse events and continuous abstinence up to 4 and 12\xa0weeks', 'self-reported continuous abstinence for 26\xa0weeks from the quit/quit re-set date verified by exhaled breath carbon monoxide measurement']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}]","[{'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0201932', 'cui_str': 'Carboxyhemoglobin measurement (procedure)'}]",468.0,0.167735,There was no clear evidence of a difference in the efficacies of the Allen Carr's Easyway (ACE) and specialist smoking cessation support involving behavioural support and pharmacotherapy.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Frings', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Albery', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Antony C', 'Initials': 'AC', 'LastName': 'Moss', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brunger', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Meda', 'Initials': 'M', 'LastName': 'Burghelea', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, UK.""}, {'ForeName': 'Kerry V', 'Initials': 'KV', 'LastName': 'Wood', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14897']
49,31691413,High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial.,"AIMS


To test the efficacy of a therapist-guided high-intensity internet intervention compared with an unguided low-intensity internet intervention among individuals with alcohol use disorder.
DESIGN


A three-group randomized controlled trial with follow-up assessments post-treatment (12 weeks) and 6 months post-randomization (primary end-point).
SETTINGS


General population sample in Sweden.
PARTICIPANTS


A total of 166 on-line self-referred adults (49% males) with a score of 14 (females)/16 (males) or more on the Alcohol Use Disorders Identification Test, a preceding week alcohol consumption of 11 (females)/14 (males) or more standard drinks and an alcohol use disorder according to a diagnostic interview.
INTERVENTIONS AND COMPARATORS


Both the high- (n = 72) and low-intensity internet interventions (n = 71) consisted of modules based on relapse prevention. Controls were on a waiting-list (n = 23), and were only followed until the post-treatment follow-up. Participants were randomized at a 7 : 7 : 2 ratio.
MEASUREMENTS


Primary outcome was self-reported alcohol consumption in the preceding week measured as (1) number of standard drinks and (2) number of heavy drinking days at the 6-month follow-up.
FINDINGS


Alcohol use disorders were largely in the severe category (74.7%), with the majority of participants having had alcohol problems for more than 5 years. Attrition was 13 and 22% at the post-treatment and 6-month follow-up, respectively. At the 6-month follow-up, an intent-to-treat analysis showed no significant differences in alcohol consumption between the high- and low-intensity interventions [standard drinks d = -0.17, 95% confidence interval (CI) = -0.50 to 0.16; heavy drinking days: d = -0.07, 95% CI = -0.40 to 0.26]. Prevalence of negative effects was somewhat low (8-14%) in both intervention groups, as was deterioration (3-5%).
CONCLUSIONS


At 6-month follow-up, there were no significant differences between a therapist-guided high-intensity internet intervention and an unguided low-intensity internet intervention in reducing alcohol consumption among individuals with an alcohol use disorder.",2020,"At six-month follow-up, there were no significant differences between a therapist-guided high-intensity internet intervention and an unguided low-intensity internet intervention in reducing alcohol consumption among individuals with an alcohol use disorder.","['individuals with an alcohol use disorder', 'alcohol use disorders', 'individuals with alcohol use disorder', '166 online self-referred adults (51% females) with a score of 14 (females)/16 (males) or more on the Alcohol Use Disorders Identification Test, a preceding week alcohol consumption of 11 (females)/14 (males) or more standard drinks and an alcohol use disorder according to a diagnostic interview', 'General population sample in Sweden']","['therapist-guided high-intensity internet intervention', 'unguided low-intensity internet intervention', 'High- versus low-intensity internet interventions', 'high-intensity internet intervention', 'low-intensity internet intervention']","['alcohol problems', 'alcohol consumption', 'self-reported alcohol consumption in the preceding week measured as 1) number of standard drinks and 2) number of heavy drinking days', 'Prevalence of negative effects']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C3266254', 'cui_str': 'Referred by self (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",166.0,0.0614733,"At six-month follow-up, there were no significant differences between a therapist-guided high-intensity internet intervention and an unguided low-intensity internet intervention in reducing alcohol consumption among individuals with an alcohol use disorder.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sundström', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Eék', 'Affiliation': 'Department of Psychology, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kraepelien', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Fahlke', 'Affiliation': 'Department of Psychology, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Gajecki', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Jakobson', 'Affiliation': 'Stockholm County Council, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Beckman', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.14871']
50,31908066,"Clinical effects beyond cocaine use of sustained-release dexamphetamine for the treatment of cocaine dependent patients with comorbid opioid dependence: secondary analysis of a double-blind, placebo-controlled randomized trial.","BACKGROUND AND AIMS


Sustained-release (SR) formulations of dexamphetamine and mixed amphetamine salts have shown positive effects in the treatment of patients with a cocaine use disorder. We previously demonstrated the efficacy of SR-dexamphetamine for patients with cocaine dependence in terms of cocaine use reductions. In this secondary analysis, we assessed whether SR-dexamphetamine treatment also improves the health status of these patients.
DESIGN


Multi-centre randomized, double-blind placebo-controlled trial.
SETTING


Four supervised heroin-assisted treatment (HAT) out-patient clinics in the Netherlands. In HAT, methadone treatment-refractory opioid-dependent patients can self-administer individually titrated doses of pharmaceutical grade diacetylmorphine, coprescribed with oral methadone.
PARTICIPANTS


Seventy-three cocaine-dependent patients (90% males; average age = 48.7 years), participating in HAT for their treatment-refractory comorbid opioid dependence.
INTERVENTIONS


Twelve weeks pharmacotherapy with once-daily, supervised intake of two tablets of SR-dexamphetamine (2 × 30 mg/day) or two identical placebo tablets.
MEASUREMENTS


Assessment every 4 weeks: cocaine use (time-line follow-back), physical health (Maudsley Addiction Profile-Health Symptoms Scale), mental health (Brief Symptom Inventory) and illegal activities (Addiction Severity Index). Primary outcome was 'overall health', a dichotomous, multi-domain response index based on physical health, mental health and social functioning.
FINDINGS


Compared with placebo, SR-dexamphetamine resulted in larger increases in the number of cocaine abstinent days (P = 0.004) and the proportion of overall health treatment responders (P = 0.045) from the 4 weeks preceding baseline to the final 4 weeks of treatment. While the number of cocaine abstinent days was not associated with overall health in the total study sample, it was positively associated with overall health among patients in poor overall health at the start of SR-dexamphetamine treatment (n = 50), i.e. patients with the potential to improve on this multi-domain response index (odds ratio = 1.076; 95% confidence interval = 1.025-1.130).
CONCLUSIONS


SR-dexamphetamine reduces cocaine use and may improve clinically relevant health-related outcomes in patients with cocaine dependence who are participating in heroin-assisted treatment for their comorbid heroin dependence.",2020,"Compared with placebo, SR-dexamphetamine resulted in larger increases in the number of cocaine abstinent days (P = 0.004) and the proportion of overall health treatment responders (P = 0.045) from the 4 weeks preceding baseline to the final 4 weeks of treatment.","['Four supervised heroin-assisted treatment (HAT) out-patient clinics in the Netherlands', 'Seventy-three cocaine-dependent patients (90% males; average age\xa0=\xa048.7\xa0years), participating in HAT for their treatment-refractory comorbid opioid dependence', 'cocaine dependent patients with comorbid opioid dependence', 'patients with cocaine dependence who are participating in heroin-assisted treatment for their comorbid heroin dependence', 'patients with cocaine dependence in terms of cocaine use reductions', 'patients with a cocaine use disorder']","['placebo, SR-dexamphetamine', 'dexamphetamine and mixed amphetamine salts', 'pharmacotherapy with once-daily, supervised intake of two tablets of SR-dexamphetamine', 'cocaine', 'SR-dexamphetamine', 'placebo']","['cocaine use (time-line follow-back), physical health (Maudsley Addiction Profile-Health Symptoms Scale), mental health (Brief Symptom Inventory) and illegal activities (Addiction Severity Index', 'multi-domain response index', 'health status', 'overall health', ""overall health', a dichotomous, multi-domain response index based on physical health, mental health and social functioning"", 'proportion of overall health treatment responders', 'number of cocaine abstinent days']","[{'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444765', 'cui_str': 'Hat (physical object)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0524662', 'cui_str': 'Opiate Dependence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600427', 'cui_str': 'Cocaine Dependence'}, {'cui': 'C0019337', 'cui_str': 'Heroin Addiction'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0451543', 'cui_str': 'Time line follow back (assessment scale)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0585663', 'cui_str': 'Maudsley addiction profile (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index (assessment scale)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.395234,"Compared with placebo, SR-dexamphetamine resulted in larger increases in the number of cocaine abstinent days (P = 0.004) and the proportion of overall health treatment responders (P = 0.045) from the 4 weeks preceding baseline to the final 4 weeks of treatment.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Blanken', 'Affiliation': 'Parnassia Addiction Research Centre (PARC), Brijder Verslavingszorg, The Hague, the Netherlands.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': 'Nuijten', 'Affiliation': 'Parnassia Addiction Research Centre (PARC), Brijder Verslavingszorg, The Hague, the Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'van den Brink', 'Affiliation': 'Department of Psychiatry, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Vincent M', 'Initials': 'VM', 'LastName': 'Hendriks', 'Affiliation': 'Parnassia Addiction Research Centre (PARC), Brijder Verslavingszorg, The Hague, the Netherlands.'}]","Addiction (Abingdon, England)",['10.1111/add.14874']
51,32153208,Randomized Feasibility Study of Meditative Practices in Hospitalized Cancer Patients.,"Introduction:  There is limited research regarding the benefits of mind-body practices such as meditation in hospitalized patients with an active diagnosis of any cancer type.  Methods:  We conducted a prospective, randomized, clinical trial (NCT03445572) comparing 2 meditative practices-Isha Kriya (IK) and meditative slow breathing (MSB)-versus wait-list controls in hospitalized cancer patients. Our aim was to determine the feasibility of meditation practice in cancer inpatients. Feasibility was defined as recruitment of more than 50% of the eligible patients approached and at least 60% of the patients having meditated at least 4 days by day 7. Acceptability was assessed on day 7 as a positive response on at least 2 questions on the modified Global Symptom Evaluation (GSE) scale.  Results:  Forty patients (39% of the eligible patients approached) consented to participate in the study and were randomly assigned to the MSB (n = 13), IK (n = 14), or wait-list (n = 13) groups. Of the 27 patients assigned to receive MSB and IK meditations, day 7 data were available for 18 patients. Fifteen of the 18 patients meditated at least once in the first 7 days, and most (12/15) responded positively on the GSE.  Conclusion:  Both IK and MSB meditations were acceptable among the hospitalized cancer patients. Feasibility for enrollment and practice was likely not achieved due to limited uninterrupted time for daily meditation, high levels of morbidity in some participants, and limited research staff support. Shorter term outcomes should be explored in future meditation studies involving hospitalized cancer patients.",2020,Acceptability was assessed on day 7 as a positive response on at least 2 questions on the modified Global Symptom Evaluation (GSE) scale.  ,"['hospitalized cancer patients', 'Results:  Forty patients (39% of the eligible patients approached) consented to participate in the study', '27 patients assigned to receive MSB and IK meditations, day 7 data were available for 18 patients', 'Hospitalized Cancer Patients', 'hospitalized patients with an active diagnosis of any cancer type', 'cancer inpatients']","['MSB', 'meditation practice', 'Meditative Practices', 'meditative practices-Isha Kriya (IK) and meditative slow breathing (MSB)-versus wait-list controls']","['Acceptability', 'Feasibility', 'modified Global Symptom Evaluation (GSE) scale']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0150277'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0150277'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration (finding)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0222045'}]",,0.119082,Acceptability was assessed on day 7 as a positive response on at least 2 questions on the modified Global Symptom Evaluation (GSE) scale.  ,"[{'ForeName': 'Santhosshi', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lopez', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Manzano', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Williams', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Smitha', 'Initials': 'S', 'LastName': 'Mallaiah', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'George', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Amaram', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Balachandar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Integrative cancer therapies,['10.1177/1534735420909903']
52,32229771,Protein Supplementation and Resistance Training in Childhood Cancer Survivors.,"PURPOSE


Muscle weakness, low lean body mass, and poor physical performance are prevalent among adult survivors of childhood cancer (survivors). We evaluated the feasibility and effects of resistance training with and without protein supplementation on lean body mass and muscle strength among survivors.
METHODS


This double-blind placebo-controlled trial enrolled survivors ≥18 to <45 yr old. Participants were randomized to resistance training with protein supplement (21 g whey protein per day, 90 kcal) (RT + S) or resistance training with placebo (sucrose, 90 kcal) (RT + P). Participants received educational materials, access to a local fitness center, and a tailored resistance training program with tapered supervision. Participant retention and adherence were used to evaluate feasibility. Lean body mass and muscle strength were assessed at baseline and 24 wk, using dual x-ray absorptiometry, and dynamometer testing or one-repetition maximum testing, respectively. Mean changes were compared with two-way ANOVA.
RESULTS


Of 70 participants randomized, 57 completed the 24-wk intervention (24 in RT + S, 33 in RT + P). The RT + S group completed 74.8% and the RT + P group completed 67.0% of exercise sessions. Mean ± SD age for those who completed was 33.1 ± 7.0 yr, 67% were White and 47% female. There were no differences in change in lean mass (RT + S, 1.05 ± 2.34 kg; RT + P, 0.13 ± 2.19 kg; P = 0.10) or strength (grip RT + S, 1.65 ± 4.17 kg; RT + P, 1.63 ± 4.47 kg; P = 0.98; mean leg press RT + S, 58.4 ± 78.8 kg; RT + P, 51.0 ± 65.1 kg; P = 0.68) between groups. Both lean mass (P = 0.03) and strength (grip P = 0.003, leg press P < 0.001) increased over time.
CONCLUSIONS


Supervised resistance training among survivors with protein supplementation is feasible but not more effective at increasing total lean body mass than resistance training alone.",2020,"Both lean mass (p=0.03) and strength (grip p=0.003, leg press p<0.001) increased over time.
","['Childhood Cancer Survivors', 'adult survivors of childhood cancer (survivors', 'Mean age for those who completed was 33.1 years (SD 7.0), 67% were white and 47% female', 'controlled trial enrolled survivors aged ≥18 to <45 years', 'Of 70 participants randomized, 57 completed the 24-week intervention (24 in RT+S, 33 in RT+P', 'survivors']","['RT+S', 'placebo', 'Supervised resistance training', 'resistance training with protein supplement (21g whey protein/day, 90kcal) (RT+S) or resistance training with placebo (sucrose, 90kcal) (RT+P', 'Protein Supplementation and Resistance Training', 'RT+P', 'educational materials, access to a local fitness center, and a tailored resistance training program with tapered supervision', 'resistance training with and without protein supplementation']","['lean mass', 'strength (grip p=0.003, leg press p<0.001) increased over time', 'Lean body mass and muscle strength', 'lean body mass and muscle strength']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C1959943', 'cui_str': '21G (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0600623', 'cui_str': 'Fitness Centers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",70.0,0.159499,"Both lean mass (p=0.03) and strength (grip p=0.003, leg press p<0.001) increased over time.
","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Krull', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Howell', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Robyn E', 'Initials': 'RE', 'LastName': 'Partin', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lanctot', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Phipps', 'Affiliation': ""Department of Psychology, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Klosky', 'Affiliation': ""Department of Pediatrics, Emory University School of Medicine, and the Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Carney', 'Affiliation': ""Department of Clinical Nutrition, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Mulrooney', 'Affiliation': ''}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Robison', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ''}, {'ForeName': 'Kirsten K', 'Initials': 'KK', 'LastName': 'Ness', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002345']
53,32277357,The effect of stoma size on the mid-term weight loss outcome of one anastomosis gastric bypass (OAGB): a single-blinded prospective randomized trial.,"BACKGROUND


One anastomosis gastric bypass (OAGB) is gaining wide spread acceptance among bariatric surgeons all over the world because of its technical simplicity and documented efficacy. However, the relation between stoma size in OAGB and magnitude of weight loss has not been addressed.
OBJECTIVES


To evaluate the effect of stoma size on the mid-term weight loss outcome for patients with obesity after OAGB.
SETTING


University Hospital.
MATERIALS AND METHODS


This is a single-blinded prospectively randomized trial. From March 2014 to September 2016, 83 patients, eligible for bariatric surgery, were included in the study. OAGB was carried out with the same technical steps, except for the size of the gastrojejunostomy (GJ). Patients were randomly allocated into two equal groups; narrow GJ group (30 mm) and wide GJ group (45 mm). The percentage of total weight loss (%TWL) and the percentage of excess weight loss (%EWL) were recorded at 6, 12 and 24 months after procedure.
RESULTS


At 6 months follow-up, patients with 30 mm GJ had better %EWL (53.3) and %TWL (23.4) than other patients with 45 mm GJ (42.6 and 18.2 respectively). However, at 12 and 24 months the %TWL and %EWL difference between the two groups have disappeared.
CONCLUSION


Patients with narrower stoma size (30 mm) of OAGB tend initially to lose more weight than patients with wider stoma (45 mm). However, this difference disappears at mid-term follow-up after 2 years.",2021,"At 6 months follow-up, patients with 30 mm GJ had better %EWL (53.3) and %TWL (23.4) than other patients with 45 mm GJ (42.6 and 18.2 respectively).","['From March 2014 to September 2016, 83 patients, eligible for bariatric surgery, were included in the study', 'University Hospital', 'patients with obesity after OAGB', 'Patients with narrower stoma size (30\xa0mm) of']","['narrow GJ group (30\xa0mm) and wide GJ', 'anastomosis gastric bypass (OAGB', 'OAGB']",['percentage of total weight loss (%TWL) and the percentage of excess weight loss'],"[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0450396', 'cui_str': '30mm'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450396', 'cui_str': '30mm'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0410316,"At 6 months follow-up, patients with 30 mm GJ had better %EWL (53.3) and %TWL (23.4) than other patients with 45 mm GJ (42.6 and 18.2 respectively).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elgeidie', 'Affiliation': 'Department of Surgery, Gastrointestinal Surgical Center, Mansoura University, Jeehan street, Mansoura, Dakahlia, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelgawad', 'Affiliation': 'Department of Surgery, Gastrointestinal Surgical Center, Mansoura University, Jeehan street, Mansoura, Dakahlia, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Sorogy', 'Affiliation': 'Department of Surgery, Gastrointestinal Surgical Center, Mansoura University, Jeehan street, Mansoura, Dakahlia, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'El Nakeeb', 'Affiliation': 'Department of Surgery, Gastrointestinal Surgical Center, Mansoura University, Jeehan street, Mansoura, Dakahlia, Egypt.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Elrefai', 'Affiliation': 'Department of Surgery, Gastrointestinal Surgical Center, Mansoura University, Jeehan street, Mansoura, Dakahlia, Egypt. mohelrefai@hotmail.com.'}]",Surgical endoscopy,['10.1007/s00464-020-07553-0']
54,21953376,MRI of colorectal cancer liver metastases: comparison of orally administered manganese with intravenously administered gadobenate dimeglumine.,"OBJECTIVES


To compare the sensitivity of MRI to detect colorectal cancer liver metastases (CRLM) after ingestion of manganese-based contrast agent (CMC-001) with that of a comprehensive intravenous gadobenate dimeglumine protocol, and to assess the safety and acceptability of oral manganese.
METHODS


20 patients suspected of having 1-6 CRLM were included prospectively in this randomised cross-over study. Liver MRI was performed with a one-week interval at 1.5 T and included T1-w VIBE and T2-HASTE, before and after administration of 1.6 g CMC-001 or 0.1 mmol/kg gadobenate dimeglumine. The metastasis-to-liver signal intensity (SI) ratio was calculated. Standard of reference was histopathology after surgery, or combination of other imaging studies and/or follow up. Adverse events (AE) and clinicolaboratory tests were monitored.
RESULTS


Of 44 metastases, 41 were detected after CMC-001 (93%) and 42 after gadobenate dimeglumine (95%). Fifteen false-positive lesions were found after CMC-001 and 2 after gadobenate dimeglumine. The metastasis-to-liver SI ratio was significantly higher after CMC-001 than after gadobenate dimeglumine (0.51 and 0.21 respectively, P < 0.0001). More AE occurred after manganese compared to gadobenate dimeglumine.
CONCLUSIONS


CMC-001 is as sensitive as an extensive intravenous gadobenate dimeglumine protocol in detecting CRLM. It was relatively well tolerated but had higher rates of gastrointestinal AE.
KEY POINTS


• Liver MRI after ingestion of manganese is highly sensitive for detecting metastases • High false-positive rate necessitates further evaluation, in some cases • The MR examination time is short • Oral ingestion of manganese seems safe and relatively well tolerated by patients • Manganese compounds may be useful for liver metastasis surveillance after colorectal cancer.",2012,"The metastasis-to-liver SI ratio was significantly higher after CMC-001 than after gadobenate dimeglumine (0.51 and 0.21 respectively, P < 0.0001).","['colorectal cancer liver metastases', 'patients •', '20 patients suspected of having 1-6 CRLM']","['gadobenate dimeglumine', 'manganese with intravenously administered gadobenate dimeglumine', 'manganese-based contrast agent (CMC-001', 'CMC-001 or 0.1 mmol/kg gadobenate dimeglumine']","['metastasis-to-liver SI ratio', 'metastasis-to-liver signal intensity (SI) ratio', 'Adverse events (AE) and clinicolaboratory tests', 'safety and acceptability']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522483', 'cui_str': 'Patient suspected of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0209453', 'cui_str': 'Gadobenate dimeglumine'}, {'cui': 'C0373677', 'cui_str': 'Manganese measurement (procedure)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C1610505', 'cui_str': 'CMC-001'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439291', 'cui_str': 'umol/g'}]","[{'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver (disorder)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",20.0,0.0560463,"The metastasis-to-liver SI ratio was significantly higher after CMC-001 than after gadobenate dimeglumine (0.51 and 0.21 respectively, P < 0.0001).","[{'ForeName': 'Torkel B', 'Initials': 'TB', 'LastName': 'Brismar', 'Affiliation': 'Division of Medical Imaging and Technology, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. torkel.brismar@karolinska.se'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Kartalis', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kylander', 'Affiliation': ''}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Albiin', 'Affiliation': ''}]",European radiology,['10.1007/s00330-011-2288-y']
55,32205547,Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial.,"BACKGROUND


The present trial was designed to assess whether individualized strategies of fluid administration using a noninvasive plethysmographic variability index could reduce the postoperative hospital length of stay and morbidity after intermediate-risk surgery.
METHODS


This was a multicenter, randomized, nonblinded parallel-group clinical trial conducted in five hospitals. Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled. Individualized hemodynamic management aimed to achieve a plethysmographic variability index under 13%, and the standard management strategy aimed to maintain a mean arterial pressure above 65 mmHg during general anesthesia. The primary outcome was the postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient.
RESULTS


In total, 447 patients were randomized, and 438 were included in the analysis. The mean hospital length of stay ± SD was 6 ± 3 days for the plethysmographic variability index group and 6 ± 3 days for the control group (adjusted difference, 0.0 days; 95% CI, -0.6 to 0.5; P = 0.860); the theoretical postoperative hospital length of stay was 4 ± 2 days for the plethysmographic variability index group and 4 ± 1 days for the control group (P = 0.238). In the plethysmographic variability index and control groups, serious postoperative cardiac complications occurred in 3 of 217 (1%) and 2 of 224 (1%) patients (P = 0.681), acute postoperative renal failure occurred in 9 (4%) and 8 (4%) patients (P = 0.808), the troponin Ic concentration was more than 0.06 μg/l within 5 days postoperatively for 6 (3%) and 5 (2%) patients (P = 0.768), and the postoperative arterial lactate measurements were 1.44 ± 1.01 and 1.43 ± 0.95 mmol/l (P = 0.974), respectively.
CONCLUSIONS


Among intermediate-risk patients having orthopedic surgery with general anesthesia, fluid administration guided by the plethysmographic variability index did not shorten the duration of hospitalization or reduce complications.",2020,Plethysmographic-guided fluid management did not reduce the duration of hospitalization or complications in moderate-risk surgery patients.,"['Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled', '447 moderate-risk major arthroplasty patients to', 'intermediate-risk patients having orthopedic surgery with general anesthesia', '447 patients were randomized, and 438 were included in the analysis', 'moderate-risk surgery patients', 'five hospitals']","['Plethysmographic-guided fluid management', 'plethysmographic-guided versus routine fluid management', 'Individualized Fluid Management']","['theoretical postoperative hospital length of stay', 'postoperative arterial lactate measurements', 'duration of hospitalization or reduce complications', 'serious postoperative cardiac complications', 'postoperative hospital length of stay and morbidity', 'acute postoperative renal failure', 'duration of hospitalization or complications', 'mean hospital length of stay ± SD', 'postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient', 'Fitness for discharge and actual hospital durations', 'troponin Ic concentration', 'noninvasive plethysmographic variability index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0340276', 'cui_str': 'Postoperative cardiac complication (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2585625', 'cui_str': 'Acute postoperative renal failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",447.0,0.161995,Plethysmographic-guided fluid management did not reduce the duration of hospitalization or complications in moderate-risk surgery patients.,"[{'ForeName': 'Marc-Olivier', 'Initials': 'MO', 'LastName': 'Fischer', 'Affiliation': 'From the Anesthesiology and Critical Care Medicine Department (M.-O.F., S.L., W.G., G.D., J.-L.H.) the INSERM COMETE 1075 Unit, Orthopedic Department, (C.H.) the Biostatistics Department (J.-J.P.), Normandy University, Caen University Hospital, Caen, France Anesthesiology and Critical Care Medicine Department, Lille University Hospital, Lille, France (B.T., M.H.) Anesthesiology and Intensive Care Medicine Department, Hospital of Catholic Institute of Lille, Saint Philibert Hospital, Lomme, France (C.-E.B., V.C.) Anesthesiology and Critical Care Medicine Department, Rouen University Hospital, Charles Nicolle Hospital, Rouen, France (V.C.) Anesthesiology and Critical Care Department, Amiens University Hospital, Amiens, France (D.T., E.L.) Research Unit on Simplified Care of Complex Surgical Patients, Jules Verne University of Picardy, Amiens, France (E.L.). Caen University Hospital, Caen, France Caen University Hospital, Caen, France Amiens Picardie University Hospital, Amiens, France Amiens Picardie University Hospital, Amiens, France Lille University Hospital, Lille, France Lille University Hospital, Lille, France Hospital of Catholic Institute of Lille, Lomme, France Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Hospital of Catholic Institute of Lille Clinical Research Department, Lille University Hospital Clinical Research Department, Lille University Hospital Clinical Research Department, Amiens Picardie University Hospital.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lemoine', 'Affiliation': ''}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Tavernier', 'Affiliation': ''}, {'ForeName': 'Chems-Eddine', 'Initials': 'CE', 'LastName': 'Bouchakour', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Colas', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Houard', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greub', 'Affiliation': ''}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Daccache', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hulet', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Compère', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Taing', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Lorne', 'Affiliation': ''}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': ''}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003260']
56,32240476,"Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder () in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-blind, Placebo-controlled Clinical Trial.","OBJECTIVE


To evaluate the effectiveness and safety of Chinese herbal external umbilicus treatment with Modified Dinggui Powder (, MDGP) in patients with chronic nonbacterial prostatitis (CNP).
METHODS


A randomized, double-blind, placebo-controlled clinical trial was conducted among 72 patients with CNP. Participants were randomly allocated to a treatment group and a placebo group using computer software in a 1:1 ratio, and received either MDGP external umbilicus treatment (MDGP group, 36 cases) or placebo control groupl (36 cases) at acupoints Shenque (CV 8), twice a week for 4 weeks. In addtion, patients all received herbal medicine treatment twice a day for 4 weeks. The primary outcomes was the US National Institutes of Health Chronic Prostatitis Symptom Scores Index (NIH-CPSI) with a questionnaire at weeks 2 and 4. The secondary outcomes including prostatic fluid examination (white blood cells and lecithin bodies), the clinical efficacy evaluation, and the adverse events were also assessed during the entire trial.
RESULTS


The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2 (P0.001) and week 4 (P0.004), respectively. NIH-CPSI scores of symptom severity, total scores, the amount of leukocytes number in the prostatic fifluid in the MDGP group were significantly improved (P<0.05). There was no statistical difference in the urinary symptoms, quality of life, lecithin and other scores between two groups (P>0.05). The clinical effective rate was 73.53% (25/34) in the MDGP group, which was significally higher than the placebo control group with 48.39% (25/31, P<0.05). Patients were blinded successfully, and no serious adverse effects were found during the trial.
CONCLUSION


A 4-week course of umbilicus treatment with modified Dinggui Powder seems to relieve pain and symptom severity effectively and increase the amount of leukocytes number in patients with CNP (Trial registration No. ChiCTR1800014687).",2021,"The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2 (P0.001) and week 4 (P0.004), respectively.","['patients with CNP (Trial registration', 'Patients with Chronic Nonbacterial Prostatitis', '72 patients with CNP', 'patients with chronic nonbacterial prostatitis (CNP']","['Placebo', 'Chinese herbal external umbilicus treatment with Modified Dinggui Powder (, MDGP', 'placebo', 'modified Dinggui Powder', 'MDGP', 'Umbilicus Treatment with Modified Dinggui Powder ', 'herbal medicine', 'MDGP external umbilicus treatment (MDGP group, 36 cases) or placebo control groupl (36 cases) at acupoints Shenque (CV 8']","['urinary symptoms, quality of life, lecithin and other scores', 'NIH-CPSI scores of symptom severity, total scores, the amount of leukocytes number in the prostatic fifluid', 'US National Institutes of Health Chronic Prostatitis Symptom Scores Index (NIH-CPSI', 'prostatic fluid examination (white blood cells and lecithin bodies), the clinical efficacy evaluation, and the adverse events', 'NIH-CPSI scores regarding pain or discomfort scores', 'clinical effective rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1511518', 'cui_str': 'Copy Number Polymorphisms'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033581', 'cui_str': 'Prostatitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031617', 'cui_str': 'Lecithin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0227977', 'cui_str': 'Prostatic fluid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",72.0,0.389531,"The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2 (P0.001) and week 4 (P0.004), respectively.","[{'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Joint Surgery, Guanghua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200052, China.'}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Zhou', 'Affiliation': 'Department of Vascular Surgery, Shanghai Traditional Chinese Medicine Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200082, China.'}, {'ForeName': 'Ke-Xie', 'Initials': 'KX', 'LastName': 'Wang', 'Affiliation': 'Department of Vascular Surgery, Shanghai Traditional Chinese Medicine Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200082, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Urology and Andrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.'}, {'ForeName': 'Yu-Hang', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'Shanghai Qigong Research Institute, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': 'Shanghai Qigong Research Institute, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'School of Acupuncture-Moxbustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'Department of Urology and Andrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. yingjian03@sina.com.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Acupuncture-Moxbustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3258-5']
57,32202163,Motivational Interviewing to Increase Physical Activity Behavior in Cancer Patients: A Pilot Randomized Controlled Trials.,"OBJECTIVE


This pilot randomized controlled trial (RCT) aimed at evaluating the feasibility and potential efficacy of a motivational interviewing (MI) intervention to increase physical activity (PA) behavior in cancer patients.
METHODS


Participants were randomly assigned to an experimental group with standard care plus 12 MI sessions within 12 weeks or a control group with standard care only. The number of recruited participants and the modality of recruitment were recorded to describe the reach of the study. The acceptability of the study was estimated using the attrition rate during the intervention phase. The potential efficacy of the intervention was evaluated by analyzing the PA behavior.
RESULTS


Twenty-five participants were recruited within the 16-month recruitment period (1.6 participants per month). Five participants (38.5%) from the experimental group (n = 13) and one participant (8.3%) from the control group (n = 12) dropped out of the study before the end of the intervention phase. No group by time interaction effect for PA behavior was observed at the end of the intervention.
CONCLUSION


Due to the low recruitment rate and compliance, no conclusion can be drawn regarding the efficacy of MI to increase PA behavior in cancer patients. Moreover, the current literature cannot provide any evidence on the effectiveness of MI to increase PA in cancer survivors. Future RCTs should consider that the percentage of uninterested patients to join the study may be as high as 60%. Overrecruitment (30% to 40%) is also recommended to accommodate the elevated attrition rate.",2020,"No group by time interaction effect for PA behavior was observed at the end of the intervention.
","['cancer patients', 'Twenty-five participants were recruited within the 16-month recruitment period (1.6 participants per month', 'Cancer Patients', 'Participants']","['standard care plus 12 MI sessions within 12 weeks or a control group with standard care only', 'motivational interviewing (MI) intervention', 'Motivational Interviewing']","['physical activity (PA) behavior', 'elevated attrition rate', 'PA behavior', 'attrition rate', 'Physical Activity Behavior']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",25.0,0.0287656,"No group by time interaction effect for PA behavior was observed at the end of the intervention.
","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Lion', 'Affiliation': 'Fédération Luxembourgeoise des Associations de Sport de Santé, Strassen, Luxembourg.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Backes', 'Affiliation': 'Luxembourg Institute of Health, Strassen, Luxembourg.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Duhem', 'Affiliation': 'Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg.'}, {'ForeName': 'Fernand', 'Initials': 'F', 'LastName': 'Ries', 'Affiliation': 'Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Delagardelle', 'Affiliation': 'Fédération Luxembourgeoise des Associations de Sport de Santé, Strassen, Luxembourg.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Urhausen', 'Affiliation': 'Luxembourg Institute of Research in Orthopedics, Sports Medicine and Science, Luxembourg, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Theisen', 'Affiliation': 'Luxembourg Institute of Health, Strassen, Luxembourg.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Malisoux', 'Affiliation': 'Luxembourg Institute of Health, Strassen, Luxembourg.'}]",Integrative cancer therapies,['10.1177/1534735420914973']
58,32251253,No Sex Difference in Mental Fatigue Effect on High-Level Runners' Aerobic Performance.,"PURPOSE


Some evidence suggests that sedentary women may be more vulnerable to cognitive task-induced mental fatigue. Mental fatigue, in turn, may worse aerobic exercise performance, presumably via increased perceived effort. However, it remains unclear whether acute mental fatigue induction increases perceived effort and worsens endurance performance in high-level professional athletes and whether such effects are influenced by sex.
METHODS


We studied 30 athletes (15 women and 16 men) in a single-blinded, randomized, controlled and crossover protocol. In separate visits, athletes either performed a 45-min cognitive task (Stroop's color-word conflict test) to induce mental fatigue or watched a 45-min documentary as control. Then athletes performed a time-to-exhaustion test on a treadmill.
RESULTS


Perceptual measures and cognitive performance indicated that the prolonged cognitive task induced a similar mental fatigue state in women and men. Cardiorespiratory and metabolic responses to the TEE did not change with mental fatigue in both sexes. Mental fatigue increased perceived effort during the time-to-exhaustion test, anticipated attainment of maximal effort, and shortened time to exhaustion similarly in women and men (mean ± SE, -27.3 ± 20.9 s for women vs -26.7 ± 15.1 s for men; P = 0.98).
CONCLUSIONS


The prolonged cognitive task provoked mental fatigue, anticipated attainment of maximal perceived effort, and worsened aerobic performance in professional runners with no sex differences. Although we did not contrasted athletes with nonathletes, our results suggest that being an athlete may somehow prevent women from developing greater mental fatigue and suffering more from its underlying effects compared with men.",2020,"The prolonged cognitive task provoked mental fatigue, anticipated attainment of maximal perceived effort and worsened aerobic performance in professional runners with no sex differences.","['sedentary women', 'professional runners with no sex differences', 'thirty athletes (15 women and 16 men', 'high-level professional athletes']","['TEE', ""45-min cognitive task (Stroop's color-word conflict test) to induce mental fatigue or watched a 45-min documentary as control""]","['mental fatigue state', ""Mental Fatigue Effect on High-Level Runners' Aerobic Performance"", 'cognitive task-induced mental fatigue', 'Mental fatigue', 'prolonged cognitive task provoked mental fatigue, anticipated attainment of maximal perceived effort and worsened aerobic performance', 'Cardiorespiratory and metabolic responses', 'mental fatigue']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341632', 'cui_str': 'Professional runner'}, {'cui': 'C0036866', 'cui_str': 'Sex Differences'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",30.0,0.127486,"The prolonged cognitive task provoked mental fatigue, anticipated attainment of maximal perceived effort and worsened aerobic performance in professional runners with no sex differences.","[{'ForeName': 'Thiago Ribeiro', 'Initials': 'TR', 'LastName': 'Lopes', 'Affiliation': ''}, {'ForeName': 'Diogo Machado', 'Initials': 'DM', 'LastName': 'Oliveira', 'Affiliation': ''}, {'ForeName': 'Paula BrandÃo', 'Initials': 'PB', 'LastName': 'Simurro', 'Affiliation': 'Interdisciplinary Laboratory of Clinical Neurosciences, Department of Psychiatry, Federal University of São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Henrique Teruo', 'Initials': 'HT', 'LastName': 'Akiba', 'Affiliation': ''}, {'ForeName': 'FÁbio Yuzo', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Graduate Program in Physical Education UPE/UFPB, João Pessoa, PB, BRAZIL.'}, {'ForeName': 'Alexandre Hideki', 'Initials': 'AH', 'LastName': 'Okano', 'Affiliation': ''}, {'ForeName': 'Álvaro Machado', 'Initials': 'ÁM', 'LastName': 'Dias', 'Affiliation': 'Interdisciplinary Laboratory of Clinical Neurosciences, Department of Psychiatry, Federal University of São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Bruno Moreira', 'Initials': 'BM', 'LastName': 'Silva', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002346']
59,32251254,Using TENS to Enhance Therapeutic Exercise in Individuals with Knee Osteoarthritis.,"Transcutaneous electrical nerve stimulation (TENS) facilitates quadriceps voluntary activation in experimental settings. Augmenting therapeutic exercise (TE) with TENS may enhance the benefits of TE in individuals with knee osteoarthritis (KOA) and quadriceps voluntary activation failure (QVAF).
PURPOSE


This study aimed to determine the effect of TENS + TE on patient-reported function, quadriceps strength, and voluntary activation, as well as physical performance compared with sham TENS + TE (Sham) and TE alone in individuals with symptomatic KOA and QVAF.
METHODS


Ninety individuals participated in a double-blinded randomized controlled trial. Everyone received 10 standardized TE sessions of physical therapy. TENS + TE and Sham groups applied the respective devices during all TE sessions and throughout activities of daily living over 4 wk. The Western Ontario and McMaster University Osteoarthritis Index (WOMAC), quadriceps strength, and voluntary activation, as well as a 20-m walk test, chair-stand test, and stair-climb test were performed at baseline, after the 4-wk intervention (post 1) and at 8 wk after the start of the intervention (post 2). Mixed-effects models were used to determine between-group differences between baseline and post 1, as well as baseline and post 2.
RESULTS


Improvements in WOMAC subscales, quadriceps strength, and voluntary activation, 20-m walk times, chair-stand repetitions, and stair-climb time were found at post 1 and post 2 compared with baseline for all groups (P < 0.05). WOMAC Pain and Stiffness improved in the TENS + TE group compared with TE alone at post 1 (P < 0.05); yet, no other between-group differences were found.
CONCLUSIONS


TE effectively improved patient-reported function, quadriceps strength, and voluntary activation, as well as physical performance in individuals with symptomatic KOA and QVAF, but augmenting TE with TENS did not improve the benefits of TE.",2020,"WOMAC Pain and Stiffness improved in the TENS+TE group compared to TE alone at Post 1 (p<0.05); yet no other between-group differences were found.
","['Ninety individuals participated', 'individuals with symptomatic KOA and QVAF', 'individuals with knee osteoarthritis (KOA) and quadriceps voluntary activation failure (QVAF', 'Individuals with Knee Osteoarthritis']","['TENS+TE', 'therapeutic exercise (TE) with TENS', 'Transcutaneous electrical nerve stimulation (TENS', 'TENS', 'sham TENS+TE (Sham), and TE alone', 'Everyone received 10 standardized TE sessions of physical therapy']","['Western Ontario and McMaster University Osteoarthritis Index [WOMAC], quadriceps strength and voluntary activation', 'WOMAC Pain and Stiffness', 'TE effectively improved patient-reported function, quadriceps strength and voluntary activation', 'WOMAC subscales, quadriceps strength and voluntary activation, 20-meter walk times, chair-stand repetitions, and stair-climb time']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0224440', 'cui_str': 'Structure of quadriceps femoris muscle'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}]",90.0,0.054057,"WOMAC Pain and Stiffness improved in the TENS+TE group compared to TE alone at Post 1 (p<0.05); yet no other between-group differences were found.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pietrosimone', 'Affiliation': ''}, {'ForeName': 'Brittney A', 'Initials': 'BA', 'LastName': 'Luc-Harkey', 'Affiliation': 'Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Harkey', 'Affiliation': ''}, {'ForeName': 'Hope C', 'Initials': 'HC', 'LastName': 'Davis-Wilson', 'Affiliation': ''}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Pfeiffer', 'Affiliation': ''}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nissman', 'Affiliation': 'Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': ''}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': ''}, {'ForeName': 'Jeffery T', 'Initials': 'JT', 'LastName': 'Spang', 'Affiliation': 'Department of Orthopaedics, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002353']
60,20625738,Dynamic contrast-enhanced CT in patients treated with sorafenib and erlotinib for non-small cell lung cancer: a new method of monitoring treatment?,"OBJECTIVE


We investigated the feasibility of serial dynamic contrast-enhanced computed tomography (DCE-CT) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving anti-angiogenic (sorafenib) and anti-EGFR (erlotinib) treatment, and correlated tumour blood flow (BF) with treatment outcome.
METHODS


DCE-CTs were performed at baseline and 3 and 6 weeks after starting treatment. Tumour BF, calculated with the maximum slope method, and percentage change were measured in 23 patients (14 male; median age 59 years). Tumour BF was compared at baseline and weeks 3 and 6; the relation with RECIST/Crabb response and progression-free survival (PFS) was assessed.
RESULTS


Mean tumour perfusion decreased from 39.2 ml/100 g/min at baseline to 15.1 ml/100 g/min at week 3 (p < 0.001) and 9.4 ml/100 g/min at week 6 (p < 0.001). Tumour perfusion was lower in RECIST and Crabb responders versus non-responders at week 3 (4.2 versus 17.7 ml/100 g/min, p = 0.03) and week 6 (0 versus 13.4 ml/100 g/min, p = 0.04). Patients with a decrease larger than the median at week 6 tended to have a longer PFS (7.1 versus 5.7 months, p = 0.06).
CONCLUSION


Serial DCE-CTs are feasible in patients with NSCLC and demonstrated a significant decrease in tumour BF following sorafenib/erlotinib therapy. Early changes in tumour BF correlated with objective response and showed a trend towards longer PFS.",2010,Mean tumour perfusion decreased from 39.2 ml/100 g/min at baseline to 15.1 ml/100 g/min at week 3 (p < 0.001) and 9.4 ml/100 g/min at week 6 (p < 0.001).,"['23 patients (14 male; median age 59 years', 'patients with NSCLC', 'patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving', 'for non-small cell lung cancer']","['sorafenib and erlotinib', 'anti-angiogenic (sorafenib) and anti-EGFR (erlotinib', 'Dynamic contrast-enhanced CT', 'serial dynamic contrast-enhanced computed tomography (DCE-CT']","['tumour BF', 'Tumour BF', 'relation with RECIST/Crabb response and progression-free survival (PFS', 'Mean tumour perfusion', 'Tumour perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.0480648,Mean tumour perfusion decreased from 39.2 ml/100 g/min at baseline to 15.1 ml/100 g/min at week 3 (p < 0.001) and 9.4 ml/100 g/min at week 6 (p < 0.001).,"[{'ForeName': 'Joline S W', 'Initials': 'JS', 'LastName': 'Lind', 'Affiliation': 'Department of Pulmonary Diseases, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Martijn R', 'Initials': 'MR', 'LastName': 'Meijerink', 'Affiliation': ''}, {'ForeName': 'Anne-Marie C', 'Initials': 'AM', 'LastName': 'Dingemans', 'Affiliation': ''}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'van Kuijk', 'Affiliation': ''}, {'ForeName': 'Michel C', 'Initials': 'MC', 'LastName': 'Ollers', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'de Ruysscher', 'Affiliation': ''}, {'ForeName': 'Pieter E', 'Initials': 'PE', 'LastName': 'Postmus', 'Affiliation': ''}, {'ForeName': 'Egbert F', 'Initials': 'EF', 'LastName': 'Smit', 'Affiliation': ''}]",European radiology,['10.1007/s00330-010-1869-5']
61,32219761,Randomized Study Design to Test Effects of Vitamin D and Omega-3 Fatty Acid Supplementation as Adjuvant Therapy in Colorectal Cancer Patients.,"This study examines the effects of vitamin D and omega-3 fatty acid co-supplementation on inflammation and nutritional status in colorectal cancer patients. Patients were randomly assigned into four groups: (1) controls, receiving placebos; (2) omega-3 fatty acid arm, receiving two 330 mg omega-3 fatty acid capsules daily and placebo (for vitamin D 3 ) weekly; (3) vitamin D arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two 330 mg omega-3 fatty acids capsules daily for 8 weeks. As outcomes, we measure height; weight; fat-free mass (FFM); serum levels of 25(OH)D, TNF-α, and IL-6; C-CRP; and albumin, before and after the intervention. The presented results show that vitamin D 3  plus omega-3 fatty acid co-supplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.",2020,"Patients were randomly assigned into four groups: (1) controls, receiving placebos; (2) omega-3 fatty acid arm, receiving two 330 mg omega-3 fatty acid capsules daily and placebo (for vitamin D 3 ) weekly; (3) vitamin D arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two 330 mg omega-3 fatty acids capsules daily for 8 weeks.","['Colorectal Cancer Patients', 'colorectal cancer patients']","['vitamin D and omega-3 fatty acid co-supplementation', 'Vitamin D and Omega-3 Fatty Acid Supplementation', 'omega-3 fatty acids capsules daily for 8\xa0weeks', 'vitamin D 3  plus omega-3 fatty acid co-supplementation', 'placebos; (2) omega-3 fatty acid arm, receiving two 330\xa0mg omega-3 fatty acid capsules daily and placebo (for vitamin D 3 ) weekly; (3) vitamin D arm, receiving a 50,000\xa0IU vitamin D 3  soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation']","['height; weight; fat-free mass (FFM); serum levels of 25(OH)D, TNF-α, and IL-6; C-CRP; and albumin', 'inflammation and nutritional status']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}]",,0.0537116,"Patients were randomly assigned into four groups: (1) controls, receiving placebos; (2) omega-3 fatty acid arm, receiving two 330 mg omega-3 fatty acid capsules daily and placebo (for vitamin D 3 ) weekly; (3) vitamin D arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two 330 mg omega-3 fatty acids capsules daily for 8 weeks.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Iravani', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. vafa.m@iums.ac.ir.'}]","Methods in molecular biology (Clifton, N.J.)",['10.1007/978-1-0716-0471-7_24']
62,32219762,"Effect of Vitamin D Supplementation on Muscle Strength, Muscle Function, and Body Composition in Vitamin D-Deficient Middle-Aged Women.","Sarcopenia is the loss of muscle strength and muscle mass with aging and is one of the major risk factors for metabolic diseases. Cross-sectional studies have shown that vitamin D is associated with sarcopenia in both men and women. We investigated the effect of vitamin D supplementation over 12 weeks on muscle strength, muscle function, and body composition in middle-aged women in randomized double-blind placebo-controlled trial format. This revealed a significant difference in serum 25-hydroxyvitamin D levels between the intervention and placebo groups. In addition, handgrip strength was improved, and the timed get up and go (TGUG) test and body fat content were decreased. This chapter presents a protocol for trial setup involving measurement of vitamin D levels, handgrip strength, the TGUT test, and body composition as readouts.",2020,This revealed a significant difference in serum 25-hydroxyvitamin D levels between the intervention and placebo groups.,"['middle-aged women', 'Vitamin D-Deficient Middle-Aged Women', 'men and women']","['vitamin D supplementation', 'vitamin D', 'Vitamin D Supplementation', 'placebo']","['vitamin D levels, handgrip strength, the TGUT test, and body composition', 'Muscle Strength, Muscle Function, and Body Composition', 'muscle strength, muscle function, and body composition', 'handgrip strength', 'timed get up and go (TGUG) test and body fat content', 'serum 25-hydroxyvitamin D levels']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1303170', 'cui_str': 'Get up and go test'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",,0.293758,This revealed a significant difference in serum 25-hydroxyvitamin D levels between the intervention and placebo groups.,"[{'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. vafa.m@iums.ac.ir.'}]","Methods in molecular biology (Clifton, N.J.)",['10.1007/978-1-0716-0471-7_25']
63,30944045,Victory is its own reward: oxytocin increases costly competitive behavior in schizophrenia.,"BACKGROUND


Aberrant sensitivity to social reward may be an important contributor to abnormal social behavior that is a core feature of schizophrenia. The neuropeptide oxytocin impacts the salience of social information across species, but its effect on social reward in schizophrenia is unknown.
METHODS


We used a competitive economic game and computational modeling to examine behavioral dynamics and oxytocin effects on sensitivity to social reward among 39 men with schizophrenia and 54 matched healthy controls. In a randomized, double-blind study, participants received one dose of oxytocin (40 IU) or placebo and completed a 35-trial Auction Game that quantifies preferences for monetary v. social reward. We analyzed bidding behavior using multilevel linear mixed models and reinforcement learning models.
RESULTS


Bidding was motivated by preferences for both monetary and social reward in both groups, but bidding dynamics differed: patients initially overbid less compared to controls, and across trials, controls decreased their bids while patients did not. Oxytocin administration was associated with sustained overbidding across trials, particularly in patients. This drug effect was driven by a stronger preference for winning the auction, regardless of monetary consequences. Learning rate and response variability did not differ between groups or drug condition, suggesting that differences in bidding derive primarily from differences in the subjective value of social rewards.
CONCLUSIONS


Our findings suggest that schizophrenia is associated with diminished motivation for social reward that may be increased by oxytocin administration.",2020,"Learning rate and response variability did not differ between groups or drug condition, suggesting that differences in bidding derive primarily from differences in the subjective value of social rewards.
",['39 men with schizophrenia and 54 matched healthy controls'],"['neuropeptide oxytocin', 'placebo', 'oxytocin', 'Oxytocin']",['Learning rate and response variability'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}]",39.0,0.338029,"Learning rate and response variability did not differ between groups or drug condition, suggesting that differences in bidding derive primarily from differences in the subjective value of social rewards.
","[{'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Bradley', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA94110, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Brustkern', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA94110, USA.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'van den Bos', 'Affiliation': 'Center for Adaptive Rationality, Max Planck Institute for Human Development, Berlin, Germany.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'McClure', 'Affiliation': 'Department of Psychology, Arizona State University, TempeAZ, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Seitz', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA94110, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA94110, USA.'}]",Psychological medicine,['10.1017/S0033291719000552']
64,32203234,The cost of baby-led vs. parent-led approaches to introducing complementary foods in New Zealand.,"Baby-led approaches to complementary feeding promote intake of family foods rather than infant specific foods, from the start of the complementary feeding period, which advocates suggest should be less expensive. However, this has never been formally examined. We recently completed a 2-year randomised controlled trial comparing baby-led (BLISS) and traditional spoon-feeding (Control) approaches to complementary feeding in 206 infants. Perceived expense was assessed at infant 7, 8, 9 and 12 months of age. The actual cost of intake (food offered, consumed and left over) was calculated from 3-day weighed diet records at 7 and 12 months of age. BLISS was perceived as less expensive than traditional feeding (P = 0.002), but comparisons of actual costs showed only small differences in total daily cost for food offered (NZ$0.20 and NZ$0.10 at 7 and 12 months, respectively), consumed (NZ$0.30, NZ$0.20) or left over (NZ$0.10, NZ$0.20). Baby-led approaches are not cheaper for families than traditional spoon-feeding.",2020,"BLISS was perceived as less expensive than traditional feeding (P = 0.002), but comparisons of actual costs showed only small differences in total daily cost for food offered (NZ$0.20 and NZ$0.10 at 7 and 12 months, respectively), consumed (NZ$0.30, NZ$0.20) or left over (NZ$0.10, NZ$0.20).",['206 infants'],['baby-led (BLISS) and traditional spoon-feeding (Control'],"['BLISS', 'total daily cost']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0581226', 'cui_str': 'Spoon (physical object)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",206.0,0.0804916,"BLISS was perceived as less expensive than traditional feeding (P = 0.002), but comparisons of actual costs showed only small differences in total daily cost for food offered (NZ$0.20 and NZ$0.10 at 7 and 12 months, respectively), consumed (NZ$0.30, NZ$0.20) or left over (NZ$0.10, NZ$0.20).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bacchus', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand. rachael.taylor@otago.ac.nz.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Fleming', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Haszard', 'Affiliation': 'Biostatistics Centre, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fangupo', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Daniels', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'A-L M', 'Initials': 'AM', 'LastName': 'Heath', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0606-7']
65,32146715,A Comparative Study on Short-Term Effects of Compression Orthosis and Exercises in the Treatment of Pectus Carinatum: A Randomized Controlled Pilot Feasibility Trial.,"INTRODUCTION


Pectus carinatum (PC) is a congenital chest wall deformity which is characterized by the protrusion of the sternum and costal cartilages. Although orthotic and exercise therapies are commonly offered by physicians for PC treatment, there is a lack of evidence on the benefits of exercises and how long the orthosis should be worn. The aim of this study is to investigate the effects and feasibility of custom-made compression orthosis and exercises in the treatment of PC.
MATERIALS AND METHODS


Patients with PC aged 7 to 17 years old were randomized into three groups: compression orthosis 23 hours, compression orthosis 8 hours, and control group. All groups received exercises for 1 hour a day for 3 weeks. Additionally, compression orthosis 23 hours group wore the orthosis for 23 hours a day, while compression orthosis 8 hours group wore the orthosis for 8 hours a day. PC protrusion, pressure of correction, thorax lateral and anteroposterior parameters, external chest wall measurements, and Nuss Questionnaire were evaluated before and after the treatment. Also, adverse effects, retention, and compliance were assessed. Feasibility was evaluated by calculating the percentages of recruitment, retention, and safety.
RESULTS


The compression orthosis 23 hours group showed greater improvements than the other groups. After treatment, all groups showed significant changes in protrusion, pressure of correction, and external chest wall measurements. Adverse events occurred with similar frequency across groups. Retention percentages did not differ among groups.
CONCLUSION


Compression orthosis use for 23 hours can be recommended rather than its use for 8 hours because 23 hours of orthosis use has better correction and similar adverse effects.",2021,"Retention percentages did not differ among groups.
","['Patients with PC aged 7 to 17 years old', 'Pectus Carinatum']","['compression orthosis 23\u2009hours, compression orthosis 8\u2009hours, and control group', 'Compression Orthosis and Exercises', 'custom-made compression orthosis and exercises']","['protrusion, pressure of correction, and external chest wall measurements', 'Retention percentages', 'Adverse events', 'adverse effects, retention, and compliance', 'percentages of recruitment, retention, and safety', 'PC protrusion, pressure of correction, thorax lateral and anteroposterior parameters, external chest wall measurements, and Nuss Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0158731', 'cui_str': 'Pectus Carinatum'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0162343', 'cui_str': 'Customs'}]","[{'cui': 'C0333056', 'cui_str': 'Protrusion (morphologic abnormality)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0348152,"Retention percentages did not differ among groups.
","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Giray', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Nezih Onur', 'Initials': 'NO', 'LastName': 'Ermerak', 'Affiliation': 'Department of Thoracic Surgery, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Bahar-Ozdemir', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Melihat', 'Initials': 'M', 'LastName': 'Kalkandelen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yuksel', 'Affiliation': 'Department of Thoracic Surgery, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Osman Hakan', 'Initials': 'OH', 'LastName': 'Gunduz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Gulseren', 'Initials': 'G', 'LastName': 'Akyuz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}]",European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie,['10.1055/s-0040-1701699']
66,32007834,Effects of a home-based exercise program on the insulin-like growth factor axis in patients operated for colorectal cancer in Sweden: Results from the randomised controlled trial PHYSSURG-C.,"OBJECTIVES


We report results from a subgroup within the ongoing PHYSSURG-C trial with the aim to examine effects of exercise on IGF-1 and IGFBP-3 in patients undergoing colorectal cancer surgery.
DESIGN


Randomised controlled trial.
SETTING


A Swedish university hospital.
PARTICIPANTS


Between 2015 and 2016, 217 patients were enrolled (I = 106, C = 111), with 122 patients that had given blood samples at baseline and at least at one follow-up (I = 51, C = 71). Patients 20 year or older with colorectal cancer were eligible. Exclusion criteria were emergency surgery, local surgery, language problems or inability to perform intervention.
INTERVENTIONS


Patients were computer-randomised to either a daily home-based aerobic exercise intervention (I), or to usual care (C). The intervention lasted two weeks before surgery and four weeks after discharge from hospital and consisted of medium-intensity aerobic exercise and inspiratory muscle training. Circulating concentrations of IGF-1 and IGFBP-3 were determined by blinded personnel at baseline, time of surgery and 4-6 weeks postoperatively.
PRIMARY AND SECONDARY OUTCOME MEASURES


The outcome of this subpopulation report was change in IGF-1/IGFBP-3 ratio, IGF-1 and IGFBP-3 concentrations from baseline to surgery, and 4-6 weeks postoperatively.
RESULTS


The IGF-1/IGFBP-3 ratio increased from baseline to surgery by 11% in I and 8% in C with no difference between groups (I vs. C: 1.04, 95%CI: 0.97-1.11; p = 1.000). Postoperative change was 5% in I and 3% in C with no difference between groups (I vs. C:1.03, 95%CI: 0.96-1.10; p = 1.000). Results concerning IGF-1 and IGFBP-3 also showed statistically significant dynamics over time with no difference between groups. No adverse events were reported.
CONCLUSIONS


The home-based exercise program in our trial did not have any effect on IGF-1, or IGFBP-3.
TRIAL REGISTRATION


The study was registered at ClinicalTrials.gov with identifier NCT02299596. This work was funded externally.",2020,"The home-based exercise program in our trial did not have any effect on IGF-1, or IGFBP-3.
","['Patients 20\xa0year or older with colorectal cancer were eligible', 'Between 2015 and 2016', '217 patients were enrolled ', 'A Swedish university hospital', 'patients undergoing colorectal cancer surgery', 'patients operated for colorectal cancer in Sweden', 'Exclusion criteria were emergency surgery, local surgery, language problems or inability to perform intervention']","['insulin-like growth factor axis', 'medium-intensity aerobic exercise and inspiratory muscle training', 'home-based exercise program', 'daily home-based aerobic exercise intervention (I), or to usual care (C']","['IGF-1/IGFBP-3 ratio, IGF-1 and IGFBP-3 concentrations', 'Circulating concentrations of IGF-1 and IGFBP-3', 'IGF-1/IGFBP-3 ratio', 'Postoperative change', 'adverse events', 'IGF-1 and IGFBP-3']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1328726', 'cui_str': 'Insulin-like growth factor'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'IGF-Binding Protein 3'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",217.0,0.297406,"The home-based exercise program in our trial did not have any effect on IGF-1, or IGFBP-3.
","[{'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Onerup', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group (SSORG), Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Pediatric Oncology, Gothenburg, Sweden. Electronic address: aron.onerup@gu.se.'}, {'ForeName': 'Sven-Egron', 'Initials': 'SE', 'LastName': 'Thörn', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Anaesthesiology and Intensive Care Medicine, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Angenete', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group (SSORG), Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Surgery, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bock', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group (SSORG), Gothenburg, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Grybäck Gillheimer', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group (SSORG), Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Haglind', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group (SSORG), Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Surgery, Gothenburg, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Nilsson', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group (SSORG), Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Surgery, Gothenburg, Sweden.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.01.005']
67,32100576,"The Efficacy and Safety of Acupuncture for Preventing Radiation Pneumonitis in Patients With Lung Cancer: A Prospective, Single-Blinded, Randomized Pilot Proof-of-Principle Study.","Purpose:  We evaluated the efficacy and safety of acupuncture for prevention of radiation pneumonitis in patients with lung cancer.  Methods:  Twenty-five patients were prospectively enrolled in this study and randomized to either intervention group or control group. The patients assigned to the intervention group received 15 minutes of acupuncture treatment twice a week. The patients assigned to the control group received RT alone without acupuncture treatment. The primary endpoint was incidence of radiation pneumonitis. The secondary endpoints were FEV1 (forced expiratory volume in 1 second), DLCO (diffusing capacity for carbon monoxide), 6-minute walk distance, and modified Borg scale.  Results:  The intervention group showed lower incidences of grade 3 and grade ≥2 radiation pneumonitis than the control group (10% vs 30% for grade 3 and 50% vs 60% for grade ≥2). In the control group, mean DLCO value was decreased from 62.1% at baseline to 49.1% after RT ( P  = .004). The DLCO was also decreased after RT in the intervention group, but the decrement was not statistically significant (56.7% at baseline and 50.9% after RT,  P  = .204). The FEV1 and 6-minute walk distance were decreased after RT in the control group. However, FEV1 and 6-minute walk distance were increased after RT in the intervention group.  Conclusions:  This study found that patients who received acupuncture treatment showed a lower incidence of radiation pneumonitis and a protective effect against aggravation of pulmonary function after RT in patients with lung cancer. To confirm the results of this study, well-designed randomized studies with large sample sizes will be required.",2020,The intervention group showed lower incidences of grade 3 and grade ≥2 radiation pneumonitis than the control group (10% vs 30% for grade 3 and 50% vs 60% for grade ≥2).,"['patients with lung cancer', 'Methods:  Twenty-five patients', 'Patients With Lung Cancer']","['acupuncture', 'Acupuncture', 'RT alone without acupuncture treatment', 'intervention group or control group']","['incidence of radiation pneumonitis', 'lower incidences of grade 3 and grade ≥2 radiation pneumonitis', 'efficacy and safety', 'FEV1 and 6-minute walk distance', 'DLCO', 'FEV1 (forced expiratory volume in 1 second), DLCO (diffusing capacity for carbon monoxide), 6-minute walk distance, and modified Borg scale', 'radiation pneumonitis', 'mean DLCO value', 'Radiation Pneumonitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0206063', 'cui_str': 'Pneumonia, Radiation'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1280474', 'cui_str': 'Transfer factor (respiratory measure) (observable entity)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",25.0,0.0423814,The intervention group showed lower incidences of grade 3 and grade ≥2 radiation pneumonitis than the control group (10% vs 30% for grade 3 and 50% vs 60% for grade ≥2).,"[{'ForeName': 'Moonkyoo', 'Initials': 'M', 'LastName': 'Kong', 'Affiliation': 'College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Hyeun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jaehyo', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Beom-Joon', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Kwan-Il', 'Initials': 'KI', 'LastName': 'Kim', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Integrative cancer therapies,['10.1177/1534735420908327']
68,32152512,Intermittent versus continuous tube feeding in patients with hemorrhagic stroke: a randomized controlled clinical trial.,"BACKGROUND


The arguments about whether intermittent or continuous tube feeding was preferred in patients with hemorrhagic stroke exist yet. This study aimed to examine the effects of intermittent versus continuous tube feeding on its intolerance performance and efficiency of calorie intake.
METHOD


A convenience sample was selected from January 2018 to January 2019 in the Neurosurgery Department of West China Hospital, Sichuan Province. The participants were randomly allocated to either intermittent or continuous tube feeding group, fed four times or 24 h a day using electric feeding pump, respectively. The incidence of the intolerance and calorie intake were recorded and analyzed.
RESULTS


78 patients took part in this study: 40 in the intermittent group and 38 in the continuous group. The incidence of the diarrhea was significantly lower in the continuous group (7.9 vs 37.5%, p = 0.002). The total intolerance rate was significantly lower in the continuous group compared with the intermittent group (63.2 vs 85.0%, p = 0.027). There was no significant difference in calorie intake between the intermittent and continuous group during the first 3 days (2595.4 ± 394.5 kcal vs 2317.8 ± 645.1 kcal, p = 0.099). No significant difference in total calorie intake was found between two groups (6265.6 ± 1261.3 kcal vs 6429.4 ± 1452.4 kcal, p = 0.597).
CONCLUSION


Continuous tube feeding was an effective way to improve the tolerance of enteral nutrition. But no enough evidence was found to support the advantage in calorie intake of continuous tube feeding in this study.",2020,"No significant difference in total calorie intake was found between two groups (6265.6 ± 1261.3 kcal vs 6429.4 ± 1452.4 kcal, p = 0.597).
","['A convenience sample was selected from January 2018 to January 2019 in the Neurosurgery Department of West China Hospital, Sichuan Province', 'patients with hemorrhagic stroke', '78 patients took part in this study: 40 in the intermittent group and 38 in the continuous group']","['intermittent versus continuous tube feeding', 'continuous tube feeding']","['incidence of the intolerance and calorie intake', 'incidence of the diarrhea', 'total intolerance rate', 'calorie intake', 'tolerance of enteral nutrition', 'total calorie intake']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0041281', 'cui_str': 'Tube Feeding'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]",78.0,0.0182528,"No significant difference in total calorie intake was found between two groups (6265.6 ± 1261.3 kcal vs 6429.4 ± 1452.4 kcal, p = 0.597).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, 610041, China. 496058235@qq.com.'}, {'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, 610041, China. jp-li@163.com.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0579-6']
69,32060156,"Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial.","INTRODUCTION


In the UK and Ireland, severe and complex obesity is managed in specialist weight management services (SWMS), which provide multicomponent lifestyle interventions to support weight loss, and use of medication if available. Liraglutide 3 mg (LIRA 3 mg) is an effective weight-loss medication, but weight loss in individual patients is variable, and its efficacy has not been assessed in SWMS. This study aims to investigate whether a targeted prescribing pathway for LIRA 3 mg with multiple prespecified stopping rules could help people with severe obesity and established complications achieve ≥15% weight loss in order to determine whether this could be considered a clinically effective and cost-effective strategy for managing severe and complex obesity in SWMS.
METHODS AND ANALYSIS


In this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m 2  plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.
ETHICS AND DISSEMINATION


The Health Research Authority and the Medicines and Healthcare products Regulatory Authority in UK, the Health Products Regulatory Authority in Ireland, the North West Deanery Research Ethics Committee (UK) and the St Vincent's University Hospital European Research Ethics Committee (Ireland) have approved the study. The findings of the study will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov-Identifier: NCT03036800.European Clinical Trials Database-Identifier: EudraCT Number 2017-002998-20.",2020,"Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.
","['384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m 2  plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea']","['Liraglutide', 'standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules']","['weight loss', 'comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2955667', 'cui_str': 'Does budget (finding)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",384.0,0.151608,"Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.
","[{'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Papamargaritis', 'Affiliation': 'Diabetes Research Centre, Leicester General Hospital, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al-Najim', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Obesity and Endocrinology Clinical Research Group, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Crane', 'Affiliation': ""Institute of Diabetes, Endocrinology and Obesity (IDEO), Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Carel', 'Initials': 'C', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McGowan', 'Affiliation': ""Institute of Diabetes, Endocrinology and Obesity (IDEO), Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Donal', 'Initials': 'D', 'LastName': ""O'Shea"", 'Affiliation': ""Department of Endocrinology and Diabetes Mellitus, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, Leicester General Hospital, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wilding', 'Affiliation': 'Obesity and Endocrinology Clinical Research Group, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, Leicester General Hospital, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK melanie.davies@uhl-tr.nhs.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034137']
70,32157250,High-intensity interval training produces a significant improvement in fitness in less than 31 days before surgery for urological cancer: a randomised control trial.,"OBJECTIVES


To assess the efficacy of high-intensity interval training (HIIT) for improving cardiorespiratory fitness (CRF) in patients awaiting resection for urological malignancy within four weeks.
SUBJECTS/PATIENTS AND METHODS


A randomised control trial of consecutive patients aged (>65 years) scheduled for major urological surgery in a large secondary referral centre in a UK hospital. The primary outcome is change in anaerobic threshold (VO 2AT ) following HIIT vs. standard care.
RESULTS


Forty patients were recruited (mean age 72 years, male (39): female (1)) with 34 completing the protocol. Intention to treat analysis showed significant improvements in anaerobic threshold (VO 2AT ; mean difference (MD) 2.26 ml/kg/min (95% CI 1.25-3.26)) following HIIT. Blood pressure (BP) also significantly reduced in following: HIIT (SBP: -8.2 mmHg (95% CI -16.09 to -0.29) and DBP: -6.47 mmHg (95% CI -12.56 to -0.38)). No reportable adverse safety events occurred during HIIT and all participants achieved >85% predicted maximum heart rate during sessions, with protocol adherence of 84%.
CONCLUSIONS


HIIT can improve CRF and cardiovascular health, representing clinically meaningful and achievable pre-operative improvements. Larger randomised trials are required to investigate the efficacy of prehabilitation HIIT upon different cancer types, post-operative complications, socio-economic impact and long-term survival.",2020,"No reportable adverse safety events occurred during HIIT and all participants achieved >85% predicted maximum heart rate during sessions, with protocol adherence of 84%.
","['consecutive patients aged (>65 years) scheduled for major urological surgery in a large secondary referral centre in a UK hospital', 'patients awaiting resection for urological malignancy within four weeks', 'Forty patients were recruited (mean age 72 years, male (39): female (1)) with 34 completing the protocol', 'urological cancer']","['High-intensity interval training', 'high-intensity interval training (HIIT']","['DBP', 'change in anaerobic threshold (VO 2AT ', 'anaerobic threshold', 'CRF and cardiovascular health', 'adverse safety events', 'maximum heart rate', 'Blood pressure (BP', 'cardiorespiratory fitness (CRF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0751571', 'cui_str': 'Cancer of Urinary Tract'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",40.0,0.373067,"No reportable adverse safety events occurred during HIIT and all participants achieved >85% predicted maximum heart rate during sessions, with protocol adherence of 84%.
","[{'ForeName': 'J E M', 'Initials': 'JEM', 'LastName': 'Blackwell', 'Affiliation': 'University of Nottingham, Nottingham, UK. james.blackwell@nhs.net.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Doleman', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Boereboom', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morton', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Atherton', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Williams', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Phillips', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Lund', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0219-1']
71,32152454,Guided walking reduces blood pressure in hypertensive sedentary subjects including those with resistant hypertension.,"Hypertension poorly responsive to medications is defined resistant hypertension. We have previously shown that 1-year of guided walking is followed by highly significant reduction of systolic blood pressure in hypertensive subjects. Aim of this study was to assess the effect of a 1-year of guided walking on the blood pressure of sedentary hypertensive subjects including patients with resistant hypertension. Two hundred and fifty-nine sedentary subjects with systolic pressure ≥130 mmHg were subdivided in a group without blood pressure medications and in a group taking three or more antihypertensive drugs, including diuretics. Blood pressure, body weight, body mass index, waist circumference, and walking speed were determined at enrollment and after 1-year of walking, supervised by exercise physiologists. At baseline, systolic pressure was significantly higher in the subjects under therapy (144.6 ± 12.2 vs. 140.2 ± 10.7). Two hundred and three subjects (124 without and 79 with therapy) completed the program. During the 1-year program each subject walked ~220 h. After 1-year a significant decrease (P < 0.0001) of systolic pressure was observed in both groups. The decrease was significantly higher (P < 0.0001) in the subjects under therapy. The decrease of systolic pressure was directly proportional to baseline values. Diastolic blood pressure decreased significantly in both groups. In conclusion, habitual walking may lead to clinically significant reductions of blood pressure in therapy resistant hypertensive subjects.",2020,After 1-year a significant decrease (P < 0.0001) of systolic pressure was observed in both groups.,"['therapy resistant hypertensive subjects', 'hypertensive subjects', 'Two hundred and three subjects (124 without and 79 with therapy) completed the program', 'hypertensive sedentary subjects including those with resistant hypertension', 'sedentary hypertensive subjects including patients with resistant hypertension', 'Two hundred and fifty-nine sedentary subjects with systolic pressure ≥130\u2009mmHg']","['guided walking', 'Guided walking', 'blood pressure medications and in a group taking three or more antihypertensive drugs, including diuretics']","['systolic blood pressure', 'Diastolic blood pressure', 'blood pressure', 'systolic pressure', 'Blood pressure, body weight, body mass index, waist circumference, and walking speed']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}]",259.0,0.0211196,After 1-year a significant decrease (P < 0.0001) of systolic pressure was observed in both groups.,"[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Mandini', 'Affiliation': 'Center for Exercise Science and Sport, University of Ferrara, Ferrara, Italy. mndsmn@unife.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Conconi', 'Affiliation': 'Center for Exercise Science and Sport, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Mori', 'Affiliation': 'Center for Exercise Science and Sport, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Caruso', 'Affiliation': 'Center for Exercise Science and Sport, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Grazzi', 'Affiliation': 'Center for Exercise Science and Sport, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Mazzoni', 'Affiliation': 'Center for Exercise Science and Sport, University of Ferrara, Ferrara, Italy.'}]",Journal of human hypertension,['10.1038/s41371-020-0324-6']
72,29876770,"Efficacies of different proton pump inhibitor-based 14-day bismuth-furazolidone quadruple regimens for the initial eradication of Helicobacter pylori in the southeast coastal region of China: an open-label, randomized clinical trial.","To evaluate potency and safety of 14-day bismuth-furazolidone quadruple regimens and to compare efficacies of five proton pump inhibitors (PPIs) for the initial eradication of Helicobacter pylori (H. pylori), 175 eligible patients were enrolled and randomly assigned to 14-day quadruple regimens consisting of bismuth (400 mg), amoxicillin (1 g), furazolidone (100 mg), and a PPI, twice a day. PPIs used were Group A (pantoprazole capsules, 40 mg), Group B (pantoprazole tablets, 40 mg), Group C (lansoprazole, 30 mg), Group D (esomeprazole, 20 mg), and Group E (rabeprazole, 10 mg). H. pylori status was reassessed by  13 C urea breath test on day 56 as the primary outcome. Gastrointestinal symptoms, parenteral side effects, compliance, and stool type were recorded simultaneously. The total eradication rates were 86.9% (152/175 [95% CI 80.9-91.5%]) and 95.6% (152/159 [91.1-98.2%]) by intention-to-treat (ITT) and per-protocol (PP) analysis. The efficacies of Group A, B, C, D, and E by ITT analysis were 91.4% (32/35 [76.9-98.2%]), 85.7% (30/35 [69.7-95.2%]), 88.6% (31/35 [73.3-96.8%]), 85.7% (30/35 [69.7-95.2%]), and 82.9% (29/35 [66.4-93.4%]) (p > 0.05). In the PP analysis, the efficacies were 97.0% (32/33), 93.8% (30/32), 93.9% (31/33), 100% (30/30), and 93.5% (29/31) (p > 0.05). Gastrointestinal symptoms and stool type were improved significantly (p < 0.05). Total side effects rate and poor compliance rate were 15.7% (25/159) and 5.0% (8/159). Fourteen-day bismuth-furazolidone quadruple regimens are of high potency and safety for the initial eradication of H. pylori. Efficacies of different PPIs and different dosages (9-32 mg omeprazole equivalents) showed no significant difference. The appropriate PPI can thus be chosen by clinicians.",2018,Efficacies of different PPIs and different dosages (9-32 mg omeprazole equivalents) showed no significant difference.,"['Helicobacter pylori (H. pylori), 175 eligible patients', 'Helicobacter pylori in the southeast coastal region of China']","['five proton pump inhibitors (PPIs', 'proton pump inhibitor-based 14-day bismuth-furazolidone quadruple regimens', 'amoxicillin', 'furazolidone', 'bismuth-furazolidone', '14-day bismuth-furazolidone quadruple regimens', 'bismuth', 'Group B (pantoprazole tablets, 40\xa0mg), Group C (lansoprazole, 30\xa0mg), Group D (esomeprazole, 20\xa0mg), and Group E (rabeprazole']","['Gastrointestinal symptoms and stool type', 'Gastrointestinal symptoms, parenteral side effects, compliance, and stool type', 'total eradication rates', 'Total side effects rate and poor compliance rate']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0441839', 'cui_str': 'Group E (qualifier value)'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}]",175.0,0.0559348,Efficacies of different PPIs and different dosages (9-32 mg omeprazole equivalents) showed no significant difference.,"[{'ForeName': 'Luyi', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.'}, {'ForeName': 'Jiamin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.'}, {'ForeName': 'Qiwei', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.'}, {'ForeName': 'Yujia', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.'}, {'ForeName': 'Yanqin', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.'}, {'ForeName': 'Yanyong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.'}, {'ForeName': 'Huiqin', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.'}, {'ForeName': 'Aiqing', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China. 3310015@zju.edu.cn.'}, {'ForeName': 'Shujie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China. chenshujie77@zju.edu.cn.'}]",Clinical and experimental medicine,['10.1007/s10238-018-0510-9']
73,29673306,Depressive Symptoms Moderate Dating Violence Prevention Outcomes Among Adolescent Girls.,"Purpose:  Few dating violence prevention programs assess how variations in initial violence risk affects responsiveness. This study examines the efficacy of Date SMART, a dating violence and sexual risk prevention program designed to target high-risk adolescent girls, in preventing dating violence in the context of varying initial levels of depressive symptoms.  Method:  A diverse sample of  N  = 109 female adolescents with a history of physical dating violence participated in a randomized controlled trial of the Date SMART program and a knowledge only (KO) comparison.  Results:  Using baseline depression level as a primary risk factor, a series of multilevel models revealed significant main effects of baseline depression such that higher baseline depression was associated with greater physical dating violence perpetration and victimization. Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration. Specifically, those with higher baseline depression in Date SMART showed significantly less physical dating violence perpetration at follow-ups compared with those with higher baseline depression in the KO group. This difference in violence reduction between conditions was not observed for those with lower baseline depression.  Discussion:  Date SMART appears to effectively reduce physical dating violence perpetration in those with higher levels of initial risk. Current findings support that adolescents with different risk profiles respond differently to violence prevention programs.",2021,"Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration.","['Adolescent Girls', 'A diverse sample of N = 109 female adolescents with a history of physical dating violence', 'risk adolescent girls']",['Date SMART program and a knowledge only (KO) comparison'],"['Depressive Symptoms Moderate Dating Violence Prevention Outcomes', 'assessment point, depressive symptoms, and condition for physical dating violence perpetration', 'physical dating violence perpetration', 'baseline depression', 'violence reduction']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",109.0,0.0234464,"Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration.","[{'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Collibee', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Christie J', 'Initials': 'CJ', 'LastName': 'Rizzo', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kemp', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hood', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Doucette', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Gittins Stone', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'DeJesus', 'Affiliation': 'Rhode Island Hospital, Providence, RI, USA.'}]",Journal of interpersonal violence,['10.1177/0886260518770189']
74,31944571,Prediction of pathological complete response to neoadjuvant chemotherapy in breast cancer using a deep learning (DL) method.,"BACKGROUND


The aim of the study was to develop a deep learning (DL) algorithm to evaluate the pathological complete response (pCR) to neoadjuvant chemotherapy in breast cancer.
METHODS


A total of 302 breast cancer patients in this retrospective study were randomly divided into a training set (n = 244) and a validation set (n = 58). Tumor regions were manually delineated on each slice by two expert radiologists on enhanced T1-weighted images. Pathological results were used as ground truth. Deep learning network contained five repetitions of convolution and max-pooling layers and ended with three dense layers. The pre-NAC model and post-NAC model inputted six phases of pre-NAC and post-NAC images, respectively. The combined model used 12 channels from six phases of pre-NAC and six phases of post-NAC images. All models above included three indexes of molecular type as one additional input channel.
RESULTS


The training set contained 137 non-pCR and 107 pCR participants. The validation set contained 33 non-pCR and 25 pCR participants. The area under the receiver operating characteristic (ROC) curve (AUC) of three models was 0.553 for pre-NAC, 0.968 for post-NAC and 0.970 for the combined data, respectively. A significant difference was found in AUC between using pre-NAC data alone and combined data (P < 0.001). The positive predictive value of the combined model was greater than that of the post-NAC model (100% vs. 82.8%, P = 0.033).
CONCLUSION


This study established a deep learning model to predict PCR status after neoadjuvant therapy by combining pre-NAC and post-NAC MRI data. The model performed better than using pre-NAC data only, and also performed better than using post-NAC data only.
KEY POINTS


Significant findings of the study. It achieved an AUC of 0.968 for pCR prediction. It showed a significantly greater AUC than using pre-NAC data only. What this study adds This study established a deep learning model to predict PCR status after neoadjuvant therapy by combining pre-NAC and post-NAC MRI data.",2020,"The model performed better than using pre-NAC data only, and also performed better than using post-NAC data only.
","['breast cancer', '302 breast cancer patients']","['neoadjuvant chemotherapy', 'deep learning (DL) algorithm']","['AUC', 'area under the receiver operating characteristic (ROC) curve (AUC']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002045'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",302.0,0.0291485,"The model performed better than using pre-NAC data only, and also performed better than using post-NAC data only.
","[{'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Qu', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Zhu', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Cao', 'Affiliation': 'Radiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': 'Radiology, Beijing, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Ying-Shi', 'Initials': 'YS', 'LastName': 'Sun', 'Affiliation': 'Radiology, Peking University Cancer Hospital & Institute, Beijing, China.'}]",Thoracic cancer,['10.1111/1759-7714.13309']
75,31904681,"Efficacy and Cost-effectiveness Comparison of 10-Day, 14-Day Sequential Versus 14-Day Triple Therapies for Treating Helicobacter pylori Infection in Egyptian Patients.","GOALS


The aim of this study was to clarify whether 10-day or 14-day sequential therapy (ST) can replace conventional triple therapy (TT) as a first-line treatment in Egypt.
BACKGROUND


Antimicrobial resistance has decreased the eradication rates for Helicobacter pylori infection worldwide.
MATERIALS AND METHODS


Patients who tested positive for H. pylori infection were randomly assigned to the 14-day triple-therapy group (n=34), 10-day ST group (n=34), or 14-day ST group (n=35). Sequential treatment includes lansoprazole 30 mg and amoxicillin 1000 mg, both twice for 5 or 7 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and tinidazole 500 mg, each twice for 5 or 7 days. Triple treatment consists of lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1000 mg, each twice for 14 days. Six weeks after treatment discontinuation, patients were examined by the urea breath test. Eradication rates, the incidence of adverse effects, compliance, and cost-effectiveness were evaluated.
RESULTS


The eradication rate was 90% with 10-day ST, 96.7% with 14-day ST, and 63.3% for TT (P=0.001). Mild tolerated adverse effects occurred in the 3 groups. The cost-effectiveness ratio was 2194 LE, 1241 LE, 1157 LE for standard triple therapy, 10-day, and 14-day ST, respectively.
CONCLUSIONS


Sequential therapies for 10 or 14 days are more cost-effective than standard TT, with 14-day ST being the most cost-effective. Accordingly, ST might replace TT as a first-line treatment for H. pylori infection in Egyptian patients.",2020,Mild tolerated adverse effects occurred in the 3 groups.,"['Egyptian patients', 'Egypt', 'Egyptian Patients', 'Patients who tested positive for H. pylori infection']","['clarithromycin 500\u2009mg, and amoxicillin', 'lansoprazole 30\u2009mg, clarithromycin 500\u2009mg, and tinidazole', 'lansoprazole 30\u2009mg and amoxicillin', '10-day ST', '14-day sequential therapy (ST', '10-Day, 14-Day Sequential Versus 14-Day Triple Therapies', 'lansoprazole']","['cost-effective', 'Efficacy and Cost-effectiveness', 'Eradication rates, the incidence of adverse effects, compliance, and cost-effectiveness', 'Helicobacter pylori Infection', 'Mild tolerated adverse effects', 'cost-effectiveness ratio', 'eradication rate']","[{'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1602204', 'cui_str': 'lansoprazole 30 MG [Prevacid]'}, {'cui': 'C0040263', 'cui_str': 'Tinidazole'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",1157.0,0.0170241,Mild tolerated adverse effects occurred in the 3 groups.,"[{'ForeName': 'Nagwan S', 'Initials': 'NS', 'LastName': 'Farhoud', 'Affiliation': 'Drug and Poison Information Centre, College of Pharmacy.'}, {'ForeName': 'Osama M', 'Initials': 'OM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy.'}, {'ForeName': 'Sherif E', 'Initials': 'SE', 'LastName': 'Ezzat', 'Affiliation': 'Department of Gastroenterology, College of Medicine, Tanta University, Tanta, Egypt.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001278']
76,31201082,"Re: Arinobu Fukunaga, Takahisa Kawaguchi, Satoshi Funada, et al. Sleep Disturbance Worsens Lower Urinary Tract Symptoms (LUTS): The Nagahama Study. J Urol. In press. https://doi.org/10.1097/JU.0000000000000212: Relationship between sleep disturbance and low urinary tract symptoms: ""Shallow Medicine"".",,2021,,['Sleep Disturbance Worsens Lower Urinary Tract Symptoms (LUTS'],[],[],"[{'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]",[],[],,0.0154617,,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Misraï', 'Affiliation': 'Department of Urology, Clinique Pasteur, Toulouse, France. Electronic address: v.misrai@clinique-pasteur.com.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Charbonneau', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Department of Cardiology, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Louvrier', 'Affiliation': 'Department of Otorhinolaryngology, Clinique Ambroise Paré, Toulouse, France.'}, {'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Maldent', 'Affiliation': 'Department of Otorhinolaryngology, Clinique Ambroise Paré, Toulouse, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Milioto', 'Affiliation': 'Department of Nephrology, Clinique Saint Exupéry, Toulouse, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Attias', 'Affiliation': 'Department of Pneumology, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Aranda', 'Affiliation': ""Department of Neurology and Sleep diseases, Clinique de l'Union, Toulouse, France.""}]",European urology focus,['10.1016/j.euf.2019.05.018']
77,31764209,A Randomized Trial of Continuous Versus Intermittent Skin-to-Skin Contact After Premature Birth and the Effects on Mother-Infant Interaction.,"BACKGROUND


Premature birth affects opportunities for interaction between infants and mothers. Skin-to-skin contact (SSC) is standard care in neonatal care but has not been sufficiently studied regarding the effects on interaction between preterm infant and mothers.
PURPOSE


The purpose of this study was to compare interaction between preterm infants and their mothers after continuous versus intermittent SSC from birth to discharge. A secondary aim was to study a potential dose-response effect between time in SSC and quality of interaction.
METHODS


Families were randomly assigned to either continuous (n = 17) or intermittent (n = 14) SSC before delivery. Interaction was measured from videotapes of a Still-Face Paradigm collected at 4 months' corrected age. Face-to-face interaction was coded according to Ainsworth's Maternal Sensitivity Scales and the Maternal Sensitivity and Responsivity Scales-R. Dose-response correlations were calculated between mean time spent in SSC and each of the interaction scales.
RESULTS


There were no statistically significant differences between groups in maternal interactive behavior toward their infants regarding sensitivity, interference, availability, acceptance, withdrawal, or intrusivity. There was no correlation between mean time in SSC and quality of interaction.
IMPLICATIONS FOR PRACTICE


Continuous SSC from birth to discharge was not superior to intermittent SSC concerning mother-infant interaction between preterm infants and their mothers at 4 months' corrected age. However, compared with other studies, mean time in SSC was also high in the intermittent group.
IMPLICATIONS FOR RESEARCH


Further studies are needed to find out how interaction between parents and preterm infants can be improved, supported, and facilitated in the neonatal intensive care unit (NICU) and whether there is an optimal dose for SSC.",2020,"There were no statistically significant differences between groups in maternal interactive behavior toward their infants regarding sensitivity, interference, availability, acceptance, withdrawal, or intrusivity.","['preterm infants and their mothers after continuous versus intermittent SSC from birth to discharge', 'parents and preterm infants', 'infants and mothers', 'Families were randomly assigned to either continuous (n = 17) or intermittent (n = 14', 'Mother-Infant Interaction']","['Skin-to-skin contact (SSC', 'Continuous Versus Intermittent Skin-to-Skin Contact']","['mean time in SSC', 'sensitivity, interference, availability, acceptance, withdrawal, or intrusivity', 'maternal interactive behavior', 'Maternal Sensitivity Scales and the Maternal Sensitivity and Responsivity Scales-R. Dose-response correlations', 'mean time in SSC and quality of interaction']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C3658199', 'cui_str': 'Mother-Infant Relations'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0222045'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.0369425,"There were no statistically significant differences between groups in maternal interactive behavior toward their infants regarding sensitivity, interference, availability, acceptance, withdrawal, or intrusivity.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sahlén Helmer', 'Affiliation': 'Division of Nursing Science, Department of Social and Welfare Studies, Linköping University, Norrköping, Sweden (Mss Sahlén Helmer and Prof Mörelius); Division of Psychology, Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden (Drs Birberg Thornberg and Frostell); and Division of Neonatology, Department of Woman and Child Health, Karolinska Institutet, Stockholm, Sweden (Dr Örtenstrand).'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Birberg Thornberg', 'Affiliation': ''}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Frostell', 'Affiliation': ''}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Örtenstrand', 'Affiliation': ''}, {'ForeName': 'Evalotte', 'Initials': 'E', 'LastName': 'Mörelius', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000675']
78,32410152,Letter to the Editor Re: Sera of Obese Type 2 Diabetic Patients Undergoing Metabolic Surgery Instead of Conventional Treatment Exert Beneficial Effects on Beta Cell Survival and Function: Results of a Randomized Clinical Study.,,2020,,['Sera of Obese Type 2 Diabetic Patients Undergoing'],"['Metabolic Surgery', 'Letter to the Editor Re']",['Beta Cell Survival and Function'],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0341806,,"[{'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Pories', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, 27834, USA. poriesw@ecu.edu.'}, {'ForeName': 'G Lynis', 'Initials': 'GL', 'LastName': 'Dohm', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, 27834, USA.'}]",Obesity surgery,['10.1007/s11695-020-04665-3']
79,23193355,Testing the Assumption of Measurement Invariance in the SAMHSA Mental Health and Alcohol Abuse Stigma Assessment in Older Adults.,"This study examined the assumption of measurement invariance of the SAMSHA Mental Health and Alcohol Abuse Stigma Assessment. This is necessary to make valid comparisons across time and groups. The data come from the Primary Care Research in Substance Abuse and Mental Health for Elderly trial, a longitudinal multisite, randomized trial examining two modes of care (Referral and Integrated). A sample of 1,198 adults over the age of 65 who screened positive for depression, anxiety, and/or at-risk drinking was used. Structural equation modeling was used to assess measurement invariance in a two-factor measurement model (Perceived Stigma, Comfort Level). Irrespective of their stigma level, one bias indicated that with time, respondents find it easier to acknowledge that it is difficult to start treatment if others know they are in treatment. Other biases indicated that sex, mental quality of life and the subject of stigma had undue influence on respondents' feeling people would think differently of them if they received treatment and on respondents' comfort in talking to a mental health provider. Still, in the present study, these biases in response behavior had little effect on the evaluation of group differences and changes in stigma. Stigma decreased for patients of both the Referral and Integrated care groups.",2012,Stigma decreased for patients of both the Referral and Integrated care groups.,"['Older Adults', '1,198 adults over the age of 65 who screened positive for depression, anxiety, and/or at-risk drinking was used']",[],['Stigma'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",1198.0,0.0211594,Stigma decreased for patients of both the Referral and Integrated care groups.,"[{'ForeName': 'Bellinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'Department of Medical Psychology, Academic Medical Centre, University of Amsterdam, Meibergdreef 15, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Frans J', 'Initials': 'FJ', 'LastName': 'Oort', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lynn', 'Affiliation': ''}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Schonfeld', 'Affiliation': ''}]",Ageing international,[]
80,31746819,Balloon Eustachian Tuboplasty Combined With Tympanocentesis Is not Superior to Balloon Eustachian Tuboplasty in Chronic Otitis Media With Effusion-A Randomized Clinical Trial.,"OBJECTIVE


Balloon Eustachian tuboplasty (BET) appears to be a promising therapeutic option for Eustachian tube dysfunction. However, data are lacking on its effect in adults with chronic otitis media with effusion (COME) and whether it should be combined with tympanocentesis. The aim of our study was to determine if there is a beneficial effect of BET combined with tympanocentesis compared with BET only and provide data on the effect of BET in adults with COME.
STUDY DESIGN


Randomized clinical trial.
SETTING


Tertiary referral hospital.
PARTICIPANTS


Adults with COME lasting more than 6 months after tympanostomy tube exclusion. Among 40 eligible ears, 30 were randomized to treatment.
INTERVENTION


BET (group 1) versus BET with concurrent tympanocentesis (group 2).
MAIN OUTCOME MEASURES


Tympanometry, Valsalva or Toynbee maneuver with tympanometry verification, Eustachian Tube Dysfunction Questionnaire, and pure-tone audiometry.
RESULTS


A total of 25 patients (14 ears in group 1 and 15 ears in group 2) were included in the analysis. No significant difference in the effect of treatment was found between the groups. When patients were evaluated as one group, after 2, 6, and 12 months, improvement was found in tympanometry in 55, 48, and 48%; in the ability to perform maneuvers in 55, 41, and 41%; in audiometry in 69, 62, and 59%; and in questionnaire scores in 76, 72, and 69%, respectively.
CONCLUSIONS


There was no beneficial outcome of tympanocentesis performed concurrently with BET and therefore it should not be routinely recommended. The success of therapy appears to be reduced compared with other pathologies caused by Eustachian tube dysfunction.",2020,No significant difference in the effect of treatment was found between the groups.,"['25 patients (14 ears in group 1 and 15 ears in group 2) were included in the analysis', 'adults with chronic otitis media with effusion (COME', 'Adults with COME lasting more than 6 months after tympanostomy tube exclusion', '40 eligible ears, 30 were randomized to treatment', 'Chronic Otitis Media With Effusion', 'Tertiary referral hospital', 'adults with COME']","['Tuboplasty Combined With Tympanocentesis', 'Eustachian Tuboplasty', 'BET', 'Balloon Eustachian tuboplasty (BET', 'Balloon Eustachian', 'BET combined with tympanocentesis', 'BET with concurrent tympanocentesis', 'Balloon']","['questionnaire scores', 'Tympanometry, Valsalva or Toynbee', 'maneuver with tympanometry verification, Eustachian Tube Dysfunction Questionnaire, and pure-tone audiometry', 'ability to perform maneuvers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2242816', 'cui_str': 'Chronic non-suppurative otitis media with effusion'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0850121', 'cui_str': 'Ventilation tube'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3266817', 'cui_str': 'Tympanocentesis'}, {'cui': 'C0198196', 'cui_str': 'Repair of eustachian tube (procedure)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry'}, {'cui': 'C0271468', 'cui_str': 'Eustachian tube disorder (disorder)'}, {'cui': 'C0004292', 'cui_str': 'Audiometry, Pure-Tone'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",40.0,0.0997188,No significant difference in the effect of treatment was found between the groups.,"[{'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Formánková', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Ostrava.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Formánek', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Ostrava.'}, {'ForeName': 'Lukáš', 'Initials': 'L', 'LastName': 'Školoudík', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Hradec Kralove, Charles University, Faculty of Medicine in Hradec Kralove, Hradec Kralove.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Zeleník', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Ostrava.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Tomášková', 'Affiliation': 'Epidemiological Studies Center, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Chrobok', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Hradec Kralove, Charles University, Faculty of Medicine in Hradec Kralove, Hradec Kralove.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Komínek', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Ostrava.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002518']
81,31738150,Comparing Intradermal Sterile Water with Intravenous Morphine in Reducing Pain in Patients with Renal Colic: A Double-Blind Randomized Clinical Trial.,"OBJECTIVE


The present study was conducted to investigate the effect of intradermal administration of sterile water compared to intravenous morphine on patients with renal colic.
METHODS


This double-blind, randomized clinical trial study was conducted in 2017 to compare the therapeutic effects of intradermal sterile water with those of intravenous morphine on patients with renal colic presenting to the emergency departments (ED) of Imam Khomeini and Golestan Hospitals in Ahvaz, Iran. The first group received 0.5 ml of intradermal sterile water, and the second group 0.1mg/kg of intravenous morphine plus 0.5 ml of intradermal sterile water in the most painful area or the center of the painful area in the flank. The pain severity was measured using a visual analogue scale (VAS), and the medication side-effects were recorded at the beginning of the study and minutes 15, 30,45 and 60.
RESULTS


A total of 94 patients were studied in two groups. The mean severity of pain was 2.97 ± 1.51 in the sterile water group and 2.34 ± 1.89 in the morphine group at minute 30 (P=0.042), 2.58 ± 1.43 in the sterile water group and 1 ± 1.23 in the morphine group at minute 45 (P<0.001), and 1.89 ± 1.7 in the sterile water group and 0.52 ± 0.79 in the morphine group at minute 60 (P<0.001).
CONCLUSION


Morphine reduces pain faster and more effectively than intradermal sterile water; nevertheless, treatment with intradermal sterile water can be used as an appropriate surrogate or adjunct therapy for pain control, particularly in special patients or in case of medication scarcity.",2020,"Morphine reduces pain faster and more effectively than intradermal sterile water; nevertheless, treatment with intradermal sterile water can be used as an appropriate surrogate or adjunct therapy for pain control, particularly in special patients or in case of medication scarcity.","['patients with renal colic', 'Patients with Renal Colic', '94 patients were studied in two groups', 'patients with renal colic presenting to the emergency departments (ED) of Imam Khomeini and Golestan Hospitals in Ahvaz, Iran']","['morphine', 'Intradermal Sterile Water with Intravenous Morphine', 'intradermal sterile water with those of intravenous morphine', 'Morphine', 'intradermal sterile water, and the second group 0.1 mg/kg of intravenous morphine plus 0.5 ml of intradermal sterile water']","['mean severity of pain', 'visual analogue scale (VAS), and the medication side-effects', 'Pain', 'pain faster', 'pain severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2364092', 'cui_str': 'Medication side effects present'}]",94.0,0.151672,"Morphine reduces pain faster and more effectively than intradermal sterile water; nevertheless, treatment with intradermal sterile water can be used as an appropriate surrogate or adjunct therapy for pain control, particularly in special patients or in case of medication scarcity.","[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Mozafari', 'Affiliation': 'Emergency Department, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza Maleki', 'Initials': 'MM', 'LastName': 'Verki', 'Affiliation': 'Emergency Department, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Tirandaz', 'Affiliation': 'Emergency Department, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mahjouri', 'Affiliation': 'Emergency Department, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Reviews on recent clinical trials,['10.2174/1574887114666191118153600']
82,30778597,Effect of Intravenous Acetaminophen vs Placebo Combined With Propofol or Dexmedetomidine on Postoperative Delirium Among Older Patients Following Cardiac Surgery: The DEXACET Randomized Clinical Trial.,"Importance


Postoperative delirium is common following cardiac surgery and may be affected by choice of analgesic and sedative.
Objective


To evaluate the effect of postoperative intravenous (IV) acetaminophen (paracetamol) vs placebo combined with IV propofol vs dexmedetomidine on postoperative delirium among older patients undergoing cardiac surgery.
Design, Setting, and Participants


Randomized, placebo-controlled, factorial clinical trial among 120 patients aged 60 years or older undergoing on-pump coronary artery bypass graft (CABG) surgery or combined CABG/valve surgeries at a US center. Enrollment was September 2015 to April 2018, with follow-up ending in April 2019.
Interventions


Patients were randomized to 1 of 4 groups receiving postoperative analgesia with IV acetaminophen or placebo every 6 hours for 48 hours and postoperative sedation with dexmedetomidine or propofol starting at chest closure and continued for up to 6 hours (acetaminophen and dexmedetomidine: n = 29; placebo and dexmedetomidine: n = 30; acetaminophen and propofol: n = 31; placebo and propofol: n = 30).
Main Outcomes and Measures


The primary outcome was incidence of postoperative in-hospital delirium by the Confusion Assessment Method. Secondary outcomes included delirium duration, cognitive decline, breakthrough analgesia within the first 48 hours, and ICU and hospital length of stay.
Results


Among 121 patients randomized (median age, 69 years; 19 women [15.8%]), 120 completed the trial. Patients treated with IV acetaminophen had a significant reduction in delirium (10% vs 28% placebo; difference, -18% [95% CI, -32% to -5%]; P = .01; HR, 2.8 [95% CI, 1.1-7.8]). Patients receiving dexmedetomidine vs propofol had no significant difference in delirium (17% vs 21%; difference, -4% [95% CI, -18% to 10%]; P = .54; HR, 0.8 [95% CI, 0.4-1.9]). There were significant differences favoring acetaminophen vs placebo for 3 prespecified secondary outcomes: delirium duration (median, 1 vs 2 days; difference, -1 [95% CI, -2 to 0]), ICU length of stay (median, 29.5 vs 46.7 hours; difference, -16.7 [95% CI, -20.3 to -0.8]), and breakthrough analgesia (median, 322.5 vs 405.3 µg morphine equivalents; difference, -83 [95% CI, -154 to -14]). For dexmedetomidine vs propofol, only breakthrough analgesia was significantly different (median, 328.8 vs 397.5 µg; difference, -69 [95% CI, -155 to -4]; P = .04). Fourteen patients in both the placebo-dexmedetomidine and acetaminophen-propofol groups (46% and 45%) and 7 in the acetaminophen-dexmedetomidine and placebo-propofol groups (24% and 23%) had hypotension.
Conclusions and Relevance


Among older patients undergoing cardiac surgery, postoperative scheduled IV acetaminophen, combined with IV propofol or dexmedetomidine, reduced in-hospital delirium vs placebo. Additional research, including comparison of IV vs oral acetaminophen and other potentially opioid-sparing analgesics, on the incidence of postoperative delirium is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT02546765.",2019,"For dexmedetomidine vs propofol, only breakthrough analgesia was significantly different (median, 328.8 vs 397.5 µg; difference, -69","['Fourteen patients in both the', 'older patients undergoing cardiac surgery', '120 patients aged 60 years or older undergoing on-pump coronary artery bypass graft (CABG) surgery or combined CABG/valve surgeries at a US center', 'Older Patients Following Cardiac Surgery', 'older patients undergoing cardiac surgery, postoperative scheduled IV', '121 patients randomized (median age, 69 years; 19 women [15.8%]), 120 completed the trial']","['acetaminophen, combined with IV propofol or dexmedetomidine', 'postoperative intravenous (IV) acetaminophen (paracetamol', 'dexmedetomidine vs propofol', 'placebo-propofol', 'placebo', 'acetaminophen-dexmedetomidine', 'placebo and dexmedetomidine', 'dexmedetomidine or propofol starting at chest closure and continued for up to 6 hours (acetaminophen and dexmedetomidine', 'acetaminophen and propofol: n\u2009=\u200931; placebo and propofol', 'postoperative analgesia with IV acetaminophen or placebo', 'Propofol or Dexmedetomidine', 'acetaminophen', 'placebo-dexmedetomidine and acetaminophen-propofol', 'Acetaminophen vs Placebo', 'placebo combined with IV propofol vs dexmedetomidine']","['ICU length of stay', 'breakthrough analgesia', 'hypotension', 'Postoperative Delirium', 'delirium', 'incidence of postoperative in-hospital delirium by the Confusion Assessment Method', 'delirium duration', 'postoperative delirium', 'delirium duration, cognitive decline, breakthrough analgesia within the first 48 hours, and ICU and hospital length of stay']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}]",120.0,0.774468,"For dexmedetomidine vs propofol, only breakthrough analgesia was significantly different (median, 328.8 vs 397.5 µg; difference, -69","[{'ForeName': 'Balachundhar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Shankar', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Shaefi', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Mueller', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': ""O'Gara"", 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': 'Department of Medicine, Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Gasangwa', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Patxot', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Packiasabapathy', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Mathur', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Eikermann', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Talmor', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Marcantonio', 'Affiliation': 'Department of Medicine, Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}]",JAMA,['10.1001/jama.2019.0234']
83,31883327,Perioperative fosfomycin disodium prophylaxis against urinary tract infection in renal transplant recipients: a randomized clinical trial.,"BACKGROUND


Symptomatic urinary tract infection (UTI) is the most common infectious complication in renal transplant recipients (RTRs). Fosfomycin (FOS) is an attractive alternative for prophylaxis because it does not interact with immunosuppressants; although 90% is excreted unchanged in the urine, it does not require adjustment for renal function for single dose prophylaxis.
METHODS


RTRs were recruited into this randomized, double-blind, placebo-controlled trial. Participants were randomized (1:1) to receive one 4 g dose of FOS disodium intravenously 3 h (FOS group) or placebo (placebo group) before placement and removal of a urinary catheter and before removal of a double-J ureteral stent. All participants received prophylaxis with trimethoprim/sulfamethoxazole. The main outcome was a comparison of the mean number of symptomatic UTI and asymptomatic bacteriuria (AB) episodes per patient during a 7-week follow-up period. The study was registered at ClinicalTrials.gov, NTC03235947.
RESULTS


Eighty-two participants were included (41 in the FOS group and 41 in placebo group). The mean number of AB or symptomatic UTI episodes per patient was lower in the FOS group [intention-to-treat (ITT) 0.29 versus 0.60, P = 0.04]. The incidence of symptomatic UTI was lower in the FOS group (ITT, 7.3% versus 36.6%, P = 0.001), and there was no difference in the incidence of AB between both groups. The incidence of adverse events was similar in both groups.
CONCLUSIONS


FOS addition is an effective and safe strategy to reduce the number of symptomatic UTIs during the first 7 weeks after renal transplant.",2020,"The incidence of symptomatic UTI was lower in the FOS group (ITT, 7.3% versus 36.6%, P = 0.001), and there was no difference in the incidence of AB between both groups.","['renal transplant recipients', 'Eighty-two participants were included (41 in the FOS group and 41 in placebo group', 'RTRs', 'renal transplant recipients (RTRs']","['Fosfomycin (FOS', 'placebo', 'FOS disodium intravenously 3\u2009h (FOS group) or placebo (placebo group) before placement and removal of a urinary catheter and before removal of a double-J ureteral stent', 'trimethoprim/sulfamethoxazole', 'Perioperative fosfomycin disodium prophylaxis']","['incidence of symptomatic UTI', 'incidence of AB', 'adverse events', 'mean number of symptomatic UTI and asymptomatic bacteriuria (AB) episodes', 'mean number of AB or symptomatic UTI episodes per patient']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0771948', 'cui_str': 'Fosfomycin disodium'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",82.0,0.577132,"The incidence of symptomatic UTI was lower in the FOS group (ITT, 7.3% versus 36.6%, P = 0.001), and there was no difference in the incidence of AB between both groups.","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Rosado-Canto', 'Affiliation': 'Department of Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Idalia', 'Initials': 'I', 'LastName': 'Parra-Avila', 'Affiliation': 'Department of Nephrology-Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Tejeda-Maldonado', 'Affiliation': 'Department of Nephrology-Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Cristopher', 'Initials': 'C', 'LastName': 'Kauffman-Ortega', 'Affiliation': 'Department of Urology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Francisco T', 'Initials': 'FT', 'LastName': 'Rodriguez-Covarrubias', 'Affiliation': 'Department of Urology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Mariedel', 'Initials': 'M', 'LastName': 'Trujeque-Matos', 'Affiliation': 'Department of Nephrology-Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cruz-Martínez', 'Affiliation': 'Department of Transplantation, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Maravilla-Franco', 'Affiliation': 'Laboratory of Clinical Microbiology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Criollo-Mora', 'Affiliation': 'Department of Pharmacy, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Arreola-Guerra', 'Affiliation': 'Department of Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Morales-Buenrostro', 'Affiliation': 'Department of Nephrology-Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Sifuentes-Osornio', 'Affiliation': 'Department of Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz261']
84,21212808,The Effects of Playing with Thin Dolls on Body Image and Food Intake in Young Girls.,"This study experimentally tested the effects of playing with thin dolls on body image and food intake in 6- to 10-year-old Dutch girls (N = 117). Girls were randomly assigned to play with a thin doll, an average-sized doll, or Legos in a no doll control condition. After 10 min, they participated in a taste-test and completed questionnaires about body image. No differences were found between conditions for any of the body image variables. However, girls who played with the average-sized doll ate significantly more food than girls in other exposure conditions. Although no support was found for the assumption that playing with thin dolls influences body image, the dolls directly affected actual food intake in these young girls.",2010,No differences were found between conditions for any of the body image variables.,"['Young Girls', '6- to 10-year-old Dutch girls (N\u2009=\u2009117']",['Playing with Thin Dolls'],"['body image and food intake', 'Body Image and Food Intake']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}]","[{'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",,0.026082,No differences were found between conditions for any of the body image variables.,"[{'ForeName': 'Doeschka J', 'Initials': 'DJ', 'LastName': 'Anschutz', 'Affiliation': 'Behavioural Science Institute, Radboud University, P.O. Box\xa09104, 6500 HE Nijmegen, The Netherlands.'}, {'ForeName': 'Rutger C M E', 'Initials': 'RC', 'LastName': 'Engels', 'Affiliation': ''}]",Sex roles,[]
85,21611733,Modifying threat-related interpretive bias in adolescents.,"Socially anxious feelings sharply increase during adolescence and such feelings have been associated with interpretive biases. Studies in adults have shown that interpretive biases can be modified using Cognitive Bias Modification procedures (CBM-I) and subsequent effects on anxiety have been observed. The current study was designed to examine whether the CBM-I procedure has similar effects in adolescents. Unselected adolescents were randomly allocated to either a positive interpretation training (n = 88) or a placebo-control condition (n = 82). Results revealed that the training was successful in modifying interpretations and effects generalized to a new task. The interpretive bias effects were most pronounced in individuals with a threat-related interpretive bias at pre-test. No effects on state anxiety were observed. The current findings are promising with regard to applying bias modification procedures to adolescents, while further research is warranted regarding emotional effects.",2011,No effects on state anxiety were observed.,"['adolescents', 'Unselected adolescents']","['placebo-control condition', 'positive interpretation training']",['state anxiety'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0377347,No effects on state anxiety were observed.,"[{'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Salemink', 'Affiliation': 'Department of Developmental Psychology, University of Amsterdam, Roetersstraat 15, 1018 WB, Amsterdam, The Netherlands. E.Salemink@uva.nl'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': ''}]",Journal of abnormal child psychology,['10.1007/s10802-011-9523-5']
86,31504495,Examining smoke-free coalitions in Armenia and Georgia: baseline community capacity.,"Local coalitions can advance public health initiative but have not been widely used or well-studied in low- and middle-income countries. This paper provides (i) an overview of an ongoing matched-pairs community-randomized controlled trial in 28 communities in Armenia and Georgia (N = 14/country) testing local coalitions to promote smoke-free policies/enforcement and (ii) characteristics of the communities involved. In July-August 2018, key informants (e.g. local public health center directors) were surveyed to compare their non-communicable disease (NCD) and tobacco-related activities across countries and across condition (intervention/control). More than half of the informants (50.0-57.1%) reported their communities had programs addressing hypertension, diabetes, cancer and human papilloma virus, with 85.7% involving community education and 32.1% patient education programs. Eleven communities (39.3%) addressed tobacco control, all of which were in Georgia. Of those, all included public/community education and the majority (72.7-81.8%) provided cessation counseling/classes, school/youth prevention programs, healthcare provider training or activities addressing smoke-free environments. Informants in Georgia versus Armenia perceived greater support for tobacco control from various sectors (e.g. government, community). No differences were found by condition assignment. This paper provides a foundation for presenting subsequent analyses of this ongoing trial. These analyses indicate wide variability regarding NCD-related activities and support across communities and countries.",2019,No differences were found by condition assignment.,['28 communities in Armenia and Georgia'],['healthcare provider training or activities addressing smoke-free environments'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003798', 'cui_str': 'Armenian SSR'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}]","[{'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",[],,0.0377896,No differences were found by condition assignment.,"[{'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Berg', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Dekanosidze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Arevik', 'Initials': 'A', 'LastName': 'Torosyan', 'Affiliation': 'National Institute of Health named after academician S. Avdalbekyan, MoH, Komitasi Ave. 49/4, Yerevan, Armenia.'}, {'ForeName': 'Lilit', 'Initials': 'L', 'LastName': 'Grigoryan', 'Affiliation': 'National Institute of Health named after academician S. Avdalbekyan, MoH, Komitasi Ave. 49/4, Yerevan, Armenia.'}, {'ForeName': 'Zhanna', 'Initials': 'Z', 'LastName': 'Sargsyan', 'Affiliation': 'Turpanjian School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave., Yerevan, Armenia.'}, {'ForeName': 'Varduhi', 'Initials': 'V', 'LastName': 'Hayrumyan', 'Affiliation': 'Turpanjian School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave., Yerevan, Armenia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Topuridze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Lela', 'Initials': 'L', 'LastName': 'Sturua', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Arusyak', 'Initials': 'A', 'LastName': 'Harutyunyan', 'Affiliation': 'Turpanjian School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave., Yerevan, Armenia.'}, {'ForeName': 'Lela', 'Initials': 'L', 'LastName': 'Kvachantiradze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Maglakelidze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Amiran', 'Initials': 'A', 'LastName': 'Gamkrelidze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Romela', 'Initials': 'R', 'LastName': 'Abovyan', 'Affiliation': 'Department of Epidemiology of Noncommunicable and Nosocomial Infectious Disease, National Center for Disease Control and Prevention, MOH RA, Mkhitar Heratsu St. 12, Yerevan, Armenia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bazarchyan', 'Affiliation': 'National Institute of Health named after academician S. Avdalbekyan, MoH, Komitasi Ave. 49/4, Yerevan, Armenia.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Kegler', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, USA.'}]",Health education research,['10.1093/her/cyz024']
87,31846923,Efficacy of Epley Maneuver on Quality of Life of Elderly Patients with Subjective BPPV.,"OBJECTIVES


This study aimed to evaluate the efficacy of the repositioning maneuver on quality of life in elderly patients with dizziness and/or vertigo.
MATERIALS AND METHODS


This controlled, prospective randomized clinical trial was conducted in elderly patients aged 65 years and above with a positive history of benign paroxysmal positional vertigo (BPPV), presence of vertigo, and no observable nystagmus during the Dix-Hallpike test, so-called Subjective BPPV (S-BPPV). Individuals were evaluated by visual analog scale (VAS) and dizziness handicap inventory (DHI). Groups were defined as treatment (treated with Epley maneuver bilaterally) or no treatment control (no treatment modality or canalith repositioning maneuver). Ten days after the first assessment, all patients were reassessed using VAS and DHI.
RESULTS


A total of 50 patients were randomized into two groups: 25 to the treatment group, and 25 to the control group. No significant differences were observed for baseline VAS and total DHI scores between the groups (p=0.636, p=0.846, respectively). On the other hand, after the reassessment, VAS and total DHI scores were both significantly reduced in the treatment group (p<0.001, p<0.001, respectively), but no reduction in either score was found in the control group (p=0.216, p=0.731, respectively).
CONCLUSION


This study showed that elderly patients with S-BPPV benefit from the Epley maneuver, in particular global and disease-specific quality of life.",2019,"No significant differences were observed for baseline VAS and total DHI scores between the groups (p=0.636, p=0.846, respectively).","['elderly patients aged 65 years and above with a positive history of benign paroxysmal positional vertigo (BPPV), presence of vertigo, and no observable nystagmus during the Dix-Hallpike test, so-called Subjective BPPV (S-BPPV', 'A total of 50 patients', 'elderly patients with S-BPPV', 'Elderly Patients with Subjective BPPV', 'elderly patients with dizziness and/or vertigo']","['repositioning maneuver', 'Epley Maneuver', 'Epley maneuver bilaterally) or no treatment control (no treatment modality or canalith repositioning maneuver']","['visual analog scale (VAS) and dizziness handicap inventory (DHI', 'baseline VAS and total DHI scores', 'Quality of Life', 'VAS and total DHI scores', 'quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]","[{'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C1279393', 'cui_str': 'Epley maneuver (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}]",,0.0369224,"No significant differences were observed for baseline VAS and total DHI scores between the groups (p=0.636, p=0.846, respectively).","[{'ForeName': 'Uzdan', 'Initials': 'U', 'LastName': 'Uz', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Uz', 'Affiliation': 'Department of Neurology, Dokuz Eylül University School of Medicine, İzmir, Turkey.'}, {'ForeName': 'Gülden', 'Initials': 'G', 'LastName': 'Akdal', 'Affiliation': 'Department of Neurology, Dokuz Eylül University School of Medicine, İzmir, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Çelik', 'Affiliation': 'Department Otolaryngology-Head and Neck Surgery, Manisa Celal Bayar University School of Medicine, Manisa, Turkey.'}]",The journal of international advanced otology,['10.5152/iao.2019.6483']
88,31258019,Effect of iron supplementation from neonatal period on the iron status of6-month-old infants at-risk for early iron deficiency: a randomized interventional trial.,"OBJECTIVE


To investigate the effects of iron supplementation from the second day after birth on 6-month hemoglobin (Hb), serum ferritin and motor development in infants at risk of early iron deficiency.
STUDY DESIGN


Term (37-41 weeks) infants of anemic (Hb ≤ 100 g L -1 ;  N  = 100) and non-anemic (Hb > 100 g L -1 ;  N  = 100) mothers were randomized to daily iron supplementation at a dose of 2 mg kg -1  from 36 h of age ( N  = 50, each of anemic and non-anemic mothers) or no iron-supplementation ( N  = 50 each of anemic and non-anemic mothers). Hb, serum ferritin and motor development at 6 months were compared in the two groups.
RESULTS


Iron-supplemented infants had higher Hb (103.7 ± 9.3 g L -1  versus 97.0 ± 9.4 g L -1 ,  p  < .0001) and serum ferritin (133.93 ± 52.41 ng mL -1  versus 78.09 ± 42.03 ng mL -1 ,  p  < .001) concentrations, compared with the no iron-supplementation group. Their motor development was closer to age-appropriate norms than the no iron-supplementation group (5.83 ± 0.69 versus 5.18 ± 1.35,  p  < .01).
CONCLUSION


Early Iron supplementation is effective for improving iron status and motor development at 6 months in infants at risk for early iron deficiency.",2021,"Their motor development was closer to age-appropriate norms than the no iron-supplementation group (5.83 ± 0.69 versus 5.18 ± 1.35,  p  < .01).  ","['non-anemic (Hb\u2009>\u2009100\u2009g\xa0L -1 ;  N \u2009=\u2009100) mothers', 'infants at risk for early iron deficiency', 'Study design:  Term (37-41\xa0weeks) infants of anemic (Hb ≤ 100\u2009g\xa0L -1 ', 'neonatal period on the iron status of6-month-old infants at-risk for early iron deficiency', 'infants at risk of early iron deficiency']","['daily iron supplementation at a dose of 2\u2009mg\xa0kg -1  from 36\u2009h of age ( N \u2009=\u200950, each of anemic and non-anemic mothers) or no iron-supplementation ( N \u2009=\u200950 each of anemic and non-anemic mothers', 'Iron-supplemented infants', 'iron supplementation']","['6-month hemoglobin (Hb), serum ferritin and motor development', 'Hb, serum ferritin and motor development', 'serum ferritin']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0673362', 'cui_str': 'L-1 (ester)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement (substance)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0243107', 'cui_str': 'development'}]",,0.126577,"Their motor development was closer to age-appropriate norms than the no iron-supplementation group (5.83 ± 0.69 versus 5.18 ± 1.35,  p  < .01).  ","[{'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Bora', 'Affiliation': 'Neonatal Unit, Assam Medical College, Dibrugarh, India.'}, {'ForeName': 'Sutharson', 'Initials': 'S', 'LastName': 'Ramasamy', 'Affiliation': 'Neonatal Unit, Assam Medical College, Dibrugarh, India.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Wolfson', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Minnesota, Minneapolis, MN, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1638358']
89,31749143,Baseline findings and safety of infrequent vs. frequent screening of human papillomavirus vaccinated women.,"Less frequent cervical cancer screening in human papillomavirus (HPV) vaccinated birth cohorts could produce considerable savings without increasing cervical cancer incidence and loss of life-years. We report here the baseline findings and interim results of safety and accuracy of infrequent screening among HPV16/18 vaccinated females. The entire 1992-1994 birth-cohorts (30,139 females) were invited to a community-randomized HPV16/18-vaccination trial. A total of 9,482 female trial participants received HPV16/18-vaccination in 2007-2009 at age of 13-15. At age 22, 4,273 (45%) of these females consented to attend a randomized trial on frequent (ages 22/25/28; Arm 1: 2,073 females) vs. infrequent screening (age 28; Arm 2: 2,200 females) in 2014-2017. Females (1,329), who had got HPV16/18 vaccination at age 18 comprised the safety Arm 3. Baseline prevalence and incidence of HPV16/18 and other high-risk HPV types were: 0.5% (53/1,000 follow-up years, 10 4  ) and 25% (2,530/10 4  ) in the frequently screened Arm 1; 0.2% (23/10 4  ) and 24% (2,413/10 4  ) in the infrequently screened Arm 2; and 3.1% (304/10 4  ) and 23% (2,284/10 4  ) in the safety Arm 3. Corresponding prevalence of HSIL/ASC-H and of any abnormal cytological findings were: 0.3 and 4.2% (Arm 1), 0.4 and 5.3% (Arm 2) and 0.3 and 4.7% (Arm 3). Equally rare HSIL/CIN3 findings in the infrequently screened safety Arm A3 (0.4%) and in the frequently screened Arm 1 (0.4%) indicate no safety concerns on infrequent screening despite the up to 10 times higher HPV16/18 baseline prevalence and incidence in the former.",2020,Less frequent cervical cancer screening in human papillomavirus (HPV) vaccinated birth cohorts could produce considerable savings without increasing cervical cancer incidence and loss of life-years.,"['The entire 1992-94 birth-cohorts (30139 females', 'A total of 9,482 female trial participants received HPV16/18-vaccinationin 2007-09 at age of 13-15', 'Females (1329), who had got HPV16/18 vaccination at age 18 comprised the safety Arm 3', 'HPV16/18 vaccinated females', 'At age 22, 4273 (45%) of these females consented to attend a randomized trial on frequent (ages 22/25/28)(Arm 1: 2073females) vs. infrequent screening (age 28)(Arm 2: 2200females) in 2014-2017', 'human papillomavirus vaccinated women']",[],"['safety Arm 3.Corresponding prevalence of HSIL/ASC-H and of any abnormal cytological findings', 'Baseline prevalence and incidence of HPV16/18 and other high-risk HPV types']","[{'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0333875', 'cui_str': 'HSIL, High-Grade Squamous Intraepithelial Lesions'}, {'cui': 'C1510966', 'cui_str': 'ASC-H'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0205471', 'cui_str': 'Cytologic (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0201679', 'cui_str': 'Human papillomavirus typing (procedure)'}]",94.0,0.0697308,Less frequent cervical cancer screening in human papillomavirus (HPV) vaccinated birth cohorts could produce considerable savings without increasing cervical cancer incidence and loss of life-years.,"[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Louvanto', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL-Medi Clinical Research Center, Family Federation Finland, Helsinki, Finland.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Baussano', 'Affiliation': 'Infections and Cancer Epidemiology Group, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bly', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Harjula', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Heikkilä', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hokkanen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Huhtinen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Ikonen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Karttunen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Mervi', 'Initials': 'M', 'LastName': 'Nummela', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Söderlund-Strand', 'Affiliation': 'Department of Clinical Microbiology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Veivo', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Elfstöm', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Nieminen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}]",International journal of cancer,['10.1002/ijc.32802']
90,20098511,"Sexual Priming, Gender Stereotyping, and Likelihood to Sexually Harass: Examining the Cognitive Effects of Playing a Sexually-Explicit Video Game.","The present study examines the short-term cognitive effects of playing a sexually explicit video game with female ""objectification"" content on male players. Seventy-four male students from a university in California, U.S. participated in a laboratory experiment. They were randomly assigned to play either a sexually-explicit game or one of two control games. Participants' cognitive accessibility to sexual and sexually objectifying thoughts was measured in a lexical decision task. A likelihood-to-sexually-harass scale was also administered. Results show that playing a video game with the theme of female ""objectification"" may prime thoughts related to sex, encourage men to view women as sex objects, and lead to self-reported tendencies to behave inappropriately towards women in social situations.",2010,"Results show that playing a video game with the theme of female ""objectification"" may prime thoughts related to sex, encourage men to view women as sex objects, and lead to self-reported tendencies to behave inappropriately towards women in social situations.","['male players', 'Seventy-four male students from a university in California, U.S. participated in a laboratory experiment', 'Sexual Priming, Gender Stereotyping, and Likelihood to Sexually Harass']","['playing a sexually explicit video game with female ""objectification"" content', 'sexually-explicit game or one of two control games', 'Playing a Sexually-Explicit Video Game']",['cognitive accessibility to sexual and sexually objectifying thoughts'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4319827', 'cui_str': 'Thought'}]",74.0,0.0141608,"Results show that playing a video game with the theme of female ""objectification"" may prime thoughts related to sex, encourage men to view women as sex objects, and lead to self-reported tendencies to behave inappropriately towards women in social situations.","[{'ForeName': 'Mike Z', 'Initials': 'MZ', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Mahood', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Linz', 'Affiliation': ''}]",Sex roles,[]
91,31186173,Multimodal Prehabilitation to Enhance Functional Capacity Following Radical Cystectomy: A Randomized Controlled Trial.,"BACKGROUND


In patients with bladder cancer, poor functional status has remarkable deleterious effects on postoperative outcome and prognosis. Conditioning intervention initiated before surgery has the potential to reduce functional decline attributable to surgery. Nonetheless, evidence is lacking in patients undergoing radical cystectomy.
OBJECTIVE


To determine whether a preoperative multimodal intervention (prehabilitation) is feasible and effective in radical cystectomy.
DESIGN, SETTING, AND PARTICIPANTS


This study, conducted at an academic tertiary health care institution, enrolled adult patients scheduled for radical cystectomy. From August 2013 to October 2017, 70 patients were randomized: 35 to multimodal prehabilitation (prehab group) and 35 to standard care (control group).
INTERVENTION


Multimodal prehabilitation was a preoperative conditioning intervention including aerobic and resistance exercise, diet therapy, and relaxation techniques.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Primary outcome was perioperative change in functional capacity, measured with the distance covered during a 6-min walk test (6MWD), assessed at baseline, before surgery, and at 4 and 8 wk after surgery. Data were compared using robust mixed linear models for repeated measures.
RESULTS AND LIMITATIONS


Preoperative change in 6MWD compared with baseline was not significantly different between groups (prehab group 40.8 [114.0] m vs control group 9.7 (108.4) m, p=0.250). However, at 4 wk after surgery, a significant difference in functional capacity was detected (6MWD, prehab group -15.4 [142.5] m vs control group -97.9 [123.8] m, p=0.014). No intervention-related adverse effects were reported.
CONCLUSIONS


Data suggested that multimodal prehabilitation resulted in faster functional recovery after radical cystectomy.
PATIENT SUMMARY


After major cancer surgery, people usually feel week and tired, and have less energy to perform activities of daily living. In this study, we showed that using the time before surgery to promote exercise and good nutrition could fasten recovery after the surgical removal of the bladder.",2021,"RESULTS AND LIMITATIONS


Preoperative change in 6MWD compared with baseline was not significantly different between groups (prehab group 40.8 [114.0] m vs control group 9.7 (108.4) m, p=0.250).","['patients with bladder cancer', 'patients undergoing radical cystectomy', 'From August 2013 to October 2017, 70 patients were randomized: 35 to']","['multimodal prehabilitation (prehab group) and 35 to standard care (control group', 'Radical Cystectomy', 'radical cystectomy', 'preoperative multimodal intervention (prehabilitation']","['functional recovery', 'adverse effects', 'functional capacity', 'perioperative change in functional capacity, measured with the distance covered during a 6-min walk test (6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",70.0,0.17277,"RESULTS AND LIMITATIONS


Preoperative change in 6MWD compared with baseline was not significantly different between groups (prehab group 40.8 [114.0] m vs control group 9.7 (108.4) m, p=0.250).","[{'ForeName': 'Enrico Maria', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: enrico.minnella@gmail.com.'}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bousquet-Dion', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Ferreira', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Berson', 'Initials': 'B', 'LastName': 'Austin', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Audi', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tanguay', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Armen', 'Initials': 'A', 'LastName': 'Aprikian', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Wassim', 'Initials': 'W', 'LastName': 'Kassouf', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}]",European urology focus,['10.1016/j.euf.2019.05.016']
92,31682972,Fatigue and sleepiness responses to experimental inflammation and exploratory analysis of the effect of baseline inflammation in healthy humans.,"Inflammation is believed to be a central mechanism in the pathophysiology of fatigue. While it is likely that dynamic of the fatigue response after an immune challenge relates to the corresponding cytokine release, this lacks evidence. Although both fatigue and sleepiness are strong signals to rest, they constitute distinct symptoms which are not necessarily associated, and sleepiness in relation to inflammation has been rarely investigated. Here, we have assessed the effect of an experimental immune challenge (administration of lipopolysaccharide, LPS) on the development of both fatigue and sleepiness, and the associations between increases in cytokine concentrations, fatigue and sleepiness, in healthy volunteers. In addition, because chronic-low grade inflammation may represent a risk factor for fatigue, we tested whether higher baseline levels of inflammation result in a more pronounced development of cytokine-induced fatigue and sleepiness. Data from four experimental studies was combined, giving a total of 120 subjects (LPS N = 79, 18 (23%) women; Placebo N = 69, 12 (17%) women). Administration of LPS resulted in a stronger increase in fatigue and sleepiness compared to the placebo condition, and the development of both fatigue and sleepiness closely paralleled the cytokine responses. Individuals with stronger increases in cytokine concentrations after LPS administration also suffered more from fatigue and sleepiness (N = 75), independent of gender. However, there was no support for the hypothesis that higher baseline inflammatory markers moderated the responses in fatigue or sleepiness after an inflammatory challenge. The results demonstrate a tight connection between the acute inflammatory response and development of both fatigue and sleepiness, and motivates further investigation of the involvement of inflammation in the pathophysiology of central fatigue.",2020,"Individuals with stronger increases in cytokine concentrations after LPS administration also suffered more from fatigue and sleepiness (N=75), independent of gender.","['120 subjects (LPS N=79, 18 (23%) women', 'healthy volunteers', 'healthy humans']","['Placebo', 'LPS', 'lipopolysaccharide, LPS']","['fatigue or sleepiness', 'cytokine concentrations', 'fatigue and sleepiness', 'cytokine concentrations, fatigue and sleepiness', 'Fatigue and sleepiness responses']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",120.0,0.0798114,"Individuals with stronger increases in cytokine concentrations after LPS administration also suffered more from fatigue and sleepiness (N=75), independent of gender.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lasselin', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45 122 Essen, Germany; Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden. Electronic address: julie.lasselin@su.se.'}, {'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Karshikoff', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Åkerstedt', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45 122 Essen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45 122 Essen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45 122 Essen, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, NSW, Australia.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Andreasson', 'Affiliation': 'Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden; Department of Psychology, Macquarie University, North Ryde, NSW, Australia.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.10.020']
93,21541727,Pre-attentive processing in children with early and continuously-treated PKU. Effects of concurrent Phe level and lifetime dietary control.,"Sixty-four children, aged 7 to 14 years, with early-treated PKU, were compared with control children on visual evoked potential (VEP) amplitudes and latencies and auditory mismatch negativity (MMN) amplitudes. It was further investigated whether indices of dietary control would be associated with these evoked potentials parameters. There were no significant differences between controls and children with PKU in VEP- and MMN-indices. However, higher lifetime Phe levels were, in varying degree and stronger than concurrent Phe level, related to increased N75 amplitudes, suggesting abnormalities in attention, and longer P110 latencies, indicating a reduction in speed of neural processing, possibly due to deficits in myelination or reduced dopamine levels in brain and retina. Similarly, higher lifetime Phe levels and Index of Dietary Control (IDC) were associated with decreased MMN amplitudes, suggesting a reduced ability to respond to stimulus change and poorer triggering of the frontally mediated attention switch. In summary, the present study in children with PKU investigated bottom-up information processing, i.e., triggered by external events, a fundamental prerequisite for the individual's responsiveness to the outside world. Results provide evidence that quality of dietary control may affect the optimal development of these pre-attentive processes, and suggest the existence of windows of vulnerability to Phe exposure.",2011,There were no significant differences between controls and children with PKU in VEP- and MMN-indices.,"['Sixty-four children, aged 7 to 14\xa0years, with early-treated PKU', 'children with early and continuously-treated PKU']",['concurrent Phe level and lifetime dietary control'],"['MMN amplitudes', 'visual evoked potential (VEP) amplitudes and latencies and auditory mismatch negativity (MMN) amplitudes', 'higher lifetime Phe levels and Index of Dietary Control (IDC', 'speed of neural processing']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0751434', 'cui_str': 'Phenylalanine Hydroxylase Deficiency'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0047143', 'cui_str': 'tmdPHE'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0047143', 'cui_str': 'tmdPHE'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]",64.0,0.0374477,There were no significant differences between controls and children with PKU in VEP- and MMN-indices.,"[{'ForeName': 'Leo M J', 'Initials': 'LM', 'LastName': 'de Sonneville', 'Affiliation': 'Leiden Institute for Brain and Cognition, and Dept. of Clinical Child and Adolescent Studies, Faculty of Social Sciences, Leiden University, Wassenaarseweg 52, 2333, AK, Leiden, The Netherlands. LdeSonneville@fsw.leidenuniv.nl'}, {'ForeName': 'Stephan C J', 'Initials': 'SC', 'LastName': 'Huijbregts', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Licht', 'Affiliation': ''}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sergeant', 'Affiliation': ''}, {'ForeName': 'Francjan J', 'Initials': 'FJ', 'LastName': 'van Spronsen', 'Affiliation': ''}]",Journal of inherited metabolic disease,['10.1007/s10545-011-9321-9']
94,30798472,"The efficacy of magnesium oxide and sodium valproate in prevention of migraine headache: a randomized, controlled, double-blind, crossover study.","Migraine is a disabling disorder that affects the quality of life of patients. Different medications have been used in prevention of migraine headache. In this study, we evaluated the effectiveness of magnesium oxide in comparison with valproate sodium in preventing migraine headache attacks. This is a single-center, randomized, controlled, crossover trial which is double-blind, 24-week, 2-sequence, 2-period, 2-treatment. After patient randomization into two sequences, the intervention group received magnesium oxide 500 mg and the control group received valproate sodium 400 mg two tablets each day (every 12 h) for 8 weeks. The primary efficacy variable was reduction in the number of migraine attacks and number of days with moderate or severe headache and hours with headache (duration) per month in the final of 8 weeks in comparison with baseline. Seventy patients were randomized and seven dropped out, leaving 63 for analysis. In an intention-to-treat analysis, 31 patients were in group 1 (magnesium oxide-valproate) and 32 patients were in group 2 (valproate-magnesium oxide). The mean number of migraine attacks and days per month was 1.72 ± 1.18 and 2.09 ± 1.70, with a mean duration of 15.50 ± 21.80 h in magnesium group and 1.27 ± 1.27 and 2.22 ± 1.96, with a mean duration 13.38 ± 14.10 in valproate group. This study has shown that 500 mg magnesium oxide appears to be effective in migraine prophylaxis similar to valproate sodium without significant adverse effect.",2021,The primary efficacy variable was reduction in the number of migraine attacks and number of days with moderate or severe headache and hours with headache (duration) per month in the final of 8 weeks in comparison with baseline.,['Seventy patients'],"['valproate sodium', 'magnesium oxide 500\xa0mg and the control group received valproate sodium', 'magnesium oxide', 'valproate-magnesium oxide', 'magnesium oxide-valproate', 'magnesium oxide and sodium valproate']","['migraine headache attacks', 'migraine headache', 'number of migraine attacks and number of days with moderate or severe headache and hours with headache (duration', 'mean number of migraine attacks']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0037567', 'cui_str': 'Sodium Valproate'}, {'cui': 'C1128322', 'cui_str': 'Magnesium Oxide 500 MG'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",31.0,0.118728,The primary efficacy variable was reduction in the number of migraine attacks and number of days with moderate or severe headache and hours with headache (duration) per month in the final of 8 weeks in comparison with baseline.,"[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Karimi', 'Affiliation': 'School of Medicine, Immunogenetics Research Center, Clinical Research Development Unit of Bou Ali Sina Hospital, Mazandaran University of Medical Sciences, Pasdaran boulevard, Sari, Mazandaran Province, Iran. drkarimi_236@yahoo.com.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Razian', 'Affiliation': 'Mazandarn University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'Department of Epidemiology and Biostatistics, School Of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}]",Acta neurologica Belgica,['10.1007/s13760-019-01101-x']
95,20689926,Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results.,"PURPOSE


To illustrate the impact on the validity of trial results due to excluding patients from a randomized controlled trial for whom no deferred consent could be obtained after randomization because study procedures had already been finished.
METHODS


The unadjusted and adjusted primary outcome measures of a recent randomized controlled multicentre study in the field of intensive care medicine were compared, including (n = 348) or excluding (n = 289) patients with missing deferred consent.
RESULTS


Thirty-nine patients (11%) died early, before the patient or his/her proxy could be approached and consent be obtained. In another 20 patients (6%), it was not possible to inform proxies and ask consent within the period of study procedures. A significant treatment effect (p = 0.006) in the adjusted analysis became non-significant (p = 0.35) when the patients with missing deferred consent were excluded.
CONCLUSIONS


Exclusion of patients without obtained deferred consent can reduce statistical power, introduce selection bias, make randomization asymmetrical, decrease external validity and thereby jeopardize study results. This may have implications for emergency research in various disciplines.",2010,"A significant treatment effect (p = 0.006) in the adjusted analysis became non-significant (p = 0.35) when the patients with missing deferred consent were excluded.
",[],[],[],[],[],[],289.0,0.152685,"A significant treatment effect (p = 0.006) in the adjusted analysis became non-significant (p = 0.35) when the patients with missing deferred consent were excluded.
","[{'ForeName': 'Tim C', 'Initials': 'TC', 'LastName': 'Jansen', 'Affiliation': 'Department of Intensive Care, Erasmus MC University Medical Center, CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': ''}, {'ForeName': 'Erwin J O', 'Initials': 'EJ', 'LastName': 'Kompanje', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-010-1988-0']
96,31683326,Influence of Intensive Care Unit Enlightenment on Premature Infants on Functional Brain Maturation Assessed by Amplitude-Integrated Electroencephalograph.,"OBJECTIVE


Amplitude-integrated electroencephalograph (aEEG) presents a valuable tool for functional brain maturation of preterm infants. However, the effect of enlightenment on functional brain maturation of premature infants has not been investigated. We aimed to do this with aEEG.
STUDY DESIGN


A total of 32 infants, 30 to 35 gestational weeks, were involved in the study. They were randomly distributed into three groups in which different lighting protocols were applied. In group 1, the infants' incubators were covered for 24 hours. In group 2, the infants' incubators were open for 24 hours. In group 3, the infants' incubators were covered for 12 hours and open for another 12 hours. The infants are evaluated with aEEG recordings done on the 3rd (first measurement) and 10th days (second measurement) along with the Burdjalov scoring. Analysis of aEEG recordings was performed, based on sleep-wake cycles (SWCs), upper and lower margin amplitudes, narrowband and broadband of SWC, and bandwidth of SWC.
RESULTS


At first, the narrowband lower amplitudes in group 1 were higher than those of the other groups ( p  = 0.042), but the difference was not significant in the second measurement ( p  = 0.110). The Burdjalov scores were higher in group 1 and group 3 on 10th day, though not statistically significant ( p  = 0.871). When the infants were re-evaluated according to the gestational weeks, the Burdjalov scores of the two groups less than 34 weeks (30-31 and 32-33 weeks) were similar, whereas 34 to 35 weeks were higher when compared with those of the two groups.
CONCLUSION


The difference observed between groups in terms of narrowband lower amplitude in the first measurement may reflect the effect of intrauterine environment rather than enlightenment at the same gestational age because it was made on the third day. However, the fact that all groups have similar results on day 10 suggests that other factors in the intensive care setting may diminish the effect of enlightenment. Burdjalov scores are associated with maturation, and high scores found in the 34- to 35-week group suggest that the 34-week maturation might be a threshold for SWC and development in our group sample.",2021,"The Burdjalov scores were higher in group 1 and group 3 on 10th day, though not statistically significant ( p  = 0.871).","['premature infants', 'preterm infants', '32 infants, 30 to 35 gestational weeks, were involved in the study']","['Amplitude-integrated electroencephalograph (aEEG', 'Intensive Care Unit Enlightenment']","['functional brain maturation', 'Functional Brain Maturation', 'Burdjalov scores', 'sleep-wake cycles (SWCs), upper and lower margin amplitudes, narrowband and broadband of SWC, and bandwidth of SWC']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0443310', 'cui_str': 'Electroencephalograph'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",,0.0207085,"The Burdjalov scores were higher in group 1 and group 3 on 10th day, though not statistically significant ( p  = 0.871).","[{'ForeName': 'Umit Ayse', 'Initials': 'UA', 'LastName': 'Tandircioglu', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, İhsan Dogramaci Children's Hospital, Hacettepe University, Sihhiye, Ankara, Turkey.""}, {'ForeName': 'Nilufer', 'Initials': 'N', 'LastName': 'Guzoglu', 'Affiliation': 'Division of Neonatology, School of Medicine, Eastern Mediterranean University, North Cyprus.'}, {'ForeName': 'Kivilcim', 'Initials': 'K', 'LastName': 'Gucuyener', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Aliefendioglu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Kirikkale University, Kirikkale, Turkey.'}]",American journal of perinatology,['10.1055/s-0039-1697681']
97,30669914,Feasibility of computerized adventitious respiratory sounds to assess the effects of airway clearance techniques in patients with bronchiectasis.,"Objective:  To examine the feasibility of adventitious respiratory sound (ARS) as an outcome measure to assess the effects of airway clearance techniques (ACTs) in outpatients with bronchiectasis.  Methods:  ARS were registered pre/post four ACTs sessions. Clinical outcomes included: number of crackles (coarse and fine), number of wheezes (monophonic and polyphonic), wheezes occupation rate (%) and sputum quantity. Feasibility outcomes of ARS included: reasons for exclusion, suitability, safety, equipment and time required, magnitude of change after intervention and sample size estimation.  Results:  Seven patients (49.7 ± 20.5 years; FEV 1  69.3 ± 15.8% predicted) were included. Recordings from four patients were excluded due to excessive environment noise. All ARS measurements were completed without any adverse events. An electronic stethoscope was acquired and the time spent to complete each assessment was 6 ± 3.5 min. The largest changes were observed for number of expiratory coarse crackles [effect size (95%CI) ES = 0.40 (0.01-0.79)], which correlated moderately with sputum quantity (r = 0.56), and inspiratory monophonic wheezes [ES = 0.61 (0.22-1.00)]. The estimated sample size for a full crossover trial was 46.  Conclusions:  ARS is feasible to assess the effects of ACTs in patients with bronchiectasis. Expiratory coarse crackles seem to be the most appropriate ARS parameter, but this finding needs to be confirmed in an adequately powered trial.",2020,"The largest changes were observed for number of expiratory coarse crackles [effect size (95%CI) ES = 0.40 (0.01-0.79)], which correlated moderately with sputum quantity (r = 0.56), and inspiratory monophonic wheezes [ES = 0.61 (0.22-1.00)].","['patients with bronchiectasis', 'outpatients with bronchiectasis', 'Seven patients (49.7\xa0±\xa020.5\xa0years; FEV 1  69.3\xa0±\xa015.8% predicted) were included']","['adventitious respiratory sound (ARS', 'computerized adventitious respiratory sounds', 'airway clearance techniques (ACTs']","['sputum quantity', 'exclusion, suitability, safety, equipment and time required, magnitude of change', 'number of crackles (coarse and fine), number of wheezes (monophonic and polyphonic), wheezes occupation rate (%) and sputum quantity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0035234', 'cui_str': 'Breathing Sounds'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C0205194', 'cui_str': 'Coarse (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}]",4.0,0.146175,"The largest changes were observed for number of expiratory coarse crackles [effect size (95%CI) ES = 0.40 (0.01-0.79)], which correlated moderately with sputum quantity (r = 0.56), and inspiratory monophonic wheezes [ES = 0.61 (0.22-1.00)].","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Herrero-Cortina', 'Affiliation': 'Health Sciences Faculty, Universidad San Jorge, Campus Universitario Villanueva de Gállego , Villanueva de Gállego, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oliveira', 'Affiliation': 'Lab 3R - Respiratory Research and Rehabilitation Laboratory, School of Health Sciences (ESSUA), University of Aveiro, Agras do Crasto - Campus Universitário de Santiago , Aveiro, Portugal.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Polverino', 'Affiliation': ""Institut de Recerca Vall d'Hebron (VHIR), Hospital Universitari Vall d'Hebron (HUVH), CIBERES , Barcelona, Spain.""}, {'ForeName': 'Eva María', 'Initials': 'EM', 'LastName': 'Gómez-Trullén', 'Affiliation': 'Faculty of Health and Sport Sciences, Department of Physiatry and Nursing, University of Zaragoza , Huesca, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': 'Servei de Pneumologia, Hospital Clinic de Barcelona, Universitat de Barcelona, IDIBAPS, CIBERES , Barcelona, Spain.'}, {'ForeName': 'Alda', 'Initials': 'A', 'LastName': 'Marques', 'Affiliation': 'Lab 3R - Respiratory Research and Rehabilitation Laboratory, School of Health Sciences (ESSUA), University of Aveiro, Agras do Crasto - Campus Universitário de Santiago , Aveiro, Portugal.'}]",Physiotherapy theory and practice,['10.1080/09593985.2019.1566945']
98,31688612,Reducing Postoperative Call Volume Through Verbal Preoperative Education.,"OBJECTIVE


To improve patient satisfaction and understanding of what to expect after chronic ear surgery and reduce call volume to an otology clinic at an academic tertiary referral center.
STUDY DESIGN


Quality improvement initiative.
SETTING


A single-academic tertiary referral center.
PATIENTS


One hundred and ten patients who underwent chronic ear surgery in March to May 2018.
INTERVENTION


Preoperative counseling over the phone 1 week before surgery.
MAIN OUTCOME MEASURES


Patient call volume to the clinic within a 2-week postoperative window, patient understanding, and satisfaction of perioperative course.
RESULTS


There was a significant increase in patient satisfaction (10.1% increase, 9.8 intervention vs. 8.9 no intervention, p = 0.0032) and in patient understanding of what to expect after surgery (6.7% increase, 9.5 intervention vs. 8.9 no intervention, p = 0.0275). There was a significant decrease in mean number of calls per patient to the clinic (57.6% decrease, 0.31 intervention vs. 0.72 no intervention, p = 0.0105) and in percentage of patients who made any number of calls to the clinic (20% intervention vs. 46%, no intervention, p = 0.00438).
CONCLUSIONS


Verbal preoperative counseling over the phone was effective in significantly reducing unnecessary call volume to the clinic and in improving patient satisfaction and overall understanding of what to expect after surgery.",2020,"There was a significant increase in patient satisfaction (10.1% increase, 9.8 intervention vs. 8.9 no intervention, p = 0.0032) and in patient understanding of what to expect after surgery (6.7% increase, 9.5 intervention vs. 8.9 no intervention, p = 0.0275).","['A single-academic tertiary referral center', 'One hundred and ten patients who underwent chronic ear surgery in March to May 2018']",['Verbal preoperative counseling'],"['patient satisfaction', 'mean number of calls per patient to the clinic']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0920638', 'cui_str': 'Preoperative counseling (procedure)'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",110.0,0.0174545,"There was a significant increase in patient satisfaction (10.1% increase, 9.8 intervention vs. 8.9 no intervention, p = 0.0032) and in patient understanding of what to expect after surgery (6.7% increase, 9.5 intervention vs. 8.9 no intervention, p = 0.0275).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Chern', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Columbia University Irving Medical Center.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Haynes', 'Affiliation': 'The Otology Group of Vanderbilt University, Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Bennett', 'Affiliation': 'The Otology Group of Vanderbilt University, Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002470']
99,31679924,Aerodynamic Vocal Measurements in Female Teachers: Finger Kazoo Intensive Short-Term Vocal Therapy.,"OBJECTIVE


Obtain aerodynamic vocal measurements of dysphonic female teachers from two groups, before and after a brief and intensive short-term voice therapy using the finger kazoo technique, compare to the respective control groups, and compare between the two study groups.
STUDY DESIGN


A randomized blind controlled clinical trial.
METHODS


A randomized blind controlled clinical trial. Measurements of maximum phonation time and sound pressure level (dB SPL) were measured before and after intensive short-term vocal therapy in 24 teachers with and without structural laryngeal disorders and 17 controls with and without structural laryngeal disorder.
RESULTS


There was significant reduction in the maximum phonation time of /e/ for the group with no structural laryngeal disorder, and a significant reduction of the maximum sound pressure level for the group with structural laryngeal disorder.
CONCLUSIONS


Based on the observed results, a significant reduction in the maximum phonation time of /e/ for the group with no structural laryngeal disorder, and a significant reduction of the maximum sound pressure level for the group with structural laryngeal disorder, it is possible that finger kazoo reduced the glottal hyperfunction by improving the balance between the respiratory and the glottal vocal production levels during speech.",2021,"There was significant reduction in the maximum phonation time of /e/ for the group with no structural laryngeal disorder, and a significant reduction of the maximum sound pressure level for the group with structural laryngeal disorder.
","['Female Teachers', '24 teachers with and without structural laryngeal disorders and 17 controls with and without structural laryngeal disorder', 'dysphonic female teachers']","['intensive short-term vocal therapy', 'Kazoo Intensive Short-Term Vocal Therapy']","['maximum sound pressure level', 'maximum phonation time', 'maximum phonation time and sound pressure level (dB SPL', 'Aerodynamic Vocal Measurements']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0023051', 'cui_str': 'Larynx Diseases'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time (observable entity)'}, {'cui': 'C0439499', 'cui_str': 'decibel sound perception level'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",24.0,0.0436197,"There was significant reduction in the maximum phonation time of /e/ for the group with no structural laryngeal disorder, and a significant reduction of the maximum sound pressure level for the group with structural laryngeal disorder.
","[{'ForeName': 'Mara Keli', 'Initials': 'MK', 'LastName': 'Christmann', 'Affiliation': 'Universidade do Vale do Itajaí (UNIVALI), Itajaí, Santa Catarina, Brazil; Associação Educacional Luterana Bom Jesus (IELUSC), Joinville, Santa Catarina, Brazil. Electronic address: marakchristmann@gmail.com.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Scapini', 'Affiliation': 'Departamento de Clínica Médica, Universidade Federal de Santa Maria, Santa Maria, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Joziane Padilha de Moraes', 'Initials': 'JPM', 'LastName': 'Lima', 'Affiliation': 'Departamento de Fonoaudiologia, Universidade Federal de Santa Maria, Santa Maria, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Bruna Franciele da Trindade', 'Initials': 'BFDT', 'LastName': 'Gonçalves', 'Affiliation': 'Departamento de Fonoaudiologia, Universidade Federal de Santa Maria, Santa Maria, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Gabriele Rodrigues', 'Initials': 'GR', 'LastName': 'Bastilha', 'Affiliation': 'Departamento de Fonoaudiologia, Universidade Federal de Santa Maria, Santa Maria, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Carla Aparecida', 'Initials': 'CA', 'LastName': 'Cielo', 'Affiliation': 'Departamento de Fonoaudiologia, Universidade Federal de Santa Maria, Santa Maria, Rio Grande do Sul, Brazil.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2019.08.018']
100,31668907,An evaluation of Short-term Treatment Outcomes of Cricothyroid Visor Maneuver: A Proof-of-Concept Pilot Study.,"INTRODUCTION


Muscle tension dysphonia (MTD) is used as a clinical and diagnostic descriptive label for a diverse range of vocal fold behaviors caused by increased tension of the (para) laryngeal musculature. These increased tension can occur in the cricothyroid muscle and in the ''visor'' mechanism, contributing to voice problems. The main goal of this study is to determine whether a new method, the cricothyroid visor maneuver (CVM), is an effective method for improving quality and other aspects of the MTD patients' voices.
METHOD(S)


Eighty-eight adult female patients participated in this quasiexperimental study. One group consisted of 30 MTD patients (mean age 28.7 ± 4.95 years) for whom manual circumlaryngeal therapy (MCT) was provided. The other group consisted of 30 MTD patients (mean age 28.9 ± 5.1 years) who received CVM. Also, 28 adult females with MTD (mean age 28.60 ± 4.56 years), who were on the clinic's waiting list, served as a control group and did not receive any treatment. Treatment was provided in a single 30-minute session. Pre- and post-treatment audio recordings of sustained vowels, selected sentences, and connected speech samples were submitted to auditory-perceptual and acoustical analysis to assess the short-term effects of the two treatment programs. Also, perceptions of patients' about their voice quality before and after therapy were assessed by visual analogue scale.
RESULTS


Perceptually, Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) ratings improved in all patients with both treatment methods. Acoustically, with CVM, harmonic-to-noise ratio and Cepstral Peak Prominence increased and perturbation (jitter and shimmer) measures decreased and there was not significant change in MCT and control groups. Visual analogue scale showed that feelings of patients improved after therapy in both treatment methods, with higher scores for patients receiving CVM in comparison to the MCT method.
DISCUSSION


These results suggest that CVM can be an effective method for voice rehabilitation in patients with MTD and manipulation of Cricothyroid muscle and ''visor'' mechanism can lead to marked voice improvement.",2021,"Perceptually, Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) ratings improved in all patients with both treatment methods.","['30 MTD patients ', 'Eighty-eight adult female patients participated in this quasiexperimental study', 'mean age 28.7 ± 4.95 years) for whom', '30 MTD patients (mean age 28.9 ± 5.1 years) who received', ""28 adult females with MTD (mean age 28.60 ± 4.56 years), who were on the clinic's waiting list, served as a control group and did not receive any treatment""]","['Muscle tension dysphonia (MTD', 'CVM', 'Cricothyroid Visor Maneuver', 'manual circumlaryngeal therapy (MCT', 'cricothyroid visor maneuver (CVM']","['CVM, harmonic-to-noise ratio and Cepstral Peak Prominence increased and perturbation (jitter and shimmer) measures', 'voice quality', 'Visual analogue scale', 'Perceptually, Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) ratings', 'visual analogue scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517763', 'cui_str': 'Four point five six'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0427195', 'cui_str': 'Muscle tension (finding)'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0042943', 'cui_str': 'Voice Quality'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4274490', 'cui_str': 'Consensus Auditory-Perceptual Evaluation of Voice (assessment scale)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}]",88.0,0.0152333,"Perceptually, Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) ratings improved in all patients with both treatment methods.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dehqan', 'Affiliation': 'Cellular and Molecular Research Center, Zahedan University of Medical Sciences, Zahedan, Iran; Department of Speech therapy, School of Rehabilitation, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Kirrie J', 'Initials': 'KJ', 'LastName': 'Ballard', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Lidcombe, New South Wales, Australia.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2019.09.016']
101,20140523,Enzyme replacement therapy for mucopolysaccharidosis VI: evaluation of long-term pulmonary function in patients treated with recombinant human N-acetylgalactosamine 4-sulfatase.,"Pulmonary function is impaired in untreated mucopolysaccharidosis type VI (MPS VI). Pulmonary function was studied in patients during long-term enzyme replacement therapy (ERT) with recombinant human arylsulfatase B (rhASB; rhN-acetylgalactosamine 4-sulfatase). Pulmonary function tests prior to and for up to 240 weeks of weekly infusions of rhASB at 1 mg/kg were completed in 56 patients during Phase 1/2, Phase 2, Phase 3 and Phase 3 Extension trials of rhASB and the Survey Study. Forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and, in a subset of patients, maximum voluntary ventilation (MVV), were analyzed as absolute volume in liters. FEV1 and FVC showed little change from baseline during the first 24 weeks of ERT, but after 96 weeks, these parameters increased over baseline by 11% and 17%, respectively. This positive trend compared with baseline continued beyond 96 weeks of treatment. Improvements from baseline in pulmonary function occurred along with gains in height in the younger group (5.5% change) and in the older patient group (2.4% change) at 96 weeks. Changes in MVV occurred earlier within 24 weeks of treatment to approximately 15% over baseline. Model results based on data from all trials showed significant improvements in the rate of change in pulmonary function during 96 weeks on ERT, whereas little or no improvement was observed for the same time period prior to ERT. Thus, analysis of mean percent change data and longitudinal modeling both indicate that long-term ERT resulted in improvement in pulmonary function in MPS VI patients.",2010,"FEV1 and FVC showed little change from baseline during the first 24 weeks of ERT, but after 96 weeks, these parameters increased over baseline by 11% and 17%, respectively.","['56 patients during Phase 1/2, Phase 2, Phase 3 and Phase 3 Extension trials of rhASB and the Survey Study', 'patients treated with recombinant human N-acetylgalactosamine 4-sulfatase']","['Enzyme replacement therapy', 'enzyme replacement therapy (ERT) with recombinant human arylsulfatase B (rhASB; rhN-acetylgalactosamine 4-sulfatase', 'rhASB']","['Forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and, in a subset of patients, maximum voluntary ventilation (MVV', 'pulmonary function', 'rate of change in pulmonary function', 'Pulmonary function', 'MVV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376159', 'cui_str': 'Arylsulfatase B'}]","[{'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C3657208', 'cui_str': 'ARSB protein, human'}, {'cui': 'C0001055', 'cui_str': '2-Acetamido-2-D-galactopyranose'}, {'cui': 'C0038717', 'cui_str': 'Sulfatases'}]","[{'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024967', 'cui_str': 'MVV (Ventilation)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0511268,"FEV1 and FVC showed little change from baseline during the first 24 weeks of ERT, but after 96 weeks, these parameters increased over baseline by 11% and 17%, respectively.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harmatz', 'Affiliation': ""Children's Hospital & Research Center Oakland, CA 94609, USA. Pharmatz@mail.cho.org""}, {'ForeName': 'Zi-Fan', 'Initials': 'ZF', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Giugliani', 'Affiliation': ''}, {'ForeName': 'Ida Vanessa D', 'Initials': 'IV', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Guffon', 'Affiliation': ''}, {'ForeName': 'Elisa Leão', 'Initials': 'EL', 'LastName': 'Teles', 'Affiliation': ''}, {'ForeName': 'M Clara Sá', 'Initials': 'MC', 'LastName': 'Miranda', 'Affiliation': ''}, {'ForeName': 'J Edmond', 'Initials': 'JE', 'LastName': 'Wraith', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Arash', 'Affiliation': ''}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Scarpa', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ketteridge', 'Affiliation': ''}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Hopwood', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Plecko', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Steiner', 'Affiliation': ''}, {'ForeName': 'Chester B', 'Initials': 'CB', 'LastName': 'Whitley', 'Affiliation': ''}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Kaplan', 'Affiliation': ''}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Swiedler', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hardy', 'Affiliation': ''}, {'ForeName': 'Kenneth I', 'Initials': 'KI', 'LastName': 'Berger', 'Affiliation': ''}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Decker', 'Affiliation': ''}]",Journal of inherited metabolic disease,['10.1007/s10545-009-9007-8']
102,21153445,"High phenylalanine levels directly affect mood and sustained attention in adults with phenylketonuria: a randomised, double-blind, placebo-controlled, crossover trial.","The main debate in the treatment of Phenylketonuria (PKU) is whether adult patients need the strict phenylalanine (Phe)-restricted diet. Physicians and patients lack evidence-based guidelines to help them make well-informed choices. We have carried out the first randomised double-blind placebo-controlled trial into the effects of short-term elevation of Phe levels on neuropsychological functions and mood of adults with PKU. Nine continuously treated adults with PKU underwent two 4-week supplementation periods: one with Phe, mimicking normal dietary intake, and one with placebo in randomly allocated order via a randomisation coding list in a double-blind cross-over design. A set of neuropsychological tests (Amsterdam Neuropsychological Tasks) was administered at the end of each study period. In addition, patients and for each patient a friend or relative, completed weekly Profile of Mood States (POMS) questionnaires, evaluating the patients' mood. Phe levels were measured twice weekly. Mean plasma Phe levels were significantly higher during Phe supplementation compared with placebo (p = 0.008). Neuropsychological tests demonstrated an impairment in sustained attention during Phe supplementation (p = 0.029). Both patients and their friend or relative reported lower scores on the POMS questionnaires during Phe supplementation (p = 0.017 and p = 0.040, respectively). High plasma Phe levels have a direct negative effect on both sustained attention and on mood in adult patients with PKU. A Phe-restricted ""diet for life"" might be an advisable option for many.",2011,Neuropsychological tests demonstrated an impairment in sustained attention during Phe supplementation (p = 0.029).,"['adults with PKU', 'adults with phenylketonuria', 'adult patients with PKU', 'Nine continuously treated adults with PKU']","['Phe, mimicking normal dietary intake, and one with placebo', 'Phenylketonuria (PKU', 'placebo']","['Mean plasma Phe levels', 'POMS questionnaires', 'Mood States (POMS) questionnaires']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751434', 'cui_str': 'Phenylalanine Hydroxylase Deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0047143', 'cui_str': 'tmdPHE'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0751434', 'cui_str': 'Phenylalanine Hydroxylase Deficiency'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0047143', 'cui_str': 'tmdPHE'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.456471,Neuropsychological tests demonstrated an impairment in sustained attention during Phe supplementation (p = 0.029).,"[{'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'ten Hoedt', 'Affiliation': 'Department of Pediatrics, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Leo M J', 'Initials': 'LM', 'LastName': 'de Sonneville', 'Affiliation': ''}, {'ForeName': 'Baudouin', 'Initials': 'B', 'LastName': 'Francois', 'Affiliation': ''}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'ter Horst', 'Affiliation': ''}, {'ForeName': 'Mirian C H', 'Initials': 'MC', 'LastName': 'Janssen', 'Affiliation': ''}, {'ForeName': 'M Estela', 'Initials': 'ME', 'LastName': 'Rubio-Gozalbo', 'Affiliation': ''}, {'ForeName': 'Frits A', 'Initials': 'FA', 'LastName': 'Wijburg', 'Affiliation': ''}, {'ForeName': 'Carla E M', 'Initials': 'CE', 'LastName': 'Hollak', 'Affiliation': ''}, {'ForeName': 'Annet M', 'Initials': 'AM', 'LastName': 'Bosch', 'Affiliation': ''}]",Journal of inherited metabolic disease,['10.1007/s10545-010-9253-9']
103,30419226,Altitude Sickness Prevention with Ibuprofen Relative to Acetazolamide.,"BACKGROUND


Acute mountain sickness is a common occurrence for travel to high altitudes. Although previous studies of ibuprofen have shown efficacy for the prevention of acute mountain sickness, recommendations have been limited, as ibuprofen has not been compared directly with acetazolamide until this study.
METHODS


Before their ascent to 3810 m on White Mountain in California, adult volunteers were randomized to ibuprofen (600 mg, 3 times daily, started 4 hours before the ascent), or to acetazolamide (125 mg, twice daily, started the night before the ascent). The main outcome measure was acute mountain sickness incidence, using the Lake Louise Questionnaire (LLQ), with a score of >3 with headache. Sleep quality and headache severity were measured with the Groningen Sleep Quality Survey (GSQS). This trial was registered at ClinicalTrials.gov: NCT03154645 RESULTS: Ninety-two participants completed the study: 45 (49%) on ibuprofen and 47 (51%) on acetazolamide. The total incidence of acute mountain sickness was 56.5%, with the incidence for the ibuprofen group being 11% greater than that for acetazolamide, surpassing the predetermined 26% noninferiority margin (62.2% vs 51.1%; 95% confidence interval [CI], -11.1 to 33.5). No difference was found in the total LLQ scores or subgroup symptoms between drugs (P = .8). The GSQS correlated with LLQ sleep (r = 0.77; 95% CI, 0.67-0.84)=%. The acetazolamide group had higher peripheral capillary oxygen saturation than the ibuprofen group (88.5% vs 85.6%; P = .001).
CONCLUSION


Ibuprofen was slightly inferior to acetazolamide for acute mountain sickness prevention and should not be recommended over acetazolamide for rapid ascent. Average symptoms and severity were similar between drugs, suggesting prevention of disease.",2019,"The acetazolamide group had higher peripheral capillary oxygen saturation than the ibuprofen group (88.5% vs 85.6%; P = .001).
","['Ninety-two participants completed the study: 45 (49%) on', '3810 m on White Mountain in California, adult volunteers']","['Acetazolamide', 'acetazolamide', 'Ibuprofen', 'ibuprofen']","['LLQ sleep', 'Groningen Sleep Quality Survey (GSQS', 'Average symptoms and severity', 'peripheral capillary oxygen saturation', 'acute mountain sickness incidence, using the Lake Louise Questionnaire (LLQ), with a score of >3 with headache', 'total incidence of acute mountain sickness', 'Sleep quality and headache severity', 'total LLQ scores']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0442533', 'cui_str': 'Mountain (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C2711376', 'cui_str': 'ScO2 - Capillary oxygen saturation'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0688854,"The acetazolamide group had higher peripheral capillary oxygen saturation than the ibuprofen group (88.5% vs 85.6%; P = .001).
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Burns', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Stanford, Calif. Electronic address: pburns@stanford.edu.'}, {'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Lipman', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Keiran', 'Initials': 'K', 'LastName': 'Warner', 'Affiliation': 'Stanford/Kaiser Emergency Medicine Residency, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Jurkiewicz', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Department of Computer Science, University of Colorado, Boulder.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sanders', 'Affiliation': 'Department of Emergency Medicine, Swedish Edmonds Hospital, Edmonds, Wash.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Soto', 'Affiliation': 'Department of Emergency Medicine, Madigan Army Medical Center, Tacoma, Wash.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hackett', 'Affiliation': 'Altitude Research Center, Department of Medicine, Anschutz Medical Campus, University of Colorado, Aurora.'}]",The American journal of medicine,['10.1016/j.amjmed.2018.10.021']
104,20730536,Enhanced eyelashes: prescription and over-the-counter options.,"Women have long strived to possess long, thick, and dark eyelashes. Prominent eyes and eyelashes are often considered a sign of beauty and can be associated with increased levels of attractiveness, confidence, and well-being. Numerous options may improve the appearance of eyelashes. Mascara aims to temporarily darken, lengthen, and thicken eyelashes using a combination of waxes, pigments, and resins. Artificial eyelashes can be adhered either to the dermal margin or to individual eyelashes. Individuals may even use eyelash transplantations to improve the appearance of their eyelashes. The unique properties of eyelashes (e.g., relatively long telogen and short anagen phases compared with scalp hairs, slow rate of growth, and a lack of influence by androgens) may allow for specific aesthetic interventions to improve the appearance of natural eyelashes. Some over-the-counter (OTC) products may contain prostaglandin analogs that can affect eyelash growth, but neither the safety nor efficacy of these OTC cosmetics has been fully studied. Originally indicated for the reduction of intraocular pressure, the synthetic prostaglandin analog bimatoprost was recently approved for the treatment of hypotrichosis of the eyelashes. In a double-blinded, randomized, vehicle-controlled trial, bimatoprost safely and effectively grew natural eyelashes, making them longer, thicker, and darker. Bimatoprost was generally safe and well tolerated and appears to provide an additional option for individuals looking to improve the appearance of their eyelashes.",2011,Bimatoprost was generally safe and well tolerated and appears to provide an additional option for individuals looking to improve the appearance of their eyelashes.,[],[],"['intraocular pressure', 'safe and well tolerated']",[],[],"[{'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",,0.0454444,Bimatoprost was generally safe and well tolerated and appears to provide an additional option for individuals looking to improve the appearance of their eyelashes.,"[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'David Geffen School of Medicine, Division of Dermatology, University of California at Los Angeles, 9201 Sunset Blvd., #602, Los Angeles, CA 90069, USA. derekjonesmd@gmail.com'}]",Aesthetic plastic surgery,['10.1007/s00266-010-9561-3']
105,22011810,Early school outcomes for children of postpartum depressed mothers: comparison with a community sample.,"Previous studies of the long-term effects of maternal postpartum depression (PPD) on child development have mostly focused on a limited set of outcomes, and have often not controlled for risk factors associated with maternal depression. The present study compared children of postpartum depressed mothers (n = 29) with children from a community sample (n = 113) in terms of a broad range of developmental outcomes in the early school period. Controlling for risk factors associated with maternal depression, we found that children of postpartum depressed mothers had lower ego-resiliency, lower peer social competence, and lower school adjustment than the community sample children. In addition, girls of postpartum depressed mothers showed lower verbal intelligence, and, unexpectedly, showed fewer externalizing problems than their counterparts in the community sample. Results show that children's capacities to deal with stress and interact with peers in the early school period may be particularly affected by their mothers' PPD.",2012,"Controlling for risk factors associated with maternal depression, we found that children of postpartum depressed mothers had lower ego-resiliency, lower peer social competence, and lower school adjustment than the community sample children.","['children of postpartum depressed mothers (n\xa0=\xa029) with children from a community sample (n\xa0=\xa0113) in terms of a broad range of developmental outcomes in the early school period', 'children of postpartum depressed mothers']",['maternal postpartum depression (PPD'],"['lower verbal intelligence', 'lower ego-resiliency, lower peer social competence', 'externalizing problems']","[{'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0683256', 'cui_str': 'Social Competence'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0333962,"Controlling for risk factors associated with maternal depression, we found that children of postpartum depressed mothers had lower ego-resiliency, lower peer social competence, and lower school adjustment than the community sample children.","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Kersten-Alvarez', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University Nijmegen, P.O. Box 9104, 6500 HE Nijmegen, The Netherlands. laurakersten@hotmail.com'}, {'ForeName': 'Clemens M H', 'Initials': 'CM', 'LastName': 'Hosman', 'Affiliation': ''}, {'ForeName': 'J Marianne', 'Initials': 'JM', 'LastName': 'Riksen-Walraven', 'Affiliation': ''}, {'ForeName': 'Karin T M', 'Initials': 'KT', 'LastName': 'van Doesum', 'Affiliation': ''}, {'ForeName': 'Sanny', 'Initials': 'S', 'LastName': 'Smeekens', 'Affiliation': ''}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Hoefnagels', 'Affiliation': ''}]",Child psychiatry and human development,['10.1007/s10578-011-0257-y']
106,20922542,The surgical stress response and postoperative immune function after laparoscopic or conventional total mesorectal excision in rectal cancer: a randomized trial.,"PURPOSE


This study evaluated differences in stress response and immunological function following laparoscopic and conventional total mesorectal excision (TME) for rectal cancer.
METHODS


Patients with non-metastasized rectal cancer were prospectively randomized to open (n = 18) or laparoscopic (n = 22) TME. Blood samples were taken preoperatively (baseline), 2, 24, and 72 h following surgery. Systemic white blood cell and monocyte count, C-reactive protein, interleukin-6 (IL-6), interleukin-8 (IL-8), HLA-DR expression on monocytes, growth hormone, prolactin, and cortisol were measured.
RESULTS


Forty patients with a median age of 66 years (interquartile range, 60-74 years) were included. Eighteen patients (45%) were randomized to open surgery and 22 patients (55%) to laparoscopic surgery. Patient demographics in terms of gender, age, BMI, ASA classification, localization of the tumor, and type of neoadjuvant therapy were comparable for both groups. Laparoscopic surgery resulted in a significantly better short-term preservation of postoperative immune function. HLA-DR expression on monocytes was significantly higher (64% vs 50%, P = 0.014) and IL-6 level increase was significantly lower (4.6 vs 10.8, P = 0.003) 2 h after laparoscopic surgery. No differences between the open and laparoscopic technique were observed in postoperative white blood cell count, monocyte count, C-reactive protein, IL-8, growth hormone, prolactin, and cortisol levels.
CONCLUSION


Short-term postoperative immune and inflammatory functions tended to be better after laparoscopic rectal surgery. However, the differences were not consistent at all time intervals, making a definitive conclusion difficult. Better preserved inflammatory function 2 h after surgery may reflect a reduction in operative trauma when the laparoscopic technique is compared with open rectal procedures.",2011,"HLA-DR expression on monocytes was significantly higher (64% vs 50%, P = 0.014) and IL-6 level increase was significantly lower (4.6 vs 10.8, P = 0.003) 2 h after laparoscopic surgery.","['Patients with non-metastasized rectal cancer', 'Eighteen patients (45', 'Forty patients with a median age of 66 years (interquartile range, 60-74 years) were included', 'rectal cancer']","['laparoscopic surgery', 'Laparoscopic surgery', 'laparoscopic and conventional total mesorectal excision (TME', 'laparoscopic (n = 22) TME', 'laparoscopic or conventional total mesorectal excision']","['Systemic white blood cell and monocyte count, C-reactive protein, interleukin-6 (IL-6), interleukin-8 (IL-8), HLA-DR expression on monocytes, growth hormone, prolactin, and cortisol', 'postoperative immune function', 'IL-6 level increase', 'HLA-DR expression on monocytes', 'operative trauma', 'surgical stress response and postoperative immune function', 'stress response and immunological function', 'postoperative white blood cell count, monocyte count, C-reactive protein, IL-8, growth hormone, prolactin, and cortisol levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]",40.0,0.233814,"HLA-DR expression on monocytes was significantly higher (64% vs 50%, P = 0.014) and IL-6 level increase was significantly lower (4.6 vs 10.8, P = 0.003) 2 h after laparoscopic surgery.","[{'ForeName': 'A A F A', 'Initials': 'AA', 'LastName': 'Veenhof', 'Affiliation': 'Department of Surgery, VU University Medical Center, Post bus 7057, 1007 MB, Amsterdam, The Netherlands. a.veenhof@vumc.nl'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sietses', 'Affiliation': ''}, {'ForeName': 'B M E', 'Initials': 'BM', 'LastName': 'von Blomberg', 'Affiliation': ''}, {'ForeName': 'I M W', 'Initials': 'IM', 'LastName': 'van Hoogstraten', 'Affiliation': ''}, {'ForeName': 'M H G M', 'Initials': 'MH', 'LastName': 'vd Pas', 'Affiliation': ''}, {'ForeName': 'W J H J', 'Initials': 'WJ', 'LastName': 'Meijerink', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'vd Peet', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'vd Tol', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Bonjer', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': ''}]",International journal of colorectal disease,['10.1007/s00384-010-1056-9']
107,22706617,Pharmacokinetics of transdermal buprenorphine patch in the elderly.,"PURPOSE


Transdermal buprenorphine patches provide comparable pain relief to that of low-potency opioids in elderly individuals. However, specific data on their use in elderly individuals is limited. This study investigated and compared the PK of buprenorphine transdermal patches in elderly (≥ 75 years) versus younger (50-60 years) individuals.
METHODS


This was a multiple-dose, open-label, parallel-group study in healthy volunteers split into two age groups (younger, 50-60 years; elderly, ≥ 75 years) with 37 individuals in each. Study participants received two consecutive 7-day buprenorphine 5 μg/h transdermal patch applications, and blood samples were collected on the week of the second patch application [day 7 (predose), days 8, 9, 10, 12, and 14] to determine PK at steady state. Pharmacokinetic parameters were determined for buprenorphine and norbuprenorphine. Safety was assessed by analyzing adverse events, hematology, clinical chemistry, urine analysis, vital signs, electrocardiogram (ECG), and physical examinations.
RESULTS


The area under the plasma concentration-time curve at steady state (AUC(tau)), measured over one dosing interval, was similar for elderly [mean ± standard deviation (SD) 9,940 pg/h/ml (4,827 pg/h/ml] and younger [mean ± SD 11,309 (3,670 pg/h/ml] individuals. Bioequivalence was not demonstrated between groups, which may be attributable to the relatively high level of variability in individual plasma profiles. More adverse events were reported by younger (216) than elderly (164) study participants.
CONCLUSIONS


No dosage alterations are necessary for PK reasons when treating elderly people with buprenorphine transdermal patches.",2013,"PURPOSE


Transdermal buprenorphine patches provide comparable pain relief to that of low-potency opioids in elderly individuals.","['elderly (≥ 75 years) versus younger (50-60 years) individuals', 'healthy volunteers split into two age groups (younger, 50-60 years; elderly, ≥ 75 years) with 37 individuals in each', 'elderly', 'elderly people with buprenorphine transdermal patches', 'elderly individuals', 'younger (216) than elderly (164) study participants']","['buprenorphine transdermal patches', 'transdermal buprenorphine patch', 'buprenorphine']","['adverse events, hematology, clinical chemistry, urine analysis, vital signs, electrocardiogram (ECG), and physical examinations', 'adverse events', 'pain relief', 'area under the plasma concentration-time curve at steady state (AUC(tau']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0008000', 'cui_str': 'Chemistry, Clinical'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0354402,"PURPOSE


Transdermal buprenorphine patches provide comparable pain relief to that of low-potency opioids in elderly individuals.","[{'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Al-Tawil', 'Affiliation': 'Karolinska Trial Alliance Phase 1 Unit, M62, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Ingegerd', 'Initials': 'I', 'LastName': 'Odar-Cederlöf', 'Affiliation': ''}, {'ForeName': 'Anna-Carin', 'Initials': 'AC', 'LastName': 'Berggren', 'Affiliation': ''}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': ''}]",European journal of clinical pharmacology,['10.1007/s00228-012-1320-8']
108,22134475,Reliance on habits at the expense of goal-directed control following dopamine precursor depletion.,"RATIONALE


Dopamine is well known to play an important role in learning and motivation. Recent animal studies have implicated dopamine in the reinforcement of stimulus-response habits, as well as in flexible, goal-directed action. However, the role of dopamine in human action control is still not well understood.
OBJECTIVES


We present the first investigation of the effect of reducing dopamine function in healthy volunteers on the balance between habitual and goal-directed action control.
METHODS


The dietary intervention of acute dietary phenylalanine and tyrosine depletion (APTD) was adopted to study the effects of reduced global dopamine function on action control. Participants were randomly assigned to either the APTD or placebo group (ns = 14) to allow for a between-subjects comparison of performance on a novel three-stage experimental paradigm. In the initial learning phase, participants learned to respond to different stimuli in order to gain rewarding outcomes. Subsequently, an outcome-devaluation test and a slips-of-action test were conducted to assess whether participants were able to flexibly adjust their behaviour to changes in the desirability of the outcomes.
RESULTS


APTD did not prevent stimulus-response learning, nor did we find evidence for impaired response-outcome learning in the subsequent outcome-devaluation test. However, when goal-directed and habitual systems competed for control in the slips-of-action test, APTD tipped the balance towards habitual control. These findings were restricted to female volunteers.
CONCLUSIONS


We provide direct evidence that the balance between goal-directed and habitual control in humans is dopamine dependent. The results are discussed in light of gender differences in dopamine function and psychopathologies.",2012,"APTD did not prevent stimulus-response learning, nor did we find evidence for impaired response-outcome learning in the subsequent outcome-devaluation test.","['female volunteers', 'healthy volunteers']","['dopamine', 'dietary intervention of acute dietary phenylalanine and tyrosine depletion (APTD', 'APTD or placebo']",['stimulus-response learning'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0335769,"APTD did not prevent stimulus-response learning, nor did we find evidence for impaired response-outcome learning in the subsequent outcome-devaluation test.","[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'de Wit', 'Affiliation': 'Behavioral and Clinical Neuroscience Institute, University of Cambridge, Cambridge, UK. S.deWit@uva.nl'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Standing', 'Affiliation': ''}, {'ForeName': 'Elise E', 'Initials': 'EE', 'LastName': 'Devito', 'Affiliation': ''}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'K Richard', 'Initials': 'KR', 'LastName': 'Ridderinkhof', 'Affiliation': ''}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': ''}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2563-2']
109,20676609,"Effects of American ginseng (Panax quinquefolius) on neurocognitive function: an acute, randomised, double-blind, placebo-controlled, crossover study.","RATIONALE


Over the last decade, Asian ginseng (Panax ginseng) has been shown to improve aspects of human cognitive function. American ginseng (Panax quinquefolius) has a distinct ginsenoside profile from P. ginseng, promising cognitive enhancing properties in preclinical studies and benefits processes linked to human cognition.
OBJECTIVES


The availability of a highly standardised extract of P. quinquefolius (Cereboost™) led us to evaluate its neurocognitive properties in humans for the first time.
METHODS


This randomised, double-blind, placebo-controlled, crossover trial (N = 32, healthy young adults) assessed the acute mood, neurocognitive and glycaemic effects of three doses (100, 200 400 mg) of Cereboost™ (P. quinquefolius standardised to 10.65% ginsenosides). Participants' mood, cognitive function and blood glucose were measured 1, 3 and 6 h following administration.
RESULTS


There was a significant improvement of working memory (WM) performance associated with P. quinquefolius. Corsi block performance was improved by all doses at all testing times. There were differential effects of all doses on other WM tasks which were maintained across the testing day. Choice reaction time accuracy and 'calmness' were significantly improved by 100 mg. There were no changes in blood glucose levels.
CONCLUSIONS


This preliminary study has identified robust working memory enhancement following administration of American ginseng. These effects are distinct from those of Asian ginseng and suggest that psychopharmacological properties depend critically on ginsenoside profiles. These results have ramifications for the psychopharmacology of herbal extracts and merit further study using different dosing regimens and in populations where cognition is fragile.",2010,There was a significant improvement of working memory (WM) performance associated with P. quinquefolius.,"['N\u2009=\u200932, healthy young adults']","['Cereboost™ (P. quinquefolius', 'placebo', 'American ginseng (Panax quinquefolius', 'P. quinquefolius (Cereboost™', 'Asian ginseng (Panax ginseng', 'American ginseng']","['acute mood, neurocognitive and glycaemic effects', 'Corsi block performance', 'neurocognitive function', ""Participants' mood, cognitive function and blood glucose"", ""Choice reaction time accuracy and 'calmness"", 'blood glucose levels', 'working memory (WM) performance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C4505907', 'cui_str': 'Cereboost'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0949314', 'cui_str': 'Panax ginseng'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",,0.314579,There was a significant improvement of working memory (WM) performance associated with P. quinquefolius.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'NICM Centre for the Study of Natural Medicines and Neurocognition, Brain Sciences Institute, Swinburne University, Melbourne, Vic 3122, Australia. andrew@scholeylab.com'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ossoukhova', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': ''}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Ibarra', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pipingas', 'Affiliation': ''}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Roller', 'Affiliation': ''}, {'ForeName': 'Con', 'Initials': 'C', 'LastName': 'Stough', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-1964-y']
110,29502508,"Sexual Assault Disclosure: The Effect of Victim Race and Perpetrator Type on Empathy, Culpability, and Service Referral for Survivors in a Hypothetical Scenario.","The aftermath of sexual assault warrants further attention surrounding the responses provided by those to whom survivors disclose, especially when perpetrator type or victim race may affect whether the bystander response is supportive or attributes culpability to the victim. Disclosure responses have significant consequences for survivors' posttrauma mental health and formal help-seeking behavior. The current study used a sample of 348 self-report, paper-and-pencil surveys administered during the fall 2015 semester to a purposive sample of undergraduate students with a mean age of 20.94 years old at a midsized, Southern public university. Survey design included a randomly assigned 2 × 2 hypothetical sexual assault disclosure vignette. The objective of the study was to assess the effect of perpetrator type (stranger vs. acquaintance) and victim race (White vs. Black) on empathic concern, culpability attributions, and resource referral. Between-subjects factorial ANOVA and multivariate ordinary least squares (OLS) regression models were estimated to identify the role of vignette manipulations, participant-sexual victimization history, and rape myth acceptance on empathy, culpability, and resource referral for the sexual assault survivor portrayed in the vignette. Multivariate analyses included main effects and moderation models. Findings revealed increased culpability and decreased resource referral for victims of acquaintance rape as compared with stranger rape, independent of victim race. Although no direct victim race effects emerged in the multivariate analyses, race moderated the effect of culpability on resource referral indicating culpability attributions decreased resource referral, but only when the victim was Black . Implications from the results presented here include a continued focus on bystander intervention strategies, empathy-building techniques, and educational programming targeting potential sexual assault disclosees and race stereotypes that disadvantage victims of color.",2021,"Findings revealed increased culpability and decreased resource referral for victims of acquaintance rape as compared with stranger rape, independent of victim race.","['sample of 348 self-report, paper-and-pencil surveys administered during the fall 2015 semester to a purposive sample of undergraduate students with a mean age of 20.94 years old at a midsized, Southern public university', 'Sexual Assault Disclosure']","['perpetrator type (stranger vs. acquaintance) and victim race (White vs. Black', 'Victim Race and Perpetrator Type']","['Empathy, Culpability, and Service Referral', 'empathic concern, culpability attributions, and resource referral']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil (physical object)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0337609', 'cui_str': 'Acquaintances'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",,0.021385,"Findings revealed increased culpability and decreased resource referral for victims of acquaintance rape as compared with stranger rape, independent of victim race.","[{'ForeName': 'Cortney A', 'Initials': 'CA', 'LastName': 'Franklin', 'Affiliation': 'Sam Houston State University, Huntsville, TX, USA.'}, {'ForeName': 'Alondra D', 'Initials': 'AD', 'LastName': 'Garza', 'Affiliation': 'Sam Houston State University, Huntsville, TX, USA.'}]",Journal of interpersonal violence,['10.1177/0886260518759656']
111,31600796,A Randomized Controlled Trial of Intact Cord Milking versus Immediate Cord Clamping in Term Infants Born by Elective Cesarean Section.,"OBJECTIVE


We evaluated whether intact umbilical cord milking (UCM) is more effective than immediate cord clamping (ICC) in enhancing placental transfusion after elective cesarean delivery.
STUDY DESIGN


In a randomized trial, volume of placental transfusion was assessed by Δ hematocrit (Hct) between neonatal cord blood and capillary heel blood at 48 hours of age, corrected for the change in body weight.
RESULTS


There were no significant differences in cord blood mean Hct values at birth (UCM, 44.5 ± 4.8 vs. ICC, 44.9 ± 4.2%,  p  = 0.74). Conversely, at 48 hours of age, the UCM group had significantly higher capillary heel Hct values (UCM, 53.7 ± 5.9 vs. ICC, 49.8 ± 4.6%,  p  < 0.001), supporting a higher placental transfusion volume (Δ Hct, UCM 9.2 ± 5.2 vs. ICC 4.8 ± 4.7,  p  < 0.001), despite comparable neonatal body weight decrease (UCM, -7.3 vs. ICC, -6.8%,  p  = 0.77).
CONCLUSION


Higher Δ Hct between cord blood at birth and capillary heel blood at 48 hours of age, corrected for the change in body weight, suggests that intact UCM is an efficacious and safe procedure to enhance placental transfusion among neonates born via elective cesarean delivery.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, www.clinicaltrials.gov, NCT03668782.",2021,"There were no significant differences in cord blood mean Hct values at birth (UCM, 44.5 ± 4.8 vs. ICC, 44.9 ± 4.2%,  p  = 0.74).","['neonates born via elective cesarean delivery', 'Term Infants Born by Elective Cesarean Section']","['immediate cord clamping (ICC', 'intact umbilical cord milking (UCM', 'Intact Cord Milking versus Immediate Cord Clamping']","['cord blood at birth and capillary', 'neonatal body weight decrease', 'cord blood mean Hct values', 'hematocrit (Hct) between neonatal cord blood and capillary heel blood', 'placental transfusion volume', 'capillary heel Hct values']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C1272667', 'cui_str': 'Born by elective cesarean section'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0005768'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.337322,"There were no significant differences in cord blood mean Hct values at birth (UCM, 44.5 ± 4.8 vs. ICC, 44.9 ± 4.2%,  p  = 0.74).","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Zanardo', 'Affiliation': 'Division of Perinatal Medicine, Policlinico AbanoTerme, Abano Terme, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Guerrini', 'Affiliation': 'Division of Perinatal Medicine, Policlinico AbanoTerme, Abano Terme, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Severino', 'Affiliation': 'Division of Perinatal Medicine, Policlinico AbanoTerme, Abano Terme, Italy.'}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Simbi', 'Affiliation': 'Division of Perinatal Medicine, Policlinico AbanoTerme, Abano Terme, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Parotto', 'Affiliation': 'Department of Anesthesiology, Toronto University, Toronto, Canada.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Straface', 'Affiliation': 'Division of Perinatal Medicine, Policlinico AbanoTerme, Abano Terme, Italy.'}]",American journal of perinatology,['10.1055/s-0039-1697673']
112,19165592,One-year follow-up of family versus child CBT for anxiety disorders: Exploring the roles of child age and parental intrusiveness.,"OBJECTIVE


To compare the relative long-term benefit of family-focused cognitive behavioral therapy (FCBT) and child-focused cognitive behavioral therapy (CCBT) for child anxiety disorders at a 1-year follow-up.
METHOD


Thirty-five children (6-13 years old) randomly assigned to 12-16 sessions of family-focused CBT (FCBT) or child-focused CBT (CCBT) participated in a 1-year follow-up assessment. Independent evaluators, parents, and children rated anxiety and parental intrusiveness. All were blind to treatment condition and study hypotheses.
RESULTS


Children assigned to FCBT had lower anxiety scores than children assigned to CCBT on follow-up diagnostician- and parent-report scores, but not child-report scores. Exploratory analyses suggested the advantage of FCBT over CCBT may have been evident more for early adolescents than for younger children and that reductions in parental intrusiveness may have mediated the treatment effect.
CONCLUSION


FCBT may yield a stronger treatment effect than CCBT that lasts for at least 1 year, although the lack of consistency across informants necessitates a circumspect view of the findings. The potential moderating and mediating effects considered in this study offer interesting avenues for further study.",2009,"RESULTS


Children assigned to FCBT had lower anxiety scores than children assigned to CCBT on follow-up diagnostician- and parent-report scores, but not child-report scores.","['child anxiety disorders at a 1-year follow-up', 'Thirty-five children (6-13 years old']","['FCBT', '12-16 sessions of family-focused CBT (FCBT) or child-focused CBT (CCBT', 'CCBT', 'family-focused cognitive behavioral therapy (FCBT) and child-focused cognitive behavioral therapy (CCBT']",['anxiety scores'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",35.0,0.0254093,"RESULTS


Children assigned to FCBT had lower anxiety scores than children assigned to CCBT on follow-up diagnostician- and parent-report scores, but not child-report scores.","[{'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Wood', 'Affiliation': 'UCLA, Los Angeles, CA, USA. jwood@gseis.ucla.edu'}, {'ForeName': 'Bryce D', 'Initials': 'BD', 'LastName': 'McLeod', 'Affiliation': ''}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Piacentini', 'Affiliation': ''}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Sigman', 'Affiliation': ''}]",Child psychiatry and human development,['10.1007/s10578-009-0127-z']
113,31898758,The effect of EMG biofeedback on lower extremity functions in hemiplegic patients.,"The aim of this study was to investigate the efficacy of electromyography biofeedback (EMG BF) therapy in the treatment of ankle dorsiflexion which complicates ambulation in patients who developed hemiplegia after a cerebrovascular accident (CVA). A total of 40 patients attending the inpatient rehabilitation programme who developed hemiplegia after CVA were included in this randomized controlled study. The patients were randomly divided into two groups. In the 20 patients included in the EMG BF group, a visual and auditory EMG BF therapy was applied to tibialis anterior muscles, the extensor of the ankle, 5 days a week for 3 weeks in addition to conventional physiotherapy. The other 20 patients in the control group were only treated with conventional physiotherapy applications. All patients were evaluated for spasticity, ankle range of movement (ROM) scores, the Modified Motor Assessment Scale (MMAS) scores, Brunnstrom's neurophysiological assessment and EMG BF electrical muscle activity before and after treatment. There were significant improvements in the posttreatment ROM, Brunnstrom and MMAS values in both groups, whereas the levels of significance were mostly higher in the EMG BF group than in the control group. In addition, there were no significant changes in spasticity and electrical activity of tibialis anterior muscles in the control group while the EMG BF group demonstrated significant changes. This study showed that the clinical and functional parameters were improved by the use of EMG BF therapy for lower extremities, in addition to conventional rehabilitation programs, in hemiplegic patients with walking difficulty due to insufficient ankle dorsiflexion.",2021,"In addition, there were no significant changes in spasticity and electrical activity of tibialis anterior muscles in the control group while the EMG BF group demonstrated significant changes.","['40 patients attending the inpatient rehabilitation programme who developed hemiplegia after CVA', 'patients who developed hemiplegia after a cerebrovascular accident (CVA', 'hemiplegic patients with walking difficulty due to insufficient ankle dorsiflexion', 'hemiplegic patients']","['visual and auditory EMG BF therapy', 'EMG BF', 'EMG BF therapy', 'conventional physiotherapy applications', 'EMG biofeedback', 'electromyography biofeedback (EMG BF) therapy']","['posttreatment ROM, Brunnstrom and MMAS values', 'lower extremity functions', 'spasticity and electrical activity of tibialis anterior muscles', ""spasticity, ankle range of movement (ROM) scores, the Modified Motor Assessment Scale (MMAS) scores, Brunnstrom's neurophysiological assessment and EMG BF electrical muscle activity""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0311394', 'cui_str': 'Ambulation Difficulty'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242690', 'cui_str': 'Anterior Tibial Muscle'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",40.0,0.016866,"In addition, there were no significant changes in spasticity and electrical activity of tibialis anterior muscles in the control group while the EMG BF group demonstrated significant changes.","[{'ForeName': 'Gülseren', 'Initials': 'G', 'LastName': 'Dost Sürücü', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Adıyaman University Education and Research Hospital, Adıyaman, Turkey. gulserendost@hotmail.com.'}, {'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Tezen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Adıyaman University Education and Research Hospital, Adıyaman, Turkey.'}]",Acta neurologica Belgica,['10.1007/s13760-019-01261-w']
114,29577843,Contributions to Depressed Affect in Latina Women: Examining the Effectiveness of the Moms' Empowerment Program.,"Intimate partner violence (IPV) is a significant social and public health problem that includes physical violence, sexual violence, threats of physical or sexual violence, stalking, and psychological aggression by an intimate partner. Estimates suggest that 35% of Latinas living in the United States experience IPV in their lifetime, with known severe negative outcomes. One mental health consequence of concern is depression, which disproportionately affects IPV-exposed Latinas. The present study tested the effectiveness of the Moms' Empowerment Program (MEP), a culturally adapted intervention to reduce depressive symptoms among IPV-exposed Spanish-speaking Latina mothers. Additional psychosocial predictors of levels of depressed affect over time are examined, including levels of post-traumatic stress, IPV exposure, positive parenting, parental acceptance of children's negative emotions, and maternal employment. Participants ( N  = 72) were assigned to a treatment or a wait-list comparison condition, and those in the treatment group completed a 10-week group intervention addressing the unique problems associated with IPV exposure, mental health, and parenting among Spanish-speaking Latinas. Results of multilevel modeling revealed that participation in the MEP was associated with significant reductions in depressed affect. Lower levels of post-traumatic stress and higher levels of positive parenting, maternal acceptance of children's negative emotions, and maternal employment predicted lower levels of depressed affect. The amount of total IPV exposure was not significantly associated with the extent of depressed affect. The MEP represents a culturally tailored, evidence-based intervention to reduce depressed affect among Spanish-speaking Latinas. The clinical implications of the additional predictors of levels of depressed affect are discussed.",2021,The amount of total IPV exposure was not significantly associated with the extent of depressed affect.,"['IPV-exposed Spanish-speaking Latina mothers', 'Latina', 'Women', 'Participants ( N = 72', 'Intimate partner violence (IPV']","[""Moms' Empowerment Program (MEP"", 'wait-list comparison condition, and those in the treatment group completed a 10-week group intervention addressing the unique problems associated with IPV exposure, mental health, and parenting among Spanish-speaking Latinas']","['total IPV exposure', ""Lower levels of post-traumatic stress and higher levels of positive parenting, maternal acceptance of children's negative emotions, and maternal employment"", 'depressive symptoms', ""levels of post-traumatic stress, IPV exposure, positive parenting, parental acceptance of children's negative emotions, and maternal employment""]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",72.0,0.0260877,The amount of total IPV exposure was not significantly associated with the extent of depressed affect.,"[{'ForeName': 'Sara F', 'Initials': 'SF', 'LastName': 'Stein', 'Affiliation': 'University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Grogan-Kaylor', 'Affiliation': 'University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Galano', 'Affiliation': 'University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Clark', 'Affiliation': 'University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Graham-Bermann', 'Affiliation': 'University of Michigan, Ann Arbor, USA.'}]",Journal of interpersonal violence,['10.1177/0886260518760005']
115,22961230,The cost-effectiveness of smoking cessation support delivered by mobile phone text messaging: Txt2stop.,"BACKGROUND


The txt2stop trial has shown that mobile-phone-based smoking cessation support doubles biochemically validated quitting at 6 months. This study examines the cost-effectiveness of smoking cessation support delivered by mobile phone text messaging.
METHODS


The lifetime incremental costs and benefits of adding text-based support to current practice are estimated from a UK NHS perspective using a Markov model. The cost-effectiveness was measured in terms of cost per quitter, cost per life year gained and cost per QALY gained. As in previous studies, smokers are assumed to face a higher risk of experiencing the following five diseases: lung cancer, stroke, myocardial infarction, chronic obstructive pulmonary disease, and coronary heart disease (i.e. the main fatal or disabling, but by no means the only, adverse effects of prolonged smoking). The treatment costs and health state values associated with these diseases were identified from the literature. The analysis was based on the age and gender distribution observed in the txt2stop trial. Effectiveness and cost parameters were varied in deterministic sensitivity analyses, and a probabilistic sensitivity analysis was also performed.
FINDINGS


The cost of text-based support per 1,000 enrolled smokers is £16,120, which, given an estimated 58 additional quitters at 6 months, equates to £278 per quitter. However, when the future NHS costs saved (as a result of reduced smoking) are included, text-based support would be cost saving. It is estimated that 18 LYs are gained per 1,000 smokers (0.3 LYs per quitter) receiving text-based support, and 29 QALYs are gained (0.5 QALYs per quitter). The deterministic sensitivity analysis indicated that changes in individual model parameters did not alter the conclusion that this is a cost-effective intervention. Similarly, the probabilistic sensitivity analysis indicated a >90 % chance that the intervention will be cost saving.
INTERPRETATION


This study shows that under a wide variety of conditions, personalised smoking cessation advice and support by mobile phone message is both beneficial for health and cost saving to a health system.",2013,The deterministic sensitivity analysis indicated that changes in individual model parameters did not alter the conclusion that this is a cost-effective intervention.,"['1,000 enrolled smokers is £16,120, which, given an estimated 58 additional quitters at 6 months, equates to £278 per quitter']",['smoking cessation support delivered by mobile phone text messaging'],"['cost-effectiveness', 'treatment costs and health state values', 'Effectiveness and cost parameters']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0290554,The deterministic sensitivity analysis indicated that changes in individual model parameters did not alter the conclusion that this is a cost-effective intervention.,"[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Guerriero', 'Affiliation': 'Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK. Carla.Guerriero@lshtm.ac.uk'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cairns', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': ''}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': ''}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-012-0424-5']
116,22430431,The 5-HT1F receptor agonist lasmiditan as a potential treatment of migraine attacks: a review of two placebo-controlled phase II trials.,"Lasmiditan is a novel selective 5-HT(1F) receptor agonist. It is both scientifically and clinically relevant to review whether a 5-HT(1F) receptor agonist is effective in the acute treatment of migraine. Two RCTs in the phase II development of lasmiditan was reviewed. In the intravenous placebo-controlled RCT, lasmiditan doses of 2.5-45 mg were used, and there was a linear association between headache relief (HR) rates and dose levels (P < 0.02). For lasmiditan 20 mg, HR was 64 % and for placebo it was 45 % (NS). In the oral placebo-controlled RCT, lasmiditan doses of 50, 100, 200 and 400 mg were used. For HR, all doses of lasmiditan were superior to placebo (P < 0.05). For lasmiditan 400 mg, HR was 64 % and it was 25 % for placebo. Adverse events (AEs) emerging from the treatment were reported by 22 % of the patients receiving placebo and by 65, 73, 87 and 87 % of patients receiving 50, 100, 200 and 400 mg, respectively. The majority of AEs after lasmiditan 100 and 400 mg were moderate or severe. For the understanding of migraine pathophysiology, it is very important to note that a selective 5-HT(1F) receptor agonist like lasmiditan is effective in the acute treatment of migraine. Thus, migraine can be treated with a drug that has no vasoconstrictor ability. While lasmiditan most likely is effective in the treatment of migraine attacks it had, unfortunately, a high incidence of CNS related AEs in the oral RCT. If confirmed in larger studies in phase III, this might adversely limit the use of this highly specific non-vascular acute treatment of migraine. Larger studies including the parameters of patients' preferences are necessary to accurately position this new treatment principle in relation to the triptans.",2012,"For HR, all doses of lasmiditan were superior to placebo (P < 0.05).",['migraine attacks'],['placebo'],['headache relief (HR) rates and dose levels'],"[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0896278,"For HR, all doses of lasmiditan were superior to placebo (P < 0.05).","[{'ForeName': 'Peer C', 'Initials': 'PC', 'LastName': 'Tfelt-Hansen', 'Affiliation': 'Department of Neurology, Danish Headache Center, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark. ptha@glo.regionh.dk'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': ''}]",The journal of headache and pain,['10.1007/s10194-012-0428-7']
117,21739267,The relationship between clinical pharmacokinetics of aripiprazole and CYP2D6 genetic polymorphism: effects of CYP enzyme inhibition by coadministration of paroxetine or fluvoxamine.,"PURPOSE


To investigate the effects of coadministration of paroxetine or fluvoxamine on the pharmacokinetics of aripiprazole in healthy adult Japanese with different CYP2D6 genotypes.
METHODS


Fourteen CYP2D6 extensive metabolizer (EM) and 14 CYP2D6 intermediate metabolizer (IM) subjects were coadministered a single oral dose of aripiprazole 3 mg after steady-state plasma concentrations of the SSRIs paroxetine (20 mg/day) or fluvoxamine (100 mg/day) were reached by repeated oral doses for 6-7 days. The pharmacokinetics of aripiprazole with and without coadministration of SSRIs were compared according to CYP2D6 genotypes.
RESULTS


Coadministration of paroxetine, a potent CYP2D6 inhibitor, decreased systemic clearance (CL/F) of aripiprazole by 58 and 23% in CYP2D6 EMs and IMs, respectively, demonstrating that the percentage inhibition of CYP2D6 activity by coadministration of paroxetine was apparently greater in CYP2D6 EMs than in IMs. Coadministration of fluvoxamine, a less potent CYP3A4 inhibitor, decreased the CL/F of aripiprazole by 39% in CYP2D6 EMs and 40% in IMs, indicating the same inhibitory effect on CYP enzymes, regardless of the CYP2D6 genotype. Percent contribution of CYP2D6 to total CL/F (CYP2D6 plus CYP3A4) of aripiprazole estimated as a reduced percentage of CL/F by CYP enzyme inhibition was 62% for CYP2D6 EMs and 24% for IMs in paroxetine coadministration, and 40% for CYP2D6 EMs and 18% for IMs in fluvoxamine coadministration.
CONCLUSIONS


There were marked differences in the degree of influence of paroxetine coadministration on the pharmacokinetics of aripiprazole between CYP2D6 EMs and IMs, but no apparent differences were found between two CYP2D6 genotypes in fluvoxamine coadministration. Aripiprazole can be used safely in combination with SSRIs that have a CYP enzyme-inhibitory action.",2012,"Coadministration of fluvoxamine, a less potent CYP3A4 inhibitor, decreased the CL/F of aripiprazole by 39% in CYP2D6 EMs and 40% in IMs, indicating the same inhibitory effect on CYP enzymes, regardless of the CYP2D6 genotype.","['Fourteen CYP2D6 extensive metabolizer (EM) and 14 CYP2D6 intermediate metabolizer (IM) subjects', 'healthy adult Japanese with different CYP2D6 genotypes']","['Aripiprazole', 'paroxetine', 'paroxetine or fluvoxamine', 'aripiprazole 3\xa0mg after steady-state plasma concentrations of the SSRIs paroxetine', 'fluvoxamine', 'aripiprazole']","['percentage of CL/F by CYP enzyme inhibition', 'systemic clearance (CL/F) of aripiprazole', 'CYP2D6 activity']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C4707312', 'cui_str': 'CYP2D6 extensive metabolizer'}, {'cui': 'C4545383', 'cui_str': 'Cytochrome P450 family 2 subfamily D member 6 intermediate metabolizer'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0085228', 'cui_str': 'Fluvoxamine'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0877008', 'cui_str': 'Enzyme inhibition'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0132639,"Coadministration of fluvoxamine, a less potent CYP3A4 inhibitor, decreased the CL/F of aripiprazole by 39% in CYP2D6 EMs and 40% in IMs, indicating the same inhibitory effect on CYP enzymes, regardless of the CYP2D6 genotype.","[{'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Azuma', 'Affiliation': 'Clinical Pharmacology and Pharmacogenomics, Department of Pharmacy, School of Pharmacy, Hyogo University of Health Sciences, 1-3-6, Minatojima, Chuo-ku, Kobe, 650-8530, Japan. azuma@huhs.ac.jp'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Hasunuma', 'Affiliation': ''}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kubo', 'Affiliation': ''}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Miyatake', 'Affiliation': ''}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Koue', 'Affiliation': ''}, {'ForeName': 'Koushi', 'Initials': 'K', 'LastName': 'Higashi', 'Affiliation': ''}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': ''}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Kitahara', 'Affiliation': ''}, {'ForeName': 'Tamiki', 'Initials': 'T', 'LastName': 'Katano', 'Affiliation': ''}, {'ForeName': 'Sumiko', 'Initials': 'S', 'LastName': 'Hara', 'Affiliation': ''}]",European journal of clinical pharmacology,['10.1007/s00228-011-1094-4']
118,29683078,Is Sexual Objectification and Victimization of Females in Video Games Associated With Victim Blaming or Victim Empathy?,"The goal of this study was to investigate whether the sexual objectification and virtual violence against females in video games increases negative attitudes toward females, when addressing a variety of noted methodological issues. Study participants were randomly assigned to a control group, where participants played Madden NFL 12, or an experimental group, where participants played Grand Theft Auto. In the experimental group, participants played the game with a confederate, who exposed participants to sexual objectification and violence against females. Study results indicated that both the experimental and control groups had equivalently low levels of rape myth acceptance prior to game play. Immediately after game play, there still was no statistically significant difference in rape myth acceptance between groups; however, there was a decrease in rape myth acceptance for the experimental group. The decrease in rape myth acceptance continued and magnified for the experimental group, over time, to the point of creating a statistically significant difference between the two groups for the follow-up measure at the end of the study.",2021,Study results indicated that both the experimental and control groups had equivalently low levels of rape myth acceptance prior to game play.,['sexual objectification and virtual violence against females in video games increases negative attitudes toward females'],['Video Games'],['rape myth acceptance'],"[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude (finding)'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0330502', 'cui_str': 'Brassica napus'}]",,0.0193336,Study results indicated that both the experimental and control groups had equivalently low levels of rape myth acceptance prior to game play.,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Beck', 'Affiliation': 'University of Wisconsin Oshkosh, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rose', 'Affiliation': 'University of Wisconsin Oshkosh, USA.'}]",Journal of interpersonal violence,['10.1177/0886260518770187']
119,29560806,Impact of music type on motor coordination task performance among introverted and extroverted students.,"Purpose . People are interested in music. In this study, we assessed the impact of music type on objective performance.  Materials and methods . We distributed 64 medical science students in Tehran into four groups: Iranian pop music, traditional music, Mozart's classical music and control groups. All participants performed the two-arm coordination test once without music and once with music (except for the control group), with an interval of 1 week. In the music groups, music was playing during the performance of the test. Participants were categorized as either introverted or extroverted and were distributed equally in the groups.  Results . There was a significant decrease of test time in the second trial, observed in all music groups, and no significant difference identified in the control group. The traditional music group had less difference of mean time compared to the pop music group. The differences in the traditional and classical groups were not significantly different. In the music groups, both extroverted and introverted students decreased their test time significantly after music intervention, but extroverted students decreased more.  Conclusion . Listening to music would enhance the speed of performance. Music with a higher tempo, such as pop music, increased the speed more.",2020,"In the music groups, both extroverted and introverted students decreased their test time significantly after music intervention, but extroverted students decreased more.
CONCLUSION


Listening to music would enhance the speed of performance.","['introverted and extroverted students', 'We distributed 64 medical science students in Tehran into four groups']","[""Iranian pop music, traditional music, Mozart's classical music and control groups"", 'music type']","['test time', 'motor coordination task performance', 'speed of performance', 'mean time']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0429928', 'cui_str': 'Test time (observable entity)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",64.0,0.0602022,"In the music groups, both extroverted and introverted students decreased their test time significantly after music intervention, but extroverted students decreased more.
CONCLUSION


Listening to music would enhance the speed of performance.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Jamshidzad', 'Affiliation': 'School of Public Health, Ilam University of Medical Science, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Maghsoudipour', 'Affiliation': 'Department of Ergonomics, University of Social Welfare and Rehabilitation Sciences, Iran.'}, {'ForeName': 'Seyed Abolfazl', 'Initials': 'SA', 'LastName': 'Zakerian', 'Affiliation': 'School of Public Health, Tehran University of Medical Science, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Iran.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Coh', 'Affiliation': 'Department of Ophthalmology, University of California San Francisco, USA.'}]",International journal of occupational safety and ergonomics : JOSE,['10.1080/10803548.2018.1455410']
120,20180011,The relation of severity and comorbidity to treatment outcome with Cognitive Behavioral Therapy for childhood anxiety disorders.,"The present study investigated the impact of comorbidity over and above the impact of symptom severity on treatment outcome of Cognitive Behavioral Therapy for children with anxiety disorders. Children (aged 8-12, n = 124) diagnosed with an anxiety disorder were treated with a short-term CBT protocol. Severity was assessed with a composite measure of parent-reported behavior problems. Two approaches to comorbidity were examined; ""total comorbidity"" which differentiated anxiety disordered children with (n = 69) or without (n = 55) a co-occurring disorder and ""non-anxiety comorbidity' which differentiated anxious children with (n = 22) or without a non-anxiety comorbid disorder (n = 102). Treatment outcome was assessed in terms of Recovery, represented by post-treatment diagnostic status, and Reliable Change, a score reflecting changes in pre- to post-treatment symptom levels. Severity contributed to the prediction of (no) Recovery and (more) Reliable Change in parent-reported internalizing and externalizing symptoms and self-reported depressive symptoms. Total and non-anxiety comorbidity added to the prediction of diagnostic recovery. Non-anxiety comorbidity added to the prediction of Reliable Change in parent reported measures by acting as a suppressor variable. Non-anxiety comorbidity operated as a strong predictor that explained all of the variance associated with severity for self-reported depressive symptoms. The results support the need for further research on mechanisms by which treatment gains in children with higher symptom severity and non-anxiety comorbidity can be achieved.",2010,Total and non-anxiety comorbidity added to the prediction of diagnostic recovery. Non-anxiety comorbidity added to the prediction of Reliable Change in parent reported measures by acting as a suppressor variable.,"['childhood anxiety disorders', 'children with anxiety disorders', 'Children (aged 8-12, n = 124) diagnosed with an anxiety disorder', 'differentiated anxiety disordered children with (n = 69) or without (n = 55) a co-occurring disorder and ""non-anxiety comorbidity\' which differentiated anxious children with (n = 22) or without a non-anxiety comorbid disorder (n = 102']",['Cognitive Behavioral Therapy'],"['Total and non-anxiety comorbidity', 'Recovery, represented by post-treatment diagnostic status, and Reliable Change, a score reflecting changes in pre- to post-treatment symptom levels', 'internalizing and externalizing symptoms and self-reported depressive symptoms']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",124.0,0.0169035,Total and non-anxiety comorbidity added to the prediction of diagnostic recovery. Non-anxiety comorbidity added to the prediction of Reliable Change in parent reported measures by acting as a suppressor variable.,"[{'ForeName': 'Juliette Margo', 'Initials': 'JM', 'LastName': 'Liber', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Curium/ Leiden University Medical Center, Leiden, the Netherlands. J.M.Liber@uva.nl'}, {'ForeName': 'Brigit M', 'Initials': 'BM', 'LastName': 'van Widenfelt', 'Affiliation': ''}, {'ForeName': 'Adelinde J M', 'Initials': 'AJ', 'LastName': 'van der Leeden', 'Affiliation': ''}, {'ForeName': 'Arnold W', 'Initials': 'AW', 'LastName': 'Goedhart', 'Affiliation': ''}, {'ForeName': 'Elisabeth M W J', 'Initials': 'EM', 'LastName': 'Utens', 'Affiliation': ''}, {'ForeName': 'Philip D A', 'Initials': 'PD', 'LastName': 'Treffers', 'Affiliation': ''}]",Journal of abnormal child psychology,['10.1007/s10802-010-9394-1']
121,19603168,Effect of rifampin on the pharmacokinetics of Axitinib (AG-013736) in Japanese and Caucasian healthy volunteers.,"PURPOSE


Axitinib, a potent and selective inhibitor of vascular endothelial growth factor receptors 1, 2, 3, is metabolized by cytochrome P450 3A4 and glucuronidation. This study evaluated the effect of rifampin, a potent inducer of drug-metabolizing enzymes, on axitinib plasma pharmacokinetics. Equal numbers of Japanese and Caucasian subjects were enrolled to assess the potential differences in axitinib pharmacokinetics between the two ethnicities.
METHODS


Forty healthy volunteers were randomized to receive 5 mg axitinib alone and with 600 mg rifampin.
RESULTS


Rifampin expectedly decreased AUCinf and Cmax of axitinib (geometric mean reduced by 79 and 71%, respectively). However, differences in axitinib pharmacokinetics were not observed between Japanese and Caucasian subjects (geometric mean ratios for axitinib treatment alone for AUCinf and Cmax were 103 and 96%).
CONCLUSIONS


The results support a common axitinib starting dose in both populations. Potent inducers of drug-metabolizing enzymes reduce axitinib exposure and dose adjustments may be needed for optimal efficacy.",2010,"RESULTS


Rifampin expectedly decreased AUCinf and Cmax of axitinib (geometric mean reduced by 79 and 71%, respectively).","['Japanese and Caucasian healthy volunteers', 'Equal numbers of Japanese and Caucasian subjects', 'Forty healthy volunteers']","['rifampin', 'axitinib alone and with 600 mg rifampin']","['AUCinf and Cmax of axitinib (geometric mean', 'axitinib pharmacokinetics']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",40.0,0.0241881,"RESULTS


Rifampin expectedly decreased AUCinf and Cmax of axitinib (geometric mean reduced by 79 and 71%, respectively).","[{'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Pithavala', 'Affiliation': 'Pfizer Oncology, Pfizer Global Research and Development, La Jolla Laboratories, 101646 Science Center Drive, San Diego, CA 92121, USA. yazdi.pithavala@pfizer.com'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tortorici', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toh', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Garrett', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hee', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Kuruganti', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ni', 'Affiliation': ''}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Klamerus', 'Affiliation': ''}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-009-1065-y']
122,29514551,A Methodological Study of Order Effects in Reporting Relational Aggression Experiences.,"Unlike the overt nature of physical aggression, which lends itself to simpler and more direct methods of investigation, the often-masked nature of relational aggression has led to difficulties and debate regarding the most effective tools of study. Given concerns with the accuracy of third-party relational aggression reports, especially as individuals age, self-report measures may be particularly useful when assessing experiences with relational aggression. However, it is important to recognize validity concerns-in particular, the potential effects of item order presentation-associated with self-report of relational aggression perpetration and victimization. To investigate this issue, surveys were administered and completed by 179 young adults randomly assigned to one of four survey conditions reflecting manipulation of item order. Survey conditions included presentation of (a) perpetration items only, (b) victimization items only, (c) perpetration items followed by victimization items, and (d) victimization items followed by perpetration items. Results revealed that participants reported perpetrating relational aggression significantly more often when asked only about perpetration or when asked about perpetration before victimization, compared with participants who were asked about victimization before perpetration. Item order manipulation did not result in significant differences in self-reported victimization experiences. Results of this study indicate a need for greater consideration of item order when conducting research using self-report data and the importance of additional investigation into which form of item presentation elicits the most accurate self-report information.",2021,"Results revealed that participants reported perpetrating relational aggression significantly more often when asked only about perpetration or when asked about perpetration before victimization, compared with participants who were asked about victimization before perpetration.","['Reporting Relational Aggression Experiences', '179 young adults randomly assigned to one of four survey conditions reflecting manipulation of item order']",[],"['presentation of (a) perpetration items only, (b) victimization items only, (c) perpetration items followed by victimization items, and (d) victimization items followed by perpetration items', 'relational aggression']","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]",[],"[{'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}]",179.0,0.0190536,"Results revealed that participants reported perpetrating relational aggression significantly more often when asked only about perpetration or when asked about perpetration before victimization, compared with participants who were asked about victimization before perpetration.","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Serico', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'NeMoyer', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Naomi E S', 'Initials': 'NES', 'LastName': 'Goldstein', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Houck', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Leff', 'Affiliation': ""The Children's Hospital of Philadelphia, PA, USA.""}]",Journal of interpersonal violence,['10.1177/0886260518760008']
123,20878293,Tailored print communication and telephone motivational interviewing are equally successful in improving multiple lifestyle behaviors in a randomized controlled trial.,"BACKGROUND


Computer tailoring and motivational interviewing show promise in promoting lifestyle change, despite few head-to-head comparative studies.
PURPOSE


Vitalum is a randomized controlled trial in which the efficacy of these methods was compared in changing physical activity and fruit and vegetable consumption in middle-aged Dutch adults.
METHODS


Participants (n = 1,629) were recruited via 23 general practices and randomly received either four tailored print letters, four motivational telephone calls, two of each type of intervention, or no information. The primary outcomes were absolute change in self-reported physical activity and fruit and vegetable consumption.
RESULTS


All three intervention groups (i.e., the tailored letters, the motivational calls, and the combined version) were equally and significantly more effective than the control group in increasing physical activity (hours/day), intake of fruit (servings/day), and consumption of vegetables (grams/day) from baseline to the intermediate measurement (week 25), follow-up 1 (week 47) and 2 (week 73). Effect sizes (Cohen's d) ranged from 0.15 to 0.18. Participants rated the interventions positively; interviews were more positively evaluated than letters.
CONCLUSIONS


Tailored print communication and telephone motivational interviewing or their combination are equally successful in changing multiple behaviors.",2011,"Participants rated the interventions positively; interviews were more positively evaluated than letters.
","['Participants (n\u2009=\u20091,629) were recruited via 23 general practices and randomly received either', 'middle-aged Dutch adults']","['Tailored print communication and telephone motivational interviewing', 'four tailored print letters, four motivational telephone calls, two of each type of intervention, or no information']","['absolute change in self-reported physical activity and fruit and vegetable consumption', 'physical activity', 'multiple lifestyle behaviors', 'physical activity and fruit and vegetable consumption']","[{'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",1629.0,0.0230878,"Participants rated the interventions positively; interviews were more positively evaluated than letters.
","[{'ForeName': 'Hilde M', 'Initials': 'HM', 'LastName': 'van Keulen', 'Affiliation': 'Department of Health Promotion, Maastricht University, The Netherlands. hilde.vankeulen@tno.nl'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Mesters', 'Affiliation': ''}, {'ForeName': 'Marlein', 'Initials': 'M', 'LastName': 'Ausems', 'Affiliation': ''}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Breukelen', 'Affiliation': ''}, {'ForeName': 'Marci', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brug', 'Affiliation': ''}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': ''}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1007/s12160-010-9231-3']
124,28711505,Practice-based research networks add value to evidence-based quality improvement.,"Background


Evidence-Based Quality Improvement (EBQI) is a systematic, multilevel approach to implementing research evidence into clinical settings. Little is known about EBQI effectiveness in the context of Practice-Based Research Networks (PBRNs), which are themselves designed to foster practice-based change. We evaluated EBQI implementation in a PBRN setting to determine the extent to which the PBRN infrastructure added value.
METHODS


We conducted a four-site cluster randomized trial of an EBQI approach to tailoring an evidence-based gender awareness curriculum in the VA Women’s Health PBRN (WH-PBRN). After curriculum implementation, site teams identified impacts of the WH-PBRN context on EBQI processes using qualitative methods, including a formal review of project call minutes, post-project debriefing calls, and structured site team input. WH-PBRN site feedback was mapped to the Replicating Effective Programs implementation phases: pre-condition, pre-implementation, implementation, and maintenance/evolution.
RESULTS


The pre-condition phase benefited from the existing WH-PBRN research-clinician relationships to facilitate stakeholder engagement and build project buy-in at local sites. During pre-implementation, differences across WH-PBRN sites offered variations in local tailoring of EBQI elements. The WH-PBRN Coordinating Center helped resolve process complexities stemming from local resource differences and the sharing of mid-project adaptations during implementation. Local efforts were amplified in the maintenance phase by WH-PBRN dissemination of findings.
Conclusions


The PBRN strengthened multi-site EBQI activities across all implementation phases.
Implications


PBRNs contribute to the uptake of evidence into everyday practice, and may serve as an important component of the future implementation of evidence-based initiatives. Level of evidence: V.",2018,"PBRNs contribute to the uptake of evidence into everyday practice, and may serve as an important component of the future implementation of evidence-based initiatives.",['VA Women’s Health PBRN (WH-PBRN'],"['EBQI approach', '\n\n\nEvidence-Based Quality Improvement (EBQI']",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}]",[],,0.0607046,"PBRNs contribute to the uptake of evidence into everyday practice, and may serve as an important component of the future implementation of evidence-based initiatives.","[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Goldstein', 'Affiliation': 'VA HSR&D Center for Health Services Research in Primary Care, Durham VA Medical Center, 508 Fulton Street, Durham, NC 27705, USA; Duke University School of Medicine, Division of General Internal Medicine, USA. Electronic address: karen.goldstein@duke.edu.'}, {'ForeName': 'Dawne', 'Initials': 'D', 'LastName': 'Vogt', 'Affiliation': ""Women's Health Sciences Division, National Center for Posttraumatic Stress Disorder, VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hamilton', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Frayne', 'Affiliation': ""Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Palo Alto, CA, USA; Women's Health Section, VA Palo Alto Health Care System, Palo Alto, CA, USA; Division of Primary Care and Population Health and Center for Primary Care and Outcomes Research, Stanford University, Stanford, CA, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gierisch', 'Affiliation': 'VA HSR&D Center for Health Services Research in Primary Care, Durham VA Medical Center, 508 Fulton Street, Durham, NC 27705, USA; Duke University School of Medicine, Division of General Internal Medicine, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Blakeney', 'Affiliation': 'VA HSR&D Center for Health Services Research in Primary Care, Durham VA Medical Center, 508 Fulton Street, Durham, NC 27705, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sadler', 'Affiliation': 'VA HSR&D Center for Comprehensive Access and Delivery Research and Evaluation, Iowa City VA Healthcare System, Iowa City, IA, USA; Department of Psychiatry, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA.'}, {'ForeName': 'Bevanne M', 'Initials': 'BM', 'LastName': 'Bean-Mayberry', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Medicine, University of California Los Angeles (UCLA), USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Carney', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'DiLeone', 'Affiliation': 'Center for Health Equity Research and Promotion, Philadelphia VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Annie B', 'Initials': 'AB', 'LastName': 'Fox', 'Affiliation': ""Women's Health Sciences Division, National Center for Posttraumatic Stress Disorder, VA Boston Healthcare System, Boston, MA, USA.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Klap', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Yee', 'Affiliation': 'VA Medical Center-New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Romodan', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Strehlow', 'Affiliation': 'VA HSR&D Center for Comprehensive Access and Delivery Research and Evaluation, Iowa City VA Healthcare System, Iowa City, IA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Yosef', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Yano', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, CA, USA.'}]","Healthcare (Amsterdam, Netherlands)",['10.1016/j.hjdsi.2017.06.008']
125,20495788,Dopamine precursor depletion improves punishment prediction during reversal learning in healthy females but not males.,"INTRODUCTION


The neurotransmitter dopamine has frequently been implicated in reward processing but is also, increasingly, implicated in punishment processing. We have previously shown that both patients with Parkinson's disease and healthy individuals with low dopamine (DA) synthesis are better at reversal learning based on punishment than reward. Here, we extend these prior findings by examining the effects of artificially reducing DA synthesis in healthy individuals performing this previously employed task.
METHODS


In a double-blind, placebo-controlled crossover design, we applied the acute tyrosine and phenylalanine depletion (ATPD) procedure to reduce global DA synthesis in 15 female and 14 male subjects. Each subject performed the reward- and punishment-based reversal-learning paradigm.
RESULTS


There was a significant three-way interaction between ATPD, the valence of the outcome signalling reversal and the gender of the participants. Examination of punishment and reward-based reversals separately revealed that this was driven by a significant improvement in punishment processing in female but not male subjects following DA depletion.
CONCLUSIONS


Reducing DA synthesis in healthy individuals shifted sensitivity of performance from reward to punishment processing. Gender differences in DA synthesis might underlie the selectivity of this effect to female subjects. Such gender biases may go some way towards explaining the gender biases in certain psychiatric disorders such as depression and Parkinson's disease.",2010,"Examination of punishment and reward-based reversals separately revealed that this was driven by a significant improvement in punishment processing in female but not male subjects following DA depletion.
","['15 female and 14 male subjects', 'healthy individuals', 'healthy females but not males', ""patients with Parkinson's disease and healthy individuals with low dopamine (DA) synthesis""]","['phenylalanine depletion', 'placebo', 'Dopamine precursor depletion']","['punishment processing', 'global DA synthesis']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0034119', 'cui_str': 'Punishment'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.0429216,"Examination of punishment and reward-based reversals separately revealed that this was driven by a significant improvement in punishment processing in female but not male subjects following DA depletion.
","[{'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Robinson', 'Affiliation': ""Department of Psychiatry and Behavioural and Clinical Neuroscience Institute, University of Cambridge, Cambridge, Addenbrooke's Hospital, P.O. Box 189, Level E4, Hills Road, Cambridge, CB2 2QQ, UK. oliver.j.robinson@googlemail.com""}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Standing', 'Affiliation': ''}, {'ForeName': 'Elise E', 'Initials': 'EE', 'LastName': 'DeVito', 'Affiliation': ''}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Cools', 'Affiliation': ''}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-1880-1']
126,20631992,5-HT modulation by acute tryptophan depletion of human instrumental contingency judgements.,"INTRODUCTION


The concept of 'depressive realism', that depression leads to more accurate perception of causal control, has been influential in the field of depression research, but remains controversial. Recent work testing contingency learning has suggested that contextual processing might determine realism-like effects. Serotonin (5-hydroxytryptamine, (5-HT)), which is implicated in the pathophysiology of depression, might also influence contextual processing. Using acute tryptophan depletion (ATD), we tested the hypothesis that dysfunctional serotoninergic neurotransmission influences contingency judgements in dysphoric subjects via an effect on contextual processing.
MATERIALS AND METHODS


We employed a novel contingency learning task to obtain separate measures (ratings) of the causal effect of participants' responses and efficacy of the background context over an outcome. Participants, without a history of depression, completed this task on and off ATD in a double-blind, placebo-controlled, within-subjects design.
RESULTS


As with other work on contingency learning, the effects of ATD were related to baseline mood levels. Although no overall effects of ATD were observed, the subgroup of participants with low Beck depression inventory (BDI) scores showed reduced ratings of contextual control and improved accuracy of contingency judgements under positive contingencies following ATD, compared to placebo. High BDI participants demonstrated low accuracy in contingency judgements, regardless of serotoninergic status.
CONCLUSIONS


No effect of ATD on contingency judgements was observed in the group as a whole, but effects were observed in a subgroup of participants with low BDI scores. We discuss these data in light of the context processing hypothesis, and prior research on 5-HT and depressive realism.",2011,"No effect of ATD on contingency judgements was observed in the group as a whole, but effects were observed in a subgroup of participants with low BDI scores.",['High BDI participants'],"['placebo', 'Serotonin (5-hydroxytryptamine, (5-HT']","['ratings of contextual control and improved accuracy of contingency judgements under positive contingencies', 'contingency judgements', 'low Beck depression inventory (BDI) scores']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score (observable entity)'}]",,0.18781,"No effect of ATD on contingency judgements was observed in the group as a whole, but effects were observed in a subgroup of participants with low BDI scores.","[{'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Behavioural and Clinical Neuroscience Institute, Department of Experimental Psychology, University of Cambridge, Cambridge, UK. henry.chase@nottingham.ac.uk'}, {'ForeName': 'Molly J', 'Initials': 'MJ', 'LastName': 'Crockett', 'Affiliation': ''}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Msetfi', 'Affiliation': ''}, {'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': ''}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-1934-4']
127,20878497,"Language barriers, physician-patient language concordance, and glycemic control among insured Latinos with diabetes: the Diabetes Study of Northern California (DISTANCE).","BACKGROUND


A significant proportion of US Latinos with diabetes have limited English proficiency (LEP). Whether language barriers in health care contribute to poor glycemic control is unknown.
OBJECTIVE


To assess the association between limited English proficiency (LEP) and glycemic control and whether this association is modified by having a language-concordant physician.
DESIGN


Cross-sectional, observational study using data from the 2005-2006 Diabetes Study of Northern California (DISTANCE). Patients received care in a managed care setting with interpreter services and self-reported their English language ability and the Spanish language ability of their physician. Outcome was poor glycemic control (glycosylated hemoglobin A1c > 9%).
KEY RESULTS


The unadjusted percentage of patients with poor glycemic control was similar among Latino patients with LEP (n = 510) and Latino English-speakers (n = 2,683), and higher in both groups than in whites (n = 3,545) (21% vs 18% vs. 10%, p < 0.005). This relationship differed significantly by patient-provider language concordance (p < 0.01 for interaction). LEP patients with language-discordant physicians (n = 115) were more likely than LEP patients with language-concordant physicians (n = 137) to have poor glycemic control (27.8% vs 16.1% p = 0.02). After controlling for potential demographic and clinical confounders, LEP Latinos with language-concordant physicians had similar odds of poor glycemic control as Latino English speakers (OR 0.89; CI 0.53-1.49), whereas LEP Latinos with language-discordant physicians had greater odds of poor control than Latino English speakers (OR 1.76; CI 1.04-2.97). Among LEP Latinos, having a language discordant physician was associated with significantly poorer glycemic control (OR 1.98; CI 1.03-3.80).
CONCLUSIONS


Language barriers contribute to health disparities among Latinos with diabetes. Limited English proficiency is an independent predictor for poor glycemic control among insured US Latinos with diabetes, an association not observed when care is provided by language-concordant physicians. Future research should determine if strategies to increase language-concordant care improve glycemic control among US Latinos with LEP.",2011,"Among LEP Latinos, having a language discordant physician was associated with significantly poorer glycemic control (OR 1.98; CI 1.03-3.80).
","['insured Latinos with diabetes', 'Latino patients with LEP (n = 510) and Latino English-speakers (n = 2,683), and higher in both groups than in whites (n = 3,545', 'LEP patients with language-discordant physicians (n = 115', 'Latinos with diabetes', '2005-2006 Diabetes Study of Northern California (DISTANCE', 'Patients received care in a managed care setting with interpreter services and self-reported their English language ability and the Spanish language ability of their physician']",[],"['glycemic control', 'glycemic control (glycosylated hemoglobin A1c > 9', 'poor glycemic control', 'patient-provider language concordance']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517800', 'cui_str': '510 (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0150646', 'cui_str': 'Interpreter (occupation)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0376245', 'cui_str': 'English language (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0037750', 'cui_str': 'Spanish language (qualifier value)'}]",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023008', 'cui_str': 'Languages'}]",115.0,0.0160796,"Among LEP Latinos, having a language discordant physician was associated with significantly poorer glycemic control (OR 1.98; CI 1.03-3.80).
","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA. afernandez@medsfgh.ucsf.edu'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': ''}, {'ForeName': 'E Margaret', 'Initials': 'EM', 'LastName': 'Warton', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Adler', 'Affiliation': ''}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Moffet', 'Affiliation': ''}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': ''}, {'ForeName': 'M Victoria', 'Initials': 'MV', 'LastName': 'Salgado', 'Affiliation': ''}, {'ForeName': 'Ameena', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Karter', 'Affiliation': ''}]",Journal of general internal medicine,['10.1007/s11606-010-1507-6']
128,20155439,Prediction of 60 day case-fatality after aneurysmal subarachnoid haemorrhage: results from the International Subarachnoid Aneurysm Trial (ISAT).,"Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating event with substantial case-fatality. Our purpose was to examine which clinical and neuro-imaging characteristics, available on admission, predict 60 day case-fatality in aSAH and to evaluate performance of our prediction model. We performed a secondary analysis of patients enrolled in the International Subarachnoid Aneurysm Trial (ISAT), a randomised multicentre trial to compare coiling with clipping in aSAH patients. Multivariable logistic regression analysis was used to develop a prognostic model to estimate the risk of dying within 60 days from aSAH based on clinical and neuro-imaging characteristics. The model was internally validated with bootstrapping techniques. The study population comprised of 2,128 patients who had been randomised to either endovascular coiling or neurosurgical clipping. In this population 153 patients (7.2%) died within 60 days. World Federation of Neurosurgical Societies (WFNS) grade was the most important predictor of case-fatality, followed by age, lumen size of the aneurysm and Fisher grade. The model discriminated reasonably between those who died within 60 days and those who survived (c statistic = 0.73), with minor optimism according to bootstrap re-sampling (optimism corrected c statistic = 0.70). Several strong predictors are available to predict 60 day case-fatality in aSAH patients who survived the early stage up till a treatment decision; after external validation these predictors could eventually be used in clinical decision making.",2010,"The model discriminated reasonably between those who died within 60 days and those who survived (c statistic = 0.73), with minor optimism according to bootstrap re-sampling (optimism corrected c statistic = 0.70).","['60 day case-fatality after aneurysmal subarachnoid haemorrhage', 'patients enrolled in the International Subarachnoid Aneurysm Trial (ISAT', '2,128 patients who had been randomised to either', 'in aSAH patients']","['coiling with clipping', 'endovascular coiling or neurosurgical clipping']",['Aneurysmal subarachnoid haemorrhage (aSAH'],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439651', 'cui_str': 'Aneurysmal (qualifier value)'}, {'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0185010', 'cui_str': 'Clipping'}]","[{'cui': 'C0439651', 'cui_str': 'Aneurysmal (qualifier value)'}, {'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}]",153.0,0.111288,"The model discriminated reasonably between those who died within 60 days and those who survived (c statistic = 0.73), with minor optimism according to bootstrap re-sampling (optimism corrected c statistic = 0.70).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Risselada', 'Affiliation': 'Department of Medical Informatics, Erasmus MC, Room Ee 2159, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands. r.risselada@erasmusmc.nl'}, {'ForeName': 'H F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bauer-Mehren', 'Affiliation': ''}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Friedrich', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Molyneux', 'Affiliation': ''}, {'ForeName': 'R S C', 'Initials': 'RS', 'LastName': 'Kerr', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yarnold', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sneade', 'Affiliation': ''}, {'ForeName': 'E W', 'Initials': 'EW', 'LastName': 'Steyerberg', 'Affiliation': ''}, {'ForeName': 'M C J M', 'Initials': 'MC', 'LastName': 'Sturkenboom', 'Affiliation': ''}]",European journal of epidemiology,['10.1007/s10654-010-9432-x']
129,21603893,Ketamine perturbs perception of the flow of time in healthy volunteers.,"RATIONALE


Disturbances in the subjective experience of time have been observed both in schizophrenia and following acute administration of ketamine. However, effects of ketamine on more objective timing tasks have not yet been measured in humans, nor has it been established that timing effects are not merely secondary to a more general dysfunction in working memory (WM).
OBJECTIVE AND METHODS


In a double-blind placebo-controlled crossover study, we characterised the effects of ketamine (100 ng/ml blood plasma level) on performance of perceptual timing and colour discrimination tasks, which were matched for WM and attentional demands. To test the ubiquity of ketamine's effects on timing, we also examined two distinct measures of temporal predictability.
RESULTS


Ketamine significantly distorted the subjective experience of time as measured by the Clinician-Administered Dissociative States Scales. Critically, ketamine also impaired accuracy on the perceptual timing task while having no effect on performance of the colour perception task. Although ketamine did not impair the ability to use prelearned temporal (or spatial) cues to predict target onset (or location), it did slow reaction times at long delays following non-informative neutral cues, suggesting an impaired ability to use the unidirectional flow of time itself to make temporal predictions.
CONCLUSIONS


Ketamine induced selective impairments in timing, which could not be explained by more fundamental effects on the ability to hold information in WM. Rather our collected findings suggest that ketamine may disturb timing by selectively impairing the way in which information is temporally manipulated within WM.",2011,"CONCLUSIONS


Ketamine induced selective impairments in timing, which could not be explained by more fundamental effects on the ability to hold information in WM.",['healthy volunteers'],"['ketamine', 'Ketamine', 'placebo']","['subjective experience of time as measured by the Clinician-Administered Dissociative States Scales', 'performance of the colour perception task']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0851878', 'cui_str': 'Dissociative states'}, {'cui': 'C0222045'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0691569,"CONCLUSIONS


Ketamine induced selective impairments in timing, which could not be explained by more fundamental effects on the ability to hold information in WM.","[{'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Coull', 'Affiliation': 'Laboratoire de Neurobiologie de la Cognition, Université de Provence & CNRS, Pôle 3C, 3 Place Victor Hugo, 13331 Marseille Cedex 3, France. jennifer.coull@univ-provence.fr'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Morgan', 'Affiliation': ''}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Cambridge', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giorlando', 'Affiliation': ''}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Adapa', 'Affiliation': ''}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Corlett', 'Affiliation': ''}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Fletcher', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2346-9']
130,27747762,Apremilast: A Phosphodiesterase 4 Inhibitor for the Treatment of Psoriatic Arthritis.,"INTRODUCTION


Psoriatic arthritis (PsA) is a spondyloarthritis that occurs in up to 30% of psoriasis patients. Patients with PsA are at risk for decreased quality of life due to both joint and skin symptoms, impaired physical function and disease progression. Treatments include non-steroidal anti-inflammatory drugs, conventional systemic disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, and biologic agents, including tumor necrosis factor-α inhibitors. The most recently introduced treatment option is apremilast, an oral phosphodiesterase 4 inhibitor.
METHODS


This review provides an in-depth discussion of apremilast's mechanism of action, and evidence of its clinical efficacy and safety from the Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) phase III pivotal clinical trials (PALACE 1, 2, and 3).
RESULTS


These trials demonstrate that apremilast is effective for the treatment of active PsA, despite prior conventional DMARDs or biologic treatment. The primary efficacy end point, a 20% improvement from baseline in modified American College of Rheumatology response criteria at Week 16, was achieved by significantly greater proportions of patients treated with apremilast 20 mg twice daily (BID) and apremilast 30 mg BID versus placebo in PALACE 1, 2, and 3. Improvements in this and other clinical and patient-reported end points, including swollen and tender joint counts, Psoriasis Area and Severity Index score, physical function, and quality of life, were maintained, extending over 52 weeks of treatment among patients initially randomized to apremilast. Apremilast's safety profile has been acceptable, with diarrhea and nausea being the most common adverse events, with no evidence for an increased risk of infection or need for laboratory monitoring. The PALACE pivotal data indicate that apremilast presents a new option for the treatment of PsA that may be appropriate for use early in the treatment ladder. Ongoing PALACE open-label extension trials of up to 4 years will characterize the long-term clinical effects and safety of apremilast therapy.
FUNDING


Celgene Corporation, Summit, NJ, USA.",2014,"Improvements in this and other clinical and patient-reported end points, including swollen and tender joint counts, Psoriasis Area and Severity Index score, physical function, and quality of life, were maintained, extending over 52 weeks of treatment among patients initially randomized to apremilast.",['Psoriatic Arthritis'],"['Phosphodiesterase 4 Inhibitor', 'placebo']","['modified American College of Rheumatology response criteria', 'swollen and tender joint counts, Psoriasis Area and Severity Index score, physical function, and quality of life', 'quality of life due to both joint and skin symptoms, impaired physical function and disease progression']","[{'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}]","[{'cui': 'C2936609', 'cui_str': 'Phosphodiesterase Type 4 Inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0586407', 'cui_str': 'Skin symptom'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",,0.0438973,"Improvements in this and other clinical and patient-reported end points, including swollen and tender joint counts, Psoriasis Area and Severity Index score, physical function, and quality of life, were maintained, extending over 52 weeks of treatment among patients initially randomized to apremilast.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center and University of Washington School of Medicine, 601 Broadway, Suite 600, Seattle, WA, 98122, USA. pmease@philipmease.com.'}]",Rheumatology and therapy,[]
131,31580931,Effects of stress-induced inflammation on reward processing in healthy young women.,"BACKGROUND


Anhedonia, or loss of interest or pleasure, is a feature of depression and transdiagnostic construct in psychopathology. Theory and compelling evidence from preclinical models implicates stress-induced inflammation as a psychobiological pathway to anhedonic behavior; however, this pathway has not been tested in human models. Further, although anhedonia may reflect dysregulation in multiple dimensions of reward, the extent to which stress-induced inflammation alters these dimensions is unclear. Thus, the current experimental study used a standardized laboratory stressor task to elicit an inflammatory response and evaluate effects of stress-induced inflammation on multiple behavioral indices of reward processing.
METHODS


Healthy young women (age 18-25) completed behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control (n = 17). Tasks were re-administered 90-120 min post-stress to coincide with the peak of the stress-induced inflammatory response. Blood samples were collected for assessment of the pro-inflammatory cytokine interleukin-6 (IL-6) at baseline and 90 and 120 min post stressor.
RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low. Sensitivity to reward in the context of a motivation task was not altered in association with stress-induced IL-6.
CONCLUSIONS


Contrary to hypotheses, mild increases in IL-6 following acute stress were associated with increased reward responsiveness during reward learning and selective increases in motivation. Results contribute to an emerging and nuanced literature linking inflammation to reward processing, and demonstrate that behavioral effects of stress-induced inflammation may be detected in the laboratory setting.
CLINICAL TRIAL REGISTRATION


NCT03828604.",2020,"RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","['Healthy Young Women', 'Healthy young women (age 18-25) completed']","['Stress-Induced Inflammation', 'behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control']",['reward responsiveness during reward learning and selective increases in motivation'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0614676,"RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","[{'ForeName': 'Chloe C', 'Initials': 'CC', 'LastName': 'Boyle', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States. Electronic address: ccboyle@ucla.edu.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Stanton', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Teresa E', 'Initials': 'TE', 'LastName': 'Seeman', 'Affiliation': 'Geffen School of Medicine, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Julienne E', 'Initials': 'JE', 'LastName': 'Bower', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.09.023']
132,27747497,The Tissue-Selective Estrogen Complex: A Review of Current Evidence.,"The tissue-selective estrogen complex (TSEC) has recently entered the market for the treatment of postmenopausal osteoporosis, and is particularly targeted to women with significant vasomotor symptoms. This review appraises the evidence behind the only approved TSEC to-date, a combination of bazedoxifene and conjugated estrogens, with regards to its efficacy and relevant safety concerns. The majority of evidence that has led to its approval is derived from the SMART study. This large phase III trial with several substudies was aimed at discerning the effects of the TSEC on various estrogen-responsive tissues in comparison to raloxifene and placebo. Overall, the evidence thus far suggests a superior improvement in lumbar bone mineral density of 1.01% ± 0.28% as well as decrease in the frequency of hot flushes. Regarding safety concerns, endometrial thickness did not change over the treatment course, and investigators also identified a modest reduction in breast density. While there was no difference in rates of venous thromboembolism between treatment and placebo groups in a 2-year follow-up period, the effects of the drug on coagulation profiles are similar to those seen with hormone replacement therapy. Thus, the drug's effects on venous thromboembolism risk over a longer treatment course remain unclear. In conclusion, the actual efficacy of the TSEC for postmenopausal osteoporosis remains as yet undefined, given the lack of fracture prevention data. The evidence thus far does seem to suggest a beneficial effect on vasomotor symptoms and a generally favorable side effect profile. However, it should be noted that only one study has addressed this question thus far, and so the repeatability of the findings is still in question.",2015,"While there was no difference in rates of venous thromboembolism between treatment and placebo groups in a 2-year follow-up period, the effects of the drug on coagulation profiles are similar to those seen with hormone replacement therapy.",[],"['placebo', 'TSEC', 'raloxifene and placebo', 'bazedoxifene']","['rates of venous thromboembolism', 'vasomotor symptoms', 'frequency of hot flushes', 'venous thromboembolism risk', 'coagulation profiles', 'lumbar bone mineral density']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C2346970', 'cui_str': 'bazedoxifene'}]","[{'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",,0.0361578,"While there was no difference in rates of venous thromboembolism between treatment and placebo groups in a 2-year follow-up period, the effects of the drug on coagulation profiles are similar to those seen with hormone replacement therapy.","[{'ForeName': 'Rinu', 'Initials': 'R', 'LastName': 'Pazhekattu', 'Affiliation': 'PGY1 Internal Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Arthur N', 'Initials': 'AN', 'LastName': 'Lau', 'Affiliation': 'Division of Rheumatology, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Adachi', 'Affiliation': 'Division of Rheumatology, Department of Medicine, McMaster University, Hamilton, ON, Canada. jd.adachi@sympatico.ca.'}]",Rheumatology and therapy,[]
133,27747530,Pharmacokinetics and Bioequivalence Study of Hydroxychloroquine Sulfate Tablets in Chinese Healthy Volunteers by LC-MS/MS.,"INTRODUCTION


Hydroxychloroquine (HCQ), 4-aminoquinoline, is an antimalarial drug and has become a basic therapy for rheumatic disease treatment. It can stabilize the condition of SLE patients and reduce the chances of patient relapse through its immunosuppressive function and antiinflammatory effects. This drug was absorbed completely and rapidly by oral administration, but has a prolonged half-life for elimination. The objective of this study was to evaluate the pharmacokinetic parameters and relative bioequivalence of a new generic (test) formulation with the branded (reference) formulation of HCQ in healthy Chinese male volunteers. This study was designed to acquire regulatory approval for the test formulation.
METHODS


This study was conducted with a randomized, single-dose, two-period, and crossover design. The male subjects were randomly assigned to two groups at a 1:1 ratio to receive 0.2 g hydroxychloroquine sulfate tablets (0.1 g/piece) of the two formulations after a 3-month washout period then administered the alternate formulation. Study drugs were administered after overnight fasting (over 10 h). Plasma concentrations of hydroxychloroquine were measured by a validated LC-MS/MS method. The following pharmacokinetic properties were determined by a noncompartmental pharmacokinetic method: C  max , T  max , AUC 0-t  , AUC 0-∝ , and t  1/2 . The bioequivalence between the test and reference products was assessed based on the following parameters: C  max , AUC0-60d, and AUC 0-∝  using the ANOVA method. If the 90% CI for AUC 0-t  was within 80-125% and for C  max  was within 70-143% of the statistical interval proposed by the SFDA, the two formulations were assumed bioequivalent. Concerning the main pharmacokinetic charateristics of hydroxychloroquine, a long half-life drug, the pharmacokinetic parameters of 0-72 h were determined according to the FDA. Furthermore, a comparison was made between the parameters at 0-60 days and 0-72 h to evaluate whether a truncated AUC method can be applied to estimate the relative bioavailability of HCQ. Tolerability was assessed by monitoring vital signs and laboratory tests and by questioning subjects about adverse events.
RESULTS


The 90% CI of C  max  for HCQ is 103.8-142.3%; the AUC0-60 is 100-114.2% and AUC 0-∝  100-115.5%. Both met the criteria according to the SFDA's guidelines for bioequivalence. The relative bioavailability was 109.5% (according to AUC 0-60d ) and 110.7% (according to AUC 0-∝ ). No serious or unexpected adverse events were observed.
CONCLUSIONS


In this study, the pharmacokinetic studies and results were conducted so that the test and reference formulations of HCQ met the Chinese criteria for assuming bioequivalence. Both formulations were well tolerated in the population studies.",2015,"No serious or unexpected adverse events were observed.
","['male subjects', 'healthy Chinese male volunteers', 'Chinese Healthy Volunteers by LC-MS/MS']","['Hydroxychloroquine (HCQ), 4-aminoquinoline', 'hydroxychloroquine', 'Hydroxychloroquine Sulfate Tablets', 'hydroxychloroquine sulfate tablets', 'new generic (test) formulation with the branded (reference) formulation of HCQ']","['Tolerability', 'Plasma concentrations of hydroxychloroquine', 'relative bioavailability', 'adverse events', 'noncompartmental pharmacokinetic method: C  max , T  max , AUC 0-t  , AUC 0-∝ , and t  1/2 ']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0048060', 'cui_str': '4-aminoquinoline'}, {'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine Sulfate'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0580272', 'cui_str': '1/2'}]",,0.0358069,"No serious or unexpected adverse events were observed.
","[{'ForeName': 'Hong-Wei', 'Initials': 'HW', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Pharmacology Laboratory, Nanjing First Hospital, Nanjing Medical University, 210006, Nanjing, Jiang Su, China. fanhongwei178@sina.com.'}, {'ForeName': 'Zhi-Xiang', 'Initials': 'ZX', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Pharmacology Laboratory, Nanjing First Hospital, Nanjing Medical University, 210006, Nanjing, Jiang Su, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'XenoBiotic Laboratories China, 210038, Nanjing, China.'}, {'ForeName': 'Xing-Ye', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'XenoBiotic Laboratories China, 210038, Nanjing, China.'}, {'ForeName': 'Jun-Lin', 'Initials': 'JL', 'LastName': 'Cheng', 'Affiliation': 'Department of Clinical Pharmacology Laboratory, Nanjing First Hospital, Nanjing Medical University, 210006, Nanjing, Jiang Su, China.'}, {'ForeName': 'Ying-Bin', 'Initials': 'YB', 'LastName': 'Li', 'Affiliation': 'The 2nd Affliated Hospital of Nanjing Medical University, 210011, Nanjing, China. Yingbinli65@sina.com.'}]",Rheumatology and therapy,[]
134,18443762,Stepwise screening for diabetes identifies people with high but modifiable coronary heart disease risk. The ADDITION study.,"AIMS/HYPOTHESIS


The Anglo-Danish-Dutch study of intensive treatment in people with screen-detected diabetes in primary care (ADDITION) is a pragmatic randomised controlled trial of the effectiveness of intensified multi-factorial treatment on 5 year cardiovascular morbidity and mortality rates in people with screen-detected type 2 diabetes in the Netherlands, UK and Denmark. This paper describes the baseline characteristics of the study population, their estimated risk of coronary heart disease and the extent to which that risk is potentially modifiable.
METHODS


Stepwise screening strategies were performed using risk questionnaires and routine general practice data plus random blood glucose, HbA(1c) and fasting blood glucose measurement. Diabetes was diagnosed using the 1999 World Health Organization criteria and estimated 10 year coronary heart disease risk was calculated using the UK Prospective Diabetes Study risk engine.
RESULTS


Between April 2001 and December 2006, 3,057 people with screen-detected diabetes were recruited to the study (mean age 59.7 years, 58% men) after a stepwise screening programme involving 76,308 people screened in 334 general practices in three countries. Their median estimated 10 year risk of coronary heart disease was 11% in women (interquartile range 7-16%) and 21% (15-30%) in men. There were differences in the distribution of risk factors by country, linked to differences in approaches to screening and the extent to which risk factors had already been detected and treated. The mean HbA(1c) at recruitment was 7.0% (SD 1.6%). Of the people recruited, 73% had a blood pressure > or =140/90 and of these 58% were not on antihypertensive medication. Cholesterol levels were above 5.0 mmol/l in 70% of participants, 91% of whom were not being treated with lipid-lowering drugs.
CONCLUSIONS/INTERPRETATION


People with type 2 diabetes detected by screening and included in the ADDITION study have a raised and potentially modifiable risk of CHD. ClinicalTrials.gov ID no.: NCT 00237549.",2008,Their median estimated 10 year risk of coronary heart disease was 11% in women (interquartile range 7-16%) and 21% (15-30%) in men.,"['diabetes identifies people with high but modifiable coronary heart disease risk', 'people with screen-detected diabetes in primary care', 'Of the people recruited, 73% had a blood pressure > or =140/90 and of these 58% were not on antihypertensive medication', 'people with screen-detected type 2 diabetes in the Netherlands, UK and Denmark', 'Diabetes was diagnosed using the 1999 World Health Organization criteria and estimated 10 year coronary heart disease risk was calculated using the UK Prospective Diabetes Study risk engine', 'Between April 2001 and December 2006, 3,057 people with screen-detected diabetes were recruited to the study (mean age 59.7 years, 58% men) after a stepwise screening programme involving 76,308 people screened in 334 general practices in three countries']",['intensified multi-factorial treatment'],"['mean HbA(1c', 'cardiovascular morbidity and mortality rates', 'Cholesterol levels', 'coronary heart disease']","[{'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]",3057.0,0.12952,Their median estimated 10 year risk of coronary heart disease was 11% in women (interquartile range 7-16%) and 21% (15-30%) in men.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sandbaek', 'Affiliation': 'Department of General Practice, Institute of Public Health, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rutten', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stolk', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Borch-Johnsen', 'Affiliation': ''}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lauritzen', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-008-1013-0']
135,31575336,Different preprocessing strategies lead to different conclusions: A [ 11 C]DASB-PET reproducibility study.,"Positron emission tomography (PET) neuroimaging provides unique possibilities to study biological processes in vivo under basal and interventional conditions. For quantification of PET data, researchers commonly apply different arrays of sequential data analytic methods (""preprocessing pipeline""), but it is often unknown how the choice of preprocessing affects the final outcome. Here, we use an available data set from a double-blind, randomized, placebo-controlled [ 11 C]DASB-PET study as a case to evaluate how the choice of preprocessing affects the outcome of the study. We tested the impact of 384 commonly used preprocessing strategies on a previously reported positive association between the change from baseline in neocortical serotonin transporter binding determined with [ 11 C]DASB-PET, and change in depressive symptoms, following a pharmacological sex hormone manipulation intervention in 30 women. The two preprocessing steps that were most critical for the outcome were motion correction and kinetic modeling of the dynamic PET data. We found that 36% of the applied preprocessing strategies replicated the originally reported finding ( p  < 0.05). For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction. In conclusion, the choice of preprocessing strategy can have a major impact on a study outcome.",2020,"For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction.",['30 women'],"['placebo', 'Positron emission tomography (PET', 'pharmacological sex hormone manipulation intervention']","['replication percentage', 'motion correction and kinetic modeling of the dynamic PET data']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]",384.0,0.255819,"For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Nørgaard', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Ganz', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Svarer', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Vibe G', 'Initials': 'VG', 'LastName': 'Frokjaer', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Douglas N', 'Initials': 'DN', 'LastName': 'Greve', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Strother', 'Affiliation': 'Rotman Research Institute, Baycrest, Department of Medical Biophysics, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Gitte M', 'Initials': 'GM', 'LastName': 'Knudsen', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X19880450']
136,28124259,Reducing the prevalence of dysglycemia: is the time ripe to test the effectiveness of intervention in high-risk individuals with elevated 1 h post-load glucose levels?,"Identifying the earliest time point on the prediabetic continuum is critical to avoid progressive deterioration in β-cell function. Progressively rising glucose levels even within the ""normal range"" occur considerably late in the evolution to diabetes thus presenting an important opportunity for earlier diagnosis, treatment, and possible reversal. An elevated 1 h postprandial glucose level, not detected by current diagnostic standards, may provide an opportunity for the early identification of those at risk. When the 1 h post-load glucose level is elevated, lifestyle intervention may have the greatest benefit for preserving β-cell function and prevent further progression to prediabetes and diabetes. In view of the considerable consistent epidemiologic data in large disparate populations supporting the predictive capacity of the1 h post-load value for predicting progression to diabetes and mortality, the time is therefore ripe to evaluate this hypothesis in a large, prospective multicenter randomized trial with lifestyle intervention.",2017,"An elevated 1 h postprandial glucose level, not detected by current diagnostic standards, may provide an opportunity for the early identification of those at risk.",[],[],"['prevalence of dysglycemia', 'elevated 1\u2009h postprandial glucose level']",[],[],"[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",,0.0170243,"An elevated 1 h postprandial glucose level, not detected by current diagnostic standards, may provide an opportunity for the early identification of those at risk.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bergman', 'Affiliation': 'NYU School of Medicine, Department of Medicine, Division of Endocrinology and Metabolism, NYU Langone Diabetes Prevention Program, New York, NY, 10016, USA. michael.bergman@nyumc.org.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Jagannathan', 'Affiliation': 'NYU School of Medicine, Department of Population Health, Division of Health Behavior Change, New York, NY, 10016, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Buysschaert', 'Affiliation': 'Department of Endocrinology and Diabetology, Université Catholique de Louvain, University Clinic Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Medina', 'Affiliation': 'Oporto Medical School, Oporto University, Oporto, Portugal.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'NYU School of Medicine, Department of Population Health, Division of Health Behavior Change, New York, NY, 10016, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Katz', 'Affiliation': 'NYU School of Medicine, Department of Medicine, Division of Endocrinology and Metabolism, NYU Langone Diabetes Prevention Program, New York, NY, 10016, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Dorcely', 'Affiliation': 'NYU School of Medicine, Department of Medicine, Division of Endocrinology and Metabolism, NYU Langone Diabetes Prevention Program, New York, NY, 10016, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Roth', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, North Shore, New York, 11030, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Chetrit', 'Affiliation': 'Unit for Cardiovascular Epidemiology, The Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Tel Hashomer, 52621, Israel.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dankner', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, North Shore, New York, 11030, USA.'}]",Endocrine,['10.1007/s12020-017-1236-2']
137,32414547,Efficacy of botulinum toxin for treating a gummy smile.,"INTRODUCTION


This study was conducted to investigate the efficacy of botulinum toxin applied to the different muscles of patients who have excessive gingival display and to evaluate the return to baseline gingival exposure value.
METHODS


Twenty-eight patients who had a gummy smile of more than 2 mm were randomly divided into 2 groups. Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2. Photographs were taken, and measurements were taken before injection and at 3 days, 15 days, 1 month, 4 months, 5 months, and 6 months after injection. The visual analogue scale was used to assess the level of satisfaction.
RESULTS


The average amount of visible gingiva in group 1 was 4.92 mm at the beginning of the treatment and 1.92 mm on the 15th day. In group 2, the average amount of visible gingiva was 4.58 mm at the beginning of treatment and 2.16 mm on the 15th day. In both treatment groups, it was determined that the measurements on the sixth month did not return to their initial values. The decrease in gingival appearances in group 1 was greater than in group 2. There was no significant difference between the groups in terms of return to baseline gingival exposure value. In both groups, it was seen that the increase in satisfaction in patients was high.
CONCLUSIONS


For gummy smile correction, botulinum toxin injection is thought to be an alternative method because it is effective and conservative and has high patient satisfaction.",2020,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"['patients who have excessive gingival display and to evaluate the return to baseline gingival exposure value', 'Twenty-eight patients who had a gummy smile of more than 2\xa0mm']","['botulinum toxin', 'Botulinum toxin', 'botulinum toxin injection']","['visual analogue scale', 'satisfaction', 'average amount of visible gingiva', 'gingival appearances', 'return to baseline gingival exposure value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C3696916', 'cui_str': 'Gummy smile'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0146754,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"[{'ForeName': 'Ahmet Fatih', 'Initials': 'AF', 'LastName': 'Cengiz', 'Affiliation': 'Private Practice, Mersin, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Goymen', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Gaziantep University, Gaziantep, Turkey. Electronic address: mervegoymen@gmail.com.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Akcali', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Gaziantep University, Gaziantep, Turkey.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.014']
138,32416780,"Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial.","BACKGROUND


Atezolizumab can induce sustained responses in metastatic urothelial carcinoma. We report the results of IMvigor130, a phase 3 trial that compared atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in first-line metastatic urothelial carcinoma.
METHODS


In this multicentre, phase 3, randomised trial, untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries, were randomly assigned to receive atezolizumab plus platinum-based chemotherapy (group A), atezolizumab monotherapy (group B), or placebo plus platinum-based chemotherapy (group C). Patients received 21-day cycles of gemcitabine (1000 mg/m 2  body surface area, administered intravenously on days 1 and 8 of each cycle), plus either carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin (70 mg/m 2  body surface area administered intravenously) on day 1 of each cycle with either atezolizumab (1200 mg administered intravenously on day 1 of each cycle) or placebo. Group B patients received 1200 mg atezolizumab, administered intravenously on day 1 of each 21-day cycle. The co-primary efficacy endpoints for the intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival (group A vs group C) and overall survival (group B vs group C), which was to be formally tested only if overall survival was positive for group A versus group C. The trial is registered with ClinicalTrials.gov, NCT02807636.
FINDINGS


Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients. 451 (37%) were randomly assigned to group A, 362 (30%) to group B, and 400 (33%) to group C. Median follow-up for survival was 11·8 months (IQR 6·1-17·2) for all patients. At the time of final progression-free survival analysis and interim overall survival analysis (May 31, 2019), median progression-free survival in the intention-to-treat population was 8·2 months (95% CI 6·5-8·3) in group A and 6·3 months (6·2-7·0) in group C (stratified hazard ratio [HR] 0·82, 95% CI 0·70-0·96; one-sided p=0·007). Median overall survival was 16·0 months (13·9-18·9) in group A and 13·4 months (12·0-15·2) in group C (0·83, 0·69-1·00; one-sided p=0·027). Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24). Adverse events that led to withdrawal of any agent occurred in 156 (34%) patients in group A, 22 (6%) patients in group B, and 132 (34%) patients in group C. 50 (11%) patients in group A, 21 (6%) patients in group B, and 27 (7%) patients in group C had adverse events that led to discontinuation of atezolizumab or placebo.
INTERPRETATION


Addition of atezolizumab to platinum-based chemotherapy as first-line treatment prolonged progression-free survival in patients with metastatic urothelial carcinoma. The safety profile of the combination was consistent with that observed with the individual agents. These results support the use of atezolizumab plus platinum-based chemotherapy as a potential first-line treatment option for metastatic urothelial carcinoma.
FUNDING


F Hoffmann-La Roche and Genentech.",2020,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","['0·82', 'patients with metastatic urothelial carcinoma', 'Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients', 'metastatic urothelial cancer (IMvigor130', 'first-line metastatic urothelial carcinoma', 'untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries', 'metastatic urothelial carcinoma']","['atezolizumab to platinum-based chemotherapy', 'carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin', 'Atezolizumab', 'atezolizumab', 'atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy', 'IMvigor130', 'atezolizumab plus platinum-based chemotherapy', 'gemcitabine', 'placebo plus platinum-based chemotherapy', 'Atezolizumab with or without chemotherapy', 'atezolizumab monotherapy', 'placebo']","['Median overall survival', 'median progression-free survival', 'Adverse events', 'overall survival', 'time of final progression-free survival analysis and interim overall survival analysis', 'intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517491', 'cui_str': '1.1'}]",1213.0,0.469836,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY, USA. Electronic address: matthew.galsky@mssm.edu.'}, {'ForeName': 'José Ángel Arranz', 'Initials': 'JÁA', 'LastName': 'Arija', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Eastern Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'De Santis', 'Affiliation': 'Charité University Hospital, Berlin, Germany; Department of Urology, Medical University, Vienna, Austria.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kikuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Garcia-Del-Muro', 'Affiliation': 'Catalan Institute of Oncology, IDIBELL, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mencinger', 'Affiliation': 'Institute of Oncology Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Panni', 'Affiliation': 'Istituti Ospitalieri Cremona, Cremona, Italy.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gumus', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Arash Rezazadeh', 'Initials': 'AR', 'LastName': 'Kalebasty', 'Affiliation': 'Norton Cancer Institute, Louisville, KY, USA.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'P Herzen Oncology Research Institute, Moscow, Russia.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Schutz', 'Affiliation': 'Beneficencia Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jian-Ri', 'Initials': 'JR', 'LastName': 'Li', 'Affiliation': 'Taichung Veterans General Hospital, HungKuang University, Taichung, Taiwan.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Bernhard', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Tayama', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Mecke', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'AnnChristine', 'Initials': 'A', 'LastName': 'Thåström', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'MD Anderson Cancer Center Madrid, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30230-0']
139,21695470,Creative mood swings: divergent and convergent thinking affect mood in opposite ways.,"Increasing evidence suggests that emotions affect cognitive processes. Recent approaches have also considered the opposite: that cognitive processes might affect people's mood. Here we show that performing and, to a lesser degree, preparing for a creative thinking task induce systematic mood swings: Divergent thinking led to a more positive mood, whereas convergent thinking had the opposite effect. This pattern suggests that thought processes and mood are systematically related but the type of relationship is process-specific.",2012,"Here we show that performing and, to a lesser degree, preparing for a creative thinking task induce systematic mood swings: Divergent thinking led to a more positive mood, whereas convergent thinking had the opposite effect.",[],[],[],[],[],[],,0.0701341,"Here we show that performing and, to a lesser degree, preparing for a creative thinking task induce systematic mood swings: Divergent thinking led to a more positive mood, whereas convergent thinking had the opposite effect.","[{'ForeName': 'Soghra', 'Initials': 'S', 'LastName': 'Akbari Chermahini', 'Affiliation': 'Cognitive Psychology Unit and Leiden Institute for Brain and Cognition, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Hommel', 'Affiliation': ''}]",Psychological research,['10.1007/s00426-011-0358-z']
140,31849035,Efficacy and safety of oral hyoscine used for outpatient cervical ripening among primiparous women with term pregnancy.,"OBJECTIVE


To assess the efficacy and safety of outpatient administration of oral hyoscine for cervical ripening.
METHODS


In a randomized controlled trial at a university hospital in Tehran between September 2017 and December 2018, 100 primiparous women with singleton pregnancy at 38 0  -40 0  gestational weeks and Bishop score of 5 or less were randomized to either routine expectant management (control group) or 10 mg of oral hyoscine twice daily for 1 week, followed by once daily for 1 week (hyoscine group).
RESULTS


Mean ± SD Bishop score in the hyoscine and control groups was, respectively, 1.19 ± 1.38 and 1.08 ± 1.70 at baseline, and 4.56 ± 2.87 and 2.76 ± 2.14 on admission for delivery (P=0.001). Duration of the first stage was 4.10 ± 5.49 hours in the hyoscine and 5.29 ± 6.48 hours in the control group (P=0.03). Duration of the second and third stages was, respectively, 0.52 ± 0.53 and 0.14 ± 0.25 hours in the hyoscine, and 0.59 ± 1.08 and 0.12 ± 0.15 hours in the control group. No adverse effects were reported.
CONCLUSION


Administration of oral hyoscine in an outpatient setting was found to ripen the cervix with no clinically significant adverse drug reaction. IRANIAN REGISTRY OF CLINICAL TRIALS (IRCT20180819040830N1).",2020,"No adverse effects were reported.
","['primiparous women with term pregnancy', 'university hospital in Tehran between September 2017 and December 2018, 100 primiparous women with singleton pregnancy at 38 0  -40 0  gestational weeks and Bishop score of 5 or less']","['oral hyoscine', 'routine expectant management (control group) or 10\xa0mg of oral hyoscine', 'hyoscine']","['Efficacy and safety', 'adverse effects', 'Mean\xa0±', 'efficacy and safety', 'SD Bishop score']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy (finding)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2585455', 'cui_str': 'Expectant management (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}]",,0.106776,"No adverse effects were reported.
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Naeiji', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Naghshvarian', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Mirzamoradi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sotudeh', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Moridi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13089']
141,23483830,Allium sativum  L.: the anti-immature leech ( Limnatis nilotica ) activity compared to Niclosomide.,"This study was carried out to determine the effects of methanolic extracts of  Allium sativum  L. on  Limnatis nilotica  compared with Niclosomide. In this experimental study in September 2010, a number of leeches (70 in total) from the southern area of Ilam province were prepared, and the effects of methanolic extract of  A. sativum  L. with Niclosomide as the control drug were compared and distilled water was evaluated as the placebo group which investigated  L. nilotica  using anti-leech assay. The average time of paralysis and death of  L. nilotica  for Niclosomide (1,250 mg/kg) and the methanol extract of  A. sativum  L. (600 μg/ml) were 6.22 ± 2.94 and 68.44 ± 28.39 min, respectively. Distilled water and garlic tablets at a dose of 400 mg were determined as the inert group. In this research, the attraction time of the leeches' death among different treatments is significant. In this study, it was determined that Niclosomide, with an intensity of 4+, and methanolic extracts of  A. sativum  L., with an intensity of 3+, have a good anti-leech effect and can be shown to be effective in cases of leech biting, while distilled water was negative.",2013,"The average time of paralysis and death of  L. nilotica  for Niclosomide (1,250 mg/kg) and the methanol extract of  A. sativum  L. (600 μg/ml) were 6.22 ± 2.94 and 68.44 ± 28.39 min, respectively.","['September 2010, a number of leeches (70 in total) from the southern area of Ilam province']","['Distilled water and garlic tablets', 'methanolic extract of  A. sativum  L. with Niclosomide', 'placebo', 'Niclosomide']",['average time of paralysis and death of  L. nilotica'],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0579183', 'cui_str': 'Hirudo (organism)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0318619,"The average time of paralysis and death of  L. nilotica  for Niclosomide (1,250 mg/kg) and the methanol extract of  A. sativum  L. (600 μg/ml) were 6.22 ± 2.94 and 68.44 ± 28.39 min, respectively.","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Bahmani', 'Affiliation': 'Young Researchers Club, Shahrekord Branch, Islamic Azad University, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Abbasi', 'Affiliation': ''}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Mohsenzadegan', 'Affiliation': ''}, {'ForeName': 'Sirous', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': ''}, {'ForeName': 'Majid Gholami', 'Initials': 'MG', 'LastName': 'Ahangaran', 'Affiliation': ''}]",Comparative clinical pathology,[]
142,25252602,Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer: results of the first prospective randomized phase II trial.,"BACKGROUND


In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging.
PATIENTS AND METHODS


Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS).
RESULTS


The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48% (A) and 52% (B, P = 0.81) and (y)pN0 was 30% (A) vs. 39% (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79).
CONCLUSION


This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543.",2015,"The R0 resection rate was 48% (A) and 52% (B, P = 0.81) and (y)pN0 was 30% (A) vs. 39% (B, P = 0.44), respectively.","['Patients with resectable adenocarcinoma of the pancreatic head', 'resectable pancreatic cancer', '254 patients', '73 patients; 66 patients were eligible for analysis', 'patients with pancreatic cancer']","['Radiotherapy', 'Chemotherapy', 'neoadjuvant chemoradiation', 'chemoradiotherapy', 'neoadjuvant chemoradiotherapy', 'Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery']","['toxicity', 'median overall survival (mOS', 'Postoperative complications', 'toxicity, perioperative morbidity, and mortality', 'survival', 'Tumor resection', 'R0 resection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]",254.0,0.0813101,"The R0 resection rate was 48% (A) and 52% (B, P = 0.81) and (y)pN0 was 30% (A) vs. 39% (B, P = 0.44), respectively.","[{'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Golcher', 'Affiliation': 'Department of Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany, henriette.golcher@uk-erlangen.de.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Brunner', 'Affiliation': ''}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Witzigmann', 'Affiliation': ''}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Marti', 'Affiliation': ''}, {'ForeName': 'Wolf-Otto', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': ''}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Bruns', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Jungnickel', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'Gerhard G', 'Initials': 'GG', 'LastName': 'Grabenbauer', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Merkel', 'Affiliation': ''}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': ''}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': ''}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-014-0737-7']
143,23772172,A Brief Parenting Intervention to Enhance the Parent-Child Relationship in Hong Kong: Harmony@Home.,"There is a dearth of high-level evidence for brief programs designed to promote positive parent-child relationships in nonwestern cultures. We present a pilot randomized controlled trial of a four-session intervention to enhance the parenting skills that promote a positive relationship with pre-adolescent children in Hong Kong. Our intervention, Harmony@Home, utilized Cunningham's culturally appropriate coping modeling, problem-solving approach to change parental behavior. Our objective was to evaluate the feasibility, acceptability and initial evidence of benefit of the intervention. We blindly randomized 150 Hong Kong parents of children 10-13 years of age to (a) a Harmony@Home intervention group, (b) a waitlist control group, or (c) a third active intervention which shared the control group. Immediately following the intervention, we report increases in satisfaction with the parent-child relationship, one of the targeted parenting behaviors and family harmony, for the Harmony@Home group versus control group. However, only the results from satisfaction with the parent-child relationship were significant at 3-months post intervention. Most respondents reported high levels of program satisfaction. The results provide preliminary evidence that this parenting intervention is culturally acceptable for a nonwestern general population, is feasible for implementation in a community setting and shows evidence of benefit. This intervention is concordant with public health priorities because of the global importance of the parent-child relationship as a protective factor for adolescent outcomes, the need for culturally-appropriate interventions for nonwestern populations, and design characteristics that promote dissemination.",2013,"The results provide preliminary evidence that this parenting intervention is culturally acceptable for a nonwestern general population, is feasible for implementation in a community setting and shows evidence of benefit.","['pre-adolescent children in Hong Kong', 'Hong Kong', '150 Hong Kong parents of children 10-13\xa0years of age to (a) a']","['waitlist control group, or (c) a third active intervention which shared the control group', 'Harmony@Home intervention']",[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",[],150.0,0.0781232,"The results provide preliminary evidence that this parenting intervention is culturally acceptable for a nonwestern general population, is feasible for implementation in a community setting and shows evidence of benefit.","[{'ForeName': 'Cecilia S', 'Initials': 'CS', 'LastName': 'Fabrizio', 'Affiliation': 'School of Public Health, The University of Hong Kong, 5/F William MW Mong Block, Room 5-05, 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'Malia R', 'Initials': 'MR', 'LastName': 'Hirschmann', 'Affiliation': ''}, {'ForeName': 'Sunita M', 'Initials': 'SM', 'LastName': 'Stewart', 'Affiliation': ''}]",Journal of child and family studies,[]
144,22042159,The mere anticipation of an interaction with a woman can impair men's cognitive performance.,"Recent research suggests that heterosexual men's (but not heterosexual women's) cognitive performance is impaired after an interaction with someone of the opposite sex (Karremans et al., 2009). These findings have been interpreted in terms of the cognitive costs of trying to make a good impression during the interaction. In everyday life, people frequently engage in pseudo-interactions with women (e.g., through the phone or the internet) or anticipate interacting with a woman later on. The goal of the present research was to investigate if men's cognitive performance decreased in these types of situations, in which men have little to no opportunity to impress her and, moreover, have little to no information about the mate value of their interaction partner. Two studies demonstrated that men's (but not women's) cognitive performance declined if they were led to believe that they interacted with a woman via a computer (Study 1) or even if they merely anticipated an interaction with a woman (Study 2). Together, these results suggest that an actual interaction is not a necessary prerequisite for the cognitive impairment effect to occur. Moreover, these effects occur even if men do not get information about the woman's attractiveness. This latter finding is discussed in terms of error management theory.",2012,Two studies demonstrated that men's (but not women's) cognitive performance declined if they were led to believe that they interacted with a woman via a computer (Study 1) or even if they merely anticipated an interaction with a woman (Study 2).,[],[],[],[],[],[],,0.0254306,Two studies demonstrated that men's (but not women's) cognitive performance declined if they were led to believe that they interacted with a woman via a computer (Study 1) or even if they merely anticipated an interaction with a woman (Study 2).,"[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Nauts', 'Affiliation': 'Behavioural Science Institute, Radboud University Nijmegen, Nijmegen, The Netherlands. s.nauts@psych.ru.nl'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Metzmacher', 'Affiliation': ''}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Verwijmeren', 'Affiliation': ''}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Rommeswinkel', 'Affiliation': ''}, {'ForeName': 'Johan C', 'Initials': 'JC', 'LastName': 'Karremans', 'Affiliation': ''}]",Archives of sexual behavior,['10.1007/s10508-011-9860-z']
145,23518903,Hepatitis B surface antigen levels: association with 5-year response to peginterferon alfa-2a in hepatitis B e-antigen-negative patients.,"PURPOSE


To investigate the durability of response to peginterferon alfa-2a up to 5 years post-treatment and factors associated with response in hepatitis B e-antigen (HBeAg)-negative patients.
METHODS


HBeAg-negative patients received peginterferon alfa-2a (180 μg/week) ± lamivudine (100 mg/day) for 48 weeks as part of a multicenter, randomized study. The planned 5-year efficacy analysis included patients (n = 230) enrolled in the long-term follow-up study. On-treatment hepatitis B surface antigen (HBsAg) decline kinetics were analyzed retrospectively in a subgroup of patients with HBsAg data available at baseline, weeks 12, 24, and 48 on-treatment, and 6 months post-treatment (n = 120). Receiver operating characteristic analyses identified the on-treatment HBsAg levels associated with response at 1 and 5 years post-treatment.
RESULTS


HBV DNA ≤2,000 IU/mL and HBsAg clearance at 5 years post-treatment were achieved by 23 and 12% of patients, respectively. High rates of HBsAg clearance at 5 years post-treatment were achieved by patients with HBV DNA ≤2,000 IU/mL at 1 year post-treatment (28%). Rates of HBV DNA ≤2,000 IU/mL at 1 year post-treatment were 47.2 and 43.4% in patients with ≥10% decline from baseline at weeks 12 and 24, respectively, compared with 16.4% (p = 0.0003) and 13.2% (p < 0.0004) in patients with a <10% decline. Rates of HBsAg clearance at 5 years post-treatment were 22.6 and 22.4% in patients with ≥10% decline at weeks 12 and 24, respectively, compared with 7.5% (p = 0.0161) and 3.8% (p < 0.0001) in patients with <10% decline.
CONCLUSIONS


Peginterferon alfa-2a results in increasing rates of HBsAg clearance during post-treatment follow-up in HBeAg-negative patients. On-treatment decline in HBsAg is significantly associated with long-term post-treatment response.",2013,"High rates of HBsAg clearance at 5 years post-treatment were achieved by patients with HBV DNA ≤2,000 IU/mL at 1 year post-treatment (28%).","['hepatitis B e-antigen-negative patients', 'hepatitis B e-antigen (HBeAg)-negative patients', 'HBeAg-negative patients received', 'patients (n\xa0=\xa0230) enrolled in the long-term follow-up study']","['Peginterferon alfa-2a', 'lamivudine', 'peginterferon alfa-2a']","['rates of HBsAg clearance', 'HBsAg', 'High rates of HBsAg clearance', 'HBsAg) decline kinetics', 'Rates of HBsAg clearance', 'mL and HBsAg clearance']","[{'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}]","[{'cui': 'C0391001', 'cui_str': 'peginterferon alfa-2a'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",230.0,0.0736979,"High rates of HBsAg clearance at 5 years post-treatment were achieved by patients with HBV DNA ≤2,000 IU/mL at 1 year post-treatment (28%).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Marcellin', 'Affiliation': ""Service d'Hépatologie and INSERM U773-CRB3, Hôpital Beaujon, University of Paris, 100 boulevard du Général Leclerc, 92110 Clichy, France.""}, {'ForeName': 'Ferruccio', 'Initials': 'F', 'LastName': 'Bonino', 'Affiliation': ''}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Yurdaydin', 'Affiliation': ''}, {'ForeName': 'Stephanos', 'Initials': 'S', 'LastName': 'Hadziyannis', 'Affiliation': ''}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Moucari', 'Affiliation': ''}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Kapprell', 'Affiliation': ''}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Rothe', 'Affiliation': ''}, {'ForeName': 'Matei', 'Initials': 'M', 'LastName': 'Popescu', 'Affiliation': ''}, {'ForeName': 'Maurizia R', 'Initials': 'MR', 'LastName': 'Brunetto', 'Affiliation': ''}]",Hepatology international,['10.1007/s12072-012-9343-x']
146,23626405,Effects of a phonological awareness program on English reading and spelling among Hong Kong Chinese ESL children.,"This study investigated the effects of a 12-week language-enriched phonological awareness instruction on 76 Hong Kong young children who were learning English as a second language. The children were assigned randomly to receive the instruction on phonological awareness skills embedded in vocabulary learning activities or comparison instruction which consisted of vocabulary learning and writing tasks but no direct instruction in phonological awareness skills. They were tested on receptive and expressive vocabulary, phonological awareness at the syllable, rhyme and phoneme levels, reading, and spelling in English before and after the program implementation. The results indicated that children who received the phonological awareness instruction performed significantly better than the comparison group on English word reading, spelling, phonological awareness at all levels and expressive vocabulary on the posttest when age, general intelligence and the pretest scores were controlled statistically. The findings suggest that phonological awareness instruction embedded in vocabulary learning activities might be beneficial to kindergarteners learning English as a second language.",2013,"The results indicated that children who received the phonological awareness instruction performed significantly better than the comparison group on English word reading, spelling, phonological awareness at all levels and expressive vocabulary on the posttest when age, general intelligence and the pretest scores were controlled statistically.","['76 Hong Kong young children who were learning English as a second language', 'English reading and spelling among Hong Kong Chinese ESL children']","['instruction on phonological awareness skills embedded in vocabulary learning activities or comparison instruction which consisted of vocabulary learning and writing tasks but no direct instruction in phonological awareness skills', 'phonological awareness program', '12-week language-enriched phonological awareness instruction', 'phonological awareness instruction']","['receptive and expressive vocabulary, phonological awareness at the syllable, rhyme and phoneme levels, reading, and spelling in English', 'English word reading, spelling, phonological awareness at all levels and expressive vocabulary on the posttest when age, general intelligence and the pretest scores']","[{'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0424920', 'cui_str': 'English as a second language (finding)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0331515', 'cui_str': 'Triticum spelta'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0154337,"The results indicated that children who received the phonological awareness instruction performed significantly better than the comparison group on English word reading, spelling, phonological awareness at all levels and expressive vocabulary on the posttest when age, general intelligence and the pretest scores were controlled statistically.","[{'ForeName': 'Susanna S S', 'Initials': 'SS', 'LastName': 'Yeung', 'Affiliation': 'Department of Psychological Studies, The Hong Kong Institute of Education, Tai Po, Hong Kong SAR ; Faculty of Education, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Siegel', 'Affiliation': ''}, {'ForeName': 'Carol K K', 'Initials': 'CK', 'LastName': 'Chan', 'Affiliation': ''}]",Reading and writing,[]
147,23658598,"A Double-Blind Clinical Study to Investigate the Effects of a Fungal Protease Enzyme System on Metabolic, Hepato-renal, and Cardiovascular Parameters Following 30 Days of Supplementation in Active, Healthy Men.","Research on the role of digestion in overall health has driven increasing interest in the use of digestive enzymes, which may improve nutrient absorption and reduce gastrointestinal symptoms. Sales of digestive aids and enzymes have grown over 8% in 2009, with enzymes accounting for $69 million of this growing category. Recent clinical research reported that acute dosing of Aminogen®, a patented blend of digestive protease enzymes isolated from  Aspergillus  and blended with whey protein concentrate, increased the rate of protein absorption. The results indicated a faster rate of amino acid absorption reflected in significantly higher blood levels of amino acids, increased nitrogen retention, and significantly reduced levels of C-reactive protein. Few studies, however, have examined the safety of repeated dosing of oral enzymes with an appropriate substrate. The purpose of this study, therefore, was to evaluate basic measures of clinical safety during 30 days of continuous, repeated dosing of Aminogen® and whey protein supplementation in healthy, active men maintaining a regimen of resistance training. Parameters evaluated include various markers of general physical health, metabolic function, hepato-renal function, and cardiovascular health including fasting blood lipids. Forty healthy, resistance-trained men (27.1 ± 7.9 years) were recruited for this double-blind, randomized study. Group A ingested two 40-g doses of whey protein per day containing Aminogen®. Group B ingested two 40-g doses of whey protein per day. No significant changes were noted in measures of general physical health, metabolic function, cardiovascular health, and hepato-renal function within or between groups. However, total cholesterol, LDL cholesterol, and serum calcium significantly increased ( P  < 0.05) in group B. In group A, whey protein containing Aminogen® was well tolerated with no adverse reactions reported. No differences in serum markers of clinical safety and an improved blood lipid profile are also reported.",2013,"However, total cholesterol, LDL cholesterol, and serum calcium significantly increased ( P  < 0.05) in group B.","['healthy, active men maintaining a regimen of resistance training', 'Forty healthy, resistance-trained men (27.1\u2009±\u20097.9\xa0years', 'Healthy Men']","['Aminogen® and whey protein supplementation', 'whey protein per day containing Aminogen®', 'Fungal Protease Enzyme System']","['rate of protein absorption', 'levels of C-reactive protein', 'total cholesterol, LDL cholesterol, and serum calcium', 'serum markers of clinical safety', 'general physical health, metabolic function, cardiovascular health, and hepato-renal function', 'blood lipid profile', 'Metabolic, Hepato-renal, and Cardiovascular Parameters', 'faster rate of amino acid absorption', 'blood levels of amino acids, increased nitrogen retention', 'various markers of general physical health, metabolic function, hepato-renal function, and cardiovascular health including fasting blood lipids']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0235432', 'cui_str': 'Nitrogen retention'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0430045', 'cui_str': 'Fasting blood lipids'}]",40.0,0.0963819,"However, total cholesterol, LDL cholesterol, and serum calcium significantly increased ( P  < 0.05) in group B.","[{'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'R&D Department, Triarco Industries, LLC, 400 Hamburg Turnpike, Wayne, NJ 07470 USA.'}]",Food digestion,[]
148,23678231,The consumption of seaweed as a protective factor in the etiology of breast cancer: proof of principle.,"Daily consumption of seaweed has been proposed as a factor in explaining lower postmenopausal breast cancer (BC) incidence and mortality rates in Japan. This clinical trial assessed the impact of introducing seaweed- to non-seaweed-consuming American postmenopausal women. Fifteen healthy postmenopausal women were recruited for a 3-month single-blinded placebo controlled clinical trial; five had no history of BC (controls) and ten were BC survivors. Participants ingested ten capsules daily (5 g day -1 ) of placebo for 4 weeks, seaweed ( Undaria ) for 4 weeks, then placebo for another 4 weeks. Blood and urine samples were collected after each treatment period. Urinary human urokinase-type plasminogen activator receptor concentrations (uPAR) were analyzed by ELISA, and urine and serum were analyzed for protein expression using surface-enhanced laser desorption/ionization-time-of-flight mass spectrometry (SELDI-TOF-MS). Urinary creatinine standardized uPAR (in pg mL μg -1  creatinine) changed significantly between groups, decreasing by about half following seaweed supplementation (placebo 1, 1.5 (95 % CI, 0.9-2.1) and seaweed, 0.9 (95 % CI, 0.6-1.1) while placebo 2 returned to pre-seaweed concentration (1.7 (95 % CI, 1.2-2.2);  p  = 0.01, ANOVA). One SELDI-TOF-MS-identified urinary protein ( m / z  9,776) showed a similar reversible decrease with seaweed and is reported to be associated with cell attachment. One serum protein ( m / z  8,928) reversibly increased with seaweed and may be the immunostimulatory complement activation C3a des-arginine. uPAR is higher among postmenopausal women generally, and for BC patients, it is associated with unfavorable BC prognosis. By lowering uPAR, dietary seaweed may help explain lower BC incidence and mortality among postmenopausal women in Japan.",2013,"Urinary creatinine standardized uPAR (in pg mL μg -1  creatinine) changed significantly between groups, decreasing by about half following seaweed supplementation (placebo 1, 1.5 (95 % CI, 0.9-2.1) and seaweed, 0.9 (95 % CI, 0.6-1.1) while placebo 2 returned to pre-seaweed concentration (1.7 (95 % CI, 1.2-2.2);  p  = 0.01, ANOVA).","['American postmenopausal women', 'Fifteen healthy postmenopausal women', 'postmenopausal women in Japan', 'controlled clinical trial; five had no history of BC (controls) and ten were BC survivors']",['placebo'],"['uPAR', 'Blood and urine samples', 'Urinary creatinine standardized uPAR', 'Urinary human urokinase-type plasminogen activator receptor concentrations (uPAR']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005768'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0071216', 'cui_str': 'U-PA Receptor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",15.0,0.21381,"Urinary creatinine standardized uPAR (in pg mL μg -1  creatinine) changed significantly between groups, decreasing by about half following seaweed supplementation (placebo 1, 1.5 (95 % CI, 0.9-2.1) and seaweed, 0.9 (95 % CI, 0.6-1.1) while placebo 2 returned to pre-seaweed concentration (1.7 (95 % CI, 1.2-2.2);  p  = 0.01, ANOVA).","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Teas', 'Affiliation': 'South Carolina Cancer Center, University of South Carolina, 915 Greene Street, 2nd Floor, Columbia, SC 29208 USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Vena', 'Affiliation': ''}, {'ForeName': 'D Lindsie', 'Initials': 'DL', 'LastName': 'Cone', 'Affiliation': ''}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Irhimeh', 'Affiliation': ''}]",Journal of applied phycology,[]
149,23316461,Effectiveness of an educational video as an instrument to refresh and reinforce the learning of a nursing technique: a randomized controlled trial.,"The Undergraduate Nursing Course has been using videos for the past year or so. Videos are used for many different purposes such as during lessons, nurse refresher courses, reinforcement, and sharing and comparison of knowledge with the professional and scientific community. The purpose of this study was to estimate the efficacy of the video (moving an uncooperative patient from the supine to the lateral position) as an instrument to refresh and reinforce nursing techniques. A two-arm randomized controlled trial (RCT) design was chosen: both groups attended lessons in the classroom as well as in the laboratory; a month later while one group received written information as a refresher, the other group watched the video. Both groups were evaluated in a blinded fashion. A total of 223 students agreed to take part in the study. The difference observed between those who had seen the video and those who had read up on the technique turned out to be an average of 6.19 points in favour of the first (P < 0.05). The results of the RCT demonstrated that students who had seen the video were better able to apply the technique, resulting in a better performance. The video, therefore, represents an important tool to refresh and reinforce previous learning.",2012,The difference observed between those who had seen the video and those who had read up on the technique turned out to be an average of 6.19 points in favour of the first (P < 0.05).,['223 students agreed to take part in the study'],"['RCT', 'educational video']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}]",[],223.0,0.0281166,The difference observed between those who had seen the video and those who had read up on the technique turned out to be an average of 6.19 points in favour of the first (P < 0.05).,"[{'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Salina', 'Affiliation': 'Via Torino 20, 10070 Fiano (Turin), Italy  ; University of Turin Undergraduate Nursing Course, Turin, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Ruffinengo', 'Affiliation': ''}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Garrino', 'Affiliation': ''}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Massariello', 'Affiliation': ''}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Charrier', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Maria Santina', 'Initials': 'MS', 'LastName': 'Favale', 'Affiliation': ''}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Dimonte', 'Affiliation': ''}]",Perspectives on medical education,['10.1007/s40037-012-0013-4']
150,23440907,Metabolic and hormonal responses to a single session of kumite (free non-contact fight) and kata (highly ritualized fight) in karate athletes.,"BACKGROUND: Several studies report martial arts as a good model for investigating neuroendocrine responses to competitive fighting. However, little is known on the metabolic responses elicited by elite athletes during fighting. In particular, the metabolic picture in elite athletes of martial arts is little known.  AIM: In the present study, our aim was to investigate the acute effects of a session of karate practice on the glucose-insulin system.  SUBJECTS AND METHODS: Ten healthy individuals (6M/4F; BMI: 22.1 ± 0.7 kg/m(2); 21.9 ± 1.1 years, mean ± SE) who practice karate in national or international competitions were enrolled. All participants completed two experimental trials in a randomised-crossover fashion. A basal blood sample was collected from each athlete to assess plasma glucose, insulin, cortisol, testosterone and catecholamines, before karate training session. In two separate days, another blood sample was collected from each participants after 3 min of real fighting (kumite) and 3 min of ritualized simulation of combat (kata).  RESULTS: In both trials, plasma glucose resulted to be higher at the end the of performance compared to the basal (p < 0.001 after kumite and p < 0.02 after kata). In contrast, insulin was similar in the basal and after physical activity in the two trials. Catecholamines were higher after kata and kumite sessions with respect to the basal values (p < 0.04) and, in particular, epinephrine post-kumite values were much greater than those measured after kata.  CONCLUSIONS: Our results indicate that unlike performances of karate (kumite and kata) elicit different plasma glucose increases. In particular, we found that glucose and epinephrine concentrations increased more after kumite than after kata.",2012,"Catecholamines were higher after kata and kumite sessions with respect to the basal values (p < 0.04) and, in particular, epinephrine post-kumite values were much greater than those measured after kata.  ","['Ten healthy individuals (6M/4F; BMI: 22.1\xa0±\xa00.7\xa0kg/m(2); 21.9\xa0±\xa01.1\xa0years, mean\xa0±\xa0SE) who practice karate in national or international competitions were enrolled', 'elite athletes of martial arts', 'karate athletes']",['real fighting (kumite) and 3\xa0min of ritualized simulation of combat (kata'],"['plasma glucose', 'glucose and epinephrine concentrations', 'plasma glucose, insulin, cortisol, testosterone and catecholamines', 'Metabolic and hormonal responses', 'Catecholamines']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0079654', 'cui_str': 'Karate'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0079801', 'cui_str': 'Martial Arts'}]","[{'cui': 'C0424324', 'cui_str': 'Fighting (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}]",10.0,0.0595715,"Catecholamines were higher after kata and kumite sessions with respect to the basal values (p < 0.04) and, in particular, epinephrine post-kumite values were much greater than those measured after kata.  ","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Benedini', 'Affiliation': 'Department of Sport, Nutrition and Health Sciences, Università degli Studi di Milano, Milan, Italy  ; Research Center of Metabolism IRCCS Policlinico San Donato Milanese, Milan, Italy  ; Research Center of Metabolism, Piazza Edmondo Malan, 20097 San Donato Milanese, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caumo', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Luzi', 'Affiliation': ''}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Invernizzi', 'Affiliation': ''}]",Sport sciences for health,[]
151,23338490,Investigating efficacy of two brief mind-body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial.,"PURPOSE


After completing treatment, cancer survivors may suffer from a multitude of physical and mental health impairments, resulting in compromised quality of life. This exploratory study investigated whether two mind-body interventions, i.e., Mind-Body Bridging (MBB) and Mindfulness Meditation (MM), could improve posttreatment cancer survivors' self-reported sleep disturbance and comorbid symptoms, as compared to sleep hygiene education (SHE) as an active control.
METHODS


This randomized controlled trial examined 57 cancer survivors with clinically significant self-reported sleep disturbance, randomly assigned to receive MBB, MM, or SHE. All interventions were conducted in three sessions, once per week. Patient-reported outcomes were assessed via the Medical Outcomes Study Sleep Scale and other indicators of psychosocial functioning relevant to quality of life, stress, depression, mindfulness, self-compassion, and well-being.
RESULTS


Mixed effects model analysis revealed that mean sleep disturbance symptoms in the MBB (p = .0029) and MM (p = .0499) groups were lower than in the SHE group, indicating that both mind-body interventions improved sleep. In addition, compared with the SHE group, the MBB group showed reductions in self-reported depression symptoms (p = .040) and improvements in overall levels of mindfulness (p = .018), self-compassion (p = .028), and well-being (p = .019) at postintervention.
CONCLUSIONS


This study provides preliminary evidence that brief sleep-focused MBB and MM are promising interventions for sleep disturbance in cancer survivors. Integrating MBB or MM into posttreatment supportive plans should enhance care of cancer survivors with sleep disturbance. Because MBB produced additional secondary benefits, MBB may serve as a promising multipurpose intervention for posttreatment cancer survivors suffering from sleep disturbance and other comorbid symptoms.
IMPLICATIONS FOR CANCER SURVIVORS


Two brief sleep-focused mind-body interventions investigated in the study were effective in reducing sleep disturbance and one of them further improved other psychosocial aspects of the cancer survivors' life. Management of sleep problems in survivors is a high priority issue that demands more attention in cancer survivorship.",2013,"RESULTS


Mixed effects model analysis revealed that mean sleep disturbance symptoms in the MBB (p = .0029) and MM (p = .0499)","['FOR CANCER SURVIVORS', 'cancer survivors', '57 cancer survivors with clinically significant self-reported sleep disturbance', 'posttreatment cancer survivors suffering from sleep disturbance and other comorbid symptoms', 'cancer survivors with sleep disturbance']","['brief mind-body intervention programs', 'MBB and MM', 'MBB, MM, or SHE', 'MBB', 'Mind-Body Bridging (MBB) and Mindfulness Meditation (MM']","['self-compassion', 'self-reported depression symptoms', 'overall levels of mindfulness', 'sleep', 'sleep disturbance', 'Medical Outcomes Study Sleep Scale and other indicators of psychosocial functioning relevant to quality of life, stress, depression, mindfulness, self-compassion, and well-being', 'mean sleep disturbance symptoms']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0222045'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",57.0,0.100211,"RESULTS


Mixed effects model analysis revealed that mean sleep disturbance symptoms in the MBB (p = .0029) and MM (p = .0499)","[{'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Utah Center for Exploring Mind-Body Interactions, Pain Research Center, Department of Anesthesiology, School of Medicine, University of Utah, 615 Arapeen Drive, Salt Lake City, UT 84108, USA. yoshi.nakamura@utah.edu'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Lipschitz', 'Affiliation': ''}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Kuhn', 'Affiliation': ''}, {'ForeName': 'Anita Y', 'Initials': 'AY', 'LastName': 'Kinney', 'Affiliation': ''}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Donaldson', 'Affiliation': ''}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-012-0252-8']
152,23293685,The predictive validity and effects of using the transtheoretical model to increase the physical activity of healthcare workers in a public hospital in South Africa.,"There have been studies conducted on the effectiveness of the transtheoretical model (TTM) in improving the level of physical activity at worksites worldwide, but no such studies have been conducted in South Africa. The aim of this study was to determine the predictive validity and effects of using the Transtheoretical Model to increase the physical activity of healthcare workers in a public hospital in South Africa. A quasi-experimental design in the form of a single-group, pretest-posttest model was used to examine the possible relationship between an exposure to interventions, attitude, knowledge, and an increased level of physical activity. Two hundred hospital staff members (medical and nonmedical staff) were randomly selected for participation in the study. The following variables were measured: TTM stages of physical activity, knowledge and attitudes, fitness level, body mass index, and level of exposure to the intervention. The interventions designed were based on the concept of progressing stages of physical activity in TTM stage sequences: (1) pamphlets about physical activity and health, (2) posters, fun runs, and sports day, and (3) a second set of posters, a daily radio program, and aerobic classes. Post-intervention, participants had significantly increased their stages of physical activity, attitudes, and knowledge compared with their pre-tests. Mean scores of TTM (3.70) and knowledge (3.65) were significantly (p < 0.05) greater at post-test. Overall accuracies of TTM at pre-test correctly predicted TTM at post-test by an average of 66.9%. The use of TTM to identify the stage of physical activity of healthcare workers has enabled the researcher to design intervention programs specific to the stage of exercise behavior of hospital staff. The predictors (TTM1), exposure levels, knowledge, attitudes, and processes of change have significant contributions to the outcome (TTM2).",2012,Mean scores of TTM (3.70) and knowledge (3.65) were significantly (p < 0.05) greater at post-test.,"['Two hundred hospital staff members (medical and nonmedical staff', 'healthcare workers in a public hospital in South Africa']","['TTM', 'transtheoretical model (TTM']","['Overall accuracies of TTM', 'TTM stages of physical activity, knowledge and attitudes, fitness level, body mass index, and level of exposure to the intervention', 'predictors (TTM1), exposure levels, knowledge, attitudes, and processes of change have significant contributions to the outcome (TTM2', 'stages of physical activity, attitudes, and knowledge', 'Mean scores of TTM (3.70) and knowledge']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0212365,Mean scores of TTM (3.70) and knowledge (3.65) were significantly (p < 0.05) greater at post-test.,"[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Skaal', 'Affiliation': 'The Department of Social and Behavioural Health Sciences, School of Public Health, University of Limpopo (MEDUNSA Campus), Pretoria, South Africa  ; P.O. Box 1018, Medunsa, Garankuwa 0204, Akasia, Pretoria, South Africa.'}, {'ForeName': 'Supa', 'Initials': 'S', 'LastName': 'Pengpid', 'Affiliation': ''}]",Translational behavioral medicine,[]
153,23293427,Effects of a brief but intensive remedial computer intervention in a sub-sample of kindergartners with early literacy delays.,"Living Letters is an adaptive game designed to promote children's combining of how the proper name sounds with their knowledge of how the name looks. A randomized controlled trial (RCT) was used to experimentally test whether priming for attending to the sound-symbol relationship in the proper name can reduce the risk for developing reading problems in the first two grades of primary education. A Web-based computer program with more intensive practice than could be offered by teachers affords activities that prompt young children to pay attention to print as an object of investigation. The study focused on a sub-sample of 110 five-year-old Dutch children from 15 schools seriously delayed in code-related knowledge. Outcomes support the need for early remedial computer programs, and demonstrate that, without a brief but intensive treatment, more children from the at-risk group lack the capacity to benefit from beginning reading instruction in the early grades. With an early intervention in kindergarten, children with code-related skills delays gained about half a standard deviation on standardized tests at the end of grade 2.",2012,Living Letters is an adaptive game designed to promote children's combining of how the proper name sounds with their knowledge of how the name looks.,"['a sub-sample of kindergartners with early literacy delays', 'sub-sample of 110 five-year-old Dutch children from 15 schools seriously delayed in code-related knowledge']",['intensive remedial computer intervention'],[],"[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}]",[],110.0,0.0421552,Living Letters is an adaptive game designed to promote children's combining of how the proper name sounds with their knowledge of how the name looks.,"[{'ForeName': 'Verna A C', 'Initials': 'VA', 'LastName': 'Van der Kooy-Hofland', 'Affiliation': 'Department of Education and Child Studies, Leiden University, P.O. Box 9555, 2300 RB Leiden, The Netherlands.'}, {'ForeName': 'Adriana G', 'Initials': 'AG', 'LastName': 'Bus', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Roskos', 'Affiliation': ''}]",Reading and writing,[]
154,23150149,NAT2 genotype guided regimen reduces isoniazid-induced liver injury and early treatment failure in the 6-month four-drug standard treatment of tuberculosis: a randomized controlled trial for pharmacogenetics-based therapy.,"OBJECTIVE


This study is a pharmacogenetic clinical trial designed to clarify whether the N-acetyltransferase 2 gene (NAT2) genotype-guided dosing of isoniazid improves the tolerability and efficacy of the 6-month four-drug standard regimen for newly diagnosed pulmonary tuberculosis.
METHODS


In a multicenter, parallel, randomized, and controlled trial with a PROBE design, patients were assigned to either conventional standard treatment (STD-treatment: approx. 5 mg/kg of isoniazid for all) or NAT2 genotype-guided treatment (PGx-treatment: approx. 7.5 mg/kg for patients homozygous for NAT2 4: rapid acetylators; 5 mg/kg, patients heterozygous for NAT2 4: intermediate acetylators; 2.5 mg/kg, patients without NAT2 4: slow acetylators). The primary outcome included incidences of 1) isoniazid-related liver injury (INH-DILI) during the first 8 weeks of therapy, and 2) early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs at the 8th week.
RESULTS


One hundred and seventy-two Japanese patients (slow acetylators, 9.3 %; rapid acetylators, 53.5 %) were enrolled in this trial. In the intention-to-treat (ITT) analysis, INH-DILI occurred in 78 % of the slow acetylators in the STD-treatment, while none of the slow acetylators in the PGx-treatment experienced either INH-DILI or early treatment failure. Among the rapid acetylators, early treatment failure was observed with a significantly lower incidence rate in the PGx-treatment than in the STD-treatment (15.0 % vs. 38 %). Thus, the NAT2 genotype-guided regimen resulted in much lower incidences of unfavorable events, INH-DILI or early treatment failure, than the conventional standard regimen.
CONCLUSION


Our results clearly indicate a great potential of the NAT2 genotype-guided dosing stratification of isoniazid in chemotherapy for tuberculosis.",2013,"Among the rapid acetylators, early treatment failure was observed with a significantly lower incidence rate in the PGx-treatment than in the STD-treatment (15.0 % vs. 38 %).","['One hundred and seventy-two Japanese patients (slow acetylators, 9.3 %; rapid acetylators, 53.5 %) were enrolled in this trial', 'newly diagnosed pulmonary tuberculosis']","['NAT2 genotype-guided treatment (PGx-treatment: approx', 'conventional standard treatment (STD-treatment: approx', 'isoniazid']","['incidences of 1) isoniazid-related liver injury (INH-DILI) during the first 8 weeks of therapy, and 2) early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs', 'unfavorable events, INH-DILI or early treatment failure', 'INH-DILI', 'tolerability and efficacy', 'incidence rate']","[{'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1827377', 'cui_str': 'Slow acetylator'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}]","[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0208681', 'cui_str': 'factor XIIa inhibitor'}, {'cui': 'C0860207', 'cui_str': 'Drug-Induced Liver Injury'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",172.0,0.0725022,"Among the rapid acetylators, early treatment failure was observed with a significantly lower incidence rate in the PGx-treatment than in the STD-treatment (15.0 % vs. 38 %).","[{'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Azuma', 'Affiliation': 'Clinical Pharmacology and Pharmacogenomics, School of Pharmacy, Hyogo University of Health Sciences, Kobe, Hyogo, Japan. azuma@huhs.ac.jp'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Ohno', 'Affiliation': ''}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Kubota', 'Affiliation': ''}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Yokota', 'Affiliation': ''}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Nagai', 'Affiliation': ''}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Tsuyuguchi', 'Affiliation': ''}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': ''}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': ''}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Kamimura', 'Affiliation': ''}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Fujio', 'Affiliation': ''}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Kawase', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of clinical pharmacology,['10.1007/s00228-012-1429-9']
155,23240102,Crossword puzzles: self-learning tool in pharmacology.,"Students of the second professional MBBS course of the Indian medical curriculum (II MBBS) perceive pharmacology as a 'Volatile Subject' because they often find it difficult to remember and recall drug names. We evaluated the usefulness of crossword puzzles as a self-learning tool to help pharmacology students to remember drug names. We also measured the students' satisfaction with this learning method. This was an open-label randomized, two-arm intervention study, conducted with II MBBS students (n = 70), randomly selected and assigned to two groups A (n = 35) and B (n = 35). Two self-learning modules containing crossword puzzles with antihypertensive and antiepileptic drug terms were prepared and pre-validated. Hard copies of both crossword puzzles were administered to Group A (Intervention group) on two different occasions. One hour was allotted to solve a puzzle. Students were allowed to refer to their textbooks. Group B (Control group) underwent the self-learning module without the crossword puzzles. In both groups, pre- and post-test knowledge was assessed. Students' perceptions of the crossword puzzles were assessed using a pre-validated 10-item questionnaire. Responses to items 1-8 were recorded using a 5-point Likert scale. Responses to item 9 were recorded on a 10-point rating scale while item 10 was an open-ended question. The crossword completion index was 92.86 %. In group A, the average pre-test score was 6.09 whereas the average post-test score was 12.87 (p < 0.05). In group B, average pre- and post-test scores were 6.03 and 9.74, respectively. A significant difference (p < 0.001) was observed between the post-test scores of the two groups. The absolute learning gain was 33.9 % in Group A and 18.55 % in Group B. The response rate for the questionnaire was 100 %. Of the students, 71.43 % strongly agreed that crossword puzzles enhanced their knowledge of antihypertensive and antiepileptic drugs and were helpful for remembering and recalling the drug names, 60 % students found it challenging and a good problem solving activity and 85.71 % students opined that it was a good self-learning, recreational activity. The test scores improved when crossword puzzles, designed to improve retention of drug names, were incorporated in the self-study modules of pharmacology training. Students rated the crossword puzzles as a challenging and effective self-learning tool. Students' acceptability for crossword puzzles further favours their usefulness as a self-learning tool. The crossword puzzle is an effective tool for 'recreational learning' and can be used as an active learning strategy to promote self-directed learning.",2012,"The test scores improved when crossword puzzles, designed to improve retention of drug names, were incorporated in the self-study modules of pharmacology training.","['Students of the second professional MBBS course of the Indian medical curriculum (II MBBS', 'II MBBS students (n\xa0=\xa070']","['self-learning module without the crossword puzzles', 'crossword puzzles']","['absolute learning gain', 'average pre- and post-test scores', 'retention of drug names', 'response rate']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0423995', 'cui_str': 'Puzzled (finding)'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}]",,0.0142671,"The test scores improved when crossword puzzles, designed to improve retention of drug names, were incorporated in the self-study modules of pharmacology training.","[{'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Gaikwad', 'Affiliation': ""Department of Pharmacology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences (Deemed University), Sawangi (Meghe), Wardha, 442004 Maharashtra India  ; 'Safal' 242, Datta Nagar, Near Shastri Nagar High School, Old Bagadganj Road, Nagpur, 440008 Maharashtra India.""}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Tankhiwale', 'Affiliation': ''}]",Perspectives on medical education,['10.1007/s40037-012-0033-0']
156,23227299,Effects of a new mixture of essential amino acids (Aminotrofic(®)) in malnourished haemodialysis patients.,"The aim of this study was to verify the clinical efficacy of a diet associated with already commercially available oral amino acid functional cluster (AFC) compared to the administration of a diet associated with a nitrogen protein-based supplement (casein) in antagonizing malnutrition in patients with Chronic renal failure (CRF) undergoing haemodialysis. The secondary aim was to assess the changes in protein levels during the acute phase such as the expression of inflammatory cytokines. Twenty patients in haemodialysis aged between 18 and 85 of both genders (13 m, 7f) were recruited, randomized and divided into two groups and treated for 4 months respectively with: (1) oral AFC supplement (*)8 g/die: group A, and (2) oral supplementation of a protein nitrogenous mixture compared to AFC with a casein protein source) of 6.6 g: group P. During the initial assessment and thereafter on a monthly basis all patients underwent the following: Dietary recall 24 h; Anthropometric: Weight, height, BMI, expected dry weight, actual weight; Biochemical: Albumin, transferrin, Na, K, Cl, Ca, P, Mg, long-interval creatinine (Aminotrofic(®): Errekappa Euroterapici, Milano) pre-albumin, α1 acid glycoprotein, C reactive protein (CRP), protein nitrogen appearance (PNA); Instrumental: Handgrip strength evaluation, Calorimetry by means of Armband, Bio-impedance analysis (BIA), Spitzer Index (quality of life), Subjective Global Assessment Generated by the patient (PG SGA). Considering the nutritional parameters, no significant differences concerning dry weight emerged between the beginning (T0) and the end (T4) (weight A to T0: kg 64.41 ± 6.34; weight A to T4: kg 64.51 ± 7.05: P = NS; weight P to T0: kg 60.17 ± 11.94; weight P to T4: kg 59.86 ± 11.43: P = NS); biochemical parameters, significant differences were observed only for two parameters: pre-albumin (Pre-albumin A to T0 30.12 ± 7.23; Pre-albumin A to T4: 28.91 ± 5.8; Pre-albumin P to T0 22.51 ± 6.04; Pre-albumin P to T4: 26.10 ± 9.82), and Transferrin (Transferrin A to T0 171.77 ± 28.87 mg/dL, Transferrin A to T4: 181.44 ± 38.83 mg/dL: P < 0.005; Transferrin P to T0 160.29 ± 27.46 mg/dL, Transferrin P to T4: 146.57 ± 24.96 mg/dL: P < 0.005), but not in other parameters. From a nutritional perspective, after 4 months of treatment an increase in protein synthesis was noted in group A compared to group P which was proved by the significant increase of transferrin. This pilot study suggests the AFC oral supplementation may represent a valid alternative to intradialytic parenteral treatment and may also allow for an improvement in blood chemical values and nutritional status.",2012,"Considering the nutritional parameters, no significant differences concerning dry weight emerged between the beginning (T0) and the end (T4) (weight A to T0: kg 64.41 ± 6.34; weight A to T4: kg 64.51 ± 7.05: P = NS; weight P to T0: kg 60.17 ± 11.94; weight P to T4: kg 59.86 ± 11.43: P = NS); biochemical parameters, significant differences were observed only for two parameters: pre-albumin (Pre-albumin A to T0 30.12 ± 7.23; Pre-albumin A to T4: 28.91 ± 5.8; Pre-albumin P to T0 22.51 ± 6.04; Pre-albumin P to T4: 26.10 ± 9.82), and Transferrin (Transferrin A","['Twenty patients in haemodialysis aged between 18 and 85 of both genders (13\xa0m, 7f', 'malnourished haemodialysis patients', 'patients with Chronic renal failure (CRF) undergoing haemodialysis']","['diet associated with already commercially available oral amino acid functional cluster (AFC', 'protein nitrogenous mixture compared to AFC with a casein protein source) of 6.6\xa0g: group P', 'Transferrin (Transferrin A', 'new mixture of essential amino acids (Aminotrofic(®', 'oral AFC supplement ', 'dL', 'nitrogen protein-based supplement (casein']","['transferrin, Na, K, Cl, Ca, P, Mg, long-interval creatinine (Aminotrofic(®): Errekappa Euroterapici, Milano', 'protein synthesis', 'dry weight', 'protein levels', 'pre-albumin, α1 acid glycoprotein, C reactive protein (CRP), protein nitrogen appearance (PNA', 'Instrumental: Handgrip strength evaluation, Calorimetry by means of Armband, Bio-impedance analysis (BIA), Spitzer Index (quality of life), Subjective Global Assessment Generated by the patient (PG SGA', 'transferrin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0040679', 'cui_str': 'beta-1 Metal-Binding Globulin'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0040679', 'cui_str': 'beta-1 Metal-Binding Globulin'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0369890', 'cui_str': 'Protein nitrogen (substance)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0006779', 'cui_str': 'Calorimetry'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034380'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment (assessment scale)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0281352,"Considering the nutritional parameters, no significant differences concerning dry weight emerged between the beginning (T0) and the end (T4) (weight A to T0: kg 64.41 ± 6.34; weight A to T4: kg 64.51 ± 7.05: P = NS; weight P to T0: kg 60.17 ± 11.94; weight P to T4: kg 59.86 ± 11.43: P = NS); biochemical parameters, significant differences were observed only for two parameters: pre-albumin (Pre-albumin A to T0 30.12 ± 7.23; Pre-albumin A to T4: 28.91 ± 5.8; Pre-albumin P to T0 22.51 ± 6.04; Pre-albumin P to T4: 26.10 ± 9.82), and Transferrin (Transferrin A","[{'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Sukkar', 'Affiliation': 'U.O. di Dietetica e Nutrizione Clinica, IRCSS Az, Ospedaliera Universitaria San Martino IST di Genova, Genoa, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gallo', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Borrini', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vaccaro', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Marchello', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Boicelli', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Borgarelli', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Solari', 'Affiliation': ''}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Ratto', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ravera', 'Affiliation': ''}]",Mediterranean journal of nutrition and metabolism,[]
157,23052751,Enhanced recovery in the management of mild gallstone pancreatitis: a prospective cohort study.,"PURPOSE


The aim of this study was to establish enhanced recovery protocols for the management of mild gallstone pancreatitis.
METHODS


Sixty consecutive patients were divided into enhanced recovery and traditional recovery (TR) groups in a randomized observational study. The basic enhanced recovery elements included early laparoscopic cholecystectomy, restrictive endoscopic intervention, and early oral nutrition. The incidence of complications, readmission, length of stay, and total medical cost were analyzed during the hospital course.
RESULTS


The length of hospital stay and medical cost were significantly lower in the enhanced recovery group in comparison to the TR group: 5.9 days vs. 10.6 days (P < 0.01) and ¥10,023 vs. ¥15,035 (P < 0.01). The complications and readmission rates in the two groups were similar.
CONCLUSIONS


The implementation of enhanced recovery protocols is feasible in the management of mild gallstone pancreatitis. The utilization of these protocols can achieve shorter hospital stays and reduced costs, with no increase in either the re-admission or peri-operative complication rates.",2013,"The utilization of these protocols can achieve shorter hospital stays and reduced costs, with no increase in either the re-admission or peri-operative complication rates.","['mild gallstone pancreatitis', 'Sixty consecutive patients']","['laparoscopic cholecystectomy, restrictive endoscopic intervention, and early oral nutrition']","['incidence of complications, readmission, length of stay, and total medical cost', 'complications and readmission rates', 'shorter hospital stays and reduced costs', 'length of hospital stay and medical cost']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0521614', 'cui_str': 'Gallstone pancreatitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",60.0,0.0146124,"The utilization of these protocols can achieve shorter hospital stays and reduced costs, with no increase in either the re-admission or peri-operative complication rates.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Hepatobiliary and Pancreatospleenic Surgery, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'Da-Zhi', 'Initials': 'DZ', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Lang', 'Affiliation': ''}, {'ForeName': 'Zhong-Kui', 'Initials': 'ZK', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Tian-Ming', 'Initials': 'TM', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Xian-Liang', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ''}]",Surgery today,['10.1007/s00595-012-0364-9']
158,23090499,Outcome of elderly patients with acute promyelocytic leukemia: results of the German Acute Myeloid Leukemia Cooperative Group.,"Despite improvement of prognosis, older age remains a negative prognostic factor in acute promyelocytic leukemia (APL). Reports on disease characteristics and outcome of older patients are conflicting. We therefore analyzed 91 newly diagnosed APL patients aged 60 years or older (30 % of 305 adults with APL) registered by the German AML Cooperative Group (AMLCG) since 1994; 68 patients (75 %) were treated in studies, 23 (25 %) were non-eligible, and 31 % had high-risk APL. Fifty-six patients received induction therapy with all-trans retinoic acid and TAD (6-thioguanine, cytarabine, daunorubicin), and consolidation and maintenance therapy. Treatment intensification with a second induction cycle (high dose cytarabine, mitoxantrone; HAM) was optional (n = 14). Twelve patients were randomized to another therapy not considered in this report. The early death rate was 48 % in non-eligible and 19 % in study patients. With the AMLCG regimen, 7-year overall, event-free and relapse-free survival (RFS) and cumulative incidence of relapse were 45 %, 40 %, 48 %, and 24 %, respectively. In patients treated with TAD-HAM induction, 7-year RFS was superior (83 %; p = 0.006) compared to TAD only, and no relapse was observed. In our registered elderly patients, we see a high rate of non-eligibility for treatment in studies and of high-risk APL. In patients who can undergo a curative approach, intensified chemotherapy is highly effective, but is restricted to a selection of patients. Therefore, new less toxic treatment approaches with broader applicability are needed. Elderly patients might be a particular target group for concepts with arsenic trioxide.",2013,"With the AMLCG regimen, 7-year overall, event-free and relapse-free survival (RFS) and cumulative incidence of relapse were 45 %, 40 %, 48 %, and 24 %, respectively.","['elderly patients with acute promyelocytic leukemia', 'Elderly patients', 'older patients', '91 newly diagnosed APL patients aged 60\xa0years or older (30\xa0% of 305 adults with APL) registered by the German AML Cooperative Group (AMLCG) since 1994; 68 patients (75\xa0%) were treated in studies, 23 (25\xa0%) were non-eligible, and 31\xa0% had high-risk APL', 'acute promyelocytic leukemia (APL']","['induction therapy with all-trans retinoic acid and TAD (6-thioguanine, cytarabine, daunorubicin), and consolidation and maintenance therapy', 'AMLCG', 'cytarabine, mitoxantrone; HAM', 'arsenic trioxide']","['early death rate', '7-year overall, event-free and relapse-free survival (RFS) and cumulative incidence of relapse']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",12.0,0.0641255,"With the AMLCG regimen, 7-year overall, event-free and relapse-free survival (RFS) and cumulative incidence of relapse were 45 %, 40 %, 48 %, and 24 %, respectively.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lengfelder', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Mannheim, Mannheim, Germany. eva.lengfelder@umm.de'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hanfstein', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Haferlach', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Braess', 'Affiliation': ''}, {'ForeName': 'Utz', 'Initials': 'U', 'LastName': 'Krug', 'Affiliation': ''}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Spiekermann', 'Affiliation': ''}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Haferlach', 'Affiliation': ''}, {'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': ''}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': ''}, {'ForeName': 'Heinz A', 'Initials': 'HA', 'LastName': 'Horst', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Schnittger', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Aul', 'Affiliation': ''}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Schultheis', 'Affiliation': ''}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Erben', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Müller-Tidow', 'Affiliation': ''}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Wörmann', 'Affiliation': ''}, {'ForeName': 'Wolfgang E', 'Initials': 'WE', 'LastName': 'Berdel', 'Affiliation': ''}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sauerland', 'Affiliation': ''}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Heinecke', 'Affiliation': ''}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': ''}, {'ForeName': 'Wolf-Karsten', 'Initials': 'WK', 'LastName': 'Hofmann', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Büchner', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of hematology,['10.1007/s00277-012-1597-9']
159,23070400,"Nabilone for the treatment of medication overuse headache: results of a preliminary double-blind, active-controlled, randomized trial.","Medication overuse headache (MOH) is a severe burden to sufferers and its treatment has few evidence-based indications. The aim of this study is to evaluate efficacy and safety of nabilone in reducing pain and frequency of headache, the number of analgesic intake and in increasing the quality of life on patients with long-standing intractable MOH. Thirty MOH patients were enrolled at the University of Modena's Interdepartmental Centre for Research on Headache and Drug Abuse (Italy) in a randomized, double-blind, active-controlled, crossover study comparing nabilone 0.5 mg/day and ibuprofen 400 mg. The patients received each treatment orally for 8 weeks (before nabilone and then ibuprofen or vice versa), with 1 week wash-out between them. Randomization and allocation (ratio 1:1) were carried out by an independent pharmacy through a central computer system. Participants, care givers, and those assessing the outcomes were blinded to treatment sequence. Twenty-six subjects completed the study. Improvements from baseline were observed with both treatments. However, nabilone was more effective than ibuprofen in reducing pain intensity and daily analgesic intake (p < 0.05); moreover, nabilone was the only drug able to reduce the level of medication dependence (-41 %, p < 0.01) and to improve the quality of life (p < 0.05). Side effects were uncommon, mild and disappeared when nabilone was discontinued. This is the first randomized controlled trial demonstrating the benefits of nabilone on headache, analgesic consumption and the quality of life in patients with intractable MOH. This drug also appears to be safe and well-tolerated. Larger scale studies are needed to confirm these preliminary findings.",2012,"However, nabilone was more effective than ibuprofen in reducing pain intensity and daily analgesic intake (p < 0.05); moreover, nabilone was the only drug able to reduce the level of medication dependence (-41 %, p < 0.01) and to improve the quality of life (p < 0.05).","[""Thirty MOH patients were enrolled at the University of Modena's Interdepartmental Centre for Research on Headache and Drug Abuse (Italy"", 'Twenty-six subjects completed the study', 'patients with long-standing intractable MOH', 'patients with intractable MOH', 'medication overuse headache']","['nabilone', 'nabilone 0.5 mg/day and ibuprofen', 'ibuprofen']","['quality of life', 'pain and frequency of headache', 'level of medication dependence', 'headache, analgesic consumption and the quality of life', 'pain intensity and daily analgesic intake']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0522254', 'cui_str': 'Analgesic Overuse Headache'}]","[{'cui': 'C0068333', 'cui_str': 'nabilone'}, {'cui': 'C1321718', 'cui_str': 'nabilone 0.5 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",30.0,0.275145,"However, nabilone was more effective than ibuprofen in reducing pain intensity and daily analgesic intake (p < 0.05); moreover, nabilone was the only drug able to reduce the level of medication dependence (-41 %, p < 0.01) and to improve the quality of life (p < 0.05).","[{'ForeName': 'Luigi Alberto', 'Initials': 'LA', 'LastName': 'Pini', 'Affiliation': 'Headache and Drug Abuse Interdepartmental Research Centre, University of Modena, Via del Pozzo 71, Modena, Italy. pinila@unimore.it'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Guerzoni', 'Affiliation': ''}, {'ForeName': 'Maria Michela', 'Initials': 'MM', 'LastName': 'Cainazzo', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': ''}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Sarchielli', 'Affiliation': ''}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Tiraferri', 'Affiliation': ''}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': ''}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Zappaterra', 'Affiliation': ''}]",The journal of headache and pain,['10.1007/s10194-012-0490-1']
160,23136031,The dual blockade of the renin-angiotensin system in hemodialysis patients requires decreased dialysate sodium concentration.,"PURPOSE


The study evaluated whether the dual blockade of the renin-angiotensin system may influence the sodium balance in hemodialysis.
METHODS


The study involved 148 hemodialysis patients (male 85, female 63), mean age 59.6 ± 12.9 years. Participants were randomly selected to receive either angiotensin-converting enzyme inhibitor (ACEI)--subgroup A--or dual blockade ACEI and angiotensin receptor blocker (ARB)--subgroup AA.
RESULTS


At baseline, in the A versus AA subgroups, the pre-dialysis sodium concentrations (mmol/l) were 137.7 ± 0.5 versus 137.9 ± 0.8, the sodium gradients 2.6 ± 0.5 versus 2.9 ± 0.4, interdialytic weight gain (IWG) (kg) 3.1 ± 0.2 versus 3.0 ± 0.3, and thirst inventory score (points) 18.1 ± 1.0 versus 19.0 ± 1.7, respectively. After 3 months of therapy, a decrease in sodium concentration to 134.5 ± 0.5 and the increase of its gradient to 5.5 ± 0.5 were noted in the AA subgroup. An elevation of mean interdialytic weight gain to 3.47 ± 0.2 and thirst score to 21.3 ± 2.1 was observed. No significant changes in subgroup A were found. One month of the dialysate sodium concentration being lowered from 140 mmol/l to 138 mmol/l was associated with reduced serum sodium concentration and gradient, decreased IWG and restored moderate thirst score in the AA subgroup (137.5 ± 0.6 and 2.9 ± 0.6, 3.0 ± 0.5 and 19.2 ± 1.3, respectively).
CONCLUSIONS


The dual blockade of the renin-angiotensin system affects sodium balance, increasing the sodium gradient, thus elevating thirst sensation and enhancing interdialytic weight gain. In maintenance hemodialysis patients treated with both ACEI and ARB, lowered dialysate sodium levels should be prescribed.",2013,An elevation of mean interdialytic weight gain to 3.47 ± 0.2 and thirst score to 21.3 ± 2.1 was observed.,"['hemodialysis patients', '148 hemodialysis patients (male 85, female 63), mean age 59.6 ± 12.9 years', 'hemodialysis']","['angiotensin-converting enzyme inhibitor (ACEI)--subgroup A--or dual blockade ACEI and angiotensin receptor blocker (ARB)--subgroup AA', 'ACEI and ARB']","['interdialytic weight gain', 'sodium concentration', 'dialysate sodium levels', 'interdialytic weight gain (IWG', 'dialysate sodium concentration', 'serum sodium concentration and gradient, decreased IWG and restored moderate thirst score', 'mean interdialytic weight gain']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C0428291', 'cui_str': 'Finding of sodium level (finding)'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",148.0,0.0162939,An elevation of mean interdialytic weight gain to 3.47 ± 0.2 and thirst score to 21.3 ± 2.1 was observed.,"[{'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Zwiech', 'Affiliation': 'Department of Kidney Transplantation, Dialysis Department, Norbert Barlicki Memorial Teaching Hospital No. 1, Medical University of Lodz, Kopcinskiego 22, 90-153, Lodz, Poland, rzwiech@mp.pl.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Bruzda-Zwiech', 'Affiliation': ''}]",International urology and nephrology,['10.1007/s11255-012-0320-z']
161,23096072,Hemoglobin decline in cancer patients receiving chemotherapy without an erythropoiesis-stimulating agent.,"PURPOSE


The aim of this study was to examine the rate and timing of hemoglobin decline from <10 g/dL to <9 g/dL in cancer patients receiving chemotherapy.
METHODS


Pooled data from the placebo arms of six randomized, controlled trials (RCTs) of darbepoetin alfa and data from an aggregated US community oncology clinic electronic medical records (EMR) database were analyzed. Patients had baseline hemoglobin ≥10 g/dL (RCTs) or baseline hemoglobin between ≥10 g/dL and <11 g/dL (EMR episodes) that declined to <10 g/dL at least once during the study period. The proportion of patients/episodes with hemoglobin decline to <9 g/dL by 3, 6, and 9 weeks without erythropoiesis-stimulating agents was estimated from data in each of the data sources, as was the rate of transfusions in the RCTs.
RESULTS


Data from 411 patients receiving placebo in the RCTs and 10,523 patients (10,942 episodes) in the EMR database were analyzed. Forty percent and 35 % of RCT patients and EMR episodes, respectively, had a hemoglobin decline from <10 g/dL to <9 g/dL at week 3, 54 % and 43 % at week 6, and 58 % and 46 % at week 9. Of patients in the RCTs, 43 % required an RBC transfusion.
CONCLUSIONS


Hemoglobin can rapidly decline in cancer patients receiving chemotherapy with hemoglobin levels around 10 g/dL, particularly in patients ≥65 years of age. The rapid rate of hemoglobin decline in these patients should be considered for optimal anemia management.",2013,"The proportion of patients/episodes with hemoglobin decline to <9 g/dL by 3, 6, and 9 weeks without erythropoiesis-stimulating agents was estimated from data in each of the data sources, as was the rate of transfusions in the RCTs.
","['Patients had baseline hemoglobin ≥10', 'cancer patients receiving chemotherapy', 'cancer patients receiving', 'cancer patients receiving chemotherapy without an erythropoiesis-stimulating agent', '411 patients receiving']","['Hemoglobin', 'placebo', 'chemotherapy', 'darbepoetin alfa']","['rate and timing of hemoglobin decline', 'Hemoglobin decline', 'hemoglobin decline', 'proportion of patients/episodes with hemoglobin decline', 'rapid rate of hemoglobin decline', 'EMR episodes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}]","[{'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",,0.0972621,"The proportion of patients/episodes with hemoglobin decline to <9 g/dL by 3, 6, and 9 weeks without erythropoiesis-stimulating agents was estimated from data in each of the data sources, as was the rate of transfusions in the RCTs.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pirker', 'Affiliation': 'Medical University Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. robert.pirker@meduniwien.ac.at'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pirolli', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Quigley', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hulnick', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Legg', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': ''}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-012-1617-2']
162,23079690,Treatment of postmenopausal osteoporosis with delayed-release risedronate 35 mg weekly for 2 years.,"UNLABELLED


Bone mineral density response to once weekly delayed-release formulation of risedronate, given before or following breakfast, was non-inferior to that seen with traditional immediate-release risedronate given daily before breakfast. Delayed-release risedronate is a convenient dosing regimen for oral bisphosphonate therapy that might avoid poor compliance.
INTRODUCTION


This 2-year, randomized, controlled, non-inferiority study assessed the efficacy and safety of a delayed-release (DR) 35-mg weekly oral formulation of risedronate that allows subjects to take their weekly risedronate dose before or immediately after breakfast. Results from the first year of the study were published previously (McClung et al. Osteoporos Int 23(1):267-276, 2012); we now report the final results after 2 years.
METHODS


Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediate-release (IR) daily (n = 307) at least 30 min before breakfast, or risedronate 35 mg DR weekly, either immediately following breakfast (FB, n = 307) or at least 30 min before breakfast (BB, n = 308). Bone mineral density (BMD), bone turnover markers (BTMs), fractures, adverse events, and bone histomorphometry were evaluated.
RESULTS


A total of 248 subjects (80.8 %) in the IR daily group, 234 subjects (76.2 %) in the DR FB weekly group, and 240 subjects (77.9 %) in the DR BB weekly group completed the 2-year study. After 2 years of treatment, BMD increases at the lumbar spine and total hip with the weekly DR doses similar to or greater than that with the IR daily dose. Decreases in BTMs were similar or significantly lower in the DR groups. Bone histomorphometry results did not differ among the DR weekly and the IR daily formulations. The three regimens were similarly well tolerated.
CONCLUSIONS


Risedronate 35 mg DR weekly is as effective and as well tolerated as risedronate 5 mg IR daily, and will allow subjects to take their weekly risedronate dose immediately after breakfast.",2013,"After 2 years of treatment, BMD increases at the lumbar spine and total hip with the weekly DR doses similar to or greater than that with the IR daily dose.","['postmenopausal osteoporosis with delayed-release', 'Women with postmenopausal osteoporosis', '248 subjects (80.8\xa0%) in the IR daily group, 234 subjects (76.2\xa0%) in the DR FB weekly group, and 240 subjects (77.9\xa0%) in the DR BB weekly group completed the 2-year study']","['risedronate', 'risedronate 5\xa0mg immediate-release (IR) daily (n\u2009=\u2009307) at least 30\xa0min before breakfast, or risedronate 35\xa0mg DR weekly, either immediately following breakfast (FB, n\u2009=\u2009307) or at least 30\xa0min before breakfast', 'Osteoporos', 'Risedronate']","['efficacy and safety', 'tolerated', 'BMD increases at the lumbar spine and total hip', 'BTMs', 'Bone mineral density (BMD), bone turnover markers (BTMs), fractures, adverse events, and bone histomorphometry']","[{'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C4544674', 'cui_str': 'Delayed-release'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1549040', 'cui_str': 'Before breakfast (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}]",248.0,0.0182064,"After 2 years of treatment, BMD increases at the lumbar spine and total hip with the weekly DR doses similar to or greater than that with the IR daily dose.","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, 5050 NE Hoyt, Suite 626, Portland, OR 97213, USA. mmcclung@orost.com'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Balske', 'Affiliation': ''}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Burgio', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wenderoth', 'Affiliation': ''}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Recker', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-012-2175-7']
163,23054063,"Comparison of tolerability and efficacy of a combination of paracetamol + caffeine and sumatriptan in the treatment of migraine attack: a randomized, double-blind, double-dummy, cross-over study.","In this study, we compared the efficacy and tolerability of the combination of paracetamol 1,000 mg + caffeine 130 mg (PCF) with sumatriptan 50 mg (SUM) in migraine attacks. This was a multi-center randomized double-blind, double-dummy, cross-over controlled trial. The efficacy was assessed by the sum of pain intensity differences, the curve of mean pain intensity, the number of pain free at 2 h, and the total pain relief. Tolerability was assessed by recording adverse events within 4 h after drug assumption and evaluating the global judgement of patients. The comparison of these parameters did not show differences between the two drugs which resulted absolutely overlapping in pain relief and patients evaluation. In conclusion, we confirm the efficacy and safety of PCF such as SUM in the treatment of migraine attacks.",2012,The comparison of these parameters did not show differences between the two drugs which resulted absolutely overlapping in pain relief and patients evaluation.,"['migraine attacks', 'migraine attack']","['paracetamol + caffeine and sumatriptan', 'paracetamol 1,000 mg + caffeine 130 mg (PCF) with sumatriptan 50 mg (SUM', 'PCF']","['Tolerability', 'pain intensity differences, the curve of mean pain intensity, the number of pain free at 2 h, and the total pain relief', 'efficacy and safety', 'tolerability and efficacy', 'pain relief', 'efficacy and tolerability']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1126222', 'cui_str': 'Sumatriptan 50 MG'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.313024,The comparison of these parameters did not show differences between the two drugs which resulted absolutely overlapping in pain relief and patients evaluation.,"[{'ForeName': 'Luigi Alberto', 'Initials': 'LA', 'LastName': 'Pini', 'Affiliation': 'Headache Study Center, University of Modena & Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Guerzoni', 'Affiliation': ''}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Cainazzo', 'Affiliation': ''}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': ''}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Prudenzano', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Livrea', 'Affiliation': ''}]",The journal of headache and pain,['10.1007/s10194-012-0484-z']
164,23052623,"Effects of formulation on the bioavailability of lutein and zeaxanthin: a randomized, double-blind, cross-over, comparative, single-dose study in healthy subjects.","PURPOSE


Lutein and zeaxanthin are macular pigments with a protective function in the retina. These xanthophylls must be obtained from the diet or added to foods or supplements via easy-to-use, stable formulations. The technique employed to produce these formulations may affect the bioavailability of the xanthophylls.
METHODS


Forty-eight healthy volunteers were randomized into this double-blind, cross-over study investigating the plasma kinetics of lutein provided as two different beadlet formulations. Subjects (n = 48) received a single dose of 20 mg of lutein as either a starch-matrix (""SMB"", FloraGLO® Lutein 5 %) or as a cross-linked alginate-matrix beadlet (""AMB"", Lyc-O-Lutein 20 %) formulation. Plasma concentrations of lutein and zeaxanthin were measured at 0, 1, 3, 6, 9, 12, 14, 24, 26, 28, 32, 36, 48, 72, 168, and 672 h.
RESULTS


The mean plasma AUC(0-72h), AUC(0-672h), and C(max) for total lutein and zeaxanthin and their all-E-isomers were significantly increased (p < 0.001) from pre-dose concentrations in response to SMB and AMB. There was no difference in lutein T max between the two test articles. However, by 14 h post-dose, total plasma lutein increased by 7 % with AMB and by 126 % with SMB. Total lutein AUC(0-72h) and AUC(0-672h) were 1.8-fold and 1.3-fold higher, respectively, for SMB compared to AMB. Both formulations were well tolerated by subjects in this study.
CONCLUSION


These findings confirm that the bioavailability of lutein and zeaxanthin critically depends on the formulation used and document a superiority of the starch-based over the alginate-based product in this study.",2013,There was no difference in lutein T max between the two test articles.,"['Forty-eight healthy volunteers', 'healthy subjects', 'Subjects (n = 48']","['Lutein and zeaxanthin', 'lutein and zeaxanthin', 'single dose of 20 mg of lutein as either a starch-matrix (""SMB"", FloraGLO® Lutein 5 %) or as a cross-linked alginate-matrix beadlet (""AMB"", Lyc-O-Lutein 20 %) formulation']","['total plasma lutein', 'Plasma concentrations of lutein and zeaxanthin', 'mean plasma AUC(0-72h), AUC(0-672h), and C(max) for total lutein and zeaxanthin and their all-E-isomers', 'lutein T max']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0075554', 'cui_str': 'SMb (sulfmyoglobin)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0102137', 'cui_str': 'alginate'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",48.0,0.087376,There was no difference in lutein T max between the two test articles.,"[{'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Synergize, London, ON, Canada.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Elliott', 'Affiliation': ''}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Etheve', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schalch', 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-012-0447-9']
165,23114849,"Lactobacillus GG (LGG) and smectite versus LGG alone for acute gastroenteritis: a double-blind, randomized controlled trial.","UNLABELLED


Diarrhea treatment with either Lactobacillus GG (LGG) or smectite as an adjuvant to standard rehydration therapy has proven efficacy. In countries where both LGG and smectite are available, concomitant use is frequently practiced. We investigated whether LGG plus smectite is superior to LGG alone in the management of children with acute gastroenteritis (AGE). A double-blind, placebo-controlled, randomized trial was performed. Children aged 4 to 60 months with AGE received LGG 6 × 10(9) colony forming units/day plus randomly either smectite (3 g) or placebo as an adjuvant to the standard rehydration therapy. Of the 88 children randomized, 81 (92 %) were available for intention-to-treat analysis. The duration of diarrhea in the LGG/smectite group (n = 44) compared with the LGG/placebo group (n = 37) was similar (P = 0.43). There were no significant differences between the study groups for the secondary outcomes, with three exceptions. On day 4, in the LGG/placebo group compared to the LGG/smectite group, there was significantly reduced stool frequency (P = 0.03). While there was a significant (P = 0.05) difference in stool consistency on the Bristol Stool Form Scale on day 4, it was not of clinical relevance. Finally, in the LGG/smectite group compared to the LGG/placebo group, there was a significantly shorter duration of intravenous therapy after randomization (P = 0.02). No adverse events were observed in the study groups.
CONCLUSION


LGG plus smectite and LGG alone are equally effective for treating young children with AGE. Combined use of the two interventions is not justified.",2013,"While there was a significant (P = 0.05) difference in stool consistency on the Bristol Stool Form Scale on day 4, it was not of clinical relevance.","['children with acute gastroenteritis (AGE', 'young children with AGE', '88 children randomized, 81 (92\xa0%) were available for intention-to-treat analysis', 'Children aged 4 to 60\xa0months with AGE received', 'acute gastroenteritis']","['placebo', 'LGG alone', 'LGG plus smectite', 'LGG', 'Lactobacillus GG (LGG) and smectite versus LGG alone', 'LGG/placebo', 'Lactobacillus GG (LGG']","['stool frequency', 'stool consistency', 'shorter duration of intravenous therapy', 'adverse events', 'duration of diarrhea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0074690', 'cui_str': 'Smectite'}, {'cui': 'C4279918', 'cui_str': 'Lactobacillus GG'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0455142', 'cui_str': 'Intravenous care'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",88.0,0.369864,"While there was a significant (P = 0.05) difference in stool consistency on the Bristol Stool Form Scale on day 4, it was not of clinical relevance.","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Pieścik-Lech', 'Affiliation': 'Department of Paediatrics, The Medical University of Warsaw, Dzialdowska 1, 01-183, Warsaw, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Urbańska', 'Affiliation': ''}, {'ForeName': 'Hania', 'Initials': 'H', 'LastName': 'Szajewska', 'Affiliation': ''}]",European journal of pediatrics,['10.1007/s00431-012-1878-2']
166,23099622,Randomized prospective trial comparing clinical outcomes 3 years after surgery by Marcy repair and Prolene Hernia System repair for adult indirect inguinal hernia.,"PURPOSE


The use of mesh in the surgical repair of adult indirect inguinal hernias is widely recommended in Western countries, but no randomized controlled trials have so far been reported in Japan. The purpose of the present randomized prospective trial was to compare a mesh method with non-mesh method for surgical repair of primary adult indirect inguinal hernias in which the diameter of the internal inguinal ring was up to 3.0 cm (I-1 or I-2 of Japanese Hernia Society Classification).
METHODS


Patients with a primary unilateral inguinal hernia and I-1 or I-2 surgical findings were randomized to undergo either Marcy repair or Prolene Hernia System repair. Primary endpoints were recurrence, infection, and pain, with follow-up continued for 3 years postoperatively.
RESULTS


Ninety-one of 479 patients with an inguinal hernia during the study period did not meet the exclusion criteria, and 46 were allocated to Marcy repair and 45 were allocated to Prolene Hernia System repair. No recurrence was observed in either group, and no significant differences were identified between the groups in any of the primary endpoints.
CONCLUSION


This randomized prospective trial of I-1 and I-2 inguinal hernias suggests that Marcy repair is not inferior to PHS repair. A large-scale randomized controlled trial appears warranted to confirm whether to use mesh for Japanese adult I-1 and I-2 hernias.",2013,"No recurrence was observed in either group, and no significant differences were identified between the groups in any of the primary endpoints.
","['Patients with a primary unilateral inguinal hernia and I-1 or I-2 surgical findings', 'Ninety-one of 479 patients with an inguinal hernia during the study period did not meet the exclusion criteria, and 46 were allocated to', 'Japanese adult I-1 and I-2 hernias']","['surgery by Marcy repair and Prolene Hernia System repair for adult indirect inguinal hernia', 'Marcy repair', 'I-2 inguinal hernias', 'mesh method with non-mesh method for surgical repair of primary adult indirect inguinal hernias', 'Marcy repair or Prolene Hernia System repair', 'Prolene Hernia System repair']","['No recurrence', 'recurrence, infection, and pain, with follow-up continued for 3 years postoperatively']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0917843', 'cui_str': 'Prolene'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019296', 'cui_str': 'Inguinal Hernia, Indirect'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",479.0,0.178994,"No recurrence was observed in either group, and no significant differences were identified between the groups in any of the primary endpoints.
","[{'ForeName': 'Motohito', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Surgery, Hiratsuka City Hospital, 1-19-1 Minamihara, Hiratsuka, Kanagawa, 254-0065, Japan, momameju@aol.com.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagase', 'Affiliation': ''}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Akatsu', 'Affiliation': ''}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Imai', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Fujimura', 'Affiliation': ''}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Asagoe', 'Affiliation': ''}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kanai', 'Affiliation': ''}]",Surgery today,['10.1007/s00595-012-0384-5']
167,23090858,Facilitating responsible gambling: the relative effectiveness of education-based animation and monetary limit setting pop-up messages among electronic gaming machine players.,"Although most gamblers set a monetary limit on their play, many exceed this limit--an antecedent of problematic gambling. Responsible gambling tools may assist players to gamble within their means. Historically, however, the impact of such tools has been assessed in isolation. In the current research, two responsible gambling tools that target adherence to a monetary limit were assessed among 72 electronic gaming machine (EGM) players. Participants watched an educational animation explaining how EGMs work (or a neutral video) and then played an EGM in a virtual reality environment. All participants were asked to set a monetary limit on their play, but only half were reminded when that limit was reached. Results showed that both the animation and pop-up limit reminder helped gamblers stay within their preset monetary limit; however, an interaction qualified these main effects. Among participants who did not experience the pop-up reminder, those who watched the animation stayed within their preset monetary limits more than those who did not watch the animation. For those who were reminded of their limit, however, there was no difference in limit adherence between those who watched the animation and those who did not watch the animation. From a responsible gambling perspective, the current study suggests that there is no additive effect of exposure to both responsible gambling tools. Therefore, for minimal disruption in play, a pop-up message reminding gamblers of their preset monetary limit might be preferred over the lengthier educational animation.",2013,"For those who were reminded of their limit, however, there was no difference in limit adherence between those who watched the animation and those who did not watch the animation.",[],"['education-based animation and monetary limit setting pop-up messages among electronic gaming machine players', 'educational animation explaining how EGMs work (or a neutral video) and then played an EGM']","['limit adherence', 'gamblers stay']",[],"[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0150269', 'cui_str': 'Limit setting (procedure)'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}]",72.0,0.0248033,"For those who were reminded of their limit, however, there was no difference in limit adherence between those who watched the animation and those who did not watch the animation.","[{'ForeName': 'Michael J A', 'Initials': 'MJ', 'LastName': 'Wohl', 'Affiliation': 'Department of Psychology, Carleton University, 1125 Colonel By Drive, Ottawa, ON, K1S 5B6, Canada, michael_wohl@carleton.ca.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Gainsbury', 'Affiliation': ''}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Sztainert', 'Affiliation': ''}]",Journal of gambling studies,['10.1007/s10899-012-9340-y']
168,23060736,A lipidomic analysis approach to evaluate the response to cholesterol-lowering food intake.,"Plant sterols (PS) are well known to reduce serum levels of total cholesterol and LDL-cholesterol. Lipidomics potentially provides detailed information on a wide range of individual serum lipid metabolites, which may further add to our understanding of the biological effects of PS. In this study, lipidomics analysis was applied to serum samples from a placebo-controlled, parallel human intervention study (n = 97) of 4-week consumption of two PS-enriched, yoghurt drinks differing in fat content (based on 0.1% vs. 1.5% dairy fat). A comprehensive data analysis strategy was developed and implemented to assess and compare effects of two different PS-treatments and placebo treatment. The combination of univariate and multivariate data analysis approaches allowed to show significant effects of PS intake on the serum lipidome, and helped to distinguish them from fat content and non-specific effects. The PS-enriched 0.1% dairy fat yoghurt drink had a stronger impact on the lipidome than the 1.5% dairy fat yoghurt drink, despite similar LDL-cholesterol lowering effects. The PS-enriched 0.1% dairy fat yoghurt drink reduced levels of several sphingomyelins which correlated well with the reduction in LDL-cholesterol and can be explained by co-localization of sphingomyelins and cholesterol on the surface of LDL lipoprotein. Statistically significant reductions in serum levels of two lysophosphatidylcholines (LPC(16:1), LPC(20:1)) and cholesteryl arachidonate may suggest reduced inflammation and atherogenic potential. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11306-011-0384-2) contains supplementary material, which is available to authorized users.",2012,"Statistically significant reductions in serum levels of two lysophosphatidylcholines (LPC(16:1), LPC(20:1)) and cholesteryl arachidonate may suggest reduced inflammation and atherogenic potential.",[],['placebo'],"['serum levels of two lysophosphatidylcholines (LPC(16:1), LPC(20:1', 'serum levels of total cholesterol and LDL-cholesterol', 'LDL-cholesterol', 'levels of several sphingomyelins']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024360', 'cui_str': 'Lysolecithins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelins'}]",,0.10759,"Statistically significant reductions in serum levels of two lysophosphatidylcholines (LPC(16:1), LPC(20:1)) and cholesteryl arachidonate may suggest reduced inflammation and atherogenic potential.","[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Szymańska', 'Affiliation': 'Netherlands Metabolomics Centre, Leiden, The Netherlands  ; Biosystems Data Analysis, Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ferdinand A', 'Initials': 'FA', 'LastName': 'van Dorsten', 'Affiliation': ''}, {'ForeName': 'Jorne', 'Initials': 'J', 'LastName': 'Troost', 'Affiliation': ''}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Paliukhovich', 'Affiliation': ''}, {'ForeName': 'Ewoud J J', 'Initials': 'EJ', 'LastName': 'van Velzen', 'Affiliation': ''}, {'ForeName': 'Margriet M W B', 'Initials': 'MM', 'LastName': 'Hendriks', 'Affiliation': ''}, {'ForeName': 'Elke A', 'Initials': 'EA', 'LastName': 'Trautwein', 'Affiliation': ''}, {'ForeName': 'John P M', 'Initials': 'JP', 'LastName': 'van Duynhoven', 'Affiliation': ''}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Vreeken', 'Affiliation': ''}, {'ForeName': 'Age K', 'Initials': 'AK', 'LastName': 'Smilde', 'Affiliation': ''}]",Metabolomics : Official journal of the Metabolomic Society,[]
169,23053458,"A randomised, multi-centre, prospective, observer and patient blind study to evaluate a non-absorbable polypropylene mesh vs. a partly absorbable mesh in incisional hernia repair.","BACKGROUND


The implantation of a polymer mesh is considered as the standard treatment for incisional hernia. It leads to lower recurrence rates compared to suture techniques without mesh implantation; however, there are also some drawbacks to mesh repair. The operation is more complex and peri-operative infectious complications are increased. Yet it is not clear to what extent a mesh implantation influences quality of life or leads to chronic pain or discomfort. The influence of the material, textile structure and size of the mesh remain unclear. The aim of this study was to evaluate if a non-absorbable, large pore-sized, lightweight polypropylene (PP) mesh leads to a better health outcome compared to a partly absorbable mesh.
METHODS/DESIGN


In this randomised, double-blinded study, 80 patients with incisional hernia after a median laparotomy received in sublay technique either a non-absorbable mesh (Optilene® Mesh Elastic) or a partly absorbable mesh (Ultrapro® Mesh). Primary endpoint was the physical health score from the SF-36 questionnaire 21 days post-operatively. Secondary variables were patients' daily activity score, pain score, wound assessment and post-surgical complications until 6 months post-operatively.
RESULTS


SF-36, daily activity and pain scores were similar in both groups after 21 days and 6 months, respectively. No hernia recurrence was observed during the observation period. Post-operative complication rates also showed no difference between the groups.
CONCLUSION


The implantation of a non-absorbable, large pore-sized, lightweight PP mesh for incisional hernia leads to similar patient-related outcome parameters, recurrence and complication rates as a partly absorbable mesh.",2012,"RESULTS


SF-36, daily activity and pain scores were similar in both groups after 21 days and 6 months, respectively.","['80 patients with incisional hernia after a median', 'incisional hernia', 'incisional hernia repair']","['non-absorbable polypropylene mesh vs. a partly absorbable mesh', 'non-absorbable, large pore-sized, lightweight polypropylene (PP) mesh', 'laparotomy received in sublay technique either a non-absorbable mesh (Optilene® Mesh Elastic) or a partly absorbable mesh (Ultrapro® Mesh']","['Post-operative complication rates', 'physical health score from the SF-36 questionnaire 21\xa0days post-operatively', 'daily activity score, pain score, wound assessment and post-surgical complications until 6\xa0months post-operatively', 'hernia recurrence', 'recurrence rates', 'SF-36, daily activity and pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0267716', 'cui_str': 'Postoperative Hernia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0342971', 'cui_str': 'Repair of incisional hernia (procedure)'}]","[{'cui': 'C1321585', 'cui_str': 'Polypropylene mesh (physical object)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0558033', 'cui_str': 'Wound assessment'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",80.0,0.212365,"RESULTS


SF-36, daily activity and pain scores were similar in both groups after 21 days and 6 months, respectively.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rickert', 'Affiliation': 'Department of Surgery, University Medical Centre Mannheim, Mannheim, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kienle', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kuthe', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Baumann', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Engemann', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kuhlgatz', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'von Frankenberg', 'Affiliation': ''}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Knaebel', 'Affiliation': ''}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': ''}]",Langenbeck's archives of surgery,['10.1007/s00423-012-1009-6']
170,23054316,The lipid story in chronic kidney disease: a long story with a happy end?,"Cardiovascular (CV) morbidity and mortality increase with the severity of kidney disease, reaching 30 times higher mortality rates in dialysis patients compared with the general population. Although dyslipidemia is a well-established CV risk factor in the general population, the relationship between lipid disorders and CV risk in patients with chronic kidney disease (CKD) is less clear. Despite the clear evidence that statins reduce the risk of atherosclerotic events and death from cardiac causes in individuals without CKD, the use of statins in patients with kidney disease is significantly less frequent. For a long time, one of the explanations was the lack of a prospective, randomized, controlled study designed specifically to CKD patients. After recent publication of the data from Study of Heart and Renal Protection trial, given the safety and potential efficacy of statins, this lipid-lowering treatment should be administered more frequently to individuals with CKD stage 1-4, as well as those undergoing dialysis.",2013,"Cardiovascular (CV) morbidity and mortality increase with the severity of kidney disease, reaching 30 times higher mortality rates in dialysis patients compared with the general population.","['chronic kidney disease', 'patients with kidney disease', 'patients with chronic kidney disease (CKD']",[],"['Cardiovascular (CV) morbidity and mortality', 'mortality rates']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}]",[],"[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",,0.0190836,"Cardiovascular (CV) morbidity and mortality increase with the severity of kidney disease, reaching 30 times higher mortality rates in dialysis patients compared with the general population.","[{'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Kujawa-Szewieczek', 'Affiliation': 'Department of Nephrology, Endocrinology and Metabolic Diseases, Medical University of Silesia, ul. Francuska 20-24, 40-027, Katowice, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Więcek', 'Affiliation': ''}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Piecha', 'Affiliation': ''}]",International urology and nephrology,['10.1007/s11255-012-0296-8']
171,22736201,"A randomized controlled trial of qigong exercise on fatigue symptoms, functioning, and telomerase activity in persons with chronic fatigue or chronic fatigue syndrome.","BACKGROUND


Chronic fatigue is common in the general population. Complementary therapies are often used by patients with chronic fatigue or chronic fatigue syndrome to manage their symptoms.
PURPOSE


This study aimed to assess the effect of a 4-month qigong intervention program among patients with chronic fatigue or chronic fatigue syndrome.
METHODS


Sixty-four participants were randomly assigned to either an intervention group or a wait list control group. Outcome measures included fatigue symptoms, physical functioning, mental functioning, and telomerase activity.
RESULTS


Fatigue symptoms and mental functioning were significantly improved in the qigong group compared to controls. Telomerase activity increased in the qigong group from 0.102 to 0.178 arbitrary units (p < 0.05). The change was statistically significant when compared to the control group (p < 0.05).
CONCLUSION


Qigong exercise may be used as an alternative and complementary therapy or rehabilitative program for chronic fatigue and chronic fatigue syndrome.",2012,Telomerase activity increased in the qigong group from 0.102 to 0.178 arbitrary units (p < 0.05).,"['Sixty-four participants', 'patients with chronic fatigue or chronic fatigue syndrome', 'persons with chronic fatigue or chronic fatigue syndrome']","['intervention group or a wait list control group', 'qigong intervention program', 'Qigong exercise', 'qigong exercise']","['Telomerase activity', 'Fatigue symptoms and mental functioning', 'fatigue symptoms, physical functioning, mental functioning, and telomerase activity', 'fatigue symptoms, functioning, and telomerase activity']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0015674', 'cui_str': 'Systemic Exertion Intolerance Disease'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",64.0,0.0695876,Telomerase activity increased in the qigong group from 0.102 to 0.178 arbitrary units (p < 0.05).,"[{'ForeName': 'Rainbow T H', 'Initials': 'RT', 'LastName': 'Ho', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, China. tinho@hku.hk'}, {'ForeName': 'Jessie S M', 'Initials': 'JS', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Chong-Wen', 'Initials': 'CW', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Benson W M', 'Initials': 'BW', 'LastName': 'Lau', 'Affiliation': ''}, {'ForeName': 'Kwok Fai', 'Initials': 'KF', 'LastName': 'So', 'Affiliation': ''}, {'ForeName': 'Li Ping', 'Initials': 'LP', 'LastName': 'Yuen', 'Affiliation': ''}, {'ForeName': 'Jonathan S T', 'Initials': 'JS', 'LastName': 'Sham', 'Affiliation': ''}, {'ForeName': 'Cecilia L W', 'Initials': 'CL', 'LastName': 'Chan', 'Affiliation': ''}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1007/s12160-012-9381-6']
172,22968678,Metformin in non-diabetic patients presenting with ST elevation myocardial infarction: rationale and design of the glycometabolic intervention as adjunct to primary percutaneous intervention in ST elevation myocardial infarction (GIPS)-III trial.,"BACKGROUND


Left ventricular dysfunction and the development of heart failure is a frequent and serious complication of myocardial infarction. Recent animal experimental studies suggested that metformin treatment reduces myocardial injury and preserves cardiac function in non-diabetic rats after experimental myocardial infarction. We will study the efficacy of metformin with the aim to preserve left ventricular ejection fraction in non-diabetic patients presenting with ST elevation myocardial infarction (STEMI).
METHODS


The Glycometabolic Intervention as adjunct to Primary percutaneous intervention in ST elevation myocardial infarction (GIPS)-III trial is a prospective, single center, double blind, randomized, placebo-controlled trial. Three-hundred-and-fifty patients, without diabetes, requiring primary percutaneous coronary intervention (PCI) for STEMI will be randomized to metformin 500 mg twice daily or placebo treatment and will undergo magnetic resonance imaging (MRI) after 4 months. Major exclusion criteria were prior myocardial infarction and severe renal dysfunction. The primary efficacy parameter is left ventricular ejection fraction 4 months after randomization. Secondary and tertiary efficacy parameters include major adverse cardiac events, new onset diabetes and glycometabolic parameters, and echocardiographic diastolic function. Safety parameters include renal function deterioration and lactic acidosis.
CONCLUSIONS


The GIPS-III trial will evaluate the efficacy of metformin treatment to preserve left ventricular ejection fraction in STEMI patients without diabetes.",2012,The GIPS-III trial will evaluate the efficacy of metformin treatment to preserve left ventricular ejection fraction in STEMI patients without diabetes.,"['non-diabetic patients presenting with ST elevation myocardial infarction (STEMI', 'ST elevation myocardial infarction (GIPS)-III trial', 'Three-hundred-and-fifty patients, without diabetes, requiring primary percutaneous coronary intervention (PCI) for STEMI', 'STEMI patients without diabetes', 'non-diabetic patients presenting with ST elevation myocardial infarction']","['Glycometabolic Intervention', 'primary percutaneous intervention', 'placebo', 'metformin', 'Primary percutaneous intervention', 'Metformin', 'metformin 500 mg twice daily or placebo', 'glycometabolic intervention']","['myocardial infarction and severe renal dysfunction', 'cardiac function', 'left ventricular ejection fraction', 'myocardial injury', 'renal function deterioration and lactic acidosis', 'major adverse cardiac events, new onset diabetes and glycometabolic parameters, and echocardiographic diastolic function']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1869036', 'cui_str': 'Lactic acidosis (SMQ)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'function'}]",350.0,0.0923836,The GIPS-III trial will evaluate the efficacy of metformin treatment to preserve left ventricular ejection fraction in STEMI patients without diabetes.,"[{'ForeName': 'Chris P H', 'Initials': 'CP', 'LastName': 'Lexis', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, PO Box 30.001, Groningen, the Netherlands. c.p.h.lexis@umcg.nl'}, {'ForeName': 'Iwan C C', 'Initials': 'IC', 'LastName': 'van der Horst', 'Affiliation': ''}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lipsic', 'Affiliation': ''}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': ''}, {'ForeName': 'Anouk N A', 'Initials': 'AN', 'LastName': 'van der Horst-Schrivers', 'Affiliation': ''}, {'ForeName': 'Bruce H R', 'Initials': 'BH', 'LastName': 'Wolffenbuttel', 'Affiliation': ''}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': ''}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': ''}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': ''}, {'ForeName': 'Bart J G L', 'Initials': 'BJ', 'LastName': 'de Smet', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular drugs and therapy,['10.1007/s10557-012-6413-1']
173,22836201,Five-year follow-up of participants in a randomised controlled trial showing benefits from exercise for breast cancer survivors during adjuvant treatment. Are there lasting effects?,"PURPOSE


In an earlier randomised controlled trial, we showed that early stage breast cancer patients who received a supervised exercise programme, with discussion of behaviour change techniques, had psychological and functional benefits 6 months after the intervention. The purpose of this study was to determine if benefits observed at 6 months persisted 18 and 60 months later.
METHODS


Women who were in the original trial were contacted at 18 and 60 months after intervention. Original measures were repeated.
RESULTS


Of the 148 women from the original study who agreed to be contacted again, 114 attended for follow-up at 18 months and 87 at 60 months. Women in the original intervention group reported more leisure time physical activity and more positive moods at 60 months than women in the original control group. Irrespective of original group allocation, women who were more active consistently reported lower levels of depression and increased quality of life compared to those who were less active.
CONCLUSIONS


We have shown that there are lasting benefits to an exercise intervention delivered during treatment to breast cancer survivors. Regular activity should be encouraged for women with early stage breast cancer as this can have lasting implications for physical and psychological functioning.",2012,"Irrespective of original group allocation, women who were more active consistently reported lower levels of depression and increased quality of life compared to those who were less active.
","['Women who were in the original trial were contacted at 18 and 60\xa0months after intervention', 'breast cancer survivors during adjuvant treatment', 'early stage breast cancer patients', '148 women from the original study who agreed to be contacted again', 'women with early stage breast cancer']","['exercise intervention', 'supervised exercise programme, with discussion of behaviour change techniques, had psychological and functional benefits']","['leisure time physical activity and more positive moods', 'levels of depression and increased quality of life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0034380'}]",148.0,0.130092,"Irrespective of original group allocation, women who were more active consistently reported lower levels of depression and increased quality of life compared to those who were less active.
","[{'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': 'School of Psychological Sciences and Health, University of Strathclyde, 76 Southbrae Drive, Glasgow G13 1PP, UK. nanette.mutrie@ed.ac.uk'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Barry', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hefferon', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ritchie', 'Affiliation': ''}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Tovey', 'Affiliation': ''}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-012-0233-y']
174,22732767,Cardiovascular safety of lumiracoxib: a meta-analysis of randomised controlled trials in patients with osteoarthritis.,"PURPOSE


To re-evaluate the cardiovascular risk of lumiracoxib compared with other non-steroidal anti-inflammatory drugs (NSAIDs) or placebo in patients with osteoarthritis.
METHODS


We conducted a meta-analysis of randomised controlled trials of lumiracoxib versus placebo or other NSAIDs in patients with osteoarthritis reported up to January 2010. Both published and unpublished trials were included. PubMed searches using predefined search criteria (lumiracoxib AND osteoarthritis, limits: none; COX-189 AND osteoarthritis, limits: none) were used to obtain the relevant published trials. Novartis granted explicit access to their company studies and the right to use these study reports for the purposes of publication in peer reviewed journals. Endpoints were the Antiplatelet Trialists' Collaboration (APTC) endpoint and individual cardiovascular endpoints.
RESULTS


Meta-analysis of 6 trials of lumiracoxib versus placebo revealed no difference in cardiovascular outcomes. Meta-analysis of 12 trials of lumiracoxib versus other NSAIDs also revealed no difference. The pooled odds ratios were: 1.16 (95% CI 0.82, 1.63); 1.66 (95% CI 0.84, 3.29); 0.95 (95% CI 0.52, 1.76) and 1.04 (95% CI 0.60, 1.80) for the APTC endpoint, myocardial infarction, stroke and cardiovascular death respectively.
CONCLUSIONS


The results suggest that there were no significant differences in cardiovascular outcomes between lumiracoxib and placebo or between lumiracoxib and other NSAIDs in patients with osteoarthritis. Wide confidence intervals mean that further research is needed in this area to confirm these findings.",2013,"The pooled odds ratios were: 1.16 (95% CI 0.82, 1.63); 1.66 (95% CI 0.84, 3.29); 0.95 (95% CI 0.52, 1.76) and 1.04 (95% CI 0.60, 1.80) for the APTC endpoint, myocardial infarction, stroke and cardiovascular death respectively.
","['patients with osteoarthritis', 'patients with osteoarthritis reported up to January 2010']","['non-steroidal anti-inflammatory drugs (NSAIDs) or placebo', 'lumiracoxib', 'placebo']","['cardiovascular risk', ""Antiplatelet Trialists' Collaboration (APTC) endpoint and individual cardiovascular endpoints"", 'cardiovascular outcomes', 'APTC endpoint, myocardial infarction, stroke and cardiovascular death respectively', 'Cardiovascular safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1176415', 'cui_str': '2-(2-((2-chloro-6-fluoro-phenyl)amino)-5-methyl-phenyl)acetic acid'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.281847,"The pooled odds ratios were: 1.16 (95% CI 0.82, 1.63); 1.66 (95% CI 0.84, 3.29); 0.95 (95% CI 0.52, 1.76) and 1.04 (95% CI 0.60, 1.80) for the APTC endpoint, myocardial infarction, stroke and cardiovascular death respectively.
","[{'ForeName': 'Isla S', 'Initials': 'IS', 'LastName': 'Mackenzie', 'Affiliation': 'Medicines Monitoring Unit (MEMO) & Hypertension Research Centre (HRC), Division of Medical Sciences, University of Dundee, Ninewells Hospital & Medical School, Dundee DD1 9SY, UK. i.s.mackenzie@dundee.ac.uk'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Macdonald', 'Affiliation': ''}]",European journal of clinical pharmacology,['10.1007/s00228-012-1335-1']
175,22907422,Role of obesity in a randomized placebo-controlled trial of difluoromethylornithine (DFMO) + sulindac for the prevention of sporadic colorectal adenomas.,"BACKGROUND


Chemoprevention with the polyamine-inhibitory regimen difluoromethylornithine (DFMO) + sulindac markedly reduces risk of recurrent adenoma in colorectal adenoma patients. Obesity is associated with risk of colorectal adenoma and colorectal cancer. This study investigates how obesity influences risk of recurrent adenoma after prolonged treatment with DFMO + sulindac versus placebo.
METHODS


Our analysis included subjects enrolled in the phase III colorectal adenoma prevention clinical trial investigating DFMO + sulindac versus placebo. Patients were classified by obesity (body mass index, BMI ≥ 30 kg/m(2)) status at baseline. Pearson χ(2) statistic and Mann-Whitney U test were used to compare baseline characteristics, including rectal tissue polyamine levels. Log-binomial regression analysis was used to determine the risk ratio (RR) of recurrent adenomas, adjusted for covariates and an interaction term for obesity and treatment.
RESULTS


The final analytic cohort was comprised of 267 patients. In separate regression models, the risk of adenoma recurrence after treatment compared to placebo was similar for obese (RR = 0.32, 95 % CI 15-71) and non-obese patients (RR = 0.27, 95 % CI 15-49). No significant interaction was detected between obesity, treatment, and risk of colorectal adenoma in the full regression model (p                            (interaction) = 0.91).
CONCLUSIONS


Obesity does not substantially modify the colorectal adenoma risk reduction ascribed to DFMO + sulindac versus placebo.",2012,"In separate regression models, the risk of adenoma recurrence after treatment compared to placebo was similar for obese (RR = 0.32","['subjects enrolled in the phase III colorectal adenoma prevention clinical trial investigating DFMO\xa0', 'Patients were classified by obesity (body mass index, BMI\xa0≥', '267 patients', 'colorectal adenoma patients', 'sporadic colorectal adenomas']","['sulindac versus placebo', 'placebo', 'DFMO\xa0+\xa0sulindac versus placebo', 'difluoromethylornithine (DFMO)\xa0+\xa0sulindac']","['rectal tissue polyamine levels', 'risk of adenoma recurrence', 'obesity, treatment, and risk of colorectal adenoma', 'colorectal adenoma risk reduction', 'risk ratio (RR) of recurrent adenomas']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0205422', 'cui_str': 'Sporadic (qualifier value)'}]","[{'cui': 'C0038792', 'cui_str': 'Sulindac'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002260', 'cui_str': 'Eflornithine'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0032433', 'cui_str': 'Polyamines'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",267.0,0.236968,"In separate regression models, the risk of adenoma recurrence after treatment compared to placebo was similar for obese (RR = 0.32","[{'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Zell', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, CA 92697, USA. jzell@uci.edu'}, {'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Madson', 'Affiliation': ''}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'McLaren', 'Affiliation': ''}, {'ForeName': 'Eugene W', 'Initials': 'EW', 'LastName': 'Gerner', 'Affiliation': ''}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Meyskens', 'Affiliation': ''}]",Cancer causes & control : CCC,['10.1007/s10552-012-0051-6']
176,22885882,"A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life.","PURPOSE


The aim of this study is to test in a double-blinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria.
BACKGROUND


There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS.
METHODS


This is a double-blinded, randomised placebo-controlled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief. The secondary endpoints were change in abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation). Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed.
RESULTS


Sixty-four IBS patients (symbiotic n = 32, 64 % females, mean age 38.7 ± 12.6 years) were studied. This symbiotic mixture reduced flatulence over a 4-week period of treatment (repeated-measures analysis of covariance, p < 0.05). Proportions of responders were not significantly different between groups. At the end of the treatment, a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group.
CONCLUSIONS


This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients, a lack of adverse events and a good side-effect profile; however, it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating. Further studies are warranted.",2013,"Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed.
","['patients with irritable bowel syndrome (IBS', 'irritable bowel syndrome (IBS) patients who meet Rome III criteria', 'Sixty-four IBS patients (symbiotic n = 32, 64 % females, mean age 38.7 ± 12.6 years']","['symbiotic mixture (Probinul', 'commercially available multi-strain symbiotic mixture', 'placebo', 'symbiotic mixture']","['symptoms, colonic transit and quality of life', 'global satisfactory relief of abdominal flatulence and bloating', 'flatulence', 'longer rectosigmoid transit time', 'Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36', 'abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation', 'most SF-36 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0034380'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0521377', 'cui_str': 'Rectum and sigmoid colon, CS'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0222045'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",64.0,0.338196,"Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed.
","[{'ForeName': 'Carmelina', 'Initials': 'C', 'LastName': 'Cappello', 'Affiliation': 'Chirurgia Generale e Geriatrica, Facoltà di Medicina e Chirurgia, Università degli Studi di Napoli Federico II, Via Pansini 5, 80131 Napoli, Italy. carmi_c@hotmail.it'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Tremolaterra', 'Affiliation': ''}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Pascariello', 'Affiliation': ''}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ciacci', 'Affiliation': ''}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Iovino', 'Affiliation': ''}]",International journal of colorectal disease,['10.1007/s00384-012-1552-1']
177,22782463,Efficacy and safety of capecitabine plus cisplatin in Japanese patients with advanced or metastatic gastric cancer: subset analyses of the AVAGAST study and the ToGA study.,"BACKGROUND


Capecitabine plus cisplatin (XP) is recognized as one of the global standard first-line chemotherapy regimens for patients with metastatic gastric cancer (mGC). Recent multinational phase III trials in mGC have been conducted with XP as the control arm, although no data on XP in Japanese patients with mGC have been published to date. The AVAGAST (XP ± bevacizumab in mGC) and ToGA (XP ± trastuzumab in human epidermal growth factor receptor 2 [HER2]-positive mGC) studies were the first two global studies including Japanese mGC patients. The aim of this analysis was to investigate the efficacy and safety of XP in Japanese mGC patients, using AVAGAST and ToGA subgroup data.
METHODS


Efficacy and safety analyses were carried out in Japanese patients with mGC receiving XP alone, based on results from the AVAGAST and ToGA studies. There were differences in the target populations between the two studies; for example, the ToGA study limited patients to those with HER2-positive tumors; therefore, efficacy was evaluated separately.
RESULTS


Ninety-four Japanese patients in the AVAGAST study and 50 in the ToGA study received XP alone. Median overall and progression-free survivals were 14.2 and 5.7 months, respectively, in the AVAGAST study, and 17.7 and 5.6 months, respectively, in the ToGA study. Overall response rates were 49.2 % in the AVAGAST and 58.5 % in the ToGA study. Adverse events were generally mild; the most common grade 3/4 events were neutropenia, anemia, anorexia, and nausea.
CONCLUSIONS


XP is effective and well tolerated in Japanese patients with mGC, and could be one of the standard regimens for the first-line treatment in this cohort.",2013,"Median overall and progression-free survivals were 14.2 and 5.7 months, respectively, in the AVAGAST study, and 17.7 and 5.6 months, respectively, in the ToGA study.","['Ninety-four Japanese patients in the AVAGAST study and 50 in the ToGA study received', 'human epidermal growth factor receptor 2', 'Japanese mGC patients', 'Japanese mGC patients, using AVAGAST and ToGA subgroup data', 'Japanese patients with mGC', 'Japanese patients with advanced or metastatic gastric cancer', 'Japanese patients with mGC receiving XP alone, based on results from the AVAGAST and ToGA studies', 'patients with metastatic gastric cancer (mGC']","['capecitabine plus cisplatin', 'XP', 'ToGA (XP ± trastuzumab', 'Capecitabine plus cisplatin (XP', 'AVAGAST (XP ± bevacizumab', 'AVAGAST']","['Adverse events', 'Efficacy and safety', 'efficacy and safety', 'Overall response rates', 'neutropenia, anemia, anorexia, and nausea', 'Median overall and progression-free survivals', 'effective and well tolerated']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",94.0,0.0317825,"Median overall and progression-free survivals were 14.2 and 5.7 months, respectively, in the AVAGAST study, and 17.7 and 5.6 months, respectively, in the ToGA study.","[{'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center Hospital, 818 Komuro, Ina-machi, Kitaadachi-gun, Saitama, 362-0806, Japan. k-yamaguchi@cancer-c.pref.saitama.jp'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sawaki', 'Affiliation': ''}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': ''}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': ''}, {'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': ''}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Omuro', 'Affiliation': ''}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': ''}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': ''}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': ''}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Takiuchi', 'Affiliation': ''}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': ''}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': ''}, {'ForeName': 'Wasaburo', 'Initials': 'W', 'LastName': 'Koizumi', 'Affiliation': ''}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Baba', 'Affiliation': ''}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': ''}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': ''}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-012-0167-0']
178,22791282,"Six months of high-dose xylitol in high-risk caries subjects--a 2-year randomised, clinical trial.","OBJECTIVES


The hypothesis was that the daily use of a high dose of a xylitol chewing gum for 6 months would reduce the increment of decayed permanent first molar surfaces (ΔD6S) in high-risk schoolchildren after 2 years.
METHODS


In this randomised, clinical trial, 204 schoolchildren with a high caries risk were assigned to two experimental groups, xylitol and non-xylitol. Caries status, salivary mutans streptococci, and lactobacilli were re-evaluated 2 years later in 74 xylitol-treated and 83 non-xylitol-treated schoolchildren. Differences in mean ∆D6S between groups registered at baseline and at follow-up were evaluated using the nonparametric Mann-Whitney U test.
RESULTS


Outcome was the development of detectable carious lesions initial (D1-D2) and manifest (D3) in the permanent first molars. In the xylitol group, the difference in proportion of children with decayed first permanent molars at baseline and follow-up was 1.43% for manifest lesion and 2.86% for initial lesions; while in the non-xylitol group was 10.26% (p < 0.01) and 16.66% (p < 0.01), respectively. A statistically significant difference regarding means was also observed in the non-xylitol group: the ∆D6S for manifest lesion was 0.18 (p = 0.03) and 0.67 (p = 0.02) for initial lesion.
CONCLUSION


The use of a chewing gum containing a high dose of xylitol for a period of 6 months has been shown to produce a long-term effect on caries development in high caries-risk children.
CLINICAL RELEVANCE


A school-based preventive programme based on 6 months' administration of a high dose of xylitol via chewing gum proved to be efficacious in controlling caries increment in high-risk children.",2013,"A statistically significant difference regarding means was also observed in the non-xylitol group: the ∆D6S for manifest lesion was 0.18 (p = 0.03) and 0.67 (p = 0.02) for initial lesion.
","['204 schoolchildren with a high caries risk', 'high-risk children', 'high-risk caries subjects']","['chewing gum containing a high dose of xylitol', 'xylitol chewing gum', 'xylitol', 'xylitol and non-xylitol', 'xylitol via chewing gum', 'xylitol-treated and 83 non-xylitol-treated schoolchildren']","['proportion of children with decayed first permanent molars', 'Caries status, salivary mutans streptococci, and lactobacilli', 'development of detectable carious lesions initial (D1-D2) and manifest (D3']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C4321298', 'cui_str': 'Chewing gum'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}]",204.0,0.064909,"A statistically significant difference regarding means was also observed in the non-xylitol group: the ∆D6S for manifest lesion was 0.18 (p = 0.03) and 0.67 (p = 0.02) for initial lesion.
","[{'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Campus', 'Affiliation': 'Department of Surgery, Microsurgery, Medical Sciences, Dental School, University of Sassari, Viale San Pietro 43/C, 07100, Sassari, Italy. gcampus@uniss.it'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Cagetti', 'Affiliation': ''}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Sale', 'Affiliation': ''}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Petruzzi', 'Affiliation': ''}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Solinas', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Strohmenger', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lingström', 'Affiliation': ''}]",Clinical oral investigations,['10.1007/s00784-012-0774-5']
179,22941391,Device life of the Provox Vega voice prosthesis.,"Device life of the Provox Vega Indwelling voice prosthesis is as yet untested outside Europe. The current study examined device life and reasons for replacement within an Australian clinical setting. Twenty-three participants were monitored for device life and reasons for replacement. Main outcome measure was days to failure of initial device. Average device life and reasons for replacement were secondary measures. Initial device life data revealed 67 % had functioning devices at 3 months, 52 % at 6 months and 29 % at 12 months. Average device life was 207 days (median of 222). The majority of devices (97 %) failed due to leakage through the prosthesis. The Provox Vega Indwelling voice prosthesis had favourable device life in this cohort of patients and in comparison to European data. Reasons for replacement were consistent with international literature.",2013,The Provox Vega Indwelling voice prosthesis had favourable device life in this cohort of patients and in comparison to European data.,[],['Provox Vega voice prosthesis'],"['days to failure of initial device', 'Average device life']",[],"[{'cui': 'C0087165', 'cui_str': 'Voice Prosthesis'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",23.0,0.121538,The Provox Vega Indwelling voice prosthesis had favourable device life in this cohort of patients and in comparison to European data.,"[{'ForeName': 'Kelli L', 'Initials': 'KL', 'LastName': 'Hancock', 'Affiliation': 'Speech Pathology Department, Princess Alexandra Hospital, Brisbane, QLD, 4102, Australia. Kelli_Hancock@health.qld.gov.au'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Lawson', 'Affiliation': ''}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Ward', 'Affiliation': ''}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-012-2154-9']
180,22933567,Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial.,"AIMS


Atrial fibrillation (AF) is common among patients with impaired renal function. Apixaban, a novel oral anticoagulant with partial renal excretion, was compared with warfarin and reduced the rate stroke, death and bleeding in the ARISTOTLE trial. We evaluated these outcomes in relation to renal function.
METHODS AND RESULTS


Baseline glomerular filtration rate (GFR) was estimated using the Cockcroft-Gault and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations as well as cystatin C measurements. According to baseline Cockcroft-Gault, there were 7518 patients (42%) with an estimated GFR (eGFR) of >80 mL/min, 7587 (42%) between >50 and 80 mL/min, and 3017 (15%) with an eGFR of ≤50 mL/min. The rate of cardiovascular events and bleeding was higher at impaired renal function (≤80 mL/min). Apixaban was more effective than warfarin in preventing stroke or systemic embolism and reducing mortality irrespective of renal function. These results were consistent, regardless of methods for GFR estimation. Apixaban was associated with less major bleeding events across all ranges of eGFRs. The relative risk reduction in major bleeding was greater in patients with an eGFR of ≤50 mL/min using Cockcroft-Gault {hazard ratio (HR) 0.50 [95% confidence interval (CI) 0.38-0.66], interaction P = 0.005} or CKD-EPI equations [HR 0.48 (95% CI 0.37-0.64), interaction P = 0.003].
CONCLUSION


In patients with AF, renal impairment was associated with increased risk of cardiovascular events and bleeding. When compared with warfarin, apixaban treatment reduced the rate of stroke, death, and major bleeding, regardless of renal function. Patients with impaired renal function seemed to have the greatest reduction in major bleeding with apixaban.",2012,The relative risk reduction in major bleeding was greater in patients with an eGFR of ≤50,"['patients with an eGFR of ≤50', 'patients with impaired renal function', 'patients with atrial fibrillation', 'Patients with impaired renal function']","['warfarin, apixaban', 'warfarin', 'apixaban', 'Apixaban']","['risk of cardiovascular events and bleeding', 'Cockcroft-Gault and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations', 'major bleeding events', 'stroke or systemic embolism and reducing mortality irrespective of renal function', 'major bleeding', 'rate stroke, death and bleeding', 'rate of cardiovascular events and bleeding', 'rate of stroke, death, and major bleeding, regardless of renal function', 'renal function', 'Baseline glomerular filtration rate (GFR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",,0.0654048,The relative risk reduction in major bleeding was greater in patients with an eGFR of ≤50,"[{'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Division of Clinical Electrophysiology, Department of Cardiology, J. W. Goethe University, Theodor-Stern-Kai 7, Frankfurt D 60590, Germany. hohnloser@em.uni-frankfurt.de'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Hijazi', 'Affiliation': ''}, {'ForeName': 'Laine', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Amerena', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': ''}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': ''}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ''}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Sendon', 'Affiliation': ''}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': ''}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehs274']
181,22810591,Addition of an induction regimen of antiangiogenesis and antitumor immunity to standard chemotherapy improves survival in advanced malignancies.,"Studies have shown that cancer requires two conditions for tumor progression: cancer cell proliferation and an environment permissive to and conditioned by malignancy. Chemotherapy aims to control the number and proliferation of cancer cells, but it does not effectively control the two best-known conditions of the tumor-permissive environment: neoangiogenesis and tolerogenic immunity. Many malignant diseases exhibit poor outcomes after treatment with chemotherapy. Therefore, we investigated the potential benefits of adding an induction regimen of antiangiogenesis and antitumor immunity to chemotherapy in poor outcome disease. In a prospective, randomized trial, we included patients with advanced, unresectable pancreatic adenocarcinomas, non-small cell lung cancer, or prostate cancer. Two groups of each primary condition were compared: group 1 (G1), n = 30, was treated with the standard chemotherapy and used as a control, and group 2 (G2), n = 30, was treated with chemotherapy plus an induction regimen of antiangiogenesis and antitumor immunity. This induction regimen included a low dose of metronomic cyclophosphamide, a high dose of Cox-2 inhibitor, granulocyte colony-stimulating factor, a sulfhydryl (SH) donor, and a hemoderivative that contained autologous tumor antigens released from patient tumors into the blood. After treatment, the G2 group demonstrated significantly longer survival, lower blood level of neoangiogenesis and immune-tolerance mediators, and higher blood levels of antiangiogenesis and antitumor immunity mediators compared with the G1 group. Toxicity and quality of life were not significantly different between the groups. In conclusion, in several advanced malignancies of different primary localizations, an increase in survival was observed by adding an induction regimen of antiangiogenesis and antitumor immunity to standard chemotherapy.",2012,"After treatment, the G2 group demonstrated significantly longer survival, lower blood level of neoangiogenesis and immune-tolerance mediators, and higher blood levels of antiangiogenesis and antitumor immunity mediators compared with the G1 group.","['patients with advanced, unresectable pancreatic adenocarcinomas, non-small cell lung cancer, or prostate cancer', 'advanced malignancies']","['Chemotherapy', 'chemotherapy plus an induction regimen of antiangiogenesis and antitumor immunity', 'chemotherapy', 'metronomic cyclophosphamide', 'standard chemotherapy']","['longer survival, lower blood level of neoangiogenesis and immune-tolerance mediators, and higher blood levels of antiangiogenesis and antitumor immunity mediators', 'survival', 'Toxicity and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C0020963', 'cui_str': 'Immune Tolerance'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}]",,0.0290515,"After treatment, the G2 group demonstrated significantly longer survival, lower blood level of neoangiogenesis and immune-tolerance mediators, and higher blood levels of antiangiogenesis and antitumor immunity mediators compared with the G1 group.","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lasalvia-Prisco', 'Affiliation': 'Interdoctors Network, Montevideo, Uruguay. interdoctors@live.com'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Goldschmidt', 'Affiliation': ''}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Galmarini', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cucchi', 'Affiliation': ''}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vázquez', 'Affiliation': ''}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Aghazarian', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lasalvia-Galante', 'Affiliation': ''}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Golomar', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gordon', 'Affiliation': ''}]","Medical oncology (Northwood, London, England)",['10.1007/s12032-012-0301-1']
182,22782539,Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.,"PURPOSE


To evaluate the pharmacokinetic and pharmacodynamic effects of concomitant administration of single loading doses of clopidogrel or multiple doses of clopidogrel with multiple doses of dabigatran etexilate.
METHODS


This was an open-label trial in healthy male subjects. In part 1 (pilot, n = 8) and part 3 (n = 12), a single dose of clopidogrel (300 or 600 mg, respectively) was given concomitantly with dabigatran etexilate at steady state; part 2 was a randomized, multiple-dose, crossover study with the test treatment being clopidogrel at steady state [300 mg loading dose on day 1, then 75 mg once daily (qd)] with concomitant dabigatran.
RESULTS


Bioavailability was moderately increased when a loading dose of clopidogrel (300 mg in part 1 and 600 mg in part 3) was administered concomitantly with dabigatran etexilate 150 mg twice daily (bid). Test/reference ratios for AUC(τ,ss) were 135% (90% CI 107-169%) and 132% (90% CI 112-156%), respectively. Steady-state dosing of clopidogrel 75 mg qd and dabigatran etexilate 150 mg bid (part 2) demonstrated minor effects on dabigatran pharmacokinetics (AUC(τ,ss) ratio test/reference: 91.9%, 90% CI 78.7-107%) or its pharmacokinetic/pharmacodynamic relationships (activated partial thromboplastin time, ecarin clotting time, thrombin time). Similarly, clopidogrel bioavailability remained unchanged by chronic administration of dabigatran etexilate (part 3: ratio test/reference for AUC(0-24) was 103%; 90% CI 80.3-131%), as did its pharmacodynamic effects on the inhibition of platelet aggregation.
CONCLUSIONS


When given concomitantly, dabigatran etexilate and clopidogrel at clinically relevant doses did not appear to have significant effects on the pharmacokinetic and pharmacodynamic profiles of either agent.",2013,"Test/reference ratios for AUC(τ,ss) were 135% (90% CI 107-169%) and 132% (90% CI 112-156%), respectively.","['healthy male volunteers', 'healthy male subjects']","['clopidogrel and dabigatran etexilate', 'clopidogrel', 'dabigatran etexilate', 'clopidogrel 75 mg qd and dabigatran etexilate', 'clopidogrel at steady state']","['clopidogrel bioavailability', 'dabigatran pharmacokinetics', 'Bioavailability', 'pharmacokinetic/pharmacodynamic relationships (activated partial thromboplastin time, ecarin clotting time, thrombin time']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0058908', 'cui_str': 'prothrombin activator (Echis carinatus venom)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0677634', 'cui_str': 'Reptilase Time'}]",,0.0474955,"Test/reference ratios for AUC(τ,ss) were 135% (90% CI 107-169%) and 132% (90% CI 112-156%), respectively.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Härtter', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Translational Medicine, Biberach an der Riss, Germany. Sebastian.haertter@boehringer-ingelheim.com'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Sennewald', 'Affiliation': ''}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Schepers', 'Affiliation': ''}, {'ForeName': 'Sybille', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': ''}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Fritsch', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Friedman', 'Affiliation': ''}]",European journal of clinical pharmacology,['10.1007/s00228-012-1304-8']
183,22752591,Agreement of self-reported items and clinically assessed nerve root involvement (or sciatica) in a primary care setting.,"INTRODUCTION


We analysed baseline measures from an RCT involving adults with low back pain (LBP) with or without referred leg pain, to identify self-report items that best identified clinically determined nerve root involvement (sciatica).
METHODS


Potential indicators of nerve root involvement were gathered using a self-reported questionnaire. Participants underwent a standardised physical examination on the same day as questionnaire completion. Self-reported items were compared to a reference standard (clinical diagnosis) using sensitivity, specificity, predictive values, likelihood ratios (LRs), the area under the receiver operating characteristic curve and logistic regression. Two reference standards are presented: one based on a clinical diagnosis of nerve root problems and excluding possible/inconclusive cases (referred to as a confirmatory reference), and the other being inclusive of possible/inconclusive cases (referred to as an indicative reference).
RESULTS


Pain below knee was the best single item for diagnostic accuracy with an area under curve (AUC) of 0.67-0.68, which however is slightly less than the 'acceptable discrimination'. A cluster of three items, including distribution of pain below the knee, leg pain that is worse than back pain, and feeling of numbness or pins and needles in the leg, did improve discrimination to an 'acceptable' level with an AUC of 0.72-0.74 in relation to confirmatory and indicative references, respectively. However, the likelihood ratios from the models were reflective of a 'small' amount of discrimination.
CONCLUSION


In this primary care population seeking treatment for LBP with or without leg pain, we found no clear set of self-report items that accurately identified patients with nerve root pain. When accurate case definition is important, clinical assessment should be the method of choice for identifying LBP with possible nerve root involvement.",2012,"RESULTS


Pain below knee was the best single item for diagnostic accuracy with an area under curve (AUC) of 0.67-0.68, which however is slightly less than the 'acceptable discrimination'.","['adults with low back pain (LBP) with or without referred leg pain, to identify self-report items that best identified clinically determined nerve root involvement (sciatica']",[],"['distribution of pain below the knee, leg pain', 'back pain, and feeling of numbness or pins and needles', 'sensitivity, specificity, predictive values, likelihood ratios (LRs), the area under the receiver operating characteristic curve and logistic regression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0036396', 'cui_str': 'Sciatic Neuralgia'}]",[],"[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0423572', 'cui_str': 'Pins and needles (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}]",,0.0369087,"RESULTS


Pain below knee was the best single item for diagnostic accuracy with an area under curve (AUC) of 0.67-0.68, which however is slightly less than the 'acceptable discrimination'.","[{'ForeName': 'Kika', 'Initials': 'K', 'LastName': 'Konstantinou', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University, Staffordshire, ST5 5BG, UK. k.konstantinou@cphc.keele.ac.uk'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Dunn', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-012-2398-5']
184,23002327,Improving word reading speed: individual differences interact with a training focus on successes or failures.,"The effect of two training procedures on the development of reading speed in poor readers is examined. One training concentrates on the words the children read correctly (successes), the other on the words they read incorrectly (failures). Children were either informed or not informed about the training focus. A randomized controlled trial was conducted with 79 poor readers. They repeatedly read regularly spelled Dutch consonant-vowel-consonant words, some children their successes, others their failures. The training used a computerized flashcards format. The exposure duration of the words was varied to maintain an accuracy rate at a constant level. Reading speed improved and transferred to untrained, orthographically more complex words. These transfer effects were characterized by an Aptitude-Treatment Interaction. Poor readers with a low initial reading level improved most in the training focused on successes. For poor readers with a high initial reading level, however, it appeared to be more profitable to practice with their failures. Informing students about the focus of the training positively affected training: The exposure duration needed for children informed about the focus of the training decreased more than for children who were not informed. This study suggests that neither of the two interventions is superior to the other in general. Rather, the improvement of general reading speed in a transparent orthography is closely related to both the children's initial reading level and the type of words they practice with: common and familiar words when training their successes and uncommon and less familiar words with training their failures.",2012,Informing students about the focus of the training positively affected training: The exposure duration needed for children informed about the focus of the training decreased more than for children who were not informed.,['79 poor readers'],[],"['Reading speed improved and transferred to untrained, orthographically more complex words']","[{'cui': 'C0857754', 'cui_str': 'Poor reader'}]",[],"[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]",79.0,0.015826,Informing students about the focus of the training positively affected training: The exposure duration needed for children informed about the focus of the training decreased more than for children who were not informed.,"[{'ForeName': 'Esther G', 'Initials': 'EG', 'LastName': 'Steenbeek-Planting', 'Affiliation': 'Behavioural Science Institute, Radboud University Nijmegen, P.O. Box 9104, 6500 HE Nijmegen, The Netherlands  ; Department of Special Education, Radboud University Nijmegen, P.O. Box 9104, 6500 HE Nijmegen, The Netherlands.'}, {'ForeName': 'Wim H J', 'Initials': 'WH', 'LastName': 'van Bon', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schreuder', 'Affiliation': ''}]",Reading and writing,[]
185,22923328,"Upper gastrointestinal tract transit times of tablet and drinkable solution formulations of alendronate: a bioequivalence and a quantitative, randomized study using video deglutition.","The bioequivalence and upper digestive tract transit time of a drinkable solution of 70 mg/100 mL alendronate was compared to reference tablets. A randomized, single- dose, two-way crossover study of the rate of urinary recovery of alendronate during 36 h (AE((0-36 h))) by HPLC, in 104 healthy young male volunteers, showed that AE((0-36 h)) and the maximum excretion rate (R (max)) were within the accepted range of bioequivalence 81.8-105.7 and 81.7-106.2, respectively. To characterize the oesophageal passage time of the two alendronate formulations, we performed a randomized, controlled study, in 24 healthy men and women (mean 52 years old), who took the formulations standing or lying down, by an X-ray video deglutition system. When taken in the standing position, both formulations had equal mean transit times from mouth to stomach and tablet disintegration but data dispersion was significantly smaller with the liquid form. When taken in lying position, drinkable alendronate had shorter and less variable median transit times compared to the tablets. These results show that the drinkable alendronate formulation is bioequivalent to the tablets and may be advantageous in patients in whom the transit or disintegration of the tablets is impaired.",2012,"When taken in the standing position, both formulations had equal mean transit times from mouth to stomach and tablet disintegration but data dispersion was significantly smaller with the liquid form.","['24 healthy men and women (mean 52 years old), who took the formulations standing or lying down, by an X-ray video deglutition system', '104 healthy young male volunteers, showed that AE((0-36 h']","['alendronate', 'drinkable solution of 70 mg/100 mL alendronate']","['bioequivalence and upper digestive tract transit time', 'maximum excretion rate (R (max', 'mean transit times', 'oesophageal passage time', 'variable median transit times']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0560843', 'cui_str': 'Does lie down (finding)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0039789', 'cui_str': 'Generic Equivalency'}, {'cui': 'C0226874', 'cui_str': 'Upper digestive tract structure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",104.0,0.0568856,"When taken in the standing position, both formulations had equal mean transit times from mouth to stomach and tablet disintegration but data dispersion was significantly smaller with the liquid form.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Gómez Acotto', 'Affiliation': 'Department of Phosphocalcium Metabolism, Maimónides University, Buenos Aires, Argentina. gomezacotto.claudia@maimonides.edu'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Antonelli', 'Affiliation': ''}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Flynn', 'Affiliation': ''}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'McDaid', 'Affiliation': ''}, {'ForeName': 'Emilio J A', 'Initials': 'EJ', 'LastName': 'Roldán', 'Affiliation': ''}]",Calcified tissue international,['10.1007/s00223-012-9639-9']
186,22903391,"Lurasidone in the treatment of schizophrenia: a 6-week, placebo-controlled study.","RATIONALE


There is an unmet need in the treatment of schizophrenia for effective medications with fewer adverse effects.
OBJECTIVE


This study aims to evaluate the efficacy and safety of lurasidone, an atypical antipsychotic, for the treatment of schizophrenia.
METHODS


Patients with an acute exacerbation of schizophrenia were randomized to 6 weeks of double-blind treatment with once-daily, fixed-dose lurasidone 40 mg (N = 50), lurasidone 120 mg (N = 49), or placebo (N = 50). The primary efficacy measure was mean change from baseline to day 42 (last observation carried forward) in the Brief Psychiatric Rating Scale derived (BPRSd) from the Positive and Negative Syndrome Scale (PANSS).
RESULTS


Mean change in BPRSd was significantly greater in patients receiving lurasidone 40 and 120 mg/day versus placebo (-9.4 and -11.0 versus -3.8; p = 0.018 and 0.004, respectively). Treatment with lurasidone 120 mg/day was superior to placebo across all secondary measures, including PANSS total (p = 0.009), PANSS positive (p = 0.005), PANSS negative (p = 0.011), and PANSS general psychopathology (p = 0.023) subscales and Clinical Global Impression of Severity (CGI-S; p = 0.001). Treatment with lurasidone 40 mg/day was superior to placebo on the PANSS positive subscale (p = 0.018) and CGI-S (p = 0.002). The most common adverse events for patients receiving lurasidone were nausea (16.2 versus 4.0 % for placebo) and sedation (16.2 versus 10.0 % for placebo). Minimal changes in weight, cholesterol, triglyceride, and glucose levels were observed.
CONCLUSIONS


In this study, which was limited by a relatively high discontinuation rate, lurasidone provided effective treatment for patients with acute exacerbation of chronic schizophrenia and had minimal effects on weight and metabolic parameters.",2013,"Mean change in BPRSd was significantly greater in patients receiving lurasidone 40 and 120 mg/day versus placebo (-9.4 and -11.0 versus -3.8; p = 0.018 and 0.004, respectively).","['Patients with an acute exacerbation of schizophrenia', 'schizophrenia', 'patients with acute exacerbation of chronic schizophrenia']","['lurasidone', 'placebo', 'Lurasidone', 'double-blind treatment with once-daily, fixed-dose lurasidone 40\xa0mg (N\u2009=\u200950), lurasidone 120\xa0mg (N\u2009=\u200949), or placebo']","['Mean change in BPRSd', 'weight, cholesterol, triglyceride, and glucose levels', 'PANSS general psychopathology', 'nausea', 'PANSS total', 'mean change from baseline to day\xa042 (last observation carried forward) in the Brief Psychiatric Rating Scale derived (BPRSd) from the Positive and Negative Syndrome Scale (PANSS', 'PANSS negative', 'PANSS positive subscale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0270383', 'cui_str': 'Acute exacerbation of chronic schizophrenia (disorder)'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",,0.324348,"Mean change in BPRSd was significantly greater in patients receiving lurasidone 40 and 120 mg/day versus placebo (-9.4 and -11.0 versus -3.8; p = 0.018 and 0.004, respectively).","[{'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ogasa', 'Affiliation': 'Dainippon Sumitomo Pharma Co., Ltd., 6-8, Doshomachi 2-Chome, Chuo-ku, Osaka, Japan. masaaki-ogasa@ds-pharma.co.jp'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': ''}, {'ForeName': 'Mitsutaka', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Guarino', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-012-2838-2']
187,22855138,A randomized phase II study to compare oxaliplatin plus 5-fluorouracil and leucovorin (FOLFOX4) versus oxaliplatin plus raltitrexed (TOMOX) as first-line chemotherapy for advanced colorectal cancer.,"INTRODUCTION


The aim of this study was to compare TOMOX versus FOLFOX4 as first-line treatment of advanced colorectal cancer (CRC).
MATERIALS AND METHODS


191 chemotherapy-naïve patients were randomized to receive TOMOX or FOLFOX4. Patients were evaluated every 3 months and chemotherapy was continued until disease progression or unacceptable toxicity. Overall response rate was the primary endpoint.
RESULTS


183 patients were included in the intent-to-treat analysis (92 TOMOX and 91 FOLFOX4). Overall response rate was 45.6 and 36.3 % (p = 0.003) for TOMOX and FOLFOX4, respectively. No statistically significant differences were observed in overall survival (15.6 and 17.2 months; p = 0.475); progression-free survival (7.7 and 8.7 months; p = 0.292), and response duration (6.4 and 7.6 months; p = 0.372) for TOMOX and FOLFOX4, respectively. Grades 3 and 4 neutropenia (p < 0.0001) and leukopenia (p = 0.028) were more common with the FOLFOX4 regimen, while hepatic disorders and asthenia were higher in TOMOX group (p = ns). There were two treatment-related deaths in the FOLFOX4 arm and one in the TOMOX arm. Quality of life analysis based on the SF-36 revealed differences between the two regimens for physical and mental composite scores after 6 weeks, and for body pain and emotional role functioning after 6 and 12 weeks; all of these favored the FOLFOX4 arm (p ≤ 0.05).
CONCLUSIONS


TOMOX and FOLFOX4 seem to have similar efficacy and are well tolerated in the first-line treatment for advanced CRC with different profiles of toxicity. The convenient TOMOX regimen may offer an alternative to fluoropyrimidine-based regimens.",2012,"Quality of life analysis based on the SF-36 revealed differences between the two regimens for physical and mental composite scores after 6 weeks, and for body pain and emotional role functioning after 6 and 12 weeks; all of these favored the FOLFOX4 arm (p ≤ 0.05).
","['191 chemotherapy-naïve patients', '183 patients were included in the intent-to-treat analysis (92 TOMOX and 91 FOLFOX4', 'advanced colorectal cancer', 'advanced colorectal cancer (CRC']","['oxaliplatin plus 5-fluorouracil and leucovorin (FOLFOX4) versus oxaliplatin plus raltitrexed (TOMOX', 'TOMOX', 'TOMOX versus FOLFOX4', 'TOMOX or FOLFOX4']","['Overall response rate', 'deaths', 'Grades 3 and 4 neutropenia', 'overall survival', 'response duration', 'progression-free survival', 'hepatic disorders and asthenia', 'physical and mental composite scores', 'body pain and emotional role functioning', 'leukopenia']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0677667', 'cui_str': 'raltitrexed'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",183.0,0.0622014,"Quality of life analysis based on the SF-36 revealed differences between the two regimens for physical and mental composite scores after 6 weeks, and for body pain and emotional role functioning after 6 and 12 weeks; all of these favored the FOLFOX4 arm (p ≤ 0.05).
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gravalos', 'Affiliation': 'Medical Oncology Department, University Hospital 12 de Octubre, Madrid, Spain. cgravalos@telefonica.net'}, {'ForeName': 'Antonieta', 'Initials': 'A', 'LastName': 'Salut', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'García-Girón', 'Affiliation': ''}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'García-Carbonero', 'Affiliation': ''}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'León', 'Affiliation': ''}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Sevilla', 'Affiliation': ''}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Maurel', 'Affiliation': ''}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Esteban', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'García-Rico', 'Affiliation': ''}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Murias', 'Affiliation': ''}, {'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Cortés-Funes', 'Affiliation': ''}]",Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico,['10.1007/s12094-012-0843-x']
188,22878520,A single supratherapeutic dose of ridaforolimus does not prolong the QTc interval in patients with advanced cancer.,"PURPOSE


This dedicated QTc study was designed to evaluate the effect of the mammalian target of rapamycin inhibitor, ridaforolimus, on the QTc interval in patients with advanced malignancies.
METHODS


We conducted a fixed-sequence, single-blind, placebo-controlled study. Patients (n = 23) received placebo on day 1 and a single 100-mg oral dose of ridaforolimus on day 2 in the fasted state. Holter electrocardiogram (ECG) monitoring was performed for 24 h after each treatment, and blood ridaforolimus concentrations were measured for 24 h after dosing. The ECGs were interpreted in a blinded fashion, and the QT interval was corrected using Fridericia's formula (QTcF). After a washout of at least 5 days, 22 patients went on to receive a therapeutic regimen of ridaforolimus (40 mg orally once daily for 5 days per week).
RESULTS


The upper limit of the two-sided 90 % confidence interval for the placebo-adjusted mean change from baseline in QTcF was <10 ms at each time point. No patient had a QTcF change from baseline >30 ms or QTcF interval >480 ms. Geometric mean exposure to ridaforolimus after the single 100-mg dose was comparable to previous experience with the therapeutic regimen. There appeared to be no clear relationship between individual QTcF change from baseline and ridaforolimus blood concentrations. Ridaforolimus was generally well tolerated, with adverse events consistent with prior studies.
CONCLUSIONS


Administration of the single 100-mg dose of ridaforolimus did not cause a clinically meaningful prolongation of QTcF, suggesting that patients treated with ridaforolimus have a low likelihood of delayed ventricular repolarization.",2012,"CONCLUSIONS


Administration of the single 100-mg dose of ridaforolimus did not cause a clinically meaningful prolongation of QTcF, suggesting that patients treated with ridaforolimus have a low likelihood of delayed ventricular repolarization.","['patients with advanced malignancies', 'patients with advanced cancer']","['ridaforolimus', 'placebo', 'rapamycin inhibitor, ridaforolimus']","['blood ridaforolimus concentrations', 'QTc interval', 'Holter electrocardiogram (ECG) monitoring', 'QTcF change', 'Geometric mean exposure to ridaforolimus']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C2713007', 'cui_str': 'ridaforolimus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0005768'}, {'cui': 'C2713007', 'cui_str': 'ridaforolimus'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]",,0.190177,"CONCLUSIONS


Administration of the single 100-mg dose of ridaforolimus did not cause a clinically meaningful prolongation of QTcF, suggesting that patients treated with ridaforolimus have a low likelihood of delayed ventricular repolarization.","[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Lush', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA. richard.lush@moffitt.org'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Patnaik', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'Kyriakos P', 'Initials': 'KP', 'LastName': 'Papadopoulos', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Trucksis', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'McCrea', 'Affiliation': ''}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Cerchio', 'Affiliation': ''}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stroh', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Selverian', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Orford', 'Affiliation': ''}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Ebbinghaus', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Agrawal', 'Affiliation': ''}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': ''}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Tolcher', 'Affiliation': ''}]",Cancer chemotherapy and pharmacology,[]
189,22828963,Intervention effects on physical activity and insulin levels in men of Pakistani origin living in Oslo: a randomised controlled trial.,"High prevalence of type 2 diabetes (T2D) is seen in some immigrant groups in Western countries, particularly in those from the Indian subcontinent. Our aims were to increase the physical activity (PA) level in a group of Pakistani immigrant men, and to see whether any increase was associated with reduced serum glucose and insulin concentrations. The intervention was developed in collaboration with the Pakistani community. It used a social cognitive theory framework and consisted of structured supervised group exercises, group lectures, individual counselling and telephone follow-up. One- hundred and fifty physically inactive Pakistani immigrant men living in Oslo, Norway, were randomised to either a control group or an intervention group. The 5-month intervention focused on increasing levels of PA, which were assessed by use of accelerometer (Actigraph MTI 7164) recordings. Risk of diabetes was assessed by serum glucose and insulin concentrations determined in a fasted state, and after an oral glucose tolerance test (OGTT). ANCOVA was used to assess differences between groups. There was a mean difference in PA between the two groups of 49 counts per minute per day, representing a 15 % (95 % CI = 8.7-21.2; P = 0.01) higher increase in total PA level in the intervention group than in the control group. Insulin values taken 2 h after an OGTT were reduced in the intervention group by 27 % (95 % CI = 18.9-35.0; P = 0.02) more than those in the control group. There were no differences in fasting or postprandial glucose values between the groups at the follow-up test. This type of intervention can increase PA and reduce serum insulin in Pakistani immigrant men, thereby presumably reducing their risk of T2D.",2013,There were no differences in fasting or postprandial glucose values between the groups at the follow-up test.,"['men of Pakistani origin living in Oslo', 'One- hundred and fifty physically inactive Pakistani immigrant men living in Oslo, Norway', 'Pakistani immigrant men']",['control group or an intervention group'],"['Insulin values', 'PA', 'fasting or postprandial glucose values', 'total PA level', 'physical activity and insulin levels', 'physical activity (PA) level', 'serum glucose and insulin concentrations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0337814', 'cui_str': 'Pakistani (Urduspeakers) (ethnic group)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",150.0,0.0226171,There were no differences in fasting or postprandial glucose values between the groups at the follow-up test.,"[{'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Department of Sport Medicine, Norwegian School of Sport Sciences, Ullevaal Stadium, Box 4014, 0806 Oslo, Norway. eivind.andersen@nih.no'}, {'ForeName': 'Arne T', 'Initials': 'AT', 'LastName': 'Høstmark', 'Affiliation': ''}, {'ForeName': 'Ingar', 'Initials': 'I', 'LastName': 'Holme', 'Affiliation': ''}, {'ForeName': 'Sigmund A', 'Initials': 'SA', 'LastName': 'Anderssen', 'Affiliation': ''}]",Journal of immigrant and minority health,['10.1007/s10903-012-9686-3']
190,22763493,"Changes in insurance physicians' attitudes, self-efficacy, intention, and knowledge and skills regarding the guidelines for depression, following an implementation strategy.","INTRODUCTION


To improve guideline adherence by insurance physicians (IPs), an implementation strategy was developed and investigated in a randomized controlled trial. This implementation strategy involved a multifaceted training programme for a group of IPs in applying the guidelines for depression. In this study we report the impact of the implementation strategy on the physicians' attitude, intention, self-efficacy, and knowledge and skills as behavioural determinants of guideline adherence. Any links between these self-reported behavioural determinants and levels of guideline adherence were also determined.
METHODS


Just before and 3 months after the implementation of the multifaceted training, a questionnaire designed to measure behavioural determinants on the basis of the ASE (attitude, social norm, self-efficacy) model was completed by the intervention (n = 21) and the control group (n = 19). Items of the questionnaire were grouped to form scales of ASE determinants. Internal consistency of the scales was calculated using Cronbach's alphas. Differences between groups concerning changes in ASE determinants, and the association of these changes with improvements in guideline adherence, were analyzed using analysis of covariance.
RESULTS


The internal consistency of the scales of ASE determinants proved to be sufficiently reliable, with Cronbach's alphas of at least 0.70. At follow-up after 3 months, the IPs given the implementation strategy showed significant improvement over the IPs in the control group for all ASE determinants investigated. Changes in knowledge and skills were only weakly associated with improvements in guideline adherence.
CONCLUSIONS


The implementation strategy developed for insurance physicians can increase their attitude, intention, self-efficacy, and knowledge and skills when applying the guidelines for depression. These changes in behavioural determinants might indicate positive changes in IPs' behaviour towards the use of the guidelines for depression. However, only changes in knowledge and skills related to the use of the guidelines were associated with improvements in IPs' actual performance when applying the guidelines.",2013,"At follow-up after 3 months, the IPs given the implementation strategy showed significant improvement over the IPs in the control group for all ASE determinants investigated.",[],[],"['attitude, intention, self-efficacy, and knowledge and skills', ""IPs' actual performance"", 'self-efficacy, intention, and knowledge and skills regarding the guidelines for depression', 'guideline adherence', 'behavioural determinants and levels of guideline adherence']",[],[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",21.0,0.0255282,"At follow-up after 3 months, the IPs given the implementation strategy showed significant improvement over the IPs in the control group for all ASE determinants investigated.","[{'ForeName': 'Feico', 'Initials': 'F', 'LastName': 'Zwerver', 'Affiliation': 'Department of Public and Occupational Health, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands. f.zwerver@vumc.nl'}, {'ForeName': 'Antonius J M', 'Initials': 'AJ', 'LastName': 'Schellart', 'Affiliation': ''}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Anema', 'Affiliation': ''}, {'ForeName': 'Allard J', 'Initials': 'AJ', 'LastName': 'van der Beek', 'Affiliation': ''}]",Journal of occupational rehabilitation,['10.1007/s10926-012-9378-9']
191,22638708,Cost-effectiveness of nutritional intervention in elderly subjects after hip fracture. A randomized controlled trial.,"UNLABELLED


Hip fracture patients can benefit from nutritional supplementation during their recovery. Up to now, cost-effectiveness evaluation of nutritional intervention in these patients has not been performed. Costs of nutritional intervention are relatively low as compared with medical costs. Cost-effectiveness evaluation shows that nutritional intervention is likely to be cost-effective.
INTRODUCTION


Previous research on the effect of nutritional intervention on clinical outcome in hip fracture patients yielded contradictory results. Cost-effectiveness of nutritional intervention in these patients remains unknown. The aim of this study was to evaluate cost-effectiveness of nutritional intervention in elderly subjects after hip fracture from a societal perspective.
METHODS


Open-label, multi-centre randomized controlled trial investigating cost-effectiveness of intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation for 3 months postoperatively. Patients allocated to the control group received care as usual. Costs, weight and quality of life were measured at baseline and at 3 and 6 months postoperatively. Incremental cost-effectiveness ratios (ICERs) were calculated for weight at 3 months and quality adjusted life years (QALYs) at 6 months postoperatively.
RESULTS


Of 152 patients enrolled, 73 were randomized to the intervention group and 79 to the control group. Mean costs of the nutritional intervention was 613 Euro. Total costs and subcategories of costs were not significantly different between both groups. Based on bootstrapping of ICERs, the nutritional intervention was likely to be cost-effective for weight as outcome over the 3-month intervention period, regardless of nutritional status at baseline. With QALYs as outcome, the probability for the nutritional intervention being cost-effective was relatively low, except in subjects aged below 75 years.
CONCLUSION


Intensive nutritional intervention in elderly hip fracture patients is likely to be cost-effective for weight but not for QALYs. Future cost-effectiveness studies should incorporate outcome measures appropriate for elderly patients, such as functional limitations and other relevant outcome parameters for elderly.",2013,Total costs and subcategories of costs were not significantly different between both groups.,"['elderly hip fracture patients', 'hip fracture patients', 'elderly subjects after hip fracture from a societal perspective', 'subjects aged below 75\xa0years', 'Hip fracture patients', 'elderly patients', 'elderly subjects after hip fracture', '152 patients enrolled']","['control group received care as usual', 'intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation', 'nutritional intervention', 'Intensive nutritional intervention']","['Total costs and subcategories of costs', 'Mean costs', 'Costs, weight and quality of life', 'Incremental cost-effectiveness ratios (ICERs', 'cost-effectiveness']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",152.0,0.0367486,Total costs and subcategories of costs were not significantly different between both groups.,"[{'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Wyers', 'Affiliation': 'Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University Medical Centre, P.O. Box 616, 6200 MD, Maastricht, The Netherlands. caroline.wyers@maastrichtuniversity.nl'}, {'ForeName': 'P L M', 'Initials': 'PL', 'LastName': 'Reijven', 'Affiliation': ''}, {'ForeName': 'S M A A', 'Initials': 'SM', 'LastName': 'Evers', 'Affiliation': ''}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Willems', 'Affiliation': ''}, {'ForeName': 'I C', 'Initials': 'IC', 'LastName': 'Heyligers', 'Affiliation': ''}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Verburg', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Helden', 'Affiliation': ''}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Dagnelie', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-012-2009-7']
192,22674141,"Efficacy and safety of eltrombopag in Japanese patients with chronic liver disease and thrombocytopenia: a randomized, open-label, phase II study.","BACKGROUND


Eltrombopag is an oral thrombopoietin receptor agonist that stimulates thrombopoiesis and shows higher exposure in East Asian patients than in non-Asian patients. We evaluated the pharmacokinetics, efficacy, and safety of eltrombopag in Japanese patients with thrombocytopenia associated with chronic liver disease (CLD).
METHODS


Thirty-eight patients with CLD and thrombocytopenia (platelets <50,000/μL) were enrolled in this phase II, open-label, dose-ranging study that consisted of 2 parts. In the first part, 12 patients received 12.5 mg of eltrombopag once daily for 2 weeks. After the evaluation of safety, 26 patients were randomly assigned to receive either 25 or 37.5 mg of eltrombopag once daily for 2 weeks in the second part.
RESULTS


Pharmacokinetics showed that the geometric means of the maximum plasma concentration (C(max)) and the area under the curve (AUC) in the 12.5 mg group were 3,413 ng/mL and 65,236 ng h/mL, respectively. At week 2, the mean increases from baseline in platelet counts were 24,800, 54,000, and 60,000/μL in the 12.5, 25, and 37.5 mg groups, respectively. The median platelet counts increased within 2 weeks of the beginning of administration in all groups, and remained at the same level throughout the 2-week post-treatment period in the 12.5 mg group, whereas the platelet counts peaked a week after the last treatment in both the 25 and 37.5 mg groups. Most adverse events reported were grade 1 or 2; 2 patients in the 37.5 mg group had drug-related serious adverse events.
CONCLUSIONS


Eltrombopag ameliorated thrombocytopenia in Japanese patients with CLD and thrombocytopenia. The recommended dose for these patients is 25 mg daily for 2 weeks.",2012,"The median platelet counts increased within 2 weeks of the beginning of administration in all groups, and remained at the same level throughout the 2-week post-treatment period in the 12.5 mg group, whereas the platelet counts peaked a week after the last treatment in both the 25 and 37.5 mg groups.","['Thirty-eight patients with CLD and thrombocytopenia (platelets <50,000/μL', 'East Asian patients than in non-Asian patients', 'Japanese patients with CLD and thrombocytopenia', '26 patients', 'Japanese patients with chronic liver disease and thrombocytopenia', 'Japanese patients with thrombocytopenia associated with chronic liver disease (CLD']",['eltrombopag'],"['median platelet counts', 'Efficacy and safety', 'thrombocytopenia', 'platelet counts', 'maximum plasma concentration (C(max)) and the area under the curve (AUC', 'pharmacokinetics, efficacy, and safety']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0055926', 'cui_str': 'endogenous clonidine-like substance'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C1831905', 'cui_str': 'eltrombopag'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",26.0,0.0312929,"The median platelet counts increased within 2 weeks of the beginning of administration in all groups, and remained at the same level throughout the 2-week post-treatment period in the 12.5 mg group, whereas the platelet counts peaked a week after the last treatment in both the 25 and 37.5 mg groups.","[{'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Digestive Disease Information & Research, and Department of Medicine, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan.'}, {'ForeName': 'Atsumasa', 'Initials': 'A', 'LastName': 'Komori', 'Affiliation': ''}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Seike', 'Affiliation': ''}, {'ForeName': 'Shigetoshi', 'Initials': 'S', 'LastName': 'Fujiyama', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': ''}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'Shotaro', 'Initials': 'S', 'LastName': 'Sakisaka', 'Affiliation': ''}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nakamuta', 'Affiliation': ''}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Sasaki', 'Affiliation': ''}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Oketani', 'Affiliation': ''}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Hattori', 'Affiliation': ''}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Katsura', 'Affiliation': ''}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Sata', 'Affiliation': ''}]",Journal of gastroenterology,['10.1007/s00535-012-0600-5']
193,22699884,A hospital-based work support intervention to enhance the return to work of cancer patients: a process evaluation.,"PURPOSE


To perform a process evaluation of a hospital-based work support intervention for cancer patients aimed at enhancing return to work and quality of life. The intervention involves the delivery of patient education and support at the hospital and involves the improvement of the communication between the treating physician and the occupational physician. In addition, the research team asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan.
METHODS


Eligible were cancer patients treated with curative intent and who have paid work. Data were collected from patients assigned to the intervention group (N = 65) and from nurses who delivered the patient education and support at the hospital (N = 4) by means of questionnaires, nurses' reports, and checklists. Data were quantitatively and qualitatively analysed.
RESULTS


A total of 47 % of all eligible patients participated. Nurses delivered the patient education and support in 85 % of the cases according to the protocol. In 100 % of the cases at least one letter was sent to the occupational physician. In 10 % of the cases the meeting with the patient, the occupational physician and the supervisor took place. Patients found the intervention in general very useful and nurses found the intervention feasible to deliver.
CONCLUSIONS


We found that a hospital- based work support intervention was easily accepted in usual psycho-oncological care but that it proved difficult to involve the occupational physician. Patients were highly satisfied and nurses found the intervention feasible.",2012,The intervention involves the delivery of patient education and support at the hospital and involves the improvement of the communication between the treating physician and the occupational physician.,"['Eligible were cancer patients treated with curative intent and who have paid work', 'cancer patients']",['hospital-based work support intervention'],[],"[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],,0.0213435,The intervention involves the delivery of patient education and support at the hospital and involves the improvement of the communication between the treating physician and the occupational physician.,"[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Tamminga', 'Affiliation': 'Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. s.j.tamminga@amc.nl'}, {'ForeName': 'A G E M', 'Initials': 'AG', 'LastName': 'de Boer', 'Affiliation': ''}, {'ForeName': 'M M E M', 'Initials': 'MM', 'LastName': 'Bos', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fons', 'Affiliation': ''}, {'ForeName': 'J J E M', 'Initials': 'JJ', 'LastName': 'Kitzen', 'Affiliation': ''}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Plaisier', 'Affiliation': ''}, {'ForeName': 'J H A M', 'Initials': 'JH', 'LastName': 'Verbeek', 'Affiliation': ''}, {'ForeName': 'M H W', 'Initials': 'MH', 'LastName': 'Frings-Dresen', 'Affiliation': ''}]",Journal of occupational rehabilitation,['10.1007/s10926-012-9372-2']
194,22661829,Dietary algae and HIV/AIDS: proof of concept clinical data.,"Dietary algae have been reported to decrease HIV viral fusion/entry and replication and increase immune response, suggesting that regular consumption of algae by people in Japan, Korea, and Chad could be an important factor in their relatively low HIV/AIDS rates. Five antiretroviral-naïve people with HIV (three females, two males; five African Americans) living in Columbia SC participated in the phase I study of acute toxicity. Subjects were randomly assigned to 5 g day(-1) brown seaweed (Undaria pinnatifida), Spirulina (Arthrospira platensis), or a combination of both. Endpoints included HIV viral load, complete blood count (CBC), metabolic and lipid panel, and quality of life questionnaire data. When no short-term toxicities were observed, six additional subjects (four females, two males; five African Americans, one Latina) were recruited to further evaluate short- and long-term toxicities (phase II). No adverse effects were observed for the 11 subjects in the phase I trial, and quality of life indicators improved at 3 weeks. No significant changes were observed in CBC, metabolic or lipid panel analyses. CD4 cells (milliliters) and HIV-1 viral load remained stable over the first 3-month phase II study period. One subject continued in the study for 13 months and had clinically significant improvement in CD4 (>100 cells mL(-1)) and decreased HIV viral load of 0.5 log(10). Our pilot data suggest that Undaria, Spirulina, and a combination of both were nontoxic and over time may improve clinical endpoints of HIV/AIDS.",2012,CD4 cells (milliliters) and HIV-1 viral load remained stable over the first 3-month phase II study period.,"['six additional subjects (four females, two males; five African Americans, one Latina', 'Five antiretroviral-naïve people with HIV (three females, two males; five African Americans) living in Columbia SC participated in the phase I study of acute toxicity']","['5\xa0g day(-1) brown seaweed (Undaria pinnatifida), Spirulina (Arthrospira platensis), or a combination of both']","['HIV viral load, complete blood count (CBC), metabolic and lipid panel, and quality of life questionnaire data', 'CD4 cells (milliliters) and HIV-1 viral load', 'CD4 (>100 cells\xa0mL(-1)) and decreased HIV viral load', 'adverse effects', 'quality of life indicators', 'CBC, metabolic or lipid panel analyses']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C1744682', 'cui_str': 'Seaweed (substance)'}, {'cui': 'C1030485', 'cui_str': 'Wakame'}, {'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C1188555', 'cui_str': 'Arthrospira platensis'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.0408207,CD4 cells (milliliters) and HIV-1 viral load remained stable over the first 3-month phase II study period.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Teas', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Irhimeh', 'Affiliation': ''}]",Journal of applied phycology,[]
195,22673937,Cytokine and satellite cell responses to muscle damage: interpretation and possible confounding factors in human studies.,"It is plausible that multiple muscle biopsies following a muscle damaging intervention can exacerbate the inflammatory and subsequent satellite cell responses. To elucidate confounding effects of muscle biopsy procedure on satellite cell number, indirect markers of damage and the inflammatory response following acute downhill running (DHR) were investigated. 10 healthy male participant were divided into a non-exercising control (n = 4) and DHR (12 × 5min bouts, 10 % decline at 85 % VO(2)max) (n = 6) group. Blood samples were taken pre, post and every 24 h for 9 days. Serum was analysed for creatine kinase (CK), myoglobin (Mb), lactate dehydrogenase (LDH), TNF-α, IL-6 and IL-10. Muscle biopsies taken on days 1 and 2 post intervention from opposing legs were analysed for Pax7(+) satellite cells. In the DHR group, Mb (536 ± 277 ng mL(-1)), IL-6 (12.6 ± 4.7 pg mL(-1)) and IL-10 (27.3 ± 11.5 pg mL(-1)) peaked immediately post DHR, while CK (2651 ± 1911 U L(-1)), LDH (202 ± 47 U L(-1)) and TNF-α (25.1 ± 8.7 pg mL(-1)) peaked on day 1. A 30 % increase in Pax7(+) satellite cells on day 1 in the DHR group was no longer apparent on day 2. H&E staining show evidence of phagocytosis in the DHR group. No significant changes over time were observed in the control group for any of the variables measured. Events observed in the DHR group were as a result of the intervention protocol and subsequent muscle damage. The relationship between SC proliferation and pro-inflammatory cytokine release appears to be complex since the IL-6/IL-10 response time differs significantly from the TNF-α response.",2012,No significant changes over time were observed in the control group for any of the variables measured.,"['acute downhill running (DHR', '10 healthy male participant']","['DHR (12\xa0×\xa05min bouts, 10\xa0% decline at 85\xa0% VO(2)max', 'non-exercising control', 'IL-6 (12.6\xa0±', 'TNF-α', 'muscle biopsy procedure']","['satellite cells', 'Pax7', 'creatine kinase (CK), myoglobin (Mb), lactate dehydrogenase (LDH), TNF-α, IL-6']","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0332221', 'cui_str': 'Satellite (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",10.0,0.0835869,No significant changes over time were observed in the control group for any of the variables measured.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'van de Vyver', 'Affiliation': 'Department of Physiological Sciences, Stellenbosch University, Matieland, Stellenbosch, South Africa.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Myburgh', 'Affiliation': ''}]",Journal of muscle research and cell motility,['10.1007/s10974-012-9303-z']
196,22638812,The role of impulsivity and perceived availability on cue-elicited craving for alcohol in social drinkers.,"RATIONALE


Previous research has demonstrated a role for impulsivity and perceived availability of the substance in cue-elicited craving. However, their effects on cue-elicited craving for alcohol are still ambiguous. Most important is that there has been no empirical evidence for the potential interaction of these factors on alcohol craving.
OBJECTIVES


The aim of the present study was to examine the effects of response inhibition and perceived availability on cue-elicited craving for alcohol in social drinkers.
METHODS


Participants were light to moderate social drinkers (N = 75) who were exposed to neutral- and alcohol-related stimuli during a single laboratory session. Response inhibition was assessed with the Stop Signal Task. Participants were randomly assigned to one of two perceived availability groups (n = 37, expecting alcohol; n = 38, not expecting alcohol).
RESULTS


Overall craving for alcohol was higher in participants who expected alcohol than in those who did not. This finding was statistically significant only in the alcohol condition. Most important is that there was a significant interaction between response inhibition, perceived availability and time on cue-elicited craving. Regardless of the cue type, impulsive people who expected alcohol experience a significant increase in cue-elicited craving relative to impulsive people who did not expect alcohol. This effect was not observed in the non-impulsive groups.
CONCLUSIONS


The results clearly show that perceived availability alone and in combination with response inhibition can modulate alcohol cue reactivity. Theoretical explanations and clinical implications of these findings are discussed.",2012,Overall craving for alcohol was higher in participants who expected alcohol than in those who did not.,"['social drinkers', 'Participants were light to moderate social drinkers (N\u2009=\u200975) who were exposed to neutral- and alcohol-related stimuli during a single laboratory session']","['expecting alcohol; n\u2009=\u200938, not expecting alcohol']","['response inhibition, perceived availability and time on cue-elicited craving', 'Response inhibition', 'Overall craving for alcohol', 'alcohol cue reactivity', 'cue-elicited craving relative']","[{'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.0180577,Overall craving for alcohol was higher in participants who expected alcohol than in those who did not.,"[{'ForeName': 'Harilaos', 'Initials': 'H', 'LastName': 'Papachristou', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands. h.papachristou@maastrichtuniversity.nl'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Nederkoorn', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Corstjens', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Jansen', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-012-2747-4']
197,22581292,Does frequency of resistance training affect tibial cortical bone density in older women? A randomized controlled trial.,"SUMMARY


This randomized controlled trial evaluated the effect of resistance training frequency (0, 1, and 2 times/week) on cortical volumetric bone mineral density (vBMD) at the tibia in older women. There was no mean difference in change in tibial cortical vBMD in older women who engaged in resistance training (RT) one or two times/week compared with the control group over 12 months after adjusting for baseline values.
INTRODUCTION


National guidelines recommend RT two to three times/week to optimize bone health. Our objective was to determine the effect of a 12-month intervention of three different RT frequencies on tibial volumetric cortical density (CovBMD) in healthy older women.
METHODS


We randomized participants to the following groups: (1) 2×/week balance and tone group (i.e., no resistance beyond body weight, BT), (2) 1×/week RT (RT1), and (3) 2×/week RT (RT2). Treatment allocation was concealed, and measurement team and the bone data analyst were blinded to group allocation. We used peripheral quantitative computed tomography to acquire one 2.3-mm scan at the 50 % tibia, and the primary outcome was CovBMD. Data were collected at baseline, 6 and 12 months, and we used linear mixed modeling to assess the effect at 12 months.
RESULTS


We assessed 147 participants; 100 women provided data at all three points. Baseline unadjusted mean (SD) tibial CovBMD (in milligrams per cubic centimeter) at the 50 % site was 1,077.4 (43.0) (BT), 1,087.8 (42.0) (RT1), and 1,058.7 (60.4) (RT2). At 12 months, there were no statistically significant differences (-0.45 to -0.17 %) between BT and RT groups for mean difference in change in tibial CovBMD for exercise interventions (BT, RT1, RT2) after adjusting for baseline tibial CovBMD.
CONCLUSION


We note no mean difference in change in tibial CovBMD in older women who engaged in RT one or two times/week compared with the control group over 12 months. It is unknown if RT of 3× or 4×/week would be enough to promote a statistically significant difference in change of bone density.",2013,"There was no mean difference in change in tibial cortical vBMD in older women who engaged in resistance training (RT) one or two times/week compared with the control group over 12 months after adjusting for baseline values.
","['147 participants; 100 women provided data at all three points', 'older women', 'healthy older women', 'older women who engaged in resistance training (RT']","['2×/week balance and tone group (i.e., no resistance beyond body weight, BT), (2) 1×/week RT (RT1), and (3) 2×/week RT (RT2', 'resistance training', 'resistance training frequency']","['cortical volumetric bone mineral density (vBMD', 'Baseline unadjusted mean (SD) tibial CovBMD', 'tibial CovBMD', 'tibial cortical vBMD', 'tibial CovBMD for exercise interventions (BT, RT1, RT2', 'baseline tibial CovBMD', 'bone density', 'tibial volumetric cortical density (CovBMD']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]","[{'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",147.0,0.241257,"There was no mean difference in change in tibial cortical vBMD in older women who engaged in resistance training (RT) one or two times/week compared with the control group over 12 months after adjusting for baseline values.
","[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Ashe', 'Affiliation': 'Center for Hip Health and Mobility, 7F-2635 Laurel Street, Vancouver, BC, V5Z 1M9, Canada. Maureen.Ashe@exchange.ubc.ca'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gorman', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Khan', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Brasher', 'Affiliation': ''}, {'ForeName': 'D M L', 'Initials': 'DM', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'McKay', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-012-2000-3']
198,22581391,A placebo-controlled study to assess Standardized Field Sobriety Tests performance during alcohol and cannabis intoxication in heavy cannabis users and accuracy of point of collection testing devices for detecting THC in oral fluid.,"RATIONALE


Standardized Field Sobriety Tests (SFST) and oral fluid devices are used to screen for driving impairment and roadside drug detection, respectively. SFST have been validated for alcohol, but their sensitivity to impairment induced by other drugs is relatively unknown. The sensitivity and specificity for Δ(9)-tetrahydrocannabinol (THC) of most oral fluid devices have been low.
OBJECTIVE


This study assessed the effects of smoking cannabis with and without alcohol on SFST performance. Presence of THC in oral fluid was examined with two devices (Dräger Drug Test® 5000 and Securetec Drugwipe® 5).
METHODS


Twenty heavy cannabis users (15 males and 5 females; mean age, 24.3 years) participated in a double-blind, placebo-controlled study assessing percentage of impaired individuals on the SFST and the sensitivity of two oral fluid devices. Participants received alcohol doses or alcohol placebo in combination with 400 μg/kg body weight THC. We aimed to reach peak blood alcohol concentration values of 0.5 and 0.7 mg/mL.
RESULTS


Cannabis was significantly related to performance on the one-leg stand (p = 0.037). Alcohol in combination with cannabis was significantly related to impairment on horizontal gaze nystagmus (p = 0.029). The Dräger Drug Test® 5000 demonstrated a high sensitivity for THC, whereas the sensitivity of the Securetec Drugwipe® 5 was low.
CONCLUSIONS


SFST were mildly sensitive to impairment from cannabis in heavy users. Lack of sensitivity might be attributed to tolerance and time of testing. SFST were sensitive to both doses of alcohol. The Dräger Drug Test® 5000 appears to be a promising tool for detecting THC in oral fluid as far as correct THC detection is concerned.",2012,Alcohol in combination with cannabis was significantly related to impairment on horizontal gaze nystagmus (p = 0.029).,"['heavy cannabis users', 'Twenty heavy cannabis users (15 males and 5 females; mean age, 24.3 years']","['placebo', 'Δ(9)-tetrahydrocannabinol (THC', 'smoking cannabis with and without alcohol', 'alcohol doses or alcohol placebo', 'THC', 'SFST']","['SFST performance', 'horizontal gaze nystagmus', 'peak blood alcohol concentration values']","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.161739,Alcohol in combination with cannabis was significantly related to impairment on horizontal gaze nystagmus (p = 0.029).,"[{'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Bosker', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands. Wendy.Bosker@maastrichtuniversity.nl'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Conen', 'Affiliation': ''}, {'ForeName': 'K P C', 'Initials': 'KP', 'LastName': 'Kuypers', 'Affiliation': ''}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Jeffery', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Walls', 'Affiliation': ''}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Kauert', 'Affiliation': ''}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Moeller', 'Affiliation': ''}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': ''}]",Psychopharmacology,[]
199,22622364,Acute tryptophan depletion in accordance with body weight: influx of amino acids across the blood-brain barrier.,"Acute tryptophan depletion (ATD) is a method of reducing central nervous serotonin (5-HT) synthesis in humans by administering an amino acid (AA) beverage lacking in tryptophan (TRP), the physiological precursor of 5-HT. However, to date, the use of conventional ATD protocols in children and adolescents was limited due to frequently observed side effects (e.g., vomiting and nausea). This study investigated the effects of diminished central nervous system 5-HT synthesis on plasma concentrations of relevant AAs and TRP influx into the brain in 24 healthy young adults using the ATD procedure Moja-De, a test protocol that has been used in preliminary research in youths. Twenty-four healthy participants received ATD and a TRP-balanced amino acid load (BAL) using a randomized double-blind within-subject crossover design. Plasma concentrations of the relevant AAs that compete with TRP on the same transport system were assessed at baseline and 90, 180, and 240 min after ATD/BAL intake. TRP influx across the blood-brain barrier was calculated using Michaelis-Menten kinetics with a correction for multiple substrate competition, indicating a significant decrease in TRP influx into the central nervous system under Moja-De. ATD Moja-De decreased TRP influx into the brain and central nervous system 5-HT synthesis safely and effectively and was well tolerated, allowing it to be used in children and adolescents. Future research into other secondary, compensatory effects induced by ATD in patients with neuropsychiatric disorders and healthy populations is needed. ATD Moja-De allows this type of research with a focus on a developmental viewpoint.",2012,"Acute tryptophan depletion (ATD) is a method of reducing central nervous serotonin (5-HT) synthesis in humans by administering an amino acid (AA) beverage lacking in tryptophan (TRP), the physiological precursor of 5-HT.","['children and adolescents', 'patients with neuropsychiatric disorders and healthy populations', 'Twenty-four healthy participants received', '24 healthy young adults using the ATD procedure Moja-De']","['diminished central nervous system 5-HT synthesis', 'ATD and a TRP-balanced amino acid load (BAL']","['TRP influx into the brain and central nervous system', 'TRP influx', 'Plasma concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",24.0,0.0507875,"Acute tryptophan depletion (ATD) is a method of reducing central nervous serotonin (5-HT) synthesis in humans by administering an amino acid (AA) beverage lacking in tryptophan (TRP), the physiological precursor of 5-HT.","[{'ForeName': 'V L S', 'Initials': 'VL', 'LastName': 'Dingerkus', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Neuenhofer Weg 21, 52074 Aachen, Germany.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Gaber', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Helmbold', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bubenzer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eisert', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Sánchez', 'Affiliation': ''}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Zepf', 'Affiliation': ''}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-012-0793-z']
200,22588333,Fibrin tissue adhesive reduces postoperative blood loss in total knee arthroplasty.,"BACKGROUND


Blood transfusion is often required in total knee replacement; various methods of blood preservation have been studied. The best solution is to reduce the loss of blood during and after surgery.
MATERIALS AND METHODS


We designed this study to evaluate the hemostatic efficacy and safety of fibrin tissue adhesive (Quixil) in patients receiving total knee arthroplasty [low contact stress (LCS, DePuy, Warsaw, IN, US) cementless total knee replacement (TKR)] with a prospective, randomized, standard treatment controlled study. Thirty-five patients were randomized to receive treatment with fibrin tissue adhesive (treatment group), and 35 were randomized to be managed with postoperative blood recovery and reinfusion (control group). Blood loss in suction drain, decrease in hemoglobin values, and transfusions were recorded.
RESULTS


A significant reduction in apparent total blood loss was detected in the treatment group compared with the control group. There was also a lower decrease in hemoglobin level, although this difference was not significant. When fibrin tissue adhesive was administered, the need for transfusions was lower. No major adverse events were recorded in our series.
CONCLUSIONS


Fibrin tissue adhesive reduced blood loss in TKR and seemed to significantly reduce the need for blood transfusion. Fibrin tissue adhesive can be an appropriate solution to enhance hemostasis and vessel sealing at the operative site in TKR, in order to reduce blood loss after surgery and the risk of complications.",2012,"Fibrin tissue adhesive can be an appropriate solution to enhance hemostasis and vessel sealing at the operative site in TKR, in order to reduce blood loss after surgery and the risk of complications.","['total knee arthroplasty', 'patients receiving total knee arthroplasty [low contact stress (LCS, DePuy, Warsaw, IN, US) cementless total knee replacement (TKR', 'Thirty-five patients']","['fibrin tissue adhesive', 'Fibrin tissue adhesive', 'postoperative blood recovery and reinfusion (control group', 'fibrin tissue adhesive (Quixil']","['apparent total blood loss', 'blood loss', 'hemoglobin level', 'hemostatic efficacy and safety', 'Blood loss', 'hemoglobin values, and transfusions']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}]","[{'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0005768'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]",35.0,0.0490261,"Fibrin tissue adhesive can be an appropriate solution to enhance hemostasis and vessel sealing at the operative site in TKR, in order to reduce blood loss after surgery and the risk of complications.","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Sabatini', 'Affiliation': 'Orthopedics and Traumatology Department, Ospedale Civile di Saluzzo, Via Spielberg 58, 12037, Saluzzo, CN, Italy. luigisabatini.ort@gmail.com'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Trecci', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Imarisio', 'Affiliation': ''}, {'ForeName': 'Marco Davide', 'Initials': 'MD', 'LastName': 'Uslenghi', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bianco', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Scagnelli', 'Affiliation': ''}]",Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology,['10.1007/s10195-012-0198-7']
201,22581111,"Effects of green tea supplementation on elements, total antioxidants, lipids, and glucose values in the serum of obese patients.","The consumption of green tea has been associated with cardiovascular and metabolic diseases. There have been some studies on the influence of green tea on the mineral status of obese subjects, but they have not yielded conclusive results. The aim of the present study is to examine the effects of green tea extract on the mineral, body mass, lipid profile, glucose, and antioxidant status of obese patients. A randomized, double-blind, placebo-controlled study was conducted. Forty-six obese patients were randomly assigned to receive either 379 mg of green tea extract, or a placebo, daily for 3 months. At baseline, and after 3 months of treatment, the anthropometric parameters, blood pressure, and total antioxidant status were assessed, as were the levels of plasma lipids, glucose, calcium, magnesium, iron, zinc, and copper. We found that 3 months of green tea extract supplementation resulted in decreases in body mass index, waist circumference, and levels of total cholesterol, low-density cholesterol, and triglyceride. Increases in total antioxidant level and in zinc concentration in serum were also observed. Glucose and iron levels were lower in the green tea extract group than in the control, although HDL-cholesterol and magnesium were higher in the green tea extract group than in the placebo group. At baseline, a positive correlation was found between calcium and body mass index, as was a negative correlation between copper and triglycerides. After 3 months, a positive correlation between iron and body mass index and between magnesium and HDL-cholesterol, as well as a negative correlation between magnesium and glucose, were observed. The present findings demonstrate that green tea influences the body's mineral status. Moreover, the results of this study confirm the beneficial effects of green tea extract supplementation on body mass index, lipid profile, and total antioxidant status in patients with obesity.",2012,"Glucose and iron levels were lower in the green tea extract group than in the control, although HDL-cholesterol and magnesium were higher in the green tea extract group than in the placebo group.","['obese patients', 'patients with obesity', 'Forty-six obese patients', 'obese subjects']","['placebo', 'green tea extract supplementation', 'green tea supplementation', 'green tea extract, or a placebo', 'green tea extract']","['body mass index, waist circumference, and levels of total cholesterol, low-density cholesterol, and triglyceride', 'mineral, body mass, lipid profile, glucose, and antioxidant status', 'Glucose and iron levels', 'total antioxidant level and in zinc concentration in serum', 'body mass index, lipid profile, and total antioxidant status', 'HDL-cholesterol and magnesium', 'anthropometric parameters, blood pressure, and total antioxidant status', 'positive correlation between iron and body mass index and between magnesium and HDL-cholesterol', 'levels of plasma lipids, glucose, calcium, magnesium, iron, zinc, and copper', 'total antioxidants, lipids, and glucose values']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C1384640', 'cui_str': 'Green Tea'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",46.0,0.294293,"Glucose and iron levels were lower in the green tea extract group than in the control, although HDL-cholesterol and magnesium were higher in the green tea extract group than in the placebo group.","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Suliburska', 'Affiliation': 'Department of Human Nutrition and Hygiene, Poznan University of Life Sciences, Wojska Polskiego 31 Str, 60-624 Poznan, Poland. jsulibur@up.poznan.pl'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Bogdanski', 'Affiliation': ''}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Szulinska', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Stepien', 'Affiliation': ''}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Pupek-Musialik', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jablecka', 'Affiliation': ''}]",Biological trace element research,['10.1007/s12011-012-9448-z']
202,22585408,Cancer cachexia and anabolic interventions: a case report.,"BACKGROUND


Standard-of-care (SOC) cancer treatments are primarily aimed at reducing size and progression of a tumor. There is a need for successful supplemental anabolic therapies to combat cancer cachexia in addition to these SOC treatment modalities. Anabolic interventions, including testosterone and amino acid supplements, may be beneficial in reducing and/or reversing muscle wasting in these patient populations.
METHODS


A 48-year-old Caucasian female with recurrent cervical cancer was scheduled to receive three 21-day cycles of cisplatin and topetecan chemotherapy. She qualified, consented, and enrolled into a blinded interventional pilot study where she received daily whey protein (10 g, three times per day with meals) and a weekly injection of testosterone enanthate (100 mg intramuscular) before and during the SOC chemotherapy treatment period. Body composition, serum inflammatory markers, mixed muscle protein synthesis and breakdown rates, physical function, fatigue, and quality of life were assessed before and after the intervention period.
RESULTS


Body composition, as assessed by an increase in body weight and lean body mass and reduction in fat mass; physical function; fatigue; and quality of life each improved across the entire intervention period despite general increases in inflammatory markers and no improvements in muscle protein turnover towards the end of the intervention.
CONCLUSIONS


Concomitant treatment of oral amino acids and testosterone may be a viable therapeutic option for fighting cachexia and improving body composition and quality of life during chemotherapeutic treatment of recurrent cervical cancer. These positive outcomes may be attainable over time despite overall poor inflammatory status.",2012,"RESULTS


Body composition, as assessed by an increase in body weight and lean body mass and reduction in fat mass; physical function; fatigue; and quality of life each improved across the entire intervention period despite general increases in inflammatory markers and no improvements in muscle protein turnover towards the end of the intervention.
","['recurrent cervical cancer', 'A 48-year-old Caucasian female with recurrent cervical cancer']","['cisplatin and topetecan chemotherapy', 'testosterone and amino acid supplements', 'testosterone enanthate', 'oral amino acids and testosterone', 'daily whey protein']","['body composition and quality of life', 'Body composition, serum inflammatory markers, mixed muscle protein synthesis and breakdown rates, physical function, fatigue, and quality of life', 'body weight and lean body mass and reduction in fat mass; physical function; fatigue; and quality of life', 'muscle protein turnover']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C0076189', 'cui_str': 'testosterone enanthate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0034380'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026832', 'cui_str': 'Muscle Proteins'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}]",,0.0531734,"RESULTS


Body composition, as assessed by an increase in body weight and lean body mass and reduction in fat mass; physical function; fatigue; and quality of life each improved across the entire intervention period despite general increases in inflammatory markers and no improvements in muscle protein turnover towards the end of the intervention.
","[{'ForeName': 'Edgar L', 'Initials': 'EL', 'LastName': 'Dillon', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch at Galveston, Galveston, TX, 77555-0569, USA.'}, {'ForeName': 'Gurjot', 'Initials': 'G', 'LastName': 'Basra', 'Affiliation': ''}, {'ForeName': 'Astrid M', 'Initials': 'AM', 'LastName': 'Horstman', 'Affiliation': ''}, {'ForeName': 'Shanon L', 'Initials': 'SL', 'LastName': 'Casperson', 'Affiliation': ''}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Randolph', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Durham', 'Affiliation': ''}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Urban', 'Affiliation': ''}, {'ForeName': 'Concepcion', 'Initials': 'C', 'LastName': 'Diaz-Arrastia', 'Affiliation': ''}, {'ForeName': 'Lyuba', 'Initials': 'L', 'LastName': 'Levine', 'Affiliation': ''}, {'ForeName': 'Sandra S', 'Initials': 'SS', 'LastName': 'Hatch', 'Affiliation': ''}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Willis', 'Affiliation': ''}, {'ForeName': 'Gwyn', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Sheffield-Moore', 'Affiliation': ''}]","Journal of cachexia, sarcopenia and muscle",['10.1007/s13539-012-0066-6']
203,22576838,The migration pattern of the Charnley femoral stem: a five-year follow-up RSA study in a well-functioning patient group.,"BACKGROUND


Implant stability is considered vital to long-time implant survival in total hip arthroplasty (THA), since loose implants are reported to be a major cause of hip revision. There is an association between early implant micromotion and increased risk of revision. More implant-specific data are needed to establish acceptable levels of early implant movement.
MATERIALS AND METHODS


Thirty-five patients (36 hips) undergoing Charnley THA were followed with repeated clinical, radiographic, and radiostereometric analysis (RSA) over 5 years. Twenty-three patients attended 5 years postoperatively.
RESULTS


The patient group was well functioning based on the radiological and clinical evaluations. The stems constantly moved up to 5 years postoperatively, with subsidence, retroversion, and varus tilt, based on the RSA.
CONCLUSION


Continuous movement of the Charnley stem was observed up to 5 years postoperatively in a well-functioning patient group. The migration data presented herein could be useful when defining acceptable migration limits for certain types of cemented femoral stems.",2012,Continuous movement of the Charnley stem was observed up to 5 years postoperatively in a well-functioning patient group.,"['Thirty-five patients (36 hips) undergoing Charnley THA were followed with repeated clinical, radiographic, and radiostereometric analysis (RSA) over 5 years', 'Twenty-three patients attended 5 years postoperatively', 'total hip arthroplasty (THA']",[],['risk of revision'],"[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C3178874', 'cui_str': 'Radiostereometry'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}]",,0.0464073,Continuous movement of the Charnley stem was observed up to 5 years postoperatively in a well-functioning patient group.,"[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Haugan', 'Affiliation': 'Orthopaedic Research Centre, Trondheim University Hospital, 7006, Trondheim, Norway. kristin.haugan@ntnu.no'}, {'ForeName': 'Otto S', 'Initials': 'OS', 'LastName': 'Husby', 'Affiliation': ''}, {'ForeName': 'Jomar', 'Initials': 'J', 'LastName': 'Klaksvik', 'Affiliation': ''}, {'ForeName': 'Olav A', 'Initials': 'OA', 'LastName': 'Foss', 'Affiliation': ''}]",Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology,['10.1007/s10195-012-0187-x']
204,22585012,Effects of mindfulness-based stress reduction on distressed (type D) personality traits: a randomized controlled trial.,"Distressed ('Type D') personality, the combination of negative affectivity (NA) and social inhibition (SI), has been associated with adverse health outcomes. The purpose of this study was to examine if an 8-week mindfulness-based stress reduction (MBSR) program could reduce Type D personality characteristics. Distressed individuals from the Dutch general population (N = 146; mean age = 46.07; 69 % female) participated in a randomized trial comparing the mindfulness intervention with waitlist control. Although change in Type D caseness did not differ between groups, the intervention group showed stronger reductions for both NA (p < .001) and SI (p < .05) dimensions, even when change in state negative affect was statistically controlled. These effects were mediated by change in self-reported mindfulness. In conclusion, MBSR may reduce characteristics of the distressed personality type, likely through the mechanism of increased mindfulness.",2013,"Although change in Type D caseness did not differ between groups, the intervention group showed stronger reductions for both NA (p < .001) and SI (p < .05) dimensions, even when change in state negative affect was statistically controlled.","['distressed (type D) personality traits', 'mean age\xa0=\xa046.07; 69\xa0% female', 'Distressed individuals from the Dutch general population (N\xa0=\xa0146']","['mindfulness-based stress reduction', 'mindfulness intervention with waitlist control', '8-week mindfulness-based stress reduction (MBSR) program', 'MBSR']","['Type D personality characteristics', 'SI', 'Type D caseness']","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0233849', 'cui_str': 'Personality finding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3658239', 'cui_str': 'Type D Personality'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",146.0,0.0388789,"Although change in Type D caseness did not differ between groups, the intervention group showed stronger reductions for both NA (p < .001) and SI (p < .05) dimensions, even when change in state negative affect was statistically controlled.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Nyklíček', 'Affiliation': 'CoRPS, Center of Research on Psychology in Somatic disease, Department of Medical Psychology, Tilburg University, Postbox 90153, 5000 LE, Tilburg, The Netherlands. i.nyklicek@tilburguniversity.edu'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'van Beugen', 'Affiliation': ''}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Denollet', 'Affiliation': ''}]",Journal of behavioral medicine,['10.1007/s10865-012-9431-3']
205,22569835,Atorvastatin added to interferon β for relapsing multiple sclerosis: a randomized controlled trial.,"Statins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects. The present study evaluated the effect of atorvastatin added to interferon beta-1b in multiple sclerosis (MS) in a multicenter, randomized, parallel-group, rater-blinded study performed in eight Swiss hospitals. Seventy-seven patients with relapsing-remitting MS started interferon beta-1b every other day. After 3 months, they were randomized 1:1 to receive atorvastatin 40 mg/day or not in addition to interferon beta-1b until month 15. The primary endpoint was the proportion of patients with new lesions on T2-weighted images at month 15 compared to baseline at month three. At study end, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.14; 95 % CI 0.36-3.56; p = 0.81). All predefined secondary endpoints including number of new lesions and total lesion volume on T2-weighted images, total number of new Gd-enhancing lesions on T1-weighted images, total brain volume, volume of grey matter, volume of white matter, EDSS, MSFC, relapse rate, time to first relapse, number of relapse-free patients and neutralizing antibodies did not show any significant differences (all p values >0.1). Transient elevations of liver enzymes were more frequent with atorvastatin (p = 0.02). In conclusion, atorvastatin 40 mg/day in addition to interferon beta-1b did not have a beneficial effect on relapsing-remitting MS compared to interferon beta-1b monotherapy over a 12-month period.",2012,Transient elevations of liver enzymes were more frequent with atorvastatin (p = 0.02).,"['Seventy-seven patients with relapsing-remitting MS started interferon beta-1b every other day', 'eight Swiss hospitals', 'relapsing multiple sclerosis']","['Atorvastatin', 'interferon β', 'atorvastatin']","['proportion of patients with new lesions on T2-weighted images', 'number of new lesions and total lesion volume on T2-weighted images, total number of new Gd-enhancing lesions on T1-weighted images, total brain volume, volume of grey matter, volume of white matter, EDSS, MSFC, relapse rate, time to first relapse, number of relapse-free patients and neutralizing antibodies', 'relapsing-remitting MS', 'Transient elevations of liver enzymes']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0682708'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}]",77.0,0.0351569,Transient elevations of liver enzymes were more frequent with atorvastatin (p = 0.02).,"[{'ForeName': 'Christian Philipp', 'Initials': 'CP', 'LastName': 'Kamm', 'Affiliation': 'University Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Freiburgstrasse, 3010, Bern, Switzerland.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'El-Koussy', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Humpert', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Findling', 'Affiliation': ''}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'von Bredow', 'Affiliation': ''}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Burren', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Schwegler', 'Affiliation': ''}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schött', 'Affiliation': ''}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Donati', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': ''}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Goebels', 'Affiliation': ''}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Slotboom', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Tettenborn', 'Affiliation': ''}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': ''}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Naegelin', 'Affiliation': ''}, {'ForeName': 'Heinrich Paul', 'Initials': 'HP', 'LastName': 'Mattle', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-012-6513-7']
206,22573261,Five-year results of a randomized clinical trial comparing a polypropylene mesh with a poliglecaprone and polypropylene composite mesh for inguinal hernioplasty.,"BACKGROUND


The aim of this study was to assess whether partially absorbable monofilament mesh could influence postoperative pain and recurrence after Lichtenstein hernioplasty over the long term.
METHODS


Patients were randomized into two groups that were treated with lightweight (LW) or heavyweight (HW) mesh in 15 centers in Poland. A modified suture technique was used in the lightweight mesh group. Clinical examination was performed. A pain questionnaire was completed five years after the surgery.
RESULTS


Of the 392 patients who underwent surgery, 161 (90.81 %) of 177 in the HW group and 195 (90.69 %) of 215 in the LW group were examined according to protocol, a median of 62 (range 57-66) months after hernia repair. There was no difference in the recurrence rate (1.9 % LW vs. 0.6 % HW; P = 0.493). There were 24 deaths in the follow-up period, but these had no connection to the surgery. The patients treated with LW mesh reported less pain in the early postoperative period. After five years of follow-up, the intensity and the presence of pain did not differ between groups (5 patients in the LW and 4 patients in the HW group). Average pain, (VAS score), was also similar in the LW and HW group (2.25 vs. 2.4) at the fifth year postoperatively.
CONCLUSION


The use of partially absorbable mesh reduced postoperative pain during the short-term postoperative period. No difference in pain or recurrence rate was observed at 60 months.",2012,No difference in pain or recurrence rate was observed at 60 months.,"['Patients', '392 patients who underwent surgery, 161 (90.81 %) of 177 in the HW group and 195 (90.69 %) of 215 in the LW group', 'inguinal hernioplasty']","['lightweight (LW) or heavyweight (HW) mesh', 'partially absorbable monofilament mesh', 'poliglecaprone and polypropylene composite mesh', 'polypropylene mesh', 'Lichtenstein hernioplasty', 'LW mesh']","['Average pain, (VAS score', 'pain', 'recurrence rate', 'intensity and the presence of pain', 'postoperative pain and recurrence', 'pain questionnaire', 'postoperative pain', 'pain or recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C4284593', 'cui_str': 'Repair of inguinal hernia using surgical mesh (procedure)'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0032582', 'cui_str': 'Propene Polymers'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh (physical object)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",392.0,0.0867363,No difference in pain or recurrence rate was observed at 60 months.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bury', 'Affiliation': 'Department of Vascular and Cardiac Surgery, Medical University of Gdańsk, ul. Dębinki 7, 80-211, Gdańsk, Poland. kbury@gumed.edu.pl'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Śmietański', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-012-0916-3']
207,22547331,Varenicline decreases alcohol consumption in heavy-drinking smokers.,"RATIONALE


Emerging evidence suggests that the α4β2 form of the nicotinic acetylcholine receptor (nAChR) modulates the rewarding effects of alcohol. The nAChR α4β2 subunit partial agonist varenicline (Chantix™), which is approved by the Food and Drug Administration for smoking cessation, also decreases ethanol consumption in rodents (Steensland et al., Proc Natl Acad Sci U S A 104:12518-12523, 2007) and in human laboratory and open-label studies (Fucito et al., Psychopharmacology (Berl) 215:655-663, 2011; McKee et al., Biol Psychiatry 66:185-190 2009).
OBJECTIVES


We present a randomized, double-blind, 16-week study in heavy-drinking smokers (n = 64 randomized to treatment) who were seeking treatment for their smoking. The study was designed to determine the effects of varenicline on alcohol craving and consumption. Outcome measures included number of alcoholic drinks per week, cigarettes per week, amount of alcohol craving per week, cumulative cigarettes and alcoholic drinks consumed during the treatment period, number of abstinent days, and weekly percentage of positive ethyl glucuronide and cotinine screens.
RESULTS


Varenicline significantly decreases alcohol consumption (χ (2) = 35.32, p < 0.0001) in smokers. Although varenicline has previously been associated with suicidality and depression, side effects were low in this study and declined over time in the varenicline treatment group.
CONCLUSIONS


Varenicline can produce a sustained decrease in alcohol consumption in individuals who also smoke. Further studies are warranted to assess varenicline efficacy in treatment-seeking alcohol abusers who do not smoke and to ascertain the relationship between varenicline effects on smoking and drinking.",2012,"RESULTS


Varenicline significantly decreases alcohol consumption (χ (2) = 35.32, p < 0.0001) in smokers.","['heavy-drinking smokers', 'heavy-drinking smokers (n\u2009=\u200964 randomized to treatment) who were seeking treatment for their smoking', 'individuals who also smoke']","['varenicline', 'Varenicline']","['alcohol consumption', 'varenicline efficacy', 'number of alcoholic drinks per week, cigarettes per week, amount of alcohol craving per week, cumulative cigarettes and alcoholic drinks consumed during the treatment period, number of abstinent days, and weekly percentage of positive ethyl glucuronide and cotinine screens', 'ethanol consumption', 'alcohol craving and consumption']","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic Beverages'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0298229', 'cui_str': 'ethylglucuronide'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.01565,"RESULTS


Varenicline significantly decreases alcohol consumption (χ (2) = 35.32, p < 0.0001) in smokers.","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'Ernest Gallo Clinic and Research Center, University of California, San Francisco, 5858 Horton Street, Suite #200, Emeryville, CA 94608, USA. jmitchell@gallo.ucsf.edu'}, {'ForeName': 'Candice H', 'Initials': 'CH', 'LastName': 'Teague', 'Affiliation': ''}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kayser', 'Affiliation': ''}, {'ForeName': 'Selena E', 'Initials': 'SE', 'LastName': 'Bartlett', 'Affiliation': ''}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Fields', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-012-2717-x']
208,22552718,Age effect on bone mineral density changes in breast cancer patients receiving anastrozole: results from the ARBI prospective clinical trial.,"PURPOSE


We investigated whether age at anastrozole (A) initiation influences the effect of treatment on bone mineral density (BMD). We conducted a post hoc analysis of the dataset of Arimidex Bone Mass Index Oral Bisphosphonates prospective trial, studying the effect of risedronate (R) on BMD of postmenopausal, early breast cancer patients receiving A.
METHODS


Patients were stratified into those with normal BMD or mild osteopenia (T > -2) receiving A-only and patients with mild or severe osteopenia (T ≤ -2) or osteoporosis (T < -2.5) receiving A and per os R (A + R). Depending on age on treatment initiation, patients were grouped into two age cohorts, above and below 65 years. BMD change in lumbar spine (LS) and hip (HP) was evaluated at 12 months. An analysis of patients with normal BMD at baseline was additionally performed.
RESULTS


Among patients receiving A-only, women ≤65 years were more likely to have a decrease in LS-BMD than older (p = 0.034). HP-BMD decrease at 12 months was not related to age (p = 0.182). In patients with mild or severe osteopenia or osteoporosis, treated with A + R, no age effect was observed for LS or HP (p = 0.099 and p = 0.939, respectively). Among patients with normal BMD at baseline, the age effect on LS-BMD change was more profound (p = 0.026).
CONCLUSIONS


Our study suggests that younger postmenopausal women with normal BMD or mild osteopenia receiving A-only face an increased risk of bone loss in LS. Among patients with mild or severe osteopenia or osteoporosis treated with A + R, 12 months LS or HP BMD variations were configured regardless of age group.",2012,"In patients with mild or severe osteopenia or osteoporosis, treated with A + R, no age effect was observed for LS or HP (p = 0.099 and p = 0.939, respectively).","['breast cancer patients receiving', 'patients receiving A-only, women ≤65\xa0years', 'patients with mild or severe osteopenia or osteoporosis treated with A\xa0+\xa0R, 12\xa0months LS or', 'younger postmenopausal women with normal BMD or mild osteopenia', 'postmenopausal, early breast cancer patients receiving A.\nMETHODS\n\n\nPatients were stratified into those with normal BMD or mild osteopenia (T\xa0>\xa0-2) receiving A-only and patients with mild or severe osteopenia (T\xa0≤\xa0-2) or osteoporosis (T\xa0<\xa0-2.5) receiving A and per os R (A\xa0+\xa0R']","['risedronate (R', 'anastrozole']","['LS or HP', 'BMD change in lumbar spine (LS) and hip (HP', 'severe osteopenia or osteoporosis', 'HP BMD variations', 'bone mineral density (BMD', 'LS-BMD change', 'bone mineral density changes', 'HP-BMD decrease', 'LS-BMD', 'risk of bone loss']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1527415', 'cui_str': 'Per oral route'}]","[{'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.117603,"In patients with mild or severe osteopenia or osteoporosis, treated with A + R, no age effect was observed for LS or HP (p = 0.099 and p = 0.939, respectively).","[{'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Markopoulos', 'Affiliation': 'Hellenic Society of Breast Surgeons, 6 Eslin Street, 11523, Athens, Greece. cmarkop@hol.gr'}, {'ForeName': 'Evagelos', 'Initials': 'E', 'LastName': 'Tzoracoleftherakis', 'Affiliation': ''}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Koukouras', 'Affiliation': ''}, {'ForeName': 'Basileios', 'Initials': 'B', 'LastName': 'Venizelos', 'Affiliation': ''}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Zobolas', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Misitzis', 'Affiliation': ''}, {'ForeName': 'Grigorios', 'Initials': 'G', 'LastName': 'Xepapadakis', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': ''}]",Journal of cancer research and clinical oncology,['10.1007/s00432-012-1233-z']
209,22539020,Short-term effects of sibutramine on mineral status and selected biochemical parameters in obese women.,"The aim of this study was to assess the effect of sibutramine on mineral status and selected biochemical parameters in obese women. The study was conducted on 24 patients who received 15 mg daily doses of sibutramine for 12 weeks, and on 20 patients who received placebo. At the baseline, after the sixth and twelfth weeks of treatment, body weight and blood pressure were measured, the BMI was calculated, and samples of blood and of first morning urine were collected. Serum lipid profiles, glucose levels, and nitric oxide levels were determined. The iron (Fe), copper (Cu), zinc (Zn), calcium (Ca), and magnesium (Mg) present in the serum and urine samples were assessed. The erythrocyte hemolysate of the patients was use to assay the activity of glutathione peroxidase (GSH-Px) and superoxide dismutase (SOD). No changes were observed in BMI, blood pressure, or nitric oxide during the study. After 12 weeks of treatment, a decrease was observed in total cholesterol, LDL cholesterol, triglyceride, glucose, and ferritin levels. GSH-Px and SOD activity increased after 12 weeks of sibutramine treatment. The Mg and Cu increases was observed in serum after the sixth and twelfth weeks of treatment. It was found that the Zn level decreased in serum after the twelfth week. The elimination of Ca, Mg, Fe, Zn, and Cu in urine also declined in the twelfth week. No differences were found in the women taking the placebo. In conclusion, we found that sibutramine had a positive effect on lipid and glucose status in obese women. However, the drug disturbed the balance of minerals, especially Zn and Mg, in the subjects.",2012,"After 12 weeks of treatment, a decrease was observed in total cholesterol, LDL cholesterol, triglyceride, glucose, and ferritin levels.","['obese women', '24 patients who received 15 mg daily doses of']","['placebo', 'sibutramine']","['iron (Fe), copper (Cu), zinc (Zn), calcium (Ca), and magnesium (Mg) present in the serum and urine samples', 'BMI was calculated, and samples of blood and of first morning urine', 'body weight and blood pressure', 'Serum lipid profiles, glucose levels, and nitric oxide levels', 'mineral status and selected biochemical parameters', 'elimination of Ca, Mg, Fe, Zn, and Cu in urine', 'lipid and glucose status', 'BMI, blood pressure, or nitric oxide', 'total cholesterol, LDL cholesterol, triglyceride, glucose, and ferritin levels', 'GSH-Px and SOD activity', 'activity of glutathione peroxidase (GSH-Px) and superoxide dismutase (SOD', 'Zn level']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074493', 'cui_str': 'sibutramine'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}]",24.0,0.0300276,"After 12 weeks of treatment, a decrease was observed in total cholesterol, LDL cholesterol, triglyceride, glucose, and ferritin levels.","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Suliburska', 'Affiliation': 'Department of Human Nutrition and Hygiene, Poznan University of Life Sciences, Wojska Polskiego 31 Str., 60-624, Poznan, Poland. jsulibur@up.poznan.pl'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Bogdański', 'Affiliation': ''}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Szulińska', 'Affiliation': ''}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Pupek-Musialik', 'Affiliation': ''}]",Biological trace element research,['10.1007/s12011-012-9425-6']
210,22544470,Brief report: oxytocin enhances paternal sensitivity to a child with autism: a double-blind within-subject experiment with intranasally administered oxytocin.,"Oxytocin seems associated with parenting style, and experimental work showed positive effects of intranasally administered oxytocin on parenting style of fathers. Here, the first double-blind, placebo-controlled, within-subject experiment with intranasal oxytocin administration to fathers of children with autism spectrum disorder (ASD) is presented. Fathers with their typically developing toddler (n = 18), and fathers of toddlers diagnosed with ASD (n = 14), were observed in two play sessions of 15 min each with an intervening period of 1 week. In all fathers oxytocin elevated the quality of paternal sensitive play: fathers stimulated their child in a more optimal way, and they showed less hostility which suggests the positive effects of oxytocin on paternal sensitive play irrespective of clinical status of their child.",2013,"In all fathers oxytocin elevated the quality of paternal sensitive play: fathers stimulated their child in a more optimal way, and they showed less hostility which suggests the positive effects of oxytocin on paternal sensitive play irrespective of clinical status of their child.","['child with autism', 'fathers of children with autism spectrum disorder (ASD', 'Fathers with their typically developing toddler (n\xa0=\xa018), and fathers of toddlers diagnosed with ASD (n\xa0=\xa014']","['Oxytocin', 'oxytocin', 'placebo', 'intranasal oxytocin']","['parenting style of fathers', 'paternal sensitivity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0337493', 'cui_str': 'Paternal (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",,0.146074,"In all fathers oxytocin elevated the quality of paternal sensitive play: fathers stimulated their child in a more optimal way, and they showed less hostility which suggests the positive effects of oxytocin on paternal sensitive play irrespective of clinical status of their child.","[{'ForeName': 'Fabiënne B A', 'Initials': 'FB', 'LastName': 'Naber', 'Affiliation': 'Centre of Child and Family Studies, University of Leiden, Leiden, The Netherlands. Fnaber@fsw.leidenuniv.nl'}, {'ForeName': 'Irina E', 'Initials': 'IE', 'LastName': 'Poslawsky', 'Affiliation': ''}, {'ForeName': 'Marinus H', 'Initials': 'MH', 'LastName': 'van Ijzendoorn', 'Affiliation': ''}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'van Engeland', 'Affiliation': ''}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'Bakermans-Kranenburg', 'Affiliation': ''}]",Journal of autism and developmental disorders,['10.1007/s10803-012-1536-6']
211,22535148,"Migraine prevalence, alexithymia, and post-traumatic stress disorder among medical students in Turkey.","The aim of this study was to investigate the prevalence of migraine, alexithymia, and post-traumatic stress disorder among medical students at Cumhuriyet University of Sivas in Turkey. A total of 250 medical students participated in this study and answered the questionnaires. The study was conducted in three stages: the self-questionnaire, the neurological evaluation, and the psychiatric evaluation. In the first stage, the subjects completed a questionnaire to assess migraine symptoms and completed the three-item Identification of Migraine Questionnaire, the Toronto Alexithymia Scale, and the Post-Traumatic Stress Disorder Checklist-Civilian Version Scale. The subjects who reported having a migraine underwent a detailed neurological evaluation conducted by a neurologist to confirm the diagnosis. In the final stage, the subjects with a migraine completed a psychiatric examination using the structured clinical interview for DSM-IV-R Axis I. The actual prevalence of migraine among these medical students was 12.6 %. The students with a migraine were diagnosed with alexithymia and post-traumatic stress disorder more frequently than those without migraine. The Migraine Disability Assessment Scale scores correlated with the post-traumatic stress disorder scores. The results of this study indicate that migraine was highly prevalent among medical students in Turkey and was associated with the alexithymic personality trait and comorbid psychiatric disorders including post-traumatic stress disorder. Treatment strategies must be developed to manage these comorbidities.",2012,The students with a migraine were diagnosed with alexithymia and post-traumatic stress disorder more frequently than those without migraine.,"['medical students at Cumhuriyet University of Sivas in Turkey', '250 medical students participated in this study and answered the questionnaires', 'subjects who reported having a migraine underwent a detailed neurological evaluation conducted by a neurologist to confirm the diagnosis', 'medical students in Turkey', 'students with a migraine were diagnosed with alexithymia and post-traumatic stress disorder more frequently than those without migraine']",[],"['alexithymic personality trait and comorbid psychiatric disorders', 'Migraine Disability Assessment Scale scores', 'Migraine Questionnaire, the Toronto Alexithymia Scale, and the Post-Traumatic Stress Disorder Checklist-Civilian Version Scale']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0237426', 'cui_str': 'Neurologists'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}]",[],"[{'cui': 'C0233849', 'cui_str': 'Personality finding'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0222045'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]",250.0,0.012391,The students with a migraine were diagnosed with alexithymia and post-traumatic stress disorder more frequently than those without migraine.,"[{'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Balaban', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Cumhuriyet University, 58140, Sivas, Turkey. haticebalaban@yahoo.com'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Semiz', 'Affiliation': ''}, {'ForeName': 'Ilteriş Ahmet', 'Initials': 'IA', 'LastName': 'Şentürk', 'Affiliation': ''}, {'ForeName': 'Önder', 'Initials': 'Ö', 'LastName': 'Kavakçı', 'Affiliation': ''}, {'ForeName': 'Ziynet', 'Initials': 'Z', 'LastName': 'Cınar', 'Affiliation': ''}, {'ForeName': 'Ayfer', 'Initials': 'A', 'LastName': 'Dikici', 'Affiliation': ''}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Topaktaş', 'Affiliation': ''}]",The journal of headache and pain,['10.1007/s10194-012-0452-7']
212,22562077,Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on dental side effects.,"OBJECTIVES


This study aimed to assess possible dental side effects associated with long-term use of an adjustable oral appliance compared with continuous positive airway pressure (CPAP) in patients with the obstructive sleep apnea syndrome and to study the relationship between these possible side effects and the degree of mandibular protrusion associated with oral appliance therapy.
MATERIALS AND METHODS


As part of a previously conducted RCT, 51 patients were randomized to oral appliance therapy and 52 patients to CPAP therapy. At baseline and after a 2-year follow-up, dental plaster study models in full occlusion were obtained which were thereupon analyzed with respect to relevant variables.
RESULTS


Long-term use of an oral appliance resulted in small but significant dental changes compared with CPAP. In the oral appliance group, overbite and overjet decreased 1.2 (±1.1) mm and 1.5 (±1.5) mm, respectively. Furthermore, we found a significantly larger anterior-posterior change in the occlusion (-1.3 ± 1.5 mm) in the oral appliance group compared to the CPAP group (-0.1 ± 0.6 mm). Moreover, both groups showed a significant decrease in number of occlusal contact points in the (pre)molar region. Linear regression analysis revealed that the decrease in overbite was associated with the mean mandibular protrusion during follow-up [regression coefficient (β) = -0.02, 95 % confidence interval (-0.04 to -0.00)].
CONCLUSIONS


Oral appliance therapy should be considered as a lifelong treatment, and there is a risk of dental side effects to occur.
CLINICAL RELEVANCE


Patients treated with the oral appliance need a thorough follow-up by a dentist or dental-specialist experienced in the field of dental sleep medicine.",2013,"Linear regression analysis revealed that the decrease in overbite was associated with the mean mandibular protrusion during follow-up [regression coefficient (β) = -0.02, 95 % confidence interval (-0.04 to -0.00)].
","['patients with the obstructive sleep apnea syndrome', 'obstructive sleep apnea syndrome', 'Patients treated with the oral appliance need a thorough follow-up by a dentist or dental-specialist experienced in the field of dental sleep medicine']","['adjustable oral appliance', 'CPAP', 'continuous positive airway pressure (CPAP', 'Long-term oral appliance therapy', 'CPAP therapy', 'oral appliance therapy']","['number of occlusal contact points', 'mean mandibular protrusion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C4304028', 'cui_str': 'Sleep medicine'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0333056', 'cui_str': 'Protrusion (morphologic abnormality)'}]",51.0,0.0337272,"Linear regression analysis revealed that the decrease in overbite was associated with the mean mandibular protrusion during follow-up [regression coefficient (β) = -0.02, 95 % confidence interval (-0.04 to -0.00)].
","[{'ForeName': 'M H J', 'Initials': 'MH', 'LastName': 'Doff', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Hanzeplein 1, PO Box 30.001, 9700 RB Groningen, The Netherlands. m.h.j.doff@umcg.nl'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Finnema', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hoekema', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': ''}, {'ForeName': 'L G M', 'Initials': 'LG', 'LastName': 'de Bont', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Stegenga', 'Affiliation': ''}]",Clinical oral investigations,['10.1007/s00784-012-0737-x']
213,22526730,Long-term functional outcome in adult prison inmates with ADHD receiving OROS-methylphenidate.,"In a recent randomized, double-blind, placebo-controlled trial, we established a robust efficacy (Cohen's d = 2.17) of osmotic release oral system-methylphenidate (OROS-methylphenidate) delivered 72 mg daily for 5 weeks versus placebo on attention deficit hyperactivity disorder (ADHD) symptoms, global severity and global functioning in 30 adult male prison inmates with ADHD and coexisting disorders. Outcomes continued to improve during the subsequent 47-week open-label extension with OROS-methylphenidate delivered at a flexible daily dosage of up to 1.3 mg/kg body weight. In the present study, we evaluated long-term effectiveness and maintenance of improvement over the cumulated 52-week trial on cognition, motor activity, institutional behaviour and quality of life. Post hoc, we explored the associations between investigators' and self-ratings of ADHD symptoms and between ratings of symptoms and functioning, respectively. Outcomes, calculated by repeated measures ANOVA, improved from baseline until week 16, with maintenance or further improvement until week 52. Both verbal and visuospatial working memory, and abstract verbal reasoning improved significantly over time, as well as several cognition-related measures and motor activity. No substance abuse was detected and a majority of participants took part in psychosocial treatment programmes. The quality of life domains of Learning, and Goals and values improved over time; the latter domain was at open-label endpoint significantly related to improvements in attention. Investigators' and self-ratings of ADHD symptoms, as well as global symptom severity related most significantly to global functioning at week 52. Finally, investigators' and self-ratings of ADHD symptoms associated significantly at baseline with increasing convergence over time.",2012,"Both verbal and visuospatial working memory, and abstract verbal reasoning improved significantly over time, as well as several cognition-related measures and motor activity.","['adult prison inmates with ADHD receiving OROS-methylphenidate', '30 adult male prison inmates with ADHD and coexisting disorders']","['methylphenidate (OROS-methylphenidate', 'placebo']","['quality of life domains of Learning, and Goals and values improved over time; the latter domain', 'Both verbal and visuospatial working memory, and abstract verbal reasoning', 'attention deficit hyperactivity disorder (ADHD) symptoms, global severity and global functioning', 'several cognition-related measures and motor activity', 'cognition, motor activity, institutional behaviour and quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034380'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]",30.0,0.0598465,"Both verbal and visuospatial working memory, and abstract verbal reasoning improved significantly over time, as well as several cognition-related measures and motor activity.","[{'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Ginsberg', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychiatry, Karolinska Institutet, Stockholm, Sweden. ylva.ginsberg@ki.se'}, {'ForeName': 'Tatja', 'Initials': 'T', 'LastName': 'Hirvikoski', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grann', 'Affiliation': ''}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Lindefors', 'Affiliation': ''}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-012-0317-8']
214,22399327,The use of telephone in genetic counseling versus in-person counseling: a randomized study on counselees' outcome.,"Increased demand for genetic counseling services necessitates exploring alternatives to in-person counseling. Telephone counseling is a less time-consuming and more cost-effective alternative. So far there is insufficient evidence to support a pre-counseling telephone model. This randomized questionnaire study aims to evaluate the oncogenetic counseling process and to compare the impact of the initial part of the oncogenetic counseling, when conducted via telephone versus in-person. The aspects of evaluations were: patients' expectations, satisfaction and experiences of genetic counseling, worry for developing hereditary cancer and health related quality of life. A total of 215 participants representing several cancer syndromes were randomized to counseling via telephone or in-person. The questionnaires were completed before and after oncogenetic nurse counseling, and 1 year after the entire counseling process. Overall, a high satisfaction rate with the oncogenetic counseling process was found among the participants regardless of whether the oncogenetic nurse counseling was conducted by telephone or in-person. The results show that a considerable number of participants experienced difficulties with the process of creating a pedigree and dissatisfaction with information on surveillance and prevention. Affected participants reported lower levels in most SF-36 domains compared to non-affected and both groups reported lower levels as compared to a Swedish reference group. The results indicate that telephone pre-counseling works as well as in-person counseling. Emotional support during genetic counseling and information on recommended cancer prevention and surveillance should be improved.",2012,Affected participants reported lower levels in most SF-36 domains compared to non-affected and both groups reported lower levels as compared to a Swedish reference group.,['215 participants representing several cancer syndromes'],"['counseling via telephone or in-person', 'Telephone counseling', 'telephone in genetic counseling versus in-person counseling']","['expectations, satisfaction and experiences of genetic counseling, worry for developing hereditary cancer and health related quality of life']","[{'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0017382', 'cui_str': 'Genetic Counseling'}]","[{'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0017382', 'cui_str': 'Genetic Counseling'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",215.0,0.0578832,Affected participants reported lower levels in most SF-36 domains compared to non-affected and both groups reported lower levels as compared to a Swedish reference group.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Platten', 'Affiliation': 'Department of Oncology and Pathology, Karolinska University Hospital, 17176, Stockholm, Sweden. ulla.platten@karolinska.se'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Rantala', 'Affiliation': ''}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Lindblom', 'Affiliation': ''}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Brandberg', 'Affiliation': ''}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Lindgren', 'Affiliation': ''}, {'ForeName': 'Brita', 'Initials': 'B', 'LastName': 'Arver', 'Affiliation': ''}]",Familial cancer,['10.1007/s10689-012-9522-x']
215,22448156,Plasma metabolomics and proteomics profiling after a postprandial challenge reveal subtle diet effects on human metabolic status.,"We introduce the metabolomics and proteomics based Postprandial Challenge Test (PCT) to quantify the postprandial response of multiple metabolic processes in humans in a standardized manner. The PCT comprised consumption of a standardized 500 ml dairy shake containing respectively 59, 30 and 12 energy percent lipids, carbohydrates and protein. During a 6 h time course after PCT 145 plasma metabolites, 79 proteins and 7 clinical chemistry parameters were quantified. Multiple processes related to metabolism, oxidation and inflammation reacted to the PCT, as demonstrated by changes of 106 metabolites, 31 proteins and 5 clinical chemistry parameters. The PCT was applied in a dietary intervention study to evaluate if the PCT would reveal additional metabolic changes compared to non-perturbed conditions. The study consisted of a 5-week intervention with a supplement mix of anti-inflammatory compounds in a crossover design with 36 overweight subjects. Of the 231 quantified parameters, 31 had different responses over time between treated and control groups, revealing differences in amino acid metabolism, oxidative stress, inflammation and endocrine metabolism. The results showed that the acute, short term metabolic responses to the PCT were different in subjects on the supplement mix compared to the controls. The PCT provided additional metabolic changes related to the dietary intervention not observed in non-perturbed conditions. Thus, a metabolomics based quantification of a standardized perturbation of metabolic homeostasis is more informative on metabolic status and subtle health effects induced by (dietary) interventions than quantification of the homeostatic situation. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11306-011-0320-5) contains supplementary material, which is available to authorized users.",2012,"The results showed that the acute, short term metabolic responses to the PCT were different in subjects on the supplement mix compared to the controls.","['human metabolic status', 'humans in a standardized manner', '36 overweight subjects']",['metabolomics and proteomics based Postprandial Challenge Test (PCT'],"['amino acid metabolism, oxidative stress, inflammation and endocrine metabolism']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C1328813', 'cui_str': 'Metabolomic'}, {'cui': 'C0872252', 'cui_str': 'Proteomics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}]","[{'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",36.0,0.0167977,"The results showed that the acute, short term metabolic responses to the PCT were different in subjects on the supplement mix compared to the controls.","[{'ForeName': 'Linette', 'Initials': 'L', 'LastName': 'Pellis', 'Affiliation': ''}, {'ForeName': 'Marjan J', 'Initials': 'MJ', 'LastName': 'van Erk', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'van Ommen', 'Affiliation': ''}, {'ForeName': 'Gertruud C M', 'Initials': 'GC', 'LastName': 'Bakker', 'Affiliation': ''}, {'ForeName': 'Henk F J', 'Initials': 'HF', 'LastName': 'Hendriks', 'Affiliation': ''}, {'ForeName': 'Nicole H P', 'Initials': 'NH', 'LastName': 'Cnubben', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kleemann', 'Affiliation': ''}, {'ForeName': 'Eugene P', 'Initials': 'EP', 'LastName': 'van Someren', 'Affiliation': ''}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Bobeldijk', 'Affiliation': ''}, {'ForeName': 'Carina M', 'Initials': 'CM', 'LastName': 'Rubingh', 'Affiliation': ''}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': ''}]",Metabolomics : Official journal of the Metabolomic Society,[]
216,22408577,Efficacy of polyethylene glycol adhesion barrier after gynecological laparoscopic surgery: Results of a randomized controlled pilot study.,"Postoperative adhesions are the most frequent complication of peritoneal surgery, causing small bowel obstruction, female infertility and chronic pain. This pilot study assessed the efficacy of a sprayable polyethylene glycol (PEG) barrier in the prevention of de novo adhesions. 16 patients undergoing laparoscopic gynecological surgery were randomly assigned by shuffled sealed envelopes to receive either the adhesion barrier or no adhesion prevention. Incidence and severity of adhesions were scored at eight sites in the pelvis and reassessed by second look laparoscopy. Adhesion prevention was considered successful if no de novo adhesion were found at second look laparoscopy. One patient was excluded before randomization. Nine patients were randomized to treatment and six patients to control group. De novo adhesions were found in 0/9 patients who received the PEG barrier compared to 4/6 without adhesion prevention (0% vs. 67%, P = 0.01). Reduction in adhesion score was significantly greater in patients receiving PEG barrier (-2.6 vs. -0.06, P = 0.03). Meta-analysis of three randomized trials demonstrated that PEG barrier reduces the incidence of adhesions (odds ratio [OR] = 0.27; 95% CI 0.11-0.67). From this study, PEG barrier seems effective in reducing postoperative formation of de novo adhesions.",2012,"Reduction in adhesion score was significantly greater in patients receiving PEG barrier (-2.6 vs. -0.06, P = 0.03).","['16 patients undergoing laparoscopic gynecological surgery', 'after gynecological laparoscopic surgery']","['polyethylene glycol adhesion barrier', 'sprayable polyethylene glycol (PEG) barrier', 'adhesion barrier or no adhesion prevention']","['Incidence and severity of adhesions', 'incidence of adhesions', 'De novo adhesions', 'adhesion score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]","[{'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",16.0,0.10545,"Reduction in adhesion score was significantly greater in patients receiving PEG barrier (-2.6 vs. -0.06, P = 0.03).","[{'ForeName': 'R P G', 'Initials': 'RP', 'LastName': 'Ten Broek', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kok-Krant', 'Affiliation': ''}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Verhoeve', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Bakkum', 'Affiliation': ''}]",Gynecological surgery,[]
217,22407339,Effect of a physical activity intervention on the metabolic syndrome in Pakistani immigrant men: a randomized controlled trial.,"Physical activity (PA) is thought to prevent the metabolic syndrome (MetS), which is prevalent among south Asian immigrants in Western countries. The purpose of this study was to explore whether increasing PA improves the MetS and associated components in a group of Pakistani immigrant men living in Norway. One- hundred and fifty physically inactive Pakistani immigrant men were randomized to either a control group (CG) or an intervention group (IG). The 5 months intervention focused on increasing PA level, which was assessed using accelerometer recordings. Total PA level (counts min(-1)) increased significantly more in the IG than in the CG. The mean difference between the two groups was 49 counts min(-1), which translates into a 15% (95% CI = 8.7% to 21.2%; P = 0.01) greater increase in total PA level in the IG than in the CG. Serum insulin concentration and waist circumference decreased more in the IG compared with the CG. Other MetS related factors and the prevalence of the MetS did not differ between the groups after the intervention. A five- month intervention program can increase PA level and cardiorespiratory fitness, and reduce insulin concentration and waist circumference. However this intervention program may not lower the prevalence of the complete MetS in Pakistani immigrant men.",2012,Total PA level (counts min(-1)) increased significantly more in the IG than in the CG.,"['Pakistani immigrant men living in Norway', 'south Asian immigrants in Western countries', 'One- hundred and fifty physically inactive Pakistani immigrant men', 'Pakistani immigrant men']","['Physical activity (PA', 'physical activity intervention', 'control group (CG) or an intervention group (IG']","['Total PA level (counts min(-1', 'metabolic syndrome', 'Serum insulin concentration and waist circumference', 'PA level', 'total PA level', 'PA level and cardiorespiratory fitness, and reduce insulin concentration and waist circumference']","[{'cui': 'C0337814', 'cui_str': 'Pakistani (Urduspeakers) (ethnic group)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",150.0,0.0218688,Total PA level (counts min(-1)) increased significantly more in the IG than in the CG.,"[{'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Department of Sport Medicine, Norwegian School of Sport Sciences, Ullevaal Stadium, Box 4014, 0806, Oslo, Norway. eivind.andersen@nih.no'}, {'ForeName': 'Arne T', 'Initials': 'AT', 'LastName': 'Høstmark', 'Affiliation': ''}, {'ForeName': 'Sigmund A', 'Initials': 'SA', 'LastName': 'Anderssen', 'Affiliation': ''}]",Journal of immigrant and minority health,['10.1007/s10903-012-9586-6']
218,22407352,A randomized trial of genetic information for personalized nutrition.,"Personal genetic information has become increasingly accessible to the public as a result of direct-to-consumer (DTC) genetic tests; however, concerns have been raised over their value and potential risks. We compared the effects of providing genotype-based dietary advice with general recommendations on behavioral outcomes using a randomized controlled study. Participants were men and women from the Toronto Nutrigenomics and Health Study between the ages of 20-35 years (n = 149) who completed a survey to assess their awareness of DTC genetic tests and nutrigenomics, as well as potential motivations for undergoing genetic testing. Participants were then randomized into an intervention (I) or control (C) group and were given either genotype-based personalized dietary advice or general dietary advice, respectively. A second survey was administered to assess the participants' opinions of the dietary reports they received. A greater proportion of participants in the intervention group agreed that they understood the dietary advice they were given (93% (I) vs. 78% (C); p = 0.009). Participants in the intervention group were more likely to agree that the dietary recommendations they received would be useful when considering their diet (88% (I) vs. 72% (C); p = 0.02) and wanted to know more about the recommendations (95% (I) vs. 76% (C); p < 0.0001). Only 9% of participants in the intervention group reported feeling uneasy about learning their genetic information. These findings suggest that individuals find dietary recommendations based on genetics more understandable and more useful than general dietary advice. Very few feel uneasy about receiving their genetic information that relates to personalized nutrition.",2012,Participants in the intervention group were more likely to agree that the dietary recommendations they received would be useful when considering their diet (88% (I) vs. 72% (C); p = 0.02) and wanted to know more about the recommendations (95% (I) vs. 76% (C); p < 0.0001).,"['Participants were men and women from the Toronto Nutrigenomics and Health Study between the ages of 20-35\xa0years (n\xa0=\xa0149) who completed a survey to assess their awareness of DTC genetic tests and nutrigenomics, as well as potential motivations for undergoing genetic testing']","['genotype-based dietary advice with general recommendations', 'intervention (I) or control (C) group and were given either genotype-based personalized dietary advice or general dietary advice, respectively']",['feeling uneasy about learning their genetic information'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1956006', 'cui_str': 'Nutritional Genomics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0424142', 'cui_str': 'Ill-at-ease (finding)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",149.0,0.0458247,Participants in the intervention group were more likely to agree that the dietary recommendations they received would be useful when considering their diet (88% (I) vs. 72% (C); p = 0.02) and wanted to know more about the recommendations (95% (I) vs. 76% (C); p < 0.0001).,"[{'ForeName': 'Daiva E', 'Initials': 'DE', 'LastName': 'Nielsen', 'Affiliation': 'Department of Nutritional Sciences, Room 350, University of Toronto, 150 College St, Toronto, ON, M5S 3E2, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Sohemy', 'Affiliation': ''}]",Genes & nutrition,[]
219,22457015,"Pharmacokinetics, pharmacodynamics, and safety of clevidipine after prolonged continuous infusion in subjects with mild to moderate essential hypertension.","PURPOSE


Clevidipine is a rapidly-acting intravenous dihydropyridine antihypertensive acting via calcium channel blockade. This was a randomized, single-blind, parallel-design study of a 72-h continuous clevidipine infusion.
METHOD


Doses of 2, 4, 8, or 16.0 mg/h or placebo were evaluated in 61 subjects with mild to moderate essential hypertension. IV clevidipine or placebo was initiated at 2.0 mg/h and force-titrated in doubling increments every 3 min to target dose, then maintained for 72 h. Blood pressure and heart rate were measured during infusion, and for 4, 6 and 8 h after termination of infusion, although oral therapy could be restarted at 4 h. Clevidipine blood levels were obtained during infusion and for 1 hour after termination.
RESULTS


Rapid onset of drug effect occurred at all clevidipine dose levels, with consistent pharmacokinetics and rapid offset after 72-h infusion. No evidence of tolerance to the clevidipine drug effect was observed at any dose level over the 72-h infusion. No evidence of rebound hypertension was found for either 4 or 6 h after termination of the clevidipine infusion. At 8 h following cessation of clevidipine, blood pressure was not significantly higher than at baseline. Placebo-treated subjects had blood pressures lower than baseline at 8 h following infusion termination; hence, placebo-adjusted blood pressures tended to be slightly higher than baseline.
CONCLUSION


This study supports the use of up to 72 h of IV clevidipine therapy for the management of blood pressure, with consistent pharmacokinetic/pharmacodynamic characteristics and context insensitive half-life across the dose ranges evaluated.",2012,No evidence of rebound hypertension was found for either 4 or 6 h after termination of the clevidipine infusion.,"['Doses of 2, 4, 8, or 16.0\xa0mg/h or', '61 subjects with mild to moderate essential hypertension', 'subjects with mild to moderate essential hypertension']","['clevidipine infusion', 'placebo', 'IV clevidipine or placebo', 'Placebo', 'clevidipine therapy', 'clevidipine', 'Clevidipine']","['Pharmacokinetics, pharmacodynamics, and safety', 'Blood pressure and heart rate', 'blood pressures', 'rebound hypertension', 'blood pressure']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}]","[{'cui': 'C0766108', 'cui_str': 'clevidipine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0520540', 'cui_str': 'Rebound hypertension (disorder)'}]",61.0,0.231185,No evidence of rebound hypertension was found for either 4 or 6 h after termination of the clevidipine infusion.,"[{'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Smith', 'Affiliation': 'Volunteer Research Group, University of Tennessee Medical Center, Knoxville, TN, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Marbury', 'Affiliation': ''}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Komjathy', 'Affiliation': ''}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Sumeray', 'Affiliation': ''}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Ming-yi', 'Initials': 'MY', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Mould', 'Affiliation': ''}]",European journal of clinical pharmacology,['10.1007/s00228-012-1260-3']
220,22382727,Patients' views on an education booklet following spinal surgery.,"PURPOSE


This study evaluated an evidence-based education booklet developed for patients undergoing spinal surgery which was used as a treatment intervention in a multi-centre, factorial, randomised controlled trial (FASTER: Function after spinal treatment, exercise and rehabilitation) investigating the post-operative management of spinal surgery patients. This study sought to determine the acceptability and content of the booklet to patients.
METHODS


Patients receiving the educational booklet before discharge from hospital as part of the FASTER study were asked to complete an evaluation, which rated the booklet ""Your Back Operation"" with regard to content, information, usability, etc. using forced and open questions. This assessment was conducted at the same time as the initial 6-week post-operative review performed as part of the larger study.
RESULTS


Therefore, 97% of the 117 trial participants who returned their 6-week evaluation and randomised to receive a booklet returned their questionnaire. The booklet was highly rated receiving an overall rating of 7 or more out of 10 from 101/111 (91%), and high ratings for content, readability and information. The booklet's key messages were clear to the majority of patients; however, many patients highlighted deficiencies with respect to content particularly in relation to wound care and exercise.
CONCLUSIONS


Patients valued the booklet and rated its content highly. Many suggested that the booklet be developed further and there was a clear desire for specific exercises to be included even though there is no evidence to support specific exercise prescription.",2012,"The booklet was highly rated receiving an overall rating of 7 or more out of 10 from 101/111 (91%), and high ratings for content, readability and information.","['Patients receiving the educational booklet before discharge from hospital as part of the FASTER study', 'patients undergoing spinal surgery', 'spinal surgery patients']",['education booklet following spinal surgery'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],,0.0586816,"The booklet was highly rated receiving an overall rating of 7 or more out of 10 from 101/111 (91%), and high ratings for content, readability and information.","[{'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'McGregor', 'Affiliation': 'Surgery and Cancer, Faculty of Medicine, Imperial College London, Charing Cross Hospital Campus, London, UK. a.mcgregor@imperial.ac.uk'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Henley', 'Affiliation': ''}, {'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-012-2242-y']
221,22527264,Exploring ART intake scenes in a human rights-based intervention to improve adherence: a randomized controlled trial.,"To assess the effectiveness of a psychosocial individual intervention to improve adherence to ART in a Brazilian reference-center, consenting PLHIV with viral load >50 copies/ml were selected. After 4 weeks of MEMS cap use, participants were randomized into an intervention group (IG) (n = 64) or control group (CG) (n = 57). CG received usual care only. The IG participated in a human rights-based intervention approach entailing four dialogical meetings focused on medication intake scenes. Comparison between IG and CG revealed no statistically significant difference in adherence measured at weeks 8, 12, 16, 20 and 24. Viral load (VL) decreased in both groups (p < 0.0001) with no significant difference between study groups. The lower number of eligible patients than expected underpowered the study. Ongoing qualitative analysis should provide deeper understanding of the trial results. NIH Clinical Trials: NCT00716040.",2013,Viral load (VL) decreased in both groups (p < 0.0001) with no significant difference between study groups.,"['Brazilian reference-center, consenting PLHIV with viral load >50 copies/ml were selected']","['psychosocial individual intervention', 'control group (CG']","['adherence', 'Viral load (VL']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.0820092,Viral load (VL) decreased in both groups (p < 0.0001) with no significant difference between study groups.,"[{'ForeName': 'Cáritas Relva', 'Initials': 'CR', 'LastName': 'Basso', 'Affiliation': 'Reference and Training Center for Sexually Transmitted Infection and Acquired Immunodeficiency Syndrome, Rua Santa Cruz, 81, Vila Mariana, São Paulo, SP, CEP: 4112-000, Brazil. cr_basso@terra.com.br'}, {'ForeName': 'Ernani Tiaraju Santa', 'Initials': 'ET', 'LastName': 'Helena', 'Affiliation': ''}, {'ForeName': 'Joselita Maria Magalhães', 'Initials': 'JM', 'LastName': 'Caraciolo', 'Affiliation': ''}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Paiva', 'Affiliation': ''}, {'ForeName': 'Maria Ines Battistela', 'Initials': 'MI', 'LastName': 'Nemes', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-012-0175-4']
222,22527308,Successful treatment of blepharitis with bibrocathol (Posiformin® 2 %).,"BACKGROUND


Bibrocathol is a well-established antiseptic drug for the treatment of acute eyelid diseases like blepharitis. Despite its frequent use in clinical practice, no controlled clinical trial on the efficacy of bibrocathol 2% eye ointment has been performed until now. The aim of the study was to investigate efficacy, safety and tolerability of bibrocathol (Posiformin® 2 %) eye ointment in patients diagnosed with blepharitis.
METHODS


In this multi-center, randomized, double-masked, placebo-controlled parallel-group comparison, the change of signs and symptoms (sum score) of blepharitis in 197 patients (ITT (intention-to-treat-group); mean age 56 ± 18 years, 56 % female, active drug:vehicle = 97:100) over 2 weeks treatment with bibrocathol 2 % eye ointment was evaluated.
RESULTS


Patients receiving bibrocathol 2 % showed greater improvement in the sum score than the placebo patients (p < 0.0001, Cohen's effect size d = 0.73). Also, the results from further efficacy assessments improvement of single symptoms and ocular discomfort measured by a VAS (visual analogue scale) supported treatment with bibrocathol. Patients and investigators provided favorable tolerability ratings preferring bibrocathol over placebo. No safety issues were observed with regard to intraocular pressure, visual acuity, or occurrence of adverse events.
CONCLUSIONS


Blepharitis therapy with the antiseptic bibrocathol 2 % in this trial was highly efficacious and safe.",2012,"No safety issues were observed with regard to intraocular pressure, visual acuity, or occurrence of adverse events.
","['patients diagnosed with blepharitis', 'acute eyelid diseases like blepharitis', '197 patients (ITT (intention-to-treat-group); mean age 56\u2009±\u200918\xa0years, 56\xa0% female, active drug:vehicle\u2009=\u200997:100) over 2\xa0weeks treatment with']","['bibrocathol (Posiformin® 2\xa0%) eye ointment', 'bibrocathol 2', 'placebo']","['efficacy, safety and tolerability', 'intraocular pressure, visual acuity, or occurrence of adverse events', 'single symptoms and ocular discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0015423', 'cui_str': 'Eyelid Diseases'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0602838', 'cui_str': 'tetrabromopyrocatechol bismuth'}, {'cui': 'C1529708', 'cui_str': 'Posiformin'}, {'cui': 'C0304651', 'cui_str': 'Ophthalmic Ointment'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0948595', 'cui_str': 'Ocular discomfort'}]",197.0,0.489164,"No safety issues were observed with regard to intraocular pressure, visual acuity, or occurrence of adverse events.
","[{'ForeName': 'Pavel A', 'Initials': 'PA', 'LastName': 'Bezdetko', 'Affiliation': 'Department of Ophthalmology, Kharkov District Clinical Hospital, Kharkov, Ukraine.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Sergienko', 'Affiliation': ''}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Dyomin', 'Affiliation': ''}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Korol', 'Affiliation': ''}, {'ForeName': 'Nik', 'Initials': 'N', 'LastName': 'Nikitin', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Merzbacher', 'Affiliation': ''}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Groß', 'Affiliation': ''}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Kohnen', 'Affiliation': ''}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-012-2001-0']
223,22406837,Carbon and nitrogen isotopic ratios of urine and faeces as novel nutritional biomarkers of meat and fish intake.,"PURPOSE


Meat and fish consumption are associated with changes in the risk of chronic diseases. Intake is mainly assessed using self-reporting, as no true quantitative nutritional biomarker is available. The measurement of plasma fatty acids, often used as an alternative, is expensive and time-consuming. As meat and fish differ in their stable isotope ratios, δ(13)C and δ(15)N have been proposed as biomarkers. However, they have never been investigated in controlled human dietary intervention studies.
OBJECTIVE


In a short-term feeding study, we investigated the suitability of δ(13)C and δ(15)N in blood, urine and faeces as biomarkers of meat and fish intake.
METHODS


The dietary intervention study (n = 14) followed a randomised cross-over design with three eight-day dietary periods (meat, fish and half-meat-half-fish). In addition, 4 participants completed a vegetarian control period. At the end of each period, 24-h urine, fasting venous blood and faeces were collected and their δ(13)C and δ(15)N analysed.
RESULTS


There was a significant difference between diets in isotope ratios in faeces and urine samples, but not in blood samples (Kruskal-Wallis test, p < 0.0001). In pairwise comparisons, δ(13)C and δ(15)N were significantly higher in urine and faecal samples following a fish diet when compared with all other diets, and significantly lower following a vegetarian diet. There was no significant difference in isotope ratio between meat and half-meat-half-fish diets for blood, urine or faecal samples.
CONCLUSIONS


The results of this study show that urinary and faecal δ(13)C and δ(15)N are suitable candidate biomarkers for short-term meat and fish intake.",2013,"In pairwise comparisons, δ(13)C and δ(15)N were significantly higher in urine and faecal samples following a fish diet when compared with all other diets, and significantly lower following a vegetarian diet.","['meat and fish intake', 'The dietary intervention study (n = 14']",[],"['isotope ratios in faeces and urine samples', 'isotope ratio', 'Carbon and nitrogen isotopic ratios of urine and faeces', '24-h urine, fasting venous blood and faeces', 'suitability of δ(13)C and δ(15)N in blood, urine and faeces as biomarkers of meat and fish intake']","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]",[],"[{'cui': 'C0022262', 'cui_str': 'Isotopes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0042037'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}]",14.0,0.0191923,"In pairwise comparisons, δ(13)C and δ(15)N were significantly higher in urine and faecal samples following a fish diet when compared with all other diets, and significantly lower following a vegetarian diet.","[{'ForeName': 'Gunter G C', 'Initials': 'GG', 'LastName': 'Kuhnle', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Whiteknights, PO Box 226, Reading, RG6 6AP, UK. g.g.kuhnle@reading.ac.uk'}, {'ForeName': 'Annemiek M C P', 'Initials': 'AM', 'LastName': 'Joosen', 'Affiliation': ''}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Kneale', 'Affiliation': ''}, {'ForeName': 'Tamsin C', 'Initials': 'TC', 'LastName': ""O'Connell"", 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-012-0328-2']
224,22258622,Cost-effectiveness of a classification-based system for sub-acute and chronic low back pain.,"PURPOSE


Identifying relevant subgroups in patients with low back pain (LBP) is considered important to guide physical therapy practice and to improve outcomes. The aim of the present study was to assess the cost-effectiveness of a modified version of Delitto's classification-based treatment approach compared with usual physical therapy care in patients with sub-acute and chronic LBP with 1 year follow-up.
METHODS


All patients were classified using the modified version of Delitto's classification-based system and then randomly assigned to receive either classification-based treatment or usual physical therapy care. The main clinical outcomes measured were; global perceived effect, intensity of pain, functional disability and quality of life. Costs were measured from a societal perspective. Multiple imputations were used for missing data. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated.
RESULTS


In total, 156 patients were included. The outcome analyses showed a significantly better outcome on global perceived effect favoring the classification-based approach, and no differences between the groups on pain, disability and quality-adjusted life-years. Mean total societal costs for the classification-based group were <euro>2,287, and for the usual physical therapy care group <euro>2,020. The difference was <euro>266 (95% CI <euro>-720 to <euro>1,612) and not statistically significant. Cost-effectiveness analyses showed that the classification-based approach was not cost-effective in comparison with usual physical therapy care for any clinical outcome measure.
CONCLUSION


The classification-based treatment approach as used in this study was not cost-effective in comparison with usual physical therapy care in a population of patients with sub-acute and chronic LBP.",2012,"Cost-effectiveness analyses showed that the classification-based approach was not cost-effective in comparison with usual physical therapy care for any clinical outcome measure.
","['patients with sub-acute and chronic LBP', '156 patients were included', 'patients with low back pain (LBP', 'sub-acute and chronic low back pain', 'patients with sub-acute and chronic LBP with 1 year follow-up']","[""modified version of Delitto's classification-based treatment approach"", 'classification-based treatment or usual physical therapy care', 'usual physical therapy care']","['Cost-effectiveness planes and cost-effectiveness acceptability curves', 'global perceived effect, intensity of pain, functional disability and quality of life', 'Mean total societal costs', 'Cost-effectiveness', 'incremental cost-effectiveness ratios', 'pain, disability and quality-adjusted life-years', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",156.0,0.0503399,"Cost-effectiveness analyses showed that the classification-based approach was not cost-effective in comparison with usual physical therapy care for any clinical outcome measure.
","[{'ForeName': 'Adri T', 'Initials': 'AT', 'LastName': 'Apeldoorn', 'Affiliation': 'Department of Epidemiology and Biostatistics and the EMGO+ Institute for Health and Care Research, VU University Medical Centre, Van der Boechorststraat 7, Amsterdam 1081 BT, The Netherlands. a.apeldoorn@vumc.nl'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': ''}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Ostelo', 'Affiliation': ''}, {'ForeName': 'Henrica C W', 'Initials': 'HC', 'LastName': 'de Vet', 'Affiliation': ''}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-011-2144-4']
225,22298017,Differential impact of a Dutch alcohol prevention program targeting adolescents and parents separately and simultaneously: low self-control and lenient parenting at baseline predict effectiveness.,"To test whether baseline levels of the factors accountable for the impact of the Prevention of Alcohol use in Students (PAS) intervention (self-control, perceived rules about alcohol and parental attitudes about alcohol), moderate the effect of the intervention. A cluster randomized trial including 3,490 Dutch early adolescents (M age=12.66, SD=.49) and their parents randomized over four conditions: 1) parent intervention, 2) student intervention, 3) combined intervention and 4) control group. Moderators at baseline were used to examine the differential effects of the interventions on onset of (heavy) weekly drinking at 34-month follow-up. The combined intervention was only effective in preventing weekly drinking among those adolescents who reported to have lower self-control and more lenient parents at baseline. No differential effect was found for the onset of heavy weekly drinking. No moderating roles of self-control and lenient parenting were found for the separate student and parent interventions regarding the onset of drinking. The combined intervention is more effective among adolescents with low-self control and lenient parents at baseline, both factors that were a specific target of the intervention. The relevance of targeting self-control in adolescents and restrictive parenting is underlined.",2012,No moderating roles of self-control and lenient parenting were found for the separate student and parent interventions regarding the onset of drinking.,"['adolescents and restrictive parenting is underlined', '3,490 Dutch early adolescents (M age=12.66, SD=.49) and their parents randomized over four conditions: 1']","['Alcohol use in Students (PAS) intervention (self-control, perceived rules about alcohol and parental attitudes about alcohol', 'Dutch alcohol prevention program', 'parent intervention, 2) student intervention, 3) combined intervention and 4) control group']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],3490.0,0.0260281,No moderating roles of self-control and lenient parenting were found for the separate student and parent interventions regarding the onset of drinking.,"[{'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Koning', 'Affiliation': 'Department of Interdisciplinary Social Science, Utrecht University, P.O. Box 80.140, 3508 TC Utrecht, the Netherlands. i.koning@uu.nl'}, {'ForeName': 'Jacqueline E E', 'Initials': 'JE', 'LastName': 'Verdurmen', 'Affiliation': ''}, {'ForeName': 'Rutger C M E', 'Initials': 'RC', 'LastName': 'Engels', 'Affiliation': ''}, {'ForeName': 'Regina J J M', 'Initials': 'RJ', 'LastName': 'van den Eijnden', 'Affiliation': ''}, {'ForeName': 'Wilma A M', 'Initials': 'WA', 'LastName': 'Vollebergh', 'Affiliation': ''}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-011-0267-9']
226,32422113,Comparison of Subthreshold 532 nm Diode Micropulse Laser with Conventional Laser Photocoagulation in the Treatment of Non-Centre Involved Clinically Significant Diabetic Macular Edema.,"BACKGROUND


The aim of the study was to investigate the effect of the 532 nm (green) diode subthreshold micropulse laser (SML) in the treatment of non-centre involved clinically significant macular edema (CSME) in comparison to the conventional laser photocoagulation (CLP).
METHODS


A total of 60 eyes of patients diagnosed with non-centre involved CSME were randomly divided into two groups. SML photocoagulation was performed in the first group (G1), while CLP in the second one (G2). Central macular thickness (CMT) and best corrected visual acuity (BCVA) were measured prior to treatment and at 3 and 6 months after intervention.
RESULTS


G1 participants had significantly better CMT at 6 months after laser application (p = 0.04) compared to G2. Additionally, CMT in both groups was significantly lower 6 months after laser application in comparison to baseline values (G1: p < 0.001, G2: p = 0.002). Moreover, significant improvement was detected 6 months after SML in G1 regarding BCVA compared to values before laser treatment (p = 0.001).
CONCLUSION


SML was more effective than CLP in reducing CMT and improving BCVA in patients with non-centre involved CSME. Therefore, it seems that SML can be a good substitute for CLP in DME treatment if confirmed in future studies.",2020,"Moreover, significant improvement was detected 6 months after SML in G1 regarding BCVA compared to values before laser treatment (p = 0.001).
","['60 eyes of patients diagnosed with non-centre involved CSME', 'patients with non-centre involved CSME']","['SML photocoagulation', 'conventional laser photocoagulation (CLP', 'SML', 'CLP', '532 nm (green) diode subthreshold micropulse laser (SML', 'Subthreshold 532 nm Diode Micropulse Laser with Conventional Laser Photocoagulation']","['Central macular thickness (CMT) and best corrected visual acuity (BCVA', 'CMT and improving BCVA', 'CMT']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0730284', 'cui_str': 'Clinically significant macular edema'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",,0.0244198,"Moreover, significant improvement was detected 6 months after SML in G1 regarding BCVA compared to values before laser treatment (p = 0.001).
","[{'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Bougatsou', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Eirini-Kanella', 'Initials': 'EK', 'LastName': 'Panagiotopoulou', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece. eipanagi@med.duth.gr.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gkika', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Doukas', 'Initials': 'D', 'LastName': 'Dardabounis', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Aristeidis', 'Initials': 'A', 'LastName': 'Konstantinidis', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Sideroudi', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Perente', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Labiris', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}]",Acta medica (Hradec Kralove),['10.14712/18059694.2020.12']
227,22252289,"Treatment of intracranial atherosclerotic disease with a balloon-expandable paclitaxel eluting stent: procedural safety, efficacy and mid-term patency.","PURPOSE


Procedural safety and high rates of in-stent recurrent stenotic lesions (ISR) remain a concern in the endovascular treatment of intracranial atherosclerotic disease (ICAD). In the present study technical feasibility, safety and efficacy of the paclitaxel eluting balloon-expandable coronary stent Coroflex(®) Please was assessed in the treatment of ICAD.
METHODS


A total of 95 patients (79 male; median age 68 years) with 106 intracranial atherosclerotic stenotic lesions underwent endovascular treatment using Coroflex(®) Please stents (B. Braun, Melsungen, Germany). Location and degree of target stenoses before and after treatment and at follow-up and adverse clinical sequelae of treatment were registered. Post-procedural medication included 100 mg acetylsalicylic acid (ASA) and 75 mg clopidogrel for 1 year. Angiographic follow-up was scheduled for 6, 12, 26 and 52 weeks after the treatment.
RESULTS


The lesion locations were as follows: internal carotid artery (ICA) petrous (n = 44, 42%), ICA cavernous (n = 43, 41%), ICA paraclinoid (n = 4, 4%), intradural vertebral artery (VA; n = 11, 10%) and basilar artery (BA; n = 4, 4%). Of the lesions seven could not be treated due to difficult anatomy and stent stiffness (7% technical failure rate). The combined post-interventional neurological morbidity and mortality rate, including stroke, intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH) and carotid cavernous fistula (CCF) was n = 4 (3.7%) within and n = 1 (0.9%) at and beyond 30 days, respectively. Angiographic and clinical follow-up examinations were carried out for 78 (78%) of the lesions (mean 16.1 months, maximum 48 months). Asymptomatic recurrent stenosis was seen in 3 out of 78 (3.8%) lesions and there was 1 case of late stent thrombosis (0.9%).
CONCLUSIONS


Treatment of ICAD using drug-eluting coronary stents is safe and effective but technical failure due to stent stiffness remains a problem. Application of the more flexible, newest generation thin-strut stents, however, shows promising results.",2012,"The lesion locations were as follows: internal carotid artery (ICA) petrous (n = 44, 42%), ICA cavernous (n = 43, 41%), ICA paraclinoid (n = 4, 4%), intradural vertebral artery (VA; n = 11, 10%) and basilar artery (BA; n = 4, 4%).","['intracranial atherosclerotic disease (ICAD', '95 patients (79 male; median age 68 years) with 106 intracranial atherosclerotic stenotic lesions underwent']","['acetylsalicylic acid (ASA', 'endovascular treatment using Coroflex(®', 'paclitaxel eluting balloon-expandable coronary stent Coroflex(®', 'clopidogrel', 'balloon-expandable paclitaxel eluting stent']","['Asymptomatic recurrent stenosis', 'Location and degree of target stenoses', 'mortality rate, including stroke, intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH) and carotid cavernous fistula (CCF', 'late stent thrombosis']","[{'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0669180', 'cui_str': 'ICAD (inhibitor)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}, {'cui': 'C0238045', 'cui_str': 'C-C Fistula'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",106.0,0.0296102,"The lesion locations were as follows: internal carotid artery (ICA) petrous (n = 44, 42%), ICA cavernous (n = 43, 41%), ICA paraclinoid (n = 4, 4%), intradural vertebral artery (VA; n = 11, 10%) and basilar artery (BA; n = 4, 4%).","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Vajda', 'Affiliation': 'Klinik für Neuroradiologie, Neurozentrum, Klinikum Stuttgart, Kriegsbergstr. 60, 70174 Stuttgart, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aguilar', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Göhringer', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Horváth-Rizea', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bäzner', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Henkes', 'Affiliation': ''}]",Clinical neuroradiology,['10.1007/s00062-011-0125-y']
228,22252793,The effect of plant sterols on serum triglyceride concentrations is dependent on baseline concentrations: a pooled analysis of 12 randomised controlled trials.,"PURPOSE


Plant sterols (PS) are well known for their low-density lipoprotein cholesterol-lowering effect. Until recently, they were believed to have little or no impact on blood triglycerides (TG). However, studies taken individually were possibly lacking statistical power to detect modest TG decreases. This study was performed to quantify the TG-lowering effect of PS by pooling individual subject data from 12 randomised controlled trials that investigated the effects of PS on blood lipids.
METHODS


The main outcome variable was the control-adjusted PS effect on relative (%) and absolute (mmol/L) changes in TG. The relative and absolute changes in high-density lipoprotein cholesterol (HDL-C) were also assessed. Differences in changes of serum lipid concentrations between PS and control treatments were estimated by an ANCOVA using a random effect model which included PS intake (active or control), study and predefined subject characteristics.
RESULTS


The twelve randomised controlled trials included in total 935 hypercholesterolaemic subjects not preselected based on their baseline TG concentrations. In most studies, the PS dose ranged between 1.6 and 2.5 g/day. PS intake significantly lowered serum TG by 6.0% (95% CI: -10.7, -1.2) or 0.12 mmol/L (95% CI: -0.20, -0.04). No significant interaction was observed between PS intake and baseline TG concentrations on relative changes, but, on absolute changes, interaction was significant with larger TG decreases observed with higher TG concentrations at baseline. No effects were observed on HDL-C concentrations.
CONCLUSIONS


These results show that PS exert a modest TG-lowering effect which is dependent on baseline concentrations.",2013,"PS intake significantly lowered serum TG by 6.0% (95% CI: -10.7, -1.2) or 0.12 mmol/L (95% CI:",['total 935 hypercholesterolaemic subjects not preselected based on their baseline TG concentrations'],['plant sterols'],"['HDL-C concentrations', 'serum TG', 'high-density lipoprotein cholesterol (HDL-C', 'blood triglycerides (TG', 'serum triglyceride concentrations', 'TG concentrations', 'PS intake and baseline TG concentrations', 'control-adjusted PS effect on relative (%) and absolute (mmol/L) changes in TG', 'serum lipid concentrations']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0031866', 'cui_str': 'Phytosterols'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",935.0,0.27556,"PS intake significantly lowered serum TG by 6.0% (95% CI: -10.7, -1.2) or 0.12 mmol/L (95% CI:","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Demonty', 'Affiliation': 'Unilever R&D Vlaardingen, P.O. Box 114, 3130 AC, Vlaardingen, The Netherlands.'}, {'ForeName': 'Rouyanne T', 'Initials': 'RT', 'LastName': 'Ras', 'Affiliation': ''}, {'ForeName': 'Henk C M', 'Initials': 'HC', 'LastName': 'van der Knaap', 'Affiliation': ''}, {'ForeName': 'Linsie', 'Initials': 'L', 'LastName': 'Meijer', 'Affiliation': ''}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Zock', 'Affiliation': ''}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Geleijnse', 'Affiliation': ''}, {'ForeName': 'Elke A', 'Initials': 'EA', 'LastName': 'Trautwein', 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-011-0297-x']
229,22347788,The Effectiveness of Mindfulness Training for Children with ADHD and Mindful Parenting for their Parents.,"This study evaluated the effectiveness of an 8-week mindfulness training for children aged 8-12 with ADHD and parallel mindful parenting training for their parents. Parents (N = 22) completed questionnaires on their child's ADHD and ODD symptoms, their own ADHD symptoms, parenting stress, parental overreactivity, permissiveness and mindful awareness before, immediately after the 8-week training and at 8-week follow-up. Teachers reported on ADHD and ODD behavior of the child. A within-group waitlist was used to control for the effects of time and repeated measurement. Training was delivered in group format. There were no significant changes between wait-list and pre-test, except on the increase of teacher-rated ODD behavior. There was a significant reduction of parent-rated ADHD behavior of themselves and their child from pre-to posttest and from pre- to follow-up test. Further, there was a significant increase of mindful awareness from pre-to posttest and a significant reduction of parental stress and overreactivity from pre-to follow-up test. Teacher-ratings showed non-significant effects. Our study shows preliminary evidence for the effectiveness of mindfulness for children with ADHD and their parents, as rated by parents. However, in the absence of substantial effects on teacher-ratings, we cannot ascertain effects are due to specific treatment procedures.",2012,"There were no significant changes between wait-list and pre-test, except on the increase of teacher-rated ODD behavior.","['Children with ADHD and Mindful Parenting for their Parents', 'children aged 8-12 with ADHD and parallel mindful parenting training for their parents', 'children with ADHD and their parents, as rated by parents']","['8-week mindfulness training', 'Mindfulness Training']","['ADHD and ODD behavior', ""questionnaires on their child's ADHD and ODD symptoms, their own ADHD symptoms, parenting stress, parental overreactivity, permissiveness and mindful awareness"", 'mindful awareness', 'parental stress and overreactivity', 'teacher-rated ODD behavior']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0233522', 'cui_str': 'Inappropriate behavior (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0031166'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]",22.0,0.0132951,"There were no significant changes between wait-list and pre-test, except on the increase of teacher-rated ODD behavior.","[{'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'van der Oord', 'Affiliation': ''}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Bögels', 'Affiliation': ''}, {'ForeName': 'Dorreke', 'Initials': 'D', 'LastName': 'Peijnenburg', 'Affiliation': ''}]",Journal of child and family studies,[]
230,22261925,Neural correlates of a single-session massage treatment.,"The current study investigated the immediate neurophysiological effects of different types of massage in healthy adults using functional magnetic resonance imaging (fMRI). Much attention has been given to the default mode network, a set of brain regions showing greater activity in the resting state. These regions (i.e. insula, posterior and anterior cingulate, inferior parietal and medial prefrontal cortices) have been postulated to be involved in the neural correlates of consciousness, specifically in arousal and awareness. We posit that massage would modulate these same regions given the benefits and pleasant affective properties of touch. To this end, healthy participants were randomly assigned to one of four conditions: 1. Swedish massage, 2. reflexology, 3. massage with an object or 4. a resting control condition. The right foot was massaged while each participant performed a cognitive association task in the scanner. We found that the Swedish massage treatment activated the subgenual anterior and retrosplenial/posterior cingulate cortices. This increased blood oxygen level dependent (BOLD) signal was maintained only in the former brain region during performance of the cognitive task. Interestingly, the reflexology massage condition selectively affected the retrosplenial/posterior cingulate in the resting state, whereas massage with the object augmented the BOLD response in this region during the cognitive task performance. These findings should have implications for better understanding how alternative treatments might affect resting state neural activity and could ultimately be important for devising new targets in the management of mood disorders.",2012,We found that the Swedish massage treatment activated the subgenual anterior and retrosplenial/posterior cingulate cortices.,"['healthy participants', 'healthy adults']",['functional magnetic resonance imaging (fMRI'],['blood oxygen level dependent (BOLD) signal'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]",,0.0186194,We found that the Swedish massage treatment activated the subgenual anterior and retrosplenial/posterior cingulate cortices.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sliz', 'Affiliation': 'Department of Neuroscience, Carleton University, 1125 Colonel By Drive, Ottawa, ON, Canada K1S 5B6.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wiebking', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Northoff', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hayley', 'Affiliation': ''}]",Brain imaging and behavior,['10.1007/s11682-011-9146-z']
231,22252796,"Switching from enoxaparin to dabigatran etexilate: pharmacokinetics, pharmacodynamics, and safety profile.","PURPOSE


Dabigatran etexilate is an oral, reversible, direct thrombin inhibitor licensed for the prevention of venous thromboembolism and stroke prevention in patients with atrial fibrillation. The aim of this study was to investigate whether, and to what extent, a switch from enoxparin to dabigatran etexilate affects the pharmacokinetic (PK) and pharmacodynamic (PD) parameters and safety profile of dabigatran.
METHODS


Enoxaparin 40 mg was administered subcutaneously once daily for 3 days followed by a single dose of dabigatran etexilate 220 mg (test treatment) on day 4 in an open-label, two-way cross-over trial in healthy volunteers. Dabigatran plasma levels were measured using a validated high-performance liquid chromatography tandem mass spectrometry method. Anticoagulant activity was measured using a number of clotting tests, including prothrombinase-induced clotting time (PiCT), activated partial thromboplastin time (aPTT), ecarin clotting time (ECT), and diluted thrombin time (dTT).
RESULTS


PK, PD, and safety data were available for 23 subjects for each treatment. The adjusted geometric mean test/reference ratio of area under the concentration-time curve for total dabigatran was 84% (90% confidence interval 67.2-105.0%) and 86% (67.0-110.0%) for maximum plasma concentration. The PiCT test/reference ratio, which represents the activity of enoxaparin and dabigatran, was elevated by approximately 15% for peak maximum effect ratio to baseline and total area under the effect curve (AUEC₀₋₄₈) activity, suggesting that some anticoagulant activity of enoxaparin was still present. Enoxaparin pre-treatment increased the AUEC₀₋₄₈ of activated partial thromboplastin time by approximately 14%. All other dabigatran-related PD markers were unaffected. Tolerability was good, with only mild and reversible adverse events during the treatment.
CONCLUSION


Prior administration of enoxaparin did not meaningfully affect the PK or PD properties of dabigatran, and the switch from enoxaparin to dabigatran etexilate was well tolerated among the study subjects. These data support the safety of switching patients from enoxaparin to dabigatran etexilate.",2012,Enoxaparin pre-treatment increased the AUEC₀₋₄₈ of activated partial thromboplastin time by approximately 14%.,"['healthy volunteers', 'patients with atrial fibrillation']","['enoxaparin', 'dabigatran etexilate', 'Enoxaparin']","['peak maximum effect ratio to baseline and total area under the effect curve (AUEC₀₋₄₈) activity', 'Tolerability', 'adjusted geometric mean test/reference ratio of area under the concentration-time curve for total dabigatran', 'Dabigatran plasma levels', 'Anticoagulant activity', 'number of clotting tests, including prothrombinase-induced clotting time (PiCT), activated partial thromboplastin time (aPTT), ecarin clotting time (ECT), and diluted thrombin time (dTT', 'pharmacokinetic (PK) and pharmacodynamic (PD) parameters and safety profile of dabigatran', 'PK or PD properties of dabigatran', 'AUEC₀₋₄₈ of activated partial thromboplastin time']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040048', 'cui_str': 'Prothrombinase'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0058908', 'cui_str': 'prothrombin activator (Echis carinatus venom)'}, {'cui': 'C0677634', 'cui_str': 'Reptilase Time'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",,0.0529407,Enoxaparin pre-treatment increased the AUEC₀₋₄₈ of activated partial thromboplastin time by approximately 14%.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Clemens', 'Affiliation': 'Department of Global Clinical Development & Medical Affairs, Boehringer Ingelheim Pharma GmbH, Ingelheim am Rhein, Germany. andreas.clemens@boehringer-ingelheim.com'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'van Ryn', 'Affiliation': ''}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Sennewald', 'Affiliation': ''}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Yamamura', 'Affiliation': ''}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Stangier', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feuring', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Härtter', 'Affiliation': ''}]",European journal of clinical pharmacology,['10.1007/s00228-011-1205-2']
232,22302614,"Effect of a combination of genistein, polyunsaturated fatty acids and vitamins D3 and K1 on bone mineral density in postmenopausal women: a randomized, placebo-controlled, double-blind pilot study.","PURPOSE


Many postmenopausal women desire non-pharmaceutical alternatives to hormone therapy for protection against osteoporosis. Soybean isoflavones, especially genistein, are being studied for this purpose. This study examined the effects of synthetic genistein in combination with other potential bone-protective dietary molecules on bone mineral density (BMD) in early postmenopausal women.
METHODS


In this 6-month double-blind pilot study, 70 subjects were randomized to receive daily either calcium only or the geniVida™ bone blend (GBB), which consisted of genistein (30 mg/days), vitamin D3 (800 IU/days), vitamin K1 (150 μg/days) and polyunsaturated fatty acids (1 g polyunsaturated fatty acids as ethyl ester: eicosapentaenoic acid/docosahexaenoic acid ratio = ~2/1). Markers of bone resorption and formation and BMD at the femoral neck, lumbar spine, Ward's triangle, trochanter and intertrochanter, total hip and whole body were assessed.
RESULTS


Subjects supplemented with the GBB (n = 30) maintained femoral neck BMD, whereas in the placebo group (n = 28), BMD significantly decreased (p = 0.007). There was also a significant difference (p < 0.05) in BMD between the groups at Ward's triangle in favor of the GBB group. Bone-specific alkaline phosphatase and N-telopeptide significantly increased in the GBB group in comparison with those in baseline and in the placebo group. The GBB was well tolerated, and there were no significant differences in adverse events between groups.
CONCLUSIONS


The GBB may help to prevent osteoporosis and reduce fracture risk, at least at the hip, in postmenopausal women. Larger and longer-term clinical trials are warranted.",2013,Bone-specific alkaline phosphatase and N-telopeptide significantly increased in the GBB group in comparison with those in baseline and in the placebo group.,"['postmenopausal women', '70 subjects', 'early postmenopausal women']","['Soybean isoflavones, especially genistein', 'placebo', 'genistein, polyunsaturated fatty acids and vitamins D3 and K1', 'hormone therapy', 'vitamin D3', 'vitamin K1 (150 μg/days) and polyunsaturated fatty acids (1 g polyunsaturated fatty acids as ethyl ester: eicosapentaenoic acid/docosahexaenoic acid ratio = ~2/1', 'synthetic genistein', 'calcium only or the geniVida™ bone blend (GBB), which consisted of genistein']","['Bone-specific alkaline phosphatase and N-telopeptide', ""Markers of bone resorption and formation and BMD at the femoral neck, lumbar spine, Ward's triangle, trochanter and intertrochanter, total hip and whole body"", 'bone mineral density (BMD', 'BMD', 'bone mineral density', 'femoral neck BMD', 'adverse events']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0037733', 'cui_str': 'Soy Beans'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0031862', 'cui_str': 'phytonadione'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C1868706', 'cui_str': 'N-telopeptide'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0205119', 'cui_str': 'Triangular (qualifier value)'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",70.0,0.249176,Bone-specific alkaline phosphatase and N-telopeptide significantly increased in the GBB group in comparison with those in baseline and in the placebo group.,"[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Lappe', 'Affiliation': 'Osteoporosis Research Center, Creighton University Medical Center, 601 North 30th Street, Suite 4820, Omaha, NE 68131, USA.e-mail: jmlappe@creighton.edu'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kunz', 'Affiliation': ''}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bendik', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Prudence', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Weber', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Recker', 'Affiliation': ''}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Heaney', 'Affiliation': ''}]",European journal of nutrition,[]
233,22237688,Addition of insulin glargine or NPH insulin to metformin monotherapy in poorly controlled type 2 diabetic patients decreases IGF-I bioactivity similarly.,"AIMS/HYPOTHESIS


The aim of this study was to compare IGF-I bioactivity 36 weeks after the addition of insulin glargine (A21Gly,B31Arg,B32Arg human insulin) or NPH insulin to metformin therapy in type 2 diabetic patients who had poor glucose control under metformin monotherapy.
METHODS


In the Lantus plus Metformin (LANMET) study, 110 poorly controlled insulin-naive type 2 diabetic patients were randomised to receive metformin with either insulin glargine (G+MET) or NPH insulin (NPH+MET). In the present study, IGF-I bioactivity was measured, retrospectively, in 104 out of the 110 initially included LANMET participants before and after 36 weeks of insulin therapy. IGF-I bioactivity was measured using an IGF-I kinase receptor activation assay.
RESULTS


After 36 weeks of insulin therapy, insulin doses were comparable between the G+MET (68 ± 5.7 U/day) and NPH+MET (71 ± 6.2 U/day) groups (p = 0.68). Before insulin therapy, circulating IGF-I bioactivity was similar between the G+MET (134 ± 9 pmol/l) and NPH+MET (135 ± 10 pmol/l) groups (p = 0.83). After 36 weeks, IGF-I bioactivity had decreased significantly (p = 0.001) and did not differ between the G+MET (116 ± 9 pmol/l) and NPH+MET (117 ± 10 pmol/l) groups (p = 0.91). At baseline and after insulin therapy, total IGF-I concentrations were comparable in both groups (baseline: G+MET 13.3 ± 1.0 vs NPH+MET 13.3 ± 1.0 nmol/l, p = 0.97; and 36 weeks: 13.4 ± 1.0 vs 13.1 ± 0.9 nmol/l, p = 0.71). Total IGF-I concentration did not change during insulin therapy (13.3 ± 0.7 vs 13.3 ± 0.7 nmol/l, baseline vs 36 weeks, p = 0.86).
CONCLUSIONS/INTERPRETATION


Addition of insulin glargine or NPH insulin to metformin monotherapy in poorly controlled type 2 diabetic patients decreases serum IGF-I bioactivity in a similar manner.",2012,"After 36 weeks, IGF-I bioactivity had decreased significantly (p = 0.001) and did not differ between the G+MET (116 ± 9 pmol/l) and NPH+MET (117 ± 10 pmol/l) groups (p = 0.91).","['110 poorly controlled insulin-naive type 2 diabetic patients', '104 out of the 110 initially included LANMET participants before and after 36 weeks of insulin therapy', 'type 2 diabetic patients who had poor glucose control under metformin monotherapy']","['IGF', 'metformin with either insulin glargine (G+MET) or NPH insulin (NPH+MET', 'Metformin (LANMET', 'insulin glargine (A21Gly,B31Arg,B32Arg human insulin) or NPH insulin to metformin therapy', 'insulin glargine or NPH insulin to metformin monotherapy']","['I bioactivity', 'total IGF-I concentrations', 'serum IGF-I bioactivity', 'Total IGF-I concentration', 'IGF-I bioactivity', 'circulating IGF-I bioactivity']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0021658', 'cui_str': 'insulin, isophane'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",,0.0500512,"After 36 weeks, IGF-I bioactivity had decreased significantly (p = 0.001) and did not differ between the G+MET (116 ± 9 pmol/l) and NPH+MET (117 ± 10 pmol/l) groups (p = 0.91).","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Varewijck', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'J A M J L', 'Initials': 'JA', 'LastName': 'Janssen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vähätalo', 'Affiliation': ''}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Hofland', 'Affiliation': ''}, {'ForeName': 'S W J', 'Initials': 'SW', 'LastName': 'Lamberts', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yki-Järvinen', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-011-2435-7']
234,22237722,The effect of surface electrical stimulation on swallowing in dysphagic Parkinson patients.,"Surface electrical stimulation has been applied on a large scale to treat oropharyngeal dysphagia. Patients suffering from oropharyngeal dysphagia in the presence of Parkinson's disease have been treated with surface electrical stimulation. Because of controversial reports on this treatment, a pilot study was set up. This study describes the effects of a single session of surface electrical stimulation using different electrode positions in ten patients with idiopathic Parkinson's disease (median Hoehn and Yahr score: II) and oropharyngeal dysphagia compared to ten age- and gender-matched healthy control subjects during videofluoroscopy of swallowing. Three different electrode positions were applied in random order per subject. For each electrode position, the electrical current was respectively turned ""on"" and ""off"" in random order. Temporal, spatial, and visuoperceptual variables were scored by experienced raters who were blinded to the group, electrode position, and status (on/off) of the electrical current. Interrater and interrater reliabilities were calculated. Only a few significant effects of a single session of surface electrical stimulation using different electrode positions in dysphagic Parkinson patients could be observed in this study. Furthermore, significant results for temporal and spatial variables were found regardless of the status of the electrical current in both groups suggesting placebo effects. Following adjustment for electrical current status as well as electrode positions (both not significant, P > 0.05) in the statistical model, significant group differences between Parkinson patients and healthy control subjects emerged. Further studies are necessary to evaluate the potential therapeutic effect and mechanism of electrical stimulation in dysphagic patients with Parkinson's disease.",2012,Only a few significant effects of a single session of surface electrical stimulation using different electrode positions in dysphagic Parkinson patients could be observed in this study.,"[""Patients suffering from oropharyngeal dysphagia in the presence of Parkinson's disease"", 'dysphagic Parkinson patients', ""ten patients with idiopathic Parkinson's disease (median Hoehn and Yahr score: II) and oropharyngeal dysphagia compared to ten age- and gender-matched healthy control subjects during videofluoroscopy of swallowing"", ""dysphagic patients with Parkinson's disease""]","['surface electrical stimulation', 'single session of surface electrical stimulation']",['Interrater and interrater reliabilities'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal Dysphagia'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",10.0,0.018257,Only a few significant effects of a single session of surface electrical stimulation using different electrode positions in dysphagic Parkinson patients could be observed in this study.,"[{'ForeName': 'Laura W J', 'Initials': 'LW', 'LastName': 'Baijens', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. laura.baijens@mumc.nl'}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'Speyer', 'Affiliation': ''}, {'ForeName': 'Valeria Lima', 'Initials': 'VL', 'LastName': 'Passos', 'Affiliation': ''}, {'ForeName': 'Walmari', 'Initials': 'W', 'LastName': 'Pilz', 'Affiliation': ''}, {'ForeName': 'Nel', 'Initials': 'N', 'LastName': 'Roodenburg', 'Affiliation': ''}, {'ForeName': 'Père', 'Initials': 'P', 'LastName': 'Clavé', 'Affiliation': ''}]",Dysphagia,['10.1007/s00455-011-9387-4']
235,22124575,Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis.,"UNLABELLED


In an open-label extension study, BMD increased continuously with strontium ranelate over 10 years in osteoporotic women (P < 0.01). Vertebral and nonvertebral fracture incidence was lower between 5 and 10 years than in a matched placebo group over 5 years (P < 0.05). Strontium ranelate's antifracture efficacy appears to be maintained long term.
INTRODUCTION


Strontium ranelate has proven efficacy against vertebral and nonvertebral fractures, including hip, over 5 years in postmenopausal osteoporosis. We explored long-term efficacy and safety of strontium ranelate over 10 years.
METHODS


Postmenopausal osteoporotic women participating in the double-blind, placebo-controlled phase 3 studies SOTI and TROPOS to 5 years were invited to enter a 5-year open-label extension, during which they received strontium ranelate 2 g/day (n = 237, 10-year population). Bone mineral density (BMD) and fracture incidence were recorded, and FRAX® scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAX®-matched placebo group identified in the TROPOS placebo arm.
RESULTS


The patients in the 10-year population had baseline characteristics comparable to those of the total SOTI/TROPOS population. Over 10 years, lumbar BMD increased continuously and significantly (P < 0.01 versus previous year) with 34.5 ± 20.2% relative change from baseline to 10 years. The incidence of vertebral and nonvertebral fracture with strontium ranelate in the 10-year population in years 6 to 10 was comparable to the incidence between years 0 and 5, but was significantly lower than the incidence observed in the FRAX®-matched placebo group over 5 years (P < 0.05); relative risk reductions for vertebral and nonvertebral fractures were 35% and 38%, respectively. Strontium ranelate was safe and well tolerated over 10 years.
CONCLUSIONS


Long-term treatment with strontium ranelate is associated with sustained increases in BMD over 10 years, with a good safety profile. Our results also support the maintenance of antifracture efficacy over 10 years with strontium ranelate.",2012,Vertebral and nonvertebral fracture incidence was lower between 5 and 10 years than in a matched placebo group over 5 years (P < 0.05).,"['postmenopausal osteoporosis', 'Postmenopausal osteoporotic women participating in the double-blind, placebo-controlled phase 3 studies SOTI and TROPOS to 5 years were invited to enter a 5-year open-label extension, during which they received']","['Strontium ranelate', 'placebo', 'strontium ranelate']","['FRAX® scores', 'incidence of vertebral and nonvertebral fracture', 'relative risk reductions for vertebral and nonvertebral fractures', 'Vertebral and nonvertebral fracture incidence', 'BMD', 'fracture incidence', 'safe and well tolerated', 'Bone mineral density (BMD) and fracture incidence', 'lumbar BMD']","[{'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0936139', 'cui_str': 'strontium ranelate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}]",,0.0301699,Vertebral and nonvertebral fracture incidence was lower between 5 and 10 years than in a matched placebo group over 5 years (P < 0.05).,"[{'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Department of Public Health and Health Economics, University of Liège, Liège, Belgium. jyreginster@ulg.ac.be'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Kaufman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Goemaere', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Devogelaer', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Benhamou', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diaz-Curiel', 'Affiliation': ''}, {'ForeName': 'M-L', 'Initials': 'ML', 'LastName': 'Brandi', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Badurski', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wark', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Balogh', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roux', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-011-1847-z']
236,22210018,Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection.,"PURPOSE


To characterize exposure-response relationships of AMG 386 in a phase 2 study in advanced ovarian cancer for the facilitation of dose selection in future studies.
METHODS


A population pharmacokinetic model of AMG 386 (N = 141) was developed and applied in an exposure-response analysis using data from patients (N = 160) with recurrent ovarian cancer who received paclitaxel plus AMG 386 (3 or 10 mg/kg once weekly) or placebo. Reduction in the risk of progression or death with increasing exposure (steady-state area under the concentration-versus-time curve [AUC(ss)]) was assessed using Cox regression analyses. Confounding factors were tested in multivariate analysis. Alternative AMG 386 doses were explored with Monte Carlo simulations using population pharmacokinetic and parametric survival models.
RESULTS


There was a trend toward increased PFS with increased AUC(ss) (hazard ratio [HR] for each one-unit increment in AUC(ss), 0.97; P = 0.097), suggesting that the maximum effect on prolonging PFS was not achieved at the highest dose tested (10 mg/kg). Among patients with AUC(ss) ≥ 9.6 mg h/mL, PFS was 8.1 months versus 5.7 months for AUC(ss) < 9.6 mg h/mL and 4.6 months for placebo. No relationship between AUC(ss) and grade ≥ 3 adverse events was observed. Simulations predicted that AMG 386 15 mg/kg once weekly would result in an AUC(ss) ≥ 9.6 mg h/mL in > 90% of patients with median PFS of 8.2 months versus 5.0 months for placebo (HR [15 mg/kg vs. placebo], 0.56).
CONCLUSIONS


Increased exposure to AMG 386 was associated with improved clinical outcomes in recurrent ovarian cancer, supporting the evaluation of a higher dose in future studies.",2012,There was a trend toward increased PFS with increased AUC(ss),"['A population pharmacokinetic model of AMG 386 (N = 141) was developed and applied in an exposure-response analysis using data from patients (N = 160) with recurrent ovarian cancer who received', 'advanced ovarian cancer']","['AUC(ss', 'placebo', 'paclitaxel plus AMG', 'AMG', 'AMG 386 in combination with weekly paclitaxel']","['risk of progression or death', 'prolonging PFS', 'AUC(ss) and grade ≥ 3 adverse events', 'PFS with increased AUC(ss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1541521', 'cui_str': 'AMG 386'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1541521', 'cui_str': 'AMG 386'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",160.0,0.132391,There was a trend toward increased PFS with increased AUC(ss),"[{'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Lu', 'Affiliation': 'Amgen Inc., One Amgen Center Drive, Mailstop 28-3-B, Thousand Oaks, CA 91320, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rasmussen', 'Affiliation': ''}, {'ForeName': 'Beth Y', 'Initials': 'BY', 'LastName': 'Karlan', 'Affiliation': ''}, {'ForeName': 'Ignace B', 'Initials': 'IB', 'LastName': 'Vergote', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Navale', 'Affiliation': ''}, {'ForeName': 'Mita', 'Initials': 'M', 'LastName': 'Kuchimanchi', 'Affiliation': ''}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Melara', 'Affiliation': ''}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Stepan', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': ''}, {'ForeName': 'Yu-Nien', 'Initials': 'YN', 'LastName': 'Sun', 'Affiliation': ''}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-011-1787-5']
237,22189755,"Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention.","Self-monitoring of blood glucose (SMBG) is a core component of diabetes management. However, the International Diabetes Federation recommends that SMBG be performed in a structured manner and that the data are accurately interpreted and used to take appropriate therapeutic actions. We designed a study to evaluate the impact of structured SMBG on glycemic control in non-insulin-treated type 2 diabetes (T2DM) patients. The Prospective, Randomized Trial on Intensive SMBG Management Added Value in Non-insulin-Treated T2DM Patients (PRISMA) is a 12-month, prospective, multicenter, open, parallel group, randomized, and controlled trial to evaluate the added value of an intensive, structured SMBG regimen in T2DM patients treated with oral agents and/or diet. One thousand patients (500 per arm) will be enrolled at 39 clinical sites in Italy. Eligible patients will be randomized to the intensive structured monitoring (ISM) group or the active control (AC) group, with a glycosylated hemoglobin (HbA1c) target of <7.0%. Intervention will comprise (1) structured SMBG (4-point daily glucose profiles on 3 days per week [ISM]; discretionary, unstructured SMBG [AC]); (2) comprehensive patient education (both groups); and (3) clinician's adjustment of diabetes medications using an algorithm targeting SMBG levels, HbA1c and hypoglycemia (ISM) or HbA1c and hypoglycemia (AC). The intervention and trial design build upon previous research by emphasizing appropriate and collaborative use of SMBG by both patients and physicians. Utilization of per protocol and intent-to-treat analyses facilitates assessment of the intervention. Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviors.",2013,"Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviors.","['non-insulin-treated T2DM patients (PRISMA', 'Non-insulin-Treated T2DM Patients (PRISMA', 'non-insulin-treated type 2 diabetes (T2DM) patients', 'One thousand patients (500 per arm) will be enrolled at 39 clinical sites in Italy', 'Eligible patients', 'T2DM patients treated with oral agents and/or diet']","[""SMBG (4-point daily glucose profiles on 3 days per week [ISM]; discretionary, unstructured SMBG [AC]); (2) comprehensive patient education (both groups); and (3) clinician's adjustment of diabetes medications using an algorithm targeting SMBG levels, HbA1c and hypoglycemia (ISM) or HbA1c and hypoglycemia (AC"", 'intensive structured monitoring (ISM) group or the active control (AC', 'Self-monitoring of blood glucose (SMBG', 'structured SMBG', 'structured SMBG intervention']",['glycemic control'],"[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0138404', 'cui_str': 'prisma'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0002045'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",1000.0,0.0367417,"Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviors.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Scavini', 'Affiliation': 'Diabetes Research Institute, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bosi', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ceriello', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giorgino', 'Affiliation': ''}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Porta', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tiengo', 'Affiliation': ''}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Vespasiani', 'Affiliation': ''}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Bottalico', 'Affiliation': ''}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Marino', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Parkin', 'Affiliation': ''}, {'ForeName': 'Erminio', 'Initials': 'E', 'LastName': 'Bonizzoni', 'Affiliation': ''}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Cucinotta', 'Affiliation': ''}]",Acta diabetologica,['10.1007/s00592-011-0357-y']
238,22169884,Methylphenidate produces selective enhancement of declarative memory consolidation in healthy volunteers.,"RATIONALE


Methylphenidate inhibits the reuptake of dopamine and noradrenaline and is used to treat children with attention deficit hyperactivity disorder (ADHD). Besides reducing behavioral symptoms, it improves their cognitive function. There are also observations of methylphenidate-induced cognition enhancement in healthy adults, although studies in this area are relatively sparse. We assessed the possible memory-enhancing properties of methylphenidate.
OBJECTIVE


In the current study, the possible enhancing effects of three doses of methylphenidate on declarative and working memory, attention, response inhibition and planning were investigated in healthy volunteers.
METHODS


In a double blind placebo-controlled crossover study, 19 healthy young male volunteers were tested after a single dose of placebo or 10, 20 or 40 mg of methylphenidate. Cognitive performance testing included a word learning test as a measure of declarative memory, a spatial working memory test, a set-shifting test, a stop signal test and a computerized version of the Tower of London planning test.
RESULTS


Declarative memory consolidation was significantly improved relative to placebo after 20 and 40 mg of methylphenidate. Methylphenidate also improved set shifting and stopped signal task performance but did not affect spatial working memory or planning.
CONCLUSIONS


To the best of our knowledge, this is the first study reporting enhanced declarative memory consolidation after methylphenidate in a dose-related fashion over a dose range that is presumed to reflect a wide range of dopamine reuptake inhibition.",2012,"Methylphenidate also improved set shifting and stopped signal task performance but did not affect spatial working memory or planning.
","['healthy adults', '19 healthy young male volunteers', 'healthy volunteers', 'children with attention deficit hyperactivity disorder (ADHD']","['methylphenidate', 'Methylphenidate', 'placebo']","['declarative and working memory, attention, response inhibition and planning', 'declarative memory consolidation', 'behavioral symptoms', 'Declarative memory consolidation', 'set shifting and stopped signal task performance', 'spatial working memory or planning']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",19.0,0.311869,"Methylphenidate also improved set shifting and stopped signal task performance but did not affect spatial working memory or planning.
","[{'ForeName': 'A M W', 'Initials': 'AM', 'LastName': 'Linssen', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, PO Box 616, 6200, MD, Maastricht, The Netherlands. anke.linssen@maastrichtuniversity.nl'}, {'ForeName': 'E F P M', 'Initials': 'EF', 'LastName': 'Vuurman', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sambeth', 'Affiliation': ''}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Riedel', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2605-9']
239,22124576,Growth hormone effects on cortical bone dimensions in young adults with childhood-onset growth hormone deficiency.,"UNLABELLED


Growth hormone (GH) treatment in young adults with childhood-onset GH deficiency has beneficial effects on bone mass. The present study shows that cortical bone dimensions also benefit from GH treatment, with endosteal expansion and increased cortical thickness leading to improved bone strength.
INTRODUCTION


In young adults with childhood-onset growth hormone deficiency (CO GHD), GH treatment after final height is reached has been shown to have beneficial effects on spine and hip bone mineral density. The objective of the study was to evaluate the influence of GH on cortical bone dimensions.
METHODS


Patients (n = 160; mean age, 21.2 years; 63% males) with CO GHD were randomised 2:1 to GH or no treatment for 24 months. Cortical bone dimensions were evaluated by digital x-ray radiogrammetry of the metacarpal bones every 6 months.
RESULTS


After 24 months, cortical thickness was increased compared with the controls (6.43%, CI 3.34 to 9.61%; p = 0.0001) and metacarpal index (MCI) (6.14%, CI 3.95 to 8.38%; p < 0.0001), while the endosteal diameter decreased (-4.64%, CI -7.15 to -2.05; p < 0.001). Total bone width did not change significantly (0.68%, CI -1.17 to 2.57%; not significant (NS)). A gender effect was seen on bone width (p < 0.0001), endosteal diameter (p < 0.01) and cortical thickness (p < 0.01), but not with MCI (NS).
CONCLUSIONS


Cortical bone reacts promptly to reinstitution of GH beyond the attainment of final height by increasing the cortical thickness through endosteal bone growth. This leads to a higher peak bone mass and may reduce the risk of cortical bone fragility later in life.",2012,"Total bone width did not change significantly (0.68%, CI -1.17 to 2.57%; not significant (NS)).","['160; mean age, 21.2\xa0years; 63% males) with', 'Patients (n\u2009', 'young adults with childhood-onset GH deficiency', 'young adults with childhood-onset growth hormone deficiency', 'young adults with childhood-onset growth hormone deficiency (CO GHD']","['Growth hormone (GH', 'GH']","['bone width', 'Cortical bone dimensions', 'metacarpal index (MCI', 'cortical thickness', 'cortical bone dimensions', 'endosteal diameter', 'Total bone width']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency (disorder)'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone (body structure)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0025526', 'cui_str': 'Metacarpals'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0345866,"Total bone width did not change significantly (0.68%, CI -1.17 to 2.57%; not significant (NS)).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hyldstrup', 'Affiliation': 'Department of Endocrinology (541), Hvidovre University Hospital, Hvidovre, Denmark. hyld@dadlnet.dk'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Conway', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Racz', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Keller', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Chanson', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zacharin', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Lysgaard', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Andreasen', 'Affiliation': ''}, {'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Kappelgaard', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-011-1854-0']
240,22130869,"Effects of single therapeutic doses of promethazine, fexofenadine and olopatadine on psychomotor function and histamine-induced wheal- and flare-responses: a randomized double-blind, placebo-controlled study in healthy volunteers.","Since most first-generation antihistamines have undesirable sedative effects on the central nervous systems (CNS), newer (second-generation) antihistamines have been developed to improve patients' quality of life. However, there are few reports that directly compare the antihistaminic efficacy and impairment of psychomotor functions. We designed a double-blind, placebo controlled, crossover study to concurrently compare the clinical effectiveness of promethazine, a first-generation antihistamine, and fexofenadine and olopatadine, second-generation antihistamines, by measuring their potency as peripheral inhibitors of histamine-induced wheal and flare. Further, we investigated their sedative effects on the CNS using a battery of psychomotor tests. When single therapeutic doses of fexofenadine (60 mg), olopatadine (5 mg) and promethazine (25 mg) were given in a double-blind manner to 24 healthy volunteers, all antihistamines produced a significant reduction in the wheal and flare responses induced by histamine. In the comparison among antihistamines, olopatadine showed a rapid inhibitory effect compared with fexofenadine and promethazine, and had a potent effect compared with promethazine. In a battery of psychomotor assessments using critical flicker fusion, choice reaction time, compensatory tracking, rapid visual information processing and a line analogue rating scale as a subjective assessment of sedation, promethazine significantly impaired psychomotor function. Fexofenadine and olopatadine had no significant effect in any of the psychomotor tests. Promethazine, fexofenadine and olopatadine did not affect behavioral activity, as measured by wrist actigraphy. These results suggest that olopatadine at a therapeutic dose has greater antihistaminergic activity than promethazine, and olopatadine and fexofenadine did not cause cognitive or psychomotor impairment.",2012,"In the comparison among antihistamines, olopatadine showed a rapid inhibitory effect compared with fexofenadine and promethazine, and had a potent effect compared with promethazine.","['healthy volunteers', '24 healthy volunteers']","['placebo', 'promethazine, a first-generation antihistamine, and fexofenadine and olopatadine, second-generation antihistamines', 'promethazine', 'olopatadine', 'promethazine, fexofenadine and olopatadine', 'antihistamines, olopatadine', 'fexofenadine and promethazine', 'Fexofenadine', 'Promethazine, fexofenadine and olopatadine', 'fexofenadine']","['psychomotor function', 'psychomotor tests', 'critical flicker fusion, choice reaction time, compensatory tracking, rapid visual information processing and a line analogue rating scale', 'psychomotor function and histamine-induced wheal- and flare-responses', 'antihistaminic efficacy and impairment of psychomotor functions', 'antihistaminergic activity', 'cognitive or psychomotor impairment', 'behavioral activity', 'rapid inhibitory effect', 'wheal and flare responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0296800', 'cui_str': 'fexofenadine'}, {'cui': 'C0527189', 'cui_str': 'olopatadine'}, {'cui': 'C1136312', 'cui_str': 'Second Generation H1 Antagonists'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0016236', 'cui_str': 'Flicker Fusion'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0221232', 'cui_str': 'Wheal'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0679465', 'cui_str': 'Psychomotor Impairment'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",24.0,0.109461,"In the comparison among antihistamines, olopatadine showed a rapid inhibitory effect compared with fexofenadine and promethazine, and had a potent effect compared with promethazine.","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kamei', 'Affiliation': 'Department of Clinical Pharmacy Practice and Health Care Management, Meijo University, Nagoya, Japan.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Isaji', 'Affiliation': ''}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Noda', 'Affiliation': ''}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': ''}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Senzaki', 'Affiliation': ''}, {'ForeName': 'Kiyofumi', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': ''}, {'ForeName': 'Kazumitsu', 'Initials': 'K', 'LastName': 'Sugiura', 'Affiliation': ''}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': ''}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nabeshima', 'Affiliation': ''}]",Archives of dermatological research,['10.1007/s00403-011-1192-2']
241,22127409,Comparison of treatment results between holmium laser endourethrotomy and optical internal urethrotomy for urethral stricture.,"PURPOSE


We comparatively evaluated urethral stricture (US) treatment outcomes, efficacy and complications, using either holmium laser endourethrotomy (HLU) or optical internal urethrotomy (OIU) since studies such as this are scarce in literature.
METHODS


During 2003-2008, 50 men aged 17-78 years were operated on for primary or refractory US, 32 (64%) and 18 (36%) patients, respectively. The average stricture length was 1.86 cm. Strictures were single or multiple, forty-one (82%) and nine (18%) patients, respectively, and were located in the anterior or posterior urethra in 27 (54%) and 32 (64%) patients, respectively. US were iatrogenic in 32 (64%) and idiopathic in 18 (36%). Patients were divided into two groups, grpA and grpB, each containing 25 patients who were treated using either HLU or OIU, respectively. An evaluation scale of 1-3 was adopted and took maximum flow rate (Q(max)), postvoid residual (PVR), and quality of life (QL) into consideration. A score of '1 was very good, '2 was good, and '3 was poor.
RESULTS


Treatment results were evaluated after 3, 6, and 12 months, respectively. Evaluation of grpA was as follows: five (20%), nine (36%), and seven (28%) patients scored a '1; thirteen (52%), nine (20%), and four (16%) patients scored a '2; and seven (28%), eleven (44%), and fourteen (56%) patients scored a '3. Evaluation of grpB: seven (28%), ten (40%), and five (20%) patients scored a '1; eleven (44%), seven (28%), and ten (40%) patients scored a '2; and seven (28%), eight (32%), and ten (40%) patients scored a '3.
CONCLUSIONS


Neither complication rate nor degree of efficacy between HLU and OIU for US revealed a significant difference. We found both laser and conventional urethrotomies to be safe and effective modes of treatment.",2012,"Strictures were single or multiple, forty-one (82%) and nine (18%) patients, respectively, and were located in the anterior or posterior urethra in 27 (54%) and 32 (64%) patients, respectively.","['urethral stricture', 'During 2003-2008, 50 men aged 17-78 years']","['holmium laser endourethrotomy and optical internal urethrotomy', 'laser and conventional urethrotomies', 'holmium laser endourethrotomy (HLU) or optical internal urethrotomy (OIU']","['average stricture length', 'maximum flow rate (Q(max)), postvoid residual (PVR), and quality of life (QL']","[{'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0565436', 'cui_str': 'Internal urethrotomy (procedure)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0034380'}]",50.0,0.0179434,"Strictures were single or multiple, forty-one (82%) and nine (18%) patients, respectively, and were located in the anterior or posterior urethra in 27 (54%) and 32 (64%) patients, respectively.","[{'ForeName': 'Slawomir A', 'Initials': 'SA', 'LastName': 'Dutkiewicz', 'Affiliation': 'Department of Urology, E. Michałowski Urological Hospital, Katowice, Poland. sad1947@wp.eu'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Wroblewski', 'Affiliation': ''}]",International urology and nephrology,['10.1007/s11255-011-0094-8']
242,22130826,A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome.,"PURPOSE


To study the therapeutic effects of probiotic Escherichia coli Nissle 1917 (EcN) in irritable bowel syndrome (IBS) and identify subgroups benefiting most.
BACKGROUND


Some trials investigating therapeutic effects in irritable bowel syndrome have shown benefits in IBS subgroups only. Probiotic treatment seems to be promising.
METHODS


Patients with irritable bowel syndrome (120; Rome II) were recruited to a prospective double-blind study and randomized to either EcN (n = 60) or placebo (n = 60) given for 12 weeks. Objectives were to describe efficacy and safety of EcN in different groups of irritable bowel syndrome. Outcome was assessed by 'Integrative Medicine Patient Satisfaction Scale'.
RESULTS


Altogether, the responder rate was higher in the EcN than in the placebo group. However, only after 10 and 11 weeks, the differences were significant (Δ 20.0% points [95% CI 2.6; 37.4], p = 0.01 and Δ 18.3% points [95% CI 1.0; 35.7], p = 0.02, respectively). The best response was observed in the subgroup of patients with gastroenteritis or antibiotics prior to irritable bowel syndrome onset (Δ 45.7% points, p = 0.029). No significant differences were observed in any other subgroup. Both treatment groups showed similar adverse events and tolerance.
CONCLUSIONS


Probiotic EcN shows effects in irritable bowel syndrome, especially in patients with altered enteric microflora, e.g. after gastroenterocolitis or administration of antibiotics.",2012,"Both treatment groups showed similar adverse events and tolerance.
","['Patients with irritable bowel syndrome (120; Rome II', 'patients with altered enteric microflora, e.g. after gastroenterocolitis or administration of antibiotics', 'irritable bowel syndrome (IBS', 'subgroups of patients with irritable bowel syndrome']","['probiotic Escherichia coli Nissle 1917 (EcN', 'placebo', 'probiotic Escherichia coli Nissle', 'EcN', 'Probiotic EcN']","['irritable bowel syndrome', 'efficacy and safety of EcN', 'responder rate', 'adverse events and tolerance', 'Integrative Medicine Patient Satisfaction Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0744314', 'cui_str': 'Gastroenterocolitis'}, {'cui': 'C0199779', 'cui_str': 'Administration of antibiotic (procedure)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0760481', 'cui_str': '(3beta,5alpha,17beta)-17-hydroxyestrane-3-carbonitrile'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0760481', 'cui_str': '(3beta,5alpha,17beta)-17-hydroxyestrane-3-carbonitrile'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C2350258', 'cui_str': 'Integrative Medicine'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0222045'}]",,0.141374,"Both treatment groups showed similar adverse events and tolerance.
","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kruis', 'Affiliation': 'Evangelisches Krankenhaus Kalk, University of Cologne, Buchforststrasse 2, 51103, Cologne, Germany. kruis@evkk.de'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Chrubasik', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Boehm', 'Affiliation': ''}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Stange', 'Affiliation': ''}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Schulze', 'Affiliation': ''}]",International journal of colorectal disease,['10.1007/s00384-011-1363-9']
243,22041970,Safety and efficacy of oral rehydration therapy until 2 h before surgery: a multicenter randomized controlled trial.,"PURPOSE


In many countries, patients are generally allowed to have clear fluids until 2-3 h before surgery. In Japan, long preoperative fasting is still common practice. To shorten the preoperative fasting period in Japan, we tested the safety and efficacy of oral rehydration therapy until 2 h before surgery.
METHODS


Three hundred low-risk patients scheduled for morning surgery in six university-affiliated hospitals were randomly assigned to an oral rehydration solution (ORS) group or to a fasting group. Patients in the ORS group consumed up to 1,000 ml of ORS containing balanced glucose and electrolytes: 500 ml between 2100 the night before surgery and the time they woke up the next morning and 500 ml during the morning of surgery until 2 h before surgery. Patients in the fasting group started fasting at 2100 the night before surgery. Primary endpoints were gastric fluid volume and pH immediately after anesthesia induction. Several physiological measures of hydration and electrolytes including the fractional excretion of sodium (FENa) and the fractional excretion of urea nitrogen (FEUN) were also evaluated.
RESULTS


Mean (SD) gastric fluid volume immediately after anesthesia induction was 15.1 (14.0) ml in the ORS group and 17.5 (23.2) ml in the fasting group (P = 0.30). The mean difference between the ORS group and fasting group was -2.5 ml. The 95% confidence interval ranged from -7.1 to +2.2 ml and did not include the noninferior limit of +8 ml. Mean (SD) gastric fluid pH was 2.1 (1.9) in the ORS group and 2.2 (2.0) in the fasting group (P = 0.59). In the ORS group, mean FENa and FEUN immediately after anesthesia induction were both significantly greater than those in the fasting group (P < 0.001 for both variables). The ORS group reported they had been less thirsty and hungry before surgery (P < 0.001, 0.01).
CONCLUSIONS


Oral rehydration therapy until 2 h before surgery is safe and feasible in the low-risk Japanese surgical population. Physicians are encouraged to use this practice to maintain the amount of water in the body and electrolytes and to improve the patient's comfort.",2012,"The ORS group reported they had been less thirsty and hungry before surgery (P < 0.001, 0.01).
",['Three hundred low-risk patients scheduled for morning surgery in six university-affiliated hospitals'],"['oral rehydration solution (ORS) group or to a fasting group', 'oral rehydration therapy until 2 h before surgery']","['gastric fluid volume and pH immediately after anesthesia induction', 'fractional excretion of sodium (FENa) and the fractional excretion of urea nitrogen (FEUN', 'safety and efficacy', 'Mean (SD) gastric fluid volume immediately after anesthesia induction', 'mean FENa and FEUN', 'Safety and efficacy', 'Mean (SD) gastric fluid pH']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0086904', 'cui_str': 'Oral Rehydration'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0029168', 'cui_str': 'Oral Rehydration Therapy'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0428601', 'cui_str': 'Measurement of fractional excretion of sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C1291218', 'cui_str': 'Urea nitrogen (substance)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",300.0,0.0743679,"The ORS group reported they had been less thirsty and hungry before surgery (P < 0.001, 0.01).
","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Itou', 'Affiliation': 'Department of Anesthesiology, Tokai University School of Medicine, Tokai University Hospital, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Fukuyama', 'Affiliation': ''}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sasabuchi', 'Affiliation': ''}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yasuda', 'Affiliation': ''}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': ''}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Hinenoya', 'Affiliation': ''}, {'ForeName': 'Chol', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Sanui', 'Affiliation': ''}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': ''}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Miyao', 'Affiliation': ''}, {'ForeName': 'Norimasa', 'Initials': 'N', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': ''}, {'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Iwao', 'Affiliation': ''}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Sakamoto', 'Affiliation': ''}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': ''}, {'ForeName': 'Toshiyasu', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': ''}]",Journal of anesthesia,['10.1007/s00540-011-1261-x']
244,22042588,"Benefit of ""transparent soft-short-hood on the scope"" for colonoscopy among experienced gastroenterologists and gastroenterologist trainee: a randomized, controlled trial.","BACKGROUND


The attachment of a transparent hood to the colonoscope tip has been reported to offer some benefits, such as enabling the endoscopist to perform the colonoscopy more easily and to save time. However, there have been no randomized, controlled trials concerning these benefits, nor have any reports been published regarding the use of hoods for the purpose of training colonoscopists. Therefore, we conducted this study to evaluate the possible benefits of the transparent soft short hood when used by both experienced and trainee endoscopist groups.
METHODS


This randomized, controlled trial to assess the results of using a transparent soft short hood attached to the tip of the colonoscope was undertaken by two groups of investigators: experienced endoscopists and gastroenterologist trainees. The cecal and ileal intubation times, as well as the doses of sedative medication required, were analyzed.
RESULTS


A total of 112 patients, 65 of whom were female, underwent colonoscopy by 2 endoscopists and 5 gastroenterologist trainees. Colonoscopy was complete in 100% of the patients. The study showed significant shortening of the cecal intubation time when using the soft short hood, in both the endoscopist and gastroenterologist trainee groups (6.8/4.61 min, P = 0.006; and 9.36/7.36 min, P = 0.03). The ileal intubation time had a trend to be significantly less when using the transparent hood in the trainee group (126.4/52.9 s), although this was not statistically significant (P = 0.08). The average dose of propofol, when using the transparent hood, was significantly lower in the endoscopist group (180/120 mg, P = 0.001). No significant complications occurred in the hood or non-hood groups.
CONCLUSIONS


The transparent soft short hood shortened the cecal intubation time in both the experienced endoscopist and gastroenterologist trainee groups, as well as reducing the dose of sedative medication required in the experienced endoscopist group. Interestingly, it also reduced the trainee ileal intubation time. The attachment of this type of hood enabled both the experienced endoscopists and gastroenterological trainees to perform colonoscopy more quickly and easily, without any complications.",2012,"The ileal intubation time had a trend to be significantly less when using the transparent hood in the trainee group (126.4/52.9 s), although this was not statistically significant (P = 0.08).","['A total of 112 patients, 65 of whom were female, underwent colonoscopy by 2 endoscopists and 5 gastroenterologist trainees']","['propofol', 'transparent soft short hood attached to the tip of the colonoscope', 'transparent soft-short-hood']","['cecal intubation time', 'ileal intubation time', 'trainee ileal intubation time', 'cecal and ileal intubation times', 'complications']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0522503', 'cui_str': 'Translucent (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0180022', 'cui_str': 'Colonoscopes'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",112.0,0.040572,"The ileal intubation time had a trend to be significantly less when using the transparent hood in the trainee group (126.4/52.9 s), although this was not statistically significant (P = 0.08).","[{'ForeName': 'Varayu', 'Initials': 'V', 'LastName': 'Prachayakul', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pitulak', 'Initials': 'P', 'LastName': 'Aswakul', 'Affiliation': ''}, {'ForeName': 'Julajak', 'Initials': 'J', 'LastName': 'Limsrivilai', 'Affiliation': ''}, {'ForeName': 'Soros', 'Initials': 'S', 'LastName': 'Anuchapreeda', 'Affiliation': ''}, {'ForeName': 'Patommatat', 'Initials': 'P', 'LastName': 'Bhanthumkomol', 'Affiliation': ''}, {'ForeName': 'Pimsiri', 'Initials': 'P', 'LastName': 'Sripongpun', 'Affiliation': ''}, {'ForeName': 'Tanyawat', 'Initials': 'T', 'LastName': 'Prangboonyarat', 'Affiliation': ''}, {'ForeName': 'Udom', 'Initials': 'U', 'LastName': 'Kachintorn', 'Affiliation': ''}]",Surgical endoscopy,['10.1007/s00464-011-1992-7']
245,22076245,Effects of alcohol (BAC 0.5‰) and ecstasy (MDMA 100 mg) on simulated driving performance and traffic safety.,"RATIONAL


An increasing number of fatal road-accidents have been reported in which ecstasy was found in the blood of drivers. Although, ecstasy is frequently found to have been used in combination with alcohol, studies on the acute effects of ecstasy co-administered with alcohol on driving performance are relatively rare.
OBJECTIVE


The present study was designed to establish the extent of driver impairment as a consequence of ecstasy or combined ecstasy and alcohol use as compared to driving under the influence of 0.3‰, 0.5‰ and 0.8‰ alcohol. Furthermore, subjective performance was also assessed.
RESULTS


Alcohol and ecstasy mainly influenced automated driving performance such as lateral and speed control. However, small to no effects of the substances were found on more complex driving behaviour. Overall, variance within the different driving measures was high especially when participants were treated with 3.4-methylenedioxy-methamphetamine (MDMA) and alcohol. Furthermore, equivalence testing showed that combined use may lead to impaired driving for some, but not all, drivers. Participants rated their own performance to be slightly worse than normal in both studies. Since driving was actually seriously deteriorated, this was a falsely positive assessment of their condition.
CONCLUSIONS


The dissociation between subjective perceptions and objective performance decrements are important notions for traffic safety since this may affect a driver's judgement of whether or not it is safe to drive. For example, an intoxicated individual might decide to drive because the feelings of alertness caused by MDMA cloud the impairing effects of other drugs such as alcohol, thereby creating a potentially serious risk for traffic safety.",2012,"Overall, variance within the different driving measures was high especially when participants were treated with 3.4-methylenedioxy-methamphetamine (MDMA) and alcohol.",[],"['3.4-methylenedioxy-methamphetamine (MDMA) and alcohol', 'alcohol (BAC 0.5‰) and ecstasy (MDMA 100 mg']","['subjective performance', 'complex driving behaviour', 'simulated driving performance and traffic safety']",[],"[{'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0887889', 'cui_str': 'BACs (Chromosomes)'}, {'cui': 'C0678156', 'cui_str': 'Ecstasy (finding)'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0221565,"Overall, variance within the different driving measures was high especially when participants were treated with 3.4-methylenedioxy-methamphetamine (MDMA) and alcohol.","[{'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Veldstra', 'Affiliation': 'Department of Neuropsychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS, Groningen, the Netherlands. j.l.veldstra@rug.nl'}, {'ForeName': 'Karel A', 'Initials': 'KA', 'LastName': 'Brookhuis', 'Affiliation': ''}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Waard', 'Affiliation': ''}, {'ForeName': 'Barbara H W', 'Initials': 'BH', 'LastName': 'Molmans', 'Affiliation': ''}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Verstraete', 'Affiliation': ''}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Skopp', 'Affiliation': ''}, {'ForeName': 'Ricarda', 'Initials': 'R', 'LastName': 'Jantos', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2537-4']
246,22081769,Total laparoscopic hysterectomy versus total abdominal hysterectomy with bilateral salpingo-oophorectomy for endometrial carcinoma: a randomised controlled trial with 5-year follow-up.,"This report is on recovery and long-term outcomes in a small-scale randomised controlled trial (RCT) after total laparoscopic hysterectomy versus total abdominal hysterectomy in (potential) endometrial carcinoma patients. An RCT was performed among women with atypical endometrial hyperplasia and endometrial carcinoma scheduled for hysterectomy in a teaching hospital in The Netherlands. Women were randomised to total laparoscopic hysterectomy versus total abdominal hysterectomy both with bilateral salpingo-oophorectomy and were followed until 5 years after the intervention. Patients completed the RAND 36-Item Short Form Health Survey (RAND-36), Quality of Recovery-40 (QoR-40) and Recovery Index-10 (RI-10) until 12 weeks after surgery. Main outcome measure was quality of life and recovery in the first 12 weeks after surgery. A linear mixed model was used for statistical analysis while accounting for baseline values where applicable. Seventeen women were included, of whom 11 allocated to the laparoscopic arm and 6 to the abdominal arm. Laparoscopic hysterectomy performed better on all scales and subscales used in the study. A statistically significant treatment effect, favouring laparoscopic hysterectomy, was found in the total RAND-36 (difference between groups 142 units, 95% confidence interval 46; 236). Clinical follow-up was completed after median 60 months, but this study was too small for conclusions regarding the safety and survival. Laparoscopic hysterectomy results in better postoperative quality of life in the first 12 weeks after surgery when compared with abdominal hysterectomy.",2011,"A statistically significant treatment effect, favouring laparoscopic hysterectomy, was found in the total RAND-36 (difference between groups 142 units, 95% confidence interval 46; 236).","['Seventeen women were included, of whom 11 allocated to the laparoscopic arm and 6 to the abdominal arm', 'potential) endometrial carcinoma patients', 'women with atypical endometrial hyperplasia and endometrial carcinoma scheduled for hysterectomy in a teaching hospital in The Netherlands', 'endometrial carcinoma']","['Total laparoscopic hysterectomy versus total abdominal hysterectomy with bilateral salpingo-oophorectomy', 'RCT', 'Laparoscopic hysterectomy', 'total laparoscopic hysterectomy versus total abdominal hysterectomy', 'total laparoscopic hysterectomy versus total abdominal hysterectomy both with bilateral salpingo-oophorectomy']","['postoperative quality of life', 'safety and survival', 'total RAND-36', 'RAND 36-Item Short Form Health Survey (RAND-36), Quality of Recovery-40 (QoR-40) and Recovery Index-10 (RI-10', 'quality of life and recovery']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0349579', 'cui_str': 'Atypical Endometrial Hyperplasia'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0542407', 'cui_str': 'Total abdominal hysterectomy with bilateral salpingo-oophorectomy'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",17.0,0.311959,"A statistically significant treatment effect, favouring laparoscopic hysterectomy, was found in the total RAND-36 (difference between groups 142 units, 95% confidence interval 46; 236).","[{'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Kluivers', 'Affiliation': ''}, {'ForeName': 'Florien A', 'Initials': 'FA', 'LastName': 'Ten Cate', 'Affiliation': ''}, {'ForeName': 'Marlies Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': ''}, {'ForeName': 'Hans A M', 'Initials': 'HA', 'LastName': 'Brölmann', 'Affiliation': ''}, {'ForeName': 'Jan C M', 'Initials': 'JC', 'LastName': 'Hendriks', 'Affiliation': ''}]",Gynecological surgery,[]
247,22081122,Neuromuscular electrical stimulation versus traditional therapy in patients with Parkinson's disease and oropharyngeal dysphagia: effects on quality of life.,"This study compares the effects of traditional logopedic dysphagia treatment with those of neuromuscular electrical stimulation (NMES) as adjunct to therapy on the quality of life in patients with Parkinson's disease and oropharyngeal dysphagia. Eighty-eight patients were randomized over three treatment groups. Traditional logopedic dysphagia treatment and traditional logopedic dysphagia treatment combined with NMES at sensor or motor level stimulation were compared. At three times (pretreatment, post-treatment, and 3 months following treatment), two quality-of-life questionnaires (SWAL-QOL and MD Anderson Dysphagia Inventory) and a single-item Dysphagia Severity Scale were scored. The Functional Oral Intake Scale was used to assess the dietary intake. After therapy, all groups showed significant improvement on the Dysphagia Severity Scale and restricted positive effects on quality of life. Minimal group differences were found. These effects remained unchanged 3 months following treatment. No significant correlations were found between dietary intake and quality of life. Logopedic dysphagia treatment results in a restricted increased quality of life in patients with Parkinson's disease. In this randomized controlled trial, all groups showed significant therapy effects on the Dysphagia Severity Scale and restricted improvements on the SWAL-QOL and the MDADI. However, only slight nonsignificant differences between groups were found.",2012,"In this randomized controlled trial, all groups showed significant therapy effects on the Dysphagia Severity Scale and restricted improvements on the SWAL-QOL and the MDADI.","['Eighty-eight patients', ""patients with Parkinson's disease"", ""patients with Parkinson's disease and oropharyngeal dysphagia""]","['traditional logopedic dysphagia treatment', 'Traditional logopedic dysphagia treatment and traditional logopedic dysphagia treatment combined with NMES', 'neuromuscular electrical stimulation (NMES', 'Neuromuscular electrical stimulation versus traditional therapy']","['SWAL-QOL and the MDADI', 'quality of life', 'Dysphagia Severity Scale', 'quality-of-life questionnaires (SWAL-QOL and MD Anderson Dysphagia Inventory) and a single-item Dysphagia Severity Scale', 'Functional Oral Intake Scale', 'dietary intake and quality of life']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal Dysphagia'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C3650840', 'cui_str': 'Traditional therapy (regime/therapy)'}]","[{'cui': 'C0034380'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",88.0,0.0220063,"In this randomized controlled trial, all groups showed significant therapy effects on the Dysphagia Severity Scale and restricted improvements on the SWAL-QOL and the MDADI.","[{'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Heijnen', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Leiden University Medical Center, Leiden, The Netherlands. B.J.Heijnen@LUMC.nl.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Speyer', 'Affiliation': ''}, {'ForeName': 'L W J', 'Initials': 'LW', 'LastName': 'Baijens', 'Affiliation': ''}, {'ForeName': 'H C A', 'Initials': 'HC', 'LastName': 'Bogaardt', 'Affiliation': ''}]",Dysphagia,['10.1007/s00455-011-9371-z']
248,22076246,Effects of dexamphetamine with and without alcohol on simulated driving.,"RATIONALE


In party circuits dexamphetamine is frequently used in combination with alcohol. It is hypothesized that co-administration of dexamphetamine to alcohol might reduce the sedative effects of alcohol, but may potentiate risk-taking behaviour.
OBJECTIVES


The study was aimed at assessing the effects of alcohol, dexamphetamine and the combination of both on simulated driving and cognitive performance.
METHOD


Eighteen subjects participated in a randomized, crossover, placebo-controlled study employing four conditions: 10 mg dexamphetamine, 0.8 g/kg alcohol, 10 mg dexamphetamine + 0.8 g/kg alcohol, and placebo. Fundamental driving skills and risk-taking behaviour were assessed in a driving simulator. Subjects also completed vigilance and divided attention tasks, and subjective ratings.
RESULTS


Mean BAC levels during simulated driving were between 0.91‰ and 0.64‰. Subjects using alcohol showed a significantly larger mean standard deviation of lateral position and shorter accepted gap time and distance. Use of alcohol or dexamphetamine + alcohol was associated with a higher frequency of red light running and collisions than the dexamphetamine or placebo conditions. Performance of vigilance and divided attention tasks was significantly impaired in the alcohol condition and, to a lesser degree, in the dexamphetamine + alcohol condition.
CONCLUSION


Single doses of 0.8 g/kg alcohol increased risk-taking behaviours and impaired tracking, attention and reaction time during a 3-h period after drinking when BACs declined from 0.9 to 0.2 mg/ml. The stimulatory effects of co-administration of dexamphetamine 10 mg were not sufficient to overcome the impairing effects of alcohol on skills related to driving.",2012,"Single doses of 0.8 g/kg alcohol increased risk-taking behaviours and impaired tracking, attention and reaction time during a 3-h period after drinking when BACs declined from 0.9 to 0.2 mg/ml.",['Eighteen subjects participated'],"['placebo', 'dexamphetamine', 'dexamphetamine with and without alcohol', 'alcohol, dexamphetamine', 'alcohol or dexamphetamine + alcohol', 'dexamphetamine, 0.8 g/kg alcohol, 10 mg dexamphetamine + 0.8 g/kg alcohol, and placebo']","['Fundamental driving skills and risk-taking behaviour', 'Mean BAC levels', 'risk-taking behaviours and impaired tracking, attention and reaction time', 'mean standard deviation of lateral position and shorter accepted gap time and distance', 'Performance of vigilance and divided attention tasks']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0887889', 'cui_str': 'BACs (Chromosomes)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0589101', 'cui_str': 'Divided attention, function (observable entity)'}]",18.0,0.0173434,"Single doses of 0.8 g/kg alcohol increased risk-taking behaviours and impaired tracking, attention and reaction time during a 3-h period after drinking when BACs declined from 0.9 to 0.2 mg/ml.","[{'ForeName': 'Ries', 'Initials': 'R', 'LastName': 'Simons', 'Affiliation': 'Department of Behavioral and Social Sciences, TNO Netherlands Organization for Applied Scientific Research, P.O. Box 23, 3769 ZG, Soesterberg, Netherlands. ries.simons@tno.nl'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Martens', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ramaekers', 'Affiliation': ''}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Krul', 'Affiliation': ''}, {'ForeName': 'Ineke', 'Initials': 'I', 'LastName': 'Klöpping-Ketelaars', 'Affiliation': ''}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Skopp', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2549-0']
249,21975580,Neurophysiological functioning of occasional and heavy cannabis users during THC intoxication.,"RATIONALE


Experienced cannabis users demonstrate tolerance to some of the impairing acute effects of cannabis.
OBJECTIVES


The present study investigates whether event-related potentials (ERPs) differ between occasional and heavy cannabis users after acute Δ9-tetrahydrocannabinol (THC) administration, as a result of tolerance.
METHODS


Twelve occasional and 12 heavy cannabis users participated in a double-blind, placebo-controlled, crossover study. On two separate days, they smoked a joint containing 0 or 500 μg/kg body weight THC. ERPs were measured while subjects performed a divided attention task (DAT) and stop signal task (SST).
RESULTS


In the DAT, THC significantly decreased P100 amplitude in occasional but not in heavy cannabis users. P300 amplitude in the DAT was significantly decreased by THC in both groups. The N200 peak in the SST was not affected by treatment in neither of the groups. Performance in the SST was impaired in both groups after THC treatment, whereas performance in the DAT was impaired by THC only in the occasional users group.
CONCLUSIONS


The present study confirms that heavy cannabis users develop tolerance to some of the impairing behavioral effects of cannabis. This tolerance was also evident in the underlying ERPs, suggesting that tolerance demonstrated on performance level is not (completely) due to behavioral compensation.",2012,"Performance in the SST was impaired in both groups after THC treatment, whereas performance in the DAT was impaired by THC only in the occasional users group.
","['occasional and heavy cannabis users after acute Δ9-tetrahydrocannabinol (THC', 'Twelve occasional and 12 heavy cannabis users participated in a double-blind', 'Neurophysiological functioning of occasional and heavy cannabis users during THC intoxication']","['placebo', 'DAT, THC']","['ERPs', 'P300 amplitude in the DAT', 'P100 amplitude']","[{'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0444781', 'cui_str': 'P300 (P3) (qualifier value)'}]",,0.161331,"Performance in the SST was impaired in both groups after THC treatment, whereas performance in the DAT was impaired by THC only in the occasional users group.
","[{'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200MD Maastricht, The Netherlands. e.theunissen@maastrichtuniversity.nl'}, {'ForeName': 'Gerold F', 'Initials': 'GF', 'LastName': 'Kauert', 'Affiliation': ''}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': ''}, {'ForeName': 'Manfred R', 'Initials': 'MR', 'LastName': 'Moeller', 'Affiliation': ''}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Sambeth', 'Affiliation': ''}, {'ForeName': 'Mathieu M', 'Initials': 'MM', 'LastName': 'Blanchard', 'Affiliation': ''}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2479-x']
250,22003279,Parenting Intervention to Reduce Attention and Behavior Difficulties in Preschoolers: A CUIDAR Evaluation Study.,"In this study, we evaluated CUIDAR, a program that provides community-based 10-week parent training to reduce attention and behavior problems in preschool children. We recruited 154 predominantly low-income and Latino preschoolers and their parents to participate in this evaluation study. We collected data prior to and immediately following intervention and one year later. At the time of follow-up, we also recruited 15 parents who had initially enrolled, but never participated in the program to serve as a comparison group for a limited set of analyses. From pre to post intervention, we observed significant, positive changes in eight out of ten measured parenting behaviors. From pre intervention to follow-up, improvements in the use of transitional statements and planning ahead were significant. Children's SDQ Total Difficulties scores significantly decreased from pre to post intervention (d = .36), and we observed significant, positive changes in all SDQ subscales. From pre intervention to follow-up, children's SDQ Total Difficulties scores significantly decreased (d = .71) and all SDQ subscales reflected significant, positive changes. We observed no significant differences in reported barriers to participation between parents who participated in the program and those who enrolled, but never participated. Intervention gains were moderated by several factors, including history of out-of-home care and family structure. Our results should be interpreted cautiously because not all analyses included a comparison group, and a randomized trial of CUIDAR effectiveness is still needed.",2011,"From pre intervention to follow-up, children's SDQ Total Difficulties scores significantly decreased (d = .71) and all SDQ subscales reflected significant, positive changes.","['Preschoolers', '154 predominantly low-income and Latino preschoolers and their parents to participate in this evaluation study', 'preschool children', '15 parents who had initially enrolled, but never participated in the program to serve as a comparison group for a limited set of analyses']",['Parenting Intervention'],"['SDQ Total Difficulties scores', 'history of out-of-home care and family structure', ""Children's SDQ Total Difficulties scores"", 'SDQ subscales']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0015196', 'cui_str': 'Evaluation Studies'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",154.0,0.0170449,"From pre intervention to follow-up, children's SDQ Total Difficulties scores significantly decreased (d = .71) and all SDQ subscales reflected significant, positive changes.","[{'ForeName': 'Kimberley D', 'Initials': 'KD', 'LastName': 'Lakes', 'Affiliation': ''}, {'ForeName': 'Danyel', 'Initials': 'D', 'LastName': 'Vargas', 'Affiliation': ''}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Riggs', 'Affiliation': ''}, {'ForeName': 'Janeth', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Baird', 'Affiliation': ''}]",Journal of child and family studies,[]
251,22072430,Ghrelin agonist TZP-101/ulimorelin accelerates gastrointestinal recovery independently of opioid use and surgery type: covariate analysis of phase 2 data.,"BACKGROUND


Delayed recovery of gastrointestinal (GI) motility is a common complication following surgery. TZP-101/ulimorelin is a macrocyclic peptidomimetic ghrelin receptor agonist with GI promotility effects that significantly accelerates time to recovery of GI motility compared to placebo following partial colectomy. It is also well tolerated. The objectives of this analysis were to identify predictors of GI motility recovery in patients undergoing partial colectomy and to evaluate whether these factors affect ulimorelin acceleration of GI recovery.
METHODS


Covariate analysis assessed the effect of eight variables-age, sex, body mass index, type of surgery (right colectomy, left colectomy, other), duration of surgery, blood loss, total opioid consumption, country-on recovery of GI motility in 236 patients randomized to ulimorelin (n = 168) or placebo (n = 68). The primary endpoint was the recovery of GI function (time from the end of surgery to first bowel movement). Stepwise regression identified a parsimonious model of the smallest subset of variables best predicting GI recovery.
RESULTS


Recovery was shorter for segmental/subtotal colectomies vs. right colectomies (P = 0.016) and longer with increased total opioid use (P = 0.037). The remaining variables had no statistically significant effect on GI recovery. Effects of ulimorelin 480 μg/kg (the most effective dose) on time to GI tract recovery remained statistically and clinically significant (hazard ratio = 1.81, P = 0.014) when adjusted for surgery type and/or total opioid use.
CONCLUSIONS


Two factors, type of surgery and total opioid use, independently modified times to recovery of GI motility following partial large bowel resection surgery. Acceleration of recovery of GI motility by ulimorelin was independent of these factors.",2012,"Two factors, type of surgery and total opioid use, independently modified times to recovery of GI motility following partial large bowel resection surgery.","['n = 168) or', 'patients undergoing partial colectomy', 'n = 68', '236 patients randomized to']","['Ghrelin agonist', 'placebo', 'partial large bowel resection surgery', 'TZP-101/ulimorelin', 'ulimorelin']","['GI recovery', 'Acceleration of recovery of GI motility', 'recovery of GI function (time from the end of surgery to first bowel movement', 'tolerated', 'total opioid use', 'time to GI tract recovery', 'segmental/subtotal colectomies vs. right colectomies', 'GI motility']","[{'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149750', 'cui_str': 'Partial resection of colon (procedure)'}]","[{'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0192834', 'cui_str': 'Large intestine excision'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2353772', 'cui_str': 'TZP-101'}, {'cui': 'C3489699', 'cui_str': 'ulimorelin'}]","[{'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0728939', 'cui_str': 'Subtotal (qualifier value)'}, {'cui': 'C0009274', 'cui_str': 'Large Bowel Resection'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]",236.0,0.204485,"Two factors, type of surgery and total opioid use, independently modified times to recovery of GI motility following partial large bowel resection surgery.","[{'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Bochicchio', 'Affiliation': 'University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Charlton', 'Affiliation': ''}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Pezzullo', 'Affiliation': ''}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Kosutic', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Senagore', 'Affiliation': ''}]",World journal of surgery,['10.1007/s00268-011-1335-9']
252,22006348,Sustained effects of incredible years as a preventive intervention in preschool children with conduct problems.,"The present study evaluated preventive effects of the Incredible Years program for parents of preschool children who were at risk for a chronic pattern of conduct problems, in the Netherlands. In a matched control design, 72 parents of children with conduct problems received the Incredible Years program. These families (intervention group) were compared with 72 families who received care as usual (control group). Two years after termination of the intervention, it appeared that observed and selfrated parenting skills were significantly improved in the intervention group. Likewise, in this group, observed child conduct problems showed sustained intervention effects. The decrease in observed critical parenting mediated the decrease in observed child conduct problems over time. In addition, it appeared that parental influence increased over time.",2012,"Two years after termination of the intervention, it appeared that observed and selfrated parenting skills were significantly improved in the intervention group.","['parents of preschool children who were at risk for a chronic pattern of conduct problems, in the Netherlands', 'preschool children with conduct problems', '72 parents of children with conduct problems received the Incredible Years program']",[],"['parental influence increased over time', 'selfrated parenting skills']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",72.0,0.027476,"Two years after termination of the intervention, it appeared that observed and selfrated parenting skills were significantly improved in the intervention group.","[{'ForeName': 'Jocelyne A', 'Initials': 'JA', 'LastName': 'Posthumus', 'Affiliation': 'Department of Child- and Adolescent Psychiatry, Rudolf Magnus Institute of Neuroscience, University Medical Centre Utrecht, Utrecht, The Netherlands. jocelyneposthumus@hotmail.com'}, {'ForeName': 'Maartje A J', 'Initials': 'MA', 'LastName': 'Raaijmakers', 'Affiliation': ''}, {'ForeName': 'Gerard H', 'Initials': 'GH', 'LastName': 'Maassen', 'Affiliation': ''}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'van Engeland', 'Affiliation': ''}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Matthys', 'Affiliation': ''}]",Journal of abnormal child psychology,['10.1007/s10802-011-9580-9']
253,21993710,"Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study.","AIMS/HYPOTHESIS


The renal and cardiovascular protective effects of angiotensin receptor blocker (ARB) remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor (ACEI).
METHODS


We examined the effects of olmesartan, an ARB, on primary composite outcome of doubling of serum creatinine, endstage renal disease and death in type 2 diabetic patients with overt nephropathy. Secondary outcome included composite cardiovascular outcomes, changes in renal function and proteinuria. Randomisation and allocation to trial group were carried out by a central computer system. Participants, caregivers, the people carrying out examinations and people assessing the outcomes were blinded to group assignment.
RESULTS


Five hundred and seventy-seven (377 Japanese, 200 Chinese) patients treated with antihypertensive therapy (73.5% [n = 424] received concomitant ACEI), were given either once-daily olmesartan (10-40 mg) (n = 288) or placebo (n = 289) over 3.2 ± 0.6 years (mean±SD). In the olmesartan group, 116 developed the primary outcome (41.1%) compared with 129 (45.4%) in the placebo group (HR 0.97, 95% CI 0.75, 1.24; p = 0.791). Olmesartan significantly decreased blood pressure, proteinuria and rate of change of reciprocal serum creatinine. Cardiovascular death was higher in the olmesartan group than the placebo group (ten vs three cases), whereas major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death were similar between the two groups (major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases). Hyperkalaemia was more frequent in the olmesartan group than the placebo group (9.2% vs 5.3%).
CONCLUSIONS/INTERPRETATION


Olmesartan was well tolerated but did not improve renal outcome on top of ACEI.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00141453.",2011,"Cardiovascular death was higher in the olmesartan group than the placebo group (ten vs three cases), whereas major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death were similar between the two groups (major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases).","['type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor (ACEI', 'type 2 diabetes with overt nephropathy', 'type 2 diabetic patients with overt nephropathy', 'Five hundred and seventy-seven (377 Japanese, 200 Chinese) patients treated with']","['olmesartan', 'placebo', 'Olmesartan', 'concomitant ACEI', 'angiotensin receptor blocker (ARB', 'antihypertensive therapy']","['Hyperkalaemia', 'blood pressure, proteinuria and rate of change of reciprocal serum creatinine', 'major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death', 'composite cardiovascular outcomes, changes in renal function and proteinuria', 'renal and cardiovascular outcomes', 'renal outcome', 'Cardiovascular death', 'serum creatinine, endstage renal disease and death']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1098320', 'cui_str': 'olmesartan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy (procedure)'}]","[{'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}]",,0.568066,"Cardiovascular death was higher in the olmesartan group than the placebo group (ten vs three cases), whereas major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death were similar between the two groups (major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Imai', 'Affiliation': 'Department of Nephrology, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550, Japan. ADS12069@nifty.com'}, {'ForeName': 'J C N', 'Initials': 'JC', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamasaki', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kobayashi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Haneda', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-011-2325-z']
254,21997675,"Pharmacokinetic analysis of absorption, distribution and disappearance of ingested water labeled with D₂O in humans.","The kinetic parameters of absorption and distribution of ingested water (300 ml labeled with D(2)O; osmolality <20 mOsm kg(-1)) in the body water pool (BWP) and of its disappearance from this pool were estimated in 36 subjects from changes in plasma or urine deuterium to protium ratio (D/H) over 10 days using one- and two-compartment and a non-compartmental pharmacokinetic models (1-CM, 2-CM and N-CM which applied well to 58, 42 and 100% of the subjects, respectively). Compared with the volume and turnover of the BWP computed with the slope-intercept method (60.7 ± 4.1% body mass or 72.7 ± 3.2% lean body mass; turnover 4.58 ± 0.80 l day(-1): i.e., complete renewal in ~50 days; n = 36), the values were accurately estimated with the N-CM and 1-CM and were slightly overestimated and underestimated, respectively, with the 2-CM (~7-8% difference, significant for water clearance only). Ingested water appeared in plasma and blood cells within 5 min and the half-life of absorption (~11-13 min) indicates a complete absorption within ~75-120 min. The 2-CM showed that in 42% of the subjects, ingested water quickly distributed within a central compartment before diffusing with a very short half-life (12.5 ± 4.3 min) to a peripheral compartment (18.5 ± 4.3 and 31.6 ± 6.4 L, respectively), which were in complete equilibrium within ~90 min. Pharmacokinetic analyses of water labeled with D(2)O can help describe water absorption and distribution, for which there is no well defined reference method and value; depending on the characteristics of the subjects and the drinks, and of environmental conditions.",2012,"Compared with the volume and turnover of the BWP computed with the slope-intercept method (60.7 ± 4.1% body mass or 72.7 ± 3.2% lean body mass; turnover 4.58 ± 0.80 l day(-1): i.e., complete renewal in ~50 days; n = 36), the values were accurately estimated with the N-CM and 1-CM and were slightly overestimated and underestimated, respectively, with the 2-CM (~7-8% difference, significant for water clearance only).",['humans'],[],"['body water pool (BWP', 'plasma and blood cells']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0005909', 'cui_str': 'Body Water'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005773', 'cui_str': 'Blood Corpuscles'}]",,0.0427178,"Compared with the volume and turnover of the BWP computed with the slope-intercept method (60.7 ± 4.1% body mass or 72.7 ± 3.2% lean body mass; turnover 4.58 ± 0.80 l day(-1): i.e., complete renewal in ~50 days; n = 36), the values were accurately estimated with the N-CM and 1-CM and were slightly overestimated and underestimated, respectively, with the 2-CM (~7-8% difference, significant for water clearance only).","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Péronnet', 'Affiliation': 'Department of Kinesiology, Université de Montréal, PO Box 6128, Centre-Ville, Montreal, QC, H3C 3J7, Canada. Francois.peronnet@umontreal.ca'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mignault', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'du Souich', 'Affiliation': ''}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Vergne', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Le Bellego', 'Affiliation': ''}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Jimenez', 'Affiliation': ''}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Rabasa-Lhoret', 'Affiliation': ''}]",European journal of applied physiology,['10.1007/s00421-011-2194-7']
255,22031847,"The selective androgen receptor modulator GTx-024 (enobosarm) improves lean body mass and physical function in healthy elderly men and postmenopausal women: results of a double-blind, placebo-controlled phase II trial.","BACKGROUND: Cachexia, also known as muscle wasting, is a complex metabolic condition characterized by loss of skeletal muscle and a decline in physical function. Muscle wasting is associated with cancer, sarcopenia, chronic obstructive pulmonary disease, end-stage renal disease, and other chronic conditions and results in significant morbidity and mortality. GTx-024 (enobosarm) is a nonsteroidal selective androgen receptor modulator (SARM) that has tissue-selective anabolic effects in muscle and bone, while sparing other androgenic tissue related to hair growth in women and prostate effects in men. GTx-024 has demonstrated promising pharmacologic effects in preclinical studies and favorable safety and pharmacokinetic profiles in phase I investigation.  METHODS: A 12-week double-blind, placebo-controlled phase II clinical trial was conducted to evaluate GTx-024 in 120 healthy elderly men (>60 years of age) and postmenopausal women. The primary endpoint was total lean body mass assessed by dual energy X-ray absorptiometry, and secondary endpoints included physical function, body weight, insulin resistance, and safety.  RESULTS: GTx-024 treatment resulted in dose-dependent increases in total lean body mass that were statistically significant (P < 0.001, 3 mg vs. placebo) and clinically meaningful. There were also significant improvements in physical function (P = 0.013, 3 mg vs. placebo) and insulin resistance (P = 0.013, 3 mg vs. placebo). The incidence of adverse events was similar between treatment groups.  CONCLUSION: GTx-024 showed a dose-dependent improvement in total lean body mass and physical function and was well tolerated. GTx-024 may be useful in the prevention and/or treatment of muscle wasting associated with cancer and other chronic diseases.",2011,"There were also significant improvements in physical function (P = 0.013, 3 mg vs. placebo) and insulin resistance (P = 0.013, 3 mg vs. placebo).","['120 healthy elderly men (>60\xa0years of age) and postmenopausal women', 'healthy elderly men and postmenopausal women']","['placebo', 'selective androgen receptor modulator GTx-024 (enobosarm']","['lean body mass and physical function', 'total lean body mass and physical function and was well tolerated', 'total lean body mass assessed by dual energy X-ray absorptiometry, and secondary endpoints included physical function, body weight, insulin resistance, and safety', 'total lean body mass', 'physical function', 'adverse events', 'insulin resistance']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}, {'cui': 'C2348173', 'cui_str': 'GTx 024'}, {'cui': 'C2742262', 'cui_str': 'ostarine'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.314147,"There were also significant improvements in physical function (P = 0.013, 3 mg vs. placebo) and insulin resistance (P = 0.013, 3 mg vs. placebo).","[{'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Dalton', 'Affiliation': 'GTx, Inc., 175 Toyota Plaza, Memphis, TN 38103 USA.'}, {'ForeName': 'Kester G', 'Initials': 'KG', 'LastName': 'Barnette', 'Affiliation': ''}, {'ForeName': 'Casey E', 'Initials': 'CE', 'LastName': 'Bohl', 'Affiliation': ''}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hancock', 'Affiliation': ''}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Shontelle T', 'Initials': 'ST', 'LastName': 'Dodson', 'Affiliation': ''}, {'ForeName': 'Ronald A', 'Initials': 'RA', 'LastName': 'Morton', 'Affiliation': ''}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Steiner', 'Affiliation': ''}]","Journal of cachexia, sarcopenia and muscle",[]
256,21949490,"A multi-site, randomized study of strengths-based case management with substance-abusing parolees.","OBJECTIVES: To test whether strengths-based case management provided during an inmate's transition from incarceration to the community increases participation in community substance abuse treatment, enhances access to needed social services, and improves drug use, crime, and HIV risk outcomes.  METHODS: In a multi-site trial, inmates (men and women) in four states (n = 812) were randomly assigned (within site) to receive either Transitional Case Management (TCM group), based on strengths-based principles, or standard parole services (SR group). Data were collected at baseline and at 3 and 9 months following release from prison. Analyses compared the two groups with respect to services received and to drug use, crime, and HIV risk behavior outcomes.  RESULTS: There were no significant differences between parolees in the TCM group and the SR group on outcomes related to participation in drug abuse treatment, receipt of social services, or drug use, crime, and HIV risk behaviors. For specific services (e.g., residential treatment, mental health), although significant differences were found for length of participation or for number of visits, the number of participants in these services was small and the direction of effect was not consistent.  CONCLUSION: In contrast to positive findings in earlier studies of strengths-based case management with mental-health and drug-abuse clients, this study found that case management did not improve treatment participation or behavioral outcomes for parolees with drug problems. The discussion includes possible reasons for the findings and suggestions for modifications to the intervention that could be addressed in future research.",2011,"There were no significant differences between parolees in the TCM group and the SR group on outcomes related to participation in drug abuse treatment, receipt of social services, or drug use, crime, and HIV risk behaviors.",['inmates (men and women) in four states (n = 812'],"['Transitional Case Management (TCM group), based on strengths-based principles, or standard parole services (SR group', 'strengths-based case management with substance-abusing parolees', 'TCM']","['participation in drug abuse treatment, receipt of social services, or drug use, crime, and HIV risk behaviors', 'length of participation or for number of visits']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}]","[{'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",812.0,0.0484592,"There were no significant differences between parolees in the TCM group and the SR group on outcomes related to participation in drug abuse treatment, receipt of social services, or drug use, crime, and HIV risk behaviors.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Prendergast', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Frisman', 'Affiliation': ''}, {'ForeName': 'Joann Y', 'Initials': 'JY', 'LastName': 'Sacks', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Staton-Tindall', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Greenwell', 'Affiliation': ''}, {'ForeName': 'Hsiu-Ju', 'Initials': 'HJ', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Cartier', 'Affiliation': ''}]",Journal of experimental criminology,[]
257,21946980,Functional performance of mobile versus fixed bearing total knee prostheses: a randomised controlled trial.,"PURPOSE


The primary goal of this study was to assess the difference in active flexion between patients with a mobile versus a fixed bearing, cruciate retaining, and total knee arthroplasty. The study was designed as a randomised controlled multi-centre trial.
METHODS


Participants were assigned to interventions by using block-stratified, random allocation. Outcome parameters were active flexion, passive flexion, and Knee Society Score (KSS). Outcome parameters were assessed preoperatively and at 3, 6, and 12 months postoperatively by an independent nurse.
RESULTS


Ninety-two patients from one centre were included, 46 in each group. Active flexion was comparable for the two groups, 99.9° for the mobile bearing group and 101° for the fixed bearing group with a baseline controlled difference of 1.0 (95% CI -3.9 to 5.8, n.s.). The Clinical KSS was comparable between the two bearing groups (Mobile 90.0 vs. fixed 92.4, n.s.). The functional KSS showed a difference that was attributable to the stair climbing subscore, which showed a difference in favour of the fixed bearing design between preoperative and 3 months (7.3 point difference; 95% CI 2.3-12.5; P = 0.005) as well as 12 months (4.8 point difference; 95% CI 0.1-9.6; P = 0.045).
CONCLUSIONS


There were no short-term differences in active flexion between fixed bearing and mobile bearing total knee arthroplasty.
LEVEL OF EVIDENCE


I.",2012,"Active flexion was comparable for the two groups, 99.9° for the mobile bearing group and 101° for the fixed bearing group with a baseline controlled difference of 1.0 (95% CI -3.9 to 5.8, n.s.).","['patients with a mobile versus a fixed bearing, cruciate retaining, and total knee arthroplasty', 'Ninety-two patients from one centre were included, 46 in each group', 'Participants']",['mobile versus fixed bearing total knee prostheses'],"['active flexion, passive flexion, and Knee Society Score (KSS', 'Clinical KSS', 'Active flexion', 'stair climbing subscore', 'active flexion', 'Functional performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022748', 'cui_str': 'Knee Prosthesis'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C3853978'}]",92.0,0.529557,"Active flexion was comparable for the two groups, 99.9° for the mobile bearing group and 101° for the fixed bearing group with a baseline controlled difference of 1.0 (95% CI -3.9 to 5.8, n.s.).","[{'ForeName': 'W C H', 'Initials': 'WC', 'LastName': 'Jacobs', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Center, Albinusdreef 2, PO Box 9600, 2300 RC, Leiden, The Netherlands. wch.jacobs@gmail.com'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Christen', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Wymenga', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schuster', 'Affiliation': ''}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'van der Schaaf', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'ten Ham', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Wehrli', 'Affiliation': ''}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-011-1684-9']
258,22071987,The Twister laser fiber degradation and tissue ablation capability during 980-nm high-power diode laser ablation of the prostate. A randomized study versus the standard side-firing fiber.,"The objective of this work is to test the ablation capability and fiber degradation of the novel Twister fibers (TW), in both the large (LTW) and the standard (STW) sizes, against the standard side-firing (SF) fiber in a clinical setting during the treatment of BPH patients using the 980-nm high-power diode laser (HPDL). One hundred and twenty BPH patients treated with HPDL (Ceralase300, Biolitec AG, Jena, Germany) were randomized to receive treatment by one of the three fibers. Operative time corrected to tissue volume, laser treatment time, and laser energy were measured. Ablation rate was calculated as follows: the decrease of the prostate volume after 6 months/laser time. The fibers' resistance to degradation was defined by the laser energy needed to degrade the fiber completely. Preoperative prostate volume of 76 ± 38, 70 ± 39, and 88 ± 49 cc decreased by 49 ± 16, 51 ± 20, and 63 ± 16% for the SF, STW, and LTW fibers, respectively. This difference was highly significant when the LTW was compared to the other two fibers (p < 0.001). Prostate volume reduction post-operatively within each group as compared to the pre-operative volume was highly significant (p < 0.001). The ablation rate was highest in LTW, being 1.31 ± 0.59, 1.09 ± 0.51, and 1.54 ± 0.44 cc/min for the SF, STW, and LTW fibers, respectively. The LTW fiber resisted degradation more than the other fibers and the STW more than the SF fiber (p < 0.001). This study demonstrates the higher ablation efficiency and resistance to degradation of the LTW fiber as compared to the STW and SF fibers. The STW fiber has a similar ablation rate of the SF fiber but resists degradation better.",2012,The LTW fiber resisted degradation more than the other fibers and the STW more than the SF fiber (p < 0.001).,"['One hundred and twenty BPH patients treated with HPDL (Ceralase300, Biolitec AG, Jena, Germany', 'Preoperative prostate volume of 76\u2009±\u200938, 70\u2009±\u200939, and 88\u2009±\u200949\xa0cc decreased by 49\u2009±\u200916, 51\u2009±\u200920, and 63\u2009±\u200916% for the SF, STW, and LTW fibers, respectively', 'BPH patients using the 980-nm high-power diode laser (HPDL']",['standard side-firing fiber'],"['ablation rate', 'Twister laser fiber degradation and tissue ablation capability', 'prostate volume', 'Ablation rate', 'Operative time corrected to tissue volume, laser treatment time, and laser energy']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205216', 'cui_str': 'Decreased (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0335670', 'cui_str': 'Twister (occupation)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",120.0,0.01773,The LTW fiber resisted degradation more than the other fibers and the STW more than the SF fiber (p < 0.001).,"[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Shaker', 'Affiliation': 'Urology Department, Ain Shams University, Cairo, Egypt. hassanshaker@live.com'}, {'ForeName': 'Alsayed', 'Initials': 'A', 'LastName': 'Alokda', 'Affiliation': ''}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Mahmoud', 'Affiliation': ''}]",Lasers in medical science,['10.1007/s10103-011-1017-8']
259,21947244,Occurrence and impact of delayed cerebral ischemia after coiling and after clipping in the International Subarachnoid Aneurysm Trial (ISAT).,"Delayed cerebral ischemia (DCI) is an important cause of poor outcome after aneurysmal subarachnoid hemorrhage (SAH). We studied differences in incidence and impact of DCI as defined clinically after coiling and after clipping in the International Subarachnoid Aneurysm Trial. We calculated odds ratios (OR) for DCI for clipping versus coiling with logistic regression analysis. With coiled patients without DCI as the reference group, we calculated ORs for poor outcome at 2 months and 1 year for coiled patients with DCI and for clipped patients without, and with DCI. With these ORs, we calculated relative excess risk due to Interaction (RERI). Clipping increased the risk of DCI compared to coiling in the 2,143 patients OR 1.24, 95% confidence interval (95% CI 1.01-1.51). Coiled patients with DCI, clipped patients without DCI, and clipped patients with DCI all had higher risks of poor outcome than coiled patients without DCI. Clipping and DCI showed no interaction for poor outcome at 2 months: RERI 0.12 (95% CI -1.16 to 1.40) or 1 year: RERI -0.48 (95% CI -1.69 to 0.74). Only for patients treated within 4 days, coiling and DCI was associated with a poorer outcome at 1 year than clipping and DCI (RERI -2.02, 95% CI -3.97 to -0.08). DCI was more common after clipping than after coiling in SAH patients in ISAT. Impact of DCI on poor outcome did not differ between clipped and coiled patients, except for patients treated within 4 days, in whom DCI resulted more often in poor outcome after coiling than after clipping.",2012,"Only for patients treated within 4 days, coiling and DCI was associated with a poorer outcome at 1 year than clipping and DCI (RERI -2.02, 95% CI -3.97 to -0.08).",['aneurysmal subarachnoid hemorrhage (SAH'],[],"['risk of DCI', 'DCI', 'Delayed cerebral ischemia (DCI']","[{'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0917798', 'cui_str': 'Cerebral Ischemia'}]",,0.111839,"Only for patients treated within 4 days, coiling and DCI was associated with a poorer outcome at 1 year than clipping and DCI (RERI -2.02, 95% CI -3.97 to -0.08).","[{'ForeName': 'Sanne M', 'Initials': 'SM', 'LastName': 'Dorhout Mees', 'Affiliation': 'Department of Neurology and Neurosurgery, Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht, Room G03.228, PO Box 85500, 3508 GA Utrecht, The Netherlands. s.m.dorhoutmees@umcutrecht.nl'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Kerr', 'Affiliation': ''}, {'ForeName': 'Gabriel J E', 'Initials': 'GJ', 'LastName': 'Rinkel', 'Affiliation': ''}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Algra', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Molyneux', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-011-6243-2']
260,21959687,Evaluation of magnetic scope navigation in screening endoscopic examination of colorectal cancer.,"BACKGROUND


Colorectal cancer is the most common cancer in Europe. Early diagnosis and treatment gives the patient a chance for complete recovery. Screening colonoscopies in the symptom-free patients are currently performed on a wide scale. The examinations are performed under local anesthesia which does not eliminate all discomfort and pain related to the examination. The aim of this study was to evaluate magnetic scope navigation in screening endoscopic examinations performed to detect early-stage colorectal cancer.
METHODS


The study group consisted of 200 patients, aged 40-65 years, who were free from colon cancer symptoms. All patients underwent complete colonoscopy under local anesthesia. The equipment could be fitted with the scope that allows three-dimensional observation of instrument localization in the bowel. The examination was performed by three experienced endoscopists, each of whom performed over 5,000 colonoscopies. The patients were randomized to two groups: those whose equipment did not have 3D navigation (group I) and those whose equipment did have 3D navigation (group II). Each group consisted of 100 cases matched by gender, age, and BMI. The authors compared the duration of introducing instrument to cecum, the pulse rate before the examination and at the time the instrument reached the cecum, and subjective pain evaluation by the patient on the visual analog scale.
RESULTS


Group I consisted of 54 women and 46 men with a mean age of 54.6 years and mean BMI of 27.8 kg/m(2), and group II had 58 women and 42 men, mean age of 55.1 years and mean BMI of 26.4 kg/m(2). The average time it took for the instrument to reach the cecum was 216s in group I and 181s in group II (P < 0.05). Pain measured on the 10-point VAS scale was 2.44 in group I and 1.85 in group II (P < 0.05). The results showed a significantly shorter time for the instrument to reach the cecum in group II and significantly lower pain intensity during the examination was reported by the group II patients. No significant differences were found in the pulse measurements between the groups (P = 0.5).
CONCLUSIONS


3D navigation during colonoscopy decreases the time for the instrument to reach the cecum and lowers pain intensity subjectively reported by the patients. The use of 3D and the possibility to observe instrument localization and maneuvers brings more comfort to the patients.",2012,The results showed a significantly shorter time for the instrument to reach the cecum in group II and significantly lower pain intensity during the examination was reported by the group II patients.,"['screening endoscopic examination of colorectal cancer', '200 patients, aged 40-65 years, who were free from colon cancer symptoms', '54 women and 46 men with a mean age of 54.6 years and mean BMI of 27.8 kg/m(2), and group II had 58 women and 42 men, mean age of 55.1 years and mean BMI of 26.4 kg/m(2']","['complete colonoscopy under local anesthesia', 'equipment did not have 3D navigation (group I) and those whose equipment did have 3D navigation', 'magnetic scope navigation']","['Pain', 'pain intensity subjectively', '10-point VAS scale', 'pulse measurements', 'average time it took for the instrument to reach the cecum', 'pain intensity']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}]",54.0,0.0208588,The results showed a significantly shorter time for the instrument to reach the cecum in group II and significantly lower pain intensity during the examination was reported by the group II patients.,"[{'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Szura', 'Affiliation': '1st Department of General and GI Surgery, Medical College Jagiellonian University, Kopernika 40, 31-501, Krakow, Poland. msszura@gmail.com'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Bucki', 'Affiliation': ''}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Matyja', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kulig', 'Affiliation': ''}]",Surgical endoscopy,['10.1007/s00464-011-1930-8']
261,21953275,"A phase I, open-label, randomized crossover study to assess the effect of dosing of the MEK 1/2 inhibitor Selumetinib (AZD6244; ARRY-142866) in the presence and absence of food in patients with advanced solid tumors.","PURPOSE


This Phase I study assessed whether food influences the rate and extent of selumetinib absorption in patients with advanced solid malignancies and determined the safety, tolerability, and pharmacokinetic (PK) profile of selumetinib and its active metabolite N-desmethyl-selumetinib in fed and fasted states.
METHODS


A single dose of 75 mg selumetinib was to be taken with food on Day 1 followed by a single dose of 75 mg after fasting for at least 10 h on Day 8, or vice versa, followed by twice daily dosing of 75 mg selumetinib from Day 10. Plasma concentrations and PK parameters were determined on Days 1 and 8. Patients could continue to receive selumetinib for as long as they benefitted from treatment.
RESULTS


In total, 31 patients were randomized to receive selumetinib; 15 to fed/fasted sequence and 16 to fasted/fed sequence. Comprehensive PK sampling was performed on 11 and 10 patients, respectively. The geometric least-squares means of C(max) and AUC for selumetinib were reduced by 62% (ratio 0.38 90% CI 0.29, 0.50) and 19% (ratio 0.81 90% CI 0.74, 0.88), respectively, under fed compared with fasting conditions. The rate of absorption (t(max)) of selumetinib (fed) was delayed by approximately 2.5 h (median). The food effect was also observed for the active metabolite N-desmethyl-selumetinib. Selumetinib was well tolerated.
CONCLUSIONS


The presence of food decreased the extent of absorption of selumetinib. It is recommended that for further clinical studies, selumetinib be taken on an empty stomach. Selumetinib demonstrated an acceptable safety profile in the advanced cancer population.",2011,"The geometric least-squares means of C(max) and AUC for selumetinib were reduced by 62% (ratio 0.38 90% CI 0.29, 0.50) and 19% (ratio 0.81 90% CI 0.74, 0.88), respectively, under fed compared with fasting conditions.","['advanced cancer population', '31 patients', 'patients with advanced solid tumors', 'patients with advanced solid malignancies']","['selumetinib', 'MEK 1/2 inhibitor Selumetinib', 'Selumetinib']","['tolerated', 'rate of absorption (t(max)) of selumetinib (fed', 'geometric least-squares means of C(max) and AUC for selumetinib', 'safety, tolerability, and pharmacokinetic (PK) profile of selumetinib', 'Plasma concentrations and PK parameters']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C2980074'}, {'cui': 'C0752313', 'cui_str': 'MAPK-ERK Kinases'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C2980074'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",31.0,0.0952275,"The geometric least-squares means of C(max) and AUC for selumetinib were reduced by 62% (ratio 0.38 90% CI 0.29, 0.50) and 19% (ratio 0.81 90% CI 0.74, 0.88), respectively, under fed compared with fasting conditions.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Leijen', 'Affiliation': 'Division of Experimental Therapy, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands.'}, {'ForeName': 'Patricia M M B', 'Initials': 'PM', 'LastName': 'Soetekouw', 'Affiliation': ''}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Jeffry Evans', 'Affiliation': ''}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Nicolson', 'Affiliation': ''}, {'ForeName': 'Jan H M', 'Initials': 'JH', 'LastName': 'Schellens', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Learoyd', 'Affiliation': ''}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Grinsted', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Zazulina', 'Affiliation': ''}, {'ForeName': 'Thinn', 'Initials': 'T', 'LastName': 'Pwint', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Middleton', 'Affiliation': ''}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-011-1732-7']
262,21953301,Reliability and efficacy of the new massage technique on the treatment in the patients with carpal tunnel syndrome.,"We aimed to bring a more understandable and applicable technique to the literature instead of ""massage therapy"" in CTS. We compared our new technique with the splint wear, of which the efficacy in CTS has been proven with many studies. Eighty-four patients between 31 and 65 years of age were included in the study. The patients were divided into two equal groups. In the first group, splint and ""Madenci"" hand massage technique were applied, and in the second group only splint was applied. A splint was provided for all patients with tendon and nerve gliding exercises, and also when needed analgesic drugs were given. When the pretreatment and posttreatment parameters were compared via repetitive measurement analysis, it was found that PGA and MDPGA were significantly decreased in both groups (P = 0.001), whereas grip strength was significantly increased (P = 0.001). While no statistically significant difference was found between the groups regarding pretreatment values (P > 0.05), the posttreatment PGA, MDPGA, and grip strength scores were significantly improved in Group I compared to Group II (P < 0.05). To the best our knowledge, the present study is the first and largest study in the literature conducted on the massage technique that will contribute to the treatment of CTS. As this new massage technique is easy for self-application, cheap, and practical, every patient with CTS can apply the massage to him/herself easily.",2012,"While no statistically significant difference was found between the groups regarding pretreatment values (P > 0.05), the posttreatment PGA, MDPGA, and grip strength scores were significantly improved in Group I compared to Group II (P < 0.05).","['patients with carpal tunnel syndrome', 'Eighty-four patients between 31 and 65 years of age were included in the study']","['new massage technique', 'CTS']","['Reliability and efficacy', 'PGA and MDPGA', 'posttreatment PGA, MDPGA, and grip strength scores', 'grip strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",84.0,0.00993542,"While no statistically significant difference was found between the groups regarding pretreatment values (P > 0.05), the posttreatment PGA, MDPGA, and grip strength scores were significantly improved in Group I compared to Group II (P < 0.05).","[{'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Madenci', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Altindag', 'Affiliation': ''}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Koca', 'Affiliation': ''}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gur', 'Affiliation': ''}]",Rheumatology international,[]
263,21927922,"Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women.","UNLABELLED


The final analysis of this 2-year, randomized, crossover study showed that postmenopausal women with osteoporosis were more adherent, compliant, and persistent with subcutaneous denosumab injections every 6 months than with once-weekly alendronate tablets. After receiving both treatments, women reported greater satisfaction with injectable denosumab and preferred it over oral alendronate.
INTRODUCTION


Osteoporosis patients who are non-compliant or non-persistent with therapy may have suboptimal clinical outcomes. This 2-year, randomized, open-label, crossover study compared treatment adherence between subcutaneous denosumab, 60 mg every 6 months, and oral alendronate, 70 mg once weekly.
METHODS


Postmenopausal women at 25 centers in the USA and Canada with bone mineral density T-scores -4.0 to -2.0 and no prior bisphosphonate use received alendronate then denosumab, or denosumab then alendronate, over successive 12-month periods. Adherence required both compliance (denosumab injections 6 months apart or ≥ 80% of alendronate tablets) and persistence (both denosumab injections or ≥ 2 alendronate doses in the last month and completion of the treatment period).
RESULTS


Of the 250 women enrolled (124 alendronate, 126 denosumab), 221 entered the second year (106 denosumab, 115 alendronate). Denosumab was associated with less non-adherence than alendronate (first year, 11.9% vs 23.4%; second year, 7.5% vs 36.5%). Risk ratios for non-adherence, non-compliance, and non-persistence favored denosumab in both years (p < 0.05). Of 198 subjects expressing treatment preference, 183 (92.4%) preferred the injections over the oral therapy. BMD improved further when subjects received denosumab after alendronate and remained stable when they received alendronate after denosumab.
CONCLUSION


Based on the final results of this crossover study after women had received each treatment for up to 1 year, postmenopausal women with osteoporosis were more adherent, compliant, and persistent with subcutaneous denosumab injections every 6 months than with once-weekly alendronate tablets and reported increased treatment preference and satisfaction with injectable denosumab over oral alendronate.",2012,"Denosumab was associated with less non-adherence than alendronate (first year, 11.9% vs 23.4%; second year, 7.5% vs 36.5%).","['Postmenopausal women at 25 centers in the USA and Canada with bone mineral density T-scores -4.0 to -2.0 and no prior bisphosphonate use received', 'postmenopausal women with osteoporosis', 'Osteoporosis patients who are non-compliant or non-persistent with therapy may have suboptimal clinical outcomes', '198 subjects expressing treatment preference, 183 (92.4%) preferred the injections over the oral therapy', '250 women enrolled (124 alendronate, 126 denosumab', 'postmenopausal women']","['subcutaneous denosumab', 'alendronate', 'denosumab after alendronate', 'oral alendronate', 'Denosumab', 'injectable denosumab over oral alendronate', 'alendronate tablets', 'alendronate then denosumab, or denosumab then alendronate']","['BMD', 'Risk ratios']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",250.0,0.0457791,"Denosumab was associated with less non-adherence than alendronate (first year, 11.9% vs 23.4%; second year, 7.5% vs 36.5%).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'University of Birmingham, Birmingham, UK. nicholas.freemantle@ucl.ac.uk'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Satram-Hoang', 'Affiliation': ''}, {'ForeName': 'E-T', 'Initials': 'ET', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Macarios', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Siddhanti', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Borenstein', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-011-1780-1']
264,21964953,Service learning in medical and nursing training: a randomized controlled trial.,"The purpose of this study was to explore the long term effect of a service learning project on medical and nursing students' knowledge in aging and their attitudes toward older adults. A total of 124 students were recruited and then randomized to intervention group (IG) and control group (CG). A pre-and-post-intervention design measured students' knowledge in aging (using modified Palmore's Fact on Aging Quiz) and attitudes toward older adults (using Kogan's Old People Scale). A total of 103 students completed all the activities and questionnaires. After the intervention, there were significant differences between the IG and CG on Palmore's mental health (MH) (P = .04), Palmore's total score (P = .02) and Kogan's negative attitudes toward older adults (P = .001). All students increased their positive attitude toward older adults after the intervention. However, both the IG and CG showed a decrease in positive attitudes 1 month after the interventon, and such decrease varied, depending on the programme which students attended. The current study showed that the 10-week service learning activities significantly increased medical and nursing students' overall knowledge of aging and their understanding of mental health needs in old age, and reduced their negative attitudes toward older adults. However, the effect is not long-lasting. On the other hand, its effect on positive attitudes toward older adults cannot be concluded. Periodic contacts with older adults via service learning activities may be needed to sustain attitude change toward older adults.",2012,"After the intervention, there were significant differences between the IG and CG on Palmore's mental health (MH) (P = .04), Palmore's total score (P = .02) and Kogan's negative attitudes toward older adults (P = .001).","[""students' knowledge in aging (using modified Palmore's Fact on Aging Quiz) and attitudes toward older adults (using Kogan's Old People Scale"", 'older adults', 'A total of 124 students', ""medical and nursing students' knowledge in aging and their attitudes toward older adults"", '103 students completed all the activities and questionnaires']","['Service learning in medical and nursing training', 'service learning project', 'intervention group (IG) and control group (CG']","[""Palmore's total score"", 'positive attitude', ""Palmore's mental health (MH"", 'positive attitudes']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",124.0,0.0246339,"After the intervention, there were significant differences between the IG and CG on Palmore's mental health (MH) (P = .04), Palmore's total score (P = .02) and Kogan's negative attitudes toward older adults (P = .001).","[{'ForeName': 'A Y M', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 4th Floor, William Mong Block, Faculty of Medicine Building, 21 Sassoon Road, Pokfulam, Hong Kong, SAR, China. angleung@hku.hk'}, {'ForeName': 'S S C', 'Initials': 'SS', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Kwan', 'Affiliation': ''}, {'ForeName': 'M K T', 'Initials': 'MK', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'S S K', 'Initials': 'SS', 'LastName': 'Leung', 'Affiliation': ''}, {'ForeName': 'D Y T', 'Initials': 'DY', 'LastName': 'Fong', 'Affiliation': ''}]",Advances in health sciences education : theory and practice,['10.1007/s10459-011-9329-9']
265,21952668,"MDMA (ecstasy) effects on actual driving performance before and after sleep deprivation, as function of dose and concentration in blood and oral fluid.","RATIONALE


Experimental research has shown that 3,4-methylenedioxymethamphetamine (MDMA) can improve some psychomotor driving skills when administered during the day. In real life, however, MDMA is taken during the night, and driving may likely occur early in the morning after a night of ""raving"" and sleep loss.
OBJECTIVES


The present study assessed the effects of MDMA on road-tracking and car-following performance in on-the-road driving tests in normal traffic.
METHODS


Sixteen recreational MDMA users participated in a randomized double-blind placebo-controlled four-way cross-over design. They received single, evening doses of 0, 25, 50, and 100 mg MDMA on separate occasions. Actual driving tests were conducted in the evening when MDMA serum concentrations were maximal and in the morning after a night of sleep loss.
RESULTS


The primary measure of driving, i.e., standard deviation of lateral position (SDLP, a measure of weaving) was significantly increased during driving tests in the morning in all treatment conditions, irrespective of MDMA dose and concentration. The increments in SDLP were of high clinical relevance and comparable to those observed for alcohol at blood alcohol concentrations >0.8 mg/mL. These impairments were primarily caused by sleep loss.
CONCLUSIONS


In general, MDMA did not affect driving performance nor did it change the impairing effects of sleep loss. It is concluded that MDMA cannot compensate for the impairing effects of sleep loss and that drivers who are under the influence of MDMA and sleep deprived are unfit to drive.",2012,"In general, MDMA did not affect driving performance nor did it change the impairing effects of sleep loss.",['Sixteen recreational MDMA users participated'],"['MDMA (ecstasy', 'MDMA', 'placebo', '3,4-methylenedioxymethamphetamine (MDMA']","['function of dose and concentration in blood and oral fluid', 'MDMA serum concentrations', 'actual driving performance', 'sleep loss', 'driving, i.e., standard deviation of lateral position (SDLP, a measure of weaving']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0678156', 'cui_str': 'Ecstasy (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005768'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",16.0,0.0522197,"In general, MDMA did not affect driving performance nor did it change the impairing effects of sleep loss.","[{'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Bosker', 'Affiliation': 'Department Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands. Wendy.bosker@maastrichtuniversity.nl'}, {'ForeName': 'Kim P C', 'Initials': 'KP', 'LastName': 'Kuypers', 'Affiliation': ''}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Conen', 'Affiliation': ''}, {'ForeName': 'Gerold F', 'Initials': 'GF', 'LastName': 'Kauert', 'Affiliation': ''}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': ''}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Skopp', 'Affiliation': ''}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2497-8']
266,21874272,Fish oil supplementation during late pregnancy does not influence plasma lipids or lipoprotein levels in young adult offspring.,"Nutritional influences on cardiovascular disease operate throughout life. Studies in both experimental animals and humans have suggested that changes in the peri- and early post-natal nutrition can affect the development of the various components of the metabolic syndrome in adult life. This has lead to the hypothesis that n-3 fatty acid supplementation in pregnancy may have a beneficial effect on lipid profile in the offspring. The aim of the present study was to investigate the effect of supplementation with n-3 fatty acids during the third trimester of pregnancy on lipids and lipoproteins in the 19-year-old offspring. The study was based on the follow-up of a randomized controlled trial from 1990 where 533 pregnant women were randomized to fish oil (n = 266), olive oil (n = 136) or no oil (n = 131). In 2009, the offspring were invited to a physical examination including blood sampling. A total of 243 of the offspring participated. Lipid values did not differ between the fish oil and olive oil groups. The relative adjusted difference (95% confidence intervals) in lipid concentrations was -3% (-11; 7) for LDL cholesterol, 3% (-3; 10) for HDL cholesterol, -1% (-6; 5) for total cholesterol,-4% (-16; 10) for TAG concentrations, 2%(-2; 7) for apolipoprotein A1, -1% (-9; 7) for apolipoprotein B and 3% (-7; 15) in relative abundance of small dense LDL. In conclusion, there was no effect of fish oil supplementation during the third trimester of pregnancy on offspring plasma lipids and lipoproteins in adolescence.",2011,"The relative adjusted difference (95% confidence intervals) in lipid concentrations was -3% (-11; 7) for LDL cholesterol, 3% (-3; 10) for HDL cholesterol, -1% (-6; 5) for total cholesterol,-4% (-16; 10) for TAG concentrations, 2%(-2; 7) for apolipoprotein A1, -1% (-9","['young adult offspring', '1990 where 533 pregnant women', '19-year-old offspring', 'A total of 243 of the offspring participated']","['supplementation with n-3 fatty acids', 'olive oil (n\xa0=\xa0136) or no oil', 'fish oil', 'fish oil supplementation', 'n-3 fatty acid supplementation', 'Fish oil supplementation']","['Lipid values', 'lipid concentrations', 'plasma lipids or lipoprotein levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",533.0,0.113654,"The relative adjusted difference (95% confidence intervals) in lipid concentrations was -3% (-11; 7) for LDL cholesterol, 3% (-3; 10) for HDL cholesterol, -1% (-6; 5) for total cholesterol,-4% (-16; 10) for TAG concentrations, 2%(-2; 7) for apolipoprotein A1, -1% (-9","[{'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Rytter', 'Affiliation': 'Department of Epidemiology, School of Public Health, Aarhus University, Denmark. dr@soci.au.dk'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Bodil H', 'Initials': 'BH', 'LastName': 'Bech', 'Affiliation': ''}, {'ForeName': 'Jeppe H', 'Initials': 'JH', 'LastName': 'Christensen', 'Affiliation': ''}, {'ForeName': 'Tine B', 'Initials': 'TB', 'LastName': 'Henriksen', 'Affiliation': ''}, {'ForeName': 'Sjurdur F', 'Initials': 'SF', 'LastName': 'Olsen', 'Affiliation': ''}]",Lipids,['10.1007/s11745-011-3606-5']
267,21833823,Atypical social modulation of imitation in autism spectrum conditions.,"Appropriate modulation of imitation according to social context is important for successful social interaction. In the present study we subliminally primed high-functioning adults with ASC and age- and IQ-matched controls with either a pro- or non- social attitude. Following priming, an automatic imitation paradigm was used to acquire an index of imitation. Whereas imitation levels were higher for pro-socially primed relative to non-socially primed control participants, there was no difference between pro- and non- socially primed individuals with ASC. We conclude that high-functioning adults with ASC demonstrate atypical social modulation of imitation. Given the importance of imitation in social interaction we speculate that difficulties with the modulation of imitation may contribute to the social problems characteristic of ASC.",2012,"Whereas imitation levels were higher for pro-socially primed relative to non-socially primed control participants, there was no difference between pro- and non- socially primed individuals with ASC.","['subliminally primed high-functioning adults with ASC and age- and IQ-matched controls with either a pro- or non- social attitude', 'autism spectrum conditions']",[],['imitation levels'],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0156764,"Whereas imitation levels were higher for pro-socially primed relative to non-socially primed control participants, there was no difference between pro- and non- socially primed individuals with ASC.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Cook', 'Affiliation': 'Institute of Cognitive Neuroscience, UCL, 17 Queen Square, London WC1N 3AR, UK. jennifer.cook@ucl.ac.uk'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Bird', 'Affiliation': ''}]",Journal of autism and developmental disorders,['10.1007/s10803-011-1341-7']
268,21842174,Bemiparin versus low dose aspirin for management of recurrent early pregnancy losses due to antiphospholipd antibody syndrome.,"STUDY OBJECTIVE


To compare the live birth rate of women presented with recurrent miscarriages in the first trimester due to antiphospholipid antibody syndrome (APS), randomized to either low molecular weight heparin (Bemiparin) or low dose aspirin (LDA) and to determine the maternal and fetal adverse effects in both treatment groups.
PATIENTS AND METHODS


A clinical comparative study was conducted in Maternity teaching Hospital, Erbil city, north of Iraq, Kurdistan region from 15th of September 2007 to the 1st of August 2010 on 141 women presented with 2 or more consecutive miscarriages due to APS, the women randomized to receive either prophylactic dose of Bemiparin with the diagnosis of pregnancy or LDA started preconceptioally and until 36 weeks gestation. The primary outcome was live birth rate in both treatment groups, the secondary outcomes were maternal and fetal complications in both trial groups.
RESULT


There was no statistically significant difference between the two groups regarding demographic characters (age groups, parity, gestational age and history of previous abortion), and mode of delivery of the viable newborns. There was a statistically significant difference between the two treatment groups regarding live birth rate. The proportions of women who gave birth to a live infant were 72.13% in the LDA group and 86.25% in the Hibor group, the mean difference between the live birth rate in both group was 0.141 (95% Confidence interval of the difference, 0.08, 0.274). The average birth weight for women received LDA was significantly lower than women who received Bemiparin.
CONCLUSION


The use of the new second generation LMWH (Bemiparin) in comparison to LDA during pregnancy for prevention of recurrent miscarriage in women with APS is a safe, reliable method with a high live birth rate and no maternal and fetal complications.",2012,"There was no statistically significant difference between the two groups regarding demographic characters (age groups, parity, gestational age and history of previous abortion), and mode of delivery of the viable newborns.","['Maternity teaching Hospital, Erbil city, north of Iraq, Kurdistan region from 15th of September 2007 to the 1st of August 2010 on 141 women presented with 2 or more consecutive miscarriages due to APS, the women randomized to receive either', 'women presented with recurrent miscarriages in the first trimester due to antiphospholipid antibody syndrome (APS']","['new second generation LMWH (Bemiparin', 'prophylactic dose of Bemiparin with the diagnosis of pregnancy or LDA', 'Bemiparin versus low dose aspirin', 'low molecular weight heparin (Bemiparin) or low dose aspirin (LDA', 'LDA']","['maternal and fetal complications', 'proportions of women who gave birth to a live infant', 'average birth weight', 'live birth rate']","[{'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0000809', 'cui_str': 'Recurrent Early Pregnancy Loss'}, {'cui': 'C0032979', 'cui_str': 'Early Placental Phase'}, {'cui': 'C0085278', 'cui_str': 'Antiphospholipid Antibody Syndrome'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0916062', 'cui_str': 'bemiparin'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0851390', 'cui_str': 'Foetal complications'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",141.0,0.109613,"There was no statistically significant difference between the two groups regarding demographic characters (age groups, parity, gestational age and history of previous abortion), and mode of delivery of the viable newborns.","[{'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Alalaf', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Medicine, Hawler Medical University, Erbil, Kurdistan, Iraq. Shahla_alaf@yahoo.com'}]",Archives of gynecology and obstetrics,['10.1007/s00404-011-2055-y']
269,21842158,A diffusion model decomposition of the effects of alcohol on perceptual decision making.,"RATIONALE


Even in elementary cognitive tasks, alcohol consumption results in both cognitive and motor impairments (e.g., Schweizer and Vogel-Sprott, Exp Clin Psychopharmacol 16: 240-250, 2008).
OBJECTIVES


The purpose of this study is to quantify the latent psychological processes that underlie the alcohol-induced decrement in observed performance.
METHODS


In a double-blind experiment, we administered three different amounts of alcohol to participants on different days: a placebo dose (0 g/l), a moderate dose (0.5 g/l), and a high dose (1 g/l). Following this, participants performed a ""moving dots"" perceptual discrimination task. We analyzed the data using the drift diffusion model. Model parameters drift rate, boundary separation, and non-decision time allow a decomposition of the alcohol effect in terms of their respective cognitive components, that is, rate of information processing, response caution, and non-decision processes (e.g., stimulus encoding, motor processes).
RESULTS


We found that alcohol intoxication causes higher mean RTs and lower response accuracies. The diffusion model decomposition showed that alcohol intoxication caused a decrease in drift rate and an increase in non-decision time.
CONCLUSIONS


In a simple perceptual discrimination task, even a moderate dose of alcohol decreased the rate of information processing and negatively affected the non-decision component. However, alcohol consumption left response caution largely intact.",2012,"The diffusion model decomposition showed that alcohol intoxication caused a decrease in drift rate and an increase in non-decision time.
",[],"['placebo', 'moving dots"" perceptual discrimination task']","['non-decision time', 'drift rate', 'rate of information processing']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}]",,0.0340553,"The diffusion model decomposition showed that alcohol intoxication caused a decrease in drift rate and an increase in non-decision time.
","[{'ForeName': 'Don', 'Initials': 'D', 'LastName': 'van Ravenzwaaij', 'Affiliation': 'Department of Psychology, University of Amsterdam, Roetersstraat 15, 1018 WB, Amsterdam, The Netherlands. d.vanravenzwaaij@uva.nl'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dutilh', 'Affiliation': ''}, {'ForeName': 'Eric-Jan', 'Initials': 'EJ', 'LastName': 'Wagenmakers', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2435-9']
270,21909622,Preventing deep vein thrombosis after stroke: strategies and recommendations.,"OPINION STATEMENT


The risk of deep vein thrombosis (DVT) after stroke is increased in patients with restricted mobility, a previous history of DVT, dehydration, or comorbidities such as malignant diseases or clotting disorders. Patients with an increased risk of DVT should receive prophylactic treatment. To reduce the chance of DVT, patients should be mobilized as soon as possible and should be kept well hydrated. Anti-embolism stockings cannot be recommended, because they have been demonstrated not useful for preventing DVT or pulmonary embolism in patients with stroke, and they are associated with a significantly increased risk of skin breaks. The usefulness of intermittent pneumatic compression is currently under study in a randomized clinical trial. Treatment with subcutaneously administered low-dose unfractionated heparin is preferred to unfractionated heparin and may be considered in patients with ischemic stroke if the risk of DVT is estimated to be higher than the risk of hemorrhagic complications. Aspirin may also be effective for patients with ischemic stroke who have contraindications to anticoagulants, although direct comparisons with anticoagulants are not available. In patients with intracerebral hemorrhage, low-dose subcutaneous low-molecular-weight heparin is probably safe after documentation of cessation of active bleeding, and may be considered on an individual basis after 3 to 4 days from stroke onset.",2011,"Anti-embolism stockings cannot be recommended, because they have been demonstrated not useful for preventing DVT or pulmonary embolism in patients with stroke, and they are associated with a significantly increased risk of skin breaks.","['patients with ischemic stroke', 'patients with intracerebral hemorrhage', 'patients with ischemic stroke who have contraindications to anticoagulants']","['Aspirin', 'heparin', 'intermittent pneumatic compression']",['risk of deep vein thrombosis (DVT'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",,0.0424832,"Anti-embolism stockings cannot be recommended, because they have been demonstrated not useful for preventing DVT or pulmonary embolism in patients with stroke, and they are associated with a significantly increased risk of skin breaks.","[{'ForeName': 'L Jaap', 'Initials': 'LJ', 'LastName': 'Kappelle', 'Affiliation': 'University Hospital Utrecht, Heidelberglaan 100,  3584 CX, Utrecht, The Netherlands, l.kappelle@umcutrecht.nl.'}]",Current treatment options in neurology,['10.1007/s11940-011-0147-4']
271,21863263,Comparison of octreotide LAR and lanreotide autogel as post-operative medical treatment in acromegaly.,"Long-acting somatostatin analogs are frequently used as adjuvant treatment of acromegaly patients after noncurative surgery. This sudy aims to compare the efficacy of octreotide long-acting release (OCT) and lanreotide Autogel (LAN) in acromegaly patients. Sixty-eight patients not cured by transsphenoidal endoscopic or microscopic pituitary surgery between 2003 and 2009 were retrospectively analyzed (25 men; 43 women; mean age 41.1 ± 10.9 years [range 18-65 years]). The patients were assigned randomly to OCT (n = 36) and LAN (n = 32) groups. Evaluations included insulin-like growth factor I (IGF-I) and growth hormone (GH) after oral glucose tolerance test (OGTT) 3, 6, 12 and 18 months after starting medical treatment; pituitary magnetic resonance imaging was performed before treatment and after 3 and 12 months. Patients achieving IGF-I levels within the age and gender normal range and GH level <1 μg/l following OGTT were considered a 'biochemical cure'. Mean IGF-I and GH values and tumor volumes (cm(3)) in the LAN and OCT groups were similar in the post-operative period before initiation of medical treatment. A statistically significant decrease in GH and IGF-I levels was obtained for both treatment groups at each follow-up visit compared to the previous value. Tumor shrinkage after 12 months of treatment was statistically significant in both groups but the percentage tumor shrinkage (28.5% vs. 34.9%, P = 0.166) and rate of patients achieving biochemical cure (63.9 and 78.1%, P = 0.454) were similar between OCT and LAN groups, respectively. OCT and LAN treatment options have similar efficacy for ensuring biochemical cure and tumor shrinkage in acromegaly patients who had noncurative surgery.",2012,A statistically significant decrease in GH and IGF-I levels was obtained for both treatment groups at each follow-up visit compared to the previous value.,"['Sixty-eight patients not cured by transsphenoidal endoscopic or microscopic pituitary surgery between 2003 and 2009 were retrospectively analyzed (25 men; 43 women; mean age 41.1 ± 10.9 years [range 18-65 years', 'acromegaly patients', 'acromegaly patients after noncurative surgery', 'acromegaly patients who had noncurative surgery']","['OCT', 'OCT and LAN', 'octreotide LAR and lanreotide autogel', 'LAN', 'octreotide long-acting release (OCT) and lanreotide Autogel (LAN']","['rate of patients achieving biochemical cure', 'Tumor shrinkage', 'insulin-like growth factor I (IGF-I) and growth hormone (GH) after oral glucose tolerance test (OGTT', 'percentage tumor shrinkage', 'GH level', 'GH and IGF-I levels', 'Mean IGF-I and GH values and tumor volumes (cm(3']","[{'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205508', 'cui_str': 'Transsphenoidal approach (qualifier value)'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001206', 'cui_str': 'Somatotropin Hypersecretion Syndrome (Acromegaly)'}]","[{'cui': 'C0023933', 'cui_str': 'LAN'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage (finding)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}]",,0.0302982,A statistically significant decrease in GH and IGF-I levels was obtained for both treatment groups at each follow-up visit compared to the previous value.,"[{'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Tutuncu', 'Affiliation': 'Department of Endocrinology and Metabolism, Ministry of Health, Ankara Numune Research and Training Hospital, Ankara, Turkey. kardelendr@yahoo.com'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Berker', 'Affiliation': ''}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Isik', 'Affiliation': ''}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Ozuguz', 'Affiliation': ''}, {'ForeName': 'Gulhan', 'Initials': 'G', 'LastName': 'Akbaba', 'Affiliation': ''}, {'ForeName': 'Ferit Kerim', 'Initials': 'FK', 'LastName': 'Kucukler', 'Affiliation': ''}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Aydin', 'Affiliation': ''}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Guler', 'Affiliation': ''}]",Pituitary,['10.1007/s11102-011-0335-y']
272,21909461,Clinical evidence of efficacy of red yeast rice and berberine in a large controlled study versus diet.,"Efficacy of a new patented proprietary combination of natural nutraceuticals (PN) containing natural hypolipidemic as red yeast, policosanol and berberine was tested in a large study on dyslipidemic patients in clinical practice. A parallel, controlled, randomized, multicenter study was designed. After 2 weeks on a stable dietary regimen, the patients were randomized to PN 1 tablet/day associated with diet (PN + D) or diet alone (D) for 16 weeks. Entry criteria were: Tot-Chol >200 mg/dL or LDL-Chol >150 mg/dL without a clear indication for statins, or plasma triglycerides >150 mg/dL. Lipid pattern and CV parameters were evaluated at baseline and monthly. 1,751 patients were enrolled in 248 Italian units, 933 patients on PN + D and 818 on D. The baseline lipid values were: Tot-Chol 255.4 versus 243.1 mg/dL, LDL-Chol 170.1 versus 162.2 mg/dL, HDL-Chol 50.0 versus 48.8 mg/dL, and TG 190.5 versus 184.4 mg/dL. PN constantly and significantly improved lipid parameters versus D group: at 16 weeks -19.1 versus -9.4% for Tot-Chol (p < 0.001), -23.5 versus -10.8% for LDL-Chol (p < 0.001), +11.6 versus +4.0% for HDL-Chol (p < 0.001), -17.9 versus -11.3% for TG (p < 0.001). In conclusions, PN plus diet allows an effective improvement of blood lipids with a significant reduction of global CV risk, suggesting a role for PN in CHD prevention.",2011,"The baseline lipid values were: Tot-Chol 255.4 versus 243.1 mg/dL, LDL-Chol 170.1 versus 162.2 ","['dyslipidemic patients in clinical practice', '1,751 patients were enrolled in 248 Italian units, 933 patients on PN\xa0+\xa0D and 818 on D']","['PN 1 tablet/day associated with diet (PN\xa0+\xa0D) or diet alone', 'new patented proprietary combination of natural nutraceuticals (PN) containing natural hypolipidemic as red yeast, policosanol and berberine', 'red yeast rice and berberine', 'Tot-Chol']","['baseline lipid values', 'lipid parameters', 'global CV risk', 'plasma triglycerides']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0997449', 'cui_str': 'Monascus purpureus'}, {'cui': 'C0215278', 'cui_str': 'policosanol'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0763533', 'cui_str': 'red yeast rice'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}]",1751.0,0.0730598,"The baseline lipid values were: Tot-Chol 255.4 versus 243.1 mg/dL, LDL-Chol 170.1 versus 162.2 ","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Trimarco', 'Affiliation': ''}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Benvenuti', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Rozza', 'Affiliation': ''}, {'ForeName': 'Claudia Sara', 'Initials': 'CS', 'LastName': 'Cimmino', 'Affiliation': ''}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Giudice', 'Affiliation': ''}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Crispo', 'Affiliation': ''}]",Mediterranean journal of nutrition and metabolism,[]
273,21822934,Challenges of clinical trial design when there is lack of clinical equipoise: use of a response-conditional crossover design.,"Clinical equipoise is widely accepted as the basis of ethics in clinical research and requires investigators to be uncertain of the relative therapeutic merits of trial comparators. When clinical equipoise is in question, innovative trial designs are needed to reduce ethical tension while satisfying regulators' requirements. We report a novel response-conditional crossover study design used in a Phase 3, randomized, double-blind, placebo-controlled clinical trial of intravenous 10% caprylate-chromatography purified immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. During the initial 24-week period, patients crossed over to the alternative treatment at the first sign of deterioration or if they failed to improve or were unable to maintain improvement at any time after 6 weeks. This trial design addressed concerns about lack of equipoise raised by physicians interested in trial participation and proved acceptable to regulatory authorities. The trial design may be applicable to other studies where clinical equipoise is in question.",2012,This trial design addressed concerns about lack of equipoise raised by physicians interested in trial participation and proved acceptable to regulatory authorities.,['chronic inflammatory demyelinating polyradiculoneuropathy'],"['intravenous 10% caprylate-chromatography purified immunoglobulin', 'placebo']",[],"[{'cui': 'C0393819', 'cui_str': 'Inflammatory Polyradiculopathy, Chronic'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0006930', 'cui_str': 'Octanoates'}, {'cui': 'C0008550', 'cui_str': 'Chromatography'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.164013,This trial design addressed concerns about lack of equipoise raised by physicians interested in trial participation and proved acceptable to regulatory authorities.,"[{'ForeName': 'Chunqin', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Grifols Inc. (formerly Talecris Biotherapeutics), 79 TW Alexander Drive, Research Triangle Park, Durham, NC 27709, USA. CQ.Deng@Talecris.com'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hanna', 'Affiliation': ''}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': ''}, {'ForeName': 'Marinos C', 'Initials': 'MC', 'LastName': 'Dalakas', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Donofrio', 'Affiliation': ''}, {'ForeName': 'Pieter A', 'Initials': 'PA', 'LastName': 'van Doorn', 'Affiliation': ''}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': ''}, {'ForeName': 'Ingemar S J', 'Initials': 'IS', 'LastName': 'Merkies', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-011-6200-0']
274,21822593,Involvement of the endocannabinoid system in reward processing in the human brain.,"RATIONALE


Disturbed reward processing in humans has been associated with a number of disorders, such as depression, addiction, and attention-deficit hyperactivity disorder. The endocannabinoid (eCB) system has been implicated in reward processing in animals, but in humans, the relation between eCB functioning and reward is less clear.
OBJECTIVES


The current study uses functional magnetic resonance imaging (fMRI) to investigate the role of the eCB system in reward processing in humans by examining the effect of the eCB agonist Δ(9)-tetrahydrocannabinol (THC) on reward-related brain activity.
METHODS


Eleven healthy males participated in a randomized placebo-controlled pharmacological fMRI study with administration of THC to challenge the eCB system. We compared anticipatory and feedback-related brain activity after placebo and THC, using a monetary incentive delay task. In this task, subjects are notified before each trial whether a correct response is rewarded (""reward trial"") or not (""neutral trial"").
RESULTS


Subjects showed faster reaction times during reward trials compared to neutral trials, and this effect was not altered by THC. THC induced a widespread attenuation of the brain response to feedback in reward trials but not in neutral trials. Anticipatory brain activity was not affected.
CONCLUSIONS


These results suggest a role for the eCB system in the appreciation of rewards. The involvement of the eCB system in feedback processing may be relevant for disorders in which appreciation of natural rewards may be affected such as addiction.",2012,"Anticipatory brain activity was not affected.
",['Eleven healthy males participated in a randomized'],"['eCB agonist Δ(9)-tetrahydrocannabinol (THC', 'placebo', 'functional magnetic resonance imaging (fMRI', 'THC', 'placebo and THC']","['Anticipatory brain activity', 'anticipatory and feedback-related brain activity', 'faster reaction times']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",11.0,0.226311,"Anticipatory brain activity was not affected.
","[{'ForeName': 'Hendrika H', 'Initials': 'HH', 'LastName': 'van Hell', 'Affiliation': 'Department of Neurology and Neurosurgery, G.03.124, Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Jager', 'Affiliation': ''}, {'ForeName': 'Matthijs G', 'Initials': 'MG', 'LastName': 'Bossong', 'Affiliation': ''}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Brouwer', 'Affiliation': ''}, {'ForeName': 'J Martijn', 'Initials': 'JM', 'LastName': 'Jansma', 'Affiliation': ''}, {'ForeName': 'Lineke', 'Initials': 'L', 'LastName': 'Zuurman', 'Affiliation': ''}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'van Gerven', 'Affiliation': ''}, {'ForeName': 'René S', 'Initials': 'RS', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': 'Nick F', 'Initials': 'NF', 'LastName': 'Ramsey', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2428-8']
275,21847570,Beta receptor-mediated modulation of the late positive potential in humans.,"RATIONALE


Electrophysiological studies have identified a scalp potential, the late positive potential (LPP), which is modulated by the emotional intensity of observed stimuli. Previous work has shown that the LPP reflects the modulation of activity in extrastriate visual cortical structures, but little is known about the source of that modulation.
OBJECTIVES


The present study investigated whether beta-adrenergic receptors are involved in the generation of the LPP.
METHODS


We used a genetic individual differences approach (experiment 1) and a pharmacological manipulation (experiment 2) to test the hypothesis that the LPP is modulated by the activation of β-adrenergic receptors.
RESULTS


In experiment 1, we found that LPP amplitude depends on allelic variation in the β1-receptor gene polymorphism. In experiment 2, we found that LPP amplitude was modulated by the β-blocker propranolol in a direction dependent on subjects' level of trait anxiety: In participants with lower trait anxiety, propranolol led to a (nonsignificant) decrease in the LPP modulation; in participants with higher trait anxiety, propranolol increased the emotion-related LPP modulation.
CONCLUSIONS


These results provide initial support for the hypothesis that the LPP reflects the downstream effects, in visual cortical areas, of β-receptor-mediated activation of the amygdala.",2012,"In experiment 2, we found that LPP amplitude was modulated by the β-blocker propranolol in a direction dependent on subjects' level of trait anxiety: In participants with lower trait anxiety, propranolol led to a (nonsignificant) decrease in the LPP modulation; in participants with higher trait anxiety, propranolol increased the emotion-related LPP modulation.
",['humans'],[],"['LPP amplitude', ""subjects' level of trait anxiety"", 'LPP modulation']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0229992,"In experiment 2, we found that LPP amplitude was modulated by the β-blocker propranolol in a direction dependent on subjects' level of trait anxiety: In participants with lower trait anxiety, propranolol led to a (nonsignificant) decrease in the LPP modulation; in participants with higher trait anxiety, propranolol increased the emotion-related LPP modulation.
","[{'ForeName': 'Mischa', 'Initials': 'M', 'LastName': 'de Rover', 'Affiliation': 'Cognitive Psychology Unit, Institute of Psychology, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, The Netherlands. rovermde@fsw.leidenuniv.nl'}, {'ForeName': 'Stephen B R E', 'Initials': 'SB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Boot', 'Affiliation': ''}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hajcak', 'Affiliation': ''}, {'ForeName': 'Martijn S', 'Initials': 'MS', 'LastName': 'van Noorden', 'Affiliation': ''}, {'ForeName': 'Nic J A', 'Initials': 'NJ', 'LastName': 'van der Wee', 'Affiliation': ''}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Nieuwenhuis', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2426-x']
276,21779817,Impact of a centralized osteoporosis coordinator on post-fracture osteoporosis management: a cluster randomized trial.,"UNLABELLED


We conducted a cluster randomized trial evaluating the effect of a centralized coordinator who identifies and follows up with fracture patients and their primary care physicians about osteoporosis. Compared with controls, intervention patients were five times more likely to receive BMD testing and two times more likely to receive appropriate management.
INTRODUCTION


To determine if a centralized coordinator who follows up with fracture patients and their primary care physicians by telephone and mail (intervention) will increase the proportion of patients who receive appropriate post-fracture osteoporosis management, compared to simple fall prevention advice (attention control).
METHODS


A cluster randomized controlled trial was conducted in small community hospitals in the province of Ontario, Canada. Hospitals that treated between 60 and 340 fracture patients per year were eligible. Patients 40 years and older presenting with a low trauma fracture were identified from Emergency Department records and enrolled in the trial. The primary outcome was 'appropriate' management, defined as a normal bone mineral density (BMD) test or taking osteoporosis medications.
RESULTS


Thirty-six hospitals were randomized to either intervention or control and 130 intervention and 137 control subjects completed the study. The mean age of participants was 65 ± 12 years and 69% were female. The intervention increased the proportion of patients who received appropriate management within 6 months of fracture; 45% in the intervention group compared with 26% in the control group (absolute difference of 19%; adjusted OR, 2.3; 95% CI, 1.3-4.1). The proportion who had a BMD test scheduled or performed was much higher with 57% of intervention patients compared with 21% of controls (absolute difference of 36%; adjusted OR, 4.8; 95% CI, 3.0-7.0).
CONCLUSIONS


A centralized osteoporosis coordinator is effective in improving the quality of osteoporosis care in smaller communities that do not have on-site coordinators or direct access to osteoporosis specialists.",2012,"The intervention increased the proportion of patients who received appropriate management within 6 months of fracture; 45% in the intervention group compared with 26% in the control group (absolute difference of 19%; adjusted OR, 2.3; 95% CI, 1.3-4.1).","['Patients 40 years and older presenting with a low trauma fracture were identified from Emergency Department records and enrolled in the trial', 'small community hospitals in the province of Ontario, Canada', 'and 130 intervention and 137 control subjects completed the study', 'centralized coordinator who follows up with fracture patients and their primary care physicians by', 'The mean age of participants was 65 ± 12 years and 69% were female', 'with fracture patients and their primary care physicians about osteoporosis', 'Thirty-six hospitals', 'Hospitals that treated between 60 and 340 fracture patients per year were eligible']","['centralized coordinator who identifies and follows up', 'telephone and mail (intervention', 'centralized osteoporosis coordinator', 'intervention or control', 'appropriate post-fracture osteoporosis management, compared to simple fall prevention advice (attention control']","[""appropriate' management, defined as a normal bone mineral density (BMD) test or taking osteoporosis medications""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2919891', 'cui_str': 'Emergency department record'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0439508', 'cui_str': 'per year'}]","[{'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]",36.0,0.116433,"The intervention increased the proportion of patients who received appropriate management within 6 months of fracture; 45% in the intervention group compared with 26% in the control group (absolute difference of 19%; adjusted OR, 2.3; 95% CI, 1.3-4.1).","[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Jaglal', 'Affiliation': 'Toronto Rehabilitation Institute, Toronto, ON, Canada. susan.jaglal@utoronto.ca'}, {'ForeName': 'O S', 'Initials': 'OS', 'LastName': 'Donescu', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bansod', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Laprade', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Thorpe', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hawker', 'Affiliation': ''}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Meadows', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Cadarette', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Papaioannou', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kloseck', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Beaton', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bogoch', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zwarenstein', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-011-1726-7']
277,21773778,"A randomized, multi-central, controlled study of patients with hepatitis B e antigen-positive chronic hepatitis B treated by adefovir dipivoxil or adefovir dipivoxil plus bicyclol.","OBJECTIVE


To evaluate the efficacy and safety profiles of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) treated with adefovir dipivoxil (ADV) or ADV plus bicyclol, and to optimize the treatment strategy for CHB patients.
PATIENTS AND METHODS


A total of 250 patients with HBeAg-positive CHB were randomized to ADV plus bicyclol combination group and ADV monotherapy group. The patients in the ADV plus bicyclol combination therapy group ( n  = 125) received ADV 10 mg orally q.d. and bicyclol 25 mg orally t.i.d. for 48 weeks, and those in the ADV monotherapy group ( n  = 125) were administered ADV 10 mg orally q.d. alone for 48 weeks. The serum aminotransferases (ALT/AST), HBV DNA, HBeAg/HBeAb, and liver biopsy were conducted before and after therapy.
RESULTS


The serum aminotransferase levels were decreased significantly in both groups. The serum aminotransferase level in ADV plus bicyclol combination therapy group decreased greater than that in ADV monotherapy group ( P  < 0.01). The virological response rate in ADV plus bicyclol combination therapy group was not significantly different from that in ADV monotherapy group ( P  > 0.05). After treatment for 48 weeks, the Knodell necroinflammatory score of the two groups were all alleviated significantly, and the Knodell score in the combination group was significantly lower than that in the ADV monotherapy group ( P  < 0.05). There were no remarkable adverse events probably related to the drug in this study.
CONCLUSION


Adefovir dipivoxil plus bicyclol combination therapy is a safe and superior treatment regimen for patients with HBeAg-positive CHB when compared with ADV monotherapy.",2012,The virological response rate in ADV plus bicyclol combination therapy group was not significantly different from that in ADV monotherapy group ( P  > 0.05).,"['CHB patients', 'patients with HBeAg-positive CHB', 'patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) treated with', 'patients with hepatitis B e antigen-positive chronic hepatitis B treated by', '250 patients with HBeAg-positive CHB']","['ADV 10\xa0mg orally q.d. and bicyclol 25\xa0mg orally t.i.d. for 48\xa0weeks, and those in the ADV monotherapy', 'adefovir dipivoxil or adefovir dipivoxil plus bicyclol', 'ADV 10\xa0mg orally q.d. alone for 48\xa0weeks', 'adefovir dipivoxil (ADV) or ADV plus bicyclol', 'Adefovir dipivoxil plus bicyclol combination therapy', 'ADV plus bicyclol combination group and ADV monotherapy']","['serum aminotransferase level', 'serum aminotransferases (ALT/AST), HBV DNA, HBeAg/HBeAb, and liver biopsy', 'efficacy and safety profiles', 'Knodell score', 'serum aminotransferase levels', 'virological response rate', 'Knodell necroinflammatory score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392390', 'cui_str': 'Hepatitis B e antigen positive'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C1312124', 'cui_str': 'bicyclol'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0540694', 'cui_str': 'adefovir dipivoxil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",250.0,0.040155,The virological response rate in ADV plus bicyclol combination therapy group was not significantly different from that in ADV monotherapy group ( P  > 0.05).,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Liver Center, Beijing Ditan Hospital, Capital Medical University, 100015 Beijing, China.'}, {'ForeName': 'Guangfeng', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatric Hepatology, The 302 Hospital of PLA, Beijing, China.'}, {'ForeName': 'Guiming', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Hepatology, Tianjin Municipal Hospital of Infectious Diseases, Tianjin, China.'}, {'ForeName': 'Zujiang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases, First Hospital, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Lang', 'Affiliation': 'Liver Center, Beijing Ditan Hospital, Capital Medical University, 100015 Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Liver Center, Beijing Ditan Hospital, Capital Medical University, 100015 Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Liver Center, Beijing Ditan Hospital, Capital Medical University, 100015 Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Liver Center, Beijing Ditan Hospital, Capital Medical University, 100015 Beijing, China.'}]",Hepatology international,[]
278,21766223,The positive effect of mirror visual feedback on arm control in children with spastic hemiparetic cerebral palsy is dependent on which arm is viewed.,"Mirror visual feedback has previously been found to reduce disproportionate interlimb variability and neuromuscular activity in the arm muscles in children with Spastic Hemiparetic Cerebral Palsy (SHCP). The aim of the current study was to determine whether these positive effects are generated by the mirror per se (i.e. the illusory perception of two symmetrically moving limbs, irrespective of which arm generates the mirror visual feedback) or by the visual illusion that the impaired arm has been substituted and appears to move with less jerk and in synchrony with the less-impaired arm (i.e. by mirror visual feedback of the less-impaired arm only). Therefore, we compared the effect of mirror visual feedback from the impaired and the less-impaired upper limb on the bimanual coupling and neuromuscular activity during a bimanual coordination task. Children with SHCP were asked to perform a bimanual symmetrical circular movement in three different visual feedback conditions (i.e. viewing the two arms, viewing only one arm, and viewing one arm and its mirror image), combined with two head orientation conditions (i.e. looking from the impaired and looking from the less-impaired body side). It was found that mirror visual feedback resulted in a reduction in the eccentric activity of the Biceps Brachii Brevis in the impaired limb compared to the condition with actual visual feedback from the two arms. More specifically, this effect was exclusive to mirror visual feedback from the less-impaired arm and absent when mirror visual feedback from the impaired arm was provided. Across conditions, the less-impaired arm was the leading limb, and the nature of this coupling was independent from visual condition or head orientation. Also, mirror visual feedback did not affect the intensity of the mean neuromuscular activity or the muscle activity of the Triceps Brachii Longus. It was concluded that the positive effects of mirror visual feedback in children with SHCP are not just the result of the perception of two symmetrically moving limbs. Instead, in order to induce a decrease in eccentric neuromuscular activity in the impaired limb, mirror visual feedback from the 'unaffected' less-impaired limb is required.",2011,It was found that mirror visual feedback resulted in a reduction in the eccentric activity of the Biceps Brachii Brevis in the impaired limb compared to the condition with actual visual feedback from the two arms.,"['children with SHCP', 'children with Spastic Hemiparetic Cerebral Palsy (SHCP', 'Children with SHCP', 'children with spastic hemiparetic cerebral palsy']",['mirror visual feedback'],"['mirror visual feedback', 'eccentric neuromuscular activity', 'eccentric activity of the Biceps Brachii Brevis', 'intensity of the mean neuromuscular activity or the muscle activity of the Triceps Brachii Longus', 'positive effects of mirror visual feedback']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0391139,It was found that mirror visual feedback resulted in a reduction in the eccentric activity of the Biceps Brachii Brevis in the impaired limb compared to the condition with actual visual feedback from the two arms.,"[{'ForeName': 'Ana R P', 'Initials': 'AR', 'LastName': 'Smorenburg', 'Affiliation': 'Institute for Biomedical Research into Human Movement and Health, School of Health Care Science, Manchester Metropolitan University, John Dalton Building, Oxford Road, Manchester, UK. a.r.p.smorenburg@vu.nl'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Ledebt', 'Affiliation': ''}, {'ForeName': 'Max G', 'Initials': 'MG', 'LastName': 'Feltham', 'Affiliation': ''}, {'ForeName': 'Frederik J A', 'Initials': 'FJ', 'LastName': 'Deconinck', 'Affiliation': ''}, {'ForeName': 'Geert J P', 'Initials': 'GJ', 'LastName': 'Savelsbergh', 'Affiliation': ''}]",Experimental brain research,['10.1007/s00221-011-2789-6']
279,21773676,Examining the role of physical activity in reducing postcancer fatigue.,"PURPOSE


Persistent fatigue is a long-term adverse effect experienced in about a quarter of patients cured of cancer. It was shown that cognitive behavior therapy (CBT) especially designed for postcancer fatigue is highly effective in reducing severe fatigue. However, it is unclear by what mechanism the fatigue reduction is reached. In many fatigue reduction programs, an increase in physical activity is assumed to reduce fatigue. The purpose of the present study is to determine whether the effect of CBT on fatigue is mediated by an increase in physical activity.
METHODS


Data of a previous randomized controlled trial on the efficacy of CBT for postcancer fatigue were reanalyzed (CBT, n = 41; waiting list condition, n = 42). Actigraphy was used to assess the level of objective physical activity. Cancer survivors were assessed prior as well as after the CBT and waiting list period. The mediation hypothesis was tested according to guidelines of Baron and Kenny. A non-parametric bootstrap approach was used to test statistical significance of the mediation effect.
RESULTS


Although CBT effectively reduced postcancer fatigue, no change in level of objective physical activity was found. The mean mediation effect was 1.4% of the total treatment effect. This effect was not significant.
CONCLUSION


The effect of CBT for postcancer fatigue is not mediated by a persistent increase in objective physical activity.",2012,It was shown that cognitive behavior therapy (CBT) especially designed for postcancer fatigue is highly effective in reducing severe fatigue.,[],"['CBT', 'cognitive behavior therapy (CBT']","['physical activity', 'level of objective physical activity', 'objective physical activity', 'postcancer fatigue', 'Cancer survivors', 'mean mediation effect']",[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",42.0,0.0349759,It was shown that cognitive behavior therapy (CBT) especially designed for postcancer fatigue is highly effective in reducing severe fatigue.,"[{'ForeName': 'Marieke F M', 'Initials': 'MF', 'LastName': 'Gielissen', 'Affiliation': 'Department of Medical Psychology 840, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands. m.gielissen@mps.umcn.nl'}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Wiborg', 'Affiliation': ''}, {'ForeName': 'Constans A H H V M', 'Initials': 'CA', 'LastName': 'Verhagen', 'Affiliation': ''}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': ''}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Bleijenberg', 'Affiliation': ''}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-011-1227-4']
280,21805328,"Influence of megestrol acetate on nutrition, inflammation and quality of life in dialysis patients.","AIM


Malnutrition is a common clinical problem in dialysis patients. The objective of this study was to evaluate the efficacy and safety of megestrol acetate in malnourished dialysis patients. Thirty-two hypoalbuminemic dialysis patients took 160 mg of megestrol acetate daily for up to 6 months.
METHODS


We measured height, dry weight, BMI, modified Subjective Global Assessment (SGA) score, and serum albumin, triglycerides, total cholesterol, hsCRP, IL-1β and IL-6 concentrations. We used validated questionnaires to evaluate selected dimensions of the quality of life.
RESULTS


Only 12 patients completed the study. All patients reported improved appetite, and there were concurrent statistically significant increases in weight, BMI, SGA and albumin concentration (P < 0.05). For the 12 patients who completed 6 months of treatment the increase in these parameters was from 63.26 ± 13.04 to 65.58 ± 12.53 kg, from 23.5 ± 3.8 to 24.66 ± 4.23 kg/m(2), from 5.16 ± 0.94 to 6.16 ± 0.72 points, and from 36.45 ± 1.82 to 40.33 ± 2.71 g/l, respectively. However, there were no significant changes in the levels of inflammatory markers and in quality of life. Side effects included overhydration, excessive weight gain and hyperglycaemia.
CONCLUSION


Megestrol acetate may be effective in reversing poor appetite in carefully selected maintenance dialysis patients, but it might not reduce inflammation or improve the quality of life. Because of the potential side effects, close monitoring is essential.",2012,"All patients reported improved appetite, and there were concurrent statistically significant increases in weight, BMI, SGA and albumin concentration (P < 0.05).","['dialysis patients', 'malnourished dialysis patients']","['megestrol acetate', 'Megestrol acetate']","['appetite', 'quality of life', 'weight, BMI, SGA and albumin concentration', 'nutrition, inflammation and quality of life', 'height, dry weight, BMI, modified Subjective Global Assessment (SGA) score, and serum albumin, triglycerides, total cholesterol, hsCRP, IL-1β and IL-6 concentrations', 'efficacy and safety', 'levels of inflammatory markers and in quality of life', 'overhydration, excessive weight gain and hyperglycaemia']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0065879', 'cui_str': 'Megestrol Acetate'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0034380'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392689', 'cui_str': 'Overhydration (disorder)'}, {'cui': 'C0000765', 'cui_str': 'Excessive weight gain (finding)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",,0.0261362,"All patients reported improved appetite, and there were concurrent statistically significant increases in weight, BMI, SGA and albumin concentration (P < 0.05).","[{'ForeName': 'Justyna E', 'Initials': 'JE', 'LastName': 'Gołębiewska', 'Affiliation': 'Department of Nephrology, Transplantology and Internal Medicine, Medical University of Gdańsk, ul. Dębinki 7, 80-952 Gdańsk, Poland. jgolebiewska@gumed.edu.pl'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Lichodziejewska-Niemierko', 'Affiliation': ''}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Aleksandrowicz-Wrona', 'Affiliation': ''}, {'ForeName': 'Mikołaj', 'Initials': 'M', 'LastName': 'Majkowicz', 'Affiliation': ''}, {'ForeName': 'Wiesława', 'Initials': 'W', 'LastName': 'Lysiak-Szydłowska', 'Affiliation': ''}, {'ForeName': 'Bolesław', 'Initials': 'B', 'LastName': 'Rutkowski', 'Affiliation': ''}]",International urology and nephrology,['10.1007/s11255-011-0025-8']
281,21800090,The high-risk plaque initiative: primary prevention of atherothrombotic events in the asymptomatic population.,"The High-Risk Plaque (HRP) Initiative is a research and development effort to advance the understanding, recognition, and management of asymptomatic individuals at risk for a near-term atherothrombotic event such as myocardial infarction or stroke. Clinical studies using the newest technologies have been initiated, including the BioImage Study in which novel approaches are tested in a typical health plan population. Asymptomatic at-risk individuals were enrolled, including a survey-only group (n = 865), a group undergoing traditional risk factor scoring (n = 718), and a group in which all were assessed for both risk factors and subclinical atherosclerosis (n = 6104). The latter two groups underwent baseline examination in a dedicated mobile facility equipped with advanced imaging tools suitable for noninvasive screening for subclinical atherosclerosis (coronary artery calcium by computed tomography [CT], carotid and aortic disease by ultrasound, and ankle-brachial index). Selected participants were offered advanced imaging (contrast-enhanced CT, magnetic resonance imaging, and positron emission tomography/CT). Plasma, PAXgene RNA, and DNA samples were obtained for biomarker discovery studies. All individuals will be followed until 600 major atherothrombotic events have occurred in those undergoing imaging.",2011,"The High-Risk Plaque (HRP) Initiative is a research and development effort to advance the understanding, recognition, and management of asymptomatic individuals at risk for a near-term atherothrombotic event such as myocardial infarction or stroke.","['Asymptomatic at-risk individuals were enrolled, including a survey-only group (n\u2009=\u2009865), a group undergoing traditional risk factor scoring (n\u2009=\u2009718), and a group in which all were assessed for both risk factors and subclinical atherosclerosis (n\u2009=\u20096104']","['dedicated mobile facility equipped with advanced imaging tools suitable for noninvasive screening', 'advanced imaging (contrast-enhanced CT, magnetic resonance imaging, and positron emission tomography/CT']","['Plasma, PAXgene RNA, and DNA samples']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",,0.0324443,"The High-Risk Plaque (HRP) Initiative is a research and development effort to advance the understanding, recognition, and management of asymptomatic individuals at risk for a near-term atherothrombotic event such as myocardial infarction or stroke.","[{'ForeName': 'Erling', 'Initials': 'E', 'LastName': 'Falk', 'Affiliation': 'Atherosclerosis Research Unit, Department of Cardiology/Institute of Clinial Medicine, Aarhus University Hospital Skejby, Brendstrupgaardsvej 100, Aarhus, Denmark. erling.falk@ki.au.dk'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Sillesen', 'Affiliation': ''}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Muntendam', 'Affiliation': ''}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': ''}]",Current atherosclerosis reports,['10.1007/s11883-011-0193-0']
282,21800218,Initial microbial spectrum in severe secondary peritonitis and relevance for treatment.,"This study aims to determine whether abdominal microbial profiles in early severe secondary peritonitis are associated with ongoing infection or death. The study is performed within a randomized study comparing two surgical treatment strategies in patients with severe secondary peritonitis (n = 229). The microbial profiles of cultures retrieved from initial emergency laparotomy were tested with logistic regression analysis for association with 'ongoing infection needing relaparotomy' and in-hospital death. No microbial profile or the presence of yeast or Pseudomonas spp. was related to the risk of ongoing infection needing relaparotomy. Resistance to empiric therapy for gram positive cocci and coliforms was moderately associated with ongoing abdominal infection (OR 3.43 95%CI 0.95-12.38 and OR 7.61, 95%CI 0.75-76.94). Presence of only gram positive cocci, predominantly Enterococcus spp, was borderline independently associated with in-hospital death (OR 3.69, 95%CI 0.99-13.80). In secondary peritonitis microbial profiles do not predict ongoing abdominal infection after initial emergency laparotomy. However, the moderate association of ongoing infection with resistance to the empiric therapy compels to more attention for resistance when selecting empiric antibiotic coverage.",2012,"Resistance to empiric therapy for gram positive cocci and coliforms was moderately associated with ongoing abdominal infection (OR 3.43 95%CI 0.95-12.38 and OR 7.61, 95%CI 0.75-76.94).",['patients with severe secondary peritonitis (n = 229'],[],"['ongoing abdominal infection', 'hospital death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1449647', 'cui_str': 'Secondary Peritonitis'}]",[],"[{'cui': 'C1112209', 'cui_str': 'Intra-Abdominal Infections'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",229.0,0.0464375,"Resistance to empiric therapy for gram positive cocci and coliforms was moderately associated with ongoing abdominal infection (OR 3.43 95%CI 0.95-12.38 and OR 7.61, 95%CI 0.75-76.94).","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'van Ruler', 'Affiliation': 'Department of Surgery (G4-129), Academic Medical Center, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'J J S', 'Initials': 'JJ', 'LastName': 'Kiewiet', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'van Ketel', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Boermeester', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-011-1357-0']
283,21629997,Prompt but inefficient: nicotine differentially modulates discrete components of attention.,"RATIONALE


Nicotine has been shown to improve both memory and attention when assessed through speeded motor responses. Since very few studies have assessed effects of nicotine on visual attention using measures that are uncontaminated by motoric effects, nicotine's attentional effects may, at least partially, be due to speeding of motor function.
OBJECTIVES


Using an unspeeded, accuracy-based test, the CombiTVA paradigm, we examined whether nicotine enhances attention when it is measured independently of motor processing.
METHODS


We modelled data with a computational theory of visual attention (TVA; Bundesen 1990) so as to derive independent estimates of several distinct components of attention from performance of the single task: threshold of visual perception, perceptual processing speed, visual short-term memory storage capacity and top-down controlled selectivity. Acute effects of nicotine (2 mg gum) on performance were assessed in 24 healthy young non-smokers in a placebo-controlled counterbalanced, crossover design. Chronic effects of nicotine were investigated in 24 age- and education-matched minimally deprived smokers.
RESULTS


Both an acute dose of nicotine in non-smokers and chronic nicotine use in temporarily abstaining smokers improved perceptual thresholds but slowed subsequent perceptual speed. Moreover, both acute and chronic nicotine use reduced attentional selectivity though visual short-term memory capacity was unimpaired.
CONCLUSIONS


Nicotine differentially affected discrete components of visual attention, with acute and chronic doses revealing identical patterns of performance. We challenge prior reports of nicotine-induced speeding of information processing by showing, for the first time, that nicotine slows down perceptual processing speed when assessed using accuracy-based measures of cognitive performance.",2011,Both an acute dose of nicotine in non-smokers and chronic nicotine use in temporarily abstaining smokers improved perceptual thresholds but slowed subsequent perceptual speed.,"['24 age- and education-matched minimally deprived smokers', '24 healthy young non-smokers in a']","['placebo', 'nicotine (2 mg gum', 'nicotine']",['attentional selectivity'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}]",[],24.0,0.0999963,Both an acute dose of nicotine in non-smokers and chronic nicotine use in temporarily abstaining smokers improved perceptual thresholds but slowed subsequent perceptual speed.,"[{'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Vangkilde', 'Affiliation': 'Center for Visual Cognition, Department of Psychology, University of Copenhagen, Oester Farimagsgade 2A, 1353, Copenhagen K, Denmark. Signe.Vangkilde@psy.ku.dk'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bundesen', 'Affiliation': ''}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Coull', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2361-x']
284,21698395,"Thalidomide, dexamethasone and lovastatin with autologous stem cell transplantation as a salvage immunomodulatory therapy in patients with relapsed and refractory multiple myeloma.","The treatment of patients with multiple myeloma usually includes many drugs including thalidomide, lenalidomide and bortezomib. Lovastatin and other inhibitors of HMG-CoA reductase demonstrated to exhibit antineoplasmatic and proapoptotic properties in numerous in vitro studies involving myeloma cell lines. We treated 91 patients with relapsed or refractory multiple myeloma with thalidomide, dexamethasone and lovastatin (TDL group, 49 patients) or thalidomide and dexamethasone (TD group, 42 patients). A clinical response defined of at least 50% reduction of monoclonal band has been observed in 32% of TD patients and 44% of TDL patients. Prolongation of overall survival and progression-free survival in the TDL group as compared with the TD group has been documented. The TDL regimen was safe and well tolerated. The incidence of side effects was comparable in both groups. Plasma cells have been cultured in vitro with thalidomide and lovastatin to assess the impact of both drugs on the apoptosis rate of plasma cells. In vitro experiments revealed that the combination of thalidomide and lovastatin induced higher apoptosis rate than apoptosis induced by each drug alone. Our results suggest that the addition of lovastatin to the TD regimen may improve the response rate in patients with relapsed or refractory myeloma.",2011,Prolongation of overall survival and progression-free survival in the TDL group as compared with the TD group has been documented.,"['91 patients with relapsed or refractory multiple myeloma with', 'group, 49 patients) or', 'patients with multiple myeloma usually includes many drugs including', 'patients with relapsed or refractory myeloma', 'patients with relapsed and refractory multiple myeloma', 'TD group, 42 patients']","['Lovastatin', 'thalidomide and lovastatin', 'HMG-CoA reductase', 'TDL', 'thalidomide, dexamethasone and lovastatin (TDL', 'thalidomide, lenalidomide and bortezomib', 'thalidomide and dexamethasone', 'lovastatin', 'Thalidomide, dexamethasone and lovastatin with autologous stem cell transplantation']","['Prolongation of overall survival and progression-free survival', 'apoptosis rate of plasma cells', 'response rate', 'safe and well tolerated', 'incidence of side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0020374', 'cui_str': 'HMG CoA Reductases'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0032112', 'cui_str': 'Plasmacytes'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",91.0,0.026124,Prolongation of overall survival and progression-free survival in the TDL group as compared with the TD group has been documented.,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Hus', 'Affiliation': 'Department of Haematology and Bone Marrow Transplantation, Medical University of Lublin, Staszica 11, Lublin, Poland. markhus@o2.pl'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Grzasko', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Szostek', 'Affiliation': ''}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Pluta', 'Affiliation': ''}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Helbig', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Woszczyk', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Adamczyk-Cioch', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Jawniak', 'Affiliation': ''}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Legiec', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Morawska', 'Affiliation': ''}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Kozinska', 'Affiliation': ''}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Waciński', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dmoszynska', 'Affiliation': ''}]",Annals of hematology,['10.1007/s00277-011-1276-2']
285,21630047,A randomised controlled trial for the effectiveness of intra-articular Ropivacaine and Bupivacaine on pain after knee arthroscopy: the DUPRA (DUtch Pain Relief after Arthroscopy)-trial.,"PURPOSE


In this double-blinded, randomised clinical trial, the aim was to compare the analgesic effects of low doses of intra-articular Bupivacaine and Ropivacaine against placebo after knee arthroscopy performed under general anaesthesia.
METHODS


A total of 282 patients were randomised to 10 cc NaCl 0.9%, 10 cc Bupivacaine 0.5% or 10 cc Ropivacaine 0.75%. Patients received the assigned therapy by intra-articular injection after closure of the portal. Pain and satisfaction were measured at one, 4 h and 5-7 days after arthroscopy with Numerical Rating Scale (NRS) -scores. NSAID consumption was also recorded.
RESULTS


One-h NRS-scores at rest were higher in the NaCl group compared with the Bupivacaine group (P < 0.01), 1 h NRS-scores in flexion were higher in the NaCl group compared with the Bupivacaine (P < 0.01) and Ropivacaine (P < 0.01) groups. NRS-satisfaction at 4 h was higher for the Bupivacaine group compared with the NaCl group (P = 0.01). Differences in NRS-scores were significant but low in magnitude. NSAID consumption was lower in the Bupivacaine group compared with the NaCl group (P < 0.01).
CONCLUSIONS


The results of this randomised clinical trial demonstrate improved analgesia after administration of low doses of intra-articular Bupivacaine and Ropivacaine after arthroscopy of the knee. Considering reports of Bupivacaine and Ropivacaine being chondrotoxic agents and the relatively small improvement on patient comfort found in this trial, it is advised to use systemic anaesthetic instead of intra-articular Bupivacaine or Ropivacaine for pain relief after knee arthroscopy.",2012,"NSAID consumption was lower in the Bupivacaine group compared with the NaCl group (P < 0.01).
","['282 patients', 'pain after knee arthroscopy: the DUPRA (DUtch Pain Relief after Arthroscopy)-trial']","['Bupivacaine and Ropivacaine', 'intra-articular Bupivacaine and Ropivacaine against placebo', 'Bupivacaine or Ropivacaine', 'NaCl', 'Bupivacaine', 'Ropivacaine', 'intra-articular Ropivacaine and Bupivacaine']","['NRS-satisfaction', 'analgesic effects', 'NRS-scores in flexion', 'NRS-scores', 'NSAID consumption', 'Pain and satisfaction']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",282.0,0.511973,"NSAID consumption was lower in the Bupivacaine group compared with the NaCl group (P < 0.01).
","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Campo', 'Affiliation': 'Department of Orthopedics and Traumatology, Tergooi Hospitals, van Riebeeckweg 212, 1213XZ Hilversum, The Netherlands.'}, {'ForeName': 'G M M J', 'Initials': 'GM', 'LastName': 'Kerkhoffs', 'Affiliation': ''}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Sierevelt', 'Affiliation': ''}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Weeseman', 'Affiliation': ''}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Van der Vis', 'Affiliation': ''}, {'ForeName': 'G H R', 'Initials': 'GH', 'LastName': 'Albers', 'Affiliation': ''}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-011-1562-5']
286,21786187,Alterations in platelet function and cell-derived microvesicles in recently menopausal women: relationship to metabolic syndrome and atherogenic risk.,"A woman's risk for metabolic syndrome (MS) increases at menopause, with an associated increase in risk for cardiovascular disease. We hypothesized that early menopause-related changes in platelet activity and concentrations of microvesicles derived from activated blood and vascular cells provide a mechanistic link to the early atherothrombotic process. Thus, platelet functions and cellular origin of blood-borne microvesicles in recently menopausal women (n = 118) enrolled in the Kronos Early Estrogen Prevention Study were correlated with components of MS and noninvasive measures of cardiovascular disease [carotid artery intima medial thickness (CIMT), coronary artery calcium (CAC) score, and endothelial reactive hyperemic index (RHI)]. Specific to individual components of the MS pentad, platelet number increased with increasing waist circumference, and platelet secretion of ATP and expression of P-selectin decreased with increasing blood glucose (p = 0.005) and blood pressure (p < 0.05), respectively. Waist circumference and systolic blood pressure were independently associated with monocyte- and endothelium-derived microvesicles (p < 0.05). Platelet-derived and total procoagulant phosphatidylserine-positive microvesicles, and systolic blood pressure correlated with CIMT (p < 0.05), but not with CAC or RHI. In summary, among recently menopausal women, specific platelet functions and concentrations of circulating activated cell membrane-derived procoagulant microvesicles change with individual components of MS. These cellular changes may explain in part how menopause contributes to MS and, eventually, to cardiovascular disease.",2011,"Early Estrogen Prevention Study were correlated with components of MS and noninvasive measures of cardiovascular disease [carotid artery intima medial thickness (CIMT), coronary artery calcium (CAC) score, and endothelial reactive hyperemic index (RHI)].","['recently menopausal women', 'recently menopausal women (n\u2009=\u2009118) enrolled in the Kronos']",[],"['Platelet-derived and total procoagulant phosphatidylserine-positive microvesicles, and systolic blood pressure', 'components of MS and noninvasive measures of cardiovascular disease [carotid artery intima medial thickness (CIMT), coronary artery calcium (CAC) score, and endothelial reactive hyperemic index (RHI', 'Waist circumference and systolic blood pressure', 'blood pressure', 'waist circumference, and platelet secretion of ATP and expression of P-selectin', 'blood glucose']","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517542', 'cui_str': '118'}]",[],"[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031623', 'cui_str': 'Phosphatidyl Serines'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0134835', 'cui_str': 'Platelet alpha-Granule Membrane Protein'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",118.0,0.024147,"Early Estrogen Prevention Study were correlated with components of MS and noninvasive measures of cardiovascular disease [carotid artery intima medial thickness (CIMT), coronary artery calcium (CAC) score, and endothelial reactive hyperemic index (RHI)].","[{'ForeName': 'Muthuvel', 'Initials': 'M', 'LastName': 'Jayachandran', 'Affiliation': 'Department of Physiology & Biomedical Engineering, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Litwiller', 'Affiliation': ''}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Lahr', 'Affiliation': ''}, {'ForeName': 'Kent R', 'Initials': 'KR', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Whyte G', 'Initials': 'WG', 'LastName': 'Owen', 'Affiliation': ''}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Mulvagh', 'Affiliation': ''}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Heit', 'Affiliation': ''}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': ''}, {'ForeName': 'S Mitchell', 'Initials': 'SM', 'LastName': 'Harman', 'Affiliation': ''}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': ''}]",Journal of cardiovascular translational research,['10.1007/s12265-011-9296-9']
287,21638103,Efficacy of radiosynoviorthesis and its impact on chosen inflammatory markers.,Radiosynoviorthesis is used for the local treatment of recurrent joint effusions and leads to synovium necrosis after radionuclide administration. This procedure provides opportunity to full recovery of normal synovium function after local corticosteroids and systemic modifying drugs failure.,2012,Radiosynoviorthesis is used for the local treatment of recurrent joint effusions and leads to synovium necrosis after radionuclide administration.,[],"['Radiosynoviorthesis', 'radiosynoviorthesis']",[],[],[],[],,0.0295347,Radiosynoviorthesis is used for the local treatment of recurrent joint effusions and leads to synovium necrosis after radionuclide administration.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zwolak', 'Affiliation': 'Department of Rheumatology and Connective Tissue Diseases, Medical University, Lublin, Poland. zwolakr@wp.pl'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Majdan', 'Affiliation': ''}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Skórski', 'Affiliation': ''}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Chrapko', 'Affiliation': ''}]",Rheumatology international,['10.1007/s00296-011-1956-1']
288,21630032,The effect of bezafibrate and omega-3 fatty acids on lymphocyte cytokine release and systemic inflammation in patients with isolated hypertriglyceridemia.,"PURPOSE


The aim of this study was to compare the effects of fibrates and omega-3 fatty acids on lymphocyte secretory function and systemic inflammation in patients with isolated hypertriglyceridemia.
METHODS


The study included 107 patients with isolated hypertriglyceridemia who received bezafibrate (200 mg twice daily), omega-3 fatty acids (1 g twice daily) or placebo for 12 weeks. The lipid profile, fasting and 2-h post-glucose load plasma glucose levels, homeostasis model assessment index (HOMA), plasma high-sensitivity C-reactive protein (hsCRP) levels and lymphocyte release of interleukin-2, interferon-γ and tumor necrosis factor-α were assessed at baseline, on the day of randomization, and after 4 and 12 weeks of treatment.
RESULTS


Both bezafibrate and omega-3 fatty acids reduced plasma triglyceride levels. Bezafibrate additionally decreased total and low-density lipoprotein-cholesterol levels and the HOMA and insignificantly decreased post-glucose load plasma glucose, as well as increased high-density lipoprotein-cholesterol. Bezafibrate treatment was associated with a reduction in lymphocyte release of interleukin-2, interferon-γ and tumor necrosis factor-α, which was accompanied by a reduction in plasma hsCRP levels. Omega-3 fatty acid did not significantly reduce lymphocyte cytokine release and plasma hsCRP. The anti-inflammatory effects of both drugs did not correlate with their action on plasma lipids, but in the case of the former the effect was related to the improvement in insulin sensitivity.
CONCLUSION


Our results indicate that bezafibrate is superior to omega-3 fatty acid in inhibiting systemic inflammation and lymphocyte secretory function.",2011,"Bezafibrate treatment was associated with a reduction in lymphocyte release of interleukin-2, interferon-γ and tumor necrosis factor-α, which was accompanied by a reduction in plasma hsCRP levels.","['107 patients with isolated hypertriglyceridemia who received', 'patients with isolated hypertriglyceridemia']","['bezafibrate (200\xa0mg twice daily), omega-3 fatty acids', 'placebo', 'fibrates and omega-3 fatty acids', 'Omega-3 fatty acid', 'Bezafibrate', 'bezafibrate and omega-3 fatty acids', 'bezafibrate']","['lymphocyte cytokine release and systemic inflammation', 'plasma triglyceride levels', 'lymphocyte secretory function and systemic inflammation', 'plasma lipids', 'lipid profile, fasting and 2-h post-glucose load plasma glucose levels, homeostasis model assessment index (HOMA), plasma high-sensitivity C-reactive protein (hsCRP) levels and lymphocyte release of interleukin-2, interferon-γ and tumor necrosis factor-α', 'lymphocyte cytokine release and plasma hsCRP', 'total and low-density lipoprotein-cholesterol levels and the HOMA', 'high-density lipoprotein-cholesterol', 'lymphocyte release of interleukin-2, interferon-γ and tumor necrosis factor-α', 'plasma hsCRP levels']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}]","[{'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1449704', 'cui_str': 'Fibrates'}]","[{'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}]",107.0,0.0591039,"Bezafibrate treatment was associated with a reduction in lymphocyte release of interleukin-2, interferon-γ and tumor necrosis factor-α, which was accompanied by a reduction in plasma hsCRP levels.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krysiak', 'Affiliation': 'Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Medyków 18, 40-752 Katowice, Poland. r.krysiak@interia.pl'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gdula-Dymek', 'Affiliation': ''}, {'ForeName': 'Boguslaw', 'Initials': 'B', 'LastName': 'Okopien', 'Affiliation': ''}]",European journal of clinical pharmacology,['10.1007/s00228-011-1063-y']
289,21681516,Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment.,"PURPOSE


To investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation.
METHODS


A multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment.
RESULTS


The completion rate among women who entered the open-label extension study was 90.5% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P < 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4%). No clinically relevant changes in laboratory parameters were observed. During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns.
CONCLUSIONS


Long-term dienogest showed a favorable efficacy and safety profile, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation.",2012,"During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns.
","['Women with endometriosis', 'A multicenter study performed in Germany, Italy and Ukraine', 'women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53\xa0weeks', 'women with endometriosis']",['placebo'],"['mean frequency and intensity of bleeding', 'Adverse events', 'efficacy and safety', 'favorable efficacy and safety profile', 'pain and bleeding irregularities', 'pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters', 'pelvic pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.04408,"During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns.
","[{'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Petraglia', 'Affiliation': 'Department of Pediatrics, Obstetrics and Reproductive Medicine, University of Siena, Viale R. Bracci N. 16, 53100, Siena, Italy. petraglia@unisi.it'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hornung', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seitz', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faustmann', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Gerlinger', 'Affiliation': ''}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Luisi', 'Affiliation': ''}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Lazzeri', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strowitzki', 'Affiliation': ''}]",Archives of gynecology and obstetrics,['10.1007/s00404-011-1941-7']
290,21607703,"A double-blind, placebo-controlled pilot study to evaluate the effect of calcium fructoborate on systemic inflammation and dyslipidemia markers for middle-aged people with primary osteoarthritis.","The objective of this pilot study was to determine whether 15 days of dietary supplementation with calcium fructoborate could acutely modulate inflammatory and lipid blood markers in individuals diagnosed with primary osteoarthritis. During 2 weeks, a placebo-controlled, randomized, double-blind study was conducted on 116 subjects that were initially recruited. Seventy-two subjects started the study, being divided into four groups, and only 60 completed the study as designed. The aim was to compare the effects of calcium fructoborate to placebo on subjects diagnosed with knee primary osteoarthritis. The obtained outcomes were inflammation biomarkers (C-reactive protein, fibrinogen, and erythrocyte sedimentation rate) and lipid markers (triglycerides, total cholesterol, LDL cholesterol, and HDL cholesterol). No serious adverse events were reported. The calcium fructoborate showed beneficial effect on the inflammatory markers for all groups subjected to the treatment when compared with the placebo group and slight changes in the lipid metabolism. This study suggests that short-term (2 weeks) calcium fructoborate supplementation in patients with osteoarthritis symptoms has a favorable prognosis on inflammation diseases.",2011,The calcium fructoborate showed beneficial effect on the inflammatory markers for all groups subjected to the treatment when compared with the placebo group and slight changes in the lipid metabolism.,"['individuals diagnosed with primary osteoarthritis', 'middle-aged people with primary osteoarthritis', 'subjects diagnosed with knee primary osteoarthritis', '116 subjects that were initially recruited', 'patients with osteoarthritis symptoms']","['placebo', 'calcium fructoborate', 'calcium fructoborate supplementation', 'dietary supplementation with calcium fructoborate', 'calcium fructoborate to placebo']","['inflammation biomarkers (C-reactive protein, fibrinogen, and erythrocyte sedimentation rate) and lipid markers (triglycerides, total cholesterol, LDL cholesterol, and HDL cholesterol', 'serious adverse events', 'lipid metabolism', 'systemic inflammation and dyslipidemia markers', 'inflammatory and lipid blood markers']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1384584', 'cui_str': 'Generalized osteoarthritis (disorder)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1684394', 'cui_str': 'calcium fructoborate'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0005768'}]",116.0,0.335244,The calcium fructoborate showed beneficial effect on the inflammatory markers for all groups subjected to the treatment when compared with the placebo group and slight changes in the lipid metabolism.,"[{'ForeName': 'Romulus', 'Initials': 'R', 'LastName': 'Scorei', 'Affiliation': 'Biochemistry Department, University of Craiova, 13 A.I. Cuza Street, 200585, Craiova, Dolj, Romania. romulus_ion@yahoo.com'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mitrut', 'Affiliation': ''}, {'ForeName': 'Iulian', 'Initials': 'I', 'LastName': 'Petrisor', 'Affiliation': ''}, {'ForeName': 'Iulia', 'Initials': 'I', 'LastName': 'Scorei', 'Affiliation': ''}]",Biological trace element research,['10.1007/s12011-011-9083-0']
291,21656179,"Efficacy and tolerability of split-dose PEG compared with split-dose aqueous sodium phosphate for outpatient colonoscopy: a randomized, controlled trial.","BACKGROUND AND AIMS


Adequate bowel cleansing is essential for a high-quality, effective, and safe colonoscopy. The aims of this study were to compare the efficacy and tolerability of split-dose polyethylene glycol with aqueous sodium phosphate for outpatients who underwent scheduled colonoscopy.
METHODS


In this prospective trial, 207 outpatients (aged between 18 and 65 years, with normal renal function, at low risk for renal damage) were randomized to receive split-dose preparation of PEG (2 L/2 L) (N = 103) or NaP (45 mL/45 mL, 12 h apart) (N = 104) without strict diet restriction the day before colonoscopy. The bowel cleansing efficacy of preparations was rated according to the Ottawa scale and the patient tolerability was assessed using a patient questionnaire.
RESULTS


There was no significant difference between the two groups for the mean total score using the Ottawa bowel preparation scale (P = 0.181). Significantly greater residual colonic fluid was observed in the split-dose PEG group (1.24 ± 0.49) than in the NaP group (1.04 ± 0.53) (P = 0.007). Patient compliance, preference, and acceptance of a two preparation regimen were similar with no significant differences (P = 0.095, P = 0.280 and P = 0.408, respectively). The overall incidence of adverse events was not significantly different between the two groups; however, the split-dose PEG group tended to have fewer adverse events (52/103 [50.5%], 66/104 [63.5%], P = 0.059) and had significantly less nausea and vomiting (P = 0.036).
CONCLUSIONS


Split-dose PEG, compared with split-dose NaP, is associated with more residual colonic fluid, but produces equivalent colon cleansing efficacy and results in less nausea and vomiting, which might improve patient tolerability (clinical trial registration number NCT01229800).",2011,There was no significant difference between the two groups for the mean total score using the Ottawa bowel preparation scale (P = 0.181).,"['outpatients who underwent scheduled colonoscopy', 'outpatient colonoscopy', '207 outpatients (aged between 18 and 65\xa0years, with normal renal function, at low risk for renal damage']","['split-dose polyethylene glycol with aqueous sodium phosphate', 'split-dose PEG', 'split-dose aqueous sodium phosphate', 'split-dose preparation of PEG (2 L/2 L', 'NaP (45\xa0mL/45']","['nausea and vomiting', 'patient tolerability', 'mean total score using the Ottawa bowel preparation scale', 'Patient compliance, preference, and acceptance', 'Efficacy and tolerability', 'adverse events', 'Ottawa scale and the patient tolerability', 'efficacy and tolerability', 'overall incidence of adverse events', 'residual colonic fluid']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0074757', 'cui_str': 'sodium phosphate'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0222045'}, {'cui': 'C1321605', 'cui_str': 'Patient Cooperation'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]",207.0,0.0680741,There was no significant difference between the two groups for the mean total score using the Ottawa bowel preparation scale (P = 0.181).,"[{'ForeName': 'Eun Hee', 'Initials': 'EH', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Haeundae Paik Hospital, Inje University School of Medicine, 1435 Jwa-dong, Haeundae-gu, Busan, 612-030, Republic of Korea.'}, {'ForeName': 'Tae Oh', 'Initials': 'TO', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Tae Gyoon', 'Initials': 'TG', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee Rin', 'Initials': 'HR', 'LastName': 'Joo', 'Affiliation': ''}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jongha', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Seung Ha', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Sung Yeon', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Young Soo', 'Initials': 'YS', 'LastName': 'Moon', 'Affiliation': ''}]",Digestive diseases and sciences,['10.1007/s10620-011-1772-1']
292,21671125,"Gaze training enhances laparoscopic technical skill acquisition and multi-tasking performance: a randomized, controlled study.","BACKGROUND


The operating room environment is replete with stressors and distractions that increase the attention demands of what are already complex psychomotor procedures. Contemporary research in other fields (e.g., sport) has revealed that gaze training interventions may support the development of robust movement skills. This current study was designed to examine the utility of gaze training for technical laparoscopic skills and to test performance under multitasking conditions.
METHODS


Thirty medical trainees with no laparoscopic experience were divided randomly into one of three treatment groups: gaze trained (GAZE), movement trained (MOVE), and discovery learning/control (DISCOVERY). Participants were fitted with a Mobile Eye gaze registration system, which measures eye-line of gaze at 25 Hz. Training consisted of ten repetitions of the ""eye-hand coordination"" task from the LAP Mentor VR laparoscopic surgical simulator while receiving instruction and video feedback (specific to each treatment condition). After training, all participants completed a control test (designed to assess learning) and a multitasking transfer test, in which they completed the procedure while performing a concurrent tone counting task.
RESULTS


Not only did the GAZE group learn more quickly than the MOVE and DISCOVERY groups (faster completion times in the control test), but the performance difference was even more pronounced when multitasking. Differences in gaze control (target locking fixations), rather than tool movement measures (tool path length), underpinned this performance advantage for GAZE training.
CONCLUSIONS


These results suggest that although the GAZE intervention focused on training gaze behavior only, there were indirect benefits for movement behaviors and performance efficiency. Additionally, focusing on a single external target when learning, rather than on complex movement patterns, may have freed-up attentional resources that could be applied to concurrent cognitive tasks.",2011,"Not only did the GAZE group learn more quickly than the MOVE and DISCOVERY groups (faster completion times in the control test), but the performance difference was even more pronounced when multitasking.",['Thirty medical trainees with no laparoscopic experience'],"['GAZE intervention', 'gaze training', 'gaze trained (GAZE), movement trained (MOVE), and discovery learning/control (DISCOVERY', 'GAZE', 'control test (designed to assess learning) and a multitasking transfer test, in which they completed the procedure while performing a concurrent tone counting task', 'eye-hand coordination"" task from the LAP Mentor VR laparoscopic surgical simulator while receiving instruction and video feedback (specific to each treatment condition', 'Gaze training']",[],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],30.0,0.0467526,"Not only did the GAZE group learn more quickly than the MOVE and DISCOVERY groups (faster completion times in the control test), but the performance difference was even more pronounced when multitasking.","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Wilson', 'Affiliation': ""College of Life and Environmental Sciences, University of Exeter, St Luke's Campus, Exeter, EX1 2LU, UK. Mark.Wilson@exeter.ac.uk""}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Vine', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bright', 'Affiliation': ''}, {'ForeName': 'Rich S W', 'Initials': 'RS', 'LastName': 'Masters', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Defriend', 'Affiliation': ''}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': ''}]",Surgical endoscopy,['10.1007/s00464-011-1802-2']
293,21656252,A participatory return-to-work program for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders: a process evaluation alongside a randomized controlled trial.,"INTRODUCTION


Beside (cost-)effectiveness, the feasibility of an intervention is important for successful implementation in daily practice. This study concerns the process evaluation of a newly developed participatory return-to-work (RTW) program for workers without an employment contract, sick-listed due to musculoskeletal disorders. The program consisted of a stepwise process, guided by an independent RTW coordinator, aimed at making a consensus-based RTW plan with the possibility of a temporary (therapeutic) workplace. The aims of this study were to describe the reach and extent of implementation of the new program, the satisfaction and experiences of all stakeholders, and the perceived barriers and facilitators for implementation of the program in daily practice.
METHODS


Temporary agency workers and unemployed workers, sick-listed for 2-8 weeks due to musculoskeletal disorders were eligible for this study. Data were collected from the workers; their insurance physicians and labour experts at the Dutch Social Security Agency; RTW coordinators; and case managers from participating vocational rehabilitation agencies. Data collection took place using professionals' reports, standardized matrices, questionnaires at baseline and at 3-month follow-up, and group interviews with the professionals.
RESULTS


Of the 79 workers who were allocated to the participatory RTW program group, 72 workers actually started with the intervention. Overall, implementation of the program was performed according to protocol. However, offering of suitable temporary workplaces was delayed with 44.5 days. Results showed satisfaction with the RTW coordinator among the workers and three quarters of the labour experts experienced a minor or major contribution of the presence of the RTW coordinator. Several barriers for implementation were identified, such as the administrative time-investment, unclear information about the program, no timely offering of temporary (therapeutic) workplaces, and the need for additional support in case of complex health problems.
CONCLUSIONS


This study indicates overall feasibility for implementation of the participatory RTW program in daily practice. However, to overcome important barriers, more attention should be paid to improve timely offering of suitable temporary workplaces, to describe more clearly the program goals and the professional's roles, and to offer additional support for workers suffering from complex multi-causal health problems.
TRIAL REGISTRATION


NTR1047.",2012,"RESULTS


Of the 79 workers who were allocated to the participatory RTW program group","['Temporary agency workers and unemployed workers, sick-listed for 2-8 weeks due to musculoskeletal disorders were eligible for this study', 'workers suffering from complex multi-causal health problems', '79 workers who were allocated to the participatory RTW program group', 'workers without an employment contract, sick-listed due to musculoskeletal disorders', '72 workers actually started with the intervention', 'temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders']","['participatory return-to-work program', 'participatory return-to-work (RTW) program']",[],"[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0400215,"RESULTS


Of the 79 workers who were allocated to the participatory RTW program group","[{'ForeName': 'Karlijn M', 'Initials': 'KM', 'LastName': 'van Beurden', 'Affiliation': 'Department of Public and Occupational Health, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands. k.vanbeurden@uvt.nl'}, {'ForeName': 'Sylvia J', 'Initials': 'SJ', 'LastName': 'Vermeulen', 'Affiliation': ''}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Anema', 'Affiliation': ''}, {'ForeName': 'Allard J', 'Initials': 'AJ', 'LastName': 'van der Beek', 'Affiliation': ''}]",Journal of occupational rehabilitation,['10.1007/s10926-011-9314-4']
294,21607581,The semisolid bolus swallow test for clinical diagnosis of oropharyngeal dysphagia: a prospective randomised study.,"Contrary to clinical experience, clinical swallow tests are predominantly performed using water (water swallow tests, WST). In this study, we examine whether swallow tests performed using a bolus of semisolid food (bolus swallow test, BST) offer benefits. In a prospective, randomised, blind study, the results of a standardised saliva swallow test (SST), WST, BST, combinations of these tests and an endoscopic swallow test (FEES) in patients with oropharyngeal swallowing disorders of neurological (NEU) and non-neurological (NNEU) origin were compared. Sensitivity, specificity, test accuracy and inter-rater reliability were analysed. 62 patients (mean age = 64.68; range = 22-84) were included in the study (NEU = 40; NNEU = 22). A sensitivity of 70.7% (NEU = 70.3%, NNEU = 71.4%) and specificity of 82.5% (NEU = 92.3%; NNEU = 100%) were determined for the WST. The BST + SST was found to have a sensitivity of 89.6% (NEU = 66.7%; NNEU = 90.9%) and a specificity of 72.7% (NEU = 87.5%; NNEU = 90.9%). Analysis of test accuracy showed a statistically significant correlation between FEES and BST + SST. Only BST + SST exhibited statistically significant inter-rater reliability. BST in combination with SST was the sensitive clinical instrument for detecting aspiration both over the patient population as a whole and over the two sub-populations. Inter-rater reliability was found to be statistically significant. The results presented here demonstrate the benefit of semisolid food in investigating clinical dysphagia.",2011,The BST + SST was found to have a sensitivity of 89.6% (NEU = 66.7%; NNEU = 90.9%) and a specificity of 72.7% (NEU = 87.5%; NNEU = 90.9%).,"['patients with oropharyngeal swallowing disorders of neurological (NEU) and non-neurological (NNEU) origin were compared', 'oropharyngeal dysphagia', '62 patients (mean age\xa0=\xa064.68; range\xa0=\xa022-84) were included in the study (NEU\xa0']","['semisolid food (bolus swallow test, BST', 'standardised saliva swallow test (SST), WST, BST, combinations of these tests and an endoscopic swallow test (FEES', 'semisolid bolus swallow test', 'BST in combination with SST']","['rater reliability', 'Sensitivity, specificity, test accuracy and inter-rater reliability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal Dysphagia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0015751', 'cui_str': 'Fees'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",,0.0224785,The BST + SST was found to have a sensitivity of 89.6% (NEU = 66.7%; NNEU = 90.9%) and a specificity of 72.7% (NEU = 87.5%; NNEU = 90.9%).,"[{'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Schultheiss', 'Affiliation': 'Department of Otolaryngology at UKB, Charité Medical School, Warener Straße 7, Berlin, Germany.'}, {'ForeName': 'Ricki', 'Initials': 'R', 'LastName': 'Nusser-Müller-Busch', 'Affiliation': ''}, {'ForeName': 'Rainer O', 'Initials': 'RO', 'LastName': 'Seidl', 'Affiliation': ''}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-011-1628-5']
295,21188654,Improved functional activity of bone marrow derived circulating progenitor cells after intra coronary freshly isolated bone marrow cells transplantation in patients with ischemic heart disease.,"OBJECTIVES


There is growing evidence that intracoronary autologous bone marrow cells transplantation (BMCs-Tx) in patients with chronic myocardial infarction beneficially affects postinfarction remodelling. In this randomized controlled study we analyzed the influence of intracoronary autologous freshly isolated bone marrow cells transplantation by use of point of care system on cardiac function and on the functional activity of bone marrow derived circulating progenitor cells (BM-CPCs) in patients with ischemic heart disease (IHD).
METHODS


56 patients with IHD were randomized to either received freshly isolated BMC-Tx or a control group that did not receive cell therapy. The functional activity of BM-CPCs in peripheral blood (PB) was measured by migration assay and colony forming unit assay pre- and 3, 6 as well as 12 months after procedure. Global ejection fraction (EF) and infarct size area were determined by left ventriculography.
RESULTS


Intracoronary transplantation of autologous freshly isolated BMCs led to a significant reduction of infarct size and an increase of global EF as well as infarct wall movement velocity after 3 and 12 months follow-up compared to control group. The colony-forming capacity of BM-CPCs significantly increased 3, 6 and 12 months after cell therapy compared to pre BMCs-Tx and control group (CFU-E: p < 0.001, CFU-GM: p < 0.001). Likewise, we found significant increase of migratory response to stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor (VEGF) after cell therapy compared to pre BMCs-Tx (SDF-1: p < 0.001, VEGF: p < 0.001) and to control (SDF-1: p < 0.001, VEGF: p < 0.001). There was no significant difference of migratory- and colony forming capacity between pre- and 3, 6, 12 months after coronary angiography in control group without cell therapy.
CONCLUSIONS


Intracoronary transplantation of autologous freshly isolated BMCs by use of point of care system may lead to improvement of BM-CPCs functional activity in peripheral blood, which might increase the regenerative potency in patients with IHD.",2011,"There was no significant difference of migratory- and colony forming capacity between pre- and 3, 6, 12 months after coronary angiography in control group without cell therapy.
","['56 patients with IHD', 'patients with ischemic heart disease (IHD', 'patients with ischemic heart disease', 'patients with IHD', 'patients with chronic myocardial infarction']","['bone marrow derived circulating progenitor cells after intra coronary freshly isolated bone marrow cells transplantation', 'bone marrow derived circulating progenitor cells (BM-CPCs', 'intracoronary autologous freshly isolated bone marrow cells transplantation', 'freshly isolated BMC-Tx or a control group that did not receive cell therapy', 'intracoronary autologous bone marrow cells transplantation (BMCs-Tx']","['migratory- and colony forming capacity', 'infarct size', 'colony-forming capacity of BM-CPCs', 'infarct wall movement velocity', 'global EF', 'migratory response to stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor (VEGF', 'Global ejection fraction (EF) and infarct size area', 'functional activity of BM-CPCs in peripheral blood (PB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C1258861', 'cui_str': 'Bone Marrow Cell Transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0302189', 'cui_str': 'Cell Therapy'}]","[{'cui': 'C0232901', 'cui_str': 'Migratory (qualifier value)'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0218504', 'cui_str': 'Chemokine (C-X-C Motif) Ligand 12'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}]",56.0,0.0248769,"There was no significant difference of migratory- and colony forming capacity between pre- and 3, 6, 12 months after coronary angiography in control group without cell therapy.
","[{'ForeName': 'R Goekmen', 'Initials': 'RG', 'LastName': 'Turan', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, Rostock-University, Ernst Hydemann Str 6, 18055, Rostock, Germany. dr_g_turan@hotmail.com'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bozdag-T', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ortak', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kische', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Turan', 'Affiliation': ''}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Rehders', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rauchhaus', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kleinfeldt', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Belu', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brehm', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yokus', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Steiner', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sahin', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Nienaber', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ince', 'Affiliation': ''}]",Stem cell reviews and reports,['10.1007/s12015-010-9220-8']
296,21611724,Human cognitive flexibility depends on dopamine D2 receptor signaling.,"RATIONALE


Accumulating evidence indicates that the cognitive effects of dopamine depend on the subtype of dopamine receptor that is activated. In particular, recent work with animals as well as current theorizing has suggested that cognitive flexibility depends on dopamine D2 receptor signaling. However, there is no evidence for similar mechanisms in humans.
OBJECTIVES


We aim to demonstrate that optimal dopamine D2 receptor signaling is critical for human cognitive flexibility.
METHODS


To this end, a pharmacological pretreatment design was employed. This enabled us to investigate whether effects of the dopamine receptor agonist bromocriptine on task-set switching were abolished by pretreatment with the D2 receptor antagonist sulpiride. To account for individual (genetic) differences in baseline levels of dopamine, we made use of a common variable number of tandem repeat (VNTR) polymorphism in the 3'-untranslated region of the dopamine transporter gene, DAT1.
RESULTS


Bromocriptine improved cognitive flexibility relative to placebo, but only in subjects with genetically determined low levels of dopamine (n = 27). This beneficial effect of bromocriptine on cognitive flexibility was blocked by pretreatment with the selective dopamine D2 receptor antagonist sulpiride (n = 14).
CONCLUSIONS


These results provide strong evidence in favor of the hypothesis that human cognitive flexibility implicates dopamine D2 receptor signaling.",2011,"RESULTS


Bromocriptine improved cognitive flexibility relative to placebo, but only in subjects with genetically determined low levels of dopamine (n = 27).",[],"['Bromocriptine', 'bromocriptine', 'dopamine receptor agonist bromocriptine', 'placebo']","['cognitive flexibility', 'cognitive flexibility relative']",[],"[{'cui': 'C0006230', 'cui_str': 'Bromocriptine'}, {'cui': 'C4521850', 'cui_str': 'Dopamine receptor agonist (disposition)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.037788,"RESULTS


Bromocriptine improved cognitive flexibility relative to placebo, but only in subjects with genetically determined low levels of dopamine (n = 27).","[{'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'van Holstein', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour (RU/DI-BCB), Radboud University Nijmegen, Kapittelweg 29, 6521 EN Nijmegen, the Netherlands. m.vanholstein@donders.ru.nl'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Aarts', 'Affiliation': ''}, {'ForeName': 'Marieke E', 'Initials': 'ME', 'LastName': 'van der Schaaf', 'Affiliation': ''}, {'ForeName': 'Dirk E M', 'Initials': 'DE', 'LastName': 'Geurts', 'Affiliation': ''}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'Verkes', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Franke', 'Affiliation': ''}, {'ForeName': 'Martine R', 'Initials': 'MR', 'LastName': 'van Schouwenburg', 'Affiliation': ''}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Cools', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2340-2']
297,21547496,Beta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trial.,"AIMS/HYPOTHESIS


Traditional blood glucose lowering agents do not prevent the progressive loss of beta cell function in patients with type 2 diabetes. The dipeptidylpeptidase (DPP)-4 inhibitor vildagliptin improves beta cell function both acutely and chronically (up to 2 years). Whether this effect persists after cessation of treatment remains unknown. Here, we assessed the insulin secretory capacity in drug-naive patients with type 2 diabetes after a 52 week treatment period with vildagliptin or placebo, and again after a 12 week washout period.
METHODS


This study was conducted at a single university medical centre, and was a double-blind, randomised clinical trial in 59 drug-naive patients with type 2 diabetes and mild hyperglycaemia to either vildagliptin 100 mg (n = 29) or placebo (n = 30). Randomisation was performed by a validated 1:1 system. Neither patient, nor caregiver, was informed about the assigned treatment. Inclusion criteria were drug-naive patients ≥30 years, with HbA(1c) ≤7.5% and BMI of 22-45 kg/m(2). The mildly hyperglycaemic patient population was chosen to minimise glucose toxicity as a confounding variable. Beta-cell function was measured during an arginine-stimulated hyperglycaemic clamp at week 0, week 52 and after a 12 week washout period. All patients with at least one post-randomisation measure were analysed (intent-to-treat).
RESULTS


Fifty-two week vildagliptin 100 mg (n = 26) treatment increased the primary efficacy variable, combined hyperglycaemia and arginine-stimulated C-peptide secretion (AIR(arg)), by 5.0 ± 1.8 nmol/l × min, while it decreased by 0.8 ± 1.8 nmol/l × min with placebo (n = 25) (between-group difference p = 0.030). No significant between-group difference in AIR(arg) was seen after the 12 week washout period. The between-group difference adjusted mean 52 week changes from baseline was -0.19 ± 0.11, p = 0.098 and -0.22 ± 0.23%, p = 0.343 for HbA(1c) and fasting plasma glucose, respectively. There were no suspected drug treatment-related serious adverse events.
CONCLUSIONS/INTERPRETATION


One year treatment with vildagliptin significantly increased beta cell secretory capacity. This effect was not maintained after the washout, indicating that this increased capacity was not a disease modifying effect on beta cell mass and/or function.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00260156.",2011,"The between-group difference adjusted mean 52 week changes from baseline was -0.19 ± 0.11, p = 0.098 and -0.22 ± 0.23%, p = 0.343 for HbA(1c) and fasting plasma glucose, respectively.","['drug-naive patients with type 2 diabetes after a 52 week treatment period with', '100 mg (n\u2009=\u200929) or', '59 drug-naive patients with type 2 diabetes and mild hyperglycaemia to either', 'patients with type 2 diabetes', 'Inclusion criteria were drug-naive patients ≥30 years, with HbA(1c) ≤7.5% and BMI of 22-45 kg/m(2', 'drug-naive patients with type 2 diabetes and mild hyperglycaemia', 'n\u2009=\u200930']","['vildagliptin', 'vildagliptin or placebo', 'placebo', 'dipeptidylpeptidase (DPP)-4 inhibitor vildagliptin']","['beta cell secretory capacity', 'glucose toxicity', 'fasting plasma glucose', 'Beta cell function', 'Beta-cell function', 'insulin secretory capacity', 'primary efficacy variable, combined hyperglycaemia and arginine-stimulated C-peptide secretion (AIR(arg', 'AIR(arg']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",59.0,0.0817293,"The between-group difference adjusted mean 52 week changes from baseline was -0.19 ± 0.11, p = 0.098 and -0.22 ± 0.23%, p = 0.343 for HbA(1c) and fasting plasma glucose, respectively.","[{'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Foley', 'Affiliation': 'Novartis Pharmaceutical Cooperation, Clinical Research and Development, One Health Plaza, East Hanover, NJ 07936, USA. james.foley@novartis.com'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Bunck', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Möller-Goede', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Poelma', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nijpels', 'Affiliation': ''}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Eekhoff', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schweizer', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Heine', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diamant', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-011-2167-8']
298,21597989,Contingent negative variation as a dopaminergic biomarker: evidence from dose-related effects of methylphenidate.,"RATIONALE


The basal ganglia play an important role in motor control, which is dependent on dopaminergic input. Preparation of a motor response has been associated with dopamine release in the basal ganglia, and response readiness may therefore serve as a pharmacodynamic marker of dopamine activity.
METHODS


We measured response readiness using the amplitude of the contingent negative variation (CNV), a slow negative shift in the electroencephalogram. The CNV is evoked in a paradigm in which a warning stimulus (S1) signals the occurrence of the imperative stimulus (S2) 4 s later, to which the participant has to respond. CNV was assessed in healthy volunteers after administration of placebo or 10, 20 or 40 mg of methylphenidate, a catecholamine re-uptake blocker which primarily enhances the synaptic concentration of dopamine and to a lesser extent also noradrenaline. In addition, participants filled out two visual analogue scales measuring subjective ratings of mood and alertness: Profile of Mood States and Bond and Lader.
RESULTS


Methylphenidate dose dependently increased CNV amplitude and decreased reaction times. Furthermore, participants reported improved mood, feeling more alert, vigorous and content and less angry and tired after methylphenidate.
CONCLUSIONS


These results indicate that dopamine availability increases response readiness as measured by the CNV paradigm. The CNV appears to be a good candidate biomarker for assessing changes in dopaminergic function by treatments that either directly or indirectly target the dopaminergic system.",2011,"CNV was assessed in healthy volunteers after administration of placebo or 10, 20 or 40 mg of methylphenidate, a catecholamine re-uptake blocker which primarily enhances the synaptic concentration of dopamine and to a lesser extent also noradrenaline.",['healthy volunteers'],"['methylphenidate', 'Methylphenidate', 'placebo']","['visual analogue scales measuring subjective ratings of mood and alertness: Profile of Mood States and Bond and Lader', 'mood, feeling more alert, vigorous and content and less angry and tired', 'CNV amplitude and decreased reaction times']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0557875', 'cui_str': 'Tired (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0423334,"CNV was assessed in healthy volunteers after administration of placebo or 10, 20 or 40 mg of methylphenidate, a catecholamine re-uptake blocker which primarily enhances the synaptic concentration of dopamine and to a lesser extent also noradrenaline.","[{'ForeName': 'Anke M W', 'Initials': 'AM', 'LastName': 'Linssen', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, PO Box 616, 6200 MD Maastricht, the Netherlands. anke.linssen@maastrichtuniversity.nl'}, {'ForeName': 'Eric F P M', 'Initials': 'EF', 'LastName': 'Vuurman', 'Affiliation': ''}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Sambeth', 'Affiliation': ''}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Nave', 'Affiliation': ''}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Spooren', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Vargas', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Santarelli', 'Affiliation': ''}, {'ForeName': 'Wim J', 'Initials': 'WJ', 'LastName': 'Riedel', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2345-x']
299,21597880,Training of attention functions in children with attention deficit hyperactivity disorder.,"Pharmacological treatment of children with ADHD has been shown to be successful; however, medication may not normalize attention functions. The present study was based on a neuropsychological model of attention and assessed the effect of an attention training program on attentional functioning of children with ADHD. Thirty-two children with ADHD and 16 healthy children participated in the study. Children with ADHD were randomly assigned to one of the two conditions, i.e., an attention training program which trained aspects of vigilance, selective attention and divided attention, or a visual perception training which trained perceptual skills, such as perception of figure and ground, form constancy and position in space. The training programs were applied in individual sessions, twice a week, for a period of four consecutive weeks. Healthy children did not receive any training. Alertness, vigilance, selective attention, divided attention, and flexibility were examined prior to and following the interventions. Children with ADHD were assessed and trained while on ADHD medications. Data analysis revealed that the attention training used in the present study led to significant improvements of various aspects of attention, including vigilance, divided attention, and flexibility, while the visual perception training had no specific effects. The findings indicate that attention training programs have the potential to facilitate attentional functioning in children with ADHD treated with ADHD drugs.",2011,"Data analysis revealed that the attention training used in the present study led to significant improvements of various aspects of attention, including vigilance, divided attention, and flexibility, while the visual perception training had no specific effects.","['children with attention deficit hyperactivity disorder', 'Children with ADHD', 'Thirty-two children with ADHD and 16 healthy children participated in the study', 'children with ADHD', 'Healthy children', 'children with ADHD treated with ADHD drugs']","['attention training program', 'attention training program which trained aspects of vigilance, selective attention and divided attention, or a visual perception training which trained perceptual skills, such as perception of figure and ground, form constancy and position in space']","['Alertness, vigilance, selective attention, divided attention, and flexibility', 'various aspects of attention, including vigilance, divided attention, and flexibility', 'attentional functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0556509', 'cui_str': 'Attention training (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention (finding)'}, {'cui': 'C0589101', 'cui_str': 'Divided attention, function (observable entity)'}, {'cui': 'C0042830', 'cui_str': 'Visual Perception'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0233421', 'cui_str': 'Selective inattention (finding)'}, {'cui': 'C0589101', 'cui_str': 'Divided attention, function (observable entity)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",32.0,0.012161,"Data analysis revealed that the attention training used in the present study led to significant improvements of various aspects of attention, including vigilance, divided attention, and flexibility, while the visual perception training had no specific effects.","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Tucha', 'Affiliation': 'Department of Clinical and Developmental Neuropsychology, University of Groningen, The Netherlands. o.m.tucha@rug.nl'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Tucha', 'Affiliation': ''}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Kaumann', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'König', 'Affiliation': ''}, {'ForeName': 'Katharina M', 'Initials': 'KM', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Stasik', 'Affiliation': ''}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Streather', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Engelschalk', 'Affiliation': ''}, {'ForeName': 'Klaus W', 'Initials': 'KW', 'LastName': 'Lange', 'Affiliation': ''}]",Attention deficit and hyperactivity disorders,['10.1007/s12402-011-0059-x']
300,21468753,Maternal health-related quality of life after induction of labor or expectant monitoring in pregnancy complicated by intrauterine growth retardation beyond 36 weeks.,"OBJECTIVE


Pregnancies complicated by intrauterine growth retardation (IUGR) beyond 36 weeks of gestation are at increased risk of neonatal morbidity and mortality. Optimal treatment in IUGR at term is highly debated. Results from the multicenter DIGITAT (Disproportionate Intrauterine Growth Intervention Trial At Term) trial show that induction of labor and expectant monitoring result in equal neonatal and maternal outcomes for comparable cesarean section rates. We report the maternal health-related quality of life (HR-QoL) that was measured alongside the trial at several points in time.
METHODS


Both randomized and non-randomized women were asked to participate in the HR-QoL study. Women were asked to fill out written validated questionnaires, covering background characteristics, condition-specific issues and the Short Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression scale (HADS), and Symptom Check List (SCL-90) at baseline, 6 weeks postpartum and 6 months postpartum. We compared the difference scores of all summary measures between the two management strategies by ANOVA. A repeated measures multivariate mixed model was defined to assess the effect of the management strategies on the physical (PCS) and mental (MCS) components of the SF-36. Analysis was by intention to treat.
RESULTS


We analyzed data of 361 randomized and 198 non-randomized patients. There were no clinically relevant differences between the treatments at 6 weeks or 6 months postpartum on any summary measures; e.g., on the SF-36 (PCS: P = .09; MCS: P = .48). The PCS and the MCS were below norm values at inclusion. The PCS improved over time but stayed below norm values at 6 months, while the MCS did not improve.
CONCLUSION


In pregnancies complicated by IUGR beyond 36 weeks, induction of labor does not affect the long-term maternal quality of life.",2011,"In pregnancies complicated by IUGR beyond 36 weeks, induction of labor does not affect the long-term maternal quality of life.","['361 randomized and 198 non-randomized patients', 'pregnancy complicated by intrauterine growth retardation beyond 36\xa0weeks']",[],"['neonatal morbidity and mortality', 'equal neonatal and maternal outcomes', 'Maternal health-related quality of life', 'Short Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression scale (HADS), and Symptom Check List (SCL-90', 'physical (PCS) and mental (MCS) components of the SF-36', 'long-term maternal quality of life', 'maternal health-related quality of life (HR-QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",361.0,0.186485,"In pregnancies complicated by IUGR beyond 36 weeks, induction of labor does not affect the long-term maternal quality of life.","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bijlenga', 'Affiliation': 'Department of Social Medicine, Academic Medical Center, PO Box 22660, 1100 DD, Amsterdam, The Netherlands. denise.bijlenga@gmail.com'}, {'ForeName': 'Kim E', 'Initials': 'KE', 'LastName': 'Boers', 'Affiliation': ''}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Birnie', 'Affiliation': ''}, {'ForeName': 'Ben-Willem J', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': ''}, {'ForeName': 'Sylvia C M', 'Initials': 'SC', 'LastName': 'Vijgen', 'Affiliation': ''}, {'ForeName': 'Joris A M', 'Initials': 'JA', 'LastName': 'Van der Post', 'Affiliation': ''}, {'ForeName': 'Christianne J', 'Initials': 'CJ', 'LastName': 'De Groot', 'Affiliation': ''}, {'ForeName': 'Robbert J P', 'Initials': 'RJ', 'LastName': 'Rijnders', 'Affiliation': ''}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Pernet', 'Affiliation': ''}, {'ForeName': 'Frans J', 'Initials': 'FJ', 'LastName': 'Roumen', 'Affiliation': ''}, {'ForeName': 'Rob H', 'Initials': 'RH', 'LastName': 'Stigter', 'Affiliation': ''}, {'ForeName': 'Friso M C', 'Initials': 'FM', 'LastName': 'Delemarre', 'Affiliation': ''}, {'ForeName': 'Henk A', 'Initials': 'HA', 'LastName': 'Bremer', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Porath', 'Affiliation': ''}, {'ForeName': 'Sicco A', 'Initials': 'SA', 'LastName': 'Scherjon', 'Affiliation': ''}, {'ForeName': 'Gouke J', 'Initials': 'GJ', 'LastName': 'Bonsel', 'Affiliation': ''}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-011-9891-x']
301,21556821,Alpe d'HuZes cancer rehabilitation (A-CaRe) research: four randomized controlled exercise trials and economic evaluations in cancer patients and survivors.,"BACKGROUND


Previous studies showed that exercise in cancer patients is feasible and may reduce fatigue and improve physical fitness and quality of life. However, many previous studies had methodological weaknesses related to trial design, sample size, comparison group, outcome measures, short follow-up durations and programme content.
PURPOSE


This paper aims to present the rationale and design of the clinical research subprogramme of the Alpe d'HuZes Cancer Rehabilitation (A-CaRe) programme.
METHOD


A-CaRe Clinical Research includes four randomized controlled trials in patients: (a) after chemotherapy, (b) during chemotherapy, (c) after stem cell transplantation and (d) during childhood cancer. These trials compare high-intensity resistance and endurance exercise interventions with usual care or a waiting list control group. In two studies, a second intervention arm consisting of low-to-moderate intensity exercise is included. All four A-CaRe trials use similar methods.
RESULTS


Outcome measures are carefully chosen based on the International Classification of Functioning Disability and Health model. Measurements will be performed prior to randomization (T0), after completion of the intervention (T1) and at follow-up (T2). The primary outcome measures are cardiorespiratory fitness, muscle strength and fatigue. Secondary outcome measures include health-related quality of life and psychosocial functioning. Furthermore, cost-effectiveness and cost-utility analyses are performed from a societal perspective.
CONCLUSION


We hypothesize that exercise is more effective at improving physical fitness and thereby reducing fatigue and more cost-effective compared with usual care or a waiting list control group. If so, the programmes will be implemented in the Dutch clinical practice.",2012,"BACKGROUND


Previous studies showed that exercise in cancer patients is feasible and may reduce fatigue and improve physical fitness and quality of life.","['cancer patients and survivors', 'patients: (a) after chemotherapy, (b) during chemotherapy, (c) after stem cell transplantation and (d) during childhood cancer', 'cancer patients']",['endurance exercise interventions with usual care or a waiting list control group'],"['health-related quality of life and psychosocial functioning', 'cost-effectiveness and cost-utility analyses', 'International Classification of Functioning Disability and Health model', 'physical fitness and quality of life', 'cardiorespiratory fitness, muscle strength and fatigue']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.120733,"BACKGROUND


Previous studies showed that exercise in cancer patients is feasible and may reduce fatigue and improve physical fitness and quality of life.","[{'ForeName': 'Mai J M', 'Initials': 'MJ', 'LastName': 'Chinapaw', 'Affiliation': 'Department of Public and Occupational Health, EMGO Institute for Health and Care Research, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. m.chinapaw@vumc.nl'}, {'ForeName': 'Laurien M', 'Initials': 'LM', 'LastName': 'Buffart', 'Affiliation': ''}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Mechelen', 'Affiliation': ''}, {'ForeName': 'Goof', 'Initials': 'G', 'LastName': 'Schep', 'Affiliation': ''}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Aaronson', 'Affiliation': ''}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Harten', 'Affiliation': ''}, {'ForeName': 'Martijn M', 'Initials': 'MM', 'LastName': 'Stuiver', 'Affiliation': ''}, {'ForeName': 'Marie José', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': ''}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': ''}, {'ForeName': 'Gertjan J L', 'Initials': 'GJ', 'LastName': 'Kaspers', 'Affiliation': ''}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'van Dulmen-den Broeder', 'Affiliation': ''}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Huisman', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Takken', 'Affiliation': ''}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'van Tulder', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brug', 'Affiliation': ''}]",International journal of behavioral medicine,['10.1007/s12529-011-9158-5']
302,21475692,"The effects of a high-caloric protein-rich oral nutritional supplement in patients with chronic heart failure and cachexia on quality of life, body composition, and inflammation markers: a randomized, double-blind pilot study.","The prevalence of cardiac cachexia in chronic heart failure is approximately 5% to 15% and 18-month mortality rates can reach 50%. Treatment with angiotensin-converting enzyme inhibitors and beta-blockers may confer some benefit but no proven therapy exists. We tested the effects of an oral nutritional supplement in cachectic patients with heart failure. This was a prospective, randomized, double-blind, placebo-controlled pilot study which randomized 29 patients to a high-caloric (600 kcal) high-protein (20 g) oral nutritional supplement or placebo for a duration of 6 weeks in addition to the patients' usual food intake. At baseline, 6 weeks, and 18 weeks, we measured body weight, quality of life, body composition, heart function, laboratory parameters, and exercise performance. Edema-free body weight increased in 19 of 20 patients receiving intervention at 6 weeks and in 17 of 19 patients at 18 weeks with an average weight gain of 2.0 ± 1.7 kg (3.1 ± 2.4%, p = 0.0001) and 2.3 ± 3.1 kg (3.6 ± 4.7%, p = 0.007) at 6 and 18 weeks, respectively. Most of the weight gain was fat tissue with an absolute gain of 1.5 ± 1.7 kg (p = 0.003) and 1.6 ± 2.7 kg (p = 0.008). A significant improvement in quality of life and decrease in serum levels of tumor necrosis factor-α were observed (p < 0.05 for both). We demonstrated the feasibility of oral nutritional supplement in cachectic patients with heart failure and significant clinical benefit in terms of body size and body composition, laboratory parameters, and quality of life (www.clinicaltrials.gov identifier NCT00654719).",2010,A significant improvement in quality of life and decrease in serum levels of tumor necrosis factor-α were observed (,"['patients with chronic heart failure and cachexia on quality of life, body composition, and inflammation markers', ""for a duration of 6\xa0weeks in addition to the patients' usual food intake"", 'cachectic patients with heart failure', '29 patients to a high-caloric (600\xa0kcal) high-protein (20\xa0g']","['angiotensin-converting enzyme inhibitors and beta-blockers', 'high-caloric protein-rich oral nutritional supplement', 'placebo', 'oral nutritional supplement or placebo', 'oral nutritional supplement']","['body weight, quality of life, body composition, heart function, laboratory parameters, and exercise performance', 'quality of life', 'serum levels of tumor necrosis factor-α', 'weight gain', 'Edema-free body weight', 'cardiac cachexia in chronic heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0034380'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0034380'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4521692', 'cui_str': 'Cardiac physiological function (observable entity)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0562491', 'cui_str': 'Cardiac cachexia (finding)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]",29.0,0.201182,A significant improvement in quality of life and decrease in serum levels of tumor necrosis factor-α were observed (,"[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rozentryt', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'von Haehling', 'Affiliation': ''}, {'ForeName': 'Mitja', 'Initials': 'M', 'LastName': 'Lainscak', 'Affiliation': ''}, {'ForeName': 'Jolanta U', 'Initials': 'JU', 'LastName': 'Nowak', 'Affiliation': ''}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Kalantar-Zadeh', 'Affiliation': ''}, {'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Polonski', 'Affiliation': ''}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': ''}]","Journal of cachexia, sarcopenia and muscle",[]
303,21562755,Low-dose glucocorticoid treatment affects multiple aspects of intermediary metabolism in healthy humans: a randomised controlled trial.,"AIM/HYPOTHESIS


To assess whether low-dose glucocorticoid treatment induces adverse metabolic effects, as is evident for high glucocorticoid doses.
METHODS


In a randomised placebo-controlled double-blind (participants and the investigators who performed the studies and assessed the outcomes were blinded) dose-response intervention study, 32 healthy men (age 22 ± 3 years; BMI 22.4 ± 1.7 kg/m(2)) were allocated to prednisolone 7.5 mg once daily (n = 12), prednisolone 30 mg once daily (n = 12), or placebo (n = 8) for 2 weeks using block randomisation. Main outcome measures were glucose, lipid and protein metabolism, measured by stable isotopes, before and at 2 weeks of treatment, in the fasted state and during a two-step hyperinsulinaemic clamp conducted in the Clinical Research Unit of the Academic Medical Centre, Amsterdam, the Netherlands
RESULTS


Prednisolone, compared with placebo, dose dependently and significantly increased fasting plasma glucose levels, whereas only prednisolone 30 mg increased fasting insulin levels (29 ± 15 pmol/l). Prednisolone 7.5 mg and prednisolone 30 mg decreased the ability of insulin to suppress endogenous glucose production (by 17 ± 6% and 46 ± 7%, respectively, vs placebo). Peripheral glucose uptake was not reduced by prednisolone 7.5 mg, but was decreased by prednisolone 30 mg by 34 ± 6% (p < 0.0001). Compared with placebo, prednisolone treatment tended to decrease lipolysis in the fasted state (p = 0.062), but both prednisolone 7.5 mg and prednisolone 30 mg decreased insulin-mediated suppression of lipolysis by 11 ± 5% and 34 ± 6%, respectively. Finally, prednisolone treatment increased whole-body proteolysis during hyperinsulinaemia, which tended to be driven by prednisolone 30 mg (5 ± 2%; p = 0.06). No side effects were reported by the study participants. All participants completed the study and were analysed.
CONCLUSIONS/INTERPRETATION


Not only at high doses but also at low doses, glucocorticoid therapy impaired intermediary metabolism by interfering with the metabolic actions of insulin on liver and adipose tissue. These data indicate that even low-dose glucocorticoids may impair glucose tolerance when administered chronically.
TRIAL REGISTRATION


ISRCTN83991850.",2011,"Compared with placebo, prednisolone treatment tended to decrease lipolysis in the fasted state (p = 0.062), but both prednisolone 7.5 mg and prednisolone 30 mg decreased insulin-mediated suppression of lipolysis by 11 ± 5% and 34 ± 6%, respectively.","['32 healthy men (age 22\u2009±\u20093 years; BMI 22.4\u2009±\u20091.7 kg/m(2', 'healthy humans']","['placebo', 'Prednisolone 7.5 mg and prednisolone', 'prednisolone', 'placebo, prednisolone', 'glucocorticoids', 'glucocorticoid therapy', 'glucocorticoid', 'Low-dose glucocorticoid']","['whole-body proteolysis', 'ability of insulin to suppress endogenous glucose production', 'side effects', 'decrease lipolysis', 'fasting insulin levels', 'fasting plasma glucose levels', 'insulin-mediated suppression of lipolysis', 'Peripheral glucose uptake', 'glucose tolerance', 'adverse metabolic effects', 'glucose, lipid and protein metabolism, measured by stable isotopes']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0597304', 'cui_str': 'Protein Degradation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope (substance)'}]",32.0,0.359982,"Compared with placebo, prednisolone treatment tended to decrease lipolysis in the fasted state (p = 0.062), but both prednisolone 7.5 mg and prednisolone 30 mg decreased insulin-mediated suppression of lipolysis by 11 ± 5% and 34 ± 6%, respectively.","[{'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, VU University Medical Centre, de Boelelaan 1117, 1007 MB, Amsterdam, the Netherlands. d.vanraalte@vumc.nl'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brands', 'Affiliation': ''}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'van der Zijl', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Muskiet', 'Affiliation': ''}, {'ForeName': 'P J W', 'Initials': 'PJ', 'LastName': 'Pouwels', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Ackermans', 'Affiliation': ''}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Sauerwein', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Serlie', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diamant', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-011-2174-9']
304,21475971,Acute effects of alcohol on feedback processing and outcome evaluation during risky decision-making: an ERP study.,"RATIONALE


Although risky decision-making is one of the hallmarks of alcohol use disorders, relatively little is known about the acute psychopharmacological effects of alcohol on decision-making processes.
OBJECTIVE


The present study investigated the acute effects of alcohol on neural mechanisms underlying feedback processing and outcome evaluation during risky decision-making, using event-related brain potentials (ERPs).
METHODS


ERPs elicited by positive and negative feedback were recorded during performance of a modified version of the Balloon Analogue Risk Task in male participants receiving either a moderate dose of alcohol (0.65 g/kg alcohol; n = 32) or a non-alcoholic placebo beverage (n = 32).
RESULTS


Overall, there was no significant difference in the mean number of pumps between the alcohol and the placebo condition. However, when analyzing over time, it was found that the alcohol group made more riskier choices at the beginning of the task than the placebo group. ERPs demonstrated that alcohol consumption did not affect early processing of negative feedback, indexed by the feedback-related negativity. By contrast, alcohol-intoxicated individuals showed significantly reduced P300 amplitudes in response to negative feedback as compared to sober controls, suggesting that more elaborate evaluation to losses was significantly diminished.
CONCLUSIONS


These results suggest that alcohol consumption does not influence the ability to rapidly evaluate feedback valence, but rather the ability to assign sufficient attention to further process motivationally salient outcomes. Blunted P300 amplitudes may reflect poor integration of feedback across trials, particularly adverse ones. Consequently, alcohol may keep people from effectively predicting the probability of future gains and losses based on their reinforcement history.",2011,"ERPs demonstrated that alcohol consumption did not affect early processing of negative feedback, indexed by the feedback-related negativity.",['male participants receiving either a moderate dose of alcohol (0.65 g/kg alcohol; n\u2009=\u200932) or a'],"['alcohol', 'non-alcoholic placebo beverage', 'placebo']","['riskier choices', 'mean number of pumps']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4517471', 'cui_str': '0.65'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0687725', 'cui_str': 'Alcoholics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]",,0.0407688,"ERPs demonstrated that alcohol consumption did not affect early processing of negative feedback, indexed by the feedback-related negativity.","[{'ForeName': 'Anja S', 'Initials': 'AS', 'LastName': 'Euser', 'Affiliation': 'Institute of Psychology, Erasmus University Rotterdam, Woudestein T12-59, P.O. Box 1738, 3000 DR, Rotterdam, the Netherlands. euser@fsw.eur.nl'}, {'ForeName': 'Catharina S', 'Initials': 'CS', 'LastName': 'van Meel', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Snelleman', 'Affiliation': ''}, {'ForeName': 'Ingmar H A', 'Initials': 'IH', 'LastName': 'Franken', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2264-x']
305,21461043,The efficacy of laparoscopic uterosacral nerve ablation (LUNA) in the treatment of unexplained chronic pelvic pain: a randomized controlled trial.,"The aim of this work is to explore the efficacy , safety, and patients' satisfaction of laparoscopic uterosacral nerve ablation (LUNA) in relief of pain in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score ≤5). The study was a prospective, single-blind, randomized trial with 12 months follow-up. It was conducted at the endoscopy unit of the Gynecology Department of El Minia University Hospital, Egypt. One hundred ninety Egyptian women consented to participate in the study. These eligible patients were randomized using computer-generated tables and were divided into two equal groups, including the control group (diagnostic laparoscopy with no pelvic denervation) and the study group (diagnostic laparoscopy plus LUNA). Diagnostic laparoscopy with or without laparoscopic uterosacral nerve ablation was done. There were no statistically significant difference between both groups regarding the efficacy and the overall success rate (between group I and group II, it was 77.64%, 76.47%, and 74.11% versus 79.06%, 75.58%, and 73.25% at 3, 6, and 12 months, respectively) and the cumulative patients' satisfaction rate (it was 74.11%, 74.11%, and 71.76% versus 75.58%, 75.58%, and 72.09% at 3, 6, and 12 months between group I and group II, respectively; P ≤ 0.05). There was no statistically significant difference between both groups as regards the effectiveness of LUNA in the treatment of primary (spasmodic) and secondary (congestive) dysmenorrhea (P ≤ 0.05), while there was a statistically significant difference between both groups in the treatment of dyspareunia (P ≥ 0.05). LUNA can be a last alternative option in well-selected patients for control of chronic pelvic pain without endometriosis; however, its effectiveness may not extend to other indications. Also, preliminary experience in the treatment of primary deep dyspareunia presents a promising perspective on the management of deep dyspareunia, especially if it will involve a team of social, psychological, and gynecological specialists.",2011,"There was no statistically significant difference between both groups as regards the effectiveness of LUNA in the treatment of primary (spasmodic) and secondary (congestive) dysmenorrhea (P ≤ 0.05), while there was a statistically significant difference between both groups in the treatment of dyspareunia (P ≥ 0.05).","['One hundred ninety Egyptian women consented to participate in the study', 'unexplained chronic pelvic pain', 'women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score ≤5']","['laparoscopic uterosacral nerve ablation (LUNA', 'Diagnostic laparoscopy with or without laparoscopic uterosacral nerve ablation', 'LUNA', 'control group (diagnostic laparoscopy with no pelvic denervation) and the study group (diagnostic laparoscopy plus LUNA']","['effectiveness of LUNA', ""cumulative patients' satisfaction rate"", 'overall success rate', 'dyspareunia', 'efficacy , safety', 'primary (spasmodic) and secondary (congestive) dysmenorrhea']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C1880304', 'cui_str': 'Diagnostic laparoscopy (procedure)'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0586973', 'cui_str': 'Laparoscopic uterosacral nerve ablation (procedure)'}, {'cui': 'C1880304', 'cui_str': 'Diagnostic laparoscopy (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0232944', 'cui_str': 'Secondary dysmenorrhea (disorder)'}]",190.0,0.0329872,"There was no statistically significant difference between both groups as regards the effectiveness of LUNA in the treatment of primary (spasmodic) and secondary (congestive) dysmenorrhea (P ≤ 0.05), while there was a statistically significant difference between both groups in the treatment of dyspareunia (P ≥ 0.05).","[{'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'El-Din Shawki', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, El Minia University, El Minia, Egypt.'}]",Gynecological surgery,[]
306,21512799,"Changed activation, oxygenation, and pain response of chronically painful muscles to repetitive work after training interventions: a randomized controlled trial.","The aim of this randomized controlled trial was to assess changes in myalgic trapezius activation, muscle oxygenation, and pain intensity during repetitive and stressful work tasks in response to 10 weeks of training. In total, 39 women with a clinical diagnosis of trapezius myalgia were randomly assigned to: (1) general fitness training performed as leg-bicycling (GFT); (2) specific strength training of the neck/shoulder muscles (SST) or (3) reference intervention without physical exercise. Electromyographic activity (EMG), tissue oxygenation (near infrared spectroscopy), and pain intensity were measured in trapezius during pegboard and stress tasks before and after the intervention period. During the pegboard task, GFT improved trapezius oxygenation from a relative decrease of -0.83 ± 1.48 μM to an increase of 0.05 ± 1.32 μM, and decreased pain development by 43%, but did not affect resting levels of pain. SST lowered the relative EMG amplitude by 36%, and decreased pain during resting and working conditions by 52 and 38%, respectively, without affecting trapezius oxygenation. In conclusion, GFT performed as leg-bicycling decreased pain development during repetitive work tasks, possibly due to improved oxygenation of the painful muscles. SST lowered the overall level of pain both during rest and work, possibly due to a lowered relative exposure as evidenced by a lowered relative EMG. The results demonstrate differential adaptive mechanisms of contrasting physical exercise interventions on chronic muscle pain at rest and during repetitive work tasks.",2012,"SST lowered the relative EMG amplitude by 36%, and decreased pain during resting and working conditions by 52 and 38%, respectively, without affecting trapezius oxygenation.",['39 women with a clinical diagnosis of trapezius myalgia'],"['GFT', 'SST', 'physical exercise interventions', 'general fitness training performed as leg-bicycling (GFT); (2) specific strength training of the neck/shoulder muscles (SST) or (3) reference intervention without physical exercise']","['pain during resting and working conditions', 'myalgic trapezius activation, muscle oxygenation, and pain intensity during repetitive and stressful work tasks', 'overall level of pain', 'relative EMG amplitude', 'chronic muscle pain', 'trapezius oxygenation', 'resting levels of pain', 'Changed activation, oxygenation, and pain response', 'pain development', 'Electromyographic activity (EMG), tissue oxygenation (near infrared spectroscopy), and pain intensity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0687023', 'cui_str': 'Structure of skeletal muscle of shoulder'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}]",39.0,0.112704,"SST lowered the relative EMG amplitude by 36%, and decreased pain during resting and working conditions by 52 and 38%, respectively, without affecting trapezius oxygenation.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Søgaard', 'Affiliation': 'Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark. ksogaard@health.sdu.dk'}, {'ForeName': 'Anne Katrine', 'Initials': 'AK', 'LastName': 'Blangsted', 'Affiliation': ''}, {'ForeName': 'Pernille Kofoed', 'Initials': 'PK', 'LastName': 'Nielsen', 'Affiliation': ''}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Vedsted', 'Affiliation': ''}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sjøgaard', 'Affiliation': ''}]",European journal of applied physiology,['10.1007/s00421-011-1964-6']
307,21494790,The D2 antagonist sulpiride modulates the neural processing of both rewarding and aversive stimuli in healthy volunteers.,"RATIONALE


Animal studies indicate that dopamine pathways in the ventral striatum code for the motivational salience of both rewarding and aversive stimuli, but evidence for this mechanism in humans is less established. We have developed a functional magnetic resonance imaging (fMRI) model which permits examination of the neural processing of both rewarding and aversive stimuli.
OBJECTIVES


The aim of the study was to determine the effect of the dopamine receptor antagonist, sulpiride, on the neural processing of rewarding and aversive stimuli in healthy volunteers.
METHODS


We studied 30 healthy participants who were randomly allocated to receive a single dose of sulpiride (400 mg) or placebo, in a double-blind, parallel-group design. We used fMRI to measure the neural response to rewarding (taste or sight of chocolate) and aversive stimuli (sight of mouldy strawberries or unpleasant strawberry taste) 4 h after drug treatment.
RESULTS


Relative to placebo, sulpiride reduced blood oxygenation level-dependent responses to chocolate stimuli in the striatum (ventral striatum) and anterior cingulate cortex. Sulpiride also reduced lateral orbitofrontal cortex and insula activations to the taste and sight of the aversive condition.
CONCLUSIONS


These results suggest that acute dopamine receptor blockade modulates mesolimbic and mesocortical neural activations in response to both rewarding and aversive stimuli in healthy volunteers. This effect may be relevant to the effects of dopamine receptor antagonists in the treatment of psychosis and may also have implications for the possible antidepressant properties of sulpiride.",2011,"Relative to placebo, sulpiride reduced blood oxygenation level-dependent responses to chocolate stimuli in the striatum (ventral striatum) and anterior cingulate cortex.","['30 healthy participants', 'healthy volunteers']","['sulpiride (400\xa0mg) or placebo', 'dopamine receptor antagonist, sulpiride', 'rewarding (taste or sight of chocolate) and aversive stimuli (sight of mouldy strawberries or unpleasant strawberry taste) 4\xa0h after drug treatment']","['lateral orbitofrontal cortex and insula activations', 'blood oxygenation level']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242702', 'cui_str': 'Dopamine Blockers'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0457802', 'cui_str': 'Strawberries'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3853024', 'cui_str': 'Lateral Orbitofrontal Cortex'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",30.0,0.110331,"Relative to placebo, sulpiride reduced blood oxygenation level-dependent responses to chocolate stimuli in the striatum (ventral striatum) and anterior cingulate cortex.","[{'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Neuroscience Building, Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX3 7JX, UK. ciara.mccabe@psych.ox.ac.uk'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Huber', 'Affiliation': ''}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': ''}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2278-4']
308,21509429,Short- and long-lasting tinnitus relief induced by transcranial direct current stimulation.,"A significant proportion of the population suffers from tinnitus, a bothersome auditory phantom perception that can severely alter the quality of life. Numerous experimental studies suggests that a maladaptive plasticity of the auditory and limbic cortical areas may underlie tinnitus. Accordingly, repetitive transcranial magnetic stimulation (rTMS) has been repeatedly used with success to reduce tinnitus intensity. The potential of transcranial direct current stimulation (tDCS), another promising method of noninvasive brain stimulation, to relieve tinnitus has not been explored systematically. In a double-blind, placebo-controlled and balanced order design, 20 patients suffering from chronic untreatable tinnitus were submitted to 20 minutes of 1 mA anodal, cathodal and sham tDCS targeting the left temporoparietal area. The primary outcome measure was a change in tinnitus intensity or discomfort assessed with a Visual Analogic Scale (VAS) change-scale immediately after tDCS and 1 hour later. Compared to sham tDCS, anodal tDCS significantly reduced tinnitus intensity immediately after stimulation; whereas cathodal tDCS failed to do so. The variances of the tinnitus intensity and discomfort VAS change-scales increased dramatically after anodal and cathodal tDCS, whereas they remained virtually unchanged after sham tDCS. Moreover, several patients unexpectedly reported longer-lasting effects (at least several days) such as tinnitus improvement, worsening, or changes in tinnitus features, more frequently after real than sham tDCS. Anodal tDCS is a promising therapeutic tool for modulating tinnitus perception. Moreover, both anodal and cathodal tDCS seem able to alter tinnitus perception and could, thus, be used to trigger plastic changes.",2011,"Compared to sham tDCS, anodal tDCS significantly reduced tinnitus intensity immediately after stimulation; whereas cathodal tDCS failed to do so.",['20 patients suffering from chronic untreatable tinnitus'],"['repetitive transcranial magnetic stimulation (rTMS', 'anodal and cathodal tDCS', 'placebo', 'Anodal tDCS', 'transcranial direct current stimulation', 'mA anodal, cathodal and sham tDCS', 'transcranial direct current stimulation (tDCS', 'sham tDCS, anodal tDCS']","['tinnitus intensity and discomfort VAS change-scales', 'tinnitus perception', 'change in tinnitus intensity or discomfort assessed with a Visual Analogic Scale (VAS) change-scale', 'quality of life', 'tinnitus improvement, worsening, or changes in tinnitus features', 'longer-lasting effects', 'tinnitus intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",20.0,0.0710209,"Compared to sham tDCS, anodal tDCS significantly reduced tinnitus intensity immediately after stimulation; whereas cathodal tDCS failed to do so.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Garin', 'Affiliation': ""Centre Universitaire d'Audiophonologie, Department of Otorhinolaryngology, CHU Mont-Godinne, Université Catholique de Louvain, Avenue Dr G. Therasse, 5530 Yvoir, Belgium.""}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Gilain', 'Affiliation': ''}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Van Damme', 'Affiliation': ''}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'de Fays', 'Affiliation': ''}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Jamart', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ossemann', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Vandermeeren', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-011-6037-6']
309,21442223,The relative timing of trunk muscle activation is retained in response to unanticipated postural-perturbations during acute low back pain.,"The purpose of this study was to assess the activation of the erector spinae (ES) and external oblique (EO) in response to unanticipated, bi-directional postural perturbations before and after the induction of acute low back pain (LBP) in healthy individuals. An experimental session consisted of a baseline, control, and an acute LBP condition. For the control and acute LBP condition, isotonic or hypertonic saline (HS), respectively, was injected into the right ES muscle. In each condition, participants stood on a moveable platform during which 32 randomized postural perturbations (8 repetitions of 4 perturbation types: 8 cm anterior slides, 8 cm posterior slides, 10° anterior tilts, and 10° posterior tilts) with varying inter-perturbation time intervals were performed over a period of 4-5 min. Bilateral surface electromyography (EMG) was recorded from the ES and EO in addition to subjective pain records. During the acute LBP condition: (1) the onset time of the ES and EO was delayed for the forward and backward sliding perturbations (P < 0.05); (2) EMG amplitude was reduced bilaterally for all perturbations (P < 0.05); (3) the order of activation and interval between the onset times of the ES and EO were unaltered and (4) ES, but not EO, activity was adjusted to account for the directional differences between the perturbations. This study revealed that re-establishment of posture and balance was a result of the individuals' ability to rapidly modulate ES with respect to EO activity and that the bi-directional postural responses, although shifted in time and amplitude, retained temporal features in the presence of acute LBP.",2011,"This study revealed that re-establishment of posture and balance was a result of the individuals' ability to rapidly modulate ES with respect to EO activity and that the bi-directional postural responses, although shifted in time and amplitude, retained temporal features in the presence of acute LBP.",['healthy individuals'],['isotonic or hypertonic saline (HS'],"['activation of the erector spinae (ES) and external oblique (EO', 'Bilateral surface electromyography (EMG', 'EMG amplitude']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}]",,0.0392769,"This study revealed that re-establishment of posture and balance was a result of the individuals' ability to rapidly modulate ES with respect to EO activity and that the bi-directional postural responses, although shifted in time and amplitude, retained temporal features in the presence of acute LBP.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boudreau', 'Affiliation': 'Center for Sensory-Motor Interaction, Department of Health Science and Technology Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Farina', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kongstad', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Buus', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Redder', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sverrisdóttir', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Falla', 'Affiliation': ''}]",Experimental brain research,['10.1007/s00221-011-2629-8']
310,21442416,Challenging medical students with an interim assessment: a positive effect on formal examination score in a randomized controlled study.,"Until now, positive effects of assessment at a medical curriculum level have not been demonstrated. This study was performed to determine whether an interim assessment, taken during a small group work session of an ongoing biomedical course, results in students' increased performance at the formal course examination. A randomized controlled trial was set up, with an interim assessment without explicit feedback as intervention. It was performed during a regular biomedical Bachelor course of 4 weeks on General Pathology at the Radboud University Nijmegen Medical Centre. Participants were 326 medical and 91 biomedical science students divided into three study arms: arm Intervention-1 (I-1) receiving one interim assessment; arm I-2 receiving two interim assessments, and control arm C, receiving no interim assessment. The study arms were stratified for gender and study discipline. The interim assessment consisted of seven multiple-choice questions on tumour pathology. Main outcome measures were overall score of the formal examination (scale 1-10), and the subscore of the questions on tumour pathology (scale 1-10). We found that students who underwent an interim assessment (arm I) had a 0.29-point (scale 1-10) higher score on the formal examination than the control group (p = 0.037). For the questions in the formal examination on tumour pathology the score amounted to 0.47 points higher (p = 0.007), whereas it was 0.17 points higher for the questions on topics related to the previous 3 weeks. No differences in formal examination score were found between arms I-1 and I-2 (p = 0.817). These findings suggest that an interim assessment during a small group work session in a randomized study setting stimulates students to increase their formal examination score.",2012,No differences in formal examination score were found between arms I-1 and I-2 (p = 0.817).,['Participants were 326 medical and 91 biomedical science students divided into three study arms'],"['arm Intervention-1 (I-1) receiving one interim assessment; arm I-2 receiving two interim assessments, and control arm C, receiving no interim assessment']","['overall score of the formal examination (scale 1-10), and the subscore of the questions on tumour pathology (scale 1-10', 'formal examination score']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0222045'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",326.0,0.0412185,No differences in formal examination score were found between arms I-1 and I-2 (p = 0.817).,"[{'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Olde Bekkink', 'Affiliation': '109 Department of Anatomy, Radboud University Nijmegen Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': ''}, {'ForeName': 'Goos N P', 'Initials': 'GN', 'LastName': 'van Muijen', 'Affiliation': ''}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Ruiter', 'Affiliation': ''}]",Advances in health sciences education : theory and practice,['10.1007/s10459-011-9291-6']
311,21445705,Adaptive memory: stereotype activation is not enough.,"Studies have shown that survival processing leads to superior memorability. The aim of the present study was to examine whether this survival recall advantage might result from stereotype activation. To test this hypothesis, we conducted a pilot study and two experiments in which participants were primed with stereotypes (Experiment 1, professor and elderly person; Experiment 2, survival-stereotype). In Experiment 1, 120 undergraduates were randomly assigned to a survival, professor stereotype, elderly person stereotype, or moving scenario and rated words for their relevance to the imagined scenario. In Experiment 2, 75 undergraduates were given a survival, survival-stereotype (based on our pilot study), or moving scenario. Both experiments showed that survival processing leads to a greater recall advantage over the stereotype groups and control group. These data indicate that the mere activation of stereotypes cannot explain the survival recall advantage.",2011,Both experiments showed that survival processing leads to a greater recall advantage over the stereotype groups and control group.,"['120 undergraduates', 'participants were primed with stereotypes (Experiment 1, professor and elderly person; Experiment 2, survival-stereotype']","['survival, professor stereotype, elderly person stereotype, or moving scenario and rated words for their relevance to the imagined scenario']","['survival, survival-stereotype', 'survival recall advantage']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0220921', 'cui_str': 'survival'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]",120.0,0.0228805,Both experiments showed that survival processing leads to a greater recall advantage over the stereotype groups and control group.,"[{'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Otgaar', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands. Henry.Otgaar@maastrichtuniversity.nl'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Smeets', 'Affiliation': ''}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Merckelbach', 'Affiliation': ''}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Jelicic', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Verschuere', 'Affiliation': ''}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Galliot', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'van Riel', 'Affiliation': ''}]",Memory & cognition,['10.3758/s13421-011-0091-2']
312,21424338,Examining the ability to detect change using the TRIM-Diabetes and TRIM-Diabetes Device measures.,"PURPOSE


Responsiveness is defined as the ability of an instrument to accurately detect change when it has occurred and is an essential psychometric property of a patient-reported outcomes (PRO) measure to understand and interpret study findings. This study examined the responsiveness of 2 Treatment Related Impact Measures (TRIMs): The TRIM-Diabetes (TRIM-D) and TRIM-Diabetes Device (TRIM-DD) as well as confirmed their measurement models in a randomized controlled trial (RCT) design.
METHODS


The data were collected in a multi-center, randomized, open-label (2 × 12 week), cross-over study of two prefilled pens in subjects with type 1 or type 2 diabetes, age 18 or older. Internal and external responsiveness were examined. To confirm the measurement model identified in the previous study, the Bentler comparative fit index (CFI) and internal consistency for the RCT sample scores were examined and compared.
RESULTS


Based on a priori criteria, tests of responsiveness were confirmed with patients having significant improvements over time ranging from 2.7 (Psychological Health) to 11.1 (Treatment Burden) (P < 0.01) (effect sizes ranging from 0.2 to 0.8). The previous measurement model factor structure was confirmed (CFI ranging from 0.8 to 1.0), and internal consistency of the TRIMs was similar to the developmental findings.
CONCLUSIONS


The total score as well as all domain scores of the TRIMs was significantly responsive over time, thus acceptable internal and external responsiveness of TRIM-D and TRIM-DD are concluded. To date, all validation evidence supports the use of these two measures in future clinical trials.",2011,"The total score as well as all domain scores of the TRIMs was significantly responsive over time, thus acceptable internal and external responsiveness of TRIM-D and TRIM-DD are concluded.","['subjects with type 1 or type 2 diabetes, age 18 or older']",['open-label'],"['Impact Measures (TRIMs', 'TRIM-Diabetes (TRIM-D) and TRIM-Diabetes Device (TRIM-DD']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441645', 'cui_str': 'Trimming - action (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",,0.0155882,"The total score as well as all domain scores of the TRIMs was significantly responsive over time, thus acceptable internal and external responsiveness of TRIM-D and TRIM-DD are concluded.","[{'ForeName': 'Meryl', 'Initials': 'M', 'LastName': 'Brod', 'Affiliation': 'The Brod Group, 219 Julia Avenue, Mill Valley, CA 94941, USA. mbrod@thebrodgroup.net'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Christensen', 'Affiliation': ''}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Hammer', 'Affiliation': ''}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Busk', 'Affiliation': ''}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Bushnell', 'Affiliation': ''}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-011-9886-7']
313,21431863,Training with anxiety: short- and long-term effects on police officers' shooting behavior under pressure.,"We investigated short- and long-term effects of training with anxiety on police officers' shooting behavior under pressure. Using a pretest, posttest, and retention test design, 27 police officers executed a shooting exercise against an opponent that did (high anxiety) or did not (low anxiety) shoot back using colored soap cartridges. During the training sessions, the experimental group practiced with anxiety and the control group practiced without anxiety. At the pretest, anxiety had a negative effect on shot accuracy for both groups. At the posttest, shot accuracy of the experimental group no longer deteriorated under anxiety, while shot accuracy of the control group was still equally affected. At the retention test, 4 months after training, positive results for the experimental group remained present, indicating that training with anxiety may have positive short- and long-term effects on police officers' shot accuracy under pressure. Additional analyses showed that these effects are potentially related to changes in visual attention on task-relevant information.",2011,"At the posttest, shot accuracy of the experimental group no longer deteriorated under anxiety, while shot accuracy of the control group was still equally affected.",[],['27 police officers executed a shooting exercise against an opponent that did (high anxiety) or did not (low anxiety) shoot back using colored soap cartridges'],['visual attention on task-relevant information'],[],"[{'cui': 'C0086825', 'cui_str': 'Policeman (occupation)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C4319642', 'cui_str': 'Cartridge (unit of presentation)'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}]",,0.0235264,"At the posttest, shot accuracy of the experimental group no longer deteriorated under anxiety, while shot accuracy of the control group was still equally affected.","[{'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Nieuwenhuys', 'Affiliation': 'Research Institute MOVE, VU University Amsterdam, Van der Boechorstraat, The Netherlands. a.nieuwenhuys@vu.nl'}, {'ForeName': 'Raôul R D', 'Initials': 'RR', 'LastName': 'Oudejans', 'Affiliation': ''}]",Cognitive processing,['10.1007/s10339-011-0396-x']
314,21431414,A multilevel analysis of the impact of socio-structural and environmental influences on condom use among female sex workers.,"This study uses multilevel analysis to examine individual, organizational and community levels of influence on condom use among female commercial sex workers (FSW) in the Philippines. A randomized controlled study involving 1,382 female commercial sex workers assigned to three intervention groups consisting of peer education, managerial training, combined peer and managerial intervention and a usual care control group was conducted. The results of the multilevel analysis show that FSWs who work in establishments with condom use rules tend to have a higher level of condom use (β = .70, P < 0.01). Among the different intervention groups, the combined peer and managerial intervention had the largest effect on condom use (β = 1.30, P < 0.01) compared with the usual care group. Using a three-level hierarchical model, we found that 62% of the variation lies within individuals, whereas 24% and 14% of the variation lies between establishments, and communities, respectively. Standard errors were underestimated when clustering of the FSWs in the different establishments and communities were not taken into consideration. The results demonstrate the importance of using multilevel analysis for community-based HIV/AIDS intervention programs to examine individual, establishment and community effects.",2012,"Among the different intervention groups, the combined peer and managerial intervention had the largest effect on condom use (β = 1.30, P < 0.01) compared with the usual care group.","['female sex workers', '1,382 female commercial sex workers', 'female commercial sex workers (FSW) in the Philippines']","['peer education, managerial training, combined peer and managerial intervention and a usual care control group']",[],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0240816', 'cui_str': 'Prostitutes'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],1382.0,0.0318043,"Among the different intervention groups, the combined peer and managerial intervention had the largest effect on condom use (β = 1.30, P < 0.01) compared with the usual care group.","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Ang', 'Affiliation': 'Department of General Internal Medicine, UCLA School of Medicine, Westwood, CA 90024, USA. acang@ucla.edu'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Morisky', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-011-9925-y']
315,21437615,"Five-year results of a randomised controlled multi-centre study comparing heavy-weight knitted versus low-weight, non-woven polypropylene implants in Lichtenstein hernioplasty.","BACKGROUND


This prospective randomised study evaluated whether non-knitted and non-woven lightweight implants can influence postoperative pain and time of return to normal activity, without increasing the recurrence rate in Lichtenstein inguinal hernioplasty.
METHODS


Patients were operated on in four centres, randomised blindly into two groups with respect to the mesh used: Surgimesh WN (non-woven polypropylene microfibre sheet) and heavy weight polypropylene mesh. The operation was performed according to the Lichtenstein technique. Follow-up was designed for 7 days, and 3, 6, 12 and 60 months. The objectives were to assess the incidence of early and late complications, recurrence rate, and postoperative pain.
RESULTS


A total of 220 patients were randomised; after monitoring visits (exclusion of one hospital), 202 qualified for the assessment. At 60 months, the recurrence rate did not differ statistically. Less pain on the 7th postoperative day, and at 3 months, was observed in the WN group. No other differences were observed.
CONCLUSIONS


Use of a lightweight non-woven polypropylene implant is a valuable alternative to the use of knitted or woven meshes in the Lichtenstein method. Postoperative pain and recurrence were reduced at short term follow-up, but no statistical difference in recurrence rate was observed at 12 and 60 month follow-up in the patient population tested.",2011,"Postoperative pain and recurrence were reduced at short term follow-up, but no statistical difference in recurrence rate was observed at 12 and 60 month follow-up in the patient population tested.","['Patients were operated on in four centres', '220 patients were randomised; after monitoring visits (exclusion of one hospital), 202 qualified for the assessment']","['lightweight non-woven polypropylene implant', 'Surgimesh WN (non-woven polypropylene microfibre sheet) and heavy weight polypropylene mesh', 'non-knitted and non-woven lightweight implants', 'heavy-weight knitted versus low-weight, non-woven polypropylene implants']","['recurrence rate', 'Less pain', 'Postoperative pain and recurrence', 'incidence of early and late complications, recurrence rate, and postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0032582', 'cui_str': 'Propene Polymers'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh (physical object)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",220.0,0.0534993,"Postoperative pain and recurrence were reduced at short term follow-up, but no statistical difference in recurrence rate was observed at 12 and 60 month follow-up in the patient population tested.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Smietański', 'Affiliation': 'Department of General and Endocrine Surgery and Transplantation, Medical University of Gdańsk, ul. Dębinki 7, 80-211 Gdańsk, Poland. smietanski@herniaweb.org'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bury', 'Affiliation': ''}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Smietańska', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Owczuk', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Paradowski', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-011-0808-y']
316,21359834,Evaluation of in-stent restenosis in the APPROACH trial (Assessment on the Prevention of Progression by Rosiglitazone On Atherosclerosis in diabetes patients with Cardiovascular History).,"To determine (1) the medium-term effect of rosiglitazone and glipizide on intra-stent neointima hyperplasia, (2) restenosis pattern as assessed by intra-vascular ultrasound (IVUS) and quantitative coronary angiography (QCA) in patients with T2DM and coronary artery disease. A total of 462 patients with T2DM were randomized to rosiglitazone or glipizide for up to 18 months in the APPROACH trial, and had evaluable baseline and follow-up IVUS examinations. There was no significant difference in the size of plaque behind stent between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (-5.6 mm(3) vs. 1.9 mm(3); P = 0.61) or with a drug-eluting stent (12.1 mm(3) vs. 5.5 mm(3); P = 0.09). Similarly, there was no significant difference in percentage intimal hyperplasia volume between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (24.1% vs. 19.8%; P = 0.38) or with a drug-eluting stent (9.8% vs. 8.3%; P = 0.57). QCA data (intra-stent late loss, intra-stent diameter stenosis or binary restenosis) were not different between the rosiglitazone and glipizide groups. This study suggests that both rosiglitazone and glipizide have a similar effect on neointimal growth at medium term follow-up, a finding that warrants investigation in dedicated randomized trials.",2012,There was no significant difference in the size of plaque behind stent between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (-5.6 mm(3) vs. 1.9 mm(3); P = 0.61) or with a drug-eluting stent (12.1 mm(3) vs. 5.5 mm(3); P = 0.09).,"['462 patients with T2DM', 'diabetes patients with Cardiovascular History', 'patients with T2DM and coronary artery disease']","['rosiglitazone and glipizide', 'rosiglitazone', 'rosiglitazone or glipizide', 'Rosiglitazone', 'quantitative coronary angiography (QCA']","['size of plaque behind stent', 'QCA data (intra-stent late loss, intra-stent diameter stenosis or binary restenosis', 'percentage intimal hyperplasia volume', 'neointimal growth']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0017642', 'cui_str': 'Glipizide'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C4705836', 'cui_str': '7-((2,5-dioxopyrrolidin-1-yl)methyl)-4-(2-fluoro-4-(11C)methoxyphenyl) quinoline-2-carboxamide'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C4705836', 'cui_str': '7-((2,5-dioxopyrrolidin-1-yl)methyl)-4-(2-fluoro-4-(11C)methoxyphenyl) quinoline-2-carboxamide'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0334096', 'cui_str': 'Intimal proliferation (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",462.0,0.0285123,There was no significant difference in the size of plaque behind stent between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (-5.6 mm(3) vs. 1.9 mm(3); P = 0.61) or with a drug-eluting stent (12.1 mm(3) vs. 5.5 mm(3); P = 0.09).,"[{'ForeName': 'Héctor M', 'Initials': 'HM', 'LastName': 'García-García', 'Affiliation': 'Erasmus Medical Center, Z120 Thoraxcentre, Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands. h.garciagarcia@erasmusmc.nl'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ''}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Morocutti', 'Affiliation': ''}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Ratner', 'Affiliation': ''}, {'ForeName': 'Nikheel S', 'Initials': 'NS', 'LastName': 'Kolatkar', 'Affiliation': ''}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Kravitz', 'Affiliation': ''}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Nesto', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The international journal of cardiovascular imaging,['10.1007/s10554-011-9836-z']
317,21369817,One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery: a prospective randomized trial.,"INTRODUCTION AND HYPOTHESIS


For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization.
METHODS


We conducted a prospective randomized trial in which 179 women were allocated to 1-day or 3-day suprapubic catheterization. The primary outcome was the duration of catheterization.
RESULTS


Mean duration of catheterization and hospital stay was significantly shorter in the 1-day catheterization group. The number of successful voiding trials was higher in the 3-day catheterization group (90.9% versus 79.3%), but this did not reach statistical significance. The percentage of urinary tract infection did not differ significantly between the groups (4.5% versus 2.4%).
CONCLUSION


Starting a voiding trial 1 day after vaginal prolapse surgery leads to shorter duration of catheterization and hospital stay.",2011,"The percentage of urinary tract infection did not differ significantly between the groups (4.5% versus 2.4%).
","['179 women', 'after vaginal prolapse surgery']","['anterior colporrhaphy', '3-day suprapubic catheterization', '1-day or 3-day suprapubic catheterization']","['percentage of urinary tract infection', 'Mean duration of catheterization and hospital stay', 'shorter duration of catheterization and hospital stay', 'number of successful voiding trials', 'duration of catheterization']","[{'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205990', 'cui_str': 'Vaginal Prolapse'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205498', 'cui_str': 'Suprapubic approach (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",179.0,0.101069,"The percentage of urinary tract infection did not differ significantly between the groups (4.5% versus 2.4%).
","[{'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Van Der Steen', 'Affiliation': 'Isala Klinieken, Zwolle, The Netherlands. a.vdsteen@yahoo.com'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Detollenaere', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Den Boon', 'Affiliation': ''}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Van Eijndhoven', 'Affiliation': ''}]",International urogynecology journal,['10.1007/s00192-011-1358-7']
318,21416219,Long-term efficacy of adding fenofibric acid to moderate-dose statin therapy in patients with persistent elevated triglycerides.,"OBJECTIVE


The objective of this study was to evaluate the long-term efficacy of adding fenofibric acid to moderate-dose statin therapy in patients at goal for low-density lipoprotein cholesterol (LDL-C) but with persistent hypertriglyceridemia.
METHODS


This is a post hoc analysis of a subset of patients (N = 92) with mixed dyslipidemia treated with moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg) for 12 weeks in three controlled trials who had achieved LDL-C <100 mg/dL but whose triglycerides remained >200 mg/dL, and had fenofibric acid 135 mg added to the moderate-dose statin in a 52-week open-label extension study. Lipid and apolipoprotein (Apo) values and the proportion of patients meeting individual and combined treatment targets with combination therapy were determined at scheduled visits during the 52-week study and compared with baseline (start of extension study).
RESULTS


Addition of fenofibric acid to moderate-dose statin for 52 weeks resulted in significant (P < 0.001) improvements in non-high-density lipoprotein cholesterol (non-HDL-C; -9.0%), ApoB (-9.8%), HDL-C (14.9%), and triglycerides (-37.6%) compared with baseline. At final visit, greater proportions of patients achieved optimal levels of individual parameters as well as combined targets of LDL-C + non-HDL-C (60.0% vs 52.2%), LDL-C + non-HDL-C + ApoB (53.3% vs 37.8%, P = 0.007), and LDL-C + non-HDL-C + ApoB + HDL-C + triglycerides (25.6% vs 0.0%) than at baseline.
CONCLUSIONS


The addition of fenofibric acid to moderate-dose statin in patients whose LDL-C was optimal but whose triglycerides remained >200 mg/dL led to additional improvements in non-HDL-C, ApoB, HDL-C, and triglycerides that resulted in greater proportions of patients attaining optimal levels of the individual parameters as well as simultaneously achieving optimal levels of these parameters and LDL-C.",2011,"At final visit, greater proportions of patients achieved optimal levels of individual parameters as well as combined targets of LDL-C + non-HDL-C","['subset of patients (N\u2009=\u200992) with mixed dyslipidemia treated with moderate-dose', 'patients at goal for low-density lipoprotein cholesterol (LDL-C) but with persistent hypertriglyceridemia', 'patients with persistent elevated triglycerides']","['statin (rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin', 'fenofibric acid 135 mg added to the moderate-dose statin', 'fenofibric acid to moderate-dose statin therapy']","['HDL-C', 'non-high-density lipoprotein cholesterol', 'Lipid and apolipoprotein (Apo) values', 'triglycerides']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0989916', 'cui_str': 'Simvastatin 40 MG'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C2370547', 'cui_str': 'fenofibric acid 135 MG [Trilipix]'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0060179', 'cui_str': 'fenofibric acid'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.0439396,"At final visit, greater proportions of patients achieved optimal levels of individual parameters as well as combined targets of LDL-C + non-HDL-C","[{'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Baylor College of Medicine, Methodist DeBakey Heart and Vascular Center, Houston, TX 77030, USA. cmb@bcm.tmc.edu'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Maureen T', 'Initials': 'MT', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Setze', 'Affiliation': ''}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Lele', 'Affiliation': ''}, {'ForeName': 'Kamlesh M', 'Initials': 'KM', 'LastName': 'Thakker', 'Affiliation': ''}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Stolzenbach', 'Affiliation': ''}]",Cardiovascular drugs and therapy,['10.1007/s10557-011-6280-1']
319,21369770,"Relationship between literacy, knowledge, self-care behaviors, and heart failure-related quality of life among patients with heart failure.","BACKGROUND


We sought to examine the relationship between literacy and heart failure-related quality of life (HFQOL), and to explore whether literacy-related differences in knowledge, self-efficacy and/or self-care behavior explained the relationship.
METHODS


We recruited patients with symptomatic heart failure (HF) from four academic medical centers. Patients completed the short version of the Test of Functional Health Literacy in Adults (TOFHLA) and questions on HF-related knowledge, HF-related self-efficacy, and self-care behaviors. We assessed HFQOL with the Heart Failure Symptom Scale (HFSS) (range 0-100), with higher scores denoting better quality of life. We used bivariate (t-tests and chi-square) and multivariate linear regression analyses to estimate the associations between literacy and HF knowledge, self-efficacy, self-care behaviors, and HFQOL, controlling for demographic characteristics. Structural equation modeling was conducted to assess whether general HF knowledge, salt knowledge, self-care behaviors, and self-efficacy mediated the relationship between literacy and HFQOL.
RESULTS


We enrolled 605 patients with mean age of 60.7 years; 52% were male; 38% were African-American and 16% Latino; 26% had less than a high school education; and 67% had annual incomes under $25,000. Overall, 37% had low literacy (marginal or inadequate on TOFHLA). Patients with adequate literacy had higher general HF knowledge than those with low literacy (mean 6.6 vs. 5.5, adjusted difference 0.63, p < 0.01), higher self-efficacy (5.0 vs. 4.1, adjusted difference 0.99, p < 0.01), and higher prevalence of key self-care behaviors (p < 0.001). Those with adequate literacy had better HFQOL scores compared to those with low literacy (63.9 vs. 55.4, adjusted difference 7.20, p < 0.01), but differences in knowledge, self-efficacy, and self-care did not mediate this difference in HFQOL.
CONCLUSION


Low literacy was associated with worse HFQOL and lower HF-related knowledge, self-efficacy, and self-care behaviors, but differences in knowledge, self-efficacy and self-care did not explain the relationship between low literacy and worse HFQOL.",2011,"Those with adequate literacy had better HFQOL scores compared to those with low literacy (63.9 vs. 55.4, adjusted difference 7.20, p < 0.01), but differences in knowledge, self-efficacy, and self-care did not mediate this difference in HFQOL.
","['605 patients with mean age of 60.7 years; 52% were male; 38% were African-American and 16% Latino; 26% had less than a high school education; and 67% had annual incomes under $25,000', 'patients with heart failure', 'patients with symptomatic heart failure (HF) from four academic medical centers']",[],"['literacy and HF knowledge, self-efficacy, self-care behaviors, and HFQOL, controlling for demographic characteristics', 'quality of life', 'worse HFQOL and lower HF-related knowledge, self-efficacy, and self-care behaviors', 'HFQOL with the Heart Failure Symptom Scale (HFSS', 'higher prevalence of key self-care behaviors', 'HFQOL scores', 'literacy, knowledge, self-care behaviors, and heart failure-related quality of life', 'HFQOL', 'general HF knowledge', 'knowledge, self-efficacy, and self-care', 'knowledge, self-efficacy and self-care', 'general HF knowledge, salt knowledge, self-care behaviors, and self-efficacy', 'higher self-efficacy', 'Functional Health Literacy in Adults (TOFHLA) and questions on HF-related knowledge, HF-related self-efficacy, and self-care behaviors', 'low literacy (marginal or inadequate on TOFHLA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]",[],"[{'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034380'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}]",605.0,0.0428066,"Those with adequate literacy had better HFQOL scores compared to those with low literacy (63.9 vs. 55.4, adjusted difference 7.20, p < 0.01), but differences in knowledge, self-efficacy, and self-care did not mediate this difference in HFQOL.
","[{'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': ""Macabasco-O'Connell"", 'Affiliation': 'UCLA School of Nursing, University of California, Olive View-UCLA Medical Center Los Angeles, 700 Tiverton Ave., 4-242 Factor Blvd., Los Angeles, CA 90095, USA. aoconnel@sonnet.ucla.edu'}, {'ForeName': 'Darren A', 'Initials': 'DA', 'LastName': 'DeWalt', 'Affiliation': ''}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Broucksou', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hawk', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': ''}, {'ForeName': 'Bernice', 'Initials': 'B', 'LastName': 'Ruo', 'Affiliation': ''}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Bibbins-Domingo', 'Affiliation': ''}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Holmes', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Erman', 'Affiliation': ''}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Weinberger', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pignone', 'Affiliation': ''}]",Journal of general internal medicine,['10.1007/s11606-011-1668-y']
320,21365405,Pharmacist intervention program to enhance hypertension control: a randomised controlled trial.,"OBJECTIVE


Studies have demonstrated that hypertension remains inadequately managed throughout the world, with lack of adherence to BP-lowering medication being a major factor. The aim of the present study was to evaluate if a pharmaceutical care program could improve antihypertensive medication adherence and blood pressure control.
SETTING


This study was conducted in a secondary care hypertension/dyslipidemia outpatient clinic in the university teaching hospital of Cova da Beira Hospital Centre, Covilhã, located in the Eastern Central Region of Portugal.
METHOD


This report evaluates the pharmacist's interventions during a prospective randomised controlled trial, from July 2009 to June 2010. Patients with diagnosis of essential hypertension attending the clinic for routine follow-up were randomly allocated either to a control group (no pharmaceutical care) or to an intervention group (quarterly follow-up by a hospital pharmacist during a 9-month period). The pharmacist interventions, aimed to increase medication adherence and blood pressure control, involved educational interventions and counselling tips directed to the patient.
MAIN OUTCOME MEASURE


Systolic blood pressure, diastolic blood pressure and blood pressure control (according to JNC 7 guidelines) assessed at the baseline visit and at the end of pharmaceutical care were the main outcome measures. Blood pressure measurements were performed by blinded nurses. Medication adherence was also evaluated, using a validated questionnaire at baseline and at the end of investigation. Results A total of 197 hypertensive patients were randomly assigned to the study (99 in the control group and 98 in the intervention group). Although there were no significant differences (P > 0.05) in both groups concerning mean age, gender, body mass index, and antihypertensive pharmacotherapy, blood pressure control was higher in the intervention group (P = 0.005) at the end of the study. Significant lower systolic blood pressure (-6.8 mmHg, P = 0.006) and diastolic blood pressure (-2.9 mmHg, P = 0.020) levels were observed in the intervention group. Medication adherence was also significantly higher in the intervention group at the end of the study (74.5% vs. 57.6%, P = 0.012).
CONCLUSION


Pharmacist intervention can significantly improve medication adherence and blood pressure control in patients treated with antihypertensive agents.",2011,"Significant lower systolic blood pressure (-6.8 mmHg, P = 0.006) and diastolic blood pressure (-2.9 mmHg, P = 0.020)","['Patients with diagnosis of essential hypertension attending the clinic for routine follow-up', '197 hypertensive patients', 'secondary care hypertension/dyslipidemia outpatient clinic in the university teaching hospital of Cova da Beira Hospital Centre, Covilhã, located in the Eastern Central Region of Portugal', 'from July 2009 to June 2010', 'patients treated with antihypertensive agents']","['Pharmacist intervention', 'Pharmacist intervention program', 'control group (no pharmaceutical care) or to an intervention group (quarterly follow-up by a hospital pharmacist']","['antihypertensive medication adherence and blood pressure control', 'levels', 'systolic blood pressure', 'medication adherence and blood pressure control', 'Medication adherence', 'blood pressure control', 'hypertension control', 'diastolic blood pressure', 'Systolic blood pressure, diastolic blood pressure and blood pressure control', 'Blood pressure measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0454907', 'cui_str': 'Central region (geographic location)'}, {'cui': 'C0032729', 'cui_str': 'Portuguese Republic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0402002', 'cui_str': 'Hospital pharmacist (occupation)'}]","[{'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}]",197.0,0.0498094,"Significant lower systolic blood pressure (-6.8 mmHg, P = 0.006) and diastolic blood pressure (-2.9 mmHg, P = 0.020)","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Morgado', 'Affiliation': 'Health Sciences Research Centre, University of Beira Interior, Av. Infante D. Henrique, 6200-506 Covilhã, Portugal. manuelaugustomorgado@gmail.com'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rolo', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Castelo-Branco', 'Affiliation': ''}]",International journal of clinical pharmacy,['10.1007/s11096-010-9474-x']
321,21347782,Thymidylate synthase as a prognostic biomarker for locally advanced rectal cancer after multimodal treatment.,"PURPOSE


For years, 5-fluorouracil (5-FU) has been the backbone of radiochemotherapy (RCT) of locally advanced rectal cancer. Its main target, thymidylate synthase (TS), is speculated to be an important biomarker for response prediction and long-term prognosis. In this study, we analyzed TS expression in the rectal cancer tissue of 208 patients to evaluate its predictive/prognostic potential.
METHODS


All patients included were diagnosed with locally advanced adenocarcinoma of the rectum (UICC II and III) and were treated within randomized clinical trials of the German Rectal Cancer Study Group. Preoperative RCT (50.4 Gy and concomitant either 5-FU or 5-FU and oxaliplatin) was administered in 167 patients followed by surgical resection with total mesorectal excision (TME). Another 41 patients received postoperative RCT. TS levels and further clinicopathological parameters were assessed in univariate and multivariate analyses. Additionally, a TS gene polymorphism was analyzed with respect to the intratumoral protein levels.
RESULTS


Low TS expression in pretreatment biopsies correlated with impaired patient survival (p = 0.015). Analysis of a 28-bp repeat revealed a correlation between the *3/*3 genotype and high TS expression in pretherapeutic biopsies. In this study, a correlation of TS expression and grade of RCT-induced tumor regression was not found. Histopathological examination confirmed a complete tumor remission in 16 patients (9.6%). Analyses of the resection specimen indicated an unfavorable prognosis for patients with low intratumoral TS expression in case of detected lymph node metastases (p = 0.04).
CONCLUSIONS


TS can serve as a prognostic biomarker indicating an unfavorable prognosis for patients with low TS expression.",2011,"RESULTS


Low TS expression in pretreatment biopsies correlated with impaired patient survival (p = 0.015).","['locally advanced rectal cancer after multimodal treatment', 'All patients included were diagnosed with locally advanced adenocarcinoma of the rectum (UICC II and III) and were treated within randomized clinical trials of the German Rectal Cancer Study Group', '208 patients', '167 patients followed by surgical resection with total mesorectal excision (TME', 'patients with low TS expression']","['radiochemotherapy (RCT', 'Preoperative RCT', 'postoperative RCT', '5-fluorouracil (5-FU', 'Thymidylate synthase', '5-FU or 5-FU and oxaliplatin']","['patient survival', 'TS levels and further clinicopathological parameters', 'complete tumor remission', 'TS expression and grade of RCT-induced tumor regression']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0009429', 'cui_str': 'Multimodal Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0441914', 'cui_str': 'UICC'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0040085', 'cui_str': 'Thymidylate Synthetase'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]",208.0,0.0517046,"RESULTS


Low TS expression in pretreatment biopsies correlated with impaired patient survival (p = 0.015).","[{'ForeName': 'Lena-Christin', 'Initials': 'LC', 'LastName': 'Conradi', 'Affiliation': 'Department of General and Visceral Surgery Department of General and Visceral Surgery, Göttingen University Medical Center, Göttingen, Germany. lena.conradi@med.uni-goettingen.de'}, {'ForeName': 'Annalen', 'Initials': 'A', 'LastName': 'Bleckmann', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schirmer', 'Affiliation': ''}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jo', 'Affiliation': ''}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Homayounfar', 'Affiliation': ''}, {'ForeName': 'Hendrik A', 'Initials': 'HA', 'LastName': 'Wolff', 'Affiliation': ''}, {'ForeName': 'Hilka', 'Initials': 'H', 'LastName': 'Rothe', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Middel', 'Affiliation': ''}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Ghadimi', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beissbarth', 'Affiliation': ''}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Liersch', 'Affiliation': ''}]",Annals of surgical oncology,['10.1245/s10434-011-1608-4']
322,21409538,Effect of worksheet scaffolds on student learning in problem-based learning.,"The purpose of this study was to investigate the effect of worksheets as a scaffolding tool on students' learning achievement in a problem-based learning (PBL) environment. Seventeen PBL classes (N = 241) were randomly assigned to two experimental groups-one with a worksheet provided and the other without. Students' learning of the topic at hand was evaluated by comparing results from pre- and post-lesson concept recall tests. We also obtained information about students' perceptions of factors impacting their learning using a Learning Impact Questionnaire. The data was analyzed by means of analyses of variance. Results of the study indicated that there was no statistically significant difference between the levels of understanding for both groups of students. In addition, survey results revealed that the strongest factor perceived by students to impact their learning in a PBL context is the tutor followed by team and class dynamics, while the influence of the worksheet was rated lowest. These findings suggest that scaffolds such as worksheets may not play a significant role in enhancing students' learning within the social constructivist framework of problem-based learning. On the other hand, the importance of the role of tutor and collaborative small group learning which are key features of PBL is reinforced.",2011,Students' learning of the topic at hand was evaluated by comparing results from pre- and post-lesson concept recall tests.,"['Seventeen PBL classes (N\xa0=\xa0241', ""students' learning achievement in a problem-based learning (PBL) environment"", 'student learning in problem-based learning']",['worksheet scaffolds'],[],"[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]",[],[],241.0,0.0236516,Students' learning of the topic at hand was evaluated by comparing results from pre- and post-lesson concept recall tests.,"[{'ForeName': 'Serene S Y', 'Initials': 'SS', 'LastName': 'Choo', 'Affiliation': 'Republic Polytechnic, Singapore. serene_choo@rp.sg'}, {'ForeName': 'Jerome I', 'Initials': 'JI', 'LastName': 'Rotgans', 'Affiliation': ''}, {'ForeName': 'Elaine H J', 'Initials': 'EH', 'LastName': 'Yew', 'Affiliation': ''}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'Schmidt', 'Affiliation': ''}]",Advances in health sciences education : theory and practice,['10.1007/s10459-011-9288-1']
323,21380493,Evaluation of a peer network-based sexual risk reduction intervention for men in beer halls in Zimbabwe: results from a randomized controlled trial.,"While much emphasis has been placed on involving men in AIDS prevention in sub-Saharan Africa, there remain few rigorously evaluated interventions in this area. A particularly appealing point of intervention is the sexual risk behavior associated with men's alcohol consumption. This article reports the outcomes of The Sahwira HIV Prevention Program, a male-focused, peer-based intervention promoting the idea that men can assist their friends in avoiding high-risk sexual encounters associated with alcohol drinking. The intervention was evaluated in a randomized, controlled trial (RCT) implemented in 24 beer halls in Harare, Zimbabwe. A cadre of 413 male beer hall patrons (~20% of the patronage) was trained to assist their male peers within their friendship networks. Activities included one-on-one interactions, small group discussions, and educational events centering on the theme of men helping their male friends avoid risk. Venues were randomized into 12 control versus 12 intervention beer halls with little cross-contamination between study arms. The penetration and impact of the intervention were assessed by pre- and post-intervention cross-sectional surveys of the beer hall patronage. The intervention was implemented with a high degree of fidelity to the protocol, with exposure to the intervention activities significantly higher among intervention patrons compared to control. While we found generally declining levels of risk behavior in both study arms from baseline to post-intervention, we found no evidence of an impact of the intervention on our primary outcome measure: episodes of unprotected sex with non-wife partners in the preceding 6 months (median 5.4 episodes for men at intervention beer halls vs. 5.1 among controls, P = 0.98). There was also no evidence that the intervention reduced other risks for HIV. It remains an imperative to find ways to productively engage men in AIDS prevention, especially in those venues where male bonding, alcohol consumption, and sexual risk behavior are intertwined.",2011,"The intervention was implemented with a high degree of fidelity to the protocol, with exposure to the intervention activities significantly higher among intervention patrons compared to control.","['men in beer halls in Zimbabwe', '413 male beer hall patrons (~20% of the patronage) was trained to assist their male peers within their friendship networks']",['peer network-based sexual risk reduction intervention'],"['risks for HIV', ' episodes of unprotected sex with non-wife partners', 'levels of risk behavior']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C2356088', 'cui_str': 'Halls'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}, {'cui': 'C0242665', 'cui_str': 'Wife (person)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",413.0,0.0250805,"The intervention was implemented with a high degree of fidelity to the protocol, with exposure to the intervention activities significantly higher among intervention patrons compared to control.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fritz', 'Affiliation': 'International Center for Research on Women, Washington, DC, USA.'}, {'ForeName': 'Willi', 'Initials': 'W', 'LastName': 'McFarland', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wyrod', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chasakara', 'Affiliation': ''}, {'ForeName': 'Knox', 'Initials': 'K', 'LastName': 'Makumbe', 'Affiliation': ''}, {'ForeName': 'Admire', 'Initials': 'A', 'LastName': 'Chirowodza', 'Affiliation': ''}, {'ForeName': 'Chamunorwa', 'Initials': 'C', 'LastName': 'Mashoko', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kellogg', 'Affiliation': ''}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Woelk', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-011-9922-1']
324,21340666,Randomized phase III study comparing the efficacy and safety of irinotecan plus S-1 with S-1 alone as first-line treatment for advanced gastric cancer (study GC0301/TOP-002).,"BACKGROUND


Irinotecan hydrochloride and S-1, an oral fluoropyrimidine, have shown antitumor activity against advanced gastric cancer as single agents in phase I/II studies. The combination of irinotecan and S-1 (IRI-S) is also active against advanced gastric cancer. This study was conducted to compare the efficacy and safety of IRI-S versus S-1 monotherapy in patients with advanced or recurrent gastric cancer.
METHODS


Patients were randomly assigned to oral S-1 (80 mg/m² daily for 28 days every 6 weeks) or oral S-1 (80 mg/m² daily for 21 days every 5 weeks) plus irinotecan (80 mg/m² by intravenous infusion on days 1 and 15 every 5 weeks) (IRI-S). The primary endpoint was overall survival. Secondary endpoints included the time to treatment failure, 1- and 2-year survival rates, response rate, and safety.
RESULTS


The median survival time with IRI-S versus S-1 monotherapy was 12.8 versus 10.5 months (P = 0.233), time to treatment failure was 4.5 versus 3.6 months (P = 0.157), and the 1-year survival rate was 52.0 versus 44.9%, respectively. The response rate was significantly higher for IRI-S than for S-1 monotherapy (41.5 vs. 26.9%, P = 0.035). Neutropenia and diarrhea occurred more frequently with IRI-S, but were manageable. Patients treated with IRI-S received more courses of therapy at a relative dose intensity similar to that of S-1 monotherapy.
CONCLUSIONS


Although IRI-S achieved longer median survival than S-1 monotherapy and was well tolerated, it did not show significant superiority in this study.",2011,"Secondary endpoints included the time to treatment failure, 1- and 2-year survival rates, response rate, and safety.
","['Patients', 'patients with advanced or recurrent gastric cancer', 'advanced gastric cancer (study GC0301/TOP-002']","['irinotecan and S-1 (IRI-S', 'IRI-S', 'Irinotecan hydrochloride and S-1, an oral fluoropyrimidine', 'irinotecan plus S-1 with S-1 alone', 'oral S-1', 'IRI-S versus S-1 monotherapy', 'irinotecan']","['median survival', 'time to treatment failure', 'Neutropenia and diarrhea', 'efficacy and safety', 'response rate', '1-year survival rate', 'overall survival', 'time to treatment failure, 1- and 2-year survival rates, response rate, and safety', 'median survival time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0594375', 'cui_str': 'Irinotecan hydrochloride'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",,0.204629,"Secondary endpoints included the time to treatment failure, 1- and 2-year survival rates, response rate, and safety.
","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Narahara', 'Affiliation': 'Division of Clinical Oncology, Hiroshima University Graduate School of Biomedical Sciences, Hiroshima, 734-8551, Japan. narahara@hiroshima-u.ac.jp'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Iishi', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Imamura', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuburaya', 'Affiliation': ''}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Imamoto', 'Affiliation': ''}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Furukawa', 'Affiliation': ''}, {'ForeName': 'Chikuma', 'Initials': 'C', 'LastName': 'Hamada', 'Affiliation': ''}, {'ForeName': 'Yuh', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': ''}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-011-0009-5']
325,21336673,A participatory return-to-work intervention for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders: results of a randomized controlled trial.,"INTRODUCTION


Within the labour force workers without an employment contract represent a vulnerable group. In most cases, when sick-listed, these workers have no workplace/employer to return to. Therefore, the aim of this study was to evaluate the effectiveness on return-to-work of a participatory return-to-work program compared to usual care for unemployed workers and temporary agency workers, sick-listed due to musculoskeletal disorders.
METHODS


The workers, sick-listed for 2-8 weeks due to musculoskeletal disorders, were randomly allocated to the participatory return-to-work program (n = 79) or to usual care (n = 84). The new program is a stepwise procedure aimed at making a consensus-based return-to-work plan, with the possibility of a temporary (therapeutic) workplace. Outcomes were measured at baseline, 3, 6, 9 and 12 months. The primary outcome measure was time to sustainable first return-to-work. Secondary outcome measures were duration of sickness benefit, functional status, pain intensity, and perceived health.
RESULTS


The median duration until sustainable first return-to-work was 161 days in the intervention group, compared to 299 days in the usual care group. The new return-to-work program resulted in a non-significant delay in RTW during the first 90 days, followed by a significant advantage in RTW rate after 90 days (hazard ratio of 2.24 [95% confidence interval 1.28-3.94] P = 0.005). No significant differences were found for the measured secondary outcomes.
CONCLUSIONS


The newly developed participatory return-to-work program seems to be a promising intervention to facilitate work resumption and reduce work disability among temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders.",2011,"The new return-to-work program resulted in a non-significant delay in RTW during the first 90 days, followed by a significant advantage in RTW rate after 90 days (hazard ratio of 2.24 [95% confidence interval 1.28-3.94] P = 0.005).","['temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders', 'unemployed workers and temporary agency workers, sick-listed due to musculoskeletal disorders', 'temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders', 'workers, sick-listed for 2-8 weeks due to musculoskeletal disorders']","['participatory return-to-work intervention', 'participatory return-to-work program', 'participatory return-to-work program (n = 79) or to usual care']","['time to sustainable first return-to-work', 'median duration until sustainable first return-to-work', 'duration of sickness benefit, functional status, pain intensity, and perceived health', 'RTW rate']","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0438920', 'cui_str': 'Sickness benefit (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0883548,"The new return-to-work program resulted in a non-significant delay in RTW during the first 90 days, followed by a significant advantage in RTW rate after 90 days (hazard ratio of 2.24 [95% confidence interval 1.28-3.94] P = 0.005).","[{'ForeName': 'Sylvia J', 'Initials': 'SJ', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Public and Occupational Health, EMGO Institute for Health and Care Research, VU University Medical Centre, P.O. Box 7057, 1007 MB Amsterdam, The Netherlands. s.vermeulen@vumc.nl'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Anema', 'Affiliation': ''}, {'ForeName': 'Antonius J M', 'Initials': 'AJ', 'LastName': 'Schellart', 'Affiliation': ''}, {'ForeName': 'Dirk L', 'Initials': 'DL', 'LastName': 'Knol', 'Affiliation': ''}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Mechelen', 'Affiliation': ''}, {'ForeName': 'Allard J', 'Initials': 'AJ', 'LastName': 'van der Beek', 'Affiliation': ''}]",Journal of occupational rehabilitation,['10.1007/s10926-011-9291-7']
326,21336679,"Effects of a weight loss intervention on body mass, fitness, and inflammatory biomarkers in overweight or obese breast cancer survivors.","BACKGROUND


Obesity is characterized by chronic mild inflammation and may influence the risk and progression of cancer.
PURPOSE


The current study is an exploratory analysis of the effect of a weight loss intervention that emphasized increased physical activity on inflammatory cytokines (tumor necrosis factor-α [TNF-α], interleukin-6 [IL-6], interleukin-8 [IL-8], and vascular endothelial growth factor [VEGF]) at the end of the 16-week intervention period in overweight breast cancer survivors.
METHODS


Study participants averaged 56 years of age (N=68). Intervention participants (n=44 vs. 24 controls) participated in a cognitive behavioral therapy-based weight management program as part of an exploratory randomized trial. The intervention incorporated strategies to promote increased physical activity and diet modification. Baseline and 16-week data included height, weight, body composition, physical activity level, and biomarkers IL-6, IL-8, TNF-α, and VEGF.
RESULTS


Weight loss was significantly greater in the intervention group than controls (-5.7 [3.5] vs. 0.2 [4.1] kg, P<0.001). Paired t tests noted favorable changes in physical activity level (P<0.001 intervention, P=0.70 control), marginally lower IL-6 levels (P=0.06 intervention, P=0.25 control) at 16 weeks for participants in the intervention group, and lower TNF-α levels for participants in the intervention (P<0.05) and control groups (P<0.001). Increased physical activity was associated with favorable changes in IL-6 for participants in the intervention group (R(2) =0.18; P<0.03).
CONCLUSION


Favorable changes in cytokine levels were observed in association with weight loss in this exploratory study with overweight breast cancer survivors.",2011,"Increased physical activity was associated with favorable changes in IL-6 for participants in the intervention group (R(2) =0.18; P<0.03).
","['overweight breast cancer survivors', 'Intervention participants (n=44 vs. 24 controls) participated in a', 'overweight or obese breast cancer survivors', 'Study participants averaged 56 years of age (N=68']","['weight loss intervention', 'cognitive behavioral therapy-based weight management program']","['physical activity on inflammatory cytokines (tumor necrosis factor-α [TNF-α], interleukin-6 [IL-6], interleukin-8 [IL-8], and vascular endothelial growth factor [VEGF', 'cytokine levels', 'IL-6 levels', 'body mass, fitness, and inflammatory biomarkers', 'height, weight, body composition, physical activity level, and biomarkers IL-6, IL-8, TNF-α, and VEGF', 'Weight loss', 'Increased physical activity', 'TNF-α levels', 'physical activity level']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}]",,0.0330231,"Increased physical activity was associated with favorable changes in IL-6 for participants in the intervention group (R(2) =0.18; P<0.03).
","[{'ForeName': 'Bilgé', 'Initials': 'B', 'LastName': 'Pakiz', 'Affiliation': 'Department of Family and Preventive Medicine, Moores UCSD Cancer Center, University of California, San Diego, 9500 Gilman Dr. MC 0901, La Jolla, CA 92093-0901, USA. bpakiz@ucsd.edu'}, {'ForeName': 'Shirley W', 'Initials': 'SW', 'LastName': 'Flatt', 'Affiliation': ''}, {'ForeName': 'Wayne A', 'Initials': 'WA', 'LastName': 'Bardwell', 'Affiliation': ''}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Rock', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mills', 'Affiliation': ''}]",International journal of behavioral medicine,['10.1007/s12529-010-9079-8']
327,21321791,99mTc-besilesomab (Scintimun) in peripheral osteomyelitis: comparison with 99mTc-labelled white blood cells.,"PURPOSE


The diagnosis of osteomyelitis is a challenge for diagnostic imaging. Nuclear medicine procedures including white blood cell imaging have been successfully used for the identification of bone infections. This multinational, phase III clinical study in 22 European centres was undertaken to compare anti-granulocyte imaging using the murine IgG antibody besilesomab (Scintimun) with (99m)Tc-labelled white blood cells in patients with peripheral osteomyelitis.
METHODS


A total of 119 patients with suspected osteomyelitis of the peripheral skeleton received (99m)Tc-besilesomab and (99m)Tc-hexamethylpropyleneamine oxime (HMPAO)-labelled white blood cells (WBCs) in random order 2-4 days apart. Planar images were acquired at 4 and 24 h after injection. All scintigraphic images were interpreted in an off-site blinded read by three experienced physicians specialized in nuclear medicine, followed by a fourth blinded reader for adjudication. In addition, clinical follow-up information was collected and a final diagnosis was provided by the investigators and an independent truth panel. Safety data including levels of human anti-mouse antibodies (HAMA) and vital signs were recorded.
RESULTS


The agreement in diagnosis across all three readers between Scintimun and (99m)Tc-HMPAO-labelled WBCs was 0.83 (lower limit of the 95% confidence interval 0.8). Using the final diagnosis of the local investigator as a reference, Scintimun had higher sensitivity than (99m)Tc-HMPAO-labelled WBCs (74.8 vs 59.0%) at slightly lower specificity (71.8 vs 79.5%, respectively). All parameters related to patient safety (laboratory data, vital signs) did not provide evidence of an elevated risk associated with the use of Scintimun except for two cases of transient hypotension. HAMA were detected in 16 of 116 patients after scan (13.8%).
CONCLUSION


Scintimun imaging is accurate, efficacious and safe in the diagnosis of peripheral bone infections and provides comparable information to (99m)Tc-HMPAO-labelled WBCs.",2011,"All parameters related to patient safety (laboratory data, vital signs) did not provide evidence of an elevated risk associated with the use of Scintimun except for two cases of transient hypotension.","['patients with peripheral osteomyelitis', 'peripheral osteomyelitis', '22 European centres', '119 patients with suspected osteomyelitis of the peripheral skeleton received']","['anti-granulocyte imaging using the murine IgG antibody besilesomab (Scintimun) with (99m)Tc-labelled white blood cells', '99mTc-labelled white blood cells', '99m)Tc-besilesomab and (99m)Tc-hexamethylpropyleneamine oxime (HMPAO)-labelled white blood cells (WBCs', '99mTc-besilesomab (Scintimun']","['HAMA', 'patient safety (laboratory data, vital signs', 'levels of human anti-mouse antibodies (HAMA) and vital signs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0816871', 'cui_str': 'Skeleton'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C3660637', 'cui_str': 'besilesomab'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C1692878', 'cui_str': '99mTc(HYNICtide)(tricine)(TPPTS)'}, {'cui': 'C0121638', 'cui_str': 'HMPAO oxime'}, {'cui': 'C3661232', 'cui_str': '99mTc-besilesomab'}, {'cui': 'C3661231', 'cui_str': 'Scintimun'}]","[{'cui': 'C1113679'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0518766'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1291910', 'cui_str': 'Human anti-mouse antibody'}]",119.0,0.0905012,"All parameters related to patient safety (laboratory data, vital signs) did not provide evidence of an elevated risk associated with the use of Scintimun except for two cases of transient hypotension.","[{'ForeName': 'Wolf S', 'Initials': 'WS', 'LastName': 'Richter', 'Affiliation': 'Pharmtrace klinische Entwicklung GmbH, Alt-Moabit 59-61, 10555 Berlin, Germany.'}, {'ForeName': 'Velimir', 'Initials': 'V', 'LastName': 'Ivancevic', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Meller', 'Affiliation': ''}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Lang', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Le Guludec', 'Affiliation': ''}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Szilvazi', 'Affiliation': ''}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Amthauer', 'Affiliation': ''}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Chossat', 'Affiliation': ''}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Dahmane', 'Affiliation': ''}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwenke', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Signore', 'Affiliation': ''}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-011-1731-2']
328,21340475,"Evaluation of sleep, puberty and mental health in children with long-term melatonin treatment for chronic idiopathic childhood sleep onset insomnia.","OBJECTIVES


To establish whether long-term use of melatonin influences pubertal development, sleep quality and mental health development in children as compared with the normal Dutch population of the same age.
METHODS


This follow-up research study was conducted in children included in a previous melatonin dose-finding trial. Outcomes were measured using questionnaires (Strength and Difficulties Questionnaire (SDQ), Children's Sleep Habits Questionnaire (CSHQ) and Tanner Stages) adopted for Dutch children. Mean duration of therapy, persistence of effect, adverse events and (other) reasons leading to cessation of therapy were additional objectives of this study.
RESULTS


Mean years of usage (n=51) was 3.1 years (min 1.0 year, max 4.6 years), mean dose 2.69 mg (min 0.3 mg, max 10 mg). Mean SDQ score, mean CSHQ score and Tanner Stages standard deviation scores did not differ in a statistically significant way from published scores of the general Dutch population of the same age and sex.
CONCLUSIONS


This follow-up study demonstrates that melatonin treatment in children can be sustained over a long period of time without substantial deviation of the development of children with respect to sleep quality, puberty development and mental health scores, as compared with the general Dutch population.",2011,"Tanner Stages standard deviation scores did not differ in a statistically significant way from published scores of the general Dutch population of the same age and sex.
","['chronic idiopathic childhood sleep onset insomnia', 'children as compared with the normal Dutch population of the same age', 'children with long-term']","['melatonin', 'melatonin treatment']","['Mean duration of therapy, persistence of effect, adverse events', 'sleep, puberty and mental health', 'pubertal development, sleep quality and mental health development', ""questionnaires (Strength and Difficulties Questionnaire (SDQ), Children's Sleep Habits Questionnaire (CSHQ) and Tanner Stages) adopted for Dutch children"", 'Mean SDQ score, mean CSHQ score and', 'Tanner Stages standard deviation scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire (assessment scale)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0335730', 'cui_str': 'Tanner (occupation)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",,0.0725612,"Tanner Stages standard deviation scores did not differ in a statistically significant way from published scores of the general Dutch population of the same age and sex.
","[{'ForeName': 'Ingeborg M', 'Initials': 'IM', 'LastName': 'van Geijlswijk', 'Affiliation': 'Faculty of Veterinary Medicine, Pharmacy Department, Utrecht University, Yalelaan 106, 3584, CM, Utrecht, The Netherlands. i.m.vangeijlswijk@uu.nl'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Mol', 'Affiliation': ''}, {'ForeName': 'Toine C G', 'Initials': 'TC', 'LastName': 'Egberts', 'Affiliation': ''}, {'ForeName': 'Marcel G', 'Initials': 'MG', 'LastName': 'Smits', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2202-y']
329,21234545,A prospective randomized study of ACL-reconstructions using bone-patellar tendon-bone grafts fixed with bioabsorbable or metal interference screws.,"INTRODUCTION


Bioabsorbable screws are, at the expense of metal screws, increasingly used as fixation device in ACL-reconstructions. The possible advantages with bioabsorbable screws are better postoperative MRI evaluations and easier revision surgery.
PURPOSE


The aim of this study was to compare the clinical outcome after ACL-reconstructions with BPTB-grafts fixed with metal interference screws or bioabsorbable screws 7 years postoperatively. The resorption of the bioabsorbable screws was also analyzed.
METHODS


Between 2000 and 2001, 41 patients with ACL deficient knees were randomized for the use of BPTB-graft fixed with either metal interference screws or bioabsorbable poly-L: -lactic acid screws. This is a 7-year follow-up with clinical examinations of both groups and, MRI of the patients with bioabsorbable screws.
RESULTS


The clinical and functional results were satisfactory in both groups. There were no significant differences between the groups in any parameter measured, except for better Pivot shift results in the bioscrew group (P = 0.04). The MRI evaluation showed degradation of the bioscrews. A residual screw tract which appeared threaded was seen in the tibia in 11 of the 16 patients. There was no sign of bony ingrowth in the previous screw site in the tibia in any of the patients.
CONCLUSION


The potential advantages of using PLLA-screws compared to metal screws are not sufficient to warrant the routine use of PLLA-screws in ACL-reconstructions.
LEVEL OF EVIDENCE


I.",2011,"There were no significant differences between the groups in any parameter measured, except for better Pivot shift results in the bioscrew group (P = 0.04).","['patients with bioabsorbable screws', 'Between 2000 and 2001, 41 patients with ACL deficient knees']","['ACL-reconstructions with BPTB-grafts fixed with metal interference screws or bioabsorbable screws', 'bioabsorbable screws', 'BPTB-graft fixed with either metal interference screws or bioabsorbable poly-L: -lactic acid screws', 'PLLA-screws', 'ACL-reconstructions using bone-patellar tendon-bone grafts fixed with bioabsorbable or metal interference screws']","['Pivot shift results', 'resorption of the bioabsorbable screws', 'postoperative MRI evaluations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}, {'cui': 'C3658331', 'cui_str': 'Bone-Patellar Tendon-Bone Grafts'}]","[{'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",41.0,0.0241555,"There were no significant differences between the groups in any parameter measured, except for better Pivot shift results in the bioscrew group (P = 0.04).","[{'ForeName': 'Jon Olav', 'Initials': 'JO', 'LastName': 'Drogset', 'Affiliation': 'Trondheim University Hospital, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Lene Granrud', 'Initials': 'LG', 'LastName': 'Straume', 'Affiliation': ''}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Bjørkmo', 'Affiliation': ''}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Myhr', 'Affiliation': ''}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-010-1353-4']
330,21258432,"Dispositional Mindfulness, Meditation, and Conditional Goal Setting.","Conditional goal setting (CGS, the tendency to regard high order goals such as happiness, as conditional upon the achievement of lower order goals) is observed in individuals with depression and recent research has suggested a link between levels of dispositional mindfulness and conditional goal setting in depressed patients. Since interventions which aim to increase mindfulness through training in meditation are used with patients suffering from depression it is of interest to examine whether such interventions might alter CGS. Study 1 examined the correlation between changes in dispositional mindfulness and changes in CGS over a 3-4 month period in patients participating in a pilot randomised controlled trial of Mindfulness-Based Cognitive Therapy (MBCT). Results indicated that increases in dispositional mindfulness were significantly associated with decreases in CGS, although this effect could not be attributed specifically to the group who had received training in meditation. Study 2 explored the impact of brief periods of either breathing or loving kindness meditation on CGS in 55 healthy participants. Contrary to expectation, a brief period of meditation increased CGS. Further analyses indicated that this effect was restricted to participants low in goal re-engagement ability who were allocated to loving kindness meditation. Longer term changes in dispositional mindfulness are associated with reductions in CGS in patients with depressed mood. However initial reactions to meditation, and in particular loving kindness meditation, may be counterintuitive and further research is required in order to determine the relationship between initial reactions and longer-term benefits of meditation practice.",2010,Further analyses indicated that this effect was restricted to participants low in goal re-engagement ability who were allocated to loving kindness meditation.,"['patients participating', 'patients with depressed mood', '55 healthy participants']","['Mindfulness-Based Cognitive Therapy (MBCT', 'breathing or loving kindness meditation']","['dispositional mindfulness and changes in CGS', 'dispositional mindfulness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0150277'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",55.0,0.0180748,Further analyses indicated that this effect was restricted to participants low in goal re-engagement ability who were allocated to loving kindness meditation.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Crane', 'Affiliation': ''}, {'ForeName': 'Danka', 'Initials': 'D', 'LastName': 'Jandric', 'Affiliation': ''}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Barnhofer', 'Affiliation': ''}, {'ForeName': 'J Mark G', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': ''}]",Mindfulness,[]
331,21301848,Comparison of liposomal cisplatin versus cisplatin in non-squamous cell non-small-cell lung cancer.,"PURPOSE


Liposomal cisplatin was developed to reduce the systemic toxicity of cisplatin, particularly the nephrotoxicity, and it has been used in combination with other agents in pancreatic and head and neck cancers and non-small-cell lung cancer (NSCLC). Our objective was to compare the effectiveness of lipoplatin combined with paclitaxel versus cisplatin with paclitaxel in advanced non-squamous NSCLC.
METHODS


During 2007-2010, 202 patients with non-squamous NSCLC (stage IIIB and IV) were recruited from the two participating institutions and divided into two arms: Arm A was treated with liposomal cisplatin 200 mg/m(2) combined with paclitaxel 135 mg/m(2) and Arm B with cisplatin 75 mg/m(2) in combination with paclitaxel 135 mg/m(2), repeated every 2 weeks. The number of cycles administered was 632 (Arm A) and 640 (Arm B), totaling 1,272.
RESULTS


A partial response was achieved by 59.22% of Arm A patients versus 42.42% of Arm B, and the difference was statistically significant (P 0.036). The median survival time in months was 10 for Arm A and 8 for Arm B (P 0.1551). After 18 months, the number of surviving patients was double for Arm A versus Arm B.
CONCLUSION


Liposomal cisplatin in combination with paclitaxel produces a statistically significantly higher response rate than cisplatin combined with paclitaxel in non-squamous NSCLC.",2011,The median survival time in months was 10 for Arm A and 8 for Arm B (P 0.1551).,"['non-squamous cell non-small-cell lung cancer', 'During 2007-2010, 202 patients with non-squamous NSCLC (stage IIIB and IV', 'advanced non-squamous NSCLC']","['paclitaxel', 'cisplatin', 'liposomal cisplatin versus cisplatin', 'lipoplatin combined with paclitaxel versus cisplatin with paclitaxel', 'cisplatin combined with paclitaxel', 'Liposomal cisplatin', 'paclitaxel 135', 'liposomal cisplatin 200']","['systemic toxicity', 'response rate', 'median survival time']","[{'cui': 'C1545484', 'cui_str': 'Non-squamous epithelial cell (cell)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1610295', 'cui_str': 'lipoplatin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4552199', 'cui_str': 'Systemic toxicity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",202.0,0.129088,The median survival time in months was 10 for Arm A and 8 for Arm B (P 0.1551).,"[{'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Stathopoulos', 'Affiliation': 'First Oncology Clinic, Errikos Dunant Hospital, Semitelou 2A, 115 28, Athens, Greece. dr-gps@ath.forthnet.gr'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Antoniou', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dimitroulis', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stathopoulos', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Marosis', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Michalopoulou', 'Affiliation': ''}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-011-1572-5']
332,21318581,Prospective evaluation of stapled haemorrhoidopexy versus transanal haemorrhoidal dearterialisation for stage II and III haemorrhoids: three-year outcomes.,"INTRODUCTION


The aim of the study was to compare short- and medium-term outcomes of transanal haemorrhoidal dearterialisation (THD) versus stapled haemorrhoidopexy (SH) for the treatment of second- and third-degree haemorrhoids.
METHODS


Patients with second- or third-degree haemorrhoids who failed conservative treatment were randomly allocated to THD or SH. Preoperative and postoperative symptoms, postoperative pain, time until return to normal activities, complications, patient satisfaction and recurrence rates were all assessed prospectively. Patients were followed up at 2, 8 months and when the study was completed.
RESULTS


Twenty-eight patients (43% third degree) underwent THD and 24 (38% third degree) underwent SH. There were no significant differences in terms of postoperative pain, expected pain and analgesia requirements, but more THD patients returned to work within 4 days (P < 0.05). One THD patient developed a sub-mucosal haematoma after surgery, one SH patient occlusion of the rectal lumen and two rectal bleeding. At 8-month follow-up, two SH patients complained of faecal urgency. At 38-month follow-up (range 33-48 months), all short-term complications resolved. Patient satisfaction (""excellent/good outcome"", THD 89 vs. SH 87%) and recurrence rate (THD 14 vs. SH 13%) were similar in the two groups.
CONCLUSIONS


Short-term results although similar seem to suggest SH may result in increased morbidity while return to work is quicker after THD. Medium-term results demonstrate that THD and SH have similar effectiveness.",2011,"There were no significant differences in terms of postoperative pain, expected pain and analgesia requirements, but more THD patients returned to work within 4 days (P < 0.05).","['Patients with second- or third-degree haemorrhoids who failed conservative treatment', 'second- and third-degree haemorrhoids', 'stage II and III haemorrhoids']","['THD or SH', 'THD and SH', 'stapled haemorrhoidopexy versus transanal haemorrhoidal dearterialisation', 'transanal haemorrhoidal dearterialisation (THD) versus stapled haemorrhoidopexy (SH']","['Patient satisfaction', 'recurrence rate', 'Preoperative and postoperative symptoms, postoperative pain, time until return to normal activities, complications, patient satisfaction and recurrence rates', 'postoperative pain, expected pain and analgesia requirements', 'faecal urgency', 'sub-mucosal haematoma']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0860132', 'cui_str': 'Internal hemorrhoids grade III (disorder)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}]","[{'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach (qualifier value)'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]",,0.0253905,"There were no significant differences in terms of postoperative pain, expected pain and analgesia requirements, but more THD patients returned to work within 4 days (P < 0.05).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Giordano', 'Affiliation': 'Department of Colorectal Surgery, Whipps Cross University Hospital, Whipps Cross Road, London E11 1NR, UK. pasquale.giordano@whippsx.nhs.uk'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nastro', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gravante', 'Affiliation': ''}]",Techniques in coloproctology,['10.1007/s10151-010-0667-z']
333,21221528,Limited effect of screening for depression with written feedback in outpatients with diabetes mellitus: a randomised controlled trial.,"AIMS/HYPOTHESIS


The aim of this study was to test the effectiveness of a screening procedure for depression (SCR) vs care as usual (CAU) in outpatients with diabetes. The primary outcome measured was depression score and the secondary outcomes were mental healthcare consumption, diabetes-distress and HbA(1c).
MATERIALS AND METHODS


In a multicentre parallel randomised controlled trial, 223 outpatients with diabetes, who had an elevated depression score, were randomly assigned to SCR (n = 116) or CAU (n = 107), using computer generated numbers. SCR-patients were invited for a Composite International Diagnostic Interview (CIDI) to diagnose depression and/or anxiety (interviewers were not blinded for group assignment). As part of the intervention, patients and their physicians were informed of the outcome of the CIDI in a letter and provided with treatment advice. At baseline and 6 month follow-up, depression and diabetes-distress were measured using the Centre for Epidemiologic Studies Depression Scale (CES-D) and the Problem Areas in Diabetes survey (PAID). HbA(1c) levels were obtained from medical charts.
RESULTS


Mean CES-D depression scores decreased from baseline to 6 months in both groups (24 ± 8 to 21 ± 8 [CAU] and 26 ± 7 to 22 ± 10 [SCR] respectively [p < 0.001]), with no significant differences between groups. Neither diabetes-distress nor HbA(1c) changed significantly within and between groups. The percentage of patients receiving mental healthcare increased in the SCR group from 20% to 28%, compared with 15% to 18% in the CAU group.
CONCLUSIONS/INTERPRETATION


Depression screening with written feedback to patient and physician does not improve depression scores and has a limited impact on mental healthcare utilisation, compared with CAU. It appears that more intensive depression management is required to improve depression outcomes in patients with diabetes.",2011,"The percentage of patients receiving mental healthcare increased in the SCR group from 20% to 28%, compared with 15% to 18% in the CAU group.
","['outpatients with diabetes', 'patients with diabetes', 'outpatients with diabetes mellitus', '223 outpatients with diabetes, who had an elevated depression score']","['screening procedure for depression (SCR) vs care as usual (CAU', 'SCR', 'CAU']","['depression and diabetes-distress', 'depression score and the secondary outcomes were mental healthcare consumption, diabetes-distress and HbA(1c', 'depression outcomes', 'percentage of patients receiving mental healthcare', 'HbA(1c) levels', 'diabetes-distress nor HbA(1c', 'Mean CES-D depression scores', 'depression scores']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",223.0,0.0951387,"The percentage of patients receiving mental healthcare increased in the SCR group from 20% to 28%, compared with 15% to 18% in the CAU group.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pouwer', 'Affiliation': 'Centre of Research on Psychology in Somatic Diseases, Department of Medical Psychology & Neuropsychology, Tilburg University, PO Box 90153, 5000 LE, Tilburg, the Netherlands. f.pouwer@uvt.nl'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Tack', 'Affiliation': ''}, {'ForeName': 'P H L M', 'Initials': 'PH', 'LastName': 'Geelhoed-Duijvestijn', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bazelmans', 'Affiliation': ''}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Beekman', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Heine', 'Affiliation': ''}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Snoek', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-010-2033-0']
334,21298412,The effect of antecedent hypoglycaemia on β₂-adrenergic sensitivity in healthy participants with the Arg16Gly polymorphism of the β₂-adrenergic receptor.,"AIMS/HYPOTHESIS


Homozygosity for glycine at codon 16 (GlyGly) of the β(2)-adrenergic receptor may alter receptor sensitivity upon chronic stimulation and has been implicated in the pathogenesis of hypoglycaemia unawareness. We compared the effect of antecedent hypoglycaemia on β(2)-adrenergic receptor sensitivity between GlyGly participants and those with arginine 16 homozygosity (ArgArg) for the β(2)-adrenergic receptor.
METHODS


We enrolled 16 healthy participants, who were either GlyGly (n = 8) or ArgArg (n = 8). They participated randomly in two 2 day experiments. Day 1 consisted of two 2-h hyperinsulinaemic hypoglycaemic (2.8 mmol/l) or euglycaemic (4.8 mmol/l) glucose clamps. On day 2, we measured the forearm vasodilator response to the β(2)-adrenergic receptor agonist salbutamol and the dose of isoprenaline required to increase the heart rate by 25 bpm (IC(25)).
RESULTS


The vasodilator response to salbutamol tended to be greater after antecedent hypoglycaemia than after euglycaemia (p = 0.078), consistent with increased β(2)-adrenergic receptor sensitivity. This effect was driven by a significant increase in β(2)-adrenergic receptor sensitivity following hypoglycaemia compared with euglycaemia in ArgArg participants (p = 0.019), whereas no such effect was observed in the GlyGly participants. Antecedent hypoglycaemia tended to decrease the IC(25) in ArgArg participants, whereas the reverse occurred in the GlyGly participants (GlyGly vs ArgArg group p = 0.047).
CONCLUSION/INTERPRETATION


Antecedent hypoglycaemia did not affect β(2)-adrenergic receptor sensitivity in healthy GlyGly participants, but increased it in ArgArg participants. If these results also hold for participants with type 1 diabetes, such an increase in β(2)-adrenergic receptor sensitivity may potentially reduce the risk of repeated hypoglycaemia and the subsequent development of hypoglycaemia unawareness in ArgArg diabetic participants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00160056.",2011,"The vasodilator response to salbutamol tended to be greater after antecedent hypoglycaemia than after euglycaemia (p = 0.078), consistent with increased β(2)-adrenergic receptor sensitivity.","['healthy GlyGly participants', 'participants with type 1 diabetes', 'healthy participants with the Arg16Gly polymorphism of the β₂-adrenergic receptor', '16 healthy participants, who were either GlyGly (n\u2009=\u20098) or ArgArg (n\u2009=\u20098', 'GlyGly participants and those with arginine 16 homozygosity (ArgArg) for the β(2)-adrenergic receptor']","['isoprenaline', 'hyperinsulinaemic hypoglycaemic (2.8 mmol/l) or euglycaemic (4.8 mmol/l) glucose clamps']","['heart rate by 25 bpm (IC(25', 'Antecedent hypoglycaemia', 'forearm vasodilator response', 'vasodilator response', 'β(2)-adrenergic receptor sensitivity', 'IC(25']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}]","[{'cui': 'C0022245', 'cui_str': 'isoprenaline'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0015159', 'cui_str': 'Glucose Clamping'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator Drugs'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",16.0,0.0776044,"The vasodilator response to salbutamol tended to be greater after antecedent hypoglycaemia than after euglycaemia (p = 0.078), consistent with increased β(2)-adrenergic receptor sensitivity.","[{'ForeName': 'B J J W', 'Initials': 'BJ', 'LastName': 'Schouwenberg', 'Affiliation': 'Department of Pharmacology-Toxicology 149, Radboud University Nijmegen Medical Centre, Geert Grooteplein 21, PO Box 9101, 6500HB Nijmegen, the Netherlands. b.schouwenberg@pharmtox.umcn.nl'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Smits', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Tack', 'Affiliation': ''}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'de Galan', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-011-2062-3']
335,21301814,A role for glutamate in subjective response to smoking and its action on inhibitory control.,"RATIONALE


Our previous study using memantine in smokers suggests that there may be a differential role for N-methyl-D-aspartate (NMDA) receptors in the subjective and cognitive effects of smoking.
OBJECTIVES


This study was designed to investigate if D-cycloserine (DCS) would modulate the subjective and cognitive effects of limited smoking.
METHODS


Forty-eight habitual smokers abstinent for a minimum of 2 h were randomly allocated to receive either placebo or 50 mg DCS (double-blind) and were subsequently required either to smoke half of one cigarette or to remain abstinent. Subjective and physiological effects of DCS were measured at baseline, 90 min postcapsule, and again after the partial-smoking manipulation, while the effects on sustained attention (rapid visual information processing test--RVIP) and cognitive flexibility (intra-extra dimensional set-shift test--IED) were evaluated only after the partial-smoking manipulation.
RESULTS


DCS alone did not produce significant subjective effects other than an increase in ratings of ""Stimulated"". In combination with partial smoking, however, DCS blocked the smoking-induced increase in ""Stimulated"" and the decrease in ""Relaxed"" ratings. Furthermore, in combination with smoking, DCS reduced the number of false alarms during the RVIP test (an index of inhibitory control) and produced a small increase in diastolic blood pressure. DCS failed to modulate IED performance.
CONCLUSIONS


These findings provide further evidence of a role for glutamate release in the subjective effects of smoking but not the effects on attention and cognitive flexibility. Furthermore, our results indicate that glutamate release may also be involved in the effect of smoking on inhibitory control.",2011,"RESULTS


DCS alone did not produce significant subjective effects other than an increase in ratings of ""Stimulated"".",['Forty-eight habitual smokers abstinent for a minimum of 2 h'],"['memantine', 'placebo or 50 mg DCS (double-blind) and were subsequently required either to smoke half of one cigarette or to remain abstinent', 'D-cycloserine (DCS', 'DCS']","['Stimulated', 'Relaxed"" ratings', 'number of false alarms', 'Subjective and physiological effects of DCS', 'ratings of ""Stimulated', 'sustained attention (rapid visual information processing test--RVIP) and cognitive flexibility (intra-extra dimensional set-shift test--IED', 'diastolic blood pressure']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",,0.0212102,"RESULTS


DCS alone did not produce significant subjective effects other than an increase in ratings of ""Stimulated"".","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nesic', 'Affiliation': 'Department of Pharmacology and Therapeutics, School of Pharmacy and Biomolecular Sciences, University of Brighton, Moulsecoomb, Brighton, BN2 4GJ, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Duka', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Rusted', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-011-2189-4']
336,21258848,Effectiveness of an interactive website aimed at empowerment of disability benefit claimants: results of a pragmatic randomized controlled trial.,"INTRODUCTION


The aim of this study was to investigate the effectiveness of an interactive website aimed at empowerment of disability claimants, prior to the assessment of disability by an insurance physician.
METHODS


A randomized controlled trial was conducted. Claimants applying for a work disability pension after being sick-listed for 104 weeks, were randomized into either an intervention group or control group. Participants who were randomized into the intervention group were able to logon to the website www.wiagesprek.nl , which mainly consisted of five interactive modules aimed at increasing knowledge, self-awareness, expectations, self-efficacy, and active participation. Participants from the control group were directed to a 'sham' website with commonly available information only. The primary outcome was empowerment. Secondary outcomes included coping, knowledge, claimant satisfaction, perceived justice, and physician satisfaction. Outcomes were assessed at baseline, 2 days before the disability assessment, as well as 1 day after, 6 weeks, and 4 months after the disability assessment.
RESULTS


Claimants were randomly assigned to the intervention group (n = 123) or a control group (n = 119). The intervention had no significant short- and long-term effects on empowerment, but the intervention increased claimants' knowledge significantly compared to the control group. Claimant satisfaction with the disability assessment interview and claimant perceived justice on the outcome of the assessment were lower in the intervention group (statistically not significant). Furthermore, the intervention had a significant negative effect on claimants perceived procedural justice.
CONCLUSION


Although knowledge increased significantly, the intervention www.wiagesprek.nl was not successful in reaching its primary target, that is, to increase levels of empowerment among disability claimants, prior to the assessment of disability.",2011,"The intervention had no significant short- and long-term effects on empowerment, but the intervention increased claimants' knowledge significantly compared to the control group.",['Claimants'],['interactive website'],"['coping, knowledge, claimant satisfaction, perceived justice, and physician satisfaction', ""claimants' knowledge""]",[],[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]",,0.0698283,"The intervention had no significant short- and long-term effects on empowerment, but the intervention increased claimants' knowledge significantly compared to the control group.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Samoocha', 'Affiliation': 'Department of Public and Occupational Health, EMGO Institute, VU University Medical Center, Amsterdam, The Netherlands. d.samoocha@vumc.nl'}, {'ForeName': 'Ingrid A K', 'Initials': 'IA', 'LastName': 'Snels', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bruinvels', 'Affiliation': ''}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Anema', 'Affiliation': ''}, {'ForeName': 'Allard J', 'Initials': 'AJ', 'LastName': 'van der Beek', 'Affiliation': ''}]",Journal of occupational rehabilitation,['10.1007/s10926-010-9283-z']
337,21243370,Pars plana vitrectomy for diabetic macular edema. Internal limiting membrane delamination vs posterior hyaloid removal. A prospective randomized trial.,"BACKGROUND


Diabetes mellitus, as well as subsequent ocular complications such as cystoid macular edema (CME), are of fundametal socio-economic relevance. Therefore, we evaluated the influence of internal limiting membrane (ILM) removal on longterm morphological and functional outcome in patients with diabetes mellitus (DM) type 2 and chronic CME without evident vitreomacular traction.
METHOD


Forty eyes with attached posterior hyaloid were included in this prospective trial and randomized intraoperatively. Prior focal (n = 31) or panretinal (n = 25) laser coagulation was permitted. Group I (n = 19 patients) underwent surgical induction of posterior vitreous detachment (PVD), group II (n = 20 patients) PVD and removal of the ILM. Eleven patients with detached posterior hyaloid (group III) were not randomized, and ILM removal was performed. One eye had to be excluded from further analysis. Examinations included ETDRS best-corrected visual acuity (BCVA), fluorescein angiography (FLA) and OCT at baseline, 3 and 6 months postoperatively. Main outcome measure was BCVA at 6 months, secondary was foveal thickness.
RESULTS


Mean BCVA over 6 months remained unchanged in 85% of patients of group II, and decreased in 53% of patients of group I. Results were not statistically significant different [group I: mean decrease log MAR 95% CI (0.06; 0.32), group II: (-0.02; 0.11)]. OCT revealed a significantly greater reduction of foveal thickness following PVD with ILM removal [group I: mean change: 95% CI (-208.95 μm; -78.05 μm), group II: (-80.90 μm: +59.17 μm)].
CONCLUSION


Vitrectomy, PVD with or without ILM removal does not improve vision in patients with DM type 2 and cystoid diabetic macular edema without evident vitreoretinal traction. ILM delamination shows improved morphological results, and appears to be beneficial in eyes with preexisting PVD.",2011,"OCT revealed a significantly greater reduction of foveal thickness following PVD with ILM removal [group I: mean change: 95% CI (-208.95 μm; -78.05 μm), group II: (-80.90 μm: +59.17 μm)].
","['Forty eyes with attached posterior hyaloid', 'patients with DM type 2 and cystoid diabetic macular edema without evident vitreoretinal traction', 'Prior focal (n\u2009=\u200931) or panretinal (n\u2009=\u200925', 'Eleven patients with detached posterior hyaloid (group III', 'diabetic macular edema', 'patients with diabetes mellitus (DM) type 2 and chronic CME without evident vitreomacular traction', 'eyes with preexisting PVD']","['Internal limiting membrane delamination vs posterior hyaloid removal', 'surgical induction of posterior vitreous detachment (PVD', 'OCT', 'Vitrectomy, PVD with or without ILM removal', 'Pars plana vitrectomy', 'internal limiting membrane (ILM) removal']","['BCVA at 6\xa0months, secondary was foveal thickness', 'PVD and removal of the ILM', 'ETDRS best-corrected visual acuity (BCVA), fluorescein angiography (FLA) and OCT', 'Mean BCVA', 'vision', 'foveal thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0442132', 'cui_str': 'Panretinal (qualifier value)'}, {'cui': 'C0860659', 'cui_str': 'Aloof'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0441514', 'cui_str': 'Delamination (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0423361', 'cui_str': 'Posterior Vitreous Detachment'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein Angiography'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}]",11.0,0.0369971,"OCT revealed a significantly greater reduction of foveal thickness following PVD with ILM removal [group I: mean change: 95% CI (-208.95 μm; -78.05 μm), group II: (-80.90 μm: +59.17 μm)].
","[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Hoerauf', 'Affiliation': 'University Eye Clinic, Georg-August-University, Robert-Koch-Str. 40, 37075, Goettingen, Germany. hanshoerauf@med.uni-goettingen.de'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Brüggemann', 'Affiliation': ''}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Muecke', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lüke', 'Affiliation': ''}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': ''}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Stefánsson', 'Affiliation': ''}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hammes', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Weiss', 'Affiliation': ''}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-010-1610-8']
338,21293900,"Efficacy of serology driven ""test and treat strategy"" for eradication of H. pylori in patients with rheumatic disease in the Netherlands.","The treatment of choice of H. pylori infections is a 7-day triple-therapy with a proton pump inhibitor (PPI) plus amoxicillin and either clarithromycin or metronidazole, depending on local antibiotic resistance rates. The data on efficacy of eradication therapy in a group of rheumatology patients on long-term NSAID therapy are reported here. This study was part of a nationwide, multicenter RCT that took place in 2000-2002 in the Netherlands. Patients who tested positive for H. pylori IgG antibodies were included and randomly assigned to either eradication PPI-triple therapy or placebo. After completion, follow-up at 3 months was done by endoscopy and biopsies were sent for culture and histology. In the eradication group 13% (20/152, 95% CI 9-20%) and in the placebo group 79% (123/155, 95% CI 72-85%) of the patients were H. pylori positive by histology or culture. H. pylori was successfully eradicated in 91% of the patients who were fully compliant to therapy, compared to 50% of those who were not (difference of 41%; 95% CI 18-63%). Resistance percentages found in isolates of the placebo group were: 4% to clarithromycin, 19% to metronidazole, 1% to amoxicillin and 2% to tetracycline.",2011,"H. pylori was successfully eradicated in 91% of the patients who were fully compliant to therapy, compared to 50% of those who were not (difference of 41%; 95% CI 18-63%).","['Patients who tested positive for H. pylori IgG antibodies', '2000-2002 in the Netherlands', 'patients with rheumatic disease in the Netherlands']","['placebo', 'eradication PPI-triple therapy or placebo', 'clarithromycin', 'amoxicillin', 'serology driven ""test', 'tetracycline', 'clarithromycin or metronidazole', 'proton pump inhibitor (PPI) plus amoxicillin', 'metronidazole']",['local antibiotic resistance rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0036745', 'cui_str': 'Serology'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0039651', 'cui_str': 'Tetracyclines'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}]",,0.192926,"H. pylori was successfully eradicated in 91% of the patients who were fully compliant to therapy, compared to 50% of those who were not (difference of 41%; 95% CI 18-63%).","[{'ForeName': 'H T J I', 'Initials': 'HT', 'LastName': 'de Leest', 'Affiliation': 'Department of Rheumatology, VU University Medical Center Amsterdam, P.O. Box 7057, Amsterdam, The Netherlands. marleen.deleest@planet.nl'}, {'ForeName': 'K S S', 'Initials': 'KS', 'LastName': 'Steen', 'Affiliation': ''}, {'ForeName': 'W F', 'Initials': 'WF', 'LastName': 'Lems', 'Affiliation': ''}, {'ForeName': 'M A F J', 'Initials': 'MA', 'LastName': 'van de Laar', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Huisman', 'Affiliation': ''}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Kadir', 'Affiliation': ''}, {'ForeName': 'H H M L', 'Initials': 'HH', 'LastName': 'Houben', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Kostense', 'Affiliation': ''}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Kuipers', 'Affiliation': ''}, {'ForeName': 'B A C', 'Initials': 'BA', 'LastName': 'Dijkmans', 'Affiliation': ''}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Debets-Ossenkopp', 'Affiliation': ''}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-011-1174-5']
339,21103921,"Nutritional supplements, COX-2 and IGF-1 expression in men on active surveillance for prostate cancer.","BACKGROUND


Nutritional factors are associated with reduced risk of prostate cancer progression, yet mechanisms remain unclear. We examined the effects of lycopene and fish oil supplements versus placebo on the normal prostate microenvironment, among men pursuing active surveillance for low-burden prostate cancer. We hypothesized that lycopene or fish oil supplements would down-regulate insulin-like growth factor-1 (IGF-1) and cyclooxygenase 2 (COX-2) gene expression, respectively, reflecting putative proliferation (IGF-1) and inflammatory (COX-2) pathways relevant to carcinogenesis.
METHODS


We conducted a 3-month randomized, double-blinded, clinical trial comparing prostate tissue gene expression profiles (assessed by qRT-PCR) among men with favorable-risk prostate cancer receiving either 30 mg/day lycopene, 3 g/day fish oil (including 1,098 mg eicosapentaenoic and 549 mg docosahexaenoic fatty acids) or placebo.
RESULTS


Among 69 men (22 assigned to lycopene, 21 to fish, and 26 to placebo), there was no difference in the change from baseline to the 3 months in IGF-1 expression level between the placebo and lycopene arms (p = 0.93) nor in COX-2 expression between the placebo and fish arms (p = 0.99).
CONCLUSION


Compared to placebo, 3-month intervention with lycopene or fish oil did not significantly change IGF-1 and COX-2 gene expression in the normal prostate microenvironment in men with low-burden prostate cancer. Further analysis of global gene expression profiles may shed light on the bioactivity and relevance of these nutrients in prostate cancer.",2011,"Compared to placebo, 3-month intervention with lycopene or fish oil did not significantly change IGF-1 and COX-2 gene expression in the normal prostate microenvironment in men with low-burden prostate cancer.","['men on active surveillance for prostate cancer', 'men with low-burden prostate cancer', '69 men (22 assigned to', 'men pursuing active surveillance for low-burden prostate cancer', 'men with favorable-risk prostate cancer receiving either']","['lycopene or fish oil', 'placebo', 'lycopene', 'prostate tissue gene expression profiles (assessed by qRT-PCR', '30\xa0mg/day lycopene, 3\xa0g/day fish oil (including 1,098\xa0mg eicosapentaenoic and 549\xa0mg docosahexaenoic fatty acids) or placebo', 'lycopene and fish oil supplements versus placebo', 'lycopene or fish oil supplements']","['regulate insulin-like growth factor-1 (IGF-1) and cyclooxygenase 2 (COX-2) gene expression', 'change IGF-1 and COX-2 gene expression', 'IGF-1 expression level', 'COX-2 expression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.629582,"Compared to placebo, 3-month intervention with lycopene or fish oil did not significantly change IGF-1 and COX-2 gene expression in the normal prostate microenvironment in men with low-burden prostate cancer.","[{'ForeName': 'June M', 'Initials': 'JM', 'LastName': 'Chan', 'Affiliation': 'Department of Urology, University of California-San Francisco, 1450 3rd Street, San Francisco, CA 94158-9001, USA. june.chan@ucsf.edu'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Weinberg', 'Affiliation': ''}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Magbanua', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sosa', 'Affiliation': ''}, {'ForeName': 'Jeffry', 'Initials': 'J', 'LastName': 'Simko', 'Affiliation': ''}, {'ForeName': 'Katsuto', 'Initials': 'K', 'LastName': 'Shinohara', 'Affiliation': ''}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Federman', 'Affiliation': ''}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Mattie', 'Affiliation': ''}, {'ForeName': 'Millie', 'Initials': 'M', 'LastName': 'Hughes-Fulford', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Haqq', 'Affiliation': ''}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Carroll', 'Affiliation': ''}]",Cancer causes & control : CCC,['10.1007/s10552-010-9684-5']
340,21140258,"Lack of effect of sublingual salvinorin A, a naturally occurring kappa opioid, in humans: a placebo-controlled trial.","RATIONALE


Salvinorin A (SA) is a highly selective kappa opioid receptor agonist and the putative psychoactive compound in Salvia divinorum (SD), an increasingly abused hallucinogenic plant.
OBJECTIVES


The objectives of this study were to characterize the physiological and subjective effects of SA versus placebo and measure drug and metabolite levels.
METHODS


Sublingual SA doses up to 4 mg were administered in dimethyl sulfoxide/polyethylene glycol 400 solution to eight SD-experienced subjects using a placebo-controlled ascending-dose design.
RESULTS


No dose of SA produced significantly greater physiological or subjective effects than placebo. Furthermore, effects did not resemble reported ""typical"" effects of smoked SD. SA was detectable in plasma and urine, but was, in most cases, below the reliable limit of quantification (0.5 ng/mL).
CONCLUSIONS


Our results suggest that the sublingual bioavailability of SA is low. Higher doses, alternate formulations, or alternate routes of administration will be necessary to study the effects of SA in humans.",2011,No dose of SA produced significantly greater physiological or subjective effects than placebo.,['humans'],"['sublingual salvinorin', 'placebo', 'dimethyl sulfoxide/polyethylene glycol 400 solution', 'SA versus placebo', 'placebo-controlled ascending-dose design', 'SA']",['physiological or subjective effects'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0290983', 'cui_str': 'salvinorin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012403', 'cui_str': 'Dimethyl Sulfoxide'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.185746,No dose of SA produced significantly greater physiological or subjective effects than placebo.,"[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Mendelson', 'Affiliation': 'Addiction and Pharmacology Research Laboratory, California Pacific Medical Center Research Institute, San Francisco, CA, USA.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Coyle', 'Affiliation': ''}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Lopez', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Baggott', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Flower', 'Affiliation': ''}, {'ForeName': 'E Thomas', 'Initials': 'ET', 'LastName': 'Everhart', 'Affiliation': ''}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Munro', 'Affiliation': ''}, {'ForeName': 'Gantt P', 'Initials': 'GP', 'LastName': 'Galloway', 'Affiliation': ''}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Cohen', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-2103-5']
341,21104251,Prospective randomized controlled trial to analyze the effects of intermittent pneumatic compression on edema following autologous femoropopliteal bypass surgery.,"BACKGROUND


Patients who undergo autologous femoropopliteal bypass surgery develop postoperative edema in the revascularized leg. The effects of intermittent pneumatic compression (IPC) to treat and to prevent postreconstructive edema were examined in this study.
METHODS


In a prospective randomized trial, patients were assigned to one of two groups. All patients suffered from peripheral arterial disease, and all were subjected to autologous femoropopliteal bypass reconstruction. Patients in group 1 used a compression stocking (CS) above the knee exerting 18 mmHg (class I) on the leg postoperatively for 1 week (day and night). Patients in group 2 used IPC on the foot postoperatively at night for 1 week. The lower leg circumference was measured preoperatively and at five postoperative time points. A multivariate analysis was done using a mixed model analysis of variance.
RESULTS


A total of 57 patients were analyzed (CS 28; IPC 29). Indications for operation were severe claudication (CS 13; IPC 13), rest pain (10/5), or tissue loss (7/11). Revascularization was performed with either a supragenicular (CS 13; IPC10) or an infragenicular (CS 15; IPC 19) autologous bypass. Leg circumference increased on day 1 (CS/IPC): 0.4%/2.7%, day 4 (2.1%/6.1%), day 7 (2.5%/7.9%), day 14 (4.7%/7.3%), and day 90 (1.0%/3.3%) from baseline (preoperative situation). On days 1, 4, and 7 there was a significant difference in leg circumference between the two treatment groups.
CONCLUSIONS


Edema following femoropopliteal bypass surgery occurs in all patients. For the prevention and treatment of that edema the use of a class I CS proved superior to treatment with IPC. The use of CS remains the recommended practice following femoropopliteal bypass surgery.",2011,"Leg circumference increased on day 1 (CS/IPC): 0.4%/2.7%, day 4 (2.1%/6.1%), day 7 (2.5%/7.9%), day 14 (4.7%/7.3%), and day 90 (1.0%/3.3%) from baseline (preoperative situation).","['Patients who undergo autologous femoropopliteal bypass surgery develop postoperative edema in the revascularized leg', '57 patients were analyzed ']","['compression stocking (CS', 'autologous femoropopliteal bypass surgery', 'autologous femoropopliteal bypass reconstruction', 'intermittent pneumatic compression', 'intermittent pneumatic compression (IPC']","['Leg circumference', 'rest pain (10/5), or tissue loss', 'leg circumference', 'lower leg circumference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0190932', 'cui_str': 'Femoral-popliteal artery bypass graft (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0038348', 'cui_str': 'Compression Stockings'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0190932', 'cui_str': 'Femoral-popliteal artery bypass graft (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1140621', 'cui_str': 'Leg'}]",57.0,0.0234836,"Leg circumference increased on day 1 (CS/IPC): 0.4%/2.7%, day 4 (2.1%/6.1%), day 7 (2.5%/7.9%), day 14 (4.7%/7.3%), and day 90 (1.0%/3.3%) from baseline (preoperative situation).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'te Slaa', 'Affiliation': 'Department of Surgery, Amphia Hospital, PO Box 90158, 4800 RK, Breda, The Netherlands.'}, {'ForeName': 'Dennis E J G J', 'Initials': 'DE', 'LastName': 'Dolmans', 'Affiliation': ''}, {'ForeName': 'Gwan H', 'Initials': 'GH', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'Paul G H', 'Initials': 'PG', 'LastName': 'Mulder', 'Affiliation': ''}, {'ForeName': 'Jan C H', 'Initials': 'JC', 'LastName': 'van der Waal', 'Affiliation': ''}, {'ForeName': 'Hans G W', 'Initials': 'HG', 'LastName': 'de Groot', 'Affiliation': ''}, {'ForeName': 'Lijckle', 'Initials': 'L', 'LastName': 'van der Laan', 'Affiliation': ''}]",World journal of surgery,['10.1007/s00268-010-0858-9']
342,21151482,Self-Verification Strivings in Children Holding Negative Self-Views: The Mitigating Effects of a Preceding Success Experience.,"Research among adults has consistently shown that people holding negative self-views prefer negative over positive feedback. The present study tested the hypothesis that this preference is less robust among pre-adolescents, such that it will be mitigated by a preceding positive event. Pre-adolescents (n = 75) holding positive or negative global self-esteem were randomized to a favorable or unfavorable peer evaluation outcome. Next, preferences for positive versus negative feedback were assessed using an unobtrusive behavioral viewing time measure. As expected, results showed that after being faced with the success outcome children holding negative self-views were as likely as their peers holding positive self-views to display a significant preference for positive feedback. In contrast, children holding negative self-views displayed a stronger preference for negative feedback after being faced with the unfavorable outcome that matched their pre-existing self-views.",2010,"In contrast, children holding negative self-views displayed a stronger preference for negative feedback after being faced with the unfavorable outcome that matched their pre-existing self-views.","['adolescents (n\xa0=\xa075) holding positive or negative global self-esteem', 'Children Holding Negative Self-Views']",[],['unobtrusive behavioral viewing time measure'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}]",[],"[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0197924,"In contrast, children holding negative self-views displayed a stronger preference for negative feedback after being faced with the unfavorable outcome that matched their pre-existing self-views.","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Reijntjes', 'Affiliation': ''}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Thomaes', 'Affiliation': ''}, {'ForeName': 'Jan Henk', 'Initials': 'JH', 'LastName': 'Kamphuis', 'Affiliation': ''}, {'ForeName': 'Bram Orobio', 'Initials': 'BO', 'LastName': 'de Castro', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Telch', 'Affiliation': ''}]",Cognitive therapy and research,[]
343,21188413,Skin advanced glycation end product accumulation and muscle strength among adult men.,"Aging is associated with decreased skeletal muscle function. Increased levels of advanced glycation end products (AGEs) in skeletal muscle tissue are observed with advancing age and in diabetes. Although serum AGE level is negatively associated with grip strength in elderly people, it is unknown whether this association is present in adult males. To determine the relationship between AGE accumulation in tissue and muscle strength and power among Japanese adult men. Skin autofluorescence (AF) (a noninvasive method for measuring tissue AGEs), grip strength (n = 232), and leg extension power (n = 138) were measured in Japanese adult men [median (interquartile range) age, 46.0 (37.0, 56.0) years]. After adjustment for potential confounders, the adjusted means [95% confidence interval (CI)] for grip strength across the tertiles of skin AF were 44.5 (43.2, 45.9) kg for the lowest tertile, 42.0 (40.6, 43.3) kg for the middle tertile, and 41.7 (40.3, 43.1) kg for the highest tertile (P for trend < 0.01). Moreover, the adjusted geometric means (95% CI) of leg extension power across the tertiles of skin AF were 17.8 (16.6, 19.1) W/kg for the lowest tertile, 17.5 (16.4, 18.7) W/kg for the middle tertile, and 16.0 (14.9, 17.1) W/kg for the highest tertile (P for trend = 0.04). Among Japanese adult men, participants with higher skin AF had lower muscle strength and power, indicating a relationship between AGE accumulation and muscle strength and power. A long-term prospective study is required to clarify the causality.",2011,Increased levels of advanced glycation end products (AGEs) in skeletal muscle tissue are observed with advancing age and in diabetes.,"['Japanese adult men, participants with higher skin AF', 'n = 232), and leg extension power (n = 138) were measured in Japanese adult men [median (interquartile range) age, 46.0 (37.0, 56.0) years', 'Japanese adult men', 'adult men', 'elderly people']",['grip strength'],"['Skin autofluorescence (AF', 'grip strength across the tertiles of skin AF', 'leg extension power across the tertiles of skin AF', 'skeletal muscle function']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0544711', 'cui_str': 'Autofluorescence'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0031843', 'cui_str': 'function'}]",138.0,0.0473568,Increased levels of advanced glycation end products (AGEs) in skeletal muscle tissue are observed with advancing age and in diabetes.,"[{'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Momma', 'Affiliation': 'Department of Medicine and Science in Sports and Exercise, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Kaijun', 'Initials': 'K', 'LastName': 'Niu', 'Affiliation': ''}, {'ForeName': 'Yoritoshi', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': ''}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Chujo', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Otomo', 'Affiliation': ''}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Yufei', 'Affiliation': ''}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Tadaura', 'Affiliation': ''}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': ''}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': ''}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Miyata', 'Affiliation': ''}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Nagatomi', 'Affiliation': ''}]",European journal of applied physiology,['10.1007/s00421-010-1779-x']
344,21174144,H5N1 influenza vaccine formulated with AS03 A induces strong cross-reactive and polyfunctional CD4 T-cell responses.,"OBJECTIVE


Adjuvantation of an H5N1 split-virion influenza vaccine with AS03(A) substantially reduces the antigen dose required to produce a putatively protective humoral response and promotes cross-clade neutralizing responses. We determined the effect of adjuvantation on antibody persistence and B- and T-cell-mediated immune responses.
METHODS


Two vaccinations with a split-virion A/Vietnam/1194/2004 (H5N1, clade 1) vaccine containing 3.75-30 μg hemagglutinin and formulated with or without adjuvant were administered to groups of 50 volunteers aged 18-60 years.
RESULTS


Adjuvantation of the vaccine led to better persistence of neutralizing and hemagglutination-inhibiting antibodies and higher frequencies of antigen-specific memory B cells. Cross-reactive and polyfunctional H5N1-specific CD4 T cells were detected at baseline and were amplified by vaccination. Expansion of CD4 T cells was enhanced by adjuvantation.
CONCLUSION


Formulation of the H5N1 vaccine with AS03(A) enhances antibody persistence and induces stronger T- and B-cell responses. The cross-clade T-cell immunity indicates that the adjuvanted vaccine primes individuals to respond to either infection and/or subsequent vaccination with strains drifted from the primary vaccine strain.",2011,Cross-reactive and polyfunctional H5N1-specific CD4 T cells were detected at baseline and were amplified by vaccination.,"['Two vaccinations with a', '50 volunteers aged 18-60 years']","['split-virion A/Vietnam/1194/2004 (H5N1, clade 1) vaccine containing 3.75-30 μg hemagglutinin and formulated with or without adjuvant', 'H5N1 split-virion influenza vaccine with AS03(A', 'H5N1 vaccine with AS03(A']","['antibody persistence and induces stronger T- and B-cell responses', 'persistence of neutralizing and hemagglutination-inhibiting antibodies and higher frequencies of antigen-specific memory B cells', 'Expansion of CD4 T cells', 'strong cross-reactive and polyfunctional CD4 T-cell responses', 'antibody persistence and B- and T-cell-mediated immune responses', 'Cross-reactive and polyfunctional H5N1-specific CD4 T cells']","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0018905', 'cui_str': 'Hemagglutination assay (procedure)'}, {'cui': 'C0301846', 'cui_str': 'Univalent antibody'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",50.0,0.144144,Cross-reactive and polyfunctional H5N1-specific CD4 T cells were detected at baseline and were amplified by vaccination.,"[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moris', 'Affiliation': 'GlaxoSmithKline Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'van der Most', 'Affiliation': ''}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Leroux-Roels', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Clement', 'Affiliation': ''}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Dramé', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Hanon', 'Affiliation': ''}, {'ForeName': 'Geert G', 'Initials': 'GG', 'LastName': 'Leroux-Roels', 'Affiliation': ''}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Van Mechelen', 'Affiliation': ''}]",Journal of clinical immunology,['10.1007/s10875-010-9490-6']
345,21174145,Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus.,"OBJECTIVE


The objective of this study was to assess the proportion of patients with type 2 diabetes mellitus (T2DM) attaining individual and combined targets of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), non-HDL-C, and apolipoprotein B (ApoB) after treatment with rosuvastatin (R) + fenofibric acid (FA) compared with corresponding-dose R monotherapy.
METHODS


This post hoc analysis evaluated data from the T2DM subset of patients with mixed dyslipidemia (LDL-C ≥130 mg/dL, HDL-C <40/50 mg/dL in men/women, and TG ≥150 mg/dL) from 2 randomized studies. Patients included in the analysis (N = 456) were treated with R (5, 10, or 20 mg), FA 135 mg, or R (5, 10, or 20 mg) + FA 135 mg for 12 weeks. Attainment of LDL-C <100 mg/dL, HDL-C >40/50 mg/dL in men/women, TG <150 mg/dL, non-HDL-C <130 mg/dL, ApoB <90 mg/dL, and the combined targets of these parameters was assessed.
RESULTS


Treatment with R + FA resulted in a significantly higher proportion of patients achieving optimal levels of HDL-C (46.8% vs. 20.8%, P = 0.009 for R 10 mg + FA), TG (60.0% vs. 34.0%, P = 0.02 for R 10 mg + FA; 54.0% vs. 26.4%, P = 0.005 for R 20 mg + FA), non-HDL-C (55.1% vs. 36.4%, P = 0.04 for R 5 mg + FA), ApoB (58.0% vs. 36.4%, P = 0.02 for R 5 mg + FA); and the combined targets of LDL-C, HDL-C, and TG (28.3% vs. 8.3%, P = 0.02 for R 10 mg + FA) and all 5 parameters (26.1% vs. 8.3%, P = 0.03 for R 10 mg + FA) than corresponding-dose R monotherapies.
CONCLUSIONS


A significantly greater proportion of T2DM patients achieved individual and combined lipid targets when treated with the combination of R + FA than corresponding-dose R monotherapies.",2011,"RESULTS


Treatment with R + FA resulted in a significantly higher proportion of patients achieving optimal levels of HDL-C (46.8% vs. 20.8%, P = 0.009 for R 10 mg + FA), TG (60.0% vs. 34.0%, P = 0.02 for R 10 mg + FA; 54.0% vs. 26.4%, P = 0.005 for R 20 mg + FA), non-HDL-C (55.1% vs. 36.4%, P = 0.04 for R 5 mg + FA), ApoB (58.0% vs. 36.4%, P = 0.02 for R 5 mg + FA); and the combined targets of LDL-C, HDL-C, and TG (28.3% vs. 8.3%, P = 0.02 for R 10 mg + FA) and all 5 parameters (26.1% vs. 8.3%, P = 0.03 for R 10 mg + FA) than corresponding-dose R monotherapies.
","['patients with type 2 diabetes mellitus (T2DM', 'patients with type 2 diabetes mellitus', 'men/women, TG']","['rosuvastatin and fenofibric Acid', 'R + FA', 'rosuvastatin (R) + fenofibric acid (FA) compared with corresponding-dose R monotherapy']","['proportion of patients achieving optimal levels of HDL-C', 'low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), non-HDL-C, and apolipoprotein B (ApoB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0060179', 'cui_str': 'fenofibric acid'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}]",456.0,0.0274904,"RESULTS


Treatment with R + FA resulted in a significantly higher proportion of patients achieving optimal levels of HDL-C (46.8% vs. 20.8%, P = 0.009 for R 10 mg + FA), TG (60.0% vs. 34.0%, P = 0.02 for R 10 mg + FA; 54.0% vs. 26.4%, P = 0.005 for R 20 mg + FA), non-HDL-C (55.1% vs. 36.4%, P = 0.04 for R 5 mg + FA), ApoB (58.0% vs. 36.4%, P = 0.02 for R 5 mg + FA); and the combined targets of LDL-C, HDL-C, and TG (28.3% vs. 8.3%, P = 0.02 for R 10 mg + FA) and all 5 parameters (26.1% vs. 8.3%, P = 0.03 for R 10 mg + FA) than corresponding-dose R monotherapies.
","[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rosenson', 'Affiliation': 'Mount Sinai Heart, Mount Sinai School of Medicine, New York, NY 10029-6574, USA. robert.rosenson@mssm.edu'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Carlson', 'Affiliation': ''}, {'ForeName': 'Maureen T', 'Initials': 'MT', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Setze', 'Affiliation': ''}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Hirshberg', 'Affiliation': ''}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Stolzenbach', 'Affiliation': ''}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Williams', 'Affiliation': ''}]",Cardiovascular drugs and therapy,['10.1007/s10557-010-6273-5']
346,21161733,Emerging ideas: Shared decision making in patients with osteoarthritis of the hip and knee.,"BACKGROUND


Despite the widely reported success of total joint arthroplasty (TJA) in reducing pain and improving quality of life and function for patients with hip or knee osteoarthritis, rates of TJA use vary widely throughout the United States, with broad disparities based on geographic, racial, and socioeconomic factors. Shared decision-making approaches, which require an exchange of information between patients and their physicians, can be helpful in improving patient satisfaction with their treatment decision and appropriate use of TJA.
QUESTIONS/HYPOTHESES


Expected-value decision analysis models incorporating evidence-based outcome data with individual patient preferences regarding health states and willingness to pay, when used in shared decision-making models, will improve satisfaction among patients with hip or knee osteoarthritis and lead to more appropriate use of TJA.
PROPOSED PROGRAM


Patients with hip or knee osteoarthritis will be randomized to usual care or participation in a shared decision-making intervention. Patients in the shared decision-making intervention arm will have their preferences for individual health states related to osteoarthritis and TJA measured using the time trade-off technique, and these values will be incorporated in an expected-value decision analysis model, which also will incorporate the patient's willingness to pay for a particular treatment intervention and evidence-based outcome probabilities. The patient's decision for operative versus nonoperative care and their level of satisfaction with their decision will be compared using chi square and Mann-Whitney rank-sum tests.
SIGNIFICANCE


Information regarding patient preferences for particular health states and willingness to pay can be combined with evidence-based outcome data in expected-value decision analysis models, which will help inform shared clinical decision making between surgeons and their patients with hip or knee osteoarthritis.",2011,"Patients in the shared decision-making intervention arm will have their preferences for individual health states related to osteoarthritis and TJA measured using the time trade-off technique, and these values will be incorporated in an expected-value decision analysis model, which also will incorporate the patient's willingness to pay for a particular treatment intervention and evidence-based outcome probabilities.","['Patients with hip or knee osteoarthritis', 'patients with osteoarthritis of the hip and knee', 'patients with hip or knee osteoarthritis']",['total joint arthroplasty (TJA'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]",[],,0.0344087,"Patients in the shared decision-making intervention arm will have their preferences for individual health states related to osteoarthritis and TJA measured using the time trade-off technique, and these values will be incorporated in an expected-value decision analysis model, which also will incorporate the patient's willingness to pay for a particular treatment intervention and evidence-based outcome probabilities.","[{'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Bozic', 'Affiliation': 'Department of Orthopaedic Surgery and Philip R. Lee Institute for Health Policy Studies, University of California-San Francisco, 500 Parnassus, MU 320 W, San Francisco, CA 94143-0728, USA. kevin.bozic@ucsf.edu'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Chiu', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1007/s11999-010-1740-7']
347,21103989,Chronic pain after laparoscopic transabdominal preperitoneal hernia repair: a randomized comparison of light and extralight titanized polypropylene mesh.,"BACKGROUND


The aim of this prospective, randomized, single-blinded clinical trial was to compare the incidence of chronic pain after laparoscopic transabdominal preperitoneal hernia repair (TAPP) using a 35-g/m2 titanized polypropylene mesh and a 16-g/m2 titanized polypropylene mesh. The reported incidence of chronic pain in patients who underwent laparoscopic hernia repair is a serious problem. The techniques of dissection, mesh fixation, and the mesh material used have all been identified as being part of the problem. Excellent biocompatibility through a unique combination of a lightweight open porous polypropylene mesh covered with a covalent-bonded titanium layer has been claimed. The aim of this study was to find out whether the titanium surface alone or the difference in material load between the two available meshes influences clinical outcomes.
METHODS


Three hundred eighty patients with 466 inguinal hernias were operated on between 2002 and 2006 with the laparoscopic transabdominal preperitoneal (TAPP) technique. Mesh fixation with staples was carried out routinely. After the dissection was completed just prior to the implantation of the mesh, patients were randomized into two groups. In Group A, 250 (53.6%) inguinal hernias were repaired with a 35-g/m2 titanized polypropylene mesh, and in Group B, 216 (46.4%) inguinal hernias were repaired with a 16-g/m2 titanized polypropylene mesh. The primary outcome was chronic pain 3 years after surgery. The degree of pain was determined using a visual analog scale (VAS) with a range from 0 to 10. The secondary outcome was the rate of recurrence.
RESULTS


The postoperative period of observation was at least 3 years for every patient. In both groups, 90% of the patients could be questioned and examined clinically: in Group A (Light), 5.3% of the patients and in Group B (Extralight), 1.5% of the patients suffered from chronic pain. Chronic pain was significantly more common in Group A than in Group B (p=0.037). There was no difference with respect to the rate of recurrence: for Group A it was 3.1% and for Group B it was 2.6% (p=0.724).
CONCLUSIONS


Chronic pain is not very common in patients who have had their inguinal hernias repaired with titanium-covered polypropylene mesh. Reducing the material load from 35 to 16 g/m2 seems to further improve the biocompatibility of these meshes, thus improving the clinical outcome by reducing chronic pain to a rare event. The role of staples in causing chronic pain following inguinal hernia repair may be overestimated. There was no evidence supporting the notion that the use of the 16-g/m2 titanized meshes is associated with increased recurrence rates.",2011,Chronic pain was significantly more common in Group A than in Group B (p=0.037).,"['patients who have had their inguinal hernias repaired with', 'Three hundred eighty patients with 466 inguinal hernias were operated on between 2002 and 2006 with the']","['laparoscopic hernia repair', 'laparoscopic transabdominal preperitoneal hernia repair', 'titanium-covered polypropylene mesh', 'inguinal hernias were repaired with a 16-g/m2 titanized polypropylene mesh', 'light and extralight titanized polypropylene mesh', 'laparoscopic transabdominal preperitoneal (TAPP) technique', 'laparoscopic transabdominal preperitoneal hernia repair (TAPP) using a 35-g/m2 titanized polypropylene mesh and a 16-g/m2 titanized polypropylene mesh']","['rate of recurrence', 'degree of pain', 'visual analog scale (VAS', 'chronic pain 3 years after surgery', 'recurrence rates', 'Chronic pain', 'chronic pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}]","[{'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach (qualifier value)'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh (physical object)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0456636', 'cui_str': '16G (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1300564', 'cui_str': 'gm/m2'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",380.0,0.181257,Chronic pain was significantly more common in Group A than in Group B (p=0.037).,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schopf', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Agatharied Academic Teaching Hospital of the Ludwig-Maximilians-University Munich, St. Agathastr. 1, 83734, Hausham/Oberbayern, Germany. sallerschopf@aol.com'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'von Ahnen', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'von Ahnen', 'Affiliation': ''}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Schardey', 'Affiliation': ''}]",World journal of surgery,['10.1007/s00268-010-0850-4']
348,21153533,"The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up.","AIMS/HYPOTHESIS


The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study was designed to establish whether weaning to a highly hydrolysed formula in infancy subsequently reduces the risk of type 1 diabetes.
METHODS


The study population comprises newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion, but not exclusion criteria. The study is being performed in 15 countries in three continents. First-degree relatives of patients with type 1 diabetes were identified from diabetes clinics, diabetes registries, and from other endocrinology or obstetrics offices and websites. HLA typing was performed at birth from cord or heel stick blood, and the results sent to the study's Data Management Unit within 2 weeks for communication of eligibility to the clinical study centre. All mothers recruited were encouraged to breastfeed. The intervention lasted for 6 to 8 months, and weaning formulas based on hydrolysed casein and standard cow's milk were compared.
RESULTS


TRIGR recruited 5,606 infants, of whom 2,160 were enrolled as eligible participants, 6% more than the target of 2,032. Of those enrolled, 80% were exposed to the study formula. The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%. The randomisation code will be opened when the last recruited child turns 10 years of age, i.e. in 2017.
CONCLUSIONS/INTERPRETATION


The TRIGR experience demonstrates the feasibility and successful implementation of an international dietary intervention study. TRIGR is the first ever primary prevention trial for type 1 diabetes and, if completed successfully, will provide a definite answer to the research question.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00179777
FUNDING


The study was funded by the National Institute of Child Health and Development (NICHD) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) (grant numbers HD040364, HD042444 and HD051997), Canadian Institutes of Health Research, the Juvenile Diabetes Research Foundation International and the Commission of the European Communities (specific RTD programme 'Quality of Life and Management of Living Resources', contract number QLK1-2002-00372 'Diabetes Prevention'. Other funding came from the EFSD/JDRF/Novo Nordisk Focused Research Grant, Academy of Finland, Dutch Diabetes Research Foundation and Finnish Diabetes Research Foundation).",2011,"The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%.","['TRIGR recruited 5,606 infants, of whom 2,160 were enrolled as eligible participants, 6% more than the target of 2,032', 'All mothers recruited were encouraged to breastfeed', '15 countries in three continents', 'newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion, but not exclusion criteria']",[],['overall retention rate'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0443192', 'cui_str': 'Continent (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",5606.0,0.0286784,"The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Hospital for Children and Adolescents, University of Helsinki, Biomedicum Helsinki 2 U, PO Box\xa020, 00014, Helsinki, Finland.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Akerblom', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krischer', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Berseth', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dupré', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ilonen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Trucco', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Savilahti', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Koski', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pajakkala', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fransiscus', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lough', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bradley', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koski', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-010-1964-9']
349,21165661,ADHD and EEG-neurofeedback: a double-blind randomized placebo-controlled feasibility study.,"Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder (ADHD) in several, mostly uncontrolled studies. This pilot study is designed to test the feasibility and safety of using a double-blind placebo feedback-controlled design and to explore the initial efficacy of individualized EEG-neurofeedback training in children with ADHD. Fourteen children (8-15 years) with ADHD defined according to the DSM-IV-TR criteria were randomly allocated to 30 sessions of EEG-neurofeedback (n = 8) or placebo feedback (n = 6). Safety measures (adverse events and sleep problems), ADHD symptoms and global improvement were monitored. With respect to feasibility, all children completed the study and attended all study visits and training sessions. No significant adverse effects or sleep problems were reported. Regarding the expectancy, 75% of children and their parent(s) in the active neurofeedback group and 50% of children and their parent(s) in the placebo feedback group thought they received placebo feedback training. Analyses revealed significant improvements of ADHD symptoms over time, but changes were similar for both groups. This pilot study shows that it is feasible to conduct a rigorous placebo-controlled trial to investigate the efficacy of neurofeedback training in children with ADHD. However, a double-blind design may not be feasible since using automatic adjusted reward thresholds may not work as effective as manually adjusted reward thresholds. Additionally, implementation of active learning strategies may be an important factor for the efficacy of EEG-neurofeedback training. Based on the results of this pilot study, changes are made in the design of the ongoing study.",2011,No significant adverse effects or sleep problems were reported.,"['children with ADHD', 'Fourteen children (8-15 years) with ADHD defined according to the DSM-IV-TR criteria', 'patients with attention-deficit/hyperactivity disorder (ADHD']","['individualized EEG-neurofeedback training', 'placebo', 'Electroencephalography (EEG)-neurofeedback', 'neurofeedback training', 'EEG-neurofeedback (n = 8) or placebo feedback', 'placebo feedback training']","['adverse effects or sleep problems', 'ADHD symptoms', 'Safety measures (adverse events and sleep problems), ADHD symptoms and global improvement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",14.0,0.236572,No significant adverse effects or sleep problems were reported.,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Lansbergen', 'Affiliation': 'Department of Psychiatry, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. mariekelansbergen@hotmail.com'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Dongen-Boomsma', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Slaats-Willemse', 'Affiliation': ''}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-010-0524-2']
350,21132493,Comparison of the haptic and visual deviations in a parallelity task.,"Deviations in both haptic and visual spatial experiments are thought to be caused by a biasing influence of an egocentric reference frame. The strength of this influence is strongly participant-dependent. By using a parallelity test, it is studied whether this strength is modality-independent. In both haptic and visual conditions, large, systematic and participant-dependent deviations were found. However, although the correlation between the haptic and visual deviations was significant, the explained variance due to a common factor was only 20%. Therefore, the degree to which a participant is ""egocentric"" depends on modality and possibly even more generally, on experimental condition.",2011,Deviations in both haptic and visual spatial experiments are thought to be caused by a biasing influence of an egocentric reference frame.,[],[],['haptic and visual deviations'],[],[],"[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",,0.0244056,Deviations in both haptic and visual spatial experiments are thought to be caused by a biasing influence of an egocentric reference frame.,"[{'ForeName': 'Astrid M L', 'Initials': 'AM', 'LastName': 'Kappers', 'Affiliation': 'Helmholtz Institute, Physics of Man, Utrecht University, Padualaan 8, 3584 CH Utrecht, The Netherlands. a.m.l.kappers@uu.nl'}, {'ForeName': 'Wouter B', 'Initials': 'WB', 'LastName': 'Schakel', 'Affiliation': ''}]",Experimental brain research,['10.1007/s00221-010-2500-3']
351,21116652,"Effect of eszopiclone on sleep, fatigue, and pain in patients with mucositis associated with hematologic malignancies.","PURPOSE


Patients with malignancy sometimes develop painful mucositis and require patient-controlled analgesia (PCA) to treat their pain. Pain disrupts sleep and there is some evidence that analgesic medications also disrupt sleep. This study examined whether treatment with the sedative hypnotic eszopiclone could improve self-reports of sleep, fatigue, and pain as well as decrease opioid self-administered via PCA.
METHODS


Inpatients who developed mucositis severe enough to require PCA treatment were randomized double-blind to a 2-day trial on eszopiclone or placebo-administered at bedtime. Patients completed questionnaires which assessed sleep, pain, and fatigue. PCA medication was calculated in terms of morphine equivalents. Data were analyzed with unpaired t tests and repeated measures analysis of variance.
RESULTS


Twenty-two patients were randomized to placebo and 23 to eszopiclone. Groups were comparable in age and treatment characteristics. Mean pain scores were lower in the eszopiclone group at all time points (morning p = 0.01, afternoon p = 0.04, evening p = 0.04). The eszopiclone group reported increased sleep time (p < 0.05), fewer nighttime awakenings (p < 0.001), better self-reported sleep quality (p = 0.01), and depth (p = 0.04). There were no significant differences between eszopiclone and placebo in terms of self-reports of fatigue or opioid usage.
CONCLUSION


Sedative hypnotic agents improve sleep and analgesia even in the setting of considerable pain and discomfort.",2011,"There were no significant differences between eszopiclone and placebo in terms of self-reports of fatigue or opioid usage.
","['Inpatients who developed mucositis severe enough to require PCA treatment', 'Twenty-two patients', 'patients with mucositis associated with hematologic malignancies', 'Patients with malignancy sometimes develop painful mucositis and require patient-controlled analgesia (PCA) to treat their pain']","['placebo', 'Sedative hypnotic agents', 'sedative hypnotic eszopiclone', 'eszopiclone', 'eszopiclone and placebo', 'eszopiclone or placebo-administered at bedtime']","['Pain disrupts sleep', 'sleep, pain, and fatigue', 'sleep time', 'self-reports of fatigue or opioid usage', 'sleep, fatigue, and pain', 'PCA medication', 'Mean pain scores', 'nighttime awakenings', 'better self-reported sleep quality', 'self-reports of sleep, fatigue, and pain']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C1436328', 'cui_str': 'Eszopiclone'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",22.0,0.224824,"There were no significant differences between eszopiclone and placebo in terms of self-reports of fatigue or opioid usage.
","[{'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Dimsdale', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, USA. jdimsdale@ucsd.edu'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Ball', 'Affiliation': ''}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Carrier', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holman', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Mulroney', 'Affiliation': ''}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Shaikh', 'Affiliation': ''}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': ''}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-010-1052-1']
352,21161463,Randomized transcoronary delivery of CD34(+) cells with perfusion versus stop-flow method in patients with recent myocardial infarction: Early cardiac retention of ⁹⁹(m)Tc-labeled cells activity.,"BACKGROUND


For transcoronary progenitor cells' administration, injections under flow arrest (over-the-wire balloon technique, OTW) are used universally despite lack of evidence for being required for cell delivery or being effective in stimulating myocardial engraftment. Flow-mediated endothelial rolling is mandatory for subsequent cell adhesion and extravasation.
METHODS


To optimize cell directing toward the coronary endothelium under maintained flow, the authors developed a cell-delivery side-holed perfusion catheter (PC). Thirty-four patients (36-69 years, 30 men) with primary stent-assisted angioplasty-treated anterior MI (peak TnI 151 [53-356]ng/dL, mean[range]) were randomly assigned to OTW or PC autologous ⁹⁹Tc-extametazime-labeled bone marrow CD34(+) cells (4.34 [0.92-7.54] × 10⁶) administration at 6-14 days after pPCI (LVEF 37.1 [24-44]%). Myocardial perfusion (⁹⁹(m)Tc-MIBI) and labeled cells' activity were evaluated (SPECT) at, respectively, 36-48 h prior to and 60 min after delivery.
RESULTS


In contrast to OTW coronary occlusions, no intolerance or ventricular arrhythmia occurred with PC cells' administration (P < .001). One hour after delivery, 4.86 [1.7-7.6]% and 5.05 [2.2-9.9]% activity was detected in the myocardium (OTW and PC, respectively, P = .84). Labeled cell activity was clearly limited to the (viable) peri-infarct zone in 88% patients, indicating that the infarct core zone may be largely inaccessible to transcoronary-administered cells.
CONCLUSIONS


Irrespective of the transcoronary delivery method, only ≈ 5% of native (i.e., non-engineered) CD34(+) cells spontaneously home to the injured myocardium, and cell retention occurs preferentially in the viable peri-infarct zone. Although the efficacy of cell delivery is not increased with the perfusion method, by avoiding provoking ischemic episodes PC offers a rational alternative to the OTW delivery.",2011,"In contrast to OTW coronary occlusions, no intolerance or ventricular arrhythmia occurred with PC cells' administration (P < .001).","['patients with recent myocardial infarction', 'Thirty-four patients (36-69 years, 30 men) with primary stent-assisted angioplasty-treated anterior MI (peak TnI 151 [53-356]ng/dL, mean[range']","['CD34(+) cells with perfusion versus stop-flow method', 'OTW or PC autologous ⁹⁹Tc-extametazime-labeled bone marrow CD34(+) cells']","['intolerance or ventricular arrhythmia', ""Myocardial perfusion (⁹⁹(m)Tc-MIBI) and labeled cells' activity"", 'Labeled cell activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction (situation)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0340293', 'cui_str': 'Anterior Wall Myocardial Infarction'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}]","[{'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia (disorder)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0478679,"In contrast to OTW coronary occlusions, no intolerance or ventricular arrhythmia occurred with PC cells' administration (P < .001).","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Musialek', 'Affiliation': 'Department of Cardiac and Vascular Diseases, John Paul II Hospital, Institute of Cardiology, Jagiellonian University, Krakow, Poland. pmusialek@szpitaljp2.krakow.pl'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Tekieli', 'Affiliation': ''}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Kostkiewicz', 'Affiliation': ''}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Majka', 'Affiliation': ''}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szot', 'Affiliation': ''}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Walter', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zebzda', 'Affiliation': ''}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Pieniazek', 'Affiliation': ''}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kadzielski', 'Affiliation': ''}, {'ForeName': 'R Pawel', 'Initials': 'RP', 'LastName': 'Banys', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Olszowska', 'Affiliation': ''}, {'ForeName': 'Mieczyslaw', 'Initials': 'M', 'LastName': 'Pasowicz', 'Affiliation': ''}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zmudka', 'Affiliation': ''}, {'ForeName': 'Wieslawa', 'Initials': 'W', 'LastName': 'Tracz', 'Affiliation': ''}]",Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology,['10.1007/s12350-010-9326-z']
353,21125023,Factors Associated with Attrition from Mindfulness-Based Cognitive Therapy in Patients with a History of Suicidal Depression.,"We report data from a randomised controlled trial of mindfulness-based cognitive therapy to pilot procedures for people with a history of suicidal ideation or behaviour, focusing in particular on the variables that distinguish those who complete an adequate 'dose' of treatment, from those who drop out. Sixty-eight participants were randomised to either immediate treatment with mindfulness-based cognitive therapy (MBCT) (n = 33) or to the waitlist (n = 36) arm of the trial. In addition to collecting demographic and clinical information, we assessed participants' cognitive reactivity using the means end problem-solving task, completed before and after a mood induction procedure. Ten participants dropped out of treatment, and eight dropped out of the waitlist condition. Those who dropped out of MBCT were significantly younger than those who completed treatment, less likely to be on antidepressants, had higher levels of depressive rumination and brooding and showed significantly greater levels of problem-solving deterioration following mood challenge. None of these factors distinguished participants in the waiting list condition who remained in the study from those who dropped out. Our results suggest that individuals with high levels of cognitive reactivity, brooding and depressive rumination may find it particularly difficult to engage with MBCT, although paradoxically they are likely to have the most to gain from the development of mindfulness skills if they remain in class. Addressing how such patients can be best prepared for treatment and supported to remain in treatment when difficulties arise is an important challenge.",2010,"Those who dropped out of MBCT were significantly younger than those who completed treatment, less likely to be on antidepressants, had higher levels of depressive rumination and brooding and showed significantly greater levels of problem-solving deterioration following mood challenge.","['Patients with a History of Suicidal Depression', 'Sixty-eight participants', ""people with a history of suicidal ideation or behaviour, focusing in particular on the variables that distinguish those who complete an adequate 'dose' of treatment, from those who drop out""]","['Mindfulness-Based Cognitive Therapy', 'immediate treatment with mindfulness-based cognitive therapy (MBCT', 'mindfulness-based cognitive therapy']","['levels of problem-solving deterioration', 'depressive rumination']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0221745', 'cui_str': 'Depression suicidal'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}]",68.0,0.0294193,"Those who dropped out of MBCT were significantly younger than those who completed treatment, less likely to be on antidepressants, had higher levels of depressive rumination and brooding and showed significantly greater levels of problem-solving deterioration following mood challenge.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford, OX3 7JX UK.'}, {'ForeName': 'J Mark G', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': ''}]",Mindfulness,[]
354,21190026,Health-related quality of life and colorectal cancer-specific symptoms in patients with chemotherapy-refractory metastatic disease treated with panitumumab.,"PURPOSE


Panitumumab monotherapy is approved for chemotherapy-refractory wild-type KRAS metastatic colorectal cancer (mCRC). Patient-reported outcomes-although important in the palliative setting-have not been reported in this patient population.
METHODS


In a phase 3 trial (n = 463), patients with chemotherapy-refractory mCRC were randomized 1:1 to panitumumab plus best supportive care (BSC) or BSC alone. Patient-reported outcomes were assessed using the NCCN/FACT CRC Symptom Index (FCSI) and EQ-5D Index. KRAS tumor status was analyzed in a prospectively defined, retrospective analysis. Average difference in change from baseline between treatment groups was evaluated using linear mixed and pattern-mixture models.
RESULTS


KRAS tumor status and post-baseline patient-reported outcomes were available for 363 patients. Linear mixed models indicated significant differences in the FCSI score (difference in least-squares [LS] adjusted means [95% CI]; 5.62 [2.38, 8.86]) and the EQ-5D Index (difference in LS adjusted means [95% CI]; 0.22 [0.12, 0.32]) favoring panitumumab over BSC in patients with wild-type KRAS mCRC. By pattern-mixture analysis, the advantage of panitumumab over BSC was more pronounced in those patients with wild-type KRAS mCRC who did not drop out of the study early. In patients with mutant KRAS mCRC, no differences were observed between groups.
CONCLUSIONS


Panitumumab-treated patients with wild-type KRAS mCRC maintained better control of CRC symptoms and quality of life compared with BSC alone, extending our understanding of the benefits of panitumumab treatment beyond improvements in progression-free survival.",2011,"In patients with mutant KRAS mCRC, no differences were observed between groups.
","['patients with chemotherapy-refractory mCRC', 'patients with chemotherapy-refractory metastatic disease treated with', 'chemotherapy-refractory wild-type KRAS metastatic colorectal cancer (mCRC']","['panitumumab', 'panitumumab plus best supportive care (BSC) or BSC alone']","['Health-related quality of life and colorectal cancer-specific symptoms', 'EQ-5D Index', 'CRC symptoms and quality of life', 'NCCN/FACT CRC Symptom Index (FCSI) and EQ-5D Index', 'progression-free survival', 'FCSI score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.146614,"In patients with mutant KRAS mCRC, no differences were observed between groups.
","[{'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Odom', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, NC 22709-2194, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Barber', 'Affiliation': ''}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': ''}, {'ForeName': 'Zhongyun', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kaye', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Wiezorek', 'Affiliation': ''}]",International journal of colorectal disease,['10.1007/s00384-010-1112-5']
355,21125277,Pharmacokinetics of aprepitant and dexamethasone after administration of chemotherapeutic agents and effects of plasma substance P concentration on chemotherapy-induced nausea and vomiting in Japanese cancer patients.,"PURPOSE


This study was conducted to determine the pharmacokinetics of aprepitant and dexamethasone as well as the relationship between the plasma concentration of substance P and nausea/vomiting in Japanese cancer patients.
METHODS


After administration of aprepitant (125/80 mg group [10 patients]: 125 mg on day 1 and 80 mg on days 2-5; 40/25 mg group [10 patients]: 40 mg on day 1 and 25 mg on days 2-5) and dexamethasone (6 mg on day 1 and 4 mg on days 2 and 3 in the 125/80 mg group, and 8 mg on day 1 and 6 mg on days 2 and 3 in the 40/25 mg group) to Japanese cancer patients receiving at least moderately emetogenic antitumor agents, the plasma concentrations of aprepitant, dexamethasone, and substance P were measured.
RESULTS


All of 20 patients were treated with the highly emetogenic agent cisplatin (≥70 mg/m(2)). The C(max) and AUC(0-24 h) of aprepitant in Japanese cancer patients were similar with those in non-Japanese patients. The clearance of dexamethasone in the 125/80 mg group was approximately one-half of that previously determined in the absence of aprepitant. The substance P concentration in plasma significantly increased only in patients with delayed nausea/vomiting.
CONCLUSIONS


This study demonstrated similar plasma pharmacokinetics of aprepitant in Japanese and non-Japanese, the validity of reducing dexamethasone dose, and the existence of increased plasma substance P concentration in patients receiving highly emetogenic cisplatin-based chemotherapy.",2011,The C(max) and AUC(0-24 h) of aprepitant in Japanese cancer patients were similar with those in non-Japanese patients.,"['20 patients were treated with the highly', '125/80\xa0mg group [10 patients', 'aprepitant in Japanese and non-Japanese', 'patients receiving highly emetogenic cisplatin-based chemotherapy', 'Japanese cancer patients']","['aprepitant and dexamethasone', 'dexamethasone', 'emetogenic agent cisplatin', 'aprepitant', 'Japanese cancer patients receiving at least moderately emetogenic antitumor agents, the plasma concentrations of aprepitant, dexamethasone, and substance P were measured']","['clearance of dexamethasone', 'substance P concentration in plasma', 'nausea and vomiting', 'plasma concentration of substance P and nausea/vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0003392', 'cui_str': 'Chemotherapeutic Anticancer Drug'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038585', 'cui_str': 'Euler-Gaddum Substance P'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038585', 'cui_str': 'Euler-Gaddum Substance P'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",20.0,0.0367898,The C(max) and AUC(0-24 h) of aprepitant in Japanese cancer patients were similar with those in non-Japanese patients.,"[{'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan. t.takahashi@scchr.jp'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': ''}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Tsuya', 'Affiliation': ''}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': ''}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': ''}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': ''}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-010-1519-2']
356,21082252,"Intention to change dietary habits, and weight loss among Norwegian-Pakistani women participating in a culturally adapted intervention.","The aim was to explore the relationships between degree of participation in a culturally adapted lifestyle intervention and stages of change for healthy eating and weight loss among Pakistani immigrant women in Norway. The intervention lasted 7 months and included 198 women, randomized into control and intervention groups. The odds of losing weight from baseline to follow-up, and being in action stages of change (compared to pre-action stages) with regard to intake of amount and type of fat, sugar and white flour at follow-up, increased significantly with number of group sessions attended. Those in action stage of reducing intake of fat and increasing intake of vegetables, as well as of reducing weight, were significantly more likely than others to have experienced weight loss at follow-up. Participation in the culturally adapted intervention was related to increase in intentions to change dietary behaviours and to weight loss.",2011,Participation in the culturally adapted intervention was related to increase in intentions to change dietary behaviours and to weight loss.,"['198 women', 'Pakistani immigrant women in Norway', 'Norwegian-Pakistani women participating in a culturally adapted intervention']",[],"['weight loss', 'healthy eating and weight loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337814', 'cui_str': 'Pakistani (Urduspeakers) (ethnic group)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]",198.0,0.0141743,Participation in the culturally adapted intervention was related to increase in intentions to change dietary behaviours and to weight loss.,"[{'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Råberg Kjøllesdal', 'Affiliation': 'Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo, 0316 Oslo, Norway. m.k.raberg@medisin.uio.no'}, {'ForeName': 'V T', 'Initials': 'VT', 'LastName': 'Hjellset', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bjørge', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Holmboe-Ottesen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wandel', 'Affiliation': ''}]",Journal of immigrant and minority health,['10.1007/s10903-010-9416-7']
357,21088959,Peripheral biomarkers of cognitive response to dopamine receptor agonist treatment.,"RATIONALE


Using biological markers to objectively measure addiction severity or to identify individuals who might benefit most from pro-cognitive treatment could potentially revolutionize neuropsychopharmacology. We investigated the use of dopamine receptor mRNA levels in circulating blood cells as predictors of cognitive response following dopamine agonist treatment, and as biomarkers of the severity of stimulant drug dependence.
METHODOLOGY


We employed a double-blind, placebo-controlled cross-over design, administering a single dose of the selective dopamine D(2/3) receptor agonist pramipexole (0.5 mg) to increase dopamine transmission in one session and a placebo treatment in another session in 36 volunteers. Half the volunteers had a formal diagnosis of stimulant dependence, while half had no psychiatric history. Participants performed neurocognitive tests from the CANTAB battery on both occasions, and stimulant-dependent individuals rated drug craving using visual analog scales. Whole-blood mRNA levels were measured for three dopamine-related genes: DRD3 and DRD4 (dopamine receptors), and catechol-O-methyltransferase (COMT; a dopamine catabolic enzyme).
RESULTS


Stimulant users performed worse than healthy volunteers on the cognitive tests. The variation in peripheral dopamine D(3) receptor mRNA expression explained over one quarter of the variation in response to pramipexole on the spatial working memory test across all participants. The severity of stimulant dependence was also significantly associated with peripheral COMT mRNA expression in stimulant users.
CONCLUSIONS


Peripheral expression of dopamine-related genes may be useful as a biomarker of cognitive response to dopamine agonist drugs and of severity of addiction to dopamine-releasing stimulant drugs.",2011,"RESULTS


Stimulant users performed worse than healthy volunteers on the cognitive tests.","['individuals who might benefit most from pro-cognitive treatment could potentially revolutionize neuropsychopharmacology', '36 volunteers']","['selective dopamine D(2/3) receptor agonist pramipexole', 'dopamine receptor agonist treatment', 'placebo', 'pramipexole']","['peripheral COMT mRNA expression', 'Whole-blood mRNA levels', 'cognitive tests']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C0074710', 'cui_str': 'Pramipexole'}, {'cui': 'C4521850', 'cui_str': 'Dopamine receptor agonist (disposition)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",36.0,0.0533907,"RESULTS


Stimulant users performed worse than healthy volunteers on the cognitive tests.","[{'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Ersche', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Herchel Smith Building for Brain and Mind Sciences, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, UK. ke220@cam.ac.uk'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Roiser', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lucas', 'Affiliation': ''}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Domenici', 'Affiliation': ''}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': ''}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-2087-1']
358,21061066,"Health-Related Quality of Life, Subjective Health Complaints, Psychological Distress and Coping in Pakistani Immigrant Women With and Without the Metabolic Syndrome : The InnvaDiab-DEPLAN Study on Pakistani Immigrant Women Living in Oslo, Norway.","The increasingly high number of immigrants from South-East Asia with The Metabolic Syndrome (MetS) is an important challenge for the public health sector. Impaired glucose is essential in MetS. The blood glucose concentration is not only governed by diet and physical activity, but also by psychological distress which could contribute to the development of MetS. The aim of this study is to describe health-related quality of life, subjective health complaints (SHC), psychological distress, and coping in Pakistani immigrant women, with and without MetS. As a part of an randomized controlled intervention study in Oslo, Norway, female Pakistani immigrants (n = 198) answered questionnaires regarding health related quality of life, SHC, psychological distress, and coping. Blood variables were determined and a standardized oral glucose tolerance test was performed. The participants had a high score on SHC and psychological distress. About 40% of the participants had MetS, and this group showed significantly lower general health, lower physical function, and more bodily pain, than those without MetS. Those with MetS also had more SHC, depressive symptoms, higher levels of somatisation, and scored significantly lower on the coping strategy of active problem solving. Pakistani immigrant women seem to have a high prevalence of SHC and psychological distress, especially those with MetS.",2011,"Those with MetS also had more SHC, depressive symptoms, higher levels of somatisation, and scored significantly lower on the coping strategy of active problem solving.","['Pakistani immigrant women', 'Pakistani immigrant women, with and without MetS', 'Oslo, Norway, female Pakistani immigrants (n\xa0=\xa0198) answered', 'Pakistani Immigrant Women Living in Oslo, Norway', 'Metabolic Syndrome ', 'Pakistani Immigrant Women']",[],"['questionnaires regarding health related quality of life, SHC, psychological distress, and coping', 'general health, lower physical function, and more bodily pain', 'blood glucose concentration', 'health-related quality of life, subjective health complaints (SHC), psychological distress, and coping', 'SHC, depressive symptoms, higher levels of somatisation', 'Health-Related Quality of Life, Subjective Health Complaints, Psychological Distress and Coping', 'SHC and psychological distress']","[{'cui': 'C0337814', 'cui_str': 'Pakistani (Urduspeakers) (ethnic group)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]",[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0281355,"Those with MetS also had more SHC, depressive symptoms, higher levels of somatisation, and scored significantly lower on the coping strategy of active problem solving.","[{'ForeName': 'Victoria Telle', 'Initials': 'VT', 'LastName': 'Hjellset', 'Affiliation': 'Institute of General Practice and Community Medicine, University of Oslo, Blindern, Box 1130, 0318, Oslo, Norway. v.t.hjellset@medisin.uio.no'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Ihlebæk', 'Affiliation': 'Uni Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Bjørge', 'Affiliation': 'Department of Nutrition, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hege R', 'Initials': 'HR', 'LastName': 'Eriksen', 'Affiliation': 'Uni Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Arne T', 'Initials': 'AT', 'LastName': 'Høstmark', 'Affiliation': ''}]",Journal of immigrant and minority health,['10.1007/s10903-010-9409-6']
359,21053028,Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up.,"This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (-45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the ""non-difference"" in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (-73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time.",2011,"Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns).","['152 patients', 'patients with chronic low back pain']","['instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF', 'disc prosthesis versus lumbar fusion', 'TDR', 'TDR or FUS', 'total disc replacement (TDR) (Charité/Prodisc/Maverick', 'lumbar FUS']","['Cost effectiveness', 'incremental cost-effectiveness ratio (ICER', 'TDR', 'Number of days on sick leave', 'total gain in quality adjusted life years (QALYs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C2144940', 'cui_str': 'Arthroplasty, Replacement, Disc'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",152.0,0.0540672,"Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fritzell', 'Affiliation': 'Department of Orthopedic Surgery, Center for Clinical Research, Falun Hospital, Dalarna, Nissers Väg 3, SE-79182 Falun, Sweden. peter.fritzell@ltdalarna.se'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Berg', 'Affiliation': ''}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Borgström', 'Affiliation': ''}, {'ForeName': 'Tycho', 'Initials': 'T', 'LastName': 'Tullberg', 'Affiliation': ''}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tropp', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-010-1607-3']
360,21088862,Comparison between cold water immersion therapy (CWIT) and light emitting diode therapy (LEDT) in short-term skeletal muscle recovery after high-intensity exercise in athletes--preliminary results.,"In the last years, phototherapy has becoming a promising tool to improve skeletal muscle recovery after exercise, however, it was not compared with other modalities commonly used with this aim. In the present study we compared the short-term effects of cold water immersion therapy (CWIT) and light emitting diode therapy (LEDT) with placebo LEDT on biochemical markers related to skeletal muscle recovery after high-intensity exercise. A randomized double-blind placebo-controlled crossover trial was performed with six male young futsal athletes. They were treated with CWIT (5°C of temperature [SD ±1°]), active LEDT (69 LEDs with wavelengths 660/850 nm, 10/30 mW of output power, 30 s of irradiation time per point, and 41.7 J of total energy irradiated per point, total of ten points irradiated) or an identical placebo LEDT 5 min after each of three Wingate cycle tests. Pre-exercise, post-exercise, and post-treatment measurements were taken of blood lactate levels, creatine kinase (CK) activity, and C-reactive protein (CRP) levels. There were no significant differences in the work performed during the three Wingate tests (p > 0.05). All biochemical parameters increased from baseline values (p < 0.05) after the three exercise tests, but only active LEDT decreased blood lactate levels (p = 0.0065) and CK activity (p = 0.0044) significantly after treatment. There were no significant differences in CRP values after treatments. We concluded that treating the leg muscles with LEDT 5 min after the Wingate cycle test seemed to inhibit the expected post-exercise increase in blood lactate levels and CK activity. This suggests that LEDT has better potential than 5 min of CWIT for improving short-term post-exercise recovery.",2011,"All biochemical parameters increased from baseline values (p < 0.05) after the three exercise tests, but only active LEDT decreased blood lactate levels (p = 0.0065) and CK activity (p = 0.0044) significantly after treatment.",['six male young futsal athletes'],"['placebo', 'LEDT', 'identical placebo LEDT', 'CWIT', 'active LEDT (69 LEDs with wavelengths 660/850', 'cold water immersion therapy (CWIT) and light emitting diode therapy (LEDT', 'cold water immersion therapy (CWIT) and light emitting diode therapy (LEDT) with placebo LEDT']","['blood lactate levels, creatine kinase (CK) activity, and C-reactive protein (CRP) levels', 'blood lactate levels and CK activity', 'CK activity', 'blood lactate levels', 'CRP values']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0449819', 'cui_str': 'Wavelength (qualifier value)'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",6.0,0.269898,"All biochemical parameters increased from baseline values (p < 0.05) after the three exercise tests, but only active LEDT decreased blood lactate levels (p = 0.0065) and CK activity (p = 0.0044) significantly after treatment.","[{'ForeName': 'Ernesto Cesar', 'Initials': 'EC', 'LastName': 'Leal Junior', 'Affiliation': 'Center for Research and Innovation in Laser, Nove de Julho University (UNINOVE), Rua Vergueiro, 235, 01504-001, São Paulo, SP, Brazil. ernesto.leal.junior@gmail.com'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'de Godoi', 'Affiliation': ''}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Mancalossi', 'Affiliation': ''}, {'ForeName': 'Rafael Paolo', 'Initials': 'RP', 'LastName': 'Rossi', 'Affiliation': ''}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'De Marchi', 'Affiliation': ''}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Parente', 'Affiliation': ''}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Grosselli', 'Affiliation': ''}, {'ForeName': 'Rafael Abeche', 'Initials': 'RA', 'LastName': 'Generosi', 'Affiliation': ''}, {'ForeName': 'Maira', 'Initials': 'M', 'LastName': 'Basso', 'Affiliation': ''}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Frigo', 'Affiliation': ''}, {'ForeName': 'Shaiane Silva', 'Initials': 'SS', 'LastName': 'Tomazoni', 'Affiliation': ''}, {'ForeName': 'Jan Magnus', 'Initials': 'JM', 'LastName': 'Bjordal', 'Affiliation': ''}, {'ForeName': 'Rodrigo Alvaro Brandão', 'Initials': 'RA', 'LastName': 'Lopes-Martins', 'Affiliation': ''}]",Lasers in medical science,['10.1007/s10103-010-0866-x']
361,21088690,"Racial differences in smoking abstinence rates in a multicenter, randomized, open-label trial in the United States.","BACKGROUND: This study evaluates differences in smoking abstinence between white and minority smokers using pharmaceutical aids. METHODS: This is an analysis of data from a multi-center, randomized, clinical trial conducted in the United States. Of the 1,684 subjects randomized to one of three medications (nicotine inhaler, bupropion, or a combination of both), 60% were women and 10% were minority races. RESULTS: Factors associated with a decreased likelihood of smoking at 12 weeks were older age (OR = 0.971, p < 0.0001), being married (OR = 0.678, p = 0.0029), using bupropion SR (OR = 0.480, p < 0.0001), and using combination therapy (OR = 0.328, p < 0.0001). Factors associated with an increased likelihood of smoking were higher tobacco dependence scores (OR = 1.244, p < 0.0001), prior quit attempts (OR = 1.812, p = 0.004), and being a minority (OR = 1.849, p = 0.0083). Compared to white smokers, minority smokers were significantly older at time of study entry (46 vs. 42 years, p < 0.0001), less likely to be married (35% vs. 59%, p < 0.0001), older at smoking initiation (21 vs. 19 years of age, p < 0.0001), and had a lower abstinence rate (16% vs. 26%, p = 0.0065). CONCLUSION: Regardless of the treatment used, minority smokers in the US have lower smoking abstinence after treatment for tobacco dependence. Future research should focus on the improvement in treatment strategies for minority smokers.",2010,"Factors associated with an increased likelihood of smoking were higher tobacco dependence scores (OR = 1.244, p < 0.0001), prior quit attempts (OR = 1.812, p = 0.004), and being a minority (OR = 1.849, p = 0.0083).","['white and minority smokers using pharmaceutical aids', 'minority smokers', '1,684 subjects randomized to one of three']","['medications (nicotine inhaler, bupropion']","['older at smoking initiation', 'abstinence rate', 'likelihood of smoking', 'tobacco dependence scores', 'prior quit attempts', 'smoking abstinence rates', 'smoking abstinence']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0031318', 'cui_str': 'Pharmaceutical Aids'}]","[{'cui': 'C0814019', 'cui_str': 'Nicotine inhaler'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}]","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0040332', 'cui_str': 'Tobacco Dependence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1684.0,0.0536263,"Factors associated with an increased likelihood of smoking were higher tobacco dependence scores (OR = 1.244, p < 0.0001), prior quit attempts (OR = 1.812, p = 0.004), and being a minority (OR = 1.849, p = 0.0083).","[{'ForeName': 'Ivana T', 'Initials': 'IT', 'LastName': 'Croghan', 'Affiliation': ''}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Hurt', 'Affiliation': ''}, {'ForeName': 'Jon O', 'Initials': 'JO', 'LastName': 'Ebbert', 'Affiliation': ''}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Croghan', 'Affiliation': ''}, {'ForeName': 'Octavius D', 'Initials': 'OD', 'LastName': 'Polk', 'Affiliation': ''}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Stella', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Novotny', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sloan', 'Affiliation': ''}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': ''}]",Zeitschrift fur Gesundheitswissenschaften = Journal of public health,[]
362,21042875,"Metabolic effects of krill oil are essentially similar to those of fish oil but at lower dose of EPA and DHA, in healthy volunteers.","The purpose of the present study is to investigate the effects of krill oil and fish oil on serum lipids and markers of oxidative stress and inflammation and to evaluate if different molecular forms, triacylglycerol and phospholipids, of omega-3 polyunsaturated fatty acids (PUFAs) influence the plasma level of EPA and DHA differently. One hundred thirteen subjects with normal or slightly elevated total blood cholesterol and/or triglyceride levels were randomized into three groups and given either six capsules of krill oil (N = 36; 3.0 g/day, EPA + DHA = 543 mg) or three capsules of fish oil (N = 40; 1.8 g/day, EPA + DHA = 864 mg) daily for 7 weeks. A third group did not receive any supplementation and served as controls (N = 37). A significant increase in plasma EPA, DHA, and DPA was observed in the subjects supplemented with n-3 PUFAs as compared with the controls, but there were no significant differences in the changes in any of the n-3 PUFAs between the fish oil and the krill oil groups. No statistically significant differences in changes in any of the serum lipids or the markers of oxidative stress and inflammation between the study groups were observed. Krill oil and fish oil thus represent comparable dietary sources of n-3 PUFAs, even if the EPA + DHA dose in the krill oil was 62.8% of that in the fish oil.",2011,No statistically significant differences in changes in any of the serum lipids or the markers of oxidative stress and inflammation between the study groups were observed.,"['One hundred thirteen subjects with normal or slightly elevated total blood cholesterol and/or triglyceride levels', 'healthy volunteers']","['krill oil', 'EPA + DHA = 543 mg) or three capsules of fish oil', 'n-3 PUFAs', 'six capsules of krill oil', 'Krill oil and fish oil', 'krill oil and fish oil']","['n-3 PUFAs', 'serum lipids or the markers of oxidative stress and inflammation', 'plasma EPA, DHA, and DPA']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]",113.0,0.0422822,No statistically significant differences in changes in any of the serum lipids or the markers of oxidative stress and inflammation between the study groups were observed.,"[{'ForeName': 'Stine M', 'Initials': 'SM', 'LastName': 'Ulven', 'Affiliation': 'Faculty of Health, Nutrition, and Management, Akershus University College, Lillestrøm, Norway. stinemarie.ulven@hiak.no'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Kirkhus', 'Affiliation': ''}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Lamglait', 'Affiliation': ''}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Elind', 'Affiliation': ''}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Haider', 'Affiliation': ''}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Berge', 'Affiliation': ''}, {'ForeName': 'Hogne', 'Initials': 'H', 'LastName': 'Vik', 'Affiliation': ''}, {'ForeName': 'Jan I', 'Initials': 'JI', 'LastName': 'Pedersen', 'Affiliation': ''}]",Lipids,['10.1007/s11745-010-3490-4']
363,20960149,Postoperative catheterization after anterior colporrhaphy: 2 versus 5 days. A multicentre randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


The aim of this study was to compare the number of temporary catheter replacements and urinary tract infections after indwelling catheterization for 2 versus 5 days following an anterior colporrhaphy.
METHODS


Two hundred forty-six patients were randomly assigned to 2 or 5 days of indwelling catheterization. Outcome measures were temporary catheter replacements because of post-voiding residual >200 mL after removal of the indwelling catheter, urinary tract infections, and hospital stay. All patients were analyzed according to the intention to treat principle.
RESULTS


Compared to the 5-day protocol group, in the 2-day protocol group more patients needed temporary catheter replacement (9% versus 28%, odds ratio (OR) 4.0, confidence interval (CI) 1.9-8.3, p < 0.01), whereas less patients had a urinary tract infection (37% versus 22%, OR 0.5, CI 0.3-0.9, p = 0.02) and median hospital stay was lower.
CONCLUSIONS


Removal of an indwelling catheter after 2 versus 5 days following anterior colporrhaphy is associated with more temporary catheter replacements, but less urinary tract infections and a shorter hospital stay.",2011,"CONCLUSIONS


Removal of an indwelling catheter after 2 versus 5 days following anterior colporrhaphy is associated with more temporary catheter replacements, but less urinary tract infections and a shorter hospital stay.",['Two hundred forty-six patients'],"['indwelling catheterization', 'Postoperative catheterization after anterior colporrhaphy']","['temporary catheter replacement', 'number of temporary catheter replacements and urinary tract infections', 'urinary tract infections, and hospital stay', 'urinary tract infection', 'median hospital stay', 'urinary tract infections', 'hospital stay', 'temporary catheter replacements because of post-voiding residual ']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy (procedure)'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0522774', 'cui_str': 'Replacement of catheter (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]",246.0,0.15275,"CONCLUSIONS


Removal of an indwelling catheter after 2 versus 5 days following anterior colporrhaphy is associated with more temporary catheter replacements, but less urinary tract infections and a shorter hospital stay.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Weemhoff', 'Affiliation': 'Department of Obstetrics & Gynecology, GROW-School for Oncology and Developmental Biology, Maastricht University Medical Centre, PO Box 5800, 6202 AZ Maastricht, The Netherlands. m.weemhoff@mumc.nl'}, {'ForeName': 'Martine M L H', 'Initials': 'MM', 'LastName': 'Wassen', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Korsten', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Serroyen', 'Affiliation': ''}, {'ForeName': 'Paul H N M', 'Initials': 'PH', 'LastName': 'Kampschöer', 'Affiliation': ''}, {'ForeName': 'Frans J M E', 'Initials': 'FJ', 'LastName': 'Roumen', 'Affiliation': ''}]",International urogynecology journal,['10.1007/s00192-010-1304-0']
364,21063868,Positive effects of Red Bull® Energy Drink on driving performance during prolonged driving.,"BACKGROUND


The purpose of this study was to examine if Red Bull® Energy Drink can counteract sleepiness and driving impairment during prolonged driving.
METHODS


Twenty-four healthy volunteers participated in this double-blind placebo-controlled crossover study. After 2 h of highway driving in the STISIM driving simulator, subjects had a 15-min break and consumed Red Bull® Energy Drink (250 ml) or placebo (Red Bull® Energy Drink without the functional ingredients: caffeine, taurine, glucuronolactone, B vitamins (niacin, pantothenic acid, B6, B12), and inositol) before driving for two additional hours. A third condition comprised 4 h of uninterrupted driving. Primary parameter was the standard deviation of lateral position (SDLP), i.e., the weaving of the car. Secondary parameters included SD speed, subjective driving quality, sleepiness, and mental effort to perform the test.
RESULTS


No significant differences were observed during the first 2 h of driving. Red Bull® Energy Drink significantly improved driving relative to placebo: SDLP was significantly reduced during the 3rd (p < 0.046) and 4th hour of driving (p < 0.011). Red Bull® Energy Drink significantly reduced the standard deviation of speed (p < 0.004), improved subjective driving quality (p < 0.0001), and reduced mental effort to perform the test (p < 0.024) during the 3rd hour of driving. Subjective sleepiness was significantly decreased during both the 3rd and 4th hour of driving after Red Bull® Energy Drink (p < 0.001 and p < 0.009, respectively). Relative to uninterrupted driving, Red Bull® Energy Drink significantly improved each parameter.
CONCLUSION


Red Bull® Energy Drink significantly improves driving performance and reduces driver sleepiness during prolonged highway driving.",2011,"Red Bull® Energy Drink significantly reduced the standard deviation of speed (p < 0.004), improved subjective driving quality (p < 0.0001), and reduced mental effort to perform the test (p < 0.024) during the 3rd hour of driving.",['Twenty-four healthy volunteers'],"['Red Bull® Energy Drink', 'placebo', 'placebo (Red Bull® Energy Drink without the functional ingredients: caffeine, taurine, glucuronolactone, B vitamins (niacin, pantothenic acid, B6, B12), and inositol']","['Subjective sleepiness', 'driving performance and reduces driver sleepiness', 'SD speed, subjective driving quality, sleepiness, and mental effort to perform the test', 'driving performance', 'standard deviation of speed', 'subjective driving quality', 'standard deviation of lateral position (SDLP), i.e., the weaving of the car']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0061446', 'cui_str': 'glucuronolactone'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0030342', 'cui_str': 'vitamin B5'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position (finding)'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}]",24.0,0.0887711,"Red Bull® Energy Drink significantly reduced the standard deviation of speed (p < 0.004), improved subjective driving quality (p < 0.0001), and reduced mental effort to perform the test (p < 0.024) during the 3rd hour of driving.","[{'ForeName': 'Monique A J', 'Initials': 'MA', 'LastName': 'Mets', 'Affiliation': 'Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, P.O. Box 80082, 3508 TB, Utrecht, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Ketzer', 'Affiliation': ''}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Blom', 'Affiliation': ''}, {'ForeName': 'Maartje H', 'Initials': 'MH', 'LastName': 'van Gerven', 'Affiliation': ''}, {'ForeName': 'Gitta M', 'Initials': 'GM', 'LastName': 'van Willigenburg', 'Affiliation': ''}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Olivier', 'Affiliation': ''}, {'ForeName': 'Joris C', 'Initials': 'JC', 'LastName': 'Verster', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-2078-2']
365,20972608,Volunteer effect and compromised randomization in the Mayo Project of screening for lung cancer.,"It has been confirmed recently that the volunteer effect in lung cancer screening is characterized by higher lung cancer mortality risk in self-selected screening participants. The Mayo Lung Project, the most influential trial of screening for lung cancer ever completed, was conducted in nonvolunteer Mayo Clinic outpatients, with a peculiar study design that rendered the randomization vulnerable to the volunteer effect. Of all nonvolunteers randomized in the Mayo Lung Project, only those allocated in the screened group were asked consent to participate in the trial. The final Mayo Lung Project report stated that 655 randomized nonvolunteers refused screening and were excluded from the study, thus documenting violation of the rule that no selection should occur after randomization. The long-term follow-up of the Mayo Lung Project showed an enigmatic result which has never been explained: the lung cancer mortality was 13% higher in the screening intervention group than in the control group [4.4 (95% CI 3.9-4.9) vs. 3.9 (95% CI 3.5-4.4) per 1,000 person-years; P = 0.09]. Such overrepresented mortality is consistent with the volunteer effect and supports the concept that the Mayo Lung Project randomization was compromised by the post-randomization self-selection of participant nonvolunteers.",2011,It has been confirmed recently that the volunteer effect in lung cancer screening is characterized by higher lung cancer mortality risk in self-selected screening participants.,"['nonvolunteer Mayo Clinic outpatients', 'lung cancer']",[],['lung cancer mortality'],"[{'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]",[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0309632,It has been confirmed recently that the volunteer effect in lung cancer screening is characterized by higher lung cancer mortality risk in self-selected screening participants.,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Dominioni', 'Affiliation': ''}, {'ForeName': 'Albino', 'Initials': 'A', 'LastName': 'Poli', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Mantovani', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rotolo', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Imperatori', 'Affiliation': ''}]",European journal of epidemiology,['10.1007/s10654-010-9519-4']
366,20959965,Multifactorial evaluation and treatment of persons with a high risk of recurrent falling was not cost-effective.,"SUMMARY


This study evaluated the cost-effectiveness of multifactorial evaluation and treatment of fall risk factors in community-dwelling older persons at high risk of falling. The intervention and usual care groups did not differ in fall risk or costs. The multifactorial approach was not cost-effective compared to usual care in this group.
INTRODUCTION


International guidelines recommend multifactorial evaluation and tailored treatment of risk factors to reduce falling in older persons. The cost-effectiveness may be enhanced in high-risk persons. Our study evaluates the cost-effectiveness of multifactorial evaluation and treatment of fall risk factors in community-dwelling older persons at high risk of recurrent falling.
METHODS


An economic evaluation was conducted alongside a randomised controlled trial. Participants (≥65 years) with a high risk of recurrent falling were randomised into an intervention (n = 106) and usual care group (n = 111). The intervention consisted of multifactorial assessment and treatment of fall risk factors. Clinical outcomes were proportions of fallers and utility during 1 year. Costs were measured using questionnaires at 3, 6 and 12 months after baseline and valued using cost prices, if available, and guideline prices. Differences in costs and cost-effectiveness were analysed using bootstrapping. Cost-effectiveness planes and acceptability curves were presented.
RESULTS


During 1 year, 52% and 56% of intervention and usual care participants reported at least one fall, respectively. The clinical outcome measures did not differ between the two groups. The mean costs were Euro 7,740 (SD 9,129) in the intervention group and Euro 6,838 (SD 8,623) in the usual care group (mean difference Euro 902, bootstrapped 95% CI: -1,534 to 3,357). Cost-effectiveness planes and acceptability curves indicated that multifactorial evaluation and treatment of fall risk factors was not cost-effective compared with usual care.
CONCLUSIONS


Multifactorial evaluation and treatment of persons with a high risk of recurrent falling was not cost-effective compared to usual care.",2011,The intervention and usual care groups did not differ in fall risk or costs.,"['persons with a high risk of recurrent falling', 'community-dwelling older persons at high risk of recurrent falling', 'older persons', 'Participants (≥65 years) with a high risk of recurrent falling', 'community-dwelling older persons at high risk of falling']",['usual care group'],"['Costs', 'fall risk or costs', 'mean costs', 'costs and cost-effectiveness', 'cost-effectiveness', 'Cost-effectiveness planes and acceptability curves']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0299534,The intervention and usual care groups did not differ in fall risk or costs.,"[{'ForeName': 'G M E E', 'Initials': 'GM', 'LastName': 'Peeters', 'Affiliation': 'Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Heymans', 'Affiliation': ''}, {'ForeName': 'O J', 'Initials': 'OJ', 'LastName': 'de Vries', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Bouter', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lips', 'Affiliation': ''}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-010-1438-4']
367,20960028,Feasibility study of two schedules of sunitinib in combination with pemetrexed in patients with advanced solid tumors.,"BACKGROUND


Sunitinib is an oral multitargeted tyrosine kinase inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptors, as well as of other receptor types. We have performed a feasibility study to investigate the safety of sunitinib in combination with pemetrexed for treatment of advanced refractory solid tumors.
METHODS


Sunitinib was administered once daily on a continuous daily dosing (CDD) schedule (37.5 mg/day) or a 2-weeks-on, 1-week-off treatment schedule (50 mg/day, Schedule 2/1) in combination with pemetrexed at 500 mg/m(2) on day 1 of repeated 21-day cycles.
RESULTS


Twelve patients were enrolled in the study: six on the CDD schedule and six on Schedule 2/1. None of the treated patients experienced a dose-limiting toxicity. Toxicities were manageable and similar in type to those observed in monotherapy studies of sunitinib and pemetrexed. Pharmacokinetic analysis did not reveal any substantial drug-drug interaction. One patient with squamous cell lung cancer showed a partial response and five patients had stable disease.
CONCLUSIONS


Combination therapy with sunitinib administered on Schedule 2/1 (50 mg/day) or a CDD schedule (37.5 mg/day) together with standard-dose pemetrexed (500 mg/m(2)) was well tolerated in previously treated patients with advanced solid tumors.",2012,Pharmacokinetic analysis did not reveal any substantial drug-drug interaction.,"['patients with advanced solid tumors', 'Twelve patients were enrolled in the study: six on the CDD schedule and six on Schedule 2/1', 'advanced refractory solid tumors', 'One patient with squamous cell lung cancer']","['sunitinib', 'pemetrexed']","['Toxicities', 'dose-limiting toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",12.0,0.0919575,Pharmacokinetic analysis did not reveal any substantial drug-drug interaction.,"[{'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Department of Medical Oncology, Kinki University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan. chi-okamoto@dotd.med.kindai.ac.jp'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': ''}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Miyazaki', 'Affiliation': ''}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': ''}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Ichikawa', 'Affiliation': ''}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': ''}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': ''}, {'ForeName': 'Soichi', 'Initials': 'S', 'LastName': 'Fumita', 'Affiliation': ''}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Ohki', 'Affiliation': ''}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Kimura', 'Affiliation': ''}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Hashimoto', 'Affiliation': ''}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': ''}]",Investigational new drugs,['10.1007/s10637-010-9565-5']
368,20963449,Evaluation of the efficacy and tolerability of miglitol in Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylureas.,"The objective of this study is to examine the efficacy and tolerability of miglitol with respect to improving glycemic control in Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylurea treatment. This was a randomized, double-blinded, placebo-controlled, multicenter study. A total of 105 patients were randomized to receive 24 weeks of treatment with miglitol (n = 52; titrated from 50 mg to 100 mg 3 times daily) or placebo (n = 53). Concomitant sulfonylurea treatment and diet remained unchanged. The primary endpoint was change in glycated hemoglobin (HbA1c) from baseline at 24 weeks. Secondary endpoints were changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and postprandial serum insulin (PSI). The miglitol treatment group showed significantly greater reductions in HbA1c and PPG levels compared with the placebo group. With respect to adverse events, abdominal discomfort, diarrhea, and hypoglycemia occurred with similar frequency in both groups. Results of this study indicate that miglitol significantly improves metabolic control in Chinese patients with type 2 diabetes mellitus. Miglitol is safe and well tolerated, with the exception of abdominal discomfort. Therefore, miglitol may be a useful adjuvant therapy for Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylurea treatment.",2011,The miglitol treatment group showed significantly greater reductions in HbA1c and PPG levels compared with the placebo group.,"['Chinese patients with type 2 diabetes mellitus', 'A total of 105 patients']","['miglitol ', 'diet and sulfonylureas', 'placebo']","['metabolic control', 'glycated hemoglobin (HbA1c', 'fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and postprandial serum insulin (PSI', 'safe and well tolerated', 'HbA1c and PPG levels', 'efficacy and tolerability', 'adverse events, abdominal discomfort, diarrhea, and hypoglycemia']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0066535', 'cui_str': 'miglitol'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",105.0,0.0648853,The miglitol treatment group showed significantly greater reductions in HbA1c and PPG levels compared with the placebo group.,"[{'ForeName': 'Sheng-Hwu', 'Initials': 'SH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Endocrinology and Metabolism, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 5 Fu-Shing Street, Kwei-Shan, Taoyuan, Taiwan, ROC. cgmhsh4821@yahoo.com.tw'}, {'ForeName': 'Kuang-Chung', 'Initials': 'KC', 'LastName': 'Shih', 'Affiliation': ''}, {'ForeName': 'Chien-Wen', 'Initials': 'CW', 'LastName': 'Chou', 'Affiliation': ''}, {'ForeName': 'Chih-Hsun', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': ''}]",Acta diabetologica,['10.1007/s00592-010-0220-6']
369,20978741,The relation of low glycaemic index fruit consumption to glycaemic control and risk factors for coronary heart disease in type 2 diabetes.,"AIMS/HYPOTHESIS


Sugar has been suggested to promote obesity, diabetes and coronary heart disease (CHD), yet fruit, despite containing sugars, may also have a low glycaemic index (GI) and all fruits are generally recommended for good health. We therefore assessed the effect of fruit with special emphasis on low GI fruit intake in type 2 diabetes.
METHODS


This secondary analysis involved 152 type 2 diabetic participants treated with glucose-lowering agents who completed either 6 months of high fibre or low GI dietary advice, including fruit advice, in a parallel design.
RESULTS


Change in low GI fruit intake ranged from -3.1 to 2.7 servings/day. The increase in low GI fruit intake significantly predicted reductions in HbA(1c) (r = -0.206, p =0.011), systolic blood pressure (r = -0.183, p = 0.024) and CHD risk (r = -0.213, p = 0.008). Change in total fruit intake ranged from -3.7 to 3.2 servings/day and was not related to study outcomes. In a regression analysis including the eight major carbohydrate foods or classes of foods emphasised in the low GI diet, only low GI fruit and bread contributed independently and significantly to predicting change in HbA(1c). Furthermore, comparing the highest with the lowest quartile of low GI fruit intake, the percentage change in HbA(1c) was reduced by -0.5% HbA(1c) units (95% CI 0.2-0.8 HbA(1c) units, p < 0.001).
CONCLUSIONS/INTERPRETATION


Low GI fruit consumption as part of a low GI diet was associated with lower HbA(1c), blood pressure and CHD risk and supports a role for low GI fruit consumption in the management of type 2 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00438698.",2011,"The increase in low GI fruit intake significantly predicted reductions in HbA(1c) (r = -0.206, p =0.011), systolic blood pressure (r = -0.183, p = 0.024) and CHD risk (r = -0.213, p = 0.008).","['152 type 2 diabetic participants treated with glucose-lowering agents who completed either 6 months of high fibre or low GI dietary advice, including fruit advice, in a parallel design', 'type 2 diabetes']",[],"['systolic blood pressure', 'lower HbA(1c), blood pressure and CHD risk', 'percentage change in HbA(1c', 'total fruit intake', 'low GI fruit intake', 'CHD risk']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}]",[],"[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake (observable entity)'}]",152.0,0.0224834,"The increase in low GI fruit intake significantly predicted reductions in HbA(1c) (r = -0.206, p =0.011), systolic blood pressure (r = -0.183, p = 0.024) and CHD risk (r = -0.213, p = 0.008).","[{'ForeName': 'D J A', 'Initials': 'DJ', 'LastName': 'Jenkins', 'Affiliation': ""Clinical Nutrition & Risk Factor Modification Center, St Michael's Hospital, Toronto, ON, Canada M5C 2T2. NutritionProject@smh.ca""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Srichaikul', 'Affiliation': ''}, {'ForeName': 'C W C', 'Initials': 'CW', 'LastName': 'Kendall', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Sievenpiper', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Abdulnour', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirrahimi', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Meneses', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nishi', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'So', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Esfahani', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mitchell', 'Affiliation': ''}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vidgen', 'Affiliation': ''}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Josse', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-010-1927-1']
370,20976617,Theory of Mind training in children with autism: a randomized controlled trial.,"Many children with Autism Spectrum Disorders (ASD) participate in social skills or Theory of Mind (ToM) treatments. However, few studies have shown evidence for their effectiveness. The current study used a randomized controlled design to test the effectiveness of a 16-week ToM treatment in 8-13 year old children with ASD and normal IQs (n = 40). The results showed that, compared to controls, the treated children with ASD improved in their conceptual ToM skills, but their elementary understanding, self reported empathic skills or parent reported social behaviour did not improve. Despite the effects on conceptual understanding, the current study does not indicate strong evidence for the effectiveness of a ToM treatment on the daily life mindreading skills.",2011,"The results showed that, compared to controls, the treated children with ASD improved in their conceptual ToM skills, but their elementary understanding, self reported empathic skills or parent reported social behaviour did not improve.","['children with Autism Spectrum Disorders (ASD', 'children with autism', '8-13\xa0year old children with ASD and normal IQs (n\xa0=\xa040']",['Mind training'],"['conceptual ToM skills', 'social behaviour']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0037397', 'cui_str': 'Social Behavior'}]",,0.0217838,"The results showed that, compared to controls, the treated children with ASD improved in their conceptual ToM skills, but their elementary understanding, self reported empathic skills or parent reported social behaviour did not improve.","[{'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Begeer', 'Affiliation': 'Developmental Psychology, VU University, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands. S.Begeer@psy.vu.nl'}, {'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Gevers', 'Affiliation': ''}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Clifford', 'Affiliation': ''}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Verhoeve', 'Affiliation': ''}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Kat', 'Affiliation': ''}, {'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Hoddenbach', 'Affiliation': ''}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'Boer', 'Affiliation': ''}]",Journal of autism and developmental disorders,['10.1007/s10803-010-1121-9']
371,20652755,Axillary dissection versus no axillary dissection in elderly patients with breast cancer and no palpable axillary nodes: results after 15 years of follow-up.,"OBJECTIVE


To assess the long-term safety of no axillary clearance in elderly patients with breast cancer and nonpalpable axillary nodes.
BACKGROUND


Lymph node evaluation in elderly patients with early breast cancer and clinically negative axillary nodes is controversial. Our randomized trial with 5-year follow-up showed no breast cancer mortality advantage for axillary clearance compared with observation in older patients with T1N0 disease.
METHODS


We further investigated axillary treatment in a retrospective analysis of 671 consecutive patients, aged ≥ 70 years, with operable breast cancer and a clinically clear axilla, treated between 1987 and 1992; 172 received and 499 did not receive axillary dissection; 20 mg/day tamoxifen was prescribed for at least 2 years. We used multivariable analysis to take account of the lack of randomization.
RESULTS


After median follow-up of 15 years (interquartile range 14-17 years) there was no significant difference in breast cancer mortality between the axillary and no axillary clearance groups. Crude cumulative 15-year incidence of axillary disease in the no axillary dissection group was low: 5.8% overall and 3.7% for pT1 patients.
CONCLUSIONS


Elderly patients with early breast cancer and clinically negative nodes did not benefit in terms of breast cancer mortality from immediate axillary dissection in this nonrandomized study. Sentinel node biopsy could also be foregone due to the very low cumulative incidence of axillary disease in this age group. Axillary dissection should be restricted to the small number of patients who later develop overt axillary disease.",2011,"Crude cumulative 15-year incidence of axillary disease in the no axillary dissection group was low: 5.8% overall and 3.7% for pT1 patients.
","['elderly patients with early breast cancer and clinically negative axillary nodes', 'elderly patients with breast cancer and nonpalpable axillary nodes', '671 consecutive patients, aged ≥ 70 years, with operable breast cancer and a clinically clear axilla, treated between 1987 and 1992; 172 received and 499 did not receive', 'elderly patients with breast cancer and no palpable axillary nodes', 'Elderly patients with early breast cancer and clinically negative nodes', 'older patients with T1N0 disease']","['axillary dissection; 20 mg/day tamoxifen', 'Axillary dissection versus no axillary dissection']","['breast cancer mortality', 'Crude cumulative 15-year incidence of axillary disease']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0456591', 'cui_str': '1987 (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0522499', 'cui_str': 'Palpable (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",671.0,0.0487443,"Crude cumulative 15-year incidence of axillary disease in the no axillary dissection group was low: 5.8% overall and 3.7% for pT1 patients.
","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Martelli', 'Affiliation': 'Breast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. gabriele.martelli@istitutotumori.mi.it'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': ''}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Daidone', 'Affiliation': ''}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Vetrella', 'Affiliation': ''}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cerrotta', 'Affiliation': ''}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Piromalli', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Agresti', 'Affiliation': ''}]",Annals of surgical oncology,['10.1245/s10434-010-1217-7']
372,20835746,Food perceptions in terms of health among Norwegian-Pakistani women participating in a culturally adapted intervention.,"OBJECTIVE


To explore food perceptions in terms of health among Pakistani immigrant women, and if such perceptions could be altered through a culturally adapted intervention.
METHODS


The study is a culturally adapted lifestyle intervention aiming at reducing diabetes risk among Pakistani women, Oslo, Norway. There were 198 participants (25-62 years) recruited through a multi-recruitment strategy and randomly assigned into intervention and control groups. Data were collected through interviews with the help of a structured questionnaire with open-ended questions.
RESULTS


Baseline data showed that many women emphasised vegetables (87%) and fish (52%) as important in a healthy diet, and perceived that the consumption of sugar (66%), oil (60%) and hard fat (39%) should be limited. After intervention, there was an increased proportion of women in the intervention group who perceived that consumption of sugar (p = 0.021) and white flour (p = 0.010) should be limited, in line with the emphasis of the intervention.
CONCLUSIONS


Food perceptions in terms of health were generally in line with public dietary advice, however, with large variation among the women. A culturally adapted intervention had the potential to alter such perceptions.",2011,"After intervention, there was an increased proportion of women in the intervention group who perceived that consumption of sugar (p = 0.021) and white flour (p = 0.010) should be limited, in line with the emphasis of the intervention.
","['Pakistani immigrant women', '198 participants (25-62 years) recruited through a multi-recruitment strategy', 'Pakistani women, Oslo, Norway', 'Norwegian-Pakistani women participating in a culturally adapted intervention']",[],[],"[{'cui': 'C0337814', 'cui_str': 'Pakistani (Urduspeakers) (ethnic group)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}]",[],[],198.0,0.0275224,"After intervention, there was an increased proportion of women in the intervention group who perceived that consumption of sugar (p = 0.021) and white flour (p = 0.010) should be limited, in line with the emphasis of the intervention.
","[{'ForeName': 'Marte Karoline', 'Initials': 'MK', 'LastName': 'Råberg Kjøllesdal', 'Affiliation': 'Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo, Oslo, Norway. m.k.raberg@medisin.uio.no'}, {'ForeName': 'Victoria Telle', 'Initials': 'VT', 'LastName': 'Hjellset', 'Affiliation': ''}, {'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Bjørge', 'Affiliation': ''}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Holmboe-Ottesen', 'Affiliation': ''}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Wandel', 'Affiliation': ''}]",International journal of public health,['10.1007/s00038-010-0191-y']
373,20835873,"Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study.","PURPOSE


A novel transdermal formulation of granisetron (the granisetron transdermal delivery system (GTDS)) has been developed to deliver granisetron continuously over 7 days. This double-blind, phase III, non-inferiority study compared the efficacy and tolerability of the GTDS to daily oral granisetron for the control of chemotherapy-induced nausea and vomiting (CINV).
PATIENTS AND METHODS


Six hundred forty-one patients were randomized to oral (2 mg/day, 3-5 days) or transdermal granisetron (one GTDS patch, 7 days), before receiving multi-day chemotherapy. The primary endpoint was complete control of CINV (no vomiting/retching, no more than mild nausea, no rescue medication) from chemotherapy initiation until 24 h after final administration. The prespecified non-inferiority margin was 15%.
RESULTS


Five hundred eighty-two patients were included in the per protocol analysis. The GTDS displayed non-inferiority to oral granisetron: complete control was achieved by 60% of patients in the GTDS group, and 65% in the oral granisetron group (treatment difference, -5%; 95% confidence interval, -13-3). Both treatments were well tolerated, the most common adverse event being constipation.
CONCLUSIONS


The GTDS provides effective, well-tolerated control of CINV associated with moderately or highly emetogenic multi-day chemotherapy. It offers a convenient alternative route for delivering granisetron for up to 7 days that is as effective as oral granisetron.",2011,"The GTDS displayed non-inferiority to oral granisetron: complete control was achieved by 60% of patients in the GTDS group, and 65% in the oral granisetron group (treatment difference, -5%; 95% confidence interval, -13-3).","['Six hundred forty-one patients', 'Five hundred eighty-two patients were included in the per protocol analysis']","['granisetron transdermal delivery system (GTDS', 'emetogenic multi-day chemotherapy', 'transdermal granisetron', 'transdermal granisetron (one GTDS patch, 7 days), before receiving multi-day chemotherapy', 'GTDS to daily oral granisetron', 'granisetron']","['nausea and vomiting', 'nausea and vomiting (CINV', 'Efficacy and tolerability', 'complete control of CINV (no vomiting/retching, no more than mild nausea, no rescue medication', 'efficacy and tolerability']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0232602', 'cui_str': 'Retching (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",641.0,0.33807,"The GTDS displayed non-inferiority to oral granisetron: complete control was achieved by 60% of patients in the GTDS group, and 65% in the oral granisetron group (treatment difference, -5%; 95% confidence interval, -13-3).","[{'ForeName': 'Ralph V', 'Initials': 'RV', 'LastName': 'Boccia', 'Affiliation': 'Center for Cancer and Blood Disorders, 6420 Rockledge Dr., No. 4100, Bethesda, MD 20817, USA. rboccia@ccbdmd.com'}, {'ForeName': 'Lucio N', 'Initials': 'LN', 'LastName': 'Gordan', 'Affiliation': ''}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Julian D', 'Initials': 'JD', 'LastName': 'Howell', 'Affiliation': ''}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Grunberg', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-010-0990-y']
374,20882268,Increased serum potassium affects renal outcomes: a post hoc analysis of the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) trial.,"AIMS/HYPOTHESIS


To assess the effect of an angiotensin receptor blocker (ARB) on serum potassium and the effect of a serum potassium change on renal outcomes in patients with type 2 diabetes and nephropathy.
METHODS


We performed a post hoc analysis in patients with type 2 diabetes participating in the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study. Renal outcomes were defined as a composite of doubling of serum creatinine or end-stage renal disease.
RESULTS


At month 6, 259 (38.4%) and 73 (10.8%) patients in the losartan group and 151 (22.8%) and 34 (5.1%) patients in the placebo group had serum potassium ≥5.0 mmol/l and ≥5.5 mmol/l, (p < 0.001), respectively. Losartan was an independent predictor for serum potassium ≥5.0 mmol/l at month 6 (OR 2.8; 95% CI 2.0-3.9). Serum potassium at month 6 ≥ 5.0 mmol/l was in turn associated with increased risk for renal events (HR 1.22; 95% CI 1.00-1.50), independent of other risk factors. Adjustment of the overall treatment effects for serum potassium augmented losartan's renoprotective effect from 21% (6-34%) to 35% (20-48%), suggesting that the renoprotective effects of losartan are offset by its effect on serum potassium.
CONCLUSIONS/INTERPRETATION


In this study, we found that treatment with the ARB losartan is associated with a high risk of increased serum potassium levels, which is in turn associated with an increased risk of renal outcomes in patients with diabetes and nephropathy. Whether additional management of high serum potassium would further increase the renal protective properties of losartan is an important clinical question.",2011,Losartan was an independent predictor for serum potassium ≥5.0 mmol/l at month 6 (OR 2.8; 95% CI 2.0-3.9).,"['patients with type 2 diabetes participating in the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study', 'patients with type 2 diabetes and nephropathy', 'patients with diabetes and nephropathy']","['placebo', 'losartan', 'ARB losartan', 'Angiotensin II Antagonist Losartan', 'angiotensin receptor blocker (ARB', 'Losartan']","['Serum potassium', 'renal outcomes', 'risk for renal events', 'composite of doubling of serum creatinine or end-stage renal disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}]","[{'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}]",,0.0505136,Losartan was an independent predictor for serum potassium ≥5.0 mmol/l at month 6 (OR 2.8; 95% CI 2.0-3.9).,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': 'Department of Clinical Pharmacology, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dobre', 'Affiliation': ''}, {'ForeName': 'H J Lambers', 'Initials': 'HJ', 'LastName': 'Heerspink', 'Affiliation': ''}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Brenner', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'H-H', 'Initials': 'HH', 'LastName': 'Parving', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shahinfar', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Grobbee', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-010-1922-6']
375,20706875,Placebo adherence and its association with morbidity and mortality in the studies of left ventricular dysfunction.,"BACKGROUND


A provocative finding from several double-blind clinical trials has been the association between greater adherence to placebo study medication and better health outcomes. We used data from the Studies of Left Ventricular Dysfunction (SOLVD) Treatment Trial (SOLVD-TT) and the SOLVD Prevention Trial (SOLVD-PT) to examine whether such associations could be validated and to examine several sources of bias and potential confounding.
METHODS


Survival analytic methods were used to estimate the association between placebo adherence and several health outcomes, employing a number of modeling techniques to test for the existence of alternative explanations for the association. Higher adherence was defined as having taken ≥75% of prescribed study medication.
RESULTS


Higher placebo adherence was associated with improved overall survival in both SOLVD-TT and SOLVD-PT [hazard ratio (HR) = 0.52, 95% confidence interval (CI): 0.35 to 0.79 and HR = 0.52, 95%CI: 0.38 to 0.71, respectively]. Associations were similar for fatal or non-fatal cardiovascular or coronary heart disease events. Adjustment for both modifiable and non-modifiable cardiac risk factors (including age, gender, diabetes, blood pressure, smoking, weight, alcohol use, and levels of education) had minimal effect on the strength of the association. Little evidence of bias was found as an explanation for this relationship.
CONCLUSIONS


In these two trials, better adherence to placebo was associated with markedly superior health outcomes, including total in-study mortality and incident cardiovascular events. No important confounders were identified. These data suggest there may exist strong but unrecognized determinants of health outcomes for which placebo adherence is a marker.",2010,"RESULTS


Higher placebo adherence was associated with improved overall survival in both SOLVD-TT and SOLVD-PT [hazard ratio (HR) = 0.52, 95% confidence interval (CI): 0.35 to 0.79 and HR = 0.52, 95%CI: 0.38 to 0.71, respectively].",[],"['Placebo', 'placebo']","['morbidity and mortality', 'total in-study mortality and incident cardiovascular events', 'overall survival', 'fatal or non-fatal cardiovascular or coronary heart disease events', 'Higher adherence', 'Left Ventricular Dysfunction (SOLVD']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}]",,0.381277,"RESULTS


Higher placebo adherence was associated with improved overall survival in both SOLVD-TT and SOLVD-PT [hazard ratio (HR) = 0.52, 95% confidence interval (CI): 0.35 to 0.79 and HR = 0.52, 95%CI: 0.38 to 0.71, respectively].","[{'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Avins', 'Affiliation': 'Northern California Kaiser-Permanente Division of Research, Oakland, CA 94612, USA. andrew.avins@ucsf.edu'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Pressman', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Ackerson', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rudd', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Neuhaus', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': ''}]",Journal of general internal medicine,['10.1007/s11606-010-1477-8']
376,20844946,The importance of male partner involvement for women's acceptability and adherence to female-initiated HIV prevention methods in Zimbabwe.,"Enlisting male partner involvement is perceived as an important component of women's successful uptake of female-initiated HIV prevention methods. We conducted a longitudinal study among a cohort of 955 Zimbabwean women participating in a clinical trial of the effectiveness of a female-initiated HIV prevention method (the diaphragm and lubricant gel) to: (a) describe the extent to which women involved their male partners in the decision to use the study products, and (b) measure the effect perceived male partner support had on their acceptability and consistent use of these methods. Reported levels of male partner involvement in discussions and decisions regarding: joining the study, study activities, the outcome of HIV/STI test results, and product use were very high. In multivariate analyses, regular disclosure of study product use and partner approval for the diaphragm and gel were significantly associated with women's acceptability and consistent use of the products; an essential component for determining efficacy of investigational prevention methods. These results support the need for more sophisticated measurement of how couples interact to make decisions that impact study participation and investigational product use as well as more rigorous adaptations and evaluations of existing strategies to involve male partners in female-initiated HIV prevention trials.",2011,Enlisting male partner involvement is perceived as an important component of women's successful uptake of female-initiated HIV prevention methods.,"[""male partner involvement for women's acceptability and adherence to female-initiated HIV prevention methods in Zimbabwe"", '955 Zimbabwean women participating in a clinical trial of the effectiveness of a female-initiated HIV prevention method (the diaphragm and lubricant gel) to: (a) describe the extent to which women involved their male partners in the decision to use the study products, and (b) measure the effect perceived male partner support']",[],[],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],[],955.0,0.0365819,Enlisting male partner involvement is perceived as an important component of women's successful uptake of female-initiated HIV prevention methods.,"[{'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco Project Office, San Francisco, CA, USA. emontgomery@rti.org""}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ''}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Chidanyika', 'Affiliation': ''}, {'ForeName': 'Tsungai', 'Initials': 'T', 'LastName': 'Chipato', 'Affiliation': ''}, {'ForeName': 'Shabbar', 'Initials': 'S', 'LastName': 'Jaffar', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Padian', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-010-9806-9']
377,20809091,"Cost-effectiveness of zoledronic acid in the prevention of skeletal-related events in patients with bone metastases secondary to advanced renal cell carcinoma: application to France, Germany, and the United Kingdom.","BACKGROUND


The use of zoledronic acid (ZOL) has recently been shown to significantly reduce the risk of new skeletal-related events (SREs) in renal cell carcinoma (RCC) patients with bone metastases. The present exploratory study assessed the cost-effectiveness of ZOL in this population, adopting a French, German, and United Kingdom (UK) government payer perspective.
MATERIALS AND METHODS


This cost-effectiveness model was based on a post hoc retrospective analysis of a subset of patients with RCC who were included in a larger randomized clinical trial of patients with bone metastases secondary to a variety of cancers. In the trial, patients were randomized to receive ZOL (n = 27) or placebo (n = 19) with concomitant antineoplastic therapy every 3 weeks for 9 months (core study) plus 12 months during a study extension. Since the trial did not collect costs or data on the quality-adjusted life years (QALYs) of the patients, these outcomes had to be assumed via modeling exercises. The costs of SREs were estimated using hospital DRG tariffs. These estimates were supplemented with literature-based costs where possible. Drug, administration, and supply costs were obtained from published and internet sources. Consistent with similar economic analyses, patients were assumed to experience quality of life decrements lasting 1 month for each SRE. Uncertainty surrounding outcomes was addressed via multivariate sensitivity analyses.
RESULTS


Patients receiving ZOL experienced 1.07 fewer SREs than patients on placebo. Patients on ZOL experienced a gain in discounted QALYs of approximately 0.1563 in France and Germany and 0.1575 in the UK. Discounted SRE-related costs were substantially lower among ZOL than placebo patients (-€ 4,196 in France, - € 3,880 in Germany, and -€ 3,355 in the UK). After taking into consideration the drug therapy costs, ZOL saved € 1,358, € 1,223, and € 719 in France, Germany, and the UK, respectively. In the multivariate sensitivity analyses, therapy with ZOL saved costs in 67-77% of simulations, depending on the country. The cost per QALY gained for ZOL versus placebo was below € 30,000 per QALY gained threshold in approximately 93-94% of multivariate sensitivity analyses simulations.
CONCLUSIONS


The present analysis suggests that ZOL saves costs and increases QALYs compared to placebo in French, German, and UK RCC patients with bone metastases. Additional prospective research may be needed to confirm these results in a larger sample of patients.",2011,"In the multivariate sensitivity analyses, therapy with ZOL saved costs in 67-77% of simulations, depending on the country.","['patients with RCC who were included in a larger randomized clinical trial of patients with bone metastases secondary to a variety of cancers', 'UK RCC patients with bone metastases', 'patients with bone metastases secondary to advanced renal cell carcinoma', 'renal cell carcinoma (RCC) patients with bone metastases']","['placebo', 'zoledronic acid (ZOL', 'concomitant antineoplastic therapy', 'ZOL', 'zoledronic acid']","['Drug, administration, and supply costs', 'Discounted SRE-related costs', 'cost per QALY gained for ZOL', 'costs of SREs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0003392', 'cui_str': 'Chemotherapeutic Anticancer Drug'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",19.0,0.0864851,"In the multivariate sensitivity analyses, therapy with ZOL saved costs in 67-77% of simulations, depending on the country.","[{'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Botteman', 'Affiliation': 'Health Economics, Pharmerit International, 4530 East-West Highway, #430, Bethesda, MD 20814, USA. mbotteman@pharmerit.com'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Meijboom', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Foley', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Stephens', 'Affiliation': ''}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kaura', 'Affiliation': ''}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-010-0272-0']
378,20721536,Probiotics versus antibiotic decontamination of the digestive tract: infection and mortality.,"PURPOSE


Selective decontamination of the digestive tract (SDD) has been shown to decrease the infection rate and mortality in intensive care units (ICUs); Lactobacillus plantarum 299/299v plus fibre (LAB) has been used for infection prevention and does not harbour the potential disadvantages of antibiotics. The objective was to assess whether LAB is not inferior to SDD in infection prevention.
METHODS


Two hundred fifty-four consecutive ICU patients with expected mechanical ventilation ≥ 48 h and/or expected ICU stay ≥ 72 h were assigned to receive SDD: four times daily an oral paste (polymyxin E, gentamicin, amphotericin B), enteral solution (same antibiotics), intravenous cefotaxime (first 4 days) or LAB: two times daily L. plantarum 299/299v with rose-hip.
RESULTS


The primary endpoint was infection rate. A difference <12% between both groups indicated non-inferiority of LAB. The trial was prematurely stopped after a study reporting increased mortality in critically ill pancreatitis patients receiving probiotics. No significant difference in infection rate [31% in the LAB group, 24% in the SDD group (OR 1.68, 95% CI 0.91-3.08; p = 0.10)] was found. ICU mortality was 26% and not significantly different between the LAB and SDD groups. Gram-positive cocci and Pseudomonas aeruginosa were significantly more frequently isolated from surveillance cultures in the SDD group compared to the LAB group (for sputum: 18 vs. 10% and 33 vs. 14%). Significantly more Enterobacteriaceae were found in the LAB group (23 vs. 50%). No increase in antibiotic resistance was found during and after SDD or LAB use.
CONCLUSIONS


The trial could not demonstrate the non-inferiority of LAB compared with SDD in infection prevention. Results suggest no increased ICU mortality risk in the LAB group.",2011,Gram-positive cocci and Pseudomonas aeruginosa were significantly more frequently isolated from surveillance cultures in the SDD group compared to the LAB group (for sputum: 18 vs. 10% and 33 vs. 14%).,"['critically ill pancreatitis patients receiving probiotics', 'Two hundred fifty-four consecutive ICU patients with expected mechanical ventilation ≥ 48 h']","['LAB', 'oral paste (polymyxin E, gentamicin, amphotericin B), enteral solution (same antibiotics), intravenous cefotaxime (first 4 days) or LAB: two times daily L. plantarum 299/299v with rose-hip', 'Probiotics versus antibiotic decontamination']","['antibiotic resistance', 'mortality', 'ICU mortality risk', 'Gram-positive cocci and Pseudomonas aeruginosa', 'infection rate', 'ICU mortality']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C1154192', 'cui_str': 'Oral Paste'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}]","[{'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018155', 'cui_str': 'Gram-Positive Cocci'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",254.0,0.147215,Gram-positive cocci and Pseudomonas aeruginosa were significantly more frequently isolated from surveillance cultures in the SDD group compared to the LAB group (for sputum: 18 vs. 10% and 33 vs. 14%).,"[{'ForeName': 'Guy J', 'Initials': 'GJ', 'LastName': 'Oudhuis', 'Affiliation': 'Department of Medical Microbiology, NUTRIM School for Nutrition, Toxicology and Metabolism, Maastricht University Medical Centre, PO Box 5800, 6202 AZ Maastricht, The Netherlands.'}, {'ForeName': 'Dennis C', 'Initials': 'DC', 'LastName': 'Bergmans', 'Affiliation': ''}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Dormans', 'Affiliation': ''}, {'ForeName': 'Jan-Harm', 'Initials': 'JH', 'LastName': 'Zwaveling', 'Affiliation': ''}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Kessels', 'Affiliation': ''}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Prins', 'Affiliation': ''}, {'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Stobberingh', 'Affiliation': ''}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-010-2002-6']
379,20661660,The effect of selenium supplementation in the prevention of DNA damage in white blood cells of hemodialyzed patients: a pilot study.,"Patients with chronic kidney disease (CKD) have an increased incidence of cancer. It is well known that long periods of hemodialysis (HD) treatment are linked to DNA damage due to oxidative stress. In this study, we examined the effect of selenium (Se) supplementation to CKD patients on HD on the prevention of oxidative DNA damage in white blood cells. Blood samples were drawn from 42 CKD patients on HD (at the beginning of the study and after 1 and 3 months) and from 30 healthy controls. Twenty-two patients were supplemented with 200 μg Se (as Se-rich yeast) per day and 20 with placebo (baker's yeast) for 3 months. Se concentration in plasma and DNA damage in white blood cells expressed as the tail moment, including single-strand breaks (SSB) and oxidative bases lesion in DNA, using formamidopyrimidine glycosylase (FPG), were measured. Se concentration in patients was significantly lower than in healthy subjects (P < 0.0001) and increased significantly after 3 months of Se supplementation (P < 0.0001). Tail moment (SSB) in patients before the study was three times higher than in healthy subjects (P < 0.01). After 3 months of Se supplementation, it decreased significantly (P < 0.01) and was about 16% lower than in healthy subjects. The oxidative bases lesion in DNA (tail moment, FPG) of HD patients at the beginning of the study was significantly higher (P < 0.01) compared with controls, and 3 months after Se supplementation it was 2.6 times lower than in controls (P < 0.01). No changes in tail moment was observed in the placebo group. In conclusion, our study shows that in CKD patients on HD, DNA damage in white blood cells is higher than in healthy controls, and Se supplementation prevents the damage of DNA.",2011,Se concentration in patients was significantly lower than in healthy subjects (P < 0.0001) and increased significantly after 3 months of Se supplementation (P < 0.0001).,"['Patients with chronic kidney disease (CKD', 'white blood cells', 'Twenty-two patients were supplemented with 200\xa0μg', 'white blood cells of hemodialyzed patients']","['selenium (Se) supplementation', 'selenium supplementation', 'placebo']","['tail moment', 'Se concentration', 'Tail moment (SSB', 'incidence of cancer']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",22.0,0.0271561,Se concentration in patients was significantly lower than in healthy subjects (P < 0.0001) and increased significantly after 3 months of Se supplementation (P < 0.0001).,"[{'ForeName': 'Bronislaw A', 'Initials': 'BA', 'LastName': 'Zachara', 'Affiliation': 'Department of Toxicology and Carcinogenesis, Nofer Institute of Occupational Medicine, Lodz, Poland. bronzach1@gmail.com'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Gromadzinska', 'Affiliation': ''}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Palus', 'Affiliation': ''}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Zbrog', 'Affiliation': ''}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Swiech', 'Affiliation': ''}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Twardowska', 'Affiliation': ''}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wasowicz', 'Affiliation': ''}]",Biological trace element research,['10.1007/s12011-010-8776-0']
380,20814766,Alpha-linolenic acid: is it essential to cardiovascular health?,"There is a large body of scientific evidence that has been confirmed in randomized controlled trials indicating a cardioprotective effect for omega-3 fatty acids from fish. For alpha-linolenic acid (ALA), which is the omega-3 fatty acid from plants, the relation to cardiovascular health is less clear. We reviewed the recent literature on dietary ALA intake, ALA tissue concentrations, and cardiovascular health in humans. Short-term trials (6-12 weeks) in generally healthy participants mostly showed no or inconsistent effects of ALA intake (1.2-3.6 g/d) on blood lipids, low-density lipoprotein oxidation, lipoprotein(a), and apolipoproteins A-I and B. Studies of ALA in relation to inflammatory markers and glucose metabolism yielded conflicting results. With regard to clinical cardiovascular outcomes, there is observational evidence for a protective effect against nonfatal myocardial infarction. However, no protective associations were observed between ALA status and risk of heart failure, atrial fibrillation, and sudden death. Findings from long-term trials of ALA supplementation are awaited to answer the question whether food-based or higher doses of ALA could be important for cardiovascular health in cardiac patients and the general population.",2010,"However, no protective associations were observed between ALA status and risk of heart failure, atrial fibrillation, and sudden death.",['humans'],"['Alpha-linolenic acid', 'alpha-linolenic acid (ALA']","['ALA intake', 'dietary ALA intake, ALA tissue concentrations, and cardiovascular health', 'ALA status and risk of heart failure, atrial fibrillation, and sudden death', 'blood lipids, low-density lipoprotein oxidation, lipoprotein(a), and apolipoproteins A-I']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0051405', 'cui_str': '9,12,15-Octadecatrienoic acid, (Z,Z,Z)-'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0622790', 'cui_str': 'Apo A-I (Giessen)'}]",,0.224612,"However, no protective associations were observed between ALA status and risk of heart failure, atrial fibrillation, and sudden death.","[{'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Geleijnse', 'Affiliation': 'Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands. marianne.geleijnse@wur.nl'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'de Goede', 'Affiliation': ''}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': ''}]",Current atherosclerosis reports,['10.1007/s11883-010-0137-0']
381,20824373,Direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt for bleeding esophageal varices in cirrhosis--Part 4.,"BACKGROUND


Emergency treatment of bleeding esophageal varices (BEV) in cirrhotic patients is of prime importance because of the high mortality rate surrounding the episode of acute bleeding. Nevertheless, there is a paucity of randomized controlled trials of emergency surgical therapy and no reports of the costs of any of the widely used forms of emergency treatment. The important issue of direct costs of care was examined in a randomized controlled trial that compared endoscopic sclerotherapy (EST) to emergency portacaval shunt (EPCS).
METHODS


Two hundred eleven unselected consecutive patients with ultimately biopsy-proven cirrhosis and endoscopically proven acute BEV were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic workup was completed, and EST or EPCS was initiated within 8 h. Criteria for failure of EST or EPCS were clearly defined, and crossover rescue treatment was applied, when primary therapy failed. Ninety-six percent of patients underwent more than 10 years follow-up, or until death. Complete charges for all aspects of care were obtained continuously for more than 10 years.
RESULTS


Direct charges for all aspects of care were significantly lower in patients treated by EPCS than in patients treated by emergency EST followed by long-term repetitive sclerotherapy. Charges per patient, per year of treatment, and per year in each child's risk class were significantly lower in patients randomized to EPCS. Charges in patients who failed endoscopic sclerotherapy and underwent a rescue portacaval shunt were significantly higher than the charges in both the unshunted sclerotherapy patients and the patients randomized to EPCS. This result was particularly noteworthy given the widespread practice of using surgical portacaval shunt as rescue treatment only when all other forms of therapy have failed.
CONCLUSIONS


In this randomized controlled trial of emergency treatment of acute BEV, EPCS was significantly superior to EST with regard to direct costs of care as reflected in charges for care as well as in survival rate, control of bleeding, and incidence of portal-systemic encephalopathy. These results provide support for the use of EPCS as a first line of emergency treatment of BEV in cirrhosis.",2011,"RESULTS


Direct charges for all aspects of care were significantly lower in patients treated by EPCS than in patients treated by emergency EST followed by long-term repetitive sclerotherapy.","['cirrhosis--Part 4', 'Two hundred eleven unselected consecutive patients with ultimately biopsy-proven cirrhosis and endoscopically proven acute BEV', 'cirrhotic patients']","['EPCS', 'EST', 'endoscopic sclerotherapy (EST', 'emergency EST', 'endoscopic sclerotherapy', 'emergency portacaval shunt', 'EST or EPCS']","['bleeding esophageal varices', 'survival rate, control of bleeding, and incidence of portal-systemic encephalopathy']","[{'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}]","[{'cui': 'C0600510', 'cui_str': 'ESTs'}, {'cui': 'C0036435', 'cui_str': 'Sclerotherapy'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0032716', 'cui_str': 'Portacaval Shunt'}]","[{'cui': 'C0155789', 'cui_str': 'Bleeding esophageal varices (disorder)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}]",211.0,0.0701078,"RESULTS


Direct charges for all aspects of care were significantly lower in patients treated by EPCS than in patients treated by emergency EST followed by long-term repetitive sclerotherapy.","[{'ForeName': 'Marshall J', 'Initials': 'MJ', 'LastName': 'Orloff', 'Affiliation': 'Department of Surgery, University of California, San Diego Medical Center, 200 West Arbor Drive, San Diego, CA 92103-8999, USA. morloff@ucsd.edu'}, {'ForeName': 'Jon I', 'Initials': 'JI', 'LastName': 'Isenberg', 'Affiliation': ''}, {'ForeName': 'Henry O', 'Initials': 'HO', 'LastName': 'Wheeler', 'Affiliation': ''}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Jinich-Brook', 'Affiliation': ''}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Rapier', 'Affiliation': ''}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Vaida', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hye', 'Affiliation': ''}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-010-1332-6']
382,20694577,The role of friends' disruptive behavior in the development of children's tobacco experimentation: results from a preventive intervention study.,"Having friends who engage in disruptive behavior in childhood may be a risk factor for childhood tobacco experimentation. This study tested the role of friends' disruptive behavior as a mediator of the effects of a classroom based intervention on children's tobacco experimentation. 433 Children (52% males) were randomly assigned to the Good Behavior Game (GBG) intervention, a universal preventive intervention targeting disruptive behavior, and facilitating positive prosocial peer interactions. Friends' disruptive behavior was assessed from age 7-10 years. Participants' experimentation with tobacco was assessed annually from age 10-13. Reduced rates in tobacco experimentation and friends' disruptive behavior were found among GBG children, as compared to controls. Support for friends' disruptive behavior as a mediator in the link between intervention status and tobacco experimentation was found. These results remained after controlling for friends' and parental smoking status, and child ADHD symptoms. The results support the role of friends' disruptive behavior in preadolescents' tobacco experimentation.",2011,"Reduced rates in tobacco experimentation and friends' disruptive behavior were found among GBG children, as compared to controls.","['433 Children (52% males', ""Participants' experimentation with tobacco was assessed annually from age 10-13"", ""children's tobacco experimentation""]","['Good Behavior Game (GBG) intervention, a universal preventive intervention targeting disruptive behavior, and facilitating positive prosocial peer interactions', 'classroom based intervention']","[""Friends' disruptive behavior"", ""rates in tobacco experimentation and friends' disruptive behavior""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]",433.0,0.0151206,"Reduced rates in tobacco experimentation and friends' disruptive behavior were found among GBG children, as compared to controls.","[{'ForeName': 'Pol A C', 'Initials': 'PA', 'LastName': 'van Lier', 'Affiliation': 'Department of Developmental Psychology, VU University Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, the Netherlands. pac.van.lier@psy.vu.nl'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Huizink', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Vuijk', 'Affiliation': ''}]",Journal of abnormal child psychology,['10.1007/s10802-010-9446-6']
383,20665254,Disruption of saccadic adaptation with repetitive transcranial magnetic stimulation of the posterior cerebellum in humans.,"Saccadic eye movements are driven by motor commands that are continuously modified so that errors created by eye muscle fatigue, injury, or-in humans-wearing spectacles can be corrected. It is possible to rapidly adapt saccades in the laboratory by introducing a discrepancy between the intended and actual saccadic target. Neurophysiological and lesion studies in the non-human primate as well as neuroimaging and patient studies in humans have demonstrated that the oculomotor vermis (lobules VI and VII of the posterior cerebellum) is critical for saccadic adaptation. We studied the effect of transiently disrupting the function of posterior cerebellum with repetitive transcranial magnetic stimulation (rTMS) on the ability of healthy human subjects to adapt saccadic eye movements. rTMS significantly impaired the adaptation of the amplitude of saccades, without modulating saccadic amplitude or variability in baseline conditions. Moreover, increasing the intensity of rTMS produced a larger impairment in the ability to adapt saccadic size. These results provide direct evidence for the role of the posterior cerebellum in man and further evidence that TMS can modulate cerebellar function.",2010,"rTMS significantly impaired the adaptation of the amplitude of saccades, without modulating saccadic amplitude or variability in baseline conditions.","['healthy human subjects to adapt saccadic eye movements', 'humans']","['repetitive transcranial magnetic stimulation (rTMS', 'TMS', 'rTMS', 'repetitive transcranial magnetic stimulation']","['adaptation of the amplitude of saccades, without modulating saccadic amplitude or variability']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0036019', 'cui_str': 'Saccadic Eye Movements'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0036019', 'cui_str': 'Saccadic Eye Movements'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}]",,0.0615889,"rTMS significantly impaired the adaptation of the amplitude of saccades, without modulating saccadic amplitude or variability in baseline conditions.","[{'ForeName': 'Ned', 'Initials': 'N', 'LastName': 'Jenkinson', 'Affiliation': 'Nuffield Department of Surgery, University of Oxford, Oxford, UK. ned.jenkinson@dpag.ox.ac.uk'}, {'ForeName': 'R Chris', 'Initials': 'RC', 'LastName': 'Miall', 'Affiliation': ''}]","Cerebellum (London, England)",['10.1007/s12311-010-0193-6']
384,20640546,Power training and postmenopausal hormone therapy affect transcriptional control of specific co-regulated gene clusters in skeletal muscle.,"At the moment, there is no clear molecular explanation for the steeper decline in muscle performance after menopause or the mechanisms of counteractive treatments. The goal of this genome-wide study was to identify the genes and gene clusters through which power training (PT) comprising jumping activities or estrogen containing hormone replacement therapy (HRT) may affect skeletal muscle properties after menopause. We used musculus vastus lateralis samples from early stage postmenopausal (50-57 years old) women participating in a yearlong randomized double-blind placebo-controlled trial with PT and HRT interventions. Using microarray platform with over 24,000 probes, we identified 665 differentially expressed genes. The hierarchical clustering method was used to assort the genes. Additionally, enrichment analysis of gene ontology (GO) terms and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways was carried out to clarify whether assorted gene clusters are enriched with particular functional categories. The analysis revealed transcriptional regulation of 49 GO/KEGG categories. PT upregulated transcription in ""response to contraction""-category revealing novel candidate genes for contraction-related regulation of muscle function while HRT upregulated gene expression related to functionality of mitochondria. Moreover, several functional categories tightly related to muscle energy metabolism, development, and function were affected regardless of the treatment. Our results emphasize that during the early stages of the postmenopause, muscle properties are under transcriptional modulation, which both PT and HRT partially counteract leading to preservation of muscle power and potentially reducing the risk for aging-related muscle weakness. More specifically, PT and HRT may function through improving energy metabolism, response to contraction as well as by preserving functionality of the mitochondria.",2010,"PT upregulated transcription in ""response to contraction""-category revealing novel candidate genes for contraction-related regulation of muscle function while HRT upregulated gene expression related to functionality of mitochondria.",['musculus vastus lateralis samples from early stage postmenopausal (50-57 years old) women participating'],"['PT and HRT interventions', 'power training (PT) comprising jumping activities or estrogen containing hormone replacement therapy (HRT', 'placebo', 'Power training and postmenopausal hormone therapy']",[],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]",[],,0.0641728,"PT upregulated transcription in ""response to contraction""-category revealing novel candidate genes for contraction-related regulation of muscle function while HRT upregulated gene expression related to functionality of mitochondria.","[{'ForeName': 'Eija', 'Initials': 'E', 'LastName': 'Pöllänen', 'Affiliation': 'Gerontology Research Centre, University Jyväskylä, Jyväskylä, Finland. eija.pollanen@jyu.fi'}, {'ForeName': 'Vidal', 'Initials': 'V', 'LastName': 'Fey', 'Affiliation': ''}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Törmäkangas', 'Affiliation': ''}, {'ForeName': 'Paula H A', 'Initials': 'PH', 'LastName': 'Ronkainen', 'Affiliation': ''}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Taaffe', 'Affiliation': ''}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Takala', 'Affiliation': ''}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Koskinen', 'Affiliation': ''}, {'ForeName': 'Sulin', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Puolakka', 'Affiliation': ''}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': ''}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Suominen', 'Affiliation': ''}, {'ForeName': 'Sarianna', 'Initials': 'S', 'LastName': 'Sipilä', 'Affiliation': ''}, {'ForeName': 'Vuokko', 'Initials': 'V', 'LastName': 'Kovanen', 'Affiliation': ''}]","Age (Dordrecht, Netherlands)",['10.1007/s11357-010-9140-1']
385,20938670,Impact of HPV infection on the clinical outcome of p-CAIR trial in head and neck cancer.,"The purpose of the study was to analyse the influence of HPV infection on the outcome of a randomized clinical trial of conventional (CF) versus 7-days-a-week postoperative radiotherapy (p-CAIR) for squamous cell cancer of the head and neck (SCCHN). Between 2001 and 2004, 279 patients with high-risk SCC of the larynx or cancer of the oral cavity/oropharynx were randomized to receive 63 Gy in fractions of 1.8 Gy given 5 days a week or 7 days a week (Radiother Oncol 87:155-163, 2008). The presence of HPV DNA in 131 archival paraffin blocks was assessed with multiplex quantitative real-time PCR using five consensus primers for the conservative L1 region and molecular beacon probes targeting 14 high-risk HPV subtypes. Following the RT-PCR procedure, we could determine the presence and type of HPV16, HPV18 and the other 12 less frequent oncogenic subtypes. Out of 131 samples, 9 were positive for HPV infection (6.9%), all of them with HPV16 subtype. None of the 65 laryngeal tumours was HPV positive. The 5-year LRC in HPV-positive patients was 100%, compared to 58% in the HPV-negative group (p = 0.02, log-rank test). Amongst 122 patients with HPV-negative tumours, 5-year LRC was 50.3% in p-CF versus 65.2 in p-CAIR (p = 0.37). HPV infection was associated with low expression of EGFR and cyclin D. This study demonstrates a favourable outcome for HPV-positive patients with SCCHN treated with postoperative radiotherapy. While considering the small number of HPV+ tumours, the data set can be considered as hypothesis generating only, the outcome raises new questions on the necessity of aggressive postoperative treatment in HPV+ patients.",2011,"Amongst 122 patients with HPV-negative tumours, 5-year LRC was 50.3% in p-CF versus 65.2 in p-CAIR (p = 0.37).","['head and neck cancer', 'squamous cell cancer of the head and neck (SCCHN', 'HPV-positive patients with SCCHN treated with postoperative radiotherapy', 'HPV+ patients', '122 patients with HPV-negative tumours', 'Between 2001 and 2004, 279 patients with high-risk SCC of the larynx or cancer of the oral cavity/oropharynx']",['conventional (CF) versus 7-days-a-week postoperative radiotherapy (p-CAIR'],"['HPV infection', 'low expression of EGFR and cyclin D', '5-year LRC']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0226896', 'cui_str': 'Cavitas Oris'}, {'cui': 'C0521367', 'cui_str': 'Oropharynxs'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0051028', 'cui_str': ""AICAriboside 5'-monophosphate""}]","[{'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0388730', 'cui_str': 'Type D Cyclins'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",279.0,0.0610977,"Amongst 122 patients with HPV-negative tumours, 5-year LRC was 50.3% in p-CF versus 65.2 in p-CAIR (p = 0.37).","[{'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Snietura', 'Affiliation': 'Department of Tumour Pathology, Center of Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Piglowski', 'Affiliation': ''}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Jaworska', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mucha-Malecka', 'Affiliation': ''}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Wozniak', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Suwinski', 'Affiliation': ''}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-010-1396-7']
386,20924751,"Acute effects of MDMA (3,4-methylenedioxymethamphetamine) on EEG oscillations: alone and in combination with ethanol or THC (delta-9-tetrahydrocannabinol).","RATIONALE


Typical users of 3,4-methylenedioxymethamphetamine (MDMA or ""ecstasy"") are polydrug users, combining MDMA with alcohol or cannabis [most active compound: delta-9-tetrahydrocannabinol (THC)].
OBJECTIVES


The aim of the present study was to investigate whether co-administration of alcohol or THC with MDMA differentially affects ongoing electroencephalogram (EEG) oscillations compared to the administration of each drug alone.
METHODS


In two separate experiments, 16 volunteers received four different drug conditions: (1) MDMA (100 mg); (2) alcohol clamp (blood alcohol concentration = 0.6‰) or THC (inhalation of 4, 6 and 6 mg, interval of 1.5 h); (3) MDMA in combination with alcohol or THC; and (4) placebo. Before and after drug administration, electroencephalography was recorded during an eyes closed resting state.
RESULTS


Theta and alpha power increased after alcohol intake compared to placebo and reduced after MDMA intake. No interaction between alcohol and MDMA was found. Significant MDMA x THC effects for theta and lower-1-alpha power indicated that the power attenuation after the combined intake of MDMA and THC was less than the sum of each drug alone. For the lower-2-alpha band, the intake of MDMA or THC alone did not significantly affect power, but the intake of combined MDMA and THC significantly decreased lower-2-alpha power.
CONCLUSIONS


The present findings indicate that the combined intake of MDMA and THC, but not of MDMA and alcohol, affects ongoing EEG oscillations differently than the sum of either one drug alone. Changes in ongoing EEG oscillations may be related to the impaired task performance that has often been reported after drug intake.",2011,"For the lower-2-alpha band, the intake of MDMA or THC alone did not significantly affect power, but the intake of combined MDMA and THC significantly decreased lower-2-alpha power.
","['16 volunteers received four different drug conditions: (1', 'Typical users of 3,4-methylenedioxymethamphetamine (MDMA or ""ecstasy"") are polydrug users, combining MDMA with alcohol or cannabis [most active compound: delta-9-tetrahydrocannabinol']","['ethanol or THC (delta-9-tetrahydrocannabinol', 'placebo', 'alcohol or THC with MDMA', 'MDMA (3,4-methylenedioxymethamphetamine', 'MDMA (100 mg); (2) alcohol clamp (blood alcohol concentration\u2009=\u20090.6‰) or THC (inhalation of 4, 6 and 6 mg, interval of 1.5 h); (3) MDMA in combination with alcohol or THC; and (4) placebo']","['lower-2-alpha power', 'Theta and alpha power', 'electroencephalogram (EEG) oscillations']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0678156', 'cui_str': 'Ecstasy (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}]",16.0,0.0404382,"For the lower-2-alpha band, the intake of MDMA or THC alone did not significantly affect power, but the intake of combined MDMA and THC significantly decreased lower-2-alpha power.
","[{'ForeName': 'Marieke M', 'Initials': 'MM', 'LastName': 'Lansbergen', 'Affiliation': 'Department of Psychiatry, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. M.Lansbergen@psy.umcn.nl'}, {'ForeName': 'Glenn J H', 'Initials': 'GJ', 'LastName': 'Dumont', 'Affiliation': ''}, {'ForeName': 'Joop M A', 'Initials': 'JM', 'LastName': 'van Gerven', 'Affiliation': ''}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': ''}, {'ForeName': 'Robbert-Jan', 'Initials': 'RJ', 'LastName': 'Verkes', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-2031-4']
387,20803028,Myofeedback training and intensive muscular strength training to decrease pain and improve work ability among female workers on long-term sick leave with neck pain: a randomized controlled trial.,"UNLABELLED


The theoretical framework is that muscle tension in the neck is related to insufficient muscular rest and is a risk factor for chronic pain and reduced work ability. Promoting muscle strength and muscle rest may increase work ability and reduce neck pain.
OBJECTIVES


To test whether myofeedback training or intensive strength training leads to decreased pain and increased work ability in women on long-term sick leave.
METHODS


This is a randomized controlled trial of two 1-month interventions with myofeedback or muscular strength training in the home environment. Female human service organization workers (n = 60) on long-term (>60 days) sick leave and with chronic neck pain were followed with self-reported and laboratory-observed data of health, pain, muscular activation, and work ability, at baseline, immediately after the intervention and 3 months after baseline.
RESULTS


For both intervention groups, pain was lowered over time compared with the control group. Decreased pain and muscular activity was associated with increased self-rated work ability and with laboratory-observed work ability at 3-month follow-up. Decreased pain was also associated with increased self-rated work ability at 1-month follow-up. Muscular strength training was associated with increased self-rated work ability and mental health. Myofeedback was associated with increased observed work ability and self- rated vitality.
CONCLUSIONS


The two interventions showed positive results, suggesting that they could be developed for use in health care practice to address pain and work ability. The intensive muscular strength training program, which is both easy to conduct at home and easy to coach, was associated with increased work ability.",2011,Decreased pain and muscular activity was associated with increased self-rated work ability and with laboratory-observed work ability at 3-month follow-up.,"['Female human service organization workers (n = 60) on long-term (>60 days) sick leave and with chronic neck pain', 'female workers on long-term sick leave with neck pain', 'women on long-term sick leave']","['Muscular strength training', 'myofeedback or muscular strength training', 'myofeedback training or intensive strength training', 'Myofeedback training and intensive muscular strength training']","['self-rated work ability and mental health', 'pain', 'self-rated work ability and with laboratory-observed work ability', 'Decreased pain', 'laboratory-observed data of health, pain, muscular activation, and work ability', 'Decreased pain and muscular activity', 'pain and increased work ability', 'self-rated work ability', 'work ability and self- rated vitality']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C3179341', 'cui_str': 'Myofeedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0366045,Decreased pain and muscular activity was associated with increased self-rated work ability and with laboratory-observed work ability at 3-month follow-up.,"[{'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Dellve', 'Affiliation': 'Occupational and Environmental Medicine, Sahlgrenska Academy, University of Gothenburg, Box 414, 405 30, Gothenburg, Sweden. lotta.dellve@amm.gu.se'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ahlstrom', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jonsson', 'Affiliation': ''}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Sandsjö', 'Affiliation': ''}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Forsman', 'Affiliation': ''}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Lindegård', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ahlstrand', 'Affiliation': ''}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kadefors', 'Affiliation': ''}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hagberg', 'Affiliation': ''}]",International archives of occupational and environmental health,['10.1007/s00420-010-0568-5']
388,20740300,Effect of ketoconazole on the pharmacokinetics of axitinib in healthy volunteers.,"OBJECTIVE


Axitinib (AG-013736), an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, is metabolized primarily by cytochrome P450 (CYP) 3A with minor contributions from CYP1A2, CYP2C19, and glucuronidation. Co-administration with CYP inhibitors may increase systemic exposure to axitinib and alter its safety profile. This study evaluated changes in axitinib plasma pharmacokinetic parameters and assessed safety and tolerability in healthy subjects, following axitinib co-administration with the potent CYP3A inhibitor ketoconazole.
METHODS


In this randomized, single-blind, two-way crossover study, 32 healthy volunteers received placebo, followed by a single 5-mg oral dose of axitinib, administered either alone or on the fourth day of dosing with oral ketoconazole (400 mg/day for 7 days).
RESULTS


Axitinib exposure was significantly increased in the presence of ketoconazole, with a geometric mean ratio for area under the plasma concentration-time curve from time zero to infinity of 2.06 (90% confidence interval [CI]: 1.84-2.30) and a geometric mean ratio for maximum plasma concentration (C(max)) of 1.50 (90% CI: 1.33-1.70). For axitinib alone or with ketoconazole, C(max) occurred 1.5 and 2.0 h after dosing, respectively. Adverse events were predominantly mild; the most commonly reported treatment-related adverse events were headache and nausea.
CONCLUSIONS


Axitinib plasma exposures and peak concentrations were increased following concurrent administration of axitinib and ketoconazole in healthy volunteers. Axitinib alone and in combination with ketoconazole was well tolerated. These findings provide an upper exposure for expected axitinib plasma concentrations in the presence of potent metabolic inhibition.",2012,Axitinib plasma exposures and peak concentrations were increased following concurrent administration of axitinib and ketoconazole in healthy volunteers.,"['32 healthy volunteers received', 'healthy subjects, following axitinib co-administration with the potent', 'healthy volunteers']","['placebo', 'CYP inhibitors', 'ketoconazole', 'oral ketoconazole', 'ketoconazole, C(max', 'axitinib and ketoconazole', 'CYP3A inhibitor ketoconazole', 'Co']","['geometric mean ratio for area under the plasma concentration-time curve', 'Adverse events', 'axitinib plasma pharmacokinetic parameters', 'Axitinib plasma exposures and peak concentrations', 'tolerated', 'headache and nausea', 'Axitinib exposure', 'geometric mean ratio for maximum plasma concentration (C(max', 'safety and tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C3850056', 'cui_str': 'CYP3A Inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",32.0,0.0669296,Axitinib plasma exposures and peak concentrations were increased following concurrent administration of axitinib and ketoconazole in healthy volunteers.,"[{'ForeName': 'Yazdi K', 'Initials': 'YK', 'LastName': 'Pithavala', 'Affiliation': 'Pfizer Oncology, 10555 Science Center Drive, San Diego, CA 92121, USA. yazdi.pithavala@pfizer.com'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Janessa', 'Initials': 'J', 'LastName': 'Mount', 'Affiliation': ''}, {'ForeName': 'Sadayappan V', 'Initials': 'SV', 'LastName': 'Rahavendran', 'Affiliation': ''}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Garrett', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hee', 'Affiliation': ''}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Selaru', 'Affiliation': ''}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Sarapa', 'Affiliation': ''}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Klamerus', 'Affiliation': ''}]",Investigational new drugs,['10.1007/s10637-010-9511-6']
389,20680432,Efficacy of personalized cognitive counseling in men of color who have sex with men: secondary data analysis from a controlled intervention trial.,"In a previous report, we demonstrated the efficacy of a cognitively based counseling intervention compared to standard counseling at reducing episodes of unprotected anal intercourse (UAI) among men who have sex with men (MSM) seeking HIV testing. Given the limited number of efficacious prevention interventions for MSM of color (MOC) available, we analyzed the data stratified into MOC and whites. The sample included 196 white MSM and 109 MOC (23 African Americans, 36 Latinos, 22 Asians, eight Alaskan Natives/Native Americans/Hawaiian/Pacific Islander, and 20 of mixed or other unspecified race). Among MOC in the intervention group, the mean number of episodes of UAI declined from 5.1 to 1.6 at six months and was stable at 12 months (1.8). Among the MOC receiving standard counseling, the mean number of UAI episodes was 4.2 at baseline, 3.9 at six months and 2.1 at 12 months. There was a significant treatment effect overall (relative risk 0.59, 95% confidence interval 0.35-0.998). These results suggest that the intervention is effective in MOC.",2011,"There was a significant treatment effect overall (relative risk 0.59, 95% confidence interval 0.35-0.998).","['The sample included 196 white MSM and 109 MOC (23 African Americans, 36 Latinos, 22 Asians, eight Alaskan Natives/Native Americans/Hawaiian/Pacific Islander, and 20 of mixed or other unspecified race', 'men of color who have sex with men', 'men who have sex with men (MSM) seeking HIV testing']","['cognitively based counseling intervention', 'standard counseling', 'personalized cognitive counseling']","['mean number of UAI episodes', 'mean number of episodes of UAI']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0337920', 'cui_str': 'Native Hawaiians'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",196.0,0.0344877,"There was a significant treatment effect overall (relative risk 0.59, 95% confidence interval 0.35-0.998).","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Dilley', 'Affiliation': 'Department of Psychiatry and the AIDS Health Project, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Schwarcz', 'Affiliation': ''}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Scheer', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-010-9771-3']
390,20676771,"A multicenter, randomized study to evaluate the efficacy and safety of mesalamine suppositories 1 g at bedtime and 500 mg Twice daily in patients with active mild-to-moderate ulcerative proctitis.","BACKGROUND


Ulcerative proctitis (UP) is a prevalent condition associated with increased morbidity and mortality. Topical mesalamine (5-aminosalicylic acid [5-ASA]) inhibits inflammatory processes in UP.
METHODS


We evaluated effects of mesalamine 1-g suppository administered QHS compared with 500-mg suppository administered BID on UP activity (e.g., disease extension/mucosal appearance), remission, onset of response, safety and compliance in 97 patients with UP. A 6-week, randomized, multicenter, parallel-group, noninferiority study was conducted (and published) with Disease Activity Index (DAI) at week 6 as the primary efficacy variable and individual components of DAI at week 6 (i.e., stool frequency, rectal bleeding, mucosal appearance, global assessment) as secondary variables. Unreported outcomes were remission (DAI < 3 at weeks 3 and 6), disease extension, and complete response to treatment (DAI = 0; post-hoc, exploratory analysis).
RESULTS


DAI values after 6 weeks were significantly reduced (±SD) from 6.6 ± 1.5 to 1.6 ± 2.3 (500-mg BID); and from 6.1 ± 1.5 to 1.3 ± 2.2 (1-g QHS). Mucosal appearance significantly improved from baseline after 3 and 6 weeks of treatment from 1.8 ± 0.5 to 0.8 ± 0.7 and 0.5 ± 0.7 (500-mg BID; P ≤ 0.0062) and from 1.7 ± 0.5 to 0.9 ± 0.5 and 0.4 ± 0.6 (1-g QHS; P ≤ 0.0001), respectively. Remission was comparable (78.3-86.1%); onset of response generally occurred within 3 weeks, and disease extension was reduced (>70%) after 6 weeks in both groups. Mesalamine was well tolerated. Compliance was >96%.
CONCLUSIONS


Mesalamine 500-mg BID and 1-g QHS suppositories are safe and effective for patients with UP. Most patients reported significant improvement within 3 weeks and UP remission and reduced disease extension after 6 weeks of treatment. Validity of QHS administration was confirmed.",2011,"Topical mesalamine (5-aminosalicylic acid [5-ASA]) inhibits inflammatory processes in UP.
","['patients with active mild-to-moderate ulcerative proctitis', 'patients with UP', '97 patients with UP']","['Mesalamine', 'QHS suppositories', 'mesalamine 1-g suppository administered QHS', 'Topical mesalamine (5-aminosalicylic acid [5-ASA', 'QHS', 'mesalamine suppositories']","['DAI values', 'UP activity (e.g., disease extension/mucosal appearance), remission, onset of response, safety and compliance', 'efficacy and safety', 'tolerated', 'Disease Activity Index (DAI', 'Mucosal appearance', 'UP remission and reduced disease extension', 'disease extension', 'stool frequency, rectal bleeding, mucosal appearance, global assessment', 'Remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2937222', 'cui_str': 'Chronic ulcerative proctitis (disorder)'}]","[{'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C1275563', 'cui_str': 'qHS'}, {'cui': 'C0789858', 'cui_str': 'mesalamine 1000 MG Rectal Suppository'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",97.0,0.146229,"Topical mesalamine (5-aminosalicylic acid [5-ASA]) inhibits inflammatory processes in UP.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lamet', 'Affiliation': 'Center for Gastrointestinal Disorders, Hollywood, FL 33021, USA. gidoc18@yahoo.com'}]",Digestive diseases and sciences,['10.1007/s10620-010-1334-y']
391,20658205,Emergency portacaval shunt versus rescue portacaval shunt in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis--part 3.,"BACKGROUND


Emergency treatment of bleeding esophageal varices in cirrhosis is of singular importance because of the high mortality rate. Emergency portacaval shunt is rarely used today because of the belief, unsubstantiated by long-term randomized trials, that it causes frequent portal-systemic encephalopathy and liver failure. Consequently, portacaval shunt has been relegated solely to salvage therapy when endoscopic and pharmacologic therapies have failed.
QUESTION


Is the regimen of endoscopic sclerotherapy with rescue portacaval shunt for failure to control bleeding varices superior to emergency portacaval shunt? A unique opportunity to answer this question was provided by a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt conducted from 1988 to 2005.
METHODS


Unselected consecutive cirrhotic patients with acute bleeding esophageal varices were randomized to endoscopic sclerotherapy (n = 106) or emergency portacaval shunt (n = 105). Diagnostic workup was completed and treatment was initiated within 8 h. Failure of endoscopic sclerotherapy was defined by strict criteria and treated by rescue portacaval shunt (n = 50) whenever possible. Ninety-six percent of patients had more than 10 years of follow-up or until death.
RESULTS


Comparison of emergency portacaval shunt and endoscopic sclerotherapy followed by rescue portacaval shunt showed the following differences in measurements of outcomes: (1) survival after 5 years (72% versus 22%), 10 years (46% versus 16%), and 15 years (46% versus 0%); (2) median post-shunt survival (6.18 versus 1.99 years); (3) mean requirements of packed red blood cell units (17.85 versus 27.80); (4) incidence of recurrent portal-systemic encephalopathy (15% versus 43%); (5) 5-year change in Child's class showing improvement (59% versus 19%) or worsening (8% versus 44%); (6) mean quality of life points in which lower is better (13.89 versus 27.89); and (7) mean cost of care per year ($39,200 versus $216,700). These differences were highly significant in favor of emergency portacaval shunt (all p < 0.001).
CONCLUSIONS


Emergency portacaval shunt was strikingly superior to endoscopic sclerotherapy as well as to the combination of endoscopic sclerotherapy and rescue portacaval shunt in regard to all outcome measures, specifically bleeding control, survival, incidence of portal-systemic encephalopathy, improvement in liver function, quality of life, and cost of care. These results strongly support the use of emergency portacaval shunt as the first line of emergency treatment of bleeding esophageal varices in cirrhosis.",2010,"CONCLUSIONS


Emergency portacaval shunt was strikingly superior to endoscopic sclerotherapy as well as to the combination of endoscopic sclerotherapy and rescue portacaval shunt in regard to all outcome measures, specifically bleeding control, survival, incidence of portal-systemic encephalopathy, improvement in liver function, quality of life, and cost of care.","['Unselected consecutive cirrhotic patients with acute bleeding esophageal varices', 'acutely bleeding esophageal varices in cirrhosis--part 3', 'versus emergency portacaval shunt conducted from 1988 to 2005', 'Ninety-six percent of patients had more than 10 years of follow-up or until death']","['endoscopic sclerotherapy', 'Emergency portacaval shunt versus rescue portacaval shunt', 'emergency portacaval shunt']","['median post-shunt survival', 'mean quality of life points', 'incidence of recurrent portal-systemic encephalopathy', 'bleeding control, survival, incidence of portal-systemic encephalopathy, improvement in liver function, quality of life, and cost of care', 'measurements of outcomes: (1) survival']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155789', 'cui_str': 'Bleeding esophageal varices (disorder)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0032716', 'cui_str': 'Portacaval Shunt'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0036435', 'cui_str': 'Sclerotherapy'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0032716', 'cui_str': 'Portacaval Shunt'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.145977,"CONCLUSIONS


Emergency portacaval shunt was strikingly superior to endoscopic sclerotherapy as well as to the combination of endoscopic sclerotherapy and rescue portacaval shunt in regard to all outcome measures, specifically bleeding control, survival, incidence of portal-systemic encephalopathy, improvement in liver function, quality of life, and cost of care.","[{'ForeName': 'Marshall J', 'Initials': 'MJ', 'LastName': 'Orloff', 'Affiliation': 'Department of Surgery, UCSD Medical Center, 200 West Arbor Drive, San Diego, CA 92103-8999, USA. morloff@ucsd.edu'}, {'ForeName': 'Jon I', 'Initials': 'JI', 'LastName': 'Isenberg', 'Affiliation': ''}, {'ForeName': 'Henry O', 'Initials': 'HO', 'LastName': 'Wheeler', 'Affiliation': ''}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Jinich-Brook', 'Affiliation': ''}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Rapier', 'Affiliation': ''}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Vaida', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hye', 'Affiliation': ''}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-010-1279-7']
392,20652627,Effect of dronedarone on exercise capacity and cardiac function in patients with severe left ventricular dysfunction and compensated stable heart failure.,"PURPOSE


Dronedarone is a novel multichannel blocker with antiadrenergic and vasodilatory properties. The aim of this study was to investigate the effects of dronedarone on functional capacity in patients with severe left ventricular (LV) dysfunction and compensated stable heart failure (HF).
METHODS


This was a multicentre, double-blind, randomized, placebo-controlled, dose-escalating study. Patients in sinus rhythm with impaired LV function (LV ejection fraction [LVEF] ≤ 30%) and compensated HF (New York Heart Association [NYHA] class I-II), who would continue to receive cardiovascular treatment (excluding antiarrhythmic agents), were eligible. A total of 124 patients were randomized to receive dronedarone (400 mg or 800 mg once daily or 600 mg twice daily) or placebo for 30 days. The primary objective was assessment of the effects of dronedarone on functional capacity, using the 6 min walk test. Secondary objectives included the effects of dronedarone on LVEF, cardiothoracic ratio, NYHA status, and Holter parameters.
RESULTS


A total of 111 patients completed the study. There were no significant differences between dronedarone and placebo with respect to walking distance and LVEF. The cardiothoracic ratio was similar in all treatment groups throughout the study, and the NYHA status did not change in the majority of patients. Dronedarone was well tolerated and, as expected, decreased heart rate. No new arrhythmic events or torsades de pointes were reported.
CONCLUSIONS


Short-term treatment with dronedarone did not affect exercise capacity and did not decrease LVEF in patients with severe LV dysfunction and compensated HF.",2010,"The cardiothoracic ratio was similar in all treatment groups throughout the study, and the NYHA status did not change in the majority of patients.","['patients with severe left ventricular (LV) dysfunction and compensated stable heart failure (HF', 'patients with severe LV dysfunction and compensated HF', 'Patients in sinus rhythm with impaired LV function (LV ejection fraction [LVEF]\u2009≤\u200930%) and compensated HF ', '111 patients completed the study', 'patients with severe left ventricular dysfunction and compensated stable heart failure', '124 patients']","['dronedarone (400\xa0mg or 800\xa0mg once daily or 600\xa0mg twice daily) or placebo', 'Dronedarone', 'placebo', 'dronedarone']","['heart rate', 'LVEF, cardiothoracic ratio, NYHA status, and Holter parameters', 'new arrhythmic events or torsades de pointes', 'exercise capacity', 'functional capacity', 'walking distance and LVEF', 'exercise capacity and cardiac function', 'cardiothoracic ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0242973', 'cui_str': 'Ventricular Dysfunction'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2363738', 'cui_str': 'Cardiothoracic ratio'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]",124.0,0.111714,"The cardiothoracic ratio was similar in all treatment groups throughout the study, and the NYHA status did not change in the majority of patients.","[{'ForeName': 'T Barry', 'Initials': 'TB', 'LastName': 'Levine', 'Affiliation': 'Michigan Institute for Heart Failure and Transplant Care, Farmington Hills, MI, USA. tblevine6000@yahoo.com'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Giles', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Radzik', 'Affiliation': ''}, {'ForeName': 'Jalal K', 'Initials': 'JK', 'LastName': 'Ghali', 'Affiliation': ''}]",Cardiovascular drugs and therapy,['10.1007/s10557-010-6251-y']
393,20652391,"Effects of upward and downward social comparison information on the efficacy of an appearance-based sun protection intervention: a randomized, controlled experiment.","This experiment examined the impact of adding upward and/or downward social comparison information on the efficacy of an appearance-based sun protection intervention (UV photos and photoaging information). Southern California college students (N = 126) were randomly assigned to one of four conditions: control, intervention, intervention plus upward social comparison, intervention plus downward social comparison. The results demonstrated that all those who received the basic UV photo/photoaging intervention reported greater perceived susceptibility to photoaging (d = .74), less favorable tanning cognitions (d = .44), and greater intentions to sun protect (d = 1.32) relative to controls. Of more interest, while the basic intervention increased sun protective behavior during the subsequent 5 weeks relative to controls (d = .44), the addition of downward comparison information completely negated this benefit. Upward comparison information produced sun protection levels that were only slightly (and nonsignificantly) greater than in the basic intervention condition and, as such, does not appear to be a cost-effective addition. Possible mechanisms that may have reduced the benefits of upward comparison information and contributed to the undermining effects of downward comparison information are discussed.",2010,"The results demonstrated that all those who received the basic UV photo/photoaging intervention reported greater perceived susceptibility to photoaging (d = .74), less favorable tanning cognitions (d = .44), and greater intentions to sun protect (d = 1.32) relative to controls.",['Southern California college students (N = 126'],"['appearance-based sun protection intervention', 'appearance-based sun protection intervention (UV photos and photoaging information', 'upward and downward social comparison information', 'control, intervention, intervention plus upward social comparison, intervention plus downward social comparison']","['favorable tanning cognitions', 'sun protection levels', 'sun protective behavior', 'greater intentions to sun protect']","[{'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0263415', 'cui_str': 'Solar degeneration (disorder)'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0205104', 'cui_str': 'Down (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0039295', 'cui_str': 'Tannings'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",126.0,0.0214346,"The results demonstrated that all those who received the basic UV photo/photoaging intervention reported greater perceived susceptibility to photoaging (d = .74), less favorable tanning cognitions (d = .44), and greater intentions to sun protect (d = 1.32) relative to controls.","[{'ForeName': 'Heike I M', 'Initials': 'HI', 'LastName': 'Mahler', 'Affiliation': 'Department of Psychology 0109, University of California, San Diego, La Jolla, CA 92093, USA. hmahler@ucsd.edu'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Kulik', 'Affiliation': ''}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Gerrard', 'Affiliation': ''}, {'ForeName': 'Frederick X', 'Initials': 'FX', 'LastName': 'Gibbons', 'Affiliation': ''}]",Journal of behavioral medicine,['10.1007/s10865-010-9279-3']
394,20623224,Bilateral superficial cervical plexus block combined with general anesthesia administered in thyroid operations.,"BACKGROUND


We investigated the analgesic efficacy of bilateral superficial cervical plexus block in patients undergoing thyroidectomy and to determine whether it reduces the adverse effects of general anesthesia.
METHODS


We prospectively recruited 162 patients who underwent elective thyroid operations from March 2006 to October 2007. They were randomly assigned to receive a bilateral superficial cervical block (12 ml per side) with isotonic saline (group A; n = 56), bupivacaine 0.5% (group B; n = 52), or levobupivacaine 0.5% (group C; n = 54) after induction of general anesthesia. The analgesic efficacy of the block was assessed with: intraoperative anesthetics (desflurane), numbers of patients needing postoperative analgesics, the time to the first analgesics required, and pain intensity by visual analog scale (VAS). Postoperative nausea and vomiting (PONV) for 24 h were also assessed by the ""PONV grade."" We also compared hospital stay, operative time, and discomfort in swallowing.
RESULTS


There were no significant differences in patient characteristics. Each average end-tidal desflurane concentration was 5.8, 3.9, and 3.8% in groups A, B, and C, respectively (p < 0.001). Fewer patients in groups B and C required analgesics (A: B: C = 33:8:7; p < 0.001), and it took longer before the first analgesic dose was needed postoperatively (group A: B: C = 82.1:360.8:410.1 min; p < 0.001). Postoperative pain VAS were lower in groups B and C for the first 24 h postoperatively (p < 0.001). Incidences of overall and severe PONV were lower, however, there were not sufficient numbers of patients to detect differences in PONV among the three groups. Hospital stay was shorter in group B and group C (p = 0.011). There was no significant difference in operative time and postoperative swallowing pain among the three groups.
CONCLUSIONS


Bilateral superficial cervical plexus block reduces general anesthetics required during thyroidectomy. It also significantly lowers the severity of postoperative pain during the first 24 h and shortens the hospital stay.",2010,Postoperative pain VAS were lower in groups B and C for the first 24 h postoperatively (p < 0.001).,"['162 patients who underwent elective thyroid operations from March 2006 to October 2007', 'patients undergoing thyroidectomy']","['bilateral superficial cervical block', 'Bilateral superficial cervical plexus block combined with general anesthesia administered in thyroid operations', 'bilateral superficial cervical plexus block', 'isotonic saline', 'bupivacaine', 'levobupivacaine', 'intraoperative anesthetics (desflurane']","['Postoperative pain VAS', 'time to the first analgesics required, and pain intensity by visual analog scale (VAS', 'hospital stay, operative time, and discomfort in swallowing', 'Hospital stay', 'Postoperative nausea and vomiting (PONV', 'analgesic efficacy', 'operative time and postoperative swallowing pain', 'severity of postoperative pain', 'hospital stay', 'Incidences of overall and severe PONV', 'tidal desflurane concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0193769', 'cui_str': 'Operative procedure on the thyroid gland'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0193769', 'cui_str': 'Operative procedure on the thyroid gland'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0722358,Postoperative pain VAS were lower in groups B and C for the first 24 h postoperatively (p < 0.001).,"[{'ForeName': 'Ming-Lang', 'Initials': 'ML', 'LastName': 'Shih', 'Affiliation': 'Division of General Surgery, Department of Surgery, Tri-service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. judeshih@gmail.com'}, {'ForeName': 'Quan-Yang', 'Initials': 'QY', 'LastName': 'Duh', 'Affiliation': ''}, {'ForeName': 'Chung-Bao', 'Initials': 'CB', 'LastName': 'Hsieh', 'Affiliation': ''}, {'ForeName': 'Yao-Chi', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Chueng-He', 'Initials': 'CH', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Chih-Shung', 'Initials': 'CS', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Jyh-Cherng', 'Initials': 'JC', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Chun-Chang', 'Initials': 'CC', 'LastName': 'Yeh', 'Affiliation': ''}]",World journal of surgery,['10.1007/s00268-010-0698-7']
395,20890622,Preventive interventions in families with parental depression: children's psychosocial symptoms and prosocial behaviour.,"The aim is to document the effectiveness of a preventive family intervention (Family Talk Intervention, FTI) and a brief psychoeducational discussion with parents (Let's Talk about the Children, LT) on children's psychosocial symptoms and prosocial behaviour in families with parental mood disorder, when the interventions are practiced in psychiatric services for adults in the finnish national health service. Patients with mood disorder were invited to participate with their families. Consenting families were randomized to the two intervention groups. The initial sample comprised 119 families and their children aged 8-16. Of these, 109 completed the interventions and the baseline evaluation. Mothers and fathers filled out questionnaires including standardized rating scales for children's symptoms and prosocial behaviour at baseline and at 4, 10 and 18 months post-intervention. The final sample consisted of parental reports on 149 children with 83 complete data sets. Both interventions were effective in decreasing children's emotional symptoms, anxiety, and marginally hyperactivity and in improving children's prosocial behaviour. The FTI was more effective than the LT on emotional symptoms particularly immediately after the intervention, while the effect of the LT emerged after a longer interval. The study supports the effectiveness of both interventions in families with depressed parents. The FTI is applicable in cultural settings other than the USA. Our findings provide support for including preventive child mental health measures as part of psychiatric services for mentally ill parents.",2010,"Both interventions were effective in decreasing children's emotional symptoms, anxiety, and marginally hyperactivity and in improving children's prosocial behaviour.","['Patients with mood disorder', ""families with parental depression: children's psychosocial symptoms and prosocial behaviour"", 'families with depressed parents', '149 children with 83 complete data sets', ""children's psychosocial symptoms and prosocial behaviour in families with parental mood disorder, when the interventions are practiced in psychiatric services for adults in the finnish national health service"", 'Consenting families', '119 families and their children aged 8-16', 'mentally ill parents']","['Preventive interventions', ""preventive family intervention (Family Talk Intervention, FTI) and a brief psychoeducational discussion with parents (Let's Talk about the Children, LT""]","[""children's emotional symptoms, anxiety, and marginally hyperactivity and in improving children's prosocial behaviour"", 'emotional symptoms', ""standardized rating scales for children's symptoms and prosocial behaviour""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0025360', 'cui_str': 'Mentally Ill'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0202024', 'cui_str': 'Free thyroxine index (procedure)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0222045'}]",149.0,0.0237783,"Both interventions were effective in decreasing children's emotional symptoms, anxiety, and marginally hyperactivity and in improving children's prosocial behaviour.","[{'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'Child and Adolescent Mental Health, National Institute of Health and Welfare, Helsinki, Finland, Tytti.Solantaus@thl.fi'}, {'ForeName': 'E Juulia', 'Initials': 'EJ', 'LastName': 'Paavonen', 'Affiliation': ''}, {'ForeName': 'Sini', 'Initials': 'S', 'LastName': 'Toikka', 'Affiliation': ''}, {'ForeName': 'Raija-Leena', 'Initials': 'RL', 'LastName': 'Punamäki', 'Affiliation': ''}]",European child & adolescent psychiatry,['10.1007/s00787-010-0135-3']
396,20683712,Sunlight exposure or vitamin D supplementation for vitamin D-deficient non-western immigrants: a randomized clinical trial.,"UNLABELLED


Vitamin D deficiency is very common in non-western immigrants. In this randomized clinical trial, vitamin D 800 IU/day or 100,000 IU/3 months were compared with advised sunlight exposure. Vitamin D supplementation was more effective than advised sunlight exposure in improving vitamin D status and lowering parathyroid hormone levels.
INTRODUCTION


Vitamin D deficiency (25-hydroxyvitamin D [25(OH)D] < 25 nmol/l) is common among non-western immigrants. It can be treated with vitamin D supplementation or sunlight exposure.
METHODS


To determine whether the effect of vitamin D(3) supplementation (daily 800 IU or 100,000 IU/3 months) or sunlight exposure advice is similar with regard to serum 25(OH)D and parathyroid hormone (PTH) concentrations. Randomized clinical trial in 11 general practices in The Netherlands. Non-western immigrants, aged 18-65 years (n = 232) and serum 25(OH)D < 25 nmol/l were randomly assigned to supplementation (daily 800 IU or 100,000 IU/3 months) or advice for sunlight exposure for 6 months (March-September). Blood samples were collected at baseline, during treatment (3 months, 6 months), and at follow-up (12 months). Statistical analysis was performed with multilevel regression modelling.
RESULTS


The intention-to-treat analysis included 211 persons. Baseline serum 25(OH)D was 22.5 ± 11.1 nmol/l. After 6 months, mean serum 25(OH)D increased to 53 nmol/l with 800 IU/day, to 50.5 nmol/l with 100,000 IU/3 months, and to 29.1 nmol/l with advised sunlight exposure (supplementation vs sunshine p < 0.001). Serum PTH decreased significantly in all groups after 3 months, more in the supplementation groups than in the advised sunlight group (p < 0.05). There was no significant effect on physical performance and functional limitations.
CONCLUSION


Vitamin D supplementation is more effective than advised sunlight exposure for treating vitamin D deficiency in non-western immigrants.",2011,"Serum PTH decreased significantly in all groups after 3 months, more in the supplementation groups than in the advised sunlight group (p < 0.05).","['211 persons', 'vitamin D-deficient non-western immigrants', '11 general practices in The Netherlands. Non-western immigrants, aged 18-65 years (n\u2009=\u2009232) and serum 25(OH)D\u2009<\u200925 nmol/l']","['vitamin D(3) supplementation', 'vitamin D supplementation', 'sunlight exposure advice', 'supplementation (daily 800 IU or 100,000 IU/3 months) or advice for sunlight exposure', 'Sunlight exposure or vitamin D supplementation', 'Vitamin D deficiency (25-hydroxyvitamin D [25(OH)D', 'vitamin D', 'Vitamin D supplementation']","['mean serum 25(OH)D', 'Blood samples', 'physical performance and functional limitations', 'serum 25(OH)D and parathyroid hormone (PTH) concentrations', 'Serum PTH']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439282', 'cui_str': 'nM'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C2607857'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}]",11.0,0.241273,"Serum PTH decreased significantly in all groups after 3 months, more in the supplementation groups than in the advised sunlight group (p < 0.05).","[{'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Wicherts', 'Affiliation': 'EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'A J P', 'Initials': 'AJ', 'LastName': 'Boeke', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'van der Meer', 'Affiliation': ''}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'van Schoor', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Knol', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lips', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-010-1343-x']
397,20683766,A pilot randomized controlled trial of omega-3 fatty acids for autism spectrum disorder.,"We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (± 4.8) points in the omega-3 group compared to 0.3 (± 7.2) points in the placebo group (p = 0.40; effect size = 0.38). Correlations were found between decreases in five fatty acid levels and decreases in hyperactivity, and the treatment was well tolerated. Although this pilot study did not find a statistically significant benefit from omega-3 fatty acids, the small sample size does not rule out small to moderate beneficial effects.",2011,"After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (± 4.8) points in the omega-3 group compared to 0.3 (± 7.2) points in the placebo group (p = 0.40; effect size = 0.38).","['autism spectrum disorder', '27 children ages 3-8 with autism spectrum disorder (ASD']","['placebo', 'omega-3 fatty acids']","['hyperactivity', 'tolerated', 'five fatty acid levels', 'Aberrant Behavior Checklist']","[{'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C1281901', 'cui_str': 'Fatty acid measurement'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",27.0,0.10981,"After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (± 4.8) points in the omega-3 group compared to 0.3 (± 7.2) points in the placebo group (p = 0.40; effect size = 0.38).","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bent', 'Affiliation': 'Osher Center for Integrative Medicine, Department of Medicine, University of California, San Francisco VAMC, 111-A1, 4150 Clement St., San Francisco, CA 94121, USA. Stephen.Bent@ucsf.edu'}, {'ForeName': 'Kiah', 'Initials': 'K', 'LastName': 'Bertoglio', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ashwood', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Bostrom', 'Affiliation': ''}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Hendren', 'Affiliation': ''}]",Journal of autism and developmental disorders,['10.1007/s10803-010-1078-8']
398,20676928,Peer navigation improves diagnostic follow-up after breast cancer screening among Korean American women: results of a randomized trial.,"OBJECTIVE


To test an intervention to increase adherence to diagnostic follow-up tests among Asian American women.
METHODS


Korean American women who were referred for a diagnostic follow-up test (mainly diagnostic mammograms) and who had missed their follow-up appointment were eligible to participate in the study. Women from two clinics (n = 176) were randomly allocated to a usual care control arm or a peer navigator intervention arm. A 20-min telephone survey was administered to women in both study arms six months after they were identified to assess demographic and socio-economic characteristics and the primary outcome, self-reported completion of the recommended follow-up exam.
RESULTS


Among women who completed the survey at six-month follow-up, self-reported completion of follow-up procedures was 97% in the intervention arm and 67% in the control arm (p < 0.001). Based on an intent-to-treat analysis of all women who were randomized and an assumption of no completion of follow-up exam for women with missing outcome data, self-reported completion of follow-up was 61% in the intervention arm and 46% in the usual care control arm (p < 0.069).
CONCLUSIONS


Our results suggest that a peer navigator intervention to assist Korean American women to obtain follow-up diagnostic tests after an abnormal breast cancer screening test is efficacious.",2010,Women from two clinics (n = 176) were randomly allocated to a usual care control arm or a peer navigator intervention arm.,"['Asian American women', 'Women from two clinics (n = 176', 'Korean American women who were referred for a diagnostic follow-up test (mainly diagnostic mammograms) and who had missed their follow-up appointment were eligible to participate in the study', 'Korean American women']","['usual care control arm or a peer navigator intervention arm', 'peer navigator intervention', 'Peer navigation']",[],"[{'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0411881', 'cui_str': 'Mammogram - symptomatic (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",[],176.0,0.059861,Women from two clinics (n = 176) were randomly allocated to a usual care control arm or a peer navigator intervention arm.,"[{'ForeName': 'Annette E', 'Initials': 'AE', 'LastName': 'Maxwell', 'Affiliation': 'School of Public Health, University of California, Los Angeles and Jonsson Comprehensive Cancer Center, University of California, 650 Charles Young Drive South, A2-125 CHS, Box 956900, Los Angeles, CA 90095-6900, USA. amaxwell@ucla.edu'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Jo', 'Affiliation': ''}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Crespi', 'Affiliation': ''}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Sudan', 'Affiliation': ''}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Bastani', 'Affiliation': ''}]",Cancer causes & control : CCC,['10.1007/s10552-010-9621-7']
399,20668840,Dose finding of melatonin for chronic idiopathic childhood sleep onset insomnia: an RCT.,"RATIONALE


Pharmacokinetics of melatonin in children might differ from that in adults.
OBJECTIVES


This study aims to establish a dose-response relationship for melatonin in advancing dim light melatonin onset (DLMO), sleep onset (SO), and reducing sleep onset latency (SOL) in children between 6 and 12 years with chronic sleep onset insomnia (CSOI).
METHODS


The method used for this study is the randomized, placebo-controlled double-blind trial. Children with CSOI (n = 72) received either melatonin 0.05, 0.1, and 0.15 mg/kg or placebo during 1 week. Sleep was assessed with log and actigraphy during this week and the week before. Outcomes were the shifts in DLMO, SO, and SOL.
RESULTS


Treatment with melatonin significantly advanced SO and DLMO by approximately 1 h and decreased SOL by 35 min. Within the three melatonin groups, effect size was not different, but the circadian time of administration (TOA) correlated significantly with treatment effect on DLMO (r (s) = -0.33, p = 0.022) and SO (r (s) = -0.38, p = 0.004), whereas clock TOA was correlated with SO shift (r = -0.35, p = 0.006) and not with DLMO shift.
CONCLUSIONS


No dose-response relationship of melatonin with SO, SOL, and DLMO is found within a dosage range of 0.05-0.15 mg/kg. The effect of exogenous melatonin on SO, SOL, and DLMO increases with an earlier circadian TOA. The soporific effects of melatonin enhance the SO shift. This study demonstrates that melatonin for treatment of CSOI in children is effective in a dosage of 0.05 mg/kg given at least 1 to 2 h before DLMO and before desired bedtime.",2010,"No dose-response relationship of melatonin with SO, SOL, and DLMO is found within a dosage range of 0.05-0.15 mg/kg.","['children between 6 and 12\xa0years with chronic sleep onset insomnia (CSOI', 'Children with CSOI (n\u2009=\u200972', 'children might differ from that in adults']","['exogenous melatonin', 'placebo', 'melatonin']","['circadian time of administration (TOA', 'advanced SO and DLMO', 'chronic idiopathic childhood sleep onset insomnia', 'SO', 'SO, SOL, and DLMO', 'advancing dim light melatonin onset (DLMO), sleep onset (SO', 'Sleep', 'shifts in DLMO, SO, and SOL', 'DLMO (r (s)\u2009', 'clock TOA', 'sleep onset latency (SOL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0701413', 'cui_str': 'Sol'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}]",,0.377879,"No dose-response relationship of melatonin with SO, SOL, and DLMO is found within a dosage range of 0.05-0.15 mg/kg.","[{'ForeName': 'Ingeborg M', 'Initials': 'IM', 'LastName': 'van Geijlswijk', 'Affiliation': 'Department of Pharmacy, Faculty of Veterinary Medicine, Utrecht University, Yalelaan 106, 3584 CM, Utrecht, The Netherlands. i.m.vangeijlswijk@uu.nl'}, {'ForeName': 'Kristiaan B', 'Initials': 'KB', 'LastName': 'van der Heijden', 'Affiliation': ''}, {'ForeName': 'A C G', 'Initials': 'AC', 'LastName': 'Egberts', 'Affiliation': ''}, {'ForeName': 'Hubert P L M', 'Initials': 'HP', 'LastName': 'Korzilius', 'Affiliation': ''}, {'ForeName': 'Marcel G', 'Initials': 'MG', 'LastName': 'Smits', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-1962-0']
400,20922510,Improving coping skills for self-management of treatment side effects can reduce antiretroviral medication nonadherence among people living with HIV.,"BACKGROUND


Human immunodeficiency virus (HIV) treatment side effects have a deleterious impact on treatment adherence, which is necessary to optimize treatment outcomes including morbidity and mortality.
PURPOSE


To examine the effect of the Balance Project intervention, a five-session, individually delivered HIV treatment side effects coping skills intervention on antiretroviral medication adherence.
METHODS


HIV+ men and women (N = 249) on antiretroviral therapy (ART) with self-reported high levels of ART side effect distress were randomized to intervention or treatment as usual. The primary outcome was self-reported ART adherence as measured by a combined 3-day and 30-day adherence assessment.
RESULTS


Intent-to-treat analyses revealed a significant difference in rates of nonadherence between intervention and control participants across the follow-up time points such that those in the intervention condition were less likely to report nonadherence. Secondary analyses revealed that intervention participants were more likely to seek information about side effects and social support in efforts to cope with side effects.
CONCLUSIONS


Interventions focusing on skills related to ART side-effects management show promise for improving ART adherence among persons experiencing high levels of perceived ART side effects.",2011,"RESULTS


Intent-to-treat analyses revealed a significant difference in rates of nonadherence between intervention and control participants across the follow-up time points such that those in the intervention condition were less likely to report nonadherence.","['HIV+ men and women (N\u2009=\u2009249) on antiretroviral therapy (ART) with self-reported high levels of ART side effect distress', 'people living with HIV']",[],"['antiretroviral medication nonadherence', 'ART adherence', 'rates of nonadherence', 'self-reported ART adherence as measured by a combined 3-day and 30-day adherence assessment']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",[],"[{'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0746935', 'cui_str': 'Medication Non-Adherence'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0872061,"RESULTS


Intent-to-treat analyses revealed a significant difference in rates of nonadherence between intervention and control participants across the follow-up time points such that those in the intervention condition were less likely to report nonadherence.","[{'ForeName': 'Mallory O', 'Initials': 'MO', 'LastName': 'Johnson', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, 94105, USA. Mallory.Johnson@ucsf.edu'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Dilworth', 'Affiliation': ''}, {'ForeName': 'Jonelle M', 'Initials': 'JM', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': ''}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1007/s12160-010-9230-4']
401,20809276,The effect of a clinical pharmacist discharge service on medication discrepancies in patients with heart failure.,"OBJECTIVE


Heart failure patients are regularly admitted to hospital and frequently use multiple medication. Besides intentional changes in pharmacotherapy, unintentional changes may occur during hospitalisation. The aim of this study was to investigate the effect of a clinical pharmacist discharge service on medication discrepancies and prescription errors in patients with heart failure.
SETTING


A general teaching hospital in Tilburg, the Netherlands.
METHOD


An open randomized intervention study was performed comparing an intervention group, with a control group receiving regular care by doctors and nurses. The clinical pharmacist discharge service consisted of review of discharge medication, communicating prescribing errors with the cardiologist, giving patients information, preparation of a written overview of the discharge medication and communication to both the community pharmacist and the general practitioner about this medication. Within 6 weeks after discharge all patients were routinely scheduled to visit the outpatient clinic and medication discrepancies were measured.
MAIN OUTCOME MEASURE


The primary endpoint was the frequency of prescription errors in the discharge medication and medication discrepancies after discharge combined.
RESULTS


Forty-four patients were included in the control group and 41 in the intervention group. Sixty-eight percent of patients in the control group had at least one discrepancy or prescription error against 39% in the intervention group (RR 0.57 (95% CI 0.37-0.88)). The percentage of medications with a discrepancy or prescription error in the control group was 14.6% and in the intervention group it was 6.1% (RR 0.42 (95% CI 0.27-0.66)).
CONCLUSION


This clinical pharmacist discharge service significantly reduces the risk of discrepancies and prescription errors in medication of patients with heart failure in the 1st month after discharge.",2010,"The percentage of medications with a discrepancy or prescription error in the control group was 14.6% and in the intervention group it was 6.1% (RR 0.42 (95% CI 0.27-0.66)).
","['patients with heart failure in the 1st month after discharge', 'patients with heart failure', 'A general teaching hospital in Tilburg, the Netherlands', 'Forty-four patients were included in the control group and 41 in the intervention group']","['control group receiving regular care by doctors and nurses', 'clinical pharmacist discharge service']","['percentage of medications with a discrepancy or prescription error', 'frequency of prescription errors in the discharge medication and medication discrepancies after discharge combined', 'discrepancy or prescription error']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",44.0,0.0541705,"The percentage of medications with a discrepancy or prescription error in the control group was 14.6% and in the intervention group it was 6.1% (RR 0.42 (95% CI 0.27-0.66)).
","[{'ForeName': 'Rixt Nynke', 'Initials': 'RN', 'LastName': 'Eggink', 'Affiliation': 'Department of Clinical Pharmacy, TweeSteden Hospital and St. Elisabeth Hospital, PO Box 90107, 5000 LA, Tilburg, The Netherlands. r.n.eggink@antonius-sneek.nl'}, {'ForeName': 'Albert W', 'Initials': 'AW', 'LastName': 'Lenderink', 'Affiliation': ''}, {'ForeName': 'Jos W M G', 'Initials': 'JW', 'LastName': 'Widdershoven', 'Affiliation': ''}, {'ForeName': 'Patricia M L A', 'Initials': 'PM', 'LastName': 'van den Bemt', 'Affiliation': ''}]",Pharmacy world & science : PWS,['10.1007/s11096-010-9433-6']
402,20645078,Methylphenidate significantly improves declarative memory functioning of adults with ADHD.,"BACKGROUND


Declarative memory deficits are common in untreated adults with attention-deficit hyperactivity disorder (ADHD), but limited evidence exists to support improvement after treatment with methylphenidate. The objective of this study was to examine the effects of methylphenidate on memory functioning of adults with ADHD.
METHODS


Eighteen adults with ADHD who were clinical responders to methylphenidate participated in this randomized crossover trial. After 3 days of no treatment, patients received in random order either their usual methylphenidate dose (mean: 14.7 mg; range: 10-30 mg) or placebo, separated by a 6-7-day washout period. Patients performed an immediate word recall test 1 h after treatment administration. Three hours after intake, patients performed the second part of the memory test (delayed word recall and a recognition test).
RESULTS


Delayed recognition and immediate recall was similar on treatment and on placebo. Delayed word recall was significantly better in the methylphenidate than in the placebo condition (F (1, 17) = 7.0, p <  0.017). A significant correlation was found between prestudy CES-D depression scores and difference scores on delayed recall (r = 0.602, p <  0.008).
CONCLUSION


Methylphenidate improves declarative memory functioning in patients with ADHD. New studies should further examine whether subclinical depressive symptoms mediate the effect of methylphenidate on declarative memory.",2010,"Delayed word recall was significantly better in the methylphenidate than in the placebo condition (F (1, 17) = 7.0, p <  0.017).","['Eighteen adults with ADHD who were clinical responders to', 'untreated adults with attention-deficit hyperactivity disorder (ADHD', 'adults with ADHD', 'patients with ADHD']","['methylphenidate', 'Methylphenidate', 'usual methylphenidate', 'placebo']","['declarative memory functioning', 'Delayed word recall', 'prestudy CES-D depression scores', 'delayed recall', 'Delayed recognition and immediate recall']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}]",18.0,0.353217,"Delayed word recall was significantly better in the methylphenidate than in the placebo condition (F (1, 17) = 7.0, p <  0.017).","[{'ForeName': 'Joris C', 'Initials': 'JC', 'LastName': 'Verster', 'Affiliation': 'Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, PO Box 80082, 3508 TB Utrecht, the Netherlands. j.c.verster@uu.nl'}, {'ForeName': 'Evelijne M', 'Initials': 'EM', 'LastName': 'Bekker', 'Affiliation': ''}, {'ForeName': 'J J Sandra', 'Initials': 'JJ', 'LastName': 'Kooij', 'Affiliation': ''}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': ''}, {'ForeName': 'Marinus N', 'Initials': 'MN', 'LastName': 'Verbaten', 'Affiliation': ''}, {'ForeName': 'Edmund R', 'Initials': 'ER', 'LastName': 'Volkerts', 'Affiliation': ''}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Olivier', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-1952-2']
403,20567807,Spatially valid proprioceptive cues improve the detection of a visual stimulus.,"Vision and proprioception are the main sensory modalities that convey hand location and direction of movement. Fusion of these sensory signals into a single robust percept is now well documented. However, it is not known whether these modalities also interact in the spatial allocation of attention, which has been demonstrated for other modality pairings. The aim of this study was to test whether proprioceptive signals can spatially cue a visual target to improve its detection. Participants were instructed to use a planar manipulandum in a forward reaching action and determine during this movement whether a near-threshold visual target appeared at either of two lateral positions. The target presentation was followed by a masking stimulus, which made its possible location unambiguous, but not its presence. Proprioceptive cues were given by applying a brief lateral force to the participant's arm, either in the same direction (validly cued) or in the opposite direction (invalidly cued) to the on-screen location of the mask. The d' detection rate of the target increased when the direction of proprioceptive stimulus was compatible with the location of the visual target compared to when it was incompatible. These results suggest that proprioception influences the allocation of attention in visual space.",2010,Participants were instructed to use a planar manipulandum in a forward reaching action and determine during this movement whether a near-threshold visual target appeared at either of two lateral positions.,[],"[""Proprioceptive cues were given by applying a brief lateral force to the participant's arm, either in the same direction (validly cued) or in the opposite direction (invalidly cued""]",[],[],"[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}]",[],,0.0385026,Participants were instructed to use a planar manipulandum in a forward reaching action and determine during this movement whether a near-threshold visual target appeared at either of two lateral positions.,"[{'ForeName': 'Carl P T', 'Initials': 'CP', 'LastName': 'Jackson', 'Affiliation': ""Centre for Neuroscience Studies, Botterell Hall, Queen's University, Kingston, ON, K7L 3N6, Canada. carl@biomed.queensu.ca""}, {'ForeName': 'R Chris', 'Initials': 'RC', 'LastName': 'Miall', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Balslev', 'Affiliation': ''}]",Experimental brain research,['10.1007/s00221-010-2330-3']
404,20596748,Influence of mild and moderate hepatic impairment on axitinib pharmacokinetics.,"OBJECTIVE


To evaluate the effects of hepatic impairment on the pharmacokinetics and safety of a single, oral axitinib dose in subjects with mild or moderate hepatic impairment.
METHODS


In this phase I, open-label, parallel-group study, a total of 24 subjects with either normal hepatic function (n = 8) or with mild (n = 8) or moderate (n = 8) hepatic impairment were administered a single, oral dose of axitinib (5 mg). Blood samples were collected at intervals up to 144 h following dosing, and plasma pharmacokinetics and safety were assessed. Changes in axitinib plasma exposures in subjects with mild or moderate hepatic impairment were predicted using computer simulations and used to guide initial dosing in the clinical study.
RESULTS


Axitinib exposure was similar in subjects with normal hepatic function and those with mild hepatic impairment, but approximately twofold higher in subjects with moderate hepatic impairment. Axitinib exposure weakly correlated with measures of hepatic function but was not affected by smoking status. Axitinib protein binding was similar in the three treatment groups. No significant treatment-related adverse events were reported.
CONCLUSIONS


Compared with subjects with normal hepatic function, moderate hepatic impairment increased axitinib exposure, suggesting that the oral clearance of axitinib is altered in these subjects. In addition, these data indicate a possible need for a dose reduction in subjects who develop moderate or worse hepatic impairment during axitinib treatment. A single 5-mg dose of axitinib was well tolerated in subjects with mild or moderate hepatic impairment.",2011,"Axitinib exposure was similar in subjects with normal hepatic function and those with mild hepatic impairment, but approximately twofold higher in subjects with moderate hepatic impairment.","['subjects with mild or moderate hepatic impairment', '24 subjects with either normal hepatic function (n = 8) or with mild (n = 8) or moderate (n = 8) hepatic impairment']",['axitinib'],"['hepatic function', 'Blood samples', 'hepatic impairment', 'mild hepatic impairment', 'Axitinib protein binding', 'adverse events', 'plasma pharmacokinetics and safety']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}]","[{'cui': 'C1700874', 'cui_str': 'axitinib'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0522527', 'cui_str': 'Protein bound (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",24.0,0.023172,"Axitinib exposure was similar in subjects with normal hepatic function and those with mild hepatic impairment, but approximately twofold higher in subjects with moderate hepatic impairment.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Tortorici', 'Affiliation': 'Pfizer Oncology, San Diego, CA 92121, USA. michael.tortorici@pfizer.com'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Toh', 'Affiliation': ''}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Rahavendran', 'Affiliation': ''}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Labadie', 'Affiliation': ''}, {'ForeName': 'Christine W', 'Initials': 'CW', 'LastName': 'Alvey', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Marbury', 'Affiliation': ''}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Fuentes', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ni', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hee', 'Affiliation': ''}, {'ForeName': 'Yazdi K', 'Initials': 'YK', 'LastName': 'Pithavala', 'Affiliation': ''}]",Investigational new drugs,['10.1007/s10637-010-9477-4']
405,20596858,Acute tryptophan depletion attenuates conscious appraisal of social emotional signals in healthy female volunteers.,"RATIONALE


Acute tryptophan depletion (ATD) decreases levels of central serotonin. ATD thus enables the cognitive effects of serotonin to be studied, with implications for the understanding of psychiatric conditions, including depression.
OBJECTIVE


To determine the role of serotonin in conscious (explicit) and unconscious/incidental processing of emotional information.
MATERIALS AND METHODS


A randomized, double-blind, cross-over design was used with 15 healthy female participants. Subjective mood was recorded at baseline and after 4 h, when participants performed an explicit emotional face processing task, and a task eliciting unconscious processing of emotionally aversive and neutral images presented subliminally using backward masking.
RESULTS


ATD was associated with a robust reduction in plasma tryptophan at 4 h but had no effect on mood or autonomic physiology. ATD was associated with significantly lower attractiveness ratings for happy faces and attenuation of intensity/arousal ratings of angry faces. ATD also reduced overall reaction times on the unconscious perception task, but there was no interaction with emotional content of masked stimuli. ATD did not affect breakthrough perception (accuracy in identification) of masked images.
CONCLUSIONS


ATD attenuates the attractiveness of positive faces and the negative intensity of threatening faces, suggesting that serotonin contributes specifically to the appraisal of the social salience of both positive and negative salient social emotional cues. We found no evidence that serotonin affects unconscious processing of negative emotional stimuli. These novel findings implicate serotonin in conscious aspects of active social and behavioural engagement and extend knowledge regarding the effects of ATD on emotional perception.",2011,ATD was associated with significantly lower attractiveness ratings for happy faces and attenuation of intensity/arousal ratings of angry faces.,"['15 healthy female participants', 'healthy female volunteers']","['explicit emotional face processing task, and a task eliciting unconscious processing of emotionally aversive and neutral images presented subliminally using backward masking', 'serotonin', 'Acute tryptophan depletion']","['mood or autonomic physiology', 'plasma tryptophan', 'attractiveness ratings for happy faces and attenuation of intensity/arousal ratings of angry faces', 'social emotional signals', 'Subjective mood']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0041654', 'cui_str': 'Unconscious'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",15.0,0.109328,ATD was associated with significantly lower attractiveness ratings for happy faces and attenuation of intensity/arousal ratings of angry faces.,"[{'ForeName': 'Felix D C C', 'Initials': 'FD', 'LastName': 'Beacher', 'Affiliation': 'Clinical Imaging Sciences Centre, Brighton and Sussex Medical School (BSMS), Brighton & Hove, UK. f.beacher@bsms.ac.uk'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Gray', 'Affiliation': ''}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Minati', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whale', 'Affiliation': ''}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'Hugo D', 'Initials': 'HD', 'LastName': 'Critchley', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-1897-5']
406,20563833,Effect of imaging and catheter characteristics on clinical outcome for patients in the PRECISE study.,"The PRECISE study used convection enhanced delivery (CED) to infuse IL13-PE38QQR in patients with recurrent glioblastoma multiforme (GBM) and compared survival to Gliadel Wafers (GW). The objectives of this retrospective evaluation were to assess: (1) catheter positioning in relation to imaging features and (2) to examine the potential impact of catheter positioning, overall catheter placement and imaging features on long term clinical outcome in the PRECISE study. Catheter positioning and overall catheter placement were scored and used as a surrogate of adequate placement. Imaging studies obtained on day 43 and day 71 after resection were each retrospectively reviewed. Catheter positioning scores, catheter overall placement scores, local tumor control and imaging change scores were reviewed and correlated using Generalized Linear Mixed Models. Cox PH regression analysis was used to examine whether these imaging based variables predicted overall survival (OS) and progression free survival (PFS) after adjusting for age and KPS. Of 180 patients in the CED group, 20 patients did not undergo gross total resection. Of the remaining 160 patients only 53% of patients had fully conforming catheters in respect to overall placement and 51% had adequate catheter positioning scores. Better catheter positioning scores were not correlated with local tumor control (P = 0.61) or imaging change score (P = 0.86). OS and PFS were not correlated with catheter positioning score (OS: P = 0.53; PFS: P = 0.72 respectively), overall placement score (OS: P = 0.55; PFS: P = 0.35) or imaging changes on day 43 MRI (P = 0.88). Catheter positioning scores and overall catheter placement scores were not associated with clinical outcome in this large prospective trial.",2011,Better catheter positioning scores were not correlated with local tumor control (P = 0.61) or imaging change score (P = 0.86).,"['patients with recurrent glioblastoma multiforme (GBM) and compared survival to Gliadel Wafers (GW', '180 patients in the CED group, 20 patients did not undergo gross total resection']","['imaging and catheter characteristics', 'Catheter positioning and overall catheter placement']","['catheter positioning score', 'Better catheter positioning scores', 'adequate catheter positioning scores', 'Catheter positioning scores, catheter overall placement scores, local tumor control and imaging change scores', 'Catheter positioning scores and overall catheter placement scores', 'OS and PFS', 'overall survival (OS) and progression free survival (PFS', 'overall placement score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1621958', 'cui_str': 'Glioblastoma Multiforme'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0720676', 'cui_str': 'Gliadel'}, {'cui': 'C1706425', 'cui_str': 'Wafer - unit of product usage (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0547141,Better catheter positioning scores were not correlated with local tumor control (P = 0.61) or imaging change score (P = 0.86).,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Mueller', 'Affiliation': 'Department of Neurology, University of San Francisco, 350 Parnassus Ave, Suite 609, San Francisco, CA 94117, USA. muellers@neuropeds.ucsf.edu'}, {'ForeName': 'Mei-Yin', 'Initials': 'MY', 'LastName': 'Polley', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kunwar', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Pedain', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wembacher-Schröder', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Mittermeyer', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Westphal', 'Affiliation': ''}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Sampson', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Croteau', 'Affiliation': ''}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Chang', 'Affiliation': ''}]",Journal of neuro-oncology,['10.1007/s11060-010-0255-0']
407,20593240,"Selective COX-2 inhibition affects fatty acids, but not COX mRNA expression in patients with FAP.","Familial adenomatous polyposis (FAP) provides a model for sporadic colorectal cancer development. Cyclooxygenase (COX) inhibition may ameliorate polyp development, but rofecoxib was withdrawn due to cardiovascular side effects. Although this selective COX-2 inhibitor, like diet, may alter the fatty acid and eicosanoid pattern, data on the potential alteration in tissues after use, are scarce. The aims were to study if rofecoxib might influence the fatty acid distribution in serum phospholipids and duodenal lesions, mRNA for COX-1 and COX-2 in leucocytes and duodenal lesions, and finally plasma levels of PGE(2) in a randomized, double-blind, placebo controlled study (n = 38). Significant reductions were found for essential fatty acid index both in serum phospholipids (P = 0.01, 95% CI = -0.9; -0.1), and in duodenal lesions (P = 0.04, 95 CI % = -0.9; -0.1) after treatment. No treatment effects were found on the COX mRNA expression, or in the plasma PGE(2) levels. Dietary AA/EPA ratio was inversely associated with all the indicators of EFA status (all P < 0.01). These findings suggest that the effects of COX chemoprevention should be further investigated in FAP and that dietary needs should be included in the treatment of FAP.",2010,"Significant reductions were found for essential fatty acid index both in serum phospholipids (P = 0.01, 95% CI = -0.9; -0.1), and in duodenal lesions (P = 0.04, 95 CI % = -0.9; -0.1) after treatment.",['patients with FAP'],"['Cyclooxygenase (COX) inhibition', 'rofecoxib', 'placebo']","['EFA status', 'fatty acid distribution in serum phospholipids and duodenal lesions, mRNA for COX-1 and COX-2 in leucocytes and duodenal lesions, and finally plasma levels of PGE(2', 'COX mRNA expression, or in the plasma PGE(2) levels', 'duodenal lesions', 'essential fatty acid index both in serum phospholipids', 'Dietary AA/EPA ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033551', 'cui_str': 'Prostaglandin H2 Synthetase'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0762662', 'cui_str': 'rofecoxib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0763149', 'cui_str': 'PG(6)E'}, {'cui': 'C0015686', 'cui_str': 'Fatty Acids, Essential'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0692447,"Significant reductions were found for essential fatty acid index both in serum phospholipids (P = 0.01, 95% CI = -0.9; -0.1), and in duodenal lesions (P = 0.04, 95 CI % = -0.9; -0.1) after treatment.","[{'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Almendingen', 'Affiliation': 'Research Centre, Akershus University Hospital, 1478 Lørenskog, Norway. kari.almendingen@hiak.no'}, {'ForeName': 'Laila N', 'Initials': 'LN', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Fausa', 'Affiliation': ''}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Bratlie', 'Affiliation': ''}, {'ForeName': 'Arne T', 'Initials': 'AT', 'LastName': 'Høstmark', 'Affiliation': ''}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Aabakken', 'Affiliation': ''}]",Familial cancer,['10.1007/s10689-010-9365-2']
408,20571786,Changes in cross-sectional area of spinal canal and vertebral body under 2 years of teriparatide treatment: results from the EUROFORS study.,"The treatment of osteoporotic patients with teriparatide is associated with a significant increase in bone formation and gain of bone mass. The purpose of this post hoc analysis was to determine if the cross-sectional area (CSA) of the spinal canal and the vertebral body is affected by teriparatide treatment. Narrowing of the spinal canal might represent a safety problem, while widening of the vertebral CSA might improve mechanical stability. High-resolution computed tomography (HRCT) scans of vertebra T12 were obtained at baseline and after 6, 12, and 24 months of teriparatide treatment (20 microg/day) from 44 postmenopausal women with established osteoporosis participating in the prospective, randomized EUROFORS study. The CSA of the spinal canal did not decrease but increased marginally by 0.9% (2.6 mm(2)) over 24 months (P < 0.001), with a range from -0.5% (-2 mm(2)) to 3.1% (+8 mm(2)). Even when analyzing the spinal CSA on a slice-by-slice basis, no clinically relevant narrowing of the spinal canal was observed. For vertebral bodies, the CSA increased by 0.7% (5.7 mm(2)) over 24 months (P < 0.001), with a range from -0.4% (-3 mm(2)) to 1.6% (+14 mm(2)). Our data do not provide evidence for safety concerns regarding spinal canal narrowing. On the other hand, the increases observed for vertebral CSA apparently also only minimally contribute to the mechanical strengthening of the vertebral body under teriparatide treatment.",2010,"For vertebral bodies, the CSA increased by 0.7% (5.7 mm(2)) over 24 months","['osteoporotic patients with', '44 postmenopausal women with established osteoporosis participating']","['High-resolution computed tomography (HRCT) scans', 'teriparatide', 'teriparatide treatment']","['vertebral CSA', 'bone formation and gain of bone mass', 'CSA of the spinal canal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0037922', 'cui_str': 'Spinal Canal'}]",44.0,0.0527849,"For vertebral bodies, the CSA increased by 0.7% (5.7 mm(2)) over 24 months","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schnell', 'Affiliation': 'Medizinische Physik, Klinik für Diagnostische Radiologie, Universitätsklinikum Schleswig Holstein, Campus Kiel, Arnold-Heller-Strasse 3, Haus 13, Kiel 24105, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Graeff', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Krebs', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oertel', 'Affiliation': ''}, {'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Glüer', 'Affiliation': ''}]",Calcified tissue international,['10.1007/s00223-010-9386-8']
409,20571894,IL-2 immunotherapy to recently HIV-1 infected adults maintains the numbers of IL-17 expressing CD4+ T (T(H)17) cells in the periphery.,"Little is known about the manipulation of IL-17 producing CD4+ T cells (T(H)17) on a per-cell basis in humans in vivo. Previous studies on the effects of IL-2 on IL-17 secretion in non-HIV models have shown divergent results. We hypothesized that IL-2 would mediate changes in IL-17 levels among recently HIV-1-infected adults receiving anti-retroviral therapy. We measured cytokine T cell responses to CD3/CD28, HIV-1 Gag, and CMV pp65 stimulation, and changes in multiple CD4+ T cell subsets. Those who received IL-2 showed a robust expansion of naive and total CD4+ T cell counts and T-reg counts. However, after IL-2 treatment, the frequency of T(H)17 cells declined, while counts of T(H)17 cells did not change due to an expansion of the CD4+ naïve T cell population (CD27+CD45RA+). Counts of HIV-1 Gag-specific T cells declined modestly, but CMV pp65 and CD3/CD28 stimulated populations did not change. Hence, in contrast with recent studies, our results suggest IL-2 is not a potent in vivo regulator of T(H)17 cell populations in HIV-1 disease. However, IL-2-mediated T-reg expansions may selectively reduce responses to certain antigen-specific populations, such as HIV-1 Gag.",2010,Those who received IL-2 showed a robust expansion of naive and total CD4+ T cell counts and T-reg counts.,"['HIV-1-infected adults receiving anti-retroviral therapy', 'HIV-1 infected adults']","['IL-2 immunotherapy', 'IL-2']","['robust expansion of naive and total CD4+ T cell counts and T-reg counts', 'IL-17 secretion', 'Counts of HIV-1 Gag-specific T cells', 'cytokine T cell responses to CD3/CD28, HIV-1 Gag, and CMV pp65 stimulation, and changes in multiple CD4+ T cell subsets', 'numbers of IL-17 expressing CD4+ T (T(H)17) cells', 'IL-17 levels', 'frequency of T(H)17 cells']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C2362651', 'cui_str': 'T cell subsets'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.137784,Those who received IL-2 showed a robust expansion of naive and total CD4+ T cell counts and T-reg counts.,"[{'ForeName': 'Lishomwa C', 'Initials': 'LC', 'LastName': 'Ndhlovu', 'Affiliation': 'Division of Experimental Medicine, Department of Medicine, San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA. lndhlovu@medsfgh.ucsf.edu'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sinclair', 'Affiliation': ''}, {'ForeName': 'Lorrie', 'Initials': 'L', 'LastName': 'Epling', 'Affiliation': ''}, {'ForeName': 'Qi Xuan', 'Initials': 'QX', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'Aashish R', 'Initials': 'AR', 'LastName': 'Jha', 'Affiliation': ''}, {'ForeName': 'Ijeoma', 'Initials': 'I', 'LastName': 'Eccles-James', 'Affiliation': ''}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Tincati', 'Affiliation': ''}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Douglas F', 'Initials': 'DF', 'LastName': 'Nixon', 'Affiliation': ''}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': ''}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Barbour', 'Affiliation': ''}]",Journal of clinical immunology,['10.1007/s10875-010-9432-3']
410,20563618,Report of 12 cases of ankylosing spondylitis patients treated with Tripterygium wilfordii.,"OBJECTIVE


Description of the clinical response of 12 consecutive cases of disease-active ankylosing spondylitis (AS) treated with the herbal medicine Tripterygium wilfordii Hook f (TwHf; lei gong teng, thunder god vine), which has been reported in controlled studies to be effective in rheumatoid arthritis (RA).
METHODS


The clinical status of 12 patients with active AS who were started on 60 mgday(-1) of a commercial tablet preparation of TwHf extract. were monitored at weeks 1, 3, and 6.
RESULTS


Compared to baseline, there was significant improvement in mean values of physician assessment, Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), and Bath ankylosing spondylitis global score (BAS-G) at weeks 3 and 6, with no changes in liver enzymes or complete blood count (CBC).
CONCLUSION


A placebo-controlled double-blind study for Tripterygium is warranted. Until then, this particular report should be considered as case reports and not an endorsement of the use of Tripterygium in clinical practice.",2010,"Compared to baseline, there was significant improvement in mean values of physician assessment, Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), and Bath ankylosing spondylitis global score (BAS-G) at weeks 3 and 6, with no changes in liver enzymes or complete blood count (CBC).
","['12 patients with active AS who were started on 60 mgday(-1) of a commercial tablet preparation of TwHf extract. were monitored at weeks 1, 3, and 6', '12 cases of ankylosing spondylitis patients treated with', '12 consecutive cases of disease-active ankylosing spondylitis (AS) treated with the']","['Tripterygium wilfordii', 'herbal medicine Tripterygium wilfordii Hook f (TwHf; lei gong teng, thunder god vine', 'placebo']","['mean values of physician assessment, Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), and Bath ankylosing spondylitis global score (BAS-G', 'liver enzymes or complete blood count (CBC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C0077273', 'cui_str': 'Tripterygium wilfordii'}, {'cui': 'C2240391', 'cui_str': 'Herbal medicine (product)'}, {'cui': 'C0181209', 'cui_str': 'Hook (attribute)'}, {'cui': 'C0621447', 'cui_str': 'lei gong teng'}, {'cui': 'C0450043', 'cui_str': 'Thunder (event)'}, {'cui': 'C0330100', 'cui_str': 'Vine (organism)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0150141'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}]",12.0,0.059245,"Compared to baseline, there was significant improvement in mean values of physician assessment, Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), and Bath ankylosing spondylitis global score (BAS-G) at weeks 3 and 6, with no changes in liver enzymes or complete blood count (CBC).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ji', 'Affiliation': 'Department of Rheumatology, Jiangsu Province Hospital of Traditional Chinese Medicine, 155 HanZhong Road, Nanjing, Jiangsu, China, 210029. weiweiji1103@yahoo.com.cn'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Miaojia', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Ke', 'Affiliation': ''}, {'ForeName': 'Yile', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Xiaohu', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Jianglin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': ''}]",Clinical rheumatology,['10.1007/s10067-010-1497-0']
411,20535445,Tadalafil increases muscle capillary recruitment and forearm glucose uptake in women with type 2 diabetes.,"AIMS/HYPOTHESIS


Recent evidence suggests that reduced synthesis of nitric oxide in endothelial cells, i.e. endothelial dysfunction, contributes to the impaired action of insulin in the vasculature of patients with type 2 diabetes. We investigated whether selective inhibition of phosphodiesterase-5 by tadalafil has beneficial effects on peripheral microcirculation and glucose uptake in these patients.
METHODS


We enrolled seven postmenopausal women with type 2 diabetes and ten age-matched healthy women as controls in a placebo-controlled study to evaluate the acute metabolic effects of tadalafil. We performed microdialysis and blood flow measurements in muscle, and sampled arterial and deep venous blood before and after a single dose of tadalafil 20 mg or placebo. Circulating glucose and insulin levels, muscle capillary recruitment as reflected by permeability surface area for glucose (PS(glu)) and forearm glucose uptake were measured.
RESULTS


In women with type 2 diabetes, but not in the control group, tadalafil induced increases in the incremental AUC for PS(glu) (tadalafil vs placebo 41 +/- 11 vs 4 +/- 2 ml [100 g](-1) min(-1), p < 0.05) and forearm glucose uptake (46 +/- 9 vs 8 +/- 4 micromol [100 g](-1) min(-1), p < 0.05). The variable that best predicted forearm glucose uptake was PS(glu), which explained 70% of its variance. However, fasting glucose and insulin concentrations were similar following treatment with placebo or tadalafil in the two groups.
CONCLUSIONS/INTERPRETATION


This study suggests that tadalafil evokes positive metabolic effects in insulin-resistant women with type 2 diabetes.",2010,"In women with type 2 diabetes, but not in the control group, tadalafil induced increases in the incremental AUC for PS(glu) (tadalafil vs placebo 41 +/-","['insulin-resistant women with type 2 diabetes', 'enrolled seven postmenopausal women with type 2 diabetes and ten age-matched healthy women as controls in a', 'women with type 2 diabetes', 'patients with type 2 diabetes']","['Tadalafil', 'placebo', 'phosphodiesterase-5 by tadalafil', 'tadalafil', 'tadalafil 20 mg or placebo']","['forearm glucose uptake', 'muscle capillary recruitment and forearm glucose uptake', 'incremental AUC for PS(glu', 'fasting glucose and insulin concentrations', 'peripheral microcirculation and glucose uptake', 'Circulating glucose and insulin levels, muscle capillary recruitment as reflected by permeability surface area for glucose (PS(glu)) and forearm glucose uptake']","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0757672', 'cui_str': 'Phosphodiesterase Type 5'}, {'cui': 'C1593807', 'cui_str': 'tadalafil 20 MG [Cialis]'}]","[{'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",7.0,0.380024,"In women with type 2 diabetes, but not in the control group, tadalafil induced increases in the incremental AUC for PS(glu) (tadalafil vs placebo 41 +/-","[{'ForeName': 'P-A', 'Initials': 'PA', 'LastName': 'Jansson', 'Affiliation': 'The Lundberg Laboratory for Diabetes Research, Center of Excellence for Cardiovascular and Metabolic Research, Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska University Hospital, University of Gothenburg, Blå Stråket 5, S-413 45 Göteborg, Sweden. per-anders.jansson@medic.gu.se'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Murdolo', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sjögren', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Nyström', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Strindberg', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lönnroth', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-010-1819-4']
412,20567823,"Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial.","Further to the patent expiry of Neupogen (Amgen filgrastim), Hospira has developed a biosimilar filgrastim (Nivestim) that may offer a clinically effective alternative for multiple hematologic and oncologic indications. Here results are reported from a phase I trial, primarily designed to compare the pharmacodynamic profiles of Hospira filgrastim and Amgen filgrastim. A phase I, single-center, double-blind, randomized trial was undertaken to demonstrate equivalence of the pharmacodynamic characteristics of Hospira filgrastim and Amgen filgrastim. Fifty healthy volunteers were randomized to receive 5 or 10 microg/kg dosing, before further randomization to treatment sequence. All volunteers received five daily subcutaneous doses of Hospira filgrastim or Neupogen, with subsequent crossover to the alternative treatment. Bioequivalence was evaluated by analysis of variance; if the estimated 90% confidence intervals (CIs) for the ratio of 'test' to 'reference' treatment means were within the conventional equivalence limits of 0.80-1.25, then bioequivalence was concluded. Forty-eight volunteers completed the study. Geometric mean absolute neutrophil count area under the curve from time 0 to the last time point at day 5 (primary endpoint) was comparable in volunteers given Hospira filgrastim or Amgen filgrastim at 5 microg/kg (ratio of means, 0.98; 90% CI, 0.92-1.05) or 10 microg/kg (ratio, 0.97; 90% CI, 0.93-1.01); 90% CIs were within the predefined range necessary to demonstrate bioequivalence. Hospira filgrastim was well tolerated with no additional safety concerns over Amgen filgrastim. Hospira filgrastim is bioequivalent with Amgen filgrastim with regard to its pharmacodynamic characteristics.",2010,Hospira filgrastim was well tolerated with no additional safety concerns over Amgen filgrastim.,"['Fifty healthy volunteers', 'Forty-eight volunteers completed the study']","['Hospira filgrastim', 'biosimilar filgrastim and Amgen filgrastim', 'Hospira filgrastim and Amgen filgrastim', 'Hospira filgrastim or Neupogen']",['Geometric mean absolute neutrophil count area'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0733468', 'cui_str': 'Neupogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",50.0,0.052813,Hospira filgrastim was well tolerated with no additional safety concerns over Amgen filgrastim.,"[{'ForeName': 'Cornelius F', 'Initials': 'CF', 'LastName': 'Waller', 'Affiliation': 'Medizinische Universitätsklinik, Freiburg, Germany. cornelius.waller@uniklinik-freiburg.de'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Bronchud', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Mair', 'Affiliation': ''}, {'ForeName': 'Rodeina', 'Initials': 'R', 'LastName': 'Challand', 'Affiliation': ''}]",Annals of hematology,['10.1007/s00277-010-0973-6']
413,20532476,Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials.,"AIMS/HYPOTHESIS


Observational and mechanistic studies have suggested a possible relationship between treatment with metformin and decreased incidence of cancer in participants with type 2 diabetes. We extracted data for malignancies from the ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) randomised controlled clinical trials, in which the efficacy and/or safety of metformin was assessed in comparison with sulfonylureas and rosiglitazone.
METHODS


Neoplasm occurrences were collected as adverse events in these studies. We reviewed and re-analysed the individual participant data in both studies for serious adverse events, malignancies reported as adverse events and related neoplasms of special interest.
RESULTS


In ADOPT, 50 participants (3.4%) on metformin and 55 (3.8%) on each of rosiglitazone and glibenclamide (known as glyburide in the USA and Canada) developed serious adverse event malignancies (excluding non-melanoma skin cancers). This corresponds to 1.03, 1.12 and 1.31 per 100 person-years, giving hazard ratios for metformin of 0.92 (95% CI 0.63-1.35) vs rosiglitazone and 0.78 (0.53-1.14) vs glibenclamide. In RECORD, on a background of sulfonylurea, 69 (6.1%) participants developed malignant neoplasms in the metformin group, compared with 56 (5.1%) in the rosiglitazone group (HR 1.22 [0.86-1.74]). On a background of metformin, 74 (6.7%) participants in the sulfonylurea group developed malignant neoplasms, compared with 57 (5.1%) in the rosiglitazone group (HR 1.33 [0.94-1.88]).
CONCLUSIONS/INTERPRETATION


The malignancy rates in these two randomised controlled clinical trials do not support a view that metformin offers any particular protection against malignancy compared with rosiglitazone. However, they do not refute the possibility of a difference compared with sulfonylureas.",2010,The malignancy rates in these two randomised controlled clinical trials do not support a view that metformin offers any particular protection against malignancy compared with rosiglitazone.,['participants with type 2 diabetes'],"['rosiglitazone and glibenclamide', 'RECORD (Rosiglitazone', 'oral glucose-lowering drugs', 'metformin', 'glibenclamide', 'rosiglitazone', 'Rosiglitazone', 'sulfonylureas and rosiglitazone', 'sulfonylurea']","['malignant neoplasms', 'serious adverse event malignancies']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.143486,The malignancy rates in these two randomised controlled clinical trials do not support a view that metformin offers any particular protection against malignancy compared with rosiglitazone.,"[{'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Home', 'Affiliation': 'ICM - Diabetes, The Medical School, Newcastle University, Newcastle upon Tyne, UK. philip.home@newcastle.ac.uk'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Noronha', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Beck-Nielsen', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viberti', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-010-1804-y']
414,20559656,"Efficacy of the pentavalent rotavirus vaccine, RotaTeq®, in Finnish infants up to 3 years of age: the Finnish Extension Study.","Rotavirus Efficacy and Safety Trial (REST) enrolled nearly 70,000 infants, of whom more than 23,000 were from Finland. REST determined the efficacy of the pentavalent rotavirus vaccine (RV5) against rotavirus-related hospitalisations and emergency department (ED) visits in the first year after vaccination. Finnish infants initially in REST transitioned into the Finnish Extension Study (FES), where they were followed for rotavirus-related hospitalisations and ED visits through their second year of life and beyond. FES identified 150 (31%) additional rotavirus gastroenteritis (RVGE) cases beyond those identified in REST in the Finnish participants. Overall, RV5 reduced RVGE hospitalisations and ED visits, regardless of the rotavirus serotype, by 93.8% (95% confidence interval [CI]: 90.8-95.9%) for up to 3.1 years following the last vaccine dose. Vaccine efficacy against combined hospitalisations and ED visits between ages 4 months to 11 months, 12 months to 23 months, and 24 months to 35 months was 93.9% (95% CI: 89.1-96.9%), 94.4% (95% CI: 90.2-97.0%), and 85.9% (95% CI: 51.6-97.2%), respectively. The reduction of hospitalisations and ED visits due to any acute gastroenteritis, rotavirus or not, was 62.4% (95% CI: 57.6-66.6%) over the entire follow-up period. The results from FES confirm that RV5 induces high and sustained protection against rotavirus-related hospitalisations and ED visits, and has a very substantial impact on all gastroenteritis-related hospitalisations and ED visits into the third year of life in Finnish children.",2010,"The reduction of hospitalisations and ED visits due to any acute gastroenteritis, rotavirus or not, was 62.4% (95% CI: 57.6-66.6%) over the entire follow-up period.","['70,000 infants, of whom more than 23,000 were from Finland', 'Finnish children', 'ages', 'Finnish infants initially in REST transitioned into the Finnish Extension Study (FES', 'Finnish infants up to 3\xa0years of age']","['pentavalent rotavirus vaccine, RotaTeq®', 'pentavalent rotavirus vaccine (RV5']","['reduction of hospitalisations and ED visits', 'Overall, RV5 reduced RVGE hospitalisations and ED visits, regardless of the rotavirus serotype']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2713569', 'cui_str': 'pentavalent rotavirus vaccine (RV5)'}, {'cui': 'C1528013', 'cui_str': 'RotaTeq'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}]",,0.050772,"The reduction of hospitalisations and ED visits due to any acute gastroenteritis, rotavirus or not, was 62.4% (95% CI: 57.6-66.6%) over the entire follow-up period.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Vaccine Research Centre, University of Tampere Medical School, Biokatu 10, Tampere, Finland. timo.vesikari@uta.fi'}, {'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Karvonen', 'Affiliation': ''}, {'ForeName': 'Shannon Allen', 'Initials': 'SA', 'LastName': 'Ferrante', 'Affiliation': ''}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Ciarlet', 'Affiliation': ''}]",European journal of pediatrics,['10.1007/s00431-010-1242-3']
415,20490908,Use of non-occupational post-exposure prophylaxis does not lead to an increase in high risk sex behaviors in men who have sex with men participating in the EXPLORE trial.,"Non-occupational post-exposure prophylaxis (nPEP) use is an HIV prevention strategy that has been recommended by the CDC to prevent HIV infection after a high risk sexual exposure since 1997. In a behavioral intervention trial of 4,295 MSM we assessed perceptions and use of nPEP over 4 years in six cities across the United States. Overall, 1.9% of MSM reported use of nPEP prior to enrollment, and 6.3% at least once during the trial. Awareness of nPEP was reported by 47.5%, with higher awareness in two sites with funded nPEP programs. Three seroconversions occurred in the 384 visits where nPEP courses were reported, with no effect of nPEP on risk of HIV acquisition in this cohort (hazard ratio = 0.91, 95% confidence interval [0.29, 2.86]). NPEP users were a riskier group: increased odds of nPEP use were observed in association with multiple partners and unprotected receptive and insertive anal sex with HIV infected partners and partners with unknown HIV status. NPEP use was also associated with use of illicit drugs (injection drugs, crack cocaine, hallucinogens, and amphetamines). Importantly, willingness to use nPEP after high risk sex was associated with lower odds of high risk sex. After an episode of nPEP use, nPEP users remained more likely to report high risk sex than those in this cohort who had not previously used nPEP. However, within the subset of people who had previously reported high risk sex, previous nPEP use was not associated with higher odds of high risk sex, thus allaying fears that availability of nPEP would lead to an increase in high risk sex.",2010,NPEP users were a riskier group: increased odds of nPEP use were observed in association with multiple partners and unprotected receptive and insertive anal sex with HIV infected partners and partners with unknown HIV status.,['men who have sex with men participating'],"['nPEP', 'occupational post-exposure prophylaxis (nPEP', 'NPEP']","['risk of HIV acquisition', 'high risk sex behaviors']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C1443861', 'cui_str': 'Post-Exposure Prevention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",4295.0,0.0302913,NPEP users were a riskier group: increased odds of nPEP use were observed in association with multiple partners and unprotected receptive and insertive anal sex with HIV infected partners and partners with unknown HIV status.,"[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Vaccine and Infectious Disease Institute, Fred Hutchinson Cancer Research Ctr, Seattle, WA 98109, USA. deborah@scharp.org'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Mimiaga', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Chesney', 'Affiliation': ''}, {'ForeName': 'Beryl', 'Initials': 'B', 'LastName': 'Koblin', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Coates', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-010-9712-1']
416,20532651,Coming home: health status and homelessness risk of older pre-release prisoners.,"BACKGROUND


Older adults comprise an increasing proportion of the prison and homeless populations. While older age is associated with adverse post-release health events and incarceration is a risk factor for homelessness, the health status and homelessness risk of older pre-release prisoners are unknown. Moreover, most post-release services are geared towards veterans; it is unknown whether the needs of non-veterans differ from those of veterans.
OBJECTIVE


To assess health status and risk of homelessness of older pre-release prisoners, and to compare veterans with non-veterans.
DESIGN/PARTICIPANTS


Cross-sectional study of 360 prisoners (≥ 55 years of age) within 2 years of release from prison using data from the 2004 Survey of Inmates in State and Federal Correctional Facilities.
MAIN MEASURES


Veteran status, health status (based on self-report), and risk of homelessness (homelessness before arrest).
KEY RESULTS


Mean age was 61 years; 93.8% were men and 56.5% were white. Nearly 40% were veterans, of whom 77.2% reported likely VA service eligibility. Veterans were more likely to be white and to have obtained a high school diploma or GED. Overall, 79.1% reported a medical condition and 13.6% reported a serious mental illness. There was little difference in health status between veterans and non-veterans. Although 1 in 12 prisoners reported a risk factor for homelessness, the risk factors did not differ according to veteran status.
CONCLUSIONS


Older pre-release prisoners had a high burden of medical and mental illness and were at risk for post-release homelessness regardless of veteran status. Reentry programs linking pre-release older prisoners to medical and psychiatric services and to homelessness prevention programs are needed for both veterans and non-veterans.",2010,"Although 1 in 12 prisoners reported a risk factor for homelessness, the risk factors did not differ according to veteran status.
","['veterans and non-veterans', '≥ 55 years of age) within 2 years of release from prison using data from the 2004 Survey of Inmates in State and Federal Correctional Facilities', '360 prisoners ', 'older pre-release prisoners', 'Mean age was 61 years; 93.8% were men and 56.5% were white', 'veterans with non-veterans', 'Older adults', '12 prisoners']",[],"['health status', 'Veteran status, health status (based on self-report), and risk of homelessness (homelessness before arrest', 'serious mental illness', 'risk factor for homelessness, the risk factors']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0425147', 'cui_str': 'Released from prison (finding)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442681', 'cui_str': 'Penal institution (environment)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",,0.0162821,"Although 1 in 12 prisoners reported a risk factor for homelessness, the risk factors did not differ according to veteran status.
","[{'ForeName': 'Brie A', 'Initials': 'BA', 'LastName': 'Williams', 'Affiliation': 'Division of Geriatrics, University of California, San Francisco, San Francisco, CA 94121, USA. brie.williams@ucsf.edu'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McGuire', 'Affiliation': ''}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Lindsay', 'Affiliation': ''}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Baillargeon', 'Affiliation': ''}, {'ForeName': 'Irena Stijacic', 'Initials': 'IS', 'LastName': 'Cenzer', 'Affiliation': ''}, {'ForeName': 'Sei J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Kushel', 'Affiliation': ''}]",Journal of general internal medicine,['10.1007/s11606-010-1416-8']
417,20499046,"Autonomic neuropathy predisposes to rosiglitazone-induced vascular leakage in insulin-treated patients with type 2 diabetes: a randomised, controlled trial on thiazolidinedione-induced vascular leakage.","AIMS/HYPOTHESIS


The mechanism of fluid-related complications caused by thiazolidinedione derivatives is unclear. One potential mechanism is thiazolidinedione-induced arterial vasodilatation, which results in vascular leakage and a fall in blood pressure, normally counterbalanced by sympathetic activation and subsequent renal fluid retention. We hypothesised that thiazolidinedione-induced vascular leakage will be particularly prominent in patients with autonomic neuropathy.
METHODS


We conducted a randomised, double-blind, placebo-controlled, parallel study in 40 patients with type 2 diabetes on insulin treatment recruited from a university medical centre. The randomisation was performed by a central office using a randomisation schedule. Both treatment groups, placebo (n = 21) and rosiglitazone (n = 19), were stratified for sex and level of autonomic neuropathy as assessed by Ewing score (<2.5 or >or=2.5). We investigated the effects of 16 weeks of treatment with rosiglitazone 4 mg twice daily on vascular leakage (transcapillary escape rate of albumin, TERalb), body weight, extracellular volume and plasma volume.
RESULTS


Thirty-nine patients were included in the analysis. In patients with high Ewing scores (n = 16), rosiglitazone increased TERalb significantly (DeltaTERalb: rosiglitazone +2.43 +/- 0.45%/h, placebo -0.11 +/- 0.15%/h, p = 0.002), while rosiglitazone had no effect in the patients with low Ewing scores (n = 23). Rosiglitazone-induced increases in TERalb and Ewing score at baseline were correlated (r = 0.65, p = 0.02). There was no correlation between Ewing score and rosiglitazone-induced changes in fluid variables. One subject was withdrawn from the study because of atrial fibrillation.
CONCLUSIONS/INTERPRETATION


Rosiglitazone may increase vascular leakage in insulin-treated patients with type 2 diabetes with autonomic neuropathy. Autonomic neuropathy did not exaggerate rosiglitazone-induced fluid retention. Therefore, autonomic neuropathy should be considered as a risk factor for thiazolidinedione-induced oedema, not for thiazolidinedione-induced fluid retention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00422955.
FUNDING


GlaxoSmithKline.",2010,"In patients with high Ewing scores (n = 16), rosiglitazone increased TERalb significantly (DeltaTERalb: rosiglitazone +2.43 +/-","['patients with autonomic neuropathy', 'insulin-treated patients with type', '2 diabetes', '40 patients with type 2 diabetes on insulin treatment recruited from a university medical centre', 'insulin-treated patients with type 2 diabetes with autonomic neuropathy', 'Thirty-nine patients were included in the analysis']","['placebo', 'placebo -0.11', 'rosiglitazone', 'thiazolidinedione', 'Rosiglitazone']","['TERalb and Ewing score', 'Autonomic neuropathy', 'fluid retention', 'vascular leakage (transcapillary escape rate of albumin, TERalb), body weight, extracellular volume and plasma volume', 'vascular leakage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy (disorder)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517425', 'cui_str': '0.11 (qualifier value)'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}]","[{'cui': 'C0337831', 'cui_str': 'Ewe (ethnic group)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy (disorder)'}, {'cui': 'C0268000', 'cui_str': 'Body fluid retention (disorder)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}]",40.0,0.290301,"In patients with high Ewing scores (n = 16), rosiglitazone increased TERalb significantly (DeltaTERalb: rosiglitazone +2.43 +/-","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Rennings', 'Affiliation': 'Department of Pharmacology-Toxicology 149, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. A.Rennings@pharmtox.umcn.nl'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Smits', 'Affiliation': ''}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Tack', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-010-1787-8']
418,20532660,"Potential unintended consequences due to Medicare's ""no pay for errors"" rule? A randomized controlled trial of an educational intervention with internal medicine residents.","BACKGROUND


Medicare has selected 10 hospital-acquired conditions for which it will not reimburse hospitals unless the condition was documented as ""present on admission."" This ""no pay for errors"" rule may have a profound effect on the clinical practice of physicians.
OBJECTIVE


To determine how physicians might change their behavior after learning about the Medicare rule.
DESIGN


We conducted a randomized trial of a brief educational intervention embedded in an online survey, using clinical vignettes to estimate behavioral changes.
PARTICIPANTS


At a university-based internal medicine residency program, 168 internal medicine residents were eligible to participate.
INTERVENTION


Residents were randomized to receive a one-page description of Medicare's ""no pay for errors"" rule with pre-vignette reminders (intervention group) or no information (control group). Residents responded to five clinical vignettes in which ""no pay for errors"" conditions might be present on admission.
MAIN MEASURES


Primary outcome was selection of the single most clinically appropriate option from three clinical practice choices presented for each clinical vignette.
KEY RESULTS


Survey administered from December 2008 to March 2009. There were 119 responses (71%). In four of five vignettes, the intervention group was less likely to select the most clinically appropriate response. This was statistically significant in two of the cases. Most residents were aware of the rule but not its impact and specifics. Residents acknowledged responsibility to know Medicare documentation rules but felt poorly trained to do so. Residents educated about the Medicare's ""no pay for errors"" were less likely to select the most clinically appropriate responses to clinical vignettes. Such choices, if implemented in practice, have the potential for causing patient harm through unnecessary tests, procedures, and other interventions.",2010,"Residents educated about the Medicare's ""no pay for errors"" were less likely to select the most clinically appropriate responses to clinical vignettes.","['Survey administered from December 2008 to March 2009', 'with internal medicine residents', 'At a university-based internal medicine residency program, 168 internal medicine residents were eligible to participate']","['educational intervention', 'Medicare\'s ""no pay for errors"" rule with pre-vignette reminders (intervention group) or no information (control group']",[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}]","[{'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0370873,"Residents educated about the Medicare's ""no pay for errors"" were less likely to select the most clinically appropriate responses to clinical vignettes.","[{'ForeName': 'Somnath', 'Initials': 'S', 'LastName': 'Mookherjee', 'Affiliation': 'Department of Medicine, Division of Hospital Medicine, University of California, San Francisco, CA 94143, USA. smookherjee@medicine.ucsf.edu'}, {'ForeName': 'Arpana R', 'Initials': 'AR', 'LastName': 'Vidyarthi', 'Affiliation': ''}, {'ForeName': 'Sumant R', 'Initials': 'SR', 'LastName': 'Ranji', 'Affiliation': ''}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Maselli', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wachter', 'Affiliation': ''}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Baron', 'Affiliation': ''}]",Journal of general internal medicine,['10.1007/s11606-010-1395-9']
419,20499150,Prevalence of child and adult sexual abuse and risk taking practices among HIV serodiscordant African-American couples.,"This study reports the prevalence of child (CSA) and adult (ASA) sexual abuse among 535 African American HIV serodiscordant couples from four major United State cities, and its relationship to personal and couple related vulnerabilities and HIV risk factors. As part of a randomized, clinical trial, CSA and ASA histories were obtained through face-to-face interviews. Results indicate that HIV positive women were significantly more likely to report one kind of abuse (32.32%), either before or since age 18 or both (32.6%). HIV-positive men (34.9%) were significantly more likely to report CSA than HIV-negative men (22.0%). Overall, 72% of couples reported that one or both had CSA histories. These findings underscore the heightened emotional vulnerability, and STI and HIV transmission risk taking practices, associated with sexual abuse. Sexual abuse histories among couples should be assessed to better understand how these histories may contribute to couples dynamics and risk-taking practices.",2010,"Results indicate that HIV positive women were significantly more likely to report one kind of abuse (32.32%), either before or since age 18 or both (32.6%).","['535 African American HIV serodiscordant couples from four major United State cities', 'HIV serodiscordant African-American couples']",[],['Prevalence of child and adult sexual abuse and risk taking practices'],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0041703', 'cui_str': 'United States'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",[],"[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",535.0,0.0261985,"Results indicate that HIV positive women were significantly more likely to report one kind of abuse (32.32%), either before or since age 18 or both (32.6%).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-010-9700-5']
420,20512336,Strontium ranelate and alendronate have differing effects on distal tibia bone microstructure in women with osteoporosis.,"The structural basis of the antifracture efficacy of strontium ranelate and alendronate is incompletely understood. We compared the effects of strontium ranelate and alendronate on distal tibia microstructure over 2 years using HR-pQCT. In this pre-planned, interim, intention-to-treat analysis at 12 months, 88 osteoporotic postmenopausal women (mean age 63.7 +/- 7.4) were randomized to strontium ranelate 2 g/day or alendronate 70 mg/week in a double-placebo design. Primary endpoints were changes in microstructure. Secondary endpoints included lumbar and hip areal bone mineral density (aBMD), and bone turnover markers. This trial is registered with http://www.controlled-trials.com, number ISRCTN82719233. Baseline characteristics of the two groups were similar. Treatment with strontium ranelate was associated with increases in mean cortical thickness (CTh, 5.3%), cortical area (4.9%) and trabecular density (2.1%) (all P < 0.001, except cortical area P = 0.013). No significant changes were observed with alendronate. Between-group differences in favor of strontium ranelate were observed for CTh, cortical area, BV/TV and trabecular density (P = 0.045, 0.041, 0.048 and 0.035, respectively). aBMD increased to a similar extent with strontium ranelate and alendronate at the spine (5.7% versus 5.1%, respectively) and total hip (3.3% versus 2.2%, respectively). No significant changes were observed in remodeling markers with strontium ranelate, while suppression was observed with alendronate. Within the methodological constraints of HR-pQCT through its possible sensitivity to X-ray attenuation of different minerals, strontium ranelate had greater effects than alendronate on distal tibia cortical thickness and trabecular volumetric density.",2010,"Between-group differences in favor of strontium ranelate were observed for CTh, cortical area, BV/TV and trabecular density (P = 0.045, 0.041, 0.048 and 0.035, respectively).","['88 osteoporotic postmenopausal women (mean age 63.7 +/- 7.4', 'women with osteoporosis']","['alendronate', 'strontium ranelate and alendronate', 'Strontium ranelate and alendronate', 'strontium ranelate 2 g/day or alendronate 70 mg/week in a double-placebo', 'strontium ranelate']","['distal tibia microstructure', 'total hip', 'mean cortical thickness', 'trabecular density', 'cortical area', 'distal tibia bone microstructure', 'CTh, cortical area, BV/TV and trabecular density', 'distal tibia cortical thickness and trabecular volumetric density', 'lumbar and hip areal bone mineral density (aBMD), and bone turnover markers', 'remodeling markers with strontium ranelate', 'changes in microstructure', 'aBMD', 'strontium ranelate']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0936139', 'cui_str': 'strontium ranelate'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0936139', 'cui_str': 'strontium ranelate'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",88.0,0.234668,"Between-group differences in favor of strontium ranelate were observed for CTh, cortical area, BV/TV and trabecular density (P = 0.045, 0.041, 0.048 and 0.035, respectively).","[{'ForeName': 'René', 'Initials': 'R', 'LastName': 'Rizzoli', 'Affiliation': 'Division of Bone Diseases, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, 1211, Geneva 14, Switzerland. Rene.Rizzoli@unige.ch'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Laroche', 'Affiliation': ''}, {'ForeName': 'Marc-Antoine', 'Initials': 'MA', 'LastName': 'Krieg', 'Affiliation': ''}, {'ForeName': 'Isolde', 'Initials': 'I', 'LastName': 'Frieling', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Delmas', 'Affiliation': ''}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': ''}]",Rheumatology international,['10.1007/s00296-010-1542-y']
421,20502929,Probiotic Lactobacillus paracasei effect on cariogenic bacterial flora.,"Lactobacillus paracasei has been demonstrated to inhibit the growth of many pathogenic microbes such as Streptococcus mutans, in vitro. However, its clinical application remains unclear. Here, we examined whether a novel probiotic L. paracasei GMNL-33 may reduce the caries-associated salivary microbial counts in healthy adults. Seventy-eight subjects (aged 20 to 26) had completed this double-blinded, randomized, placebo-controlled study. A probiotic/test (n = 42) and a control group (n = 36) took a L. paracasei GMNL-33 and a placebo oral tablet three times per day for 2 weeks, respectively. Bacterial counts of salivary S. mutans, lactobacilli, and salivary buffer capacity were measured with chair-side kits at the beginning (T1), the completion (T2) of medication, and 2 weeks after medication (T3). The results did not show differences in the counts of S. mutans and lactobacilli between probiotic and control groups at T1, T2, and T3. Nevertheless, within the probiotic group, an interesting probiotic effect was noticed. Between T1 and T2, no inhibitory effect against S. mutans was observed. However, a significant count reduction in the salivary S. mutans was detected between T2 and T3 (p = 0.016). Thus, a 2-week period of medication via oral administration route may be needed for L. paracasei GMNL-33 to be effective in the probiotic action.",2011,"The results did not show differences in the counts of S. mutans and lactobacilli between probiotic and control groups at T1, T2, and T3.","['Seventy-eight subjects (aged 20 to 26', 'healthy adults']","['Probiotic Lactobacillus paracasei', 'placebo', 'control group (n\u2009=\u200936) took a L. paracasei GMNL-33 and a placebo', 'Lactobacillus paracasei', 'novel probiotic L. paracasei GMNL-33']","['salivary S. mutans', 'counts of S. mutans and lactobacilli', 'Bacterial counts of salivary S. mutans, lactobacilli, and salivary buffer capacity', 'cariogenic bacterial flora']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0004618', 'cui_str': 'Bacterial Count'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}]",78.0,0.0517365,"The results did not show differences in the counts of S. mutans and lactobacilli between probiotic and control groups at T1, T2, and T3.","[{'ForeName': 'Li-Chuan', 'Initials': 'LC', 'LastName': 'Chuang', 'Affiliation': 'Department of Pediatric Dentistry, Chang Gung Memorial Hospital (Linkou), No. 5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan, Republic of China.'}, {'ForeName': 'Chiung-Shing', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Li-Wei', 'Initials': 'LW', 'LastName': 'Ou-Yang', 'Affiliation': ''}, {'ForeName': 'Shiao-Yu', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': ''}]",Clinical oral investigations,['10.1007/s00784-010-0423-9']
422,20352318,Vaginal practices and associations with barrier methods and gel use among Sub-Saharan African women enrolled in an HIV prevention trial.,"Vaginal practices may interfere with the use and/or the effectiveness of female-initiated prevention methods. We investigated whether vaginal practices differed by randomization group in a phase III trial of the diaphragm with lubricant gel (MIRA) in Sub-Saharan Africa (n = 4925), and if they were associated with consistent use of study methods. At baseline, vaginal practices were commonly reported: vaginal washing (82.77%), wiping (56.47%) and insertion of dry or absorbent materials (20.58%). All three practices decreased during the trial. However, women in the intervention group were significantly more likely to report washing or wiping during follow-up compared to those in the control group. Additionally, washing, wiping, and insertion, were all independently and inversely associated with consistent diaphragm and gel use and with condom use as well, regardless of study arm. A better understanding of the socio-cultural context in which these practices are embedded could improve educational strategies to address these potentially modifiable behaviors, and may benefit future HIV prevention interventions of vaginal methods.",2010,"At baseline, vaginal practices were commonly reported: vaginal washing (82.77%), wiping (56.47%) and insertion of dry or absorbent materials (20.58%).",['Sub-Saharan African women enrolled in an HIV prevention trial'],['diaphragm with lubricant gel (MIRA'],['likely to report washing or wiping'],"[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",4925.0,0.126179,"At baseline, vaginal practices were commonly reported: vaginal washing (82.77%), wiping (56.47%) and insertion of dry or absorbent materials (20.58%).","[{'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative, RTI International, 114 Sansome Street, Suite 500, San Francisco, CA 94104, USA. ariane@rti.org""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Chidanyika', 'Affiliation': ''}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'De Bruyn', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Padian', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-010-9690-3']
423,20496000,Chumnguh thleum: understanding liver illness and hepatitis B among Cambodian immigrants.,"Cambodian immigrants are over 25 times more likely to have evidence of chronic hepatitis B infection than the general US population. Carriers of HBV are over 100 times more likely to develop liver cancer than non-carriers. Liver cancer incidence is the second leading cancer for Cambodian men and the sixth for Cambodian women. Despite this, this underserved population has received very little attention from health disparities researchers. Culturally and linguistically appropriate interventions are necessary to increase hepatitis B knowledge, serologic testing, and vaccination among Cambodian Americans. Eight group interviews were held with Cambodian American men (48) and women (49). Focus group discussion revealed unanticipated information about sociocultural influences on participants' understanding about hepatitis B transmission, disease course, and prevention and treatment informed by humoral theories underlying Khmer medicine, by biomedicine, and by migration experiences. Our findings reveal the value of qualitative exploration to providing cultural context to biomedical information--a formula for effective health promotion and practice.",2011,"Focus group discussion revealed unanticipated information about sociocultural influences on participants' understanding about hepatitis B transmission, disease course, and prevention and treatment informed by humoral theories underlying Khmer medicine, by biomedicine, and by migration experiences.","['Cambodian immigrants', 'Eight group interviews were held with Cambodian American men (48) and women (49', 'Cambodian men and the sixth for Cambodian women', 'Cambodian Americans']",[],[],"[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0018260', 'cui_str': 'Group Interviews'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C4505365', 'cui_str': 'Cambodian Americans'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205440', 'cui_str': 'Sixth (qualifier value)'}]",[],[],,0.0162401,"Focus group discussion revealed unanticipated information about sociocultural influences on participants' understanding about hepatitis B transmission, disease course, and prevention and treatment informed by humoral theories underlying Khmer medicine, by biomedicine, and by migration experiences.","[{'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Burke', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center and Department of Anthropology, History, and Social Medicine, University of California, San Francisco, 1450 3rd Street, MC 0128, PO Box 589001, San Francisco, CA 94158-9001, USA. nburke@cc.ucsf.edu'}, {'ForeName': 'Hoai Huyen', 'Initials': 'HH', 'LastName': 'Do', 'Affiliation': ''}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Talbot', 'Affiliation': ''}, {'ForeName': 'Channdara', 'Initials': 'C', 'LastName': 'Sos', 'Affiliation': ''}, {'ForeName': 'Danika', 'Initials': 'D', 'LastName': 'Svy', 'Affiliation': ''}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Taylor', 'Affiliation': ''}]",Journal of community health,['10.1007/s10900-010-9277-y']
424,20442991,Postprocedural CT for perivertebral cement leakage in percutaneous vertebroplasty is not necessary--results from VERTOS II.,"INTRODUCTION


During percutaneous vertebroplasty (PV), perivertebral cement leakage frequently occurs. There is some concern that cement deposits may migrate towards the lungs via the veins during follow-up. We used baseline and follow-up computed tomography (CT) to assess the incidence and extend of late cement migration in a large consecutive patient cohort.
METHODS


VERTOS II is a prospective multicenter randomized controlled trial comparing PV with conservative therapy for osteoporotic vertebral compression fractures (OVCFs). Patients assigned to PV had baseline postprocedural CT scans of the treated vertebral bodies. After a mean follow-up of 22 months, 54 of 78 patients (69%) had follow-up CT. CT scans were analyzed and compared for perivertebral venous, discal, and soft tissue leakage.
RESULTS


Perivertebral cement leakage occurred in 64 of 80 treated vertebrae (80%; 95% CI, 70% to 87%). All patients remained asymptomatic. Perivertebral venous leakage was present in 56 vertebrae (88%), mostly in the anterior external venous plexus (46 of 56, 82%). Discal leakage occurred in 22 of 64 vertebrae (34%) and soft tissue leakage in two of 64 (4%). Mean injected cement volume in vertebrae with leakage was higher (4.5 versus 3.7 cm(3), p = 0.04). Follow-up CT scan showed unchanged perivertebral cement leakages without late cement migration.
CONCLUSION


Perivertebral cement leaks during PV for OVCFs occurred frequently in the VERTOS II trial. Cement leakage occurred more frequently with higher injected volumes. However, all patients remained asymptomatic, and late cement migration during follow-up did not occur. Standard postprocedural CT of the treated vertebral body in PV is not necessary.",2011,"Mean injected cement volume in vertebrae with leakage was higher (4.5 versus 3.7 cm(3), p = 0.04).",['osteoporotic vertebral compression fractures (OVCFs'],"['PV with conservative therapy', 'baseline and follow-up computed tomography (CT']","['Perivertebral cement leakage', 'Cement leakage', 'baseline postprocedural CT scans', 'Perivertebral venous leakage', 'soft tissue leakage', 'CT scans', 'Mean injected cement volume in vertebrae with leakage', 'Discal leakage']","[{'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0549207', 'cui_str': 'Vertebra'}]",,0.0228277,"Mean injected cement volume in vertebrae with leakage was higher (4.5 versus 3.7 cm(3), p = 0.04).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Venmans', 'Affiliation': 'Department of Radiology, St. Elisabeth Ziekenhuis Tilburg, Tilburg, The Netherlands. alexandervenmans@hotmail.com'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Klazen', 'Affiliation': ''}, {'ForeName': 'Willem Jan', 'Initials': 'WJ', 'LastName': 'van Rooij', 'Affiliation': ''}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'de Vries', 'Affiliation': ''}, {'ForeName': 'Willem P', 'Initials': 'WP', 'LastName': 'Mali', 'Affiliation': ''}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Lohle', 'Affiliation': ''}]",Neuroradiology,['10.1007/s00234-010-0705-6']
425,20401617,Effects of food on physical and sleep complaints in children with ADHD: a randomised controlled pilot study.,"Attention deficit/hyperactivity disorder (ADHD), a common behavioural disorder in children, may be associated with comorbid physical and sleep complaints. Dietary intervention studies have shown convincing evidence of efficacy in reducing ADHD symptoms in children. In this pilot study, we investigated the effects of an elimination diet on physical and sleep complaints in children with ADHD. A group of 27 children (3.8-8.5 years old), who all met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD, were assigned randomly to either a diet group (15/27) or a control group (12/27). The diet group followed a 5-week elimination diet; the control group adhered to their normal diet. Parents of both groups had to keep an extended diary and had to monitor the behaviour and the physical and sleep complaints of their child conscientiously. The primary endpoint was the clinical response, i.e. a decrease of physical and sleep complaints, at the end of the trial, based on parent ratings on a Physical Complaints Questionnaire. The number of physical and sleep complaints was significantly decreased in the diet group compared to the control group (p < 0.001), with a reduction in the diet group of 77% (p < 0.001, effect size = 2.0) and in the control group of 17% (p = 0.08, effect size = 0.2). Specific complaints that were significantly reduced were in three domains: headaches or bellyaches, unusual thirst or unusual perspiration, and sleep complaints. The reduction of complaints seemed to occur independently of the behavioural changes (p = 0.1). However, the power of this comparison was low. A positive correlation existed between the reduction of physical and behavioural symptoms (p < 0.01). The reduction did not differ between children with or without an atopic constitution (p = 0.7). An elimination diet may be an effective instrument to reduce physical complaints in children with ADHD, but more research is needed to determine the effects of food on (functional) somatic symptoms in children with and without ADHD. This trial was registered as an International Standard Randomised Controlled Trial, ISRCTN47247160.",2010,"The number of physical and sleep complaints was significantly decreased in the diet group compared to the control group (p < 0.001), with a reduction in the diet group of 77% (p < 0.001, effect size = 2.0) and in the control group of 17% (p = 0.08, effect size = 0.2).","['children with ADHD', '27 children (3.8-8.5 years old), who all met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD', 'children with and without ADHD', 'children']","['5-week elimination diet; the control group adhered to their normal diet', 'elimination diet']","['headaches or bellyaches, unusual thirst or unusual perspiration, and sleep complaints', 'clinical response, i.e. a decrease of physical and sleep complaints', 'number of physical and sleep complaints', 'parent ratings on a Physical Complaints Questionnaire', 'physical and sleep complaints', 'physical and behavioural symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0452376', 'cui_str': 'Elimination diet (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.039784,"The number of physical and sleep complaints was significantly decreased in the diet group compared to the control group (p < 0.001), with a reduction in the diet group of 77% (p < 0.001, effect size = 2.0) and in the control group of 17% (p = 0.08, effect size = 0.2).","[{'ForeName': 'Lidy M', 'Initials': 'LM', 'LastName': 'Pelsser', 'Affiliation': 'ADHD Research Centre, Liviuslaan 49, 5624 JE Eindhoven, The Netherlands. lmjpelsser@adhdresearchcentre.nl'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'Frankena', 'Affiliation': ''}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': ''}, {'ForeName': 'Nanda N', 'Initials': 'NN', 'LastName': 'Rommelse', 'Affiliation': ''}]",European journal of pediatrics,['10.1007/s00431-010-1196-5']
426,20440639,Randomized controlled trial of the focus parent training for toddlers with autism: 1-year outcome.,"This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five toddlers with autism spectrum disorder (65 autism, 10 PDD-NOS, mean age = 34.4 months, SD = 6.2) were enrolled. Analyses were conducted on a final sample of 67 children (lost to follow-up = 8). No significant intervention effects were found for any of the primary (language), secondary (global clinical improvement), or mediating (child engagement, early precursors of social communication, or parental skills) outcome variables, suggesting that the 'Focus parent training' was not of additional value to the more general care-as-usual.",2010,"No significant intervention effects were found for any of the primary (language), secondary (global clinical improvement), or mediating (child engagement, early precursors of social communication, or parental skills) outcome variables, suggesting that the 'Focus parent training' was not of additional value to the more general care-as-usual.","['Seventy-five toddlers with autism spectrum disorder (65 autism, 10 PDD-NOS, mean age\xa0=\xa034.4\xa0months, SD\xa0=\xa06.2) were enrolled', '67 children (lost to follow-up\xa0=\xa08', 'toddlers with autism']",['nonintensive parent training plus care-as-usual and care-as-usual alone'],"['primary (language), secondary (global clinical improvement), or mediating (child engagement, early precursors of social communication, or parental skills) outcome variables']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",75.0,0.116575,"No significant intervention effects were found for any of the primary (language), secondary (global clinical improvement), or mediating (child engagement, early precursors of social communication, or parental skills) outcome variables, suggesting that the 'Focus parent training' was not of additional value to the more general care-as-usual.","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Oosterling', 'Affiliation': 'Karakter Child and Adolescent Psychiatry University Centre, Reinier Postlaan 12, Nijmegen, The Netherlands. i.oosterling@karakter.com'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Visser', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Swinkels', 'Affiliation': ''}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Rommelse', 'Affiliation': ''}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Woudenberg', 'Affiliation': ''}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Roos', 'Affiliation': ''}, {'ForeName': 'Rutger Jan', 'Initials': 'RJ', 'LastName': 'van der Gaag', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Buitelaar', 'Affiliation': ''}]",Journal of autism and developmental disorders,['10.1007/s10803-010-1004-0']
427,20454851,"Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency.","Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5-72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs.",2010,Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG).,"['primary immunodeficiency (PID', 'patients with PID over 15\xa0months', 'patients with primary immunodeficiency', 'Forty-nine patients (5-72\xa0years) previously treated with']","['Subcutaneous human IgG (SCIG) therapy', 'new 20% immunoglobulin preparation', 'IVIG received weekly subcutaneous infusions of IgPro20']","['PID against infections and maintained serum IgG levels', 'Efficacy and safety', 'rate of days missed from work/school', 'rate of hospitalization', 'efficacy and safety of IgPro20', 'mean serum IgG level']","[{'cui': 'C0398686', 'cui_str': 'Primary immune deficiency disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0576773', 'cui_str': 'Subcutaneous Infusions'}, {'cui': 'C3181507', 'cui_str': 'IgPro20'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C3181507', 'cui_str': 'IgPro20'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0269836,Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG).,"[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Hagan', 'Affiliation': 'Division of Allergic Diseases, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905, USA. hagan.john@mayo.edu'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Fasano', 'Affiliation': ''}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Spector', 'Affiliation': ''}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Wasserman', 'Affiliation': ''}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Melamed', 'Affiliation': ''}, {'ForeName': 'Mikhail A', 'Initials': 'MA', 'LastName': 'Rojavin', 'Affiliation': ''}, {'ForeName': 'Othmar', 'Initials': 'O', 'LastName': 'Zenker', 'Affiliation': ''}, {'ForeName': 'Jordan S', 'Initials': 'JS', 'LastName': 'Orange', 'Affiliation': ''}]",Journal of clinical immunology,['10.1007/s10875-010-9423-4']
428,20454891,Effects of high-dose B vitamin complex with vitamin C and minerals on subjective mood and performance in healthy males.,"RATIONALE


A significant proportion of the general population report supplementing their diet with one or more vitamins or minerals, with common reasons for doing so being to combat stress and fatigue and to improve mental functioning. Few studies have assessed the relationship between supplementation with vitamins/minerals and psychological functioning in healthy cohorts of non-elderly adults.
OBJECTIVES


The present randomised, placebo-controlled, double-blind, parallel groups trial assessed the cognitive and mood effects of a high-dose B-complex vitamin and mineral supplement (Berocca(R)) in 215 males aged 30 to 55 years, who were in full-time employment.
METHODS


Participants attended the laboratory prior to and on the last day of a 33-day treatment period where they completed the Profile of Mood States (POMS), Perceived Stress Scale (PSS) and General Health Questionnaire (GHQ-12). Cognitive performance and task-related modulation of mood/fatigue were assessed with the 60 min cognitive demand battery. On the final day, participants also completed the Stroop task for 40 min whilst engaged in inclined treadmill walking and subsequent executive function was assessed.
RESULTS


Vitamin/mineral supplementation led to significant improvements in ratings on the PSS, GHQ-12 and the 'vigour' subscale of the POMS. The vitamin/mineral group also performed better on the Serial 3s subtractions task and rated themselves as less 'mentally tired' both pre- and post-completion of the cognitive demand battery.
CONCLUSIONS


Healthy members of the general population may benefit from augmented levels of vitamins/minerals via direct dietary supplementation. Specifically, supplementation led to improved ratings of stress, mental health and vigour and improved cognitive performance during intense mental processing.",2010,"RESULTS


Vitamin/mineral supplementation led to significant improvements in ratings on the PSS, GHQ-12 and the 'vigour' subscale of the POMS.","['Participants attended the laboratory prior to and on the last day of a 33-day treatment period where they completed the', '215 males aged 30 to 55 years, who were in full-time employment', 'healthy cohorts of non-elderly adults', 'healthy males', 'Healthy members of the general population']","['placebo', 'Stroop task for 40 min whilst engaged in inclined treadmill walking', 'high-dose B vitamin complex with vitamin C and minerals', 'high-dose B-complex vitamin and mineral supplement (Berocca(R']","['subjective mood and performance', ""PSS, GHQ-12 and the 'vigour' subscale of the POMS"", 'Cognitive performance and task-related modulation of mood/fatigue', 'Profile of Mood States (POMS), Perceived Stress Scale (PSS) and General Health Questionnaire (GHQ-12', 'ratings of stress, mental health and vigour and improved cognitive performance']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0556112', 'cui_str': 'Mineral supplementation (product)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",215.0,0.206337,"RESULTS


Vitamin/mineral supplementation led to significant improvements in ratings on the PSS, GHQ-12 and the 'vigour' subscale of the POMS.","[{'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Kennedy', 'Affiliation': 'Brain, Performance and Nutrition Research Centre, Northumbria University, Newcastle-upon-Tyne, NE1 8ST, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Veasey', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Watson', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Dodd', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Maggini', 'Affiliation': ''}, {'ForeName': 'Crystal F', 'Initials': 'CF', 'LastName': 'Haskell', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-1870-3']
429,20454958,The effect of the Müller-Lyer illusion on saccades is modulated by spatial predictability and saccadic latency.,"Studies investigating the effect of visual illusions on saccadic eye movements have provided a wide variety of results. In this study, we test three factors that might explain this variability: the spatial predictability of the stimulus, the duration of the stimulus and the latency of the saccades. Participants made a saccade from one end of a Müller-Lyer figure to the other end. By changing the spatial predictability of the stimulus, we find that the illusion has a clear effect on saccades (16%) when the stimulus is at a highly predictable location. Even stronger effects of the illusion are found when the stimulus location becomes more unpredictable (19-23%). Conversely, manipulating the duration of the stimulus fails to reveal a clear difference in illusion effect. Finally, by computing the illusion effect for different saccadic latencies, we find a maximum illusion effect (about 30%) for very short latencies, which decreases by 7% with every 100 ms latency increase. We conclude that spatial predictability of the stimulus and saccadic latency influences the effect of the Müller-Lyer illusion on saccades.",2010,We conclude that spatial predictability of the stimulus and saccadic latency influences the effect of the Müller-Lyer illusion on saccades.,[],"['Müller-Lyer illusion', 'visual illusions']","['spatial predictability and saccadic latency', 'maximum illusion effect']",[],"[{'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0751246', 'cui_str': 'Illusions, Visual'}]","[{'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0334372,We conclude that spatial predictability of the stimulus and saccadic latency influences the effect of the Müller-Lyer illusion on saccades.,"[{'ForeName': 'Denise D J', 'Initials': 'DD', 'LastName': 'de Grave', 'Affiliation': 'Research Institute MOVE, Faculty of Human Movement Sciences, VU University Amsterdam, Van der Boechorststraat 9, 1081 BT, Amsterdam, The Netherlands. d.degrave@fbw.vu.nl'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bruno', 'Affiliation': ''}]",Experimental brain research,['10.1007/s00221-010-2275-6']
430,20428872,"Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial.","Recombinant human granulocyte colony-stimulating factor (filgrastim) has multiple hematologic and oncologic indications as Neupogen (Amgen filgrastim). Hospira has developed a biosimilar filgrastim (Nivestim). Here, results are reported from a phase I trial, primarily designed to compare the pharmacokinetic profiles of Hospira filgrastim and Amgen filgrastim. A phase I, single-center, open-label, randomized trial was undertaken to demonstrate equivalence of the pharmacokinetic characteristics of Hospira filgrastim and Amgen filgrastim. Forty-eight healthy volunteers were randomized to receive intravenous (i.v.) or subcutaneous (s.c.) dosing and then further randomized to order of treatment. Volunteers in each of the two dosing groups received a single 10microg/kg dose of Hospira filgrastim or Amgen filgrastim, with subsequent crossover. Bioequivalence was evaluated by analysis of variance; if the estimated 90% confidence intervals (CIs) for the ratio of 'test' to 'reference' treatment means were within the conventional equivalence limits of 0.80-1.25, then bioequivalence was concluded. Forty-six volunteers completed the study. Geometric mean area under the curve from time 0 to the last time point (primary endpoint) was similar in volunteers given Hospira filgrastim or Amgen filgrastim following i.v. (ratio of means: 0.96; 90% CI: 0.90-1.02) or s.c. (ratio of means: 1.02; 90% CI: 0.95-1.09) dosing; 90% CIs were within the predefined range necessary to demonstrate bioequivalence. Hospira filgrastim was well tolerated with no additional safety concerns over Amgen filgrastim. Hospira filgrastim is bioequivalent with Amgen filgrastim in terms of its pharmacokinetic properties and may provide a clinically effective alternative.",2010,Geometric mean area under the curve from time 0 to the last time point (primary endpoint) was similar in volunteers given Hospira filgrastim or Amgen filgrastim following i.v.,"['Forty-eight healthy volunteers', 'Forty-six volunteers completed the study']","['Hospira filgrastim', 'Hospira filgrastim and Amgen filgrastim', 'single 10microg/kg dose of Hospira filgrastim or Amgen filgrastim', 'Recombinant human granulocyte colony-stimulating factor (filgrastim', 'biosimilar filgrastim and Amgen filgrastim']",[],"[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]",[],48.0,0.0531661,Geometric mean area under the curve from time 0 to the last time point (primary endpoint) was similar in volunteers given Hospira filgrastim or Amgen filgrastim following i.v.,"[{'ForeName': 'Cornelius F', 'Initials': 'CF', 'LastName': 'Waller', 'Affiliation': 'Medizinische Universitätsklinik, Abt. Innere Medizin I, Hugstetter Strasse 55, Freiburg, Germany. cornelius.waller@uniklinik-freiburg.de'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Bronchud', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Mair', 'Affiliation': ''}, {'ForeName': 'Rodeina', 'Initials': 'R', 'LastName': 'Challand', 'Affiliation': ''}]",Annals of hematology,['10.1007/s00277-010-0961-x']
431,20431994,Learning to dislike alcohol: conditioning negative implicit attitudes toward alcohol and its effect on drinking behavior.,"RATIONALE


Since implicit attitudes toward alcohol play an important role in drinking behavior, a possible way to obtain a behavioral change is changing these implicit attitudes.
OBJECTIVES


This study examined whether a change in implicit attitudes and in drinking behavior can be achieved via evaluative conditioning.
METHODS


Participants were randomly assigned to an experimental condition and a control condition. In the experimental condition, participants were subjected to an evaluative conditioning procedure that consistently pairs alcohol-related cues with negative stimuli. In the control condition, alcohol-related cues were consistently paired with neutral stimuli during the evaluative conditioning phase. Implicit attitudes, explicit attitudes, and drinking behavior were measured before and after the evaluative conditioning phase.
RESULTS


Following the evaluative conditioning procedure, participants in the experimental condition showed stronger negative implicit attitudes toward alcohol and consumed less alcohol compared to participants in the control condition. However, this effect was only found when the evaluative conditioning task paired alcohol-related cues with general negative pictures, but not when using pictures of frowning faces.
CONCLUSIONS


These results demonstrate that evaluative conditioning can effectively change implicit attitudes toward alcohol and also suggest that this procedure can be used to change drinking behavior. Hence, evaluative conditioning may be a useful new intervention tool to combat alcohol misuse.",2010,"Following the evaluative conditioning procedure, participants in the experimental condition showed stronger negative implicit attitudes toward alcohol and consumed less alcohol compared to participants in the control condition.",['Participants'],['evaluative conditioning procedure that consistently pairs alcohol-related cues with negative stimuli'],"['Implicit attitudes, explicit attitudes, and drinking behavior', 'drinking behavior', 'implicit attitudes', 'stronger negative implicit attitudes']",[],"[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.00998424,"Following the evaluative conditioning procedure, participants in the experimental condition showed stronger negative implicit attitudes toward alcohol and consumed less alcohol compared to participants in the control condition.","[{'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Houben', 'Affiliation': 'Clinical Psychological Science, Maastricht University, P. O. Box 616, 6200 MD, Maastricht, The Netherlands. K.Houben@maastrichtuniversity.nl'}, {'ForeName': 'Remco C', 'Initials': 'RC', 'LastName': 'Havermans', 'Affiliation': ''}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-1872-1']
432,20339571,Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period.,"We present the conceptual and empirical foundation and curriculum content of the Mindfulness-Based Childbirth and Parenting (MBCP) program and the results of a pilot study of n = 27 pregnant women participating in MBCP during their third trimester of pregnancy. MBCP is a formal adaptation of the Mindfulness-Based Stress Reduction program and was developed and refined over the course of 11 years of clinical practice with 59 groups of expectant couples. MBCP is designed to promote family health and well-being through the practice of mindfulness during pregnancy, childbirth, and early parenting. Quantitative results from the current study include statistically significant increases in mindfulness and positive affect, and decreases in pregnancy anxiety, depression, and negative affect from pre- to post-test (p < .05). Effect sizes for changes in key hypothesized intervention mediators were large (d > .70), suggesting that MBCP is achieving its intended effects on maternal well-being during pregnancy. Qualitative reports from participants expand upon the quantitative findings, with the majority of participants reporting perceived benefits of using mindfulness practices during the perinatal period and early parenting. Our future research will involve conducting a randomized controlled trial of MBCP to test effects on psychophysiological stress mechanisms and to examine effects on birth outcomes, family relationship quality, and child development outcomes.",2010,"Qualitative reports from participants expand upon the quantitative findings, with the majority of participants reporting perceived benefits of using mindfulness practices during the perinatal period and early parenting.",['n = 27 pregnant women participating in MBCP during their third trimester of pregnancy'],"['Mindfulness-Based Childbirth and Parenting Education', 'Mindfulness-Based Childbirth and Parenting (MBCP) program', 'MBCP']","['pregnancy anxiety, depression, and negative affect from pre- to post-test']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",27.0,0.0332079,"Qualitative reports from participants expand upon the quantitative findings, with the majority of participants reporting perceived benefits of using mindfulness practices during the perinatal period and early parenting.","[{'ForeName': 'Larissa G', 'Initials': 'LG', 'LastName': 'Duncan', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bardacke', 'Affiliation': ''}]",Journal of child and family studies,[]
433,20379742,Electronic reminders for pathologists promote recognition of patients at risk for Lynch syndrome: cluster-randomised controlled trial.,"We investigated success factors for the introduction of a guideline on recognition of Lynch syndrome in patients recently diagnosed with colorectal cancer (CRC) below age 50 or a second CRC below age 70. Pathologists were asked to start microsatellite instability (MSI) testing and report to surgeons with the advice to consider genetic counselling when MSI test or family history was positive. A multicentre cluster-randomised controlled trial (ClinicalTrials.gov, number NCT00141466) was performed in 12 pathology laboratories (clusters), serving 29 community hospitals. All received an introduction to the new guideline. In the intervention group, surgeons received education and tumour test result reminders; pathologists were provided with inclusion criteria cards, an electronic patient inclusion reminder system and feedback on inclusion. Two hundred sixty-six CRC patients were eligible for recognition as at risk for Lynch syndrome. The actual recognition was 18% more successful in the intervention as compared to the control arm (77% (120 of 156) compared to 59% (65 of 110)), with an adjusted odds ratio (OR) = 2.8 (95% confidence interval (CI) 1.1-7.0). The electronic reminder system for pathologists was most strongly associated with recognition of high-risk patients, OR = 4.2 (95% CI 1.7-10.1). An electronic reminder system for pathologists appeared effective for adherence to a new complex guideline and will enhance the recognition of Lynch syndrome.",2010,"The actual recognition was 18% more successful in the intervention as compared to the control arm (77% (120 of 156) compared to 59% (65 of 110)), with an adjusted odds ratio (OR) =","['Two hundred sixty-six CRC patients were eligible for recognition as at risk for Lynch syndrome', '12 pathology laboratories (clusters), serving 29 community hospitals', 'patients at risk for Lynch syndrome', 'patients recently diagnosed with colorectal cancer (CRC) below age 50 or a second CRC below age 70']","['Electronic reminders', 'education and tumour test result reminders; pathologists were provided with inclusion criteria cards, an electronic patient inclusion reminder system and feedback on inclusion']",['actual recognition'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4552100', 'cui_str': 'Lynch Syndrome'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0334866', 'cui_str': 'Pathologists'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085519', 'cui_str': 'Reminder Systems'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}]",266.0,0.186185,"The actual recognition was 18% more successful in the intervention as compared to the control arm (77% (120 of 156) compared to 59% (65 of 110)), with an adjusted odds ratio (OR) =","[{'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Overbeek', 'Affiliation': 'Department of Human Genetics 849, Radboud University Nijmegen Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Hermens', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'van Krieken', 'Affiliation': ''}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Adang', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Casparie', 'Affiliation': ''}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Nagengast', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Ligtenberg', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hoogerbrugge', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Virchows Archiv : an international journal of pathology,['10.1007/s00428-010-0907-7']
434,20145986,Randomized controlled caregiver mediated joint engagement intervention for toddlers with autism.,This study aimed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism. The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later. Compared to caregivers and toddlers randomized to the waitlist control group the immediate treatment (IT) group made significant improvements in targeted areas of joint engagement. The IT group demonstrated significant improvements with medium to large effect sizes in their responsiveness to joint attention and their diversity of functional play acts after the intervention with maintenance of these skills 1 year post-intervention. These are among the first randomized controlled data to suggest that short-term parent-mediated interventions can have important effects on core impairments in toddlers with autism. Clinical Trials #: NCT00065910.,2010,The IT group demonstrated significant improvements with medium to large effect sizes in their responsiveness to joint attention and their diversity of functional play acts after the intervention with maintenance of these skills 1 year post-intervention.,"['caregivers and toddlers with autism', 'toddlers with autism']","['Randomized controlled caregiver mediated joint engagement intervention', 'joint attention intervention']","['targeted areas of joint engagement', 'joint engagement', 'joint attention and their diversity of functional play acts']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",24.0,0.0728498,The IT group demonstrated significant improvements with medium to large effect sizes in their responsiveness to joint attention and their diversity of functional play acts after the intervention with maintenance of these skills 1 year post-intervention.,"[{'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': 'Division of Psychological Studies in Education, University of California Los Angeles, 3132 Moore Hall, UCLA, Los Angeles, CA 90095, USA. kasari@gseis.ucla.edu'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Gulsrud', 'Affiliation': ''}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kwon', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Locke', 'Affiliation': ''}]",Journal of autism and developmental disorders,['10.1007/s10803-010-0955-5']
435,20217117,Plasma triglyceride concentrations are rapidly reduced following individual bouts of endurance exercise in women.,"It is known that chronic endurance training leads to improvements in the lipoprotein profile, but less is known about changes that occur during postexercise recovery acutely. We analyzed triglyceride (TG), cholesterol classes and apolipoproteins in samples collected before, during and after individual moderate- and hard-intensity exercise sessions in men and women that were isoenergetic between intensities. Young healthy men (n = 9) and young healthy women (n = 9) were studied under three different conditions with diet unchanged between trials: (1) before, during and 3 h after 90 min of exercise at 45% VO(2)peak (E45); (2) before, during and 3 h after 60 min of exercise at 65% VO(2)peak (E65), and (3) in a time-matched sedentary control trial (C). At baseline, high-density lipoprotein cholesterol (HDL-C) was higher in women than men (P < 0.05). In men and in women, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), HDL-C, apolipoprotein A-I (apoA-I), apolipoprotein B (apoB), and LDL peak particle size were unaltered by exercise either during exertion or after 3 h of recovery. In women, but not in men, average plasma TG was significantly reduced below C at 3 h postexercise by approximately 15% in E45 and 25% in E65 (P < 0.05) with no significant difference between exercise intensities. In summary, plasma TG concentration rapidly declines following exercise in women, but not in men. These results demonstrate an important mechanism by which each individual exercise session may incrementally reduce the risk for cardiovascular disease (CVD) in women.",2010,"In women, but not in men, average plasma TG was significantly reduced below C at 3 h postexercise by approximately 15% in E45 and 25% in E65 (P < 0.05) with no significant difference between exercise intensities.","['women', 'Young healthy men (n = 9) and young healthy women (n = 9']",['individual moderate- and hard-intensity exercise sessions'],"['triglyceride (TG), cholesterol classes and apolipoproteins', 'high-density lipoprotein cholesterol (HDL-C', 'average plasma TG', 'total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), HDL-C, apolipoprotein A-I (apoA-I), apolipoprotein B (apoB), and LDL peak particle size', 'risk for cardiovascular disease (CVD', 'Plasma triglyceride concentrations']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0622790', 'cui_str': 'Apo A-I (Giessen)'}, {'cui': 'C0756567', 'cui_str': 'apoA-I(Zavalla)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",9.0,0.108,"In women, but not in men, average plasma TG was significantly reduced below C at 3 h postexercise by approximately 15% in E45 and 25% in E65 (P < 0.05) with no significant difference between exercise intensities.","[{'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Henderson', 'Affiliation': 'Exercise Physiology Laboratory, Department of Integrative Biology, University of California, 5101 Valley Life Sciences Building, Berkeley, CA 94720-3140, USA.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Krauss', 'Affiliation': ''}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Fattor', 'Affiliation': ''}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Faghihnia', 'Affiliation': ''}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Luke-Zeitoun', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Brooks', 'Affiliation': ''}]",European journal of applied physiology,['10.1007/s00421-010-1409-7']
436,20198491,Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease.,"BACKGROUND


This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD).
METHODS


A prospective, randomized, sham-controlled, single-blinded, international multicenter study planned final enrollment of 204 patients in three groups: up to 60 lead-in, 96 GK, and 48 sham patients. The sham patients were allowed to cross over to the GK treatment arm or exit the study at 6 months. The primary end points were (1) reduction in serious device- and procedure-related adverse device effects compared with a surgical composite complication rate and (2) reduction in heartburn symptoms 6 months after the GK procedure compared with the sham procedure. The secondary end point was improved esophageal pH (total time pH was <4) 6 months after the GK procedure compared with baseline.
RESULTS


A planned interim analysis was performed after 143 patients were enrolled (25 lead-in, 75 GK, and 43 sham patients), and the GK study was terminated early due to lack of compelling efficacy data. Four reported serious adverse events had occurred (2 perforations, 1 pulmonary infiltrate related to a perforation, and 1 severe chest pain) at termination of the study with no mortality or long-term sequelae. Heartburn symptoms had improved significantly at 6 months compared with baseline in the GK group (p < 0.0001) and the sham group (p < 0.0001), but no significant between-group difference in improvement was observed (p = 0.146). Esophageal acid exposure had improved significantly at 6 months compared with baseline in the GK group (p = 0.021) and the sham group (p = 0.003), but no significant between-group difference in improvement was observed (p = 0.27).
CONCLUSIONS


The GK procedure was associated with some serious but infrequent complications. No statistically significant difference in outcomes was observed between the treatment and control groups at 6 months compared with baseline.",2010,"Esophageal acid exposure had improved significantly at 6 months compared with baseline in the GK group (p = 0.021) and the sham group (p = 0.003), but no significant between-group difference in improvement was observed (p = 0.27).
","['gastroesophageal reflux disease', '204 patients in three groups: up to 60 lead-in, 96 GK, and 48 sham patients', '143 patients were enrolled (25 lead-in, 75 GK, and 43 sham patients']","['injectable esophageal prosthesis', 'endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK']","['Heartburn symptoms', 'esophageal pH (total time pH', 'serious adverse events', 'serious device- and procedure-related adverse device effects', 'surgical composite complication rate and (2) reduction in heartburn symptoms', 'Esophageal acid exposure']","[{'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}]","[{'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0182452', 'cui_str': 'Esophageal prosthesis (physical object)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C1504385', 'cui_str': 'Oesophageal pH'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",143.0,0.34024,"Esophageal acid exposure had improved significantly at 6 months compared with baseline in the GK group (p = 0.021) and the sham group (p = 0.003), but no significant between-group difference in improvement was observed (p = 0.27).
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fockens', 'Affiliation': 'Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, the Netherlands.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Edmundowicz', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Binmoeller', 'Affiliation': ''}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Rothstein', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Nickl', 'Affiliation': ''}, {'ForeName': 'Bergein', 'Initials': 'B', 'LastName': 'Overholt', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kahrilas', 'Affiliation': ''}, {'ForeName': 'Nimish', 'Initials': 'N', 'LastName': 'Vakil', 'Affiliation': ''}, {'ForeName': 'Ayman M', 'Initials': 'AM', 'LastName': 'Abdel Aziz Hassan', 'Affiliation': ''}, {'ForeName': 'Glen A', 'Initials': 'GA', 'LastName': 'Lehman', 'Affiliation': ''}]",Surgical endoscopy,['10.1007/s00464-009-0784-9']
437,20155327,"No negative effects of a multi-factorial, intensified treatment on self-reported health status, treatment satisfaction, and diabetes-related distress in screen-detected type 2 diabetes patients. The ADDITION-Netherlands study.","PURPOSE


To examine the effects of a multi-factorial, intensified treatment on self-reported health status, treatment satisfaction, and diabetes-related distress in screen-detected type 2 diabetes patients.
METHODS


Cluster-randomised controlled trial; A total of 498 screen-detected type 2 diabetes patients from 79 general practices were assigned to intensified (n = 255) or routine treatment according to Dutch guidelines (n = 243). At baseline and after 3 years, patients completed the Short Form-36 and the European Quality of Life-5 Dimensions questionnaires. After 4.5 years, patients completed the Diabetes Treatment Satisfaction Questionnaire and the Problem Areas In Diabetes scale. We analysed the effects of intensified treatment on self-rated health status, treatment satisfaction, and diabetes-related distress, using random effects models to account for clustering at practice level.
RESULTS


Three to 5 years after type 2 diabetes was detected by screening, there were no differences between intensified and routine treatment in self-reported health status, treatment satisfaction, and diabetes-related distress.
CONCLUSIONS


Multi-factorial, intensified treatment did not influence self-rated health status, treatment satisfaction, and distress in screen-detected type 2 diabetes patients. Therefore, health care professionals do not have to fear negative effects of an intensified treatment on these psychological outcomes.",2010,"We analysed the effects of intensified treatment on self-rated health status, treatment satisfaction, and diabetes-related distress, using random effects models to account for clustering at practice level.
","['screen-detected type 2 diabetes patients', '498 screen-detected type 2 diabetes patients from 79 general practices']",[],"['self-reported health status, treatment satisfaction, and diabetes-related distress', 'European Quality of Life-5 Dimensions questionnaires', 'health status, treatment satisfaction, and diabetes-related distress']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0034380'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",498.0,0.0345886,"We analysed the effects of intensified treatment on self-rated health status, treatment satisfaction, and diabetes-related distress, using random effects models to account for clustering at practice level.
","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'van den Donk', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Str. 6.131, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands. m.vandendonk@umcutrecht.nl'}, {'ForeName': 'Kees J', 'Initials': 'KJ', 'LastName': 'Gorter', 'Affiliation': ''}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Rutten', 'Affiliation': ''}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-010-9604-x']
438,20157623,Adherence to Scheduled Sessions in a Randomized Field Trial of Case Management: The Criminal Justice-Drug Abuse Treatment Studies Transitional Case Management Study.,"The Transitional Case Management (TCM) study, one of the projects of the Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) cooperative, was a multi-site randomized test of whether a strengths-based case management intervention provided during an inmate's transition from incarceration to the community increases participation in community substance abuse treatment, enhances access to needed social services, and improves drug use and crime outcomes. As in many intervention studies, TCM experienced a relatively large percentage of treatment-group participants who attended few or no scheduled sessions. The paper discusses issues with regard to participation in community case management sessions, examines patterns of session attendance among TCM participants, and analyzes client and case manager characteristics that are associated with number of sessions attended and with patterns of attendance. The average number of sessions (out of 12) attended was 5.7. Few client or case manager characteristics were found to be significantly related to session attendance. Clinical and research implications of the findings and of adherence in case management generally are discussed.",2009,Few client or case manager characteristics were found to be significantly related to session attendance.,['Case Management'],['TCM'],[],"[{'cui': 'C0085971', 'cui_str': 'Case Management'}]",[],[],12.0,0.0184088,Few client or case manager characteristics were found to be significantly related to session attendance.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Prendergast', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Greenwell', 'Affiliation': ''}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Cartier', 'Affiliation': ''}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Sacks', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Frisman', 'Affiliation': ''}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Rodis', 'Affiliation': ''}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Havens', 'Affiliation': ''}]",Journal of experimental criminology,[]
439,20204538,Cost-effectiveness of strategies to improve HIV testing and receipt of results: economic analysis of a randomized controlled trial.,"BACKGROUND


The CDC recommends routine voluntary HIV testing of all patients 13-64 years of age. Despite this recommendation, HIV testing rates are low even among those at identifiable risk, and many patients do not return to receive their results.
OBJECTIVE


To examine the costs and benefits of strategies to improve HIV testing and receipt of results.
DESIGN


Cost-effectiveness analysis based on a Markov model. Acceptance of testing, return rates, and related costs were derived from a randomized trial of 251 patients; long-term costs and health outcomes were derived from the literature. SETTING/TARGET POPULATION: Primary-care patients with unknown HIV status.
INTERVENTIONS


Comparison of three intervention models for HIV counseling and testing: Model A = traditional HIV counseling and testing; Model B = nurse-initiated routine screening with traditional HIV testing and counseling; Model C = nurse-initiated routine screening with rapid HIV testing and streamlined counseling.
MAIN MEASURES


Life-years, quality-adjusted life-years (QALYs), costs and incremental cost-effectiveness.
KEY RESULTS


Without consideration of the benefit from reduced HIV transmission, Model A resulted in per-patient lifetime discounted costs of $48,650 and benefits of 16.271 QALYs. Model B increased lifetime costs by $53 and benefits by 0.0013 QALYs (corresponding to 0.48 quality-adjusted life days). Model C cost $66 more than Model A with an increase of 0.0018 QALYs (0.66 quality-adjusted life days) and an incremental cost-effectiveness of $36,390/QALY. When we included the benefit from reduced HIV transmission, Model C cost $10,660/QALY relative to Model A. The cost-effectiveness of Model C was robust in sensitivity analyses.
CONCLUSIONS


In a primary-care population, nurse-initiated routine screening with rapid HIV testing and streamlined counseling increased rates of testing and receipt of test results and was cost-effective compared with traditional HIV testing strategies.",2010,Model B increased lifetime costs by $53 and benefits by 0.0013 QALYs (corresponding to 0.48 quality-adjusted life days).,"['patients 13-64 years of age', '251 patients', 'HIV counseling and testing', ' Primary-care patients with unknown HIV status']",['traditional HIV counseling and testing; Model B = nurse-initiated routine screening with traditional HIV testing and counseling; Model C = nurse-initiated routine screening with rapid HIV testing and streamlined counseling'],"['reduced HIV transmission, Model C cost $10,660/QALY relative to Model A', 'lifetime costs', 'incremental cost-effectiveness', 'Life-years, quality-adjusted life-years (QALYs), costs and incremental cost-effectiveness', 'Model C cost', 'Acceptance of testing, return rates, and related costs', 'long-term costs and health outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",251.0,0.0524181,Model B increased lifetime costs by $53 and benefits by 0.0013 QALYs (corresponding to 0.48 quality-adjusted life days).,"[{'ForeName': 'Gillian D', 'Initials': 'GD', 'LastName': 'Sanders', 'Affiliation': 'Duke Clinical Research Institute, Duke University, PO Box 17969, Durham, NC 27715, USA. gillian.sanders@duke.edu'}, {'ForeName': 'Henry D', 'Initials': 'HD', 'LastName': 'Anaya', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Asch', 'Affiliation': ''}, {'ForeName': 'Tuyen', 'Initials': 'T', 'LastName': 'Hoang', 'Affiliation': ''}, {'ForeName': 'Joya F', 'Initials': 'JF', 'LastName': 'Golden', 'Affiliation': ''}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Bayoumi', 'Affiliation': ''}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Owens', 'Affiliation': ''}]",Journal of general internal medicine,['10.1007/s11606-010-1265-5']
440,20349155,A randomized community-based intervention trial comparing faith community nurse referrals to telephone-assisted physician appointments for health fair participants with elevated blood pressure.,"OBJECTIVE


To measure the effect of faith community nurse referrals versus telephone-assisted physician appointments on blood pressure control among persons with elevated blood pressure at health fairs.
METHODS


Randomized community-based intervention trial conducted from October 2006 to October 2007 of 100 adults who had an average blood pressure reading equal to or above a systolic of 140 mm Hg or a diastolic of 90 mm Hg obtained at a faith community nurse-led church health event. Participants were randomized to either referral to a faith community nurse or to a telephone-assisted physician appointment. The average enrollment systolic blood pressure (SBP) was 149 +/- 14 mm Hg, diastolic blood pressure (DBP) was 87 +/- 11 mm Hg, 57% were uninsured and 25% were undiagnosed at the time of enrollment.
RESULTS


The follow-up rate was 85% at 4 months. Patients in the faith community nurse referral arm had a 7 +/- 15 mm Hg drop in SBP versus a 14 +/- 15 mm Hg drop in the telephone-assisted physician appointment arm (p = 0.04). Twenty-seven percent of the patients in the faith community nurse referral arm had medication intensification compared to 32% in the telephone-assisted physician appointment arm (p = 0.98).
CONCLUSIONS


Church health fairs conducted in low-income, multiethnic communities can identify many people with elevated blood pressure. Facilitating physician appointments for people with elevated blood pressure identified at health fairs confers a greater decrease in SBP than referral to a faith community nurse at four months.",2010,Facilitating physician appointments for people with elevated blood pressure identified at health fairs confers a greater decrease in SBP than referral to a faith community nurse at four months.,"['persons with elevated blood pressure at health fairs', 'Randomized community-based intervention trial conducted from October 2006 to October 2007 of 100 adults who had an average blood pressure reading equal to or above a systolic of 140 mm Hg or a diastolic of 90 mm Hg obtained at a faith community nurse-led church health event', 'Patients in the faith community nurse referral arm had a 7 +/- 15 mm Hg drop in SBP versus a 14 ', 'for health fair participants with elevated blood pressure']","['referral to a faith community nurse or to a telephone-assisted physician appointment', 'telephone-assisted physician appointments']","['SBP', 'medication intensification', 'blood pressure control', 'diastolic blood pressure (DBP', 'average enrollment systolic blood pressure (SBP']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0018715', 'cui_str': 'Health Fairs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4301973', 'cui_str': 'Average blood pressure (observable entity)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0557521', 'cui_str': 'Community nurse (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]","[{'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0557521', 'cui_str': 'Community nurse (occupation)'}, {'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",57.0,0.0436341,Facilitating physician appointments for people with elevated blood pressure identified at health fairs confers a greater decrease in SBP than referral to a faith community nurse at four months.,"[{'ForeName': 'Arshiya A', 'Initials': 'AA', 'LastName': 'Baig', 'Affiliation': 'Department of Medicine, Section of General Internal Medicine, University of Chicago, Chicago, IL 60637, USA. abaig@uchicago.edu'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Mangione', 'Affiliation': ''}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Sorrell-Thompson', 'Affiliation': ''}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Miranda', 'Affiliation': ''}]",Journal of general internal medicine,['10.1007/s11606-010-1326-9']
441,20340049,Health-related quality of life after fast-track treatment results from a randomized controlled clinical equivalence trial.,"PURPOSE


This randomized clinical equivalence trial was designed to evaluate health-related quality of life (HRQoL) after fast-track treatment for low-risk coronary artery bypass (CABG) patients.
METHODS


Four hundred and ten CABG patients were randomly assigned to undergo either short-stay intensive care treatment (SSIC, 8 h of intensive care stay) or control treatment (care as usual, overnight intensive care stay). HRQoL was measured at baseline and 1 month, and one year after surgery using the multidimensional index of life quality (MILQ), the EQ-5D, the Beck Depression Inventory and the State-Trait Anxiety Inventory.
RESULTS


At one month after surgery, no statistically significant difference in overall HRQoL was found (MILQ-score P-value=.508, overall MILQ-index P-value=.543, EQ-5D VAS P-value=.593). The scores on the MILQ-domains, physical, and social functioning were significantly higher at one month postoperatively in the SSIC group compared to the control group (P-value=.049; 95%CI: 0.01-2.50 and P-value=.014, 95% CI: 0.24-2.06, respectively). However, these differences were no longer observed at long-term follow-up.
CONCLUSIONS


According to our definition of clinical equivalence, the HRQoL of SSIC patients is similar to patients receiving care as usual. Since safety and the financial benefits of this intervention were demonstrated in a previously reported analysis, SSIC can be considered as an adequate fast-track intensive care treatment option for low-risk CABG patients.",2010,"The scores on the MILQ-domains, physical, and social functioning were significantly higher at one month postoperatively in the SSIC group compared to the control group (P-value=.049; 95%CI: 0.01-2.50 and P-value=.014, 95% CI: 0.24-2.06, respectively).","['Four hundred and ten CABG patients', 'low-risk coronary artery bypass (CABG) patients', 'low-risk CABG patients']","['short-stay intensive care treatment (SSIC, 8 h of intensive care stay) or control treatment (care as usual, overnight intensive care stay']","['Health-related quality of life', 'overall HRQoL', 'MILQ-domains, physical, and social functioning', 'multidimensional index of life quality (MILQ), the EQ-5D, the Beck Depression Inventory and the State-Trait Anxiety Inventory', 'HRQoL', 'health-related quality of life (HRQoL']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0085559'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",410.0,0.174417,"The scores on the MILQ-domains, physical, and social functioning were significantly higher at one month postoperatively in the SSIC group compared to the control group (P-value=.049; 95%CI: 0.01-2.50 and P-value=.014, 95% CI: 0.24-2.06, respectively).","[{'ForeName': 'Ghislaine A P G', 'Initials': 'GA', 'LastName': 'van Mastrigt', 'Affiliation': 'Clinical Epidemiology and Medical Technology Assessment, University Hospital Maastricht, Maastricht, Netherlands. ghislainevanmastrigt@orange.nl'}, {'ForeName': 'Manuela A', 'Initials': 'MA', 'LastName': 'Joore', 'Affiliation': ''}, {'ForeName': 'Fred H M', 'Initials': 'FH', 'LastName': 'Nieman', 'Affiliation': ''}, {'ForeName': 'Johan L', 'Initials': 'JL', 'LastName': 'Severens', 'Affiliation': ''}, {'ForeName': 'Jos G', 'Initials': 'JG', 'LastName': 'Maessen', 'Affiliation': ''}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-010-9625-5']
442,20229077,Health locus of control and assimilation of cervical cancer information in Deaf women.,"This study assessed the relationship between Deaf women's internal health locus of control (IHLC) and their cervical cancer knowledge acquisition and retention. A blind, randomized trial evaluated Deaf women's (N = 130) baseline cancer knowledge and knowledge gained and retained from an educational intervention, in relation to their IHLC. The Multidimensional Health Locus of Control scales measured baseline IHLC, and a cervical cancer knowledge survey evaluated baseline to post-intervention knowledge change. Women's IHLC did not significantly predict greater cervical cancer knowledge at baseline or over time. IHLC does not appear to be a characteristic that must be considered when creating Deaf women's cancer education programs.",2010,Women's IHLC did not significantly predict greater cervical cancer knowledge at baseline or over time.,"['Deaf women', ""Deaf women's internal health locus of control (IHLC) and their cervical cancer knowledge acquisition and retention"", ""Deaf women's (N = 130) baseline cancer knowledge and knowledge gained and retained from an educational intervention, in relation to their IHLC""]",['IHLC'],['cervical cancer knowledge'],"[{'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}]",[],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0568919,Women's IHLC did not significantly predict greater cervical cancer knowledge at baseline or over time.,"[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Moores UCSD Cancer Center, La Jolla, CA, USA.'}, {'ForeName': 'Arianna A', 'Initials': 'AA', 'LastName': 'Aldridge', 'Affiliation': ''}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Malcarne', 'Affiliation': ''}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Choe', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Branz', 'Affiliation': ''}, {'ForeName': 'Georgia Robins', 'Initials': 'GR', 'LastName': 'Sadler', 'Affiliation': ''}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-010-0053-6']
443,20229132,Interventions delivered in clinical settings are effective in reducing risk of HIV transmission among people living with HIV: results from the Health Resources and Services Administration (HRSA)'s Special Projects of National Significance initiative.,"To support expanded prevention services for people living with HIV, the US Health Resources and Services Administration (HRSA) sponsored a 5-year initiative to test whether interventions delivered in clinical settings were effective in reducing HIV transmission risk among HIV-infected patients. Across 13 demonstration sites, patients were randomized to one of four conditions. All interventions were associated with reduced unprotected vaginal and/or anal intercourse with persons of HIV-uninfected or unknown status among the 3,556 participating patients. Compared to the standard of care, patients assigned to receive interventions from medical care providers reported a significant decrease in risk after 12 months of participation. Patients receiving prevention services from health educators, social workers or paraprofessional HIV-infected peers reported significant reduction in risk at 6 months, but not at 12 months. While clinics have a choice of effective models for implementing prevention programs for their HIV-infected patients, medical provider-delivered methods are comparatively robust.",2010,"All interventions were associated with reduced unprotected vaginal and/or anal intercourse with persons of HIV-uninfected or unknown status among the 3,556 participating patients.","['3,556 participating patients', 'people living with HIV', 'Patients receiving prevention services from health educators, social workers or paraprofessional HIV-infected peers']",[],"['risk of HIV transmission', 'unprotected vaginal and/or anal intercourse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1136362', 'cui_str': 'Health Educators'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}]",3556.0,0.0294312,"All interventions were associated with reduced unprotected vaginal and/or anal intercourse with persons of HIV-uninfected or unknown status among the 3,556 participating patients.","[{'ForeName': 'Janet J', 'Initials': 'JJ', 'LastName': 'Myers', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, 50 Beale Street, Suite 1300, San Francisco, CA 94105, USA. janet.myers@ucsf.edu'}, {'ForeName': 'Starley B', 'Initials': 'SB', 'LastName': 'Shade', 'Affiliation': ''}, {'ForeName': 'Carol Dawson', 'Initials': 'CD', 'LastName': 'Rose', 'Affiliation': ''}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Koester', 'Affiliation': ''}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': ''}, {'ForeName': 'Faye E', 'Initials': 'FE', 'LastName': 'Malitz', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bie', 'Affiliation': ''}, {'ForeName': 'Mi-Suk', 'Initials': 'MS', 'LastName': 'Kang-Dufour', 'Affiliation': ''}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Morin', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-010-9679-y']
444,20358216,"Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial.","Lower limb spasticity in post-stroke patients can impair ambulation and reduces activities of daily living (ADL) performance of patients. Botulinum toxin type A (BoNTA) has been shown effective for upper limb spasticity. This study assesses the treatment of lower limb spasticity in a large placebo-controlled clinical trial. In this multicenter, randomized, double-blind, parallel-group, placebo-controlled study, we evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke lower limb spasticity. One hundred twenty patients with lower limb spasticity were randomized to a single treatment with BoNTA 300 U or placebo. The tone of the ankle flexor was assessed at baseline and through 12 weeks using the Modified Ashworth Scale (MAS). Gait pattern and speed of gait were also assessed. The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS ankle score. Significant improvement in spasticity with BoNTA 300 U was demonstrated by a mean difference in the AUC of the change from baseline in the MAS ankle score between the BoNTA and placebo groups (-3.428; 95% CIs, -5.841 to -1.016; p = 0.006; t test). A significantly greater decrease from baseline in the MAS ankle score was noted at weeks 4, 6 and 8 in the BoNTA group compared to the placebo group (p < 0.001). Significant improvement in the Clinicians Global Impression was noted by the investigator at weeks 4, 6 and 8 (p = 0.016-0.048, Wilcoxon test), but not by the patient or physical/occupational therapist. Assessments of gait pattern using the Physician's Rating Scale and speed of gait revealed no significant treatment differences but showed a tendency towards improvement with BoNTA. No marked difference was noted in the frequency of treatment-related adverse events between BoNTA and placebo groups. This was the first large-scale trial to indicate that BoNTA significantly reduced spasticity in lower limb muscles.",2010,Lower limb spasticity in post-stroke patients can impair ambulation and reduces activities of daily living (ADL) performance of patients.,"['post-stroke lower limb spasticity', 'One hundred twenty patients with lower limb spasticity', 'Japanese patients with post-stroke lower limb spasticity', 'patients']","['Botulinum toxin type A', 'Botulinum toxin type A (BoNTA', 'placebo', 'botulinum toxin type A (BoNTA']","['frequency of treatment-related adverse events', 'MAS ankle score', 'efficacy and safety', 'Gait pattern and speed of gait', ""Physician's Rating Scale and speed of gait"", 'limb spasticity', 'Clinicians Global Impression', 'activities of daily living (ADL) performance', 'tone of the ankle flexor', 'spasticity', 'area under the curve (AUC) of the change from baseline in the MAS ankle score']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0222045'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}]",120.0,0.412916,Lower limb spasticity in post-stroke patients can impair ambulation and reduces activities of daily living (ADL) performance of patients.,"[{'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Kaji', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Health Biosciences, Tokushima University Graduate School, 2-50-1 Kuramotocho, Tokushima, Tokushima 770-8503, Japan. rkaji@clin.med.tokushima-u.ac.jp'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Osako', 'Affiliation': ''}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Suyama', 'Affiliation': ''}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': ''}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Uechi', 'Affiliation': ''}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Iwasaki', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-010-5526-3']
445,20358265,Predictors of hepatitis knowledge improvement among methadone maintained clients enrolled in a hepatitis intervention program.,"This randomized, controlled study (n = 256) was conducted to compare three interventions designed to promote hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination completion, among clients undergoing methadone maintenance treatment (MMT) in Los Angeles and Santa Monica. The participants were randomized into three groups: Motivational Interviewing-Single Session (MI-Single), Motivational Interviewing-Group (MI-Group), or Nurse-Led Hepatitis Health Promotion (HHP). All three treatment groups received the 3-series HAV/HBV vaccine. The MI sessions were provided by trained therapists, the Nurse-Led HHP sessions were delivered by a research nurse. The main outcome variable of interest was improvement in HBV and HCV knowledge, measured by a 6-item HBV and a 7-item HCV knowledge and attitude tool that was administered at baseline and at 6-month follow-up. The study results showed that there was a significant increase in HBV- and HCV-related knowledge across all three groups (p < 0.0001). There were no significant differences found with respect to knowledge acquisition among the groups. Irrespective of treatment group, gender (P = 0.008), study site (P < 0.0001) and whether a participant was abused as a child (P = 0.017) were all found to be predictors of HCV knowledge improvement; only recruitment site (P < 0.0001) was found to be a predictor of HBV knowledge. The authors concluded that, although MI-Single, MI-Group and Nurse-Led HHP are all effective in promoting HBV and HCV knowledge acquisition among MMT clients, Nurse-Led HHP may be the method of choice for this population as it may be easier to integrate and with additional investigation may prove to be more cost efficient.",2010,There were no significant differences found with respect to knowledge acquisition among the groups.,"['maintained clients enrolled in a hepatitis intervention program', 'clients undergoing methadone maintenance treatment (MMT) in Los Angeles and Santa Monica', 'n = 256']","['methadone', '3-series HAV/HBV vaccine', 'interventions designed to promote hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination completion', 'Motivational Interviewing-Single Session (MI-Single), Motivational Interviewing-Group (MI-Group), or Nurse-Led Hepatitis Health Promotion (HHP']","['HBV- and HCV-related knowledge', 'hepatitis knowledge improvement', 'HBV and HCV knowledge, measured by a 6-item HBV and a 7-item HCV knowledge and attitude tool', 'knowledge acquisition']","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0376325', 'cui_str': 'Hepatitis A Virus'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}]",256.0,0.0186159,There were no significant differences found with respect to knowledge acquisition among the groups.,"[{'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Nyamathi', 'Affiliation': 'UCLA, School of Nursing, 700 Tiverton Avenue, Los Angeles, CA 90095-1702, USA. anyamath@sonnet.ucla.edu'}, {'ForeName': 'Darlene', 'Initials': 'D', 'LastName': 'Tyler', 'Affiliation': ''}, {'ForeName': 'Karabi', 'Initials': 'K', 'LastName': 'Sinha', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Marfisee', 'Affiliation': ''}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Greengold', 'Affiliation': ''}]",Journal of community health,['10.1007/s10900-010-9266-1']
446,20234765,"Testing the Efficacy of INSIGHTS on Student Disruptive Behavior, Classroom Management, and Student Competence in Inner City Primary Grades.","A prevention trial tested the efficacy of INSIGHTS into Children's Temperament as compared to a Read Aloud attention control condition in reducing student disruptive behavior and enhancing student competence and teacher classroom management. Participants included 116 first and second grade students, their parents, and their 42 teachers in six inner city schools. Teachers completed the Sutter-Eyberg Student Behavior Inventory (SESBI) and the Teacher's Rating Scale of Child's Actual Competence and Social Acceptance (TRS) at baseline and again upon completion of the intervention. Boys participating in INSIGHTS, compared with those in the Read Aloud program, showed a significant decline in attentional difficulties and overt aggression toward others. Teachers in INSIGHTS, compared to those in the attention control condition, reported significantly fewer problems managing the emotional-oppositional behavior, attentional difficulties, and covert disruptive behavior of their male students. They also perceived the boys as significantly more cognitively and physically competent.",2010,"Teachers in INSIGHTS, compared to those in the attention control condition, reported significantly fewer problems managing the emotional-oppositional behavior, attentional difficulties, and covert disruptive behavior of their male students.","['Participants included 116 first and second grade students, their parents, and their 42 teachers in six inner city schools', ""Children's Temperament""]",[],"['emotional-oppositional behavior, attentional difficulties, and covert disruptive behavior', ""Sutter-Eyberg Student Behavior Inventory (SESBI) and the Teacher's Rating Scale of Child's Actual Competence and Social Acceptance (TRS"", 'attentional difficulties and overt aggression', 'Student Disruptive Behavior, Classroom Management, and Student Competence']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205452', 'cui_str': 'Six'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}]",[],"[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0222045'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}]",116.0,0.0241015,"Teachers in INSIGHTS, compared to those in the attention control condition, reported significantly fewer problems managing the emotional-oppositional behavior, attentional difficulties, and covert disruptive behavior of their male students.","[{'ForeName': 'Sandra Graham', 'Initials': 'SG', 'LastName': 'McClowry', 'Affiliation': ''}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Snow', 'Affiliation': ''}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Tamis-Lemonda', 'Affiliation': ''}, {'ForeName': 'Eileen T', 'Initials': 'ET', 'LastName': 'Rodriguez', 'Affiliation': ''}]",School mental health,[]
447,20234828,"Relationship between atomoxetine plasma concentration, treatment response and tolerability in attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder.","The purpose of this study was to examine whether atomoxetine plasma concentration predicts attention-deficit/hyperactivity disorder (ADHD) or oppositional defiant disorder (ODD) response. This post-hoc analysis assessed the relationship between atomoxetine plasma concentration and ADHD and ODD symptoms in patients (with ADHD and comorbid ODD) aged 6-12 years. Patients were randomly assigned to atomoxetine 1.2 mg/kg/day (n=156) or placebo (n=70) for 8 weeks (Study Period II). At the end of 8 weeks, ODD non-remitters (score >9 on the SNAP-IV ODD subscale and CGI-I > 2) with atomoxetine plasma concentration <800 ng/ml at 2 weeks were re-randomized to either atomoxetine 1.2 mg/kg/day or 2.4 mg/kg/day for an additional 4 weeks (Study Period III). ODD remitters and non-remitters with plasma atomoxetine ≥800 ng/ml remained on 1.2 mg/kg/day atomoxetine for 4 weeks. Patients who received atomoxetine, completed Study Period II, and entered Study Period III were included in these analyses. All the groups demonstrated improvement on the SNAP-IV ODD and ADHD-combined subscales (P<.001). At the end of Study Periods II and III, ODD and ADHD improvement was significantly greater in the remitter group compared with the non-remitter groups. Symptom improvement was numerically greater in the non-remitter (2.4 mg/kg/day compared with the non-remitter 1.2 mg/kg/day) group. Atomoxetine plasma concentration was not indicative of ODD and ADHD improvement after 12 weeks of treatment. ADHD and ODD symptoms improved in all the groups with longer duration on atomoxetine. Results suggest atomoxetine plasma concentration does not predict ODD and ADHD symptom improvement. However, a higher atomoxetine dose may benefit some patients.",2009,All the groups demonstrated improvement on the SNAP-IV ODD and ADHD-combined subscales (P<.001).,"['patients (with ADHD and comorbid ODD) aged 6-12 years', 'attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder']","['atomoxetine plasma concentration', 'atomoxetine', 'placebo', 'plasma atomoxetine']","['atomoxetine plasma concentration and ADHD and ODD symptoms', 'ADHD and ODD symptoms', 'ODD and ADHD improvement', 'ODD and ADHD symptom improvement', 'Atomoxetine plasma concentration', 'SNAP-IV ODD and ADHD-combined subscales', 'oppositional defiant disorder (ODD) response', 'Symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0074709', 'cui_str': 'Snap (resin)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}]",,0.0659676,All the groups demonstrated improvement on the SNAP-IV ODD and ADHD-combined subscales (P<.001).,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hazell', 'Affiliation': 'Discipline of Psychological Medicine, Concord Clinical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'Eija A', 'Initials': 'EA', 'LastName': 'Nikkanen', 'Affiliation': ''}, {'ForeName': 'Paula T', 'Initials': 'PT', 'LastName': 'Trzepacz', 'Affiliation': ''}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Tabas', 'Affiliation': ''}, {'ForeName': 'Deborah N', 'Initials': 'DN', 'LastName': ""D'Souza"", 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Witcher', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ponsler', 'Affiliation': ''}, {'ForeName': 'Ralf W', 'Initials': 'RW', 'LastName': 'Dittmann', 'Affiliation': ''}]",Attention deficit and hyperactivity disorders,['10.1007/s12402-009-0012-4']
448,20234858,Effect of vitamin D supplementation on bone health parameters of healthy young Indian women.,"SUMMARY: There is a huge prevalence of hypovitaminosis D in the Indian population. We studied the efficacy and safety of oral vitamin D supplementation in apparently healthy adult women. Monthly cholecalciferol given orally, 60,000 IU/month during summers and 120,000 IU/month during winters, safely increases 25-hydroxyvitamin D (25(OH)D) levels to near normal levels. INTRODUCTION: There is a huge burden of hypovitaminosis D in the Indian population. The current recommendation for vitamin D supplementation is not supported by sufficient evidence. METHODS: Study subjects included 100 healthy adult women of reproductive age group from hospital staff. They were randomized into group A (control) and group B (supplement) by simple randomization. Group B received 60,000 IU of cholecalciferol/month administered orally for 3 months, and then group A received 60,000 IU and group B 120,000 IU/month for 6 months. RESULTS: Mean baseline 25(OH)D level was 4.5 +/- 3.1 ng/ml and parathyroid hormone level was 50 +/- 25 pg/ml. In group B, 25(OH)D levels increased from 4.8 +/- 3.5 to 31.6 +/- 15.5 ng/ml (P < 0.001) in 3 months. Interestingly, the increase, although of lower magnitude, was also observed in control group A, from 4.5 +/- 3.4 ng/ml (in spring) to 10.8 +/- 7.2 ng/ml (in summer; P < 0.001). In group A (60,000 IU/month), mean 25(OH)D level had increased to 22.3 +/- 12.4 ng/ml (P < 0.001) at 9 months (winter). In group B (120,000 IU/month), 25(OH)D levels were maintained at 30.7 +/- 12.8 ng/ml at 9 months (winter). CONCLUSION: Our data show that monthly administration of 60,000 IU cholecalciferol in healthy subjects with hypovitaminosis D may suffice in summer months, but higher doses may be more appropriate during winter months.",2009,"Interestingly, the increase, although of lower magnitude, was also observed in control group A, from 4.5 +/-","['healthy young Indian women', 'Study subjects included 100 healthy adult women of reproductive age group from hospital staff', 'healthy subjects with hypovitaminosis D', 'apparently healthy adult women']","['Monthly cholecalciferol', 'oral vitamin D supplementation', 'cholecalciferol', 'vitamin D supplementation']","['efficacy and safety', '25(OH)D levels', 'mean 25(OH)D level', 'Mean baseline 25(OH)D level', '25-hydroxyvitamin D (25(OH)D) levels', 'bone health parameters', 'parathyroid hormone level']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}]",100.0,0.150866,"Interestingly, the increase, although of lower magnitude, was also observed in control group A, from 4.5 +/-","[{'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Malhotra', 'Affiliation': ''}, {'ForeName': 'Ambrish', 'Initials': 'A', 'LastName': 'Mithal', 'Affiliation': ''}, {'ForeName': 'Sushil', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Shukla', 'Affiliation': ''}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Godbole', 'Affiliation': ''}]",Archives of osteoporosis,[]
449,20208984,Using Tailored Information and Public Commitment to Improve the Environmental Quality of Farm Lands: An Example from the Netherlands.,"By adopting nature conservation practices, farmers can enhance the environmental quality and biodiversity of their land. In this exploratory study, a behavioral intervention that focused on improving Dutch farmers' nature conservation practices was developed and tested. This intervention was based on insights derived from social psychology and combined tailored information and public commitment. Participating farmers were divided in three groups: one group received tailored information only, one group received both tailored information and a public commitment manipulation, and one group served as a control. A questionnaire measuring relevant aspects of conservation was completed before and after the intervention. Results show that tailored information combined with public commitment making resulted in a stronger desire to engage in conservation, an increase in surface area of non-subsidized natural habitat, and an increase in time farmers spent on conservation. The intervention affected both subsidized and non-subsidized conservation, but the effects were stronger for non-subsidized conservation.",2010,"The intervention affected both subsidized and non-subsidized conservation, but the effects were stronger for non-subsidized conservation.",['Participating farmers'],"['tailored information only, one group received both tailored information and a public commitment manipulation, and one group served as a control']",[],"[{'cui': 'C0221460', 'cui_str': 'Agricultural Workers'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0192942,"The intervention affected both subsidized and non-subsidized conservation, but the effects were stronger for non-subsidized conservation.","[{'ForeName': 'Anne Marike', 'Initials': 'AM', 'LastName': 'Lokhorst', 'Affiliation': ''}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'van Dijk', 'Affiliation': ''}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Staats', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'van Dijk', 'Affiliation': ''}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'de Snoo', 'Affiliation': ''}]",Human ecology: an interdisciplinary journal,[]
450,20140470,Ten-year survival of ART restorations in permanent posterior teeth.,"This study evaluated the 10-year clinical performance of high-viscosity glass-ionomer cement placed in posterior permanent teeth by means of the Atraumatic Restorative Treatment (ART) approach. One operator placed 167 single- and 107 multiple-surface restorations in 43 high-risk caries pregnant women (mean decayed teeth = 9.8 ± 5.5). Examinations were performed at 1-, 2-, and 10-year intervals according to ART criteria. In the last evaluation, the US Public Health Service (USPHS) criteria were also used. After 10 years, 129 restorations (47.1%) were evaluated and achieved a cumulative survival rate of 49.0% (SE 7.2%). The 10-year survival of single- and multiple-surface ART restorations assessed using the ART criteria were 65.2% (SE 7.3%) and 30.6% (SE 9.9%), respectively. This difference was significant (jackknife SE of difference; p < 0.05). Using the USPHS criteria, the 10-year survival of single- and multiple-surface ART restorations were 86.5% and 57.6%, respectively. The primary causes of failure were total loss (9.3%) and marginal defects (5.4%). The survival rates observed, especially for the single-surface restorations, confirm the potential of the ART approach for restoring and saving posterior permanent teeth.",2011,"After 10 years, 129 restorations (47.1%) were evaluated and achieved a cumulative survival rate of 49.0% (SE 7.2%).","['43 high-risk caries pregnant women (mean decayed teeth = 9.8 ± 5.5', 'posterior permanent teeth by means of the Atraumatic Restorative Treatment (ART) approach']",[],"['cumulative survival rate', 'total loss', '10-year survival of single- and multiple-surface ART restorations', 'survival rates']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",[],"[{'cui': 'C0010456', 'cui_str': 'Cumulative Survival Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.125405,"After 10 years, 129 restorations (47.1%) were evaluated and achieved a cumulative survival rate of 49.0% (SE 7.2%).","[{'ForeName': 'Regia Luzia', 'Initials': 'RL', 'LastName': 'Zanata', 'Affiliation': 'University Basic Health Care Centre (UBAS), Bauru School of Dentistry, University of São Paulo, Bauru, SP, Brazil.'}, {'ForeName': 'Ticiane Cestari', 'Initials': 'TC', 'LastName': 'Fagundes', 'Affiliation': ''}, {'ForeName': 'Maria Cristina Carvalho de Almendra', 'Initials': 'MC', 'LastName': 'Freitas', 'Affiliation': ''}, {'ForeName': 'José Roberto Pereira', 'Initials': 'JR', 'LastName': 'Lauris', 'Affiliation': ''}, {'ForeName': 'Maria Fidela de Lima', 'Initials': 'MF', 'LastName': 'Navarro', 'Affiliation': ''}]",Clinical oral investigations,['10.1007/s00784-009-0378-x']
451,20177839,Medial knee osteoarthritis treated by insoles or braces: a randomized trial.,"BACKGROUND


There is controversial evidence regarding whether foot orthoses or knee braces improve pain and function or correct malalignment in selected patients with osteoarthritis (OA) of the medial knee compartment. However, insoles are safe and less costly than knee bracing if they relieve pain or improve function.
QUESTIONS/PURPOSES


We therefore asked whether laterally wedged insoles or valgus braces would reduce pain, enhance functional scores, and correct varus malalignment comparable to knee braces.
PATIENTS AND METHODS


We prospectively enrolled 91 patients with symptomatic medial compartmental knee OA and randomized to treatment with either a 10-mm laterally wedged insole (index group, n = 45) or a valgus brace (control group, n = 46). All patients were assessed at 6 months. The primary outcome measure was pain severity as measured on a visual analog scale. Secondary outcome measures were knee function score using WOMAC and correction of varus alignment on AP whole-leg radiographs taken with the patient in the standing position. Additionally, we compared the percentage of responders according to the OMERACT-OARSI criteria for both groups.
RESULTS


We observed no differences in pain or WOMAC scores between the two groups. Neither device achieved correction of knee varus malalignment in the frontal plane. According to the OMERACT-OARSI criteria, 17% of our patients responded to the allocated intervention. Patients in the insole group complied better with their intervention. Although subgroup analysis results should be translated into practice cautiously, we observed a slightly higher percentage of responders for the insole compared with bracing for patients with mild medial OA.
CONCLUSIONS


Our data suggest a laterally wedged insole may be an alternative to valgus bracing for noninvasively treating symptoms of medial knee OA.
LEVEL OF EVIDENCE


Level I, therapeutic study. See the Guidelines for Authors for a complete description of level of evidence.",2010,We observed no differences in pain or WOMAC scores between the two groups.,"['selected patients with osteoarthritis (OA) of the medial knee compartment', 'We prospectively enrolled 91 patients with symptomatic medial compartmental knee OA']","['laterally wedged insoles or valgus braces', '10-mm laterally wedged insole (index group, n = 45) or a valgus brace (control', 'Medial knee osteoarthritis treated by insoles or braces', 'foot orthoses or knee braces']","['pain severity as measured on a visual analog scale', 'pain, enhance functional scores', 'pain and function or correct malalignment', 'knee function score using WOMAC and correction of varus alignment on AP whole-leg radiographs taken with the patient in the standing position', 'pain or WOMAC scores', 'knee varus malalignment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0443344', 'cui_str': 'Valgus (qualifier value)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1283250', 'cui_str': 'Foot Orthotic Devices'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0443345', 'cui_str': 'Varus (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position (finding)'}]",91.0,0.100551,We observed no differences in pain or WOMAC scores between the two groups.,"[{'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'van Raaij', 'Affiliation': 'Department of Orthopaedics, HS-105, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands. t.vanraaij@mac.com'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Reijman', 'Affiliation': ''}, {'ForeName': 'Reinoud W', 'Initials': 'RW', 'LastName': 'Brouwer', 'Affiliation': ''}, {'ForeName': 'Sita M A', 'Initials': 'SM', 'LastName': 'Bierma-Zeinstra', 'Affiliation': ''}, {'ForeName': 'Jan A N', 'Initials': 'JA', 'LastName': 'Verhaar', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1007/s11999-010-1274-z']
452,20177974,Improved HIV and substance abuse treatment outcomes for released HIV-infected prisoners: the impact of buprenorphine treatment.,"HIV-infected prisoners fare poorly after release. Though rarely available, opioid agonist therapy (OAT) may be one way to improve HIV and substance abuse treatment outcomes after release. Of the 69 HIV-infected prisoners enrolled in a randomized controlled trial of directly administered antiretroviral therapy, 48 (70%) met DSM-IV criteria for opioid dependence. Of these, 30 (62.5%) selected OAT, either as methadone (N = 7, 14.5%) or buprenorphine/naloxone (BPN/NLX; N = 23, 48.0%). Twelve-week HIV and substance abuse treatment outcomes are reported as a sub-study for those selecting BPN/NLX. Retention was high: 21 (91%) completed BPN/NLX induction and 17 (74%) remained on BPN/NLX after 12 weeks. Compared with baseline, the proportion with a non-detectable viral load (61% vs 63% log(10) copies/mL) and mean CD4 count (367 vs 344 cells/mL) was unchanged at 12 weeks. Opiate-negative urine testing remained 83% for the 21 who completed induction. Using means from 10-point Likert scales, opioid craving was reduced from 6.0 to 1.8 within 3 days of BPN/NLX induction and satisfaction remained high at 9.5 throughout the 12 weeks. Adverse events were few and mild. BPN/NLX therapy was acceptable, safe and effective for both HIV and opioid treatment outcomes among released HIV-infected prisoners. Future randomized controlled trials are needed to affirm its benefit in this highly vulnerable population.",2010,"BPN/NLX therapy was acceptable, safe and effective for both HIV and opioid treatment outcomes among released HIV-infected prisoners.","['69 HIV-infected prisoners enrolled in a randomized controlled trial of directly administered antiretroviral therapy, 48 (70%) met DSM-IV criteria for opioid dependence', 'released HIV-infected prisoners']","['buprenorphine/naloxone', 'opioid agonist therapy (OAT', 'BPN/NLX therapy', 'buprenorphine', 'methadone']","['mean CD4 count', 'Adverse events', '10-point Likert scales, opioid craving', 'proportion with a non-detectable viral load']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0524662', 'cui_str': 'Opiate Dependence'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.0501383,"BPN/NLX therapy was acceptable, safe and effective for both HIV and opioid treatment outcomes among released HIV-infected prisoners.","[{'ForeName': 'Sandra Ann', 'Initials': 'SA', 'LastName': 'Springer', 'Affiliation': 'Yale AIDS Program, 135 College Street, Suite 323, New Haven, CT 06510, USA. Sandra.springer@yale.edu'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Altice', 'Affiliation': ''}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-010-9438-4']
453,20054522,Long-term lifestyle intervention lowers the incidence  of stroke in Japanese patients with type 2 diabetes:  a nationwide multicentre randomised controlled  trial (the Japan Diabetes Complications Study).,"AIMS/HYPOTHESIS


The aim of the study was to clarify whether a therapeutic intervention focused on lifestyle modification affected the incidence of vascular complications in patients with established diabetes.
METHODS


A total of 2,033 eligible Japanese men and women aged 40-70 years with type 2 diabetes from 59 institutes were randomised to a conventional treatment group (CON), which continued to receive the usual care, and a lifestyle intervention group (INT), which received education on lifestyle modification regarding dietary habits, physical activities and adherence to treatment by telephone counselling and at each outpatient clinic visit, in addition to the usual care. Randomisation and open-label allocation were done by a central computer system. Primary analysis regarding measurements of control status and occurrence of macro- and microvascular complications was based on 1,304 participants followed for an 8 year period.
RESULTS


Although status of control of most classic cardiovascular risk factors, including body weight, glycaemia, serum lipids and BP, did not differ between groups during the study period, the incidence of stroke in the INT group (5.48/1,000 patient-years) was significantly lower than in the CON group (9.52/1,000 patient-years) by Kaplan- Meier analysis (p=0.02 by logrank test) and by multivariate Cox analysis (HR 0.62, 95% CI 0.39-0.98, p=0.04). The incidence of CHD, retinopathy and nephropathy did not differ significantly between groups. Lipoprotein(a) was another significant independent risk factor for stroke.
CONCLUSIONS/INTERPRETATION


These findings suggest that lifestyle modification had limited effects on most typical control variables, but did have a significant effect on stroke incidence in patients with established type 2 diabetes.
CLINICAL TRIAL REGISTRATION


UMIN-CTR C000000222
FUNDING


The Ministry of Health, Labour and Welfare, Japan",2010,"The incidence of CHD, retinopathy and nephropathy did not differ significantly between groups.","['Japanese patients with type 2 diabetes', 'patients with established type 2 diabetes', 'patients with established diabetes', '1,304 participants followed for an 8 year period', '2,033 eligible Japanese men and women aged 40-70 years with type 2 diabetes from 59 institutes']","['Long-term lifestyle intervention', 'CON', 'conventional treatment group (CON), which continued to receive the usual care, and a lifestyle intervention group (INT), which received education on lifestyle modification regarding dietary habits, physical activities and adherence to treatment by telephone counselling and at each outpatient clinic visit, in addition to the usual care']","['body weight, glycaemia, serum lipids and BP', 'Ministry of Health, Labour and Welfare, Japan', 'stroke incidence', 'vascular complications', 'control status and occurrence of macro- and microvascular complications', 'incidence  of stroke', 'incidence of CHD, retinopathy and nephropathy', 'risk factor for stroke', 'incidence of stroke']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",2033.0,0.104476,"The incidence of CHD, retinopathy and nephropathy did not differ significantly between groups.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sone', 'Affiliation': 'Department of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Iimuro', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Oida', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yamasaki', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Oikawa', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ishibashi', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Katayama', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yoshimura', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Akanuma', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-009-1622-2']
454,20165941,Greater cardiac response of colloid than saline fluid loading in septic and non-septic critically ill patients with clinical hypovolaemia.,"BACKGROUND AND OBJECTIVE


The haemodynamics of crystalloid and colloid fluid loading may depend on underlying disease, i.e. sepsis versus non-sepsis.
DESIGN AND SETTING


A single-centre, single-blinded, randomized clinical trial was carried out on 24 critically ill sepsis and 24 non-sepsis patients with clinical hypovolaemia, assigned to loading with normal saline, gelatin 4%, hydroxyethyl starch 6% or albumin 5% in a 90-min (delta) central venous pressure (CVP)-guided fluid loading protocol. Transpulmonary thermodilution was done each 30 min, yielding, among others, global end-diastolic volume and cardiac indices (GEDVI, CI).
RESULTS


Sepsis patients had hyperdynamic hypotension in spite of myocardial depression and dilatation, and greater inotropic/vasopressor requirements than non-sepsis patients. Independent of underlying disease, CVP and GEDVI increased more after colloid than saline loading (P < 0.018), so that CI increased by about 2% after saline and 12% after colloid loading (P = 0.029). The increase in preload-recruitable stroke work was also greater with colloids and did not differ among conditions.
CONCLUSION


Fluid loading with colloids results in a greater linear increase in cardiac filling, output and stroke work than does saline loading, in both septic and non-septic clinical hypovolaemia, in spite of myocardial depression and presumably increased vasopermeability potentially decreasing the effects of colloid fluid loading in the former.",2010,"Independent of underlying disease, CVP and GEDVI increased more after colloid than saline loading (P < 0.018), so that CI increased by about 2% after saline and 12% after colloid loading (P = 0.029).","['septic and non-septic critically ill patients with clinical hypovolaemia', '24 critically ill sepsis and 24 non-sepsis patients with clinical hypovolaemia, assigned to']","['loading with normal saline, gelatin 4%, hydroxyethyl starch 6% or albumin 5% in a 90-min (delta) central venous pressure (CVP)-guided fluid loading protocol', 'saline fluid loading']","['global end-diastolic volume and cardiac indices (GEDVI, CI', 'hyperdynamic hypotension', 'cardiac filling, output and stroke work', 'myocardial depression and dilatation', 'preload-recruitable stroke work', 'CVP and GEDVI']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction (disorder)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",24.0,0.453775,"Independent of underlying disease, CVP and GEDVI increased more after colloid than saline loading (P < 0.018), so that CI increased by about 2% after saline and 12% after colloid loading (P = 0.029).","[{'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Trof', 'Affiliation': 'Department of Intensive Care, Medical Spectrum Twente, Haaksbergerstraat 55, 7513 ER, Enschede, The Netherlands.'}, {'ForeName': 'Sharwan P', 'Initials': 'SP', 'LastName': 'Sukul', 'Affiliation': ''}, {'ForeName': 'Jos W R', 'Initials': 'JW', 'LastName': 'Twisk', 'Affiliation': ''}, {'ForeName': 'Armand R J', 'Initials': 'AR', 'LastName': 'Girbes', 'Affiliation': ''}, {'ForeName': 'A B Johan', 'Initials': 'AB', 'LastName': 'Groeneveld', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-010-1776-x']
455,20087760,Prospective multicenter randomized trial of fast ventricular tachycardia termination by prolonged versus conventional anti-tachyarrhythmia burst pacing in implantable cardioverter-defibrillator patients-Atp DeliVery for pAiNless ICD thErapy (ADVANCE-D) Trial results.,"PURPOSE


The purpose of the trial was to quantify and compare the efficacy of two different sequences of burst anti-tachycardia pacing (ATP) strategies for the termination of fast ventricular tachycardia.
METHODS


The trial was prospective, multicenter, parallel and randomized, enrolling patients with an indication for implantable cardioverter-defibrillator implantation.
RESULTS


From February 2004, 925 patients were randomized and followed-up for 12 months. Eight pulses ATP terminated 64% of episodes vs. 70% in the 15-pulse group (p = 0.504). Fifteen pulses proved significantly better in patients without a previous history of heart failure (p = 0.014) and in patients with LVEF >or= 40% (p = 0.016). No significant differences between groups were observed with regard to syncope/near-syncope occurrence.
CONCLUSION


In the general population, 15-pulse ATP is as effective and safe as eight-pulse ATP. The efficacy of ATP on fast ventricular arrhythmias confirmed once more the striking importance of careful device programming in order to reduce painful shocks.",2010,Eight pulses ATP terminated 64% of episodes vs. 70% in the 15-pulse group (p = 0.504).,"['implantable cardioverter-defibrillator patients-Atp DeliVery for pAiNless ICD thErapy (ADVANCE-D', 'From February 2004, 925 patients', 'enrolling patients with an indication for implantable cardioverter-defibrillator implantation']","['ATP', 'burst anti-tachycardia pacing (ATP', 'conventional anti-tachyarrhythmia burst pacing']","['syncope/near-syncope occurrence', 'heart failure']","[{'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0234226', 'cui_str': 'Painless (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517904', 'cui_str': 'Nine hundred and twenty-five'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}]","[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0700200', 'cui_str': 'Presyncope'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",925.0,0.0350839,Eight pulses ATP terminated 64% of episodes vs. 70% in the 15-pulse group (p = 0.504).,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Santini', 'Affiliation': 'Ospedale S. Filippo Neri, Roma, Italy. m.santini@rmnet.it'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Lunati', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Defaye', 'Affiliation': ''}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Mermi', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Proclemer', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'del Castillo-Arroys', 'Affiliation': ''}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Molon', 'Affiliation': ''}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Santi', 'Affiliation': ''}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'De Santo', 'Affiliation': ''}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Navarro', 'Affiliation': ''}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kloppe', 'Affiliation': ''}]",Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing,['10.1007/s10840-009-9454-z']
456,20049605,Initial load-to-failure and failure analysis in single- and double-row repair techniques for rotator cuff repair.,"AIM


This experimental study aimed to compare the load-to-failure rate and stiffness of single- versus double-row suture techniques for repairing rotator cuff lesions using two different suture materials. Additionally, the mode of failure of each repair was evaluated.
METHOD


In 32 sheep shoulders, a standardized tear of the infraspinatus tendon was created. Then, n = 8 specimen were randomized to four repair methods: (1) Double-row Anchor Ethibond coupled with polyester sutures, USP No. 2; (2) Double-Row Anchor HiFi with polyblend polyethylene sutures, USP No. 2; (3) Single-Row Anchor Ethibond coupled with braided polyester sutures, USP No. 2; and (4) Single-Row Anchor HiFi with braided polyblend polyethylene sutures, USP No. 2. Arthroscopic Mason-Allen stitches were placed (single-row) and combined with medial horizontal mattress stitches (double-row). All specimens were loaded to failure at a constant displacement rate on a material testing machine.
RESULTS


Group 4 showed lowest load-to-failure result with 155.7 +/- 31.1 N compared to group 1 (293.4 +/- 16.1 N) and group 2 (397.7 +/- 7.4 N) (P < 0.001). Stiffness was highest in group 2 (162 +/- 7.3 N/mm) and lowest in group 4 (84.4 +/- 19.9 mm) (P < 0.001). In group 4, the main cause of failure was due to the suture cutting through the tendon (n = 6), a failure case observed in only n = 1 specimen in group 2 (P < 0.001).
CONCLUSIONS


A double-row technique combined with arthroscopic Mason-Allen/horizontal mattress stitches provides high initial failure strength and may minimize the risk of the polyethylene sutures cutting through the tendon in rotator cuff repair when a single load force is used.",2010,"In group 4, the main cause of failure was due to the suture cutting through the tendon (n = 6), a failure case observed in only n = 1 specimen in group 2 (P < 0.001).
","['32 sheep shoulders', 'rotator cuff repair']","['arthroscopic Mason-Allen/horizontal mattress stitches', 'single- and double-row repair techniques', 'Arthroscopic Mason-Allen stitches were placed (single-row) and combined with medial horizontal mattress stitches (double-row', 'Double-row Anchor Ethibond coupled with polyester sutures, USP No. 2; (2', 'single- versus double-row suture techniques']",['lowest load-to-failure'],"[{'cui': 'C0036945', 'cui_str': 'Ovis'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0059711', 'cui_str': 'Ethibond'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0183738', 'cui_str': 'Polyester suture (physical object)'}, {'cui': 'C0038968', 'cui_str': 'Suture Technics'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",8.0,0.260879,"In group 4, the main cause of failure was due to the suture cutting through the tendon (n = 6), a failure case observed in only n = 1 specimen in group 2 (P < 0.001).
","[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Baums', 'Affiliation': 'Department of Orthopaedic Surgery, University of Göttingen Medical Centre, Georg-August-University, Robert-Koch-Street 40, Göttingen, Germany. mbaums@t-online.de'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Buchhorn', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gilbert', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Spahn', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Schultz', 'Affiliation': ''}, {'ForeName': 'H-M', 'Initials': 'HM', 'LastName': 'Klinger', 'Affiliation': ''}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-009-1036-0']
457,20084368,"Dose-related effects of MDMA on psychomotor function and mood before, during, and after a night of sleep loss.","INTRODUCTION


3,4-methylenedioxymethamphetamine (MDMA) is known to improve psychomotor function and mood when measured during daytime. However, MDMA users tend to take this drug at dance parties while staying awake for prolonged periods of time.
SUBJECTS AND METHODS


This study was designed to assess dose-related residual effects of MDMA on psychomotor function and mood after a night without sleep. Sixteen recreational MDMA users received single doses of 25, 50, and 100 mg MDMA in a randomized, double-blind, placebo-controlled cross-over study.
RESULTS


Results showed that sleep loss significantly impaired psychomotor function. MDMA generally did not affect performance but did improve rapid information processing at the highest dose in the morning after administration. In the evening, MDMA also increased subjective ratings of positive mood at every dose and subjective arousal at the highest dose. These subjective effects were no longer present after a night of sleep loss.
DISCUSSION


It is concluded that sleep deprivation impairs psychomotor function and that stimulant effects of MDMA are not sufficient to compensate for this impairment.",2010,"In the evening, MDMA also increased subjective ratings of positive mood at every dose and subjective arousal at the highest dose.",['Sixteen recreational MDMA users'],"['MDMA', '3,4-methylenedioxymethamphetamine (MDMA', 'placebo-controlled cross-over study']","['psychomotor function and mood', 'psychomotor function', 'rapid information processing', 'subjective ratings of positive mood at every dose and subjective arousal']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",16.0,0.104459,"In the evening, MDMA also increased subjective ratings of positive mood at every dose and subjective arousal at the highest dose.","[{'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Bosker', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Maastricht University, Maastricht, The Netherlands. Wendy.bosker@maastrichtuniversity.nl'}, {'ForeName': 'Kim P C', 'Initials': 'KP', 'LastName': 'Kuypers', 'Affiliation': ''}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Conen', 'Affiliation': ''}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-009-1767-1']
458,20058059,A randomized controlled study of parent-assisted Children's Friendship Training with children having autism spectrum disorders.,"This study evaluated Children's Friendship Training (CFT), a manualized parent-assisted intervention to improve social skills among second to fifth grade children with autism spectrum disorders. Comparison was made with a delayed treatment control group (DTC). Targeted skills included conversational skills, peer entry skills, developing friendship networks, good sportsmanship, good host behavior during play dates, and handling teasing. At post-testing, the CFT group was superior to the DTC group on parent measures of social skill and play date behavior, and child measures of popularity and loneliness, At 3-month follow-up, parent measures showed significant improvement from baseline. Post-hoc analysis indicated more than 87% of children receiving CFT showed reliable change on at least one measure at post-test and 66.7% after 3 months follow-up.",2010,"At post-testing, the CFT group was superior to the DTC group on parent measures of social skill and play date behavior, and child measures of popularity and loneliness, At 3-month follow-up, parent measures showed significant improvement from baseline.","['grade children with autism spectrum disorders', ""Children's"", 'children having autism spectrum disorders']","['Friendship Training (CFT), a manualized parent-assisted intervention', ""parent-assisted Children's Friendship Training"", 'CFT', 'DTC']","['conversational skills, peer entry skills, developing friendship networks, good sportsmanship, good host behavior during play dates, and handling teasing', 'social skill and play date behavior, and child measures of popularity and loneliness']","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0018578', 'cui_str': 'Handling'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}]",,0.021245,"At post-testing, the CFT group was superior to the DTC group on parent measures of social skill and play date behavior, and child measures of popularity and loneliness, At 3-month follow-up, parent measures showed significant improvement from baseline.","[{'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Frankel', 'Affiliation': 'UCLA Semel Institute For Neuroscience and Human Behavior, Los Angeles, CA 90095, USA. ffrankel@mednet.ucla.edu'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Myatt', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sugar', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Whitham', 'Affiliation': ''}, {'ForeName': 'Clarissa M', 'Initials': 'CM', 'LastName': 'Gorospe', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Laugeson', 'Affiliation': ''}]",Journal of autism and developmental disorders,['10.1007/s10803-009-0932-z']
459,20052461,"Absorption and distribution of etoricoxib in plasma, CSF, and wound tissue in patients following hip surgery--a pilot study.","The perioperative administration of selective cyclooxygenase-2 (COX-2)-inhibitors to avoid postoperative pain is an attractive option: they show favorable gastro-intestinal tolerability, lack inhibition of blood coagulation, and carry a low risk of asthmatic attacks. The purpose of this study was to determine the cerebrospinal fluid (CSF), plasma, and tissue pharmacokinetics of orally administered etoricoxib and to compare it with effect data, i.e., COX-2-inhibition in patients after hip surgery. The study was performed in a blinded, randomized, parallel group design. A total of 12 adult patients were included who received 120 mg etoricoxib (n = 8) or placebo (n = 4) on day 1 post-surgery. Samples from plasma, CSF, and tissue exudates were collected over a period of 24 h post-dosing and analyzed for etoricoxib and prostaglandin E(2) (PGE(2)) using liquid chromatography-tandem mass spectrometry and immuno-assay techniques. CSF area under the curve (AUC) [AUCs((O-24h))] for etoricoxib amounted to about 5% of the total AUC in plasma (range: 2-7%). Individual CSF lag times with respect to (50%) peak plasma concentration were </=2 h in all but one case (median: 1 h). PGE(2) production in tissue was significantly blocked by the COX-2 inhibitor starting with the appearance of etoricoxib in tissue and lasting for the whole observation period of 24 h (P < 0.01). In conclusion, etoricoxib reaches the CSF and site of surgery at effective concentrations and reduces PGE(2) production at the presumed site of action.",2010,Individual CSF lag times with respect to (50%) peak plasma concentration were </=2,"['12 adult patients', 'patients after hip surgery', 'patients following hip surgery--a pilot study']","['placebo', 'etoricoxib and prostaglandin E(2', 'liquid chromatography-tandem mass spectrometry and immuno-assay techniques', 'etoricoxib', 'selective cyclooxygenase-2 (COX-2)-inhibitors']","['cerebrospinal fluid (CSF), plasma, and tissue pharmacokinetics', 'plasma, CSF, and wound tissue', 'plasma, CSF, and tissue exudates', 'PGE(2) production in tissue', 'CSF and site of surgery at effective concentrations and reduces PGE(2) production', 'Individual CSF lag times', 'peak plasma concentration', 'CSF area under the curve (AUC) [AUCs((O-24h']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0008565', 'cui_str': 'Liquid Chromatography'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0007807'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0763149', 'cui_str': 'PG(6)E'}, {'cui': 'C0033268'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",12.0,0.0522583,Individual CSF lag times with respect to (50%) peak plasma concentration were </=2,"[{'ForeName': 'Bertold', 'Initials': 'B', 'LastName': 'Renner', 'Affiliation': 'Institute of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen-Nuremberg, Krankenhausstr. 9, 91054 Erlangen, Germany. renner@pharmakologie.uni-erlangen.de'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Zacher', 'Affiliation': ''}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': ''}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Walter', 'Affiliation': ''}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Strauss', 'Affiliation': ''}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Brune', 'Affiliation': ''}]",Naunyn-Schmiedeberg's archives of pharmacology,['10.1007/s00210-009-0482-0']
460,20049658,Sun protection intervention for highway workers: long-term efficacy of UV photography and skin cancer information on men's protective cognitions and behavior.,"BACKGROUND


The risk for skin cancer is increased among older males and outdoor workers who have high levels of ultraviolet (UV) exposure.
PURPOSE


This study was designed to examine the long-term efficacy of UV photography interventions on male outdoor workers, the potential mediators of its impact, and the efficacy of UV photography and skin cancer vs. aging information with this population.
METHODS


One hundred forty-eight male outdoor workers were randomly assigned to one of four intervention conditions or a control condition in a two by two plus one factorial design. The men in the intervention conditions received or did not receive a UV photo of their face and watched either a photoaging or skin cancer educational video. Participants completed pre-intervention, immediate post-intervention, and 2-month and 1-year follow-up assessments.
RESULTS


Analysis of covariance and structural equation modeling revealed that participants in the UV photography and cancer information interventions reported higher levels of sun protection cognitions, which were significant partial mediators of increases in sun protection behaviors and decreases in skin color.
CONCLUSIONS


This study provides evidence for effective sun protection interventions on male outdoor workers that may help reduce skin cancer risk.",2009,"RESULTS


Analysis of covariance and structural equation modeling revealed that participants in the UV photography and cancer information interventions reported higher levels of sun protection cognitions, which were significant partial mediators of increases in sun protection behaviors and decreases in skin color.
","[""men's protective cognitions and behavior"", 'male outdoor workers', 'older males and outdoor workers who have high levels of ultraviolet (UV) exposure', 'One hundred forty-eight male outdoor workers', 'highway workers']","['UV photography interventions', 'UV photo of their face and watched either a photoaging or skin cancer educational video', 'UV photography and skin cancer information', 'Sun protection intervention']","['skin color', 'skin cancer risk', 'sun protection cognitions', 'sun protection behaviors']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0567410', 'cui_str': 'Highway environment (environment)'}]","[{'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}]","[{'cui': 'C0037290', 'cui_str': 'Skin Tone'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",148.0,0.0498138,"RESULTS


Analysis of covariance and structural equation modeling revealed that participants in the UV photography and cancer information interventions reported higher levels of sun protection cognitions, which were significant partial mediators of increases in sun protection behaviors and decreases in skin color.
","[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Stock', 'Affiliation': 'Department of Psychology, The George Washington University, Washington, DC 20052, USA. mstock@gwu.edu'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Gerrard', 'Affiliation': ''}, {'ForeName': 'Frederick X', 'Initials': 'FX', 'LastName': 'Gibbons', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dykstra', 'Affiliation': ''}, {'ForeName': 'Chih-Yuan', 'Initials': 'CY', 'LastName': 'Weng', 'Affiliation': ''}, {'ForeName': 'Heike I M', 'Initials': 'HI', 'LastName': 'Mahler', 'Affiliation': ''}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Kulik', 'Affiliation': ''}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1007/s12160-009-9151-2']
461,19855955,Elevated PAI-1 is associated with poor clinical outcomes in pediatric patients with acute lung injury.,"PURPOSE


Deposition of fibrin in the alveolar space is a hallmark of acute lung injury (ALI). Plasminogen activator inhibitor-1 (PAI-1) is an antifibrinolytic agent that is activated during inflammation. Increased plasma and pulmonary edema fluid levels of PAI-1 are associated with increased mortality in adults with ALI. This relationship has not been examined in children. The objective of this study was to test whether increased plasma PAI-1 levels are associated with worse clinical outcomes in pediatric patients with ALI.
DESIGN/METHODS


We measured plasma PAI-1 levels on the first day of ALI among 94 pediatric patients enrolled in two separate prospective, multicenter investigations and followed them for clinical outcomes. All patients met American European Consensus Conference criteria for ALI.
RESULTS


A total of 94 patients were included. The median age was 3.2 years (range 16 days-18 years), the PaO(2)/F(i)O(2) was 141 +/- 72 (mean +/- SD), and overall mortality was 14/94 (15%). PAI-1 levels were significantly higher in nonsurvivors compared to survivors (P < 0.01). The adjusted odds of mortality doubled for every log increase in the level of plasma PAI-1 after adjustment for age and severity of illness.
CONCLUSIONS


Higher PAI-1 levels are associated with increased mortality and fewer ventilator-free days among pediatric patients with ALI. These findings suggest that impaired fibrinolysis may play a role in the pathogenesis of ALI in pediatric patients and suggest that PAI-1 may serve as a useful biomarker of prognosis in patients with ALI.",2010,PAI-1 levels were significantly higher in nonsurvivors compared to survivors (P < 0.01).,"['patients with ALI', '94 pediatric patients', 'A total of 94 patients were included', 'The median age was 3.2 years (range 16 days-18 years), the PaO(2)/F(i)O(2) was 141 ', 'pediatric patients with ALI', 'pediatric patients', 'pediatric patients with acute lung injury', 'adults with ALI']",['Plasminogen activator inhibitor-1 (PAI-1'],"['plasma PAI-1 levels', 'PAI-1 levels', 'overall mortality', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0242488', 'cui_str': 'Acute Lung Injury'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",94.0,0.12293,PAI-1 levels were significantly higher in nonsurvivors compared to survivors (P < 0.01).,"[{'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Sapru', 'Affiliation': 'Division of Critical Care Medicine, Department of Pediatrics, University of California, San Francisco, Box 0106, San Francisco, CA 94143, USA. anil.sapru@ucsf.edu'}, {'ForeName': 'Martha A Q', 'Initials': 'MA', 'LastName': 'Curley', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Brady', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Flori', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-009-1690-2']
462,19876613,Determinants of urinary albumin excretion within the normal range in patients with type 2 diabetes: the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study.,"AIMS/HYPOTHESIS


In contrast to microalbuminuric type 2 diabetic patients, the factors correlated with urinary albumin excretion are less well known in normoalbuminuric patients. This may be important because even within the normoalbuminuric range, higher rates of albuminuria are known to be associated with higher renal and cardiovascular risk.
METHODS


At the time of screening for the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) Study, the urinary albumin/creatinine ratio (UACR) was 0.44 mg/mmol in 4,449 type 2 diabetic patients. The independent correlates of UACR were analysed.
RESULTS


Independent correlates of UACR during baseline were (in descending order): night-time systolic BP (r(s) = 0.19); HbA(1c) (r(s) = 0.18); mean 24 h systolic BP (r(s) = 0.16); fasting blood glucose (r(s) = 0.16); night-time diastolic BP (r(s) = 0.12); office systolic BP, sitting (r(s) = 0.11), standing (r(s) = 0.10); estimated GFR (r(s) = 0.10); heart rate, sitting (r(s) = 0.10); haemoglobin (r(s) = -0.10); triacylglycerol (r(s) = 0.09); and uric acid (r(s) = -0.08; all p <or= 0.001). Significantly higher albumin excretion rates were found for the following categorical variables: higher waist circumference (more marked in men); presence of the metabolic syndrome; smoking (difference more marked in males); female sex; antihypertensive treatment; use of amlodipine; insulin treatment; family history of diabetes; and family history of cardiovascular disease (more marked in women).
CONCLUSIONS/INTERPRETATION


Although observational correlations do not prove causality, in normoalbuminuric type 2 diabetic patients the albumin excretion rate is correlated with many factors that are potentially susceptible to intervention.
TRIAL REGISTRATION


ClinicalTrials.gov ID no.: NCT00185159
FUNDING


This study was sponsored by Daichii-Sankyo.",2010,"Significantly higher albumin excretion rates were found for the following categorical variables: higher waist circumference (more marked in men); presence of the metabolic syndrome; smoking (difference more marked in males); female sex; antihypertensive treatment; use of amlodipine; insulin treatment; family history of diabetes; and family history of cardiovascular disease (more marked in women).
","['microalbuminuric type 2 diabetic patients', 'patients with type 2 diabetes', '4,449 type 2 diabetic patients']","['Olmesartan', 'amlodipine']","['albumin excretion rates', 'fasting blood glucose', 'night-time systolic BP', 'night-time diastolic BP (r(s) = 0.12); office systolic BP, sitting', 'heart rate, sitting (r(s) = 0.10); haemoglobin (r(s) = -0.10); triacylglycerol (r(s) = 0.09); and uric acid', 'urinary albumin excretion', 'urinary albumin/creatinine ratio (UACR']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1098320', 'cui_str': 'olmesartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4517426', 'cui_str': '0.12 (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4517419', 'cui_str': 'Zero point zero nine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}]",,0.0759719,"Significantly higher albumin excretion rates were found for the following categorical variables: higher waist circumference (more marked in men); presence of the metabolic syndrome; smoking (difference more marked in males); female sex; antihypertensive treatment; use of amlodipine; insulin treatment; family history of diabetes; and family history of cardiovascular disease (more marked in women).
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ritz', 'Affiliation': 'Department of Nephrology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Viberti', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Rabelink', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Izzo', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Katayama', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mimran', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Menne', 'Affiliation': ''}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Rump', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Januszewicz', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Haller', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-009-1577-3']
463,19856194,Plant stanol esters lower serum triacylglycerol concentrations via a reduced hepatic VLDL-1 production.,"Plant stanol esters not only lower low density lipoprotein cholesterol but also have previously been shown to lower serum triacylglycerol (TAG) concentrations, especially in subjects with elevated TAG concentrations. To find a possible explanation, we explored changes in serum lipoprotein profiles, as measured with nuclear magnetic resonance. For this, serum samples from two parallel-designed controlled studies were evaluated before and 8 weeks after the consumption of plant stanol esters. In the first study, dyslipidemic metabolic syndrome subjects participated and in the second study normolipidemic subjects. In metabolic syndrome subjects, plant stanol esters lowered concentrations of large (>60 nm) and medium (35-60 nm) VLDL particles as compared to controls. In normolipidemic subjects, the serum concentration of large VLDL-1 particles was also lowered, although less pronounced. Based on these findings, we hypothesize that the effect of plant stanol esters on serum TAG concentrations origins from a lowered hepatic production of large TAG-rich VLDL-1 particles.",2009,"In normolipidemic subjects, the serum concentration of large VLDL-1 particles was also lowered, although less pronounced.",['dyslipidemic metabolic syndrome subjects participated and in the second study normolipidemic subjects'],"['Plant stanol esters', 'plant stanol esters']","['serum concentration of large VLDL-1 particles', 'low density lipoprotein cholesterol', 'serum lipoprotein profiles', 'serum triacylglycerol (TAG) concentrations']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0872973', 'cui_str': 'plant stanol ester'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.0135285,"In normolipidemic subjects, the serum concentration of large VLDL-1 particles was also lowered, although less pronounced.","[{'ForeName': 'Jogchum', 'Initials': 'J', 'LastName': 'Plat', 'Affiliation': 'Department of Human Biology, School for Nutrition, Toxicology and Metabolism (NUTRIM), Maastricht University, P.O. Box 616, 6200 MD Maastricht, The Netherlands. j.plat@hb.unimaas.nl'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': ''}]",Lipids,['10.1007/s11745-009-3361-z']
464,20033629,Low goal ownership predicts drop-out from a weight intervention study in overweight patients with type 2 diabetes.,"BACKGROUND


Drop-out is a major problem in weight loss studies. Although previous attrition research has examined some predictors of drop-out, theoretically grounded research on psychological predictors of drop-out from weight interventions has been lacking.
PURPOSE


To examine psychological predictors of drop-out from a weight reduction study in diabetes type 2 patients.
METHOD


A clinical trial was conducted with 101 overweight/obese (body mass index >27) diabetes type 2 patients. Patients were randomly assigned to a self-regulation intervention, an active control group, and a passive control group. Psychological, somatic, socio-demographic, and lifestyle variables were examined as predictors of drop-out from baseline to 6 months follow-up.
RESULTS


Multiple logistic regression analysis indicated that low autonomous regulation or low 'goal ownership' was the best predictor of drop-out.
CONCLUSION


It is suggested that the assessment of 'goal ownership' prior to a weight reduction intervention could identify patients who are sufficiently motivated to participate. Patients who score low on 'goal ownership' may be offered pretreatment interventions to increase their motivation.",2010,"RESULTS


Multiple logistic regression analysis indicated that low autonomous regulation or low 'goal ownership' was the best predictor of drop-out.
","['diabetes type 2 patients', '101 overweight/obese (body mass index >27) diabetes type 2 patients', ""Patients who score low on 'goal ownership"", 'overweight patients with type 2 diabetes']","['self-regulation intervention, an active control group, and a passive control group']","['Psychological, somatic, socio-demographic, and lifestyle variables']","[{'cui': 'C1320657', 'cui_str': 'Diabetes type'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",101.0,0.0182054,"RESULTS


Multiple logistic regression analysis indicated that low autonomous regulation or low 'goal ownership' was the best predictor of drop-out.
","[{'ForeName': 'Sasja', 'Initials': 'S', 'LastName': 'Huisman', 'Affiliation': 'Section of Clinical and Health Psychology, Leiden University, Wassenaarseweg 52, PO Box 9555, 2300 RB, Leiden, The Netherlands. shuisman@fsw.leidenuniv.nl'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Maes', 'Affiliation': ''}, {'ForeName': 'Véronique J', 'Initials': 'VJ', 'LastName': 'De Gucht', 'Affiliation': ''}, {'ForeName': 'Marlène', 'Initials': 'M', 'LastName': 'Chatrou', 'Affiliation': ''}, {'ForeName': 'Harm R', 'Initials': 'HR', 'LastName': 'Haak', 'Affiliation': ''}]",International journal of behavioral medicine,['10.1007/s12529-009-9071-3']
465,19949852,Sensing senses: tactile feedback for the prevention of decubitus ulcers.,"Decubitus ulcers, also known as pressure sores, is a major problem in health care, in particular for patients with spinal cord injuries. These patients cannot feel the discomfort that would urge healthy people to change their posture. We describe a system that uses a sensor mat to detect problematic postures and provides tactile feedback to the user. The results of our preliminary study with healthy subjects show that the tactile feedback is a viable option to spoken feedback. We envision the system being used for rehabilitation games, but also for everyday Decubitus ulcers prevention.",2010,"Decubitus ulcers, also known as pressure sores, is a major problem in health care, in particular for patients with spinal cord injuries.","['healthy subjects', 'patients with spinal cord injuries', 'decubitus ulcers']",['Sensing senses: tactile feedback'],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0442303', 'cui_str': 'Decubitus (qualifier value)'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",[],,0.0118934,"Decubitus ulcers, also known as pressure sores, is a major problem in health care, in particular for patients with spinal cord injuries.","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Verbunt', 'Affiliation': 'Department of Industrial Design, Eindhoven University of Technology, Den Dolech 2, 5600 MB, Eindhoven, The Netherlands. m.n.c.verbunt@student.tue.nl'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bartneck', 'Affiliation': ''}]",Applied psychophysiology and biofeedback,['10.1007/s10484-009-9124-z']
466,19921145,The gait and balance of patients with diabetes  can be improved: a randomised controlled trial.,"AIMS/HYPOTHESIS


Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients.
METHODS


This was a randomised controlled trial (n=71) with an intervention (n=35) and control group (n=36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening (twice weekly over 12 weeks). Controls received no treatment. Individuals were allocated to the groups in a central office. Gait, balance, fear of falls, muscle strength and joint mobility were measured at baseline, after intervention and at 6-month follow-up.
RESULTS


The trial is closed to recruitment and follow-up. After training, the intervention group increased habitual walking speed by 0.149 m/s (p<0.001) compared with the control group. Patients in the intervention group also significantly improved their balance (time to walk over a beam, balance index recorded on Biodex balance system), their performance-oriented mobility, their degree of concern about falling, their hip and ankle plantar flexor strength, and their hip flexion mobility compared with the control group. After 6 months, all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength. Two patients developed pain in their Achilles tendon: the progression for two related exercises was slowed down.
CONCLUSIONS/INTERPRETATION


Specific training can improve gait speed, balance, muscle strength and joint mobility in diabetic patients. Further studies are needed to explore the influence of these improvements on the number of reported falls, patients' physical activity levels and quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00637546
FUNDING


This work was supported by the Swiss National Foundation (SNF): PBSKP-123446/1/",2010,"After 6 months, all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength.","['patients with diabetes', 'diabetic patients', 'n=71) with an intervention (n=35) and control group (n=36']","['specific training programme', 'physiotherapeutic group training including gait and balance exercises with function-orientated strengthening']","['gait and balance', 'pain', 'habitual walking speed', 'gait speed, balance, muscle strength and joint mobility', 'degree of concern about falling, their hip and ankle plantar flexor strength, and their hip flexion mobility', 'balance (time to walk over a beam, balance index recorded on Biodex balance system', 'Biodex sway index and ankle plantar flexor strength', 'Gait, balance, fear of falls, muscle strength and joint mobility', 'Gait characteristics and balance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0424013', 'cui_str': 'Orientated (finding)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",71.0,0.0408671,"After 6 months, all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Allet', 'Affiliation': 'Department of Epidemiology, Maastricht University and Caphri Research School, Maastricht, the Netherlands. lara.allet@hcuge.ch'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Armand', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'de Bie', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Golay', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Monnin', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Aminian', 'Affiliation': ''}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Staal', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'de Bruin', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-009-1592-4']
467,19921150,Effects of reducing beta-lactam antibiotic pressure on intestinal  colonization of antibiotic-resistant gram-negative bacteria.,"BACKGROUND


We determined the effects of two antibiotic policies (predominance of either beta-lactam antibiotics or fluroquinolones) on acquisition with third-generation cephalosporin-resistant Enterobacteriaceae (CRE) and fluoroquinolone-resistant CRE (FCRE) in two ICUs, with monitoring of other variables that may influence acquisition.
METHODS


After an 8-month baseline period, units were randomized to a predominant beta-lactam antibiotic regimen (weekly cycling of ceftriaxone, amoxicillin-clavulanic acid and fluroquinolones) or a fluoroquinolone regimen for 3 months, with cross-over for another 3 months. Acquisition of CRE and FCRE was determined by microbiological surveillance.
RESULTS


During baseline, acquisition rates for CRE and FCRE were 14/1,000 and 2/1,000 patient days at risk, respectively. Cross-transmission of CRE accounted for <or=25% of acquisitions, and CRE acquisition was associated with the use of beta-lactam antibiotics (amoxicillin-clavulanic acid in particular). As compared to baseline, beta-lactam antibiotic use [in defined daily dose (DDD)/1,000 patient days] was reduced from 854 to 526 (-39%) and 555 (-35%) during both intervention periods. Fluoroquinolone use was increased from 150 and 129 DDD/1,000 patient days in baseline and the beta-lactam period to 514 DDD/1,000 patient days (+243%) in the fluoroquinolone period. Reductions in beta-lactam use were not associated with reduced CRE acquisition [adjusted HRs were 1.0 (95% CR: 0.5-2.2) and 1.1 (95% CI: 0.5-2.5) during both periods, respectively]. Increased use of fluoroquinolones was associated with increased acquisition of FCRE [adjusted HR 4.1 (95% CI: 1.4-11.9; p < 0.01]. Infection control variables remained comparable during all periods.
CONCLUSION


A 35-39% reduction of beta-lactam exposure was not associated with reduced acquisition of CRE, whereas a 243% increase of fluoroquinolone use increased acquisition of FCRE.",2010,"Reductions in beta-lactam use were not associated with reduced CRE acquisition [adjusted HRs were 1.0 (95% CR: 0.5-2.2) and 1.1 (95% CI: 0.5-2.5) during both periods, respectively].",[],"['beta-lactam antibiotic pressure', 'Fluoroquinolone', 'cephalosporin-resistant Enterobacteriaceae (CRE) and fluoroquinolone-resistant CRE (FCRE', 'fluoroquinolone', 'predominant beta-lactam antibiotic regimen (weekly cycling of ceftriaxone, amoxicillin-clavulanic acid and fluroquinolones', 'antibiotic policies (predominance of either beta-lactam antibiotics or fluroquinolones', 'fluoroquinolones', 'fluoroquinolone regimen']","['acquisition rates for CRE and FCRE', 'acquisition of FCRE', 'reduced CRE acquisition', 'beta-lactam exposure']",[],"[{'cui': 'C0026458', 'cui_str': 'Monocyclic beta-Lactams'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C4706514', 'cui_str': 'Cephalosporin product'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0282215', 'cui_str': 'beta-Lactams'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0853801,"Reductions in beta-lactam use were not associated with reduced CRE acquisition [adjusted HRs were 1.0 (95% CR: 0.5-2.2) and 1.1 (95% CI: 0.5-2.5) during both periods, respectively].","[{'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Nijssen', 'Affiliation': 'Department of Medical Microbiology, St. Elisabethziekenhuis, Hilvarenbeekse Weg 60, 5022 GC Tilburg, The Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Fluit', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van de Vijver', 'Affiliation': ''}, {'ForeName': 'Janetta', 'Initials': 'J', 'LastName': 'Top', 'Affiliation': ''}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Willems', 'Affiliation': ''}, {'ForeName': 'Marc J M', 'Initials': 'MJ', 'LastName': 'Bonten', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-009-1714-y']
468,19921223,Multimodal preoperative evaluation system in surgical decision making for rectal cancer: a randomized controlled trial.,"PURPOSE


Multimodal preoperative evaluation (MPE) is a novel strategy for surgical decision making, incorporating the transrectal ultrasound (TRUS), 64 multi-slice spiral computer tomography (MSCT), and serum amyloid A protein (SAA) for rectal cancer. This trial aims to determine the accuracy of MPE in preoperative staging and its role in surgical decision making for rectal cancer.
METHODS


Two hundred twenty-five participants with histologically proven rectal cancer with tumor height less than 10 cm were randomly assigned into three arms in the ratio 1:1:1. Arm A (MPE) was multimodal staged by the combination of MSCT, TRUS, and SAA. Arm B (MSCT+SAA) was staged by MSCT and SAA. Arm C (MSCT) was staged only by MSCT. The primary endpoints were the accuracy of preoperative staging and expected surgical procedures. This study is registered as an International Standard Randomised Controlled Trial, number ChiCTR-DT-00000409.
RESULTS


The analysis showed statistical difference in the accuracy of T staging between arm A and B (94.6% vs. 77.8%, P=0.003) and arm A and C (94.6% vs. 80.6%, P=0.010). Statistical difference was also observed between the accuracies of preoperative N staging between arm A and C (85.1% vs. 69.4%, P=0.023) and arm A and B (85.1% vs. 84.7%, P=0.029). Surgical decision making in arm A was more accurate than that in arm C (95.9% vs. 80.6%, P=0.001). Pathological T stage (P<0.001), N stage (P<0.001), tumor node metastasis stage (P<0.001), serum level of SAA (P=0.002), and tumor height (P=0.030) were significantly associated with final surgical procedures.
CONCLUSION


MPE is an effective strategy in preoperative staging and more accurate than other available strategies in surgical decision making for rectal cancer.",2010,MPE is an effective strategy in preoperative staging and more accurate than other available strategies in surgical decision making for rectal cancer.,"['rectal cancer', 'Two hundred twenty-five participants with histologically proven rectal cancer with tumor height less than 10 cm']","['MPE', 'Multimodal preoperative evaluation (MPE', 'Multimodal preoperative evaluation system']","['tumor height', 'accuracy of preoperative staging and expected surgical procedures', 'Pathological T stage', 'serum level of SAA', 'tumor node metastasis stage', 'accuracy of T staging']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456533', 'cui_str': 'M stage'}]",225.0,0.138411,MPE is an effective strategy in preoperative staging and more accurate than other available strategies in surgical decision making for rectal cancer.,"[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Anal-Colorectal Surgery, West China Hospital, Sichuan University, 37, Guo Xue Xiang, Chengdu, China.'}, {'ForeName': 'Donghao', 'Initials': 'D', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Yingyu', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}]",International journal of colorectal disease,['10.1007/s00384-009-0839-3']
469,19941048,Telephone-administered psychotherapy for depression in MS patients: moderating role of social support.,"Depression is common in individuals with multiple sclerosis (MS). While psychotherapy is an effective treatment for depression, not all individuals benefit. We examined whether baseline social support might differentially affect treatment outcome in 127 participants with MS and depression randomized to either Telephone-administered Cognitive-Behavioral Therapy (T-CBT) or Telephone-administered Emotion-Focused Therapy (T-EFT). We predicted that those with low social support would improve more in T-EFT, since this approach emphasizes the therapeutic relationship, while participants with strong social networks and presumably more emotional resources might fare better in the more structured and demanding T-CBT. We found that both level of received support and satisfaction with that support at baseline did moderate treatment outcome. Individuals with high social support showed a greater reduction in depressive symptoms in the T-CBT as predicted, but participants with low social support showed a similar reduction in both treatments. This suggests that for participants with high social support, CBT may be a more beneficial treatment for depression compared with EFT.",2010,"Individuals with high social support showed a greater reduction in depressive symptoms in the T-CBT as predicted, but participants with low social support showed a similar reduction in both treatments.","['127 participants with MS and depression randomized to either', 'individuals with multiple sclerosis (MS', 'MS patients']","['Telephone-administered Cognitive-Behavioral Therapy (T-CBT) or Telephone-administered Emotion-Focused Therapy (T-EFT', 'Telephone-administered psychotherapy']",['depressive symptoms'],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C4277722', 'cui_str': 'Emotion-Focused Therapy'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",127.0,0.0238208,"Individuals with high social support showed a greater reduction in depressive symptoms in the T-CBT as predicted, but participants with low social support showed a similar reduction in both treatments.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Beckner', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA. victoria.beckner@ucsf.edu'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Vella', 'Affiliation': ''}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': ''}]",Journal of behavioral medicine,['10.1007/s10865-009-9235-2']
470,19921347,Correlations of gene expression with blood lead levels in children with autism compared to typically developing controls.,"The objective of this study was to examine the correlation between gene expression and lead (Pb) levels in blood in children with autism (AU, n = 37) compared to typically developing controls (TD, n = 15). We postulated that, though lead levels did not differ between the groups, AU children might metabolize lead differently compared to TD children. RNA was isolated from blood and processed on Affymetrix microarrays. Separate analyses of covariance (ANCOVA) corrected for age and gender were performed for TD, AU, and all subjects (AU + TD). To reduce false positives, only genes that overlapped these three ANCOVAs were considered. Thus, 48 probe sets correlated with lead levels in both AU and TD subjects and were significantly different between the groups (p(Diagnosis x log₂Pb) < 0.05). These genes were related mainly to immune and inflammatory processes, including MHC Class II family members and CD74. A large number (n = 791) of probe sets correlated (P ≤ 0.05) with lead levels in TD but not in AU subjects; and many probe sets (n = 162) correlated (P ≤ 0.05) with lead levels in AU but not in TD subjects. Only 30 probe sets correlated (P ≤ 0.05) with lead levels in a similar manner in the AU and TD groups. These data show that AU and TD children display different associations between transcript levels and low levels of lead. We postulate that this may relate to the underlying genetic differences between the two groups, though other explanations cannot be excluded.",2011,A large number (n = 791) of probe sets correlated (P ≤ 0.05) with lead levels in TD but not in AU subjects; and many probe sets (n = 162) correlated (P ≤ 0.05) with lead levels in AU but not in TD subjects.,"['children with autism', 'children with autism (AU, n = 37) compared to typically developing controls (TD, n = 15']",[],"['gene expression and lead (Pb) levels', 'false positives']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0524167', 'cui_str': 'Lead measurement (procedure)'}, {'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}]",162.0,0.0207141,A large number (n = 791) of probe sets correlated (P ≤ 0.05) with lead levels in TD but not in AU subjects; and many probe sets (n = 162) correlated (P ≤ 0.05) with lead levels in AU but not in TD subjects.,"[{'ForeName': 'Yingfang', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Neurology, University of California at Davis, Sacramento, CA 95817, USA. yftian@ucdavis.edu'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Boryana', 'Initials': 'B', 'LastName': 'Stamova', 'Affiliation': ''}, {'ForeName': 'Irva', 'Initials': 'I', 'LastName': 'Hertz-Picciotto', 'Affiliation': ''}, {'ForeName': 'Isaac N', 'Initials': 'IN', 'LastName': 'Pessah', 'Affiliation': ''}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Gregg', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ashwood', 'Affiliation': ''}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Jickling', 'Affiliation': ''}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Van de Water', 'Affiliation': ''}, {'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Sharp', 'Affiliation': ''}]",Neurotoxicity research,['10.1007/s12640-009-9126-x']
471,20035358,Prognostic factors for perceived recovery or functional improvement in non-specific low back pain: secondary analyses of three randomized clinical trials.,"The objective of this study was to report on secondary analyses of a merged trial dataset aimed at exploring the potential importance of patient factors associated with clinically relevant improvements in non-acute, non-specific low back pain (LBP). From 273 predominantly male army workers (mean age 39 +/- 10.5 years, range 20-56 years, 4 women) with LBP who were recruited in three randomized clinical trials, baseline individual patient factors, pain-related factors, work-related psychosocial factors, and psychological factors were evaluated as potential prognostic variables in a short-term (post-treatment) and a long-term logistic regression model (6 months after treatment). We found one dominant prognostic factor for improvement directly after treatment as well as 6 months later: baseline functional disability, expressed in Roland-Morris Disability Questionnaire scores. Baseline fear of movement, expressed in Tampa Scale for Kinesiophobia scores, had also significant prognostic value for long-term improvement. Less strongly associated with the outcome, but also included in our final models, were supervisor social support and duration of complaints (short-term model), and co-worker social support and pain radiation (long-term model). Information about initial levels of functional disability and fear-avoidance behaviour can be of value in the treatment of patient populations with characteristics comparable to the current army study population (e.g., predominantly male, physically active, working, moderate but chronic back problems). Individuals at risk for poor long-term LBP recovery, i.e., individuals with high initial level of disability and prominent fear-avoidance behaviour, can be distinguished that may need additional cognitive-behavioural treatment.",2010,"Baseline fear of movement, expressed in Tampa Scale for Kinesiophobia scores, had also significant prognostic value for long-term improvement.","['patient populations with characteristics comparable to the current army study population (e.g., predominantly male, physically active, working, moderate but chronic back problems', '10.5 years, range 20-56 years, 4 women) with LBP', 'non-specific low back pain', 'non-acute, non-specific low back pain (LBP', 'From 273 predominantly male army workers (mean age 39 ']",[],"['baseline functional disability, expressed in Roland-Morris Disability Questionnaire scores', 'Baseline fear of movement, expressed in Tampa Scale for Kinesiophobia scores', 'supervisor social support and duration of complaints (short-term model), and co-worker social support and pain radiation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0579085', 'cui_str': 'Back problem (finding)'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}, {'cui': 'C0037438'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]",273.0,0.0360067,"Baseline fear of movement, expressed in Tampa Scale for Kinesiophobia scores, had also significant prognostic value for long-term improvement.","[{'ForeName': 'Pieter H', 'Initials': 'PH', 'LastName': 'Helmhout', 'Affiliation': 'Department of Training Medicine and Training Physiology, Personnel Command, Royal Netherlands Army, PO Box 90004, 3509 AA Utrecht, The Netherlands. p.h.helmhout@mindef.nl'}, {'ForeName': 'J Bart', 'Initials': 'JB', 'LastName': 'Staal', 'Affiliation': ''}, {'ForeName': 'Martijn W', 'Initials': 'MW', 'LastName': 'Heymans', 'Affiliation': ''}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Harts', 'Affiliation': ''}, {'ForeName': 'Erik J M', 'Initials': 'EJ', 'LastName': 'Hendriks', 'Affiliation': ''}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'de Bie', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-009-1254-8']
472,32431023,Fatigue and activity after stroke. Secondary results from the Life After Stroke study.,"OBJECTIVES


The aim of this study was to describe how the prevalence of fatigue changed from the subacute phase to the chronic phase after stroke, and to investigate how activity was associated with fatigue among participants included in the randomized controlled multicentre-study Life After STroke (LAST).
METHODS


The present study represents secondary analysis based on data from the LAST study. One-hundred-and-forty-five patients with mild and moderate stroke (mean (SD) age: 71.5 (10.5) years, 57.2% males) recruited from St. Olav's University Hospital were included. Fatigue was assessed by the Fatigue Severity Scale (FSS-7) at inclusion, 3 months after stroke, and at follow-up 18 months later. activPAL was used to measure activity at follow-up.
RESULTS


A total of 46 (31.7%) participants reported fatigue at inclusion and 43 (29.7%) at follow-up (p = .736). In the univariable regression analysis, sedentary behaviour, walking and sedentary bouts were significantly associated with fatigue (p ≤ .015), whereas only time spent walking was significantly associated with fatigue in the multivariable regression analysis (p = .017).
CONCLUSIONS


The present study showed that fatigue is a common symptom after stroke and that the prevalence of fatigue remained unchanged from the subacute to the chronic phase. The study also showed that increased time spent walking was strongly related to lower fatigue, while no such associations were found between the other activity categories and fatigue.",2020,"In the univariable regression analysis, sedentary behaviour, walking and sedentary bouts were significantly associated with fatigue (p ≤ .015), whereas only time spent walking was significantly associated with fatigue in the multivariable regression analysis (p = .017).
","[""One-hundred-and-forty-five patients with mild and moderate stroke (mean (SD) age: 71.5 (10.5) years, 57.2% males) recruited from St. Olav's University Hospital were included""]",['activPAL'],"['Life', 'sedentary behaviour, walking and sedentary bouts', 'Fatigue and activity', 'fatigue', 'activity categories and fatigue', 'Fatigue', 'time spent walking', 'Fatigue Severity Scale (FSS-7']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0265224', 'cui_str': 'Freeman-Sheldon syndrome'}]",145.0,0.0425954,"In the univariable regression analysis, sedentary behaviour, walking and sedentary bouts were significantly associated with fatigue (p ≤ .015), whereas only time spent walking was significantly associated with fatigue in the multivariable regression analysis (p = .017).
","[{'ForeName': 'Ragnhild Sunde', 'Initials': 'RS', 'LastName': 'Braaten', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Torunn', 'Initials': 'T', 'LastName': 'Askim', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Gunnes', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Indredavik', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1851']
473,19774475,Significant increase in factual knowledge with web-assisted problem-based learning as part of an undergraduate cardio-respiratory curriculum.,"In recent years, increasing attention has been paid to web-based learning although the advantages of computer-aided instruction over traditional teaching formats still need to be confirmed. This study examined whether participation in an online module on the differential diagnosis of dyspnoea impacts on student performance in a multiple choice examination of factual knowledge in cardiology and pneumology. A virtual problem-based learning environment for medical students supervised by postgraduate teachers was created. Seventy-four out of 183 fourth-year medical students volunteered to use the online module while attending a 6-week cardio-respiratory curriculum in summer 2007. Of these, 40 were randomly selected to be included (intervention group); the remaining 34 served as an internal control group. Analysis of all written exams taken during the preceding term showed that both groups were comparable (86.4 ± 1.1 vs. 85.9 ± 1.1%; p = 0.751). Students in the intervention group scored significantly higher in the final course assessment than students allocated to the control group (84.8 ± 1.3 vs. 79.5 ± 1.4%; p = 0.006; effect size 0.67). Thus, additional problem-based learning with an online module as part of an undergraduate cardio-respiratory curriculum lead to higher students' scores in an exam testing factual knowledge. Whether using this teaching format increases overall student motivation to engage in the learning process needs to be further investigated.",2010,Students in the intervention group scored significantly higher in the final course assessment than students allocated to the control group (84.8 ± 1.3 vs. 79.5 ± 1.4%; p = 0.006; effect size 0.67).,"['Seventy-four out of 183 fourth-year medical students volunteered to use the online module while attending a 6-week cardio-respiratory curriculum in summer 2007', 'medical students supervised by postgraduate teachers']",[],"['overall student motivation', 'factual knowledge', 'final course assessment']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0164202,Students in the intervention group scored significantly higher in the final course assessment than students allocated to the control group (84.8 ± 1.3 vs. 79.5 ± 1.4%; p = 0.006; effect size 0.67).,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Raupach', 'Affiliation': 'Department of Cardiology and Pneumology, University Hospital Göttingen, Georg August University of Göttingen, University Clinic, Germany. raupach@med.uni-goettingen.de'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Münscher', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pukrop', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Anders', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Harendza', 'Affiliation': ''}]",Advances in health sciences education : theory and practice,['10.1007/s10459-009-9201-3']
474,19763634,"Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up.","A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A-P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4 degrees . Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23), respectively (P = 0.001). The patients' global assessments of their neck and arm symptoms 2 years postoperatively for the TM group were rated as 79% much better or better after fusion with TM and 75% using autograft. Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group. There was no statistically significant difference in clinical outcomes between fusion techniques or between patients who appeared radiologically fused or non-fused. There was no difference in pelvic/hip pain between patients operated on with or without autograft. In our study, Trabecular Metal showed a lower fusion rate than the Smith-Robinson technique with autograft after single-level anterior cervical fusion without plating. There was no difference in clinical outcomes between the groups. The operative time was shorter with Trabecular Metal implants.",2010,"Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group.","['anterior cervical fusion for degenerative disease', '80 consecutive patients planned for ACDF']","['Trabecular Metal and the Smith-Robinson technique', 'TM or tricortical autograft', 'anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft']","['Pain intensity', 'visual analog scale (VAS) and neck function', 'pelvic/hip pain', 'lower fusion rate', 'Fusion rate', 'neck pain', 'operative time', 'Pain scores and NDI scores', 'Operating time', 'clinical outcomes']","[{'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C4552416', 'cui_str': 'Anterior cervical discectomy with fusion'}]","[{'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0443050', 'cui_str': 'Robinson (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.034936,"Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group.","[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Löfgren', 'Affiliation': 'Neuro-Orthopedic Center, Ryhov Hospital, 55185 Jönköping, Sweden. Hakan.Lofgren@lj.se'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Engquist', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hoffmann', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sigstedt', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vavruch', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-009-1161-z']
475,19816648,"Comparison of monthly ibandronate versus weekly risedronate in preference, convenience, and bone turnover markers in Korean postmenopausal osteoporotic women.","Patient preferences, convenience, and bone turnover markers were evaluated for the monthly ibandronate over the weekly risedronate regimen in Korean postmenopausal osteoporotic women. This was a 6-month, prospective, randomized, open-label, multicenter study with a two-period and two-sequence crossover treatment design. After a 30-day screening period, eligible participants with postmenopausal osteoporosis were randomized to receive either monthly oral ibandronate 150 mg for 3 months followed by weekly oral risedronate 35 mg for 12 weeks (sequence A) or the same regimen in reverse order (sequence B). Patient preference and convenience were evaluated by questionnaire. The changes in serum C-telopeptide after 3 months of treatment were analyzed. A total of 365 patients were enrolled in this study (sequence A 182, sequence B 183). Of patients expressing a preference (83.4%), 74.8% preferred the monthly ibandronate regimen over the weekly regimen (25.2%). More women stated that the monthly ibandronate regimen was more convenient (84.2%) than the weekly regimen (15.8%). There was no significant difference in the change in bone turnover marker between the two treatments. The two regimens were similarly tolerable. There were fewer adverse events in the monthly ibandronate group compared to the weekly risedronate group in terms of gastrointestinal side effects (nausea and abdominal distension). This study revealed a strong preference and convenience for monthly ibandronate over weekly risedronate in Korean postmenopausal osteoporotic women. There was no significant difference in change of bone turnover marker and safety profile between the two regimens.",2009,There were fewer adverse events in the monthly ibandronate group compared to the weekly risedronate group in terms of gastrointestinal side effects (nausea and abdominal distension).,"['eligible participants with postmenopausal osteoporosis', '365 patients were enrolled in this study (sequence A 182, sequence B 183', 'Korean postmenopausal osteoporotic women']","['risedronate', 'oral ibandronate 150 mg for 3 months followed by weekly oral risedronate']","['Patient preferences, convenience, and bone turnover markers', 'serum C-telopeptide', 'bone turnover marker', 'gastrointestinal side effects (nausea and abdominal distension', 'adverse events', 'change of bone turnover marker and safety profile']","[{'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",365.0,0.0151476,There were fewer adverse events in the monthly ibandronate group compared to the weekly risedronate group in terms of gastrointestinal side effects (nausea and abdominal distension).,"[{'ForeName': 'Yoon-Sok', 'Initials': 'YS', 'LastName': 'Chung', 'Affiliation': 'Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Sung-Kil', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Ho-Yeon', 'Initials': 'HY', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'In-Kyu', 'Initials': 'IK', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Il-Hyung', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Ghi-Su', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yong-Ki', 'Initials': 'YK', 'LastName': 'Min', 'Affiliation': ''}, {'ForeName': 'Moo-Il', 'Initials': 'MI', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Dong-Jin', 'Initials': 'DJ', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Yong-Ki', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Woong Hwan', 'Initials': 'WH', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Min Ho', 'Initials': 'MH', 'LastName': 'Shong', 'Affiliation': ''}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Dong-Won', 'Initials': 'DW', 'LastName': 'Byun', 'Affiliation': ''}, {'ForeName': 'Hyun-Koo', 'Initials': 'HK', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Chan Soo', 'Initials': 'CS', 'LastName': 'Shin', 'Affiliation': ''}, {'ForeName': 'Yil-Seob', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Nam-Hee', 'Initials': 'NH', 'LastName': 'Kwon', 'Affiliation': ''}]",Calcified tissue international,['10.1007/s00223-009-9294-y']
476,19771504,Using electronic drug monitor feedback to improve adherence to antiretroviral therapy among HIV-positive patients in China.,"Effective antiretroviral therapy (ART) requires excellent adherence. Little is known about how to improve ART adherence in many HIV/AIDS-affected countries, including China. We therefore assessed an adherence intervention among HIV-positive patients in southwestern China. Eighty subjects were enrolled and monitored for 6 months. Sixty-eight remaining subjects were randomized to intervention/control arms. In months 7-12, intervention subjects were counseled using EDM feedback; controls continued with standard of care. Among randomized subjects, mean adherence and CD4 count were 86.8 vs. 83.8% and 297 vs. 357 cells/microl in intervention vs. control subjects, respectively. At month 12, among 64 subjects who completed the trial, mean adherence had risen significantly among intervention subjects to 96.5% but remained unchanged in controls. Mean CD4 count rose by 90 cells/microl and declined by 9 cells/microl among intervention and control subjects, respectively. EDM feedback as a counseling tool appears promising for management of HIV and other chronic diseases.",2010,"Mean CD4 count rose by 90 cells/microl and declined by 9 cells/microl among intervention and control subjects, respectively.","['Sixty-eight remaining subjects', 'Eighty subjects were enrolled and monitored for 6 months', 'HIV-positive patients in southwestern China', 'HIV-positive patients in China']",['antiretroviral therapy (ART'],"['ART adherence', 'Mean CD4 count', 'mean adherence and CD4 count']","[{'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",80.0,0.0566986,"Mean CD4 count rose by 90 cells/microl and declined by 9 cells/microl among intervention and control subjects, respectively.","[{'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Sabin', 'Affiliation': 'Center for International Health and Development, Boston University, Boston, MA, USA. lsabin@bu.edu'}, {'ForeName': 'Mary Bachman', 'Initials': 'MB', 'LastName': 'DeSilva', 'Affiliation': ''}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': ''}, {'ForeName': 'Keyi', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ira B', 'Initials': 'IB', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gill', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-009-9615-1']
477,19757019,Reducing HIV risks among active injection drug and crack users: the safety counts program.,"The efficacy of Safety Counts, a CDC-diffused intervention, was reanalyzed. In a quasi experimental, cross-over design, injection drug users (IDU) and crack users in two neighborhoods were assigned by neighborhood to receive individual Voluntary HIV Counseling and Testing or Safety Counts and 78% were reassessed at 5-9 months. Drug users in the Safety Counts program reported significantly greater reductions in risky sex, crack and hard drug use, and risky drug injection. The more sessions of Safety Counts attended, the greater were the reductions in risky acts. Different analytic decisions result in very different findings for the same intervention. Safety Counts is an effective intervention for IDU and crack users. Analytic decision of intervention outcomes is highly related to evaluations of an intervention's efficacy.",2010,"Drug users in the Safety Counts program reported significantly greater reductions in risky sex, crack and hard drug use, and risky drug injection.",[],[],"['risky sex, crack and hard drug use, and risky drug injection', 'risky acts', 'HIV risks']",[],[],"[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0248219,"Drug users in the Safety Counts program reported significantly greater reductions in risky sex, crack and hard drug use, and risky drug injection.","[{'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Center for HIV Identification, Prevention, and Treatment Services, University of California, Los Angeles, CA, USA. Rotheram@ucla.edu'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Rhodes', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Desmond', 'Affiliation': ''}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Weiss', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-009-9606-2']
478,19757018,Acceptability and use of the diaphragm and Replens lubricant gel for HIV prevention in Southern Africa.,"The acceptability and use of the diaphragm and lubricant gel were assessed as part of a large randomized controlled trial to determine the effectiveness of the methods in women's HIV acquisition. 2,452 intervention-arm women were enrolled at five Southern African clinics and followed quarterly for 12-24 months. Acceptability and use data were collected by face-to-face interviews at Month 3 and Exit. Participants were ""very comfortable"" with the physical mechanics of diaphragm use throughout the trial, and approval of the gel consistency, quantity and the applicator was high. At Exit, consistent disclosure of use (AOR 1.97, 95% CI: 1.10-3.55); an overall high diaphragm rating (AOR 1.84, 95% CI: 1.45-2.34) and perception of partner approval (AOR 1.75, 95% CI: 1.35-2.26) were the most significant acceptability factors independently associated with consistent use. Despite being female-initiated, disclosure of use to male partners and his perceived approval of the products were factors significantly associated with their consistent use.",2010,"At Exit, consistent disclosure of use (AOR 1.97, 95% CI: 1.10-3.55); an overall high diaphragm rating (AOR 1.84, 95% CI: 1.45-2.34) and perception of partner approval (AOR 1.75, 95% CI: 1.35-2.26) were the most significant acceptability factors independently associated with consistent use.","['2,452 intervention-arm women were enrolled at five Southern African clinics and followed quarterly for 12-24 months', ""women's HIV acquisition"", 'HIV prevention in Southern Africa']","['diaphragm and lubricant gel', 'diaphragm and Replens lubricant gel']","['perception of partner approval', 'overall high diaphragm rating']","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0001746', 'cui_str': 'Africa, Southern'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0251132', 'cui_str': 'Replens'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}]",,0.083196,"At Exit, consistent disclosure of use (AOR 1.97, 95% CI: 1.10-3.55); an overall high diaphragm rating (AOR 1.84, 95% CI: 1.45-2.34) and perception of partner approval (AOR 1.75, 95% CI: 1.35-2.26) were the most significant acceptability factors independently associated with consistent use.","[{'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco Project Office, 114 Sansome Street, Suite 500, San Francisco, CA 94104, USA. emontgomery@rti.org""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ''}, {'ForeName': 'Agnes C', 'Initials': 'AC', 'LastName': 'Chidanyika', 'Affiliation': ''}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Lince', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Blanchard', 'Affiliation': ''}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramjee', 'Affiliation': ''}, {'ForeName': 'Busisiwe', 'Initials': 'B', 'LastName': 'Nkala', 'Affiliation': ''}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Padian', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-009-9609-z']
479,19834635,One-year follow-up after sacrospinous hysteropexy and vaginal hysterectomy for uterine descent: a randomized study.,"INTRODUCTION AND HYPOTHESIS


In a retrospective study, the sacrospinous hysteropexy was associated with a shorter recovery time compared to a vaginal hysterectomy with no differences in anatomical outcomes. No randomized trials are performed.
METHODS


Sixty-six women with stage 2-4 uterine descent were randomized for vaginal hysterectomy(31) or sacrospinous hysteropexy(35). Recovery time, anatomical outcomes, functional outcomes, and quality of life were measured.
RESULTS


Length of time to return to work was shorter after a sacrospinous hysteropexy (43 versus 66 days, p = 0.02). The difference in risk for recurrent prolapse stage 2 or more of the apical compartment at 1-year follow-up was 17% (95% confidence interval, 2 to 30) in favor of the vaginal hysterectomy. No differences in quality of life and urogenital symptoms were found.
CONCLUSIONS


The sacrospinous hysteropexy for uterine descent is associated with an earlier recovery time, more recurrent apical prolapses but no differences in functional outcomes, and quality of life.",2010,"Length of time to return to work was shorter after a sacrospinous hysteropexy (43 versus 66 days, p = 0.02).",['Sixty-six women with stage 2-4 uterine descent'],"['vaginal hysterectomy(31) or sacrospinous hysteropexy(35', 'sacrospinous hysteropexy and vaginal hysterectomy']","['functional outcomes, and quality of life', 'quality of life and urogenital symptoms', 'Length of time to return to work', 'Recovery time, anatomical outcomes, functional outcomes, and quality of life']","[{'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}]","[{'cui': 'C0020700', 'cui_str': 'Colpohysterectomy'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy (procedure)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}]",66.0,0.146273,"Length of time to return to work was shorter after a sacrospinous hysteropexy (43 versus 66 days, p = 0.02).","[{'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Dietz', 'Affiliation': 'Department of Obstetrics and Gynecology, Catharina Medical Center, Michelangelolaan 2, 5623, Eindhoven, The Netherlands. viviane.dietz@sapio.nl'}, {'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'van der Vaart', 'Affiliation': ''}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'van der Graaf', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Heintz', 'Affiliation': ''}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schraffordt Koops', 'Affiliation': ''}]",International urogynecology journal,['10.1007/s00192-009-1014-7']
480,19757017,Acceptability of UC781 gel as a rectal microbicide among HIV-uninfected women and men.,"We studied the overall acceptability of UC781 gel formulation when applied rectally. Ten women and twenty-six men, all HIV-uninfected, were enrolled in a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of the vaginal microbicide gel UC781 applied rectally. Participants were randomized to three groups: 0.1% UC781 gel, 0.25% UC781 gel, or a placebo gel. Acceptability was assessed using structured questionnaires and qualitative in-depth interviews. After using UC781 gel rectally for seven consecutive days, participants' reports suggest that a UC781 gel formulation is highly acceptable and comparable to a placebo gel. The gels received favorable ratings overall and on attributes such as color, smell and consistency. All of the participants reported high intentions to use a gel like the one they used in this study. Acceptability research is essential in early phases of microbicide development to identify potential problems, understand user preferences, and introduce changes if needed.",2010,"The gels received favorable ratings overall and on attributes such as color, smell and consistency.","['HIV-uninfected women and men', 'Ten women and twenty-six men, all HIV-uninfected']","['UC781 gel formulation', 'UC781 gel, 0.25% UC781 gel, or a placebo gel', 'placebo', 'UC781 gel rectally', 'UC781 gel', 'vaginal microbicide gel UC781 applied rectally']","['Acceptability', 'favorable ratings overall and on attributes such as color, smell and consistency']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}]","[{'cui': 'C0391448', 'cui_str': 'UC781'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",10.0,0.128003,"The gels received favorable ratings overall and on attributes such as color, smell and consistency.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ventuneac', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY 10032, USA. ventune@pi.cpmc.columbia.edu'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McGowan', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dennis', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Adler', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Khanukhova', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Saunders', 'Affiliation': ''}, {'ForeName': 'Chomchay', 'Initials': 'C', 'LastName': 'Siboliban', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Anton', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-009-9611-5']
481,19830449,Information and feedback to improve occupational physicians' reporting of occupational diseases: a randomised controlled trial.,"PURPOSE


To assess the effectiveness of supplying occupational physicians (OPs) with targeted and stage-matched information or with feedback on reporting occupational diseases to the national registry in the Netherlands.
METHODS


In a randomized controlled design, 1076 OPs were divided into three groups based on previous reporting behaviour: precontemplators not considering reporting, contemplators considering reporting and actioners reporting occupational diseases. Precontemplators and contemplators were randomly assigned to receive stage-matched, stage-mismatched or general information. Actioners were randomly assigned to receive personalized or standardized feedback upon notification. Outcome measures were the number of OPs reporting and the number of reported occupational diseases in a 180-day period before and after the intervention.
RESULTS


Precontemplators were significantly more male and self-employed compared to contemplators and actioners. There was no significant effect of stage-matched information versus stage-mismatched or general information on the percentage of reporting OPs and on the mean number of notifications in each group. Receiving any information affected reporting more in contemplators than in precontemplators. The mean number of notifications in actioners increased more after personalized feedback than after standardized feedback, but the difference was not significant.
CONCLUSIONS


This study supports the concept that contemplators are more susceptible to receiving information but could not confirm an effect of stage-matching this information on reporting occupational diseases to the national registry.",2010,There was no significant effect of stage-matched information versus stage-mismatched or general information on the percentage of reporting OPs and on the mean number of notifications in each group.,['1076 OPs'],"['personalized or standardized feedback upon notification', 'supplying occupational physicians (OPs) with targeted and stage-matched information or with feedback']","['number of OPs reporting and the number of reported occupational diseases', 'mean number of notifications in actioners']",[],"[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0401976', 'cui_str': 'Occupational physician (occupation)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0028797', 'cui_str': 'Occupational Illnesses'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}]",1076.0,0.0418081,There was no significant effect of stage-matched information versus stage-mismatched or general information on the percentage of reporting OPs and on the mean number of notifications in each group.,"[{'ForeName': 'Annet F', 'Initials': 'AF', 'LastName': 'Lenderink', 'Affiliation': 'Netherlands Centre for Occupational Diseases, Coronel Institute of Occupational Health, Academic Medical Center (AMC), University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, The Netherlands. a.f.lenderink@amc.uva.nl'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Spreeuwers', 'Affiliation': ''}, {'ForeName': 'Jac J L', 'Initials': 'JJ', 'LastName': 'van der Klink', 'Affiliation': ''}, {'ForeName': 'Frank J H', 'Initials': 'FJ', 'LastName': 'van Dijk', 'Affiliation': ''}]",International archives of occupational and environmental health,['10.1007/s00420-009-0468-8']
482,19830496,Preoperative and early postoperative quality of life predict survival in potentially curable patients with esophageal cancer.,"BACKGROUND


In patients with esophageal cancer, evidence for prognostic significance of preoperative quality of life (QoL) is limited, while the prognostic significance of postoperative QoL has not been investigated at all.
AIM


To determine whether preoperative and postoperative QoL measurements can predict survival independently from clinical and pathological factors, in patients with potentially curable esophageal adenocarcinoma.
METHODS


A randomized controlled trial was performed from 1994 to 2000 in two academic medical centres, comparing transthoracic and transhiatal esophagectomy. QoL questionnaires were sent before and 3 months after surgery (Medical Outcome Study Short Form-20 and Rotterdam Symptom Checklist). Uni- and multivariate Cox regression analyses were used to examine firstly the prognostic value of preoperative QoL and several clinical factors, and secondly of postoperative QoL, several clinical factors, and pathological staging.
RESULTS


Out of 220 randomized patients, 199 participated in the QoL-study. In the multivariate preoperative model physical symptom scale (p = 0.021), tumor length (p = 0.034), and endosonographic T-stage (p = 0.003) were predictive for overall survival. In the postoperative multivariate analysis, social functioning (p = 0.035), pain (p = 0.026), and activity level (p = 0.037) predicted survival, besides pathological T-stage (p < 0.001) and N-stage (p < 0.001).
CONCLUSION


In the present paper the first large consecutive series of potentially curable esophageal cancer patients is presented in whom prospectively collected QoL data before and after potentially curative surgical resection were used to predict survival. Both preoperative (physical symptoms) and postoperative (social functioning, pain, and activity level) QoL subscales are independent predictors of survival in potentially curable patients with esophageal adenocarcinoma.",2010,"In the postoperative multivariate analysis, social functioning (p = 0.035), pain (p = 0.026), and activity level (p = 0.037) predicted survival, besides pathological T-stage (p < 0.001) and N-stage (p < 0.001).
","['1994 to 2000 in two academic medical centres, comparing', 'patients with potentially curable esophageal adenocarcinoma', 'curable patients with esophageal adenocarcinoma', 'patients with esophageal cancer', '220 randomized patients, 199 participated in the QoL-study', 'curable esophageal cancer patients', 'potentially curable patients with esophageal cancer']",['transthoracic and transhiatal esophagectomy'],"['tumor length', 'pain', 'Preoperative and early postoperative quality of life predict survival', 'multivariate preoperative model physical symptom scale', 'endosonographic T-stage', 'overall survival', 'survival, besides pathological T-stage', 'QoL questionnaires', 'Both preoperative (physical symptoms) and postoperative (social functioning, pain, and activity level) QoL subscales', 'activity level', 'social functioning']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma Of Esophagus'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205503', 'cui_str': 'Transthoracic approach (qualifier value)'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034380'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",220.0,0.0999879,"In the postoperative multivariate analysis, social functioning (p = 0.035), pain (p = 0.026), and activity level (p = 0.037) predicted survival, besides pathological T-stage (p < 0.001) and N-stage (p < 0.001).
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Heijl', 'Affiliation': 'Department of Surgery, G4-115, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. m.i.vanbergehenegouwen@amc.uva.nl'}, {'ForeName': 'Mirjam A G', 'Initials': 'MA', 'LastName': 'Sprangers', 'Affiliation': ''}, {'ForeName': 'Angela G E M', 'Initials': 'AG', 'LastName': 'de Boer', 'Affiliation': ''}, {'ForeName': 'Sjoerd M', 'Initials': 'SM', 'LastName': 'Lagarde', 'Affiliation': ''}, {'ForeName': 'Hans B', 'Initials': 'HB', 'LastName': 'Reitsma', 'Affiliation': ''}, {'ForeName': 'Olivier R C', 'Initials': 'OR', 'LastName': 'Busch', 'Affiliation': ''}, {'ForeName': 'Hugo W', 'Initials': 'HW', 'LastName': 'Tilanus', 'Affiliation': ''}, {'ForeName': 'Jan J B', 'Initials': 'JJ', 'LastName': 'van Lanschot', 'Affiliation': ''}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': ''}]",Annals of surgical oncology,['10.1245/s10434-009-0731-y']
483,19756478,Combined randomised controlled trial experience of malignancies in studies using insulin glargine.,"AIMS/HYPOTHESIS


Recent publications of data extracted from population registries have suggested a possible relationship between treatment with insulin glargine and increased incidence of cancer/breast cancer. The aim of the present study was investigate this possible relationship using data from the manufacturer's (sanofi-aventis) pharmacovigilance database.
METHODS


We analysed the manufacturer's (sanofi-aventis) pharmacovigilance database for all randomised clinical trials (RCTs; Phase 2-4) comparing insulin glargine with any comparator in type 1 or type 2 diabetes. We identified all serious adverse events coded under the System Organ Class of 'neoplasms, benign, malignant and unspecified'. Treatment-emergent neoplasms judged to be malignant were included in this analysis.
RESULTS


The database included 31 studies, 12 in type 1 diabetes and 19 in type 2 diabetes. Twenty compared insulin glargine with NPH insulin, 29 were parallel-group studies and two had a crossover design. Studies were generally of 6 months' duration, except for trial reference number 4016 (n = 1,017), which had a duration of 5 years. Overall, 10,880 people were included in the analysis (insulin glargine, 5,657; comparator, 5,223). Forty-five people (0.8%) vs 46 people (0.9%) reported 52 and 48 cases of malignant cancer in the insulin glargine and comparator groups, respectively (RR 0.90, 95% CI 0.60-1.36). Skin (12 people with 16 events vs six people with seven events, RR 1.85, 95% CI 0.69-4.92), colon and rectum (six vs ten people, RR 0.55, 95% CI 0.20-1.52), breast (four vs six people, RR 0.62, 95% CI 0.17-2.18) and gastrointestinal tract (six vs four people, RR 1.38, 95% CI 0.39-4.90) were the most commonly reported sites.
CONCLUSIONS/INTERPRETATION


In these 31 RCTs, insulin glargine was not associated with an increased incidence of cancer, including breast cancer, compared with the comparator group.",2009,"In these 31 RCTs, insulin glargine was not associated with an increased incidence of cancer, including breast cancer, compared with the comparator group.","['10,880 people were included in the analysis (insulin glargine, 5,657; comparator, 5,223', 'The database included 31 studies, 12 in type 1 diabetes and 19 in type 2 diabetes']","['insulin glargine', 'insulin glargine with NPH insulin']","['malignant cancer', 'colon and rectum', 'incidence of cancer, including breast cancer', 'gastrointestinal tract']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0021658', 'cui_str': 'insulin, isophane'}]","[{'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}]",10880.0,0.282731,"In these 31 RCTs, insulin glargine was not associated with an increased incidence of cancer, including breast cancer, compared with the comparator group.","[{'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Home', 'Affiliation': 'ICM-Diabetes, The Medical School, Newcastle University, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK. philip.home@newcastle.ac.uk'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lagarenne', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-009-1530-5']
484,19756742,Newly acquired Onchocerca volvulus filariae after doxycycline treatment.,"Despite successful mass drug administration and vector control programs, the nematode Onchocerca volvulus is far from being eradicated. Therefore, new long-term sterilizing or macrofilaricidal drugs are needed. The depletion of Wolbachia endobacteria using doxycycline leads to long-term sterilizing effects and macrofilaricidal activity against female filariae of more than 60%. The worms die or degenerate 18-27 months after doxycycline. However, during this time patients may be exposed to new infections. We evaluated these newly acquired worms in onchocercomas of doxycycline-treated patients in relation to transmission using morphology, histochemistry, and immunohistology. On an average, 10% of the female filariae had been newly acquired per year in the treated groups. Our observations showed: (a) Sixty-three of 68 newly acquired worms harbored many intact Wolbachia, whereas none of the other surviving worms contained many bacteria. (b) Higher percentages of dead filariae than originally reported were calculated, when the new worms were excluded, indicating a stronger macrofilaricidal activity than previously reported. The difference was significant for female filariae after doxycycline treatment for 6 weeks. (c) Only newly acquired worms presented normal embryogenesis and microfilariae production after sufficient treatment. We conclude that newly acquired filariae have to be considered when evaluating drug efficacy in onchocerciasis.",2009,The depletion of Wolbachia endobacteria using doxycycline leads to long-term sterilizing effects and macrofilaricidal activity against female filariae of more than 60%.,[],['doxycycline'],"['female filariae', 'normal embryogenesis and microfilariae production']",[],"[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}]","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0013936', 'cui_str': 'Embryonic Development'}, {'cui': 'C0025980', 'cui_str': 'Microfilaria'}, {'cui': 'C0033268'}]",,0.0414996,The depletion of Wolbachia endobacteria using doxycycline leads to long-term sterilizing effects and macrofilaricidal activity against female filariae of more than 60%.,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Specht', 'Affiliation': 'Institute for Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, 53105, Bonn, Germany. specht@microbiology-bonn.de'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Hoerauf', 'Affiliation': ''}, {'ForeName': 'Ohene', 'Initials': 'O', 'LastName': 'Adjei', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Debrah', 'Affiliation': ''}, {'ForeName': 'Dietrich W', 'Initials': 'DW', 'LastName': 'Büttner', 'Affiliation': ''}]",Parasitology research,['10.1007/s00436-009-1624-5']
485,19779804,Reliability and validity of the Disability Assessment Structured Interview (DASI): a tool for assessing functional limitations in claimants.,"OBJECTIVE


The aim of this study is to investigate the reliability and validity of the Disability Assessment Structured Interview (DASI). The DASI is a semi-structured interview for assessing long-term functional limitations concerning the work disability assessment of claimants.
METHODS


A randomized controlled trial was conducted. Patients applying for a work-disability pension after 21 months of sick leave were independently interviewed and examined either by two physicians who had completed a DASI training period (n = 32) or by two physicians from a control group (n = 30) without any DASI training. Agreement percentages within both groups of physicians, eligibility for a disability benefit, and differences between the groups in terms of the scores given on the work-limitation items from the Functional Ability List (FAL) were measured to investigate reliability and concurrent validity. To determine the content validity, the insurance physicians who completed DASI training (n = 8) were asked to fill out a questionnaire concerning their opinion of the DASI. Additionally, patients filled out a questionnaire to measure their satisfaction as to the behavioral aspects of the physicians.
RESULTS


The groups showed no important differences in agreement percentages (mean percentage about 80%) and eligibility for a disability benefit. In 9 out of 21 items the physicians of the control group indicated fewer work limitations compared to physicians using the DASI. All physicians agreed on the fact that the DASI was an acceptable tool in daily practice, one that provided a realistic picture of the patient and provided sufficient information to assess functional limitations. In addition, between the two groups, no differences were found as to the satisfaction of patients concerning the behavioral aspects of the physicians.
CONCLUSION


The DASI is a tool with a reasonable to good inter-rater reliability and content validity, and it appears to be acceptable to both patients and physicians. It did not improve inter-observer agreement beyond that of usual interview procedures used in the Netherlands. The DASI would seem to be a worthwhile tool for collecting self-reported information in order to assess functional limitations in claimants.",2010,In 9 out of 21 items the physicians of the control group indicated fewer work limitations compared to physicians using the DASI.,"['Patients applying for a work-disability pension after 21 months of sick leave were independently interviewed and examined either by two physicians who had completed a DASI training period (n = 32) or by two physicians from a control group (n = 30) without any', 'claimants']","['Disability Assessment Structured Interview (DASI', 'DASI training']",['Functional Ability List (FAL'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030854', 'cui_str': 'Retirement Benefits'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",30.0,0.0180832,In 9 out of 21 items the physicians of the control group indicated fewer work limitations compared to physicians using the DASI.,"[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Spanjer', 'Affiliation': 'Social Security Office, Assen, The Netherlands. jerry.spanjer@uwv.nl'}, {'ForeName': 'Boudien', 'Initials': 'B', 'LastName': 'Krol', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Brouwer', 'Affiliation': ''}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Popping', 'Affiliation': ''}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'Groothoff', 'Affiliation': ''}, {'ForeName': 'Jac J L', 'Initials': 'JJ', 'LastName': 'van der Klink', 'Affiliation': ''}]",Journal of occupational rehabilitation,['10.1007/s10926-009-9203-2']
486,19728035,Neuroactive steroids after estrogen exposure in depressed postmenopausal women treated with sertraline and asymptomatic postmenopausal women.,"Neuroactive steroids (NAS) allopregnanolone (ALLO), Allotetrahydrodeoxycorticosterone (THDOC) and dehydroepiandrosterone (DHEA) are important in the regulation of mood and behavior. Knowledge about these steroids in postmenopausal depression and the effect of estrogen on NAS is lacking. We elected to determine if there were differences in NAS between postmenopausal depressed women and age matched controls. We also investigated the effect of estradiol on NAS in post menopausal depressed women receiving a selective serotonin reuptake inhibitor (SSRI), and in non-depressed postmenopausal controls. As part of a previously published double blind study on estrogen acceleration of antidepressant action, post menopausal women with major depression receiving sertraline and healthy non depressed controls were randomized to transdermal estrogen patch 0.1 mg or placebo. NAS were measured at baseline and after 10 weeks of treatment. Depressed subjects were treated with sertraline 50 mg/day to 100 mg/day for 9 weeks. At the baseline and after treatment ALLO and DHEA were significantly lower in depressed women compared to controls. Although all depressed subjects experienced a positive clinical response, estrogen administration was not associated with changes in NAS in either the depressed or the asymptomatic postmenopausal women. The lower ALLO and DHEA in postmenopausal depressed women suggests that symptoms of depression may be influenced by the synthesis or fluctuation of these NAS. Estradiol exposure did not alter ALLO, DHEA, or THDOC, implying these NAS are unlikely to play a role in any mood changes in post menopausal women given estrogen therapy.",2010,"Estradiol exposure did not alter ALLO, DHEA, or THDOC, implying these NAS are unlikely to play a role in any mood changes in post menopausal women given estrogen therapy.","['post menopausal women with major depression receiving sertraline and healthy non depressed controls', 'depressed postmenopausal women treated with sertraline and asymptomatic postmenopausal women', 'post menopausal depressed women receiving a selective serotonin reuptake inhibitor (SSRI), and in non-depressed postmenopausal controls', 'postmenopausal depressed women and age matched controls']","['transdermal estrogen patch 0.1 mg or placebo', 'Neuroactive steroids', 'sertraline', 'Neuroactive steroids (NAS) allopregnanolone (ALLO), Allotetrahydrodeoxycorticosterone (THDOC) and dehydroepiandrosterone (DHEA', 'estradiol']",['NAS'],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0376202', 'cui_str': 'Allopregnanolone'}, {'cui': 'C1122472', 'cui_str': 'allotetrahydrodeoxycorticosterone'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]",[],,0.0466707,"Estradiol exposure did not alter ALLO, DHEA, or THDOC, implying these NAS are unlikely to play a role in any mood changes in post menopausal women given estrogen therapy.","[{'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Morgan', 'Affiliation': 'Department of Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, Los Angeles, CA 90095-1740, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Rapkin', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Biggio', 'Affiliation': ''}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Serra', 'Affiliation': ''}, {'ForeName': 'Maria Giuseppina', 'Initials': 'MG', 'LastName': 'Pisu', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rasgon', 'Affiliation': ''}]",Archives of women's mental health,['10.1007/s00737-009-0106-1']
487,19669176,"Three-year randomised clinical trial to evaluate the clinical performance, quantitative and qualitative wear patterns of hybrid composite restorations.","The aim of the study was to compare the clinical performance, quantitative and qualitative wear patterns of conventional hybrid (Tetric Ceram), micro-filled hybrid (Gradia Direct Posterior) and nano-hybrid (Tetric EvoCeram, TEC) posterior composite restorations in a 3-year randomised clinical trial. Sixteen Tetric Ceram, 17 TEC and 16 Gradia Direct Posterior restorations were placed in human molars and evaluated at baseline, 6, 12, 24 and 36 months of clinical service according to US Public Health Service criteria. The gypsum replicas at each recall were used for 3D laser scanning to quantify wear, and the epoxy resin replicas were observed under scanning electron microscope to study the qualitative wear patterns. After 3 years of clinical service, the three hybrid restorative materials performed clinically well in posterior cavities. Within the observation period, the nano-hybrid and micro-hybrid restorations evolved better in polishability with improved surface gloss retention than the conventional hybrid counterpart. The three hybrid composites showed enamel-like vertical wear and cavity-size dependant volume loss magnitude. Qualitatively, while the micro-filled and nano-hybrid composite restorations exhibited signs of fatigue similar to the conventional hybrid composite restorations at heavy occlusal contact area, their light occlusal contact areas showed less surface pitting after 3 years of clinical service.",2010,"Within the observation period, the nano-hybrid and micro-hybrid restorations evolved better in polishability with improved surface gloss retention than the conventional hybrid counterpart.","['Sixteen Tetric Ceram, 17 TEC and 16 Gradia Direct Posterior restorations were placed in human molars and evaluated at baseline, 6, 12, 24 and 36 months of clinical service according to US Public Health Service criteria']","['conventional hybrid (Tetric Ceram), micro-filled hybrid (Gradia Direct Posterior) and nano-hybrid ']",['enamel-like vertical wear and cavity-size dependant volume loss magnitude'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0909537', 'cui_str': 'Tetric ceram'}, {'cui': 'C1173385', 'cui_str': 'Gradia Direct'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0699943', 'cui_str': 'Public health service (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0909537', 'cui_str': 'Tetric ceram'}, {'cui': 'C1173385', 'cui_str': 'Gradia Direct'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}]",16.0,0.045851,"Within the observation period, the nano-hybrid and micro-hybrid restorations evolved better in polishability with improved surface gloss retention than the conventional hybrid counterpart.","[{'ForeName': 'Senthamaraiselvi', 'Initials': 'S', 'LastName': 'Palaniappan', 'Affiliation': 'Leuven BIOMAT Research Cluster, Department of Conservative Dentistry, School of Dentistry, Oral Pathology and Maxillo-Facial Surgery, Catholic University of Leuven, Kapucijnenvoer 7, 3000 Leuven, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Elsen', 'Affiliation': ''}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Lijnen', 'Affiliation': ''}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Peumans', 'Affiliation': ''}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Van Meerbeek', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lambrechts', 'Affiliation': ''}]",Clinical oral investigations,['10.1007/s00784-009-0313-1']
488,19639415,"Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension.","The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly. The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored according to biochemical response. Serum samples were assessed for growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels, at weeks 4, 13, 14, 15, 16, 32 and 52. 108 patients were enrolled and 99 completed 52 weeks' treatment. Four weeks after the first injection, serum GH levels decreased by >50% from baseline in 63% of patients receiving Lan-Autogel compared with 0% receiving placebo (P < 0.001). After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1. The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively. In patients not requiring dose escalation to 120 mg, 85% achieved biochemical control (combined criterion). Treatment was well tolerated by all patients. In conclusion, Lan-Autogel was effective in controlling GH and IGF-1 hypersecretion in patients with acromegaly and showed a rapid onset of action.",2010,"Four weeks after the first injection, serum GH levels decreased by >50% from baseline in 63% of patients receiving Lan-Autogel compared with 0% receiving placebo (P < 0.001).","[""108 patients were enrolled and 99 completed 52 weeks' treatment"", 'patients with acromegaly receiving lanreotide Autogel therapy', 'unselected patients with acromegaly']","['somatostatin analogue lanreotide (Lan-Autogel', 'placebo']","['GH and IGF-1 hypersecretion', 'serum GH levels', 'tolerated', 'growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels', 'normalized IGF-1', 'GH levels']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001206', 'cui_str': 'Somatotropin Hypersecretion Syndrome (Acromegaly)'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}]","[{'cui': 'C0732165', 'cui_str': 'Somatostatin analog'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0023933', 'cui_str': 'LAN'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]",108.0,0.204917,"Four weeks after the first injection, serum GH levels decreased by >50% from baseline in 63% of patients receiving Lan-Autogel compared with 0% receiving placebo (P < 0.001).","[{'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Melmed', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Shlomo.melmed@cshs.org'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schopohl', 'Affiliation': ''}, {'ForeName': 'Miklos I', 'Initials': 'MI', 'LastName': 'Goth', 'Affiliation': ''}, {'ForeName': 'Karen S L', 'Initials': 'KS', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Marek', 'Affiliation': ''}]",Pituitary,['10.1007/s11102-009-0191-1']
489,19707760,Correction accuracy and collateral laxity in open versus closed wedge high tibial osteotomy. A one-year randomised controlled study.,"In a randomised clinical trial in 50 patients with symptomatic osteoarthritis of the medial compartment of the knee, the clinical results of high tibial osteotomy (HTO) according to the open wedge osteotomy (OWO) and closed wedge osteotomy (CWO) were compared. In both groups locked plate fixation was used. Clinical and radiological assessments were performed preoperatively and after one year. Postoperative hip-knee-ankle (HKA) correction angles were monitored on standing leg X-rays. The effect of HTO on collateral laxity of the knee was measured with a specially designed varus-valgus device. The WOMAC osteoarthritis index, the modified knee society score (KS) and visual analogue scales (VAS) were used to assess symptoms of osteoarthritis, function, pain and patient satisfaction. At one-year follow-up we found accurate corrections in both groups and the planned correction angles were achieved. No loss of correction was observed. Furthermore, the medial collateral laxity and the patellar height significantly decreased after OWO. Significant improvements of WOMAC and KS scores were found in both groups. All patients had significantly less pain and were very satisfied with the results. Surgery time was significantly longer in the CWO group, and complications were more frequent in this group. Both techniques led to good and comparable clinical results. The choice of whether to perform an open or a closed wedge osteotomy may be based on preoperative patellar height or concomitant collateral laxity.",2010,"The WOMAC osteoarthritis index, the modified knee society score (KS) and visual analogue scales (VAS) were used to assess symptoms of osteoarthritis, function, pain and patient satisfaction.","['50 patients with symptomatic osteoarthritis of the medial compartment of the knee, the clinical results of high tibial osteotomy (HTO) according to the']","['HTO', 'CWO', 'open versus closed wedge high tibial osteotomy', 'open wedge osteotomy (OWO) and closed wedge osteotomy (CWO']","['symptoms of osteoarthritis, function, pain and patient satisfaction', 'pain', 'medial collateral laxity and the patellar height', 'WOMAC and KS scores', 'Postoperative hip-knee-ankle (HKA) correction angles', 'collateral laxity of the knee', 'WOMAC osteoarthritis index, the modified knee society score (KS) and visual analogue scales (VAS', 'Correction accuracy and collateral laxity', 'Surgery time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia (procedure)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444884', 'cui_str': 'Closing wedge (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia (procedure)'}, {'cui': 'C0445153', 'cui_str': 'Opening wedge (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0185153', 'cui_str': 'Wedge osteotomy (procedure)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1275670', 'cui_str': 'Collateral'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",50.0,0.0242717,"The WOMAC osteoarthritis index, the modified knee society score (KS) and visual analogue scales (VAS) were used to assess symptoms of osteoarthritis, function, pain and patient satisfaction.","[{'ForeName': 'Robert D A', 'Initials': 'RD', 'LastName': 'Gaasbeek', 'Affiliation': 'Department of Orthopedics and Traumatology, Meander Medical Center, Ringweg Randenbroek 110, 3816 CP, Amersfoort, The Netherlands. rda.gaasbeek@meandermc.nl'}, {'ForeName': 'Loes', 'Initials': 'L', 'LastName': 'Nicolaas', 'Affiliation': ''}, {'ForeName': 'Willard J', 'Initials': 'WJ', 'LastName': 'Rijnberg', 'Affiliation': ''}, {'ForeName': 'Corne J M', 'Initials': 'CJ', 'LastName': 'van Loon', 'Affiliation': ''}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'van Kampen', 'Affiliation': ''}]",International orthopaedics,['10.1007/s00264-009-0861-7']
490,19711183,Improvements in spelling after QEEG-based neurofeedback in dyslexia: a randomized controlled treatment study.,"Phonological theories of dyslexia assume a specific deficit in representation, storage and recall of phonemes. Various brain imaging techniques, including qEEG, point to the importance of a range of areas, predominantly the left hemispheric temporal areas. This study attempted to reduce reading and spelling deficits in children who are dyslexic by means of neurofeedback training based on neurophysiological differences between the participants and gender and age matched controls. Nineteen children were randomized into an experimental group receiving qEEG based neurofeedback (n = 10) and a control group (n = 9). Both groups also received remedial teaching. The experimental group improved considerably in spelling (Cohen's d = 3). No improvement was found in reading. An indepth study of the changes in the qEEG power and coherence protocols evidenced no fronto-central changes, which is in line with the absence of reading improvements. A significant increase of alpha coherence was found, which may be an indication that attentional processes account for the improvement in spelling. Consideration of subtypes of dyslexia may refine the results of future studies.",2010,"An indepth study of the changes in the qEEG power and coherence protocols evidenced no fronto-central changes, which is in line with the absence of reading improvements.","['Nineteen children', 'children who are dyslexic by means of neurofeedback training based on neurophysiological differences between the participants and gender and age matched controls']","['remedial teaching', 'qEEG based neurofeedback']","['reading and spelling deficits', 'alpha coherence']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035051', 'cui_str': 'Remedial Teaching'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}]",19.0,0.0184602,"An indepth study of the changes in the qEEG power and coherence protocols evidenced no fronto-central changes, which is in line with the absence of reading improvements.","[{'ForeName': 'Marinus H M', 'Initials': 'MH', 'LastName': 'Breteler', 'Affiliation': 'EEG Resource Institute, P.O. Box 31070, 6503 CB Nijmegen, The Netherlands. r.breteler@eegbiofeedback.nl'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': ''}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'Ine', 'Initials': 'I', 'LastName': 'Giepmans', 'Affiliation': ''}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Verhoeven', 'Affiliation': ''}]",Applied psychophysiology and biofeedback,['10.1007/s10484-009-9105-2']
491,19657698,Prognostic value of postoperative CEA clearance in rectal cancer patients with high preoperative CEA levels.,"PURPOSE


We determined the prognostic value of carcinoembryonic antigen (CEA) clearance after tumor resection with serial evaluation of postoperative CEA levels in rectal cancer.
METHODS


Between 1994 and 2004, we retrospectively reviewed 122 patients with rectal cancer whose serum CEA levels were measured on the preoperative day and postoperative days 7 and 30. Patients with preoperative CEA levels <5.0 ng/ml were excluded. An exponential trend line was drawn using the three CEA values. Patients were categorized into three groups based on R(2) values calculated through trend line, which indicates the correlation coefficient between exponential graph and measured CEA values: exponential decrease group (group 1: 0.9 < R(2) < or = 1.0), nearly exponential decrease group (group 2: 0.5 < R(2) < or = 0.9), and randomized clearance group (group 3: 0.5 < or = R(2)). We then analyzed the CEA clearance pattern as a prognostic indicator.
RESULTS


With a median follow-up of 57 months, the 5-year overall survival was 62.3% vs. 48.1% vs. 25% and the 5-year disease-free survival was 58.6% vs. 52.7% vs. 25% among groups 1, 2, and 3 (P = 0.014, P = 0.027, respectively) in patients with stage III rectal cancer. For those with stage II rectal cancer, the 5-year overall survival rate of group 1 was significantly better than groups 2 and 3 (88.8% vs. 74.1%, respectively, P = 0.021).
CONCLUSIONS


The postoperative pattern of CEA clearance is a useful prognostic determinant in patients with rectal cancer. Patients with a randomized pattern of CEA clearance after tumor resection should be regarded as having the possibility of a persistent CEA source and may require consideration of intensive follow-up or adjuvant therapy.",2009,"For those with stage II rectal cancer, the 5-year overall survival rate of group 1 was significantly better than groups 2 and 3 (88.8% vs. 74.1%, respectively, P = 0.021).
","['Patients with preoperative CEA levels', 'patients with rectal cancer', 'patients with stage III rectal cancer', 'rectal cancer', '122 patients with rectal cancer', 'Between 1994 and 2004', 'rectal cancer patients with high preoperative CEA levels']",[],"['5-year overall survival rate', 'carcinoembryonic antigen (CEA) clearance', 'serum CEA levels', '5-year overall survival', '5-year disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0007082', 'cui_str': 'Antigens, CD66e'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",122.0,0.0667526,"For those with stage II rectal cancer, the 5-year overall survival rate of group 1 was significantly better than groups 2 and 3 (88.8% vs. 74.1%, respectively, P = 0.021).
","[{'ForeName': 'Jeong Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Colorectal Cancer Special Clinic, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Nam Kyu', 'Initials': 'NK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Seung Kook', 'Initials': 'SK', 'LastName': 'Sohn', 'Affiliation': ''}, {'ForeName': 'Yong Wan', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Kim Jin Soo', 'Initials': 'KJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hyuk', 'Initials': 'H', 'LastName': 'Hur', 'Affiliation': ''}, {'ForeName': 'Byung Soh', 'Initials': 'BS', 'LastName': 'Min', 'Affiliation': ''}, {'ForeName': 'Chang Hwan', 'Initials': 'CH', 'LastName': 'Cho', 'Affiliation': ''}]",Annals of surgical oncology,['10.1245/s10434-009-0651-x']
492,19436941,Vertebral anti-fracture efficacy of strontium ranelate according to pre-treatment bone turnover.,"UNLABELLED


Osteoporotic post-menopausal women patients in two randomised trials comparing the anti-fracture efficacy of strontium ranelate with placebo were separated into tertiles according to their baseline levels of biochemical markers of bone formation and resorption. The vertebral anti-fracture efficacy of strontium ranelate was shown to be independent of baseline bone turnover levels.
INTRODUCTION


Bone turnover (BTO) levels vary among women at risk of osteoporotic fracture. Strontium ranelate is an anti-osteoporotic treatment increasing bone formation and reducing bone resorption. It was hypothesised that its anti-fracture efficacy would be independent of baseline BTO levels.
METHODS


Post-menopausal women with osteoporosis from two pooled studies were stratified in tertiles according to baseline levels of two BTO markers: bone-specific alkaline phosphatase (b-ALP, n = 4995) and serum C-telopeptide cross-links (sCTX, n = 4891). Vertebral fracture risk was assessed over 3 years with strontium ranelate 2 g/day or placebo.
RESULTS


In the placebo group, relative risk of vertebral fractures increased with BTO tertiles by 32% and 24% for patients in the highest tertile for b-ALP and CTX, respectively, compared to those in the lowest tertile. In the strontium ranelate group, incidences of vertebral fracture did not differ significantly across BTO tertiles. Significant reductions in vertebral fractures with strontium ranelate were seen in all tertiles of both markers, with relative risk reductions of 31% to 47% relative to placebo. Risk reduction did not differ among tertiles (b-ALP: p = 0.513; sCTX: p = 0.290).
CONCLUSION


The vertebral anti-fracture efficacy of strontium ranelate was independent of baseline BTO levels. Strontium ranelate offers clinical benefits to women across a wide range of metabolic states.",2010,"The vertebral anti-fracture efficacy of strontium ranelate was shown to be independent of baseline bone turnover levels.
","['Post-menopausal women with osteoporosis from two pooled studies were stratified in tertiles according to baseline levels of two BTO markers: bone-specific alkaline phosphatase (b-ALP, n = 4995) and serum C-telopeptide cross-links (sCTX, n = 4891', 'Osteoporotic post-menopausal women patients', 'women at risk of osteoporotic fracture']","['placebo', 'strontium', 'Strontium ranelate', 'strontium ranelate with placebo', 'strontium ranelate 2 g/day or placebo', 'strontium ranelate']","['bone formation and reducing bone resorption', 'vertebral fractures with strontium ranelate', 'Vertebral fracture risk', 'incidences of vertebral fracture', 'relative risk of vertebral fractures', 'BTO tertiles', 'Risk reduction', 'Vertebral anti-fracture efficacy']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272017', 'cui_str': 'At risk of osteoporotic fracture'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}, {'cui': 'C0936139', 'cui_str': 'strontium ranelate'}, {'cui': 'C0439417', 'cui_str': 'g/day'}]","[{'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0936139', 'cui_str': 'strontium ranelate'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",4995.0,0.0833848,"The vertebral anti-fracture efficacy of strontium ranelate was shown to be independent of baseline bone turnover levels.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Collette', 'Affiliation': 'Department of Clinical Biology, Bone and Cartilage Markers Laboratory, University of Liège, Liège, Belgium. J.Collette@chu.ulg.ac.be'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Kaufman', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lorenc', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': ''}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Spector', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diaz-Curiel', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boonen', 'Affiliation': ''}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-009-0940-z']
493,19582579,Long-term quality of life improvement in subjects with healed erosive esophagitis: treatment with lansoprazole.,"BACKGROUND


Gastroesophageal reflux disease (GERD) is a chronic symptomatic condition and may be associated with erosive esophagitis (EE). Considerable data on the long-term maintenance of healing of EE are available, but data on long-term GERD symptom prevention and patient quality of life (QOL) are limited.
AIMS


To investigate QOL in subjects with healed EE who received 12 months of double-blind maintenance treatment with lansoprazole or ranitidine, followed by long-term open-label lansoprazole therapy to prevent recurrence of EE.
METHODS


Subjects with healed EE received 12 months of double-blind maintenance treatment with lansoprazole 15 mg once daily or ranitidine 150 mg twice daily, followed by dose-titrated, open-label lansoprazole therapy for up to 82 months.
RESULTS


During double-blind treatment (n = 206), lansoprazole-treated patients showed significantly (P <or= 0.05) greater improvements than ranitidine-treated patients in the frequency, severity, and 'bothersomeness' of heartburn, the symptom index, problems of activity limitation, eating and drinking problems, symptom problems, health distress, and social functioning. During dose-titrated, open-label treatment (n = 195), all disease-specific QOL scales except sleep improved significantly (P < 0.001) from open-label baseline at each time-point.
CONCLUSIONS


Maintenance treatment with lansoprazole for 12 months in healed EE subjects produced significantly greater improvements in QOL indicators than ranitidine. These improvements were sustained during dose-titrated, open-label lansoprazole treatment.",2010,"During dose-titrated, open-label treatment (n = 195), all disease-specific QOL scales except sleep improved significantly (P < 0.001) from open-label baseline at each time-point.
","['Subjects with healed EE', 'subjects with healed EE', 'subjects with healed erosive esophagitis']","['lansoprazole', 'ranitidine', 'lansoprazole or ranitidine, followed by long-term open-label lansoprazole therapy', 'lansoprazole 15 mg once daily or ranitidine 150 mg twice daily, followed by dose-titrated, open-label lansoprazole therapy']","['QOL indicators', ""frequency, severity, and 'bothersomeness' of heartburn, the symptom index, problems of activity limitation, eating and drinking problems, symptom problems, health distress, and social functioning"", 'disease-specific QOL scales except sleep']","[{'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0267055', 'cui_str': 'Erosive esophagitis (disorder)'}]","[{'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0034665', 'cui_str': 'Ranitidine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1145804', 'cui_str': 'lansoprazole 15 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C2370020', 'cui_str': 'Ranitidine 150 MG [Zantac]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",206.0,0.039554,"During dose-titrated, open-label treatment (n = 195), all disease-specific QOL scales except sleep improved significantly (P < 0.001) from open-label baseline at each time-point.
","[{'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Kovacs', 'Affiliation': 'CURE Digestive Diseases Research Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA. TKovacs@mednet.ucla.edu'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Freston', 'Affiliation': ''}, {'ForeName': 'Marian M', 'Initials': 'MM', 'LastName': 'Haber', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Atkinson', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hunt', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Peura', 'Affiliation': ''}]",Digestive diseases and sciences,['10.1007/s10620-009-0871-8']
494,19536605,"Prognostic value of myocardial perfusion scintigraphy in type 2 diabetic patients with mild, stable angina pectoris.","AIM


To determine the prognostic value of reversible myocardial perfusion defects on myocardial perfusion scintigraphy (MPS) in patients with type 2 diabetes mellitus and mild anginal complaints.
METHODS AND RESULTS


In the MERIDIAN trial, patients with diabetes mellitus type 2, stable, mild anginal symptoms (Canadian Cardiovascular Society classification (CCS) I-II/IV) and reversible perfusion defects were randomized to either continued pharmacological treatment or early invasive treatment. In this sub analysis, the severity of the myocardial perfusion defect was related to the occurrence of cardiac death and non-fatal myocardial infarction, in 319 patients (63% male, 65 +/- 9 years). During follow-up (2.2 +/- 0.6 years), 14 patients had a cardiac event: 3 in 171 patients without myocardial ischemia and 11 in 148 patients with myocardial ischemia. Annual event rates rose from 0.8% to 5.8% with increasing severity of myocardial ischemia. Multivariable analysis identified the presence of severe myocardial ischemia (hazard ratio (HR) 5.45, 95%CI 1.89-15.71) and insulin use (HR 4.00, 95%CI 1.25-12.75) as independent predictors of cardiac events.
CONCLUSIONS


Type 2 diabetics with mild anginal symptoms with no or moderate myocardial ischemia have a low annual cardiac event rate. In patients with severe myocardial ischemia event rate increased 3-6 fold.",2009,"Multivariable analysis identified the presence of severe myocardial ischemia (hazard ratio (HR) 5.45, 95%CI 1.89-15.71) and insulin use (HR 4.00, 95%CI 1.25-12.75) as independent predictors of cardiac events.
","['type 2 diabetic patients with mild, stable angina pectoris', 'patients with diabetes mellitus type 2, stable, mild anginal symptoms (Canadian Cardiovascular Society classification (CCS) I-II/IV) and reversible perfusion defects', 'Type 2 diabetics with mild anginal symptoms with no or moderate myocardial ischemia', '14 patients had a cardiac event: 3 in 171 patients without myocardial ischemia and 11 in 148 patients with myocardial ischemia', '319 patients (63% male, 65 ', 'patients with type 2 diabetes mellitus and mild anginal complaints']","['continued pharmacological treatment or early invasive treatment', 'myocardial perfusion scintigraphy', 'myocardial perfusion scintigraphy (MPS']","['severe myocardial ischemia', 'severe myocardial ischemia event rate', 'cardiac death and non-fatal myocardial infarction']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",171.0,0.0336038,"Multivariable analysis identified the presence of severe myocardial ischemia (hazard ratio (HR) 5.45, 95%CI 1.89-15.71) and insulin use (HR 4.00, 95%CI 1.25-12.75) as independent predictors of cardiac events.
","[{'ForeName': 'Jacobijne J', 'Initials': 'JJ', 'LastName': 'Wiersma', 'Affiliation': 'Department of Cardiology, Academic Medical Center, Meibergdreef 9, 1105AZ, Amsterdam, The Netherlands. j.j.wiersma@amc.uva.nl'}, {'ForeName': 'Hein J', 'Initials': 'HJ', 'LastName': 'Verberne', 'Affiliation': ''}, {'ForeName': 'Wik L', 'Initials': 'WL', 'LastName': 'ten Holt', 'Affiliation': ''}, {'ForeName': 'Ineke M', 'Initials': 'IM', 'LastName': 'Radder', 'Affiliation': ''}, {'ForeName': 'Lea M', 'Initials': 'LM', 'LastName': 'Dijksman', 'Affiliation': ''}, {'ForeName': 'Berthe L F', 'Initials': 'BL', 'LastName': 'van Eck-Smit', 'Affiliation': ''}, {'ForeName': 'Mieke D', 'Initials': 'MD', 'LastName': 'Trip', 'Affiliation': ''}, {'ForeName': 'Jan G P', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': ''}]",Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology,['10.1007/s12350-009-9111-z']
495,19597718,TVT-O versus Monarc after a 2-4-year follow-up: a prospective comparative study.,"INTRODUCTION AND HYPOTHESIS


The aim of this study was to compare outcome and quality of life of tension-free vaginal tape ""inside-out"" (TVT-O) and Monarc transobturator tapes after 2-4 years.
METHODS


The method used was a prospective comparative study. Participants (n = 191) were assigned to either a TVT-O (n = 93) or a Monarc (n = 98) procedure. Cure of stress urinary incontinence (SUI) was defined as the statement of the woman of not experiencing any loss of urine upon physical exercise.
RESULTS


Cure rates after 2-4 years were 72% for TVT-O and 65% for Monarc, while improvement was observed in, respectively, 12% and 21% (p = 0.3). There was a statistically significant improvement in quality of life but no differences were found between both procedures.
CONCLUSIONS


After a 2-4-year follow-up period, both procedures were equally safe and effective in curing SUI.",2009,"RESULTS


Cure rates after 2-4 years were 72% for TVT-O and 65% for Monarc, while improvement was observed in, respectively, 12% and 21% (p = 0.3).",['Participants (n = 191'],"['TVT-O', 'tension-free vaginal tape ""inside-out"" (TVT-O) and Monarc transobturator tapes', 'TVT-O versus Monarc']","['quality of life', 'Cure rates', 'Cure of stress urinary incontinence (SUI', 'safe and effective in curing SUI']",[],"[{'cui': 'C1721083', 'cui_str': 'Tension-Free Vaginal Tape'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C1721084', 'cui_str': 'Transobturator Suburethral Tape'}]","[{'cui': 'C0034380'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",191.0,0.0141147,"RESULTS


Cure rates after 2-4 years were 72% for TVT-O and 65% for Monarc, while improvement was observed in, respectively, 12% and 21% (p = 0.3).","[{'ForeName': 'R Marijn', 'Initials': 'RM', 'LastName': 'Houwert', 'Affiliation': 'Department of Obstetrics and Gynecology, St Elisabeth Hospital Tilburg, Rooseveltlaan 35 III 1079 AC, Amsterdam, The Netherlands. marijnhouwert@hotmail.com'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Renes-Zijl', 'Affiliation': ''}, {'ForeName': 'M Caroline', 'Initials': 'MC', 'LastName': 'Vos', 'Affiliation': ''}, {'ForeName': 'Harry A M', 'Initials': 'HA', 'LastName': 'Vervest', 'Affiliation': ''}]",International urogynecology journal and pelvic floor dysfunction,['10.1007/s00192-009-0943-5']
496,19562362,The effect of a Heat and Moisture Exchanger (Provox HME) on pulmonary protection after total laryngectomy: a randomized controlled study.,"The goal of this randomized controlled study was to investigate the effect of Heat and Moisture Exchanger use on pulmonary symptoms and quality of life aspects in laryngectomized patients. Eighty laryngectomized patients were included and randomized into an HME and Control group. The effect of the HME was evaluated by means of Tally Sheets and Structured Questionnaires. The results showed a significant decrease in the frequency of coughing, forced expectoration, and stoma cleaning in the HME group. There were trends for the prosthetic speakers to report more fluent speech with the HME and for the HME group to report fewer sleeping problems. In conclusion, this study, performed in Poland, confirms the results of previous studies performed in other countries, showing that pulmonary symptoms decrease significantly with HME use and that related aspects such as speech and sleeping tend to improve, regardless of country or climate.",2010,There were trends for the prosthetic speakers to report more fluent speech with the HME and for the HME group to report fewer sleeping problems.,"['laryngectomized patients', 'Eighty laryngectomized patients', 'pulmonary protection after total laryngectomy']","['Heat and Moisture Exchanger', 'HME', 'Heat and Moisture Exchanger (Provox HME']","['frequency of coughing, forced expectoration, and stoma cleaning', 'pulmonary symptoms and quality of life aspects', 'sleeping problems', 'fluent speech']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0189231', 'cui_str': 'Total laryngectomy (procedure)'}]","[{'cui': 'C0181233', 'cui_str': 'Heat and moisture exchanger (physical object)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",80.0,0.0179129,There were trends for the prosthetic speakers to report more fluent speech with the HME and for the HME group to report fewer sleeping problems.,"[{'ForeName': 'Stanisław', 'Initials': 'S', 'LastName': 'Bień', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Regional Cancer Center, ul. Artwińskiego 3, 25-734 Kielce, Poland. stanislaw.bien@onkol.kielce.pl'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Okła', 'Affiliation': ''}, {'ForeName': 'Corina J', 'Initials': 'CJ', 'LastName': 'van As-Brooks', 'Affiliation': ''}, {'ForeName': 'Annemieke H', 'Initials': 'AH', 'LastName': 'Ackerstaff', 'Affiliation': ''}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-009-1018-4']
497,19466476,"Atomoxetine improves patient and family coping in attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in Swedish children and adolescents.","This 10-week study assessed the efficacy of atomoxetine in combination with psychoeducation compared to placebo and psychoeducation in the improvement of Quality of Life in Swedish stimulant-naive children and adolescents with attention deficit/hyperactivity disorder. A total of 99 patients were treated with atomoxetine (49 patients) or placebo (50 patients) for 10 weeks and assessed regarding broader areas of functioning using the Quality of Life measures Child Health and Illness Profile-Child Edition (CHIP-CE), Family Strain Index [FSI; equivalent to the Family Burden of Illness Module used in the study], Appraisal of Stress in Child-Rearing (ASCR), Five to fifteen (FTF), ""I think I am"" (""Jag tycker jag är""), and Children's Depression Rating Scale-Revised (CDRS-R) before and after the active treatment phase. Simultaneously, the patients' parents participated in a 4-session psychoeducation program. A statistically significant difference in favor of atomoxetine was seen in the improvement from baseline to study endpoint for the CHIP-CE domains ""Achievement"" and ""Risk avoidance"", for the FSI total score, for the ASCR section (I) domain ""Child as a burden"", for all FTF domains except for ""Language and Speech"", and for the CDRS-R total score. No difference between treatment groups was observed in the patient-assessed evaluation of self-esteem using the ""I think I am"" scale. Atomoxetine combined with psychoeducation had a positive effect on various everyday coping abilities of the patients as well as their families during 10 weeks of treatment, whereas the patients' self-image and the parents' image of the climate in the family were not significantly improved.",2009,"No difference between treatment groups was observed in the patient-assessed evaluation of self-esteem using the ""I think I am"" scale.","['Swedish children and adolescents', ""patients' parents participated in a"", 'attention deficit/hyperactivity disorder', '99 patients were treated with', '49 patients) or', 'Swedish stimulant-naive children and adolescents with attention deficit/hyperactivity disorder']","['atomoxetine', 'placebo', 'placebo and psychoeducation', '4-session psychoeducation program', 'Atomoxetine', 'ASCR section']","['Quality of Life measures Child Health and Illness Profile-Child Edition (CHIP-CE), Family Strain Index [FSI; equivalent to the Family Burden of Illness Module used in the study], Appraisal of Stress in Child-Rearing (ASCR), Five to fifteen (FTF), ""I think I am"" (""Jag tycker jag är""), and Children\'s Depression Rating Scale-Revised (CDRS-R', 'CHIP-CE domains ""Achievement"" and ""Risk avoidance', 'various everyday coping abilities', 'Quality of Life', 'patient-assessed evaluation of self-esteem']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C1510451', 'cui_str': 'Fries'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0162698', 'cui_str': 'Economic Burden of Disease'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0008091', 'cui_str': 'Child Rearing'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",99.0,0.144205,"No difference between treatment groups was observed in the patient-assessed evaluation of self-esteem using the ""I think I am"" scale.","[{'ForeName': 'Pär', 'Initials': 'P', 'LastName': 'Svanborg', 'Affiliation': 'Eli Lilly Sweden AB, Box 721, 169 27 Solna, Sweden. svanborg_par@lilly.com'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Thernlund', 'Affiliation': ''}, {'ForeName': 'Per A', 'Initials': 'PA', 'LastName': 'Gustafsson', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Hägglöf', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schacht', 'Affiliation': ''}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Kadesjö', 'Affiliation': ''}]",European child & adolescent psychiatry,['10.1007/s00787-009-0031-x']
498,23086659,Dual lag screw cephalomedullary nail versus the classic sliding hip screw for the stabilization of intertrochanteric fractures. A prospective randomized study.,"This study is a randomized prospective study comparing two fracture fixation implants, the extramedullary sliding hip screw (SHS) and the dual lag screw cephalomedullary nail, in the treatment of intertrochanteric femoral fractures in the elderly. One hundred and sixty-five patients with low-energy intertrochanteric fractures, classified as AO/OTA 31A, were prospectively included during a 2-year period (2005-2006). Patients were randomized into two groups: group A included 79 hip fractures managed with sliding hip screws and group B included 86 fractures treated with cephalomedullary nails. Delay to surgery, duration of surgery, time of fluoroscopy, total hospital stay, implant-related complications, transfusion requirements, re-operation details, functional recovery, and mortality were recorded. The mean follow-up was 36 months (24-56 months). The mean surgical time was statistically significantly shorter and fluoroscopy time longer for the group B. No intraoperative femoral shaft fractures occurred. There was no statistically significant difference in the functional recovery score, reoperation, and mortality rates between the 2 groups. A new type of complication, the so-called Z-effect phenomenon, was noticed in the cephalomedullary nail group. There are no statistically significant differences between the two techniques in terms of type and rate of complications, functional outcome, reoperation and mortality rates when comparing the SHS and the cephalomedullary nail for low-energy AO/OTA 31A intertrochanteric fractures. Our data do not support recommendations for the use of one implant over the other.",2012,"There are no statistically significant differences between the two techniques in terms of type and rate of complications, functional outcome, reoperation and mortality rates when comparing the SHS and the cephalomedullary nail for low-energy AO/OTA 31A intertrochanteric fractures.","['One hundred and sixty-five patients with low-energy intertrochanteric fractures, classified as AO/OTA 31A, were prospectively included during a 2-year period (2005-2006', 'intertrochanteric femoral fractures in the elderly', 'intertrochanteric fractures']","['79 hip fractures managed with sliding hip screws and group B included 86 fractures treated with cephalomedullary nails', 'Dual lag screw cephalomedullary nail versus the classic sliding hip screw', 'extramedullary sliding hip screw (SHS) and the dual lag screw cephalomedullary nail', 'fracture fixation implants']","['intraoperative femoral shaft fractures', 'type and rate of complications, functional outcome, reoperation and mortality rates', 'Delay to surgery, duration of surgery, time of fluoroscopy, total hospital stay, implant-related complications, transfusion requirements, re-operation details, functional recovery, and mortality', 'mean surgical time', 'functional recovery score, reoperation, and mortality rates']","[{'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0016641', 'cui_str': 'Fracture Reduction'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",165.0,0.0244656,"There are no statistically significant differences between the two techniques in terms of type and rate of complications, functional outcome, reoperation and mortality rates when comparing the SHS and the cephalomedullary nail for low-energy AO/OTA 31A intertrochanteric fractures.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kouvidis', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, University of Crete, Heraklion, Greece.'}, {'ForeName': 'V I', 'Initials': 'VI', 'LastName': 'Sakellariou', 'Affiliation': ''}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Mavrogenis', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stavrakakis', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kampas', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Galanakis', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Papagelopoulos', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Katonis', 'Affiliation': ''}]",Strategies in trauma and limb reconstruction,['10.1007/s11751-012-0146-3']
499,18689599,A Search for subgroups of patients with ARDS who may benefit from surfactant replacement therapy: a pooled analysis of five studies with recombinant surfactant protein-C surfactant (Venticute).,"BACKGROUND


Studies to date have shown no survival benefit for the use of exogenous surfactant to treat patients with the ARDS. To identify specific patient subgroups for future study, we performed an exploratory post hoc analysis of clinical trials of recombinant surfactant protein-C (rSP-C) surfactant (Venticute; Nycomed GmbH; Konstanz, Germany).
METHODS


We performed a pooled analysis of all five multicenter studies in which patients with ARDS due to various predisposing events were treated with rSP-C surfactant. Patients received either usual care (n = 266) or usual care plus up to four intratracheal doses (50 mg/kg) of rSP-C surfactant (n = 266). Factors influencing the study end points were analyzed using descriptive statistics, analysis of covariance, and logistic regression models.
RESULTS


ARDS was most often associated with pneumonia or aspiration, sepsis, and trauma or surgery. For the overall patient population, treatment with rSP-C surfactant significantly improved oxygenation (p = 0.002) but had no effect on mortality (32.6%). Multivariate analysis showed age and acute physiology and chronic health evaluation (APACHE) II score to be the strongest predictors of mortality. In the subgroup of patients with severe ARDS due to pneumonia or aspiration, surfactant treatment was associated with markedly improved oxygenation (p = 0.0008) and improved survival (p = 0.018).
CONCLUSIONS


rSP-C surfactant improved oxygenation in patients with ARDS irrespective of the predisposition. Post hoc evidence of reduced mortality associated with surfactant treatment was obtained in patients with severe respiratory insufficiency due to pneumonia or aspiration. Those patients are the focus of a current randomized, blinded, clinical trial with rSP-C surfactant.",2008,"For the overall patient population, treatment with rSP-C surfactant significantly improved oxygenation (p = 0.002) but had no effect on mortality (32.6%).","['subgroups of patients with ARDS who may benefit from surfactant replacement therapy', 'patients with ARDS due to various predisposing events', 'patients with the ARDS', 'patients with severe respiratory insufficiency due to pneumonia or aspiration', 'patients with ARDS irrespective of the predisposition']","['rSP-C surfactant', 'recombinant surfactant protein-C (rSP-C) surfactant (Venticute', 'exogenous surfactant', 'usual care', 'recombinant surfactant protein-C surfactant (Venticute']","['survival', 'oxygenation', 'pneumonia or aspiration, sepsis, and trauma or surgery', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C3661922', 'cui_str': 'Surfactant replacement therapy (procedure)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035229', 'cui_str': 'Respiratory Insufficiency'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]","[{'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1997477', 'cui_str': 'Lusupultide product'}, {'cui': 'C1959272', 'cui_str': 'Venticute'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",266.0,0.0995173,"For the overall patient population, treatment with rSP-C surfactant significantly improved oxygenation (p = 0.002) but had no effect on mortality (32.6%).","[{'ForeName': 'Friedemann J H', 'Initials': 'FJH', 'LastName': 'Taut', 'Affiliation': 'Department of Clinical Research, Nycomed, Konstanz, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Rippin', 'Affiliation': 'Department of Biometrics, Omnicare Clinical Research, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schenk', 'Affiliation': 'Department of Internal Medicine IV, General Hospital Vienna, Vienna, Austria.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Findlay', 'Affiliation': 'Department of Intensive Care, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Wurst', 'Affiliation': 'Department of Clinical Research, Nycomed, Konstanz, Germany.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Häfner', 'Affiliation': 'Department of Clinical Research, Nycomed, Konstanz, Germany.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Lewis', 'Affiliation': ""St. Joseph's Health Center, University of Western Ontario, London, ON, Canada.""}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Seeger', 'Affiliation': 'Department of Pulmonology, Justus-Liebig University, Giessen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Günther', 'Affiliation': 'Department of Pulmonology, Justus-Liebig University, Giessen, Germany.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Spragg', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of California San Diego and the San Diego VA Healthcare System, La Jolla, CA. Electronic address: rspragg@ucsd.edu.'}]",Chest,['10.1378/chest.08-0362']
500,19160053,Population-based prevention of child maltreatment: the U.S. Triple p system population trial.,"The prevention of child maltreatment necessitates a public health approach. In the U.S. Triple P System Population Trial, 18 counties were randomly assigned to either dissemination of the Triple P-Positive Parenting Program system or to the services-as-usual control condition. Dissemination involved Triple P professional training for the existing workforce (over 600 service providers), as well as universal media and communication strategies. Large effect sizes were found for three independently derived population indicators: substantiated child maltreatment, child out-of-home placements, and child maltreatment injuries. This study is the first to randomize geographical areas and show preventive impact on child maltreatment at a population level using evidence-based parenting interventions.",2009,This study is the first to randomize geographical areas and show preventive impact on child maltreatment at a population level using evidence-based parenting interventions.,['18 counties'],"['Triple P-Positive Parenting Program system or to the services-as-usual control condition', 'Triple P professional training']",[],[],"[{'cui': 'C4040683', 'cui_str': 'Triple P - Positive Parenting Program'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],18.0,0.0543752,This study is the first to randomize geographical areas and show preventive impact on child maltreatment at a population level using evidence-based parenting interventions.,"[{'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Prinz', 'Affiliation': 'Psychology Department, University of South Carolina, Columbia, SC, 29208, USA. prinz@sc.edu'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Cheri J', 'Initials': 'CJ', 'LastName': 'Shapiro', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Whitaker', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Lutzker', 'Affiliation': ''}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-009-0123-3']
501,32430507,Impact of Myc in HIV-associated non-Hodgkin lymphomas treated with EPOCH and outcomes with vorinostat (AMC-075 trial).,"EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) is a preferred regimen for HIV-non-Hodgkin lymphomas (HIV-NHLs), which are frequently Epstein-Barr virus (EBV) positive or human herpesvirus type-8 (HHV-8) positive. The histone deacetylase (HDAC) inhibitor vorinostat disrupts EBV/HHV-8 latency, enhances chemotherapy-induced cell death, and may clear HIV reservoirs. We performed a randomized phase 2 study in 90 patients (45 per study arm) with aggressive HIV-NHLs, using dose-adjusted EPOCH (plus rituximab if CD20+), alone or with 300 mg vorinostat, administered on days 1 to 5 of each cycle. Up to 1 prior cycle of systemic chemotherapy was allowed. The primary end point was complete response (CR). In 86 evaluable patients with diffuse large B-cell lymphoma (DLBCL; n = 61), plasmablastic lymphoma (n = 15), primary effusion lymphoma (n = 7), unclassifiable B-cell NHL (n = 2), and Burkitt lymphoma (n = 1), CR rates were 74% vs 68% for EPOCH vs EPOCH-vorinostat (P = .72). Patients with a CD4+ count <200 cells/mm3 had a lower CR rate. EPOCH-vorinostat did not eliminate HIV reservoirs, resulted in more frequent grade 4 neutropenia and thrombocytopenia, and did not affect survival. Overall, patients with Myc+ DLBCL had a significantly lower EFS. A low diagnosis-to-treatment interval (DTI) was also associated with inferior outcomes, whereas preprotocol therapy had no negative impact. In summary, EPOCH had broad efficacy against highly aggressive HIV-NHLs, whereas vorinostat had no benefit; patients with Myc-driven DLBCL, low CD4, and low DTI had less favorable outcomes. Permitting preprotocol therapy facilitated accruals without compromising outcomes. This trial was registered at www.clinicaltrials.gov as #NCT0119384.",2020,The overall and event-free survival (EFS) rates were similar between arms.,"['86 evaluable patients with diffuse large B-cell lymphoma (n=61), plasmablastic lymphoma (n=15), primary effusion lymphoma (n=7), unclassifiable B-cell NHL (n=2), and Burkitt lymphoma (n=1', '90 patients (45 per arm) with aggressive HIV-NHLs using dose']",['adjusted EPOCH (plus rituximab if CD20+) alone or with vorinostat 300 mg administered on days 1-5 of each cycle'],"['CR rates', 'EPOCH efficacy', 'complete response (CR', 'Low diagnosis-to-treatment interval (DTI', 'EFS', 'overall and event-free survival (EFS) rates', 'and/or HIV clearance', 'frequent grade 4 neutropenia and thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0079746', 'cui_str': ""Diffuse non-Hodgkin's lymphoma, immunoblastic (clinical)""}, {'cui': 'C1292753', 'cui_str': 'Primary effusion lymphoma'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",90.0,0.175059,The overall and event-free survival (EFS) rates were similar between arms.,"[{'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Ramos', 'Affiliation': 'Department of Medicine, University of Miami School of Medicine, Miami, FL.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Department of Oncology, Albert Einstein Comprehensive Cancer Center, Bronx, NY.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Weill Medical College of Cornell University, New York, NY.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ambinder', 'Affiliation': 'Department of Oncology, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Siegel', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Page C', 'Initials': 'PC', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Rubinstein', 'Affiliation': 'Section of Hematology/Oncology, John H. Stroger Jr Hospital of Cook County, Chicago, IL.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Durand', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Cesarman', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Weill Medical College of Cornell University, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aboulafia', 'Affiliation': 'Division of Hematology and Oncology, Virginia Mason Medical Center, Seattle, WA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Internal Medicine, Ohio State University, Columbus, OH.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ratner', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Kaplan', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Capoferri', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Jeannette Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mitsuyasu', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Noy', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY; and.'}]",Blood,['10.1182/blood.2019003959']
502,19305972,Comparative evaluation of the tendon-bone interface contact pressure in different single- versus double-row suture anchor repair techniques.,"The aim of the study was to evaluate the time zero contact pressure over a defined rotator cuff footprint using different repair and stitch techniques in an established sheep model. Forty fresh-frozen sheep shoulders were randomly assigned to five repair groups: single-row repair using simple stitches (SRA-s), single-row repair using horizontal mattress stitches (SRA-m), and single-row repair using arthroscopic Mason-Allen stitches (SRA-ama). Double-row repair was either performed with a combination of simple and horizontal mattress stitches (DRA-sm) or with arthroscopic Mason-Allen/horizontal mattress stitches (DRA-amam). Investigations were performed using a pressure-sensitive film system. The average contact pressure and pressure pattern were measured for each group. Contact pressure was lowest in SRA-m followed by SRA-s. SRA-ama showed highest contact pressure of all single-row treatment groups (P < 0.05). DRA-amam presented the highest overall contact pressure (P < 0.05), whereas DRA-sm exerted contact pressure equal to that of SRA-ama. Both double-row techniques showed the most expanded pressure pattern. Average contact pressures for the more complex single- and double-row techniques utilizing arthroscopic Mason-Allen stitches were greater than were those of the repair techniques utilizing simple and horizontal mattress stitches. However, the contact pattern between the anchors could be increased by using the double-row technique, resulting in more footprint coverage compared to patterns utilizing the single-row techniques. These results support the use of the more complex arthroscopic Mason-Allen stitches and may improve the environment for healing of the repaired rotator cuff tendon.",2009,SRA-ama showed highest contact pressure of all single-row treatment groups (P < 0.05).,['Forty fresh-frozen sheep shoulders'],"['single-row repair using simple stitches (SRA-s), single-row repair using horizontal mattress stitches (SRA-m), and single-row repair using arthroscopic Mason-Allen stitches (SRA-ama', 'single- versus double-row suture anchor repair techniques', 'Double-row repair was either performed with a combination of simple and horizontal mattress stitches (DRA-sm) or with arthroscopic Mason-Allen/horizontal mattress stitches (DRA-amam']","['Contact pressure', 'time zero contact pressure', 'highest overall contact pressure', 'average contact pressure and pressure pattern', 'highest contact pressure', 'Average contact pressures']","[{'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0036945', 'cui_str': 'Ovis'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1720977', 'cui_str': 'Suture Anchors'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",40.0,0.0374013,SRA-ama showed highest contact pressure of all single-row treatment groups (P < 0.05).,"[{'ForeName': 'Mike H', 'Initials': 'MH', 'LastName': 'Baums', 'Affiliation': 'Department of Orthopaedic Surgery, University of Göttingen Medical Centre (UMG), Georg-August-University, Postfach 37099 Göttingen, Germany. mbaums@t-online.de'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Spahn', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Steckel', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Schultz', 'Affiliation': ''}, {'ForeName': 'H-M', 'Initials': 'HM', 'LastName': 'Klinger', 'Affiliation': ''}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-009-0771-7']
503,19415242,"Validating a human model for anxiety using startle potentiated by cue and context: the effects of alprazolam, pregabalin, and diphenhydramine.","BACKGROUND


Fear-potentiated startle has been suggested as a translational model for evaluating efficacy of anxiolytic compounds in humans. Several known anxiolytic compounds have been tested as well as several putative anxiolytics. Because results of these studies have been equivocal, the aim of the present study was to examine another pharmacological permutation of the human potentiated startle model by comparing two anxiolytic agents to a non-anxiolytic sedative and placebo.
METHODS


Twenty healthy volunteers participated in a double-blind, placebo-controlled, cross-over study with four sessions in which they received single doses of the anxiolytics alprazolam (1 mg) and pregabalin (200 mg), as well as diphenhydramine (50 mg) as a non-anxiolytic sedative control and placebo. The design included a cued shock condition that presumably evokes fear and an unpredictable shock context condition presumably evoking anxiety.
RESULTS


None of the treatments reliably reduced either fear- or anxiety-potentiated startle. Alprazolam and diphenhydramine reduced overall baseline startle. Alprazolam was found to only affect contextual anxiety in a statistical significant way after two subjects who failed to show a contextual anxiety effect in the placebo condition were excluded from the analysis. Pregabalin did not significantly affect any of the physiological measures.
DISCUSSION


The negative findings from this study are discussed in terms of methodological differences between designs and in variability of startle both between and within study participants.
CONCLUSION


Even though fear-potentiated startle may be used to translate preclinical evidence to human populations, methodological issues still hamper the application of this model to early screening of putative anxiolytic drugs.",2009,Alprazolam was found to only affect contextual anxiety in a statistical significant way after two subjects who failed to show a contextual anxiety effect in the placebo condition were excluded from the analysis.,"['human populations', 'Twenty healthy volunteers']","['diphenhydramine', 'placebo', 'pregabalin', 'anxiolytics alprazolam', 'Alprazolam', 'Alprazolam and diphenhydramine', 'Pregabalin', 'anxiolytic sedative control and placebo', 'alprazolam, pregabalin, and diphenhydramine']","['overall baseline startle', 'fear- or anxiety-potentiated startle', 'contextual anxiety', 'contextual anxiety effect']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0040616', 'cui_str': 'Anti-Anxiety Drugs'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",20.0,0.04333,Alprazolam was found to only affect contextual anxiety in a statistical significant way after two subjects who failed to show a contextual anxiety effect in the placebo condition were excluded from the analysis.,"[{'ForeName': 'J M P', 'Initials': 'JM', 'LastName': 'Baas', 'Affiliation': 'Department of Experimental Psychology, Faculty of Social Sciences, Utrecht University, Van Unnik Building, Heidelberglaan 2, 3584 CS, Utrecht, The Netherlands. j.m.p.baas@uu.nl'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mol', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Kenemans', 'Affiliation': ''}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Prinssen', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Niklson', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Xia-Chen', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Broeyer', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Gerven', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-009-1516-5']
504,19350378,"Stress biomarkers as outcomes for HIV+ prevention: participation, feasibility and findings among HIV+ Latina and African American mothers.","Mothers living with HIV (MLH) are at high risk for acute and chronic stress, given challenges related to their HIV status, ethnicity, economic and urban living conditions. Biomarkers combined into a composite index show promise in quantifying psychosocial stress in healthy people, but have not yet been examined among MLH. According, we examined potential biomarker correlates of stress [cortisol and catecholamines from home-collected urine and basic health indicators (blood pressure, height and weight, waist-to-hip ratio) measured during an interview] among 100 poor African American and Latina mothers MLH and demographic-matched control mothers without HIV (n = 50). Participants had been enrolled in a randomized controlled trial about 18 months earlier and had either received (MLH-I) or were awaiting (MLH-W) the psychosocial intervention. Participation was high, biomarkers were correctly collected for 93% of cases, and a complete composite biomarker index (CBI) calculated for 133 mothers (mean age = 42). As predicted, MLH had a significantly higher CBI than controls, but there was no CBI difference across ethnicity or intervention group. CBI predicted CD4 counts independently after controlling for age, years since diagnosis, prior CD4 counts, medication adherence, and depression symptoms. The study demonstrates acceptability, feasibility and potential utility of community-based biomarker collections in evaluating individual differences in psychosocial stress.",2010,"CBI predicted CD4 counts independently after controlling for age, years since diagnosis, prior CD4 counts, medication adherence, and depression symptoms.","['HIV+ Latina and African American mothers', 'healthy people', '100 poor African American and Latina mothers MLH and demographic-matched control mothers without HIV (n = 50', '133 mothers (mean age = 42', 'Mothers living with HIV (MLH']","['MLH-I) or were awaiting (MLH-W) the psychosocial intervention', 'community-based biomarker collections']","['stress [cortisol and catecholamines from home-collected urine and basic health indicators (blood pressure, height and weight, waist-to-hip ratio', 'CBI predicted CD4 counts', 'CD4 counts, medication adherence, and depression symptoms', 'CBI']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0042037'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0259095', 'cui_str': 'C(2)BI'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0221738,"CBI predicted CD4 counts independently after controlling for age, years since diagnosis, prior CD4 counts, medication adherence, and depression symptoms.","[{'ForeName': 'Dorie A', 'Initials': 'DA', 'LastName': 'Glover', 'Affiliation': 'Semel Institute, Child Division, Department of Psychiatry and Biobehavioral Sciences, University of California, 760 Westwood Blvd., Los Angeles, CA 90024, USA. dglover@mednet.ucla.edu'}, {'ForeName': 'Elena F', 'Initials': 'EF', 'LastName': 'Garcia-Aracena', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lester', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rothram-Borus', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-009-9549-7']
505,19132412,Timing of surgery for sciatica: subgroup analysis alongside a randomized trial.,"Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while ""sciatica provoked by sitting"" showed to be a significant effect modifier (P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7-3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8-2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent.",2009,"Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent.","['283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care']",[],"['recovery rates', 'Roland Disability Questionnaire and visual analogue scale pain']","[{'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",[],"[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",283.0,0.0980768,"Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent.","[{'ForeName': 'Wilco C', 'Initials': 'WC', 'LastName': 'Peul', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands. w.c.peul@lumc.nl'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Arts', 'Affiliation': ''}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Brand', 'Affiliation': ''}, {'ForeName': 'Bart W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-008-0867-7']
506,18758777,Computer assisted versus conventional cemented total knee prostheses alignment accuracy and micromotion of the tibial component.,"We evaluated the influence of CT-free or CT-based computer assisted orthopaedic surgery (CAOS) on the alignment of total knee prostheses (TK) and micromotion of tibial components. This randomised study compared 19 CT-free, 17 CT-based CAOS TK, and a matched control group of 21 conventionally placed TK. Using Roentgen stereophotogrammetric analysis (RSA) the migration was measured. The alignment and component positions were measured on radiographs. No significant difference in leg and tibial component alignment was present between the three groups. A significant difference was found for micromotion in subsidence, with the conventional group having a mean of 0.16 mm, compared to the CT-free group at 0.01 mm and the CT-based group at -0.05 mm. No clinical significant difference in alignment was found between CAOS and conventionally operated TK. More subsidence of the tibial component was seen in the conventional group compared to both CAOS groups at two year follow-up.",2009,More subsidence of the tibial component was seen in the conventional group compared to both CAOS groups at two year follow-up.,[],"['19 CT-free, 17 CT-based CAOS TK', 'CT-free or CT-based computer assisted orthopaedic surgery (CAOS']","['leg and tibial component alignment', 'tibial component']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",21.0,0.0173319,More subsidence of the tibial component was seen in the conventional group compared to both CAOS groups at two year follow-up.,"[{'ForeName': 'Thisbe', 'Initials': 'T', 'LastName': 'van Strien', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Enrike', 'Initials': 'E', 'LastName': 'van der Linden-van der Zwaag', 'Affiliation': ''}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Kaptein', 'Affiliation': ''}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'van Erkel', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Valstar', 'Affiliation': ''}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Nelissen', 'Affiliation': ''}]",International orthopaedics,['10.1007/s00264-008-0642-8']
507,18663487,Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial.,"Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study. In the intensive group training protocol exercise therapy, back school and operant-conditioning behavioural principles are combined. Patients were treated during 10 individual sessions along 20 group sessions. Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain. Main outcome measures were functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain assessed at baseline and after 6, 13, 26 and 52 weeks. Both an intention-to-treat analysis and a per-protocol analysis were performed. Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception. After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group, but this difference was absent after 52 weeks. We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain.",2008,"Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception.","['patients with chronic low back pain', 'workers with chronic low back pain', 'primary care patients with non-specific chronic low back pain', '105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study']","['Intensive group training protocol versus guideline physiotherapy', 'intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy', 'usual physiotherapy']","['functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain', 'pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]",,0.136903,"Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'van der Roer', 'Affiliation': 'EMGO-Institute, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'van Tulder', 'Affiliation': ''}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Barendse', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Knol', 'Affiliation': ''}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Mechelen', 'Affiliation': ''}, {'ForeName': 'Henrica', 'Initials': 'H', 'LastName': 'de Vet', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-008-0718-6']
508,18641106,Alendronate once weekly for the prevention and treatment of bone loss in Canadian adult cystic fibrosis patients (CFOS trial).,"BACKGROUND


Patients with cystic fibrosis (CF) are at risk for early bone loss, and demonstrate increased risks for vertebral fractures and kyphosis. A multicenter, randomized, controlled trial was conducted to assess the efficacy, tolerability, and safety of therapy with oral alendronate (FOSAMAX; Merck; Whitehouse Station, NJ) in adults with CF and low bone mass.
METHODS


Participants received placebo or alendronate, 70 mg once weekly, for 12 months. All participants received 800 IU of vitamin D and 1,000 mg of calcium daily. Adults with confirmed CF with a bone mineral density (BMD) T score of < - 1.0 were eligible for inclusion. Participants who had undergone organ transplantation or had other reported contraindications were excluded from the study. The primary outcome measure was the mean (+/- SD) percentage change in lumbar spine BMD after 12 months. Secondary measures included the percentage change in total hip BMD, the number of new vertebral fractures (grade 1 or 2), and changes in quality of life.
RESULTS


A total of 56 participants were enrolled in the study (mean age, 29.1 +/- 8.78 years; 61% male). The absolute percentage changes in lumbar spine and total hip BMDs at follow-up were significantly higher in the alendronate therapy group (5.20 +/- 3.67% and 2.14 +/- 3.32%, respectively) than those in the control group (- 0.08 +/- 3.93% and - 1.3 +/- 2.70%, respectively; p < 0.001). At follow-up, two participants (both in the control group) had a new vertebral fracture (not significant), and there were no differences in quality of life or the number of adverse events (including serious and GI-related events).
CONCLUSION


Alendronate therapy was well tolerated and produced a significantly greater increase in BMD over 12 months compared with placebo.",2008,The absolute percentage changes in lumbar spine and total hip BMDs at follow-up were significantly higher in the alendronate therapy group (5.20 +/-,"['Participants who had undergone organ transplantation or had other reported contraindications were excluded from the study', 'Adults with confirmed CF with a bone mineral density (BMD) T score of < - 1.0 were eligible for inclusion', '8.78 years; 61% male', 'Canadian adult cystic fibrosis patients (CFOS trial', 'A total of 56 participants were enrolled in the study (mean age, 29.1 ', 'adults with CF and low bone mass', 'Patients with cystic fibrosis (CF']","['placebo or alendronate', 'placebo', 'vitamin D and 1,000 mg of calcium daily', 'oral alendronate (FOSAMAX', 'Alendronate', 'Alendronate therapy']","['quality of life or the number of adverse events (including serious and GI-related events', 'bone loss', 'BMD', 'percentage change in total hip BMD, the number of new vertebral fractures (grade 1 or 2), and changes in quality of life', 'lumbar spine and total hip BMDs', 'new vertebral fracture', 'mean (+/- SD) percentage change in lumbar spine BMD', 'efficacy, tolerability, and safety']","[{'cui': 'C0029216', 'cui_str': 'Grafting, Organ'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0376569', 'cui_str': 'Fosamax'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.23963,The absolute percentage changes in lumbar spine and total hip BMDs at follow-up were significantly higher in the alendronate therapy group (5.20 +/-,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Papaioannou', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada. Electronic address: papaioannou@hhsc.ca.'}, {'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Kennedy', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Freitag', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ioannidis', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Department of Nuclear Medicine, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pui', 'Affiliation': 'Department of Diagnostic Imaging, Scarborough Hospital, Scarborough, ON, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Berthiaume', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Harvey R', 'Initials': 'HR', 'LastName': 'Rabin', 'Affiliation': 'Adult Cystic Fibrosis Clinic, University of Calgary Medical Clinic of the Foothills Medical Center, Calgary, AB, Canada.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Paterson', 'Affiliation': 'Schulich School of Medicine and Dentistry, University of Western Ontario, London Health Science Centre, London, ON, Canada.'}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Jeanneret', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Matouk', 'Affiliation': 'Montreal Chest Institute, Montreal, QC, Canada.'}, {'ForeName': 'Josee', 'Initials': 'J', 'LastName': 'Villeneuve', 'Affiliation': 'Le Centre Hospitalier Universitaire de Québec, Quebec City, QC, Canada.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Adachi', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}]",Chest,['10.1378/chest.08-0608']
509,18625676,"Sitaxsentan for the treatment of pulmonary arterial hypertension: a 1-year, prospective, open-label observation of outcome and survival.","BACKGROUND


Despite advances in the management of pulmonary arterial hypertension (PAH), the mortality rate remains excessive. Long-term efficacy evaluations are needed to guide therapeutic management. The purpose of this study is to present 1-year observational data with two endothelin antagonists, sitaxsentan and bosentan, in a prospective, open-label study.
METHODS


The present study was a prospective, international, multicenter, randomized, open-label extension of the Sitaxsentan To Relieve Impaired Exercise-2 trial. All-cause mortality, time to discontinuation (all causes) from monotherapy, time to discontinuation due to adverse events, time to elevations in and time to discontinuation due to elevated hepatic transaminases, and time to first clinical worsening event were evaluated. Patients initially receiving sitaxsentan at 50 mg were excluded from the main analysis. The distributions of time-to-event variables are estimated using Kaplan-Meier methods, and treatment effects are evaluated using the Cox proportional hazards model.
RESULTS


Patients treated with sitaxsentan at 100 mg had 96% overall survival and a 34% risk for a clinical worsening event by 1 year. In addition, there was a 6% risk of elevated aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels > 3 x upper limit of normal range (ULN) at 1 year and a 15% risk of discontinuation due to adverse events. Patients treated with bosentan had 88% overall survival and a 40% risk of a clinical worsening event by 1 year. In addition, there was a 14% risk for elevated AST and/or ALT levels > 3 x ULN at 1 year and a 30% risk of discontinuation due to adverse events.
CONCLUSIONS


At 1 year, sitaxsentan therapy appears safe and efficacious for patients with PAH; reductions in mortality and the risk for clinical worsening events provide support for durability of efficacy.",2008,"RESULTS


Patients treated with sitaxsentan at 100 mg had 96% overall survival and a 34% risk for a clinical worsening event by 1 year.","['patients with PAH', 'pulmonary arterial hypertension']","['sitaxsentan therapy', 'Sitaxsentan', 'endothelin antagonists, sitaxsentan and bosentan', 'sitaxsentan']","['elevated aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels', 'elevated AST and/or ALT levels ', 'adverse events, time to elevations in and time to discontinuation due to elevated hepatic transaminases, and time to first clinical worsening event', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}]","[{'cui': 'C1704271', 'cui_str': 'N-(4-chloro-3-methyl-5-isoxazolyl)-2-((4,5-(methylenedioxy)-O-toly)acetyl)-3-thiophenesulfonamide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0079284', 'cui_str': 'Endothelium-Derived Vasoconstrictor Factors'}, {'cui': 'C0252643', 'cui_str': 'bosentan'}]","[{'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0852988,"RESULTS


Patients treated with sitaxsentan at 100 mg had 96% overall survival and a 34% risk for a clinical worsening event by 1 year.","[{'ForeName': 'Raymond L', 'Initials': 'RL', 'LastName': 'Benza', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL. Electronic address: rbenza@wpahs.org.'}, {'ForeName': 'Robyn J', 'Initials': 'RJ', 'LastName': 'Barst', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Nazzareno', 'Initials': 'N', 'LastName': 'Galie', 'Affiliation': 'Cardiology Institute, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Adaani', 'Initials': 'A', 'LastName': 'Frost', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Reda E', 'Initials': 'RE', 'LastName': 'Girgis', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD.'}, {'ForeName': 'Kristin B', 'Initials': 'KB', 'LastName': 'Highland', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Strange', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Black', 'Affiliation': 'Royal College of Physicians of London, London, UK.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Badesch', 'Affiliation': 'University of Colorado Health Sciences Center, Denver, CO.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Rubin', 'Affiliation': 'University of California, San Diego Medical Center, La Jolla, CA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Fleming', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Naeije', 'Affiliation': 'Erasmus University Brussels, Brussels, Belgium.'}]",Chest,['10.1378/chest.07-0767']
510,18625670,Differences in the response to methacholine between the tidal breathing and dosimeter methods: influence of the dose of bronchoconstrictor agent delivered to the mouth.,"BACKGROUND


It has been postulated that differences in provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) values between the dosimeter method and tidal breathing method might be due to differences in the dose of agonist delivered to the mouth. The aim of the present study was to determine the influence of the dose of aerosol delivered to the mouth on differences in the response obtained with each challenge method.
METHODS


This study measured airway responsiveness to methacholine by dosimeter method and tidal breathing method in 27 subjects with suspected asthma. The dosimeter was modified to deliver an identical volume to that obtained with the tidal breathing method. Concentration-response curves were characterized by the PC20.
RESULTS


The dosimeter method PC20 was significantly higher than the tidal breathing method PC20, with geometric mean values of 4.03 (95% confidence interval [CI], 1.86 to 8.78 mg/mL) and 2.19 (95% CI, 1.32 to 3.64 mg/mL; p = 0.04), respectively. The mean difference in the PC20 value detected with each method was similar in subjects with tidal breathing method PC20 values > or = 2 mg/mL (0.77 doubling concentrations) and in those with PC20 values < 2 mg/mL (0.96 doubling concentrations; p = 0.83).
CONCLUSIONS


The tidal breathing method produces PC20 values significantly lower than a modified dosimeter method, which delivers the same volume of aerosol. These results suggest that the discordant PC20 values obtained with the two methods are not due to differences in the dose of agonist delivered to the mouth.",2008,"The dosimeter method PC20 was significantly higher than the tidal breathing method PC20, with geometric mean values of 4.03 (95% confidence interval [CI], 1.86 to 8.78 mg/mL) and 2.19 (95% CI, 1.32 to 3.64 mg/mL; p = 0.04), respectively.",['27 subjects with suspected asthma'],['methacholine'],"['tidal breathing method produces PC20 values', 'PC20 value', 'Concentration-response curves']","[{'cui': 'C1271086', 'cui_str': 'Suspected asthma'}]","[{'cui': 'C0600370', 'cui_str': 'Methacholine'}]","[{'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",27.0,0.0442977,"The dosimeter method PC20 was significantly higher than the tidal breathing method PC20, with geometric mean values of 4.03 (95% confidence interval [CI], 1.86 to 8.78 mg/mL) and 2.19 (95% CI, 1.32 to 3.64 mg/mL; p = 0.04), respectively.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Prieto', 'Affiliation': 'Seccion de Alergologia, Hospital Universitario Dr. Peset, Valencia, Spain. Electronic address: prieto_jes@gva.es.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Lopez', 'Affiliation': 'Seccion de Alergologia, Hospital Universitario Dr. Peset, Valencia, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Llusar', 'Affiliation': 'Seccion de Alergologia, Hospital Universitario Dr. Peset, Valencia, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Rojas', 'Affiliation': 'Seccion de Alergologia, Hospital Universitario Dr. Peset, Valencia, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Marin', 'Affiliation': 'Universidad de Valencia, Valencia, Spain.'}]",Chest,['10.1378/chest.08-0093']
511,31478556,Comparison of long-term radial artery occlusion following trans-radial coronary intervention using 6-french versus 7-french sheaths.,"BACKGROUND


The aim of this study was to explore the impact of 6-Fr and 7-Fr sheaths on the incidence of long-term radial artery occlusion (RAO) after trans-radial coronary intervention (TRI).
METHODS


From September 2013 to January 2016, patients with ischemic heart disease including acute myocardial infarction and true bifurcation lesions were randomly assigned to 6-Fr group and 7-Fr group immediately after coronary angiography in a 1:1 ratio. The radial artery diameters were observed by ultrasound examination one day prior to TRI as well as at 30 days and 1 year after TRI. The primary endpoint was the incidence of RAO at 1-year after TRI. The secondary endpoints were the incidence of local vascular complications during hospitalization and changes of radial artery diameters within 1-year after TRI between the two groups. Additionally, multivariate logistic regression analysis was used to explore potential factors related to the incidence of long-term RAO after TRI.
RESULTS


A total of 214 patients were enrolled and randomly assigned to 6-Fr group (n = 105) or 7-Fr group (n = 109). There was no significant difference in the incidence of RAO at 1-year after TRI (8.57% vs. 12.84%, p = 0.313). Moreover, no significant difference was observed in the incidence of local vascular complications during hospitalization (20% vs. 24.77%, p = 0.403). After 1-year follow-up, no significant difference was found in radial artery diameters (2.63 ± 0.31 mm vs. 2.64 ± 0.27 mm, p = 0.802). Multivariate logistic analysis revealed that repeated TRI was an independent risk factor of long-term RAO 1 year after TRI (OR = 10.316, 95% CI 2.928-36.351, p = 0.001).
CONCLUSIONS


Compared to 6-Fr sheath, 7-Fr sheath did not increase short-term or long-term incidence of RAO after TRI.",2021,"Compared to 6-Fr sheath, 7-Fr sheath did not increase short-term or long-term incidence of RAO after TRI.","['From September 2013 to January 2016', 'patients with ischemic heart disease including acute myocardial infarction and true bifurcation lesions', '214 patients were enrolled and randomly assigned to 6-Fr group (n = 105) or 7-Fr group (n = 109']","['6-Fr group and 7-Fr group immediately after coronary angiography', 'long-term radial artery occlusion following trans-radial coronary intervention using 6-french versus 7-french sheaths', 'trans-radial coronary intervention (TRI', '6-Fr and 7-Fr sheaths']","['incidence of long-term radial artery occlusion (RAO', 'incidence of local vascular complications', 'incidence of local vascular complications during hospitalization and changes of radial artery diameters', 'radial artery diameters', 'incidence of RAO']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]",214.0,0.326384,"Compared to 6-Fr sheath, 7-Fr sheath did not increase short-term or long-term incidence of RAO after TRI.","[{'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Xingtai People's hospital.""}, {'ForeName': 'Qingmin', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': ""Xingtai People's hospital.""}, {'ForeName': 'Junna', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': ""Xingtai People's hospital.""}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Second Hospital of Hebei Medical University.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'The Second Hospital of Hebei Medical University. fuxh999@163.com.'}]",Cardiology journal,['10.5603/CJ.a2019.0085']
512,18625672,A possible association between suspected restrictive pattern as assessed by ordinary pulmonary function test and the metabolic syndrome.,"BACKGROUND


Impaired restrictive pulmonary function has been reported to be associated with insulin resistance and metabolic abnormalities. However, the possible association of restrictive pulmonary defect with metabolic syndrome (MetS) is not well understood. We examined the association in comparison with C-reactive protein (CRP), which is a predictor for MetS.
METHODS


We recruited 2,396 apparently healthy adults and investigated the associations among pulmonary function, metabolic abnormality, and MetS, as defined by three different criteria. Abnormal pulmonary function was evaluated by both continuous pulmonary function variables including the percentage of predicted FVC (%PFVC) and a clinical category defined according to the American Thoracic Society/European Respiratory Society guidelines.
RESULTS


CRP and %PFVC, but not FEV1/FVC ratio, were significantly correlated with metabolic abnormalities even after adjustment for confounders including waist circumference. After adjustment for age, sex, and height, the odds ratios (ORs) of a restrictive pattern (RP), as defined by a reduced FVC and a normal FEV1/FVC ratio using the lower limit of normal and RP substitutively defined by reduced FVC and an FEV1/FVC ratio of > or = 85% for MetS, were 1.76 to 2.52 (p < 0.05 to < 0.0001) and 1.87 to 2.28 (p < 0.05 to < 0.01), respectively. The obstructive pattern (OP) was not significantly associated with any MetS criteria. A moderate-to-severe RP, but not a high CRP level (> 3.0 mg/L), was consistently associated with the three MetS criteria (OR, 2.08 to 3.57; p < 0.05 to < 0.01), even after adjustment for confounders.
CONCLUSION


Impaired restrictive pulmonary function, but not OP, might be associated with metabolic disorders and MetS in a severity-dependent manner.",2008,"RESULTS


CRP and %PFVC, but not FEV1/FVC ratio, were significantly correlated with metabolic abnormalities even after adjustment for confounders including waist circumference.","['We recruited 2,396 apparently healthy adults and investigated the associations among pulmonary function, metabolic abnormality, and MetS, as defined by three different criteria']",['C-reactive protein (CRP'],"['CRP level', 'Abnormal pulmonary function', 'obstructive pattern (OP', 'metabolic abnormalities']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",2396.0,0.0192131,"RESULTS


CRP and %PFVC, but not FEV1/FVC ratio, were significantly correlated with metabolic abnormalities even after adjustment for confounders including waist circumference.","[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Nakajima', 'Affiliation': 'Department of Medical Dietetics, Faculty of Pharmaceutical Sciences, Josai University, Saitama, Japan. Electronic address: keinaka@josai.ac.jp.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Kubouchi', 'Affiliation': 'Department of Internal Medicine, Social Insurance Omiya General Hospital, Saitama, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Muneyuki', 'Affiliation': 'Department of Internal Medicine, Social Insurance Omiya General Hospital, Saitama, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Ebata', 'Affiliation': 'Department of Medical Dietetics, Faculty of Pharmaceutical Sciences, Josai University, Saitama, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Eguchi', 'Affiliation': 'Department of Medical Dietetics, Faculty of Pharmaceutical Sciences, Josai University, Saitama, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Munakata', 'Affiliation': 'Department of Internal Medicine, Social Insurance Omiya General Hospital, Saitama, Japan.'}]",Chest,['10.1378/chest.07-3003']
513,18625674,Patterns of domestic activity and ambulatory oxygen usage in COPD.,"BACKGROUND


The aim of this study was to examine patterns of domestic activity and ambulatory oxygen usage in patients with COPD in their domestic environment.
METHODS


Twenty patients (14 men; mean age, 73.4 years [SD, 6.8 years]; FEV1, 1.0 L [SD, 0.5 L]) with stable COPD were recruited after completing a 7-week pulmonary rehabilitation program. Patients were either hypoxic at rest or had desaturation during exercise. Patients were randomized to an 8-week, double-blind, placebo-controlled trial of cylinder oxygen vs cylinder air. Total domestic physical activity and health-related quality of life (HRQL) measures were recorded before and after intervention.
RESULTS


There were no significant changes in domestic activity or HRQL measures after the intervention for either cylinder oxygen or cylinder air, except for a worsening of the Chronic Respiratory Questionnaire dyspnea domain on cylinder air. There was a significant increase in mean duration (minutes per day) of cylinder use (p < 0.05) between weeks 1 vs 7 and weeks 1 vs 8 for the oxygen group. However, when comparing the two groups together, there were no between-group differences in cylinder use or time spent outside the home. Over the 8 weeks the majority of patients were using the cylinders in the home rather than outside, however, the number of times patients reported using the cylinders outside the home increased over the 8 weeks for the oxygen group.
CONCLUSION


In the short term, ambulatory oxygen therapy is not associated with improvements in physical activity, HRQL, or time spent away from home. However, the use of cylinder oxygen increased over the 8 weeks compared to cylinder air. Patients need time to learn how to use oxygen, and ambulatory oxygen appears to enhance activities rather than increase them.",2008,"There were no significant changes in domestic activity or HRQL measures after the intervention for either cylinder oxygen or cylinder air, except for a worsening of the Chronic Respiratory Questionnaire dyspnea domain on cylinder air.","['patients with COPD in their domestic environment', 'COPD', 'Twenty patients (14 men; mean age, 73.4 years [SD, 6.8 years]; FEV1, 1.0 L [SD, 0.5 L]) with stable COPD were recruited after completing a 7-week']","['ambulatory oxygen therapy', 'placebo', 'cylinder oxygen vs cylinder air', 'pulmonary rehabilitation program']","['Total domestic physical activity and health-related quality of life (HRQL) measures', 'Chronic Respiratory Questionnaire dyspnea domain on cylinder air', 'cylinder use or time spent outside the home', 'mean duration', 'cylinder oxygen', 'domestic activity or HRQL measures', 'physical activity, HRQL, or time spent away from home']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441660', 'cui_str': 'Domestic activity (observable entity)'}]",20.0,0.0332272,"There were no significant changes in domestic activity or HRQL measures after the intervention for either cylinder oxygen or cylinder air, except for a worsening of the Chronic Respiratory Questionnaire dyspnea domain on cylinder air.","[{'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Sandland', 'Affiliation': 'University Hospitals of Leicester, Leicester, UK. Electronic address: carolyn.sandland@uhl-tr.nhs.uk.'}, {'ForeName': 'Mike D L', 'Initials': 'MDL', 'LastName': 'Morgan', 'Affiliation': 'University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'University Hospitals of Leicester, Leicester, UK.'}]",Chest,['10.1378/chest.07-1848']
514,18581100,Direct effects of diazepam on emotional processing in healthy volunteers.,"RATIONALE


Pharmacological agents used in the treatment of anxiety have been reported to decrease threat relevant processing in patients and healthy controls, suggesting a potentially relevant mechanism of action. However, the effects of the anxiolytic diazepam have typically been examined at sedative doses, which do not allow the direct actions on emotional processing to be fully separated from global effects of the drug on cognition and alertness.
OBJECTIVES


The aim of this study was to investigate the effect of a lower, but still clinically effective, dose of diazepam on emotional processing in healthy volunteers.
MATERIALS AND METHODS


Twenty-four participants were randomised to receive a single dose of diazepam (5 mg) or placebo. Sixty minutes later, participants completed a battery of psychological tests, including measures of non-emotional cognitive performance (reaction time and sustained attention) and emotional processing (affective modulation of the startle reflex, attentional dot probe, facial expression recognition, and emotional memory). Mood and subjective experience were also measured.
RESULTS


Diazepam significantly modulated attentional vigilance to masked emotional faces and significantly decreased overall startle reactivity. Diazepam did not significantly affect mood, alertness, response times, facial expression recognition, or sustained attention.
CONCLUSIONS


At non-sedating doses, diazepam produces effects on attentional vigilance and startle responsivity that are consistent with its anxiolytic action. This may be an underlying mechanism through which benzodiazepines exert their therapeutic effects in clinical anxiety.",2008,"Diazepam did not significantly affect mood, alertness, response times, facial expression recognition, or sustained attention.
","['Twenty-four participants', 'patients and healthy controls', 'healthy volunteers']","['placebo', 'benzodiazepines', 'anxiolytic diazepam', 'diazepam', 'Diazepam']","['mood, alertness, response times, facial expression recognition, or sustained attention', 'attentional vigilance and startle responsivity', 'overall startle reactivity', 'attentional vigilance to masked emotional faces', 'measures of non-emotional cognitive performance (reaction time and sustained attention) and emotional processing (affective modulation of the startle reflex, attentional dot probe, facial expression recognition, and emotional memory', 'emotional processing', 'Mood and subjective experience']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0040616', 'cui_str': 'Anti-Anxiety Drugs'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0038186', 'cui_str': 'Startle Response'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",24.0,0.0525959,"Diazepam did not significantly affect mood, alertness, response times, facial expression recognition, or sustained attention.
","[{'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'University Department of Psychiatry, Warneford Hospital, Warneford Lane, Oxford,UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Downham', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-008-1082-2']
515,18403668,"Rapid effect of inhaled ciclesonide in asthma: a randomized, placebo-controlled study.","BACKGROUND


Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma, and it is important to measure the onset of effect of this therapy on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and levels of eosinophils in induced sputum.
METHODS


In a randomized, double-blind, crossover study, 21 patients with mild asthma inhaled ciclesonide 320 microg (ex-actuator) qd, ciclesonide 640 microg (ex-actuator) bid, and placebo for 7 days. Exhaled NO and AHR to adenosine monophosphate (AMP), measured as the provocative concentration of AMP producing a 20% reduction in FEV1 (PC20FEV1), were assessed after inhalation on days 1, 3 and 7. Eosinophil levels in induced sputum were also measured.
RESULTS


Ciclesonide 320 microg qd and 640 microg bid produced significantly greater improvements in PC20FEV1 compared with placebo on day 1 (within 2.5 h), and on days 3 and 7 (all p < 0.0001). On day 3, both ciclesonide doses significantly reduced exhaled NO levels by - 17.7 parts per billion (p < 0.0001) and - 15.4 parts per billion (p < 0.003) vs placebo, respectively. Significant reductions were maintained during the study with both ciclesonide doses (p < 0.01). A nonsignificant trend towards a decrease in eosinophil cell numbers was observed after 7 days of ciclesonide treatment, especially in patients receiving the higher dose.
CONCLUSIONS


A single dose of ciclesonide decreased AHR to AMP and exhaled NO within 3 h, while FEV, improved at 3 days and 7 days.",2008,"A nonsignificant trend towards a decrease in eosinophil cell numbers was observed after 7 days of ciclesonide treatment, especially in patients receiving the higher dose.
","['asthma', '21 patients with mild asthma inhaled']","['placebo', 'ciclesonide 320 microg (ex-actuator) qd, ciclesonide 640 microg (ex-actuator) bid, and placebo', 'inhaled ciclesonide', 'Ciclesonide', 'ciclesonide']","['eosinophil cell numbers', 'Exhaled NO and AHR to adenosine monophosphate (AMP', 'Eosinophil levels', 'airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and levels of eosinophils', 'exhaled NO levels', 'PC20FEV1']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C1706706', 'cui_str': 'Actuator (physical object)'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0001465', 'cui_str': 'Adenosine Monophosphate'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",21.0,0.190888,"A nonsignificant trend towards a decrease in eosinophil cell numbers was observed after 7 days of ciclesonide treatment, especially in patients receiving the higher dose.
","[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Erin', 'Affiliation': 'National Heart and Lung Institute Clinical Studies Unit, Imperial College, London, UK.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Zacharasiewicz', 'Affiliation': 'Department of Pediatric and Adolescent Medicine, Pulmonary and Infectious Diseases, Wilhelminenspital, Vienna, Austria.'}, {'ForeName': 'Grant C', 'Initials': 'GC', 'LastName': 'Nicholson', 'Affiliation': 'National Heart and Lung Institute Clinical Studies Unit, Imperial College, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Tan', 'Affiliation': 'National Heart and Lung Institute Clinical Studies Unit, Imperial College, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Neighbour', 'Affiliation': 'National Heart and Lung Institute Clinical Studies Unit, Imperial College, London, UK.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Engelstätter', 'Affiliation': 'Nycomed GmbH, Konstanz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hellwig', 'Affiliation': 'Nycomed GmbH, Konstanz, Germany.'}, {'ForeName': 'Onn Min', 'Initials': 'OM', 'LastName': 'Kon', 'Affiliation': ""St. Mary's Hospital, Paddington, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Barnes', 'Affiliation': 'Department of Thoracic Medicine, Imperial College, London, UK.'}, {'ForeName': 'Trevor T', 'Initials': 'TT', 'LastName': 'Hansel', 'Affiliation': 'National Heart and Lung Institute Clinical Studies Unit, Imperial College, London, UK. Electronic address: t.hansel@ic.ac.uk.'}]",Chest,['10.1378/chest.07-2575']
516,17999080,Wolbachia endobacteria depletion by doxycycline as antifilarial therapy has macrofilaricidal activity in onchocerciasis: a randomized placebo-controlled study.,"In a randomized, placebo-controlled trial in Ghana, 67 onchocerciasis patients received 200-mg/day doxycycline for 4-6 weeks, followed by ivermectin (IVM) after 6 months. After 6-27 months, efficacy was evaluated by onchocercoma histology, PCR and microfilariae determination. Administration of doxycycline resulted in endobacteria depletion and female worm sterilization. The 6-week treatment was macrofilaricidal, with >60% of the female worms found dead, despite the presence of new, Wolbachia-containing worms acquired after the administration of doxycycline. Doxycycline may be developed as second-line drug for onchocerciasis, to be administered in areas without transmission, in foci with IVM resistance and in areas with Loa co-infections.",2008,"After 6-27 months, efficacy was evaluated by onchocercoma histology, PCR and microfilariae determination.","['Ghana, 67 onchocerciasis patients received', 'onchocerciasis']","['doxycycline', 'placebo', 'Doxycycline', '200-mg/day doxycycline', 'ivermectin (IVM']",['endobacteria depletion and female worm sterilization'],"[{'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0029001', 'cui_str': 'Onchocerciasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0018889', 'cui_str': 'Helminthiasis'}, {'cui': 'C0362065', 'cui_str': 'Sterilization'}]",67.0,0.49433,"After 6-27 months, efficacy was evaluated by onchocercoma histology, PCR and microfilariae determination.","[{'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Hoerauf', 'Affiliation': 'Institute for Medical Microbiology, Immunology and Parasitology, University Clinic, Bonn, Sigmund-Freud-Strasse 25, Bonn, Germany. hoerauf@parasit.meb.uni-bonn.de'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Specht', 'Affiliation': ''}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Büttner', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Pfarr', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Mand', 'Affiliation': ''}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': ''}, {'ForeName': 'Yeboah', 'Initials': 'Y', 'LastName': 'Marfo-Debrekyei', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Konadu', 'Affiliation': ''}, {'ForeName': 'Alexander Yaw', 'Initials': 'AY', 'LastName': 'Debrah', 'Affiliation': ''}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bandi', 'Affiliation': ''}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Brattig', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Albers', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Larbi', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Batsa', 'Affiliation': ''}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Ohene', 'Initials': 'O', 'LastName': 'Adjei', 'Affiliation': ''}, {'ForeName': 'Dietrich W', 'Initials': 'DW', 'LastName': 'Büttner', 'Affiliation': ''}]",Medical microbiology and immunology,[]
517,18386046,"Effect of an EBM course in combination with case method learning sessions: an RCT on professional performance, job satisfaction, and self-efficacy of occupational physicians.","OBJECTIVE


An intervention existing of an evidence-based medicine (EBM) course in combination with case method learning sessions (CMLSs) was designed to enhance the professional performance, self-efficacy and job satisfaction of occupational physicians.
METHODS


A cluster randomized controlled trial was set up and data were collected through questionnaires at baseline (T0), directly after the intervention (T1) and 7 months after baseline (T2). The data of the intervention group [T0 (n = 49), T1 (n = 31), T2 (n = 29)] and control group [T0 (n = 49), T1 (n = 28), T2 (n = 28)] were analysed in mixed model analyses. Mean scores of the perceived value of the CMLS were calculated in the intervention group.
RESULTS


The overall effect of the intervention over time comparing the intervention with the control group was statistically significant for professional performance (p < 0.001). Job satisfaction and self-efficacy changes were small and not statistically significant between the groups. The perceived value of the CMLS to gain new insights and to improve the quality of their performance increased with the number of sessions followed.
CONCLUSION


An EBM course in combination with case method learning sessions is perceived as valuable and offers evidence to enhance the professional performance of occupational physicians. However, it does not seem to influence their self-efficacy and job satisfaction.",2008,An EBM course in combination with case method learning sessions is perceived as valuable and offers evidence to enhance the professional performance of occupational physicians.,[],[],"['professional performance', 'self-efficacy and job satisfaction', 'Mean scores of the perceived value of the CMLS', 'professional performance, job satisfaction, and self-efficacy', 'Job satisfaction and self-efficacy changes']",[],[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",49.0,0.0391328,An EBM course in combination with case method learning sessions is perceived as valuable and offers evidence to enhance the professional performance of occupational physicians.,"[{'ForeName': 'Nathalie I R', 'Initials': 'NI', 'LastName': 'Hugenholtz', 'Affiliation': 'Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. n.i.hugenholtz@amc.uva.nl'}, {'ForeName': 'Frederieke G', 'Initials': 'FG', 'LastName': 'Schaafsma', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Nieuwenhuijsen', 'Affiliation': ''}, {'ForeName': 'Frank J H', 'Initials': 'FJ', 'LastName': 'van Dijk', 'Affiliation': ''}]",International archives of occupational and environmental health,['10.1007/s00420-008-0315-3']
518,18172697,Physical therapy plus general practitioners' care versus general practitioners' care alone for sciatica: a randomised clinical trial with a 12-month follow-up.,"A randomised clinical trial in primary care with a 12-months follow-up period. About 135 patients with acute sciatica (recruited from May 2003 to November 2004) were randomised in two groups: (1) the intervention group received physical therapy (PT) added to the general practitioners' care, and (2) the control group with general practitioners' care only. To assess the effectiveness of PT additional to general practitioners' care compared to general practitioners' care alone, in patients with acute sciatica. There is a lack of knowledge concerning the effectiveness of PT in patients with sciatica. The primary outcome was patients' global perceived effect (GPE). Secondary outcomes were severity of leg and back pain, severity of disability, general health and absence from work. The outcomes were measured at 3, 6, 12 and 52 weeks after randomisation. At 3 months follow-up, 70% of the intervention group and 62% of the control group reported improvement (RR 1.1; 95% CI 0.9-1.5). At 12 months follow-up, 79% of the intervention group and 56% of the control group reported improvement (RR 1.4; 95% CI 1.1; 1.8). No significant differences regarding leg pain, functional status, fear of movement and health status were found at short-term or long-term follow-up. At 12 months follow-up, evidence was found that PT added to general practitioners' care is only more effective regarding GPE, and not more cost-effective in the treatment of patients with acute sciatica than general practitioners' care alone. There are indications that PT is especially effective regarding GPE in patients reporting severe disability at presentation.",2008,"No significant differences regarding leg pain, functional status, fear of movement and health status were found at short-term or long-term follow-up.","['patients with acute sciatica', '135 patients with acute sciatica (recruited from May 2003 to November 2004', 'patients with sciatica']","[""intervention group received physical therapy (PT) added to the general practitioners' care, and (2) the control group with general practitioners' care only"", ""Physical therapy plus general practitioners' care versus general practitioners' care alone for sciatica""]","['severity of leg and back pain, severity of disability, general health and absence from work', 'leg pain, functional status, fear of movement and health status', ""patients' global perceived effect (GPE""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585051', 'cui_str': 'Acute sciatica (disorder)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0036396', 'cui_str': 'Sciatic Neuralgia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0036396', 'cui_str': 'Sciatic Neuralgia'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",135.0,0.0855791,"No significant differences regarding leg pain, functional status, fear of movement and health status were found at short-term or long-term follow-up.","[{'ForeName': 'Pim A J', 'Initials': 'PA', 'LastName': 'Luijsterburg', 'Affiliation': 'Department of General Practice, Erasmus MC, PO Box 2040, 3000 CA, Rotterdam, The Netherlands. pimluijsterburg@home.nl'}, {'ForeName': 'Arianne P', 'Initials': 'AP', 'LastName': 'Verhagen', 'Affiliation': ''}, {'ForeName': 'Raymond W J G', 'Initials': 'RW', 'LastName': 'Ostelo', 'Affiliation': ''}, {'ForeName': 'Hans J M M', 'Initials': 'HJ', 'LastName': 'van den Hoogen', 'Affiliation': ''}, {'ForeName': 'Wilco C', 'Initials': 'WC', 'LastName': 'Peul', 'Affiliation': ''}, {'ForeName': 'Cees J J', 'Initials': 'CJ', 'LastName': 'Avezaat', 'Affiliation': ''}, {'ForeName': 'Bart W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-007-0569-6']
519,31504417,Residual inflammatory risk associated with interleukin-18 and interleukin-6 after successful interleukin-1β inhibition with canakinumab: further rationale for the development of targeted anti-cytokine therapies for the treatment of atherothrombosis.,"AIMS


The Canakinumab Antiinflammatory Thrombosis Outcomes Study (CANTOS) established that targeting inflammation with interleukin-1β (IL-1β) inhibition can significantly reduce cardiovascular (CV) event rates in the absence of any beneficial effects on cholesterol. Yet, CANTOS participants treated with both high-intensity statins and canakinumab remain at considerable risk for recurrent CV events. Both interleukin-18 (IL-18, which like IL-1β requires the NLRP3 inflammasome for activation) and interleukin-6 (IL-6, a pro-inflammatory cytokine downstream of IL-1) may contribute to the recurrent events that occur even on canakinumab therapy, and thus represent novel targets for treating atherothrombosis.
METHODS AND RESULTS


Plasma samples from 4848 stable post-myocardial infarction patients who were assigned to active IL-1β inhibition or placebo within CANTOS underwent measurement of IL-18 and IL-6 both before and after initiation of canakinumab using validated ELISA. All participants were followed over a median 3.7-year period (maximum 5 years) for recurrent major adverse cardiovascular events (MACE) and for all-cause mortality. Compared to placebo, canakinumab significantly reduced IL-6 levels in a dose-dependent manner yielding placebo-subtracted median percent reductions in IL-6 at 3 months of 24.8%, 36.3%, and 43.2% for the 50, 150, and 300 mg doses, respectively (all P-values <0.001). By contrast, no dose of canakinumab significantly altered IL-18 levels measured at 3 months (all effects <1%, all P-values > 0.05). Yet, despite these differential plasma effects, either baseline and on-treatment levels of IL-18 or IL-6 associated with rates of future CV events. For example, for MACE, each tertile increase in IL-18 measured 3 months after canakinumab initiation associated with a 15% increase in risk [95% confidence interval (CI) 3-29%, P = 0.016], while each tertile increase in IL-6 measured 3 months after canakinumab initiation associated with a 42% increase in risk (95% CI 26-59%, P < 0.0001). Similar effects were observed for MACE-plus, CV death, all-cause mortality, and the for the combination endpoint of all vascular events inclusive of revascularization procedures and hospitalization for congestive heart failure. In baseline as well as on-treatment analyses, risks were highest among those with the highest levels of both IL-18 and IL-6.
CONCLUSION


There remains substantial residual inflammatory risk related to both IL-18 and IL-6 after IL-1β inhibition with canakinumab These data support further pharmacologic development of therapies for atherothrombosis that target IL-18 or IL-6 signalling, or that can simultaneously inhibit both IL-1β and IL-18 (such as NLRP3 inflammasome inhibitors).
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT01327846.",2020,"Compared to placebo, canakinumab significantly reduced IL-6 levels in a dose-dependent manner yielding placebo-subtracted median percent reductions in IL-6 at 3 months of 24.8%, 36.3%, and 43.2% for the 50, 150, and 300 mg doses, respectively (all P-values <0.001).",['Plasma samples from 4848 stable post-myocardial infarction patients who were assigned to active IL-1β inhibition or'],"['placebo', 'canakinumab']","['IL-18 levels', 'IL-6', 'recurrent major adverse cardiovascular events (MACE', 'MACE-plus, CV death, all-cause mortality', 'IL-6 levels', 'IL-18', 'cardiovascular (CV) event rates']","[{'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}]","[{'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.35441,"Compared to placebo, canakinumab significantly reduced IL-6 levels in a dose-dependent manner yielding placebo-subtracted median percent reductions in IL-6 at 3 months of 24.8%, 36.3%, and 43.2% for the 50, 150, and 300 mg doses, respectively (all P-values <0.001).","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Department of Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""Department of Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover, NJ 07936, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}]",European heart journal,['10.1093/eurheartj/ehz542']
520,18188559,Report on short-term side effects of treatments with 177Lu-octreotate in combination with capecitabine in seven patients with gastroenteropancreatic neuroendocrine tumours.,"PURPOSE


Treatment with the radiolabelled somatostatin analogue (177)Lu-octreotate results in tumour remission in 47% of patients with gastroenteropancreatic neuroendocrine tumours. Adding capecitabine to (177)Lu-octreotate, as a radio-sensitiser, may enhance these anti-tumour effects. We now present the short-term toxicity profile of this novel combination.
METHODS


Seven patients were treated with 7.4 GBq (177)Lu-octreotate and capecitabine (1650 mg/m(2) per day) for 2 weeks with an intended number of four cycles. Toxicity, and especially haematological and renal parameters, were monitored on a weekly basis for the first two cycles and 4 and 6 weeks after subsequent cycles.
RESULTS


None of the patients had hand-foot syndrome. One patient had grade 1 stomatitis occurring after one of four cycles. Grade 3 or 4 leukopenia or neutropenia did not occur. One patient had grade 3 anaemia, but none had grade 4 anaemia. One patient had grade 2 thrombocytopenia after the fourth cycle, and one had grade 3 thrombocytopenia. Grade 4 thrombocytopenia did not occur. No significant changes in serum creatinine levels were observed. None of the patients had symptoms of cardiac ischaemia.
CONCLUSIONS


Treatment with the combination of (177)Lu-octreotate and capecitabine was feasible and safe considering acute and subacute side effects. We therefore started a randomised, controlled clinical trial to compare this combination with (177)Lu-octreotate as single agent with regard to anti-tumour effects and side effects.",2008,No significant changes in serum creatinine levels were observed.,"['seven patients with gastroenteropancreatic neuroendocrine tumours', 'Seven patients were treated with 7.4', 'tumour remission in 47% of patients with gastroenteropancreatic neuroendocrine tumours']","['capecitabine', '177)Lu-octreotate and capecitabine', 'radiolabelled somatostatin analogue (177)Lu-octreotate', 'GBq (177)Lu-octreotate and capecitabine', '177Lu-octreotate']","['grade 4 anaemia', 'grade 2 thrombocytopenia', 'Toxicity, and especially haematological and renal parameters', 'Grade 3 or 4 leukopenia or neutropenia', 'grade 3 thrombocytopenia', 'grade 3 anaemia', 'serum creatinine levels', 'symptoms of cardiac ischaemia', 'Grade 4 thrombocytopenia']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0732165', 'cui_str': 'Somatostatin analog'}, {'cui': 'C1688582', 'cui_str': 'Gigabecquerel'}, {'cui': 'C2975721', 'cui_str': '177Lu-octreotate'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}]",7.0,0.0513065,No significant changes in serum creatinine levels were observed.,"[{'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'van Essen', 'Affiliation': 'Department of Nuclear Medicine, Erasmus MC, Rotterdam, The Netherlands. m.vanessen@erasmusmc.nl'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Krenning', 'Affiliation': ''}, {'ForeName': 'Boen L', 'Initials': 'BL', 'LastName': 'Kam', 'Affiliation': ''}, {'ForeName': 'Wouter W', 'Initials': 'WW', 'LastName': 'de Herder', 'Affiliation': ''}, {'ForeName': 'Maarten O', 'Initials': 'MO', 'LastName': 'van Aken', 'Affiliation': ''}, {'ForeName': 'Dik J', 'Initials': 'DJ', 'LastName': 'Kwekkeboom', 'Affiliation': ''}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-007-0688-7']
521,18535870,Effects of mindfulness-based stress reduction intervention on psychological well-being and quality of life: is increased mindfulness indeed the mechanism?,"BACKGROUND


Although several studies have reported positive effects of mindfulness-based stress reduction (MBSR) intervention on psychological well-being, it is not known whether these effects are attributable to a change in mindfulness.
PURPOSE


The aim of this study is to compare the effects of MBSR to a waiting-list control condition in a randomized controlled trial while examining potentially mediating effects of mindfulness.
METHODS


Forty women and 20 men from the community with symptoms of distress (mean age 43.6 years, SD = 10.1) were randomized into a group receiving MBSR or a waiting-list control group. Before and after the intervention period, questionnaires were completed on psychological well-being, quality of life, and mindfulness.
RESULTS


Repeated measures multiple analysis of variance (MANCOVAs) showed that, compared with the control group, the intervention resulted in significantly stronger reductions of perceived stress (p = 0.016) and vital exhaustion (p = 0.001) and stronger elevations of positive affect (p = 0.006), quality of life (p = .009), as well as mindfulness (p = 0.001). When mindfulness was included as a covariate in the MANCOVA, the group effects on perceived stress and quality of life were reduced to nonsignificance.
CONCLUSION


Increased mindfulness may, at least partially, mediate the positive effects of mindfulness-based stress reduction intervention.",2008,"Before and after the intervention period, questionnaires were completed on psychological well-being, quality of life, and mindfulness.
","['Forty women and 20 men from the community with symptoms of distress (mean age 43.6 years, SD = 10.1']","['MBSR or a waiting-list control group', 'MBSR', 'mindfulness-based stress reduction (MBSR) intervention', 'mindfulness-based stress reduction intervention']","['psychological well-being, quality of life, and mindfulness', 'quality of life', 'psychological well-being and quality of life', 'perceived stress', 'vital exhaustion', 'perceived stress and quality of life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}]",40.0,0.0236535,"Before and after the intervention period, questionnaires were completed on psychological well-being, quality of life, and mindfulness.
","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Nyklícek', 'Affiliation': 'CoRPS, Department of Psychology and Health, Tilburg University, P.O. Box 90153, 5000, LE Tilburg, The Netherlands. i.nyklicek@uvt.nl'}, {'ForeName': 'Karlijn F', 'Initials': 'KF', 'LastName': 'Kuijpers', 'Affiliation': ''}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1007/s12160-008-9030-2']
522,18551283,Effects of acute tryptophan depletion on affective processing in first-degree relatives of depressive patients and controls after exposure to uncontrollable stress.,"RATIONALE


Individuals with a family history of depression may be more likely to develop depression due to an innate vulnerability of their serotonergic system. However, even though serotonergic vulnerability may constitute a risk factor in the development of depression, it does not seem to be sufficient to cause a depressive episode. Based on previous data, it is suggested that stress may be a mediating factor.
OBJECTIVES


This study examined the role of serotonin (5-HT) in stress coping in individuals with or without a family history of depression.
MATERIALS AND METHODS


Nineteen healthy first-degree relatives of depressive patients (FH+) and 19 healthy controls without a family history of depression (FH-) were tested in a double-blind placebo-controlled design for affective processing under acute stress exposure, following acute tryptophan depletion (ATD) or placebo.
RESULTS


Significant negative effects were found of stress on affective processing in FH- and FH+. In addition, FH- responded slower to positive words after stress only following ATD, whereas FH+ responded marginally slower under stress already after placebo and before stress following ATD.
CONCLUSION


Acute stress exposure reduces positive affective bias; supporting the role of stress as an important predecessor in the development of depression. Furthermore, FH+ may be more susceptible than FH- to the negative effects of stress as well as to the negative effects of ATD. The results support the assumption that the 5-HT system is involved in stress resilience and may be more vulnerable in first-degree relatives of depression.",2008,"RESULTS


Significant negative effects were found of stress on affective processing in FH- and FH+.","['Individuals with a family history of depression', 'individuals with or without a family history of depression', 'first-degree relatives of depressive patients and controls after exposure to uncontrollable stress', 'Nineteen healthy first-degree relatives of depressive patients (FH+) and 19 healthy controls without a family history of depression (FH']","['serotonin (5-HT', 'placebo', 'acute tryptophan depletion']",['affective processing'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0455383', 'cui_str': 'Family history of depression'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}]",[],19.0,0.0573032,"RESULTS


Significant negative effects were found of stress on affective processing in FH- and FH+.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Firk', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology, Maastricht University, Maastricht, The Netherlands. christine.firk@psychology.unimaas.nl'}, {'ForeName': 'C Rob', 'Initials': 'CR', 'LastName': 'Markus', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-008-1125-8']
523,17175424,Effects of mannitol in the prevention of lipid peroxidation during liver resection with hepatic vascular exclusion.,"STUDY OBJECTIVE


To examine the efficacy of mannitol in the prevention of lipid peroxidation during major liver resections performed during hepatic inflow occlusion.
DESIGN


Prospective, randomized, open-label study.
SETTING


Aretaieion Hospital, a university-affiliated hospital.
PATIENTS


30 ASA physical status II and III patients, less than 75 years of age, scheduled for elective liver resection.
INTERVENTIONS


All patients received combined general and epidural anesthesia. Laparotomy was performed through a bilateral subcostal incision, and hepatectomy was performed by inflow vascular exclusion (Pringle's maneuver). Before this maneuver, and if the patients were hemodynamically stable, they were randomized to receive either mannitol 20% 1.5 mL kg(-1) (group M) or normal saline 1.5 mL kg(-1) (group S) intravenously for 30 minutes.
MEASUREMENTS


Venous blood malondialdehyde (MDA) concentration, as an index of lipid peroxidation, was measured spectrophotometrically at selected time points.
MAIN RESULTS


Patients in both groups presented with raised MDA values (P < 0.05) for the period starting before the release of vascular occlusion until 6 days postoperatively. In patients receiving mannitol, lower MDA values were observed (P < 0.05) compared with group S at the end of operation.
CONCLUSION


Mannitol has an antioxidant activity, but we were unable to confirm a positive impact on the postoperative clinical course.",2006,"In patients receiving mannitol, lower MDA values were observed (P < 0.05) compared with group S at the end of operation.
","['Aretaieion Hospital, a university-affiliated hospital', 'liver resection with hepatic vascular exclusion', '30 ASA physical status II and III patients, less than 75 years of age, scheduled for elective liver resection', 'patients were hemodynamically stable']","['mannitol 20% 1.5 mL kg(-1) (group M) or normal saline 1.5 mL kg(-1) (group S) intravenously for 30 minutes', 'mannitol', 'combined general and epidural anesthesia', 'Mannitol']","['Venous blood malondialdehyde (MDA) concentration, as an index of lipid peroxidation', 'lipid peroxidation', 'raised MDA values', 'MDA values']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}]","[{'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0730794,"In patients receiving mannitol, lower MDA values were observed (P < 0.05) compared with group S at the end of operation.
","[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Kostopanagiotou', 'Affiliation': '2nd Department of Anesthesiology, School of Medicine, University of Athens, Attikon Hospital, Athens 12462, Greece. banesthclin@attikonhospital.gr'}, {'ForeName': 'Ageliki K', 'Initials': 'AK', 'LastName': 'Pandazi', 'Affiliation': ''}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': ''}, {'ForeName': 'Sofia L', 'Initials': 'SL', 'LastName': 'Markantonis', 'Affiliation': ''}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Niokou', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Teloudis', 'Affiliation': ''}, {'ForeName': 'Constantinos', 'Initials': 'C', 'LastName': 'Costopanagiotou', 'Affiliation': ''}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Arkadopoulos', 'Affiliation': ''}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Smyrniotis', 'Affiliation': ''}]",Journal of clinical anesthesia,[]
524,32513229,"Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial.","BACKGROUND


The epiretinal membrane (ERM) is a degenerative condition associated with age, which can cause loss of vision and/or metamorphopsia. The treatment of symptomatic ERM involves surgical removal including a vitrectomy followed by peeling of the ERM using a microforceps. As the internal limiting membrane (ILM) is adherent to the ERM, it is sometimes removed with it (spontaneous peeling). If ILM remains in place, it can be removed to reduce ERM recurrence. However, it is important to clarify the safety of ILM peeling, while it increases surgical risks and cause histological disorganization of the retina that can lead to microscotomas, may be responsible for definitive visual discomfort.
METHODS


PEELING is a prospective, randomized, controlled, single-blind, and multicentered trial with two parallel arms. This study investigates the benefit/risk ratio of active ILM peeling among individuals undergoing ERM surgery without spontaneous ILM peeling. Randomization is done in the operating room after ERM removal if ILM remains in place. After randomization, the two groups-""active peeling of the ILM"" and ""no peeling of the ILM""-are compared during a total of three follow-up visits scheduled at month 1, month 6, and month 12. Primary endpoint is the difference in microscotomas before surgery and 6 months after surgery. Patients with spontaneous peeling are not randomized and are included in the ancillary study with the same follow-up visits and the same examinations as the principal study. Relevant inclusion criteria involve individuals aged > 18 years living with idiopathic symptomatic ERM, including pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts. The calculated sample size corresponds to 53 randomized eyes (one eye/patient) per arm that means 106 randomized eyes (106 randomized patients) in total and a maximum of 222 included patients (116 spontaneous peeling).
DISCUSSION


ILM peeling is often practiced in ERM surgery to reduce ERM recurrence. It does not impair postoperative visual acuity, but it increases the surgical risks and causes anatomical damages. If active ILM peeling is significantly associated with more microscotomas, it may contraindicate the ILM peeling during primitive idiopathic ERM surgery.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02146144. Registered on 22 May 2014. Recruitment is still ongoing.",2020,This study investigates the benefit/risk ratio of active ILM peeling among individuals undergoing ERM surgery without spontaneous ILM peeling.,"['Patients with spontaneous peeling', 'individuals undergoing ERM surgery without spontaneous ILM peeling', 'Relevant inclusion criteria involve individuals aged >\u200918\u2009years living with idiopathic symptomatic ERM, including pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts', '53 randomized eyes (one eye/patient) per arm that means 106 randomized eyes (106 randomized patients) in total and a maximum of 222 included patients (116 spontaneous peeling']",[],"['surgical risks', 'ERM recurrence', 'postoperative visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",106.0,0.255661,This study investigates the benefit/risk ratio of active ILM peeling among individuals undergoing ERM surgery without spontaneous ILM peeling.,"[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Ducloyer', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Ivan', 'Affiliation': 'Clinical Investigation Centre CIC1413, INSERM and CHU Nantes, Nantes, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Poinas', 'Affiliation': 'Clinical Investigation Centre CIC1413, INSERM and CHU Nantes, Nantes, France. alexandra.poinas@chu-nantes.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lebreton', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Bonissent', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fossum', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Volteau', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Ophthalmology Department, Hôpital Lariboisière, AP-HP, Université Paris 7 - Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Creuzot-Garchet', 'Affiliation': 'Ophthalmology Department, CHU Dijon, Dijon, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Le Mer', 'Affiliation': 'Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Perol', 'Affiliation': ""Ophthalmology Department, Polyclinique de l'Atlantique, Saint-Herblain, France.""}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Fortin', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chiffoleau', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Billaud', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ivan', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}]",Trials,['10.1186/s13063-020-04433-9']
525,32090630,Long-Term Favorable Effects of Physical Exercise on Burdensome Symptoms in the OptiTrain Breast Cancer Randomized Controlled Trial.,"Purpose:  We evaluate longitudinal changes in symptom clusters and core burdensome symptoms in breast cancer patients who participated in the OptiTrain trial.  Methods:  240 women were randomized to 16 weeks of supervised exercise (RT-HIIT or AT-HIIT) or usual care (UC) during adjuvant chemotherapy. Symptom clusters were composed using the Memorial Symptom Assessment Scale (MSAS), assessed at baseline, 16 weeks and 12 months later. Three symptom clusters were formed.  Results:  Three symptom clusters were identified: ""emotional,"" ""treatment-related toxicity,"" and ""physical,"" with core burdensome symptoms present over time. At 16 weeks, the reported burdens of ""feeling sad"" (RT-HIIT vs UC: effect size [ES] = -0.69; AT-HIIT vs UC: ES = -0.56) and ""feeling irritable"" (ES = -0.41 RT-HIIT; ES = -0.31 AT-HIIT) were significantly lower in both intervention groups compared with UC. At 12 months, the AT-HIIT group continued to have significantly lower scores for the core burdensome symptoms ""feeling sad"" (ES = -0.44), ""feeling irritable"" (ES = -0.44), and ""changes in the way food tastes"" (ES = -0.53) compared with UC. No between-group differences were found for physical symptoms.  Conclusion:  We identified 3 symptom clusters in breast cancer patients during and after adjuvant chemotherapy, composed of ""emotional,"" ""treatment-related toxicity,"" and ""physical"" symptoms. After treatment completion up to 12 months post-baseline, patients in the physical exercise groups reported lower symptom burden scores for emotional symptoms, compared with UC. Our findings indicate a preserved and long-term beneficial effect of physical exercise on self-reported emotional well-being in chemotherapy-treated breast cancer patients.",2020,"After treatment completion up to 12 months post-baseline, patients in the physical exercise groups reported lower symptom burden scores for emotional symptoms, compared with UC.","['breast cancer patients during and after adjuvant chemotherapy, composed of ""emotional,"" ""treatment-related toxicity,"" and ""physical"" symptoms', '240 women', 'chemotherapy-treated breast cancer patients', 'breast cancer patients who participated in the OptiTrain trial']","['physical exercise', 'Physical Exercise', 'supervised exercise (RT-HIIT or AT-HIIT) or usual care (UC) during adjuvant chemotherapy']","['Memorial Symptom Assessment Scale (MSAS', 'feeling irritable', 'symptom burden scores for emotional symptoms', 'Burdensome Symptoms', 'burdens of ""feeling sad"" (RT-HIIT vs UC: effect size [ES', 'physical symptoms']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",240.0,0.055644,"After treatment completion up to 12 months post-baseline, patients in the physical exercise groups reported lower symptom burden scores for emotional symptoms, compared with UC.","[{'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Wiggenraad', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Bolam', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mijwel', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elsken', 'Initials': 'E', 'LastName': 'van der Wall', 'Affiliation': 'University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Renske', 'Initials': 'R', 'LastName': 'Altena', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}]",Integrative cancer therapies,['10.1177/1534735420905003']
526,32510573,Hyperhidrosis Quality of Life Index (HidroQoL©): further validation and clinical application in patients with axillary hyperhidrosis using data from a phase III randomized controlled trial.,"BACKGROUND


The Hyperhidrosis Quality of Life Index (HidroQoL©) is a validated patient-reported outcome measure capturing the quality of life of people affected by hyperhidrosis.
OBJECTIVES


We aimed to extend the validity evidence to physician-confirmed diagnosis of primary axillary hyperhidrosis.
METHODS


Data from a phase III randomized placebo-controlled clinical trial were used (n = 171). Confirmatory factor analysis was carried out to confirm the a priori two-factor structure of the HidroQoL. Internal consistency was assessed using Cronbach's α. Intraclass correlation coefficients (ICCs) were calculated to evaluate test-retest reliability after days -7 to -4. Convergent validity was assessed using correlations with the Dermatology Life Quality Index (DLQI), the Hyperhidrosis Disease Severity Scale (HDSS) and gravimetric sweat production. Known groups were analysed to evaluate discriminative validity. Responsiveness after 29 days was assessed and minimal important difference (MID) values were calculated using both anchor- and distribution-based approaches. All analyses were carried out for total HidroQoL and its two domains.
RESULTS


The two-factor structure of the HidroQoL was confirmed. Internal consistency and test-retest reliability were strong (Cronbach's α 0·81-0·90; ICCs 0·89-0·93). Correlations with other outcome measures were in line with a priori hypotheses. The HidroQoL discriminated between different severity groups (P ≤ 0·001) and showed sensitivity to change towards improvement (P < 0·001). An MID value of 4 is proposed for the total scale.
CONCLUSIONS


This study supports excellent measurement properties including clinical applicability of the HidroQoL in primary axillary hyperhidrosis and suggests a MID of 4 be applied to clinical trial data.",2021,The HidroQoL discriminated between different severity groups (p ≤ .001) and showed sensitivity to change towards improvement (p < .001).,['patients with axillary hyperhidrosis using data from a phase III RCT'],"['HidroQoL', 'placebo']","['Dermatology Life Quality Index (DLQI), the Hyperhidrosis Disease Severity Scale (HDSS) and gravimetric sweat production', 'Internal consistency and test-retest reliability', 'Intraclass correlation coefficients (ICCs', 'minimal important difference (MID) values', 'Hyperhidrosis Quality of Life Index (HidroQoL©', 'Life Index (HidroQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",171.0,0.0777212,The HidroQoL discriminated between different severity groups (p ≤ .001) and showed sensitivity to change towards improvement (p < .001).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gabes', 'Affiliation': 'Institute of Social Medicine and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jourdan', 'Affiliation': 'FGK Clinical Research GmbH, Munich, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schramm', 'Affiliation': 'FGK Clinical Research GmbH, Munich, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Masur', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Abels', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kamudoni', 'Affiliation': 'Darmstadt, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Salek', 'Affiliation': 'School of Life and Medical Sciences, University of Hertfordshire, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Apfelbacher', 'Affiliation': 'Institute of Social Medicine and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19300']
527,32513153,The effects of integrating work-related factors and improving cooperation in musculoskeletal physical therapy practice: protocol for the 'WORK TO BE DONE' cluster randomised controlled trial.,"BACKGROUND


Musculoskeletal disorders (MSDs) are the primary cause of disability worldwide and a major societal burden. Recent qualitative research found that although a patient's work is considered important, physical therapists take work participation insufficiently into account as a determining factor in the treatment of patients with MSDs. Therefore, the aim of this study is to improve the effectiveness of physical therapy (in primary healthcare) with respect to the work participation of employees with MSDs by increasing the knowledge and skills of generalist physical therapists and by improving the collaboration between generalist physical therapists and physical therapists specialised in occupational health.
METHODS/DESIGN


This trial is a two-arm non-blinded cluster randomised controlled trial. Working patients with MSDs visiting a physical therapy practice are the target group. The control group will receive normal physical therapy treatment. The intervention group will receive treatment from a physical therapist with more knowledge about work-related factors and skills in terms of integrating work participation into the patients' care. Data are gathered at baseline (T0), at four months (T1) and eight months (T2) follow-up. Most outcomes will be assessed with validated patient-reported questionnaires. Primary outcomes are the limitations in specific work-related activities and pain during work. Secondary outcomes include limitations in general work-related activities, general pain, quality of life, presenteeism, sick leave (absenteeism), estimated risk for future work disability, work-related psychosocial risk factors, job performance, and work ability. Based on a sample size calculation we need to include 221 patients in each arm (442 in total). During data analysis, each outcome variable will be analysed independently at T1 and at T2 as a dependent variable using the study group as an independent variable. In addition to the quantitative evaluation, a process evaluation will be performed by interviewing physical therapists as well as patients.
DISCUSSION


The trial is expected to result in a more effective physical therapy process for working patients with MSDs. This will lead to a substantial reduction of costs: lower costs thanks to a more effective physical therapy process and lower costs due to less or shorter sick leave and decreased presenteeism.
TRIAL REGISTRATION


Netherlands Trial Register, registration number: NL8518, date of registration 9 April 2020, URL registration: https://www.trialregister.nl/trial/8518.",2020,"This will lead to a substantial reduction of costs: lower costs thanks to a more effective physical therapy process and lower costs due to less or shorter sick leave and decreased presenteeism.
","['working patients with MSDs', '221 patients in each arm (442 in total', 'Working patients with MSDs visiting a physical therapy practice', 'patients with MSDs']","[""physical therapist with more knowledge about work-related factors and skills in terms of integrating work participation into the patients' care"", 'normal physical therapy treatment', 'physical therapy']","['limitations in specific work-related activities and pain during work', 'limitations in general work-related activities, general pain, quality of life, presenteeism, sick leave (absenteeism), estimated risk for future work disability, work-related psychosocial risk factors, job performance, and work ability']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C3887623', 'cui_str': 'Job Performance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0831669,"This will lead to a substantial reduction of costs: lower costs thanks to a more effective physical therapy process and lower costs due to less or shorter sick leave and decreased presenteeism.
","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hutting', 'Affiliation': 'School of Organisation and Development, Research Group Occupation & Health, HAN University of Applied Sciences, P.O. Box 6960, 6503 GL, Nijmegen, The Netherlands. Nathan.Hutting@han.nl.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Oswald', 'Affiliation': 'School of Organisation and Development, Research Group Occupation & Health, HAN University of Applied Sciences, P.O. Box 6960, 6503 GL, Nijmegen, The Netherlands.'}, {'ForeName': 'Maria W G', 'Initials': 'MWG', 'LastName': 'Nijhuis-van der Sanden', 'Affiliation': 'Radboud Institute for Health Sciences, IQ healthcare, Radboud university medical centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Filart', 'Affiliation': 'School of Health, Physical Therapy, Saxion University of Applied Sciences, Enschede, The Netherlands.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Raaijmakers', 'Affiliation': 'Centre Work Health, Amersfoort, The Netherlands.'}, {'ForeName': 'Hendrik J', 'Initials': 'HJ', 'LastName': 'Bieleman', 'Affiliation': 'Saxion University of Applied Sciences, Research Group Health and Physical Activity, Enschede, The Netherlands.'}, {'ForeName': 'J Bart', 'Initials': 'JB', 'LastName': 'Staal', 'Affiliation': 'Radboud Institute for Health Sciences, IQ healthcare, Radboud university medical centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Yvonne F', 'Initials': 'YF', 'LastName': 'Heerkens', 'Affiliation': 'School of Organisation and Development, Research Group Occupation & Health, HAN University of Applied Sciences, P.O. Box 6960, 6503 GL, Nijmegen, The Netherlands.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03375-2']
528,32513424,"Glutamatergic Contribution to Probabilistic Reasoning and Jumping to Conclusions in Schizophrenia: A Double-Blind, Randomized Experimental Trial.","BACKGROUND


Impaired probabilistic reasoning and the jumping-to-conclusions reasoning bias are hallmark features of schizophrenia (SCZ), yet the neuropharmacological basis of these deficits remains unclear. Here we tested the hypothesis that glutamatergic neurotransmission specifically contributes to jumping to conclusions and impaired probabilistic reasoning in SCZ.
METHODS


A total of 192 healthy participants received either NMDA receptor agonists/antagonists (D-cycloserine/dextromethorphan), dopamine type 2 receptor agonists/antagonists (bromocriptine/haloperidol), or placebo in a randomized, double-blind, between-subjects design. In addition, we tested 32 healthy control participants matched to 32 psychotic inpatients with SCZ-a state associated with compromised probabilistic reasoning due to reduced glutamatergic neurotransmission. All experiments employed two versions of a probabilistic reasoning (beads) task, which required participants to either sample individual amounts of sensory information to infer correct decisions or provide explicit probability estimates for presented sensory information. Our task instantiations assessed both information sampling and explicit probability estimates in different probabilistic contexts (easy vs. difficult conditions) and changing sensory information through random transitions among easy, difficult, and ambiguous trial types.
RESULTS


Following administration of D-cycloserine, haloperidol, and bromocriptine, healthy participants displayed data-gathering behavior that was normal compared with placebo and was adequate in the context of all employed task conditions and trial level difficulties. However, healthy participants receiving dextromethorphan displayed a jumping-to-conclusions bias, abnormally increased probability estimates, and overweighting of sensory information. These effects were mirrored in patients with SCZ performing the same versions of the beads task.
CONCLUSIONS


Our findings provide novel neuropharmacological evidence linking reduced glutamatergic neurotransmission to impaired information sampling and to disrupted probabilistic reasoning, namely to overweighting of sensory evidence, in patients with SCZ.",2020,"However, healthy participants receiving dextromethorphan displayed a jumping-to-conclusions bias, abnormally increased probability estimates, and overweighting of sensory information.","['32 healthy control participants matched to 32 psychotic inpatients with SCZ-a state associated with compromised probabilistic reasoning due to reduced glutamatergic neurotransmission', 'Schizophrenia', '192 healthy participants', 'healthy participants receiving', 'patients with SCZ']","['probabilistic reasoning (beads) task', 'NMDA receptor agonists/antagonists (D-cycloserine/dextromethorphan), dopamine type 2 receptor agonists/antagonists (bromocriptine/haloperidol), or placebo', 'D-cycloserine, haloperidol, and bromocriptine', 'dextromethorphan', 'placebo']","['data-gathering behavior', 'probability estimates, and overweighting of sensory information']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0027793', 'cui_str': 'Synaptic transmission'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0006230', 'cui_str': 'Bromocriptine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]",192.0,0.404789,"However, healthy participants receiving dextromethorphan displayed a jumping-to-conclusions bias, abnormally increased probability estimates, and overweighting of sensory information.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany. Electronic address: wolfgang.strube@med.uni-muenchen.de.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marshall', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Quattrocchi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom; Department of Neurology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Camelia Lucia', 'Initials': 'CL', 'LastName': 'Cimpianu', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ulbrich', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schneider-Axmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics of the University Augsburg, Bezirkskrankenhaus Augsburg, University of Augsburg, Augsburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bestmann', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom; Wellcome Centre for Human Neuroimaging, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom.'}]",Biological psychiatry,['10.1016/j.biopsych.2020.03.018']
529,32515246,Novel Insights Into the Effects of Interleukin 6 Antagonism in Non-ST-Segment-Elevation Myocardial Infarction Employing the SOMAscan Proteomics Platform.,"Background Interleukin 6 concentration is associated with myocardial injury, heart failure, and mortality after myocardial infarction. In the Norwegian tocilizumab non-ST-segment-elevation myocardial infarction trial, the first randomized trial of interleukin 6 blockade in myocardial infarction, concentration of both C-reactive protein and troponin T were reduced in the active treatment arm. In this follow-up study, an aptamer-based proteomic approach was employed to discover additional plasma proteins modulated by tocilizumab treatment to gain novel insights into the effects of this therapeutic approach. Methods and Results Plasma from percutaneous coronary intervention-treated patients, 24 in the active intervention and 24 in the placebo-control arm, drawn 48 hours postrandomization were randomly selected for analysis with the SOMAscan assay. Employing slow off-rate aptamers, the relative abundance of 1074 circulating proteins was measured. Proteins identified as being significantly different between groups were subsequently measured by enzyme immunoassay in the whole trial cohort (117 patients) at all time points (days 1-3 [7 time points] and 3 and 6 months). Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration. The acute-phase proteins lipopolysaccharide-binding protein, hepcidin, and insulin-like growth factor-binding protein 4 were all reduced during the hospitalization phase, as was the monocyte chemoattractant C-C motif chemokine ligand 23. Proteinase 3, released primarily from neutrophils, was significantly elevated. Conclusions Employing the SOMAscan aptamer-based proteomics platform, 5 proteins were newly identified that are modulated by interleukin 6 antagonism and may mediate the therapeutic effects of tocilizumab in non-ST-segment-elevation myocardial infarction.",2020,"Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration.","['percutaneous coronary intervention-treated patients, 24 in the active intervention and 24 in the placebo-control arm, drawn 48\xa0hours postrandomization', 'Non-ST-Segment-Elevation Myocardial Infarction']",['tocilizumab'],"['myocardial infarction, concentration of both C-reactive protein and troponin T']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}]",5.0,0.0679143,"Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'George', 'Affiliation': 'Department of Clinical Pharmacology University College London London United Kingdom.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Kleveland', 'Affiliation': 'Clinic of Cardiology St Olavs Hospital Trondheim Norway.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Garcia-Hernandez', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Palmen', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lovering', 'Affiliation': 'Functional Gene Annotation, Preclinical and Fundamental Science Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': 'Clinic of Cardiology St Olavs Hospital Trondheim Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'K.G. Jebsen Thrombosis Research and Expertise Center University of Tromsø Tromsø Norway.'}, {'ForeName': 'Jorgen', 'Initials': 'J', 'LastName': 'Engmann', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Jan Kristian', 'Initials': 'JK', 'LastName': 'Damås', 'Affiliation': 'Centre of Molecular Inflammation Research Department of Clinical and Molecular Medicine NTNU Trondheim Norway.'}, {'ForeName': 'Aroon D', 'Initials': 'AD', 'LastName': 'Hingorani', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Institute of Clinical Medicine University of Oslo Norway.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Casas', 'Affiliation': 'Institute of Health Informatics University College London London United Kingdom.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'K.G. Jebsen Thrombosis Research and Expertise Center University of Tromsø Tromsø Norway.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015628']
530,32500519,The impact of athletic clothing style and body awareness on motor performance in women.,"The type of clothing worn, revealing versus concealing, can affect the performance of women on cognitive tasks. This difference in performance may arise because of changes in body awareness that may draw cognitive resources from the goal task. The present study investigated the influence of the style of athletic clothing and body awareness on visual-motor performance in women. Participants (women ages 18-35 years) were randomly assigned to wear tight and revealing (TR group, n = 40) or loose and concealing (LC group, n = 40) athletic clothing. All participants completed the same visual-motor aiming task to assess spatiotemporal measures of motor performance. In addition to the clothing, participants were primed to be conscious of their bodies via measurements of height, weight, and waist circumference; photographs taken of their bodies; a computerized body-size distortion task; and a mirror in the testing chamber. Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group. These differences suggest that style of clothing may influence motor performance in women by reallocating cognitive resources towards the body and away from the motor task at hand. This research highlights the interactions between cognitive and motor processes and, potentially, the importance of considering the impact of clothing on performance in many different contexts.",2020,Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group.,"['Participants (women ages 18-35 years', 'women']","['wear tight and revealing (TR group, n = 40) or loose and concealing (LC group, n = 40) athletic clothing', 'athletic clothing and body awareness', 'athletic clothing style and body awareness']","['visual-motor performance', 'movement time variability', 'motor performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",40.0,0.11005,Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Department of Psychology, Faculty of Arts & Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sabiston', 'Affiliation': 'Mental Health and Physical Activity Research Centre, Faculty of Kinesiology & Physical Education, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Karlinsky', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Manzone', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather F', 'Initials': 'HF', 'LastName': 'Neyedli', 'Affiliation': 'Kinesiology, School of Health and Human Performance, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Timothy N', 'Initials': 'TN', 'LastName': 'Welsh', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada. t.welsh@utoronto.ca.'}]",Psychonomic bulletin & review,['10.3758/s13423-020-01755-2']
531,32503392,A Pilot Study of a Videoconferencing-Based Binge Eating Disorder Program in Overweight or Obese Females.,"Background:   There has been increasing interest in using videoconferencing in health care, but limited research was conducted in Binge Eating Disorder (BED) patients. This 3-month pilot study aimed to assess the feasibility, acceptability, and preliminary efficacy of a videoconferencing (VC)-based treatment program in overweight and obese females with BED.   Methods:   Eighteen participants, aged 20-73, were diagnosed and randomized into either a face-to-face (F2F) group or a VC-based group. In the F2F group, participants received 12 one-on-one weekly counseling sessions from a Licensed Mental Health Counselor and Registered Dietitian Nutritionist. In the VC group, participants received the same counseling through an online telemedicine software. Measured outcomes include retention, adherence to treatment, and attitudinal and behavioral changes of participants.   Results:   In the end of study, of the 9 participants randomized into each group, 8 (88.9%) F2F participants and 4 (44.4%) VC participants completed the study. On average, F2F finishers attended 94.8% of sessions and completed 66.2% of dietary diaries. VC finishers attended 95.8% of sessions and completed 55.4% of diaries. No changes in weight and binge eating episode were observed in either group. F2F finishers had significant improvement on uncontrolled eating ( p  = 0.01), emotional eating ( p  = 0.004), food addiction diagnosis ( p  = 0.04), loss of control ( p  = 0.04), and clinical significance ( p  = 0.04). VC finishers observed significant improvements in eating disorder examination shape concern ( p  = 0.03) and global score ( p  = 0.03).   Conclusion:   VC-based treatment program is feasible and could be effective for BED patients. Long-term large-scale randomized clinical trials are warranted to further assess the efficacy.",2021,"F2F finishers had significant improvement on uncontrolled eating ( p  = 0.01), emotional eating ( p  = 0.004), food addiction diagnosis ( p  = 0.04), loss of control ( p  = 0.04), and clinical significance ( p  = 0.04).","['9 participants randomized into each group, 8 (88.9%) F2F participants and 4 (44.4%) VC participants completed the study', 'overweight and obese females with BED', 'Overweight or Obese Females', 'Binge Eating Disorder (BED) patients', 'Eighteen participants, aged 20-73']","['videoconferencing (VC)-based treatment program', 'Videoconferencing-Based Binge Eating Disorder Program', 'same counseling through an online telemedicine software', 'face-to-face (F2F) group or a VC-based group']","['uncontrolled eating', 'loss of control', 'retention, adherence to treatment, and attitudinal and behavioral changes of participants', 'emotional eating', 'eating disorder examination shape concern', 'global score', 'food addiction diagnosis', 'weight and binge eating episode']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",9.0,0.0653382,"F2F finishers had significant improvement on uncontrolled eating ( p  = 0.01), emotional eating ( p  = 0.004), food addiction diagnosis ( p  = 0.04), loss of control ( p  = 0.04), and clinical significance ( p  = 0.04).","[{'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Nutrition and Dietetics, University of North Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Brittnee', 'Initials': 'B', 'LastName': 'Roberts', 'Affiliation': 'Department of Nutrition and Dietetics, University of North Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Snyder', 'Affiliation': 'Department of Nutrition and Dietetics, University of North Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Stuart', 'Affiliation': 'Katie Stuart Coaching and Counseling, Jacksonville Beach, Florida, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilburn', 'Affiliation': 'Jen Wilburn Coaching and Counseling, Neptune Beach, Florida, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Pudwill', 'Affiliation': 'Balanced Nutrition of Jacksonville, Jacksonville, Florida, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Cortazzo', 'Affiliation': 'Department of Nutrition and Dietetics, University of North Florida, Jacksonville, Florida, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0070']
532,32513252,Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial.,"BACKGROUND


Intraarticular distal humeral fractures of AO/OTA type 13 C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results vary and are sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semi-constrained TEA. No studies have compared the results of EHA to that of ORIF, but case series have reported promising results.
METHODS/DESIGN


This is a study protocol describing an investigator-initiated, non-blinded randomized controlled trial comparing the outcome of EHA with ORIF for AO/OTA type 13 C2 and C3 fractures of the distal humerus in patients who are 50 years or older. Forty-four patients with AO/OTA type 13 C2 and C3 fractures of distal humerus will be randomized to either EHA or ORIF. The Oxford Elbow Score (OES) will be used as primary outcome. Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction will be used as secondary outcomes. Reoperations, complications, and the length of sick leave will be recorded. The patients will be examined after the operation and at 3 months and 1, 2, 5, and 10 years.
DISCUSSION


The main objective of this study is to investigate the best treatment option for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above. We hypothesize that EHA results in fewer complications and superior functional outcome compared with ORIF and that the mechanical complications related to the linked articulation of TEA can be avoided.
TRIAL REGISTRATION


ClinicalTrials.gov, PRS, NCT04163172. Registered November 13, 2019. https://clinicaltrials.gov/ct2/results?cond=&term=evori&cntry=&state=&city=&dist= (Table 2). The protocol has been approved by The Scientific Ethics Committee of the Capital Region of Denmark (Jr. no.: H - 19,035,590 ). The processing of personal data has been approved by the Danish Data Protection Agency (Jr. no. P-2019-246). Inclusion started on February 1, 2020.",2020,"Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction will be used as secondary outcomes.","['patients aged 50\u2009years or above', 'Forty-four patients with AO/OTA type 13 C2 and C3 fractures of distal humerus', 'patients who are 50\u2009years or older']","['internal fixation (ORIF', 'Elbow hemiarthroplasty versus open reduction and internal fixation', 'EHA or ORIF', 'EHA with ORIF', 'Total elbow arthroplasty (TEA', 'Elbow hemiarthroplasty (EHA']","['Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction', 'Reoperations, complications, and the length of sick leave', 'Oxford Elbow Score (OES']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0069299', 'cui_str': 'ochratoxin A'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0588211', 'cui_str': 'Bone structure of distal humerus'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0186781', 'cui_str': 'Total elbow replacement'}]","[{'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C2960719', 'cui_str': 'Oxford elbow score'}]",44.0,0.0605465,"Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction will be used as secondary outcomes.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Hamdani', 'Affiliation': 'Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. akhamdani@hotmail.com.'}, {'ForeName': 'Jeppe V', 'Initials': 'JV', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Holtz', 'Affiliation': 'Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bo S', 'Initials': 'BS', 'LastName': 'Olsen', 'Affiliation': 'Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-04418-8']
533,32513257,"Beta-adrenergic antagonist for the healing of chronic diabetic foot ulcers: study protocol for a prospective, randomized, double-blinded, controlled and parallel-group study.","BACKGROUND


Diabetic foot ulcers (DFUs) are the most common cause of leg amputations and their management is extremely challenging. Despite many advances and expensive therapies, there has been little success in improving outcomes of DFUs. In prior work our laboratory has examined the effects of beta-adrenergic antagonists (βAAs) on skin and skin-derived cells. We have shown that βAAs enhance the rate of keratinocyte migration, promote angiogenesis, and hasten wound healing in scratch wounds in vitro, in animal wound models, and in anecdotally reported cases of chronic wounds that healed successfully after topical application of the βAA timolol. Thus, we propose to test timolol directly on DFUs to determine if it improves healing above the current standard of care (SOC). This study will examine the efficacy and safety of topically applied beta-antagonist Timoptic-XE® (timolol maleate ophthalmic gel forming solution) in subjects with DFUs.
METHODS/DESIGN


This is a phase two, randomized, double-blinded, controlled, and parallel-group clinical trial with two treatment arms, SOC plus topical Timoptic-XE® and SOC plus a non-biologically active gel (hydrogel, as placebo drug). Study subjects with a DFU will be selected from the Veterans Affairs Northern California Health Care System (VANCHCS). Study duration is up to 31 weeks, with three phases (screening phase for two weeks, active phase for up to 12 weeks, with an additional second consecutive confirmatory visit after 2 weeks, and follow-up phase comprising monthly visits for 4 months). Subjects will apply daily either the topical study drug or the placebo on the foot ulcer for 12 weeks or until healed, whichever comes first. Measurements of wound size and other data will be collected at baseline, followed by weekly visits for 12 weeks, and then a monthly follow-up period.
DISCUSSION


This is a clinical translation study, moving the investigators' pre-clinical laboratory research into a translational study in which we will analyze clinical outcomes to assess for safety and estimate the efficacy of a topical beta-antagonist in healing of DFUs. The results from this trial may establish new treatment paradigms and safety profile for DFU treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03282981. Registered on June 14th, 2018.",2020,"Subjects will apply daily either the topical study drug or the placebo on the foot ulcer for 12 weeks or until healed, whichever comes first.","['subjects with DFUs', 'chronic diabetic foot ulcers', 'Diabetic foot ulcers (DFUs', 'Study subjects with a DFU will be selected from the Veterans Affairs Northern California Health Care System (VANCHCS']","['Beta-adrenergic antagonist', 'beta-antagonist Timoptic-XE® (timolol maleate ophthalmic gel forming solution', 'βAA timolol', 'SOC plus topical Timoptic-XE® and SOC plus a non-biologically active gel (hydrogel, as placebo', 'timolol', 'topical beta-antagonist', 'placebo']","['efficacy and safety', 'healing above the current standard of care (SOC']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0040235', 'cui_str': 'Timoptic'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}, {'cui': 'C0991531', 'cui_str': 'Eye gel'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",,0.264798,"Subjects will apply daily either the topical study drug or the placebo on the foot ulcer for 12 weeks or until healed, whichever comes first.","[{'ForeName': 'Ramanjot', 'Initials': 'R', 'LastName': 'Kaur', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tchanque-Fossuo', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'West', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Hadian', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gallegos', 'Affiliation': 'Department of Dermatology, UC Davis Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Yoon', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Ligia', 'Initials': 'L', 'LastName': 'Ismailyan', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Schaefer', 'Affiliation': 'Department of Internal Medicine, UC Davis Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Dahle', 'Affiliation': 'Department of Dermatology, UC Davis Medical Center, Sacramento, CA, USA. sara.dahle@va.gov.'}, {'ForeName': 'R Rivkah', 'Initials': 'RR', 'LastName': 'Isseroff', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA. rrisseroff@ucdavis.edu.'}]",Trials,['10.1186/s13063-020-04413-z']
534,32513260,Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial.,"BACKGROUND


A wound that does not heal in the orderly stages of the healing process or does not heal within 3 months is considered a chronic wound. Wound healing is impaired when the wound remains in the inflammatory stage for too long. A range of factors can delay the healing process: imbalance between proteases and protease inhibitors in the wound bed; bacterial colonization and the presence of biofilm; and oxidative stress. Recently, wound management has improved significantly. A new antioxidant dressing has been developed, which combines an absorbent matrix obtained from locust bean gum galactomannan and a hydration solution with curcumin and N-acetylcysteine. This dressing combines the advantages of moist healing in exudate management and free radical neutralization, achieving wound reactivation. The primary aim of this study is to compare the effect of the antioxidant dressing on chronic wound healing against the use of a standard wound dressing in patients with hard-to-heal wounds.
METHODS


We will conduct a multicentre, single-blind, randomized controlled trial with parallel groups. Participants will be selected from three primary public health care centres located in Andalucía (southern Spain). Patients will be randomized into an intervention group (antioxidant dressing) or a control group (standard wound dressing). Assessments will be carried out at weeks 2, 4, 6 and 8. Follow-up will be for a period of 8 weeks or until complete healing if this occurs earlier.
DISCUSSION


The findings from this study should provide scientific evidence on the efficacy of the antioxidant dressing as an alternative for the treatment of chronic wounds. This study fills some of the gaps in the existing knowledge about patients with hard-to-heal wounds.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03934671. Registered on 2 May 2019.",2020,"A new antioxidant dressing has been developed, which combines an absorbent matrix obtained from locust bean gum galactomannan and a hydration solution with curcumin and N-acetylcysteine.","['Participants will be selected from three primary public health care centres located in Andalucía (southern Spain', 'patients with hard-to-heal wounds']","['antioxidant dressing', 'standard wound dressing', 'Antioxidant dressing therapy', 'intervention group (antioxidant dressing) or a control group (standard wound dressing']",['Wound healing'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",,0.119934,"A new antioxidant dressing has been developed, which combines an absorbent matrix obtained from locust bean gum galactomannan and a hydration solution with curcumin and N-acetylcysteine.","[{'ForeName': 'Inés María', 'Initials': 'IM', 'LastName': 'Comino-Sanz', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Las Lagunillas S/N, 23071, Jaén, Spain. icomino@ujaen.es.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'López-Franco', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Las Lagunillas S/N, 23071, Jaén, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Castro', 'Affiliation': 'Histocell S.L., Bizkaia Science and Technology Park, Derio, Bizkaia, Spain.'}, {'ForeName': 'Pedro Luis', 'Initials': 'PL', 'LastName': 'Pancorbo-Hidalgo', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Las Lagunillas S/N, 23071, Jaén, Spain.'}]",Trials,['10.1186/s13063-020-04445-5']
535,31450987,Direct anterior versus posterolateral approach for bipolar hip hemiarthroplasty in femoral neck fractures: a prospective randomised study.,"INTRODUCTION


Femoral neck fractures are a major problem in orthopaedic practice, having a huge impact on society, and involving a large number of elderly patients for whom early recovery is paramount. Thus, the aim of this study was to compare 2 surgical approaches, direct anterior (DA group) versus posterolateral (PL group), used for bipolar hip hemiarthroplasty (BHA) with femoral neck fractures in order to assess pain recovery after surgery. Our hypothesis was that early pain recovery would be faster in the DA group.
METHODS


100 patients were randomised to surgery using either a DA group or PL group approach, and were then followed up for 6 months. Surgical time, intra- and postoperative complications were recorded for each patient. The main outcome, pain, was recorded using an NRS scale at 3 days, 1, 3 and 6 months after surgery. At the same time, patient status was evaluated using Activities of Daily Living and Cumulated Ambulation Score scales.
RESULTS


Surgical time was longer in the DA group ( p   <  0.0001). Pain perception at 3 days and at 1 month after surgery was significantly lower in DA group patients ( p   <  0.0001). The results of the other scales were comparable in the 2 groups (at 3 days, 1 and 3 months after surgery).
DISCUSSION


The DA approach offers a significant advantage in terms of pain perception up to 1 month after the operation. Early recovery in terms of pain perception is an important finding. Future studies should explore whether this early pain reduction could translate into a faster rehabilitation programme for an earlier recovery of full function.Clinical trial registration: Protocol 423/CE; Study n. CE 41/15.",2020,"The results of the other scales were comparable in the 2 groups (at 3 days, 1 and 3 months after surgery).
","['100 patients', 'bipolar hip hemiarthroplasty in femoral neck fractures']","['DA group or PL group approach', 'bipolar hip hemiarthroplasty (BHA) with femoral neck fractures', 'direct anterior (DA group) versus posterolateral (PL group', 'Direct anterior versus posterolateral approach']","['pain', 'pain perception', 'Activities of Daily Living and Cumulated Ambulation Score scales', 'Surgical time, intra- and postoperative complications', 'pain recovery', 'Surgical time', 'Pain perception']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C1112760', 'cui_str': 'Hip hemiarthroplasty'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C1112760', 'cui_str': 'Hip hemiarthroplasty'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral (qualifier value)'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",100.0,0.0508432,"The results of the other scales were comparable in the 2 groups (at 3 days, 1 and 3 months after surgery).
","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Verzellotti', 'Affiliation': 'Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Candrian', 'Affiliation': 'Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Molina', 'Affiliation': 'Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Filardo', 'Affiliation': 'Laboratory NABI, Orthopedic Institute Rizzoli, Bologna, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Alberio', 'Affiliation': 'University Hospital Maggiore della Carita, Novara, Italy.'}, {'ForeName': 'Federico A', 'Initials': 'FA', 'LastName': 'Grassi', 'Affiliation': 'University Hospital Maggiore della Carita, Novara, Italy.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019872117']
536,32438407,Thrombosis in patients with myeloma treated in the Myeloma IX and Myeloma XI phase 3 randomized controlled trials.,"Newly diagnosed multiple myeloma (NDMM) patients treated with immunomodulatory drugs are at high risk of venous thromboembolism (VTE), but data are lacking from large prospective cohorts. We present thrombosis outcome data from Myeloma IX (n = 1936) and Myeloma XI (n = 4358) phase 3 randomized controlled trials for NDMM that treated transplant-eligible and transplant-ineligible patients before and after publication of thrombosis prevention guidelines. In Myeloma IX, transplant-eligible patients randomly assigned to cyclophosphamide, vincristine, doxorubicin, and dexamethasone (CVAD) induction had higher risk of VTE compared with patients treated with cyclophosphamide, thalidomide, and dexamethasone (CTD) (22.5% [n = 121 of 538] vs 16.1% [n = 89 of 554]; adjusted hazard ratio [aHR],1.46; 95% confidence interval [95% CI], 1.11-1.93). For transplant-ineligible patients, those randomly assigned to attenuated CTD (CTDa) induction had a higher risk of VTE compared with those treated with melphalan and prednisolone (MP) (16.0% [n = 68 of 425] vs 4.1% [n = 17 of 419]; aHR, 4.25; 95% CI, 2.50-7.20). In Myeloma XI, there was no difference in risk of VTE (12.2% [n = 124 of 1014] vs 13.2% [n = 133 of 1008]; aHR, 0.92; 95% CI, 0.72-1.18) or arterial thrombosis (1.2% [n = 12 of 1014] vs 1.5% [n = 15 of 1008]; aHR, 0.80; 95% CI, 0.37-1.70) between transplant-eligible pathways for patients treated with cyclophosphamide, lenalidomide, and dexamethasone (CRD) or CTD. For transplant-ineligible patients, there was no difference in VTEs between attenuated CRD (CRDa) and CTDa (10.4% [n = 95 of 916] vs 10.7% [n = 97 of 910]; aHR, 0.97; 95% CI, 0.73-1.29). However, arterial risk was higher with CRDa than with CTDa (3.1% [n = 28 of 916] vs 1.6% [n = 15 of 910]; aHR, 1.91; 95% CI, 1.02-3.57). Thrombotic events occurred almost entirely within 6 months of treatment initiation. Thrombosis was not associated with inferior progression-free survival (PFS) or overall survival (OS), apart from inferior OS for patients with arterial events (aHR, 1.53; 95% CI, 1.12-2.08) in Myeloma XI. The Myeloma XI trial protocol incorporated International Myeloma Working Group (IMWG) thrombosis prevention recommendations and compared with Myeloma IX, more patients received thromboprophylaxis (80.5% vs 22.3%) with lower rates of VTE for identical regimens (CTD, 13.2% vs 16.1%; CTDa, 10.7% vs 16.0%). However, thrombosis remained frequent in spite of IMWG-guided thromboprophylaxis, suggesting that new approaches are needed.",2020,"Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI.","['Patients with Myeloma Treated in the Myeloma IX and Myeloma XI', 'Newly diagnosed multiple myeloma (NDMM) patients treated with', 'Myeloma IX (n=1936) and Myeloma XI (n=4358), phase III randomized controlled trials for NDMM, treating transplant-eligible and ineligible patients before and after publication of thrombosis prevention guidelines']","['immunomodulatory drugs (IMiDs', 'CRD (cyclophosphamide, lenalidomide and dexamethasone', 'CVAD induction (cyclophosphamide, vincristine, doxorubicin and dexamethasone', 'MP (melphalan and prednisolone', 'CTD (cyclophosphamide, thalidomide and dexamethasone']","['Thrombosis', 'arterial risk', 'VTE rates', 'Thrombotic events', 'inferior progression-free or overall survival (OS', 'VTE or arterial thrombosis risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0082139', 'cui_str': 'CVAD protocol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}]","[{'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}]",,0.147899,"Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI.","[{'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Bradbury', 'Affiliation': 'School of Translational Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Craig', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hockaday', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paterson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Jones', 'Affiliation': 'Kings College Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology, School of Immunity and Infection, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, New York University Langone Health, New York, NY; and.'}, {'ForeName': 'J Anthony', 'Initials': 'JA', 'LastName': 'Child', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, New York University Langone Health, New York, NY; and.'}, {'ForeName': 'Graham H', 'Initials': 'GH', 'LastName': 'Jackson', 'Affiliation': 'Freeman Hospital, University of Newcastle, Newcastle Upon Tyne, United Kingdom.'}]",Blood,['10.1182/blood.2020005125']
537,32513307,Implementation and evaluation of a nurse-led decision-coaching program for healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers: a study protocol for the randomized controlled EDCP-BRCA study.,"BACKGROUND


Female BRCA mutation carriers have an increased lifetime risk for breast and ovarian cancer compared to the general population. Women who carry this mutation have several options to deal with their cancer risk, such as risk-reducing surgeries or intensified breast cancer screening. Previous research has shown that preferences in this scenario are highly dependent on affected women's personalities and value systems. To support these women in the decision-making process, a structured decision support consisting of decision coaching combined with a decision aid might be helpful.
METHODS/DESIGN


A randomized controlled trial will be conducted in order to compare usual care with structured decision support alongside usual care. The decision support program entails nurse-led decision coaching as well as an evidence-based patient decision aid. Nurses are qualified by a 4-day training program in informed decision-making and decision coaching. Six centers for Familial Breast and Ovarian Cancer in Germany will be included in the study, with a planned sample size of 398 women. The primary outcome is the congruence between the preferred and the actual played role in the decision-making process as measured by the Control Preferences Scale. It is hypothesized that the structured decision support will enable women to play the preferred role in the decision-making process. Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept. A process evaluation will accompany the study.
DISCUSSION


The EDCP-BRCA study is the first study to implement and evaluate decision coaching combined with a decision aid for healthy BRCA mutation carriers worldwide. TRIAL REGISTRATION {2A}: DRKS-ID: DRKS00015527. Registered 30 October 2019.",2020,"Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept.","['398 women', 'healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers']","['usual care with structured decision support alongside usual care', 'nurse-led decision-coaching program']","['knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept', 'congruence between the preferred and the actual played role in the decision-making process as measured by the Control Preferences Scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0646838,"Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Isselhard', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany. anna.isselhard@uk-koeln.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Töpper', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Berger-Höger', 'Affiliation': 'Institute for Health and Nursing Science, Faculty of Medicine, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Steckelberg', 'Affiliation': 'Institute for Health and Nursing Science, Faculty of Medicine, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychosomatics and Psychotherapy, Faculty of Medicine, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vitinius', 'Affiliation': 'Department of Psychosomatics and Psychotherapy, Faculty of Medicine, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Beifus', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Köberlein-Neu', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wiedemann', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rhiem', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schmutzler', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stock', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany.'}]",Trials,['10.1186/s13063-020-04431-x']
538,32686502,Bone mineralisation adjacent to cemented and uncemented acetabular cups: analysis by [18F]-fluoride-PET in a randomised clinical trial.,"PURPOSE


We present a randomised clinical trial using F-PET/CT to analyse new bone metabolic mineralisation adjacent to acetabular cups following total hip arthoplasty (THA).
PATIENTS AND METHODS


THA was performed on 26 patients (26 cases) with hip OA. Patients with hip osteoarthritis (OA) were randomly assigned to operations with cemented or uncemented acetabular components. The contralateral, healthy acetabulum was used as referent for normal bone metabolism. The patients were analysed with radiography, clinical scoring, and F-PET/CT preoperatively, and at 6 weeks and 6 months postoperatively.
RESULTS


No major complications were recorded, and clinical results were good in all patients. Radiography showed all cups to be stable. The bone-forming activity, as measured by F-PET/CT, was quantified as standardised uptake values (SUV). The mean SUV was 4.6 (6 weeks) and 3.5 (6 months) around the uncemented cups, and 4.8 and 4.0, respectively, for the cemented cups. Normal healthy bone metabolism in the referent was 2.8 and 2.7 SUV at 6 weeks and 6 months, respectively.  P  < 0.01 for the cemented group at 6 weeks and 6 months, for the uncemented group only at 6 weeks.
INTERPRETATION


An acetabulum affected by OA has elevated SUV activity. Both cemented and uncemented cups had elevated bone metabolic activity at 6 weeks. The raised activity was interpreted as an effect from bone mineralisation secondary to surgical trauma and healing, and to the OA. At 6 months, activity was more normalised for the uncemented group than for the cemented, suggesting healing may terminate faster in the uncemented group. Postoperative bone metabolic activity can be analysed in detail by F-PET/CT.ClinicalTrials.gov Identifier: NCT01623687.",2020,"P  < 0.01 for the cemented group at 6 weeks and 6 months, for the uncemented group only at 6 weeks.
","['total hip arthoplasty (THA', '26 patients (26 cases) with hip OA', 'Patients with hip osteoarthritis (OA']","['Bone mineralisation adjacent to cemented and uncemented acetabular cups: analysis by [18F]-fluoride-PET', 'Radiography', 'operations with cemented or uncemented acetabular components', 'F-PET/CT']","['elevated SUV activity', 'Normal healthy bone metabolism', 'elevated bone metabolic activity', 'Postoperative bone metabolic activity', 'activity', 'mean SUV']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",26.0,0.0403775,"P  < 0.01 for the cemented group at 6 weeks and 6 months, for the uncemented group only at 6 weeks.
","[{'ForeName': 'Gösta', 'Initials': 'G', 'LastName': 'Ullmark', 'Affiliation': '¹Department of Orthopaedics, Gävle Hospital, Gävle, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sörensen', 'Affiliation': 'Department of Nuclear Medicine, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Nilsson', 'Affiliation': 'Department of Orthopaedics, Uppsala University Hospital, Sweden.'}, {'ForeName': 'Enn', 'Initials': 'E', 'LastName': 'Maripuu', 'Affiliation': 'Department of Nuclear Medicine, Uppsala University Hospital, Uppsala, Sweden.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019861274']
539,32004567,Apremilast in Combination with Narrowband UVB in the Treatment of Vitiligo: A 52-Week Monocentric Prospective Randomized Placebo-Controlled Study.,"BACKGROUND


Scientific rationale and encouraging first clinical results suggest the interest of using apremilast for treating vitiligo.
OBJECTIVE


This study aimed to compare the efficacy of apremilast in combination therapy with narrowband (NB)-UVB versus placebo and NB-UVB treatment for repigmentation in patients with nonsegmental vitiligo.
DESIGN


This was a 52-week prospective randomized placebo-controlled study.
PARTICIPANTS


Adult patients with vitiligo participated.
INTERVENTIONS


Group A received, in addition to phototherapy, apremilast at the label dosage, and group B received placebo. After 24 weeks, patients who responded (decreased Vitiligo Area Scoring Index >30%) were rerandomized to receive apremilast or placebo, combined with twice-weekly NB-UVB for 24 additional weeks. Main outcome and measure: The primary outcome measure was the comparison between the two groups of the Vitiligo Area Scoring Index score at 24 weeks.
RESULTS


Eighty patients were randomized (40 in each group). After 24 weeks, the mean Vitiligo Area Scoring Index score decreased from 23.63 to 19.49 (P = 0.011) in the apremilast + UVB group and from 21.57 to 15.25 (P < 0.0001) in the placebo + UVB group. The difference between the two groups was not statistically significant (P = 0.18). No statistically significant differences were observed between the two groups after an additional 24 weeks of treatment.
CONCLUSIONS AND RELEVANCE


Apremilast does not bring any benefit to NB-UVB for treating vitiligo.",2020,"After 24 weeks, the mean VASI score decreased from 23.63 to 19.49 (p=0.011) in apremilast+UVB group and from 21.57 to 15.25 (p<0.0001) in the placebo+UVB group.","['80 patients', 'After 24 weeks, patients who responded (decreased VASI>30', 'Adult patients with vitiligo', 'patients with non-segmental vitiligo']","['narrowband UVB', 'apremilast or placebo', 'narrowband (NB)-UVB versus placebo and NB-UVB treatment', 'placebo', 'placebo+UVB']","['VASI score', 'mean VASI score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}]","[{'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",80.0,0.280086,"After 24 weeks, the mean VASI score decreased from 23.63 to 19.49 (p=0.011) in apremilast+UVB group and from 21.57 to 15.25 (p<0.0001) in the placebo+UVB group.","[{'ForeName': 'Abdallah', 'Initials': 'A', 'LastName': 'Khemis', 'Affiliation': ""Department of Dermatology, University Hospital Center of Nice, University of Côte d'Azur, Nice, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': ""Department of Research and Innovation, University Hospital Center of Nice, University of Côte d'Azur, Nice, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Moulin', 'Affiliation': ""Department of Dermatology, University Hospital Center of Nice, University of Côte d'Azur, Nice, France.""}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Montaudié', 'Affiliation': ""Department of Dermatology, University Hospital Center of Nice, University of Côte d'Azur, Nice, France; Université Côte d'Azur, INSERM U1065, Team 12, C3M, Nice, France.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Department of Dermatology, University Hospital Center of Nice, University of Côte d'Azur, Nice, France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Department of Dermatology, University Hospital Center of Nice, University of Côte d'Azur, Nice, France; Université Côte d'Azur, INSERM U1065, Team 12, C3M, Nice, France. Electronic address: passeron@unice.fr.""}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.11.031']
540,32513291,"A group- and smartphone-based psychological intervention to increase and maintain physical activity in patients with musculoskeletal conditions: study protocol for a randomized controlled trial (""MoVo-App"").","BACKGROUND


Interventions designed to increase the level of physical activity are crucial in the treatment of patients with musculoskeletal conditions. The psychological group-based intervention MoVo-LISA based on the Motivation-Volition (MoVo) Process Model has been shown to effectively promote physical activity. The aim of this study is to evaluate whether a MoVo-based app (MoVo-App) subsequent to MoVo-LISA during orthopedic inpatient care can support people to increase and maintain their amount of physical activity.
METHODS/DESIGN


In this parallel-group randomized controlled trial, patients with musculoskeletal disorders will be randomized to either (a) a combination of the group-based intervention program MoVo-LISA to promote physical activity plus the MoVo-App or (b) the group-based intervention program alone without the app. The intervention group will receive the MoVo-App after discharge from inpatient rehabilitation. They receive help to increase and maintain their level of physical activity (initiated by the group program) by tracking their health goals, activity plans, major barriers, and barrier management that were developed during the group-based program. We will recruit 224 initially minimally active participants during orthopedic rehabilitation care. Outcomes are assessed at clinic admission; discharge; 6 weeks; and 3 (post-treatment), 6, and 12 months after discharge (follow-up). The primary outcome is sport activity (active/inactive and minutes of activity) at 6-month follow-up. Secondary outcomes are movement activity, cognitive mediators of behavioral change (e.g., self-efficacy, action planning), and health-related variables (e.g., pain intensity, depression). To evaluate intervention effects, linear mixed effects models (both on intention-to-treat basis with an additional per-protocol analysis) will be conducted with each outcome variable and with time as the within-subjects factor and group as the between-subjects factor, along with all two-way interactions and accounting for covariates as fixed effects.
DISCUSSION


This is the first evaluation of the effectiveness of an app in combination with a face-to-face group intervention to promote physical activity. The approach of using an app in addition to an effective face-to-face intervention program, both based on the MoVo model, might sustain positive intervention effects introduced in routine health care.
TRIAL REGISTRATION


The trial ""A group- and smartphone-based psychological intervention to increase physical activity in patients with musculoskeletal conditions: A randomized controlled trial"" is registered at the World Health Organization International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS), DRKS00014814. Registered on 18 October 2018; URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014814.",2020,The psychological group-based intervention MoVo-LISA based on the Motivation-Volition (MoVo) Process Model has been shown to effectively promote physical activity.,"['patients with musculoskeletal disorders', '224 initially minimally active participants during orthopedic rehabilitation care', 'patients with musculoskeletal conditions']","['smartphone-based psychological intervention', 'MoVo-based app (MoVo-App) subsequent to MoVo-LISA', 'intervention program MoVo-LISA to promote physical activity plus the MoVo-App or (b) the group-based intervention program alone without the app']","['sport activity (active/inactive and minutes of activity', 'physical activity', 'movement activity, cognitive mediators of behavioral change (e.g., self-efficacy, action planning), and health-related variables (e.g., pain intensity, depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",224.0,0.0913607,The psychological group-based intervention MoVo-LISA based on the Motivation-Volition (MoVo) Process Model has been shown to effectively promote physical activity.,"[{'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry and Psychotherapy Medical Center, Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Wurst', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Paganini', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany. sarah.paganini@sport.uni-freiburg.de.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Hohberg', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kinkel', 'Affiliation': 'Schwarzwaldkliniken Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Göhner', 'Affiliation': 'Department of Health Psychology, Catholic University of Applied Sciences, Freiburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ramsenthaler', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}]",Trials,['10.1186/s13063-020-04438-4']
541,32513294,Prednisolone versus placebo addition in the treatment of patients with recent-onset psychotic disorder: a trial design.,"BACKGROUND


The symptom severity of a substantial group of schizophrenia patients (30-40%) does not improve through pharmacotherapy with antipsychotic medication, indicating a clear need for new treatment options to improve schizophrenia outcome. Meta-analyses, genetic studies, randomized controlled trials, and post-mortem studies suggest that immune dysregulation plays a role in the pathophysiology of schizophrenia. Some anti-inflammatory drugs have shown beneficial effects on the symptom severity of schizophrenia patients. Corticosteroids are effective in various chronic inflammatory and autoimmune disorders. Prednisolone, a potent glucocorticosteroid, has minor mineral-corticosteroid potencies and can adequately pass the blood-brain barrier and its side effects and safety profile are well known. Therefore, the effect of prednisolone can be studied as a proof of concept for immune modulation as a treatment for schizophrenia.
METHODS/DESIGN


In total, 90 subjects aged 18-70 years and diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder (Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) 295.x) or psychosis not otherwise specified (NOS; 298.9) will be included. The time interval between the onset of psychosis and study entry should not exceed 7 years. Patients will be randomized 1:1 to either prednisolone or placebo daily for a period of 6 weeks in addition to a stable dose of antipsychotic medication. Study medication will be initiated at 40 mg for 3 days, after which it will be tapered down within 6 weeks after initiation, following inflammatory bowel diseases treatment guidelines. Primary outcome is change in symptom severity, expressed as change in total score on the Positive and Negative Symptom Scale (PANSS) from baseline to end of treatment. Cognitive functioning (measured through the Brief Assessment of Cognition in Schizophrenia (BACS)) and change in Global Assessment Functioning (GAF) and depressive symptoms as measured with the Calgary Depression Scale for Schizophrenia (CDS) will be assessed, in addition to various immunological biomarkers. Secondary outcomes are a 4- and 6-month follow-up assessment of PANSS, BACS, and GAF scores and immunological biomarkers. Additionally, a subgroup of patients will be included in the magnetic resonance imaging (MRI) part of the study where MR spectroscopy and structural, functional, and diffusion MRI will be conducted.
DISCUSSION


It is expected that prednisolone addition to current antipsychotic medication use will reduce symptom severity and will improve cognition when compared to placebo.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02949232 and NCT03340909. Registered 31 October 2016 and 14 November 2017. EudraCT-number 2014-000520-14 and 2017-000163-32.",2020,"Cognitive functioning (measured through the Brief Assessment of Cognition in Schizophrenia (BACS)) and change in Global Assessment Functioning (GAF) and depressive symptoms as measured with the Calgary Depression Scale for Schizophrenia (CDS) will be assessed, in addition to various immunological biomarkers.","['patients with recent-onset psychotic disorder', 'schizophrenia patients', 'Registered 31 October 2016\xa0and 14 November 2017', '90 subjects aged 18-70\u2009years and diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder (Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) 295.x) or psychosis not otherwise specified (NOS; 298.9']","['Corticosteroids', 'Prednisolone', 'prednisolone or placebo', 'prednisolone', 'antipsychotic medication', 'placebo']","['4- and 6-month follow-up assessment of PANSS, BACS, and GAF scores and immunological biomarkers', 'Calgary Depression Scale for Schizophrenia (CDS', 'Cognition in Schizophrenia (BACS)) and change in Global Assessment Functioning (GAF) and depressive symptoms', 'Cognitive functioning', 'change in symptom severity, expressed as change in total score on the Positive and Negative Symptom Scale (PANSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0036358', 'cui_str': 'Schizophreniform disorder'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",90.0,0.285186,"Cognitive functioning (measured through the Brief Assessment of Cognition in Schizophrenia (BACS)) and change in Global Assessment Functioning (GAF) and depressive symptoms as measured with the Calgary Depression Scale for Schizophrenia (CDS) will be assessed, in addition to various immunological biomarkers.","[{'ForeName': 'Lyliana G', 'Initials': 'LG', 'LastName': 'Nasib', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Lnasib@umcutrecht.nl.'}, {'ForeName': 'Iris E', 'Initials': 'IE', 'LastName': 'Sommer', 'Affiliation': 'Cognitive Neurosciences, Department of Biomedical Sciences of Cells & Systems, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Winter-van Rossum', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'de Vries', 'Affiliation': ""Reinier van Arkel, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'Shiral S', 'Initials': 'SS', 'LastName': 'Gangadin', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Priscilla P', 'Initials': 'PP', 'LastName': 'Oomen', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Gurmeet', 'Initials': 'G', 'LastName': 'Judge', 'Affiliation': 'GGZ Delfland, Delft, The Netherlands.'}, {'ForeName': 'Renske E', 'Initials': 'RE', 'LastName': 'Blom', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jurjen J', 'Initials': 'JJ', 'LastName': 'Luykx', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Nico J M', 'Initials': 'NJM', 'LastName': 'van Beveren', 'Affiliation': 'Antes Center for Mental Health Care, Rotterdam, The Netherlands.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Veen', 'Affiliation': 'GGZ Delfland, Delft, The Netherlands.'}, {'ForeName': 'Rune A', 'Initials': 'RA', 'LastName': 'Kroken', 'Affiliation': 'Norment, Division of Psychiatry, Haukeland University Hospital, Jonas Lies vei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Erik L', 'Initials': 'EL', 'LastName': 'Johnsen', 'Affiliation': 'Norment, Division of Psychiatry, Haukeland University Hospital, Jonas Lies vei 65, 5021, Bergen, Norway.'}]",Trials,['10.1186/s13063-020-04365-4']
542,32514830,Handheld robotic needle holder training: slower but better.,"BACKGROUND


Handheld robotic laparoscopic instruments fill the gap between robotic and conventional instruments, combining the advantages of degrees of freedom and low price. The difficulty and value in learning these new instruments require detailed investigation.
METHODS


Forty novice surgeons with no laparoscopic experience were randomly assigned to two groups: conventional instrument group (Group Conv) and robotic instrument group (Group Rob). The same training protocol was used in both groups: after viewing a standard operation film, laparoscopic suture training was administered using the corresponding instruments. After each training period, surgeons were tested using a force-sensing test platform. Maximum force (MF) and impulse (IMP) of operators through each ring were recorded. Learning curves based on MF and IMP for both instruments were compared. Institutional review board approval is not needed for this study.
RESULTS


MF and IMP of both groups decreased with increased training time; the learning curve of Group Conv decreased faster than that of Group Rob. When training time reached 13 h, the MF of Group Rob was significantly lower than that of Group Conv (P < 0.05), while IMP showed no significant difference between the two groups.
CONCLUSIONS


Effective training reduces operator MF and IMP, possibly decreasing damage to tissues with both conventional and handheld robotic needle holders. Group Rob took longer to reach a plateau, but subsequently had lower suture tension than did Group Conv. MF is more sensitive than IMP for measuring performance progress.",2021,"CONCLUSIONS


Effective training reduces operator MF and IMP, possibly decreasing damage to tissues with both conventional and handheld robotic needle holders.",['Forty novice surgeons with no laparoscopic experience'],"['laparoscopic suture training', 'conventional instrument group (Group Conv) and robotic instrument group (Group Rob', 'Handheld robotic needle holder training']","['MF of Group Rob', 'suture tension', 'training time; the learning curve', 'Maximum force (MF) and impulse (IMP']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0181952', 'cui_str': 'Needle holder'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}]",,0.0168976,"CONCLUSIONS


Effective training reduces operator MF and IMP, possibly decreasing damage to tissues with both conventional and handheld robotic needle holders.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Robotics and System, Harbin Institute of Technology, No. 92, Xidazhi Street, Nangang District, Harbin, 150000, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China.'}, {'ForeName': 'XiaoJia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China.'}, {'ForeName': 'Zhijiang', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Robotics and System, Harbin Institute of Technology, No. 92, Xidazhi Street, Nangang District, Harbin, 150000, China. Duzj01@hit.edu.cn.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China. jesuisking198411@hotmail.com.'}]",Surgical endoscopy,['10.1007/s00464-020-07550-3']
543,32506558,Telephone-based motivational interviewing enhanced with individualised personality-specific coping skills training for young people with alcohol-related injuries and illnesses accessing emergency or rest/recovery services: a randomized controlled trial (QuikFix).,"BACKGROUND AND AIMS


Recent meta-analyses of motivational interviewing (MI) for reducing risky alcohol use in young people have reported modest effects. Few studies have targeted individual patient factors to increase MI effectiveness. This study determined if MI enhanced with individualised personality-specific coping skills training (QuikFix) was more efficacious than standard MI or an assessment feedback/information (AF/I) control among young people with alcohol-related injuries or illnesses.
DESIGN AND SETTING


Single-centre, single-blind, three-group superiority randomized controlled trial with 1-, 3-, 6- and 12-months follow-ups. Telephone intervention, Brisbane, Australia.
PARTICIPANTS


A total of 398 young people (16-25 years; M age = 20.30 years, SD = 2.12; 54% female) with alcohol-related injuries and/or illnesses were recruited from an emergency department (ED) or rest/recovery service (RRS).
MEASURES


The primary outcome was total standard (10 g ethanol) drinks in the past month (Timeline Follow back [TLFB]) at 12 months (primary time point). Secondary outcomes were total drinking days and standard drinks per drinking day (TLFB) in the past month and the frequency of alcohol-related problems in the past 3 months (Rutgers Alcohol Problem Index).
INTERVENTIONS


Young people were randomized to two sessions of QuikFix enhanced with individualised personality-specific coping skills training (n = 132), two sessions of MI (n = 136) or one session of AF/I (n = 130), all delivered by telehealth.
FINDINGS


QuikFix resulted in greater reductions (all P < 0.0017) in the primary outcome of total standard drinks (M = 19.50, CI 99.75% = [11.31, 27.68]) than both MI (M = 32.61, CI 99.75% = [24.82, 40.40]; Cohen's D = 0.40) and AF/I (M = 34.12, CI 99.75% = [26.59, 41.65]; D = 0.45) at 12 months (retention n = 324/398, 81%). QuikFix had greater reductions on drinking days (M = 3.16, CI 99.75% = [2.37, 3.96]) than both MI (M = 4.53, CI 99.75% = [3.57, 5.48];D = 0.38) and AF/I (M = 4.69, CI 99.75% = [3.73, 5.65];D = 0.42) and fewer drinks per drinking day (M = 5.02, CI 99.75% = [3.71, 6.33]) than AF/I (M = 7.15, CI 99.75% = [5.93, 8.38;D = 0.47) at 12 months.
CONCLUSIONS


Young people with alcohol-related injuries and/or illnesses who attended ED and rest/recovery services and received an individualised personality-specific coping skills training intervention (QuikFix) had greater reductions in the amount of alcohol consumed at 12 months compared with those who received motivational interviewing or an assessment feedback/information intervention.",2021,"FINDINGS


QuikFix resulted in greater reductions (all p< 0.0017) in the primary outcome of total standard drinks (M=19.50, CI 99.75%=[11.31-27.68]) than both MI (M=32.61, CI 99.75%=[24.82-40.40];Cohen's D=0.40) and AF/I (M=34.12, CI 99.75%=[26.59-41.65];D=0.45) at 12 months (retention n=324/398, 81%).","['young people with alcohol-related injuries or illnesses', 'Young people with alcohol-related injuries and/or illnesses who attended emergency department and rest/recovery services', 'Young people', '398 young people (16-25 years; Mage=20.30 years, SD=2.12; 54% female) with alcohol-related injuries and/or illnesses were recruited from an emergency department (ED) or rest/recovery service (RRS', 'young people with alcohol-related injuries and illnesses accessing emergency or rest/recovery services']","['individualised personality-specific coping skills training intervention (QuikFix', 'motivational interviewing or an assessment feedback/information intervention', 'motivational interviewing (MI', 'Telephone-based motivational interviewing enhanced with individualised personality-specific coping skills training', 'MI enhanced with individualised personality-specific coping skills training (QuikFix', 'QuikFix enhanced with individualised personality-specific coping skills training']","['MI effectiveness', 'total standard drinks', 'total standard (10 grams ethanol) drinks in the past month (Timeline Followback, TLFB', 'total drinking days and standard drinks per drinking day (TLFB) in the past month and the frequency of alcohol-related problems in the past 3 months (Rutgers Alcohol Problem Index', 'drinking days']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",398.0,0.107775,"FINDINGS


QuikFix resulted in greater reductions (all p< 0.0017) in the primary outcome of total standard drinks (M=19.50, CI 99.75%=[11.31-27.68]) than both MI (M=32.61, CI 99.75%=[24.82-40.40];Cohen's D=0.40) and AF/I (M=34.12, CI 99.75%=[26.59-41.65];D=0.45) at 12 months (retention n=324/398, 81%).","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, National Centre for Youth Substance Use Research, The University of Queensland, St Lucia, Brisbane, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'School of Psychology, National Centre for Youth Substance Use Research, The University of Queensland, St Lucia, Brisbane, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, St Lucia, Brisbane, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cotton', 'Affiliation': 'Orygen The National Centre of Excellence in Youth Mental Health, University of Melbourne, Parkville, Melbourne, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Pocuca', 'Affiliation': 'School of Psychology, National Centre for Youth Substance Use Research, The University of Queensland, St Lucia, Brisbane, Australia.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Connor', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, St Lucia, Brisbane, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, Center on Alcoholism, Substance Abuse and Addictions (CASAA), University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Mark R C', 'Initials': 'MRC', 'LastName': 'Daglish', 'Affiliation': 'Discipline of Psychiatry, Faculty of Medicine, The University of Queensland, Herston, Brisbane, Australia.'}, {'ForeName': 'Ross McD', 'Initials': 'RM', 'LastName': 'Young', 'Affiliation': 'School of Psychology and Counselling and Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove, Brisbane, Australia.'}, {'ForeName': 'Stoyan', 'Initials': 'S', 'LastName': 'Stoyanov', 'Affiliation': 'School of Psychology, National Centre for Youth Substance Use Research, The University of Queensland, St Lucia, Brisbane, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kavanagh', 'Affiliation': 'School of Psychology and Counselling and Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove, Brisbane, Australia.'}]","Addiction (Abingdon, England)",['10.1111/add.15146']
544,32510984,Genotype-Guided Dosing of Warfarin in Chinese Adults: A Multicenter Randomized Clinical Trial.,"BACKGROUND


Warfarin is an effective treatment for thromboembolic disease but has a narrow therapeutic index; optimal anticoagulation dosage can differ tremendously among individuals. We aimed to evaluate whether genotype-guided warfarin dosing is superior to routine clinical dosing for the outcomes of interest in Chinese patients.
METHODS


We conducted a multicenter, randomized, single-blind, parallel-controlled trial from September 2014 to April 2017 in 15 hospitals in China. Eligible patients were ≥18 years of age, with atrial fibrillation or deep vein thrombosis without previous treatment of warfarin or a bleeding disorder. Nine follow-up visits were performed during the 12-week study period. The primary outcome measure was the percentage of time in the therapeutic range of the international normalized ratio during the first 12 weeks after starting warfarin therapy.
RESULTS


A total of 660 participants were enrolled and randomly assigned to a genotype-guided dosing group or a control group under standard dosing. The genotype-guided dosing group had a significantly higher percentage of time in the therapeutic range than the control group (58.8% versus 53.2% [95% CI of group difference, 1.1-10.2];  P =0.01). The genotype-guided dosing group also achieved the target international normalized ratio sooner than the control group. In subgroup analyses, warfarin normal sensitivity group had an even higher percentage of time in the therapeutic range during the first 12 weeks compared with the control group (60.8% versus 48.9% [95% CI, 1.1-24.4]). The incidence of adverse events was low in both groups.
CONCLUSIONS


The outcomes of genotype-guided warfarin dosing were superior to those of clinical standard dosing. These findings raise the prospect of precision warfarin treatment in China. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02211326.",2020,"The genotype-guided dosing group had a significantly higher %TTR than the control group (58.8% vs. 53.2%, 95% confidence interval of group difference (95%CI): 1.1-10.2; P=0.01).","['Chinese patients', '660 participants', 'Eligible patients were 18 years or older, with atrial fibrillation or deep vein thrombosis without previous treatment of warfarin or a bleeding disorder', 'September 2014 to April 2017 in 15 hospitals in China', 'Chinese Adults']","['genotype-guided dosing group or a control group under standard dosing', 'Genotype-Guided Dosing of Warfarin', 'genotype-guided warfarin', '  - Warfarin']","['percentage of time in the therapeutic range (%TTR) of the international normalized ratio (INR', 'adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",660.0,0.107551,"The genotype-guided dosing group had a significantly higher %TTR than the control group (58.8% vs. 53.2%, 95% confidence interval of group difference (95%CI): 1.1-10.2; P=0.01).","[{'ForeName': 'Chengxian', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Honghao', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital (H.Z., Xiaoping Chen), Central South University, Changsha, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy (C.G., Q.P., L.H., Jinfu Peng, G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Jingle', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Chee M', 'Initials': 'CM', 'LastName': 'Ng', 'Affiliation': 'College of Pharmacy, University of Kentucky, Lexington (C.M.N.).'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital (H.Z., Xiaoping Chen), Central South University, Changsha, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology (Y.H.), Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital (Y.C.), Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Center on the Early Life Origins of Disease, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD (Xiaobin Wang).'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Miao', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Third Hospital of Changsha, China (Y.Z.).'}, {'ForeName': 'Zewei', 'Initials': 'Z', 'LastName': 'Ouyang', 'Affiliation': 'Department of Cardiology, Shaoyang Central Hospital, China (Z.O., X. Shi).'}, {'ForeName': 'Xiangjiang', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Shaoyang Central Hospital, China (Z.O., X. Shi).'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Shaoyang, China (C.L., Z.P.).""}, {'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Shaoyang, China (C.L., Z.P.).""}, {'ForeName': 'Guozuo', 'Initials': 'G', 'LastName': 'Xiong', 'Affiliation': 'Department of Vascular Surgery (G.X.), The Second Affiliated Hospital, University of South China, Hengyang.'}, {'ForeName': 'Gaofeng', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Cardiology (G.Z.), The Second Affiliated Hospital, University of South China, Hengyang.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Department of Cardiology, Xiangtan Central Hospital, China (J.Z.).'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiology, Changsha Central Hospital, China (H.D.).'}, {'ForeName': 'Jianqiang', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ""Department of Cardiology, Hunan Provincial People's Hospital, China (Jianqiang Peng).""}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Third Hospital of Changsha, China (Y.Z.).'}, {'ForeName': 'Fanghua', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, First People's Hospital of Xiangtan City, China (F.X.).""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of University of South China, Hengyang (J.W.).'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Chenzhou First People's Hospital, China (Xiaoliang Chen).""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Cardiology, The Fourth Hospital of Changsha, China (H.G.).'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Loudi Central Hospital, China (Z. Yang).'}, {'ForeName': 'Xianming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Yiyang Central Hospital, China (X. Wu).'}, {'ForeName': 'Qiulian', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'School of Mathematics and Statistics (Q.F., L.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'School of Mathematics and Statistics (Q.F., L.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Haigang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Changsha Medical University, China (H.L.).'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Shanjie', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy (C.G., Q.P., L.H., Jinfu Peng, G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Jinfu', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of Pharmacy (C.G., Q.P., L.H., Jinfu Peng, G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Zou', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}]",Circulation. Genomic and precision medicine,['10.1161/CIRCGEN.119.002602']
545,32520909,Impact of Routine Point-of-Care Versus Laboratory Testing for Early Infant Diagnosis of HIV: Results From a Multicountry Stepped-Wedge Cluster-Randomized Controlled Trial.,"BACKGROUND


Although the World Health Organization recommends HIV-exposed infants receive a 6-week diagnostic test, few receive results by 12 weeks. Point-of-care (POC) early infant diagnosis (EID) may improve timely diagnosis and treatment. This study assesses the impact of routine POC versus laboratory-based EID on return of results by 12 weeks of age.
METHODS


This was a cluster-randomized stepped-wedge trial in Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected for inclusion and randomized to timing of POC implementation.
FINDINGS


Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC. In Kenya and Zimbabwe, respectively, caregivers were 1.29 times [95% confidence interval (CI): 1.27 to 1.30, P < 0.001] and 4.56 times (95% CI: 4.50 to 4.60, P < 0.001) more likely to receive EID results by 12 weeks of age with POC versus laboratory-based EID. POC significantly reduced the time between sample collection and return of results to caregiver by an average of 23.03 days (95% CI: 4.85 to 21.21, P < 0.001) in Kenya and 62.37 days (95% CI: 58.94 to 65.80, P < 0.001) in Zimbabwe. For HIV-infected infants, POC significantly increased the percentage initiated on treatment, from 43.2% to 79.6% in Zimbabwe, and resulted in a nonsignificant increase in Kenya from 91.7% to 100%. The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe.
CONCLUSIONS


POC confers significant advantage on the proportion of caregivers receiving timely EID results, and improves time to results receipt and treatment initiation for infected infants. Where laboratory-based EID systems are unable to deliver results to caregivers rapidly, POC should be implemented as part of an integrated testing system.",2020,"The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe.
","['18 health facilities', 'Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC', 'Early Infant Diagnosis of HIV']","['routine POC versus laboratory-based EID', 'Routine Point-of-Care Versus Laboratory Testing']",['time to antiretroviral therapy initiation'],"[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4708915', 'cui_str': '9000'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",9539.0,0.210826,"The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe.
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sacks', 'Affiliation': 'Department of Global Health, George Washington School of Public Health, Washington, DC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cohn', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ochuka', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya.'}, {'ForeName': 'Haurovi', 'Initials': 'H', 'LastName': 'Mafaune', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Harare, Zimbabwe.'}, {'ForeName': 'Addmore', 'Initials': 'A', 'LastName': 'Chadambuka', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Harare, Zimbabwe.'}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Odhiambo', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Masaba', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Githuka', 'Affiliation': 'Ministry of Health, Nairobi, Kenya; and.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Mahomva', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mushavi', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Lemaire', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Bianchi', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC.'}, {'ForeName': 'Rhoderick', 'Initials': 'R', 'LastName': 'Machekano', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002383']
546,32522060,Feasibility and acceptability of a nutritional intervention testing the effects of nitrate-rich beetroot juice and folic acid on blood pressure in Tanzanian adults with elevated blood pressure.,"Sub-Saharan African countries are experiencing an alarming increase in hypertension prevalence. This study evaluated the feasibility and acceptability of nitrate-rich beetroot and folate supplementation, alone or combined, for the reduction of blood pressure (BP) in Tanzanian adults with elevated BP. This was a three-arm double-blind, placebo-controlled, parallel randomised clinical trial. Forty-eight participants were randomised to one of three groups to follow a specific 60-day intervention which included a: (1) combined intervention (beetroot juice + folate), (2) single intervention (beetroot juice + placebo), and (3) control group (nitrate-depleted beetroot juice + placebo). Forty-seven participants (age: 50-70 years) completed the study. The acceptability of the interventions was high. Self-reported compliance to the interventions was more than 90% which was confirmed by the significant increase in nitrate and folate concentrations in plasma and saliva samples in the treatment arms. This study provides important information for the design of high-nitrate interventions to reduce BP in Sub-Saharan African countries.",2021,Self-reported compliance to the interventions was more than 90% which was confirmed by the significant increase in nitrate and folate concentrations in plasma and saliva samples in the treatment arms.,"['Tanzanian adults with elevated BP', 'Tanzanian adults with elevated blood pressure', 'Forty-seven participants (age: 50-70\u2009years) completed the study', 'Forty-eight participants', 'Sub-Saharan African countries']","['nitrate-rich beetroot and folate supplementation', 'specific 60-day intervention which included a: (1) combined intervention (beetroot juice\u2009+\u2009folate), (2) single intervention (beetroot juice\u2009+\u2009placebo), and (3) control group (nitrate-depleted beetroot juice\u2009+\u2009placebo', 'nitrate-rich beetroot juice and folic acid', 'placebo']","['blood pressure', 'nitrate and folate concentrations in plasma and saliva samples', 'blood pressure (BP', 'hypertension prevalence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0454695', 'cui_str': 'African country'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C4551652', 'cui_str': 'Folate supplementation'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",48.0,0.137876,Self-reported compliance to the interventions was more than 90% which was confirmed by the significant increase in nitrate and folate concentrations in plasma and saliva samples in the treatment arms.,"[{'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Kandhari', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Prabhakar', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Shannon', 'Affiliation': 'Human Nutrition Research Centre, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fostier', 'Affiliation': 'Human Nutrition Research Centre, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Koehl', 'Affiliation': 'Human Nutrition Research Centre, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Rogathi', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Kilimanjaro Christian Medical University College, Tanzania, UK.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Temu', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Kilimanjaro Christian Medical University College, Tanzania, UK.'}, {'ForeName': 'Blossom C M', 'Initials': 'BCM', 'LastName': 'Stephan', 'Affiliation': 'Institute of Mental Health, The University of Nottingham Medical School, Nottingham, UK.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Gray', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Haule', 'Affiliation': 'District Medical Officer, Hai District Hospital, Bomangombe, Tanzania.'}, {'ForeName': 'Stella-Maria', 'Initials': 'SM', 'LastName': 'Paddick', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Kilimanjaro Christian Medical University College, Tanzania, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': ""School of Life Sciences, Queen's Medical Centre, The University of Nottingham Medical School, Nottingham, UK.""}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1776226']
547,32682929,"Antioxidant supplementation, redox deficiencies and exercise performance: A falsification design.","The aim of the present study was to validate the idea of personalized redox supplementation by subjecting individuals to targeted and non-targeted antioxidant supplementation schemes. Seventy-three volunteers were screened for plasma vitamin C and erythrocyte glutathione levels. Three groups were formed: i) the ""low vitamin C″ group (12 individuals with the lowest vitamin C levels; Low VitC), ii) the ""low glutathione"" group (12 individuals with the lowest glutathione levels; Low GSH) and iii) a control group (12 individuals with moderate vitamin C and glutathione levels). The three groups received 1 g of vitamin C or 1.2 g of NAC daily for 30 days in a crossover design with a wash-out period of 30 days. Both antioxidant treatments reduced the increased resting systemic oxidative stress levels, assessed via urine F 2 -isoprostanes, in the Low VitC and Low GSH groups (P < .05). A significant group × time interaction (P < .05) was found for VO 2 max and isometric peak torque after both treatments, with the Low VitC and Low GSH groups exhibiting improved performance only after the targeted treatment (vitamin C and NAC, respectively). A significant group × time interaction (P < .05) was found for fatigue index after NAC treatment, but not after vitamin C treatment. No interaction was found for the Wingate test after both treatments. Most of the evidence verifies the idea that antioxidant supplementation increases performance when a particular deficiency is reversed. This indicates that the presence of oxidative stress per se does not rationalize the use of antioxidants and emphasizes the need to identify ""responsive"" phenotypes.",2020,"A significant group × time interaction (P<.05) was found for VO 2 max and isometric peak torque after both treatments, with the Low VitC and Low GSH groups exhibiting improved performance only after the targeted treatment (vitamin C and NAC, respectively).",[],"['low vitamin C"" group (12 individuals with the lowest vitamin C levels; Low VitC), ii) the ""low glutathione"" group (12 individuals with the lowest glutathione levels; Low GSH) and iii) a control group (12 individuals with moderate vitamin C and glutathione levels', 'antioxidant supplementation', 'personalized redox supplementation', 'vitamin C or 1.2g of NAC']","['Antioxidant supplementation, redox deficiencies and exercise performance', 'fatigue index', 'resting systemic oxidative stress levels', 'VO 2 max and isometric peak torque', 'plasma vitamin C and erythrocyte glutathione levels']",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201898', 'cui_str': 'Ascorbic acid measurement'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}]",73.0,0.0729379,"A significant group × time interaction (P<.05) was found for VO 2 max and isometric peak torque after both treatments, with the Low VitC and Low GSH groups exhibiting improved performance only after the targeted treatment (vitamin C and NAC, respectively).","[{'ForeName': 'Nikos V', 'Initials': 'NV', 'LastName': 'Margaritelis', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Serres, Greece; Dialysis Unit, 424 General Military Hospital of Thessaloniki, Thessaloniki, Greece. Electronic address: nvmargar@auth.gr.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Paschalis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: vpaschalis@phed.uoa.gr.'}, {'ForeName': 'Anastasios A', 'Initials': 'AA', 'LastName': 'Theodorou', 'Affiliation': 'Department of Health Sciences, School of Sciences, European University Cyprus, Nicosia, Cyprus. Electronic address: a.theodorou@euc.ac.cy.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Kyparos', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Serres, Greece. Electronic address: akyparos@auth.gr.'}, {'ForeName': 'Michalis G', 'Initials': 'MG', 'LastName': 'Nikolaidis', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Serres, Greece. Electronic address: nikolaidis@auth.gr.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.029']
548,32534724,The Effectiveness of a Time Management Workshop on Job Stress of Nurses Working in Emergency Departments: An Experimental Study.,"INTRODUCTION


One of the main risk factors for poor health is a high level of job stress. Time management skills can greatly reduce job stress. The current study aimed to evaluate the effectiveness of a one-time management training workshop on job stress among nurses working in emergency departments.
METHODS


This randomized experimental study was carried out with 80 nurses working in emergency departments affiliated with a university of medical sciences. The intervention was an 8-hour workshop on time management. Pre- and posttest data were collected by demographic questionnaire and an occupational stress inventory before and 1 month after intervention. Data were analyzed using descriptive, chi-square, t test, Fisher exact, and analysis of covariance statistics.
RESULTS


The mean of job stress in the intervention group increased after the intervention (186.22, SD = 22.97) from baseline (182.52, SD = 34.39) compared with the mean of job stress in the control group (204.42, SD = 22.42) and (204.35, SD = 22.45). The control group had a significantly higher job stress score before the intervention (t = -3.37, P = 0.001). There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
DISCUSSION


The time management skills training program did not reduce the moderate-high levels of job stress of nurses in emergency departments. Addressing other sources of job stress, besides time management, is needed.",2020,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
","['80 nurses working in emergency departments affiliated with a university of medical sciences', 'nurses working in emergency departments', 'Job Stress of Nurses Working in Emergency Departments']","['one-time management training workshop', 'Time Management Workshop']","['job stress score', 'job stress scores', 'job stress', 'mean of job stress', 'moderate-high levels of job stress']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}]","[{'cui': 'C0556514', 'cui_str': 'Time management training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",80.0,0.0212648,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Karbakhsh Ravari', 'Affiliation': ''}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': ''}, {'ForeName': 'Monirsadat', 'Initials': 'M', 'LastName': 'Nematollahi', 'Affiliation': ''}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Miri', 'Affiliation': ''}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Foroughameri', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.03.013']
549,32534568,How does the EQ-5D-5L perform in asthma patients compared with an asthma-specific quality of life questionnaire?,"BACKGROUND


Asthma patients experience impairments in health-related quality of life (HRQL). Interventions are available to improve HRQL. EQ-5D-5L is a common generic tool used to evaluate health interventions. However, there is debate over whether the use of this measure is adequate in asthma patients.
METHODS


We used data from 371 asthma patients participating in a pulmonary rehabilitation (PR) program from the EPRA randomized controlled trial. We used four time points: T0 randomization, T1 start PR, T2 end PR, T3 3 months follow-up. We calculated floor and ceiling effects, intra-class correlation (ICC), Cohen's d, and regression analysis to measure the sensitivity to changes of EQ-5D-5 L (EQ-5D index and Visual Analog Scale (VAS)) and the disease-specific Asthma Quality of Life Questionnaire (AQLQ). Furthermore, we estimated the minimally important difference (MID). Based on the Asthma Control Test (ACT) scores, we defined three groups: 1. ACT-A (ACT> 19) controlled asthma, 2. ACT-B (14 < ACT≤19) not well-controlled asthma, and 3. ACT-C (ACT≤14) very poorly controlled asthma.
RESULTS


Only the EQ-5D index showed ceiling effects at T2 and T3 (32%). ICC (between T0 and T1) was moderate or good for all measures. Cohen's d at T2 and T3 was better at differentiating between ACT-A and ACT-B than between ACT-B and ACT-C. The EQ-5D index showed moderate effect sizes (0.63-0.75), while AQLQ showed large effect sizes (0.74-1,48). VAS was responsive to pronounced positive and negative ACT changes in every period, and AQLQ mostly to the positive changes, whereas the EQ-5D index was less responsive. We estimated a MID of 0.08 for the EQ-5D index, 12.3 for VAS, and 0.65 for AQLQ.
CONCLUSION


All presented HRQL tools had good discriminatory power and good reliability. However, EQ-5D-5 L did not react very sensitively to small changes in asthma control. Therefore, we would suggest using supplementary measures in addition to EQ-5D-5 L to evaluate asthma-specific interventions more comprehensively.
TRIAL REGISTRATION


German Clinical Trial Register, DRKS00007740 (date of registration: 05/15/2015), https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007740. The registration took place prospectively.",2020,"The EQ-5D index showed moderate effect sizes (0.63-0.75), while AQLQ showed large effect sizes (0.74-1,48).","['asthma patients', '371 asthma patients participating in a pulmonary rehabilitation (PR) program from the EPRA randomized controlled trial', 'Asthma patients experience impairments in health-related quality of life (HRQL']","['EQ-5D-5L', 'VAS', 'EQ-5D-5']","['ICC', 'EQ-5D-5\u2009L (EQ-5D index and Visual Analog Scale (VAS)) and the disease-specific Asthma Quality of Life Questionnaire (AQLQ', 'EQ-5D index']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",371.0,0.068442,"The EQ-5D index showed moderate effect sizes (0.63-0.75), while AQLQ showed large effect sizes (0.74-1,48).","[{'ForeName': 'Boglárka L', 'Initials': 'BL', 'LastName': 'Szentes', 'Affiliation': 'Institute of Health Economics and Health Care Management, Helmholtz Zentrum München (GmbH) - German Research Center for Environmental Health, Comprehensive Pneumology Center Munich (CPC-M), Member of the German Center for Lung Research (DZL), Ingolstädter Landstraße 1, 85764, Neuherberg, Germany. szentesboglarka@gmail.com.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Schultz', 'Affiliation': 'Klinik Bad Reichenhall, Center for Rehabilitation, Pulmonology and Orthopedics, Salzburger Str. 8, 83435, Bad Reichenhall, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Nowak', 'Affiliation': 'LMU University of München, Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ziemssenstraße 1, 80336, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schuler', 'Affiliation': 'University of Würzburg, Institute of Clinical Epidemiology and Biometry, Sanderring 2, 97070, Würzburg, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Schwarzkopf', 'Affiliation': 'Institute of Health Economics and Health Care Management, Helmholtz Zentrum München (GmbH) - German Research Center for Environmental Health, Comprehensive Pneumology Center Munich (CPC-M), Member of the German Center for Lung Research (DZL), Ingolstädter Landstraße 1, 85764, Neuherberg, Germany.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01205-8']
550,32513245,Study protocol for prognosis and treatment strategy of peripheral persistent avascular retina after intravitreal anti-VEGF therapy in retinopathy of prematurity.,"BACKGROUND


Prophylactic peripheral photocoagulation has been proposed to be applied to persistent, peripheral, avascular retina for retinopathy of prematurity (ROP) patients who have received an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents. However, there are doubts regarding the necessity of this prophylactic action regardless of fundus fluorescein angiography (FFA) results. The adverse prognosis for persistent avascular retina after anti-VEGF therapy in ROP patients is not well understood. The relationship between vascular leakage and an adverse prognosis is also unknown. Therefore, it would be of value to study the above issues to shape the treatment strategy of persistent avascular retina after intravitreal anti-VEGF therapy in ROP patients.
METHODS/DESIGN


This is a prospective study of ROP patients with persistent avascular retina who have received anti-VEGF intravitreal therapy and have never received laser therapy. All the eyes being studied will be followed up and examined by FFA after anti-VEGF treatment and categorized into two groups, a leakage group and a non-leakage group according to the extent of vascular leakage from FFA results. The eyes being studied in the leakage group will be further randomized into two groups, a laser group and a non-laser group. A cohort study (observational) will be conducted on the non-leakage group and the non-laser group (with leakage) to investigate the incidence of an adverse prognosis for reactivation, retinal tear and retinal detachment; as well as to investigate the relationship between vascular leakage from FFA results and the abovementioned pathological changes. A randomized controlled study (experimental) will be conducted on the leakage group to compare the prognosis between the laser group and the non-laser group.
DISCUSSION


The present study aims to investigate the occurrence rates of an adverse prognosis including reactivation, retinal tear and retinal detachment after anti-VEGF therapy in ROP patients with persistent avascular retina; to assess the relationship between vascular leakage from FFA results and the abovementioned pathological changes; to compare the prognosis of persistent avascular retina with or without prophylactic peripheral photocoagulation in these patients; to shape the treatment strategy and provide evidence for the indications of prophylactic photocoagulation.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR), ID: ChiCTR-ROC-17013253. Registered on 5 November 2017. http://www.chictr.org.cn/showproj.aspx?proj=22703.",2020,"BACKGROUND


Prophylactic peripheral photocoagulation has been proposed to be applied to persistent, peripheral, avascular retina for retinopathy of prematurity (ROP) patients who have received an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents.","['ROP patients with persistent avascular retina who have received', 'ROP patients with persistent avascular retina', 'retinopathy of prematurity']","['prophylactic peripheral photocoagulation', 'laser therapy', 'laser group and a non-laser group', 'intravitreal anti-VEGF therapy', 'VEGF therapy', 'Prophylactic peripheral photocoagulation', 'anti-VEGF intravitreal therapy']",[],"[{'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0311809,"BACKGROUND


Prophylactic peripheral photocoagulation has been proposed to be applied to persistent, peripheral, avascular retina for retinopathy of prematurity (ROP) patients who have received an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Jianxun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Wensi', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Daoman', 'Initials': 'D', 'LastName': 'Xiang', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China. xiangdm35@126.com.""}]",Trials,['10.1186/s13063-020-04371-6']
551,32568845,Anesthesia and Circulating Tumor Cells in Primary Breast Cancer Patients: A Randomized Controlled Trial.,"BACKGROUND


The effect of anesthetic drugs on cancer outcomes remains unclear. This trial aimed to assess postoperative circulating tumor cell counts-an independent prognostic factor for breast cancer-to determine how anesthesia may indirectly affect prognosis. It was hypothesized that patients receiving sevoflurane would have higher postoperative tumor cell counts.
METHODS


The parallel, randomized controlled trial was conducted in two centers in Switzerland. Patients aged 18 to 85 yr without metastases and scheduled for primary breast cancer surgery were eligible. The patients were randomly assigned to either sevoflurane or propofol anesthesia. The patients and outcome assessors were blinded. The primary outcome was circulating tumor cell counts over time, assessed at three time points postoperatively (0, 48, and 72 h) by the CellSearch assay. Secondary outcomes included maximal circulating tumor cells value, positivity (cutoff: at least 1 and at least 5 tumor cells/7.5 ml blood), and the association between natural killer cell activity and tumor cell counts. This trial was registered with ClinicalTrials.gov (NCT02005770).
RESULTS


Between March 2014 and April 2018, 210 participants were enrolled, assigned to sevoflurane (n = 107) or propofol (n = 103) anesthesia, and eventually included in the analysis. Anesthesia type did not affect circulating tumor cell counts over time (median circulating tumor cell count [interquartile range]; for propofol: 1 [0 to 4] at 0 h, 1 [0 to 2] at 48 h, and 0 [0 to 1] at 72 h; and for sevoflurane: 1 [0 to 4] at 0 h, 0 [0 to 2] at 48 h, and 1 [0 to 2] at 72 h; rate ratio, 1.27 [95% CI, 0.95 to 1.71]; P = 0.103) or positivity. In one secondary analysis, administrating sevoflurane led to a significant increase in maximal tumor cell counts postoperatively. There was no association between natural killer cell activity and circulating tumor cell counts.
CONCLUSIONS


In this randomized controlled trial investigating the effect of anesthesia on an independent prognostic factor for breast cancer, there was no difference between sevoflurane and propofol with respect to circulating tumor cell counts over time.",2020,"There was no association between natural killer cell activity and circulating tumor cell counts.
","['nonmetastatic and metastatic breast cancer', 'n = 103) anesthesia, and eventually included in the analysis', 'Between March 2014 and April 2018, 210 participants were enrolled, assigned to', 'n = 107) or', 'Patients aged 18 to 85 yr without metastases and scheduled for primary breast cancer surgery were eligible', 'two centers in Switzerland', 'primary breast cancer patients receiving', 'Primary Breast Cancer Patients']","['sevoflurane anesthesia', 'sevoflurane and propofol', 'sevoflurane or propofol anesthesia', 'sevoflurane', 'propofol']","['natural killer cell activity and tumor cell counts', 'maximal tumor cell counts postoperatively', 'maximal circulating tumor cells value, positivity (cutoff', 'circulating tumor cell counts', 'natural killer cell activity and circulating tumor cell counts', 'postoperative tumor cell counts']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",210.0,0.167967,"There was no association between natural killer cell activity and circulating tumor cell counts.
","[{'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Hovaguimian', 'Affiliation': 'From the Institute of Anesthesiology, University Hospital of Zurich and University of Zurich, Zurich, Switzerland (F.H., M.S., B.B.-S.) the Epidemiology, Biostatistics and Prevention Institute, Department of Public and Global Health (F.H.) the Epidemiology, Biostatistics and Prevention Institute, Department of Epidemiology (J.B., M.A.P.) the Institute of Physiology and Zurich Center for Integrative Human Physiology (B.R.Z., M.S., B.B.-S.) the Cytometry Facility (C.D., C.E.), University of Zurich, Zurich, Switzerland the Department of Gynecology, University Hospital of Zurich, Zurich, Switzerland (K.J.D., D.F.) the Institute of Anesthesiology, Hirslanden Clinic Zurich, Zurich, Switzerland (U.R., M.S.) the Faculty of Medicine, University of Basel, Basel, Switzerland (M.S.) the Department of Surgery (C.T.) the Clinical Trial Unit (B.P.), Breast Center Zurich, Zurich, Switzerland the Department of Anesthesiology, University of Illinois College of Medicine at Chicago, Chicago, Illinois (B.B.-S.).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': ''}, {'ForeName': 'Birgit Roth', 'Initials': 'BR', 'LastName': ""Z'graggen"", 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schläpfer', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dumrese', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ewald', 'Affiliation': ''}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': ''}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Rölli', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Seeberger', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tausch', 'Affiliation': ''}, {'ForeName': 'Bärbel', 'Initials': 'B', 'LastName': 'Papassotiropoulos', 'Affiliation': ''}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Beck-Schimmer', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003409']
552,32547310,N-acetylcysteine Restored Heart Rate Variability and Prevented Serious Adverse Events in Transfusion-dependent Thalassemia Patients: a Double-blind Single Center Randomized Controlled Trial.,"Regular blood transfusions in transfusion-dependent thalassemia (TDT) patients can lead to iron overload, causing oxidative stress and sympathovagal imbalance, resulting in increased cardiac complications. We hypothesized that administrating of N-acetylcysteine (NAC) prevents serious adverse events including cardiac complications in TDT patients by reducing systemic oxidative stress and balancing cardiac sympathovagal control. This study was double-blind, randomized control trial, investigating in 59 Thai TDT patients. After randomization, the participants were divided into two groups. The control group received standard care of TDT patient plus placebo, whereas the intervention group received 600 mg of NAC orally for six months. Serum 8-isoprostane, TNF-alpha, IL-10, 24-hour ECG monitoring, echocardiograms and the incidence of thalassemia-related complications were collected. At baseline, no significant difference in any parameters between the control and the intervention groups. At the end of intervention, the incidence of serious adverse events (i.e. infection, worsening thalassemia) was significantly higher in the control group when compared with the intervention group (24.1% vs. 3.3%, p=0.019) (Chi-square test; absolute risk reduction=20.8%, number needed to treat=4.8). The control group also had significantly lower time-dependent HRV parameters, compared with the intervention group (p=0.025 and 0.030, independent t-test). Treatment with NAC restored HRV and reduced serious adverse event in TDT patients, however, no difference in cardiac complications could be demonstrated. NAC could prevent serious adverse events in TDT patients. The proposed mechanism might be the balancing of sympathovagal control.",2020,"The control group also had significantly lower time-dependent HRV parameters, compared with the intervention group (p=0.025 and 0.030, independent t-test).","['TDT patients', 'Transfusion-dependent Thalassemia Patients', '59 Thai TDT patients']","['NAC', 'N-acetylcysteine (NAC', 'standard care of TDT patient plus placebo']","['cardiac complications', 'Heart Rate Variability', 'serious adverse events', 'Serum 8-isoprostane, TNF-alpha, IL-10, 24-hour ECG monitoring, echocardiograms and the incidence of thalassemia-related complications', 'incidence of serious adverse events (i.e. infection, worsening thalassemia', 'lower time-dependent HRV parameters']","[{'cui': 'C4760934', 'cui_str': 'Transfusion dependent thalassaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4760934', 'cui_str': 'Transfusion dependent thalassaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0430461', 'cui_str': '24 Hour ECG'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.207315,"The control group also had significantly lower time-dependent HRV parameters, compared with the intervention group (p=0.025 and 0.030, independent t-test).","[{'ForeName': 'Sintip', 'Initials': 'S', 'LastName': 'Pattanakuhar', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Arintaya', 'Initials': 'A', 'LastName': 'Phrommintikul', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Adisak', 'Initials': 'A', 'LastName': 'Tantiworawit', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Somdet', 'Initials': 'S', 'LastName': 'Srichairattanakool', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Siriporn C', 'Initials': 'SC', 'LastName': 'Chattipakorn', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Nipon', 'Initials': 'N', 'LastName': 'Chattipakorn', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}]",International journal of medical sciences,['10.7150/ijms.45795']
553,32572628,Efficacy comparison of laparoscopic sleeve gastrectomy in type 2 diabetes patients with a BMI 30-34.9 kg/m 2  versus BMI < 30 kg/m 2 .,"BACKGROUND


Laparoscopic sleeve gastrectomy (LSG) is safe and effective in type 2 diabetes mellitus (T2DM) with body mass index (BMI) ≥ 35 kg/m 2 . However, the effect and safety of LSG in the treatment of T2DM patients with BMI less than 35 kg/m 2 , especially in patients with BMI less than 30 kg/m 2 , are still debatable.
METHODS


A total of 51 T2DM patients with BMI less than 35 kg/m 2  treated successfully with LSG were included in our study. All patients were divided into two groups for subgroup analysis, namely group A (BMI 23.23-29.97 kg/m 2 ) and group B (BMI 30.0-34.9 kg/m 2 ). The weight loss and diabetic characteristics of LSG in the two groups at 3 months, 6 months, and 12 months after operation were compared, respectively.
RESULTS


In group A, the complete remission rates of T2DM were 20%, 36%, and 44% at 3, 6, and 12 months after operation, respectively. In group B, the complete remission rates of T2DM were 30.8%, 61.5%, and 88.5% at 3, 6, and 12 months after operation, respectively. Besides, none of the patients with a duration more than 15 years achieved complete remission. For T2DM patients with BMI < 30 kg/m 2  at 12 months after LSG, the complete remission rate of T2DM was 15.4% in patients with ABCD scores ≤ 2, and the complete remission rate of T2DM was 100% in patients with ABCD scores ≥ 5.
CONCLUSION


LSG is safe and effective for T2DM patients with BMI less than 35 kg/m 2  in the short-term. However, the complete remission rate of T2DM in patients with BMI less than 30 kg/m 2  is far from the diabetes patients with BMI at 30-34.9 kg/m 2 .",2021,"In group B, the complete remission rates of T2DM were 30.8%, 61.5%, and 88.5% at 3, 6, and 12 months after operation, respectively.","['type 2 diabetes mellitus (T2DM) with body mass index (BMI)\u2009≥\u200935\xa0kg', 'type 2 diabetes patients with a BMI 30-34.9\xa0kg/m 2  versus BMI\u2009<\u200930\xa0kg/m 2 ', '51 T2DM patients with BMI less than 35\xa0kg/m 2  treated successfully with']","['Laparoscopic sleeve gastrectomy (LSG', 'laparoscopic sleeve gastrectomy', 'LSG']","['weight loss and diabetic characteristics of LSG', 'complete remission rate of T2DM', 'complete remission', 'complete remission rates of T2DM']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",51.0,0.0210851,"In group B, the complete remission rates of T2DM were 30.8%, 61.5%, and 88.5% at 3, 6, and 12 months after operation, respectively.","[{'ForeName': 'Diqing', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, China-Japan Union Hospital, Jilin University, No. 126 Xiantai Avenue, Changchun City, 130033, Jilin Province, China.'}, {'ForeName': 'Lun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, China-Japan Union Hospital, Jilin University, No. 126 Xiantai Avenue, Changchun City, 130033, Jilin Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, China-Japan Union Hospital, Jilin University, No. 126 Xiantai Avenue, Changchun City, 130033, Jilin Province, China. jiangtao1099899@163.com.'}]",Surgical endoscopy,['10.1007/s00464-020-07749-4']
554,32569414,Randomized Pragmatic Pilot Trial Comparing Perpendicular Thin Electrode Versus Parallel Thick Electrode Approaches for Lumbar Medial Branch Neurotomy in Facetogenic Low Back Pain.,"OBJECTIVES


Although there are different ways of performing medial branch neurotomy on facetogenic low back pain, few studies have compared clinical outcomes of a parallel technique over the medial branch vs. a perpendicular technique. We investigated differences in pain outcome with both techniques.
DESIGN


This was a prospective, pilot, randomized, pragmatic trial (double blinded in the diagnostic phase).
SETTING


A comparative pilot trial was conducted at an academic pain center.
METHODS


Patients who did not respond to conservative medications and had severe lumbar pain for more than 3 months (VAS score ≥ 65) were included. A double diagnostic block with local anesthetic and placebo was performed, double blinded. Patients who had 80% relief from the local anesthetic and no substantial relief from placebo were randomized to undergo medial branch neurotomy under fluoroscopy, placing an electrode parallel or perpendicular to the medial branch. The primary outcome was differences in the VAS score at 1, 3, and 6 months. The secondary outcomes were Oswestry Disability Index score, Roland Morris Questionnaire score, and other functional Likert scale scores.
RESULTS


Forty-three consecutive patients were randomized to parallel (n = 20) or perpendicular (n = 23) neurotomy. There were no significant differences in VAS, Oswestry Disability Index, or Roland Morris Questionnaire scores at 1, 3, or 6 months between groups. Statistically significant differences were found in the categorical analysis at 6 months in the evolution of pain, Oswestry Disability Index score, Roland Morris Questionnaire score, and some Likert scale scores in favor of the parallel group.
CONCLUSIONS


There were differences at 6 months in the categorical analysis of the evolution of pain, Oswestry Disability Index score, Roland Morris Questionnaire score, and some functional Likert scale scores, all in favor of the parallel group.",2020,"There were no significant differences in Visual Analogue Scale, Oswestry or Roland Morris at 1, 3 or 6 months between groups.","['academic pain centre', 'Patients who had an 80% relief from the local anaesthetic and no substantial relief from', 'Forty-three consecutive patients were randomized to parallel (n=20) or perpendicular (n=23) neurotomy', 'facetogenic low back pain', 'Patients who did not respond to conservative medications and had severe lumbar pain for more than 3 months (VAS≥65) were included']","['local anaesthetic and placebo', 'medial branch neurotomy placing an electrode parallel or perpendicular to the medial branch, under fluoroscopy', 'perpendicular thin electrodes versus parallel thick electrodes approaches', 'placebo']","['Oswestry Disability Index, Roland Morris Questionnaire and other functional Likert scales', 'Visual Analogue Scale', 'evolution of pain, Oswestry, Roland Morris and some Likert scales', 'pain outcome', 'evolution of pain, Oswestry, Roland Morris and in some functional Likert scales', 'Visual Analogue Scale, Oswestry or Roland Morris']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0196558', 'cui_str': 'Incision of nerve'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0196558', 'cui_str': 'Incision of nerve'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",43.0,0.572113,"There were no significant differences in Visual Analogue Scale, Oswestry or Roland Morris at 1, 3 or 6 months between groups.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Andrés Ares', 'Affiliation': 'Unidad del Dolor Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gilsanz', 'Affiliation': 'Unidad del Dolor Hospital Universitario La Paz, Madrid, Spain.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12928']
555,32572778,"Essential Oil from Citrus aurantium Alleviates Anxiety of Patients Undergoing Coronary Angiography: A Single-Blind, Randomized Controlled Trial.","OBJECTIVE


To determine the effectiveness and safety of essential oil from Citrus aurantium on anxiety in patients undergoing coronary angiography.
METHODS


A single-blind, randomized controlled trial was conducted in 80 patients experiencing coronary angiography in Imam Ali Hospital in Kermanshah, Iran from April to November in 2016. All patients were randomly divided into intervention and control groups by a random number table, 40 cases in each group. The patients in the intervention group inhaled Citrus aurantium essential oil for 15-20 min about 60 min before angiography. Following the same procedure, distilled water was used instead of Citrus aurantium in the control group. Spielbergers State-Trait Anxiety Inventory (STAI) was filled in and vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory and pulse rate were recorded before and 20 min after the intervention. Adverse reactions after intervention were observed.
RESULTS


In the intervention group, the mean scores of STAI, SBP, DBP, respiratory and pulse rate were 53.30 ± 10.13, 134.82 ± 11.75 mm Hg, 84.49 ± 6.99 mm Hg, 17.87 ± 1.73 times/min, and 76.48 ± 12.55 beats/min at baseline and significantly decreased to 42.37 ± 10.15, 124.49 ± 10.48 mm Hg, 79.23 ± 6.62 mm Hg, 14.54 ± 1.43 times/min, and 70.03 ± 13.66 beats/min respectively 20 min after intervention (all P<0.05); however, in the control group, neither anxiety scores nor vital signs changed significantly (P>0.05). All subjects reported no adverse reactions.
CONCLUSION


Inhalation of the essential oil from Citrus aurantium was effective in reducing anxiety and stress levels in patients undergoing coronary angiography.
TRIAL REGISTRATION


IRCT2016040816797N2 (retrospectively registered on 21 April 2016, https://en.irct.ir/trial/15600 ).",2021,"Inhalation of the essential oil from Citrus aurantium was effective in reducing anxiety and stress levels in patients undergoing coronary angiography.
","['patients undergoing coronary angiography', 'Patients Undergoing Coronary Angiography', '80 patients experiencing coronary angiography in Imam Ali Hospital in Kermanshah, Iran from April to November in 2016']","['essential oil from Citrus aurantium', 'intervention group inhaled Citrus aurantium essential oil']","['systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory and pulse rate', 'Spielbergers State-Trait Anxiety Inventory (STAI', 'anxiety and stress levels', 'anxiety scores nor vital signs', 'Adverse reactions', 'mean scores of STAI, SBP, DBP, respiratory and pulse rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0330922', 'cui_str': 'Citrus aurantium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",80.0,0.0549123,"Inhalation of the essential oil from Citrus aurantium was effective in reducing anxiety and stress levels in patients undergoing coronary angiography.
","[{'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Moradi', 'Affiliation': 'Intensive Care Unit, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ashtarian', 'Affiliation': 'Health Education Department, Health School, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nicholas Yakubu', 'Initials': 'NY', 'LastName': 'Danzima', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Saeedi', 'Affiliation': 'Student Research Committee, School of Nursing, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Bijan', 'Affiliation': 'Intensive Care Unit, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Akbari', 'Affiliation': 'Intensive Care Unit, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Mohammadi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. mehdi20.mohamadi@gmail.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3266-5']
556,32569102,Effects of Massage on Post-Operative Pain in Infants with Complex Congenital Heart Disease.,"BACKGROUND


Pain management is an essential component of care for pediatric patients following surgery. Massage reduces self-reported post-operative pain in adults with heart disease but has received little attention in post-operative pediatric patients with congenital heart disease (CCHD).
OBJECTIVES


To evaluate the effectiveness of massage compared to a rest period on post-operative pain scores and physiologic responses in infants with CCHD.
METHODS


We used a two-group randomized clinical trial design with a sample of 60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard post-operative care. Group 1 received a daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed using descriptive statistics, GLMM repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate.
RESULTS


Adjusted pain scores were lower for the massage group on all days except day 7. Overall there were no group effects on level of pain or differential rate of change in pain. However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR. There was little difference between groups in SpO2. Infants demonstrated immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing.
DISCUSSION


This study provides beginning evidence that post-operative massage may reduce pain and improve physiologic parameters in infants with congenital heart disease. This non-pharmacological adjunct to pain management may provide a particular benefit for this population by reducing demand on the cardiorespiratory system.",2020,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","['infants with CCHD', 'adults with heart disease', 'pediatric patients with congenital heart disease (CCHD', 'infants with congenital heart disease', 'pediatric patients following surgery', '60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery', 'Infants with Complex Congenital Heart Disease']","['standard post-operative care', 'daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage', 'Fentanyl-equivalent narcotic values', 'Massage']","['Daily averages and pre- and post- intervention FLACC scores and physiologic responses', 'Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2', 'Pain', 'Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC', 'immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing', 'daily pain scores', 'Adjusted pain scores', 'level of pain or differential rate of change in pain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0852710', 'cui_str': 'Oxygen saturation increased'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",60.0,0.174636,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","[{'ForeName': 'Tondi M', 'Initials': 'TM', 'LastName': 'Harrison', 'Affiliation': ""The Ohio State University College of Nursing, Columbus, Ohio University of Wisconsin-Madison School of Nursing, Madison, Wisconsin Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio COPC Ohio Center for Pediatrics, Dublin, Ohio The Ohio State University College of Nursing, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Duffey', 'Affiliation': ''}, {'ForeName': 'Corrie', 'Initials': 'C', 'LastName': 'Frey', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fitch', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000459']
557,32576049,MENSTRUAL DISORDERS AND ANDROGEN-RELATED TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS: A CLINICAL STUDY.,"Objective.  To investigate possible causes of menstrual disorders and androgen-related traits in young women with T1DM.  Patients and Methods.  Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited.  Results.  Two women (3.8%) in the T1DM group had not experienced menarche (at 15.5 and 16.6 years); of the rest, 23.5% had oligomenorrhea, 32.1% hirsutism, 45.3% acne. The age at menarche was delayed in the T1DM group compared to controls (12.7±1.3 vs. 12.0±1.0 years, p=0.004), while no difference was observed with the PCOS group (12.4±1.2 years). There were no differences in total testosterone (0.43±0.14 vs. 0.39±0.14 ng/ml, p>0.05), DHEA-S (269±112 vs. 238±106 μg/dl, p>0.05) or Δ4-androstenedione (2.4±1.3 vs. 1.9±0.5 ng/ml, p>0.05) concentrations between T1DM and controls. However, patients with T1DM had lower SHBG concentrations than controls (61±17 vs. 83±18.1 nmol/l, p=0.001), which were even lower in the PCOS group (39.5±12.9 nmol/, p=0.001 compared with T1DM). FAI (free androgen index) was higher in the PCOS group compared with both other groups (T1DM vs. PCOS vs. controls: 2.53±0.54 vs 7.88±1.21 vs. 1.6±0.68, p<0.001). FAI was higher in patients with T1DM compared to controls, too (p=0.038). There was no difference in DHEA-S concentrations between T1DM and PCOS patients (269±112 vs. 297±100 μg/dl, p>0.05).  Conclusions.  Menstrual disorders and androgen-related traits in young women with T1DM may be attributed to an increase in androgen bioavailability due to decreased SHBG concentrations.",2020,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","['TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS', 'Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited', 'young women with T1DM']",[],"['lower SHBG concentrations', 'FAI (free androgen index', 'total testosterone', 'DHEA-S concentrations', 'FAI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}]",53.0,0.0903609,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","[{'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Paschou', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Andromachi', 'Initials': 'A', 'LastName': 'Vryonidou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Melissourgou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosteria', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios G', 'Initials': 'DG', 'LastName': 'Goulis', 'Affiliation': 'Unit of Reproductive Endocrinology, First Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Chrousos', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kanaka-Gantenbein', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0153']
558,32572446,Exposure and Absorption of PAHs in Wildland Firefighters: A Field Study with Pilot Interventions.,"OBJECTIVES


There is limited knowledge of exposure to polycyclic aromatic hydrocarbons (PAHs) in wildland firefighters, or of the effectiveness of interventions to reduce this. This study of wildland firefighters assessed whether PAHs were present and considered respiratory protection and enhanced skin hygiene as possible interventions.
METHODS


1-Hydroxypyrene (1-HP) was measured in urine samples collected pre-shift, post-shift, and next morning from wildland firefighters in Alberta and British Columbia. Skin wipes, collected pre- and post-shift, were analysed for eight PAHs. Breathing zone air samples were analysed for 11 PAHs. As pilot interventions, participants were randomized to either normal or enhanced skin hygiene. A sample of volunteers was assigned to a disposable N95 mask or a half facepiece mask with P100 organic vapour cartridge. Participants completed a brief questionnaire on activities post-shift and respiratory symptoms.
RESULTS


Non-smoking firefighters (66 male and 20 female) were recruited from 11 fire crews. Air sampling pumps were carried for the full shift by 28 firefighters, 25 firefighters wore masks (14 N95 and 11 P100); 42 were assigned to the enhanced skin hygiene intervention. Sixty had hot spotting as their main task. Air monitoring identified PAHs (benzo(b,j,k)fluoranthene in particulates, phenanthrene in the gaseous phase) for 6 of the 11 crews. PAHs (largely naphthalene) were found post-shift on 40/84 skin wipes from the hand and 38/84 from jaw/throat. The mean increase in 1-HP in urine samples collected after the shift (compared with samples collected before the shift) was 66 ng g-1 creatinine (P < 0.001) with an increase over the shift found for 76% of participants. 1-HP in next morning urine samples was significantly lower than at the end of shift (a reduction of 39.3 ng g-1: P < 0.001). The amount of naphthalene on skin wipes was greater at the end of the shift (post) than at the start (pre). The mean post-pre weight difference of naphthalene on skin wipes taken from the hand was 0.96 ng wipe-1 (P = 0.01) and from the jaw/throat 1.28 ng wipe-1 (P = 0.002). The enhanced skin hygiene intervention lead to a larger reduction in 1-HP between end of shift and next morning urine samples but only for those with naphthalene on skin wipes at the end of shift. The difference in 1-HP concentration in urine samples collected before and after the shift was reduced for those wearing a mask (linear tend P = 0.063, one-sided). In multivariable models, 1-HP at end of shift was related to gaseous phase phenanthrene, estimated from air sampling [β = 318.2, 95% confidence interval (CI) 67.1-569.2]. Naphthalene on hand skin wipes reflected work in hot spotting during the shift (β = 0.53, 95% CI 0.22-0.86).
CONCLUSIONS


This study provided evidence of PAHs in the air and on the skin of many, but not all, fire crew. Absorbed PAHs, reflected in 1-HP in urine, increased over the shift. Results from the pilot interventions suggest that enhanced skin hygiene would reduce absorption post fire where PAHs had been accumulated on the skin, and that masks could be effective in reducing PAH inhalation exposure. Interventions to reduce PAH absorption are supported by the pilot work reported here and warrant further evaluation across a full fire season.",2021,"The difference in 1-HP concentration in urine samples collected before and after the shift was reduced for those wearing a mask (linear tend P = 0.063, one-sided).","['Non-smoking firefighters (66 male and 20 female) were recruited from 11 fire crews', 'Wildland Firefighters']","['normal or enhanced skin hygiene', 'disposable N95 mask or a half facepiece mask with P100 organic vapour cartridge', 'enhanced skin hygiene intervention']","['skin wipes', 'urine samples', 'Breathing zone air samples', 'mean post-pre weight difference of naphthalene on skin wipes taken', '1-HP concentration']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1286234', 'cui_str': 'Skin hygiene'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0597635', 'cui_str': 'Vapor'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1546536', 'cui_str': 'Air sample'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0027375', 'cui_str': 'Naphthalene'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0044415', 'cui_str': '1-hydroxypyrene'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0342456,"The difference in 1-HP concentration in urine samples collected before and after the shift was reduced for those wearing a mask (linear tend P = 0.063, one-sided).","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cherry', 'Affiliation': 'Division of Preventive Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Galarneau', 'Affiliation': 'Division of Preventive Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kinniburgh', 'Affiliation': 'Alberta Centre for Toxicology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Quemerais', 'Affiliation': 'Division of Preventive Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Tiu', 'Affiliation': 'Alberta Centre for Toxicology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Alberta Centre for Toxicology, University of Calgary, Calgary, Alberta, Canada.'}]",Annals of work exposures and health,['10.1093/annweh/wxaa064']
559,32573912,Effects of water- and land-based exercises on quality of life and physical aspects in women with fibromyalgia: A randomized clinical trial.,"INTRODUCTION


Fibromyalgia (FM) is consistently associated with fatigue, sleep disturbances, morning stiffness, and anxiety and depression, affecting physical capacities and skills and thereby reducing quality of life. The aim of this study was to compare the effects of water-based and land-based therapies as an adjuvant treatment for women with FM in relation to quality of life and physical aspects.
METHODS


FM women were randomized into a water-based exercise group (WG) and land-based exercise group (LG). The interventions were conducted for 8 weeks, three times a week, and each therapy session had a 60-min duration. Evaluations were performed before and after intervention using the Fibromyalgia Impact Questionnaire, the Visual Analogue Scale, the number of tender points (TPs), and the Wells bench sit and reach test score.
RESULTS


Both interventions produced significantly positive clinical effects in most aspects evaluated. However, only WG obtained significant improvements for the variables functional capacity, number of TPs, and flexibility.
CONCLUSIONS


The findings suggest that water-based exercise is effective as an adjuvant FM treatment, including FM-related physical and psychological health aspects.",2020,"Evaluations were performed before and after intervention using the Fibromyalgia Impact Questionnaire, the Visual Analogue Scale, the number of tender points (TPs), and the Wells bench sit and reach test score.
","['women with fibromyalgia', 'women with FM in relation to quality of life and physical aspects', 'FM women']","['water-based exercise group (WG) and land-based exercise group (LG', 'water-based and land-based therapies', 'water- and land-based exercises']","['Fibromyalgia Impact Questionnaire, the Visual Analogue Scale, the number of tender points (TPs), and the Wells bench sit and reach test score', 'variables functional capacity, number of TPs, and flexibility', 'quality of life and physical aspects', 'positive clinical effects']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0205170', 'cui_str': 'Good'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0554292,"Evaluations were performed before and after intervention using the Fibromyalgia Impact Questionnaire, the Visual Analogue Scale, the number of tender points (TPs), and the Wells bench sit and reach test score.
","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Britto', 'Affiliation': 'School of Medicine, Federal University of Maranhão, Pinheiro, Brazil.'}, {'ForeName': 'Vandilson', 'Initials': 'V', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Morphology, Federal University of Maranhão, São Luís, Brazil.'}, {'ForeName': 'Alcione M', 'Initials': 'AM', 'LastName': 'Dos Santos', 'Affiliation': 'Collective Health Graduate Program, Federal University of Maranhão, São Luís, Brazil.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rizzini', 'Affiliation': 'Collective Health Graduate Program, Federal University of Maranhão, São Luís, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Britto', 'Affiliation': 'Physiotherapy Service, Club Sante, São Luís, Brazil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Britto', 'Affiliation': 'Physiotherapy Service, Club Sante, São Luís, Brazil.'}, {'ForeName': 'João B S', 'Initials': 'JBS', 'LastName': 'Garcia', 'Affiliation': 'Health Science Graduate Program, Federal University of Maranhão, São Luís, Brazil.'}]",Musculoskeletal care,['10.1002/msc.1481']
560,32578029,"Reminiscence therapy-based care program relieves post-stroke cognitive impairment, anxiety, and depression in acute ischemic stroke patients: a randomized, controlled study.","BACKGROUND


Cognitive and mental impairments are common health problems in acute ischemic stroke (AIS) patients. In this study, we aimed to assess the benefit of a reminiscence therapy-based care (RTBC) program on cognitive impairment restoration, anxiety, and depression reduction in AIS patients.
METHODS


Totally 130 AIS patients were recruited in this randomized, controlled study and randomly assigned to the RTBC group or control group in 1:1 ratio for 12-month intervention. Mini-Mental State Examination (MMSE), Montreal cognitive assessment (MoCA), Hospital Anxiety and Depression Scale for anxiety/depression (HADS-A/HADS-D), and Zung self-rating anxiety/depression scale (SAS/SDS) were assessed at month 0 (M0), M3, M6, M9, and M12. Meanwhile, patients' satisfaction was also evaluated at M3, M6, M9, and M12.
RESULTS


RTBC increased MMSE score and MoCA score and reduced cognitive impairment patients' percentage assessed by MoCA score at M12 compared with control. RTBC reduced HADS-A score at M12, but not anxiety patients' percentage or severity by HADS-A at M12; besides, RTBC significantly lowered the SAS score at M9 and M12, and anxiety patients' percentage and severity by SAS at M12 compared with control. RTBC reduced HADS-D score at M9 and M12 (while statistically non-significant), but not depression patients' percentage or severity by HADS-D at M12; it decreased SDS score at M9 and M12, but not depression patients' percentage or severity by SDS at M12 compared with control. Additionally, RTBC obsessed higher patients' satisfaction at M3, M6, and M12 compared with control.
CONCLUSION


RTBC could help reduce cognitive impairment, anxiety, and depression in post-stroke management for AIS patients.",2021,"RTBC reduced HADS-A score at M12, but not anxiety patients' percentage or severity by HADS-A at M12; besides, RTBC significantly lowered the SAS score at M9 and M12, and anxiety patients' percentage and severity by SAS at M12 compared with control.","['acute ischemic stroke patients', 'acute ischemic stroke (AIS) patients', 'Totally 130 AIS patients', 'AIS patients']","['Reminiscence therapy-based care program', 'RTBC', 'reminiscence therapy-based care (RTBC) program']","['RTBC reduced HADS-D score', 'cognitive impairment restoration, anxiety, and depression reduction', 'MoCA score', ""SAS score at M9 and M12, and anxiety patients' percentage and severity by SAS"", 'MMSE score and MoCA score', 'Mini-Mental State Examination (MMSE), Montreal cognitive assessment (MoCA), Hospital Anxiety and Depression Scale for anxiety/depression (HADS-A/HADS-D), and Zung self-rating anxiety/depression scale (SAS/SDS', 'RTBC reduced HADS-A score', 'cognitive impairment, anxiety, and depression', 'SDS score']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}]",130.0,0.03323,"RTBC reduced HADS-A score at M12, but not anxiety patients' percentage or severity by HADS-A at M12; besides, RTBC significantly lowered the SAS score at M9 and M12, and anxiety patients' percentage and severity by SAS at M12 compared with control.","[{'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Harbin Medical University, 246 Xuefu Road, Harbin, 150001, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Harbin Medical University, 246 Xuefu Road, Harbin, 150001, China. xintong2871964996@163.com.'}]",Irish journal of medical science,['10.1007/s11845-020-02273-9']
561,32576042,SHORT-TERM VERSUS 6-WEEK PREDNISONE IN THE TREATMENT OF SUBACUTE THYROIDITIS: A RANDOMIZED CONTROLLED TRIAL.,"Objective : Moderate-to-severe subacute thyroiditis is clinically managed with 6-8 weeks of glucocorticoid therapy. However, no studies have evaluated short-term prednisone treatment for subacute thyroiditis.  Methods : This 24-week, prospective, single-blind, randomized controlled study enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014. Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/d prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy. The primary endpoint was intergroup differences in treatment efficacy at the end of treatment course. Secondary endpoints included between-group differences in post-withdrawal adverse effect parameters and thyroid function at weeks 6, 12, and 24.  Results : We screened 96 patients, randomized 52 participants, and 50 completed the study. Efficacy and recurrence rates were not significantly different at withdrawal in both groups ( P=0.65 ). At treatment discontinuation, parathyroid hormone (28.8 vs 38.9 pg/mL,  p=0.011 ) and systolic blood pressure (113.9 vs 122.4 mmHg,  p=0.023 ) were significantly lower in the experimental group than in the control group. There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24.  Conclusions : Fewer side effects of glucocorticoids and similar efficacy and recurrence rates were observed with short-term prednisone compared with in the 6-week treatment for subacute thyroiditis. Short-term prednisone with a better safety profile may be an alternative strategy for ameliorating moderate-to-severe symptoms of subacute thyroiditis.",2020,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24.  ","['Patients with moderate-to-severe symptoms', '96 patients, randomized 52 participants, and 50 completed the study', 'enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014']","['30 mg/d prednisone', 'prednisone', 'nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy', 'glucocorticoid therapy', 'glucocorticoids']","['Efficacy and recurrence rates', 'treatment efficacy', 'post-withdrawal adverse effect parameters and thyroid function', 'systolic blood pressure', 'efficacy and recurrence rates', 'parathyroid hormone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040149', 'cui_str': 'Subacute thyroiditis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",52.0,0.0775229,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24.  ","[{'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': 'From: Department of Endocrinology, The Third Affiliated Hospital of Chongqing Medical University (Jie er Hospital), Chongqing, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rufei', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Hongting', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0096']
562,32574478,Single-Sided Deafness-Outcomes of Three Interventions for Profound Unilateral Sensorineural Hearing Loss: A Randomized Clinical Trial.,"OBJECTIVE


A comparison of three interventions for profound unilateral sensorineural hearing loss.
STUDY DESIGN


Prospective, crossover randomized clinical trial.
PARTICIPANTS


Fifteen participants with profound unilateral sensorineural hearing loss.
INTERVENTIONS


Three potential technical interventions were compared: Bone Conduction Device on softband, Contralateral Routing of Signal (CROS), and Remote Microphone . Each intervention was randomly trialed for a period of 3 weeks, separated by a 1 week washout period.
OUTCOME MEASURES


Speech in noise recognition test performed under four conditions (lateral noise poorer ear, lateral noise better ear, speech poorer ear, speech better ear). Standardized questionnaires (Abbreviated Profile of Hearing Aid Benefit, Bern Benefit in Single Sided Deafness Questionnaire, and Speech, Spatial, and Other Qualities 12) were used to evaluate amplification benefit at baseline and following each intervention.
RESULTS


The use of remote microphone provided the best results in the speech recognition in noise test. A benefit in some signal-to-noise ratios was presented of the CROS over bone conduction device on softband in the Speech Poor Ear condition. On questionnaires of benefit, participants did not rate a particular intervention as significantly better than any other. Following the study, CROS was the intervention preferred by the 8 of 15 participants (53%). The majority of participants (80%) chose to continue with an intervention rather than no treatment.
CONCLUSION


The use of all interventions resulted in increased performance in speech recognition in noise and rated higher on subjective benefits in comparison with baseline. People with SSD are a heterogeneous population when considering perceived difficulties. Future research should focus on segmenting the population of SSD depending on factors such as etiology, high frequency loss in the better ear, and age of acquired loss for the poorer ear. This stratification may possibly increase the benefit for the patient in terms of more individual-based clinical routines.",2020,The use of all interventions resulted in increased performance in speech recognition in noise and rated higher on subjective benefits in comparison with baseline.,"['Fifteen participants with profound unilateral sensorineural hearing loss', 'Profound Unilateral Sensorineural Hearing Loss']",[],"['Bone Conduction Device on softband, Contralateral Routing of Signal (CROS), and Remote Microphone ', 'Speech in noise recognition test performed under four conditions (lateral noise poorer ear, lateral noise better ear, speech poorer ear, speech better ear', 'performance in speech recognition']","[{'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}]",[],"[{'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",15.0,0.0614705,The use of all interventions resulted in increased performance in speech recognition in noise and rated higher on subjective benefits in comparison with baseline.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Fogels', 'Affiliation': 'Division of Audiology, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Radi', 'Initials': 'R', 'LastName': 'Jönsson', 'Affiliation': 'Department of Otorhinolaryngology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Division of Audiology, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Better Health, Healthcare and Treatment Global Impact Cluster, Research and Innovation, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Flynn', 'Affiliation': 'School of Humanities and Social Science, Faculty of Education and Arts, University of New Castle, Australia.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002633']
563,32444161,Using a Mobile Phone Application Versus Telephone Assistance During Cardiopulmonary Resuscitation: A Randomized Comparative Study.,"INTRODUCTION


In recent years, the way CPR instructions are given has changed because of the development of new technology that allows bystanders who witness a cardiac arrest to be guided in performing CPR. This study aimed to compare the effectiveness of using a mobile phone application (app) versus telephone operator assistance in performing cardiopulmonary resuscitation (CPR) techniques in simulated settings.
METHODS


A comparative study was performed with 2 intervention groups: (1) mobile phone app and (2) telephone assistance. A total of 128 students participated and were distributed randomly into each intervention group. A CPR observation checklist and standard CPR quality parameter measurements were used for data collection.
RESULTS


The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.81; P < 0.05), asking for help (X 2 (1) = 66.07; P < 0.05), opening of airways (X 2 (1) = 12.03; P < 0.05), checking for breathing (X 2 (1) = 6.10; P < 0.05), and contacting emergency services (X 2 (1) = 12.41; P < 0.05). Regarding the skill level of CPR, no statistically significant differences were found when comparing the 2 intervention groups (X 2 (1) = 0.91; P = 0.33). As for the parameters measured, there were only statistically significant differences found in the item compression fraction (U = 1,593.00; Z = -2.16; P < 0.05), with the group that used the app obtaining better results.
DISCUSSION


Better outcomes were observed in recognizing if the area was safe, asking for help, opening up the airways, checking for breathing, and calling emergency services in the mobile phone app group. However, the results indicated that there were no differences in the CPR parameters, except compression fraction, when the app was used as opposed to being guided by telephone.",2020,"The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.812; P < 0.05), asking for help (X 2 (1) =","['128 students participated', 'During Cardiopulmonary Resuscitation']","['mobile phone application (app) versus telephone operator assistance', 'Mobile Phone Application Versus Telephone Assistance', 'mobile phone app and (2) telephone assistance']","['CPR parameters, except compression fraction', 'contacting emergency services', 'item compression fraction', 'checking for breathing', 'opening of airways']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",128.0,0.0187919,"The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.812; P < 0.05), asking for help (X 2 (1) =","[{'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Márquez-Hernández', 'Affiliation': ''}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Gutiérrez-Puertas', 'Affiliation': ''}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Garrido-Molina', 'Affiliation': ''}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'García-Viola', 'Affiliation': ''}, {'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Granados-Gámez', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Aguilera-Manrique', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.03.015']
564,32469084,"The impact of high-fidelity simulation on knowledge, critical thinking, and clinical decision-making for the management of pre-eclampsia.","OBJECTIVE


To investigate the impact of high-fidelity simulation on nursing students' knowledge, critical thinking, and clinical decision-making in the management of pre-eclampsia, and to explore the students' views and learning experiences.
METHODS


A mixed-methods design study was conducted on 107 third-year nursing students. The students were randomly assigned to the control group (n=54) or the experimental group (n=53). The students in the experimental group attended the simulation training using a high-fidelity simulator, while the students in the control group attended only the classical training on ""the management of pre-eclampsia.""
RESULTS


Knowledge (P<0.001), critical thinking (P<0.05), and clinical decision-making (P<0.05) scores of students in the experimental group increased after the simulation. In the focus group interviews, five themes were identified: learning development; closing the gap between theory and practice; confident decision-making and self-confidence; professional preparation; and recommendations.
CONCLUSION


High-fidelity simulation is efficacious for improving the management of pre-eclampsia among nursing students.",2020,"RESULTS


Knowledge (P<0.001), critical thinking (P<0.05), and clinical decision-making (P<0.05) scores of students in the experimental group increased after the simulation.",['107 third-year nursing students'],"['simulation training using a high-fidelity simulator, while the students in the control group attended only the classical training on ""the management of pre-eclampsia', 'High-fidelity simulation']",[],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]",[],5.0,0.0259582,"RESULTS


Knowledge (P<0.001), critical thinking (P<0.05), and clinical decision-making (P<0.05) scores of students in the experimental group increased after the simulation.","[{'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Akalin', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Duzce University, Duzce, Turkey.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Sahin', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Ankara Yildirim Beyazit University, Ankara, Turkey.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13243']
565,32468883,The use of mind mapping in health education in extended care for children with caries.,"OBJECTIVE


To investigate the application of mind mapping-based health education in extended care for children with caries.
METHODS


This was a prospective study of 159 eligible children with caries. Participants were randomly assigned to an observation group and a control group, and received extended health education and guidance. Patients in the observation group received health education with mind mapping. In the third month after the first visit, a questionnaire survey was conducted to assess knowledge of extended caries diagnosis and treatment in children and their parents. Children also underwent a bacterial plaque test.
RESULTS


Caries knowledge was significantly greater in the observation group than in the control group. There was no significant between-group difference in debris index on the bacterial plaque test. The observation group had a significantly greater number of follow-up visits in 12 months than the control group.
CONCLUSIONS


Mind mapping was effective in the implementation of extended care. Mind mapping information was more accessible to children and their parents, increasing their compliance with health education. Thus, mind mapping is an appropriate health education tool for use in extended care for children with caries.",2020,There was no significant between-group difference in debris index on the bacterial plaque test.,"['159 eligible children with caries', 'children with caries']","['health education with mind mapping', 'mind mapping-based health education', 'control group, and received extended health education and guidance']","['number of follow-up visits', 'Caries knowledge', 'debris index']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",159.0,0.0311492,There was no significant between-group difference in debris index on the bacterial plaque test.,"[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Comprehensive, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Xue-Bin', 'Initials': 'XB', 'LastName': 'Gao', 'Affiliation': 'Department of Pediatric Dentistry, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Ming-He', 'Initials': 'MH', 'LastName': 'Li', 'Affiliation': 'Department of Dentofacial Surgery, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Department of Pediatric Dentistry, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Pediatric Dentistry, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Comprehensive, Hospital of Stomatology, Jilin University, Changchun, China.'}]",The Journal of international medical research,['10.1177/0300060519898053']
566,31815770,"Development of an Alarm Algorithm, With Nanotechnology Multimodal Sensor, to Predict Impending Infusion Failure and Improve Safety of Peripheral Intravenous Catheters in Neonates.","BACKGROUND


Peripheral intravenous catheters connected to an infusion pump are necessary for the delivery of fluids, nutrition, and medications to hospitalized neonates but are not without complications. These adverse events contribute to hospital-acquired patient harm. An artificial intelligence theory called fuzzy logic may allow the use of appropriate variables to predict infusion failure.
PURPOSE


This innovative study aimed to develop an intravenous infusion nanotechnology monitoring system that would alert the nurse to impending peripheral intravenous infusion failure.
METHODS


An intravenous infusion nanotechnology monitoring system, using predictor variables of pressure, pH, and oxygen saturation used in a fuzzy logic alarm algorithm was developed to alert the nurse to impending peripheral intravenous infusion failure.
FINDINGS


The developed intravenous infusion nanotechnology monitoring system is composed of a peripheral intravenous catheter with nanotechnology multimodal sensor, an intravenous pump, a fuzzy logic algorithm, and alarm. For example, using this system, an elevated in-line pressure, a low pH, and a low venous oxygen level would generate an alarm for possible impending infusion failure.
IMPLICATIONS FOR PRACTICE


With further development, this technology may help nurses predict and prevent adverse outcomes from intravenous infusions. This work shows how nurses can be content experts and innovators of technology that they use to make clinical decisions.
IMPLICATIONS FOR RESEARCH


After regulatory approval, a randomized controlled trial may be performed to investigate whether interventions at the time of an alarm would result in fewer adverse outcomes and improve safety.",2020,"This innovative study aimed to develop an intravenous infusion nanotechnology monitoring system that would alert the nurse to impending peripheral intravenous infusion failure.
",['Neonates'],[],[],"[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]",[],[],,0.0554223,"This innovative study aimed to develop an intravenous infusion nanotechnology monitoring system that would alert the nurse to impending peripheral intravenous infusion failure.
","[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Bosque', 'Affiliation': ""Neonatology Regional Program, Seattle Children's Hospital, Seattle, Washington.""}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000690']
567,32466729,"Computable Phenotype Implementation for a National, Multicenter Pragmatic Clinical Trial: Lessons Learned From ADAPTABLE.","BACKGROUND


Many large-scale cardiovascular clinical trials are plagued with escalating costs and low enrollment. Implementing a computable phenotype, which is a set of executable algorithms, to identify a group of clinical characteristics derivable from electronic health records or administrative claims records, is essential to successful recruitment in large-scale pragmatic clinical trials. This methods paper provides an overview of the development and implementation of a computable phenotype in ADAPTABLE (Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness)-a pragmatic, randomized, open-label clinical trial testing the optimal dose of aspirin for secondary prevention of atherosclerotic cardiovascular disease events.
METHODS AND RESULTS


A multidisciplinary team developed and tested the computable phenotype to identify adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria. Using the computable phenotype, investigators identified over 650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network-a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks. Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019. During the process of developing and implementing the ADAPTABLE computable phenotype, several key lessons were learned. The accuracy and utility of a computable phenotype are dependent on the quality of the source data, which can be variable even with a common data model. Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns. Sustained collaboration among a diverse team of researchers is needed during computable phenotype development and implementation.
CONCLUSIONS


The ADAPTABLE computable phenotype served as an efficient method to recruit patients in a multisite pragmatic clinical trial. This process of development and implementation will be informative for future large-scale, pragmatic clinical trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02697916.",2020,"Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns.","['Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019', '650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network-a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks', 'adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria']","['Aspirin', 'aspirin']",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0018727', 'cui_str': 'Health Planning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]",[],15076.0,0.152651,"Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns.","[{'ForeName': 'Faraz S', 'Initials': 'FS', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (F.S.A.).'}, {'ForeName': 'Iben M', 'Initials': 'IM', 'LastName': 'Ricket', 'Affiliation': 'Louisiana Public Health Institute, New Orleans (I.M.R.).'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Hammill', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Eskenazi', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Robertson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Lesley H', 'Initials': 'LH', 'LastName': 'Curtis', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Cecilia D', 'Initials': 'CD', 'LastName': 'Dobi', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA (C.D.D.).'}, {'ForeName': 'Saket', 'Initials': 'S', 'LastName': 'Girotra', 'Affiliation': 'University of Iowa Carver College of Medicine, Iowa City (S.G.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'Scientific Affairs, HealthCore, Inc., Wilmington, DE (K.H.).'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Kizer', 'Affiliation': 'Cardiology Section, San Francisco Veterans Affairs Health Care System, CA (J.R.K.).'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, Health Services Research and Development Center, Nashville, TN (S.K., C.L.R.).'}, {'ForeName': 'Mathew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, Health Services Research and Development Center, Nashville, TN (S.K., C.L.R.).'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Waitman', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS (R.W.).'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Weiner', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, New York Presbyterian-Weill Cornell Campus, New York (M.G.W.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006292']
568,32475159,Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study.,"Background The objectives of this study were to develop and test in real-world clinical practice the effectiveness of a comprehensive postacute stroke transitional care (TC) management program. Methods and Results The COMPASS study (Comprehensive Post-Acute Stroke Services) was a pragmatic cluster-randomized trial where the hospital was the unit of randomization. The intervention (COMPASS-TC) was initiated at 20 hospitals, and 20 hospitals provided their usual care. Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018. COMPASS-TC was patient-centered and assessed social and functional determinates of health to inform individualized care plans. Ninety-day outcomes were evaluated by blinded telephone interviewers. The primary outcome was functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls. The primary analysis was intention to treat. Of intervention hospitals, 58% had uninterrupted intervention delivery. Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit. The primary outcome was measured for 59% of patients and was not significantly influenced by the intervention. Mean Stroke Impact Scale-16 (±SD) was 80.6±21.1 in TC versus 79.9±21.4 in usual care. Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]). No other secondary outcomes differed. Conclusions Although designed according to the best available evidence with input from various stakeholders and consistent with Centers for Medicare and Medicaid Services TC policies, the COMPASS model of TC was not consistently incorporated into real-world health care. We found no significant effect of the intervention on functional status at 90 days post-discharge. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.",2020,"Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]).","['Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit', 'Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018']",['comprehensive postacute stroke transitional care (TC) management program'],"['Home blood pressure monitoring', 'functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls', 'Mean Stroke Impact Scale-16 (±SD', 'functional status']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0031228', 'cui_str': 'Hospital Personnel'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",6024.0,0.100697,"Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]).","[{'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Psioda', 'Affiliation': 'Department of Biostatistics, Collaborative Studies Coordinating Center (M.A.P.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Social Sciences and Health Policy, Division of Public Health Sciences (S.B.G.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Ralph B', 'Initials': 'RB', 'LastName': ""D'Agostino"", 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science (R.B.D., W.T.A.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Mysha E', 'Initials': 'ME', 'LastName': 'Sissine', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Sylvia W', 'Initials': 'SW', 'LastName': 'Coleman', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Blair F', 'Initials': 'BF', 'LastName': 'Barton-Percival', 'Affiliation': 'Area Agency on Aging, Piedmont Triad Regional Council, Kernersville, NC (B.F.B.-P., A.G.C.).'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Prvu-Bettger', 'Affiliation': 'Duke University School of Medicine, Durham, NC (J.P.-B., A.M.P.).'}, {'ForeName': 'Adrienne G', 'Initials': 'AG', 'LastName': 'Calhoun', 'Affiliation': 'Area Agency on Aging, Piedmont Triad Regional Council, Kernersville, NC (B.F.B.-P., A.G.C.).'}, {'ForeName': 'Doyle M', 'Initials': 'DM', 'LastName': 'Cummings', 'Affiliation': 'Brody School of Medicine, East Carolina University, Greenville, NC (D.M.C.).'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'Department of Physical Therapy School of Health and Rehabilitation Science, University of Pittsburgh, PA (J.K.F.).'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Halladay', 'Affiliation': 'Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill (J.R.H.).'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kucharska-Newton', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Lundy-Lamm', 'Affiliation': 'Minority Women Health Alliance (TriStroke), Raleigh, NC (G.L.-L.).'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Lutz', 'Affiliation': 'University of North Carolina at Wilmington School of Nursing (B.J.L.).'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Mettam', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Pastva', 'Affiliation': 'Duke University School of Medicine, Durham, NC (J.P.-B., A.M.P.).'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Xenakis', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health (J.G.X.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science (R.B.D., W.T.A.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Meghan D', 'Initials': 'MD', 'LastName': 'Radman', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Vetter', 'Affiliation': 'American Heart Association, Raleigh, NC (B.V.).'}, {'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006285']
569,32473216,"High-School Students Can Stop the Bleed: A Randomized, Controlled Educational Trial.","OBJECTIVE


To determine high-school students' ability to learn hemorrhage control skills and knowledge via 3 educational modalities.
BACKGROUND


Trauma is the leading cause of death for young Americans, and there are calls to teach children about hemorrhage control. However, little is known about adolescents' ability to perform hemorrhage control, and the ideal way(s) to teach them.
METHODS


This randomized controlled trial enrolled high-school students from 39 states at a 2019 national conference. After answering questions about their willingness to use tourniquets, participants received hemorrhage control education in 1 of 3 formats: instructor-led, web-only, or blended (combining web and instructor-led). Participants were then assessed on their ability to apply a tourniquet and to identify wounds that require a tourniquet. Finally, they completed an attitude questionnaire.
RESULTS


Two hundred and four (82%) of 248 participants applied a tourniquet correctly: 72 (88%) instructor-led, 50 (61%) web-only, and 79 (94%) blended. The instructor-led and blended arms were superior to the web-only arm (P < .001). Nearly all participants passed an assessment requiring them to identify wounds warranting a tourniquet (99% instructor-led and blended, and 98% web-only). All modalities improved participants' self-reported willingness and comfort in using tourniquets (P < .001).
CONCLUSIONS


This is the first study to demonstrate that high-school students can learn hemorrhage control via multiple methods. Blended and instructor-led education led to highly successful skill performance. Students learned to identify wounds requiring tourniquets and showed an improved willingness to aid from all modalities. These findings should encourage educators to offer multiple educational modalities.",2021,Participants were then assessed on their ability to apply a tourniquet and to identify wounds that require a tourniquet.,"['High-School Students Can Stop the Bleed', 'enrolled high-school students from 39 states at a 2019 national conference', 'high school students', 'young Americans']",[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],[],,0.114711,Participants were then assessed on their ability to apply a tourniquet and to identify wounds that require a tourniquet.,"[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Goolsby', 'Affiliation': 'Department of Military and Emergency Medicine, Uniformed Services University of the Health Sciences (C Goolsby), Bethesda, Md; National Center for Disaster Medicine and Public Health (C Goolsby, LE Rojas, and RH Rodzik), Rockville, Md. Electronic address: craig.goolsby@usuhs.edu.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Rojas', 'Affiliation': 'National Center for Disaster Medicine and Public Health (C Goolsby, LE Rojas, and RH Rodzik), Rockville, Md; The Henry M. Jackson Foundation for the Advancement of Military Medicine (LE Rojas and RH Rodzik), Bethesda, Md.'}, {'ForeName': 'Raphaelle H', 'Initials': 'RH', 'LastName': 'Rodzik', 'Affiliation': 'National Center for Disaster Medicine and Public Health (C Goolsby, LE Rojas, and RH Rodzik), Rockville, Md; The Henry M. Jackson Foundation for the Advancement of Military Medicine (LE Rojas and RH Rodzik), Bethesda, Md.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gausche-Hill', 'Affiliation': 'Los Angeles County Emergency Medical Services Agency (M Gausche-Hill), Los Angeles, Calif; Departments of Emergency Medicine and Pediatrics, David Geffen School of Medicine at the University of California (M Gausche-Hill), Los Angeles, Calif; Departments of Emergency Medicine and Pediatrics, Harbor-UCLA Medical Center (M Gausche-Hill), Torrance, Calif.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Departments of Surgery, Critical Care Medicine, and the Clinical and Translational Science Institute (CTSI), University of Pittsburgh (MD Neal), Pittsburgh, Pa; University of Pittsburgh Medical Center (MD Neal), Pittsburgh, Pa.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Levy', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University School of Medicine (MJ Levy), Baltimore, Md; Howard County Department of Fire and Rescue Services (MJ Levy), Columbia, Md.'}]",Academic pediatrics,['10.1016/j.acap.2020.05.012']
570,32470312,Neuromuscular electrical stimulation and protein during bed rest increases CD11b +  skeletal muscle macrophages but does not correspond to muscle size or insulin sensitivity.,"With this cohort, we previously demonstrated preservation of thigh lean tissue with neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO) treatment during bed rest in healthy older adults. Because macrophage polarization plays a significant role in the repair and maintenance of muscle size and insulin sensitivity, we hypothesized that muscle macrophages would be induced by NMES+PRO and would correspond to an increase in lean mass and an attenuated insulin resistance response altered by bed rest. Older adults (60-80 years old; body mass index < 30 kg/m 2 ) underwent 5 days of bed rest and were randomized to either thrice daily treatment of NMES+PRO ( n  = 8) or CON ( n  = 8). Lean mass, insulin sensitivity, and markers of muscle macrophages, inflammation, and connective tissue were determined before and after bed rest. Glucose intolerance and insulin resistance occurred after bed rest but there was not a treatment effect ( p  > 0.10). Proinflammatory-like macrophages (CD11b + , CD206 - ) increased ( p  < 0.05) with NMES+PRO treatment and was different than CON. Minor changes in noncontractile tissue were observed. However, changes in muscle macrophages or extracellular matrix were not related to the preservation of thigh lean mass or insulin resistance. Daily NMES+PRO treatment during bed rest induced a muscle proinflammatory-like macrophage response and was unrelated to muscle size or metabolic function. This study is listed as clinical trial NCT02566590.  Novelty  Neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO) increased proinflammatory-like macrophages and extracellular matrix content in older adults after bed rest. NMES+PRO changes in macrophages and noncontractile tissue macrophages were not related to muscle size preservation or insulin sensitivity.",2020,"Pro-inflammatory-like macrophages (CD11b+,CD206-) increased (p<0.05) with NMES+PRO treatment and was different than CON.","['Older adults (60-80y; BMI <30 kg/m2) underwent 5-days of bed rest', 'healthy older adults', 'older adults after bed rest']","['NMES+PRO', 'NMES+PRO(n=8) or CON', 'Daily NMES+PRO', 'neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO', 'Neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO']","['insulin resistance response', 'Lean mass, insulin sensitivity, and markers of muscle macrophages, inflammation and connective tissue', 'Glucose intolerance and insulin resistance', 'Pro-inflammatory-like macrophages (CD11b+,CD206', 'Novelty Bullets •']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}]",,0.065583,"Pro-inflammatory-like macrophages (CD11b+,CD206-) increased (p<0.05) with NMES+PRO treatment and was different than CON.","[{'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Reidy', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Logan T', 'Initials': 'LT', 'LastName': 'Edvalson', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Alec I', 'Initials': 'AI', 'LastName': 'McKenzie', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Petrocelli', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Ziad S', 'Initials': 'ZS', 'LastName': 'Mahmassani', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Micah J', 'Initials': 'MJ', 'LastName': 'Drummond', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0064']
571,32634624,Effects of Screening Compliance on Long-Term Reductions in All-Cause and Colorectal Cancer Mortality.,"BACKGROUND & AIMS


Randomized trials have shown that biennial fecal occult blood test (FOBT) screening reduces mortality from colorectal cancer (CRC), but not overall mortality. Differences in benefit for men vs women, and by age, are unknown. We sought to evaluate long-term reduction in all-cause and CRC-specific mortality in men and women who comply with offered screening, and in different age groups, using individual participant data from 2 large randomized trials of biennial FOBT screening, compared with an intention to treat analysis.
METHODS


We updated the CRC and all-cause mortality from the Danish CRC screening trial (n = 61,933) through 30 years of follow up and pooled individual participant data with individual 30-year follow-up data from the Minnesota Colon Cancer Control trial (n = 46,551). We compared the biennial screening groups to usual care (controls) in individuals 50-80 years old using Kaplan Meier estimates of relative risks and risk differences, adjusted for study differences in age, sex, and compliance.
RESULTS


Through 30 years of follow up, there were 33,478 (71.9%) and 33,479 (72.2%) total deaths and 1023 (2.2%) and 1146 (2.5%) CRC deaths in the biennial screening (n = 46,553) and control groups (n = 46,358), respectively. Among compliers, biennial FOBT screening significantly reduced CRC mortality by 16% (relative risk [RR], 0.84; 95% CI, 0.74-0.96) and all-cause mortality by 2% (RR, 0.98; 95% CI, 0.97-0.99). Among compliers, the reduction in CRC mortality was larger for men (RR, 0.75; 95% CI, 0.62-0.90) than women (RR, 0.91; 95% CI, 0.75-1.09). The largest reduction in CRC mortality was in compliant men 60-69 years old (RR, 0.59; 95% CI, 0.42-0.81) and women 70 years and older (RR, 0.53; 95% CI, 0.30-0.94).
CONCLUSIONS


Long-term CRC mortality outcomes of screening among compliers using biennial FOBT are sustained, with a statistically significant reduction in all-cause mortality. The reduction in CRC mortality is greater in men than women-the benefit in women lags that of men by about 10 years.",2020,"Among compliers, the reduction in CRC mortality was larger for men (RR, 0.75; 95% CI, 0.62-0.90) than women (RR, 0.91; 95% CI, 0.75-1.09).","['men and women who comply with offered screening, and in different age groups']","['biennial screening groups to usual care (controls', 'biennial FOBT screening']","['total deaths', 'CRC mortality', 'CRC deaths', 'cause mortality', 'Colorectal Cancer Mortality']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",61933.0,0.195055,"Among compliers, the reduction in CRC mortality was larger for men (RR, 0.75; 95% CI, 0.62-0.90) than women (RR, 0.91; 95% CI, 0.75-1.09).","[{'ForeName': 'Aasma', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'Division of Gastroenterology, Minneapolis Veterans Affairs Healthcare System Minneapolis, Minnesota; Department of Medicine, University of Minnesota School of Medicine, Minneapolis, Minnesota; Division of Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis, Minnesota. Electronic address: shaukat@umn.edu.'}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Kaalby', 'Affiliation': 'Open Patient Data Explorative Network, Odense University Hospital and University of Southern Denmark, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Baatrup', 'Affiliation': 'Open Patient Data Explorative Network, Odense University Hospital and University of Southern Denmark, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Kronborg', 'Affiliation': 'Open Patient Data Explorative Network, Odense University Hospital and University of Southern Denmark, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Duval', 'Affiliation': 'Cardiovascular Division, University of Minnesota Medical School, Minneapolis, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shyne', 'Affiliation': 'Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}, {'ForeName': 'Jack S', 'Initials': 'JS', 'LastName': 'Mandel', 'Affiliation': 'Division of Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Church', 'Affiliation': 'Division of Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.06.019']
572,32618627,Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial.,"BACKGROUND


Perioperative pediatric anxiety is common and can have a negative psychological impact on children undergoing surgery and anesthesia. Studies have shown an incidence of anxiety at induction of up to 50%. Audiovisual distraction, including virtual reality (VR), is a noninvasive, nonpharmacological modality that may reduce perioperative anxiety. The goal of this study was to determine whether immersive audiovisual distraction with a VR headset during induction of general anesthesia (GA) in pediatric patients reduced preoperative anxiety.
METHODS


In this randomized-controlled, parallel-group study, 71 children 5-12 years of age scheduled for elective surgery with GA were randomly allocated to a VR group or a non-VR (No VR) control group. VR group patients underwent audiovisual distraction with a VR headset during induction in the operating room, whereas the control group received no audiovisual distraction. The primary outcome was the Modified Yale Preoperative Anxiety Scale (mYPAS), which was measured at 3 time points to assess patient anxiety: in the preoperative holding area before randomization, on entering the operating room, and during induction of GA. The primary outcome was analyzed using univariate analysis and a linear mixed-effects model. Secondary outcomes included postinduction parental anxiety measured by the State-Trait Anxiety Inventory, pediatric induction compliance, and parental satisfaction.
RESULTS


Average patient age was 8.0 ± 2.3 years (mean ± standard deviation [SD]), and 51.4% of patients were female. Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients). No patients received preoperative anxiolytic medication. Baseline mYPAS scores were not different between the groups, with scores of 28.3 (23.3-28.3) (median [interquartile range {IQR}]) in both. The change in mYPAS scores from baseline to time of induction was significantly lower in the VR group versus control group (0.0 [0.0-5.0] vs 13.3 [5.0-26.7]; P < .0001). In the mixed-effects model, the VR group had an estimated 6.0-point lower mYPAS score (95% confidence interval [CI], 0.7-11.3; P = .03) at room entry than the No VR group, and 14.5-point lower score (95% CI, 9.3-19.8; P < .0001) at induction versus control. Randomization to VR did not alter parental anxiety (0 [-2 to 2]), pediatric induction compliance (0 [0-0]), or parental satisfaction (-3 [-8 to 2]) (difference in medians [95% CI]).
CONCLUSIONS


This study demonstrates a reduction in pediatric preoperative anxiety with the use of VR. Preoperative VR may be an effective noninvasive modality for anxiolysis during induction of anesthesia in children.",2021,Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients).,"['children', 'Average patient age was 8.0 ± 2.3 years (mean ± standard deviation [SD]), and 51.4% of patients were female', 'children undergoing surgery and anesthesia', '71 children 5-12 years of age scheduled for elective surgery with GA', 'pediatric patients reduced preoperative anxiety']","['Anesthesia With Virtual Reality and Perioperative Anxiolysis', 'immersive audiovisual distraction with a VR headset during induction of general anesthesia (GA', 'Audiovisual distraction, including virtual reality (VR', 'audiovisual distraction with a VR headset', 'preoperative anxiolytic medication', 'Pediatric Distraction', 'control group received no audiovisual distraction', 'VR group or a non-VR (No VR) control group']","['Modified Yale Preoperative Anxiety Scale (mYPAS), which was measured at 3 time points to assess patient anxiety', 'pediatric induction compliance (0 [0-0]), or parental satisfaction (-3 ', 'postinduction parental anxiety measured by the State-Trait Anxiety Inventory, pediatric induction compliance, and parental satisfaction', 'mYPAS score', 'pediatric preoperative anxiety', 'parental anxiety', 'perioperative anxiety', 'Baseline mYPAS scores', 'mYPAS scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1961138', 'cui_str': 'Induction of minimal sedation'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",71.0,0.0798988,Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Jung', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Libaw', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Whitlock', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Feiner', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Jina L', 'Initials': 'JL', 'LastName': 'Sinskey', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005004']
573,32588717,Sustained Effects From a School-Based Intervention Pilot Study for Children With Asthma and Anxiety.,"Children with chronic conditions (i.e., asthma) are more likely to have anxiety or depressive symptoms. Comorbid asthma and anxiety in children leads to increased morbidity, causing children to miss instructional time and parent/caregiver (CG) work absences. Asthma educational programs and mental health interventions have been developed, though no scalable programs integrate asthma education and mental health behavioral interventions for school-aged children. This study evaluated the sustained preliminary effects of an integrated asthma education and cognitive behavioral skills-building program, Creating Opportunities for Personal Empowerment for Asthma. Thirty-two children ages 8-12 years with asthma and symptoms of anxiety received the intervention. At 6-weeks postintervention, anxiety and CG-reported behavioral symptoms were significantly reduced, there were fewer missed doses of asthma controller medications, and asthma-related self-efficacy, personal beliefs, and the children's understanding of asthma significantly increased. Most children ( n  = 29, 91%) reported continued use of coping skills.",2020,"At 6-weeks postintervention, anxiety and CG-reported behavioral symptoms were significantly reduced, there were fewer missed doses of asthma controller medications, and asthma-related self-efficacy, personal beliefs, and the children's understanding of asthma significantly increased.","['school-aged children', 'Children with chronic conditions (i.e., asthma', 'Thirty-two children ages 8-12 years with asthma and symptoms of anxiety received the intervention', 'Personal Empowerment for Asthma', 'Children With Asthma and Anxiety']",['integrated asthma education and cognitive behavioral skills-building program'],"['continued use of coping skills', 'asthma controller medications, and asthma-related self-efficacy, personal beliefs', 'anxiety and CG-reported behavioral symptoms']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}]",32.0,0.0159614,"At 6-weeks postintervention, anxiety and CG-reported behavioral symptoms were significantly reduced, there were fewer missed doses of asthma controller medications, and asthma-related self-efficacy, personal beliefs, and the children's understanding of asthma significantly increased.","[{'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'McGovern', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Arcoleo', 'Affiliation': 'University of Rhode Island, Providence, RI, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Melnyk', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, OH, USA.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840520934178']
574,32598090,Effect of information and exercise programmes after lumbar disc surgery: A randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare two physiotherapy interventions following lumber disc surgery regarding effect on pain, functioning and fear of movement.
METHODS


This study is a prospective randomized controlled study. When admitted to hospital for first time lumbar disc surgery, the participants were randomized to one of two post-operative intervention groups: one group received information only and the other exercise in combination with information. Outcomes were collected at baseline, 6-8 weeks and 12-months post-surgery. The primary outcome was to record changes in back/hip pain and leg pain. Secondary outcomes were evaluation of changes in function, fear-avoidance beliefs and kinesiophobia.
RESULTS


Seventy patients completed the study and were included in the analysis, of which 37 were randomized to the group receiving information only and the remaining 33 receiving both exercise and information. For primary outcomes, at 12 months postoperatively, the group receiving both exercise and information had significantly lower leg pain compared with those receiving only information (p < .033). For secondary outcomes, at 12 months postoperatively, a significant difference (p < .027) was detected for function, which favoured those that received both exercise and information. There was no significant difference in the results for the other secondary outcomes. Both groups showed clinically important changes in relation to pain and function from baseline to 12 months. The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant.
CONCLUSION


Exercise in combination with information reduced leg pain and improved function, which was statistically more evident over a period of time. Postoperative physiotherapy after lumbar disc surgery could include exercises in addition to information, but perhaps not for all patients, as both groups improved, and the difference between the two groups was not clinically relevant.",2020,"The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant.
","['lumbar disc surgery', 'Seventy patients completed the study and were included in the analysis, of which 37']","['information and exercise programmes', 'information only and the other exercise in combination with information']","['leg pain', 'record changes in back/hip pain and leg pain', 'leg pain and improved function', 'pain, functioning and fear of movement', 'evaluation of changes in function, fear-avoidance beliefs and kinesiophobia']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",37.0,0.202768,"The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant.
","[{'ForeName': 'Eva Saltskår', 'Initials': 'ES', 'LastName': 'Jentoft', 'Affiliation': 'Orthopedic Clinic Kysthospitalet in Hagevik, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kvåle', 'Affiliation': 'Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Assmus', 'Affiliation': 'Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Vegard Pihl', 'Initials': 'VP', 'LastName': 'Moen', 'Affiliation': 'Western Norway University of Applied Sciences, Bergen, Norway.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1864']
575,32613374,Supportive health education reduces health care utilization and costs in Latinas with breast cancer and their caregivers.,"PURPOSE


To compare costs and relative cost savings from reductions in unscheduled health services use for two 8-week psychosocial interventions (telephone interpersonal counseling [TIPC], supportive health education [SHE]) delivered by telephone to Latinas with breast cancer and their informal caregivers. Cost information is required before adopting supportive care interventions as part of routine care. There is limited information on costs of producing supportive care interventions or their impact on service use.
METHODS


Latinas and their caregivers were randomized to either TIPC or SHE. At baseline and month 4, hospitalizations and urgent care and emergency department (ED) visits in the previous month were recorded. These were compared by trial arm for 181 survivors and 169 caregivers using logistic regression, adjusting for age and health services use at baseline.
RESULTS


Total cost per 100 survivors was $28,695 for SHE and $27,399 for TIPC. Urgent care and ED visits were reduced for survivors in SHE versus TIPC (odds ratio (OR) = 0.31, 95% confidence interval (CI) [0.12, 0.88], p = .03). For hospitalizations, OR for SHE versus TIPC was 0.59, 95% CI [0.26, 1.37], p = .07. There were no differences between trial arms for caregiver health services use. Cost savings for SHE versus TIPC from reductions in health services use per 100 survivors ranged from $800 for urgent care to $17,000 for ED visits and $13,000 for hospitalizations.
CONCLUSIONS


Based on this evidence, SHE can be a cost-saving supportive care solution that benefits not only survivors and caregivers, but also oncology practices reimbursed through episodes of care.",2021,"Urgent care and ED visits were reduced for survivors in SHE versus TIPC (odds ratio (OR) = 0.31, 95% confidence interval (CI) [","['Latinas and their caregivers', '181 survivors and 169 caregivers using logistic regression, adjusting for age and health services use at baseline', 'Latinas with breast cancer and their caregivers', 'Latinas with breast cancer and their informal caregivers']","['psychosocial interventions (telephone interpersonal counseling [TIPC], supportive health education [SHE', 'Supportive health education', 'TIPC or SHE', 'SHE versus TIPC']","['Cost savings', 'hospitalizations and urgent care and emergency department (ED) visits']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",,0.0690219,"Urgent care and ED visits were reduced for survivors in SHE versus TIPC (odds ratio (OR) = 0.31, 95% confidence interval (CI) [","[{'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Badger', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ, 85721, USA. tbadger@email.arizona.edu.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Segrin', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, 48824, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05593-9']
576,32479641,Secukinumab shows high and sustained efficacy in nail psoriasis: 2.5-year results from the randomized placebo-controlled TRANSFIGURE study.,"BACKGROUND


Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A, a cornerstone cytokine in psoriasis, has shown long-lasting efficacy and safety in the complete spectrum of psoriasis manifestations.
OBJECTIVES


To report the long-term (2·5-year) efficacy and safety of secukinumab in nail psoriasis.
METHODS


TRANSFIGURE, a double-blind, randomized, placebo-controlled, parallel-group, multicentre phase IIIb study in 198 patients, investigated secukinumab 150 mg and 300 mg in patients with moderate-to-severe nail psoriasis.
RESULTS


At week 16, the primary endpoint Nail Psoriasis Severity Index (NAPSI) was met, demonstrating superiority of secukinumab to placebo. The effect was sustained over 2·5 years with a large benefit for nail clearance, with mean NAPSI improvement of -73·3% and -63·6% with secukinumab 300 mg and 150 mg, respectively. At 2·5 years, secukinumab demonstrated sustained clinically significant reductions in total mean Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) quality-of-life (QoL) scores of -52·4% and -18·1%, and 70% and 71% of patients achieved a weighted NAPPA Patient Benefit Index global score of ≥ 2 with secukinumab 300 mg and 150 mg, respectively. Patients showed considerable improvements in the EuroQol 5-Dimension health status questionnaire at 2·5 years, reporting a decrease in pain and discomfort. No new safety findings were observed.
CONCLUSIONS


Secukinumab demonstrated strong and clinically meaningful efficacy for up to 2·5 years in nail psoriasis, with significant sustained QoL improvements and a favourable safety profile.",2021,"Patients showed considerable improvements in Euro-QoL 5-Dimension Health Status Questionnaire at 2.5 years, reporting decreased pain and discomfort.","['nail psoriasis', '198 patients, investigated secukinumab 150 and 300 mg in moderate to severe nail psoriasis patients']","['Secukinumab', 'secukinumab', 'placebo']","['NAil Psoriasis Severity Index (NAPSI', 'weighted NAPPA-PBI', 'Euro-QoL 5-Dimension Health Status Questionnaire', 'total mean Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) QoL scores', 'nail clearance with mean NAPSI improvement', 'pain and discomfort']","[{'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",198.0,0.366335,"Patients showed considerable improvements in Euro-QoL 5-Dimension Health Status Questionnaire at 2.5 years, reporting decreased pain and discomfort.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sullivan', 'Affiliation': 'Sutherland Hospital, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Arenberger', 'Affiliation': 'Department of Dermatovenereology, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jazayeri', 'Affiliation': 'Alliance Dermatology and Mohs Center, Phoenix, AZ, USA.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Universität Hamburg, Hamburg, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': 'Department of Dermatology, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'You', 'Affiliation': 'China Novartis Institutes for BioMedical Research, Shanghai, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Regnault', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Frueh', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",The British journal of dermatology,['10.1111/bjd.19262']
577,32490353,Putative modulation of the gut microbiome by probiotics enhances preference for novelty in a preliminary double-blind placebo-controlled study in ferrets.,"Background


Increasing evidence suggests a causal relationship between the gut microbiome and psychiatric illnesses. In particular, autism spectrum disorder is associated with gastrointestinal symptoms and alterations in the gut microbiome. Administration of probiotics is a commonly used strategy by caregivers of people with neurodevelopmental illness. However, evidence for successful improvement in gut microbiome and (behavioral) symptoms has been lacking.
Results


Here, we use a novel ferret model of maternal immune activation to show that high-dose probiotic administration in a placebo-controlled study design causes changes in the gut microbiome in the form of a transient increase in the administered bacterial species. In contrast, we found no differences in baseline microbiome composition or changes induced by probiotic administration between animals exposed in utero to maternal immune activation and control animals. However, the relative presence of several bacterial species correlated with an increased preference for novelty (object and conspecific). Intriguingly, several of the hits in this screen are species that have previously emerged in the literature as being associated with autism and anxiety.
Conclusions


Together, our results suggest that high-dose probiotic interventions may be beneficial for the adjunct treatment of psychiatric illnesses. Placebo-controlled clinical trials in humans are urgently needed.",2020,"In contrast, we found no differences in baseline microbiome composition or changes induced by probiotic administration between animals exposed in utero to maternal immune activation and control animals.",['caregivers of people with neurodevelopmental illness'],"['probiotics', 'Placebo']",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.209566,"In contrast, we found no differences in baseline microbiome composition or changes induced by probiotic administration between animals exposed in utero to maternal immune activation and control animals.","[{'ForeName': 'Supritha', 'Initials': 'S', 'LastName': 'Dugyala', 'Affiliation': 'Department of Biology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Travis S', 'Initials': 'TS', 'LastName': 'Ptacek', 'Affiliation': 'UNC Neuroscience Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Simon', 'Affiliation': 'UNC Neuroscience Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'UNC Neuroscience Center, University of North Carolina, Chapel Hill, NC, USA.'}]",Animal microbiome,['10.1186/s42523-020-00030-y']
578,32684099,"The effect of canola, sesame and sesame-canola oils on body fat and composition in adults: a triple-blind, three-way randomised cross-over clinical trial.","The present study aimed to examine the effect of replacing edible oils with sesame oil (SO), canola oil (CO) and sesame-canola oil (SCO) on body weight and composition in adults. Adults without any chronic diseases ( n  = 77) were entered a 4-week run-in period and then were randomised to receive SO, CO and SCO for their household use in 9-week intervention periods (separated by 4-week washout intervals). Anthropometric measurements, as well as body composition markers, were assessed at baseline, middle and after each intervention period. In total, 73 participants completed the study. Although significant time effects were seen for waist and hip circumference, waist-to-hip ratio, central obesity index, body adiposity index, muscle mass and body fat percent ( p time <.05), the treatment and treatment × time effects were not significant ( p >.05). The present clinical trial revealed that CO, SO and SCO might not differently affect body fat and composition. Trial registration code: IRCT2016091312571N6 (http://en.irct.ir/trial/12622).",2021,"Although significant time effects were seen for waist and hip circumference, waist-to-hip ratio, central obesity index, body adiposity index, muscle mass and body fat percent ( p   time <.05), the treatment and treatment × time effects were not significant ( p >.05).","['Adults without any chronic diseases ( n \u2009=\u200977', '73 participants completed the study', 'adults']","['SO, CO and SCO', 'canola, sesame and sesame-canola oils', 'replacing edible oils with sesame oil (SO), canola oil (CO) and sesame-canola oil (SCO']","['body weight and composition', 'waist and hip circumference, waist-to-hip ratio, central obesity index, body adiposity index, muscle mass and body fat percent']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036845', 'cui_str': 'Sesame Oil'}, {'cui': 'C0054599', 'cui_str': 'canola oil'}, {'cui': 'C1123051', 'cui_str': 'Sesame'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",77.0,0.100148,"Although significant time effects were seen for waist and hip circumference, waist-to-hip ratio, central obesity index, body adiposity index, muscle mass and body fat percent ( p   time <.05), the treatment and treatment × time effects were not significant ( p >.05).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moghtaderi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zimorovat', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Raeisi-Dehkordi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rahmanian', 'Affiliation': 'Diabetes Research Center, School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Research Center of Prevention and Epidemiology of Non-Communicable Disease, Department of Biostatistics and Epidemiology, School of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1786024']
579,32621262,Cost-effectiveness randomized clinical trial on the effect of photobiomodulation therapy for prevention of radiotherapy-induced severe oral mucositis in a Brazilian cancer hospital setting.,"OBJECTIVES


This study aimed to assess the cost-effectiveness of photobiomodulation therapy (PBMT) in association with a Preventive Oral Care Program (POCP) compared with POCP alone in the treatment of radiotherapy (RT)-induced oral mucositis (OM).
METHODS


The cost-effectiveness was evaluated from the health provider perspective and conducted alongside a randomized, double-blind clinical trial. Participants were randomly assigned to either PBMT (n = 25) or control (n = 23) group. The PBMT group participants received PBMT associated with POCP. In the control group, patients were submitted to POCP alone. Costs were identified, quantified, and valued through observation and consultation of the hospital's financial sector database and estimated in Brazilian real and converted to international dollars using the purchasing power parity exchange rate. The incremental cost-effectiveness ratio (ICER) was estimated by considering the prevention of severe OM, interruption of RT, and oral health-related quality of life (OHRQoL) scores, measured by the OHIP-14 and patient-reported OM symptoms scale (PROMS).
RESULTS


The incremental cost of PBMT was $857.35, and the cost per session was $25.69. The ICER was $ 2867.39 to avoid one case of severe OM and $ 2756.75 to prevent one interruption in RT due to OM. ICER to reduce 1 point in OHIP-14 and PROMS scores were $170.79 and $31.75, respectively.
CONCLUSION


PBMT is more cost-effective than POCP alone in preventing severe OM, worsening of the OHRQoL, and RT interruptions. PBMT is a promising therapy, especially to avoid interruptions in oncological treatment.
TRIAL REGISTRATION


ReBEC-RBR-5h4y4n.",2021,"PBMT is more cost-effective than POCP alone in preventing severe OM, worsening of the OHRQoL, and RT interruptions.",['Brazilian cancer hospital setting'],"['ICER', 'photobiomodulation therapy (PBMT', 'POCP alone', 'photobiomodulation therapy', 'PBMT', 'POCP']","['OM symptoms scale (PROMS', 'severe oral mucositis', 'incremental cost of PBMT', 'cost-effectiveness', 'OHIP-14 and PROMS scores', 'severe OM, interruption of RT, and oral health-related quality of life (OHRQoL) scores', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0019999', 'cui_str': 'Cancer hospital'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.135908,"PBMT is more cost-effective than POCP alone in preventing severe OM, worsening of the OHRQoL, and RT interruptions.","[{'ForeName': 'Allisson Filipe', 'Initials': 'AF', 'LastName': 'Lopes Martins', 'Affiliation': 'Laboratory of Oral Pathology, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Túlio Eduardo', 'Initials': 'TE', 'LastName': 'Nogueira', 'Affiliation': 'Department of Prevention and Oral Rehabilitation, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Marília Oliveira', 'Initials': 'MO', 'LastName': 'Morais', 'Affiliation': 'Araujo Jorge Cancer Hospital, R. 239, 206 - Setor Universitário, Goiânia, Goiás, CEP 74175-120, Brazil.'}, {'ForeName': 'Sebastião Silvério', 'Initials': 'SS', 'LastName': 'de Sousa-Neto', 'Affiliation': 'Laboratory of Oral Pathology, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Angélica Ferreira', 'Initials': 'AF', 'LastName': 'Oton-Leite', 'Affiliation': 'Araujo Jorge Cancer Hospital, R. 239, 206 - Setor Universitário, Goiânia, Goiás, CEP 74175-120, Brazil.'}, {'ForeName': 'Marize Campos', 'Initials': 'MC', 'LastName': 'Valadares', 'Affiliation': 'Laboratory of Pharmacology and Cellular Toxicology, Pharmacy Faculty, Federal University of Goias, 5ª Avenida Esquina com Rua 240, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-170, Brazil.'}, {'ForeName': 'Nilceana Maya', 'Initials': 'NM', 'LastName': 'Aires Freitas', 'Affiliation': 'Department of Radiotherapy, Araujo Jorge Cancer Hospital, R. 239, 206-Setor Universitário, Goiânia, Goiás, CEP 74175-120, Brazil.'}, {'ForeName': 'Cláudio Rodrigues', 'Initials': 'CR', 'LastName': 'Leles', 'Affiliation': 'Department of Prevention and Oral Rehabilitation, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Elismauro Francisco', 'Initials': 'EF', 'LastName': 'Mendonça', 'Affiliation': 'Department of Prevention and Oral Rehabilitation, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil. elismaur@ufg.br.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05607-6']
580,32621263,A randomized controlled trial on the efficacy of life review therapy targeting incurably ill cancer patients: do their informal caregivers benefit?,"PURPOSE


Investigate whether Life Review Therapy and Memory Specificity Training (LRT-MST) targeting incurably ill cancer patients may also have a beneficial effect on caregiving burden, symptoms of anxiety and depression, and posttraumatic growth of the informal caregivers.
METHODS


Data was collected in the context of a randomized controlled trial (RCT) (secondary analyses) on the effect of LRT-MST among incurably cancer patients. Informal caregivers of participating patients were asked to complete outcome measures at baseline (T0), post-intervention (T1), and 1-month follow-up (T2): caregiver burden (caregivers reaction assessment scale (CRA)), symptoms of anxiety and depression (hospital anxiety and depression scale), and posttraumatic growth (posttraumatic growth inventory). Linear mixed models (intention to treat) were used to assess group differences in changes over time. Effect size and independent samples t tests were used to assess group differences at T1 and T2.
RESULTS


In total, 64 caregivers participated. At baseline, 56% of the caregivers experienced anxiety and 30% depression. No significant effect was found on these symptoms nor on posttraumatic growth or most aspects of caregiver burden. There was a significant effect of LRT-MST on the course of self-esteem (subscale CRA) (p = 0.013). Effect size was moderate post-intervention (ES = - 0.38, p = 0.23) and at 3-month follow-up (ES = 0.53, p = 0.083).
CONCLUSIONS


Many caregivers of incurably ill cancer patients experience symptoms of anxiety and depression. LRT-MST does not improve symptoms of depression and anxiety, negative aspects of caregiver burden, or posttraumatic growth. LRT-MST may have a protective effect on self-esteem of informal caregivers (positive aspect of caregiver burden).
TRIAL REGISTRATION NUMBER


Netherlands Trial Register (NTR 2256), registered on 23-3-2010.",2021,"LRT-MST does not improve symptoms of depression and anxiety, negative aspects of caregiver burden, or posttraumatic growth.","['Informal caregivers of participating patients', '64 caregivers participated', 'incurably cancer patients', 'ill cancer patients', 'Many caregivers of incurably ill cancer patients experience symptoms of anxiety and depression']","['Life Review Therapy and Memory Specificity Training (LRT-MST', 'LRT-MST']","['course of self-esteem (subscale CRA', '1-month follow-up (T2): caregiver burden (caregivers reaction assessment scale (CRA)), symptoms of anxiety and depression (hospital anxiety and depression scale), and posttraumatic growth (posttraumatic growth inventory', 'symptoms of depression and anxiety, negative aspects of caregiver burden, or posttraumatic growth']","[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",64.0,0.193034,"LRT-MST does not improve symptoms of depression and anxiety, negative aspects of caregiver burden, or posttraumatic growth.","[{'ForeName': 'Gitta', 'Initials': 'G', 'LastName': 'Kleijn', 'Affiliation': 'Department of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Birgit I', 'Initials': 'BI', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Department of Psychology, Health & Technology, University Twente, Enschede, Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Willemsen', 'Affiliation': 'Center for Psychosocial Oncology Care, Ingeborg Douwes Center, Amsterdam, Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Becker-Commissaris', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Corien M', 'Initials': 'CM', 'LastName': 'Eeltink', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Anna M E', 'Initials': 'AME', 'LastName': 'Bruynzeel', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Maurice J', 'Initials': 'MJ', 'LastName': 'van der Vorst', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Irma M', 'Initials': 'IM', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. im.verdonck@amsterdamumc.nl.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05592-w']
581,32624702,The efficacy of addition of Tenofovir Disoproxil Fumarate to Peg-IFNα-2b is superior to the addition of Entecavir in HBeAg positive CHB patients with a poor response after 12 weeks of Peg-IFNα-2b treatment alone.,"Background:  There are limited data regarding the efficacy of addition of entecavir (ETV) or tenofovir disoproxil fumarate (TDF) to Peg-IFNα-2b in HBeAg positive chronic hepatitis B (CHB) patients without early response to Peg-IFNα-2b. In this study, we aimed to evaluate the efficacy of ETV and TDF in HBeAg positive CHB patients who had a poor response to Peg-INFα-2b at the end of 12 weeks of monotherapy.  Methods:  A total of 40 HBeAg-positive CHB patients who were naive to antiviral therapy were recruited. The patients received a subcutaneous injection of Peg-IFNα-2b (180 µg) once a week for 12 weeks. However, the patients had a poor response to Peg-INFα-2b at the end of the 12-week-period monotherapy. The patients were then divided into two therapeutic protocol groups: (1) Group A: Patients received Peg-IFNα-2b (180 µg) subcutaneously weekly and ETV (0.5 mg) orally once daily for 48 weeks; (2) Group B: Patients received Peg-IFNα-2b (180 µg) subcutaneously weekly and TDF (300 mg) orally once daily for 48 weeks. The therapeutic efficacy was evaluated. Blood samples were collected at baseline and every 12 weeks. Routine biochemical tests including ALT, AST, etc. were measured by automated biochemical technique. HBV DNA was quantified using the TaqMan PCR assay. The levels of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb were measured using a commercial chemiluminescent microparticle immunoassay.  Results:  The HBsAg level declined rapidly in both two treatment groups during the first 12 weeks and declined gradually in the next 36 weeks. At week 48, the mean ΔHBsAg level in Peg-IFNα-2b+TDF group was significantly higher than that in Peg-IFNα-2b +ETV group (-1.799 ± 0.3063 vs. -1.078 ± 0.2028,  P =0.0491). The HBeAg loss rate was significantly higher in TDF add-on group than that in ETV add-on group at week 48 (40% vs. 10%,  P =0.028). At week 48, the proportions of patients with undetectable HBV DNA (<500 IU/mL) were 80% (16 out of 20) and 95% (19 out of 20) in Peg-IFNα-2b+ETV group and Peg-IFNα-2b+TDF group, respectively.  Conclusions:  This real world study demonstrated that the efficacy of addition of TDF to Peg-IFNα-2b is superior to the efficacy of addition of ETV to Peg-IFNα-2b in HBeAg positive CHB patients with a poor response after 12 weeks of Peg-IFNα-2b treatment alone. However, this present study also requires a larger sample size study to verify in the future.",2020,The HBsAg level declined rapidly in both two treatment groups during the first 12 weeks and declined gradually in the next 36 weeks.,"['HBeAg positive CHB patients with a poor response after 12 weeks of Peg-IFNα-2b treatment alone', 'HBeAg positive CHB patients who had a poor response to Peg-INFα-2b at the end of 12 weeks of monotherapy', '40 HBeAg-positive CHB patients who were naive to antiviral therapy were recruited']","['TDF', 'entecavir (ETV) or tenofovir disoproxil fumarate (TDF', 'Tenofovir Disoproxil Fumarate', 'subcutaneous injection of Peg-IFNα-2b', 'Peg-IFNα-2b (180 µg) subcutaneously weekly and ETV', 'ETV and TDF', 'Peg-IFNα-2b (180 µg) subcutaneously weekly and TDF']","['HBsAg level', 'levels of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb', 'HBeAg loss rate', 'Blood samples', 'mean ΔHBsAg level', 'therapeutic efficacy']","[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0312634', 'cui_str': 'Antibody to hepatitis Be antigen'}, {'cui': 'C0312631', 'cui_str': 'Antibody to hepatitis B core antigen'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0481784,The HBsAg level declined rapidly in both two treatment groups during the first 12 weeks and declined gradually in the next 36 weeks.,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Wennan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Tianbin', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Ningdai', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Xun', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Qishui', 'Initials': 'Q', 'LastName': 'Ou', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Yongbin', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Huanhuan', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}]",International journal of medical sciences,['10.7150/ijms.45658']
582,32631713,A randomized controlled trial of minor hand surgeries comparing wide awake local anesthesia no tourniquet and local anesthesia with tourniquet.,"INTRODUCTION


Epinephrine and sodium bicarbonate (NaHCO 3 ) used in wide-awake local anesthesia no tourniquet (WALANT) affect many areas such as hemostasis, injection pain, anesthetic effect and others. However, few clinical trials have focused on injection pain and the duration of anesthetic effect, and no prospective studies have reported the benefits of WALANT post operation. This study compared WALANT with conventional local anesthesia with tourniquet in minor hand surgeries, and aimed to answer following questions: (1) Does WALANT have enough benefits for injection pain and duration of anesthetic effect?; (2) How does WALANT affect postoperative management (such as postoperative pain and use of analgesics)?; (3) How satisfied are the patients with the surgery?
HYPOTHESIS


We hypothesized that WALANT had advantages in injection pain, duration of anesthetic effect, and postoperative management compared to conventional local anesthesia.
MATERIALS AND METHODS


The present study is designed as a randomized prospective one center study. This study included 185 patients who received surgical treatment for the diagnosis of carpal tunnel syndrome, trigger finger, or de Quervain's disease between 2017 and 2019. We randomly allocated the patients to either the WALANT group or the conventional group. We inquired and recorded patients' injection pain, duration of anesthetic effect, postoperative pain, the use of analgesics, and satisfaction with the surgery.
RESULTS


The injection pain was significantly lower in the WALANT group in all procedures (p<0.001). The duration of anesthetic effect was significantly longer in the WALANT group in all procedures (p<0.001). As for the postoperative management of all procedures, the pain score was significantly lower in the WALANT group until the first day after surgery, with the biggest difference at 6hours after surgery. The use of analgesics was significantly lower in the WALANT group until the second day after surgery. Satisfaction with surgery was significantly higher in the WALANT group in all procedures: A1 pulley release (p=0.026), 1st extensor retinaculum (p=0.045), and carpal tunnel release (p=0.003).
DISCUSSION


Our study showed better results in WALANT than in the conventional method, with no tourniquet pain, lower injection pains, longer anesthetic duration, and less postoperative pain. It provided patients with great satisfaction. In addition, WALANT has the potential benefits of no time limit due to tourniquet pain and long anesthetic effect. Therefore, WALANT is comfortable and cost effective, and could be a good alternative to conventional local lidocaine anesthesia.
LEVEL OF EVIDENCE


II.",2020,The duration of anesthetic effect was significantly longer in the WALANT group in all procedures (p<0.001).,"[""185 patients who received surgical treatment for the diagnosis of carpal tunnel syndrome, trigger finger, or de Quervain's disease between 2017 and 2019""]","['Epinephrine and sodium bicarbonate (NaHCO 3 ', 'minor hand surgeries comparing wide awake local anesthesia no tourniquet and local anesthesia with tourniquet']","['carpal tunnel release', 'injection pain, duration of anesthetic effect, postoperative pain, the use of analgesics, and satisfaction with the surgery', 'postoperative pain', 'Satisfaction with surgery', 'tourniquet pain, lower injection pains, longer anesthetic duration', 'pain score', 'injection pain', 'duration of anesthetic effect']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0158328', 'cui_str': 'Trigger finger'}, {'cui': 'C0149870', 'cui_str': 'Radial styloid tenosynovitis'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3179301', 'cui_str': 'Anesthetic Effects'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",185.0,0.0554681,The duration of anesthetic effect was significantly longer in the WALANT group in all procedures (p<0.001).,"[{'ForeName': 'Sang', 'Initials': 'S', 'LastName': 'Ki Lee', 'Affiliation': 'Department of Orthopedic Surgery, Eulji University College of Medicine, Daejeon, Korea. Electronic address: sklee@eulji.ac.kr.'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Gul Kim', 'Affiliation': 'Department of Orthopedic Surgery, Eulji University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Sik Choy', 'Affiliation': 'Department of Orthopedic Surgery, Eulji University College of Medicine, Daejeon, Korea.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.03.013']
583,32649011,Early-term elective Caesarean sections did not increase the risk of behavioural problems at six to eight years of age.,"AIM


Our aim was to explore the under-researched associations between an elective Caesarean section (C-section) at early-term or full-term gestation and behaviour at 6-8 years of age.
METHODS


We identified 1220 eligible children born by elective C-sections at Danish hospital from 2009 to 2011. Their mothers were randomised to elective C-sections at either 38+3 (early-term) or 39+3 (full-term) weeks of gestation. From December 2017 to August 2018, the parents completed the Strengths and Difficulties Questionnaire. The results were adjusted for maternal education, parity and the child's sex.
RESULTS


Of the 574 (45%) children followed up, 288 were delivered early-term and 286 were delivered full-term. The groups had similar baseline characteristics. There were no differences in the total difficulties score, subscale scores or the risk of being classified as having a possible or probable psychiatric disorder. Early-term boys had a lower risk of being classified as having a possible or probable psychiatric disorder and early-term girls had higher risk, but the results were not statistically significant.
CONCLUSION


We found no difference in behaviour at 6-8 years of age between children born by elective C-section at early- versus full-term gestation.",2021,We found no difference in behaviour at 6-8 years of age between children born by elective C-section at early versus full term gestation.,"['Of the 574 (45%) children followed up, 288 were delivered early term and 286 were delivered full term', '1220 eligible children born by elective C-sections at Danish hospital from 2009-2011']",['elective Caesarean section (C-section'],"['risk of behavioural problems', 'behaviour', 'lower risk of being classified as having a possible or probable psychiatric disorder', 'total difficulties score, subscale scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",,0.0627165,We found no difference in behaviour at 6-8 years of age between children born by elective C-section at early versus full term gestation.,"[{'ForeName': 'Trine Muhs', 'Initials': 'TM', 'LastName': 'Nielsen', 'Affiliation': 'Perinatal Epidemiology Research Unit, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Glavind', 'Affiliation': 'Perinatal Epidemiology Research Unit, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Milidou', 'Affiliation': 'Perinatal Epidemiology Research Unit, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Tine Brink', 'Initials': 'TB', 'LastName': 'Henriksen', 'Affiliation': 'Perinatal Epidemiology Research Unit, Aarhus University, Aarhus, Denmark.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15468']
584,32586139,Patients with Obesity Have Better Long-Term Outcomes after Hospitalization for COPD Exacerbation.,"Obesity has been shown to have a paradoxical benefit in a number of conditions, but the long-term effects in obesity after chronic obstructive pulmonary disease (COPD) exacerbation is still unclear. In this study, the effects of obesity on short- and long-term outcomes after a COPD exacerbation were evaluated. This was a secondary analysis of the Rapid Empiric Treatment with Oseltamivir Study (RETOS): a prospective, randomized, unblinded clinical trial. Patients were included in the study if they were hospitalized for acute exacerbation of COPD. Obesity was noted as patients with BMI >30. Clinical outcomes of time to clinical stability, length of stay, and mortality were compared. A total of 301 patients were included in the study, 122 (41%) patients were obese. There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity. Mortality for patients with and without obesity was 3% and 3% at 30 days, 7% and 18% at six months, and 8% and 28% at one year, respectively. After adjusting with multivariable regression analysis, patients with obesity had a significant reduction in odds of dying at one year (adjusted odds ratio (aOR): 0.18; 95% CI: 0.06-0.58;  p  = .004) and at six months (aOR: 0.28; 95% CI: 0.09-0.89;  p  = .031). Our study showed that obesity was associated with reduced mortality at one year and six months after a COPD exacerbation. Although patients with obesity had higher rates of comorbidities, they had reduced mortality at one year after multivariable regression analysis.",2020,There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity.,"['Patients were included in the study if they were hospitalized for acute exacerbation of COPD', 'A total of 301 patients were included in the study, 122 (41%) patients were obese', 'Patients with Obesity']",[],"['reduced mortality', 'Obesity', 'Mortality', 'time to clinical stability, length of stay, and mortality', 'length of stay and time to clinical stability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",301.0,0.17615,There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'DeLapp', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Glick', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Furmanek', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Ramirez', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cavallazzi', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville School of Medicine, Louisville, KY, USA.'}]",COPD,['10.1080/15412555.2020.1781805']
585,32622394,"Ambulatory management of primary spontaneous pneumothorax: an open-label, randomised controlled trial.","BACKGROUND


Primary spontaneous pneumothorax occurs in otherwise healthy young patients. Optimal management is not defined and often results in prolonged hospitalisation. Data on efficacy of ambulatory options are poor. We aimed to describe the duration of hospitalisation and safety of ambulatory management compared with standard care.
METHODS


In this open-label, randomised controlled trial, adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years. Patients were randomly assigned (1:1) to treatment with either an ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both). The primary outcome was total length of hospital stay including re-admission up to 30 days after randomisation. Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis. The trial was prospectively registered with the International Standard Randomised Clinical Trials Number, ISRCTN79151659.
FINDINGS


Of 776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119). At day 30, the median hospitalisation was significantly shorter in the 114 patients with available data who received ambulatory treatment (0 days [IQR 0-3]) than in the 113 with available data who received standard care (4 days [IQR 0-8]; p<0·0001; median difference 2 days [95% CI 1-3]). 110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm. All 14 serious adverse events occurred in patients who received ambulatory care, eight (57%) of which were related to the intervention, including an enlarging pneumothorax, asymptomatic pulmonary oedema, and the device malfunctioning, leaking, or dislodging.
INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests that primary spontaneous pneumothorax can be managed for outpatients, using ambulatory devices in those who require intervention.
FUNDING


UK National Institute for Health Research.",2020,"INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","['Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis', '110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm', '776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119', 'primary spontaneous pneumothorax', 'adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years', 'otherwise healthy young patients']","['ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both', 'ambulatory management compared with standard care']","['duration of hospitalisation including re-admissions', 'total length of hospital stay including re-admission', 'adverse events', 'median hospitalisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.148264,"INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","[{'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Hallifax', 'Affiliation': 'Oxford Centre for Respiratory Medicine, University of Oxford, Oxford, UK. Electronic address: robert.hallifax@ndm.ox.ac.uk.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McKeown', 'Affiliation': 'Royal Berkshire National Health Service (NHS) Foundation Trust, Reading, UK.'}, {'ForeName': 'Parthipan', 'Initials': 'P', 'LastName': 'Sivakumar', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fairbairn', 'Affiliation': 'Queen Margaret Hospital, NHS Fife, Dunfermline, UK.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Peter', 'Affiliation': 'Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leitch', 'Affiliation': 'Western General Hospital, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Knight', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stanton', 'Affiliation': 'Great Western Hospital NHS Foundation Trust, Swindon, UK.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Ijaz', 'Affiliation': 'University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Marciniak', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cameron', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Amrithraj', 'Initials': 'A', 'LastName': 'Bhatta', 'Affiliation': 'Blackpool Fylde and Wyre Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Reddy', 'Affiliation': 'Kettering General Hospital, Kettering, UK.'}, {'ForeName': 'Marie-Clare', 'Initials': 'MC', 'LastName': 'Harris', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Maddekar', 'Affiliation': 'University Hospitals of North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'West', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Laskawiec-Szkonter', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Corcoran', 'Affiliation': 'University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Corran', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harvey', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31043-6']
586,32638995,Cost-effectiveness of a preventive self-care health management program for community-dwelling older adults: a randomised controlled trial.,"OBJECTIVE


To examine the cost-effectiveness of a preventive self-care health management program for community-dwelling older adults as compared to usual care.
DESIGN/INTERVENTION


A cost-effectiveness analysis was executed alongside a randomised controlled trial. Nurse case managers provided interventions, including holistic assessment, empowerment of self-care, preventive health behaviours and self-efficacy with co-produced care planning, supported by nursing students. The control group received social control calls.
PARTICIPANTS/SETTING


Community-dwelling older adults were randomly assigned to the intervention (n = 271) or control (n = 269) group. The intervention was conducted in collaboration with 11 community centres under four non-government organisations in various districts of Hong Kong.
MEASUREMENTS


Cost and quality-adjusted life years (QALYs) were collected pre (baseline, 0 months) and post intervention (3 months) and 3 months after completion of the program (6 months). Incremental cost-effectiveness ratios between the groups were calculated, dividing the difference in cost by the difference in QALYs.
RESULTS


Analysis showed that the net incremental QALY gain was 0.0014 (3 months) and 0.0033 (6 months) when the intervention group was compared to the control group. The probability of being cost-effective at 6 months was 53.2% and 53.4%, based on the cost-effectiveness thresholds recommended by both the National Institute for Health and Clinical Excellence ($200,000/QALYs) and the World Health Organization (Hong Kong gross domestic product/capita, HK$381,780).
CONCLUSIONS


The results provide some evidence to suggest that the addition of a home-based, preventive self-care health management program may have effects on cost outcomes for community-dwelling older adults in Hong Kong.",2021,"Nurse case managers provided interventions, including holistic assessment, empowerment of self-care, preventive health behaviours and self-efficacy with co-produced care planning, supported by nursing students.","['Community-dwelling older adults', 'community-dwelling older adults', 'community-dwelling older adults in Hong Kong', '11 community centres under four non-government organisations in various districts of Hong Kong']","['preventive self-care health management program', 'social control calls']","['Cost-effectiveness', 'probability of being cost-effective', 'Cost and quality-adjusted life years (QALYs', 'Incremental cost-effectiveness ratios', 'cost-effectiveness', 'net incremental QALY gain']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037405', 'cui_str': 'Social Control'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",,0.0354808,"Nurse case managers provided interventions, including holistic assessment, empowerment of self-care, preventive health behaviours and self-efficacy with co-produced care planning, supported by nursing students.","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Ching', 'Initials': 'C', 'LastName': 'So', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Age and ageing,['10.1093/ageing/afaa127']
587,32480413,STEEER-AF: a cluster-randomized education trial from the ESC.,,2020,,[],[],[],[],[],[],,0.0707677,,"[{'ForeName': 'Karina V', 'Initials': 'KV', 'LastName': 'Bunting', 'Affiliation': 'Postdoctoral Fellow, University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, UK; STEEER-AF coordinator.'}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Van Gelder', 'Affiliation': 'Professor of Cardiology, University of Groningen, University Medical Center Groningen, Netherlands; EHRA & ESC Council on Stroke; STEEER-AF Co-Chief Investigator.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Kotecha', 'Affiliation': 'Professor of Cardiology, University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, UK; ESC Education & ESC Congress Planning Committees; ESC 2016 AF Guidelines Taskforce; STEEER-AF Chief Investigator.'}]",European heart journal,['10.1093/eurheartj/ehaa421']
588,32589613,Cognitive enhancement of healthy older adults using hyperbaric oxygen: a randomized controlled trial.,"More than half of community-dwelling individuals sixty years and older express concern about declining cognitive abilities. The current study's aim was to evaluate hyperbaric oxygen therapy (HBOT) effect on cognitive functions in healthy aging adults.A randomized controlled clinical trial randomized 63 healthy adults (>64) either to HBOT(n=33) or control arms(n=30) for three months. Primary endpoint included the general cognitive function measured post intervention/control. Cerebral blood flow (CBF) was evaluated by perfusion magnetic resonance imaging.There was a significant group-by-time interaction in global cognitive function post-HBOT compared to control (p=0.0017). The most striking improvements were in attention (net effect size=0.745) and information processing speed (net effect size=0.788).Voxel-based analysis showed significant cerebral blood flow increases in the HBOT group compared to the control group in the right superior medial frontal gyrus (BA10), right and left supplementary motor area (BA6), right middle frontal gyrus (BA6), left middle frontal gyrus (BA9), left superior frontal gyrus (BA8) and the right superior parietal gyrus (BA7).In this study, HBOT was shown to induce cognitive enhancements in healthy aging adults via mechanisms involving regional changes in CBF. The main improvements include attention, information processing speed and executive functions, which normally decline with aging.",2020,There was a significant group-by-time interaction in global cognitive function post-HBOT compared to control (p=0.0017).,"['63 healthy adults (>64) either to HBOT(n=33) or control arms(n=30) for three months', 'healthy older adults', 'healthy aging adults']","['hyperbaric oxygen', 'hyperbaric oxygen therapy (HBOT']","['global cognitive function post-HBOT', 'attention, information processing speed and executive functions, which normally decline with aging', 'Cerebral blood flow (CBF', 'right and left supplementary motor area (BA6), right middle frontal gyrus (BA6), left middle frontal gyrus (BA9), left superior frontal gyrus (BA8', 'cognitive functions', 'general cognitive function measured post intervention/control', 'cerebral blood flow increases']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152296', 'cui_str': 'Structure of superior frontal gyrus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",63.0,0.0790879,There was a significant group-by-time interaction in global cognitive function post-HBOT compared to control (p=0.0017).,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadanny', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Daniel-Kotovsky', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Suzin', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Rahav', 'Initials': '', 'LastName': 'Boussi-Gross', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Catalogna', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Kobi', 'Initials': 'K', 'LastName': 'Dagan', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Hachmo', 'Affiliation': 'Research and Development Unit, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Ramzia', 'Initials': 'R', 'LastName': 'Abu Hamed', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Sasson', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Fishlev', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Erez', 'Initials': 'E', 'LastName': 'Lang', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Polak', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Doenyas', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Mony', 'Initials': 'M', 'LastName': 'Friedman', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Tal', 'Affiliation': 'Radiology Department, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Zemel', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bechor', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Efrati', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}]",Aging,['10.18632/aging.103571']
589,32608055,Can radiographic patellofemoral osteoarthritis be diagnosed using clinical assessments?,"INTRODUCTION


The aim of this study was to determine whether participant characteristics and clinical assessments could identify radiographic osteoarthritis (OA) in individuals with clinically diagnosed, symptomatic patellofemoral osteoarthritis (PFOA).
METHODS


Participant characteristics and clinical assessments were obtained from 179 individuals aged 50 years and over with clinically diagnosed symptomatic PFOA, who were enrolled in a randomised trial. Anteroposterior, lateral, and skyline X-rays were taken of the symptomatic knee. The presence of radiographic PFOA was defined as ""no or early PFOA"" (Kellgren and Lawrence [KL] grade ≤1 in the PF compartment) or ""definite PFOA"" (KL grade ≥2). Diagnostic test statistics were applied to ascertain which participant characteristics and clinical assessments could identify the presence of definite radiographic PFOA.
RESULTS


A total of 118 participants (66%) had definite radiographic PFOA. Univariate analysis identified that older age (>61 years), female sex, higher body mass index (BMI) (>29 kg/m 2  ), longer pain duration (>2.75 years), higher maximum knee pain during stair ambulation (>47/100 mm), and fewer repeated single step-ups to pain onset (<21) were associated with the presence of definite radiographic PFOA. Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%.
CONCLUSION


In individuals over 50 years of age with a clinical diagnosis of PFOA, higher BMI, longer pain duration, and fewer repeated single step-ups to pain onset increased the likelihood of radiographic PFOA. However, overall diagnostic accuracy was modest, suggesting that radiographic PFOA cannot be confidently identified using these tests.",2020,"Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%.
","['older age (>61 years), female sex, higher body mass index (BMI) (>29 kg/m 2  ), longer pain duration (>2.75 years), higher maximum knee pain during stair ambulation (>47/100 mm), and fewer repeated single step-ups to pain onset (<21', '118 participants (66%) had definite radiographic PFOA', '179 individuals aged 50 years and over with clinically diagnosed symptomatic PFOA, who were enrolled in a randomised trial', 'individuals with clinically diagnosed, symptomatic patellofemoral osteoarthritis (PFOA']",[],"['BMI, pain duration, and repeated single step-ups to pain onset', 'radiographic osteoarthritis (OA', 'overall diagnostic accuracy', 'radiographic PFOA']","[{'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}]",118.0,0.0692962,"Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%.
","[{'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Tan', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Collins', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Harvi F', 'Initials': 'HF', 'LastName': 'Hart', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Joel W', 'Initials': 'JW', 'LastName': 'Donnar', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Gearoid', 'Initials': 'G', 'LastName': 'Cleary', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Isobel C', 'Initials': 'IC', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Liam R', 'Initials': 'LR', 'LastName': 'Maclachlan', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Derham', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}]",Musculoskeletal care,['10.1002/msc.1490']
590,32605472,Similar late effects of a 7-week orthodox religious fasting and a time restricted eating pattern on anthropometric and metabolic profiles of overweight adults.,"A hypocaloric diet, based on Orthodox fasting (OF) was followed by 29 overweight adults. A low-calorie, 16/8, time restricted eating (TRE) pattern was followed by 16 age- and weight-matched participants. Anthropometric, lipid, glycaemic and inflammation markers were assessed at baseline, at the end of the intervention (7 weeks from baseline) and 6 weeks after the cessation of diets (13 weeks from baseline). There was a trend of weight loss in both groups, which was evident at week 7 (TRE: -2.1 ± 1.0; OF: -2.0 ± 0.5 kg,  p  < 0.001 from baseline) and remained significant at week 13 (TRE: -2.9 ± 0.7; OF: -2.6 ± 0.3 kg,  p  < 0.001 from baseline). In the OF group, lipid concentrations declined at week 7 compared with baseline, increasing at week 13 compared with week 7. Our findings suggest that OF promotes a decrease in lipid concentrations, which however, is not evident 6 weeks after its end.",2021,"In the OF group, lipid concentrations declined at week 7 compared with baseline, increasing at week 13 compared with week 7.","['overweight adults', '29 overweight adults']",[],"['weight loss', 'Anthropometric, lipid, glycaemic and inflammation markers', 'lipid concentrations']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",29.0,0.0697591,"In the OF group, lipid concentrations declined at week 7 compared with baseline, increasing at week 13 compared with week 7.","[{'ForeName': 'Spyridon N', 'Initials': 'SN', 'LastName': 'Karras', 'Affiliation': 'Division of Endocrinology and Metabolism, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Theocharis', 'Initials': 'T', 'LastName': 'Koufakis', 'Affiliation': 'Division of Endocrinology and Metabolism, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adamidou', 'Affiliation': 'Department of Dietetics and Nutrition, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Paraskevi', 'Initials': 'P', 'LastName': 'Karalazou', 'Affiliation': 'Laboratory of Biological Chemistry, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Thisiadou', 'Affiliation': 'Laboratory of Biological Chemistry, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Zebekakis', 'Affiliation': 'Division of Endocrinology and Metabolism, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Kali', 'Initials': 'K', 'LastName': 'Makedou', 'Affiliation': 'Laboratory of Biological Chemistry, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Kotsa', 'Affiliation': 'Division of Endocrinology and Metabolism, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1787959']
591,32621555,"The long-term effectiveness of universal, selective and combined prevention for alcohol use during adolescence: 36-month outcomes from a cluster randomized controlled trial.","AIM


To compare the long-term universal outcomes of the Climate Schools programme, the selective preventure programme and their combined implementation to standard substance use education in reducing the uptake of alcohol use, engagement in binge drinking and alcohol-related harms over a 3-year period.
DESIGN


A cluster-randomized controlled trial.
SETTING AND PARTICIPANTS


Substance use prevention programmes delivered in Australian secondary schools. Students from 26 Australian secondary schools (n = 2190), mean age at baseline 13.3 years (standard deviation = 0.48), 57.4% male. Schools were recruited between September 2011 and February 2012.
INTERVENTIONS


Schools were block-randomized to one of four groups: universal prevention (climate; 12 × 40-minute lessons); selective prevention (preventure; 2 × 90-minute sessions); combined prevention (climate and preventure; CAP); or health education as usual (control). The climate intervention delivered 12 × 40-minute lessons aimed at reducing alcohol and cannabis use and related harms. The preventure intervention delivered 2 × 90-minute group sessions to high-risk students. The CAP group implemented the climate programme to the entire year group and the preventure programme to the high-risk students.
MEASUREMENTS


Participants were all consenting 8th grade students (in 2012) assessed at baseline, post-intervention (6-9 months post-baseline) and at 12, 24 and 36 months post-baseline on measures of alcohol use, knowledge and related harms. Primary outcomes were alcohol use, binge drinking (five or more standard drinks) and alcohol-related harms, obtained from all students regardless of whether or not they received intervention. Intervention effects at 36 months post-baseline were estimated from generalized multi-level mixed models using data from all time-points and accounting for school-level clustering. Exploratory analyses examined intervention effects among low- and high-risk adolescents.
FINDINGS


Compared with students in the control condition, students in the climate, preventure and CAP groups demonstrated significantly slower increases in their likelihood to drink any alcohol [odds ratio (OR) = 0.64, 95% confidence interval (CI) = 0.50-0.82 for climate; OR = 0.55, 95% CI = 0.43-0.71 for preventure and OR = 0.67, 95% CI = 0.53-0.84 for CAP] to engage in binge drinking (OR = 0.60, 95% CI = 0.44-0.82 for climate; OR = 0.59, 95% CI = 0.44-0.80 for preventure and OR = 0.68, 95% CI = 0.51-0.92 for CAP) and to experience alcohol harms (OR = 0.63, 95% CI = 0.49-0.82 for climate; OR = 0.55, 95% CI = 0.43-0.71 for preventure and OR = 0.64, 95% CI = 0.50-0.81 for CAP). There was no strong evidence that the combined approach showed advantages over universal prevention. The direction and magnitude of effects were consistent in low- and high-risk adolescents.
CONCLUSIONS


The universal Climate Schools programme and the selective preventure programme were effective in reducing alcohol consumption and alcohol problems compared with standard Australian health education, when trialled individually and together over a 3-year period.",2021,"The universal Climate Schools program and the selective Preventure program were effective in reducing alcohol consumption and alcohol problems compared with standard Australian health education, when trialled individually and together over a 3-year period.","['Substance use prevention programs delivered in Australian secondary schools', 'Schools were recruited between September 2011 and February 2012', 'Students from 26 Australian secondary schools (n = 2,190), mean age at baseline 13.3 years (SD 0.48), 57.4% male']","['universal prevention (Climate;12 x 40min lessons); selective prevention (Preventure; 2 x 90min sessions); combined prevention (Climate and Preventure; CAP); or health education as usual (Control', 'universal, selective and combined prevention']","['likelihood to drink any alcohol', 'alcohol use, binge drinking (5+ standard drinks) and alcohol-related harms', 'engage in binge drinking', 'alcohol consumption and alcohol problems']","[{'cui': 'C0150358', 'cui_str': 'Substance use prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]",2190.0,0.113799,"The universal Climate Schools program and the selective Preventure program were effective in reducing alcohol consumption and alcohol problems compared with standard Australian health education, when trialled individually and together over a 3-year period.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Slade', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Newton', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Mather', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Barrett', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Champion', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lexine', 'Initials': 'L', 'LastName': 'Stapinski', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Conrod', 'Affiliation': 'Department of Psychiatry, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, New South Wales, Australia.'}]","Addiction (Abingdon, England)",['10.1111/add.15178']
592,32633650,Viewing nature scenes reduces the pain of social ostracism.,"In a series of four studies ( N s = 245, 135, 155, 222), we explored the effects of viewing nature scenes on promoting recovery from ostracism. We first manipulated experiences of ostracism, then randomly assigned participants to view photos of either nature, urban scenes, or neutral objects. Across all four studies, participants who viewed nature photos reported significantly lower levels of state social pain, along with significantly higher levels of affect balance and self-esteem. Moreover, when asked to look back and recall how they felt at the time of being ostracized, participants who viewed nature photos reported significantly higher levels of retrospective satisfaction of basic emotional needs than did participants in control conditions. An internal meta-analysis revealed an effect size of  d  = 0.58. These studies are the first, to our knowledge, to provide experimental evidence of how exposure to nature can alleviate the pain of social ostracism.",2021,"Across all four studies, participants who viewed nature photos reported significantly lower levels of state social pain, along with significantly higher levels of affect balance and self-esteem.",[],[],"['balance and self-esteem', 'pain of social ostracism', 'retrospective satisfaction of basic emotional needs', 'levels of state social pain']",[],[],"[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0343304,"Across all four studies, participants who viewed nature photos reported significantly lower levels of state social pain, along with significantly higher levels of affect balance and self-esteem.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lishen', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Education College, Shaoguan University, Shaoguan, China.'}, {'ForeName': 'Holli-Anne', 'Initials': 'HA', 'LastName': 'Passmore', 'Affiliation': 'Nature Connectedness Group, University of Derby, Derby, United Kingdom.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, University of British Columbia, British Columbia, Canada.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Mental Health Education & Counseling Centre, Zhejiang Ocean University, Zhoushan, China.'}, {'ForeName': 'Huajian', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology Chinese Academy of Sciences, Beijing, China.'}]",The Journal of social psychology,['10.1080/00224545.2020.1784826']
593,32642953,Photobiomodulation for mucosal repair in patients submitted to dental extraction after head and neck radiation therapy: a double-blind randomized pilot study.,"OBJECTIVE


The aim of this study was to evaluate the efficacy of photobiomodulation therapy (PBMT) on the mucosal healing of patients submitted to simple dental extractions after head and neck radiation therapy (HNRT).
METHODS


Forty surgical procedures were randomly assigned into two groups: G1: dental extraction + PBMT (n = 19) and G2: dental extraction + sham-PBMT (n = 21). All patients received antibiotic therapy and the surgical alveolotomy to promote primary closure of the surgical site. Group 1 was submitted to PMBT according to the following parameters: 808 nm, 40 mW, 100 J/cm 2 , 70 s, 2.8 J/point, 14 J/session, and area of 0.028cm 2 . The primary outcome was complete mucosal lining at 14 days, and the secondary outcomes were the presence of infection, postoperative pain, and analgesics intake at 7 days. The patients were evaluated every 7 days until 28 days.
RESULTS


Alveolar mucosal lining was faster in G1, and at 14 postoperative days, 94.7% patients evolved with complete alveolar mucosal lining compared to no patient from G2 (p < 0.001). Patients from G1 reported postoperative pain less frequently (G1 = 4, 21.1% × G2 = 14, 66.7%, p = 0.005), and also reported lower intake of analgesic pills at D7 (21.1% × 66.7%, p = 0.005%). PBMT had a significant positive impact on both postoperative pain (NNT = 2.192, CI95% = 1.372-5.445) and mucosal healing (NNT = 1.056, CI95% = 0.954-1.181).
CONCLUSIONS


This preliminary study strongly supports the use of PMBT to promote surgical alveolar mucosal lining in a shorter time and with less postoperative pain.",2021,"PBMT had a significant positive impact on both postoperative pain (NNT = 2.192, CI95% = 1.372-5.445) and mucosal healing (NNT = 1.056, CI95% = 0.954-1.181).
","['patients submitted to simple dental extractions after head and neck radiation therapy (HNRT', 'patients submitted to dental extraction after head and neck radiation therapy', 'Forty surgical procedures']","['photobiomodulation therapy (PBMT', 'PMBT', 'G1: dental extraction + PBMT (n\u2009=\u200919) and G2: dental extraction + sham-PBMT', 'antibiotic therapy', 'PBMT']","['lower intake of analgesic pills', 'presence of infection, postoperative pain, and analgesics intake', 'Alveolar mucosal lining', 'postoperative pain', 'complete mucosal lining', 'mucosal healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0176391', 'cui_str': 'Simple extraction of tooth'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0449970', 'cui_str': 'Presence of infection'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",,0.0962627,"PBMT had a significant positive impact on both postoperative pain (NNT = 2.192, CI95% = 1.372-5.445) and mucosal healing (NNT = 1.056, CI95% = 0.954-1.181).
","[{'ForeName': 'Thyago Morais Vicente', 'Initials': 'TMV', 'LastName': 'da Silva', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'Thayanara Silva', 'Initials': 'TS', 'LastName': 'Melo', 'Affiliation': 'Graduate Program in Dentistry, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Romulo Cesar', 'Initials': 'RC', 'LastName': 'de Alencar', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'José Ricardo Dias', 'Initials': 'JRD', 'LastName': 'Pereira', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'Jair Carneiro', 'Initials': 'JC', 'LastName': 'Leão', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'Igor Henrique Morais', 'Initials': 'IHM', 'LastName': 'Silva', 'Affiliation': 'Dental Oncology Unit, Hospital do Câncer de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Luiz Alcino', 'Initials': 'LA', 'LastName': 'Gueiros', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil. luiz.mgueiros@ufpe.br.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05608-5']
594,32645158,Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial.,"BACKGROUND


People with human immunodeficiency virus (PWH) face increased risks for heart failure and adverse heart failure outcomes. Myocardial steatosis predisposes to diastolic dysfunction, a heart failure precursor. We aimed to characterize myocardial steatosis and associated potential risk factors among a subset of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) participants.
METHODS


Eighty-two PWH without known heart failure successfully underwent cardiovascular magnetic resonance spectroscopy, yielding data on intramyocardial triglyceride (IMTG) content (a continuous marker for myocardial steatosis extent). Logistic regression models were applied to investigate associations between select clinical characteristics and odds of increased or markedly increased IMTG content.
RESULTS


Median (Q1, Q3) IMTG content was 0.59% (0.28%, 1.15%). IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants. Parameters associated with increased IMTG content included age (P = .013), body mass index (BMI) ≥ 25 kg/m2 (P = .055), history of intravenous drug use (IVDU) (P = .033), and nadir CD4 count < 350 cells/mm³ (P = .055). Age and BMI ≥ 25 kg/m2 were additionally associated with increased odds of markedly increased IMTG content (P = .049 and P = .046, respectively).
CONCLUSIONS


A substantial proportion of antiretroviral therapy-treated PWH exhibited myocardial steatosis. Age, BMI ≥ 25 kg/m2, low nadir CD4 count, and history of IVDU emerged as possible risk factors for myocardial steatosis in this group.
CLINICAL TRIALS REGISTRATION


NCT02344290; NCT03238755.",2020,IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants.,"['Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial', '25 kg/m2 ', 'HIV (REPRIEVE) participants', 'People with human immunodeficiency virus (PWH', 'Eighty-two PWH without known heart failure successfully underwent']","['cardiovascular magnetic resonance spectroscopy, yielding data on intramyocardial triglyceride (IMTG) content', 'Antiretroviral Therapy']","['Median (Q1, Q3', 'Age and BMI ≥', 'myocardial steatosis', 'body mass index (BMI) ≥', 'Myocardial Steatosis', 'IMTG content', 'nadir CD4 count', 'history of intravenous drug use (IVDU']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0242566', 'cui_str': 'Intravenous drug user'}]",,0.0838812,IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants.,"[{'ForeName': 'Tomas G', 'Initials': 'TG', 'LastName': 'Neilan', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kim-Lien', 'Initials': 'KL', 'LastName': 'Nguyen', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine at the University of California, Los Angeles and the Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.'}, {'ForeName': 'Vlad G', 'Initials': 'VG', 'LastName': 'Zaha', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Advanced Imaging Research Center, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Kara W', 'Initials': 'KW', 'LastName': 'Chew', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Leavitt', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Ntobeko A B', 'Initials': 'NAB', 'LastName': 'Ntusi', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Toribio', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Magid', 'Initials': 'M', 'LastName': 'Awadalla', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Zsofia D', 'Initials': 'ZD', 'LastName': 'Drobni', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Nelson', 'Affiliation': 'Applied Physiology and Advanced Imaging Laboratory, Department of Kinesiology, University of Texas at Arlington, Arlington, Texas, USA.'}, {'ForeName': 'Tricia H', 'Initials': 'TH', 'LastName': 'Burdo', 'Affiliation': 'Department of Neuroscience, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Clinical Research Unit, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Skiest', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, Massachusetts, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Tashima', 'Affiliation': 'Division of Infectious Diseases, The Miriam Hospital and Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'Center for Clinical AIDS Research and Education, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Daar', 'Affiliation': 'Lundquist Institute at Harbor-University of California, Los Angeles Medical Center and David Geffen School of Medicine at the University of Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Alysse G', 'Initials': 'AG', 'LastName': 'Wurcel', 'Affiliation': 'Division of Geographic Medicine and Infectious Diseases, Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Robbins', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Bolan', 'Affiliation': 'Los Angeles Lesbian Gay Bisexual Transgender Center, Los Angeles, California, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Duke Clinical Research Institute, Duke Global Health Institute, Department of Medicine, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Dawson', 'Affiliation': 'Division of Pulmonology and Department of Medicine, University of Cape Town Lung Institute, Mowbray, Cape Town, South Africa.'}, {'ForeName': 'Matthew Bidwell', 'Initials': 'MB', 'LastName': 'Goetz', 'Affiliation': 'Infectious Diseases Section, Department of Medicine, Veterans Affairs Greater Los Angeles Healthcare System and David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Alberta', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine at the University of California, Los Angeles and the Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.'}, {'ForeName': 'Lidia S', 'Initials': 'LS', 'LastName': 'Szczepaniak', 'Affiliation': 'Biomedical Research Consulting in Magnetic Resonance Spectroscopy, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa245']
595,32645161,Leveraging a Landmark Trial of Primary Cardiovascular Disease Prevention in Human Immunodeficiency Virus: Introduction From the REPRIEVE Coprincipal Investigators.,"The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus. Enrolling 7770 participants from 2015 to 2019 with sites across 5 continents, REPRIEVE will assess the effects of a statin as a cardiovascular disease prevention strategy in people with HIV (PWH) receiving antiretroviral therapy (ART). Although the primary purpose of REPRIEVE, and its substudy assessing coronary plaque, is to assess cardiovascular outcomes, the trial is a rich source of data on population characteristics and critical comorbidities in PWH, particularly across Global Burden of Disease (GBD) regions, reflective of the ethnic, racial, and gender diversity in this global epidemic. The purpose of this Supplement is to leverage the rich phenotyping in REPRIEVE, to provide data on detailed patterns of baseline ART and immune function by GBD region, reproductive aging among cisgender women, and data on the participation and clinical characteristics of transgender participants. We also leveraged REPRIEVE to assess critical comorbidities, including renal dysfunction, muscle function and frailty, and myocardial steatosis. REPRIEVE is a remarkable collaboration between funders, trial networks, clinical research sites, clinical and data coordinating centers, and willing participants who devoted their time to make the trial possible.",2020,The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus.,"['Human Immunodeficiency Virus', 'human immunodeficiency virus', 'Enrolling 7770 participants from 2015 to 2019 with sites across 5 continents', 'people with HIV (PWH) receiving antiretroviral therapy (ART']",[],"['renal dysfunction, muscle function and frailty, and myocardial steatosis']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],"[{'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}]",7770.0,0.113634,The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus.,"[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Center, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa098']
596,32615798,Incidence and Factors Associated With Major Amputation in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.,"BACKGROUND


Peripheral artery disease (PAD) is associated with increased risk of mortality, cardiovascular morbidity, and major amputation. Data on major amputation from a large randomized trial that included a substantial cohort of patients without critical limb ischemia (CLI) have not been described. The objective was to describe the incidence and types of amputations in the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) population, subcategorize amputations in the CLI versus no CLI cohorts, and describe the events surrounding major amputation.
METHODS AND RESULTS


Postrandomization major amputation was analyzed in the EUCLID trial. Patients were stratified by baseline CLI status. The occurrence of major amputation was ascertained and defined as the highest level. Perioperative events surrounding major amputation were obtained including acute limb ischemia, revascularization, and all-cause mortality. All variables were assessed for significance in univariable and multivariable models. The rate of major amputation during the course of the trial was 1.6% overall, 8.4% in the CLI at baseline group, and 1.2% in the no CLI at baseline group. The annualized rate of major amputation was 0.6% in PAD overall, 3.9% in the CLI at baseline group, and 0.5% in the no CLI at baseline group. Several factors were associated with increased risk of major amputation, including history of amputation, the presence of diabetes mellitus, baseline Rutherford category 4 to 6, and an ankle-brachial index <0.8. Factors associated with a lower risk for major amputation included prior statin use. The 30-day mortality rate after major amputation was 6.5% overall, 5.6% in the CLI at baseline group, and 6.8% in the no CLI at baseline group. The annual mortality rate following major amputation was 22.8% in the CLI at baseline group and 16.0% in the no CLI at baseline group.
CONCLUSIONS


The risk factors for major amputation in EUCLID patients are similar to previous large registries' reports except for diabetes mellitus in patients with CLI. The mortality following major amputation is lower in the EUCLID trial compared with registry data. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01732822.",2020,"The 30-day mortality rate after major amputation was 6.5% overall, 5.6% in the CLI at baseline group, and 6.8% in the no CLI at baseline group.","['patients with CLI', 'patients without critical limb ischemia (CLI', 'Patients With Peripheral Artery Disease']",['Ticagrelor'],"['occurrence of major amputation', 'risk of major amputation, including history of amputation, the presence of diabetes mellitus', '30-day mortality rate after major amputation', 'annualized rate of major amputation', 'rate of major amputation', 'annual mortality rate following major amputation', 'risk of mortality, cardiovascular morbidity, and major amputation', 'acute limb ischemia, revascularization, and all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",,0.0731566,"The 30-day mortality rate after major amputation was 6.5% overall, 5.6% in the CLI at baseline group, and 6.8% in the no CLI at baseline group.","[{'ForeName': 'Chandler A', 'Initials': 'CA', 'LastName': 'Long', 'Affiliation': 'Department of Surgery, Division of Vascular Surgery and Endovascular Surgery (C.A.L.), Duke University Health System, Durham, NC.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (H.M., F.W.R., M.R.P., W.S.J.).'}, {'ForeName': 'F Gerry R', 'Initials': 'FGR', 'LastName': 'Fowkes', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, United Kingdom (F.G.R.F.).'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Division of Angiology, Swiss Cardiovascular Centre, Inselspital, Bern University Hospital, University of Bern, Switzerland (I.B.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Departments of Medicine (J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca, Gaithersburg, MD (B.G.K.).'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Norgren', 'Affiliation': 'Faculty of Medicine and Health, Örebro University, Sweden (L.N.).'}, {'ForeName': 'Juuso I', 'Initials': 'JI', 'LastName': 'Blomster', 'Affiliation': 'Heart Centre, Turku University Hospital, University of Turku, Finland (J.I.B.).'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (H.M., F.W.R., M.R.P., W.S.J.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'Department of Medicine, Division of Cardiology (W.R.H.), University of Colorado School of Medicine and CPC Clinical Research, Aurora.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Cardiology (M.R.P., W.S.J.), Duke University Health System, Durham, NC.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Department of Medicine, Division of Cardiology (M.R.P., W.S.J.), Duke University Health System, Durham, NC.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nehler', 'Affiliation': ''}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006399']
597,32621368,A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder.,"BACKGROUND AND AIMS


Although medications for opioid use disorder (OUD), including extended-release naltrexone (XR-NTX), have demonstrated effectiveness, adherence is often low. We tested the preliminary efficacy of youth opioid recovery support (YORS), a multi-component intervention designed to improve engagement and medication adherence for young adults with OUD.
DESIGN


Single-site randomized controlled trial with 24-week follow-up.
SETTING


Community substance use disorder treatment program in Baltimore, MD, USA.
PARTICIPANTS


Young adults aged 18-26 years enrolled in inpatient/residential OUD treatment intending to pursue outpatient OUD treatment with XR-NTX. Twenty-one participants were randomized to YORS and 20 to treatment as usual (TAU). The analyzed sample was 65.8% male.
INTERVENTION AND COMPARATOR


Components of YORS include: (1) home delivery of XR-NTX; (2) family engagement; (3) assertive outreach; and (4) contingency management for receipt of XR-NTX doses. The comparator was TAU, which consisted of a standard referral to outpatient care following an inpatient stay.
MEASUREMENTS


Primary outcomes were number of XR-NTX doses received over 24 weeks and relapse to opioid use (defined as ≥ 10 days of use within 28 days) at 24 weeks.
FINDINGS


Participants in the YORS condition received more XR-NTX doses [mean = 4.28; standard deviation (SD) = 2.3] compared with those in TAU (mean = 0.70; SD = 1.2), P < 0.01. Participants in the YORS group compared with TAU had lower rates of relapse (61 versus 95%; P < 0.01). Survival analyses revealed group differences on time to relapse with participants in TAU being more likely to relapse sooner compared with participants in the YORS condition [hazard ratio (HR) = 2.72, 95% confidence interval (CI) = 1.26-5.88, P < 0.01].
CONCLUSIONS


The youth opioid recovery support intervention for extended-release naltrexone adherence and opioid relapse prevention among young adults with opioid use disorder appeared to improve treatment and relapse outcomes compared with standard treatment.",2021,"Survival analyses revealed group differences on time to relapse with participants in TAU being more likely to relapse sooner compared with participants in the YORS condition (HR 2.72, 95% CI 1.26-5.88, p< .01).
","['young adults with opioid use disorder', 'Young adults aged 18-26 years enrolled in inpatient/residential OUD treatment intending to pursue outpatient OUD treatment with XR-NTX', 'young adults with OUD', 'Community substance use disorder treatment program in Baltimore, Maryland, USA']","['YORS', 'naltrexone (XR-NTX', 'XR-NTX', 'assertive treatment including family involvement and home delivery of medication', 'Youth Opioid Recovery Support (YORS']","['time to relapse', 'rates of relapse', 'number of XR-NTX doses received over 24 weeks and relapse to opioid use', 'engagement and medication adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0019857', 'cui_str': 'Home birth'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",21.0,0.137624,"Survival analyses revealed group differences on time to relapse with participants in TAU being more likely to relapse sooner compared with participants in the YORS condition (HR 2.72, 95% CI 1.26-5.88, p< .01).
","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Mountain Manor Treatment Center, Baltimore, MD, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wenzel', 'Affiliation': 'Mountain Manor Treatment Center, Baltimore, MD, USA.'}, {'ForeName': 'Hoa', 'Initials': 'H', 'LastName': 'Vo', 'Affiliation': 'Mountain Manor Treatment Center, Baltimore, MD, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Wildberger', 'Affiliation': 'Mountain Manor Treatment Center, Baltimore, MD, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Burgower', 'Affiliation': 'Mountain Manor Treatment Center, Baltimore, MD, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15181']
598,32624377,"Transdermal buprenorphine patch versus oral celecoxib for pain management after total knee arthroplasty: An open- label, randomized controlled trial.","BACKGROUND


This study was performed to evaluate the analgesic efficacy and safety of transdermal buprenorphine (TDB) patched for post-operative pain control after total knee arthroplasty (TKA). The hypothesis was that patients receiving the TDB patch would have less pain in comparison to those treated with the oral COX-2 inhibitor celecoxib without increasing side effects.
PATIENTS AND METHODS


A total of 160 patients scheduled for primary TKA were randomly assigned to two groups: patients provided the TDB patch (10μg/h) (TDB group) and those provided oral celecoxib (CX group). The outcomes were pain scores measured using the visual analogue scale (VAS) during rest and activity, as well as morphine requirement, operated knee functional recovery and adverse events post-operatively.
RESULTS


The total morphine given during the first 72h post-operatively was significantly lower in the TDB group than CX group. The VAS scores were significantly lower in the TDB group than CX group during rest at 2, 4, 6, 12, 24 and 48h post-operatively, and during activity at 12, 24 and 48h and 3 days post-operatively. The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group. In addition, the Lysholm score was significantly higher in the TDB group on PD 3. There were no remarkable adverse events in either group.
DISCUSSION


Use of the TDB patch provides effective pain relief and reduces the requirement for rescue morphine without increasing side effects in comparison with oral celecoxib during the early post-operative stage following TKA.
LEVEL OF EVIDENCE


II.",2020,"The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group.","['160 patients scheduled for primary TKA', 'pain management after total knee arthroplasty']","['Transdermal buprenorphine patch versus oral celecoxib', 'TDB', 'oral COX-2 inhibitor celecoxib', 'TDB patch', 'celecoxib', 'transdermal buprenorphine', 'TDB patch (10μg/h) (TDB group) and those provided oral celecoxib (CX group', 'CX']","['mean range of motion on post-operative days (PD', 'Lysholm score', 'analgesic efficacy and safety', 'effective pain relief', 'adverse events', 'pain', 'pain scores measured using the visual analogue scale (VAS) during rest and activity, as well as morphine requirement, operated knee functional recovery and adverse events post-operatively', 'VAS scores']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",160.0,0.0687527,"The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group.","[{'ForeName': 'Xinxian', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.""}, {'ForeName': 'Linghui', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'The Radiology Department of Wenzhou Seventh Hospital, Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Haixiao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.""}, {'ForeName': 'Yuezheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China. Electronic address: huyuezheng3@163.com.""}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.04.010']
599,32645714,A Randomized Controlled Trial to Investigate Safety and Variability of Egg Excretion After Repeated Controlled Human Hookworm Infection.,"BACKGROUND


Controlled human hookworm infections could significantly contribute to the development of a hookworm vaccine. However, current models are hampered by low and unstable egg output, reducing generalizability and increasing sample sizes. This study aims to investigate the safety, tolerability, and egg output of repeated exposure to hookworm larvae.
METHODS


Twenty-four healthy volunteers were randomized, double-blindly, to 1, 2, or 3 doses of 50 Necator americanus L3 larvae at 2-week intervals. Volunteers were monitored weekly and were treated with albendazole at week 20.
RESULTS


There was no association between larval dose and number or severity of adverse events. Geometric mean egg loads stabilized at 697, 1668, and 1914 eggs per gram feces for the 1 × 50L3, 2 × 50L3, and 3 × 50L3 group, respectively. Bayesian statistical modeling showed that egg count variability relative to the mean was reduced with a second infectious dose; however, the third dose did not increase egg load or decrease variability. We therefore suggest 2 × 50L3 as an improved challenge dose. Model-based simulations indicates increased frequency of stool sampling optimizes the power of hypothetical vaccine trials.
CONCLUSIONS


Repeated infection with hookworm larvae increased egg counts to levels comparable to the field and reduced relative variability in egg output without aggravating adverse events.
CLINICAL TRIALS REGISTRATION


NCT03257072.",2021,"DISCUSSION


Repeated infection with hookworm larvae increased egg counts to levels comparable to the field and reduced relative variability in egg output without aggravating adverse events.",['Twenty-four healthy volunteers'],['albendazole'],"['safety, tolerability and egg output', 'larval dose and number or severity of adverse events']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",24.0,0.239602,"DISCUSSION


Repeated infection with hookworm larvae increased egg counts to levels comparable to the field and reduced relative variability in egg output without aggravating adverse events.","[{'ForeName': 'Marie-Astrid', 'Initials': 'MA', 'LastName': 'Hoogerwerf', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jan Pieter R', 'Initials': 'JPR', 'LastName': 'Koopman', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jacqueline J', 'Initials': 'JJ', 'LastName': 'Janse', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marijke C C', 'Initials': 'MCC', 'LastName': 'Langenberg', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Roos', 'Initials': 'R', 'LastName': 'van Schuijlenburg', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Yvonne C M', 'Initials': 'YCM', 'LastName': 'Kruize', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Eric A T', 'Initials': 'EAT', 'LastName': 'Brienen', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Mikhael D', 'Initials': 'MD', 'LastName': 'Manurung', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Verbeek-Menken', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Martha T', 'Initials': 'MT', 'LastName': 'van der Beek', 'Affiliation': 'Clinical Microbiology Laboratory, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Westra', 'Affiliation': 'Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Meij', 'Affiliation': 'Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Leo G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van Lieshout', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Sake J', 'Initials': 'SJ', 'LastName': 'de Vlas', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Yazdanbakhsh', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Luc E', 'Initials': 'LE', 'LastName': 'Coffeng', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa414']
600,32651768,Role of nebulized epinephrine in moderate bronchiolitis: a quasi-randomized trial.,"BACKGROUND/AIMS


Bronchiolitis is the most common lower respiratory illness that characteristically affects the children below 2 years of age accounting about 2-3% of patients admitted to hospital each year [1-4]. We compared the effect of racemic epinephrine (RE) and 3% hypertonic saline (HS) nebulization on the length of stay (LOS) in the hospital.
METHODS


We looked at the infants with moderate bronchiolitis, from October 2013 to March 2014. Out of eighty cases, 16 in HS and 18 in RE groups were enrolled. At the time of admission, 0.2 ml of RE added to 1.8 ml of distilled water was nebulized to RE group, as compared with 2 ml of 3% HS in nebulized form. RE was re-administered if needed on 6 h in comparison with 3% HS at the frequency of 1 to 4 h.
RESULTS


One infant from RE group and three infants from HS group were excluded due to progression towards severe bronchiolitis. The LOS in RE group ranged between 18 and 160 h (mean 45 h), while in HS group, LOS was 18.50-206 h (mean 74.3 h). The LOS was significantly short in RE group (p value 0.015) which was statistically significant.
CONCLUSION


Racemic epinephrine nebulization as first-line medication may significantly reduce the length of hospital stay in infants with moderate bronchiolitis in comparison with nebulized HS.",2021,"The LOS was significantly short in RE group (p value 0.015) which was statistically significant.
","['Out of eighty cases, 16 in HS and 18 in RE groups were enrolled', 'infants with moderate bronchiolitis in comparison with nebulized HS', 'infants with moderate bronchiolitis, from October 2013 to March 2014', 'moderate bronchiolitis']","['Racemic epinephrine', 'racemic epinephrine (RE) and 3% hypertonic saline (HS) nebulization', 'nebulized epinephrine']","['length of stay (LOS', 'progression towards severe bronchiolitis', 'length of hospital stay', 'LOS']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0205758', 'cui_str': 'Racepinephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0205758', 'cui_str': 'Racepinephrine'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}]",,0.222084,"The LOS was significantly short in RE group (p value 0.015) which was statistically significant.
","[{'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Yasin', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland. mkmb_12@yahoo.com.'}, {'ForeName': 'Zahir Shah', 'Initials': 'ZS', 'LastName': 'Afridi', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}, {'ForeName': 'Qasim', 'Initials': 'Q', 'LastName': 'Mahmood', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}, {'ForeName': 'Akhter Ali', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Condon', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}, {'ForeName': 'Rizwan Ahmed', 'Initials': 'RA', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}]",Irish journal of medical science,['10.1007/s11845-020-02293-5']
601,32666652,Promoting engagement in physical activity in early rheumatoid arthritis: A proof-of-concept intervention study.,"OBJECTIVE(S)


The aim of this study is to test the feasibility and acceptability of promoting engagement in physical activity in early rheumatoid arthritis (PEPA-RA) to inform a future trial.
DESIGN


A 'proof of concept' study was carried out.
SETTING


This study was conducted in community hospitals delivered by musculoskeletal primary care physiotherapists.
PARTICIPANTS


Participants were 12 adults with rheumatoid arthritis (RA) diagnosed 6-24 months previously (nine females, three males; mean age 58 years, range 23-79).
INTERVENTION


The intervention consisted of five sessions, that is, four group sessions and one individual session facilitated by a physiotherapist over 12 weeks including patient education and support for behaviour change as well as supervised practical exercise.
MAIN OUTCOMES


The main outcomes were attendance, completion of outcome measures, adverse events, and participant and physiotherapist feedback views relating to the intervention.
RESULTS


Overall attendance was 85%, with sessions missed due to illness or RA flare. Outcome measure completion ranged from 83% to 100%. There were no clinically meaningful changes in pain or function at 12 weeks, but mean 6-min walk distance improved from 394 to 440 m. No serious adverse events were reported, and participants were generally positive about the intervention. Suggested minor modifications for the group sessions included venue accessibility and ensuring that physical activity time was protected. Several participants indicated that they would have liked to receive the intervention earlier following diagnosis.
CONCLUSIONS


PEPA-RA and the outcomes appear feasible and acceptable. Overall, small beneficial effects were noted at 12 weeks for most outcomes. Challenges to recruitment resulted in a smaller than anticipated sample size, and the majority of participants were active at baseline indicating that future recruitment needs to target less active individuals.",2020,"There were no clinically meaningful changes in pain or function at 12 weeks, but mean 6-min walk distance improved from 394 to 440 m.","['Participants were 12 adults with rheumatoid arthritis (RA) diagnosed 6-24 months previously (nine females, three males; mean age 58 years, range 23-79', 'early rheumatoid arthritis (PEPA-RA', 'community hospitals delivered by musculoskeletal primary care physiotherapists', 'early rheumatoid arthritis']",['individual session facilitated by a physiotherapist over 12 weeks including patient education and support for behaviour change as well as supervised practical exercise'],"['illness or RA flare', 'attendance, completion of outcome measures, adverse events, and participant and physiotherapist feedback views relating to the intervention', 'pain or function', 'serious adverse events', 'mean 6-min walk distance', 'small beneficial effects', 'venue accessibility and ensuring that physical activity time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",12.0,0.11645,"There were no clinically meaningful changes in pain or function at 12 weeks, but mean 6-min walk distance improved from 394 to 440 m.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cramp', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Haase', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Domaille', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Manns', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Swales', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hurfurt', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Nicola E', 'Initials': 'NE', 'LastName': 'Walsh', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}]",Musculoskeletal care,['10.1002/msc.1493']
602,32664290,Effects of Pre-Sleep Whey vs. Plant-Based Protein Consumption on Muscle Recovery Following Damaging Morning Exercise.,"Pre-sleep whey protein intake has been shown to improve overnight muscle protein synthesis, muscle size and strength, and muscle recovery. Despite a growing interest in alternative protein sources, such as plant-based protein, there is no evidence regarding the efficacy of plant-based proteins consumed pre-sleep. Therefore, we aimed to compare whey vs. plant-based pre-sleep protein dietary supplementation on muscle recovery in middle-aged men. Twenty-seven recreationally active, middle-aged men performed 5 sets of 15 repetitions of maximal eccentric voluntary contractions (ECC) for the knee extensors (ext) and flexors (flex), respectively, in the morning. Participants consumed 40 g of either whey hydrolysate (WH,  n  = 9), whey isolate (WI,  n  = 6), rice and pea combination (RP,  n  = 6), or placebo (PL,  n  = 6) 30 min pre-sleep on the day of ECC and the following two nights. Catered meals (15% PRO, 55% CHO, 30% Fat) were provided to participants for 5 days to standardize nutrition. Plasma creatine kinase (CK), interleukin-6 (IL-6), and interleukin-10 (IL-10) were measured at pre, immediately post (+0), +4, +6, +24, +48, and +72 h post-ECC. Isometric (ISOM) and isokinetic (ISOK) maximal voluntary contraction force were measured at pre, immediately post (+0), +24, +48, and +72 h post-ECC. Muscle soreness, thigh circumference, and HOMA-IR were measured at pre, +24, +48, and +72 h post-ECC. CK was increased at +4 h post-ECC, remained elevated at all time points compared to baseline ( p  < 0.001), and was significantly greater at +72 h compared to all other time points ( p  < 0.001). IL-6 was increased at +6 h ( p  = 0.002) with no other time differing from baseline. ISOMext was reduced after ECC ( p  = 0.001) and remained reduced until returning to baseline at +72 h. ISOMflex, ISOKext, and ISOKflex were reduced after ECC and remained reduced at +72 h ( p  < 0.001). Muscle soreness increased post-ECC ( p  < 0.001) and did not return to baseline. Thigh circumference ( p  = 0.456) and HOMA-IR ( p  = 0.396) did not change post-ECC. There were no significant differences between groups for any outcome measure. These data suggest that middle-aged men consuming 1.08 ± 0.02 g/kg/day PRO did not recover from damaging eccentric exercise at +72 h and that pre-sleep protein ingestion, regardless of protein source, did not aid in muscle recovery when damaging eccentric exercise was performed in the morning.",2020,Thigh circumference ( p  = 0.456) and HOMA-IR ( p  = 0.396) did not change post-ECC.,"['Twenty-seven recreationally active, middle-aged men', 'middle-aged men']","['whey vs. plant-based pre-sleep protein dietary supplementation', 'maximal eccentric voluntary contractions (ECC', 'Pre-Sleep Whey vs. Plant-Based Protein Consumption', 'whey hydrolysate (WH,  n  = 9), whey isolate (WI,  n  = 6), rice and pea combination (RP,  n  = 6), or placebo (PL,  n  = 6) 30 min pre-sleep on the day of ECC']","['Muscle soreness', 'ISOMflex, ISOKext, and ISOKflex', 'HOMA-IR', 'Plasma creatine kinase (CK), interleukin-6 (IL-6), and interleukin-10 (IL-10', 'ISOMext', 'Isometric (ISOM) and isokinetic (ISOK) maximal voluntary contraction force', 'IL-6', 'Muscle soreness, thigh circumference, and HOMA-IR', 'CK', 'Thigh circumference']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]",,0.178006,Thigh circumference ( p  = 0.456) and HOMA-IR ( p  = 0.396) did not change post-ECC.,"[{'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Saracino', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Saylor', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Hanna', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hickner', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Jeong-Su', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}]",Nutrients,['10.3390/nu12072049']
603,32645162,Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial.,"BACKGROUND


Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.
METHODS


The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.
RESULTS


A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
CONCLUSIONS


There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","['HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk', 'people living with HIV', '7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers']",['nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI)\u2005plus nonnucleoside reverse-transcriptase inhibitor'],"['GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts', 'entry CD4 cell count and CD4/CD8 ratio', 'median CD4 T-cell count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4277729', 'cui_str': 'Global Burden of Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",7770.0,0.18883,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","[{'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Leon-Cruz', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlos D', 'Initials': 'CD', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Centre for Research with Ubuntu, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Hospital Clinic and University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Breno Riegel', 'Initials': 'BR', 'LastName': 'Santos', 'Affiliation': 'Infectious Diseases Service, Hospital Nossa, Senhora da Conceição/GHC, Porto Alegre, Brazil.'}, {'ForeName': 'Yvetot', 'Initials': 'Y', 'LastName': 'Joseph', 'Affiliation': 'Les Centres GHESKIO, Port-au-Prince, Haiti.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Siminski', 'Affiliation': 'Frontier Science and Technology Foundation, Amherst, Massachusetts, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': 'HIV Medical Sciences, Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Montgomery, Alabama, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung and Blood Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, University of California-Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa259']
604,32645164,An Evaluation of Baseline Kidney Function in the REPRIEVE Trial of Pitavastatin in Human Immunodeficiency Virus.,"BACKGROUND


Chronic kidney disease is a common comorbid condition among persons living with human immunodeficiency virus (PWH). We characterized baseline kidney function in the REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) trial cohort.
METHODS


REPRIEVE enrolled PWH with low to moderate cardiovascular risk based on traditional risk factors to evaluate the effect of statin therapy on cardiovascular events. We determined baseline estimated glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations, and we evaluated baseline factors associated with eGFR <90 mL/min/1.73 m2 by logistic regression. We performed Bland-Altman plots and scatterplots to assess agreement between equations.
RESULTS


Among 7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the median body mass index (calculated as calculated as weight in kilograms divided by height in meters squared) was 25.8, and the median CD4 cell count 620/µL. The median CKD-EPI eGFR was 97 mL/min/1.73 m2, and 38% had an eGFR <90 mL/min/1.73 m2. In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate. The CKD-EPI and Modification of Diet in Renal Disease equations demonstrated strong agreement, particularly at lower eGFR values. Overall, there was 56% concordance between the 3 equations (categories <60, 60 to <90, ≥90 mL/min), improving to 73% after accounting for individual body surface area.
CONCLUSIONS


REPRIEVE enrolled a diverse cohort including a substantial number of PWH with reduced kidney function. Factors associated with reduced eGFR included traditional risk factors and tenofovir disoproxil fumarate exposure. Three commonly used equations have only fair agreement, with potential implications for both clinical care and epidemiologic studies.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","['7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the', 'Human Immunodeficiency Virus', 'persons living with human immunodeficiency virus (PWH']","['tenofovir disoproxil fumarate exposure', 'statin therapy', 'eGFR', 'tenofovir disoproxil fumarate', 'Pitavastatin']","['median CKD-EPI eGFR', 'median CD4 cell count', 'median body mass index', 'glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations', 'cardiovascular events']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",7770.0,0.0804019,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","[{'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'HIV Treatment Clinical Research Site, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Mosepele', 'Initials': 'M', 'LastName': 'Mosepele', 'Affiliation': 'University of Botswana and Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Lerato', 'Initials': 'L', 'LastName': 'Mohapi', 'Affiliation': 'Soweto Clinical Research Site, Chris Hani Baragwanath Hospital, Johannesburg, Gauteng, South Africa.'}, {'ForeName': 'Sandra Wagner', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'Fiocruz Therapeutic and Prevention HIV/AIDS Clinical Trials Unit, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Marcus V G', 'Initials': 'MVG', 'LastName': 'de Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Doutor Heitor Viera Dourado, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'McComsey', 'Affiliation': 'Division of Pediatric Infectious Diseases and Rheumatology, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Wyatt', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa222']
605,32665394,Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer.,"INTRODUCTION


Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers. However, older adults do not complete ACP at expected rates due to patient and clinician barriers. We present the original design, methods and rationale for a trial aimed at improving ACP for older patients with advanced cancer and the modified protocol in response to changes brought by the COVID-19 pandemic.
METHODS AND ANALYSIS


The Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly study is a pragmatic, stepped-wedge cluster randomised trial examining a Comprehensive ACP Program. The programme combines two complementary evidence-based interventions: clinician communication skills training (VitalTalk) and patient video decision aids (ACP Decisions). We will implement the programme at 36 oncology clinics across three unique US health systems. Our primary outcome is the proportion of eligible patients with ACP documentation completed in the electronic health record. Our secondary outcomes include resuscitation preferences, palliative care consultations, death, hospice use and final cancer-directed therapy. From a subset of our patient population, we will collect surveys and video-based declarations of goals and preferences. We estimate 11 000 patients from the three sites will be enrolled in the study.
ETHICS AND DISSEMINATION


Regulatory and ethical aspects of this trial include Institutional Review Board (IRB) approval via single IRB of record mechanism at Dana-Farber Cancer Institute, Data Use Agreements among partners and a Data Safety and Monitoring Board. We plan to present findings at national meetings and publish the results.
TRIAL REGISTRATION NUMBER


NCT03609177; Pre-results.",2020,"INTRODUCTION


Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers.","['older adults', '11 000 patients from the three sites will be enrolled in the study', 'patients with cancer', 'older patients with cancer', 'older patients with advanced cancer']","['complementary evidence-based interventions: clinician communication skills training (VitalTalk) and patient video decision aids (ACP Decisions', 'Advance care planning (ACP', 'Advance Care Planning']","['proportion of eligible patients with ACP documentation', 'resuscitation preferences, palliative care consultations, death, hospice use and final cancer-directed therapy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",11000.0,0.103925,"INTRODUCTION


Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers.","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lakin', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USA jlakin@partners.org.'}, {'ForeName': 'Elise N', 'Initials': 'EN', 'LastName': 'Brannen', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Tulsky', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Department of General Internal Medicine, Boston University School of Medicine, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Lindvall', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Gundersen', 'Affiliation': 'Department of Survey and Data Management Core, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Volandes', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-040999']
606,32669957,Management of Postoperative Pain after Elective Craniotomy: A Prospective Randomized Controlled Trial of a Neurosurgical Enhanced Recovery after Surgery (ERAS) Program.,"Objective:  To prospectively evaluate the efficacy of a neurosurgical enhanced recovery after surgery (ERAS) protocol on the management of postoperative pain after elective craniotomies.  Methods:  This randomized controlled trial was conducted in the neurosurgical center of Tangdu Hospital (Fourth Military Medical University, Xi'an, China). A total of 129 patients undergoing craniotomies between October 2016 and July 2017 were enrolled in a randomized clinical trial comparing an ERAS protocol to a conventional postoperative care regimen. The primary outcome was the postoperative pain score assessed by a verbal numerical rating scale (NRS).  Results:  Patients in the ERAS group had a significant reduction in their postoperative pain scores on POD 1 compared to patients in the control group (p < 0.05). More patients (n = 44, 68.8%) in the ERAS group experienced mild pain (NRS: 1 to 3) on POD1 compared with patients (n = 23, 35.4%) in the control group (p < 0.05). A further reduction in pain scores was also observed on POD 2 and maintained on POD 3 in the ERAS group compared with that in the control group. In addition, the median postoperative length of hospital stay was significantly decreased with the incorporation of the ERAS protocol compared to controls (ERAS: 4 days, control: 7 days, P<0.001).  Conclusion:  The implementation of a neurosurgical ERAS protocol for elective craniotomy patients has significant benefits in alleviating postoperative pain and enhancing recovery leading to early discharge after surgery compared to conventional care. Further evaluation of this protocol in larger, multi-center studies is warranted.",2020,Patients in the ERAS group had a significant reduction in their postoperative pain scores on POD 1 compared to patients in the control group (p < 0.05).,"['Postoperative Pain after Elective Craniotomy', ""neurosurgical center of Tangdu Hospital (Fourth Military Medical University, Xi'an, China"", '129 patients undergoing craniotomies between October 2016 and July 2017', 'elective craniotomy patients', 'postoperative pain after elective craniotomies']","['neurosurgical enhanced recovery after surgery (ERAS) protocol', 'ERAS protocol to a conventional postoperative care regimen', 'ERAS', 'Neurosurgical Enhanced Recovery after Surgery (ERAS) Program']","['pain scores', 'postoperative pain scores', 'POD1', 'postoperative pain score assessed by a verbal numerical rating scale (NRS', 'median postoperative length of hospital stay', 'mild pain']","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}]",129.0,0.125422,Patients in the ERAS group had a significant reduction in their postoperative pain scores on POD 1 compared to patients in the control group (p < 0.05).,"[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Qu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Sankey', 'Affiliation': 'Duke University Hospital. Durham, NC. USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chai', 'Affiliation': ""Department of Anesthesiology, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Binrong', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhengmin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Jiangtao', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Binfang', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Nutrition, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Lanfu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Yufu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Haijing', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}]",International journal of medical sciences,['10.7150/ijms.46403']
607,33084980,"Bovine surfactant in the treatment of pneumonia-induced-neonatal acute respiratory distress syndrome (NARDS) in neonates beyond 34 weeks of gestation: a multicentre, randomized, assessor-blinded, placebo-controlled trial.","Neonatal acute respiratory distress syndrome (NARDS) reflects pulmonary surfactant dysfunction, and the usage of bovine surfactant (Calsurf) supplement may therefore be beneficial. To determine whether bovine surfactant given in NARDS can improve oxygenation and survival rate, we conducted a multicenter, randomized trial between January 2018 and June 2019, and we compared Calsurf treatment to controls in neonates with pneumonia accompanied by NARDS. Neonates who met the Montreux criteria definition of NARDS were included, and those with congenital heart and lung malformations were excluded. Primary outcomes were oxygenation index (OI) after Calsurf administration, and secondary outcomes were mortality, and duration of ventilator and oxygen between the two groups, and also other morbidities. Cumulatively, 328 neonates were recruited and analyzed, 162 in the control group, and 166 in the Calsurf group. The results shows that OI in the Calsurf group were significantly lower than that in the control group at 4 h (7.2 ± 2.7 and 11.4 ± 9.1, P = 0.001); similarly, OI in the Calsurf group were significantly lower than in the control group at 12 h ( 7.5 ± 3.1 and 11.2 ± 9.2, P = 0.001). Mortality and duration of ventilator support or oxygen use between the two groups were not significantly different.Conclusion: Calsurf acutely improved OI immediately after administration in pneumonia-induced NARDS; although, we observed no significant decrease in mortality, duration of ventilator or oxygen, or major morbidity. What is known: • The definition proposed as the Monteux criteria for neonatal acute respiratory distress syndrome (NARDS). • Surfactant acutely improved oxygenation and significantly decreased mortality in children and adolescents with acute lung injury. What is new: • This is the first large randomized controlled trail to study on surfactant treatment of neonates with acute respiratory distress syndromes. • Surfactant acutely improved oxygenation immediately after administration in pneumonia-induced NARDS at a gestational age beyond 34 weeks.",2021,Mortality and duration of ventilator support or oxygen use between the two groups were not significantly different.,"['Neonates who met the Montreux criteria definition of NARDS were included, and those with congenital heart and lung malformations', 'neonates with acute respiratory distress syndromes', 'pneumonia-induced-neonatal acute respiratory distress syndrome (NARDS) in neonates beyond 34 weeks of gestation', 'Neonatal acute respiratory distress syndrome (NARDS', 'neonatal acute respiratory distress syndrome (NARDS', 'neonates with pneumonia accompanied by NARDS', '328 neonates were recruited and analyzed, 162 in the control group, and 166 in the Calsurf group', 'children and adolescents with acute lung injury']","['bovine surfactant (Calsurf) supplement', 'placebo', 'Bovine surfactant', 'bovine surfactant given in NARDS']","['Mortality and duration of ventilator support or oxygen use', 'oxygenation and survival rate', 'mortality, duration of ventilator or oxygen, or major morbidity', 'oxygenation index (OI) after Calsurf administration, and secondary outcomes were mortality, and duration of ventilator and oxygen', 'mortality']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",328.0,0.0738327,Mortality and duration of ventilator support or oxygen use between the two groups were not significantly different.,"[{'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Rong', 'Affiliation': 'Department of Neonatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Luxia', 'Initials': 'L', 'LastName': 'Mo', 'Affiliation': 'Department of Neonatology, Wuhan Maternal and Child Healthcare Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Pan', 'Affiliation': 'Department of Neonatology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, China.'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Neonatology, Jingzhou Central Hospital, Jingzhou, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Neonatology, HuangShi Maternal and Child Healthcare Hospital, Huangshi, China.'}, {'ForeName': 'Maojun', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Neonatology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Sichuan, China.""}, {'ForeName': 'Lubiao', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Neonatology, Maternal and Child Healthcare Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Lang', 'Affiliation': ""Department of Neonatology, Children's Hospital of Jinan, Jinan, China.""}, {'ForeName': 'Xiaoshan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Neonatology, Anhui Provincial Children's Hospital, Hefei, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neonatology, Jiangxi Provincial Children's Hospital, Jiangxi, China.""}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Department of Neonatology, Hubei Maternity and Child Heath Hospital, Wuhan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Neonatology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Department of Neonatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. 13871530925@163.com.'}]",European journal of pediatrics,['10.1007/s00431-020-03821-2']
608,32679209,Intralymphatic immunotherapy improves grass pollen allergic rhinoconjunctivitis: A 3-year randomized placebo-controlled trial.,"BACKGROUND


Allergic rhinoconjunctivitis is a global health problem. Different allergen immunotherapy regimes are marketed but have low adherence because they are expensive, complex, and time-consuming. New allergen immunotherapy forms are needed.
OBJECTIVE


In a 3-year follow-up double-blind randomized placebo-controlled trial, we aimed to investigate the effect of intralymphatic allergen immunotherapy (ILIT).
METHODS


Patients with grass pollen rhinoconjunctivitis were treated with 3 ILIT injections and an ILIT booster 1 year later, 3 ILIT injections and a placebo booster, or 3 placebo injections and a placebo booster. Primary outcome was improvement in a combined symptom and medication score (cSMS). A novel evaluation tool with a linear regression model of cSMS and grass pollen counts was developed. Secondary outcomes were changes in grass specific immunoglobulins and skin and nasal provocation tests to grass pollen.
RESULTS


A total of 36 patients were included. Log 10 -transformed cSMS was reduced by 0.30 (95% CI, 0.11-0.49; P = .002), equaling 48.5% (95% CI, 24.5%-62%), in the entire 3-year follow-up period, significant only in the first follow-up season but not in the second and third seasons. The regression model showed a 37% (P < .001) reduction in cSMS. The booster injection 1 year later had no additional effect. Secondary, repeated measures of IgE and IgG 4  to grass showed significant between-group difference and within-group change in the ILIT groups. No change in provocation test results was found.
CONCLUSIONS


ILIT gives a substantial reduction in grass pollen allergy symptoms and use of rescue medication, significant in the first season after treatment. A booster injection had no additional effect.",2021,"Secondary, repeated measures of IgE and IgG 4  to grass, showed significant between-group difference and within-group change in the ILIT groups.","['36 patients were included', 'Patients with grass pollen rhinoconjunctivitis']","['ILIT injections and an ILIT booster one year later, three ILIT injection and a placebo booster or three placebo injections and a placebo booster', 'intralymphatic AIT (ILIT', 'Intralymphatic Immunotherapy', 'placebo']","['grass pollen allergic rhinoconjunctivitis', 'provocation test', 'cSMS', 'combined symptom and medication score, cSMS', 'repeated measures of IgE and IgG 4  to grass', 'changes in grass specific immunoglobulins and skin and nasal provocation tests to grass pollen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}]","[{'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162352', 'cui_str': 'Hyposensitization to allergens'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4521841', 'cui_str': 'US Military enlisted E9'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0027431', 'cui_str': 'Nasal provocation test'}]",36.0,0.678572,"Secondary, repeated measures of IgE and IgG 4  to grass, showed significant between-group difference and within-group change in the ILIT groups.","[{'ForeName': 'Søren Helbo', 'Initials': 'SH', 'LastName': 'Skaarup', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Johannes Martin', 'Initials': 'JM', 'LastName': 'Schmid', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Skjold', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Graumann', 'Affiliation': 'Department of Radiology, Odense University Hospital, Odense, Denmark; Research and Innovation Unit of Radiology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Hans Jürgen', 'Initials': 'HJ', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: hjh@clin.au.dk.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.07.002']
609,32677499,Effects of Simulation Video on Parental Recall of Seizure First Aid: A Quality Improvement Project.,"Many parents of children do not recall anticipatory guidance on acute seizure management, which can lead to unnecessary emergency department visits. This quality improvement project evaluated if adding a video simulation of seizure first aid improved parental recall. Parents of children with seizures were randomized to standard verbal counseling or video group, which were shown a video simulation of seizure first aid. All families also received a standardized written action plan. Eighty-three patients were randomized from July to October 2018. Overall, 53% of families who received standard counseling accurately recalled seizure first aid compared with 31% in video group (χ 2  = 3.24,  P  = .07). Among families without baseline knowledge of seizure first aid, 43% in the standard counseling group recalled accurately compared with 16% of video group (χ 2  = 4.52,  P  = .03). These results underscore the importance of face-to-face patient education despite the popularity of video-based media. Future Plan-Do-Study-Act cycles will include piloting a hands-on seizure first aid simulation with mannequins.",2020,"Many parents of children do not recall anticipatory guidance on acute seizure management, which can lead to unnecessary emergency department visits.","['Parents of children with seizures', 'Eighty-three patients were randomized from July to October 2018']","['Simulation Video', 'standard verbal counseling or video group']",['Parental Recall of Seizure First Aid'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016143', 'cui_str': 'First aid'}]",83.0,0.0518988,"Many parents of children do not recall anticipatory guidance on acute seizure management, which can lead to unnecessary emergency department visits.","[{'ForeName': 'Xinran Maria', 'Initials': 'XM', 'LastName': 'Xiang', 'Affiliation': '12258Louisiana State University Health Sciences Center, New Orleans, LA, USA.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': '12258Louisiana State University Health Sciences Center, New Orleans, LA, USA.'}]",Journal of child neurology,['10.1177/0883073820939390']
610,33077275,"Increased bioavailability of phenolic acids and enhanced vascular function following intake of feruloyl esterase-processed high fibre bread: A randomized, controlled, single blind, crossover human intervention trial.","BACKGROUND & AIMS


Clinical trial data have indicated an association between wholegrain consumption and a reduction in surrogate markers of cardiovascular disease. Phenolics present in wholegrain bound to arabinoxylan fibre may contribute these effects, particularly when released enzymatically from the fiber prior to ingestion. The aim of the present study was therefore to determine whether the intake of high fibre bread containing higher free ferulic acid (FA) levels (enzymatically released during processing) enhances human endothelium-dependent vascular function.
METHODS


A randomized, single masked, controlled, crossover, human intervention study was conducted on 19 healthy men. Individuals consumed either a high fibre flatbread with enzymatically released free FA (14.22 mg), an equivalent standard high fibre bread (2.34 mg), or a white bread control (0.48 mg) and markers of vascular function and plasma phenolic acid concentrations were measured at baseline, 2, 5 and 7 h post consumption.
RESULTS


Significantly increased brachial arterial dilation was observed following consumption of the high free FA ('enzyme-treated') high fibre bread verses both a white bread (2 h: p < 0.05; 5 h: p < 0.01) and a standard high fibre bread (5 h: p < 0.05). Concurrently, significant increases in plasma FA levels were observed, at 2 h (p < 0.01) after consumption of the enzyme-treated bread, relative to control treatments. Blood pressure, heart rate, DVP-SI and DVP-RI were not significantly altered following intake of any of the breads (p > 0.05).
CONCLUSION


Dietary intake of bread, processed enzymatically to release FA from arabinoxylan fiber during production increases the bioavailability of FA, and induces acute endothelium-dependent vasodilation.
CLINICAL TRIAL REGISTRY


NO: NCT03946293. WEBSITE: www.clinicaltrials.gov.",2021,"Concurrently, significant increases in plasma FA levels were observed, at 2 h (p < 0.01) after consumption of the enzyme-treated bread, relative to control treatments.",['19 healthy men'],['feruloyl esterase-processed high fibre bread'],"['Blood pressure, heart rate, DVP-SI and DVP-RI', 'bioavailability of phenolic acids and enhanced vascular function', 'free ferulic acid (FA) levels', 'vascular function and plasma phenolic acid concentrations', 'bioavailability of FA', 'brachial arterial dilation', 'plasma FA levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0117605', 'cui_str': 'feruloyl esterase'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0006138', 'cui_str': 'Bread'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0078144', 'cui_str': 'VDP protocol'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C2586298', 'cui_str': 'Hydroxybenzoic acid'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0060291', 'cui_str': 'ferulic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",19.0,0.147132,"Concurrently, significant increases in plasma FA levels were observed, at 2 h (p < 0.01) after consumption of the enzyme-treated bread, relative to control treatments.","[{'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Turner', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Food and Pharmacy, University of Reading, Reading, UK (ALT, JPES).'}, {'ForeName': 'Louise V', 'Initials': 'LV', 'LastName': 'Michaelson', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, Harpenden, UK (LVM, PRS, AL).'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Shewry', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, Harpenden, UK (LVM, PRS, AL).; School of Agriculture, Policy and Development, University of Reading, Reading, Berks, UK (PRS).'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lovegrove', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, Harpenden, UK (LVM, PRS, AL).'}, {'ForeName': 'Jeremy P E', 'Initials': 'JPE', 'LastName': 'Spencer', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Food and Pharmacy, University of Reading, Reading, UK (ALT, JPES).. Electronic address: j.p.e.spencer@reading.ac.uk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.026']
611,33084335,Increased Intestinal Permeability in Older Subjects Impacts the Beneficial Effects of Dietary Polyphenols by Modulating Their Bioavailability.,"Polyphenols have great potential in regulating intestinal health and ameliorating pathological conditions related to increased intestinal permeability (IP). However, the efficacy of dietary interventions with these phytochemicals may significantly be influenced by interindividual variability factors affecting their bioavailability and consequent biological activity. In the present study, urine samples collected from older subjects undergoing a crossover intervention trial with polyphenol-rich foods were subjected to metabolomics analysis for investigating the impact of increased IP on the bioavailability of polyphenols. Interestingly, urinary levels of phase II and microbiota-derived metabolites were significantly different between subjects with healthier intestinal barrier integrity and those with increased IP disruption. Our results support that this IP-dependent impaired bioavailability of polyphenols could be attributed to disturbances in the gut microbial metabolism and phase II methylation processes. Furthermore, we also observed that microbiota-derived metabolites could be largely responsible for the biological activity elicited by dietary polyphenols against age-related disrupted IP.",2020,"Interestingly, urinary levels of phase II and microbiota-derived metabolites were significantly different between subjects with healthier intestinal barrier integrity and those with increased IP disruption.","['Older Subjects', 'older subjects undergoing a crossover intervention trial with']","['Polyphenols', 'Dietary Polyphenols', 'polyphenol-rich foods']","['Intestinal Permeability', 'urinary levels of phase II and microbiota-derived metabolites']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0234876,"Interestingly, urinary levels of phase II and microbiota-derived metabolites were significantly different between subjects with healthier intestinal barrier integrity and those with increased IP disruption.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hidalgo-Liberona', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'González-Domínguez', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Vegas', 'Affiliation': 'CIBER Fragilidad y Envejecimiento Saludable (CIBERfes), Instituto de Salud Carlos III, 28029 Barcelona, Spain.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Riso', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': ""Del Bo'"", 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bernardi', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Peron', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Guglielmetti', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gargari', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Paul Antony', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, NR4 7UQ Norwich, United Kingdom.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cherubini', 'Affiliation': ""Geriatria, Accettazione Geriatrica e Centro di Ricerca per l'Invecchiamento, IRCCS INRCA, 60127 Ancona, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andrés-Lacueva', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}]",Journal of agricultural and food chemistry,['10.1021/acs.jafc.0c04976']
612,33076707,"""Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.""","OBJECTIVE


To evaluate the effect of adding an Upper Cervical Translatoric Mobilization (UCTM) or an Inhibitory Suboccipital Technique (IST) to a physiotherapy treatment in the symptomatology and function of mechanical chronic neck pain patients.
DESIGN


Randomized controlled trial.
SETTING


Primary Care Center in Cornellà, Spain.
SUBJECTS


78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain were divided in three groups: control, IST and UCTM groups.
INTERVENTIONS


All groups received 15 physiotherapy sessions for three weeks. The UCTM and IST groups added 5 minutes of the assigned technique during six sessions.
MAIN MEASURES


Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain were measured baseline, three-weeks and 15-weeks follow-up.
RESULTS


NDI (SD) at baseline, three-weeks and 15-weeks were 11.62 (7.08), 9.65 (6.25), 7.58 (5.64) for the control group, 14.38 (6.92), 8.50 (6.11), 7.12 (4.98) for the IST group and 13.19(7.23), 5.35(6.10), 4.35(2.76) for the UCTM group. NPRS (SD) at baseline, three-weeks and 15-weeks were 58.69 (19.46), 45.19 (23.43), 44.58 (24.08) for the control group; 64.08 (19.26), 42.19 (19.69), 34 (21.14) for the IST group; and 67.65 (20.65), 36.23 (20.10), 39.85 (25.44) for the UCTM group.
CONCLUSIONS


Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups.
TRIAL REGISTRATION


This study was registered in Clinicaltrials.gov (NCT02832232).",2021,"Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups.
","['78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain', 'Primary Care Center in Cornellà, Spain', 'patients with chronic mechanical neck pain', 'mechanical chronic neck pain patients']","['physiotherapy treatment', 'Upper Cervical Translatoric Mobilization (UCTM', 'control, IST and UCTM groups', 'Inhibitory Suboccipital Technique (IST', 'upper cervical manual therapy', 'conventional physical therapy program']","['Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain', 'NPRS (SD', 'reduced disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",78.0,0.19135,"Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups.
","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'González-Rueda', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-de-Celis', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bueno-Gracia', 'Affiliation': 'Unidad de Investigación en Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Pérez-Bellmunt', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Martín Eusebio', 'Initials': 'ME', 'LastName': 'Barra-López', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Hidalgo García', 'Affiliation': 'Unidad de Investigación en Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Spain.'}]",Clinical rehabilitation,['10.1177/0269215520965054']
613,33071012,"Anthocyanins attenuate vascular and inflammatory responses to a high fat high energy meal challenge in overweight older adults: A cross-over, randomized, double-blind clinical trial.","BACKGROUND & AIMS


Postprandial metabolic imbalances are important indicators of later developing cardiovascular disease (CVD). This study investigated the effects of food anthocyanins on vascular and microvascular function, and CVD associated biomarkers following a high fat high energy (HFHE) meal challenge in overweight older adults.
METHODS


Sixteen subjects (13 female, 3 male, mean age 65.9 SD 6.0 and body mass index 30.6 kg/m 2  SD 3.9) participated in a crossover, randomized, controlled, double-blind clinical trial (registered under Australian New Zealand Clinical Trials Registry, identifier no. ACTRN12620000437965). Participants consumed a HFHE meal with a 250 mL dose of either intervention (anthocyanins-rich Queen Garnet Plum) or control (apricot) juice. Blood samples and blood pressure measures were collected at baseline, 2 h and 4 h following the HFHE meal. Vascular and microvascular function were evaluated at baseline and 2 h after the HFHE meal.
RESULTS


Participants had a higher 2 h postprandial flow-mediated dilatation (+1.14%) and a higher microvascular post-occlusive reactive hyperaemia (+0.10 perfusion units per mmHg) when allocated to the anthocyanin compared to the control arm (P = 0.019 and P = 0.049, respectively). C-reactive protein was lower 4 h postprandially in the anthocyanins (1.80 mg/L, IQR 0.90) vs control arm (2.30 mg/L, IQR 1.95) (P = 0.026), accompanied by a trend for lower concentrations of interleukin-6 (P = 0.075). No significant postprandial differences were observed between treatments for blood pressure, triacylglycerol, total cholesterol, serum derivatives of reactive oxidative metabolites, tumor necrosis factor alpha, interleukin-1 beta, or maximum microvascular perfusion following iontophoresis of acetylcholine.
CONCLUSION


Fruit-based anthocyanins attenuated the potential postprandial detrimental effects of a HFHE challenge on parameters of vascular and microvascular function, and inflammatory biomarkers in overweight older adults. Anthocyanins may reduce cardiovascular risk associated with endothelial dysfunction and inflammatory responses to a typical high fat 'Western' meal. Further studies are required to better elucidate the clinical implications of postprandial biomarkers of CVD.",2021,"C-reactive protein was lower 4 h postprandially in the anthocyanins (1.80 mg/L, IQR 0.90) vs control arm (2.30 mg/L, IQR 1.95)","['Sixteen subjects (13 female, 3 male, mean age 65.9 SD 6.0 and body mass index 30.6\xa0kg/m 2  SD 3.9', 'overweight older adults']","['food anthocyanins', 'HFHE meal', 'Anthocyanins', 'Fruit-based anthocyanins', 'intervention (anthocyanins-rich Queen Garnet Plum) or control (apricot) juice']","['C-reactive protein', 'vascular and microvascular function, and inflammatory biomarkers', 'higher 2\xa0h postprandial flow-mediated dilatation', 'microvascular post-occlusive reactive hyperaemia', 'blood pressure, triacylglycerol, total cholesterol, serum derivatives of reactive oxidative metabolites, tumor necrosis factor alpha, interleukin-1 beta, or maximum microvascular perfusion', 'Blood samples and blood pressure measures', 'Vascular and microvascular function']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1268568', 'cui_str': 'Juice'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.405399,"C-reactive protein was lower 4 h postprandially in the anthocyanins (1.80 mg/L, IQR 0.90) vs control arm (2.30 mg/L, IQR 1.95)","[{'ForeName': 'Vinicius A', 'Initials': 'VA', 'LastName': 'do Rosario', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia. Electronic address: vadr998@uowmail.edu.au.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia. Electronic address: cchang@uow.edu.au.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Spencer', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia. Electronic address: jes647@uowmail.edu.au.'}, {'ForeName': 'Thilani', 'Initials': 'T', 'LastName': 'Alahakone', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia. Electronic address: tsa598@uowmail.edu.au.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Roodenrys', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia. Electronic address: steven@uow.edu.au.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Francois', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia. Electronic address: francois@uow.edu.au.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Weston-Green', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia; Molecular Horizons, University of Wollongong, NSW, 2522, Australia. Electronic address: kweston@uow.edu.au.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hölzel', 'Affiliation': 'Tasmanian Institute of Agriculture, University of Tasmania, Hobart, 7000, Australia. Electronic address: nadine.macha@utas.edu.au.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Nichols', 'Affiliation': 'Central Sciences Laboratory, University of Tasmania, Hobart, TAS, 7000, Australia. Electronic address: d.nichols@utas.edu.au.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kent', 'Affiliation': 'Centre for Rural Health, University of Tasmania, Launceston, TAS, 7250, Australia. Electronic address: katherine.kent@utas.edu.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Department of Agriculture and Fisheries, QLD, 4108, Australia. Electronic address: david.williams@daf.qld.gov.au.'}, {'ForeName': 'Ian M R', 'Initials': 'IMR', 'LastName': 'Wright', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia; College of Medicine and Dentistry, James Cook University, Cairns, QLD, 4870, Australia. Electronic address: ian.wright@jcu.edu.au.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Charlton', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia. Electronic address: karenc@uow.edu.au.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.041']
614,33077817,Enhanced physical and cognitive performance in active duty Airmen: evidence from a randomized multimodal physical fitness and nutritional intervention.,"Achieving military mission objectives requires high levels of performance from Airmen who operate under extreme physical and cognitive demands. Thus, there is a critical need to establish scientific interventions to enhance physical fitness and cognitive performance-promoting the resilience of Airmen and aiding in mission success. We therefore conducted a comprehensive, 12-week randomized controlled trial in active-duty Air Force Airmen (n = 148) to compare the efficacy of a multimodal intervention comprised of high-intensity interval aerobic fitness and strength training paired with a novel nutritional supplement [comprised of β-hydroxy β-methylbutyrate (HMB), lutein, phospholipids, DHA and selected micronutrients including B12 and folic acid] to high-intensity interval aerobic fitness and strength training paired with a standard of care placebo beverage. The exercise intervention alone improved several dimensions of physical fitness [strength and endurance (+ 8.3%), power (+ 0.85%), mobility and stability (+ 22%), heart rate (- 1.1%) and lean muscle mass (+ 1.4%)] and cognitive function [(episodic memory (+ 9.5%), processing efficiency (+ 7.5%), executive function reaction time (- 4.8%) and fluid intelligence accuracy (+ 19.5%)]. Relative to exercise training alone, the multimodal fitness and nutritional intervention further improved working memory (+ 9.0%), fluid intelligence reaction time (- 7.7%), processing efficiency (+ 1.8%), heart rate (- 2.4%) and lean muscle mass (+ 1.5%). These findings establish the efficacy of a multimodal intervention that incorporates aerobic fitness and strength training with a novel nutritional supplement to enhance military performance objectives and to provide optimal exercise training and nutritional support for the modern warfighter.",2020,"Relative to exercise training alone, the multimodal fitness and nutritional intervention further improved working memory (+ 9.0%), fluid intelligence reaction time (- 7.7%), processing efficiency (+ 1.8%), heart rate (- 2.4%) and lean muscle mass (+ 1.5%).","['active duty Airmen', 'active-duty Air Force Airmen (n\u2009=\u2009148']","['multimodal intervention comprised of high-intensity interval aerobic fitness and strength training paired with a novel nutritional supplement [comprised of β-hydroxy β-methylbutyrate (HMB), lutein, phospholipids, DHA and selected micronutrients including B12 and folic acid']","['lean muscle mass', 'processing efficiency', 'executive function reaction time', 'cognitive function [(episodic memory', 'fluid intelligence reaction time', 'fluid intelligence accuracy', 'mobility and stability', 'working memory', 'heart rate', 'several dimensions of physical fitness [strength and endurance', 'Enhanced physical and cognitive performance']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0233174,"Relative to exercise training alone, the multimodal fitness and nutritional intervention further improved working memory (+ 9.0%), fluid intelligence reaction time (- 7.7%), processing efficiency (+ 1.8%), heart rate (- 2.4%) and lean muscle mass (+ 1.5%).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Zwilling', 'Affiliation': 'Decision Neuroscience Laboratory, University of Illinois, 405 North Mathews Avenue, Urbana, IL, 61801, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Strang', 'Affiliation': 'Applied Neuroscience Branch, Wright Patterson Air Force Base, Dayton, OH, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Anderson', 'Affiliation': 'Decision Neuroscience Laboratory, University of Illinois, 405 North Mathews Avenue, Urbana, IL, 61801, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jurcsisn', 'Affiliation': 'Applied Neuroscience Branch, Wright Patterson Air Force Base, Dayton, OH, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'Applied Neuroscience Branch, Wright Patterson Air Force Base, Dayton, OH, USA.'}, {'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Das', 'Affiliation': 'Discovery Research, Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Kuchan', 'Affiliation': 'Discovery Research, Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Aron K', 'Initials': 'AK', 'LastName': 'Barbey', 'Affiliation': 'Decision Neuroscience Laboratory, University of Illinois, 405 North Mathews Avenue, Urbana, IL, 61801, USA. barbey@illinois.edu.'}]",Scientific reports,['10.1038/s41598-020-74140-7']
615,33077895,"A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism.","PURPOSE


To evaluate effectiveness of elamipretide in Barth syndrome (BTHS), a genetic condition of defects in TAZ, which causes abnormal cardiolipin on the inner mitochondrial membrane.
METHODS


We performed a randomized, double-blind, placebo-controlled crossover trial followed by an open-label extension in BTHS to test the effect of elamipretide, a mitochondrial tetrapeptide that interacts with cardiolipin. In part 1, 12 subjects were randomized to 40 mg per day of elamipretide or placebo for 12 weeks, followed by a 4-week washout and then 12 weeks on the opposite arm. Ten subjects continued on the open-label extension (part 2) of 40 mg per day of elamipretide, with eight subjects reaching 36 weeks. Primary endpoints were improvement on the 6-minute walk test (6MWT) and improvement on a BTHS Symptom Assessment (BTHS-SA) scale.
RESULTS


In part 1 neither primary endpoint was met. At 36 weeks in part 2, there were significant improvements in 6MWT (+95.9 m, p = 0.024) and BTHS-SA (-2.1 points, p = 0.031). There were also significant improvements in secondary endpoints including knee extensor strength, patient global impression of symptoms, and some cardiac parameters.
CONCLUSION


In this interventional clinical trial in BTHS, daily administration of elamipretide led to improvement in BTHS symptoms.",2021,"Primary endpoints were improvement on the 6-minute walk test (6MWT) and improvement on a BTHS Symptom Assessment (BTHS-SA) scale.
",['12 subjects'],"['elamipretide', 'placebo', 'elamipretide or placebo']","['6-minute walk test (6MWT) and improvement on a BTHS Symptom Assessment (BTHS-SA) scale', '6MWT', 'BTHS symptoms', 'BTHS-SA', 'knee extensor strength, patient global impression of symptoms, and some cardiac parameters']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0574083', 'cui_str': '3-Methylglutaconic aciduria type 2'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",12.0,0.297293,"Primary endpoints were improvement on the 6-minute walk test (6MWT) and improvement on a BTHS Symptom Assessment (BTHS-SA) scale.
","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Reid Thompson', 'Affiliation': 'Department of Pediatric Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Hornby', 'Affiliation': 'Department of Physical Therapy, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Manuel', 'Affiliation': 'Department of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bradley', 'Affiliation': 'Department of Physical Therapy, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Laux', 'Affiliation': 'Department of Physical Therapy, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Stealth BioTherapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Vernon', 'Affiliation': 'Department of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. hvernon1@jhmi.edu.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-020-01006-8']
616,33085578,Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care.,"Background:   Best practice guidelines for smoking cessation treatment through primary care advise the 5As model. However, compliance with these guidelines is poor, leaving many smokers untreated. The purpose of this study was to develop and preliminarily evaluate an asynchronous smoking cessation electronic visit (e-visit) that could be delivered proactively through the electronic health record (EHR) to adult smokers treated within primary care. The goal of the e-visit is to automate 5As delivery to ensure that all smokers receive evidence-based cessation treatment. As such, the aims of this study were twofold: (1) to examine acceptability, feasibility, and treatment metrics associated with e-visit utilization and (2) to preliminarily examine efficacy relative to treatment as usual (TAU) within primary care.   Methods:   Participants ( n  = 51) were recruited from primary care practices between November 2018 and October 2019 and randomized 2:1 to receive either the smoking cessation e-visit or TAU. Participants completed assessments of cessation outcomes 1-month and 3-months postenrollment and e-visit analytics data were gathered from the EHR.   Results:   Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future. Nearly all e-visits resulted in prescription of a U.S. Food and Drug Administration (FDA)-approved smoking cessation medication. In general, smoking cessation outcomes favored the e-visit condition at both 1 (odds ratios [ORs]: 2.10-5.39) and 3 months (ORs: 1.31-4.67).   Conclusions:   These results preliminarily indicate the feasibility, acceptability, and efficacy of this smoking cessation e-visit within primary care. Future studies should focus on larger scale examination of effectiveness and implementation across settings. The clinicaltrials.gov registration number for this trial is NCT04316260.",2021,Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future.,"['Participants ( n \u2009=\u200951) were recruited from primary care practices between November 2018 and October 2019', 'adult smokers treated within primary care']","['asynchronous smoking cessation electronic visit (e-visit', 'smoking cessation e-visit or TAU']","['feasibility, acceptability, and efficacy']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0402341,Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Player', 'Affiliation': 'Department of Family Medicine,Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Dee W', 'Initials': 'DW', 'LastName': 'Ford', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Diaz', 'Affiliation': 'Department of Family Medicine,Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0167']
617,33069584,"Treatment with benfotiamine in patients with diabetic sensorimotor polyneuropathy: A double-blind, randomized, placebo-controlled, parallel group pilot study over 12 months.",,2020,,['patients with diabetic sensorimotor polyneuropathy'],"['benfotiamine', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0271682', 'cui_str': 'Mixed sensory-motor polyneuropathy'}]","[{'cui': 'C0053116', 'cui_str': 'benphothiamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.552718,,"[{'ForeName': 'Ovidiu Alin', 'Initials': 'OA', 'LastName': 'Stirban', 'Affiliation': 'Internistische Fachklinik Dr. Steger, Nürnberg, Germany. Electronic address: stirban@web.de.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Zeller-Stefan', 'Affiliation': 'Diabetes Zentrum, Essen, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': 'Diabetes Zentrum, Essen, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Gaus', 'Affiliation': 'Institute for Epidemiology and Medical Biometry, University of Ulm, Germany.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at Heinrich Heine University, Division of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schuerholz', 'Affiliation': 'Wörwag Pharma GmbH & Co. KG, Böblingen, Germany; InnoDiab Forschung GmbH, Essen, Germany.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes, University of Michigan, USA.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107757']
618,33079303,Novel Technique for Single-Layer Pancreatojejunostomy is Not Inferior to Modified Blumgart Anastomosis in Robotic Pancreatoduodenectomy: Results of a Randomized Controlled Trial.,"BACKGROUND


A novel technique of single-layer continuous suturing (SCS) for pancreaticojejunostomy (PJ) during robotic pancreaticoduodenectomy (RPD), a technically straightforward procedure, has been shown to produce promising results in a previous study. The present RCT aims to show that SCS during RPD does not increase the incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) when compared with modified Blumgart anastomosis (MBA).
PATIENTS AND METHODS


Between January 2019 and September 2019, consecutive patients (ASA score ≤ 2) who underwent RPD were enrolled and randomized to the SCS or the MBA group. The primary endpoint was the rate of CR-POPF. A noninferiority margin of 10% was chosen.
RESULTS


Of the 186 patients, 4 were excluded because PJ was not performed. The remaining 182 patients were randomized to the SCS group (n = 89) or MBA group (n = 93). CR-POPF rate was not inferior in the SCS group [SCS: 6.7%, MBA: 11.8%; 95% confidence interval (- 0.76, - 0.06), P = 0.0002]. PJ duration was significantly lower in the SCS group (P < 0.01). No significant differences were found between the two groups in operative time, estimated blood loss, postoperative hospital stay, or rates of conversion to laparotomy, morbidity, reoperation, or mortality. On subgroup analysis of patients with a soft pancreas and small main pancreatic duct, SCS significantly reduced the duration of PJ.
CONCLUSIONS


This study showed that SCS was not inferior to MBA in terms of the CR-POPF rate during RPD. Registration number: ChiCTR1800020086 ( www.Chictr.org.cn ).",2021,"No significant differences were found between the two groups in operative time, estimated blood loss, postoperative hospital stay, or rates of conversion to laparotomy, morbidity, reoperation, or mortality.","['186 patients', 'Robotic Pancreatoduodenectomy', '182 patients', 'Between January 2019 and September 2019, consecutive patients (ASA score\u2009≤\u20092) who underwent RPD were enrolled and randomized to the SCS or the MBA group']","['single-layer continuous suturing (SCS) for pancreaticojejunostomy (PJ) during robotic pancreaticoduodenectomy (RPD', 'SCS', 'MBA']","['CR-POPF rate', 'duration of PJ', 'operative time, estimated blood loss, postoperative hospital stay, or rates of conversion to laparotomy, morbidity, reoperation, or mortality', 'PJ duration', 'rate of CR-POPF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.153508,"No significant differences were found between the two groups in operative time, estimated blood loss, postoperative hospital stay, or rates of conversion to laparotomy, morbidity, reoperation, or mortality.","[{'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Yuanxing', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Wan Yee', 'Initials': 'WY', 'LastName': 'Lau', 'Affiliation': 'Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, SAR, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China. Liurong301@126.com.""}]",Annals of surgical oncology,['10.1245/s10434-020-09204-z']
619,33088573,"What is the optimal time-response window for the use of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) for the improvement of exercise performance and recovery, and for how long the effects last? A randomized, triple-blinded, placebo-controlled trial.","Background


The optimal time-response window for photobiomodulation therapy (PBMT) using low-level laser therapy (LLLT) and/or light emitting diodes therapy (LEDT) combined with static magnetic fields (sMF) before physical activity still was not fully investigated. The aim of the present study was to investigate the better of four time-response windows for PBMT combined with sMF (PBMT-sMF) use before exercise in humans.
Methods


A prospectively registered, randomized, triple-blinded (volunteers, therapists and assessors) placebo-controlled trial was carried out. Sixty healthy untrained male subjects were randomly allocated to six experimental groups ( n  = 10 per group): PBMT-sMF 5 mins, PBMT-sMF 3 h, PBMT-sMF 6 h, PBMT-sMF 1-day, placebo, and control. The control group performed all procedures, however did not receive any kind of intervention. PBMT-sMF active or PBMT-sMF placebo was applied precisely in different time points after baseline MVC test to ensure that both MVC tests and eccentric exercise protocol would occur at the same hour of the day in all groups. Then, after five minutes, 3 h, 6 h or 1-day (24 h) of PBMT-sMF treatment (active or placebo) the eccentric exercise protocol was performed. The primary outcome was peak torque obtained from maximum voluntary contraction (MVC). The secondary outcomes were creatine kinase (CK), and delayed onset muscle soreness (DOMS). The primary and secondary outcomes were measured at baseline, immediately after, 1 h, 24 h and 48 h after the eccentric exercise protocol.
Results


Sixty patients were randomized and analyzed to each sequence. The outcomes in absolute values show that all active PBMT-sMF groups increased ( p  < 0.05) MVC from immediately after to 1 h after eccentric exercise, and decreased (p < 0.05) CK activity at all time points. However, PBMT-sMF 5 mins, 3 h and 6 h groups showed better results in MVC and CK analysis from 24 h to 48 h, and also to DOMS ( p  < 0.05) at all time points. Participants did not report any adverse events.
Conclusions


PBMT-sMF can be used from 5 min to 6 h before exercise, and the effects can last up to 54 h after treatment. However, the effects start to decrease when a 1-day (24 h) time-response window is used.
Trial registration


NCT03420391. Registered 05 February 2018.",2020,"The outcomes in absolute values show that all active PBMT-sMF groups increased ( p  < 0.05) MVC from immediately after to 1 h after eccentric exercise, and decreased (p < 0.05)","['Sixty healthy untrained male subjects', 'humans', 'Sixty patients']","['PBMT combined with sMF (PBMT-sMF', 'PBMT-sMF 5 mins, PBMT-sMF 3\u2009h, PBMT-sMF 6\u2009h, PBMT-sMF 1-day, placebo, and control', 'PBMT-sMF active or PBMT-sMF placebo', 'PBMT-sMF treatment (active or placebo', 'photobiomodulation therapy (PBMT) using low-level laser therapy (LLLT) and/or light emitting diodes therapy (LEDT) combined with static magnetic fields (sMF', 'placebo', 'photobiomodulation therapy combined with static magnetic field (PBMT-sMF']","['CK activity', 'peak torque obtained from maximum voluntary contraction (MVC', 'MVC and CK analysis', 'creatine kinase (CK), and delayed onset muscle soreness (DOMS']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}]",60.0,0.271832,"The outcomes in absolute values show that all active PBMT-sMF groups increased ( p  < 0.05) MVC from immediately after to 1 h after eccentric exercise, and decreased (p < 0.05)","[{'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Post-graduate Program in Rehabilitation Sciences, Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Marcelo Ferreira Duarte', 'Initials': 'MFD', 'LastName': 'de Oliveira', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Post-graduate Program in Rehabilitation Sciences, Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Joensen', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Martin Bjørn', 'Initials': 'MB', 'LastName': 'Stausholm', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jan Magnus', 'Initials': 'JM', 'LastName': 'Bjordal', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Shaiane Silva', 'Initials': 'SS', 'LastName': 'Tomazoni', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00214-8']
620,33093133,Patients Requiring Conversion to General Anesthesia during Endovascular Therapy Have Worse Outcomes: A Post Hoc Analysis of Data from the SAGA Collaboration.,"BACKGROUND AND PURPOSE


Endovascular therapy for acute ischemic stroke is often performed with the patient under conscious sedation. Emergent conversion from conscious sedation to general anesthesia is sometimes necessary. The aim of this study was to assess the functional outcome in converted patients compared with patients who remained in conscious sedation and to identify predictors associated with the risk of conversion.
MATERIALS AND METHODS


Data from 368 patients, included in 3 trials randomizing between conscious sedation and general anesthesia before endovascular therapy (SIESTA, ANSTROKE, and GOLIATH) constituted the study cohort. Twenty-one (11%) of 185 patients randomized to conscious sedation were emergently converted to general anesthesia.
RESULTS


Absence of hyperlipidemia seemed to be the strongest predictor of conversion to general anesthesia, albeit a weak predictor (area under curve = 0.62). Sex, hypertension, diabetes, smoking status, atrial fibrillation, blood pressure, size of the infarct, and level and side of the occlusion were not significantly associated with conversion to general anesthesia. Neither age (mean age, 71.3   ± 13.8 years for conscious sedation versus 71.6  ± 12.3 years for converters,  P  = .58) nor severity of stroke (mean NIHSS score, 17 ± 4 versus 18 ± 4, respectively,  P  = .27) were significantly different between converters and those who tolerated conscious sedation. The converters had significantly worse outcome with a common odds ratio of 2.67 ( P  = .015) for a shift toward a higher mRS score compared with the patients remaining in the conscious sedation group.
CONCLUSIONS


Patients undergoing conversion had significantly worse outcome compared with patients remaining in conscious sedation. No factor was identified that predicted conversion from conscious sedation to general anesthesia.",2020,"The converters had significantly worse outcome with a common odds ratio of 2.67 ( P  = .015) for a shift toward a higher mRS score compared with the patients remaining in the conscious sedation group.
","['Data from 368 patients, included in 3 trials randomizing between conscious sedation and general anesthesia before endovascular therapy (SIESTA, ANSTROKE, and GOLIATH) constituted the study cohort', 'Twenty-one (11%) of 185 patients randomized to', 'patient under conscious sedation']",['conscious sedation'],"['Sex, hypertension, diabetes, smoking status, atrial fibrillation, blood pressure, size of the infarct, and level and side of the occlusion', 'functional outcome', 'tolerated conscious sedation', 'mRS score', 'severity of stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0079159', 'cui_str': 'Conscious sedation'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",185.0,0.0362995,"The converters had significantly worse outcome with a common odds ratio of 2.67 ( P  = .015) for a shift toward a higher mRS score compared with the patients remaining in the conscious sedation group.
","[{'ForeName': 'C Z', 'Initials': 'CZ', 'LastName': 'Simonsen', 'Affiliation': 'From the Department of Neurology (C.Z.S.) clasim@rm.dk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schönenberger', 'Affiliation': 'Department of Neurology (S.S.), Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Hendén', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine (P.L.H.).'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Yoo', 'Affiliation': 'Division of Neurointervention (A.J.Y.), Texas Stroke Institute, Dallas-Fort Worth, Texas.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Uhlmann', 'Affiliation': 'Institute of Medical Biometry and Informatics (L.U.), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rentzos', 'Affiliation': 'Radiology (A.R.), Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bösel', 'Affiliation': 'Department of Neurology (J.B.), Klinikum Kassel, Kassel, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Valentin', 'Affiliation': 'Department of Clinical Medicine, (J.V.), Danish Center for Clinical Health Services Research, Aalborg University and Aalborg University Hospital, North Denmark Region, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'Anesthesia (M.R.), Section of Neuroanesthesia, Aarhus University Hospital, Aarhus, Denmark.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6823']
621,33095038,Ivacaftor in People with Cystic Fibrosis and a  3849+10kb C → T  or  D1152H  Residual Function Mutation.,"Rationale:  Ivacaftor's clinical effects in the residual function mutations  3849 + 10kb C→T  and  D1152H  warrant further characterization. Objectives:  To evaluate ivacaftor's effect in people with cystic fibrosis aged ≥6 years with  3849 + 10kb C→T  or  D1152H  residual function mutations and to explore the correlation between ivacaftor-induced organoid-based cystic fibrosis transmembrane conductance regulator function measurements and clinical response to ivacaftor. Methods:  Participants were randomized (1:1) in this placebo-controlled crossover study; each treatment sequence included two 8-week treatments with an 8-week washout period. The primary endpoint was absolute change in lung clearance index 2.5  from baseline through Week 8. Additional endpoints included lung function, patient-reported outcomes, and  in vitro  intestinal organoid-based measurements of ivacaftor-induced cystic fibrosis transmembrane conductance regulator function. Results:  Of 38 participants, 37 completed the study. The primary endpoint was met; the Bayesian posterior probability of improvement in lung clearance index 2.5  with ivacaftor versus placebo was >99%. Additional endpoints improved with ivacaftor. Safety findings were consistent with ivacaftor's known safety profile. Dose-dependent swelling was observed in 23 of 25 viable organoid cultures with ivacaftor treatment. Correlations between ivacaftor-induced organoid swelling and clinical endpoints were negligible to low. Conclusions:  In people with cystic fibrosis aged ≥6 years with a  3849 + 10kb C→T  or  D1152H  mutation, ivacaftor treatment improved clinical endpoints compared with placebo; however, there was no correlation between organoid swelling and change in clinical endpoints. The organoid assay may assist in identification of ivacaftor-responsive mutations but in this study did not predict magnitude of clinical benefit for individual people with cystic fibrosis with these two mutations.Clinical trial registered with ClinicalTrials.gov (NCT03068312).",2021,The primary endpoint was met; the Bayesian posterior probability of improvement in lung clearance index2.5 with ivacaftor vs placebo was >99%.,"['people with cystic fibrosis aged ≥6 years with a 3849+10kb C →T or D1152H mutation', 'People With Cystic Fibrosis and a 3849+10kb C →T or D1152H Residual Function Mutation', 'people with cystic fibrosis aged ≥6 years with 3849+10kb C→T or D1152H residual function mutations', '38 participants, 37 completed the study']","['ivacaftor', 'placebo', 'ivacaftor vs placebo', 'Ivacaftor']","['absolute change in lung clearance index2.5', 'lung function, patient-reported outcomes, and in vitro intestinal organoid-based measurements of ivacaftor-induced cystic fibrosis transmembrane conductance regulator function', 'Bayesian posterior probability of improvement in lung clearance index2.5']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0855766', 'cui_str': 'Residual function'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0029250', 'cui_str': 'Organoids'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.107007,The primary endpoint was met; the Bayesian posterior probability of improvement in lung clearance index2.5 with ivacaftor vs placebo was >99%.,"[{'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Kerem', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Malena', 'Initials': 'M', 'LastName': 'Cohen-Cymberknoh', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Reuven', 'Initials': 'R', 'LastName': 'Tsabari', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wilschanski', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Reiter', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shoseyov', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gileles-Hillel', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Pugatsch', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'European Cystic Fibrosis Society Lung Clearance Index Core Over Reading Centre, London, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Short', 'Affiliation': 'European Cystic Fibrosis Society Lung Clearance Index Core Over Reading Centre, London, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'European Cystic Fibrosis Society Lung Clearance Index Core Over Reading Centre, London, United Kingdom.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'Vertex Pharmaceuticals Inc., Boston, Massachusetts.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Sullivan', 'Affiliation': 'Vertex Pharmaceuticals Inc., Boston, Massachusetts.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Doyle', 'Affiliation': 'Vertex Pharmaceuticals Inc., Boston, Massachusetts.'}, {'ForeName': 'Keval', 'Initials': 'K', 'LastName': 'Chandarana', 'Affiliation': 'Vertex Pharmaceuticals Inc., Boston, Massachusetts.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kinnman', 'Affiliation': 'Vertex Pharmaceuticals (Europe) Ltd., London, United Kingdom.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202006-659OC']
622,33091549,Intra-Articular Platelet-Rich Plasma Combined With Hyaluronic Acid Injection for Knee Osteoarthritis Is Superior to Platelet-Rich Plasma or Hyaluronic Acid Alone in Inhibiting Inflammation and Improving Pain and Function.,"PURPOSE


To evaluate the effectiveness and explore the therapeutic mechanisms of platelet-rich plasma (PRP) combined with hyaluronic acid (HA) as a treatment for knee osteoarthritis (KOA).
METHODS


In total, 122 knees were randomly divided into HA (34 knees), PRP (40 knees), and PRP+HA (48 knees) groups. Platelet densities in whole blood and PRP were examined using Wright-Giemsa staining. Visual analogue scale, Lequesne, Western Ontario and McMaster Universities Osteoarthritis Index, Lysholm scores, and postoperative complications were evaluated. High-frequency color Doppler imaging was used to observe the synovium and cartilage. Enzyme-linked immunosorbent assays were used to quantify interleukin-1β, tumor necrosis factor-α, matrix metalloproteinase-3, and tissue inhibitor of metalloproteinase-1 levels in synovial fluid.
RESULTS


The platelet density in PRP was 5.13-times that in whole blood (P = .002). At 24 months, pain and function scores in the PRP+HA group were better than those in the HA-alone and PRP-alone groups (P pain  = .000; P function  = .000). At 6 and 12 months, synovial hyperplasia in the PRP and PRP+HA groups was improved (P < .05). After 6 and 12 months, the synovial peak systolic velocity, synovial end-diastolic velocity, systolic/diastolic ratio, and resistance index were improved in the PRP+HA group (P < .05). Complications were greatest in the PRP group (P = .008). After 6 and 12 months, interleukin-1β, tumor necrosis factor-α, matrix metalloproteinase-3, and tissue inhibitor of metalloproteinase-1 in the PRP and PRP+HA groups decreased (P < .05), with more apparent inhibition in the PRP+HA group (P < .05).
CONCLUSIONS


PRP combined with HA is more effective than PRP or HA alone at inhibiting synovial inflammation and can effectively improve pain and function and reduce adverse reactions. Its mechanism involves changes in the synovium and cytokine content.
LEVEL OF EVIDENCE


Level II, Prospective cohort study.",2021,"At 6 and 12 months, synovial hyperplasia in the PRP and PRP+HA groups was improved (P < .05).","['knee osteoarthritis (KOA', '122 knees were randomly divided into HA (34 knees), PRP (40 knees), and PRP+HA (48 knees) groups']","['PRP combined with HA', 'hyaluronic acid injection']","['pain and function scores', 'interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), matrix metalloproteinase-3 (MMP-3), and tissue inhibitor of metalloproteinase-1 (TIMP-1) levels', 'synovial hyperplasia', 'WOMAC), Lysholm scores and postoperative complications', 'synovial peak systolic velocity (PSV), synovial end diastolic velocity (EDV), systolic/diastolic ratio (S/D) and resistance index (RI', 'Complications', 'pain and function and reduce adverse reactions', 'platelet density', 'Lequesne, Western Ontario and McMaster Universities Osteoarthritis Index', 'Visual Analogue Scale (VAS', 'IL-1β, TNF-α, MMP-3, and TIMP-1']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0451868', 'cui_str': 'Localized osteoporosis - Lequesne'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",122.0,0.0190107,"At 6 and 12 months, synovial hyperplasia in the PRP and PRP+HA groups was improved (P < .05).","[{'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Guizhou Medical University, Guiyang, China; Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang, China; National-Local Joint Engineering Laboratory of Cell Engineering and Biomedicine, Guiyang, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Zhixu', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Shu', 'Affiliation': 'Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang, China; National-Local Joint Engineering Laboratory of Cell Engineering and Biomedicine, Guiyang, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Xuanze', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Guizhou Medical University, Guiyang, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Minxian', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang, China; National-Local Joint Engineering Laboratory of Cell Engineering and Biomedicine, Guiyang, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Guizhou Medical University, Guiyang, China; Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang, China; National-Local Joint Engineering Laboratory of Cell Engineering and Biomedicine, Guiyang, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang, China; China Orthopaedic Regenerative Medicine Group (CORMed), Hangzhou, China. Electronic address: yechuanchina@hotmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.10.013']
623,33093816,Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial.,"Background


Percutaneous occlusion under fluoroscopy guidance has become the preferred method for the treatment of patent ductus arteriosus (PDA). To avoid radiation exposure and contrast agent use, PDA occlusion under transthoracic echocardiography (TTE) guidance was conducted.
Objectives


We assessed the hypothesis that the success rate of percutaneous PDA occlusion under TTE was noninferior to that under fluoroscopy guidance.
Methods


In this single-center trial, 100 patients were randomly assigned in a 1 : 1 ratio to the TTE group ( n  = 50) or to the fluoroscopy group ( n  = 50). The primary endpoint was the success rate of occlusion, with the noninferiority margin set at 8% for the between-group difference in intention-to-treat analysis. Secondary endpoints were hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up.
Results


Patient, defect, and device characteristics were similarly distributed between groups. The success rate of occlusion was 98% for the TTE group and 100% for the fluoroscopy group (absolute difference: -2%; 95% confidence interval: -5.9% to 1.9%). Cost and procedure duration were significantly lower in the TTE group, without adverse events in either group at a median of 12.0 months (range, 10.0-15.5 months) of follow-up.
Conclusion


Percutaneous PDA occlusion can be performed via TTE guidance safely and effectively, and the success rate of the TTE-guided procedure was noninferior to that under fluoroscopy guidance, with reduced cost and procedure time. The trial is registered with http://www.chictr.org.cn (ChiCTR-ICR-15006334).",2020,"Secondary endpoints were hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up.
","['Arteriosus under Echocardiography Guidance', 'patent ductus arteriosus (PDA', '100 patients']","['TTE', 'Transcatheter Closure of Patent Ductus', 'PDA occlusion under transthoracic echocardiography (TTE) guidance']","['Cost and procedure duration', 'success rate of occlusion', 'hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up', 'success rate of occlusion, with the noninferiority margin set']","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0161817', 'cui_str': 'Peripheral vascular complication'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]",100.0,0.171864,"Secondary endpoints were hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up.
","[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Fengwen', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Guangzhi', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Mengxuan', 'Initials': 'M', 'LastName': 'Zou', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}]",Journal of interventional cardiology,['10.1155/2020/4357017']
624,33094666,An evaluation of olaparib for the treatment of pancreatic cancer.,"INTRODUCTION


Advanced pancreatic cancer remains a lethal, incurable malignancy. Chemotherapy is the mainstay of systemic therapy consideration in metastatic pancreas cancer. Homologous recombinant DNA repair mutations are reported in about 7% of pancreas cancer cases and have rapidly emerged as actionable mutations.
AREAS COVERED


A review was conducted of publications of PARP inhibitors in pancreatic malignancies with a focus on clinical trials with olaparib. This included a review of the phase II and phase III clinical trials of olaparib in pancreatic cancer.
EXPERT OPINION


Olaparib was compared to placebo in a randomized double blind trial in cases with advanced pancreatic cancer and germline  BRCA1/2  mutations, with a clinical response or stable disease after at least 16 weeks of platinum based chemotherapy. Olaparib significantly improved progression free survival, [HR = -.53,  p  = 0.0035] but did not improve overall survival. No differences in quality of life were noted between the two arms. Adverse events from olaparib were noted in 40% of treated patients. Objective response rate was 20% in olaparib arm and 10% in placebo treated arm. A careful consideration of the risks and benefits of this personalized therapy is advisable, prior to clinical application in germline BRCA1/2 mutated advanced pancreatic cancer.",2021,"Olaparib significantly improved progression free survival, [HR=-.53, p=0.0035] but did not improve overall survival.","['cases with advanced pancreatic cancer and germline  BRCA1/2  mutations, with a clinical response or stable disease after at least 16 weeks of platinum based chemotherapy', 'metastatic pancreas cancer', 'pancreatic cancer', 'germline BRCA1/2 mutated advanced pancreatic cancer']","['PARP inhibitors', 'Chemotherapy', 'placebo', 'Olaparib']","['Objective response rate', 'quality of life', 'progression free survival', 'overall survival']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}]","[{'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.296974,"Olaparib significantly improved progression free survival, [HR=-.53, p=0.0035] but did not improve overall survival.","[{'ForeName': 'Ulka N', 'Initials': 'UN', 'LastName': 'Vaishampayan', 'Affiliation': 'Department of Internal Medicine/Oncology, University of Michigan, Ann Arbor, MI, USA.'}]",Expert opinion on pharmacotherapy,['10.1080/14656566.2020.1837113']
625,33097422,Effect of continuous antibiotic prophylaxis in children with postoperative JJ stents: A prospective randomized study.,"OBJECTIVE


We aimed to investigate the effectiveness of continuous antibiotic prophylaxis (CAP) in patients with JJ stent and tried to identify the group that could specifically benefit from CAP by a prospective randomized study.
METHODS


A prospective, randomized, controlled, non-blind, non-placebo study was performed in a single center.A total of 105 patients who underwent surgery with JJ stent (PNL, URS, pyeloplasty, UNC) were randomized into two groups. 53 patients in Group A received CAP and 52 patients in Group B were controlled without CAP, during the presence of a JJ stent. Patients with external stents, nephrostomy tubes, indwelling long-term urethral catheters were excluded. History of preoperative use of CAP and lower urinary tract symptoms were noted. Trimethoprim/sulfamethoxazole (TMP/SMX) was used as the initial choice of antibiotic however if there was a history of antibiotic resistance in previous urinary cultures, Nitrofurantoin was administrated. Urinary cultures were obtained before surgery and before stent extraction. JJ stents were sent to culture. Symptomatic febrile urinary tract infections with positive urine cultures (10 5  CFU on a clean catch or 10 3 with urethral catheterization) were compared between groups.
DISCUSSION


Our study has some limitations; the study is the single-center, we did not follow-up of patients in terms of scar, there were low number of uncircumcised patients, multiple types of surgical procedures were performed. JJ stent is a frequently used instrument in children. Unfortunately, any randomized prospective on antibiotics administration while using a JJ stent is not available in the current literature. We hope our research will contribute to the existing literature and cause a significant change in clinical practice.
RESULTS


The mean age among all patients was 4.8 ± 3.9 years. The mean length of time jj stents stayed inside was 16.34 ± 6.45 days in group A and 15.29 ± 7.71 days in group B. The incidence of febrile urinary tract infections with CAP was significantly reduced (3.8% vs. 19% (p 0.015)). Multivariate regression analysis revealed that a positive history for preop febrile urinary tract infections and/or LUTS has a significantly higher association with the incidence of febrile urinary tract infecitons.
CONCLUSIONS


CAP in the presence of JJ stents reduced the incidence of febrile urinary tract infections in a short period, especially in children with the previous history of febrile urinary tract infections and lower urinary tract symptoms.",2021,The incidence of febrile urinary tract infections with CAP was significantly reduced (3.8% vs. 19% (p 0.015)).,"['105 patients who underwent surgery with JJ stent (PNL, URS, pyeloplasty, UNC', 'children', 'Patients with', 'children with postoperative JJ stents', 'patients with JJ stent']","['continuous antibiotic prophylaxis', 'JJ stents', 'continuous antibiotic prophylaxis (CAP', 'CAP', 'placebo', 'external stents, nephrostomy tubes, indwelling long-term urethral catheters', 'JJ stent', 'Trimethoprim/sulfamethoxazole (TMP/SMX']","['urinary tract symptoms', 'mean length of time jj stents stayed inside', 'febrile urinary tract infections', 'incidence of febrile urinary tract infections with CAP', 'Symptomatic febrile urinary tract infections']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0554139', 'cui_str': 'Pyeloplasty'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0184149', 'cui_str': 'Nephrostomy tube'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0179800', 'cui_str': 'Urethral catheter'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}]","[{'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C3875265', 'cui_str': 'Febrile urinary tract infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",105.0,0.0387543,The incidence of febrile urinary tract infections with CAP was significantly reduced (3.8% vs. 19% (p 0.015)).,"[{'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Akinci', 'Affiliation': ""Department of Pediatric Urology, Ankara University School of Medicine, Cebeci Children's Hospital, Ankara, Turkey. Electronic address: aykut-akinci@hotmail.com.""}, {'ForeName': 'Eralp', 'Initials': 'E', 'LastName': 'Kubilay', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Vahid Talha', 'Initials': 'VT', 'LastName': 'Solak', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Murat Can', 'Initials': 'MC', 'LastName': 'Karaburun', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Can Utku', 'Initials': 'CU', 'LastName': 'Baklaci', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ezel', 'Initials': 'E', 'LastName': 'Aydoğ', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Yakup Tarkan', 'Initials': 'YT', 'LastName': 'Soygür', 'Affiliation': ""Department of Pediatric Urology, Ankara University School of Medicine, Cebeci Children's Hospital, Ankara, Turkey.""}, {'ForeName': 'Berk', 'Initials': 'B', 'LastName': 'Burgu', 'Affiliation': ""Department of Pediatric Urology, Ankara University School of Medicine, Cebeci Children's Hospital, Ankara, Turkey.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.10.004']
626,33095658,Efficacy of microcurrent therapy for treatment of acute knee pain: A randomized double-blinded controlled clinical trial.,"OBJECTIVE


We would like to determine whether electrotherapy, specifically microcurrent therapy, increases function and decreases pain in people who have acute knee pain.
DESIGN


Randomized, double-blinded, placebo-controlled clinical trial.
SETTING


University laboratory and patient home.
SUBJECTS


A total of 52 subjects (35 females and 17 males) with acute knee pain.
INTERVENTION


Treatment group ( n  = 26) wore the active microcurrent therapy device at home for 3 hours per day for 4 weeks and the control group ( n  = 26) wore the placebo for 3 hours per day for 4 weeks.
MAIN MEASURES


Numeric Pain Rating Scale (NPRS) and Short Form 12 (SF-12) health scale were used to measure the pain level and the functionality of the participants. Secondary assessments included musculoskeletal ultrasound imaging (MSK US) and Lower Extremity Functional Scale (LEFS).
RESULTS


A total of 52 subjects completed the study; 26 in the treatment group and 26 in the control group. Microcurrent therapy significantly reduced pain over 4 weeks. Especially week three was significant ( P  < 0.01) after adjusting for the family-wise error rate. The analysis on SF-12 revealed those with microcurrent therapy showed an increasing trend in the improvement of physical function score until week three.
CONCLUSION


An active microcurrent therapy device decreased knee pain and increased function. Microcurrent therapy may be an alternative or used with a pharmacological approach for people with acute knee pain.",2021,"The analysis on SF-12 revealed those with microcurrent therapy showed an increasing trend in the improvement of physical function score until week three.
","['University laboratory and patient home', 'people who have acute knee pain', 'acute knee pain', 'A total of 52 subjects (35 females and 17 males) with acute knee pain', 'people with acute knee pain', '52 subjects completed the study; 26 in the treatment group and 26 in the control group']","['electrotherapy', 'Microcurrent therapy', 'microcurrent therapy', 'placebo', 'Treatment group ( n \u2009=\u200926) wore the active microcurrent therapy device']","['pain level and the functionality of the participants', 'Numeric Pain Rating Scale (NPRS) and Short Form 12 (SF-12) health scale', 'knee pain and increased function', 'physical function score', 'musculoskeletal ultrasound imaging (MSK US) and Lower Extremity Functional Scale (LEFS', 'pain']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}]",52.0,0.451954,"The analysis on SF-12 revealed those with microcurrent therapy showed an increasing trend in the improvement of physical function score until week three.
","[{'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Lawson', 'Affiliation': 'Department of Physical Therapy, Western Michigan University, Kalamazoo, MI, USA.'}, {'ForeName': 'Kevin H', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Western Michigan University, Kalamazoo, MI, USA.'}, {'ForeName': 'Hyun Bin', 'Initials': 'HB', 'LastName': 'Kang', 'Affiliation': 'Department of Statistics, Western Michigan University, Kalamazoo, MI, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Therapy, Elon University, Elon, NC, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Llewellyn', 'Affiliation': 'Department of Physical Therapy, Elon University, Elon, NC, USA.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Takamatsu', 'Affiliation': 'OMRON Healthcare, Inc., Muko City, Kyoto, Japan.'}]",Clinical rehabilitation,['10.1177/0269215520965320']
627,33098672,Perinatal death audit and classification of stillbirths in two provinces in Papua New Guinea: A retrospective analysis.,"OBJECTIVE


To undertake a retrospective perinatal death audit and assessment of avoidable factors associated with stillbirths among a cohort of women in two provinces in Papua New Guinea.
METHODS


We used data from an ongoing cluster-randomized crossover trial in 10 sites among 4600 women in Papua New Guinea (from 2017 to date). The overarching aim is to improve birth outcomes. All stillbirths from July 2017 to January 2020 were identified. The Perinatal Problem Identification Program was used to analyze each stillbirth and review associated avoidable factors.
RESULTS


There were 59 stillbirths among 2558 births (23 per 1000 births); 68% (40/59) were classified ""fresh"" and 32% as ""macerated"". Perinatal cause of death was identified for 63% (37/59): 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth and 19% (7/37) were the result of pre-eclampsia. At least one avoidable factor was identified for 95% (56/59) of stillbirths. Patient-associated factors included lack of response to reduced fetal movements and delay in seeking care during labor. Health personnel-associated factors included poor intrapartum care, late diagnosis of breech presentation, and prolonged second stage with no intervention.
CONCLUSION


Factors associated with stillbirths in this setting could be avoided through a package of interventions at both the community and health-facility levels.",2021,Perinatal cause of death was identified for 63% (37/59); 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth; and 19% (7/37) due to pre-eclampsia. 95% (56/59) of stillbirths had at least one avoidable factor identified.,"['4,600 women in Papua New Guinea (2017-date', 'All stillbirths from July 2017 to January 2020 were identified', 'two provinces in Papua New Guinea', 'women in two provinces in Papua New Guinea']",[],"['Perinatal death audit and classification of stillbirths', 'Perinatal cause of death', 'intrapartum asphyxia and traumatic breech birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030375', 'cui_str': 'Papua New Guinea'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",4600.0,0.072143,Perinatal cause of death was identified for 63% (37/59); 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth; and 19% (7/37) due to pre-eclampsia. 95% (56/59) of stillbirths had at least one avoidable factor identified.,"[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Vallely', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Bolnga', 'Affiliation': 'Modilon Hospital, Madang, Papua New Guinea.'}, {'ForeName': 'Delly', 'Initials': 'D', 'LastName': 'Babona', 'Affiliation': ""St Mary's Hospital Vunapope, East New Britain Province, Papua New Guinea.""}, {'ForeName': 'Michaela A', 'Initials': 'MA', 'LastName': 'Riddell', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mengi', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Au', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.'}, {'ForeName': 'Cherolyn', 'Initials': 'C', 'LastName': 'Polomon', 'Affiliation': 'Pacific Adventist University, Port Moresby, Papua New Guinea.'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Vogel', 'Affiliation': 'Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Pomat', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Vallely', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Caroline S E', 'Initials': 'CSE', 'LastName': 'Homer', 'Affiliation': 'Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, VIC, Australia.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13431']
628,33098114,Impact of group prenatal care on key prenatal services and educational topics in Malawi and Tanzania.,"OBJECTIVE


To examine whether group prenatal care (PNC) increased key services and educational topics women reported receiving, compared with individual PNC in Malawi and Tanzania.
METHODS


Data come from a previously published randomized trial (n=218) and were collected using self-report surveys. Late pregnancy surveys asked whether women received all seven services and all 13 topics during PNC. Controlling for sociodemographics, country, and PNC attendance, multivariate logistic regression used forward selection to produce a final model showing predictors of receipt of all key services and topics.
RESULTS


In multivariate logistic regression, women in group PNC were 2.49 times more likely to receive all seven services than those in individual care (95% confidence interval [CI] 1.78-3.48) and 5.25 times more likely to have received all 13 topics (95% CI 2.62-10.52).
CONCLUSION


This study provides strong evidence that group PNC meets the clinical standard of care for providing basic clinical services and perinatal education for pregnant women in sub-Saharan Africa. The greater number of basic PNC services and educational topics may provide one explanatory mechanism for how group PNC achieves its impact on maternal and neonatal outcomes. ClinicalTrials.gov: NCT03673709, NCT02999334.",2021,"In multivariate logistic regression, women in group ANC were 2.49 times more likely to receive all 7 services than those in individual care (95% CI, 1.78 - 3.48) and 5.25 times more likely to have received all 13 topics (95% CI = 2.62, 10.52).
","['pregnant women in SSA', 'Data come from a previously published randomized trial (n = 218) and were collected using self-report surveys']",[],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2732618', 'cui_str': 'Sessile serrated adenoma'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],[],218.0,0.0577475,"In multivariate logistic regression, women in group ANC were 2.49 times more likely to receive all 7 services than those in individual care (95% CI, 1.78 - 3.48) and 5.25 times more likely to have received all 13 topics (95% CI = 2.62, 10.52).
","[{'ForeName': 'Kylea L', 'Initials': 'KL', 'LastName': 'Liese', 'Affiliation': 'Department of Human Development Nursing Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Esnath', 'Initials': 'E', 'LastName': 'Kapito', 'Affiliation': 'Kamuzu College of Nursing, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Chirwa', 'Affiliation': 'Kamuzu College of Nursing, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Mei', 'Affiliation': 'School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Norr', 'Affiliation': 'Department of Human Development Nursing Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Patil', 'Affiliation': 'Department of Human Development Nursing Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13432']
629,33103916,"Clinical effectiveness of peroneal nerve functional electrical stimulation in chronic stroke patients with hemiplegia (PLEASURE): A multicentre, prospective, randomised controlled trial.","OBJECTIVE


To compare the effectiveness of gait training using a peroneal nerve stimulation device with the effectiveness of gait training without the device in improving gait ability and ankle-specific body functions.
DESIGN


Multicentre, prospective, randomised, open-label trial.
SETTING


Twenty-three hospitals.
SUBJECTS


In total, 119 stroke patients with foot drop were randomly assigned to the experimental (with the device) or control (without the device) group.
INTERVENTION


Subjects underwent 480-minute self-directed training over four weeks, followed by 260-minute physical therapist-assisted gait training with or without the device.
MAIN MEASURES


The primary endpoint was a change in the six-minute walk test (6MWT) without the device from baseline to after the four-week intervention. The secondary endpoints were changes in the 10-metre walk test (10MWT) without the device, Fugl-Meyer Assessment, range of motion, muscle strength, Modified Ashworth Scale, Stroke Impact Scale Japanese edition (J-SIS) and adverse events.
RESULTS


Fifty-six experimental and 59 control group participants, with an average age of 59 years (SD 12) completed the trial. The 6MWT distance changes (m) for the experimental and control groups were 14.7 (SD 37.6) and 22.2 (SD 49.3), respectively. The 10MWT speed changes (m/sec) for the experimental and control groups were 0.06 (SD 0.12) and 0.07 (SD 0.17), respectively. No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient's subjective assessment ( P  = 0.048).
CONCLUSION


The improvement in gait ability and body functions were equivalent with or without the use of the device.",2021,"No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient's subjective assessment ( P  = 0.048).
","['Twenty-three hospitals', 'Fifty-six experimental and 59 control group participants, with an average age of 59\u2009years (SD 12) completed the trial', '119 stroke patients with foot drop', 'chronic stroke patients with hemiplegia (PLEASURE']","['480-minute self-directed training over four weeks, followed by 260-minute physical therapist-assisted gait training with or without the device', 'gait training', 'peroneal nerve functional electrical stimulation']","['gait ability and body functions', 'change in the six-minute walk test (6MWT', '10-metre walk test (10MWT) without the device, Fugl-Meyer Assessment, range of motion, muscle strength, Modified Ashworth Scale, Stroke Impact Scale Japanese edition (J-SIS) and adverse events', '6MWT distance changes (m']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085684', 'cui_str': 'Foot-drop'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031173', 'cui_str': 'Structure of common peroneal nerve'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",119.0,0.0855705,"No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient's subjective assessment ( P  = 0.048).
","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hachisuka', 'Affiliation': 'Kyushu Rosai Byoin Moji Medical Center, Japan Organization of Occupational Health and Safety, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Ochi', 'Affiliation': 'Department of Rehabilitation Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kikuchi', 'Affiliation': 'Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Hyogo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': 'Department of Rehabilitation Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}]",Clinical rehabilitation,['10.1177/0269215520966702']
630,33099836,"The early and late efficacy of single-pass fractional carbondioxide laser, fractional radiofrequency, and their combination in acne scars: A prospective, split-face, single-blinded, controlled clinical study.","We investigated the effectiveness of fractional carbon dioxide laser (FCO 2  ) vs fractional radiofrequency (FRF) and FCO 2  vs FRF plus FCO 2  combination in the treatment of acne scars. Twenty-seven patients were included. Scar severity was scored with ""Echelle d'évaluation clinique des cicatrices d'acné"" (ECCA) by a dermatologist blinded to treatment. FCO 2  and FRF were administered to the right and left halves of the patients' faces, respectively, at the first three visits, once a month. At the fourth visit, FCO 2  was administered to both sides. Last evaluation was performed 6 months after the last treatment. Mean ECCA scores for both face halves decreased gradually at each visit compared with Visit-1; however, the effect size of decrease was higher in the right half of the face and in terms of gender differences was higher in women for both sides that the difference was more pronounced for the FRF side. There was no statistically significant change in the mean VAS patient satisfaction scores in the following visits compared with Visit-2 on both halves (P > .05). Side effects were similar; but lasted longer in the FCO 2  side. Both FCO 2  and FRF are effective treatment methods in the treatment of atrophic acne scars. Combining FCO 2  to FRF improves patient satisfaction. FRF may achieve better results in women compared with men. To our knowledge the study is unique prospective, controlled clinical study comparing the efficacy of FCO 2  and FRF plus FCO 2  combination treatments.",2020,There was no statistically significant change in the mean VAS patient satisfaction scores in the following visits compared to Visit-2 on both halves (p> 0.05).,"['atrophic acne scars', 'acne scars', 'Twenty-seven patients were included']","['single-pass fractional carbondioxide laser, fractional radiofrequency and their combination', 'FCO2 and FRF', 'FRF', 'fractional carbon dioxide laser (FCO2) vs. fractional radiofrequency (FRF) and FCO2 vs. FRF plus FCO2 combination', 'FCO2 and FRF plus FCO2']","['Mean ECCA scores', 'Scar severity', 'Side effects', 'mean VAS patient satisfaction scores']","[{'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0445262', 'cui_str': 'Single pass'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",27.0,0.0323366,There was no statistically significant change in the mean VAS patient satisfaction scores in the following visits compared to Visit-2 on both halves (p> 0.05).,"[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Kaçar', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Recep', 'Initials': 'R', 'LastName': 'Dursun', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Akbay', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Şule', 'Initials': 'Ş', 'LastName': 'Gökşin', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Pamukkale University, Denizli, Turkey.'}]",Dermatologic therapy,['10.1111/dth.14444']
631,33106057,Impact of anti-gravity treadmill rehabilitation therapy on the clinical outcomes after fixation of lower limb fractures: A randomized clinical trial.,"OBJECTIVE


To compare the effects of anti-gravity treadmill rehabilitation with those of standard rehabilitation on surgically treated ankle and tibial plateau fractures.
DESIGN


Open-label prospective randomized multicenter study.
SETTING


Three level 1 trauma centers.
SUBJECTS


Patients with tibial plateau or ankle fractures who underwent postoperative partial weight-bearing were randomized into the intervention (anti-gravity treadmill use) or control (standard rehabilitation protocol) groups.
MAIN MEASURES


The primary endpoint was the change in the Foot and Ankle Outcome Score for ankle fractures and total Knee injury and Osteoarthritis Outcome Score for tibial plateau fractures (0-100 points) from baseline (T1) to six weeks after operation (T4) in both groups. Leg circumference of both legs was measured to assess thigh muscle atrophy in the operated leg.
RESULTS


Thirty-seven patients constituted the intervention and 36 the control group, respectively; 14 patients dropped out during the follow-up period. Among the 59 remaining patients (mean age 42 [range, 19-65] years), no difference was noted in the Foot and Ankle Outcome Score (54.2 ± 16.1 vs. 56.0 ± 16.6) or Knee injury and Osteoarthritis Outcome Score (52.8 ± 18.3 vs 47.6 ± 17.7) between the intervention and control groups 6 weeks after operation. The change in the leg circumference from T1 to T4 was greater by 4.6 cm in the intervention group (95% confidence interval: 1.2-8.0,  P  = 0.005). No adverse event associated with anti-gravity treadmill rehabilitation was observed.
CONCLUSION


No significant difference was noted in patient-reported outcomes between the two groups. Significant differences in muscular atrophy of the thigh were observed six weeks after operation.",2021,"The change in the leg circumference from T1 to T4 was greater by 4.6 cm in the intervention group (95% confidence interval: 1.2-8.0,  P  = 0.005).","['Three level 1 trauma centers', 'lower limb fractures', 'Patients with tibial plateau or ankle fractures who underwent postoperative partial weight-bearing', '59 remaining patients (mean age 42 [range, 19-65] years']","['anti-gravity treadmill rehabilitation', 'anti-gravity treadmill rehabilitation therapy', 'standard rehabilitation', 'intervention (anti-gravity treadmill use) or control (standard rehabilitation protocol) groups']","['muscular atrophy of the thigh', 'leg circumference', 'Leg circumference of both legs', 'change in the Foot and Ankle Outcome Score for ankle fractures and total Knee injury and Osteoarthritis Outcome Score for tibial plateau fractures', 'Knee injury and Osteoarthritis Outcome Score', 'Foot and Ankle Outcome Score']","[{'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0204014', 'cui_str': 'Use of treadmill'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0262489', 'cui_str': 'Fracture of tibial plateau'}]",,0.0652364,"The change in the leg circumference from T1 to T4 was greater by 4.6 cm in the intervention group (95% confidence interval: 1.2-8.0,  P  = 0.005).","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Henkelmann', 'Affiliation': 'Department of Orthopedics, Trauma and Plastic Surgery, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Palke', 'Affiliation': 'Department of Orthopedics, Trauma and Plastic Surgery, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Clinic of Trauma, Orthopedic and Septic Surgery, Hospital St. Georg gGmbH, Leipzig, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Müller', 'Affiliation': 'Ambulantes Reha Centrum Leipzig GmbH, Leipzig, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Karich', 'Affiliation': 'Department of Trauma and Physical Medicine, Heinrich-Braun-Klinikum Gemeinnützige GmbH, Zwickau, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Mende', 'Affiliation': 'Coordinating Centre for Clinical Trials and Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Josten', 'Affiliation': 'Department of Orthopedics, Trauma and Plastic Surgery, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Böhme', 'Affiliation': 'Clinic of Trauma, Orthopedic and Septic Surgery, Hospital St. Georg gGmbH, Leipzig, Germany.'}]",Clinical rehabilitation,['10.1177/0269215520966857']
632,33104373,Do personal resources and strengths use increase work engagement? The effects of a training intervention.,"This study uses a quasi-experimental research design to investigate whether a personal resources intervention combined with strengths use can increase work engagement. Following job demands-resources theory, we argue that when employees strengthen their beliefs regarding how much control they have over their environment (i.e., increase their personal resources) and use their character strengths, they will be more engaged at work. The intervention focused specifically on impacting assertiveness, self-efficacy, and resilience. We hypothesized that the intervention would increase work engagement through an increase in personal resources. Participants were all enrolled for a personal resources training and were assigned to training intervention groups (n = 54) or waiting-list control groups (n = 48). Results of multivariate analyses of variance supported our hypotheses that the intervention increased personal resources, strengths use, and work engagement. In addition, process analyses using a bootstrapping procedure showed that in the intervention group (not in the control group), the intervention had a positive impact on changes in work engagement through changes in self-efficacy and resilience. We discuss the implications of these findings for job demands-resources theory, as well as the practical implications. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Results of multivariate analyses of variance supported our hypotheses that the intervention increased personal resources, strengths use, and work engagement.",[],"['training intervention groups (n = 54) or waiting-list control groups', 'training intervention', 'personal resources training']","['personal resources, strengths use, and work engagement', 'self-efficacy and resilience']",[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4505268', 'cui_str': 'Employee Engagement'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]",,0.0172636,"Results of multivariate analyses of variance supported our hypotheses that the intervention increased personal resources, strengths use, and work engagement.","[{'ForeName': 'Arnold B', 'Initials': 'AB', 'LastName': 'Bakker', 'Affiliation': 'Center of Excellence for Positive Organizational Psychology.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'van Wingerden', 'Affiliation': 'Center of Excellence for Positive Organizational Psychology.'}]",Journal of occupational health psychology,['10.1037/ocp0000266']
633,33126825,Altered Antibody Responses in Persons Infected with HIV-1 While Using Preexposure Prophylaxis.,"Preexposure prophylaxis (PrEP) is an effective HIV prevention tool, although effectiveness is dependent upon adherence. It is important to characterize the impact of PrEP on HIV antibody responses in people who experience breakthrough infections to understand the potential impact on timely diagnosis and treatment. Longitudinal HIV-1-specific antibody responses were evaluated in 42 people who inject drugs (PWID) from the Bangkok Tenofovir Study (BTS) (placebo = 28; PrEP = 14) who acquired HIV while receiving PrEP. HIV-1 antibody levels and avidity to three envelope proteins (gp41, gp160, and gp120) were measured in the plasma using a customized Bio-Plex (Bio-Rad Laboratories, Hercules, CA) assay. A time-to-event analysis was performed for each biomarker to compare the distribution of times at which study subjects exceeded the recent/long-term assay threshold, comparing PrEP and placebo treatment groups. We fit mixed-effects models to identify longitudinal differences in antibody levels and avidity between groups. Overall, longitudinal antibody levels and avidity were notably lower in the PrEP breakthrough group compared to the placebo group. Time-to-event analyses demonstrated a difference in time to antibody reactivity between treatment groups for all Bio-Plex biomarkers. Longitudinal gp120 antibody levels within the PrEP breakthrough group were decreased compared to the placebo group. When accounting for PrEP adherence, both gp120 and gp160 antibody levels were lower in the PrEP breakthrough group compared to the placebo group. We demonstrate hindered envelope antibody maturation in PWID who became infected while receiving PrEP in the BTS, which has significant implications for HIV diagnosis. Delayed maturation of the antibody response to HIV may increase the time to detection for antibody-based tests. Clinical Trial Registration Number, NCT00119106.",2021,"When accounting for PrEP adherence, both gp120 and gp160 antibody levels were lower in the PrEP breakthrough group compared to the placebo group.
","['Persons Infected with HIV-1', '42 people who inject drugs (PWID) from the Bangkok Tenofovir Study (placebo=28; PrEP=14) who acquired HIV while receiving PrEP']","['Pre-exposure prophylaxis (PrEP', 'placebo', 'PrEP']","['HIV-1 antibody levels and avidity to three envelope proteins (gp41, gp160, and gp120', 'Altered Antibody Responses', 'Longitudinal gp120 antibody levels', 'gp120 and gp160 antibody levels', 'time to antibody reactivity', 'Overall, longitudinal antibody levels and avidity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0369497', 'cui_str': 'Human immunodeficiency virus type 1 antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017278', 'cui_str': 'env Gene Products'}, {'cui': 'C0019692', 'cui_str': 'Envelope Protein gp41, HIV'}, {'cui': 'C0062790', 'cui_str': 'gp160(HIV)'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",42.0,0.0388449,"When accounting for PrEP adherence, both gp120 and gp160 antibody levels were lower in the PrEP breakthrough group compared to the placebo group.
","[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Parker', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Khalil', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Suphak', 'Initials': 'S', 'LastName': 'Vanichseni', 'Affiliation': 'Thailand Ministry of Public Health, U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Wanna', 'Initials': 'W', 'LastName': 'Leelawiwat', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'McNicholl', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hickey', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'J Gerardo', 'Initials': 'JG', 'LastName': 'García-Lerma', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Kachit', 'Initials': 'K', 'LastName': 'Choopanya', 'Affiliation': 'Bangkok Metropolitan Association, Bangkok, Thailand.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Curtis', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]",AIDS research and human retroviruses,['10.1089/AID.2020.0137']
634,33112463,"Efficacy and safety of a novel herbal solution for the treatment of androgenetic alopecia and comparison with 5% minoxidil: A double-blind, randomized controlled trial study.","FDA-approved drugs for the most common type of hair loss, androgenetic alopecia (AGA), present many side effects and disadvantages. However, herbal compounds are characterized by patient compliance, fewer side effects, and several mechanisms of action. The present study set to evaluate the effectiveness and safety of the topical herbal solution and to compare it with 5% minoxidil in men with AGA. A randomized, double-blind controlled trial was conducted from 28 November 2018 to 2 September 2019, in Sina Hospital, Tabriz, Iran. 24 healthy males (mean [SD] age 33.04 [5.81]) with mild to moderate AGA were selected from 44 volunteer participants. Participants were randomly assigned (1:1) into two groups. They received 1 ml of topical solutions at morning and evening intervals for 9 months. Primary outcomes consisted of measured hair diameters at baseline and repeated at weeks 12, 24, and 36. Furthermore, hair density was measured at baseline and week 36. The MTS + THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement. At week 36, the mean hair diameter of the MTS + THS group significantly increased compared to the MTS group (P = .001). Hair density increased in both groups; however, only in the MTS + THS group, it was significant (P < .05). The findings established that the topical herbal solution has significant influence on patients with AGA and improvement of their quality of life. This solution can be considered a significant step towards the prevention and treatment of AGA. clinicaltrials.gov Identifier: NCT03753113.",2020,The MTS+THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement.,"['November 28, 2018, to September 2, 2019, in Sina Hospital, Tabriz, Iran', 'men with AGA', '24 healthy males (mean (SD) age 33.04 (5.81)) with mild to moderate AGA were selected from 44 volunteer participants']","['novel herbal solution', 'topical herbal solution', 'MTS', 'minoxidil', 'MTS + THS']","['mean hair diameter', 'Furthermore, hair density', 'measured hair diameters', 'effectiveness and safety', 'Efficacy and safety', 'quality of life', 'Hair density']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0796074', 'cui_str': 'Deafness-dystonia-optic neuronopathy syndrome'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",24.0,0.29193,The MTS+THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement.,"[{'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Masoud', 'Affiliation': 'Faculty of Pharmacy, Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamideh Azimi', 'Initials': 'HA', 'LastName': 'Alamdari', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Asnaashari', 'Affiliation': 'Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Faculty of Pharmacy, Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Javadzadeh', 'Affiliation': 'Faculty of Pharmacy, Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Dermatologic therapy,['10.1111/dth.14467']
635,33115615,Gravity and Mastoid Effusion.,"BACKGROUND


Asymptomatic mastoid effusions have recently been observed in astronauts returning from long-term spaceflight. In hospitalized patients, mastoid effusion increases the risks for bacterial otitis and mastoiditis. We reasoned that cephalad fluid shifts during strict -6° head down tilt bed rest could reproduce space-flight associated mastoid effusion and that artificial gravity may reverse the response.
METHODS


The recent Artificial Gravity Bed Rest Study-European Space Agency study (AGBRESA) tested influences of artificial gravity during 60 days head down bed rest on a short-arm human centrifuge in healthy participants. The two intervention groups received daily artificial gravity with 30 minutes continuous artificial gravity or intermittent artificial gravity. A third group served as a control group and received no artificial gravity. We assessed cranial magnetic resonance images for mastoid effusions 1 day before bed rest, at days 14 and 52 of bed rest, and 3 days after bed rest.
RESULTS


None of the participants exhibited mastoid effusions before bed rest. Six participants showed mastoid effusions at bed rest day 14 (4 continuous, 2 intermittent, 0 control). Fifteen participants showed mastoid effusions at bed rest day 52 and 3 days after bed rest (7 continuous, 3 intermittent, 5 control).
CONCLUSIONS


Mastoid effusions commonly occur during strict head down tilt bed rest. The model can be applied to study the mechanisms and potential countermeasures for space flight-associated mastoid effusions. Formation of mastoid effusions during head down tilt bed rest is not prevented by daily 30 minutes short-arm intermittent or continuous centrifugation.",2021,Formation of mastoid effusions during HDT is not prevented by daily 30 minutes short-arm intermittent or continuous centrifugation.,['healthy subjects'],"['strict -6° head down tilt bed-rest (HDT', 'daily AG with 30 minutes continuous AG (cAG) or Intermittend AG', 'control group with no AG']","['Gravity and Mastoid effusion', 'Formation of mastoid effusions', 'mastoid effusions', 'cranial magnetic resonance images (MRI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242678', 'cui_str': 'Gravity, Artificial'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C2609130', 'cui_str': 'Mastoid effusion'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",,0.0531499,Formation of mastoid effusions during HDT is not prevented by daily 30 minutes short-arm intermittent or continuous centrifugation.,"[{'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Lecheler', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany. Electronic address: leopold.lecheler@dlr.de.'}, {'ForeName': 'Freia', 'Initials': 'F', 'LastName': 'Paulke', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Sonnow', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Hannover Medical School, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Limper', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany; Department of Anesthesiology and Intensive Care Medicine, Merheim Medical Center, Hospitals of Cologne, University of Witten/Herdecke, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schwarz', 'Affiliation': 'University of Cologne, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Jansen', 'Affiliation': 'University of Cologne, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, Germany.'}, {'ForeName': 'Jens Peter', 'Initials': 'JP', 'LastName': 'Klussmann', 'Affiliation': 'University of Cologne, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Tank', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.09.020']
636,33113567,Effects of switching from clopidogrel to prasugrel at the chronic phase after coronary stenting on antiplatelet action and vascular endothelial function: Switch-Pras study.,"Compared to clopidogrel, prasugrel has a lower incidence of ischemic events following percutaneous coronary intervention (PCI) because of an early reduction during the acute phase in P2Y12 reaction units (PRU). The objective of this study was to compare the antiplatelet effect and vascular endothelial function of both drugs during the chronic phase after PCI. Patients who had undergone PCI and were confirmed to have no restenosis by follow-up coronary angiography under dual anti-platelet therapy with clopidogrel (75 mg/day) and aspirin (100 mg/day) were randomized to either continue clopidogrel or switch to prasugrel (3.75 mg/day). At baseline, prior to randomization we determined the CYP2C19 genotype. At the baseline and 24 weeks after randomization, the P2Y12 reactivity unit (PRU) was measured using the VerifyNow™ P2Y12 assay. Endothelial function was evaluated by flow-mediated vasodilation (FMD) and reactive hyperemia peripheral arterial tonometry (RH-PAT), while and circulating CD34+/CD133+/CD45 low  progenitor cells were measured by flow cytometric analysis. Serum high-sensitivity C-reactive protein (hsCRP) level was also measured. The PRU was reduced significantly in the prasugrel group (P = 0.0008), especially in patients who were intermediate or poor metabolizers based on the CYP2C19 genotype (P < 0.0001). This reduction was not observed in the clopidogrel group. The number of CD34+/CD133+/CD45 low  cells increased in the clopidogrel group (P = 0.008), but not in the prasugrel group. The hsCRP, FMD and reactive hyperemia index measured by RH-PAT did not change in either group. Prasugrel is potentially better than clopidogrel for preventing thrombotic events, although clopidogrel may have an advantage over prasugrel in terms of preventing atherosclerotic events. Proper use of thienopyridine drugs based on the CYP2C19 genotype has promising clinical potential.",2021,"The PRU was reduced significantly in the prasugrel group (P = 0.0008), especially in patients who were intermediate or poor metabolizers based on the CYP2C19 genotype (P < 0.0001).",['Patients who had undergone PCI and were confirmed to have no restenosis by follow-up coronary angiography under dual anti-platelet therapy with'],"['percutaneous coronary intervention (PCI', 'continue clopidogrel or switch to prasugrel', 'clopidogrel', 'Prasugrel', 'aspirin', 'clopidogrel, prasugrel']","['Serum high-sensitivity C-reactive protein (hsCRP) level', 'hsCRP, FMD and reactive hyperemia index', 'P2Y12 reactivity unit (PRU', 'number of CD34+/CD133+/CD45 low  cells', 'Endothelial function', 'PRU', 'antiplatelet effect and vascular endothelial function', 'ischemic events', 'flow-mediated vasodilation (FMD) and reactive hyperemia peripheral arterial tonometry (RH-PAT), while and circulating CD34+/CD133+/CD45 low  progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C5197905', 'cui_str': 'Dual Anti-Platelet Therapy'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]",,0.023463,"The PRU was reduced significantly in the prasugrel group (P = 0.0008), especially in patients who were intermediate or poor metabolizers based on the CYP2C19 genotype (P < 0.0001).","[{'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Masuyama', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan. masakuma@dokkyomed.ac.jp.'}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Waku', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Hirose', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Kitahara', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Naganuma', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Yazawa', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Shichiro', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01714-w']
637,33125516,"Safety, pharmacodynamic, and pharmacokinetic characterization of vericiguat: results from six phase I studies in healthy subjects.","PURPOSE


To characterize the safety, pharmacodynamics, and pharmacokinetics (PK) of vericiguat in healthy males.
METHODS


Six phase I studies were conducted in European, Chinese, and Japanese males. Subjects received oral vericiguat as a single dose (0.5-15.0 mg solution [for first-in-human study] or 1.25-10.0 mg immediate release [IR tablets]) or multiple doses (1.25-10.0 mg IR tablets once daily [QD] or 5.0 mg IR tablets twice daily for 7 consecutive days). Bioavailability and food effects on vericiguat PK (IR tablets) were also studied in European subjects.
RESULTS


Overall, 255 of 265 randomized subjects completed their respective studies. There were no deaths or serious adverse events. Vericiguat was generally well tolerated at doses ≤ 10.0 mg. In the first-in-human study, the most frequent drug-related adverse events were headache and postural dizziness (experienced by five subjects each [7.2%]). Three of four subjects who received vericiguat 15.0 mg (oral solution, fasted) experienced orthostatic reactions. Vericiguat (≤ 10.0 mg, IR tablets) was rapidly absorbed (median time to reach maximum plasma concentration ≤ 2.5 h [fasted]) with a mean half-life of about 22.0 h (range 17.9-27.0 h for single and multiple doses). No evidence for deviation from dose proportionality or unexpected accumulation was observed. Administration of vericiguat 5.0 mg IR tablets with food increased bioavailability by 19% (estimated ratio 119% [90% confidence interval]: 108; 131]), reduced PK variability, and prolonged vericiguat absorption relative to the fasted state.
CONCLUSION


In general, vericiguat was well tolerated. These results supported further clinical evaluation of vericiguat QD in patients with heart failure.
REGISTRY NUMBERS


EudraCT: 2011-001627-21; EudraCT: 2012-000953-30.",2021,There were no deaths or serious adverse events.,"['I studies were conducted in European, Chinese, and Japanese males', 'European subjects', 'healthy subjects', 'patients with heart failure', 'healthy males', 'Six phase']","['oral vericiguat as a single dose (0.5-15.0\xa0mg solution [for first-in-human study] or 1.25-10.0\xa0mg immediate release [IR tablets]) or multiple doses (1.25-10.0\xa0mg IR tablets once daily [QD', 'Vericiguat (≤', 'vericiguat 15.0\xa0mg (oral solution']","['Safety, pharmacodynamic, and pharmacokinetic characterization of vericiguat', 'Bioavailability and food effects on vericiguat PK (IR tablets', 'orthostatic reactions', 'headache and postural dizziness', 'reduced PK variability, and prolonged vericiguat absorption relative', 'tolerated', 'bioavailability', 'deaths or serious adverse events', 'safety, pharmacodynamics, and pharmacokinetics (PK']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0234987', 'cui_str': 'Postural dizziness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",265.0,0.0413024,There were no deaths or serious adverse events.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boettcher', 'Affiliation': 'Research & Development, Pharmaceuticals, Clinical PD CV, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Experimental Medicine, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Mueck', 'Affiliation': 'Research & Development, Pharmaceuticals, Clinical PK CV, Bayer AG, Aprather Weg 18a, 42113, Wuppertal, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Loewen', 'Affiliation': 'Chrestos Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Arens', 'Affiliation': 'Research & Development, Pharmaceuticals, Clinical PD CV, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshikawa', 'Affiliation': 'Clinical Sciences, Research & Development Japan, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Research & Development, Pharmaceuticals, Clinical PD CV, Bayer AG, Wuppertal, Germany. corina.becker@bayer.com.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-03023-7']
638,33125517,Protective effect of flumazenil infusion in severe acute benzodiazepine toxicity: a pilot randomized trial.,"OBJECTIVE


We aimed to investigate the efficacy of flumazenil infusion in the maintenance of arousal and prevention of development of complications in severe benzodiazepine poisoning.
MATERIALS AND METHOD


Sixty severely poisoned patients (intubated due to loss of consciousness) intoxicated by sole benzodiazepines referred to Loghman Hakim hospital between May 2018 and August 2019 were considered to be included in the current study. All were evaluated for possible contraindications of flumazenil administration. If there were no contraindications, we continued supportive care in one group and supportive care plus flumazenil infusion in the second group. Following response to the stat dose of flumazenil, complications, hospital stay, and outcome were compared between these two groups.
RESULTS


A total of 60 benzodiazepine-poisoned patients aged between 16 and 84 years old (37 males and 23 females) were enrolled. There was no statistically significant difference between these two groups regarding the period of hospital stay. Need for intubation significantly decreased in the infusion group. None of the patients experienced seizure or dysrhythmia. One patient died in the control group which received only a stat dose of flumazenil.
CONCLUSIONS


Administration of flumazenil is safe in benzodiazepine-poisoned patients with appropriate indications. Flumazenil infusion can significantly decrease the need for intubation and subsequent ICU admission. Even though flumazenil is an expensive antidote, its administration may decrease the need for ICU beds in the setting of acute poisoning.",2021,Need for intubation significantly decreased in the infusion group.,"['A total of 60 benzodiazepine-poisoned patients aged between 16 and 84 years old (37 males and 23 females', 'Sixty severely poisoned patients (intubated due to loss of consciousness) intoxicated by sole benzodiazepines referred to Loghman Hakim hospital between May 2018 and August 2019 were considered to be included in the current study', 'severe acute benzodiazepine toxicity']","['flumazenil infusion', 'Flumazenil', 'benzodiazepine', 'flumazenil']","['seizure or dysrhythmia', 'need for intubation and subsequent ICU admission', 'period of hospital stay']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0032346', 'cui_str': 'Toxic substance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]","[{'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",60.0,0.0601011,Need for intubation significantly decreased in the infusion group.,"[{'ForeName': 'Akram Sadat', 'Initials': 'AS', 'LastName': 'Razavizadeh', 'Affiliation': 'Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Zamani', 'Affiliation': 'Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Ziaeefar', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ebrahimi', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Hassanian-Moghaddam', 'Affiliation': 'Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. hassanian@sbmu.ac.ir.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-03031-7']
639,33130147,Variability in Blood Eosinophil Counts in Patients with Eosinophilic Asthma.,"BACKGROUND


Blood eosinophil (EOS) counts are critical to the accurate identification of asthma phenotypes. However, there are few long-term data on intraindividual EOS count variability among patients with eosinophilic asthma.
OBJECTIVE


This post hoc analysis of 2 phase III clinical trials from the reslizumab BREATH program explored the variability of blood EOS counts in patients with eosinophilic asthma receiving placebo.
METHODS


Pooled data from study participants receiving placebo (previously randomized 1:1 to receive reslizumab or placebo) were analyzed for blood EOS count variability over 52 weeks. EOS counts were measured up to twice during screening, every 4 weeks from randomization to the end of treatment and at the 90-day follow-up visit.
RESULTS


Of 476 included patients, 31 (6.5%), 38 (8.0%), 55 (11.6%), and 352 (73.9%) patients had baseline blood EOS counts of <150, ≥150 to <300, ≥300 to <400, and ≥400 cells/μL, respectively. Patients frequently shifted between EOS count categories during the 52-week treatment period, most often moving to the highest EOS category. Among patients in each of the lower 3 EOS categories, 27% to 56% of patients shifted to the ≥400 cells/μL category at some point during the treatment period.
CONCLUSION


Intraindividual variability in blood EOS count was high among patients with eosinophilic asthma receiving placebo, with shifts to ≥400 cells/μL from lower categories frequently observed. Repeat determinations of blood EOS count may be important to ensure appropriate selection of therapy in patients with severe asthma.",2021,"CONCLUSION


Intra-individual variability in blood EOS count was high among eosinophilic asthma patients receiving placebo, with shifts to ≥400 cells/μL from lower categories frequently observed.","['Pooled data from study participants receiving', 'patients with eosinophilic asthma receiving placebo', 'patients with eosinophilic asthma', 'patients with severe asthma', 'Patients with Eosinophilic Asthma', 'eosinophilic asthma patients receiving']","['reslizumab BREATH program', 'reslizumab or placebo', 'placebo']","['EOS counts', 'blood EOS counts', 'Blood Eosinophil Counts', 'blood EOS count', 'blood EOS count variability', 'baseline blood EOS counts']","[{'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",476.0,0.133089,"CONCLUSION


Intra-individual variability in blood EOS count was high among eosinophilic asthma patients receiving placebo, with shifts to ≥400 cells/μL from lower categories frequently observed.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'Division of Clinical Immunology and Allergy, David Geffen School of Medicine at University of California, Los Angeles, Calif. Electronic address: jcorren@ucla.edu.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Du', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc., West Chester, Pa.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Gubbi', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc., West Chester, Pa.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Vanlandingham', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc., West Chester, Pa.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.033']
640,33119332,Supportive supervisor training improves family relationships among employee and spouse dyads.,"Employee family relationships have been increasingly tied to job outcomes and are known to be a strong predictor of employee health and well-being. As such, taking steps toward uncovering actionable tools organizations can implement to foster improvements in family relationship quality is important and should not be overlooked in occupational health psychology interventions. Supportive supervisor training (SST) targets improving employees' ability to meet their nonwork needs; however, the focus and discussions of the implications tied to SST have largely excluded marital and parent-child relationships, spouses, and spousal outcomes. Further, mounting evidence suggests contextual factors shape when SST is most meaningful; however, more research is needed to uncover individual-level factors that may facilitate training effects. This study used a cluster-randomized controlled trial design to evaluate a worksite-based SST with a sample of 250 employees (separated military veterans) and their matched spouses. Using an intent-to-treat approach and 2-level random effects models, results demonstrated that the SST promoted couples' dyadic marital relationship quality 9 months following baseline. Additionally, when employees were under higher levels of baseline stress, couples' dyadic marital relationship quality and positive parenting both improved following the SST. Thus, an SST is beneficial for family relationships as reported by both employees and spouses, which goes beyond previously demonstrated employee health and well-being benefits. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Additionally, when employees were under higher levels of baseline stress, couples' dyadic marital relationship quality and positive parenting both improved following the SST.",['250 employees (separated military veterans) and their matched spouses'],"['Supportive supervisor training', 'Supportive supervisor training (SST', 'worksite-based SST']","[""baseline stress, couples' dyadic marital relationship quality and positive parenting both improved following the SST"", ""couples' dyadic marital relationship quality""]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}]","[{'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0024818', 'cui_str': 'Marital Relationship'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0863655,"Additionally, when employees were under higher levels of baseline stress, couples' dyadic marital relationship quality and positive parenting both improved following the SST.","[{'ForeName': 'Jacquelyn M', 'Initials': 'JM', 'LastName': 'Brady', 'Affiliation': 'Department of Psychology, San José State University.'}, {'ForeName': 'Leslie B', 'Initials': 'LB', 'LastName': 'Hammer', 'Affiliation': 'Department of Psychology, Portland State University.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Mohr', 'Affiliation': 'Department of Psychology, Portland State University.'}, {'ForeName': 'Todd E', 'Initials': 'TE', 'LastName': 'Bodner', 'Affiliation': 'Department of Psychology, Portland State University.'}]",Journal of occupational health psychology,['10.1037/ocp0000264']
641,33121980,Pitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP: A Randomized Trial.,"BACKGROUND


Excessive daytime sleepiness (EDS) in individuals with OSA syndrome persisting despite good adherence to CPAP is a disabling condition. Pitolisant is a selective histamine H3-receptor antagonist with wake-promoting effects.
RESEARCH QUESTION


Is pitolisant effective and safe for reducing daytime sleepiness in individuals with moderate to severe OSA adhering to CPAP treatment but experiencing residual EDS?
STUDY DESIGN AND METHODS


In a multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was titrated individually at up to 20 mg/day and taken over 12 weeks. The primary end point was change in the Epworth Sleepiness Scale (ESS) score in the intention-to-treat population. Key secondary end points were maintenance of wakefulness assessed by the Oxford Sleep Resistance Test, Clinical Global Impressions scale of severity, the patient's global opinion, EuroQoL quality-of-life questionnaire score, Pichot fatigue questionnaire score, and safety.
RESULTS


Two hundred forty-four OSA participants (82.8% men; mean age, 53.1 years; mean Apnea Hypopnea Index with CPAP, 4.2/h; baseline ESS score, 14.7) were randomized to pitolisant (n = 183) or placebo (n = 61). ESS significantly decreased with pitolisant compared with placebo (-2.6; 95% CI, -3.9 to -1.4; P < .001), and the rate of responders to therapy (ESS ≤ 10 or change in ESS ≥ 3) was significantly higher with pitolisant (71.0% vs 54.1%; P = .013). Adverse event occurrence (mainly headache and insomnia) was higher in the pitolisant group compared with the placebo group (47.0% and 32.8%, respectively; P = .03). No cardiovascular or other significant safety concerns were reported.
INTERPRETATION


Pitolisant used as adjunct to CPAP therapy for OSA with residual sleepiness despite good CPAP adherence significantly reduced subjective and objective sleepiness and improved participant-reported outcomes and physician-reported disease severity.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT01071876; URL: www.clinicaltrials.gov; EudraCT N°: 2009-017248-14; URL: eudract.ema.europa.eu.",2020,ESS significantly decreased with pitolisant compared to placebo -2.6,"['Obstructive Sleep Apnea patients adhering to Continuous positive Airway Pressure', 'individuals with obstructive sleep apnea syndrome', '244 OSA participants (82.8% male; mean age: 53.1 years, mean apnea+hypopnea index under CPAP: 4.2/hour, baseline ESS score: 14.7, were randomized to pitolisant (n=183) or', 'individuals presenting moderate to severe OSA adhering to CPAP treatment but having residual EDS']","['placebo', 'continuous positive airway pressure (CPAP']","['daytime sleepiness', 'Adverse event occurrence (mainly headache and insomnia', 'ESS', ""maintenance of wakefulness assessed by the Oxford Sleep Resistance Test (OSleR), clinical global impressions of severity, the patient's global opinion, EQ-5D quality-of-life, Pichot Fatigue questionnaire scores and safety"", 'Epworth Sleepiness Scale (ESS) score', 'rate of responders to therapy (ESS≤10 or ΔESS≥3']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",244.0,0.29983,ESS significantly decreased with pitolisant compared to placebo -2.6,"[{'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'HP2 Laboratory, INSERM U1042, University Grenoble Alpes, and EFCR Laboratory, Grenoble Alpes University Hospital, Grenoble, France. Electronic address: JPepin@chu-grenoble.fr.'}, {'ForeName': 'Ognian', 'Initials': 'O', 'LastName': 'Georgiev', 'Affiliation': 'Department of Internal Medicine, Pulmonology, Alexandrovska Hospital Medical University, Sofia, Bulgaria.'}, {'ForeName': 'Rumen', 'Initials': 'R', 'LastName': 'Tiholov', 'Affiliation': 'Department of Internal Diseases, Sv. Ivan Rilski Multiprofile Hospital for Active Treatment, Kozloduy, Bulgaria.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Attali', 'Affiliation': 'Neurophysiologie Respiratoire Expérimentale et Clinique UMRS1158, Sorbonne Université, INSERM, and Service des Pathologies du Sommeil (Departement R3S, DMU APPROCHES), Groupe Hospitalier Universitaire APHP-Sorbonne Université, Paris, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Verbraecken', 'Affiliation': 'Universitair Multidisciplinair Slaap Centrum, Edegem-Antwerp, Belgium.'}, {'ForeName': 'Bertien', 'Initials': 'B', 'LastName': 'Buyse', 'Affiliation': 'Leuvens Universitair Centrum voor Slaap-en waakstoornissen, Department of Respiratory Diseases, University Hospitals Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Partinen', 'Affiliation': 'Helsinki Sleep Clinic, Vitalmed Research Center, Department of Clinical Neurosciences, University of Helsinki, Finland.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Fietze', 'Affiliation': 'Interdisziplinares Schlafmedizinisches Zentrum, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Georgi', 'Initials': 'G', 'LastName': 'Belev', 'Affiliation': 'Pulmonology Division, Department of Internal Medicine, St. George Hospital Medical University, Plovdiv, Bulgaria.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Dokic', 'Affiliation': 'Department of Pulmology and Allergy, Mother Teresa Medical University, Skopje, Macedonia.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'HP2 Laboratory, INSERM U1042, University Grenoble Alpes, and EFCR Laboratory, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lévy', 'Affiliation': 'HP2 Laboratory, INSERM U1042, University Grenoble Alpes, and EFCR Laboratory, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, Paris, France.'}, {'ForeName': 'Jeanne-Marie', 'Initials': 'JM', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, Paris, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet, Paris, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Centre National de Référence Narcolepsie, Unité du Sommeil, CHU Montpellier, Hôpital Gui-de-Chauliac, Service de Neurologie, Université de Montpellier, INSERM U1061, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.09.281']
642,33121984,Bleaching toothpaste with two different concentrations of hydrogen peroxide: A randomized double-blinded clinical trial.,"OBJECTIVES


This randomized double-blinded clinical trial evaluated the bleaching efficacy and incidence of contact hypersensitivity of three kinds of bleaching toothpaste.
METHODS


Forty-nine participants above A2 shade on the maxillary central incisor (#11) and canine (#13) were randomized into three groups: TW group (n = 15), 0.75 % HP-containing toothpaste (Toothwhole white); VL group (n = 15), 0.75 % HP-containing toothpaste (Vussen 7); and VH group (n = 17), 2.8 % of HP-containing toothpaste (Vussen 28). Participants were instructed to manually brush their teeth for 3 min, 3 times per day for 12 weeks. They were followed-up after 4 and 12 weeks. Shade measurements were performed using a spectrophotometer (SP), and data were calculated with CIELab (ΔE ab * ) and CIEDE2000 (ΔE 00 ) formula. Additionally, visual inspection (VI) using the Vitapan classical shade guide was also performed, and the correlation between the two measurements was analyzed by comparing the CIELab (ΔE ab * ) values. The incidence of contact hypersensitivity at each follow-up was recorded. A mixed-effect model was performed to assess shade changes and chi-square tests for the incidence of contact hypersensitivity, respectively.
RESULTS


At 12 week follow-up, all groups showed ΔE ab *   above 3.46, and ΔE 00  above 2.25 for tooth #11. For tooth #13, the ΔE ab *  and ΔE 00  of VH and TW groups only were above those thresholds. Shade change varied according to toothpaste and follow-up points. SP and VI showed a moderate positive correlation for L*, a*, and b*, respectively (P < 0.05). Contact hypersensitivity was not significantly different among the groups (P > 0.05).
CONCLUSIONS


Bleaching toothpaste with higher HP yields a better shade change than other toothpaste after 12 weeks.
CLINICAL SIGNIFICANCE


The use of bleaching toothpaste with a higher HP concentration results in a better shade improvement.",2020,"Contact hypersensitivity was not significantly different among the groups (P > 0.05).
",['Forty-nine participants above A2 shade on the maxillary central incisor (#11) and canine (#13'],"['Bleaching toothpaste', 'HP-containing toothpaste (Toothwhole white); VL group (n\u2009=\u200915), 0.75% HP-containing toothpaste', 'HP-containing toothpaste', 'hydrogen peroxide', 'bleaching toothpaste']","['Contact hypersensitivity', 'incidence of contact hypersensitivity']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0162351', 'cui_str': 'Contact hypersensitivity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",49.0,0.12685,"Contact hypersensitivity was not significantly different among the groups (P > 0.05).
","[{'ForeName': 'Hyun-Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, Kyung Hee University Dental Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Dongseok', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea; Division of Biostatistics, Oregon Health and Science University, Portland State University of Public Health, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Jei', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Shim', 'Affiliation': 'Department of Conservative Dentistry, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Duck-Su', 'Initials': 'DS', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea. Electronic address: dentist96@khu.ac.kr.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103508']
643,33137340,"EOS789, a broad-spectrum inhibitor of phosphate transport, is safe with an indication of efficacy in a phase 1b randomized crossover trial in hemodialysis patients.","The treatment of hyperphosphatemia remains challenging in patients receiving hemodialysis. This phase 1b study assessed safety and efficacy of EOS789, a novel pan-inhibitor of phosphate transport (NaPi-2b, PiT-1, PiT-2) on intestinal phosphate absorption in patients receiving intermittent hemodialysis therapy. Two cross-over, randomized order studies of identical design (ten patients each) compared daily EOS789 50 mg to placebo with meals and daily EOS789 100 mg vs EOS789 100 mg plus 1600 mg sevelamer with meals. Patients ate a controlled diet of 900 mg phosphate daily for two weeks and began EOS789 on day four. On day ten, a phosphate absorption testing protocol was performed during the intradialytic period. Intestinal fractional phosphate absorption was determined by kinetic modeling of serum data following oral and intravenous doses of  33 Phosphate ( 33 P). The results demonstrated no study drug related serious adverse events. Fractional phosphate absorption was 0.53 (95% confidence interval: 0.39,0.67) for placebo vs. 0.49 (0.35,0.63) for 50 mg EOS789; and 0.40 (0.29,0.50) for 100 mg EOS789 vs. 0.36 (0.26,0.47) for 100 mg EOS789 plus 1600 mg sevelamer (all not significantly different). The fractional phosphate absorption trended lower in six patients who completed both studies with EOS789 100 mg compared with placebo. Thus, in this phase 1b study, EOS789 was safe and well tolerated. Importantly, the use of  33 P as a sensitive and direct measure of intestinal phosphate absorption allows specific testing of drug efficacy. The effectiveness of EOS789 needs to be evaluated in future phase 2 and phase 3 studies.",2020,"Fractional phosphate absorption was 0.53 (95% confidence interval: 0.39,0.67) for placebo vs. 0.49 (0.35,0.63) for 50 mg EOS789; and 0.40 (0.29,0.50) for 100 mg EOS789 vs. 0.36 (0.26,0.47) for 100 mg EOS789 plus 1600 mg sevelamer (all not significantly different).","['patients receiving hemodialysis', 'patients receiving intermittent hemodialysis therapy', 'hemodialysis patients']","['EOS789', 'placebo', 'EOS789 50 mg to placebo with meals and daily EOS789 100 mg vs EOS789 100 mg plus 1600 mg sevelamer with meals', 'EOS789, a novel pan-inhibitor of phosphate transport (NaPi-2b, PiT-1, PiT-2']","['safe and well tolerated', 'Fractional phosphate absorption', 'Intestinal fractional phosphate absorption', 'fractional phosphate absorption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0472676', 'cui_str': 'Intermittent hemodialysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4553624', 'cui_str': 'With meals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0718050', 'cui_str': 'sevelamer'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C1529328', 'cui_str': 'SLC34A2 protein, human'}, {'cui': 'C0175697', 'cui_str': 'Van der Woude syndrome'}]","[{'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",,0.0560639,"Fractional phosphate absorption was 0.53 (95% confidence interval: 0.39,0.67) for placebo vs. 0.49 (0.35,0.63) for 50 mg EOS789; and 0.40 (0.29,0.50) for 100 mg EOS789 vs. 0.36 (0.26,0.47) for 100 mg EOS789 plus 1600 mg sevelamer (all not significantly different).","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hill Gallant', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana, USA; Division of Nephrology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Stremke', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana, USA.'}, {'ForeName': 'Laurie L', 'Initials': 'LL', 'LastName': 'Trevino', 'Affiliation': 'Clinical Translational Sciences Institute, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ranjani N', 'Initials': 'RN', 'LastName': 'Moorthi', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Simit', 'Initials': 'S', 'LastName': 'Doshi', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Meryl E', 'Initials': 'ME', 'LastName': 'Wastney', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana, USA; Metabolic Modeling Services, West Lafayette, Indiana, USA.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Hisada', 'Affiliation': 'Chugai Pharmaceutical Co., Tokyo, Japan.'}, {'ForeName': 'Jotaro', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': 'Chugai Pharmaceutical Co., Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Ogita', 'Affiliation': 'Chugai Pharmaceutical Co., Tokyo, Japan.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Chugai Pharmaceutical Co., Tokyo, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Chugai Pharmaceutical Co., Tokyo, Japan.'}, {'ForeName': 'Takei', 'Initials': 'T', 'LastName': 'Kake', 'Affiliation': 'Chugai Pharmaceutical Co., Tokyo, Japan.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Moe', 'Affiliation': 'Clinical Translational Sciences Institute, Indiana University School of Medicine, Indianapolis, Indiana, USA; Division of Nephrology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA. Electronic address: smoe@iu.edu.'}]",Kidney international,['10.1016/j.kint.2020.09.035']
644,33129989,Cardiovascular safety and efficacy of vadadustat for the treatment of anemia in non-dialysis-dependent CKD: Design and baseline characteristics.,"Current clinical practice guidelines for anemia management in non-dialysis-dependent chronic kidney disease (NDD-CKD) recommend the use of erythropoiesis-stimulating agents (ESAs) as standard of care. Vadadustat, an investigational oral hypoxia-inducible factor prolyl-hydroxylase inhibitor, stimulates endogenous erythropoietin production. The PRO 2 TECT program comprises 2 global, Phase 3, randomized, open-label, active-controlled, sponsor-blind clinical trials to evaluate safety and efficacy of vadadustat vs darbepoetin alfa in adult patients with anemia associated with NDD-CKD. Patients recruited into the ESA-untreated NDD-CKD trial (N = 1751) had hemoglobin <10 g/dL and had not received an ESA within 8 weeks prior to inclusion in the study. Patients recruited into the ESA-treated NDD-CKD trial (N = 1725) had hemoglobin between 8 and 11 g/dL (US) or 9 and 12 g/dL (non-US) and were actively treated with an ESA for anemia associated with CKD. Trial periods in both trials include (1) correction/conversion (weeks 0-23); (2) maintenance (weeks 24-52); (3) long-term treatment (week 53 to end of treatment); and (4) safety follow-up (end-of-treatment to 4 weeks later). The primary safety endpoint is time to first adjudicated major adverse cardiovascular event, defined as all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke, pooled across both trials. The primary efficacy endpoint in each trial is change in hemoglobin from baseline to primary evaluation period (weeks 24-36), comparing vadadustat vs darbepoetin alfa treatment groups. Demographics and baseline characteristics are similar among patients in both trials and broadly representative of the NDD-CKD population. These trials will help to evaluate the safety and efficacy of vadadustat for management of anemia associated with NDD-CKD.",2020,"The primary efficacy endpoint in each trial is change in hemoglobin from baseline to primary evaluation period (weeks 24-36), comparing vadadustat vs darbepoetin alfa treatment groups.","['Patients recruited into the ESA-treated NDD-CKD trial (N=1725) had hemoglobin between 8-11 g/dL (US) or 9-12 g/dL (non-US) and were actively treated with an ESA for anemia associated with CKD', 'adult patients with anemia associated with NDD-CKD', 'Anemia in Non-Dialysis Dependent CKD', 'Patients recruited into the ESA-untreated NDD-CKD trial (N=1751) had hemoglobin <10 g/dL and had not received an']","['vadadustat vs darbepoetin alfa', 'ESA', 'erythropoiesis-stimulating agents (ESAs']","['change in hemoglobin', 'time to first adjudicated major adverse cardiovascular event, defined as all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke', 'Cardiovascular Safety and Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1318182', 'cui_str': '10G'}]","[{'cui': 'C4519730', 'cui_str': 'vadadustat'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1751.0,0.0657826,"The primary efficacy endpoint in each trial is change in hemoglobin from baseline to primary evaluation period (weeks 24-36), comparing vadadustat vs darbepoetin alfa treatment groups.","[{'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA. Electronic address: gchertow@stanford.edu.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, TX.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'U.S. Renal Care, Plano, TX.'}, {'ForeName': 'Youssef M K', 'Initials': 'YMK', 'LastName': 'Farag', 'Affiliation': 'Akebia Therapeutics, Inc, Cambridge, MA.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Jardine', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Koury', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Akebia Therapeutics, Inc, Cambridge, MA.'}, {'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Khawaja', 'Affiliation': 'Akebia Therapeutics, Inc, Cambridge, MA.'}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'McCullough', 'Affiliation': 'Baylor University Medical Center, Baylor Scott & White Heart and Vascular Hospital, Dallas, TX.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Parfrey', 'Affiliation': ""Department of Medicine, Memorial University, St John's, Newfoundland, Canada.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': 'Statistics Collaborative, Inc., Washington, DC.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Walters', 'Affiliation': 'Statistics Collaborative, Inc., Washington, DC.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Tseng', 'Affiliation': 'Firma Clinical Research, Baltimore, MD.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Firma Clinical Research, Baltimore, MD.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Vargo', 'Affiliation': 'Akebia Therapeutics, Inc, Cambridge, MA.'}, {'ForeName': 'Wolfgang C', 'Initials': 'WC', 'LastName': 'Winkelmayer', 'Affiliation': 'Section of Nephrology, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Kai-Uwe', 'Initials': 'KU', 'LastName': 'Eckardt', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",American heart journal,['10.1016/j.ahj.2020.10.068']
645,33132094,Mid-term gender-specific differences in periprosthetic bone remodelling after implantation of a curved bone-preserving hip stem.,"BACKGROUND


The implant-specific periprosthetic bone remodelling in the proximal femur is considered to be an important factor influencing the long-term survival of cementless hip stems. Particularly data of gender-specific differences regarding bone-preserving stems are very rare in literature and mainly limited to short-term investigations. Therefore, we investigated at mid-term one arm of a prospective randomised study to evaluate if there is an influence of gender on implant-specific stress shielding after implantation of a curved bone preserving hip stem (Fitmore) 5 years postoperatively.
HYPOTHESIS


We hypothesised there will be no gender-specific differences in periprosthetic bone remodelling.
PATIENTS AND METHODS


A total of 20 female and 37 male patients underwent total hip arthroplasty using the Fitmore stem. Clinical, radiological as well as osteodensitometric examinations were performed preoperatively, 7 days and 3, 12 and 60 months postoperatively. Clinical data collection included the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Harris Hip Score (HHS). Periprosthetic bone mineral density (BMD) was measured using Dual Energy X-ray Absorptiometry (DXA) and the periprosthetic bone was divided into 7 regions of interest (ROI) for analysis. The results at 3, 12 and 60 months were compared with the first postoperative measurement after 7 days to obtain a percentage change.
RESULTS


Periprosthetic BMD showed a decrease in all 7 ROIs for both groups 5 years postoperatively referred to the baseline value, except ROI 3 (0.8%, p=0.761), representing the distal lateral part of the stem, and ROI 5 (0.3%, p=0.688), representing the distal medial part of the stem in the male cohort. Significant gender differences were found in ROI 1 (-16.0% vs. -3.5%, p=0.016) and ROI 6 (-9.9% vs. -2.1%, p=0.04) in favour of the male patients. Clinical results showed no significant gender differences 5 years postoperatively with regard to WOMAC (mean 0.4 (±0.8, 0-3.3) in women vs. 0.3 (±0.8, 0-4.2) in men, p=0.76) and HHS (mean 93.0 (±9.7, 66.0-100.0) in women vs. 93.9 (±11.5, 53.0-100.0) in men, p=0.36).
CONCLUSION


Proximal stress shielding was observed independent of gender 5 years postoperatively. However, there was a significantly lower bone loss proximal lateral and medial below the calcar in male patients, indicating a more physiological load transfer. [ClinicalTrials.gov identifier: NCT03147131 (Study ID D.3067-244/10). Registered 10 May 2017 - retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03147131?term=Bieger&draw=2&rank=1] LEVEL OF EVIDENCE: IV; prospective study without control group.",2020,"RESULTS


Periprosthetic BMD showed a decrease in all 7 ROIs for both groups 5 years postoperatively referred to the baseline value, except ROI 3 (0.8%, p=0.761), representing the distal lateral part of the stem, and ROI 5 (0.3%, p=0.688), representing the distal medial part of the stem in the male cohort.","['20 female and 37 male patients underwent', 'male patients']","['total hip arthroplasty using the Fitmore stem', 'implant-specific stress shielding after implantation of a curved bone preserving hip stem (Fitmore) 5 years postoperatively', 'curved bone-preserving hip stem']","['Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Harris Hip Score (HHS', 'ROI 1', 'HHS', 'Periprosthetic BMD', 'WOMAC', 'Periprosthetic bone mineral density (BMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",20.0,0.0574682,"RESULTS


Periprosthetic BMD showed a decrease in all 7 ROIs for both groups 5 years postoperatively referred to the baseline value, except ROI 3 (0.8%, p=0.761), representing the distal lateral part of the stem, and ROI 5 (0.3%, p=0.688), representing the distal medial part of the stem in the male cohort.","[{'ForeName': 'Julian Stefan', 'Initials': 'JS', 'LastName': 'Meyer', 'Affiliation': 'Department of orthopaedic surgery, University of Ulm, Oberer Eselsberg 45, 89081 Ulm, Germany; Department of orthopaedic surgery, Koenig-Ludwig-Haus, University of Wuerzburg, Brettreichstraße 11, 97074 Wuerzburg, Germany. Electronic address: jsmeyer@mail.de.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Freitag', 'Affiliation': 'Department of orthopaedic surgery, University of Ulm, Oberer Eselsberg 45, 89081 Ulm, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Reichel', 'Affiliation': 'Department of orthopaedic surgery, University of Ulm, Oberer Eselsberg 45, 89081 Ulm, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Bieger', 'Affiliation': 'Department of orthopaedic surgery, University of Ulm, Oberer Eselsberg 45, 89081 Ulm, Germany.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.04.023']
646,33142016,"Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial.","OBJECTIVE


In the SENSCIS trial in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo. This study was undertaken to investigate the effects of nintedanib on categorical changes in FVC and other measures of ILD progression.
METHODS


In post hoc analyses, we assessed the proportions of subjects with categorical changes in FVC % predicted at week 52 and the time to absolute decline in FVC of ≥5% predicted or death and absolute decline in FVC of ≥10% predicted or death.
RESULTS


A total of 288 subjects received nintedanib and 288 subjects received placebo. At week 52, in subjects treated with nintedanib and placebo, respectively, 55.7% and 66.3% had any decline in FVC % predicted, 13.6% and 20.1% had a decline in FVC of >5% to ≤10% predicted, and 3.5% and 5.2% had a decline in FVC of >10% to ≤15% predicted; 34.5% and 43.8% had a decrease in FVC of ≥3.3% predicted (proposed minimal clinically important difference [MCID] for worsening of FVC), while 23.0% and 14.9% had an increase in FVC of ≥3.0% predicted (proposed MCID for improvement in FVC). Over 52 weeks, the hazard ratio (HR) for an absolute decline in FVC of ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% confidence interval [95% CI] 0.66-1.06) (P = 0.14), and the HR for an absolute decline in FVC of ≥10% predicted was 0.64 (95% CI 0.43-0.95) (P = 0.029).
CONCLUSION


These results suggest that nintedanib has a clinically relevant benefit on the progression of SSc-ILD.",2020,"Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI: 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI: 0.43, 0.95); P=0.029.
","['subjects with systemic sclerosis-associated ILD (SSc-ILD', 'patients with systemic sclerosis-associated interstitial lung disease', '288 subjects received nintedanib and 288 received']","['nintedanib and placebo', 'placebo', 'nintedanib']","['lung function', 'FVC decline']","[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",288.0,0.283625,"Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI: 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI: 0.43, 0.95); P=0.029.
","[{'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London and NIHR Clinical Research Facility, Royal Brompton Hospital, London, UK, and Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'University of Texas McGovern Medical School, Houston.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Thoraxklinik, University of Heidelberg, and the German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'University of California, David Geffen School of Medicine, Los Angeles.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Aringer', 'Affiliation': 'University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Castellvi', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cutolo', 'Affiliation': 'University of Genova, IRCCS San Martino Polyclinic Hospital, Genova, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stock', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Schoof', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41576']
647,33141616,Metabolomic Effects of Hormone Therapy and Associations With Coronary Heart Disease Among Postmenopausal Women.,"BACKGROUND


In the WHI-HT trials (Women's Health Initiative Hormone Therapy), treatment with oral conjugated equine estrogens and medroxyprogesterone acetate (CEE+MPA) resulted in increased risk of coronary heart disease (CHD), whereas oral conjugated equine estrogens (CEE) did not.
METHODS


Four hundred eighty-one metabolites were measured at baseline and at 1-year in 503 and 431 participants in the WHI CEE and CEE+MPA trials, respectively. The effects of randomized HT on the metabolite profiles at 1-year was evaluated in linear models adjusting for baseline metabolite levels, age, body mass index, race, incident CHD, prevalent hypertension, and diabetes. Metabolites with discordant effects by HT type were evaluated for association with incident CHD in 944 participants (472 CHD cases) in the WHI-OS (Women's Health Initiative Observational Study), with replication in an independent cohort of 980 men and women at high risk for cardiovascular disease.
RESULTS


HT effects on the metabolome were profound; 62% of metabolites significantly changed with randomized CEE and 52% with CEE+MPA (false discovery rate-adjusted  P  value<0.05) in multivariable models. Concerted increases in abundance were seen within various metabolite classes including triacylglycerols, phosphatidylethanolamines, and phosphatidylcholines; decreases in abundance was observed for acylcarnitines, lysophosphatidylcholines, quaternary amines, and cholesteryl/cholesteryl esters. Twelve metabolites had discordant effects by HT type and were associated with incident CHD in the WHI-OS; a metabolite score estimated in a Least Absolute Shrinkage and Selection Operator regression was associated with CHD risk with an odds ratio of 1.47 per SD increase (95% CI, 1.27-1.70,  P <10 -6 ). All twelve metabolites were altered in the CHD protective direction by CEE treatment. One metabolite (lysine) was significantly altered in the direction of increased CHD risk by CEE+MPA; the remaining 11 metabolites were not significantly changed by CEE+MPA. The CHD associations of a subset of 4 metabolites including C58:11 triacylglycerol, C54:9 triacylglycerol, C36:1 phosphatidylcholine and sucrose replicated in an independent dataset of 980 participants in the PREDIMED trial (Prevención con Dieta Mediterránea).
CONCLUSIONS


Randomized treatment with oral HT resulted in large metabolome shifts that generally favored CEE alone over CEE+MPA in term of CHD risk. Discordant metabolite effects between HT regimens may partially mediate the differences in CHD risk between the 2 WHI-HT trials.",2020,"Concerted increases in abundance were seen within various metabolite classes including triacylglycerols (TAG), phosphatidylethanolamines and phosphatidylcholines (PC); decreases in abundance was observed for acylcarnitines, lysophosphatidylcholines, quaternary amines and cholesteryl/cholesteryl esters.","['Postmenopausal Women', '944 participants (472 CHD cases) in the WHI Observational Study (WHI-OS), with replication in an independent cohort of 980 men and women at high risk for cardiovascular disease']","['oral HT', 'randomized HT', 'CEE+MPA', 'Hormone Therapy', 'oral conjugated equine estrogens and medroxyprogesterone acetate (CEE+MPA']","['triacylglycerols (TAG), phosphatidylethanolamines and phosphatidylcholines (PC); decreases in abundance', 'risk of coronary heart disease (CHD', 'CHD risk', 'acylcarnitines, lysophosphatidylcholines, quaternary amines and cholesteryl/cholesteryl esters']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0031618', 'cui_str': 'Phosphatidylethanolamines'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1282512', 'cui_str': 'At risk of coronary heart disease'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0024360', 'cui_str': 'Lysolecithin'}, {'cui': 'C0002508', 'cui_str': 'Amine'}, {'cui': 'C0008387', 'cui_str': 'Cholesterol ester'}]",980.0,0.171214,"Concerted increases in abundance were seen within various metabolite classes including triacylglycerols (TAG), phosphatidylethanolamines and phosphatidylcholines (PC); decreases in abundance was observed for acylcarnitines, lysophosphatidylcholines, quaternary amines and cholesteryl/cholesteryl esters.","[{'ForeName': 'Raji', 'Initials': 'R', 'LastName': 'Balasubramanian', 'Affiliation': 'Department of Biostatistics & Epidemiology, University of Massachusetts-Amherst (R.B., R.S.).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Demler', 'Affiliation': ""Division of Preventive Medicine (O.D., J.P.P., J.E.M.), Brigham and Women's Hospital, Harvard Medical School.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Guasch-Ferré', 'Affiliation': 'Department of Nutrition (M.G.-F., M.A.M.-G., F.B.H.).'}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Division of Preventive Medicine (O.D., J.P.P., J.E.M.), Brigham and Women's Hospital, Harvard Medical School.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Sheehan', 'Affiliation': 'Department of Biostatistics & Epidemiology, University of Massachusetts-Amherst (R.B., R.S.).'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA (S.L., J.E.M., F.B.H.).'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine (O.D., J.P.P., J.E.M.), Brigham and Women's Hospital, Harvard Medical School.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Universitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició Humana, Hospital Universitari San Joan de Reus (J.S.-S.).'}, {'ForeName': 'Miguel Á', 'Initials': 'MÁ', 'LastName': 'Martínez-Gonzalez', 'Affiliation': 'Department of Nutrition (M.G.-F., M.A.M.-G., F.B.H.).'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition (M.G.-F., M.A.M.-G., F.B.H.).'}, {'ForeName': 'Clary', 'Initials': 'C', 'LastName': 'Clish', 'Affiliation': 'Broad Institute of the Massachusetts Institute of Technology & Harvard University, Cambridge, MA (C.C.).'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rexrode', 'Affiliation': ""Division of Women's Health (K.M.R.), Brigham and Women's Hospital, Harvard Medical School.""}]",Circulation. Genomic and precision medicine,['10.1161/CIRCGEN.119.002977']
648,33143436,Letter to the editor concerning the article: Scapular exercise combined with cognitive functional therapy is more effective at reducing chronic neck pain and kinesiophobia than scapular exercise alone: A randomized controlled trial.,,2021,,[],['Scapular exercise combined with cognitive functional therapy'],[],[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.128193,,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Castro', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Centro Universitário Augusto Motta, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Luciana C', 'Initials': 'LC', 'LastName': 'Lunkes', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Centro Universitário Augusto Motta, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Menezes', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Centro Universitário Augusto Motta, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Ney', 'Initials': 'N', 'LastName': 'Meziat-Filho', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Centro Universitário Augusto Motta, Rio de Janeiro, RJ, Brazil.'}]",Clinical rehabilitation,['10.1177/0269215520967940']
649,33144646,Comparison of two tDCS protocols on pain and EEG alpha-2 oscillations in women with fibromyalgia.,"Transcranial Direct Current Stimulation (tDCS) has been used as an alternative treatment for pain reduction in fibromyalgia. In this study, in addition to behavioral measures, we analyzed oscillations in alpha 2 frequency band in the frontal, occipital, and parietal regions, in response to the application of two neuromodulation protocols in fibromyalgia. The study was a randomized, double-blind, placebo-controlled clinical trial with 31 women diagnosed with fibromyalgia. The participants were allocated to three groups with the anodic stimulation applied on the left motor cortex: Group 1, for five consecutive days; Group 2, for 10 consecutive days; and Group 3, sham stimulation for five consecutive days. Statistical analysis showed a reduction in pain intensity after treatment for groups in general [F (1.28) = 8.02; p = 0.008; η 2  = 0.223], in addition to a reduction in alpha 2 in the frontal (p = 0.039; d = 0.384) and parietal (p = 0.021; d = 0.520) regions after the treatment on five consecutive days. We conclude that neuromodulation protocols produced similar effects on pain reduction, but differed with respect to the changes in the alpha 2 frequency band in the frontal and parietal regions.",2020,"Statistical analysis showed a reduction in pain intensity after treatment for groups in general [F (1.28) = 8.02; p = 0.008; η 2  = 0.223], in addition to a reduction in alpha 2 in the frontal (p = 0.039; d = 0.384) and parietal (p = 0.021; d = 0.520) regions after the treatment on five consecutive days.","['women with fibromyalgia', '31 women diagnosed with fibromyalgia']","['tDCS protocols', 'Transcranial Direct Current Stimulation (tDCS', 'placebo', 'anodic stimulation']","['pain reduction', 'pain and EEG alpha-2 oscillations', 'pain intensity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",31.0,0.0633094,"Statistical analysis showed a reduction in pain intensity after treatment for groups in general [F (1.28) = 8.02; p = 0.008; η 2  = 0.223], in addition to a reduction in alpha 2 in the frontal (p = 0.039; d = 0.384) and parietal (p = 0.021; d = 0.520) regions after the treatment on five consecutive days.","[{'ForeName': 'Géssika Araújo', 'Initials': 'GA', 'LastName': 'de Melo', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, 58051-900, Brazil. gessika.fisio@gmail.com.'}, {'ForeName': 'Eliane Araújo', 'Initials': 'EA', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Physiotherapy, Federal University of Paraiba, João Pessoa, 58051-900, Brazil.'}, {'ForeName': 'Suellen Mary Marinho', 'Initials': 'SMM', 'LastName': 'Dos Santos Andrade', 'Affiliation': 'Department of Physiotherapy, Federal University of Paraiba, João Pessoa, 58051-900, Brazil.'}, {'ForeName': 'Bernardino', 'Initials': 'B', 'LastName': 'Fernández-Calvo', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, 58051-900, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Torro', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, 58051-900, Brazil.'}]",Scientific reports,['10.1038/s41598-020-75861-5']
650,33145494,A structured mixed method process evaluation of a randomized controlled trial of Individual Placement and Support (IPS).,"Background


Individual Placement and Support (IPS) is an evidence-based work rehabilitation program helping people with moderate to severe mental illness to obtain ordinary employment. Although IPS has proven superior to other work rehabilitation programs, in many studies, the majority of the participants remain unemployed. Structured process evaluations of IPS that use mixed methods are scarce, although they could identify implementation aspects that may enhance its effect. The aim of the current study is to assess reach, fidelity, and identify barriers and facilitators to implement IPS.
Methods


The process evaluation was conducted alongside a randomized controlled trial including six IPS centers, comparing IPS with treatment as usual in a population of patients in treatment for moderate to severe mental illness. Mixed methods were used in the process evaluation, including focus group interviews with service providers, individual interviews and survey data from participants, and fidelity reviews using the validated IPS Fidelity Scale.
Results


The intervention reached the intended target group. All centers reached fair to good fidelity according to the IPS Fidelity Scale within the project period (range 97-109, SD 8.1) (see Table 5). Certain fidelity items indicated implementation issues related to employer contact, community-based services, and integration with health services. Survey data showed that less than half of the participants regarded their illness as a barrier for participating in IPS and that freedom of disclosure was important. Participant interviews gave further insight into the role of the IPS specialist, emphasizing their availability and consistent job focus.
Conclusions


Indications of implementation challenges across centers during the first year suggest special attention should be given to these aspects in an early phase to ensure higher fidelity from the start and thus enhance the effectiveness of IPS. The IPS specialist played an important role for participants and was described as positive, pushing in a positive way, and encouraging. More knowledge on the characteristics of successful IPS specialists could further enhance the effectiveness of the intervention.
Trial registration


The study was registered on clinicaltrials.gov prior to the inclusion period (reg.no: NCT01964092, registered 17/07/2013).
Supplementary information


Supplementary information  accompanies this paper at 10.1186/s43058-020-00083-9.",2020,"All centers reached fair to good fidelity according to the IPS Fidelity Scale within the project period (range 97-109, SD 8.1) (see Table 5).","['six IPS centers, comparing IPS with treatment as usual in a population of patients in treatment for moderate to severe mental illness']","['IPS', 'Individual Placement and Support (IPS', '\n\n\nIndividual Placement and Support (IPS']",['IPS Fidelity Scale'],"[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}]","[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0647471,"All centers reached fair to good fidelity according to the IPS Fidelity Scale within the project period (range 97-109, SD 8.1) (see Table 5).","[{'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Fyhn', 'Affiliation': 'NORCE Norwegian Research Centre, Postboks 7810, 5020 Bergen, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Ludvigsen', 'Affiliation': 'Department of Pedagogy, Religion and Social Studies, Western Norway University of Applied Sciences, Inndalsveien 28, 5063 Bergen, Norway.'}, {'ForeName': 'Silje E', 'Initials': 'SE', 'LastName': 'Reme', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Frederieke', 'Initials': 'F', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam University Medical Centers, Amsterdam Public Health Research Institute, PO Box 7057, Amsterdam, 1007 MB The Netherlands.'}]",Implementation science communications,['10.1186/s43058-020-00083-9']
651,33152408,A randomised controlled trial of two-unit cantilevered or three-unit fixed-movable resin-bonded fixed partial dentures replacing missing molars.,"OBJECTIVE


To examine the short-term clinical performance and patient-reported outcomes of two-unit cantilevered (CL2) and three-unit fixed-movable (FM3) RBFPDs for replacement of single molar-sized spans.
MATERIALS AND METHODS


Subjects with an 8-10 mm molar-sized edentulous span(s) and 12 pairs of occluding units were randomly assigned to receive either CL2 or FM3 RBFPD (ratio 1:1). The survival (retention of original prosthesis) and success (survival, complication-free) of RBFPDs at one-year were analysed. Patient-reported outcomes were assessed by prosthesis satisfactory questionnaire and Oral Health Impact Profile (OHIP-49). Data in mean, proportion and longevity were analysed by t-test/Mann-Whitney U test/Wilcoxon signed-rank test, chi-square and log-rank tests respectively at significance level α = 0.05.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02239718.
RESULTS


Ninety-eight RBFPDs (42 CL2 and 56 FM3) were delivered in eighty-three patients. Majority (n = 89) of the prostheses were provided by operators who have less than 2 years of clinical experience. Sixty-six patients with seventy-eight RBFPDs (35 CL2 and 43 FM3) were reviewed at one-year. One CL2 and one FM3 RBFPDs debonded, resulting in a success rate at 97.1 % and 97.7 % respectively (P > 0.05). Both RBFPDs were rebonded and the survival rate were 100 % for both designs. No significant difference in satisfactions and summary OHIP-49 scores were observed (P > 0.05).
CONCLUSION


CL2 RBFPDs can be used for replacing molar-sized edentulous spans with minimal observable complications up to one-year. Longer-term data is being collected.
CLINICAL SIGNIFICANCE


This clinical trial demonstrates CL2 RBFPDs have comparable clinical and patient-reported outcomes as the FM3 design. This challenges the current dogma in prosthodontics and expands the clinical use of CL2 design which is more conservative, simpler and easier for patients to maintain.",2020,"The survival (retention of original prosthesis) and success (survival, complication-free) of RBFPDs at one-year were analysed.","['Sixty-six patients with seventy-eight RBFPDs (35 CL2 and 43 FM3', 'Subjects with an 8-10\u2009mm molar-sized edentulous span(s) and 12 pairs of occluding units', 'Majority (n\u2009=\u200989) of the prostheses were provided by operators who have less than 2 years ofclinical experience', 'two-unit cantilevered or three-unit fixed-movable resin-bonded fixed partial dentures replacing missing molars: Molar RBB RCT']","['two-unit cantilevered (CL2) and three-unit fixed-movable (FM3) RBFPDs', 'CL2 or FM3 RBFPD', 'CL2 RBFPDs']","['survival (retention of original prosthesis) and success (survival, complication-free) of RBFPDs', 'success rate', 'satisfactions and summary OHIP-49 scores', 'prosthesis satisfactory questionnaire and Oral Health Impact Profile (OHIP-49', 'survival rate']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0085071', 'cui_str': 'Maryland bridge'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",66.0,0.136544,"The survival (retention of original prosthesis) and success (survival, complication-free) of RBFPDs at one-year were analysed.","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Botelho', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong. Electronic address: botelho@hku.hk.'}, {'ForeName': 'Madeline J Y', 'Initials': 'MJY', 'LastName': 'Yon', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ken C K', 'Initials': 'KCK', 'LastName': 'Mak', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Walter Y H', 'Initials': 'WYH', 'LastName': 'Lam', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103519']
652,33149729,A Randomized Trial Comparing Short versus Prolonged Hemostasis with Rescue Recanalization by Ipsilateral Ulnar Artery Compression: Impact on Radial Artery Occlusion-The RESCUE-RAO Trial.,"Background


Despite the enormous benefits of radial access, this route is associated with a risk of radial artery occlusion (RAO).
Objective


We compared the incidence of RAO in patients undergoing transradial coronary angiography and intervention after short versus prolonged hemostasis protocol. Also we assessed the efficacy of rescue 1-hour ipsilateral ulnar artery compression if RAO was observed after hemostasis.  Material and Methods . Patients referred for elective transradial coronary procedures were eligible. After 6 F radial sheath removal, patients were randomized to short (3 hours) ( n  = 495) or prolonged (8 hours) ( n  = 503) hemostasis and a simple bandage was placed over the puncture site. After hemostasis was completed, oximetry plethysmography was used to assess the patency of the radial artery.
Results


One thousand patients were randomized. Baseline characteristics were similar between both groups with average age 61.4 ± 9.4 years (71% male) and PCI performed on half of the patients. The RAO rate immediately after hemostasis was 3.2% in the short hemostasis group and 10.1% in the prolonged group ( p  < 0.001). Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group ( p  < 0.001).
Conclusion


Shorter hemostasis was associated with significantly less RAO compared to prolonged hemostasis. Rescue radial artery recanalization was effective in > 50%, but only in the short hemostasis group.",2020,"Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group ( p  < 0.001).
","['Patients referred for elective transradial coronary procedures were eligible', 'patients undergoing transradial coronary angiography and intervention after short versus prolonged hemostasis protocol']",['Prolonged Hemostasis with Rescue Recanalization by Ipsilateral Ulnar Artery Compression'],"['RAO rate immediately after hemostasis', 'Rescue recanalization', 'Rescue radial artery recanalization', 'RAO', 'hospital discharge, RAO rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",1000.0,0.560317,"Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group ( p  < 0.001).
","[{'ForeName': 'Dmitrii V', 'Initials': 'DV', 'LastName': 'Ognerubov', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sedaghat', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Sergey I', 'Initials': 'SI', 'LastName': 'Provatorov', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Andrey S', 'Initials': 'AS', 'LastName': 'Tereshchenko', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Olivier F', 'Initials': 'OF', 'LastName': 'Bertrand', 'Affiliation': 'Quebec Heart-Lung Institute, Quebec, Canada.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Bernat', 'Affiliation': 'University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.'}, {'ForeName': 'Goar K', 'Initials': 'GK', 'LastName': 'Arutyunyan', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Olga A', 'Initials': 'OA', 'LastName': 'Pogorelova', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tripoten', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Tatyana V', 'Initials': 'TV', 'LastName': 'Balakhonova', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Anatoliy N', 'Initials': 'AN', 'LastName': 'Samko', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Merkulov', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}]",Journal of interventional cardiology,['10.1155/2020/7928961']
653,33148013,Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial.,"Background The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) demonstrated noninferiority of once-daily 60 mg (30 mg dose-reduced) edoxaban compared with warfarin for prevention of stroke/systemic embolism in patients with atrial fibrillation. No previous analysis has explored the impact of treatment with edoxaban versus warfarin on rates of hospitalizations. Methods Detailed healthcare resource utilization data from ENGAGE AF-TIMI 48 for the 14 024 randomized patients who received at least one dose of study drug were used to compare the rates of bleeding- and cardiovascular-related hospitalizations for edoxaban versus warfarin. Hospitalization rates were calculated for each treatment group, and relative rates were estimated using Poisson regression. The influence of patient characteristics on the impact of edoxaban versus warfarin was evaluated through the inclusion of interaction terms. Results The overall rate of cardiovascular- or bleeding-related hospitalization was significantly lower for edoxaban than warfarin (relative rate [RR], 0.91 [95% CI, 0.85-0.97],  P =0.003). Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97],  P =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88],  P <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99],  P =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68],  P <0.0001) were also lower for edoxaban. Notably, significantly greater reductions with edoxaban versus warfarin were seen for ischemic stroke-related hospitalizations in vitamin K antagonist naive patients and patients with CHADS 2  scores 4 to 6, previous stroke or transient ischemic attack, age ≥75, and no previous coronary artery disease. For nonstroke bleeding-related hospitalizations, greater reductions with edoxaban were seen in vitamin K antagonist naive patients, patients with CHADS 2  scores 4 to 6, and patients with moderate renal dysfunction. Conclusions Edoxaban 60 mg (30 mg dose-reduced) was associated with a significantly lower overall rate of cardiovascular- or bleeding-related hospitalization and significant reductions in the subcategories of cardiovascular-related, stroke-related, bleed-related, and nonstroke cardiovascular-related hospitalizations, when compared with warfarin. These results suggest the potential for cost offsets with edoxaban, with even greater reductions in higher-risk patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781391.",2020,"Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97],  P =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88],  P <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99],  P =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68],  P <0.0001) were also lower for edoxaban.","['patients with atrial fibrillation', 'AF-TIMI 48 for the 14 024 randomized patients who received at least one dose of study drug', 'Patients With Atrial Fibrillation']","['Conclusions Edoxaban', 'edoxaban', 'edoxaban versus warfarin', 'warfarin', 'Edoxaban Versus Warfarin']","['Cardiovascular- and Bleeding-Related Hospitalization Rates', 'ischemic stroke-related hospitalizations', 'Hospitalization rates', 'rates of hospitalizations', 'rates of bleeding- and cardiovascular-related hospitalizations', 'stroke', 'overall rate of cardiovascular- or bleeding-related hospitalization', 'Rates of hospitalizations for cardiovascular reasons']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",14024.0,0.325494,"Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97],  P =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88],  P <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99],  P =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68],  P <0.0001) were also lower for edoxaban.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Vilain', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).""}, {'ForeName': 'Wingham J', 'Initials': 'WJ', 'LastName': 'Kwong', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ (W.J.K.).'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine (D.J.C., E.A.M.).'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': 'University of Missouri-Kansas City School of Medicine (D.J.C., E.A.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006511']
654,33153527,Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression.,"BACKGROUND


Early childhood depression is associated with anhedonia and reduced event-related potential (ERP) responses to rewarding or pleasant stimuli. Whether these neural measures are indicators of target engagement or treatment outcome is not yet known.
METHODS


We measured ERP responses to win and loss feedback in a guessing task and to pleasant versus neutral pictures in young (4.0-6.9 years of age) depressed children before and after randomization to either 18 weeks of Parent-Child Interaction Therapy-Emotion Development (PCIT-ED) or waitlist.
RESULTS


Analyses included reward positivity (RewP) data from 118 children randomly assigned to PCIT-ED (n = 60) or waitlist (n = 58) at baseline and late positive potential (LPP) data from 99 children (44 assigned to PCIT-ED vs. 55 assigned to waitlist) at baseline. Children undergoing PCIT-ED showed a greater reduction in anhedonia (F 1,103  = 10.32, p = .002, partial η 2  = .09). RewP reward responses increased more (F 1,86  = 5.98, p = .02, partial η 2  = .07) for PCIT-ED, but a greater change in RewP was not significantly associated with a greater reduction in major depressive disorder symptoms (r = -.12, p > .4). Baseline RewP did not predict treatment change. LPPs to positive pictures did not change across treatment, but greater baseline LPPs to positive pictures predicted a higher likelihood of remission from major depressive disorder in children undergoing PCIT-ED (B = 0.14; SE = 0.07; odds ratio = 1.15; p = .03).
CONCLUSIONS


The ERP reward response improved in young children with depression during a treatment designed to enhance emotion development, providing evidence of target engagement of the neural systems associated with reward. Further, greater baseline LPP responses to positive pictures was associated with a greater likelihood of depression remission, suggesting that this ERP measure can predict which children are most likely to respond to treatment.",2020,"Children undergoing PCIT-ED showed a greater reduction in anhedonia (F 1,103  = 10.32, p = .002, partial η 2  = .09).","['in young (4.0-6.9 years of age) depressed children before and after randomization to either 18 weeks of', '118 children randomly assigned to', 'Early Childhood Depression']","['Parent-Child Interaction Therapy-Emotion Development (PCIT-ED) or waitlist', 'guessing task and to pleasant versus neutral pictures', 'PCIT-ED']","['ERP reward response', 'major depressive disorder symptoms', 'anhedonia', 'RewP reward responses', 'ERP responses']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]","[{'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}]",118.0,0.323599,"Children undergoing PCIT-ED showed a greater reduction in anhedonia (F 1,103  = 10.32, p = .002, partial η 2  = .09).","[{'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, Missouri; Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri; Department of Radiology, Washington University in St. Louis, St. Louis, Missouri. Electronic address: dbarch@wustl.edu.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Kappenman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hajcak', 'Affiliation': 'Department of Biomedical Science and Psychology, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}]",Biological psychiatry,['10.1016/j.biopsych.2020.06.032']
655,33151727,Does multidimensional forced-choice prevent faking? Comparing the susceptibility of the multidimensional forced-choice format and the rating scale format to faking.,"A common concern with self-reports of personality traits in selection contexts is faking. The multidimensional forced-choice (MFC) format has been proposed as an alternative to rating scales (RS) that could prevent faking. The goal of this study was to compare the susceptibility of the MFC format and the RS format to faking in a simulated high-stakes setting when using normative scoring for both formats. Participants were randomly assigned to 3 groups (total  N  = 1,867) and filled out the Big Five Triplets once under an honest instruction and once under a fake-good instruction. Latent mean differences between the honest and fake-good administrations indicated that the Big Five domains were faked in the expected direction. Faking effects for all traits were larger for RS compared with MFC. Faking effects were also larger for the MFC version with mixed triplets compared with the MFC version with triplets that were fully matched regarding their social desirability. The MFC format does not prevent faking completely, but it reduces faking substantially. Faking can be further reduced in the MFC format by matching the items presented in a block regarding their social desirability. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,Faking effects were also larger for the MFC version with mixed triplets compared with the MFC version with triplets that were fully matched regarding their social desirability.,[],['filled out the Big Five Triplets once under an honest instruction and once under a fake-good instruction'],['Faking effects'],[],"[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0336043,Faking effects were also larger for the MFC version with mixed triplets compared with the MFC version with triplets that were fully matched regarding their social desirability.,"[{'ForeName': 'Eunike', 'Initials': 'E', 'LastName': 'Wetzel', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Frick', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'School of Psychology.'}]",Psychological assessment,['10.1037/pas0000971']
656,33157268,FibroMeter scores for the assessment of liver fibrosis in patients with autoimmune liver diseases.,"INTRODUCTION AND OBJECTIVES


We assessed FibroMeter virus (FMvirus) and FibroMeter vibration-controlled transient elastography (FMVCTE) in 134 patients with autoimmune liver diseases [ALD, autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC)], in order to assess new potential non-invasive biomarkers of liver fibrosis in patients with ALD, as similar data are missing.
PATIENTS AND METHODS


The following groups were included: group 1: n = 78 AIH; group 2: n = 56 PBC. FMvirus and FMVCTE were determined in all 134 patients who underwent liver biopsy and TE the same day with sera collection. In addition, APRI and FIB-4 scores were calculated.
RESULTS


The AUCs for TE and FMVCTE were significantly better (0.809; p < 0.001 and 0.772; p = 0.001, respectively for AIH and 0.997; p < 0.001 and 1; p < 0.001, for PBC) than the other three markers in predicting ≥ F3 fibrosis irrespective of the biochemical activity. FMVCTE and TE had good diagnostic accuracy (75.6% and 73%, respectively) for predicting severe fibrosis in AIH and performed even better in PBC (94.6% and 96.4%, respectively). The cut-offs of TE and FMVCTE had the best sensitivity and specificity in predicting ≥ F3 fibrosis in both AIH and PBC.
CONCLUSIONS


FMVCTE seems to detect severe fibrosis equally to TE in patients with ALD but with better specificity. Biochemical disease activity did not seem to affect their diagnostic accuracy in ALD and therefore, could be helpful for the assessment of fibrosis, especially if they are performed sequentially (first TE with the best sensitivity and then FMVCTE with the best specificity).",2020,"The cut-offs of TE and FMVCTE had the best sensitivity and specificity in predicting ≥ F3 fibrosis in both AIH and PBC.
","['134 patients with autoimmune liver diseases [ALD, autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC', 'patients with autoimmune liver diseases', 'patients with ALD', '134 patients who underwent liver biopsy and TE the same day with sera collection']",['FibroMeter virus (FMvirus) and FibroMeter vibration-controlled transient elastography (FMVCTE'],"['good diagnostic accuracy', 'APRI and FIB-4 scores', 'FibroMeter scores']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400936', 'cui_str': 'Autoimmune liver disease'}, {'cui': 'C0162309', 'cui_str': 'Adrenoleukodystrophy'}, {'cui': 'C0241910', 'cui_str': 'Chronic autoimmune hepatitis'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C3854624', 'cui_str': 'Vibration controlled transient elastography'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",134.0,0.0241128,"The cut-offs of TE and FMVCTE had the best sensitivity and specificity in predicting ≥ F3 fibrosis in both AIH and PBC.
","[{'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Zachou', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Lygoura', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Pinelopi', 'Initials': 'P', 'LastName': 'Arvaniti', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giannoulis', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Nikolaos K', 'Initials': 'NK', 'LastName': 'Gatselis', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Koukoulis', 'Affiliation': 'Department of Pathology, Medical School, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'George N', 'Initials': 'GN', 'LastName': 'Dalekos', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece. Electronic address: georgedalekos@gmail.com.'}]",Annals of hepatology,['10.1016/j.aohep.2020.10.013']
657,33181534,Influence of dapivirine vaginal ring use on cervicovaginal immunity and functional microbiome in adolescent girls.,"OBJECTIVE


The antiretroviral-based dapivirine vaginal ring reduced HIV risk among women in phase III clinical trials. However, limited data exists on the impact of dapivirine on the vaginal microenvironment in adolescents.
DESIGN


A comprehensive metaproteomics approach was used to assess host proteome and microbiome changes in cervicovaginal mucus with dapivirine ring use in adolescents enrolled in the MTN-023/IPM 030 (MTN-023) trial.
METHODS


Participants were randomized 3 : 1 to use dapivirine or placebo vaginal rings monthly for 6 months. Cervicovaginal samples from a subset of 35 participants (8 placebo, 27 dapivirine) were analyzed.
RESULTS


Mass spectrometry analysis identified 405 human and 2467 bacterial proteins belonging to 15 unique genera. The host proteome belonged to many functional pathways primarily related to inflammation. When stratified by study treatment arm, 18 (4.4%) and 28 (6.9%) human proteins were differentially abundant (adjusted P < 0.05) between baseline and follow-up in the placebo and dapivirine arms, respectively. The vaginal microbiome was predominantly composed of Lactobacillus, Gardnerella, and Prevotella. Although bacterial taxa did not differ by arm or change significantly, Lactobacillus crispatus increased (P < 0.001) and Lactobacillus iners decreased (P < 0.001) during the 6-month follow-up. There were no significant differences in bacterial functions by arm or time in the trial. Protected vaginal sex significantly associated with decreased neutrophil inflammatory biomarkers and may be associated with changes in bacterial taxa and metabolism.
CONCLUSION


Condom use may associate with differences to inflammation and bacterial function but dapivirine ring use does not, thereby supporting the mucosal safety profile of this vaginal ring for adolescents.",2021,"While bacterial taxa did not differ by arm or change significantly, L. crispatus increased (P < 0.001) and L. iners decreased (P < 0.001) during the six month follow-up.","['Participants were randomized 3\u200a:\u200a1 to use', 'women in Phase III clinical trials', 'adolescents enrolled in the MTN-023/IPM 030 (MTN-023) trial', 'adolescent girls', 'adolescents']","['antiretroviral-based dapivirine vaginal', 'dapivirine vaginal ring', 'dapivirine or placebo vaginal rings', 'placebo', 'dapivirine']","['HIV risk', 'neutrophil inflammatory biomarkers', 'cervicovaginal immunity and functional microbiome', 'bacterial functions']","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}]","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.155016,"While bacterial taxa did not differ by arm or change significantly, L. crispatus increased (P < 0.001) and L. iners decreased (P < 0.001) during the six month follow-up.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Farr Zuend', 'Affiliation': 'Center for Global health and Diseases, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Noël-Romas', 'Affiliation': 'Center for Global health and Diseases, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hoger', 'Affiliation': 'Departments of Obstetrics and Gynecology and Medical Microbiology, University of Manitoba.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McCorriser', 'Affiliation': 'Mass Spectrometry and Proteomics Core Facility, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Westmacott', 'Affiliation': 'Mass Spectrometry and Proteomics Core Facility, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Marrazzo', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, Alabama.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'University of Pittsburgh School of Medicine.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Dezzutti', 'Affiliation': 'University of Pittsburgh School of Medicine.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Squires', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Bunge', 'Affiliation': 'University of Pittsburgh School of Medicine.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Burgener', 'Affiliation': 'Center for Global health and Diseases, Case Western Reserve University, Cleveland, Ohio, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002751']
658,33165148,Identifying Relative Changes in Social Risk Factors: An Analytic Approach.,"BACKGROUND


Individuals often report concurrent social risk factors such as food insecurity, unstable housing, and transportation barriers. Comparing relative changes between pairs of social risk factors may identify those that are more resistant to change.
OBJECTIVE


The objective of this study was to develop a method to describe relative changes in pairs of social risk factors.
RESEARCH DESIGN


This was a prospective cohort study.
SUBJECTS


Participants in a randomized controlled trial of hypertension care in an Urban Indian Health Organization.
MEASURES


We measured 7 social risk factors (housing, transportation, food, clothing, health care, utilities, and debts) at enrollment, 6, and 12 months among 295 participants in the trial. We hypothesized that pairwise comparisons could identify social risk factors that were less likely to change over time. We used conditional odds ratios (ORs) with 95% confidence intervals (CIs) to rank each pair.
RESULTS


Food, clothing, health care, utilities, and debts had more changes between 0 and 6 months relative to housing (OR=2.3, 3.4, 4.7, 3.5, and 3.4, respectively; all 95% CI excluded 1.0). These same social risk factors also had more changes between baseline and 6 months relative to transportation (OR=2.8, 3.4, 4.9, 4.7, and 4.1, respectively; all 95% CI excluded 1.0). Changes in housing and transportation risk factors were comparable (OR=0.7, 95% CI: 0.4-1.4). Relative changes between 6 and 12 months were similar.
CONCLUSIONS


Housing and transportation exhibited fewer relative changes than other social risk factors and might be more resistant to change. Awareness of the relationships between social risk factors can help define priorities for intervention.",2021,"Changes in housing and transportation risk factors were comparable (OR=0.7, 95% CI: 0.4-1.4).","['295 participants in the trial', 'Participants in a randomized controlled trial of hypertension care in an Urban Indian Health Organization']",[],"['social risk factors', 'Changes in housing and transportation risk factors', 'social risk factors (housing, transportation, food, clothing, health care, utilities, and debts']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]",[],"[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0581901', 'cui_str': 'In debt'}]",295.0,0.0644767,"Changes in housing and transportation risk factors were comparable (OR=0.7, 95% CI: 0.4-1.4).","[{'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Goodrich', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Moore', 'Affiliation': 'Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Spero M', 'Initials': 'SM', 'LastName': 'Manson', 'Affiliation': 'Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Schroeder', 'Affiliation': 'Parkview Health, Fort Wayne, IN.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Steiner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado.'}]",Medical care,['10.1097/MLR.0000000000001441']
659,33166594,Arresting early childhood caries using silver and fluoride products - A randomised trial.,"OBJECTIVE


The aim of this randomised non-inferiority clinical trial was to compare the effectiveness of semi-annual (every six months) applications of 25 % silver nitrate (AgNO 3 ) solution followed by 5 % sodium fluoride (NaF) varnish to semi-annual applications of 38 % silver diamine fluoride (SDF) solution in arresting early childhood caries (ECC).
METHODS


Three-year-old children with active cavitated carious lesions were recruited and randomly assigned to two intervention groups. Children in Group A received semi-annual applications of 25 % AgNO 3  solution followed by 5 % NaF varnish on carious lesions. Children in Group B received semi-annual applications of 38 % SDF solution followed by a placebo varnish. One trained dentist assessed ECC status at baseline and in all follow-up examinations. An independent operator performed the interventions. The dentist, the children, and their caretakers were blinded to the intervention allocation. Data were analysed using a non-inferiority test. Group A's non-inferiority would be accepted if the lower limit of the 95 % confidence interval (CI) for the difference in the mean number of arrested decayed surfaces (ds) was greater than -0.5.
RESULTS


At baseline, 1,070 children were recruited, and 535 children were assigned to each group. After 30 months, the mean arrested ds in Groups A (n = 447) and B (n = 433) were 3.7 ± 3.6 and 3.6 ± 3.7, respectively (p = 0.694). The difference in the mean arrested ds between the two groups was 0.088 (95 % CI: -0.351 to 0.526).
CONCLUSION


Semi-annual application of 25 % AgNO 3  followed by 5 % NaF is at least as effective as the semi-annual application of 38 % SDF in arresting ECC.
CLINICAL SIGNIFICANCE


Silver and fluoride products are effective in arresting caries. As a simple, non-invasive, and inexpensive strategy, it can be used in young children, elderly adults, and people with special needs.",2020,"The difference in the mean arrested ds between the two groups was 0.088 (95% CI: -0.351 to 0.526).
","['young children, elderly adults, and people with special needs', '1,070 children were recruited, and 535 children', 'Three-year-old children with active cavitated carious lesions']","['placebo varnish', 'semi-annual applications of 25% AgNO 3  solution followed by 5% NaF varnish', '25% silver nitrate (AgNO 3 ) solution followed by 5% sodium fluoride (NaF) to semi-annual applications of 38% silver diamine fluoride (SDF) solution']",[],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0037129', 'cui_str': 'Silver Nitrate'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}]",[],1070.0,0.189509,"The difference in the mean arrested ds between the two groups was 0.088 (95% CI: -0.351 to 0.526).
","[{'ForeName': 'Sherry Shiqian', 'Initials': 'SS', 'LastName': 'Gao', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kitty Jieyi', 'Initials': 'KJ', 'LastName': 'Chen', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Duangporn', 'Initials': 'D', 'LastName': 'Duangthip', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'May Chun Mei', 'Initials': 'MCM', 'LastName': 'Wong', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Edward Chin Man', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chun Hung', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China. Electronic address: chchu@hku.hk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103522']
660,33184627,Energy deficit increases hepcidin and exacerbates declines in dietary iron absorption following strenuous physical activity: a randomized-controlled cross-over trial.,"BACKGROUND


Strenuous physical activity promotes inflammation and depletes muscle glycogen, which may increase the iron regulatory hormone hepcidin. Hepcidin reduces dietary iron absorption and may contribute to declines in iron status frequently observed following strenuous physical activity.
OBJECTIVES


To determine the effects of strenuous physical activity on hepcidin and dietary iron absorption and whether energy deficit compared with energy balance modifies those effects.
METHODS


This was a randomized, cross-over, controlled-feeding trial in healthy male subjects (n = 10, mean ± SD age: 22.4 ± 5.4 y, weight: 87.3 ± 10.9 kg) with sufficient iron status (serum ferritin 77.0 ± 36.7 ng/mL). Rest measurements were collected before participants began a 72-h simulated sustained military operation (SUSOPS), designed to elicit high energy expenditure, glycogen depletion, and inflammation, followed by a 7-d recovery period. Two 72-h SUSOPS trials were performed where participants were randomly assigned to consume either energy matched (±10%) to their individual estimated total daily energy expenditure (BAL) or energy at 45% of total daily energy expenditure to induce energy deficit (DEF). On the rest day and at the completion of BAL and DEF, participants consumed a beverage containing 3.8 mg of a stable iron isotope, and plasma isotope appearance was measured over 6 h.
RESULTS


Muscle glycogen declined during DEF and was preserved during BAL (-188 ± 179 mmol/kg, P-adjusted < 0.01). Despite similar increases in interleukin-6, plasma hepcidin increased during DEF but not BAL, such that hepcidin was 108% greater during DEF compared with BAL (7.8 ± 12.2 ng/mL, P-adjusted < 0.0001). Peak plasma isotope appearance at 120 min was 74% lower with DEF (59 ± 38% change from 0 min) and 49% lower with BAL (117 ± 81%) compared with rest (230 ± 97%, P-adjusted < 0.01 for all comparisons).
CONCLUSIONS


Strenuous physical activity decreases dietary iron absorption compared with rest. Energy deficit exacerbates both the hepcidin response to physical activity and declines in dietary iron absorption compared with energy balance. This trial was registered at clinicaltrials.gov as NCT03524690.",2021,"Peak plasma isotope appearance at 120 min was 74% lower with DEF (59 ± 38% change from 0 min) and 49% lower with BAL (117 ± 81%) compared with rest (230 ± 97%, P-adjusted < 0.01 for all comparisons).
","['SD age: 22.4\xa0±\xa05.4 y, weight: 87.3\xa0±\xa010.9 kg) with sufficient iron status (serum ferritin 77.0\xa0±\xa036.7 ng/mL', 'healthy male subjects (n\xa0=\xa010, mean\xa0±', 'strenuous physical activity']","['Hepcidin', 'consume either energy matched (±10%) to their individual estimated total daily energy expenditure (BAL) or energy at 45% of total daily energy expenditure to induce energy deficit (DEF']","['dietary iron absorption', 'plasma isotope appearance', 'interleukin-6, plasma hepcidin', 'Peak plasma isotope appearance']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0439175', 'cui_str': '% of total'}]","[{'cui': 'C0376520', 'cui_str': 'Dietary Iron'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022262', 'cui_str': 'Isotope'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",,0.312364,"Peak plasma isotope appearance at 120 min was 74% lower with DEF (59 ± 38% change from 0 min) and 49% lower with BAL (117 ± 81%) compared with rest (230 ± 97%, P-adjusted < 0.01 for all comparisons).
","[{'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Hennigar', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'McClung', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Hatch-McChesney', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Jillian T', 'Initials': 'JT', 'LastName': 'Allen', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Marques A', 'Initials': 'MA', 'LastName': 'Wilson', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Carrigan', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Murphy', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Hilde K', 'Initials': 'HK', 'LastName': 'Teien', 'Affiliation': 'Norwegian Defense Research Establishment, Kjeller, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Martini', 'Affiliation': 'Norwegian Defense Research Establishment, Kjeller, Norway.'}, {'ForeName': 'Jess A', 'Initials': 'JA', 'LastName': 'Gwin', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Margolis', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Pasiakos', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, Natick, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa289']
661,33169699,Immediate effects of a single session of physical exercise on cognition and cerebral blood flow: A randomized controlled study of older adults.,"BACKGROUND


Regular physical activity is beneficial for cognitive performance in older age. A single bout of aerobic physical exercise can transiently improve cognitive performance. Researchers have advanced improvements in cerebral circulation as a mediator of long-term effects of aerobic physical exercise on cognition, but the immediate effects of exercise on cognition and cerebral perfusion are not well characterized and the effects in older adults are largely unknown.
METHODS


Forty-nine older adults were randomized to a 30-min aerobic exercise at moderate intensity or relaxation. Groups were matched on age and cardiovascular fitness (VO2 max). Average Grey Matter Blood Flow (GMBF), measured by a pulsed arterial-spin labeling (pASL) magnetic resonance imaging (MRI) acquisition, and working memory performance, measured by figurative n-back tasks with increasing loads were assessed before and 7 min after exercising/resting.
RESULTS


Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity. GMBF decreased after exercise, relative to the control (resting) group. In the exercise group, higher n-back performance after exercise was associated with lower GMBF in the right hippocampus, left medial frontal cortex and right orbitofrontal cortex, and higher cardiovascular fitness was associated with lower GMBF.
CONCLUSION


The decrease of GMBF reported in younger adults shortly after exercise also occurs in older adults and relates to cardiovascular fitness, potentially supporting the link between cardiovascular fitness and cerebrovascular reactivity in older age.",2021,"RESULTS


Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity.","['older adults', 'Forty-nine older adults', 'older age']","['aerobic physical exercise', 'physical exercise', '30-min aerobic exercise at moderate intensity or relaxation']","['cognitive performance', 'GMBF', 'Average Grey Matter Blood Flow (GMBF), measured by a pulsed arterial-spin labeling (pASL) magnetic resonance imaging (MRI) acquisition, and working memory performance, measured by figurative n-back tasks with increasing loads', 'higher n-back performance', 'cardiovascular fitness', 'cognition and cerebral blood flow']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231337', 'cui_str': 'Senility'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",49.0,0.0349679,"RESULTS


Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity.","[{'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Olivo', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden. Electronic address: gaia.olivo@ki.se.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; The Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Garzón', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; Department of Psychology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lebedev', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wåhlin', 'Affiliation': 'Department of Radiation Sciences, Umeå University, Umeå, Sweden; Umeå Center for Functional Brain Imaging (UFBI), Umeå University, Umeå, Sweden.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Tarassova', 'Affiliation': 'The Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ekblom', 'Affiliation': 'The Swedish School of Sport and Health Sciences, Stockholm, Sweden; Department of Neuroscience, Karolinska Institute, Stockhom, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lövdén', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; Department of Psychology, University of Gothenburg, Gothenburg, Sweden.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117500']
662,33176460,Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchronization Therapy: The COAPT Trial.,"BACKGROUND


In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT) reduced 2-year rates of HF hospitalization and all-cause mortality compared with GDMT alone. Whether the benefits of the MitraClip extend to patients with previously implanted cardiac resynchronization therapy (CRT) is unknown. We sought to examine the effect of prior CRT in patients enrolled in COAPT.
METHODS


Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only (control arm). Outcomes were assessed according to prior CRT use.
RESULTS


Among 614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively). Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%,  P =0.32). Death or HF hospitalization at 2 years was lower with TMVr versus control treatment in patients with prior CRT (48.6% versus 67.2%, hazard ratio, 0.60 [95% CI, 0.42-0.86]) and without CRT (42.5% versus 66.9%, hazard ratio, 0.52 [95% CI, 0.39-0.69]; adjusted  P interaction =0.23). The effects of TMVr with the MitraClip on reducing the 2-year rates of all-cause death (adjusted  P interaction =0.14) and HF hospitalization (adjusted  P interaction =0.82) were also consistent in patients with and without CRT as were improvements in quality-of-life and exercise capacity.
CONCLUSIONS


In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.",2020,"Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%,  P =0.32).","['patients enrolled in COAPT', 'Patients With and', 'Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the', 'patients with previously', '614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively', 'Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT']","['CRT', 'TMVr', 'implanted cardiac resynchronization therapy (CRT', 'MitraClip Percutaneous Therapy', 'MitraClip', 'MitraClip (TMVr arm) versus GDMT', 'Transcatheter Mitral Valve Repair', 'MitraClip plus guideline-directed medical therapy (GDMT', 'Cardiac Resynchronization Therapy']","['2-year rates of the composite of death or HF hospitalization', '2-year rates of all-cause death', 'Death or HF hospitalization', 'quality-of-life and exercise capacity', 'HF hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",614.0,0.134835,"Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%,  P =0.32).","[{'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt Heart and Vascular Institute, Nashville, TN (J.L.).'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus (W.T.A., K.D.B.).'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Los Robles Regional Medical Center, Thousand Oaks, CA (S.K.).'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, University of Virginia, Charlottesville (D.S.L.).'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Mishell', 'Affiliation': 'Kaiser Permanente-San Francisco Hospital, CA (J.M.M.).'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Whisenant', 'Affiliation': 'Intermountain Heart Center, Salt Lake City, UT (B.K.W.).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Kipperman', 'Affiliation': 'Gagnon Cardiovascular Institute, Morristown Medical Center, NJ (R.M.K.).'}, {'ForeName': 'Konstantinos D', 'Initials': 'KD', 'LastName': 'Boudoulas', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus (W.T.A., K.D.B.).'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}, {'ForeName': 'Bahira', 'Initials': 'B', 'LastName': 'Shahim', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott and White Health, Plano, TX (M.J.M.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.120.007293']
663,33176462,Cause of Death Among Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.,"BACKGROUND


Peripheral artery disease is common and associated with high mortality. There are limited data detailing causes of death among patients with peripheral artery disease.
METHODS


EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) was a randomized clinical trial that assigned patients with peripheral artery disease to clopidogrel or ticagrelor. We describe the causes of death in EUCLID using mortality end points adjudicated through a clinical events classification process. The association between baseline factors and cardiovascular death was evaluated by Cox proportional hazards modeling. The competing risk of noncardiovascular death was assessed by the cumulative incidence function for cardiovascular death and the Fine and Gray method to ascertain the association between baseline characteristics and cardiovascular mortality.
RESULTS


A total of 1263 out of 13 885 (9.1%) patients died (median follow-up: 30 months). There were 706 patients (55.9%) with a cardiovascular cause of death and 522 (41.3%) with a noncardiovascular cause of death. The most common cause of cardiovascular death was sudden cardiac death (20.1%); while myocardial infarction (5.2%) and ischemic stroke (3.2%) were uncommon. The most common causes of noncardiovascular death were malignancies (17.9%) and infections (11.9%). The factor most associated with a higher risk of cardiovascular death was age per 5 year increase (HR, 1.26 [95% CI, 1.20-1.32]). Female sex was associated with a lower risk of cardiovascular death (HR, 0.68 [95% CI, 0.56-0.82]). To evaluate the effect of noncardiovascular death as a competing risk, we superimposed the cumulative incidence function curve with the Kaplan-Meier curve. These curves closely approximated each other. After accounting for the competing risk of noncardiovascular death, the magnitude and direction of the factors associated with cardiovascular death were minimally changed.
CONCLUSIONS


Among patients with symptomatic peripheral artery disease, noncardiovascular causes of death reflected a high proportion (40%) of deaths. Accounting for noncardiovascular deaths as a competing risk, there was not a significant change in the risk estimation for cardiovascular death. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01732822.",2020,"Female sex was associated with a lower risk of cardiovascular death (HR, 0.68","['Patients With Peripheral Artery Disease', 'patients with peripheral artery disease', 'EUCLID', 'Peripheral Artery Disease', '706 patients (55.9%) with a cardiovascular cause of death and 522 (41.3%) with a noncardiovascular cause of death', 'patients with peripheral artery disease to', 'patients with symptomatic peripheral artery disease, noncardiovascular causes of death reflected a high proportion (40%) of deaths']","['Ticagrelor', 'clopidogrel or ticagrelor']","['cardiovascular death was sudden cardiac death', 'noncardiovascular deaths', 'myocardial infarction', 'Cause of Death', 'ischemic stroke', 'noncardiovascular death', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",13885.0,0.242571,"Female sex was associated with a lower risk of cardiovascular death (HR, 0.68","[{'ForeName': 'Ajar', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (A.K.).""}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute (H.M., F.W.R., R.D.L., H.R.A.-K., M.R.P.), Duke University, Durham, NC.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute (H.M., F.W.R., R.D.L., H.R.A.-K., M.R.P.), Duke University, Durham, NC.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Cardiovascular Centre, Inselspital, Bern University Hospital, University of Switzerland (I.B.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Departments of Medicine and Surgery, New York University School of Medicine (J.S.B.).'}, {'ForeName': 'Juuso I', 'Initials': 'JI', 'LastName': 'Blomster', 'Affiliation': 'Heart Centre, Turku University Hospital, Finland (J.I.B.).'}, {'ForeName': 'F Gerry R', 'Initials': 'FGR', 'LastName': 'Fowkes', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, United Kingdom (F.G.R.F.).'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Gaithersburg, MD (B.G.K.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Heart Center, Division of Cardiology, School of Medicine (R.D.L., M.R.P., W.S.J.), Duke University, Durham, NC.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute (H.M., F.W.R., R.D.L., H.R.A.-K., M.R.P.), Duke University, Durham, NC.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Norgren', 'Affiliation': 'Faculty of Medicine and Health, Örebro University, Sweden (L.N.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke Heart Center, Division of Cardiology, School of Medicine (R.D.L., M.R.P., W.S.J.), Duke University, Durham, NC.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke Heart Center, Division of Cardiology, School of Medicine (R.D.L., M.R.P., W.S.J.), Duke University, Durham, NC.'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006550']
664,33181655,"The effect of comprehensive assessment and multi-disciplinary management for the geriatric and frail patient: A multi-center, randomized, parallel controlled trial.","BACKGROUND


A comprehensive geriatric assessment (CGA) of elderly patients is useful for detecting the patients vulnerabilities. Exercise and early rehabilitation, nutritional intervention, traditional Chinese medicine (TCM), standardized medication guidance, and patient education can, separately, improve and even reverse the physical frailty status. However, the effect of combining a CGA and multi-disciplinary management on frailty in elderly patients remains unclear. The present study assessed the effects of a CGA and multi-disciplinary management on elderly patients with frailty in China.
METHODS


In this study, 320 in patients with frailty ≥70 years old will be randomly divided into an intervention group and a control group. The intervention group will be given routine management, a CGA and multi-disciplinary management involving rehabilitation exercise, diet adjustment, multi-drug evaluation, acupoint massage in TCM and patient education for 12 months, and the control group will be followed up with routine management for basic diseases. The primary outcomes are the Fried phenotype and short physical performance battery (SPPB). The secondary outcomes are the clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL), 5-level European quality of life 5 dimensions index (EQ-5D), nutrition risk screening-2002 (NRS-2002), medical insurance expenses, fall events, and all-cause mortality. In addition, a cost-effectiveness study will be carried out.
DISCUSSION


This paper outlines the protocol for a randomized, single-blind, parallel multi-center clinical study. This protocol, if beneficial, will demonstrate the interaction of various intervention strategies, will help improve elderly frailty patients, and will be useful for clinicians, nurses, policymakers, public health authorities, and the general population.
TRIAL REGISTRATION


Chinese Clinical Trials Register, ChiCTR1900022623. Registered on April 19, 2019, http://www.chictr.org.cn/showproj.aspx?proj=38141.",2020,"The secondary outcomes are the clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL),","['geriatric and frail patient', 'elderly patients', '320 in patients with frailty ≥70 years old', 'elderly patients with frailty in China', 'elderly frailty patients']","['routine management, a CGA and multi-disciplinary management involving rehabilitation exercise, diet adjustment, multi-drug evaluation, acupoint massage in TCM and patient education for 12 months, and the control group will be followed up with routine management for basic diseases', 'comprehensive assessment and multi-disciplinary management', 'CGA and multi-disciplinary management', 'Exercise and early rehabilitation, nutritional intervention, traditional Chinese medicine (TCM), standardized medication guidance, and patient education']","['Fried phenotype and short physical performance battery (SPPB', 'clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL', '5-level European quality of life 5 dimensions index (EQ-5D), nutrition risk screening-2002 (NRS-2002), medical insurance expenses, fall events, and all-cause mortality']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",320.0,0.0516481,"The secondary outcomes are the clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL),","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences.'}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Pharmacy.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Rehabilitation.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nutriology.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of TCM, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, PR China.'}, {'ForeName': 'Yuhao', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences.'}, {'ForeName': 'Jiefu', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences.'}]",Medicine,['10.1097/MD.0000000000022873']
665,33181049,Brexanolone in Postpartum Depression:  Post Hoc  Analyses to Help Inform Clinical Decision-Making.,"Background:  Brexanolone (BRX) injection was approved by the United States Food and Drug Administration in 2019 for the treatment of adults with postpartum depression (PPD) based on two Phase 3 clinical trials.  Materials and Methods:  Data from the three trials were combined. PPD-specific 17-item Hamilton Rating Scale for Depression (HAMD-17) group-level minimal important difference (MID) and patient-level meaningful change (meaningful change threshold [MCT]) were estimated and applied to differences in BRX versus placebo (PBO) at hour 60 (primary endpoint) and day 30 (end of trial follow-up). Likelihood of HAMD-17 response and remission and Clinical Global Impression of Improvement (CGI-I) response for BRX versus PBO were assessed at hour 60 and as sustained through day 30 using relative risk. Associated number needed to treat (NNT) and number needed to harm (NNH) values were also estimated.  Results:  Two-hundred nine patients were included. The average HAMD-17 MID estimate was -2.1; the least-squared mean difference between BRX and PBO exceeded this at hour 60 and day 30. Minimal, moderate, and large MCTs were estimated to be -9, -15, and -20 points, respectively. Significantly more BRX-treated than PBO-treated patients achieved minimal, moderate, and large change (all  p s < 0.05) at hour 60 and large meaningful response at day 30 ( p  < 0.05). BRX-treated patients were more likely to sustain HAMD-17 remission and CGI-I response through day 30 versus PBO. NNTs ranged from 4 to 8, with NNH of 97.  Conclusions:  BRX provided meaningful changes relative to PBO, rapid (hour 60), and sustained improvements (day 30) in PPD symptoms, low NNT, and large NNH. These results may help inform treatment decision-making. Clinicaltrials.gov registration numbers: NCT02614547, NCT02942004, and NCT02942017.",2021,BRX-treated patients were more likely to sustain HAMD-17 remission and CGI,"['adults with postpartum depression (PPD) based on two Phase 3 clinical trials', 'Postpartum Depression', 'Results:  Two-hundred nine patients were included']","['Brexanolone (BRX) injection', 'Brexanolone']","['Minimal, moderate, and large MCTs', 'level minimal important difference (MID) and patient-level meaningful change (meaningful change threshold [MCT', 'sustain HAMD-17 remission and CGI', 'average HAMD-17 MID estimate', 'number needed to treat (NNT) and number needed to harm (NNH) values', 'Likelihood of HAMD-17 response and remission and Clinical Global Impression of Improvement (CGI-I) response', 'PPD-specific 17-item Hamilton Rating Scale for Depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4765158', 'cui_str': 'brexanolone Injection'}, {'cui': 'C4548848', 'cui_str': 'brexanolone'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",209.0,0.100019,BRX-treated patients were more likely to sustain HAMD-17 remission and CGI,"[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Gerbasi', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Acaster', 'Affiliation': 'Acaster Lloyd Consulting Ltd., London, United Kingdom.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Fridman', 'Affiliation': 'AMF Consulting, Los Angeles, California, USA.'}, {'ForeName': 'Vijayveer', 'Initials': 'V', 'LastName': 'Bonthapally', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hodgkins', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kanes', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Eldar-Lissai', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, Massachusetts, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2020.8483']
666,33169240,Efficacy of Citicoline as a Neuroprotector in children with post cardiac arrest: a randomized controlled clinical trial.,"Brain hypoxia after cardiac arrest leads to damage of the neuronal cell membrane. Citicoline is necessary for the synthesis of cell membrane. We planned to assess the neuroprotective effect of citicoline in children after cardiac arrest. This randomized controlled trial was carried out at pediatric intensive care units (PICU) and surgical ICU at Tanta university hospital on 80 consecutive children surviving in-hospital cardiac arrest who were subdivided into two groups. Group I (citicoline group) included 40 children with post-cardiac arrest who received citicoline 10 mg /kg /12 h IV for 6 weeks plus other supportive measures and group II (control group) included 40 children with post-cardiac arrest who were managed with only supportive measures. All patients were evaluated for Glasgow coma score (GCS), modified Rankin scale (mRS) for children, seizures frequency, type and duration, and serum neuron-specific enolase (NSE) before and 3 months after the treatment. GCS and mRS significantly improved in citicholine group compared to the control group. Seizure frequency and duration, mortality, PICU and hospital stay significantly decreased in citicholine group compared to the control group. Serum NSE levels significantly decreased in citicholine group only. No side effects were recorded.Conclusion: Citicoline is a promising neuroprotective drug in children with post-cardiac arrest.Trial Registration: The study was registered at Pan African Clinical Trials Registry (PACTR) www.pactr.samrc.ac.za with trial number PACTR201907742119058. What is known? • Post-resuscitation brain injury is one of the major complications that can lead to death or disability. • CDP-choline has been studied for acute ischemic stroke in several adult studies because of its reparative effect. What is new? • Our study was the first in pediatrics that assessed the neuroprotective effect of CDP-choline on the brain in children after cardiac arrest. • We found that Citicoline is a promising neuroprotective drug in children with post-cardiac arrest.",2021,"Seizure frequency and duration, mortality, PICU and hospital stay significantly decreased in citicholine group compared to the control group.","['12', '40 children with post-cardiac arrest who received', 'children with post cardiac arrest', 'children after cardiac arrest', 'pediatric intensive care units (PICU) and surgical ICU at Tanta university hospital on 80 consecutive children surviving in-hospital cardiac arrest who were subdivided into two groups', '40 children with post-cardiac arrest who were managed with only supportive measures', 'children with post-cardiac arrest']","['citicholine', 'Citicoline', 'CDP-choline', 'citicoline']","['GCS and mRS', 'Serum NSE levels', 'side effects', 'Seizure frequency and duration, mortality, PICU and hospital stay', 'Glasgow coma score (GCS), modified Rankin scale (mRS) for children, seizures frequency, type and duration, and serum neuron-specific enolase (NSE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0010725', 'cui_str': 'Citicoline'}]","[{'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",40.0,0.0605571,"Seizure frequency and duration, mortality, PICU and hospital stay significantly decreased in citicholine group compared to the control group.","[{'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Salamah', 'Affiliation': 'Pediatric Department, Kafr Elsheikh University, Kafr Elsheikh, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mehrez', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Faheem', 'Affiliation': 'Anesthesiology and Surgical ICU Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'El Amrousy', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt. doaamoha@yahoo.com.'}]",European journal of pediatrics,['10.1007/s00431-020-03871-6']
667,33186492,Polypill with or without Aspirin in Persons without Cardiovascular Disease.,"BACKGROUND


A polypill comprising statins, multiple blood-pressure-lowering drugs, and aspirin has been proposed to reduce the risk of cardiovascular disease.
METHODS


Using a 2-by-2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the outcomes for the polypill alone as compared with matching placebo, for aspirin alone as compared with matching placebo, and for the polypill plus aspirin as compared with double placebo. For the polypill-alone and polypill-plus-aspirin comparisons, the primary outcome was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization. For the aspirin comparison, the primary outcome was death from cardiovascular causes, myocardial infarction, or stroke. Safety was also assessed.
RESULTS


A total of 5713 participants underwent randomization, and the mean follow-up was 4.6 years. The low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo. The primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.63 to 1.00). The primary outcome for the aspirin comparison occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.67 to 1.10). The primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and in 83 (5.8%) in the double-placebo group (hazard ratio, 0.69; 95% CI, 0.50 to 0.97). The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups.
CONCLUSIONS


Combined treatment with a polypill plus aspirin led to a lower incidence of cardiovascular events than did placebo among participants without cardiovascular disease who were at intermediate cardiovascular risk. (Funded by the Wellcome Trust and others; TIPS-3 ClinicalTrials.gov number, NCT01646437.).",2021,"The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups.
","['Persons without Cardiovascular Disease', '5713 participants underwent randomization, and the mean follow-up was 4.6 years', 'participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a', 'participants without cardiovascular disease who were at intermediate cardiovascular risk']","['polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin', 'Polypill with or without Aspirin', 'placebo', 'aspirin', 'placebo daily, and vitamin D or placebo']","['Safety', 'low-density lipoprotein cholesterol level', 'hypotension or dizziness', 'systolic blood pressure', 'death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization', 'cardiovascular events', 'polypill-plus-aspirin comparison', 'death from cardiovascular causes, myocardial infarction, or stroke']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]",5713.0,0.785055,"The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups.
","[{'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Joseph', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dans', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Koon', 'Initials': 'K', 'LastName': 'Teo', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'López-Jaramillo', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Yusoff', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Santoso', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Gamra', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Talukder', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Christou', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Girish', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Yeates', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Freeda', 'Initials': 'F', 'LastName': 'Xavier', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dagenais', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Rocha', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McCready', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tyrwhitt', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': ""From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2028220']
668,33191061,"Comparison of Effectiveness of Density and Number of Sessions of Extracorporeal Shock Wave Therapy in Plantar Fasciitis Patients: A Double-Blind, Randomized-Controlled Study.","This study aimed to investigate the effect of density and number of sessions extracorporeal shock wave therapy (ESWT) on pain, fatigue, disability, physical function, and quality of life in patients with plantar fasciitis (PF). Between September 2019 and December 2019, a total of 94 patients with the diagnosis of PF were included in the study. All patients were randomly divided into 3 groups. Group 1 (n = 33) received a total of 7 sessions of high-energy flux density (H-ESWT) (0.26 mJ/mm 2  ) , group 2 (n = 31) received a total of 3 sessions of H-ESWT (0.26 mJ/mm 2 ), group 3 (n = 30) received total of 7 sessions of low-energy flux density (<0.08 mJ/mm 2 ) with 3 days interval. At baseline and 1 month after the treatment, the Visual Analog Scale (VAS), Short Form-36, Foot Function Index (FFI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale, and Six-Minute Walking Test (6MWT) scores were compared among the groups. Of the patients, 69 were females and 25 were males with a mean age of 45.0 ± 8.43 (range, 25-67) years. There were no statistically significant differences in the age, sex, demographic characteristics, and baseline VAS, FFI, 6MWT, and FACIT scores between the groups (p > .05). However, there was a statistically significant decrease in the VAS, FACIT, and FFI scores in all groups after treatment compared to baseline, although only the 6MWT, and Short Form-36 subscale scores were statistically significantly higher (p < .05). There was also a statistically significant difference in the scale scores in Group 1 versus Group 2 and in Group 2 versus Group 3. Our study results suggest that H-ESWT for high number of sessions is more effective than LESWT for low number of sessions on pain, quality of life, physical function, fatigue, and disability in patients with PF.",2021,"However, there was a statistically significant decrease in the VAS, FACIT, and FFI scores in all groups after treatment compared to baseline, although only the 6MWT, and Short Form-36 subscale scores were statistically significantly higher (p < .05).","['patients with PF', 'Plantar Fasciitis Patients', 'Of the patients, 69 were females and 25 were males with a mean age of 45.0 ± 8.43 (range, 25-67) years', 'Between September 2019 and December 2019, a total of 94 patients with the diagnosis of PF were included in the study', 'patients with plantar fasciitis (PF']","['Density and Number of Sessions of Extracorporeal Shock Wave Therapy', 'H-ESWT', 'sessions extracorporeal shock wave therapy (ESWT', 'LESWT']","['pain, fatigue, disability, physical function, and quality of life', '6MWT, and Short Form-36 subscale scores', 'pain, quality of life, physical function, fatigue, and disability', '6MWT) scores', 'VAS, FACIT, and FFI scores', 'age, sex, demographic characteristics, and baseline VAS, FFI, 6MWT, and FACIT scores', 'Visual Analog Scale (VAS), Short Form-36, Foot Function Index (FFI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale, and Six-Minute Walking Test', 'scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0206042', 'cui_str': 'Fatal familial insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",94.0,0.0389034,"However, there was a statistically significant decrease in the VAS, FACIT, and FFI scores in all groups after treatment compared to baseline, although only the 6MWT, and Short Form-36 subscale scores were statistically significantly higher (p < .05).","[{'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Gezginaslan', 'Affiliation': 'Medical Doctor, Physical Therapy and Rehabilitation Clinic, University of Health Sciences, Umraniye Training and Research Hospital, Istanbul, Turkey. Electronic address: omergezginaslan@hotmail.com.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Başar', 'Affiliation': 'Medical Doctor, Physical Therapy and Rehabilitation Clinic, University of Health Sciences, Umraniye Training and Research Hospital, Istanbul, Turkey.'}]",The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons,['10.1053/j.jfas.2020.08.001']
669,33187890,Onabotulinum toxin-A versus extended release tolterodine in the management of idiopathic overactive bladder in children: A pilot randomised controlled trial (OVERT trial).,"BACKGROUND


Idiopathic Overactive Bladder is the most common cause of urinary incontinence in children. Anticholinergic medications are successful in only 20% of those with daily wetting so there is a real need to find a more effective treatment for this condition. Onabotulinum toxin A injections are often used as a treatment but there have been no randomised controlled trials investigating effectiveness in children.
OBJECTIVE


To provide information that would inform the design and conduct of a definitive trial comparing onabotulinum toxin A with extended-release tolterodine for the management of therapy resistant idiopathic overactive bladder in children. Specific objectives were to assess rates of eligibility, recruitment, acceptability of randomisation, loss to follow-up, acceptability of urodynamic assessment and obtain primary outcome data for sample size estimation.
STUDY DESIGN


Single-centre, parallel, two-arm, open-label pilot randomised controlled trial. Eligible patients (aged 7-16 years) were recruited at Royal Manchester Children's Hospital and randomised (1:1) using a web-based system.
TRIAL REGISTRATION


EudraCT 2014-001068-36; Funding: UK NIHR Research for Patient Benefit Programme.
RESULTS


98 patients were assessed for eligibility, 85 (87%) were eligible for screening, parents of 62 (73%) provided consent, 46 (74%) remained eligible and were randomised (onabotulinum = 22, tolterodine = 24). All participants commenced allocated treatment. Two patients withdrew from follow-up. All participants underwent urodynamic assessment at baseline and 35 (76%) additionally at week 6. The mean (standard deviation) number of wetting episodes per day at week 6 was 1.4 (1.7) in the onabotulinum group and 1.6 (1.0) in the tolterodine group. There was one serious adverse event (probably related to the drug) and 22 non-serious adverse events reported by 8 participants in the onabotulinum group (36%). There were 23 non-serious adverse events reported by 9 participants in the tolterodine group (38%).
DISCUSSION


Recruitment was challenging but eligibility and consent rates were high as were retention rates. Treatment compliance in the botox group was high but it was difficult to measure in the tolterodine group. Treatment switching was also an issue.
CONCLUSIONS


Recruitment to a definitive trial was demonstrated to be feasible if a large number of centres are involved, though further consideration is required regarding trial design.",2021,"There were 23 non-serious adverse events reported by 9 participants in the tolterodine group (38%).
","['children', 'idiopathic overactive bladder in children', '98 patients were assessed for eligibility, 85 (87%) were eligible for screening, parents of 62 (73%) provided consent, 46 (74%) remained eligible and were randomised ', ""Eligible patients (aged 7-16 years) were recruited at Royal Manchester Children's Hospital and randomised (1:1) using a web-based system""]","['Onabotulinum toxin-A versus extended release tolterodine', 'Anticholinergic medications', 'Onabotulinum toxin A injections', 'tolterodine', 'onabotulinum toxin A with extended-release tolterodine', 'EudraCT']","['23 non-serious adverse events', 'serious adverse event', 'rates of eligibility, recruitment, acceptability of randomisation, loss to follow-up, acceptability of urodynamic assessment', 'mean (standard deviation) number of wetting episodes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C4743433', 'cui_str': 'onabotulinum toxin A'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0162598', 'cui_str': 'Wetability'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",98.0,0.269736,"There were 23 non-serious adverse events reported by 9 participants in the tolterodine group (38%).
","[{'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sutton', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, UK; Clinical Trials Research Unit, ScHARR, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Melling', 'Affiliation': ""Royal Manchester Children's Hospital, UK.""}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': ""Royal Manchester Children's Hospital, UK.""}, {'ForeName': 'Nicholas J A', 'Initials': 'NJA', 'LastName': 'Webb', 'Affiliation': ""Royal Manchester Children's Hospital, UK.""}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Goyal', 'Affiliation': ""Royal Manchester Children's Hospital, UK. Electronic address: Anju.Goyal@mft.nhs.uk.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.10.012']
670,33176437,Effects of Omecamtiv Mecarbil on Symptoms and Health-Related Quality of Life in Patients With Chronic Heart Failure: Results From the COSMIC-HF Study.,"BACKGROUND


Chronic heart failure with reduced ejection fraction impairs health-related quality of life (HRQL). Omecamtiv mecarbil (OM)-a novel activator of cardiac myosin-improves left ventricular systolic function and remodeling and reduces natriuretic peptides. We sought to evaluate the effect of OM on symptoms and HRQL in patients with chronic heart failure with reduced ejection fraction and elevated natriuretic peptides enrolled in the COSMIC-HF trial (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure).
METHODS


Patients (n=448) were randomized 1:1:1 to placebo, 25 mg of OM BID, or to pharmacokinetically guided dose titration (OM-PK) for 20 weeks. The Kansas City Cardiomyopathy Questionnaire was administered to assess HRQL at baseline, 16 weeks, and 20 weeks. The primary scores of interest were the Total Symptom Score, Physical Limitation Scale, and Clinical Summary Score.
RESULTS


Mean change in score from baseline to 20 weeks for the Total Symptom Score was 5.0 (95% CI, 1.8-8.1) for placebo, 6.6 (95% CI, 3.4-9.8) for OM 25 mg ( P =0.32 versus placebo), and 9.9 (95% CI, 6.7-13.0) for OM-PK ( P =0.03 versus placebo); for the Physical Limitation Scale, it was 3.1 for placebo (95% CI, -0.3 to 6.6), 6.0 (95% CI, 3.1-8.9) for OM 25 mg ( P =0.12), and 4.3 (95% CI, 0.7-7.9) for OM-PK ( P =0.42); for the Clinical Summary Score, it was 4.1 (95% CI, 1.4-6.9) for placebo, 6.3 (95% CI, 3.6-9.0) for OM 25 mg ( P =0.19), and 7.0 (95% CI, 4.1-10.0) for OM-PK ( P =0.14). Differences between OM and placebo were greater in patients who were more symptomatic at baseline.
CONCLUSIONS


HRQL as measured by the Total Symptom Score improved in patients with heart failure with reduced ejection fraction assigned to the OM-PK group relative to placebo. Ongoing trials are prospectively testing whether OM improves symptoms and HRQL in heart failure with reduced ejection fraction. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01786512.",2020,Conclusions : HRQL as measured by the TSS improved in patients with HFrEF assigned to omecamtiv mecarbil (OM-PK group) relative to placebo.,"['Patients with Chronic Heart Failure', 'Methods : Patients (n = 448', 'patients with chronic HFrEF and elevated natriuretic peptides enrolled in the COSMIC-HF trial']","['omecamtiv mecarbil', 'Omecamtiv Mecarbil', ' : Chronic HF with reduced ejection fraction (HFrEF', 'placebo', 'placebo, 25 mg of omecamtiv mecarbil twice daily (OM 25 mg), or to pharmacokinetically-guided dose titration (OM-PK']","['Total Symptom Score (TSS), Physical Limitation Scale (PLS), and Clinical Summary Score (CSS', 'Symptoms and Health-Related Quality of Life', 'Mean change in score', 'left ventricular systolic function and remodeling and reduces natriuretic peptides', 'Kansas City Cardiomyopathy Questionnaire (KCCQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0056409', 'cui_str': 'Cosmic composite resin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2932035', 'cui_str': 'omecamtiv mecarbil'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",448.0,0.610413,Conclusions : HRQL as measured by the TSS improved in patients with HFrEF assigned to omecamtiv mecarbil (OM-PK group) relative to placebo.,"[{'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute and Duke University School of Medicine, Durham, NC (G.M.F.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (S.D.S.).""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.).'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow Royal Infirmary, United Kingdom (J.G.F.C.).'}, {'ForeName': 'Siddique A', 'Initials': 'SA', 'LastName': 'Abbasi', 'Affiliation': 'Amgen, Inc, Thousand Oaks, CA (S.A.A., H.Z., G.G.).'}, {'ForeName': 'Fady I', 'Initials': 'FI', 'LastName': 'Malik', 'Affiliation': 'Cytokinetics, Inc, San Francisco, CA (F.I.M.).'}, {'ForeName': 'Hanze', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Amgen, Inc, Thousand Oaks, CA (S.A.A., H.Z., G.G.).'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Globe', 'Affiliation': 'Amgen, Inc, Thousand Oaks, CA (S.A.A., H.Z., G.G.).'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco (J.R.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.120.007814']
671,33184024,"A Randomized, Noninferiority Trial Comparing ICS + LABA with ICS + LABA + LAMA in Asthma-COPD Overlap (ACO) Treatment: The ACO Treatment with Optimal Medications (ATOMIC) Study.","BACKGROUND


Current guidelines for the treatment of asthma and chronic obstructive pulmonary disease overlap (ACO) recommend initial treatment using inhaled corticosteroids (ICSs) plus 1 or more bronchodilators.
OBJECTIVE


To clarify which therapeutic effect is better between the ICS + long-acting β 2  agonist (LABA) and ICS + LABA + long-acting muscarinic antagonist (LAMA) treatment in patients with ACO.
METHODS


We conducted a multicenter, 48-week, randomized, noninferiority trial. Patients with ACO were enrolled if they were treated with a moderate to high dose of ICS + LABA. In total, 303 patients were involved in the present trial, with 149 receiving ICS + LABA + LAMA. The primary end point was the time to first exacerbation. Secondary outcomes included changes in FEV 1 , forced vital capacity, FEV 1 /forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide.
RESULTS


In the ICS + LABA treatment group, 29 of 154 patients (18.83%) experienced exacerbation, whereas 28 of 149 patients (18.79%) experienced exacerbation in the ICS + LABA + LAMA treatment group. The results of this noninferiority study were ultimately inconclusive (hazard ratio, 1.1; 95% CI, 0.66-1.84). However, the patients treated with the addition of LAMA showed significant improvements in FEV 1  and forced vital capacity (P < .001). Asthma control did not improve in either group.
CONCLUSIONS


Although this study was unable to conclude that ICS + LABA treatment is not inferior to ICS + LABA + LAMA in terms of exacerbation, it is obvious that the ICS + LABA + LAMA treatment group had improved lung function in ACO.",2021,"Secondary outcomes included changes in FEV 1 , forced vital capacity, FEV 1 /forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide.
","['asthma and chronic obstructive pulmonary disease overlap (ACO', 'patients with ACO', '303 patients were involved in the present trial, with 149 receiving ICS\xa0+ LABA\xa0+ LAMA', 'Asthma-COPD Overlap (ACO', 'Patients with ACO']","['inhaled corticosteroids (ICSs', 'ICS\xa0+ LABA', 'LAMA', 'ICS\xa0+ LABA with ICS\xa0+ LABA\xa0+ LAMA']","['FEV 1  and forced vital capacity', 'changes in FEV 1 , forced vital capacity, FEV 1 /forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide', 'time to first exacerbation', 'lung function']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0999593', 'cui_str': 'Lama'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0999593', 'cui_str': 'Lama'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",303.0,0.155535,"Secondary outcomes included changes in FEV 1 , forced vital capacity, FEV 1 /forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide.
","[{'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea. Electronic address: tbkim@amc.seoul.kr.'}, {'ForeName': 'Solmi', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Division of Allergy and Clinical Immunology, Armed Forces Capital Hospital, Seongnam, Korea.'}, {'ForeName': 'Sae-Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Division of Allergy and Clinical Immunology, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Taehoon', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Chungnam National University Hospital, Chungnam University School of Medicine, Daejeon, Korea.'}, {'ForeName': 'Min-Hye', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji-Yong', 'Initials': 'JY', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Min-Suk', 'Initials': 'MS', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Jae-Woo', 'Initials': 'JW', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.'}, {'ForeName': 'Jeong-Hee', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Department of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea; Allergy and Clinical Immunology Research Center, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Chan Sun', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea.'}, {'ForeName': 'Sujeong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Jaechun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea.'}, {'ForeName': 'Jae-Woo', 'Initials': 'JW', 'LastName': 'Kwon', 'Affiliation': 'Department of Allergy and Clinical Immunology, Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Gyu Young', 'Initials': 'GY', 'LastName': 'Hur', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Ha', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Hee-Kyoo', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Yoo Seob', 'Initials': 'YS', 'LastName': 'Shin', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Sang-Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Eulji University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hee', 'Initials': 'YH', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'An-Soo', 'Initials': 'AS', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University School of Medicine, Bucheon, Korea.'}, {'ForeName': 'Seo Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae-Bum', 'Initials': 'TB', 'LastName': 'Kim', 'Affiliation': 'Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.09.066']
672,33191252,Embryo incubation by time-lapse systems versus conventional incubators in Chinese women with diminished ovarian reserve undergoing IVF/ICSI: a study protocol for a randomised controlled trial.,"INTRODUCTION


The time-lapse imaging system (TLS) is a newly developed non-invasive embryo assessment system. Compared with conventional incubators, a TLS provides stable culture conditions and consistent observations of embryo development, thereby potentially improving embryo quality and selection of the best quality embryo. Although TLSs have been routinely used in many in vitro fertilisation (IVF) centres globally, there is insufficient evidence to indicate that TLSs result in higher cumulative live birth rates over conventional incubators. The purpose of this study is to compare the cumulative live birth rates and safety including miscarriage in infertile patients with diminished ovarian reserve (DOR) from both TLSs and conventional incubators.
METHODS AND ANALYSIS


This study is a double-blind randomised controlled clinical trial (1:1 treatment ratio of TLSs vs conventional incubator). A total of 730 patients with DOR undergoing the first or second cycle of IVF or intracytoplasmic sperm injection (ICSI) will be enrolled and randomised into two parallel groups. Participants will undergo embryo culture in the TLSs (group A) or the conventional incubators (group B), respectively. Embryos are selected for transfer in both groups by the morphological characteristics. The embryo selection algorithm software is not used in the TLSs. The primary outcome is the cumulative live birth rate of the trial IVF/ICSI cycle within 12 months after randomisation. This study is powered to detect an absolute difference of 10% (35% vs 25%) at the significance level of 0.05% and 80% statistical power based on a two-sided test.
ETHICS AND DISSEMINATION


This trial has been approved by the Institutional Ethical Committee of Shanghai First Maternity and Infant Hospital (KS1958). All participants in the trial will provide written informed consent. The study will be conducted according to the principles outlined in the Declaration of Helsinki and its amendments. Results of this study will be disseminated in peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR1900027746).",2020,The primary outcome is the cumulative live birth rate of the trial IVF/ICSI cycle within 12 months after randomisation.,"['Chinese women with diminished ovarian reserve undergoing', 'infertile patients with diminished ovarian reserve (DOR) from both TLSs and conventional incubators', '730 patients with DOR undergoing the first or second cycle of IVF or intracytoplasmic sperm injection (ICSI']","['IVF/ICSI', 'Embryo incubation by time-lapse systems versus conventional incubators', 'TLSs vs conventional incubator', 'conventional incubators']","['cumulative live birth rate of the trial IVF/ICSI cycle', 'cumulative live birth rates and safety including miscarriage', 'time-lapse imaging system (TLS']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1452561', 'cui_str': 'Democratic Republic of Timor-Leste'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C1452561', 'cui_str': 'Democratic Republic of Timor-Leste'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C2936618', 'cui_str': 'Time-Lapsed Imaging'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",730.0,0.448096,The primary outcome is the cumulative live birth rate of the trial IVF/ICSI cycle within 12 months after randomisation.,"[{'ForeName': 'Miaoxin', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash Medical Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Ai', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuanling', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kunming', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yonglun', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhiqin', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wenqiang', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash Medical Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Teng', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China tengxiaoming@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-038657']
673,33191251,Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65): protocol and statistical analysis plan for a randomised clinical trial.,"INTRODUCTION


Vasodilatory hypotension is common among intensive care unit (ICU) patients; vasopressors are considered standard of care. However, optimal mean arterial pressure (MAP) targets for vasopressor titration are unknown. The objective of the Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65) trial is to ascertain the effect of permissive hypotension (vasopressor titration to achieve MAP 60-65 mm Hg) versus usual care on biomarkers of organ injury in hypotensive patients aged ≥65 years.
METHODS AND ANALYSIS


OVATION-65 is an allocation-concealed randomised trial in 7 Canadian hospitals. Eligible patients are ≥65 years of age, in an ICU with vasodilatory hypotension, receiving vasopressors for ≤12 hours to maintain MAP ≥65 mm Hg during or after adequate fluid resuscitation, and expected to receive vasopressors for ≥6 additional hours. Patients are excluded for any of the following: active treatment for spinal cord or acute brain injury; vasopressors given solely for bleeding, ventricular failure or postcardiopulmonary bypass vasoplegia; withdrawal of life-sustaining treatments expected within 48 hours; death perceived as imminent; previous enrolment in OVATION-65; organ transplant within the last year; receiving extracorporeal life support or lack of physician equipoise. Patients are randomised to permissive hypotension versus usual care for up to 28 days. The primary outcome is high-sensitivity troponin T, a biomarker of cardiac injury, on day 3. Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months). Assessors of biomarkers, mortality and cognitive function are blinded to allocation.
ETHICS AND DISSEMINATION


This protocol has been approved at all sites. Consent is obtained from the eligible patient, the substitute decision-maker if the patient is incapable, or in a deferred fashion where permitted. End-of-grant dissemination plans include presentations, publications and social media platforms and discussion forums.
TRIAL REGISTRATION NUMBER


NCT03431181.",2020,"Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months).","['Patients are excluded for any of the following: active treatment for spinal cord or acute brain injury; vasopressors given solely for bleeding, ventricular failure or postcardiopulmonary bypass vasoplegia; withdrawal of life-sustaining treatments expected within 48 hours; death perceived as imminent; previous enrolment in OVATION-65; organ transplant within the last year; receiving extracorporeal life support or lack of physician equipoise', 'patients 65 years and older (OVATION-65) trial', '7 Canadian hospitals', 'Eligible patients are ≥65 years of age, in an ICU with vasodilatory hypotension, receiving vasopressors for ≤12\u2009hours to maintain MAP ≥65\u2009mm Hg during or after adequate fluid resuscitation, and expected to receive vasopressors for ≥6 additional hours', 'hypotensive patients aged ≥65 years', 'patients 65 years and older']","['permissive hypotension (vasopressor titration to achieve MAP 60-65 mm Hg) versus usual care', 'permissive hypotension versus usual care']","['high-sensitivity troponin T, a biomarker of cardiac injury, on day 3', 'biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function', 'mean arterial pressure (MAP) targets']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0085742', 'cui_str': 'Acute Brain Injuries'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0849925', 'cui_str': 'Ventricular failure'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C2717957', 'cui_str': 'Vasoplegia'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",7.0,0.292856,"Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months).","[{'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Masse', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Battista', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Mary Elizabeth', 'Initials': 'ME', 'LastName': 'Wilcox', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marinoff', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Frédérick', 'Initials': 'F', 'LastName': ""D'Aragon"", 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'St-Arnaud', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mayette', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Leclair', 'Affiliation': 'Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Quiroz Martinez', 'Affiliation': 'Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Grondin-Beaudoin', 'Affiliation': 'Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Élaine', 'Initials': 'É', 'LastName': 'Carbonneau', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Andrew J E', 'Initials': 'AJE', 'LastName': 'Seely', 'Affiliation': 'Departments of Surgery and Critical Care Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Watpool', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Porteous', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Chassé', 'Affiliation': 'Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Lebrasseur', 'Affiliation': ""Centre de recherche, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lauzier', 'Affiliation': 'Population Health and Optimal Health Practices Research Unit, Centre de recherche du CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'Population Health and Optimal Health Practices Research Unit, Centre de recherche du CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bellemare', 'Affiliation': 'Population Health and Optimal Health Practices Research Unit, Centre de recherche du CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Charbonney', 'Affiliation': 'Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Émilie', 'Initials': 'É', 'LastName': 'Belley-Côté', 'Affiliation': 'Department of Medicine, Division of Cardiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Édouard', 'Initials': 'É', 'LastName': 'Botton', 'Affiliation': 'Patient partners, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Patient partners, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Neill K J', 'Initials': 'NKJ', 'LastName': 'Adhikari', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada neill.adhikari@utoronto.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-037947']
674,33191260,ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis.,"INTRODUCTION


The many benefits of exercise for persons with multiple sclerosis (MS) are well established, yet patients often refrain from exercise due to overheating and exhaustion. The present randomised controlled trial tests aspirin (acetylsalicylic acid (ASA)) as a convenient method to prevent overheating and improve exercise performance in persons with MS. The effects of ASA are compared with those of acetaminophen (APAP) and placebo.
METHODS AND ANALYSIS


Participants are seen for a laboratory maximal exercise test on 3 separate days separated by at least 1 week. At each session, body temperature is measured before oral administration of a standard adult dose (650 mg) of ASA, APAP or placebo. One hour after drug administration, participants perform a maximal ramp test on a cycle ergometer. Primary outcomes are (a) time to exhaustion (that is, time spent cycling to peak exertion) and (b) body temperature change. Crossover analyses will include tests for effects of treatment, period, treatment-period interaction (carryover effect) and sequence.
ETHICS AND DISSEMINATION


Ethical approval was granted by the institutional review board at Columbia University Irving Medical Center (reference: AAAS2529). Results of the trial will be published in peer-reviewed scientific journals and presented at national and international conferences. Neurologists, physiatrists, primary care physicians and physiotherapists are important stakeholders and will be targeted during dissemination. Positive trial results have the potential to promote aspirin therapy, an inexpensive and readily available treatment, to reduce overheating and allow more persons with MS to benefit from exercise.
TRIAL REGISTRATION NUMBER


NCT03824938.",2020,"Positive trial results have the potential to promote aspirin therapy, an inexpensive and readily available treatment, to reduce overheating and allow more persons with MS to benefit from exercise.
","['persons with MS', 'multiple sclerosis', 'persons with multiple sclerosis (MS']","['acetaminophen (APAP) and placebo', 'ASA', 'aspirin', 'ASA, APAP or placebo', 'aspirin (acetylsalicylic acid (ASA']","['a) time to exhaustion (that is, time spent cycling to peak exertion) and (b) body temperature change', 'exercise performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0005904', 'cui_str': 'Body Temperature Changes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.489021,"Positive trial results have the potential to promote aspirin therapy, an inexpensive and readily available treatment, to reduce overheating and allow more persons with MS to benefit from exercise.
","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kever', 'Affiliation': 'Translational Cognitive Neuroscience Laboratory, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Nelson', 'Affiliation': 'Translational Cognitive Neuroscience Laboratory, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ines M', 'Initials': 'IM', 'LastName': 'Aguerre', 'Affiliation': 'Translational Cognitive Neuroscience Laboratory, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Riley', 'Affiliation': 'Multiple Sclerosis Center, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Boehme', 'Affiliation': 'Department of Neurology and Epidemiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation and Regenerative Medicine, Columbia University Vangelos College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Strauss Farber', 'Affiliation': 'Multiple Sclerosis Center, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Seth N', 'Initials': 'SN', 'LastName': 'Levin', 'Affiliation': 'Multiple Sclerosis Center, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Department of Rehabilitation and Regenerative Medicine, Columbia University Vangelos College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Leavitt', 'Affiliation': 'Translational Cognitive Neuroscience Laboratory, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA VL2337@cumc.columbia.edu.'}]",BMJ open,['10.1136/bmjopen-2020-039691']
675,33200390,The effects of tropicamide and cyclopentolate hydrochloride on laser flare meter measurements in uveitis patients: a comparative study.,"PURPOSE


To investigate the effects of 1% cyclopentolate hydrochloride and 1% tropicamide eye drops on aqueous flare measurements by using the laser flare meter.
METHODS


One hundred forty eight eyes of 83 patients with inactive uveitis were enrolled. The patients were randomly assigned to receive either 1% tropicamide (Group 1) or 1% cyclopentolate hydrochloride (Group 2) as the mydriatic agent. Best corrected visual acuity (BCVA), intraocular pressure (IOP), aqueous flare reaction levels measured by laser flare meter device (FM 600, Kowa, Kowa Company Ltd, Nagoya, Japan) before and post dilatation agents were evaluated.
RESULTS


Group 1 consisted of 75 eyes and Group 2 consisted of 77 eyes. The mean age of Group 1 patients was 34.85 ± 12.60 (range, 12-64) years; the mean age of Group 2 was 36.92 ± 13.30 (range, 12-70) years (p > 0.05). The mean BCVAs of two groups were 0.16 ± 0.43 (range, 0.00-3.10) logMAR and 0.17 ± 0.42 (range, 0.00-3.10) logMAR, respectively. There were no statistically significant differences between Groups 1 and 2 regarding gender or clinical characteristics (p > 0.05). No significant differences were detected in pre- or post-dilatation values between two groups (p = 0.470, p = 0.998).
CONCLUSIONS


As a result, anterior chamber flare values in uveitis patients do not differ significantly between 1% tropicamide and 1% cyclopentolate hydrochloride, and both agents can be safely used for dilatation during examination of patients with uveitis.",2021,There were no statistically significant differences between Groups 1 and 2 regarding gender or clinical characteristics (p > 0.05).,"['uveitis patients', 'One hundred forty eight eyes of 83 patients with inactive uveitis were enrolled']","['tropicamide and cyclopentolate hydrochloride', 'cyclopentolate hydrochloride', 'mydriatic agent', 'tropicamide', 'cyclopentolate hydrochloride and 1% tropicamide eye drops']","['anterior chamber flare values', 'pre- or post-dilatation values', 'Best corrected visual acuity (BCVA), intraocular pressure (IOP), aqueous flare reaction levels measured by laser flare meter device (FM 600, Kowa, Kowa Company Ltd, Nagoya, Japan', 'mean BCVAs', 'laser flare meter measurements']","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0357664', 'cui_str': 'Cyclopentolate hydrochloride'}, {'cui': 'C0026964', 'cui_str': 'Mydriatic agent'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",83.0,0.0214928,There were no statistically significant differences between Groups 1 and 2 regarding gender or clinical characteristics (p > 0.05).,"[{'ForeName': 'Medine', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Manisa Merkezefendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Guven Yilmaz', 'Affiliation': 'Department of Ophthalmology, Ege University School of Medicine, 35100, Bornova, Izmir, Turkey. drsuzan2003@yahoo.com.'}, {'ForeName': 'Melis', 'Initials': 'M', 'LastName': 'Palamar', 'Affiliation': 'Department of Ophthalmology, Ege University School of Medicine, 35100, Bornova, Izmir, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Ates', 'Affiliation': 'Department of Ophthalmology, Ege University School of Medicine, 35100, Bornova, Izmir, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Yagci', 'Affiliation': 'Department of Ophthalmology, Ege University School of Medicine, 35100, Bornova, Izmir, Turkey.'}]",International ophthalmology,['10.1007/s10792-020-01639-3']
676,33200812,"Low dose of ROSuvastatin in combination with EZEtimibe effectively and permanently reduce low density lipoprotein cholesterol concentration independently of timing of administration (ROSEZE): A randomized, crossover study - preliminary results.","BACKGROUND


In an attempt to improve low density lipoprotein-cholesterol (LDL-C) level control in patients ineffectively treated with statins, we evaluated the effectiveness of a fixed-dose combination (FDC) of 10 mg rosuvastatin and ezetimibe and its relation to the timing of drug administration.
METHODS


A randomized, open label, single center, crossover study involving 83 patients with coronary artery disease and hypercholesterolemia with baseline LDL-C ≥ 70 mg/dL. In arm I the FDC drug was administered in the morning for 6 weeks, then in the evening for the following 6 weeks and vice versa in arm II. The primary endpoint was the change in LDL-C after 6 and 12 weeks.
RESULTS


The median LDL-C concentration at baseline, after 6 and 12 weeks respectively was: 98.10 mg/dL (Q1;Q3: 85.10;116.80), 63.14 mg/dL (50.70;77.10) and 59.40 mg/dL (49.00;73.30); p < 0.001. LDL-C levels were similar regardless of the timing of drug administration (morning 62.50 mg/dL [50.70;76.00] vs. evening 59.70 mg/dL [48.20;73.80]; p = 0.259], in both time points: 6 week: 63.15 mg/dL (50.75;80.65) vs. 63.40 mg/dL (50.60;74.00), p = 0.775; and 12 week: 62.00 mg/dL (50.20;74.40) vs. 59.05 mg/dL (47.65;66.05), p = 0.362. The absolute change in LDL-C concentration for the morning vs. evening drug administration was - 6 week: -34.6 mg/dL (-56.55; -19.85) (-34.87%) vs. -31.10 mg/dL (-44.20; -16.00) (-35.87%) (p not significant); 12. week: -34.20 mg/dL (-47.8; -19.0) (-37.12%) vs. -37.20 mg/dL (-65.55; -23.85) (-40.06%) (p not significant). The therapy was safe and well tolerated.
CONCLUSIONS


Fixed-dose combination of rosuvastatin and ezetimibe significantly and permanently decreases LDL-C regardless of the timing of drug administration.",2021,"The median LDL-C concentration at baseline, after 6 and 12 weeks respectively was: 98.10 mg/dL","['patients ineffectively treated with statins', '83 patients with coronary artery disease and hypercholesterolemia with baseline LDL-C ≥']","['dL', 'ROSuvastatin', 'rosuvastatin and ezetimibe']","['low density lipoprotein-cholesterol (LDL-C) level control', 'safe and well tolerated', 'LDL-C levels', 'low density lipoprotein cholesterol concentration', 'LDL-C concentration', 'median LDL-C concentration', 'change in LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C3700394', 'cui_str': 'rosuvastatin and ezetimibe'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",83.0,0.0791776,"The median LDL-C concentration at baseline, after 6 and 12 weeks respectively was: 98.10 mg/dL","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Obońska', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland. k.obonska@cm.umk.pl.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Kasprzak', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Tymosiak', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Fabiszak', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Krintus', 'Affiliation': 'Department of Laboratory Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Sklodowskiej-Curie Street, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland.'}]",Cardiology journal,['10.5603/CJ.a2020.0166']
677,33202169,"Effect of Domperidone on Breast Milk Production in Mothers of Sick Neonates: A Randomized, Double-Blinded, Placebo-Controlled Trial.","Objective:  Mothers of many preterm babies are unable to produce sufficient milk for their babies during the prolonged hospitalization. Domperidone stimulates the release of prolactin, thereby increasing breast milk production. The primary outcome was to study the efficacy of domperidone in augmenting breast milk production in mothers with lactation failure (LF). The secondary outcomes included the effect of domperidone on prolactin levels, adverse effects of domperidone, and outcome on breastfeeding rates at discharge.  Materials and Methods:  This was a randomized, double-blinded, placebo-controlled trial where mothers with LF were either allocated domperidone (10 mg) or placebo, 2 tablets three times a day for 14 days. Milk volumes were recorded daily for 14 days. Serum prolactin levels were measured at the start and at day 7 of study.  Results:  Out of 166 women eligible for the study, 119 (71.7%) mothers were able to increase their breast milk production without pharmacological treatment after being counseled on the advantages of human milk and proper breastfeeding management. Forty-seven mothers were finally enrolled in the study; 24 in the domperidone group (DG) and 23 in the placebo group (PG). Breast milk production increased from a baseline of 156 + 141.1 to 400.9 + 239.2 mL in the DG and increased from a baseline of 175.8 + 150.7 to 260.5 + 237.5 mL in the PG, after 14 days ( p  < 0.01). The prolactin levels in the DG and PG increased from 72.85 (22.2-167.15) and 42.33 (14.02-93.54) ng/mL, respectively, to 223.4 (49.79-280.2) ng/mL ( p  = 0.005) in the DG and 60.08 (14.31-132.14) ng/mL ( p  = 0.232) in the PG on the 7th day of treatment. No adverse effects were recorded. Ninety-five percent of babies in the DG were exclusively breastfeeding at hospital discharge, compared with 52.4% in the PG ( p  = 0.008).  Conclusion:  Domperidone treatment can result in an increase in breast milk production with no adverse effects. The study was registered with the Thai Clinical Trials Registry ID TCTR2020091008.",2021,The prolactin levels in the DG and PG increased from 72.85 (22.2-167.15) and 42.33 (14.02-93.54),"['Forty-seven mothers were finally enrolled in the study; 24 in the domperidone group (DG) and 23 in the placebo group (PG', '166 women eligible for the study, 119 (71.7', 'mothers with LF', 'Mothers of many preterm babies', 'mothers with lactation failure (LF', 'Mothers of Sick Neonates']","['placebo', 'Domperidone', 'domperidone', 'Placebo']","['Breast milk production', 'prolactin levels', 'adverse effects', 'breast milk production', 'Serum prolactin levels', 'prolactin levels, adverse effects of domperidone, and outcome on breastfeeding rates at discharge', 'Milk volumes', 'Breast Milk Production']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0152158', 'cui_str': 'Failure of lactation'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",166.0,0.509817,The prolactin levels in the DG and PG increased from 72.85 (22.2-167.15) and 42.33 (14.02-93.54),"[{'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Khorana', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.'}, {'ForeName': 'Panrada', 'Initials': 'P', 'LastName': 'Wongsin', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.'}, {'ForeName': 'Roongrawee', 'Initials': 'R', 'LastName': 'Torbunsupachai', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.'}, {'ForeName': 'Wiboon', 'Initials': 'W', 'LastName': 'Kanjanapattanakul', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0234']
678,33205372,Clinical efficacy of 0.01% atropine in retarding the progression of myopia in children.,"PURPOSE


To investigate the clinical efficacy of 0.01% atropine in slowing the progression of myopia in children and to evaluate the influence of 0.01% atropine on secretion of basal tear and stability of tear film.
METHODS


Eighty children aged 5-14 years with myopia, 40 were randomly divided into two groups consisting of those who received spectacles in addition to 0.01% atropine (SA group) and those who received only spectacles (S group). The remaining 40 children who were wearing orthokeratology (OK) lenses for 3 months were randomly divided into two groups comprising those who received OK lenses in addition to 0.01% atropine (OKA group) and those who received only OK lenses (OK group). Comprehensive ophthalmologic examinations, including slit-lamp examination, visual acuity testing, autorefraction, intraocular pressure, axial length (AL), corneal topography, Schirmer's test, and tear film break-up time (TBuT), were performed before treatment and after every 3 months treatment.
RESULTS


During the follow-up visits, evidently better spherical equivalent (SE) control over 3, 6 and 12 months was observed in the SA and OKA groups compared with the S and OK groups. The AL over 3, 6, and 12 months was evidently inhibited in the SA and OKA groups compared with the S and OK groups. No statistically significant differences in Schirmer's test and TBuT results were observed between the S and SA groups and between the OK and OKA groups. However, statistically significant differences were found in TBuT results between before treatment and after 3 months treatment in the OK group (P < 0.05, paired t test) and the OKA group (P < 0.05, paired t test).
CONCLUSIONS


0.01% atropine can effectively control myopia progression and axial elongation regardless of combined treatment with spectacles or OK lenses. And 0.01% atropine has no evident effect on Schirmer's test and TBuT results; however, researchers also found that Schirmer's test and TBuT results showed a tendency to reduce after treatment with 0.01% atropine.",2021,No statistically significant differences in Schirmer's test and TBuT results were observed between the S and SA groups and between the OK and OKA groups.,"['40 children who were wearing orthokeratology (OK) lenses for 3\xa0months', 'Eighty children aged 5-14\xa0years with myopia, 40', 'myopia in children']","['atropine (SA group) and those who received only spectacles', 'OK lenses in addition to 0.01% atropine (OKA group) and those who received only OK lenses', 'atropine']","[""Schirmer's test and TBuT results"", 'TBuT results', 'secretion of basal tear and stability of tear film', ""slit-lamp examination, visual acuity testing, autorefraction, intraocular pressure, axial length (AL), corneal topography, Schirmer's test, and tear film break-up time (TBuT""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0069389', 'cui_str': 'Okadaic acid'}]","[{'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0200150', 'cui_str': 'Visual acuity testing'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}]",80.0,0.0182668,No statistically significant differences in Schirmer's test and TBuT results were observed between the S and SA groups and between the OK and OKA groups.,"[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ""Department of Ophthalmology, The Second Hospital of Dalian Medical University, 467 Zhongshan Road, Shahekou District, Dalian, People's Republic of China. zhaoqidyey@126.com.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Hao', 'Affiliation': ""Department of Ophthalmology, The Second Hospital of Dalian Medical University, 467 Zhongshan Road, Shahekou District, Dalian, People's Republic of China.""}]",International ophthalmology,['10.1007/s10792-020-01658-0']
679,33218863,Talectomy for the Management of Resistant Talipes Equinovarus Deformity; Does Adding Ilizarov External Fixator Provide Extra Advantages?,"BACKGROUND


The management of resistant talipes equinovarus (TEV) is challenging. Residual deformity and recurrence are among the most feared complications. This study was conducted to evaluate the effectiveness of talectomy in the management of arthrogrypotic TEV and to investigate the value of adding a simplified Ilizarov fixator (SIF).
PATIENTS AND METHODS


A total of 42 resistant TEV feet among 23 arthrogrypotic children were operated between January 2012 and 2016. The average age was 6.7 ± 1.67 years. The feet were divided into 2 groups; group A (Casting group) included 20 feet (11 children) that were managed by talectomy and casting, while group B (Fixator group) included 22 feet (12 children) that were treated using a SIF concomitant with talectomy. The results were evaluated morphologically by Dimeglio grading system and functionally by Legaspi system.
RESULTS


The average follow-up was 36.62 ± 3.88 months. With the numbers available in this study, there was significant improvement (p ≤ .05) in the Dimeglio scores in both groups, which was significantly more evident (p ≤ .05) among the fixator group. The majority of the good functional results were reported among the fixator group, while the poor feet were observed mainly in the casting group (p ≤ .05). The functional end results were significantly affected (p≤ .05) by the final Dimeglio scores. The age had also statistically significant effect (p≤ .05) on the functional end results in group A only.
CONCLUSION


Talectomy is an effective procedure for salvaging arthrogrypotic TEV. Supplementation of the procedure by SIF was associated with more satisfactory morphological and functional results particularly in older children.",2021,"With the numbers available in this study, there was significant improvement (p ≤ .05) in the Dimeglio scores in both groups, which was significantly more evident (p ≤ .05) among the fixator group.","['23 arthrogrypotic children were operated between January 2012 and 2016', 'Resistant Talipes Equinovarus Deformity', 'older children']","['SIF concomitant with talectomy', 'simplified Ilizarov fixator (SIF']",['Dimeglio scores'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0441254', 'cui_str': 'Fixation device'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0188551', 'cui_str': 'Talectomy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",23.0,0.0130709,"With the numbers available in this study, there was significant improvement (p ≤ .05) in the Dimeglio scores in both groups, which was significantly more evident (p ≤ .05) among the fixator group.","[{'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Atef', 'Affiliation': 'Assistant Professor, Department of Orthopedics, Faculty of Medicine, Tanta University, Tanta, Egypt. Electronic address: ashraf.mohamed@med.tanta.edu.eg.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El-Rosasy', 'Affiliation': 'Professor, Department of Orthopedics, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'El-Tantawy', 'Affiliation': 'Assistant Professor, Department of Orthopedics, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons,['10.1053/j.jfas.2020.08.033']
680,33212360,Efficacy of a decision support intervention for reducing decisional conflict in patients with elevated serum prostate-specific antigen: A randomized controlled trial.,"PURPOSE


The study purpose is to test the efficacy of a decision support intervention for reducing decisional conflict, increasing prostate biopsy knowledge, and enhancing decision self-efficacy in patients with elevated serum prostate-specific antigen.
METHOD


The study is based on a randomized pre-post test design. A convenience sample of men with elevated prostate-specific antigen was recruited and 1:1 randomized to the intervention and control groups. The intervention group received the decision support intervention and the control group received health education. Data were collected at the baseline and post-test by using self-reported questionnaires, including the Prostate Biopsy Knowledge Scale, the Decision Self-Efficacy Scale, the Decisional Conflict Scale, and questions regarding the prostate biopsy decision (post-test only). Data on prostate-specific antigen levels were collected from the patients' medical records.
RESULTS


A total of 110 patients participated in the study. At baseline, the intervention group had significantly higher knowledge scores than the control group. The analysis of the covariance model with the baseline score as a covariate was used to analyze the intervention effect. After controlling for the baseline scores, the mean differences (95% CI) between the two groups were 11.75 (11.17-12.32), 76.45 (72.52-80.37), and -23.53 (-26.31-20.20) for knowledge, decision self-efficacy, and decisional conflict, respectively. The between-group difference in willingness to accept prostate biopsy at the post-test was not statistically significant (χ 2 = 1.704).
CONCLUSIONS


The decision support intervention significantly reduced patients' decisional conflict while improving their knowledge and self-efficacy. However, the intervention did not affect patients' biopsy decision.",2021,"At baseline, the intervention group had significantly higher knowledge scores than the control group.","['men with elevated prostate-specific antigen', ""patients' medical records"", 'patients with elevated serum prostate-specific antigen', '110 patients participated in the study']","['decision support intervention', 'decision support intervention and the control group received health education']","[""patients' decisional conflict"", 'Prostate Biopsy Knowledge Scale, the Decision Self-Efficacy Scale, the Decisional Conflict Scale, and questions regarding the prostate biopsy decision', 'willingness to accept prostate biopsy', 'knowledge and self-efficacy', 'knowledge, decision self-efficacy, and decisional conflict', 'knowledge scores', 'decisional conflict']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",110.0,0.0369011,"At baseline, the intervention group had significantly higher knowledge scores than the control group.","[{'ForeName': 'Tsae-Jyy', 'Initials': 'TJ', 'LastName': 'Wang', 'Affiliation': ', School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan. Electronic address: tsaejyy@ntunhs.edu.tw.'}, {'ForeName': 'Pei-Pei', 'Initials': 'PP', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: kyoto.sakura0106@gmail.com.'}, {'ForeName': 'Kuang-Kuo', 'Initials': 'KK', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: kkchen@vghtpe.gov.tw.'}, {'ForeName': 'Lun-Ping', 'Initials': 'LP', 'LastName': 'Hung', 'Affiliation': 'Department of Information Management, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan. Electronic address: lunping@ntunhs.edu.tw.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101865']
681,33207233,"Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study, a response.",,2021,,['gynecological surgery'],[],[],"[{'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]",[],[],,0.0609988,,"[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili di Brescia, Piazzale Spedali Civili, 1, Brescia 25126, Italy. Electronic address: f.ferrari.obgyn@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Forte', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Odicino', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.11.009']
682,33217374,Treating Heel Pain in Adults: A Randomized Controlled Trial of Hard vs Modified Soft Custom Orthotics and Heel Pads.,"OBJECTIVES


This study compared the effectiveness of soft vs hard orthotics in treating heel pain and plantar fasciitis in adults. It also compared the level of function after orthotic use, cost, and number of visits for orthotics and explored whether age was a factor in orthotic effectiveness.
DESIGN


Randomized controlled trial. Before randomization, patients were stratified by age (younger vs older adults) in blocks of 4 to ensure that there were an equal number of participants in each group (soft vs hard orthotics).
SETTING


An orthotic clinic in a community-based hospital and a private orthotic clinic.
PARTICIPANTS


The participants were adults aged 18 years or older (N=44) with heel pain and plantar fasciitis.
INTERVENTION


Participants received hard or soft customized orthotics.
MAIN OUTCOME MEASURES


Participants rated their pain intensity and pain interference before and after orthotic use using subscales from the Brief Pain Inventory. Function was similarly measured using the Late Life Function and Disability Instrument: Function component. Analyses of age, cost, and number of visits were also compared.
RESULTS


There was a reduction in pain intensity (P=.010) and pain interference (P<.001) but no change in function over time (P=.333), and no difference between the groups who received hard vs soft orthotics. Age had no effect on orthotic effectiveness. Soft orthotics were less expensive (P<.0001) and required fewer visits for fabrication (P<.0001).
CONCLUSION


Both soft and hard orthotics provided effective pain relief, but soft orthotics are less expensive.",2021,"There was a reduction in pain intensity (P=0.010) and pain interference (P<0.001) but no change in function over time (P=0.333), and no difference between the groups who received hard versus soft orthotics.","['heel pain and plantar fasciitis in adults', 'patients were stratified by age (younger versus older adults', 'participants were adults (18+) with heel pain and plantar fasciitis', 'Adults', 'The settings that participants were recruited from were 1) an orthotic clinic in a community-based hospital and 2) a private orthotic clinic']","['Hard Versus Modified Soft Custom Orthotics and Heel Pads', 'soft versus hard orthotics', 'Participants received hard or soft customized orthotics']","['pain interference', 'pain intensity', 'orthotic effectiveness', 'pain intensity and pain interference pre', 'effective pain relief']","[{'cui': 'C0231780', 'cui_str': 'Heel pain'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}]","[{'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0332568', 'cui_str': 'Pad'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",,0.197917,"There was a reduction in pain intensity (P=0.010) and pain interference (P<0.001) but no change in function over time (P=0.333), and no difference between the groups who received hard versus soft orthotics.","[{'ForeName': 'Deborah A R', 'Initials': 'DAR', 'LastName': 'Seligman', 'Affiliation': 'Department of Occupational Therapy, Baycrest, Toronto, Ontario, Canada; Department of Rehabilitation Science, University of Toronto, Toronto, Ontario, Canada; Orthotics Clinic, Toronto, Ontario, Canada. Electronic address: debbieseligman@hotmail.com.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Dawson', 'Affiliation': 'Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, University of Toronto, Toronto, Ontario, Canada; Rotman Research Institute, Baycrest, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': ""Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario, Canada; St. Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Seligman', 'Affiliation': 'Faculty of Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Krembil Research Institute, University Health Network, Toronto, Ontario, Canada; Department of Physical Therapy and Surgery, Rehabilitation Science Institute, Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.10.124']
683,33217147,Blood markers in remote ischaemic conditioning for acute ischaemic stroke: data from the REmote ischaemic Conditioning After Stroke Trial.,"BACKGROUND AND PURPOSE


Remote ischaemic per-conditioning (RIC) is neuroprotective in experimental ischaemic stroke. Several neurohumoral, vascular and inflammatory mediators are implicated. The effect of RIC on plasma biomarkers was assessed using clinical data from the REmote ischaemic Conditioning After Stroke Trial (RECAST-1).
METHODS


RECAST-1 was a pilot sham-controlled blinded trial in 26 patients with ischaemic stroke, randomized to receive four 5-min cycles of RIC within 24 h of ictus. Plasma taken pre-intervention, immediately post-intervention and on day 4 was analysed for nitric oxide (nitrate/nitrite) using chemiluminescence and all other biomarkers by multiplex analysis. Biomarkers were correlated with clinical outcome (day 90 National Institutes of Health Stroke Scale, modified Rankin Scale, Barthel index).
RESULTS


Remote ischaemic per-conditioning reduced serum amyloid protein (SAP) and tissue necrosis factor α (TNF-α) levels from pre- to post-intervention (n = 13, two-way ANOVA, p < 0.05). Overall (n = 26), increases in SAP pre- to post-intervention and pre-intervention to day 4 were moderately correlated with worse day 90 clinical outcomes. No consistent significant changes over time, or by treatment, or correlations with outcome were seen for other biomarkers.
CONCLUSIONS


Remote ischaemic per-conditioning reduced SAP and TNF-α levels from pre- to post-intervention. Increases in plasma levels of SAP were associated with worse clinical outcomes after ischaemic stroke. Larger studies assessing biomarkers and the safety and efficacy of RIC in acute ischaemic stroke are warranted to further understand these relationships.",2021,"RESULTS


RIC reduced serum amyloid protein (SAP) and tissue necrosis factor-α (TNF-α) levels from pre- to post-intervention (n=13, 2-way ANOVA, p<0.05).","['acute ischaemic stroke', '26 patients with ischaemic stroke']","['Remote ischaemic per-conditioning (RIC', 'RIC']","['serum amyloid protein (SAP) and tissue necrosis factor-α (TNF-α) levels', 'plasma levels of SAP', 'SAP and TNF-α levels', 'Blood markers', 'Health Stroke Scale [NIHSS], modified Rankin scale [mRS], Barthel index [BI', 'SAP pre']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0311444', 'cui_str': 'Serum amyloid protein'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",26.0,0.120839,"RESULTS


RIC reduced serum amyloid protein (SAP) and tissue necrosis factor-α (TNF-α) levels from pre- to post-intervention (n=13, 2-way ANOVA, p<0.05).","[{'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Appleton', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Saoirse E', 'Initials': 'SE', 'LastName': ""O'Sullivan"", 'Affiliation': 'Division of Medical Sciences and GEM, School of Medicine, Vascular Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hedstrom', 'Affiliation': 'Division of Medical Sciences and GEM, School of Medicine, Vascular Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'May', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Donnelly', 'Affiliation': 'Division of Medical Sciences and GEM, School of Medicine, Vascular Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Division of Medical Sciences and GEM, School of Medicine, Vascular Medicine, University of Nottingham, Derby, UK.'}]",European journal of neurology,['10.1111/ene.14650']
684,33220353,"A randomized double-blind, placebo-controlled study of omalizumab for idiopathic anaphylaxis.","BACKGROUND


Idiopathic anaphylaxis (IA) is a diagnosis of exclusion, thus taking away the option of therapeutic management focused on eliminating the inciting agent. Epinephrine and antihistamines followed by systemic corticosteroids are the mainstays of therapy for acute events. There is no prophylactic therapy that reliably prevents anaphylaxis.
OBJECTIVE


We sought to determine the efficacy of omalizumab in the management of patients with frequent episodes of IA in a double-blind, placebo-controlled trial.
METHODS


We prospectively enrolled 19 patients with frequent IA (≥6 episodes/y) who then underwent a medical evaluation that included a serum tryptase determination, mutational analysis for KIT D816V, and bone marrow evaluation to rule out a clonal mast cell disorder. Computer-generated random numbers were provided by the study pharmacist. The primary end point was anaphylactic events in the 6 months after baseline. Sixteen patients completed the primary trial.
RESULTS


No statistically significant difference was demonstrated between the placebo and treated groups. There was a trend for efficacy in the treatment group, particularly after 60 days. Overall, the safety profile was favorable without long-term side effects.
CONCLUSIONS


Omalizumab was safely administered to a difficult-to-treat patient population with IA. The efficacy results trended modestly in favor of the treatment group, but no statistically significant differences were detected.",2021,No statistically significant difference was demonstrated between the placebo and treated groups.,"['Sixteen patients completed the primary trial', 'patients with frequent episodes of IA in a DBPC trial', '19 patients with frequent IA (≥6 episodes/yr) and who then underwent a medical evaluation that included a serum tryptase determination, mutational analysis for KIT D816V and bone marrow evaluation to rule out a clonal mast cell disorder']","['placebo', 'omalizumab', 'Placebo', 'Omalizumab', 'Epinephrine and antihistamines']","['anaphylactic events', 'safety profile', 'efficacy']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0147080', 'cui_str': 'Tryptase'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0024899', 'cui_str': 'Mast cell hyperplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",19.0,0.33268,No statistically significant difference was demonstrated between the placebo and treated groups.,"[{'ForeName': 'Melody C', 'Initials': 'MC', 'LastName': 'Carter', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md. Electronic address: mcarter@niaid.nih.gov.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Maric', 'Affiliation': 'Hematology Section, Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Erica H', 'Initials': 'EH', 'LastName': 'Brittain', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda; Md.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Lumbard', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Md.'}, {'ForeName': 'Hyejeong', 'Initials': 'H', 'LastName': 'Bolan', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Daly', 'Initials': 'D', 'LastName': 'Cantave', 'Affiliation': 'Department of Nursing, Clinical Center, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Scott', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Dean D', 'Initials': 'DD', 'LastName': 'Metcalfe', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.11.005']
685,33223095,Possible Protective Effect of Omalizumab on Lung Function Decline in Patients Experiencing Asthma Exacerbations.,"BACKGROUND


Frequent exacerbations are associated with greater FEV 1  decline in patients with asthma. The effect of omalizumab versus placebo on lung function in patients experiencing asthma exacerbations has not been previously examined.
OBJECTIVE


To evaluate the relationship between postbaseline (treatment phase) exacerbation status and lung function decline in children, adolescents, and adults treated with omalizumab versus placebo using data from 3 pediatric and adolescent/adult studies.
METHODS


Changes in percent predicted FEV 1  (ppFEV 1 ) and FEV 1  by treatment (omalizumab/placebo) and postbaseline exacerbation status (exacerbators/nonexacerbators) were assessed in patients aged 6 to 11 years (IA05, n = 576) and 12 to 75 years (EXTRA/INNOVATE pooled, n = 1202). Pediatric patients were examined at treatment weeks 12, 24, 28, 40, and 52, and adolescent/adult data at weeks 4, 12, 20, and 28.
RESULTS


Omalizumab-treated patients experienced larger increases in ppFEV 1  and FEV 1  compared with placebo-treated patients in the pediatric and pooled adolescent/adult populations. The response was observed in pediatric exacerbators, with significantly larger increases in ppFEV 1  and FEV 1  at week 12 (mean difference [95% CI], 4.11% [0.93%-7.30%], P = .011 for ppFEV 1 ; 80 [10-140] mL, P = .017 for FEV 1 ) and week 28 (mean difference [95% CI], 3.65% [0.11%-7.19%], P = .043 for ppFEV 1 ; 100 [30-170] mL, P = .007 for FEV 1 ). In the adolescent/adult population, both exacerbators and nonexacerbators derived similar benefit with omalizumab compared with placebo.
CONCLUSIONS


Findings from this post hoc analysis suggest that omalizumab may confer some protection against lung function decline among patients who experienced exacerbations during treatment.",2021,"RESULTS


Omalizumab-treated patients experienced larger increases in ppFEV 1  and FEV 1  compared with placebo-treated patients in the pediatric and pooled adolescent/adult populations.","['using data from 3 pediatric and adolescent/adult studies', 'Patients Experiencing Asthma Exacerbations', 'patients who experienced exacerbations during treatment', 'Changes in percent predicted FEV 1  (ppFEV 1 ) and FEV 1  by treatment (omalizumab/placebo) and postbaseline exacerbation status (exacerbators/nonexacerbators) were assessed in patients aged 6 to 11 years (IA05, n\xa0= 576) and 12 to 75 years (EXTRA/INNOVATE pooled, n\xa0= 1202', 'patients with asthma', 'Pediatric patients were examined at treatment weeks 12, 24, 28, 40, and 52, and adolescent/adult data at weeks 4, 12, 20, and\xa028', 'patients experiencing asthma exacerbations', 'children, adolescents, and adults treated with']","['Omalizumab', 'omalizumab', 'omalizumab versus placebo', 'placebo']","['lung function', 'Lung Function Decline']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",1202.0,0.349298,"RESULTS


Omalizumab-treated patients experienced larger increases in ppFEV 1  and FEV 1  compared with placebo-treated patients in the pediatric and pooled adolescent/adult populations.","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis. Electronic address: wwb@medicine.wisc.edu.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Children's Hospital Colorado, and University of Colorado School of Medicine, Aurora, Colo.""}, {'ForeName': 'Tmirah', 'Initials': 'T', 'LastName': 'Haselkorn', 'Affiliation': 'EpiMetrix, Inc., Los Altos, Calif.'}, {'ForeName': 'Ahmar', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ortiz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Bobby Q', 'Initials': 'BQ', 'LastName': 'Lanier', 'Affiliation': 'University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Bradley E', 'Initials': 'BE', 'LastName': 'Chipps', 'Affiliation': 'Capital Allergy & Respiratory Disease Center, Sacramento, Calif.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.027']
686,33221274,First Real-World Effectiveness Analysis of Preschool Peanut Oral Immunotherapy.,"BACKGROUND


We previously described safety of preschool peanut oral immunotherapy (P-OIT) in a real-world setting; 0.4% of patients experienced a severe reaction, and 4.1% received epinephrine, during build-up.
OBJECTIVE


To determine the effectiveness of preschool P-OIT after 1 year of maintenance.
METHODS


Preschoolers (9-70 months) with at least 1 objective reaction to peanut (during baseline oral food challenge (OFC) or P-OIT build-up) received a follow-up OFC to cumulative 4000 mg protein after 1 year on 300 mg peanut daily maintenance. Effectiveness of desensitization was defined as proportion of patients with a negative follow-up OFC. Symptoms and treatment at follow-up OFC were recorded.
RESULTS


Of the 117 patients who successfully completed 1 year of P-OIT and subsequently underwent a cumulative 4000-mg follow-up OFC, 92 (78.6%) had a negative OFC and 115 (98.3%) tolerated a cumulative dose of greater than or equal to 1000 mg. For the 25 (21.4%) who reacted, their threshold increased by 3376 mg (95% CI, 2884-3868) from baseline to follow-up; 17 (14.5%) patients experienced grade 1 reactions, 7 (6.00%) grade 2, and 1 (0.85%) grade 3. Two patients (1.71%) received epinephrine associated with P-OIT, and 1 (0.85%) went to the emergency department.
CONCLUSIONS


Our data demonstrate that real-world preschool P-OIT is effective after 1 year of maintenance for those who received a follow-up OFC. For those who reacted, their threshold increased sufficiently to protect against accidental exposures. P-OIT should be considered for preschoolers as an alternative to current recommendations to avoid peanut.",2021,"For the 25 (21.4%) who reacted, their threshold increased by 3376 mg (95% CI, 2884-3868) from baseline to follow-up; 17 (14.5%) patients experienced grade 1 reactions, 7 (6.00%) grade 2, and 1 (0.85%) grade 3.","['Preschoolers (9-70 months) with at least 1 objective reaction to peanut (during baseline oral food challenge (OFC) or P-OIT build-up) received a', 'patients with a negative follow-up OFC']","['epinephrine', 'follow-up OFC to cumulative 4000 mg protein after 1 year on 300 mg peanut daily maintenance', 'preschool peanut oral immunotherapy (P-OIT', 'Preschool Peanut Oral Immunotherapy', 'preschool P-OIT']",['negative OFC'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1861537', 'cui_str': 'Orofacial Cleft 1'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1861537', 'cui_str': 'Orofacial Cleft 1'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1861537', 'cui_str': 'Orofacial Cleft 1'}]",,0.110417,"For the 25 (21.4%) who reacted, their threshold increased by 3376 mg (95% CI, 2884-3868) from baseline to follow-up; 17 (14.5%) patients experienced grade 1 reactions, 7 (6.00%) grade 2, and 1 (0.85%) grade 3.","[{'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Soller', 'Affiliation': ""British Columbia Children's Hospital, Vancouver, BC, Canada; Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada. Electronic address: lsoller@bcchr.ca.""}, {'ForeName': 'Elissa M', 'Initials': 'EM', 'LastName': 'Abrams', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; Department of Pediatrics, Section of Allergy and Clinical Immunology, University of Manitoba, Winnipeg, MB, Canada; Meadowood Medical Center, Winnipeg, MB, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Carr', 'Affiliation': 'Pediatric Allergy & Asthma, Department of Pediatrics, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kapur', 'Affiliation': 'Division of Allergy, Department of Pediatrics, Dalhousie University/IWK Health Centre, Halifax, NS, Canada; Halifax Allergy & Asthma Associates, Halifax, NS, Canada.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Rex', 'Affiliation': 'Division of Allergy, Department of Pediatrics, Dalhousie University/IWK Health Centre, Halifax, NS, Canada; Halifax Allergy & Asthma Associates, Halifax, NS, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Leo', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; West Coast Allergy and Immunology Clinic, Vancouver, BC, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McHenry', 'Affiliation': 'Division of Allergy, Department of Pediatrics, Dalhousie University/IWK Health Centre, Halifax, NS, Canada; Halifax Allergy & Asthma Associates, Halifax, NS, Canada.'}, {'ForeName': 'Timothy K', 'Initials': 'TK', 'LastName': 'Vander Leek', 'Affiliation': 'Pediatric Allergy & Asthma, Department of Pediatrics, University of Alberta, Edmonton, AB, Canada; Pediatric Allergy & Immunology, Edmonton, AB, Canada.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; Vancouver Pediatric and Allergy Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cook', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; Community Allergy Clinic, Victoria, BC, Canada.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Wong', 'Affiliation': ""British Columbia Children's Hospital, Vancouver, BC, Canada; Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Kyla J', 'Initials': 'KJ', 'LastName': 'Hildebrand', 'Affiliation': ""British Columbia Children's Hospital, Vancouver, BC, Canada; Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Mak', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Gerstner', 'Affiliation': 'Department of Pediatrics, Section of Allergy and Clinical Immunology, University of Manitoba, Winnipeg, MB, Canada; Meadowood Medical Center, Winnipeg, MB, Canada.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Cameron', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; Community Allergy Clinic, Victoria, BC, Canada.'}, {'ForeName': 'Edmond S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': ""British Columbia Children's Hospital, Vancouver, BC, Canada; Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.045']
687,33223453,Early identification of the critical view of safety in laparoscopic cholecystectomy using indocyanine green fluorescence cholangiography: A randomised controlled study.,"BACKGROUND


Achieving critical view of safety (CVS) is vital during laparoscopic cholecystectomy (LC). There is no known study determining use of indocyanine green fluorescence cholangiography (ICGFC) in early identification of CVS during LC. This study aims to compare use of ICGFC in LC against conventional LC in early identification of CVS.
METHODOLOGY


Patients undergoing LC in a single centre were randomized into ICGFC-LC and conventional LC. Surgery was performed by a single surgeon and the time taken to achieve CVS from the time of gallbladder fundus retraction was measured. Difficulty level for each surgery was rated and analysed using a modified scoring system (Level 1- Easy to Level 4-Very difficult).
RESULTS


63 patients were recruited where mean time (min) to achieve CVS was 22.3 ± 12.9 in ICGFC-LC (n = 30) and 22.8 ± 14.3 in conventional LC (p = 0.867). The time taken to achieve CVS was shorter in ICGFC-LC group across all difficulty levels, although not significant (p > 0.05). No major complication was observed in the study.
CONCLUSIONS


This study had shown ICGFC-LC reduces time to CVS across all difficulty levels but not statistically significant. ICGFC-LC maybe useful in difficult LC and in surgical training.
TRIAL REGISTRATION


Clinical Trials NCT04228835.
STUDY GRANT


UMMI Surgical - Karl Storz Distributor (Malaysia).",2021,"The time taken to achieve CVS was shorter in ICGFC-LC group across all difficulty levels, although not significant (p > 0.05).","['63 patients were recruited where mean time (min) to achieve CVS was 22.3\xa0±\xa012.9 in ICGFC-LC (n\xa0=\xa030) and 22.8\xa0±', 'Patients undergoing LC in a single centre']","['UMMI Surgical - Karl Storz Distributor (Malaysia', 'indocyanine green fluorescence cholangiography', 'ICGFC', 'laparoscopic cholecystectomy', 'indocyanine green fluorescence cholangiography (ICGFC', 'conventional LC', 'laparoscopic cholecystectomy (LC', 'ICGFC-LC and conventional LC']","['major complication', 'time taken to achieve CVS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0008307', 'cui_str': 'Cholangiogram'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0008307', 'cui_str': 'Cholangiogram'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",63.0,0.0352523,"The time taken to achieve CVS was shorter in ICGFC-LC group across all difficulty levels, although not significant (p > 0.05).","[{'ForeName': 'Jun Kit', 'Initials': 'JK', 'LastName': 'Koong', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Wilayah Perseketuan, Malaysia. Electronic address: jkkoong@um.edu.my.'}, {'ForeName': 'Gaik Huey', 'Initials': 'GH', 'LastName': 'Ng', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Wilayah Perseketuan, Malaysia. Electronic address: gaikhuey@gmail.com.'}, {'ForeName': 'Kamarajan', 'Initials': 'K', 'LastName': 'Ramayah', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Wilayah Perseketuan, Malaysia. Electronic address: rkamar2@gmail.com.'}, {'ForeName': 'Peng Soon', 'Initials': 'PS', 'LastName': 'Koh', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Wilayah Perseketuan, Malaysia. Electronic address: kohps2000@yahoo.com.'}, {'ForeName': 'Boon Koon', 'Initials': 'BK', 'LastName': 'Yoong', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Wilayah Perseketuan, Malaysia. Electronic address: bkyoong@gmail.com.'}]",Asian journal of surgery,['10.1016/j.asjsur.2020.11.002']
688,33221203,"The BaSICS (Baby Skin Integrity Comparison Survey) study: A prospective experimental study using maternal observations to report the effect of baby wipes on the incidence of irritant diaper dermatitis in infants, from birth to eight weeks of age.","BACKGROUND


Baby wipes have been shown to be safe and effective in maintaining skin integrity when compared to the use of water alone. However, no previous study has compared different formulations of wipe. The aim of the BaSICS study was to identify any differences in incidence of irritant diaper dermatitis (IDD) in infants assigned to three different brands of wipe, all marketed as suitable for neonates, but which contained varying numbers of ingredients.
METHODS


Women were recruited during the prenatal period. Participants were randomly assigned to receive one of three brands of wipe for use during the first eight weeks following childbirth. All participants received the same nappies. Participants reported their infant's skin integrity on a scale of 1-5 daily using a bespoke smartphone application. Analysis of effect of brand on clinically significant IDD (score 3 or more) incidence was conducted using a negative binomial generalised linear model, controlling for possible confounders at baseline. Analysts were blind to brand of wipe.
RESULTS


Of 737 women enrolled, 15 were excluded (admitted to neonatal intensive care, premature or other infant health issues). Of the 722 eligible babies, 698 (97%) remained in the study for the full 8-week duration, 24.6% of whom had IDD at some point during the study. Mothers using the brand with the fewest ingredients reported fewer days of clinically significant nappy rash (score≥3) than participants using the two other brands (p = 0.002 and p < 0.001). Severe IDD (grades 4 and 5) was rare (2.4%).
CONCLUSIONS


Rarity of severe IDD suggested that sensitive formula baby wipes are safe when used in cleansing babies from birth to eight weeks during nappy changes. The brand with fewest ingredients had significantly fewer days of clinically significant IDD. Daily observations recorded on a smartphone application proved to be a highly acceptable method of obtaining real-time data on IDD.
CLINICAL TRIAL REGISTRATION


This study was not designed or registered as a clinical trial as no intervention in normal patterns of infant care took place. Mothers who had already decided to use disposable nappies and a baby wipe product agreed to observe and report on their infants' skin condition; in return they received a 9-week supply of free nappies and wipes.",2021,Mothers using the brand with the fewest ingredients reported fewer days of clinically significant nappy rash (score≥3) than participants using the two other brands (p = 0.002 and p < 0.001).,"['irritant diaper dermatitis in infants, from birth to eight weeks of age', 'normal patterns of infant care took place', '737 women enrolled, 15 were excluded (admitted to neonatal intensive care, premature or other infant health issues', 'Women were recruited during the prenatal period', '722 eligible babies, 698 (97%) remained in the study for the full 8-week duration, 24.6% of whom had IDD at some point during the study', ""Mothers who had already decided to use disposable nappies and a baby wipe product agreed to observe and report on their infants' skin condition""]",[],"['clinically significant nappy rash (score≥3', 'irritant diaper dermatitis (IDD', 'Severe IDD']","[{'cui': 'C0022108', 'cui_str': 'Irritant'}, {'cui': 'C0011974', 'cui_str': 'Diaper rash'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021711', 'cui_str': 'Neonatal Intensive Care'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0180416', 'cui_str': 'Diaper'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}]",[],"[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0011974', 'cui_str': 'Diaper rash'}, {'cui': 'C0022108', 'cui_str': 'Irritant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",737.0,0.0726026,Mothers using the brand with the fewest ingredients reported fewer days of clinically significant nappy rash (score≥3) than participants using the two other brands (p = 0.002 and p < 0.001).,"[{'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Price', 'Affiliation': 'School of Health & Society, University of Salford, United Kingdom. Electronic address: a.d.price2@salford.ac.uk.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Lythgoe', 'Affiliation': 'School of Health & Society, University of Salford, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ackers-Johnson', 'Affiliation': 'School of Health & Society, University of Salford, United Kingdom.'}, {'ForeName': 'Penny A', 'Initials': 'PA', 'LastName': 'Cook', 'Affiliation': 'School of Health & Society, University of Salford, United Kingdom.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Clarke-Cornwell', 'Affiliation': 'School of Health & Society, University of Salford, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'MacVane Phipps', 'Affiliation': 'School of Health & Society, University of Salford, United Kingdom.'}]",Pediatrics and neonatology,['10.1016/j.pedneo.2020.10.003']
689,33227408,Adjuvant chemotherapy is superior to chemoradiation after D2 surgery for gastric cancer in the per-protocol analysis of the randomized CRITICS trial.,"BACKGROUND


The Intergroup 0116 and the MAGIC trials changed clinical practice for resectable gastric cancer in the Western world. In these trials, overall survival improved with post-operative chemoradiotherapy (CRT) and perioperative chemotherapy (CT). Intention-to-treat analysis in the CRITICS trial of post-operative CT or post-operative CRT did not show a survival difference. The current study reports on the per-protocol (PP) analysis of the CRITICS trial.
PATIENTS AND METHODS


The CRITICS trial was a randomized, controlled trial in which 788 patients with stage Ib-Iva resectable gastric or esophagogastric adenocarcinoma were included. Before start of preoperative CT, patients from the Netherlands, Sweden and Denmark were randomly assigned to receive post-operative CT or CRT. For the current analysis, only patients who started their allocated post-operative treatment were included. Since it is uncertain that the two treatment arms are balanced in such PP analysis, adjusted proportional hazards regression analysis and inverse probability weighted analysis were used to minimize the risk of selection bias and to estimate and compare overall and event-free survival.
RESULTS


Of the 788 patients, 478 started post-operative treatment according to protocol, 233 (59%) patients in the CT group and 245 (62%) patients in the CRT group. Patient and tumor characteristics between the groups before start of the post-operative treatment were not different. After a median follow-up of 6.7 years since the start of post-operative treatment, the 5-year overall survival was 57.9% (95% confidence interval: 51.4% to 64.3%) in the CT group versus 45.5% (95% confidence interval: 39.2% to 51.8%) in the CRT group (adjusted hazard ratio CRT versus CT: 1.62 (1.24-2.12), P = 0.0004). Inverse probability weighted analysis resulted in similar hazard ratios.
CONCLUSION


After adjustment for all known confounding factors, the PP analysis of patients who started the allocated post-operative treatment in the CRITICS trial showed that the CT group had a significantly better 5-year overall survival than the CRT group (NCT00407186).",2021,Patient and tumor characteristics between the groups before start of the postoperative treatment were not different.,"['patients from the Netherlands, Sweden, and Denmark', '788 patients', 'resectable gastric cancer in the Western world', '788 patients with stage Ib-IVa resectable gastric or esophagogastric adenocarcinoma were included']","['Adjuvant chemotherapy', 'postoperative chemoradiotherapy and perioperative chemotherapy', 'postoperative CT or CRT', 'postoperative chemotherapy (CT) or postoperative chemoradiotherapy']","['5-year overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0376556', 'cui_str': 'Western World'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",788.0,0.316095,Patient and tumor characteristics between the groups before start of the postoperative treatment were not different.,"[{'ForeName': 'W O', 'Initials': 'WO', 'LastName': 'de Steur', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'van Amelsfoort', 'Affiliation': 'Department of Radiation Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Hartgrink', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'N C T', 'Initials': 'NCT', 'LastName': 'van Grieken', 'Affiliation': 'Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'van Sandick', 'Affiliation': 'Department of Surgical Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Y H M', 'Initials': 'YHM', 'LastName': 'Claassen', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'J P B M', 'Initials': 'JPBM', 'LastName': 'Braak', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'E P M', 'Initials': 'EPM', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiation Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Department of Biometrics, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'Department of Biometrics, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Walraven', 'Affiliation': 'Department of Radiation Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands; Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lind', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nordsmark', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam University Medical Centers (UMC), University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'H W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers (UMC), University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cats', 'Affiliation': 'Department of Gastrointestinal Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Verheij', 'Affiliation': 'Department of Radiation Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands; Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'C J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: C.J.H.van_de_Velde@lumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.11.004']
690,33226501,Intestinal microbiome: a new target for chalaziosis treatment in children?,"Intestinal dysbiosis (changes in the gut commensal microbiome) is related to several ophthalmic diseases. The aim of this study was to verify whether oral specific probiotics can alter the clinical course of chalaziosis and its recurrence. A prospective comparative pilot study involving 26 children suffering from chalaziosis was conducted. Children were randomly divided into two groups. The first group received medical treatment (lid hygiene, warm compression and dexamethasone/tobramycin ointment for at least 20 days), and the second group received medical treatment plus a daily supplementation of oral probiotics (≥ 1 × 10^9 live cells of Streptococcus thermophilus ST10 (DSM 25246), ≥ 1 × 10^9 live cells of Lactococcus lactis LCC02 (DSM 29536) and ≥ 1 × 10^9 live cells of Lactobacillus delbrueckii subsp. bulgaricus (DSM 16606) with maltodextrin as the bulking agent (Probiotical S.p.A., Novara, Italy). All patients were evaluated at 2-week intervals for 3 months. If the lesion had not disappeared or decreased in size to 1 mm or less in diameter at the time of subsequent visits, the same procedure was repeated for another 3-month cycle. There was a significant difference in the time taken for complete resolution of the chalazion between the two groups in favour of the children receiving the probiotics. The treatment was not associated with any significant complications in either group. Trial registration: The trial was registered at clinical trials.gov under NCT04322500 on 25/03/2020 (""retrospectively registered"").Conclusions: Modification of the intestinal microbiome with specific probiotics can alter the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis. Probiotic supplementation can increase the effectiveness of traditional therapies by prompting the complete resolution of chalaziosis in a shorter amount of time, in an easy and feasible way. What is Known: • The intestinal microbiome plays a crucial role in several inflammatory diseases of the eye and is considered a therapeutic target. • Probiotics play a role in the prevention and treatment of different conditions in children. What is New: • In children probiotic supplementation is safe and effective. • Probiotic supplementation reduced the time required for complete resolution of the chalazion.",2021,There was a significant difference in the time taken for complete resolution of the chalazion between the two groups in favour of the children receiving the probiotics.,"['26 children suffering from chalaziosis was conducted', 'children by re-establishing intestinal and immune homeostasis', 'children']","['oral specific probiotics', 'medical treatment plus a daily supplementation of oral probiotics (≥\xa01', 'maltodextrin', 'Streptococcus thermophilus ST10 (DSM 25246), ≥\xa01', 'intestinal microbiome with specific probiotics', 'Probiotic supplementation', '• Probiotic supplementation', 'medical treatment (lid hygiene, warm compression and dexamethasone/tobramycin ointment']","['time required for complete resolution of the chalazion', 'time taken for complete resolution of the chalazion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0318180', 'cui_str': 'Streptococcus salivarius subsp. thermophilus'}, {'cui': 'C0450507', 'cui_str': 'ST10'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1276848', 'cui_str': 'Dexamethasone- and tobramycin-containing product'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007933', 'cui_str': 'Chalazion'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",26.0,0.0201949,There was a significant difference in the time taken for complete resolution of the chalazion between the two groups in favour of the children receiving the probiotics.,"[{'ForeName': 'Mariaelena', 'Initials': 'M', 'LastName': 'Filippelli', 'Affiliation': 'Department of Medicine and Health Sciences ""V. Tiberio"", University of Molise, Campobasso, Molise, Italy. oftelena@gmail.com.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""dell'Omo"", 'Affiliation': 'Department of Medicine and Health Sciences ""V. Tiberio"", University of Molise, Campobasso, Molise, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Amoruso', 'Affiliation': 'R&D Department, PROBIOTICAL RESEARCH Srl, Novara, Piemonte, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Paiano', 'Affiliation': 'Department of Medicine and Health Sciences ""V. Tiberio"", University of Molise, Campobasso, Molise, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pane', 'Affiliation': 'R&D Department, PROBIOTICAL RESEARCH Srl, Novara, Piemonte, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Napolitano', 'Affiliation': 'Department of Medicine and Health Sciences ""V. Tiberio"", University of Molise, Campobasso, Molise, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bartollino', 'Affiliation': 'Department of Medicine and Health Sciences ""V. Tiberio"", University of Molise, Campobasso, Molise, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Department of Medicine and Health Sciences ""V. Tiberio"", University of Molise, Campobasso, Molise, Italy.'}]",European journal of pediatrics,['10.1007/s00431-020-03880-5']
691,33228950,Randomized Comparison of Exercise Intervention Versus Usual Care in Older Adult Patients with Frailty After Acute Myocardial Infarction.,"BACKGROUND


Older adult patients with frailty are rarely involved in rehabilitation programs after myocardial infarction. Our aim was to investigate the benefits of exercise intervention in these patients.
METHODS


A total of 150 survivors after acute myocardial infarction, ≥70 years and with pre-frailty or frailty (Fried scale ≥1 points), were randomized to control (n = 77) or intervention (n = 73) groups. The intervention consisted of a 3-month exercise program, under physiotherapist supervision, followed by an independent home-based program. The main outcome was frailty (Fried scale) at 3 months and 1 year. Secondary endpoints were clinical events (mortality or any readmission) at 1 year.
RESULTS


Mean age was 80 years (range = 70-96). In the intervention group, 44 (60%) out of 73 patients participated in the program and 23 (32%) completed it. Overall, there was a decrease in the Fried score in the intervention group at 3 months, with no effect at 1 year. However, in the intention-to-treat analysis, such change did not achieve statistical significance (P = 0.110). Only treatment comparisons made among the subgroups that participated in (P = 0.033) and completed (P = 0.018) the program achieved statistical significance. There were no differences in clinical events. Worse Fried score trajectory along follow-up increased mortality risk (hazard ratio [HR] = 2.38, 95% confidence interval [CI] 1.24-4.55, P = 0.009) CONCLUSIONS: Recruitment and retention for a physical program in older adult patients with frailty after myocardial infarction was challenging. Frailty status improved in the subgroup that participated in the program, although this benefit was attenuated after shifting to a home-based program. A better frailty trajectory might influence midterm prognosis. (ClinicalTrials.govNCT02715453).",2021,"Frailty status improved in the subgroup that participated in the program, although this benefit was attenuated after shifting to a home-based program.","['150 survivors after acute myocardial infarction, ≥70 years and with pre-frailty or frailty (Fried scale', 'Mean age was 80 years (range\xa0=\xa070-96', 'older adult patients with frailty after myocardial infarction', 'Older adult patients with frailty', 'Older Adult Patients with Frailty']","['exercise intervention', 'Exercise Intervention Versus Usual Care', '3-month exercise program, under physiotherapist supervision, followed by an independent home-based program']","['mortality risk', 'clinical events (mortality or any readmission', 'Fried score', 'Frailty status']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",73.0,0.0922778,"Frailty status improved in the subgroup that participated in the program, although this benefit was attenuated after shifting to a home-based program.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sanchis', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain. Electronic address: sanchis_juafor@gva.es.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Sastre', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'Ruescas', 'Affiliation': 'Departamento de Fisioterapia. Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Ruiz', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Valero', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Bonanad', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'García-Blas', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Fernández-Cisnal', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain.'}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'González', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Miñana', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.09.019']
692,32689839,Inspiratory Muscle Training Potentiates the Beneficial Effects of Proportional Assisted Ventilation on Exertional Dyspnea and Exercise Tolerance in COPD: A Proof-of-Concept Randomized and Controlled Trial.,"During pulmonary rehabilitation, a subset of subjects with COPD requires adjunct therapy to achieve high-intensity training. Both noninvasive ventilation (NIV) and inspiratory muscle training (IMT) are available to assist these subjects. We aimed to prime the respiratory muscles before NIV with IMT, anticipating additive effects for maximal exercise tolerance ( T   lim ) and dyspnea/leg fatigue relief throughout the exercise as primary outcomes. Changes in the respiratory pattern were secondary outcomes. COPD subjects performed a total of four identical constant work rate tests on a cycle ergometer at 75% of maximum work rate, under control ventilation (SHAM, 4 cm H 2 O) or proportional assisted ventilation (PAV, individually adjusted), before and after 10 sessions of high-intensity IMT (three times/week) during 30 days. Two-way RM ANOVA with appropriate corrections were performed. Final analysis in nine subjects showed improved  T   lim  (Δ = 111 s) and lower minute-ventilation (Δ = 4 L . min -1 ) at exhaustion, when comparing the IMT effects within the PAV modality ( p =  0.001 and  p =  0.036, respectively) and improved  T   lim  for PAV  vs.  SHAM (PAV main-effect,  p  = 0.001; IMT main-effect,  p  = 0.006; PAV  vs.  IMT interaction,  p  = 0.034). In addition, IMT + PAV association, compared to PAV alone, resulted in lower respiratory frequency (IMT main-effect,  p  = 0.009; time main-effect,  p  < 0.0001; IMT  vs.  time interaction,  p  = 0.242) and lower inspiratory time related to duty cycle (IMT main-effect,  p  = 0.018; time main-effect,  p  = 0.0001; IMT  vs.  time interaction,  p  = 0.004) throughout exercise. The addition of IMT prior to a PAV-supported aerobic bout potentiates exercise tolerance and dyspnea relief and induces favourable changes in ventilatory pattern in severe COPD during high-intensity training ( Brazilian Registry of Clinical Trials ,  number  RBR-6n3dzz).",2020,"min -1 ) at exhaustion, when comparing the IMT effects within the PAV modality ( p =  0.001 and  p =  0.036, respectively) and improved  T   lim  for PAV  vs.  SHAM","['COPD subjects', 'COPD']","['control ventilation (SHAM, 4\u2009cm H 2 O) or proportional assisted ventilation', 'SHAM', 'noninvasive ventilation (NIV) and inspiratory muscle training (IMT', 'Proportional Assisted Ventilation', 'Inspiratory Muscle Training', 'IMT']","['lower minute-ventilation', 'Exertional Dyspnea and Exercise Tolerance', 'maximal exercise tolerance ( T   lim ) and dyspnea/leg fatigue relief', 'lower inspiratory time related to duty cycle (IMT main-effect']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C3178855', 'cui_str': 'Proportional Assist Ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0449205', 'cui_str': 'LIM'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0682771,"min -1 ) at exhaustion, when comparing the IMT effects within the PAV modality ( p =  0.001 and  p =  0.036, respectively) and improved  T   lim  for PAV  vs.  SHAM","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Koch', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Tiago Rodrigues de Lemos', 'Initials': 'TRL', 'LastName': 'Augusto', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Alessandro Gomes', 'Initials': 'AG', 'LastName': 'Ramos', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Paulo de Tarso', 'Initials': 'PT', 'LastName': 'Müller', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}]",COPD,['10.1080/15412555.2020.1789085']
693,33227569,"A pilot randomized double-blind, placebo-controlled study on the effects of the topical application of pyridoxine on palmar-plantar erythrodysesthesia (PPE) induced by capecitabine or pegylated liposomal doxorubicin (PLD).","PURPOSE


Palmar-Plantar Erythrodysesthesia (PPE) is a dose-limiting adverse event that commonly occurs with capecitabine and Pegylated Liposomal Doxorubicin-PLD treatment. The study aimed to test the effectiveness of a Pyridoxine (B6) treatment protocol in the management of PPE in patients receiving treatment with capecitabine or pegylated liposomal doxorubicin.
METHODS


This was a pilot randomized double-blind, placebo-controlled study. Patients receiving capecitabine or pegylated liposomal doxorubicin with PPE grade 1 or above were randomly allocated to receive pyridoxine or placebo. The PPE grade, Quality of Life-QoL, Pain and patients' activities of daily living were assessed.
RESULTS


Thirty patients were assigned in the Control and 24 in the Intervention group. No statistically significant difference was found in the PPE grade between baseline and week 6 in the 2 groups (p = 0.263). The control group exhibited worst PPE-associated QoL and higher PAIN levels between baseline and week 6. Respectively, the intervention group showed improved PPE-associated QoL and lower PAIN levels. At week 6, the ECOG status in the Intervention group was improved compared to the control (p = 0.018). Patients in the Intervention group experienced better Global Health Status (p = 0.012), Physical (p = 0.003), Emotional (p = 0.008), and Social function (p < 0.001), lower Fatigue (p = 0.001) and Pain (p = 0.006) compared to Control.
CONCLUSION


Topical pyridoxine was not shown to have an effect on the treatment of PPE. However, results demonstrated its effectiveness on health related QoL, QoL-associated with PPE and pain levels. Due to the high attrition rate further validation of these results in a larger population is warranted. CLINICALTRIALS.
GOV IDENTIFIER


NCT02625415.",2021,"Patients in the Intervention group experienced better Global Health Status (p = 0.012), Physical (p = 0.003), Emotional (p = 0.008), and Social function (p < 0.001), lower Fatigue (p = 0.001) and Pain (p = 0.006) compared to Control.
","['patients receiving treatment with', 'Thirty patients', 'with PPE grade 1 or above']","['pyridoxine', 'placebo', 'capecitabine and Pegylated Liposomal Doxorubicin-PLD', 'Topical pyridoxine', 'capecitabine or pegylated liposomal doxorubicin (PLD', 'capecitabine or pegylated liposomal doxorubicin', 'Pyridoxine (B6', 'pyridoxine or placebo']","['ECOG status', 'PPE grade', 'Global Health Status', 'lower Fatigue', 'Pain', ""PPE grade, Quality of Life-QoL, Pain and patients' activities of daily living"", 'palmar-plantar erythrodysesthesia (PPE', 'worst PPE-associated QoL and higher PAIN levels', 'health related QoL, QoL-associated with PPE and pain levels', 'Social function', 'PPE-associated QoL and lower PAIN levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0044369', 'cui_str': '1-dodecylpyridoxal'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",30.0,0.22609,"Patients in the Intervention group experienced better Global Health Status (p = 0.012), Physical (p = 0.003), Emotional (p = 0.008), and Social function (p < 0.001), lower Fatigue (p = 0.001) and Pain (p = 0.006) compared to Control.
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Charalambous', 'Affiliation': 'Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus; University of Turku, Department of Nursing, Finland. Electronic address: andreas.charalambous@cut.ac.cy.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Tsitsi', 'Affiliation': 'Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Astras', 'Affiliation': 'American Medical Center, 215, 2047, B22, Nicosia, Cyprus.'}, {'ForeName': 'Lefkios', 'Initials': 'L', 'LastName': 'Paikousis', 'Affiliation': 'Improvast, Arkadias 7, Fairdeal House, Flat 206, 1048, Nicosia, Cyprus.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Filippou', 'Affiliation': 'Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101866']
694,32692425,Adolescent cannabis and tobacco use are associated with opioid use in young adulthood-12-year longitudinal study in an urban cohort.,"BACKGROUND AND AIMS


Cannabis, tobacco and alcohol use are prevalent among youth in the United States and may be risk factors for opioid use. The current study aimed at investigating associations between developmental trajectories of cannabis, tobacco and alcohol use in adolescence and opioid use in young adulthood in an urban cohort over the span of 12 years.
DESIGN


Cohort study of adolescents originally recruited for a randomized prevention trial with yearly assessments into young adulthood.
SETTING


Nine urban elementary schools in Baltimore, MD in the United States.
PARTICIPANTS


Participants (n = 583, 86.8% African American, 54.7% male) were originally recruited as first grade students.
MEASUREMENTS


Cannabis, tobacco and alcohol use were assessed annually from ages 14-18 years and opioid use from ages 19-26. Socio-demographics were assessed at age 6. Intervention status was also randomly assigned at age 6. Gender, race, free/reduced-priced lunch and intervention status were included as covariates in individual and sequential growth models.
FINDINGS


There were significant positive associations between the cannabis use intercept at age 14 and the opioid use intercept at age 19 (beta = 1.43; P = 0.028), the tobacco use intercept at age 14 and the opioid use intercept at age 19 (beta = 0.82; P = 0.042). Specifically, more frequent use of cannabis or tobacco at age 14 was associated with more frequent use of opioids at age 19.
CONCLUSIONS


Cannabis and tobacco use in early adolescence may be risk factors for opioid use in young adulthood among African Americans living in urban areas.",2021,"Specifically, more frequent use of cannabis or tobacco at age 14 was associated with more frequent use of opioids at age 19.
","['young adulthood in an urban cohort over the span of 12\xa0years', 'young adulthood-12-year longitudinal study in an urban cohort', 'Nine urban elementary schools in Baltimore, MD in the United States', 'African Americans living in urban areas', 'Participants (n\xa0=\xa0583, 86.8% African American, 54.7% male) were originally recruited as first grade students', 'Cohort study of adolescents originally recruited for a randomized prevention trial with yearly assessments into young adulthood']",[],"['Socio-demographics', 'Cannabis, tobacco and alcohol use']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C5191355', 'cui_str': '583'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.0279499,"Specifically, more frequent use of cannabis or tobacco at age 14 was associated with more frequent use of opioids at age 19.
","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Rabinowitz', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC,, USA.'}, {'ForeName': 'Brion S', 'Initials': 'BS', 'LastName': 'Maher', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Ialongo', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15183']
695,32713721,"Effects of time-restricted feeding on body weight, body composition and vital signs in low-income women with obesity: A 12-month randomized clinical trial.","BACKGROUND & AIMS


Time-restricted feeding (TRF) studies usually are of short-term, involving heterogeneous populations, without a control group with similar energy restriction. Besides, it seldom assess vital signs such as body temperature and heart rate, which may be influenced by the fasting state. In this investigation, we assessed the long-term effects of TRF on body weight, body composition and vital signs of low-income women with obesity undergoing diets with the same energy deficit.
METHODS


Low-income women with obesity were randomly allocated to a group with a hypoenergetic diet and 12 h of TRF or to a group with only a hypoenergetic diet, for 12 months. Body fat and waist circumference were estimated using a tetrapolar electrical bioimpedance and an inelastic measuring tape, respectively, at baseline and after 4, 6 and 12 months of intervention. Systolic and diastolic blood pressure, heart rate, and axillary temperature were measured at baseline and 12 months of intervention. The energy content of the diets was determined based on the women's resting metabolic rate (by indirect calorimetry) and level of physical activity (by triaxial accelerometers). Effects were analyzed using an intention-to-treat approach.
RESULTS


Fifty-eight women were randomized and 31 (53.44%) were lost to follow-up at 12 months. Dropout rates were similar between groups. In the intention-to-treat analysis, there were no significant changes in the body weight after 12 months (Differences in changes from baseline between groups: -0.05 95%CI [-2.34; 2.24] Kg; p = 0.96). An increase in axillary temperature (0.40 °C, 95% CI [-0.14; 0.67]°C, p < 0.01), a reduction in the percentage of body fat (-1.64%, 95% CI [-3.08; -0.19]%, p = 0.02) and waist circumference (-2.57 cm, 95% CI [-5.73; 0.58] cm, p = 0.03 in the mixed model involving 4 measurements) were observed in the intervention group, when compared to the control group.
CONCLUSIONS


TRF showed no effects on weight loss. Nevertheless the findings on waist circumference and body fat, although not clinically meaningful, suggest that this strategy may help in the long-term management of obesity in this population, since it is an easy to apply intervention. Axillary temperature findings warrants further investigation. Registered under www.ensaiosclinicos.gov.br Identifier no. RBR-387v6v.
TRIAL REGISTRATION


http://www.ensaiosclinicos.gov.br/rg/RBR-387v6v/.",2021,"An increase in axillary temperature (0.40 °C, 95% CI","['low-income women with obesity', 'low-income women with obesity undergoing diets with the same energy deficit', 'Fifty-eight women', 'Low-income women with obesity']","['RBR-387v6v', 'TRF', 'time-restricted feeding', 'hypoenergetic diet and 12\xa0h of TRF or to a group with only a hypoenergetic diet']","['waist circumference', 'axillary temperature', 'body weight', 'Dropout rates', 'weight loss', 'body weight, body composition and vital signs', 'percentage of body fat', 'Body fat and waist circumference', 'Systolic and diastolic blood pressure, heart rate, and axillary temperature']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1531924', 'cui_str': 'Axillary temperature'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",58.0,0.141779,"An increase in axillary temperature (0.40 °C, 95% CI","[{'ForeName': 'Isabele Rejane', 'Initials': 'IR', 'LastName': 'de Oliveira Maranhão Pureza', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, 57072-900, Cidade Universitária, Maceió-AL, Brazil.'}, {'ForeName': 'André Eduardo', 'Initials': 'AE', 'LastName': 'da Silva Junior', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, 57072-900, Cidade Universitária, Maceió-AL, Brazil.'}, {'ForeName': 'Dafiny Rodrigues', 'Initials': 'DR', 'LastName': 'Silva Praxedes', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, 57072-900, Cidade Universitária, Maceió-AL, Brazil.'}, {'ForeName': 'Laís Gomes', 'Initials': 'LG', 'LastName': 'Lessa Vasconcelos', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, 57072-900, Cidade Universitária, Maceió-AL, Brazil.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'de Lima Macena', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, 57072-900, Cidade Universitária, Maceió-AL, Brazil.'}, {'ForeName': 'Ingrid Sofia', 'Initials': 'IS', 'LastName': 'Vieira de Melo', 'Affiliation': 'Instituto Federal de Alagoas, Rua 17 de agosto, s/n, 57120-000, Satuba-AL, Brazil.'}, {'ForeName': 'Telma Maria', 'Initials': 'TM', 'LastName': 'de Menezes Toledo Florêncio', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, 57072-900, Cidade Universitária, Maceió-AL, Brazil.'}, {'ForeName': 'Nassib Bezerra', 'Initials': 'NB', 'LastName': 'Bueno', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, 57072-900, Cidade Universitária, Maceió-AL, Brazil. Electronic address: nassib.bueno@fanut.ufal.br.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.06.036']
696,32701201,Age-related macular degeneration in a randomized trial of selenium and vitamin E in men: the Select Eye Endpoints (SEE) study (SWOG S0000B).,,2021,,['men'],['selenium and vitamin E'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}]",[],,0.0755668,,"[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Christen', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Darke', 'Affiliation': 'Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Gaziano', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Department of Urology, Cancer Therapy and Research Center, University of Texas Health Science Center, San Antonio, TX, USA.'}]",Acta ophthalmologica,['10.1111/aos.14538']
697,32703721,Effects of Ketogenic metabolic therapy on patients with breast cancer: A randomized controlled clinical trial.,"BACKGROUND


Ketogenic metabolic therapy (KMT) using ketogenic diets (KD) is emerging as viable alternative or complementary strategy for managing cancer; however, few clinical trials have been reported. The present study aimed to evaluate the effects of a KD in patients with locally advanced and metastatic breast cancer receiving chemotherapy.
METHODS


A total of 80 patients undergoing treatment with chemotherapy were randomly assigned to KD or control group for 12 weeks. Concurrent with the admission, midway point, and at 12 weeks, fasting blood samples were collected for evaluation of insulin, IGF-1, CEA, CA15-3, ESR, CRP, IL-10, and TNF-α. Sonography for patients with locally advanced disease and CT or MRI scans for patients with metastatic disease were done on admission and at 12 weeks. At the completion of the chemotherapy, patients with locally advanced disease underwent surgery and stage was recalculated. Also patients with metastases were evaluated for response rate.
RESULTS


TNF-α decreased significantly after 12 weeks of treatment (MD: 0.64 [CI 95%: -3.7, 5] P < 0.001), while IL-10 increased (MD: 0.95 [CI 95%: -1,3] P < 0.001) in the intervention compared to the control group. Patients in the KD group had lower adjusted serum insulin compared to the control group (MD:-1.1 [CI 95%: -3,1] p < 0.002). KD lead to a reduction in tumor size in the KD compared to the control (27 vs 6 mm, P = 0.01). Stage decreased significantly in patients with locally advanced disease in the KD group after 12 weeks (P < 0.01). No significant differences in response rate were observed in patients with metastatic disease.
CONCLUSIONS


KMT in breast cancer patients might exert beneficial effects through decreasing TNF-α and insulin and increasing IL-10. KD may result in a better response through reductions in tumor size and downstaging in patients with locally advanced disease; however, more studies are needed to elucidate the potential beneficial effects of KD in patients with metastases.
TRIAL REGISTRATION


This trial has been registered on Iranian Registry of Clinical Trials (IRCT) under the identification code: IRCT20171105037259N2. https://www.irct.ir/trial/30755.",2021,Stage decreased significantly in patients with locally advanced disease in the KD group after 12 weeks (P < 0.01).,"['80 patients undergoing treatment with', 'patients with locally advanced disease underwent surgery and stage was recalculated', 'patients with locally advanced disease', 'patients with metastases', 'breast cancer patients', 'patients with metastatic disease', 'patients with locally advanced and metastatic breast cancer receiving chemotherapy', 'patients with breast cancer']","['chemotherapy', 'KD', 'Ketogenic metabolic therapy (KMT) using ketogenic diets (KD', 'Ketogenic metabolic therapy']","['insulin, IGF-1, CEA, CA15-3, ESR, CRP, IL-10, and TNF-α. Sonography', 'TNF-α', 'fasting blood samples', 'lower adjusted serum insulin', 'tumor size', 'response rate', 'IL-10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0730490', 'cui_str': 'Stage 1S'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0587059', 'cui_str': 'Metabolic therapy'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0006611', 'cui_str': 'Cancer antigen 15-3'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}]",80.0,0.11375,Stage decreased significantly in patients with locally advanced disease in the KD group after 12 weeks (P < 0.01).,"[{'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Khodabakhshi', 'Affiliation': 'Department of Nutrition, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran; Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Esmaeil', 'Initials': 'ME', 'LastName': 'Akbari', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Mirzaei', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Seyfried', 'Affiliation': 'Department of Biology, Boston College, Chestnut Hill, MA, United States.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kalamian', 'Affiliation': 'Dietary Therapies LLLC, Hamilton, MT, United States.'}, {'ForeName': 'Sayed Hossein', 'Initials': 'SH', 'LastName': 'Davoodi', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Cellular and Molecular Nutrition, Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: khodabakhshiadeleh@yahoo.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.06.028']
698,32694328,The Impact of Unguided Trauma Simulation Practice on Novice Performance: A Randomized Controlled Trial.,"INTRODUCTION


The purpose of this investigation was to determine the impact of simulator practice on task completion time, radiation use, success rate, and overall quality in a simulation of placing a distal locking screw.
METHODS


This was a prospective, randomized control trial with one-to-one randomization and parallel group design. Twenty-eight volunteer novice trainees (medical and premedical students) participated. Using the TraumaVision Virtual Reality Simulator (Swemac, Sweden), subjects performed locking screw placement using the ""perfect circle"" technique. All subjects underwent a pretest and posttest on the simulator. The simulator group completed three additional simulator training sessions. The primary outcome variables were simulator-collected task completion time, success rate, radiation exposure time, and overall score.
RESULTS


No notable difference existed between groups for pretest completion time, radiation use, success rate, or overall score. No notable difference in posttest radiation use or overall procedure score was found between groups. A significant difference existed in posttest total completion time (trained = 251.2 ± 103.4; control = 497.3 ± 223.1; P = 0.001) and success rate (64.3% versus 100%; P = 0.041) between groups. In addition, a significant difference existed in variance between groups for completion time (P = 0.029).
CONCLUSIONS


These findings suggest that independent simulator practice leads to improved speed and success rates; however, radiation use and overall score do not improve in the same manner. The design of simulator-based curriculum must be tailored to specific educational objectives and ultimately validated in the clinical setting.",2021,"No notable difference existed between groups for pretest completion time, radiation use, success rate, or overall score.","['Twenty-eight volunteer novice trainees (medical and premedical students) participated', 'Novice Performance']","['additional simulator training sessions', 'locking screw placement', 'Unguided Trauma Simulation Practice']","['posttest total completion time', 'posttest radiation use or overall procedure score', 'task completion time, radiation use, success rate, and overall quality', 'simulator-collected task completion time, success rate, radiation exposure time, and overall score', 'pretest completion time, radiation use, success rate, or overall score', 'success rate']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038498', 'cui_str': 'Premedical Student'}]","[{'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441273', 'cui_str': 'Locking screw'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}]",28.0,0.168417,"No notable difference existed between groups for pretest completion time, radiation use, success rate, or overall score.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Wang', 'Affiliation': 'From the Department of Orthopaedic Surgery, Mount Sinai Icahn School of Medicine, New York, NY (Dr. Wang), the Department of Orthopaedic Surgery, University of Wisconsin School of Medicine, Madison, WI (Dr. Bernardoni and Dr. Cotter), the Department of Orthopaedic Surgery, Midwest Orthopaedics, Rush University Medical Center, Chicago, IL (Dr. Levine), and the Department of Orthopaedic Surgery, University of Colorado School of Medicine, Denver, CO (Dr. Frank).'}, {'ForeName': 'Eamon D', 'Initials': 'ED', 'LastName': 'Bernardoni', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Cotter', 'Affiliation': ''}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Levine', 'Affiliation': ''}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Frank', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-19-00225']
699,32701172,The effect of orally administered glycerol on anterior chamber depth during cataract surgery in eyes with narrow anterior chambers.,"PURPOSE


Cataract surgery on eyes with shallow anterior chambers may be demanding. Glycerol intake prior to surgery has been a well-known method in an effort to increase anterior chamber depth. It is used since it is thought that glycerol as an osmotic agent causes the vitreous body to shrink, pulling back the iris and thereby deepening the anterior chamber - making the surgery easier. Our controlled clinical trial tests this hypothesis and investigates the effect of glycerol on anterior chamber depth (ACD), intraocular pressure (IOP), corneal thickness (CCT), pupil diameter change after viscodilation (PD), operating time and perioperative complications.
METHODS


We performed a controlled clinical trial. All patients underwent cataract surgery on both eyes with at least 7 days apart. Preoperatively the patient was given glycerol orally when the right eye was operated - when the left eye was operated, nothing was given. In this way, each patient was serving as its own control. Measurements of ACD, IOP and CCT were performed before and after glycerol intake, pupillary diameter was measured before and after viscoelastics during the operation, and operating time and surgical complications were noted.
RESULTS


The study included 22 patients with bilateral cataract and anterior chambers depth <2.5 mm. Glycerol caused the anterior chamber to increase by 0.022 mm (p < 0.05), and IOP was lowered by 5.1 mmHg compared to the control group (p < 0.05). However, exposure to glycerol showed no effect on CCT, pupillary dilation of viscoelastics, operating time or surgical complications.
CONCLUSION


Glycerol increases anterior chamber depth and lowers intraocular pressure significantly. These changes had no significant impact on operating time nor on the complication rate, suggesting that these changes are too subtle to have a clinical impact on the cataract procedure.",2021,"Glycerol caused the anterior chamber to increase by 0.022 mm (p < 0.05), and IOP was lowered by 5.1 mmHg compared to the control group (p < 0.05).","['eyes with shallow anterior chambers', '22 patients with bilateral cataract and anterior chambers depth <2.5\xa0mm', 'eyes with narrow anterior chambers']","['glycerol', 'cataract surgery', 'Glycerol']","['pupillary diameter', 'anterior chamber depth', 'Measurements of ACD, IOP and CCT', 'anterior chamber depth and lowers intraocular pressure', 'IOP', 'operating time and surgical complications', 'anterior chamber depth (ACD), intraocular pressure (IOP), corneal thickness (CCT), pupil diameter change after viscodilation (PD), operating time and perioperative complications', 'complication rate', 'CCT, pupillary dilation of viscoelastics, operating time or surgical complications']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0423276', 'cui_str': 'Shallow anterior chamber of eye'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}]","[{'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0028841', 'cui_str': 'Hypotony of eye'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}]",22.0,0.0321974,"Glycerol caused the anterior chamber to increase by 0.022 mm (p < 0.05), and IOP was lowered by 5.1 mmHg compared to the control group (p < 0.05).","[{'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Nissen', 'Affiliation': 'Department of Ophthalmology, University Hospital of Copenhagen, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Jesper Skovlund', 'Initials': 'JS', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Ophthalmology, University Hospital of Copenhagen, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Jens Christian', 'Initials': 'JC', 'LastName': 'Nørregaard', 'Affiliation': 'Private Practice, Frederiksberg, Denmark.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Storr-Paulsen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Bach-Holm', 'Affiliation': 'Department of Ophthalmology, University Hospital of Copenhagen, Rigshospitalet, Glostrup, Denmark.'}]",Acta ophthalmologica,['10.1111/aos.14543']
700,32700655,Incidence of silent venous thromboembolism after total hip arthroplasty: A comparison of rivaroxaban and enoxaparin.,"PROPOSE


Total hip arthroplasty (THA) is associated with a significant risk of venous thromboembolism (VTE). Different thromboprophylaxis strategies have been used to prevent VTE. The primary aim of this study was to report the incidence of VTE and compare the efficacy and safety of rivaroxaban to enoxaparin. The secondary outcome was to report the incidence of silent deep venous thrombosis (DVT) using computed tomography venography.
METHODS


One hundred sixty patients who underwent THA were enrolled in a prospective study. Patients were randomized into two groups as follows: those who received rivaroxaban 10 mg oral daily (group RXE) and those who received enoxaparin 40 IU/day subcutaneously for 14 days (group ENO).
RESULTS


Both groups were matched for age, sex, comorbidities, special habits and preoperative laboratory investigations. The overall incidence of DVT was 5% ( n  = 8), which included four patients clinically diagnosed as having DVT and four with silent DVT. All the DVT cases occurred in veins below the knee and in the group RXE; none of the cases occurred in group ENO ( p  = 0.04). The incidence of DVT was significantly higher in patients with high body mass indexes ( p  < 0.001), older age ( p  = 0.024) and medical comorbidities ( p  = 0.14). No mortality, pulmonary embolism, stroke, wound infection or major bleeding occurred in either group.
CONCLUSIONS


Among the patients who underwent hip arthroplasty, rivaroxaban prophylaxis was found to be associated with lower efficacy and similar safety outcomes as compared with enoxaparin anticoagulants.",2020,"The incidence of DVT was significantly higher in patients with high body mass indexes ( p  < 0.001), older age ( p  = 0.024) and medical comorbidities ( p  = 0.14).","['One hundred sixty patients who underwent THA were enrolled in a prospective study', 'total hip arthroplasty']","['rivaroxaban', 'enoxaparin', 'rivaroxaban prophylaxis', 'rivaroxaban and enoxaparin']","['overall incidence of DVT', 'No mortality, pulmonary embolism, stroke, wound infection or major bleeding', 'incidence of silent deep venous thrombosis (DVT', 'Incidence of silent venous thromboembolism', 'efficacy and safety', 'medical comorbidities', 'incidence of DVT']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",160.0,0.0228021,"The incidence of DVT was significantly higher in patients with high body mass indexes ( p  < 0.001), older age ( p  = 0.024) and medical comorbidities ( p  = 0.14).","[{'ForeName': 'Wael A', 'Initials': 'WA', 'LastName': 'Rahman', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Gamal H', 'Initials': 'GH', 'LastName': 'Habsa', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'Al-Mohrej', 'Affiliation': 'Department of orthopedics, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hammad', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Naser M', 'Initials': 'NM', 'LastName': 'Selim', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Hammad', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020938865']
701,32740476,Efficacy of Intragastric Balloon Placement and Botulinum Toxin Injection in Bariatric Endoscopy.,"BACKGROUND


To evaluate the results obtained from the combination of intragastric botulinum toxin A (IGBTA), intragastric balloon (IGB), and IGBTA(+)IGB in the treatment of obesity.
MATERIALS AND METHODS


Three separate treatment groups were set up. IGBTA, IGB, and IGBTA(+)IGB were administered to Group 1, 2, and 3, respectively. The body mass indexes (BMI) of patients were measured before and 6 months after the treatment. The intragroup and intergroup treatment results have been evaluated. P<0.05 was considered significant.
RESULTS


The mean BMI decreased by 1.6 kg/m in 40 patients who received IGBTA in group 1 (P<0.001), 3.95 kg/m in 42 patients who received IGB in group 2 (P<0.001), and 4.9 kg/m in 39 patients who received IGBTA and IGB in group 3 (P<0.001) after 6 months of treatment. The intolerance because of the application was the highest in group 3, followed by group 2.
CONCLUSION


The treatment was most successful in group 3 followed by group 2 and group 1, respectively. The authors recommend the group 3 treatment, provided that nausea, vomiting, and flatulence have a high index of probability in such a treatment. However, when deciding between group 1 and group 2 treatments, the authors recommend opting for group 2 treatment that shows to be more efficient.",2020,"The treatment was most successful in group 3 followed by group 2 and group 1, respectively.",['Bariatric Endoscopy'],"['intragastric botulinum toxin A (IGBTA), intragastric balloon (IGB), and IGBTA(+)IGB', 'IGBTA and IGB', 'IGB', 'Intragastric Balloon Placement and Botulinum Toxin Injection']","['mean BMI', 'nausea, vomiting, and flatulence']","[{'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",42.0,0.0453207,"The treatment was most successful in group 3 followed by group 2 and group 1, respectively.","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kanlioz', 'Affiliation': 'Private Beylikduzu Kolan Hospital, Clinic of General Surgery.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Ekici', 'Affiliation': 'Istanbul Gelişim University, Health Science Colleges, Istanbul.'}, {'ForeName': 'Faik', 'Initials': 'F', 'LastName': 'Tatli', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Harran University, Şanliurfa.'}, {'ForeName': 'Turgay', 'Initials': 'T', 'LastName': 'Karatas', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, İnonu University, Malatya, Turkey.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000829']
702,32739355,Exclusive endocrine therapy or partial breast irradiation for women aged ≥70  years with luminal A-like early stage breast cancer (NCT04134598 - EUROPA): Proof of concept of a randomized controlled trial comparing health related quality of life by patient reported outcome measures.,"BACKGROUND


Postoperative radiation therapy after breast conserving surgery in the older adult population is a matter of debate; although radiation therapy was shown to benefit these patients concerning local disease control, the absolute benefit was small and potentially negligible. Partial breast irradiation has been introduced as an alternative treatment approach for low-risk patients. Older adult patients with early breast cancer constitute a unique population with regards to prognosis and potential comorbidities, thus minimizing treatment to maintain health-related quality of life (HRQoL) without compromising survival is extremely important. Estimates of the patient's risk of benefit and/or harm with treatment should be performed together with an assessment of baseline comorbidities, life expectancy, and care preferences. Published data suggest that radiation therapy or endocrine therapy alone resulted in excellent disease control in older women with early breast cancer, and that the combination of both treatments has less incremental benefit than expected. Conversely, the toxicity profile of endocrine therapy is well known, often significantly impacting long term HRQoL of these potentially frail patients.
METHODS


Patients older than 70  years receiving breast conserving surgery with T1N0, Luminal A-like tumors will be randomized to receive partial breast irradiation-alone or endocrine therapy-alone. The main objectives are to determine patient reported outcome measures in terms of HRQoL, as assessed by the EORTC QLQ-C30 using the global health status of patients, and to demonstrate a non-inferior local control rate between arms. Secondary endpoints are represented by individual scales from QLQ-C30 and module QLQ-BR45 scores; ELD14 questionnaire; geriatric COre DatasEt assessment; distant control rate, adverse events rates, breast cancer specific, and overall survival.
DISCUSSION


The EUROPA trial is a new randomized trial focused on older adults (≥70  years) affected by good prognosis primary breast cancer. Our assumption is that postoperative radiation therapy-alone avoids the long-term toxicity of endocrine therapy and favorably impacts on HRQoL in this population. In the current report we present the trial's background and methods, focusing on perspectives in the field of precision medicine.
TRIAL REGISTRATION


The trial is registered with ClinicalTrial.gov Identifier NCT04134598 / EUROPA trial.",2021,"Published data suggest that radiation therapy or endocrine therapy alone resulted in excellent disease control in older women with early breast cancer, and that the combination of both treatments has less incremental benefit than expected.","['Patients older than 70\u202f years receiving breast conserving surgery with T1N0, Luminal A-like tumors', 'older women with early breast cancer', 'Older adult patients with early breast cancer', 'low-risk patients', 'older adults (≥70 \u202fyears) affected by good prognosis primary breast cancer', 'women aged ≥70 \u202fyears with luminal A-like early stage breast cancer (NCT04134598 - EUROPA']","['Postoperative radiation therapy', 'Partial breast irradiation', 'partial breast irradiation-alone or endocrine therapy-alone', 'Exclusive endocrine therapy or partial breast irradiation', 'radiation therapy or endocrine therapy alone']","['toxicity profile', 'individual scales from QLQ-C30 and module QLQ-BR45 scores; ELD14 questionnaire; geriatric COre DatasEt assessment; distant control rate, adverse events rates, breast cancer specific, and overall survival', 'excellent disease control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242751', 'cui_str': 'Europa'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.197402,"Published data suggest that radiation therapy or endocrine therapy alone resulted in excellent disease control in older women with early breast cancer, and that the combination of both treatments has less incremental benefit than expected.","[{'ForeName': 'Icro', 'Initials': 'I', 'LastName': 'Meattini', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""M. Serio"", University of Florence, Florence, Italy; Azienda Ospedaliero Universitaria Careggi, Florence, Italy. Electronic address: icro.meattini@unifi.it.'}, {'ForeName': 'Philip M P', 'Initials': 'PMP', 'LastName': 'Poortmans', 'Affiliation': 'Iridium Kankernetwerk, Wilrijk-Antwerp, Belgium; University of Antwerp, Faculty of Medicine and Health Sciences, Wilrijk-Antwerp, Belgium.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Marrazzo', 'Affiliation': 'Azienda Ospedaliero Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Isacco', 'Initials': 'I', 'LastName': 'Desideri', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""M. Serio"", University of Florence, Florence, Italy; Azienda Ospedaliero Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Brain', 'Affiliation': 'Institut Curie, Hopital René Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Hamaker', 'Affiliation': 'Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Breast Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy; Department of Internal Medicine and Medical Specialties (DiMI), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Miccinesi', 'Affiliation': 'Istituto per lo Studio, la Prevenzione e la Rete Oncologica (ISPRO), Florence, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Russell', 'Affiliation': 'The Netherland Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Calogero', 'Initials': 'C', 'LastName': 'Saieva', 'Affiliation': 'Istituto per lo Studio, la Prevenzione e la Rete Oncologica (ISPRO), Florence, Italy.'}, {'ForeName': 'Vratislav', 'Initials': 'V', 'LastName': 'Strnad', 'Affiliation': 'Universitatklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Visani', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""M. Serio"", University of Florence, Florence, Italy; Azienda Ospedaliero Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Kaidar-Person', 'Affiliation': 'Sheba Tel Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Livi', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""M. Serio"", University of Florence, Florence, Italy; Azienda Ospedaliero Universitaria Careggi, Florence, Italy.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2020.07.013']
703,32723507,Effectiveness of early versus delayed exercise and nutritional intervention on segmental body composition of sarcopenic elders - A randomized controlled trial.,"BACKGROUND & AIMS


Although resistance training with nutritional support is considered the best treatment option for sarcopenia, the importance of home-based exercise should not be overlooked. For managing sarcopenia, a fundamental issue is whether home-based exercise or a supervised training program should be administered first. Therefore, the present trial aimed to compare the effect of early versus delayed exercise intervention with nutritional support on the physical performance and body composition of sarcopenic elders.
METHODS


The study was a randomized controlled trial using a parallel-group design. Each group received two therapeutic periods lasted 12 weeks with an interval of 2 weeks in between. Physical performance and body composition were assessed at baseline and immediately following the end of the first and second phases. One phase included hospital-based resistance training and nutritional support (amino acid, calcium, and vitamin D3), whereas the other phase included home-based exercise. In the early intervention group, supervised exercise and nutrition supplementation were administered first followed by home-based exercise, whereas the sequence was reversed in the delayed intervention group. The influence of intervention sequence on the outcome variables was examined using a 3∗2 repeated-measures analysis of variance. The primary endpoints were defined as changes in lean mass and related physical function (grip strength and gait speed) over 12 and 26 weeks of interventions.
RESULTS


A total of 57 sarcopenic elders were randomly assigned to the early (n = 29) and delayed (n = 28) intervention groups. Among the primary endpoints, the only significant group-time interaction was recognized on the changes of lower extremity lean mass (p = 0.039). The early intervention was associated with an earlier increase in lower extremity lean mass (770.8 g, 95% confidence interval (CI), 564.8 g-976.9 g) than delayed intervention (294.2 g, 95% CI, -42.13 to 630.5 g) which was evident from the between-group comparison between baseline and the 1st follow-up (p = 0.016). No significant effect of group-time interaction was observed on the physical performance and other components of body composition.
CONCLUSIONS


Early exercise and nutritional intervention may be helpful in an earlier restoration of lower extremity muscle mass but not physical function in sarcopenic elders. When designing a rehabilitation program for patients with sarcopenia, resistance training with nutrition support can be prescribed first for the rapid enlargement of the muscle volume, and structuralized home-based exercise can be administered subsequently to preserve the prior intervention effect.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02779088).",2021,The early intervention was associated with an earlier increase in lower extremity lean mass (770.8 ,"['sarcopenic elders', '57 sarcopenic elders']","['hospital-based resistance training and nutritional support (amino acid, calcium, and vitamin D3', 'delayed exercise and nutritional intervention', 'delayed exercise intervention with nutritional support', 'supervised exercise and nutrition supplementation', 'Early exercise and nutritional intervention']","['physical performance and other components of body composition', 'changes of lower extremity lean mass', 'Physical performance and body composition', 'lower extremity lean mass', 'changes in lean mass and related physical function (grip strength and gait speed']","[{'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",57.0,0.0653281,The early intervention was associated with an earlier increase in lower extremity lean mass (770.8 ,"[{'ForeName': 'Ke-Vin', 'Initials': 'KV', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taiwan; Community and Geriatric Medicine Research Center, National Taiwan University Hospital, Bei-Hu Branch, Taiwan; Department of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taiwan; Department of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Chin', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Community and Geriatric Medicine Research Center, National Taiwan University Hospital, Bei-Hu Branch, Taiwan; Department of Family Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Der-Sheng', 'Initials': 'DS', 'LastName': 'Han', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taiwan; Community and Geriatric Medicine Research Center, National Taiwan University Hospital, Bei-Hu Branch, Taiwan; Department of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, Taiwan; Health Science and Wellness Center, National Taiwan University, Taipei, Taiwan. Electronic address: dshan1121@yahoo.com.tw.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.06.037']
704,32747206,Parenteral nutrition impairs plasma bile acid and gut hormone responses to mixed meal testing in lean healthy men.,"BACKGROUND & AIMS


To investigate the acute effects of intravenous vs enteral meal administration on circulating bile acid and gut hormone responses.
METHODS


In a randomized crossover design, we compared the effects of duodenal (via a nasoduodenal tube) vs parenteral (intravenous) administration over 180 min of identical mixed meals on circulating bile acid and gut hormone concentrations in eight healthy lean men. We analysed the bile acid and gut hormone responses in two periods: the intraprandial period from time point (T) 0 until T180 during meal administration and the postprandial period from T180 until T360, after discontinuation of meal administration.
RESULTS


Intravenous meal administration decreased the intraprandial (AUC (μmol/L∗min) duodenal 1469 ± 284 vs intravenous 240 ± 39, p < 0.01) and postprandial bile acid response (985 ± 240 vs 223 ± 5, p < 0.05) and was accompanied by decreased gut hormone responses including glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, glucagon-like peptide 2 and fibroblast growth factor 19. Furthermore, intravenous meal administration elicited greater glucose concentrations, but similar insulin concentrations compared to enteral administration.
CONCLUSIONS


Compared to enteral administration, parenteral nutrition results in lower postprandial bile acid and gut hormone responses in healthy lean men. This was accompanied by higher glucose concentrations in the face of similar insulin concentrations exposing a clear incretin effect of enteral mixed meal administration. The alterations in bile acid homeostasis were apparent after only one intravenous meal.",2021,"284 vs intravenous 240 ± 39, p < 0.01) and postprandial bile acid response (985 ± 240 vs 223 ± 5, p < 0.05) and was accompanied by decreased gut hormone responses including glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, glucagon-like peptide 2 and fibroblast growth factor 19.","['eight healthy lean men', 'healthy lean men', 'lean healthy men']","['duodenal (via a nasoduodenal tube) vs parenteral (intravenous) administration over 180\xa0min of identical mixed meals', 'Parenteral nutrition', 'intravenous vs enteral meal']","['gut hormone responses including glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, glucagon-like peptide 2 and fibroblast growth factor 19', 'glucose concentrations', 'bile acid and gut hormone responses', 'bile acid homeostasis', 'intraprandial (AUC (μmol/L∗min) duodenal 1469\xa0±', 'circulating bile acid and gut hormone responses', 'plasma bile acid and gut hormone responses', 'postprandial bile acid response', 'postprandial bile acid and gut hormone responses', 'insulin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C3204189', 'cui_str': 'Nasoduodenal feeding tube'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0912332', 'cui_str': 'Glucagon-like peptide 2'}, {'cui': 'C1431711', 'cui_str': 'FGF19 protein, human'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",8.0,0.043536,"284 vs intravenous 240 ± 39, p < 0.01) and postprandial bile acid response (985 ± 240 vs 223 ± 5, p < 0.05) and was accompanied by decreased gut hormone responses including glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, glucagon-like peptide 2 and fibroblast growth factor 19.","[{'ForeName': 'Emma C E', 'Initials': 'ECE', 'LastName': 'Meessen', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam University Medical Centers - Location AMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Bakker', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers - Location AMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers - Location AMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Geesje M', 'Initials': 'GM', 'LastName': 'Dallinga-Thie', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers - Location AMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'E Marleen', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Department of Hospital Pharmacy, Amsterdam University Medical Centers - Location AMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Olde Damink', 'Affiliation': 'Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, the Netherlands; Department of General, Visceral and Transplantation Surgery, RWTH University Hospital Aachen, Germany.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Romijn', 'Affiliation': 'Department of Internal Medicine, Amsterdam University Medical Centers - Location AMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences and NNF Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences and NNF Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Albert K', 'Initials': 'AK', 'LastName': 'Groen', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers - Location AMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Schaap', 'Affiliation': 'Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, the Netherlands; Department of General, Visceral and Transplantation Surgery, RWTH University Hospital Aachen, Germany.'}, {'ForeName': 'Maarten R', 'Initials': 'MR', 'LastName': 'Soeters', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam University Medical Centers - Location AMC, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: m.r.soeters@amsterdamumc.nl.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.06.032']
705,32747412,Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial.,"OBJECTIVE


There is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.
DESIGN


Data were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010-2017 ('ASPirin in Reducing Events in the Elderly (ASPREE)', n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.
RESULTS


Over a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.
CONCLUSION


Aspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.
TRIAL REGISTRATION NUMBER


ASPREE. NCT01038583.",2021,"The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.
","[""primary prevention trial conducted throughout 2010-2017 ('ASPirin in Reducing Events in the Elderly (ASPREE)', n=19\u2009114) in community-dwelling persons aged ≥70 years"", 'older persons', 'older people using']","['Aspirin', 'aspirin', 'aspirin versus placebo']","['major GI bleeding that resulted in transfusion, hospitalisation, surgery or death', 'overall GI bleeding risk', 'GI bleeds', 'absolute 5-year risk of bleeding', 'smoking, hypertension, chronic kidney disease and obesity increased bleeding risk', 'bleeding overall', 'fatal bleeds', '5-year absolute risk of serious bleeding', 'Major GI bleeding', 'gastrointestinal bleeding']","[{'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",,0.488227,"The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.
","[{'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mahady', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia suzanne.mahady@monash.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Reid', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Division of Geriatrics, Department of Medicine, Hennepin Healthcare, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ltp', 'Initials': 'L', 'LastName': 'Thao', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}]",Gut,['10.1136/gutjnl-2020-321585']
706,32745170,p16/ki67 and E6/E7 mRNA Accuracy and Prognostic Value in Triaging HPV DNA-Positive Women.,"BACKGROUND


The study presents cross-sectional accuracy of E6 and E7 (E6/E7) mRNA detection and p16/ki67 dual staining, alone or in combination with cytology and human papillomavirus (HPV)16/18 genotyping, as a triage test in HPV DNA-positive women and their impact on cervical intraepithelial neoplasia (CIN2+) overdiagnosis.
METHODS


Women aged 25-64 years were recruited. HPV DNA-positive women were triaged with cytology and tested for E6/E7 mRNA and p16/ki67. Cytology positive women were referred to colposcopy, and negatives were randomly assigned to immediate colposcopy or to 1-year HPV retesting. Lesions found within 24 months since recruitment were included. All P values were 2-sided.
RESULTS


40 509 women were recruited, and 3147 (7.8%) tested HPV DNA positive; 174 CIN2+ were found: sensitivity was 61.0% (95% confidence interval [CI] = 53.6 to 68.0), 94.4% (95% CI = 89.1 to 97.3), and 75.2% (95% CI = 68.1 to 81.6) for cytology, E6/E7 mRNA, and p16/ki67, respectively. Immediate referral was 25.6%, 66.8%, and 28.3%, respectively. Overall referral was 65.3%, 78.3%, and 63.3%, respectively. Cytology or p16/ki67, when combined with HPV16/18 typing, reached higher sensitivity with a small impact on referral. Among the 2306 HPV DNA-positive and cytology-negative women, relative CIN2+ detection in those randomly assigned at 1-year retesting vs immediate colposcopy suggests a -28% CIN2+ regression (95% CI = -57% to +20%); regression was higher in E6/E7 mRNA-negatives (Pinteraction = .29). HPV clearance at 1 year in E6/E7 mRNA and in p16/ki67 negative women was about 2 times higher than in positive women (Pinteraction < .001 for both).
CONCLUSIONS


p16/ki67 showed good performance as a triage test. E6/E7 mRNA showed the highest sensitivity, at the price of too high a positivity rate to be efficient for triage. However, when negative, it showed a good prognostic value for clearance and CIN2+ regression.",2021,"HPV clearance at 1 year in E6/E7 mRNA and in p16/ki67 negatives was about 2 times higher than in positive women (Pinteraction < .001 for both).
","['Women aged 25-64 were recruited', '40,509 women', 'triaging HPV DNA-positive women']","['E6/E7 mRNA detection and p16/ki67 dual staining, alone or in combination with cytology and HPV16/18 genotyping']","['Immediate referral', 'sensitivity', 'relative CIN2+ detection', 'Overall referral', 'p16/ki67 negatives', 'highest sensitivity', 'HPV clearance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3872595', 'cui_str': 'Human papillomavirus DNA'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",40509.0,0.212199,"HPV clearance at 1 year in E6/E7 mRNA and in p16/ki67 negatives was about 2 times higher than in positive women (Pinteraction < .001 for both).
","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giorgi Rossi', 'Affiliation': 'Epidemiology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Carozzi', 'Affiliation': 'ISPRO Oncological Network, Prevention and Research Institute, Regional Laboratory of Cancer Prevention Unit, Florence, Italy.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Ronco', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Allia', 'Affiliation': 'Center for Cervical Cancer Screening, City of Health and Science Hospital, Turin, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Bisanzi', 'Affiliation': 'ISPRO Oncological Network, Prevention and Research Institute, Regional Laboratory of Cancer Prevention Unit, Florence, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gillio-Tos', 'Affiliation': 'Unit of Cancer Epidemiology and Center for Cancer Prevention (CPO), City of Health and Science Hospital, Turin, Italy.'}, {'ForeName': 'Laura De', 'Initials': 'L', 'LastName': 'Marco', 'Affiliation': 'Center for Cervical Cancer Screening, City of Health and Science Hospital, Turin, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Rizzolo', 'Affiliation': 'Unit of Cancer Epidemiology and Center for Cancer Prevention (CPO), City of Health and Science Hospital, Turin, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Gustinucci', 'Affiliation': 'Laboratorio Unico di Screening, Unità Sanitaria Locale Umbria1, Perugia, Italy.'}, {'ForeName': 'Annarosa', 'Initials': 'A', 'LastName': 'Del Mistro', 'Affiliation': 'Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Frayle', 'Affiliation': 'Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Confortini', 'Affiliation': 'ISPRO Oncological Network, Prevention and Research Institute, Regional Laboratory of Cancer Prevention Unit, Florence, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Iossa', 'Affiliation': 'ISPRO Oncological Network, Prevention and Research Institute, Screening Unit, Florence, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cesarini', 'Affiliation': 'Laboratorio Unico di Screening, Unità Sanitaria Locale Umbria1, Perugia, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Bulletti', 'Affiliation': 'Laboratorio Unico di Screening, Unità Sanitaria Locale Umbria1, Perugia, Italy.'}, {'ForeName': 'Basilio', 'Initials': 'B', 'LastName': 'Passamonti', 'Affiliation': 'Laboratorio Unico di Screening, Unità Sanitaria Locale Umbria1, Perugia, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gori', 'Affiliation': 'Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Toniolo', 'Affiliation': 'Assessorato alla Salute, Regione Lazio, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Barca', 'Affiliation': 'Clinical and Experimental Medicine PhD Program, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonvicini', 'Affiliation': 'Epidemiology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Mancuso', 'Affiliation': 'Epidemiology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Venturelli', 'Affiliation': 'Epidemiology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Benevolo', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa105']
707,32725178,Efficacy of a Psychosocial Pain Management Intervention for Men and Women With Substance Use Disorders and Chronic Pain: A Randomized Clinical Trial.,"Importance


Chronic pain is common in those with substance use disorders (SUDs) and predicts poorer addiction treatment outcomes. A critical challenge for addiction treatment is to develop effective methods to improve pain-related and substance use-related outcomes for those in treatment for SUDs.
Objective


To examine the efficacy of an integrated behavioral pain management intervention (Improving Pain During Addiction Treatment [ImPAT]) for men and women with SUDs to treat pain, functioning, and substance use.
Design, Setting, and Participants


In this randomized clinical trial, 8 sessions of ImPAT were compared with 8 sessions of a supportive psychoeducational control (SPC) condition for adults with pain treated at a large residential SUD treatment program. Follow-up occurred at 3, 6, and 12 months postbaseline. A total of 1372 adults were screened, including 960 men and 412 women, and 510 adults were randomized, including 264 men and 246 women. The goal was to recruit approximately equal numbers of men and women to examine results separately in men and women. A total of 470 of 510 participants (92.2%) completed at least 1 follow-up assessment. Data were collected from October 3, 2011, to January 14, 2016. Data were analyzed from February 1, 2016, to May 1, 2020.
Interventions


ImPAT focused on how a psychosocial model of pain was associated with functioning and relapse prevention and provides skills to manage pain. SPC served as the active control condition and involved discussions of topics like nutrition and the course of addiction, which were intended to be relevant to the patient population and to have face validity but be distinct from the content of ImPAT.
Main Outcomes and Measurements


The primary outcomes were pain intensity, pain-related functioning, and behavioral pain tolerance at 12 months. Secondary outcomes were frequency of alcohol and drug use over 12 months.
Results


Of the 510 included participants, the mean (SD) age was 34.8 (10.3) years. A total of 133 men and 122 women were assigned to ImPAT, and a total of 131 men and 124 women were assigned to the SPC condition. Over 12 months of follow-up, randomization to the ImPAT intervention was associated with higher tolerance of pain among men, higher by a mean score of 0.11 (95% CI, 0.03 to 0.18; P = .004; Cohen d = 0.40) at 3 months and by 0.07 (95% CI, -0.01 to 0.19; P = .11; Cohen d = 0.25) at 12 months. Women receiving the ImPAT intervention experienced a reduction in pain intensity from 3 to 12 months, while women receiving the SPC condition experienced an increase in pain intensity, resulting in lower pain in the ImPAT condition by a mean score of 0.58 (95% CI, -0.07 to 1.22; P = .08; Cohen d = -0.22) at 12 months. No differences were found between the ImPAT and SPC conditions on alcohol or drug use.
Conclusions and Relevance


Behavioral pain management is not typically included in addiction treatment, but the present results indicate that this type of intervention was associated with better pain-related outcomes, including pain tolerance in men and pain intensity in women. Improvements in substance use-related outcomes beyond that achieved by treatment as usual were not observed. Treatment programs should consider providing psychosocial pain management services to augment standard addiction treatment.
Trial Registration


ClinicalTrials.gov Identifier: NCT01372267.",2020,"Over 12 months of follow-up, randomization to the ImPAT intervention was associated with higher tolerance of pain among men, higher by a mean score of 0.11 (95% CI, 0.03 to 0.18; P = .004; Cohen d = 0.40) at 3 months and by 0.07 (95% CI, -0.01 to 0.19; P = .11; Cohen d = 0.25) at 12 months.","['men and women with SUDs to treat pain, functioning, and substance use', 'adults with pain treated at a large residential SUD treatment program', 'men and pain intensity in women', 'A total of 470 of 510 participants (92.2%) completed at least 1 follow-up assessment', 'men and women', '1372 adults were screened, including 960 men and 412 women, and 510 adults were randomized, including 264 men and 246 women', 'A total of 133 men and 122 women were assigned to ImPAT, and a total of 131 men and 124 women', 'Men and Women With Substance Use Disorders and Chronic Pain']","['supportive psychoeducational control (SPC) condition', 'Psychosocial Pain Management Intervention', 'ImPAT intervention', 'integrated behavioral pain management intervention (Improving Pain During Addiction Treatment [ImPAT', 'ImPAT']","['frequency of alcohol and drug use over 12 months', 'ImPAT and SPC conditions on alcohol or drug use', 'pain intensity', 'pain intensity, pain-related functioning, and behavioral pain tolerance', 'lower pain', 'pain tolerance', 'tolerance of pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",1372.0,0.146191,"Over 12 months of follow-up, randomization to the ImPAT intervention was associated with higher tolerance of pain among men, higher by a mean score of 0.11 (95% CI, 0.03 to 0.18; P = .004; Cohen d = 0.40) at 3 months and by 0.07 (95% CI, -0.01 to 0.19; P = .11; Cohen d = 0.25) at 12 months.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ilgen', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Lara N', 'Initials': 'LN', 'LastName': 'Coughlin', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Amy S B', 'Initials': 'ASB', 'LastName': 'Bohnert', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chermack', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jannausch', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Frederic C', 'Initials': 'FC', 'LastName': 'Blow', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.2369']
708,32735903,Ultra-Response to Ranibizumab: Improvement by 4 or More Steps in Diabetic Retinopathy Severity in Diabetic Retinopathy Clinical Research Network Protocol S.,"PURPOSE


To quantify and evaluate patients with diabetic retinopathy (DR) who had at least a 4-step improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) in response to treatment with ranibizumab in the Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S study, and factors predictive of such improvements.
DESIGN


Post hoc retrospective analysis of 2-year outcomes in the phase 3 Protocol S study.
PARTICIPANTS


Patients randomized to treatment with ranibizumab 0.5 mg with sufficient baseline DRSS severity (≥47) to allow for an at least 4-step improvement (n = 181).
METHODS


Study eyes received a ranibizumab 0.5 mg injection at baseline and every 4 weeks for 12 weeks, with subsequent as-needed injections. Fundus photographs graded at baseline and years 1 and 2 using DRSS were used for this analysis. The data source is DRCR.net, but analyses, content, and conclusions of this report are solely the responsibility of the authors.
MAIN OUTCOME MEASURES


Proportion of eyes achieving at least a 4-step DRSS improvement (DR ultra-response) at years 1 and 2; treatment course for eyes achieving ultra-response; mean change in best-corrected visual acuity (BCVA) in eyes with and without ultra-response; factors associated with ultra-response (identified by univariate and multivariable analyses).
RESULTS


Approximately 30% of ranibizumab-treated eyes achieved DR ultra-response at year 1 (43/148; 29.1%) and year 2 (38/136; 27.9%); 74% of eyes with ultra-response at year 1 maintained their response at year 2. At year 2, patients with DR ultra-response had gained more than 5 additional ETDRS letters compared with those without DR ultra-response. Multivariable analyses identified presence of vitreous hemorrhage at baseline, increasing age, absence of epiretinal membrane, and glycated hemoglobin below 9 as predictive of DR ultra-response. Mean number of injections received was similar for eyes with versus without DR ultra-response to ranibizumab (mean, 7.4 vs. 7.6 in year 1; mean, 4.2 vs. 3.9 in year 2).
CONCLUSIONS


Approximately 30% of eyes with a DRSS score of at least 47 receiving ranibizumab 0.5 mg per study protocol experienced at least a 4-step DR severity improvement on the DRSS, accompanied by meaningful improvements in BCVA.",2021,"Approximately 30% of eyes with an DRSS score of at least 47 receiving ranibizumab 0.5 mg per study protocol experienced at least 4-step DR severity improvement on the DRSS, accompanied by meaningful improvements in BCVA.","['patients with diabetic retinopathy (DR) who had at least 4-step improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) in response to treatment with', 'Diabetic Retinopathy Severity in DRCR.net Protocol S']","['ranibizumab 0.5 mg with sufficient baseline DRSS severity', 'ranibizumab 0.5 mg injection', 'Ranibizumab', 'ranibizumab']","['Proportion of eyes achieving an at least 4-step DRSS improvement (DR ultra-response', 'visual acuity (BCVA', 'vitreous hemorrhage', 'Mean number of injections', 'BCVA', 'ultra-response', 'DR ultra-response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",181.0,0.139807,"Approximately 30% of eyes with an DRSS score of at least 47 receiving ranibizumab 0.5 mg per study protocol experienced at least 4-step DR severity improvement on the DRSS, accompanied by meaningful improvements in BCVA.","[{'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Chiang', 'Affiliation': 'Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania. Electronic address: achiang@midatlanticretina.com.'}, {'ForeName': 'Sunir J', 'Initials': 'SJ', 'LastName': 'Garg', 'Affiliation': 'Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Klufas', 'Affiliation': 'Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Ho', 'Affiliation': 'Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Ivaylo', 'Initials': 'I', 'LastName': 'Stoilov', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.07.009']
709,32747990,Risk factors of skeletal-related events in patients with bone metastasis from non-small cell lung cancer undergoing treatment with zoledronate-a post hoc analysis of a randomized clinical trial.,"BACKGROUND


Skeletal-related events (SREs) are critical events for patients with bone metastasis from non-small cell lung cancer (NSCLC). Thus, bone-modifying agents are recommended in this population. However, the baseline risk factors of SREs in patients with bone metastasis from NSCLC are not well established.
METHODS


We analyzed the patient-level data from the zoledronate arm of a clinical trial comparing denosumab with zoledronate in patients with bone metastasis ( ClinicalTrial.gov ID: NCT00330759) available at Project Data Sphere, a broad-access research platform. The primary endpoint was the first SRE from the inclusion to the trial, and the time to the first SRE was analyzed using Cox proportional hazards model.
RESULTS


We analyzed 302 patients with NSCLC without a documented history of osteopenia or osteoporosis included in the zoledronate arm of the trial. Ninety-eight patients (32%) had at least one SRE. The univariate analysis showed that low serum albumin and elevated serum alkaline phosphatase (ALP) are significant baseline risk factors for SREs (hazard ratio (HR) [95% confidence interval (CI)]; 2.27 [1.43-3.61], and 1.91 [1.26-2.90], respectively). Additionally, osteoblastic and mixed type of bone metastasis showed a significantly lower risk of SREs compared with the osteolytic lesion (HR [95% CI]; 0.39 [0.21-0.72], and 0.31 [0.15-0.63], respectively). These factors also showed a significant association with the risk of SREs in multivariate analysis.
CONCLUSIONS


We revealed that osteolytic bone metastasis, low serum albumin, and elevated serum ALP are risk factors for SREs in patients with bone metastasis from NSCLC.",2021,The univariate analysis showed that low serum albumin and elevated serum alkaline phosphatase (ALP) are significant baseline risk factors for SREs (hazard ratio (HR),"['patients with bone metastasis from NSCLC', 'Ninety-eight patients (32%) had at least one SRE', 'patients with bone metastasis ( ClinicalTrial.gov ID', 'patients with bone metastasis', '302 patients with NSCLC without a documented history of osteopenia or osteoporosis included in the zoledronate arm of the trial', 'patients with bone metastasis from non-small cell lung cancer undergoing treatment with', 'patients with bone metastasis from non-small cell lung cancer (NSCLC']","['denosumab with zoledronate', 'zoledronate']","['low serum albumin and elevated serum alkaline phosphatase (ALP', 'osteolytic bone metastasis, low serum albumin', 'SREs (hazard ratio (HR', 'time to the first SRE', 'risk of SREs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C3532898', 'cui_str': 'History of osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}]","[{'cui': 'C0580493', 'cui_str': 'Serum albumin low'}, {'cui': 'C0750857', 'cui_str': 'Alkaline phosphatase serum increased'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",302.0,0.277759,The univariate analysis showed that low serum albumin and elevated serum alkaline phosphatase (ALP) are significant baseline risk factors for SREs (hazard ratio (HR),"[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Miyashita', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, New York, NY, USA. miyashita.hirotaka@gmail.com.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Cruz', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, New York, NY, USA.'}, {'ForeName': 'Cardinale', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Division of Hematology and Medical Oncology, Department of Medicine, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05665-w']
710,32753348,Oxidation of dietary linoleate occurs to a greater extent than dietary palmitate in vivo in humans.,"BACKGROUND


It has been suggested that dietary polyunsaturated fatty acids (PUFA) are partitioned into oxidation pathways to a greater extent than dietary saturated fatty acids (SFA). Whilst this has been demonstrated in animal models, evidence in humans is lacking. The potential divergence in the metabolic fate of these dietary fatty acids (FA) may explain some of the reported differences in ectopic fat deposition with SFA and PUFA enriched diets.
AIMS


To compare whole-body oxidation of dietary palmitate and linoleate after consumption of a single test meal.
METHODS


In a randomized, crossover design 24 healthy volunteers (12 males and 12 females, matched for age and BMI) underwent two study days separated by 2-week washout period. During each study day participants consumed a standardized test meal which contained [U 13 C]palmitate or [U 13 C]linoleate. Blood and breath samples were collected over the 6 h postprandial period and the  13 C enrichment in breath CO 2  samples and plasma lipid fractions was determined.
RESULTS


Appearance of  13 C in expired CO 2  was significantly (p < 0.05) increased after consumption of the meal containing [U 13 C]linoleate compared to the meal containing [U 13 C]palmitate. The recovery of tracer was 8.9 ± 1.2% [U 13 C]linoleate vs. 5.6 ± 0.4% [U 13 C]palmitate (p < 0.05). The incorporation of  13 C from [U 13 C]palmitate was greater in plasma triacylglycerol and non-esterified fatty acids than [U 13 C]linoleate, whereas the incorporation of  13 C from [U 13 C]linoleate was greater than [U 13 C]palmitate in plasma phospholipids. Although  13 CO 2  was significantly (p < 0.05) higher in females compared to males after consumption of [U 13 C]palmitate, there was no difference in  13 CO 2  between sexes after consumption of [U 13 C]linoleate.
CONCLUSIONS


We demonstrate that whole-body oxidation of dietary linoleate is comparatively higher than that of dietary palmitate in humans following consumption of a single mixed-test meal. We found indications of sexual dimorphism for dietary palmitate but not dietary linoleate.
STUDY REGISTRATION


http://www.clinicaltrials.org/ ID number NCT03587753.",2021,"RESULTS


Appearance of  13 C in expired CO 2  was significantly (p < 0.05) increased after consumption of the meal containing [U 13 C]linoleate compared to the meal containing [U 13 C]palmitate.","['24 healthy volunteers (12 males and 12 females, matched for age and BMI']","['dietary polyunsaturated fatty acids (PUFA', 'dietary palmitate and linoleate', 'dietary palmitate']","['recovery of tracer', 'Blood and breath samples', 'plasma triacylglycerol and non-esterified fatty acids']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0220871', 'cui_str': 'linoleate'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}]",24.0,0.0206381,"RESULTS


Appearance of  13 C in expired CO 2  was significantly (p < 0.05) increased after consumption of the meal containing [U 13 C]linoleate compared to the meal containing [U 13 C]palmitate.","[{'ForeName': 'Siôn A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Rosqvist', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK; Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cornfield', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Barrett', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK; Oxford NIHR Biomedical Research Centre, Churchill Hospital, Oxford, UK. Electronic address: leanne.hodson@ocdem.ox.ac.uk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.013']
711,32745768,Oxylipin regulation by phenolic compounds from coffee beverage: Positive outcomes from a randomized controlled trial in healthy adults and macrophage derived foam cells.,"Oxylipins are considered biomarkers related to cardiovascular diseases (CVDs). They are generated in vivo via the oxygenation of polyunsaturated fatty acids as a result of oxidative stress and inflammation. Oxylipins are involved in vascular functions and are produced during foam cell formation in atherogenesis. Additionally, the consumption coffee is associated with the regulation on a particular oxylipin group, the F 2t -isoprostanes (F 2t -IsoPs). This function has been attributed to the chlorogenic acids (CGAs) from the coffee beverage. Considering the anti-inflammatory and antioxidant properties of CGAs, we evaluated the effects of two types of coffee that provided 787 mg CGAs/day (Coffee A) and 407 mg CGAs/day (Coffee B) by reducing 35 selected oxylipins in healthy subjects. Furthermore, we assessed the effect of CGAs on the cellular proatherogenic response in foam cells by using an oxidized LDL (oxLDL)-macrophage interaction model. After eight weeks of coffee consumption, the contents of 12 urine oxylipins were reduced. However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs. Neither of the two coffees reduced the levels of oxLDL. Moreover, the in vitro oxylipin induction by oxLDL on foam cells was ameliorated by phenolic acids and CGAs, including the inhibition of IsoPs and PGs by caffeoylquinic and dicaffeoylquinic acids, respectively, while the phenolic acids maintained both antioxidant and anti-inflammatory activities. These findings suggest that coffee antioxidants are strong regulators of oxylipins related to CVDs. The clinical trial was registered on the International Clinical Trials Registry Platform, WHO primary registry (RPCEC00000168).",2020,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","['healthy adults and macrophage derived foam cells', 'healthy subjects']",['CGAs'],"['levels of oxLDL', 'IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0016390', 'cui_str': 'Foam cell'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0055633', 'cui_str': 'Chromogranin A'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0997851', 'cui_str': 'Geodia'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0588372,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","[{'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Lara-Guzmán', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Medina', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Álvarez', 'Affiliation': 'Grupo de Investigación en Sustancias Bioactivas, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Oger', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Durand', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Galano', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Zuluaga', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Gil-Izquierdo', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain. Electronic address: angelgil@cebas.csic.es.'}, {'ForeName': 'Katalina', 'Initials': 'K', 'LastName': 'Muñoz-Durango', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia. Electronic address: kmunoz@serviciosnutresa.com.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.07.020']
712,32761620,Diagnostic workup including CD203c-based basophil activation test in immediate hypersensitivity due to metronidazole and ornidazole and evaluation of cross-reactivity in between.,"BACKGROUND


Little is known about the diagnostic approaches for immediate hypersensitivity reactions (IHRs) due to 5-nitroimidazole antibiotics. The aim was to evaluate the usefulness of in vivo tests and basophil activation test (BAT) for the diagnosis of IHRs due to metronidazole and ornidazole and to determine possible cross-reactivity in between.
METHODS


Forty-nine patients with a clear history of IHRs due to these drugs and 20 healthy subjects who were known to tolerate these drugs were included. Skin tests (STs) and single-blind placebo-controlled drug provocation tests (SBPCDPTs) were performed with both drugs whereas BAT was applied only with the culprit drug.
RESULTS


The most and least common reaction types were urticaria/angioedema (34.7%) and anaphylaxis (14.3%), respectively. SBPCDPTs were positive in 15 out of 47 patients, and only 7 had positive STs. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of STs for metronidazole/ornidazole were 33.3%/16.6%, 94.2%/97.3%, 60%/50%, and 84.6%/88.1%, respectively. BAT was positive in 12 out of 15 patients and negative in 10 control subjects, giving a sensitivity rate of 71.4% (CI, 29.0%-96.3%) for metronidazole and 83.3% (CI, 35.8%-99.5%) for ornidazole. The optimal concentration of both drugs for BAT was determined as 5 mg/mL. No cross-reactivity among two drugs was observed according to in vivo tests.
CONCLUSIONS


Our study showed that SBPCDPT and BAT are both useful diagnostic tools for IHRs due to 5-nitroimidazole antibiotics and can be used as supplementary to each other. No cross-reactivity between metronidazole and ornidazole in IHRs exists.",2021,"The most and least common reaction types were urticaria/angioedema (34.7%) and anaphylaxis (14.3%), respectively.",['Forty-nine patients with a clear history of IHRs due to these drugs and 20 healthy subjects who were known to tolerate these drugs were included'],"['metronidazole', 'SBPCDPT and BAT', 'basophil activation test (BAT', 'Skin tests (STs), and single-blind placebo-controlled drug provocation tests (SBPCDPTs']","['sensitivity rate', 'urticaria/angioedema', 'Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of STs for metronidazole/ornidazole', 'BAT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0020523', 'cui_str': 'IgE-mediated allergic disorder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013168', 'cui_str': 'Drug Control'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0029274', 'cui_str': 'Ornidazole'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}]",49.0,0.0301092,"The most and least common reaction types were urticaria/angioedema (34.7%) and anaphylaxis (14.3%), respectively.","[{'ForeName': 'Şengül', 'Initials': 'Ş', 'LastName': 'Beyaz', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Nilgün', 'Initials': 'N', 'LastName': 'Akdeniz', 'Affiliation': 'Department of Immunology, Aziz Sancar Institute of Experimental Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Immunology, Aziz Sancar Institute of Experimental Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Demir', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Öztop', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Bahauddin', 'Initials': 'B', 'LastName': 'Çolakoğlu', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Suna', 'Initials': 'S', 'LastName': 'Büyüköztürk', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Günnur', 'Initials': 'G', 'LastName': 'Deniz', 'Affiliation': 'Department of Immunology, Aziz Sancar Institute of Experimental Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Aslı', 'Initials': 'A', 'LastName': 'Gelincik', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}]",Allergy,['10.1111/all.14542']
713,32761372,ImpaCt of aspirin regimen on THrombin generation in diabEtic patients with acute coronary syndrome: CARTHaGE-ACS trial.,"BACKGROUND


Diabetes is associated with a high rate of events after acute coronary syndrome. It was recently reported that once-daily aspirin might not provide stable biological efficacy in patients with diabetes.
AIMS


We sought to compare the biological efficacy of aspirin given once a day versus aspirin divided twice per day in a population of diabetic patients with non-ST elevation acute coronary syndrome (NSTE-ACS) as assessed by the thrombin generation test.
METHODS


We performed an open-label single-blind randomized study including 59 consecutive diabetic patients admitted for NSTE-ACS. Patients were randomly treated with aspirin 100 mg once a day (GA100; n = 20), aspirin 160 mg once a day (GA160; n = 19) or aspirin 100 mg twice a day (G2A100; n = 20). The primary endpoint was endogenous thrombin potential (ETP) at discharge and after 6 months.
RESULTS


The mean age of our patients was 61.5 ± 9 years, and 73% were male. The baseline characteristics were comparable between the three groups. In the GA100 group, there was no significant effect on ETP variation at 6 months (1150.46 ± 504.84 vs. 1087.63 ± 454.18; p = 0.794). An increase in aspirin dose with a second daily administration of 100 mg was associated with a significant reduction in ETP at 6 months (1004.87 ± 196.2 vs. 1233.63 ± 333.5; p = 0.003). A nonsignificant decrease in ETP was seen in the GA160 group (from 1173.8 ± 388.07 to 1053.64 ± 269.93 at 6 months, p = 0.117).
CONCLUSION


Only the twice-daily aspirin regimen led to better control of hypercoagulability in NSTE-ACS diabetic patients. However, no thrombin generation normalization was reported.",2021,"In the GA100 group, there was no significant effect on ETP variation at 6 months (1150.46 ± 504.84 vs. 1087.63 ± 454.18; p = 0.794).","['patients with diabetes', 'diabetic patients with non-ST elevation', '59 consecutive diabetic patients admitted for NSTE-ACS', 'The mean age of our patients was 61.5\u2009±\u20099\xa0years, and 73% were male', 'NSTE-ACS diabetic patients', 'diabEtic patients with acute coronary syndrome']","['aspirin 160\xa0mg once a day (GA160; n\u2009=\u200919) or aspirin', 'aspirin']","['thrombin generation normalization', 'ETP variation', 'control of hypercoagulability', 'ETP', 'endogenous thrombin potential (ETP) at discharge and after 6 months', 'biological efficacy', 'THrombin generation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",59.0,0.0963132,"In the GA100 group, there was no significant effect on ETP variation at 6 months (1150.46 ± 504.84 vs. 1087.63 ± 454.18; p = 0.794).","[{'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Boussofara', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia.'}, {'ForeName': 'Lobna', 'Initials': 'L', 'LastName': 'Laroussi', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia. lobna_laroussi@hotmail.com.'}, {'ForeName': 'Hela', 'Initials': 'H', 'LastName': 'Baccouche', 'Affiliation': 'Faculty of Medicine of Tunis- Tunis University El Manar, Tunis, Tunisia.'}, {'ForeName': 'Emna', 'Initials': 'E', 'LastName': 'Bennour', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Kasbaoui', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia.'}, {'ForeName': 'Hbib', 'Initials': 'H', 'LastName': 'Triki', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia.'}, {'ForeName': 'Ibn El Haj', 'Initials': 'EH', 'LastName': 'Zied', 'Affiliation': 'Faculty of Medicine of Tunis- Tunis University El Manar, Tunis, Tunisia.'}, {'ForeName': 'Ikram', 'Initials': 'I', 'LastName': 'Kammoun', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia.'}, {'ForeName': 'Afef Ben', 'Initials': 'AB', 'LastName': 'Halima', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia.'}, {'ForeName': 'Faouzi', 'Initials': 'F', 'LastName': 'Addad', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Marrakchi', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia.'}, {'ForeName': 'Neila Ben', 'Initials': 'NB', 'LastName': 'Romdhane', 'Affiliation': 'Faculty of Medicine of Tunis- Tunis University El Manar, Tunis, Tunisia.'}, {'ForeName': 'Salem', 'Initials': 'S', 'LastName': 'Kachboura', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02969-y']
714,32795561,Comparative Effect of Liuzijue Qigong and Conventional Respiratory Training on Trunk Control Ability and Respiratory Muscle Function in Patients at an Early Recovery Stage From Stroke: A Randomized Controlled Trial.,"OBJECTIVES


To compare the effects of Liuzijue Qigong and conventional respiratory training on trunk control ability and respiratory muscle functions in patients at an early recovery stage from stroke.
DESIGN


A single-blind, randomized controlled trial.
SETTING


A hospital.
PARTICIPANTS


Patients (N=60) within 2 months poststroke.
INTERVENTIONS


The experimental group (n=30) received conventional rehabilitation training combined with Liuzijue exercise, and the control group (n=30) received conventional rehabilitation training combined with conventional respiration training. The training in the 2 groups was conducted 5 times per week for 3 weeks.
MAIN OUTCOME MEASURES


Trunk Impairment Scale (TIS), maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), maximum expiratory mid-flow (MMEF), diaphragmatic movement, the change of intra-abdominal pressure (IAP), Berg Balance Scale (BBS), and Modified Barthel Index (MBI). All outcome measures were assessed twice (at baseline and 3 weeks).
RESULTS


Both groups significantly improved in TIS, MIP, FVC, PEF, and the change of IAP, BBS, and MBI when pre- and postassessments (P<.05) were compared. Compared with the control group, there was a significant difference in the experimental group in the static sitting balance subscale (P=.014), dynamic balance subscale (P=.001), coordination subscale (P<.001), TIS total scores (P<.001; effect size [ES]=0.9), MIP (P=.012; 95% confidence interval [CI], 2.23-17.69; ES=0.67), MEP (P=.015; 95% CI, 1.85-16.57; ES=0.65), change of IAP (P=.001), and MBI (P=.016; 95% CI, 1.51-14.16; ES=0.64). No significant differences were found between the 2 groups in FEV1 (P=.24), FVC (P=.43), PEF (P=.202), MMEF (P=.277), the diaphragmatic movement of quiet breathing (P=.146), deep breathing (P=.102), and BBS (P=.124).
CONCLUSIONS


Liuzijue exercise showed more changes than conventional respiratory training in improving trunk control ability, respiratory muscle functions, and activities of daily living ability in patients at an early recovery stage from stroke.",2021,"Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared.","[' 60 patients within 2 months post-stroke', 'patients at an early recovery stage from stroke']","['Liuzijue Qigong and conventional respiratory training', 'conventional rehabilitation training combined with Liuzijue exercise, the control group', 'conventional rehabilitation training combined with conventional respiration training', 'conventional respiratory training']","['Trunk Impairment Scale (TIS), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), Forced Expiratory Volume in the first second (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Maximum Expiratory Mid-flow (MMEF), diaphragmatic movement, the change of intra-abdominal pressure (IAP), Berg Balance Scale (BBS) and Modified Barthel Index (MBI', 'TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI', 'static sitting balance subscale', 'change of IAP', 'dynamic balance subscale', 'PEF', 'diaphragmatic movement of quiet breathing', 'deep breathing', 'trunk control ability and respiratory muscle function', 'MIP', 'BBS', 'MEP', 'trunk control ability, respiratory muscle functions and ADL ability', 'trunk control ability and respiratory muscle functions', 'TIS total scores', 'FEV1', 'coordination subscale', 'MBI', 'FVC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0232079', 'cui_str': 'Diaphragmatic movement'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",,0.0701272,"Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared.","[{'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China; School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China. Electronic address: ZhangYing032317@163.com.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Shenyuan Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Gaiyan', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yong', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.007']
715,32762462,Faith Beliefs of African American Church Leaders Are Aligned With the Principles of Palliative and Hospice Care: A Community-Based Assessment and Intervention.,"BACKGROUND


African American (AA) church leaders often advise AAs with serious and life-limiting illnesses (LLIs).
OBJECTIVES


1) determine beliefs of AA church leaders about palliative care and hospice care (PCHC), 2) assess association of participants' attitude about encouraging a loved one to learn about PCHC with whether PC or HC is consistent with faith beliefs and can reduce suffering and bring comfort, and 3) evaluate an interactive, educational intervention.
DESIGN


prospective, one group, pre and post assessment of beliefs and attitudes Settings/Subjects: 100 church leaders from 3 AA Churches and one AA Church Consortium.
RESULTS


At baseline, participants held more receptive beliefs about HC than about PC. Those who reported knowing the meaning of PC believed PC is consistent with their faith (81% vs 28%, phi=.53) and can reduce suffering and bring comfort (86% vs 38%, phi =.50). Participants who believed PC was consistent with their faith were more likely to encourage a loved one with a LLI to learn about PCHC than did participants who did not (100% vs 77%, phi =.39, p < 0.001). Post intervention, more participants: 1) perceived that they knew the meaning of PC (48% vs 96%), 2) viewed PC as consistent with their faith (58% vs. 94%), and 3) viewed PC as a means to reduce suffering and bring comfort (67% vs 93%) with a p < 0.0001 for each item. The post intervention results for HC were variable.
CONCLUSIONS


Faith beliefs of AA Church leaders may be aligned with the principles of PCHC.",2021,"Post intervention, more participants: 1) perceived that they knew the meaning of PC (48% vs 96%), 2) viewed PC as consistent with their faith (58% vs. 94%), and 3) viewed PC as a means to reduce suffering and bring comfort (67% vs 93%) with a p < 0.0001 for each item.","['African American Church Leaders', 'beliefs and attitudes Settings/Subjects: 100 church leaders from 3 AA Churches and one AA Church Consortium', 'African American (AA) church leaders']",[],['suffering and bring comfort'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],"[{'cui': 'C0332302', 'cui_str': 'Brought on by'}]",,0.0509667,"Post intervention, more participants: 1) perceived that they knew the meaning of PC (48% vs 96%), 2) viewed PC as consistent with their faith (58% vs. 94%), and 3) viewed PC as a means to reduce suffering and bring comfort (67% vs 93%) with a p < 0.0001 for each item.","[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': '14640Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Hayden', 'Affiliation': '14640Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lynne Allen', 'Initials': 'LA', 'LastName': 'Taylor', 'Affiliation': '14640Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gilbert M', 'Initials': 'GM', 'LastName': 'Arthur', 'Affiliation': 'Pastoral Counselor, 175218Wissahickon Hospice, Philadelphia, PA, USA.'}]",The American journal of hospice & palliative care,['10.1177/1049909120948225']
716,32762590,Communicating value to patients-a high-value care communication skills curriculum.,"INTRODUCTION


With rising health care costs in the United States, trainees will be increasingly challenged in discussing testing stewardship with patients.
OBJECTIVE


We piloted a high-value care (HVC) communication skills curriculum utilizing the Four Habits Model for communication. We hoped residents would 1) learn to apply the Four Habits communication model to HVC discussions with standardized patients (SP) and 2) improve value-based communication skills through training in a high-intensity curriculum with feedback from trained faculty facilitators and peers.
METHODS


Thirty interns at the University of Minnesota were randomized to a standard HVC communication SP encounter (n = 15) or a high-intensity HVC communication skills curriculum (n = 15). The high-intensity curriculum included video and audio-recorded SP encounters followed by facilitated small group discussions/feedback. Experiences were reported in a post-intervention survey; communication skills were assessed with the CARE empathy scale.
RESULTS


70% (21/30) of interns (57% high intensity, 43% standard) responded to the survey. In total, 88% of high intensity v. 44% of standard interns agreed/strongly agreed that the curriculum was valuable for their communication skills. High-intensity interns were more likely to report that feedback was valuable with subsequent incorporation of feedback into future patient encounters. High-intensity participants also reported higher levels of interest in future HVC curricula (55% vs 22%).
CONCLUSION


There was no difference in overall performance on the CARE empathy scale. Our HVC high-intensity skills curriculum was well received by interns and provided opportunities to practice structured conversations and debrief around testing stewardship.",2021,88% of high intensity v. 44% of standard interns agreed/strongly agreed that the curriculum was valuable for their communication skills.,['Thirty interns at the University of Minnesota'],['standard HVC communication SP encounter (n=15) or a high intensity HVC communication skills curriculum'],"['CARE empathy scale', 'overall performance on the CARE empathy scale']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0332911,88% of high intensity v. 44% of standard interns agreed/strongly agreed that the curriculum was valuable for their communication skills.,"[{'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Duran', 'Affiliation': ""Section of Women's Health and General Internal Medicine, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.""}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Donelan', 'Affiliation': 'Department of Emergency Medicine, George Washington University, Washington D.C., USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bowman Peterson', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sophia P', 'Initials': 'SP', 'LastName': 'Gladding', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Weissmann', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Roth', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1807728']
717,32772460,Informing American Muslims about living donation through tailored health education: A randomized controlled crossover trial evaluating increase in biomedical and religious knowledge.,"Biomedical and religious knowledge affects organ donation attitudes among Muslims. We tested the effectiveness of mosque-based, religiously tailored, ethically balanced education on organ donation among Muslim Americans. Our randomized, controlled, crossover trial took place at 4 mosques randomized to an early arm where organ donation education preceded a control educational workshop or a late arm with the order reversed. Primary outcomes were changes in biomedical (Rotterdam Renal Replacement Knowledge Test living donation subscale, R3KT) and religious (Islamic Knowledge of Living Organ Donation, IK-LOD) living kidney donation knowledge. Statistical analysis employed a 2 (Treatment Arm) X 3 (Time of Assessment) mixed-method analysis of variance. Of 158 participants, 59 were in the early arm and 99 in the late arm. A between group t test comparison at Period 1 (Time 1 - Time 2), demonstrated that the early arm had a significantly higher mean IK-LOD (7.11 v 5.19, P < .05) and R3KT scores (7.65 v 4.90, P < .05) when compared to the late arm. Late arm participants also had significant increases in mean IK-LOD (5.19 v 7.16, P < .05) and R3KT scores (4.90 v. 6.81, P < .05) postintervention (Time 2-Time 3). Our novel program thus yielded significant kidney donation-related knowledge gains among Muslim Americans (NCT04443114 Clinicaltrials.gov).",2021,Late arm participants also had significant increases in mean IK-LOD (,"['Muslim Americans', 'Of 158 participants, 59 were in the early arm and 99 in the late arm']","['mosque-based, religiously-tailored, ethically-balanced education', 'control educational workshop']","['mean IK-LOD', 'R3KT scores', 'mean IK-LOD ', 'changes in biomedical (Rotterdam Renal Replacement Knowledge living donation subscale, R3KT) and religious (Islamic Knowledge of Living Organ Donation, IK-LOD) living kidney donation knowledge']","[{'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0562614', 'cui_str': 'Mosque'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}]",158.0,0.0499988,Late arm participants also had significant increases in mean IK-LOD (,"[{'ForeName': 'Aasim I', 'Initials': 'AI', 'LastName': 'Padela', 'Affiliation': 'Initiative on Islam and Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Duivenbode', 'Affiliation': 'Initiative on Islam and Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Quinn', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Milda R', 'Initials': 'MR', 'LastName': 'Saunders', 'Affiliation': 'MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, Illinois, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16242']
718,32776698,"Progressive task-oriented circuit training for cognition, physical functioning and societal participation in individuals with dementia.","BACKGROUND AND OBJECTIVES


Dementia is commonly associated with cognitive deficit, functional decline and societal participation restriction across multiple domains of functioning. The decline impacts not only on the individual, but also on their informal caregivers, healthcare and the social system. This clinical random controlled study investigated the efficacy of 12-week Progressive Task-oriented circuit training on cognition, physical functioning and societal participation of individuals with dementia.
METHODS


This study involved 31 individuals living with dementia recruited from a tertiary health institution in Lagos Nigeria. They were randomized into two groups: Progressive Task-oriented circuit training (involved in 12-week circuit training, two times a week for 70 min per session consisting of six workstations) and Control group (training with conventional treatment and home programmes). They were assessed at baseline, mid-intervention and post-intervention using Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog), Bristol ADLs, Community integration Questionnaire, 6-min walk test. Data analysed using the independent-samples t tests, paired t tests, Friedman two-way analysis of variance and Mann-Whitney U test (p ≤ .05).
RESULTS


Participants were aged 69.61 ± 3.44 years. There was significant improvement from baseline to post-intervention in cognition (30.77 ± 1.02 vs. 28.77 ± 3.30), physical functioning (28.19 ± 3.90 vs. 25.84 ± 6.26) and societal participation (3.64 ± 0.73 vs. 5.59 ± 2.76). However, the progressive Task-oriented circuit training had more significant improvement than the control group within the group in cognition (p = .000), physical functioning (p = .000), and societal participation (p = .000). There was no statistical difference within the Control group with cognition (p = .097), Physical functioning (p = 1.000). Meanwhile there was statistically significant effect between both groups on cognition, physical functioning and societal participation post-intervention (p < .005).
CONCLUSION


Although both Task-oriented Circuit Training and conventional treatment with home exercise programmes are efficacious, Progressive Task-oriented Circuit Training is more efficacious in enhancing and developing therapeutic strategies to train cognition, improve functional performance and societal participation in the rehabilitation of individuals with dementia.",2020,"There was no statistical difference within the Control group with cognition (p = .097), Physical functioning (p = 1.000).","['individuals with dementia', 'Participants were aged 69.61\u2009±\u20093.44\u2009years', '31 individuals living with dementia recruited from a tertiary health institution in Lagos Nigeria']","['Control group (training with conventional treatment and home programmes', 'Progressive Task-oriented circuit training', 'Progressive task-oriented circuit training']","['societal participation', ""Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog), Bristol ADLs, Community integration Questionnaire, 6-min walk test"", 'Physical functioning', 'physical functioning', 'cognition, physical functioning and societal participation post-intervention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",31.0,0.0161671,"There was no statistical difference within the Control group with cognition (p = .097), Physical functioning (p = 1.000).","[{'ForeName': 'Caleb Ademola Omuwa', 'Initials': 'CAO', 'LastName': 'Gbiri', 'Affiliation': 'Department of Physiotherapy, Stroke and Nervous System Disorders Research Group, College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Biliafeez Francisca', 'Initials': 'BF', 'LastName': 'Amusa', 'Affiliation': 'Department of Physiotherapy, Lagos State University Teaching Hospital, Lagos, Nigeria.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1866']
719,32784930,"Safety, Tolerability, Pharmacokinetics, and Concentration-QTc Analysis of Tetrodotoxin: A Randomized, Dose Escalation Study in Healthy Adults.","Tetrodotoxin (TTX) is a highly specific voltage-gated sodium channel (VGSC) blocker in clinical evaluation as a peripheral-acting analgesic for chronic pain. This study presents the first published results of the safety including cardiac liability of TTX at therapeutic-relevant concentrations in twenty-five healthy adults. Randomized, double-blind, placebo-, and positive- (moxifloxacin) controlled study evaluated single ascending doses of 15 µg, 30 µg, and 45 µg TTX over 3 periods with a 7-day washout between each period. Subcutaneous injections of TTX were readily absorbed, reaching maximum plasma concentration (C max ) within 1.5 h. Both extent of exposure (AUC) and C max  increased in proportion to dose. No QT prolongation was identified by concentration-QTc analysis and the upper bounds of the two-sided 90% confidence interval of predicted maximum baseline and placebo corrected QTcF (ΔΔQTcF) value did not exceed 10 ms for all tetrodotoxin doses, thereby meeting the criteria of a negative QT study. Safety assessments showed no clinically relevant changes with values similar between all groups and no subject withdrawing due to adverse events. Paresthesia, oral-paresthesia, headache, dizziness, nausea, and myalgia were the most common TEAEs (overall occurrence ≥5%) in the TTX treatment groups. TTX doses investigated in this study are safe, well-tolerated, and lack proarrhythmic proclivity.",2020,"No QT prolongation was identified by concentration-QTc analysis and the upper bounds of the two-sided 90% confidence interval of predicted maximum baseline and placebo corrected QTcF (ΔΔQTcF) value did not exceed 10 ms for all tetrodotoxin doses, thereby meeting the criteria of a negative QT study.","['Healthy Adults', 'twenty-five healthy adults']","['sodium channel (VGSC) blocker', 'placebo-, and positive- (moxifloxacin', 'Tetrodotoxin (TTX', 'TTX']","['Paresthesia, oral-paresthesia, headache, dizziness, nausea, and myalgia', 'QT prolongation', 'Safety, Tolerability, Pharmacokinetics, and Concentration-QTc Analysis of Tetrodotoxin']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0037492', 'cui_str': 'Sodium Channel'}, {'cui': 'C3494197', 'cui_str': 'Sodium Channels, Voltage-Gated'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0039705', 'cui_str': 'Tetrodotoxin'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0521591', 'cui_str': 'Oral paresthesia'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0039705', 'cui_str': 'Tetrodotoxin'}]",25.0,0.197221,"No QT prolongation was identified by concentration-QTc analysis and the upper bounds of the two-sided 90% confidence interval of predicted maximum baseline and placebo corrected QTcF (ΔΔQTcF) value did not exceed 10 ms for all tetrodotoxin doses, thereby meeting the criteria of a negative QT study.","[{'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Kavoosi', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Terry E', 'Initials': 'TE', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion Inc., Tempe, AZ 85283, USA.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Kavoosi', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chai', 'Affiliation': 'Celerion Inc., Lincoln, NE 68502, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': 'Celerion Inc., Montreal, QC H4M-2P1, Canada.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Korz', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Gallen', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Lester', 'Affiliation': 'Celerion Inc., Tempe, AZ 85283, USA.'}]",Toxins,['10.3390/toxins12080511']
720,32786002,Benzodiazepine Use and Deprescribing in Belgian Nursing Homes: Results from the COME-ON Study.,"BACKGROUND/OBJECTIVES


To describe the use and deprescribing of benzodiazepine receptor agonists (BZRAs) among nursing home residents (NHRs), to evaluate appropriateness of use and to identify factors associated with BZRA use and deprescribing.
DESIGN


Posthoc analysis of the Collaborative Approach to Optimize Medication Use for Older People in Nursing Homes (COME-ON) study, a cluster controlled trial that evaluated the impact of a complex intervention on potentially inappropriate prescriptions (PIPs) in nursing homes (NHs).
SETTING


A total of 54 NHs in Belgium.
PARTICIPANTS


A total of 797 NHRs included in the study who had complete medical, clinical, and medication information at baseline and at the end of the study (month 15).
MEASUREMENTS


Data were recorded by participating healthcare professionals. Reasons why BZRA use was considered as PIPs were assessed using the 2019 American Geriatrics Society Beers Criteria® and the Screening Tool of Older Persons' Prescriptions (STOPP) criteria, version 2. Deprescribing included complete cessation or decreased daily dose. We identified factors at the NHR, prescriber, and NH levels associated with BZRA use and BZRA deprescribing using multivariable binary and multinomial logistic regression, respectively.
RESULTS


At baseline, 418 (52.4%) NHRs were taking a BZRA. The use of BZRA for longer than 4 weeks, with two or more other central nervous system active drugs, and in patients with delirium, cognitive impairment, falls, or fractures was found in more than 67% of BZRA users. Eight NHR-related variables and two prescriber-related variables were associated with regular BZRA use. Deprescribing occurred in 28.1% of BZRA users (32.9% in the intervention group and 22.1% in the control group). In addition to four other factors, dementia (odds ratio [OR] = 2.35; 95% confidence interval [CI] = [1.45-3.83]) and intervention group (OR = 1.74; 95% CI = 1.07-2.87) were associated with deprescribing.
CONCLUSION


Use of BZRAs was highly prevalent, and reasons to consider it as PIP were frequent. Deprescribing occurred in one-fourth of NHRs, which is encouraging. Future interventions should focus on specific aspects of PIPs (ie, indication, duration, drug-drug and drug-disease interactions) as well as on nondementia patients.",2020,"In addition to four other factors, dementia (odds ratio [OR] = 2.35; 95% confidence interval [CI] = [1.45-3.83]) and intervention group (OR = 1.74; 95% CI = 1.07-2.87) were associated with deprescribing.
","['nursing homes (NHs', 'A total of 54 NHs in Belgium', 'nursing home residents (NHRs', ""2019 American Geriatrics Society Beers Criteria® and the Screening Tool of Older Persons' Prescriptions (STOPP) criteria, version 2"", 'Older People in Nursing Homes', 'Belgian Nursing Homes', 'A total of 797 NHRs included in the study who had complete medical, clinical, and medication information at baseline and at the end of the study (month 15']","['benzodiazepine receptor agonists (BZRAs', 'complex intervention', 'Benzodiazepine', 'BZRA', 'BZRAs']",['Deprescribing'],"[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C4042847', 'cui_str': 'de Beers Criteria'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205923', 'cui_str': 'Benzodiazepine Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]",[],,0.0500697,"In addition to four other factors, dementia (odds ratio [OR] = 2.35; 95% confidence interval [CI] = [1.45-3.83]) and intervention group (OR = 1.74; 95% CI = 1.07-2.87) were associated with deprescribing.
","[{'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Evrard', 'Affiliation': 'Clinical Pharmacy Research Group, Université Catholique de Louvain, Louvain Drug Research Institute, Brussels, Belgium.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Henrard', 'Affiliation': 'Clinical Pharmacy Research Group, Université Catholique de Louvain, Louvain Drug Research Institute, Brussels, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Foulon', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Spinewine', 'Affiliation': 'Clinical Pharmacy Research Group, Université Catholique de Louvain, Louvain Drug Research Institute, Brussels, Belgium.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16751']
721,32800386,Long-term effects of folic acid and vitamin-B12 supplementation on fracture risk and cardiovascular disease: Extended follow-up of the B-PROOF trial.,"BACKGROUND & AIMS


In the initial B-proof, we found inconsistent results of B vitamin supplementation. However, the debate regarding the effects of B vitamins on age-related diseases continues. Therefore, our aim was to investigate the long-term effects (5-7 years follow-up) of an intervention with folic acid and vitamin-B12 supplementation on fracture and cardiovascular disease risk.
METHODS


Extended follow-up of the B-PROOF trial, a multi-center, double-blind randomized placebo-controlled trial designed to assess the effect of 2-3 years daily supplementation with folic acid (400 μg) and vitamin-B12 (500 μg) versus placebo (n = 2,919). Primary outcome was verified self-reported fracture incidence and secondary outcomes were self-reported cardiovascular endpoints, which were collected through a follow-up questionnaires Proportional hazard analyses was used for the effect of the intervention on risk of fracture(s) and logistic regression for the effect of the intervention on risk of cardiovascular disease.
RESULTS


A total of 1,298 individuals (44.5%) participated in the second follow-up round with median of 54 months [51-58], (n = 662 and n = 636, treatment versus placebo group). Median age at baseline was 71.0 years [68.0-76.0] for both groups. No effect was observed of the intervention on osteoporotic fracture or any fracture risk after a follow-up (HR: 0.99, 95% CI: 0.62-1.59 and HR: 0.77; 95% CI: 0.50-1.19, respectively), nor on cardiovascular or cerebrovascular disease risk (OR: 1.05; 95%CI: 0.80-1.44 and OR: 0.85; 95%CI: 0.50-1.45, respectively). Potential interaction by baseline homocysteine concentration was observed for osteoporotic- and any fracture (p = 0.10 and 0.06 respectively), which indicated a significantly lower risk of any fracture in the treatment group with higher total homocysteine concentrations (>15.1 μmol/l). No age-dependent effects were present.
CONCLUSIONS


This study supports and extends previous null-findings of the B-PROOF trial and shows that supplementation of folic acid and vitamin-B12 has no effect on fracture risk, nor on cardiovascular disease in older individuals over a longer follow-up period. However, B-vitamin supplementation may be beneficial in reducing fractures in individuals with high total homocysteine concentrations, a finding which needs to be replicated.",2021,"No effect was observed of the intervention on osteoporotic fracture or any fracture risk after a follow-up (HR: 0.99, 95% CI: 0.62-1.59 and HR: 0.77; 95% CI: 0.50-1.19, respectively), nor on cardiovascular or cerebrovascular disease risk (OR: 1.05; 95%CI: 0.80-1.44 and OR: 0.85; 95%CI: 0.50-1.45, respectively).","['1,298 individuals (44.5%) participated in the second follow-up round with median of 54 months [51-58], (n\xa0=\xa0662 and n\xa0=\xa0636, treatment versus placebo group']","['folic acid (400\xa0μg) and vitamin-B12 (500\xa0μg) versus placebo', 'folic acid and vitamin-B12', 'B vitamins', 'vitamin supplementation', 'folic acid and vitamin-B12 supplementation', 'placebo']","['osteoporotic fracture or any fracture risk', 'baseline homocysteine concentration', 'total homocysteine concentrations', 'fracture risk and cardiovascular disease', 'cardiovascular or cerebrovascular disease risk', 'verified self-reported fracture incidence and secondary outcomes were self-reported cardiovascular endpoints', 'risk of cardiovascular disease']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0302837', 'cui_str': 'Vitamin supplement agent'}, {'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}]","[{'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.549828,"No effect was observed of the intervention on osteoporotic fracture or any fracture risk after a follow-up (HR: 0.99, 95% CI: 0.62-1.59 and HR: 0.77; 95% CI: 0.50-1.19, respectively), nor on cardiovascular or cerebrovascular disease risk (OR: 1.05; 95%CI: 0.80-1.44 and OR: 0.85; 95%CI: 0.50-1.45, respectively).","[{'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Oliai Araghi', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: s.oliaiaraghi@erasmusmc.nl.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Kiefte-de Jong', 'Affiliation': 'Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Public Health and Primary Care, Leiden University Medical Center/LUMC Campus, The Hague, the Netherlands.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Geriatric Medicine, Franciscus Gasthuis & Vlietland, Schiedam, the Netherlands.'}, {'ForeName': 'Karin M A', 'Initials': 'KMA', 'LastName': 'Swart', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Kim J', 'Initials': 'KJ', 'LastName': 'Ploegmakers', 'Affiliation': 'Amsterdam UMC, (University) of Amsterdam, Section of Geriatric Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M Carola', 'Initials': 'MC', 'LastName': 'Zillikens', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Natasja M', 'Initials': 'NM', 'LastName': 'van Schoor', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Lisette C P G M', 'Initials': 'LCPGM', 'LastName': 'de Groot', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lips', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Internal Medicine, Endocrine Section, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Bruno H', 'Initials': 'BH', 'LastName': 'Stricker', 'Affiliation': 'Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'André G', 'Initials': 'AG', 'LastName': 'Uitterlinden', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'van der Velde', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Amsterdam UMC, (University) of Amsterdam, Section of Geriatric Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.033']
722,32768315,"Effects of high versus standard essential amino acid intakes on whole-body protein turnover and mixed muscle protein synthesis during energy deficit: A randomized, crossover study.","BACKGROUND & AIMS


Consuming 0.10-0.14 g essential amino acids (EAA)/kg/dose (0.25-0.30 g protein/kg/dose) maximally stimulates muscle protein synthesis (MPS) during energy balance. Whether consuming EAA beyond that amount enhances MPS and whole-body anabolism following energy deficit is unknown. The aims of this study were to determine the effects of standard and high EAA ingestion on mixed MPS and whole-body protein turnover following energy deficit.
DESIGN


Nineteen males (mean ± SD; 23 ± 5 y; 25.4 ± 2.7 kg/m 2 ) completed a randomized, double-blind crossover study consisting of two, 5-d energy deficits (-30 ± 4% of total energy requirements), separated by 14-d. Following each energy deficit, mixed MPS and whole-body protein synthesis (PS), breakdown (PB), and net balance (NET) were determined at rest and post-resistance exercise (RE) using primed, constant L-[ 2 H 5 ]-phenylalanine and L-[ 2 H 2 ]-tyrosine infusions. Beverages providing standard (0.1 g/kg, 7.87 ± 0.87 g) or high (0.3 g/kg, 23.5 ± 2.54 g) EAA were consumed post-RE. Circulating EAA were measured.
RESULTS


Postabsorptive mixed MPS (%/h) at rest was not different (P = 0.67) between treatments. Independent of EAA, postprandial mixed MPS at rest (standard EAA, 0.055 ± 0.01; high EAA, 0.061 ± 0.02) and post-RE (standard EAA, 0.055 ± 0.01; high EAA, 0.065 ± 0.02) were greater than postabsorptive mixed MPS at rest (P = 0.02 and P = 0.01, respectively). Change in (Δ postabsorptive) whole-body (g/180 min) PS and PB was greater for high than standard EAA [mean treatment difference (95% CI), 3.4 (2.3, 4.4); P = 0.001 and -15.6 (-17.8, -13.5); P = 0.001, respectively]. NET was more positive for high than standard EAA [19.0 (17.3, 20.7); P = 0.001]. EAA concentrations were greater in high than standard EAA (P = 0.001).
CONCLUSIONS


These data demonstrate that high compared to standard EAA ingestion enhances whole-body protein status during underfeeding. However, the effects of consuming high and standard EAA on mixed MPS are the same during energy deficit.
CLINICAL TRIAL REGISTRY


NCT03372928, https://clinicaltrials.gov.",2021,"RESULTS


Postabsorptive mixed MPS (%/h) at rest was not different (P = 0.67) between treatments.","['Nineteen males (mean\xa0±\xa0SD; 23\xa0±', 'energy deficit', 'y; 25.4\xa0±\xa02.7\xa0kg/m 2 ']","['high versus standard essential amino acid intakes', 'resistance exercise (RE) using primed, constant L-[ 2 H 5 ]-phenylalanine and L', 'standard and high EAA ingestion']","['Circulating EAA', 'EAA concentrations', 'PS and PB', 'mixed MPS and whole-body protein synthesis (PS), breakdown (PB), and net balance (NET']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0556115', 'cui_str': 'Essential amino acid intake'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.113231,"RESULTS


Postabsorptive mixed MPS (%/h) at rest was not different (P = 0.67) between treatments.","[{'ForeName': 'Jess A', 'Initials': 'JA', 'LastName': 'Gwin', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA; Oak Ridge Institute for Science and Education, Belcamp, MD, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Church', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Hatch-McChesney', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Howard', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA; Oak Ridge Institute for Science and Education, Belcamp, MD, USA.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Carrigan', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Murphy', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Marques A', 'Initials': 'MA', 'LastName': 'Wilson', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Margolis', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Carbone', 'Affiliation': 'School of Health Sciences, Eastern Michigan University, Ypsilanti, MI, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Pasiakos', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, MA, USA. Electronic address: stefan.m.pasiakos.civ@mail.mil.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.019']
723,32781050,"Systemic Inflammation, Vascular Function, and Endothelial Progenitor Cells after an Exercise Training Intervention in COPD.","BACKGROUND


Exercise training is a cornerstone of the treatment of chronic obstructive pulmonary disease (COPD) in all disease stages. Data about the training effects with supplemental oxygen in nonhypoxemic patients remains inconclusive. In this study we set out to investigate the training and oxygen effects on inflammatory markers, vascular function, and endothelial progenitor cells in this population of increased cardiovascular risk.
METHODS


In this prospective, randomized, double-blind, crossover study, 29 patients with nonhypoxemic COPD performed combined endurance and strength training 3 times a week while breathing medical air or supplemental oxygen for the first 6-week period, and were then reallocated to the opposite gas for the following 6 weeks. Exercise capacity, inflammatory biomarkers, endothelial function (peripheral arterial tone analysis), and endothelial progenitor cells were assessed. Data were also analyzed for a subgroup with endothelial dysfunction (reactive hyperemia index <1.67).
RESULTS


Following 12 weeks of exercise training, patients demonstrated a significant improvement of peak work rate and an associated decrease of blood fibrinogen and leptin. Eosinophils were found significantly reduced after exercise training in patients with endothelial dysfunction. In this subgroup, peripheral arterial tone analysis revealed a significant improvement of reactive hyperemia index. Generally, late endothelial progenitor cells were found significantly reduced after the exercise training intervention. Supplemental oxygen during training positively influenced the effect on exercise capacity without impact on inflammation and endothelial function.
CONCLUSIONS


This is the first randomized controlled trial in patients with COPD to show beneficial effects of exercise training not only on exercise capacity, but also on systemic/eosinophilic inflammation and endothelial dysfunction.",2021,"Following 12 weeks of exercise training, patients demonstrated a significant improvement of peak work rate and an associated decrease of blood fibrinogen and leptin.","['29 patients with non-hypoxemic COPD performed', 'patients with COPD', 'patients with endothelial dysfunction']","['combined endurance and strength training three times a week while breathing medical air or supplemental oxygen', 'Exercise Training Intervention', 'Exercise training', 'exercise training']","['inflammatory markers, vascular function and endothelial progenitor cells', 'Eosinophils', 'blood fibrinogen and leptin', 'peak work rate', 'Exercise capacity, inflammatory biomarkers, endothelial function (Peripheral Arterial Tone analysis) and endothelial progenitor cells', 'RHI', 'Systemic Inflammation, Vascular Function and Endothelial Progenitor Cells', 'systemic/eosinophilic inflammation and endothelial dysfunction', 'endothelial dysfunction (Reactive Hyperemia Index', 'late endothelial progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0853182', 'cui_str': 'Blood fibrinogen'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3687252', 'cui_str': 'Eosinophilic inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",29.0,0.115684,"Following 12 weeks of exercise training, patients demonstrated a significant improvement of peak work rate and an associated decrease of blood fibrinogen and leptin.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Neunhäuserer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Patti', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Division of Cardiology, University Heart Centre, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kaiser', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University of Salzburg, Austria.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Cadamuro', 'Affiliation': 'Department of Laboratory Medicine, Paracelsus Medical University of Salzburg, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lamprecht', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University of Salzburg, Austria; Department of Pulmonary Medicine, Faculty of Medicine, Kepler-University-Hospital, Johannes-Kepler-University, Linz, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ermolao', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Studnicka', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University of Salzburg, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University of Salzburg, Austria. Electronic address: j.niebauer@salk.at.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.07.004']
724,32800385,High protein versus medium protein delivery under equal total energy delivery in critical care: A randomized controlled trial.,"BACKGROUND


Appropriate protein delivery amounts during the acute phase of critical care are unknown. Along with nutrition, early mobilization and the combination are important. We conducted a randomized controlled trial during critical care to assess high-protein and medium-protein delivery under equal total energy delivery with and without active early rehabilitation.
METHODS


ICU patients of August 2018-September 2019 were allocated to a high-protein group (target energy 20 kcal/kg/day, protein 1.8 g/kg/day) or a medium-protein group (target energy 20 kcal/kg/day, protein 0.9 g/kg/day) with the same nutrition protocol by day 10. By dividing the study period, standard rehabilitation was administered during the initial period. Rehabilitation with belt-type electrical muscle stimulation was given from day 2 in the latter as a historical comparison. Femoral muscle volume was evaluated on day 1 and day 10 using computed tomography.
RESULTS


This study analyzed 117 eligible patients with similar characteristics assigned to a high-protein or medium-protein group. Total energy delivery was around 20 kcal/kg/day in both groups, but protein delivery was 1.5 g/kg/day and 0.8 g/kg/day. As a primary outcome, femoral muscle volume loss was 12.9 ± 8.5% in the high-protein group and 16.9 ± 7.0% in the medium-protein group, with significant difference (p = 0.0059). Persistent inflammation, immunosuppression, and catabolism syndrome were significantly less frequent in the high-protein group. Muscle volume loss was significantly less in the high-protein group only during the electrical muscle stimulation period.
CONCLUSIONS


For critical care, high protein delivery provided better muscle volume maintenance, but only with active early rehabilitation.
REGISTRATION


University Hospital Medical Information Network, UMIN000033783 Registered on 16 Aug 2018. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038538.",2021,"Persistent inflammation, immunosuppression, and catabolism syndrome were significantly less frequent in the high-protein group.","['critical care', 'ICU patients of August 2018-September 2019', '117 eligible patients with similar characteristics assigned to a high-protein or medium-protein group']","['High protein versus medium protein delivery', 'Rehabilitation with belt-type electrical muscle stimulation', 'high-protein and medium-protein delivery under equal total energy delivery with and without active early rehabilitation', 'high-protein group (target energy 20\xa0kcal/kg/day, protein 1.8\xa0g/kg/day) or a medium-protein']","['Persistent inflammation, immunosuppression, and catabolism syndrome', 'Muscle volume loss', 'femoral muscle volume loss', 'Femoral muscle volume', 'Total energy delivery']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1690969', 'cui_str': 'Kcal/kg/day'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}]","[{'cui': 'C1265824', 'cui_str': 'Persistent inflammation'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",117.0,0.0284124,"Persistent inflammation, immunosuppression, and catabolism syndrome were significantly less frequent in the high-protein group.","[{'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: knakamura-tky@umin.ac.jp.'}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Nakano', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: be.rann1988jp@gmail.com.'}, {'ForeName': 'Hiromu', 'Initials': 'H', 'LastName': 'Naraba', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan; TXP Medical Co. Ltd., 3-13 Nihonbashiyokoyamacho, Chuo-ku, Tokyo, 103-0003, Japan. Electronic address: nrbhrm@gmail.com.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: kurakan72@gmail.com.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: yuji.mail@icloud.com.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sonoo', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan; TXP Medical Co. Ltd., 3-13 Nihonbashiyokoyamacho, Chuo-ku, Tokyo, 103-0003, Japan. Electronic address: sonopy77@gmail.com.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: hidehashimoto-tky@umin.ac.jp.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Morimura', 'Affiliation': 'Department of Emergency and Critical Care Medicine, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo, Tokyo, 113-8655, Japan. Electronic address: molimula@r6.dion.ne.jp.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.036']
725,32768569,The effect of conservative oxygen therapy on systemic biomarkers of oxidative stress in critically ill patients.,"BACKGROUND


Supplemental oxygen is delivered to critically ill patients who require mechanical ventilation. Oxidative stress is a potential complication of oxygen therapy, resulting in damage to essential biomolecules such as proteins, lipids, and nucleic acids. Whether plasma levels of oxidative stress biomarkers vary based on how liberally oxygen therapy is applied during mechanical ventilation is unknown.
METHODS


We carried out an oxidative stress substudy nested within a large multi-centre randomized controlled trial in which critically ill adults were randomized to receive either conservative oxygen therapy or standard oxygen therapy. Blood samples were collected at enrolment, and daily thereafter for up to three days. The antioxidant ascorbate (vitamin C) was assessed using HPLC with electrochemical detection and protein oxidation using a sensitive protein carbonyl ELISA. We also assessed whether critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers.
RESULTS


A total of 125 patients were included. Mean ascorbate concentrations decreased over time (from 25 ± 9 μmol/L to 14 ± 2 μmol/L, p < 0.001), however, there was no significant difference between the conservative oxygen group and standard care (p = 0.2), despite a significantly lower partial pressure of oxygen (PaO 2 ) in the conservative oxygen group (p = 0.03). Protein carbonyl concentrations increased over time (from 208 ± 30 μmol/L to 249 ± 29 μmol/L; p = 0.016), however, there was no significant difference between the conservative and standard oxygen groups (p = 0.3). Patients with sepsis had significantly higher protein carbonyl concentrations than the other critically ill patients (293 ± 92 μmol/L vs 184 ± 24 μmol/L, p = 0.03). Within the septic subgroup, there were no significant differences in protein carbonyl concentrations between the two interventions (p = 0.4).
CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy. Patients with sepsis exhibited elevated protein carbonyls compared with the other critically ill patients implying increased oxidative stress in this patient subgroup.",2020,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","['critically ill adults', 'critically ill patients', 'critically ill ventilated patients', 'critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers', 'A total of 125 patients were included', 'critically ill patients who require mechanical ventilation']","['conservative oxygen therapy', 'antioxidant ascorbate (vitamin C', 'Conservative oxygen therapy', 'standard oxygen therapy', 'conservative oxygen therapy or standard oxygen therapy']","['Mean ascorbate concentrations', 'systemic biomarkers of oxidative stress', 'oxidative stress', 'Blood samples', 'protein carbonyl concentrations', 'Protein carbonyl concentrations', 'systemic markers of oxidative stress', 'partial pressure of oxygen (PaO 2 ']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}]",125.0,0.329893,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","[{'ForeName': 'Anitra C', 'Initials': 'AC', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: anitra.carr@otago.ac.nz.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Judd', 'Affiliation': 'Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrtens', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Parker', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Stockwell', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, Australia; College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.018']
726,32811743,"Outcomes of open ""crown"" type v. percutaneous Bunnell type repair of acute Achilles tendon ruptures. Randomized control study.",,2020,,['acute Achilles tendon ruptures'],"['open ""crown"" type v. percutaneous Bunnell type repair']",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.0970176,,"[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Carmont', 'Affiliation': 'The Department of Trauma & Orthopaedic Surgery, Princess Royal Hospital, Shrewsbury & Telford Hospital NHS Trust, Shropshire, United Kingdom; The Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, Gothenburg University, Sweden. Electronic address: mcarmont@hotmail.com.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2020.08.001']
727,32778876,Effect of Aspirin on Cancer Incidence and Mortality in Older Adults.,"BACKGROUND


ASPirin in Reducing Events in the Elderly, a randomized, double-blind, placebo-controlled trial of daily low-dose aspirin (100 mg) in older adults, showed an increase in all-cause mortality, primarily due to cancer. In contrast, prior randomized controlled trials, mainly involving younger individuals, demonstrated a delayed cancer benefit with aspirin. We now report a detailed analysis of cancer incidence and mortality.
METHODS


19 114 Australian and US community-dwelling participants aged 70 years and older (US minorities 65 years and older) without cardiovascular disease, dementia, or physical disability were randomly assigned and followed for a median of 4.7 years. Fatal and nonfatal cancer events, a prespecified secondary endpoint, were adjudicated based on clinical records.
RESULTS


981 cancer events occurred in the aspirin and 952 in the placebo groups. There was no statistically significant difference between groups for all incident cancers (hazard ratio [HR] = 1.04, 95% confidence interval [CI] = 0.95 to 1.14), hematological cancer (HR = 0.98, 95% CI = 0.73 to 1.30), or all solid cancers (HR = 1.05, 95% CI = 0.95 to 1.15), including by specific tumor type. However, aspirin was associated with an increased risk of incident cancer that had metastasized (HR = 1.19, 95% CI = 1.00 to 1.43) or was stage 4 at diagnosis (HR = 1.22, 95% CI = 1.02 to 1.45), and with higher risk of death for cancers that presented at stages 3 (HR = 2.11, 95% CI = 1.03 to 4.33) or 4 (HR = 1.31, 95% CI = 1.04 to 1.64).
CONCLUSIONS


In older adults, aspirin treatment had an adverse effect on later stages of cancer evolution. These findings suggest that in older persons, aspirin may accelerate the progression of cancer and, thus, suggest caution with its use in this age group.",2021,"However, aspirin was associated with an increased risk of incident cancer that had metastasized (HR = 1.19, 95% CI = 1.00 to 1.43) or was stage 4 at diagnosis (HR = 1.22, 95% CI = 1.02 to 1.45), and with higher risk of death for cancers that presented at stages 3 (HR = 2.11, 95% CI = 1.03 to 4.33) or 4 (HR = 1.31, 95% CI = 1.04 to 1.64).
","['older persons', '19,114 Australian and U.S. community-dwelling participants aged 70+ years (U.S. minorities 65+ years) without cardiovascular disease, dementia or physical disability were randomized and followed for a median of 4.7 years', 'older adults']","['ASPirin', 'aspirin', 'placebo']","['cancer incidence and mortality', 'adverse effect on later stages of cancer evolution', 'risk of incident cancer', 'hematological cancer']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",19114.0,0.510099,"However, aspirin was associated with an increased risk of incident cancer that had metastasized (HR = 1.19, 95% CI = 1.00 to 1.43) or was stage 4 at diagnosis (HR = 1.22, 95% CI = 1.02 to 1.45), and with higher risk of death for cancers that presented at stages 3 (HR = 2.11, 95% CI = 1.03 to 4.33) or 4 (HR = 1.31, 95% CI = 1.04 to 1.64).
","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Bernstein', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Ford', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Health Research Institute, Hennepin, HealthCare, Minneapolis, MN, USA.'}, {'ForeName': 'Finlay', 'Initials': 'F', 'LastName': 'Macrae', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia; and Department of Colorectal Medicine and Genetics, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McLean', 'Affiliation': 'Department of Anatomical Pathology, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Millar', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Health Research Institute, Hennepin, HealthCare, Minneapolis, MN, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Richmond', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Luz Maria', 'Initials': 'LM', 'LastName': 'Rodríguez', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, USA.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Tie', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Umar', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'G J van', 'Initials': 'GJV', 'LastName': 'Londen', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathlyn', 'Initials': 'K', 'LastName': 'Ronaldson', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa114']
728,33231126,Exercise training (ET) in adult and elderly patients receiving anti-lymphoma treatments is feasible and may improve the provision of care.,"Lymphoma treatments can produce adverse effects leading to a reduced quality-of-life (QoL). Besides, in patients ≥65years, it can promote an accelerated geriatric decay. We conducted a prospective study on supervised Exercise-Training (ET), in consecutive, patients aged 18-80years, during anti-lymphoma treatments.16/30 (53%), median-age = 65.5y, participated to the ET sessions, this was the Interventional Group (IG); 14/30 (47%), median-age = 63y, were the Reference Group (RG). Both groups participated to the fitness and the QoL assessments, at baseline (T0), 3-months (T1) and 6-months (T2) after the start of chemotherapy. The adherence to the ET program was 50% (95% CI:36-64%). The IG showed substantial improvements compared to the CG in cardiorespiratory fitness (Cooper test) at both T1 and T2 and in all the functional domain of the QoL questionnaire (QLQ-C30) at T2. This study showed ET, during chemotherapy, is feasible and safe, even in patients ≥65 years. Furthermore, it may improve the provision of care.",2021,The IG showed substantial improvements compared to the CG in cardiorespiratory fitness (Cooper test) at both T1 and T2 and in all the functional domain of the QoL questionnaire (QLQ-C30) at T2.,"['consecutive, patients aged 18-80years, during anti-lymphoma treatments.16/30 (53%), median-age = 65.5y, participated to the ET sessions, this was the Interventional Group (IG); 14/30 (47%), median-age = 63y, were the Reference Group (RG', 'patients ≥65\u2009years', 'adult and elderly patients receiving']","['Exercise training (ET', 'supervised Exercise-Training (ET', 'anti-lymphoma treatments']",['quality-of-life (QoL'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0157338,The IG showed substantial improvements compared to the CG in cardiorespiratory fitness (Cooper test) at both T1 and T2 and in all the functional domain of the QoL questionnaire (QLQ-C30) at T2.,"[{'ForeName': 'Maria Christina', 'Initials': 'MC', 'LastName': 'Cox', 'Affiliation': ""Haematology Unit, Sant'Andrea Hospital, 'Sapienza' University of Rome, Rome, Italy.""}, {'ForeName': 'Sveva Maria', 'Initials': 'SM', 'LastName': 'Nusca', 'Affiliation': 'Department of Medical and Surgical Sciences and Translational Medicine, Sant\'Andrea University Hospital, PhD Course in ""Translational Medicine and Oncology"", \'Sapienza\' University of Rome, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Di Landro', 'Affiliation': ""Haematology Unit, Sant'Andrea Hospital, 'Sapienza' University of Rome, Rome, Italy.""}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Marsilli', 'Affiliation': ""Physical Medicine and Rehabilitation Unit, Sant'Andrea Hospital, 'Sapienza' University of Rome, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Stella', 'Affiliation': ""Physical Medicine and Rehabilitation Unit, Sant'Andrea Hospital, 'Sapienza' University of Rome, Italy.""}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Sigona', 'Affiliation': ""Physical Medicine and Rehabilitation Unit, Sant'Andrea Hospital, 'Sapienza' University of Rome, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Ponzelli', 'Affiliation': ""Physical Medicine and Rehabilitation Unit, Sant'Andrea Hospital, 'Sapienza' University of Rome, Italy.""}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Passerini Desideri', 'Affiliation': ""Division of Cardiology, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, 'Sapienza' University of Rome, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Di Gregorio', 'Affiliation': ""Radiology Unit, Sant'Andrea Hospital, 'Sapienza' University of Rome, Italy.""}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Santoboni', 'Affiliation': ""Physical Medicine and Rehabilitation Unit, Sant'Andrea Hospital, 'Sapienza' University of Rome, Italy.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Vetrano', 'Affiliation': 'Department of Medical and Surgical Sciences and Translational Medicine, Sant\'Andrea University Hospital, PhD Course in ""Translational Medicine and Oncology"", \'Sapienza\' University of Rome, Rome, Italy.'}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Trischitta', 'Affiliation': ""Physical Medicine and Rehabilitation Unit, Sant'Andrea Hospital, 'Sapienza' University of Rome, Italy.""}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Manno', 'Affiliation': 'Università Telematica San Raffaele, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Vulpiani', 'Affiliation': 'Department of Medical and Surgical Sciences and Translational Medicine, Sant\'Andrea University Hospital, PhD Course in ""Translational Medicine and Oncology"", \'Sapienza\' University of Rome, Rome, Italy.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1842396']
729,32808394,Effects of horse riding simulator on sitting motor function in children with spastic cerebral palsy.,"BACKGROUND


Horse riding simulator (HRS) is an electronic horse, working under the principles of hippotherapy. It is one of the advanced therapeutic methods to improve postural control and balance in sitting, which could be recommended in the rehabilitation of cerebral palsy if real horses are unavailable.
OBJECTIVE


To investigate the therapeutic effects of HRS on sitting motor function in children with spastic diplegia and evaluate the changes in sitting motor function at different periods of time (4, 8 and 12 weeks).
METHODS


This study is a randomized controlled trial conducted over a period of 12 weeks. Thirty children with spastic diplegia age between 2 and 4 years with Gross Motor Function Classification System (GMFCS) Level I-III were included and divided into two groups. The control group received the conventional physiotherapy while the experimental group received HRS along with conventional physiotherapy. Sitting motor function was assessed by Gross Motor Function Measure (GMFM)-88 (sitting dimension B) at baseline, 4, 8 and 12 weeks. Pre- and post-intervention scores were measured and analysed.
RESULTS


The baseline characteristics were similar in both groups before the intervention with p > .01. The observed mean value of GMFM in both groups improved over a period of 12 weeks. The results denote that the sitting motor function gradually improved over a period of time in both groups and the experimental group showed significant improvement (p < .01) than the control group in all the weeks.
CONCLUSION


The study results confirmed that gradual improvement in sitting motor function was observed in both groups. Children exposed to HRS show better improvement than the children in the control group. It was concluded that HRS is effective in improving the sitting motor function in children with spastic diplegia and the continuous provision of HRS in longer duration provide more benefits than the shorter duration.",2020,"The results denote that the sitting motor function gradually improved over a period of time in both groups and the experimental group showed significant improvement (p < .01) than the control group in all the weeks.
","['Thirty children with spastic diplegia age between 2 and 4\u2009years with Gross Motor Function Classification System (GMFCS', 'children with spastic cerebral palsy', 'children with spastic diplegia', 'Level I-III']","['horse riding simulator', 'conventional physiotherapy while the experimental group received HRS along with conventional physiotherapy', 'HRS', 'Horse riding simulator (HRS']","['sitting motor function', 'mean value of GMFM', 'Gross Motor Function Measure (GMFM)-88 (sitting dimension B', 'Sitting motor function']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",30.0,0.019812,"The results denote that the sitting motor function gradually improved over a period of time in both groups and the experimental group showed significant improvement (p < .01) than the control group in all the weeks.
","[{'ForeName': 'Hemachithra', 'Initials': 'H', 'LastName': 'Chinniah', 'Affiliation': 'Division of PM&R, RMMC&H, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Natarajan', 'Affiliation': 'Division of PM&R, RMMC&H, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Paediatrics, RMMC&H, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}, {'ForeName': 'John William Felix', 'Initials': 'JWF', 'LastName': 'Ambrose', 'Affiliation': 'RMMC, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1870']
730,32866396,Acute supplementation with beetroot juice improves endothelial function in HIV-infected individuals.,"Human immunodeficiency virus (HIV) is associated with lower nitric oxide (NO) bioavailability and vascular dysfunction. Nitrate-rich beetroot juice (BJ) has been shown to acutely increase NO availability and vascular function in healthy and individuals at high risk for cardiovascular disease. Thus, we tested the effects of BJ ingestion on flow-mediated dilation (FMD) and pulse wave velocity (PWV) measurements in healthy and HIV-infected patients. Thirteen HIV-infected individuals (age, 36 ± 10 years) and 18 healthy (age, 27 ± 8 years) participated in the study. Individuals were submitted to vascular tests such as FMD and pulse PWV at pre (T0) and at 120 min (T120) after BJ and placebo (PLA) ingestion. The %FMD at T0 of the control group was significantly higher than the %FMD at T0 of the HIV individuals in both interventions. BJ improved the %FMD at T120 when compared with T0 in the HIV and control groups. There was no change in %FMD after PLA ingestion in the control and HIV groups. There were no differences between groups (control vs HIV), time points (T0 vs T120), and interventions (BJ vs PLA) for PWV. Our findings showed that nitrate-rich BJ ingestion acutely improved vascular function in healthy and HIV-infected patients. Clinical Trials Registry no. NCT03485248.  Novelty:  HIV is associated with lower NO bioavailability and vascular dysfunction. Acute supplementation with nitrate-rich BJ has been shown to acutely increases NO bioavailability. We showed for the first time that BJ acutely improves endothelial function in HIV-infected patients.",2021,"There were no differences between groups (control vs HIV), time points (T0 vs T120) and interventions (BJ vs PLA) for PWV.","['healthy and individuals at high risk for CVD ', 'Human immunodeficiency virus (HIV', '13 HIV-infected (36±10 years old) and 18 healthy (27±8 years old) participated in the study', 'healthy and HIV-infected patients', 'HIV-infected individuals']","['nitrate-rich beetroot juice (BJ', 'BJ', 'Nitrate-rich beetroot juice (BJ', 'BJ ingestion', 'placebo (PLA) ingestion', 'beetroot juice']","['BJ improved the %FMD', 'NO bioavailability', 'flow-mediated dilation (FMD) and pulse wave velocity (PWV) measurements', 'vascular function', 'nitric oxide (NO) bioavailability and vascular dysfunction', 'endothelial function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.045786,"There were no differences between groups (control vs HIV), time points (T0 vs T120) and interventions (BJ vs PLA) for PWV.","[{'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Nogueira Soares', 'Affiliation': 'Faculty of kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Machado-Santos', 'Affiliation': 'Nutrition and Exercise Metabolism Group, Federal University of Rio de Janeiro, Macaé, RJ 27900-000, Brazil.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Barros-Santos', 'Affiliation': 'Nutrition and Exercise Metabolism Group, Federal University of Rio de Janeiro, Macaé, RJ 27900-000, Brazil.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Vieira De Oliveira', 'Affiliation': 'Nutrition and Exercise Metabolism Group, Federal University of Rio de Janeiro, Macaé, RJ 27900-000, Brazil.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Murias', 'Affiliation': 'Faculty of kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Thiago Silveira', 'Initials': 'TS', 'LastName': 'Alvares', 'Affiliation': 'Nutrition and Exercise Metabolism Group, Federal University of Rio de Janeiro, Macaé, RJ 27900-000, Brazil.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0498']
731,32828737,Randomized Trial Comparing Consumption of Military Rations to Usual Intake for 21 Consecutive Days: Nutrient Adequacy and Indicators of Health Status.,"BACKGROUND


The US military Meal, Ready-to-Eat food ration is approved as a nutritionally adequate sole source of nutrition for ≤21 days. However, the ration continuously evolves, requiring periodic reassessment of its influence on nutritional status and health.
OBJECTIVE


To determine the effects of consuming the US Armed Services Meal, Ready-to-Eat ration for 21 days, relative to usual diets, on nutrient intake, and indicators of nutritional status and cardiometabolic health.
DESIGN


Parallel-arm, randomized, controlled trial, secondary analysis.
PARTICIPANTS


Sixty healthy, weight stable, free-living adults from the Natick, MA, area participated between June 2015 and March 2017.
INTERVENTION


Participants were randomized to consume their usual diet for 31days (CON), or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE).
MAIN OUTCOME MEASURES


Nutrient intake (absolute and adjusted) throughout the study period, and indicators of nutrition status (vitamins B, D, folate, homocysteine, iron, magnesium, and zinc) and cardiometabolic health (glucose, insulin, and blood lipid levels) before (Day 0), during (Day 10 through Day 21), and after (Day 31) the intervention period.
STATISTICAL ANALYSIS PERFORMED


Between-group differences over time were assessed using marginal models. Models for nutritional status and cardiometabolic health indicators were adjusted for age, initial body mass index, and baseline value of the dependent variable.
RESULTS


Energy-adjusted fiber; polyunsaturated fatty acids; vitamins A, thiamin, riboflavin, B-6, C, D, and E; and magnesium and zinc intakes all increased in MRE during the intervention and were higher compared with CON (P<0.05), whereas relative protein intake decreased and was lower (P<0.05). Serum triglyceride concentrations averaged 19% (95% CI 0% to 41%) higher in MRE relative to CON during Days 10 to 31 (P=0.05). No statistically significant effects of diet on any other nutritional status or cardiometabolic health indicators were observed.
CONCLUSIONS


Findings demonstrate that a Meal, Ready-to-Eat ration diet can provide a more micronutrient-dense diet than usual dietary intake aiding in maintenance of nutritional status over 21 days.",2020,Serum triglyceride concentrations averaged 19% (95% CI 0% to 41%) higher in MRE relative to CON during Days 10 to 31 (P=0.05).,"['Sixty healthy, weight stable, free-living adults from the Natick, MA, area participated between June 2015 and March\xa02017']","['consume their usual diet for 31days (CON), or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE', 'Consumption of Military Rations']","['nutritional status or cardiometabolic health indicators', 'Serum triglyceride concentrations', 'relative protein intake', 'MRE relative to CON', 'thiamin, riboflavin, B-6, C, D, and E; and magnesium and zinc intakes', 'nutrition status (vitamins B, D, folate, homocysteine, iron, magnesium, and zinc) and cardiometabolic health (glucose, insulin, and blood lipid levels']","[{'cui': 'C0424657', 'cui_str': 'Weight steady'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0564449', 'cui_str': 'Zinc intake'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",60.0,0.0422149,Serum triglyceride concentrations averaged 19% (95% CI 0% to 41%) higher in MRE relative to CON during Days 10 to 31 (P=0.05).,"[{'ForeName': 'Holly L', 'Initials': 'HL', 'LastName': 'McClung', 'Affiliation': ''}, {'ForeName': 'Nicholes J', 'Initials': 'NJ', 'LastName': 'Armstrong', 'Affiliation': ''}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Hennigar', 'Affiliation': ''}, {'ForeName': 'Jeffery S', 'Initials': 'JS', 'LastName': 'Staab', 'Affiliation': ''}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Montain', 'Affiliation': ''}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2020.06.018']
732,32835711,The influence of a liner on deep bulk-fill restorations: Randomized clinical trial.,"OBJECTIVE


The aim of this study was to evaluate the influence of a liner on the clinical performance of deep posterior restorations performed with bulk-fill composite.
METHODS


30 subjects received two restorations on deep preparations in posterior teeth, without pulpal exposure, after selective carious-tissue removal in one-stage. The internal walls reached the inner quarter of dentin, but with a radiographically detectable zone of firm dentin remaining. The pulpal protection using a layer of glass ionomer composite liner (Ionoseal, Voco) was applied in just one preparation. The adhesive system Futurabond U (Voco) was applied in all preparations, which were restored with the bulk-fill pure Ormocer nanohybrid composite (Admira Fusion Xtra - Voco), in up to 4 mm thick increments. All restorations were evaluated using the FDI criteria after 7 days, 6, 12 and 24 months postoperatively.
RESULTS


After 24-months, 25 patients attended the recall and 50 restorations were evaluated. The Fisher's statistical analysis (5%) showed no difference between the techniques for the esthetic, functional and biological properties. No postoperative sensitivity was reported for both groups.
CONCLUSION


The application of a liner did not influence the clinical performance of deep restorations with bulk-fill Ormocer composite.
CLINICAL RELEVANCE


The application of a liner with a GIC-based material did not have a significant effect on the clinical performance of bulk-fill restorations and seems to be unnecessary for the material tested.",2020,"The application of a liner did not influence the clinical performance of deep restorations with bulk-fill Ormocer composite.
","['25 patients attended the recall and 50 restorations were evaluated', '30 subjects received two restorations on deep preparations in posterior teeth, without pulpal exposure, after selective carious-tissue removal in one-stage']",['bulk-fill composite'],['postoperative sensitivity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",50.0,0.0409598,"The application of a liner did not influence the clinical performance of deep restorations with bulk-fill Ormocer composite.
","[{'ForeName': 'Carlos Rocha Gomes', 'Initials': 'CRG', 'LastName': 'Torres', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: carlos.rg.torres@unesp.br.'}, {'ForeName': 'Mariane Cintra', 'Initials': 'MC', 'LastName': 'Mailart', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: mariane_mailart@yahoo.com.br.'}, {'ForeName': 'Rafael Santos', 'Initials': 'RS', 'LastName': 'Rocha', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: rafaelrocha_ss@hotmail.com.'}, {'ForeName': 'Pablo Lenin Benitez', 'Initials': 'PLB', 'LastName': 'Sellan', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: drpablobens@gmail.com.'}, {'ForeName': 'Sheila Célia Mondragón', 'Initials': 'SCM', 'LastName': 'Contreras', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: sheilamondragon90@gmail.com.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Di Nicoló', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: rebeca.nicolo@unesp.br.'}, {'ForeName': 'Alessandra Bühler', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: alessandra.buhler@unesp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103454']
733,32857643,Evaluation of a Discussion Guide to Promote Patient Understanding of Menopause and Informed Treatment Decision-Making.,"Background:  Patient-provider communication surrounding menopause symptoms and treatment is often limited. We developed and evaluated a health literacy-appropriate discussion guide to support patient education.  Materials and Methods:  A cross-sectional randomized study was conducted among 100 English-speaking women, aged 45-60 years, in Chicago, IL, and Durham, NC. Participants were randomly assigned to review either the discussion guide or a standard education material ( n  = 50 per arm) and to complete an open book knowledge questionnaire; they then rated the appearance and quality of both materials. Bivariate analyses examined knowledge and satisfaction by study arm and across sociodemographic characteristics. Multivariable models tested the effectiveness of the discussion guide to improve knowledge compared with the standard material.  Results:  Women receiving the discussion guide demonstrated significantly higher knowledge scores compared with those who reviewed the standard material (mean [ M ] = 20.0, standard deviation [SD] = 2.7, vs.  M  = 18.1, SD = 2.6;  p  < 0.001); 82.0% of those exposed to the discussion guide correctly answered ≥85% of knowledge items compared with only 48.0% of those reviewing the standard material ( p  < 0.001). In multivariable analyses, participants receiving the discussion guide displayed significantly greater knowledge in comparison with those receiving the standard material regardless of whether knowledge was examined as a score ( ∝  = 1.9, 95% confidence interval [CI]: 0.9-2.9,  p  < 0.001) or 85% threshold (odds ratio: 5.7, 95% CI: 2.0-16.2,  p  < 0.001). More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content.  Conclusions:  The discussion guide improved understanding of menopause symptoms and treatment options in comparison with a current standard and was well received by a diverse audience.",2021,More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content.  ,"['100 English-speaking women, aged 45-60 years, in Chicago, IL, and Durham, NC']",['discussion guide or a standard education material ( n \u2009=\u200950 per arm) and to complete an open book knowledge questionnaire'],['knowledge scores'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0454851', 'cui_str': 'Durham'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0698567,More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content.  ,"[{'ForeName': 'Stacy Cooper', 'Initials': 'SC', 'LastName': 'Bailey', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Emma N', 'Initials': 'EN', 'LastName': 'Andrews', 'Affiliation': 'U.S./Global Medical Affairs, Pfizer, Inc., New York, New York, USA.'}, {'ForeName': 'Candida C', 'Initials': 'CC', 'LastName': 'Halton', 'Affiliation': 'School of Social Sciences, University of Westminster, London, United Kingdom.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2020.8436']
734,32861484,Derivation and validation of a simple anthropometric equation to predict fat-free mass in patients with chronic hepatitis C.,"BACKGROUND


Loss of skeletal muscle mass is very common in chronic liver diseases and affects 30.0-70.0% of the patients with cirrhosis. Given the relevance of muscle wasting in hepatic diseases, a practical screening tool for earlier detection of skeletal muscle mass loss is of utmost significance.
AIMS


To develop and validate a simple anthropometric prediction equation for fat-free mass estimation by using Bioelectrical Impedance Analysis (BIA) as a reference method in patients with chronic hepatitis C (CHC).
METHODS


We prospectively, included 209 CHC patients, randomly allocated into two groups, 158 patients in a development model (derivation sample) and 51 patients in a validation group (validation sample). Predictive equations were developed using backward stepwise multiple regression and the most adequate and simplest derived predictive equation was further explored for agreement and bias in the validation sample. The accuracy of the predictive equation was evaluated using the coefficient of determination (R 2 ).
RESULTS


The predictive equation with an optimal R 2  was Fat-Free Mass (Kg) = Sex × 0.17 + Height (m) × 16.83 + Weight (Kg) × 0.62 + Waist Circumference (cm) × (-0.15) + Weight (Kg) × Sex × (-0.30) + Sex × Waist Circumference (cm) × 0.14-6.23; where sex = 1 for female and 0 for male. R 2  = 0.93, standard error of the estimate = 2.6 Kg and coefficient of variation = 20.0%, p < 0.001.
CONCLUSIONS


Our developed and cross-validated anthropometric prediction equation for fat-free mass estimation by using BIA attained a high coefficient of determination, a low standard error of the estimate, and lowermost coefficient of variation. This study indicates that predictive equations may be reliable and useful alternative methods for clinical evaluation of fat-free mass in patients with CHC.",2021,This study indicates that predictive equations may be reliable and useful alternative methods for clinical evaluation of fat-free mass in patients with CHC.,"['patients with CHC', '209 CHC patients, randomly allocated into two groups, 158 patients in a development model (derivation sample) and 51 patients in a validation group (validation sample', 'patients with chronic hepatitis C (CHC', 'patients with chronic hepatitis C']",['\xa0Weight (Kg'],"['Sex', 'Waist Circumference (cm']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",209.0,0.0854474,This study indicates that predictive equations may be reliable and useful alternative methods for clinical evaluation of fat-free mass in patients with CHC.,"[{'ForeName': 'Kiara Gonçalves Dias', 'Initials': 'KGD', 'LastName': 'Diniz', 'Affiliation': 'Sciences Applied to Adult Health Care Post-Graduate Programme, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil; Outpatient Clinic of Viral Hepatitis, Instituto Alfa de Gastroenterologia, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Diego Alves', 'Initials': 'DA', 'LastName': 'Vieira', 'Affiliation': 'Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Enrico Antonio', 'Initials': 'EA', 'LastName': 'Colosimo', 'Affiliation': 'Department of Statistics, Instituto de Ciências Exatas, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Marta Paula Pereira', 'Initials': 'MPP', 'LastName': 'Coelho', 'Affiliation': 'Sciences Applied to Adult Health Care Post-Graduate Programme, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil; Outpatient Clinic of Viral Hepatitis, Instituto Alfa de Gastroenterologia, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Bering', 'Affiliation': 'Outpatient Clinic of Viral Hepatitis, Instituto Alfa de Gastroenterologia, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil; Department of Food and Nutrition, Universidade Federal de Mato Grosso (UFMT), Cuiabá, Mato Grosso, Brazil.'}, {'ForeName': 'Rosangela', 'Initials': 'R', 'LastName': 'Teixeira', 'Affiliation': 'Sciences Applied to Adult Health Care Post-Graduate Programme, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil; Outpatient Clinic of Viral Hepatitis, Instituto Alfa de Gastroenterologia, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil; Department of Internal Medicine, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Maria Isabel Toulson Davidson', 'Initials': 'MITD', 'LastName': 'Correia', 'Affiliation': 'Department of Surgery, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Gifone Aguiar', 'Initials': 'GA', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Research in Bacteriology, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Luciana Diniz', 'Initials': 'LD', 'LastName': 'Silva', 'Affiliation': 'Sciences Applied to Adult Health Care Post-Graduate Programme, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil; Outpatient Clinic of Viral Hepatitis, Instituto Alfa de Gastroenterologia, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil; Department of Internal Medicine, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil. Electronic address: lucianadiniz@medicina.ufmg.br.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.011']
735,32863088,Long-term occlusal changes and patient satisfaction in patients treated with and without extractions: 37 years after treatment.,"INTRODUCTION


The objective of this research was to evaluate the treatment outcomes, long-term occlusal changes, and patient satisfaction after 37 years of nonextraction and extraction treatments.
METHODS


Fifty-seven patients with Class I and Class II malocclusion were divided into 2 groups. Group 1 included 16 patients treated with nonextraction therapy, with mean initial (T1), final (T2), and long-term posttreatment (T3) ages of 13.2, 15.0, and 50.3 years, respectively. Mean treatment time (T2 - T1) and long-term follow-up time (T3 - T2) were 1.8 and 35.2 years, respectively. Group 2 included 41 patients treated with extraction of 4 first premolars, with mean ages at T1, T2, and T3 of 13.3, 15.6, and 53.6 years, respectively. Mean treatment (T2 - T1) and long-term follow-up (T3 - T2) times were 2.3 and 37.9 years, respectively. The Peer Assessment Rating (PAR) index and Objective Grading System (OGS) indexes were evaluated at T1, T2, and T3 stages. The subjects also answered an online questionnaire regarding esthetic and occlusal self-perception at T3. Intergroup comparison was performed with t tests.
RESULTS


The PAR index improved with treatment and similarly worsened at T3 for both groups. OGS scores were close to the passing score at T2 for both groups. The nonextraction group presented worse OGS scores at T3 than the extraction group. Nonextraction patients perceived more changes in alignment over time, but overall satisfaction was similar.
CONCLUSIONS


The PAR index improved with treatment, and the PAR and OGS scores showed a significant increase, indicating great occlusal changes in the long-term stage. The nonextraction group showed more occlusal changes and perceived more changes in their alignment over time, but overall patient satisfaction was similar in both groups.",2020,"The nonextraction group showed more occlusal changes and perceived more changes in their alignment over time, but overall patient satisfaction was similar in both groups.","['Fifty-seven patients with Class I and Class II malocclusion', 'Group 2 included 41 patients treated with extraction of 4 first premolars, with mean ages at T1, T2, and T3 of 13.3, 15.6, and 53.6\xa0years, respectively', '16 patients treated with nonextraction therapy, with mean initial (T1), final (T2), and long-term posttreatment (T3) ages of 13.2, 15.0, and 50.3\xa0years, respectively']",[],"['Mean treatment time', 'great occlusal changes', 'overall satisfaction', 'PAR index', 'overall patient satisfaction', 'OGS scores', 'occlusal changes', 'Peer Assessment Rating (PAR) index and Objective Grading System (OGS) indexes', 'PAR and OGS scores']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429164', 'cui_str': 'Peer assessment rating (orthodontic index)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",57.0,0.0282571,"The nonextraction group showed more occlusal changes and perceived more changes in their alignment over time, but overall patient satisfaction was similar in both groups.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cotrin', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil. Electronic address: cotrin@hotmail.com.'}, {'ForeName': 'Caroline Martins', 'Initials': 'CM', 'LastName': 'Gambardela-Tkacz', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Wilana', 'Initials': 'W', 'LastName': 'Moura', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Iunes', 'Affiliation': 'Department of Orthodontics, Inga University Center, Maringá, Paraná, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Janson', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Marcos Roberto', 'Initials': 'MR', 'LastName': 'Freitas', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Karina Maria Salvatore', 'Initials': 'KMS', 'LastName': 'Freitas', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil; Department of Orthodontics, Inga University Center, Maringá, Paraná, Brazil.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.07.012']
736,32864144,"Does photobiomodulation therapy combined to static magnetic field (PBMT-sMF) promote ergogenic effects even when the exercised muscle group is not irradiated? A randomized, triple-blind, placebo-controlled trial.","Background


The direct application of photobiomodulation therapy (PBMT) using low-level laser therapy (LLLT) and light emitting diodes (LEDs) combined with a static magnetic field (sMF) (PBMT-sMF) to target tissues is shown to improve muscle performance and recovery. Studies have reported possible PBMT effects when a local distant to the target tissue is irradiated. Notably, the extent of these effects on musculoskeletal performance and the optimal site of irradiation remain unclear, although this information is clinically important since these aspects could directly affect the magnitude of the effect. Therefore, we investigated the effects of local and non-local PBMT-sMF irradiations on musculoskeletal performance and post-exercise recovery before an eccentric exercise protocol.
Methods


This randomized, triple-blind (participants, therapists and assessors), placebo-controlled trial included 30 healthy male volunteers randomly assigned to the placebo, local, and non-local groups. Active or placebo PBMT-sMF was applied to 6 sites of the quadriceps muscle of both legs. An eccentric exercise protocol was used to induce fatigue. The primary outcome was peak torque assessed by maximal voluntary contraction (MVC). The secondary outcomes were delayed onset muscle soreness (DOMS) measured by visual analogue scale (VAS), muscle injury assessed by serum creatine kinase activity (CK), and blood lactate levels. Evaluations were performed before the eccentric exercise protocol (baseline), as well as immediately after and 1, 24, 48, and 72 h upon protocol completion.
Results


Ten volunteers were randomized per group and analysed for all outcomes. Compared to the placebo and non-local groups, irradiation with PBMT-SMF led to statistically significant improvement ( p  < 0.05) with regard to all variables in the local group. The outcomes observed in the non-local group were similar to those in the placebo group with regard to all variables.The volunteers did not report any adverse effects.
Conclusion


Our results support the current evidence that local irradiation of all exercised muscles promotes ergogenic effects. PBMT-sMF improved performance and reduced muscle fatigue only when applied locally to muscles involved in physical activity.
Trial registration


NCT03695458. Registered October 04th 2018.",2020,"Compared to the placebo and non-local groups, irradiation with PBMT-SMF led to statistically significant improvement ( p  < 0.05) with regard to all variables in the local group.",['30 healthy male volunteers randomly assigned to the'],"['placebo PBMT-sMF', 'local and non-local PBMT-sMF irradiations', 'PBMT-sMF', 'placebo, local, and non-local groups', 'placebo', 'eccentric exercise protocol', 'photobiomodulation therapy (PBMT) using low-level laser therapy (LLLT) and light emitting diodes (LEDs) combined with a static magnetic field (sMF) (PBMT-sMF', 'photobiomodulation therapy combined to static magnetic field (PBMT-sMF']","['muscle fatigue', 'delayed onset muscle soreness (DOMS) measured by visual analogue scale (VAS), muscle injury assessed by serum creatine kinase activity (CK), and blood lactate levels', 'musculoskeletal performance and post-exercise recovery', 'peak torque assessed by maximal voluntary contraction (MVC']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0410256', 'cui_str': 'Injury of muscle'}, {'cui': 'C0858112', 'cui_str': 'Serum creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",30.0,0.496285,"Compared to the placebo and non-local groups, irradiation with PBMT-SMF led to statistically significant improvement ( p  < 0.05) with regard to all variables in the local group.","[{'ForeName': 'Caroline Dos Santos Monteiro', 'Initials': 'CDSM', 'LastName': 'Machado', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Heliodora Leão', 'Initials': 'HL', 'LastName': 'Casalechi', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Adriane Aver', 'Initials': 'AA', 'LastName': 'Vanin', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, São Paulo, SP Brazil.'}, {'ForeName': 'Jônatas Bezerra', 'Initials': 'JB', 'LastName': 'de Azevedo', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, São Paulo, SP Brazil.'}, {'ForeName': 'Paulo de Tarso Camillo', 'Initials': 'PTC', 'LastName': 'de Carvalho', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, São Paulo, SP Brazil.'}, {'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00197-6']
737,32868247,"Focused, low tube potential, coronary calcium assessment prior to coronary CT angiography: A prospective, randomized clinical trial.","BACKGROUND


Coronary artery calcium (CAC) scanning is commonly performed before coronary CT angiography (CTA) based partly on its potential to influence CTA scan parameters. Encompassing the whole heart and performed at high tube potential (120 ​kVp), standard (Agatston) CAC scanning adds to patient radiation exposure. Most CAC exists in the proximal and mid coronary segments and is easily visualized at low kVp.
METHODS


We tested the impact of a modified calcium scan on coronary CTA acquisition decision-making and image quality in a randomized clinical trial. Providers documented planned CTA acquisition parameters prior to CAC scanning in a blinded manner. Standard Agatston CAC scans proceeded in typical fashion whereas modified scans utilized 80 ​kVp and reduced z-axis length focused on the proximal-to-mid coronary arteries. CTA providers reviewed the CAC burden then documented final acquisition parameters.
RESULTS


The study included 172 patients (48% female; mean age 59 ​± ​6.7). As planned, the calcium scan effective dose was significantly lower in the modified CAC scan group (0.14 vs. 0.74 ​mSv using a 0.014 k-factor or 0.26 vs. 1.38 ​mSv using a 0.026 k-factor; both p ​< ​0.001). Initially selected CTA parameters were changed at an identical rate following visual CAC assessment (59%). There was no significant difference in coronary CTA image quality (median quality score ​= ​4 in both groups, p ​= ​0.26), noise (31.0 vs 31.4 HU; p ​= ​0.81), or signal/noise ratio (17.9 vs 16.8; p ​= ​0.26).
CONCLUSIONS


A low-kVp scan with focused field-of-view provides actionable information regarding the presence and severity of CAC prior to coronary CTA. Coronary CTA parameters based on patient variables are frequently modified after assessing CAC burden in the CTA suite. CLINICALTRIALS.
GOV REGISTRATION NUMBER


NCT02972242.",2020,"There was no significant difference in coronary CTA image quality (median quality score = 4 in both groups, p = 0.26), noise (31.0 vs 31.4 HU; p = 0.81), or signal/noise ratio (17.9 vs 16.8; p = 0.26).
",['172 patients (48% female; mean age 59\xa0±\xa06.7'],"['standard (Agatston) CAC scanning', 'coronary CT angiography (CTA', 'modified CAC scan', 'Coronary artery calcium (CAC) scanning', 'modified calcium scan', 'low tube potential, coronary calcium assessment prior to coronary CT angiography']","['z-axis length', 'coronary CTA image quality', 'calcium scan effective dose']","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",172.0,0.051731,"There was no significant difference in coronary CTA image quality (median quality score = 4 in both groups, p = 0.26), noise (31.0 vs 31.4 HU; p = 0.81), or signal/noise ratio (17.9 vs 16.8; p = 0.26).
","[{'ForeName': 'Hampton A', 'Initials': 'HA', 'LastName': 'Crimm', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA. Electronic address: hampton.a.crimm.mil@mail.mil.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Fergestrom', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Cicely', 'Initials': 'C', 'LastName': 'Dye', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Philip', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Binh T', 'Initials': 'BT', 'LastName': 'Nguyen', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'University of Virginia Health System, Charlottesville, VA, USA.'}]",Journal of cardiovascular computed tomography,['10.1016/j.jcct.2020.08.011']
738,32830368,"Time-varying effects of 'optimized smoking treatment' on craving, negative affect and anhedonia.","AIMS


To identify when smoking cessation treatments affect craving, negative affect and anhedonia, and how these symptoms relate to abstinence, to help evaluate the effects of particular intervention components in multi-component treatments and accelerate treatment refinement.
DESIGN


Secondary analysis of data from a two-arm randomized controlled trial.
SETTING


Seven primary care clinics in Wisconsin, United States.
PARTICIPANTS


Adult primary care patients who smoked daily (n = 574).
INTERVENTION AND COMPARATOR


Intervention was abstinence-optimized treatment (A-OT, n = 276) comprising 3 weeks of nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD and extensive psychosocial support. The comparator was recommended usual care (RUC, n = 298), comprising brief counseling and 8 weeks of nicotine patch post-TQD.
MEASUREMENTS


Time-varying effect models examined dynamic effects of A-OT (versus RUC) on the primary outcomes of nightly cigarette craving, negative affect and anhedonia from 1 week pre- to 2 weeks post-TQD. Exploratory models examined within-person relations between nicotine medication use and same-day symptom ratings. Secondary logistic regression analyses examined associations between post-TQD craving, negative affect and anhedonia and 1-month post-TQD abstinence.
FINDINGS


A-OT significantly suppressed pre- and post-TQD craving (β = -0.27 to -0.46 across days) and post-TQD anhedonia (β = -0.24 to -0.38 across days), relative to RUC. Within individuals, using patches was associated with lower negative affect in RUC (β = -0.42 to -0.52), but not in A-OT. Using more mini-lozenges was associated with greater craving (β = 0.04-0.07) and negative affect (β = 0.03-0.05) early, and with lower anhedonia (β = -0.06 to -0.12) later. Greater post-TQD craving (OR = 0.68) and anhedonia (OR = 0.85) predicted lower odds of abstinence 1 month post-TQD.
CONCLUSION


Time-varying effect models showed that a multi-component treatment intervention for smoking cessation suppressed significant withdrawal symptoms more effectively than recommended usual care among daily adult smokers motivated to quit. The intervention reduced craving pre- and post-target quit day (TQD) and anhedonia post-TQD.",2021,"Using more mini-lozenges was associated with greater craving (β=0.04 to 0.07) and negative affect (β=0.03 to 0.05) early, and with lower anhedonia (β=-0.06 to -0.12) later.","['Seven primary care clinics in Wisconsin, USA', 'Adult primary care patients who smoked daily (N=574']","['nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD, and extensive psychosocial support', 'nicotine patch post-TQD']","['post-TQD anhedonia', 'nightly cigarette craving, negative affect, and anhedonia', 'post-TQD craving, negative affect and anhedonia and 1-month post-TQD abstinence', 'Craving, Negative Affect, and Anhedonia', 'Greater post-TQD craving', 'anhedonia', 'Time-varying effect models examined dynamic effects of A-OT (versus RUC', 'pre- and post-TQD craving', 'RUC', 'craving pre- and post-target quit day (TQD) and anhedonia post-TQD', 'greater craving', 'lower anhedonia', 'withdrawal symptoms']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0523964', 'cui_str': 'Urea nitrogen renal clearance measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}]",,0.0239201,"Using more mini-lozenges was associated with greater craving (β=0.04 to 0.07) and negative affect (β=0.03 to 0.05) early, and with lower anhedonia (β=-0.06 to -0.12) later.","[{'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15232']
739,32858247,"Control of Pain in Intravitreal Injections: Evaluation of Combination Topical Anesthetics and Non-steroidal Anti-inflammatory Drops: A Randomized, Placebo-Controlled Clinical Trial.",,2021,The addition of topical NSAID to proparacaine drops and lidocaine ophthalmic gel had negligible effect on subjective pain.,['pain control following intravitreal injection'],"['proparacaine', 'Combination Topical Anesthetics and Non-Steroidal Anti-Inflammatory Drops (NSAIDs', 'lidocaine ophthalmic gel', 'NSAID drops', 'placebo']",['subjective pain'],"[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0072510', 'cui_str': 'proparacaine'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C2366224', 'cui_str': 'Lidocaine Ophthalmic Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.496621,The addition of topical NSAID to proparacaine drops and lidocaine ophthalmic gel had negligible effect on subjective pain.,"[{'ForeName': 'Maxwell J', 'Initials': 'MJ', 'LastName': 'Wingelaar', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin. Electronic address: mwingelaar@uwhealth.org.'}, {'ForeName': 'C Rufus', 'Initials': 'CR', 'LastName': 'Sweeney', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Thomas-Virnig', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Raevis', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Mititelu', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.08.015']
740,32866619,Aerobic exercise training partially reverses the impairment of Nrf2 activation in older humans.,"Nuclear factor erythroid-2-related factor 2 (Nrf2), is an inducible transcription factor that improves redox balance through stimulating antioxidant gene expression. In older humans the Nrf2 response to a single bout of acute exercise is blunted compared to young indicating impaired redox signaling. The purpose of this randomized controlled trial was to investigate if the signaling impairment could be reversed with exercise training in older men and women, while also comparing to young. Young (18-28y, n = 21) and older (≥60y, n = 19) men and women were randomized to 8-week aerobic exercise training (ET; 3 d/wk, 45 min/d) or a non-exercise control group (CON). Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein were measured in PBMCs in response to acute exercise trial (AET; 30-min cycling at 70% VO 2  peak pre- and post-intervention at 7 timepoints (Pre, +10 m, +30 m, +1 h, +4 h, +8 h, +24 h). Young had greater Nrf2 signaling response compared to older at pre-intervention (p = 0.05), whereas the older had significantly higher basal Nrf2 levels (p = 0.004). ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05). The degree of restoration in Nrf2 signaling response was related to the degree of change in basal Nrf2 (p = 0.039), which was driven by older adults (p = 0.014). Lower basal nuclear Nrf2 levels were associated with changes seen in AET responses for Nrf2 and GCLC protein, as well as NQO1 and GCLC mRNA. Together these data demonstrate that exercise training improves Nrf2 signaling and downstream gene expression and that lower basal Nrf2 levels are associated with a more dynamic acute response. Our results provide evidence that the impaired Nrf2 signaling in sedentary older adults can be restored to a degree with moderate exercise training, albeit not to the level seen in young. CLINICALTRIALS.GOV ID: NCT03419988.",2020,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"['sedentary older adults', 'older humans', 'older men and women, while also comparing to young', 'Young (18-28y, n\u202f=\u202f21) and older (≥60y, n\u202f=\u202f19) men and women']","['Aerobic exercise training', 'aerobic exercise training (ET; 3\u202fd/wk, 45\u202fmin/d) or a non-exercise control group (CON', 'exercise training', 'CON']","['Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein', 'Nrf2 signaling response', 'basal Nrf2 levels', 'basal Nrf2 expression', 'impairment of Nrf2 activation', 'Nrf2 signaling and downstream gene expression']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1136197', 'cui_str': 'NAD(P)H dehydrogenase (quinone) 1, human'}, {'cui': 'C0018969', 'cui_str': 'Heme oxygenase (decyclizing)'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}]",,0.0441431,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"[{'ForeName': 'Ethan L', 'Initials': 'EL', 'LastName': 'Ostrom', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA.'}, {'ForeName': 'Tinna', 'Initials': 'T', 'LastName': 'Traustadóttir', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA. Electronic address: tinna.traustadottir@nau.edu.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.08.016']
741,32820982,The impact of intradialytic cycling on the removal of protein-bound uraemic toxins: A randomised cross-over study.,"The evidence on impact of intradialytic exercise on the removal of urea, is conflictive. Impact of exercise on kinetics of serum levels of protein-bound uraemic toxins, known to exert toxicity and to have kinetics dissimilar of those of urea, has so far not been explored. Furthermore, if any effect, the most optimal intensity, time point and/or required duration of intradialytic exercise to maximise removal remain obscure. We therefore studied the impact of different intradialytic cycling schedules on the removal of protein-bound uraemic toxins during haemodialysis (HD).This randomised cross-over study included seven stable patients who were dialysed with an FX800 dialyser during three consecutive midweek HD sessions of 240 min: (A) without cycling; (B) cycling for 60 min between 60th and 120th minutes of dialysis; and (C) cycling for 60 min between 150th and 210th minutes, with the same cycling load as in session B. Blood and dialysate flows were respectively 300 and 500 mL/min. Blood was sampled from the blood inlet at different time points, and dialysate was partially collected (300 mL/h). Small water soluble solutes and protein-bound toxins were quantified and intradialytic reduction ratios (RR) and overall removal were calculated per solute.Total solute removal and reduction ratios were not different between the three test sessions, except for the reduction ratios RR 60-120  and RR 150-210  for potassium.In conclusion, we add evidence to the existing literature that, regardless of the timing within the dialysis session, intradialytic exercise has no impact on small solute clearance, and demonstrated also a lack of impact for protein-bound solutes.",2021,"Total solute removal and reduction ratios were not different between the three test sessions, except for the reduction ratios RR 60-120  and RR 150-210  for potassium.",['seven stable patients who were dialysed with an FX800 dialyser during three consecutive midweek HD sessions of 240\u2009min: (A'],"['intradialytic exercise', 'without cycling; (B) cycling for 60\u2009min between 60th and 120th minutes of dialysis', 'intradialytic cycling']","['Total solute removal and reduction ratios', 'intradialytic reduction ratios (RR) and overall removal']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",7.0,0.0511764,"Total solute removal and reduction ratios were not different between the three test sessions, except for the reduction ratios RR 60-120  and RR 150-210  for potassium.","[{'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'De Vos', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Lemarcq', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Dhondt', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Griet', 'Initials': 'G', 'LastName': 'Glorieux', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Van Biesen', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Eloot', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}]",The International journal of artificial organs,['10.1177/0391398820949880']
742,32852294,"Comparison of Chloroprocaine Versus Lidocaine With Epinephrine, Sodium Bicarbonate, and Fentanyl for Epidural Extension Anesthesia in Elective Cesarean Delivery: A Randomized, Triple-Blind, Noninferiority Study.","BACKGROUND


For emergent intrapartum cesarean delivery (CD), the literature does not support the use of any particular local anesthetic solution to extend epidural analgesia to cesarean anesthesia. We hypothesized that 3% chloroprocaine (CP) would be noninferior to a mixture of 2% lidocaine, 150 µg of epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF) in terms of onset time to surgical anesthesia.
METHODS


In this single-center randomized noninferiority trial, adult healthy women undergoing CD were randomly assigned to epidural anesthesia with either CP or LEBF. Sensory blockade (pinprick) to T10 was established before operating room (OR) entry for elective CD. On arrival to the OR, participants received the epidural study medications in a standardized manner to simulate the conversion of ""epidural labor analgesia to surgical anesthesia."" The primary outcome was the time to loss of touch sensation at the T7 level. A noninferiority margin was set at 3 minutes. The secondary outcome was the need for intraoperative analgesia supplementation.
RESULTS


In total, 70 women were enrolled in the study. The mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level was 655 (standard deviation [SD] = 258) seconds for group CP and 558 (269) seconds for group LEBF, a difference in means of 97 seconds (90% confidence interval [CI], SD = -10.6 to 204; P = .10 for noninferiority). The upper limit of the 90% CI for the mean difference exceeded the prespecified 3-minute noninferiority margin. There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
CONCLUSION


Both anesthetic solutions have a rapid onset of anesthesia when used to extend low-dose epidural sensory block to surgical anesthesia. Data from the current study provide insufficient evidence to confirm that CP is noninferior to LEBF for rapid epidural extension anesthesia for CD, and further research is required to determine noninferiority.",2021,"There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
","['70 women were enrolled in the study', 'adult healthy women undergoing CD', 'Epidural Extension Anesthesia in Elective Cesarean Delivery']","['epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF', 'epidural anesthesia with either CP or LEBF', 'LEBF', 'Epinephrine, Sodium Bicarbonate, and Fentanyl', 'Chloroprocaine', 'chloroprocaine (CP', 'Lidocaine', 'lidocaine']","['mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level', 'time to loss of touch sensation at the T7 level', 'intraoperative analgesia', 'need for intraoperative analgesia supplementation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0448760', 'cui_str': 'Dermatome of seventh thoracic nerve'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0702221', 'cui_str': 'Touch sensation, function'}, {'cui': 'C0446425', 'cui_str': 'Level of the seventh thoracic vertebra'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",70.0,0.19062,"There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
","[{'ForeName': 'Nadir', 'Initials': 'N', 'LastName': 'Sharawi', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Prannal', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Horace', 'Initials': 'H', 'LastName': 'Spencer', 'Affiliation': 'Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Mhyre', 'Affiliation': 'From the Departments of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005141']
743,32862694,Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization.,"BACKGROUND


Longitudinal bleeding risk scores have been validated in patients treated with dual antiplatelet therapy (DAPT) following percutaneous coronary intervention. How these scores apply to the population of patients with acute coronary syndrome (ACS) treated without revascularization remains unknown. The objective was to evaluate and compare the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) bleeding risk scores in the medically managed patients with ACS treated with DAPT.
METHODS AND RESULTS


TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) was a double-blind, placebo-controlled randomized trial conducted from 2008 to 2012 over a median follow-up of 17.0 months in 966 sites (52 countries). High-risk patients with unstable angina or non-ST-segment-elevation myocardial infarction who did not undergo revascularization were randomized to prasugrel or clopidogrel. The PRECISE-DAPT, PARIS, and DAPT (bleeding component) risk scores were applied in the TRILOGY ACS population to evaluate their performance to predict adjudicated non-coronary artery bypass grafting-related GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) severe/life-threatening/moderate and TIMI (Thrombolysis in Myocardial Infarction) major/minor bleeding with time-dependent c-indices. Among the 9326 participants, median age was 66 years (interquartile range, 59-74 years), and 3650 were females (39.1%). A total of 158 (1.69%) GUSTO severe/life-threatening/moderate and 174 (1.87%) TIMI major/minor non-coronary artery bypass grafting bleeding events occurred. The c-indices (95% CI) of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores through 12 months were 0.716 (0.677-0.758), 0.693 (0.658-0.733), and 0.674 (0.637-0.713), respectively, for GUSTO bleeding and 0.624 (0.582-0.666), 0.612 (0.578-0.651), and 0.608 (0.571-0.649), respectively, for TIMI bleeding. There was no significant difference in the c-indices of each score based upon pairwise comparisons.
CONCLUSIONS


Among medically managed patients with ACS treated with DAPT, the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores were reasonable and similar to their performances in the derivation percutaneous coronary intervention populations. Bleeding risk scores may be used to predict longitudinal bleeding risk in patients with ACS treated with DAPT without revascularization and help support shared decision making. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00699998.",2020,Bleeding risk scores may be used to predict longitudinal bleeding risk in patients with ACS treated with DAPT without revascularization and help support shared decision making.,"['9326 participants, median age was 66 years (interquartile range, 59-74 years), and 3650 were females (39.1', 'patients treated with dual antiplatelet therapy (DAPT) following percutaneous coronary intervention', 'Thrombolysis in Myocardial Infarction', '2008 to 2012 over a median follow-up of 17.0 months in 966 sites (52 countries', 'medically managed patients with ACS treated with DAPT', 'High-risk patients with unstable angina or non-ST-segment-elevation myocardial infarction who did not undergo revascularization', 'patients with acute coronary syndrome (ACS', 'patients with ACS treated with', 'medically managed patients with ACS treated with']","['Open Occluded Coronary Arteries', 'prasugrel or clopidogrel', 'coronary artery bypass grafting-related GUSTO', 'DAPT', 'placebo', 'Dual Antiplatelet Therapy']","['TIMI bleeding', 'TIMI major/minor non-coronary artery bypass grafting bleeding events', 'Bleeding risk scores', 'severe/life-threatening/moderate and TIMI']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",9326.0,0.0299741,Bleeding risk scores may be used to predict longitudinal bleeding risk in patients with ACS treated with DAPT without revascularization and help support shared decision making.,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Marquis-Gravel', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Neely', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital, Switzerland (M.V., F.C.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital, Switzerland (M.V., F.C.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Van Klaveren', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, the Netherlands (D.V.K.).'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Altner', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre and Division of Cardiology, University of Alberta, Edmonton, Canada (P.W.A.).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (K.A.A.F.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Service, Auckland City Hospital, New Zealand (H.D.W.).'}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006582']
744,32873354,"Beneficial effect on serum cholesterol levels, but not glycaemic regulation, after replacing SFA with PUFA for 3 d: a randomised crossover trial.","Replacing intake of SFA with PUFA reduces serum cholesterol levels and CVD risk. The effect on glycaemic regulation is, however, less clear. The main objective of the present study was to investigate the short-term effect of replacing dietary SFA with PUFA on glycaemic regulation. Seventeen healthy, normal-weight participants completed a 25-d double-blind, randomised and controlled two-period crossover study. Participants were allocated to either interventions with PUFA products or SFA products (control) in a random order for three consecutive days, separated by a 1·5-week washout period between the intervention periods. Glucose, insulin and TAG were measured before and after an oral glucose tolerance test. In addition, fasting total cholesterol, NEFA and plasma total fatty acid profile were measured before and after the 3-d interventions. Fasting and postprandial glucose, insulin, and TAG levels and fasting levels of NEFA and plasma fatty acid profile did not differ between the groups. However, replacing dietary SFA with PUFA significantly reduced total cholesterol levels by 8 % after 3 d (P = 0·002). Replacing dietary SFA with PUFA for only 3 d has beneficial cardio-metabolic effects by reducing cholesterol levels in healthy individuals.",2021,"However, replacing dietary SFA with PUFA significantly reduced total cholesterol levels with 8 % after three days (P = 0.002).","['Seventeen healthy, normal-weight participants', 'healthy individuals']","['interventions with PUFA products or SFA products (control', 'saturated fatty acids (SFA) with polyunsaturated fatty acids (PUFA']","['Fasting and postprandial glucose, insulin, and triglyceride levels and fasting levels of non-esterified fatty acids and plasma fatty acids profile', 'Glucose, insulin and triglycerides', 'serum cholesterol levels', 'cholesterol levels', 'fasting total cholesterol, non-esterified fatty acids and plasma total fatty acid profile', 'total cholesterol levels', 'serum cholesterol levels and cardiovascular disease risk']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.12481,"However, replacing dietary SFA with PUFA significantly reduced total cholesterol levels with 8 % after three days (P = 0.002).","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Gaundal', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, 0130Oslo, Norway.'}, {'ForeName': 'Mari C W', 'Initials': 'MCW', 'LastName': 'Myhrstad', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, 0130Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Leder', 'Affiliation': 'Mills AS, 0558Oslo, Norway.'}, {'ForeName': 'Marte Gjeitung', 'Initials': 'MG', 'LastName': 'Byfuglien', 'Affiliation': 'Mills AS, 0558Oslo, Norway.'}, {'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Gjøvaag', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, 0130Oslo, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rud', 'Affiliation': 'Nofima (Norwegian Institute of Food, Fisheries and Aquaculture Research), 1433Ås, Norway.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Retterstøl', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, 0317Oslo, Norway.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Holven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, 0317Oslo, Norway.'}, {'ForeName': 'Stine M', 'Initials': 'SM', 'LastName': 'Ulven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, 0317Oslo, Norway.'}, {'ForeName': 'Vibeke H', 'Initials': 'VH', 'LastName': 'Telle-Hansen', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, 0130Oslo, Norway.'}]",The British journal of nutrition,['10.1017/S0007114520003402']
745,32860696,Does High-Frequency Chest Wall Oscillation Have an Impact on Improving Pulmonary Function in Patients With Smoke Inhalation Injury?,"Smoke inhalation results in bronchospasm of the trachea, increasing secretion of mucus, casts formation, and improvement of blood flow of the airway. High frequency chest wall oscillation is a common modality used for clearing mucus secretion in patients suffering from hypersecretion of thick mucus and used also to help cough clearance. This study aimed to detect the effect of high frequency chest wall oscillation in improving pulmonary function in burn patients suffering from smoke inhalation. Sixty smoke inhalation injury patients were randomly distributed into two groups of equal size. Group A: received high frequency chest wall oscillation and conventional chest physical therapy (breathing exercises, early ambulation, and cough training) thrice per week for 8 weeks. Group B: received traditional chest physical therapy (breathing exercises, early ambulation, and cough training) thrice per week for 8 weeks. Pulmonary function test (forced vital capacity, forced expiratory volume in the first second and peak expiratory flow rate) was measured at enrollment and after 8 weeks by using spirometer. Pulmonary function increased significantly posttreatment when compared with that pretreatment in groups A and B (P > .001). Also, they increased significantly in group A compared with that of group B posttreatment (P > .05). High-frequency chest wall oscillation have an impact on improving pulmonary function and should be handled to be a part of the pulmonary rehabilitation plan for smoke inhalation injury patients.",2021,Pulmonary function increased significantly post-treatment when compared with that pre-treatment in group A and B (p > 0.001).,"['patients suffering from hypersecretion of thick mucus', 'Patients with Smoke Inhalation Injury', '\n\n\n60 smoke inhalation injury patients', 'burn patients suffering from smoke inhalation', 'smoke inhalation injury patients']","['traditional chest physical therapy (breathing exercises, early ambulation and cough training', 'high frequency chest wall oscillation', 'high frequency chest wall oscillation and conventional chest physical therapy (breathing exercises, early ambulation and cough training']","['Pulmonary function test (forced vital capacity, forced expiratory volume in the first second and peak expiratory flow rate', 'bronchospasm of the trachea, increasing secretion of mucus, casts formation, and improvement of blood flow of the airway', 'pulmonary function', 'Pulmonary function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0037367', 'cui_str': 'Smoke inhalation injury'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0013457', 'cui_str': 'Ambulation, Early'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1136075', 'cui_str': 'High-Frequency Chest Compression'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0040578', 'cui_str': 'Tracheal structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",60.0,0.0130483,Pulmonary function increased significantly post-treatment when compared with that pre-treatment in group A and B (p > 0.001).,"[{'ForeName': 'Nesma M', 'Initials': 'NM', 'LastName': 'Allam', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Manar M', 'Initials': 'MM', 'LastName': 'Badawy', 'Affiliation': 'Department of Physical Therapy for Cardiovascular, Pulmonary Disorders and Geriatrics, Faculty of Physical Therapy, Misr University for Science and Technology, Egypt.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/iraa147']
746,32826188,How periarticular corticosteroid injections impact the integrity of arthroscopic rotator cuff repair.,"INTRODUCTION


Multimodal analgesic (MMA) injections combined with corticosteroids have recently been shown to be effective for managing pain after arthroscopic rotator cuff repair.
HYPOTHESIS


The goal of this study was to analyze the effects of corticosteroid injections on the integrity of tendon repairs using magnetic resonance imaging (MRI). The hypothesis was that MMA injections combined with corticosteroids have no deleterious effects on functional outcomes and tendon healing 1 year after surgical rotator cuff repair.
METHODS


This was a prospective, double-blind study of 50 patients undergoing arthroscopic rotator cuff repair who were randomized into two groups. The study group (n=25) received a periarticular injection of a mixture of ropivacaine, morphine and methylprednisolone at the end of the procedure. The control group (n=25) received a placebo injection. The clinical outcomes were the pain level and complications, while the functional outcomes consisted of the Constant-Murley Score (CMS), American Shoulder and Elbow Surgeons Shoulder (ASES) score and Simple Shoulder Test (SST). The structural integrity of the operated tendons was analyzed on MRI at a mean follow-up of 15.1±1.3 months for the study group and 15.2±1.1 for the control group (p=0.848).
RESULTS


Pain on a visual analog scale was significantly reduced in both groups after the surgery. Nevertheless, there was no significant difference between groups at the final follow-up visit (p=0.803). Compared to the preoperative values, the CMS, ASES and SST significantly improved in both groups after surgery but were not significantly different between groups at the final assessment (p=0.801, 0.869 and 0.769, respectively). MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107). There were no infections in the study group as of the final assessment. Advanced age (p=0.049), diabetes (p<0.01) and posterior extension of the tear (p=0.039) negatively impact healing. Corticosteroid injection did not negatively impact healing (p=0.197).
CONCLUSION


This study shows that MMA injection combined with corticosteroids does not alter the tendon healing, clinical outcomes, or functional outcomes 1 year after arthroscopic rotator cuff repair. It remains a safe and effective analgesia method during rotator cuff repair surgery.
LEVEL OF EVIDENCE


II, low-powered placebo-controlled, randomized study.",2020,MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107).,"['50 patients undergoing arthroscopic rotator cuff repair', 'arthroscopic rotator cuff repair']","['periarticular injection of a mixture of ropivacaine, morphine and methylprednisolone', 'Corticosteroid injection', 'MMA injections combined with corticosteroids', 'placebo injection', 'Multimodal analgesic (MMA) injections combined with corticosteroids', 'magnetic resonance imaging (MRI', 'corticosteroid injections', 'MMA injection combined with corticosteroids']","['CMS, ASES and SST', 'pain level and complications, while the functional outcomes consisted of the Constant-Murley Score (CMS), American Shoulder and Elbow Surgeons Shoulder (ASES) score and Simple Shoulder Test (SST', 'visual analog scale', 'supraspinatus tendon retears']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",50.0,0.151985,MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107).,"[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Perdreau', 'Affiliation': ""Orthopedic and Trauma Surgery Department, Centre Hospitalier de l'Ardenne, 35, Avenue de Houffalize 35, 6800 Libramont-Chevigny, Belgium. Electronic address: perdreaua@hotmail.com.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Duysens', 'Affiliation': 'Institut Européen de la main, Centre Hospitalier du Kirchberg, 9, Rue Edward Steichen, 2540 Luxembourg, Grand Duchy of Luxembourg, Luxembourg.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Joudet', 'Affiliation': 'Orthopedic Surgery Department, Clinique Chirurgicale du Libournais, 119, Rue de la Marne, 33500 Libourne, France.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.05.009']
747,32871095,Association between favourable changes in objectively measured physical activity and telomere length after a lifestyle intervention in pediatric patients with abdominal obesity.,"The purpose of this study was to assess the effect of physical activity (PA) changes, measured by accelerometry, on telomere length (TL) in pediatric patients with abdominal obesity after a lifestyle intervention. One hundred and twenty-one children (7-16 years old) with abdominal obesity were randomized to the intervention (a moderately hypocaloric Mediterranean diet) or the usual care group (standard pediatric recommendations) for 22 months (a 2 month intensive phase and a subsequent 20 month follow-up). Both groups were encouraged to accumulate an extra 200 min/week of PA. TL was measured by MMqPCR. Data were analyzed in 102 subjects after 2 months and 64 subjects at the first 10 months of follow-up. Light PA level decreased in both groups after 12 months of intervention. At month 2, moderate to vigorous PA (MVPA) increased in the intervention group (+5.4 min/day,  p  = 0.035) and so did sedentary time in the usual care group (+49.7 min/day,  p  = 0.010). TL changes were positively associated ( p  < 0.050) with metabolic equivalents (METs), MVPA level, and number of steps, and were inversely associated with sedentary and light PA levels in the intervention group after the intensive phase. In conclusion, favourable changes in PA levels in the intensive phase of a lifestyle intervention could contribute to TL maintenance in a pediatric population with abdominal obesity.  Novelty  Changes in physical activity levels had a direct effect on telomere length, a biomarker of cellular aging and oxidative stress. PA advice based on The American College of Sports Medicine included in this intervention is easy to implement in primary care.",2021,"TL changes were positively associated (p<0.050) with metabolic equivalents (METs), MVPA level and number of steps; and inversely associated with sedentary and light PA levels in the intervention group after the intensive phase.","['pediatric population with abdominal obesity', '121 children with abdominal obesity (7-16 years old', 'pediatric patients with abdominal obesity after a lifestyle intervention', '102 subjects after 2-month and 64 subjects at the first 10 months of follow-up', 'pediatric patients with abdominal obesity']","['physical activity (PA', 'intervention (moderately hypocaloric Mediterranean Diet) or usual care group (standard pediatrics recommendations']","['moderate-to-vigorous PA (MVPA', 'Novelty', 'sedentary and light PA levels', 'TL changes', 'physical activity levels', 'PA levels', 'telomere length (TL', 'telomere length, a biomarker of cellular aging and oxidative stress', 'metabolic equivalents (METs), MVPA level and number of steps', 'TL', 'Light PA level']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",121.0,0.0171883,"TL changes were positively associated (p<0.050) with metabolic equivalents (METs), MVPA level and number of steps; and inversely associated with sedentary and light PA levels in the intervention group after the intensive phase.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ojeda-Rodríguez', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra. C/Irunlarrea, 1. 31008 Pamplona, Spain.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Morell-Azanza', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra. C/Irunlarrea, 1. 31008 Pamplona, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Martín-Calvo', 'Affiliation': 'Instituto de Investigación Sanitaria de Navarra (IdiSNA). C/Irunlarrea, 3. 31008 Pamplona, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Zalba', 'Affiliation': 'Instituto de Investigación Sanitaria de Navarra (IdiSNA). C/Irunlarrea, 3. 31008 Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Chueca', 'Affiliation': 'Instituto de Investigación Sanitaria de Navarra (IdiSNA). C/Irunlarrea, 3. 31008 Pamplona, Spain.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Azcona-Sanjulian', 'Affiliation': 'Instituto de Investigación Sanitaria de Navarra (IdiSNA). C/Irunlarrea, 3. 31008 Pamplona, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Marti', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra. C/Irunlarrea, 1. 31008 Pamplona, Spain.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0297']
748,32881797,A multilevel intervention to reduce stigma among alcohol consuming men living with HIV receiving antiretroviral therapy: findings from a randomized control trial in India.,"OBJECTIVE


To examine the effectiveness of a multilevel intervention to reduce HIV stigma among alcohol consuming men living with HIV in India.
DESIGN


A crossover randomized controlled trial in four sites.
SETTING


Government ART centres (ARTCs) offering core services in the greater Mumbai area.
PARTICIPANTS


Seven hundred and fifty two (188 per site) alcohol-consuming male PLHIV on ART were recruited.
INTERVENTION


Multilevel intervention to reduce alcohol consumption and promote adherence by addressing stigma, implemented at the individual (individual counselling, IC), group (group intervention, GI) and community levels (collective advocacy, CA) in three distinct sequences over three cycles of 9 months each.
MAIN OUTCOME MEASURE


HIV stigma, measured using the 16-item Berger Stigma scale.
METHODS


The article examines the effectiveness of the interventions to reduce stigma using Linear Mixed Model regression.
RESULTS


At baseline, 57% of participants had moderate-high levels of stigma (scores >40). All three counseling interventions were effective in reducing stigma when delivered individually, in the first cycle (collective advocacy: βcoeff = -9.71; p < 0.001; group intervention: βcoeff = -5.22; p < 0.001; individual counselling: βcoeff = -4.43; p < 0.001). At then end of the second cycle, effects from the first cycle were sustained with no significant change in stigma scores. At the end of the third cycle, the site, which received CA+IC+GI sequence had maximum reduction in stigma scores (βcoeff = -10.29; p < 0.001), followed by GI+CA+IC (βcoeff = -8.23, p < 0.001).
CONCLUSION


Baseline findings suggest that stigma remains a problem even with experienced patients, despite advances in treatment and adherence. Results of multilevel stigma reduction interventions argue for inclusion in HIV prevention and treatment program.",2020,"All three counseling interventions were effective in reducing stigma when delivered individually, in the first cycle (collective advocacy:","['Government ART centres (ARTCs) offering core services in the greater Mumbai area', 'consuming men living with HIV in India', 'Seven hundred and fifty two (188 per site) alcohol-consuming male PLHIV on ART were recruited', 'consuming men living with HIV receiving antiretroviral therapy']","['alcohol', 'multilevel intervention', 'Multilevel intervention to reduce alcohol consumption and promote adherence by addressing stigma, implemented at the individual (individual counselling, IC), group (group intervention, GI) and community levels (collective advocacy, CA']","['stigma scores', 'HIV stigma, measured using the 16-item Berger Stigma scale', 'moderate-high levels of stigma', 'HIV stigma']","[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150446', 'cui_str': 'Advocacy'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",752.0,0.0978675,"All three counseling interventions were effective in reducing stigma when delivered individually, in the first cycle (collective advocacy:","[{'ForeName': 'Roopal J', 'Initials': 'RJ', 'LastName': 'Singh', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Avina', 'Initials': 'A', 'LastName': 'Sarna', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Jean J', 'Initials': 'JJ', 'LastName': 'Schensul', 'Affiliation': 'Institute for Community Research, Hartford.'}, {'ForeName': 'Bidhubhushan', 'Initials': 'B', 'LastName': 'Mahapatra', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Ha', 'Affiliation': 'University of Connecticut, School of Medicine, Farmington, Connecticut, USA.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Schensul', 'Affiliation': 'University of Connecticut, School of Medicine, Farmington, Connecticut, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002604']
749,32881835,"Long-term resveratrol supplementation improves pain perception, menopausal symptoms, and overall well-being in postmenopausal women: findings from a 24-month randomized, controlled, crossover trial.","OBJECTIVE


Following concerns about hormone therapy, postmenopausal women need alternative options to manage menopause-related symptoms and improve their well-being. A 14-week pilot study has shown that supplementation with resveratrol, a phytoestrogen with circulatory benefits, can improve aspects of well-being including chronic pain, which is a common complaint in postmenopausal women. We aimed to confirm these benefits in a larger, long-term study.
METHODS


The Resveratrol for Healthy Ageing in Women study, a 24-month randomized, double-blind, placebo-controlled, two-period crossover intervention trial of resveratrol supplementation (75 mg BID) was conducted in 125 healthy postmenopausal women to evaluate effects on cognitive performance (results published elsewhere). Aspects of well-being including pain perception, mood and depressive symptoms, menopausal symptoms, sleep quality, and quality of life were assessed with questionnaires as secondary outcomes of the study. Cerebrovascular responsiveness to hypercapnia was measured as a surrogate marker of cerebrovascular function.
RESULTS


Resveratrol supplementation reduced composite pain score (P < 0.001), especially in overweight individuals; this was associated with improvements in cerebrovascular responsiveness to hypercapnia (R = -0.329, P = 0.014). Somatic menopausal symptoms (P = 0.024) and general well-being (P = 0.010) were also improved after resveratrol supplementation.
CONCLUSIONS


These results confirm the pilot study finding that resveratrol supplementation can reduce chronic pain in age-related osteoarthritis and improve menopause-related quality of life in postmenopausal women. These improvements are sustained by supplementation for at least 12 months and are associated with enhancement of circulatory function.
CLINICAL TRIAL REGISTRATION


ACTRN12616000679482p.",2020,"RESULTS


Resveratrol supplementation reduced composite pain score (P < 0.001), especially in overweight individuals; this was associated with improvements in cerebrovascular responsiveness to hypercapnia (R = -0.329","['125 healthy postmenopausal women', 'postmenopausal women']","['Long-term resveratrol supplementation', 'resveratrol supplementation', 'placebo']","['Somatic menopausal symptoms', 'cerebrovascular responsiveness to hypercapnia', 'pain perception, mood and depressive symptoms, menopausal symptoms, sleep quality, and quality of life', 'Cerebrovascular responsiveness to hypercapnia', 'composite pain score', 'chronic pain', 'pain perception, menopausal symptoms']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",125.0,0.634047,"RESULTS


Resveratrol supplementation reduced composite pain score (P < 0.001), especially in overweight individuals; this was associated with improvements in cerebrovascular responsiveness to hypercapnia (R = -0.329","[{'ForeName': 'Jay Jay', 'Initials': 'JJ', 'LastName': 'Thaung Zaw', 'Affiliation': 'University of Newcastle, School of Biomedical Sciences and Pharmacy, Callaghan, NSW, Australia.'}, {'ForeName': 'Peter R C', 'Initials': 'PRC', 'LastName': 'Howe', 'Affiliation': 'University of Newcastle, School of Biomedical Sciences and Pharmacy, Callaghan, NSW, Australia.'}, {'ForeName': 'Rachel H X', 'Initials': 'RHX', 'LastName': 'Wong', 'Affiliation': 'University of Newcastle, School of Biomedical Sciences and Pharmacy, Callaghan, NSW, Australia.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001643']
750,32853755,"Effect of Simulation-Based Training and Neurofeedback Interventions on Radiation Technologists' Workload, Situation Awareness, and Performance.","PURPOSE


Our purpose was to assess the effect of a combined intervention - simulation-based training supported by neurofeedback sessions - on radiation technologists' (RTs') workload, situation awareness, and performance during routine quality assurance and treatment delivery tasks.
METHODS AND MATERIALS


As part of a prospective institutional review board approved study, 32 RTs previously randomized to receive versus not receive simulation-based training focused on patient safety were again randomized to receive versus not receive a 3-week neurofeedback intervention (8 sessions of alpha-theta protocol) focused on stress reduction as well as conscious precision, strong focus, and ability to solve arising problems. Perceived workload was quantified using the NASA Task Load Index. Situation awareness was quantified using the situation awareness rating technique. Performance score was calculated using procedural compliance with time-out components and error detection.
RESULTS


RTs randomized to simulation-based training followed by neurofeedback sessions demonstrated no significant changes in perceived workload or situation awareness scores, but did have better performance compared with other study groups (P < .01).
CONCLUSIONS


This finding is encouraging and provides basis for using neurofeedback as means to possibly augment performance improvements gained during simulation-based training.",2021,"RESULTS


RTs randomized to simulation-based training followed by neurofeedback sessions demonstrated no significant changes in perceived workload or situation awareness scores, but did have better performance, when compared with other study groups (p < 0.01).
",[],"['neurofeedback intervention (8 sessions of alpha-theta protocol', 'Simulation-based Training and Neurofeedback Interventions', 'combined intervention - simulation-based training']","['Radiation Technologists Workload, Situation Awareness, and Performance', 'perceived workload or situation awareness scores', ""radiation technologists (RTs') workload, situation awareness, and performance during routine quality assurance (QA"", 'Performance score', 'situation awareness rating technique (SART']",[],"[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0260280', 'cui_str': 'Technologist'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",32.0,0.017154,"RESULTS


RTs randomized to simulation-based training followed by neurofeedback sessions demonstrated no significant changes in perceived workload or situation awareness scores, but did have better performance, when compared with other study groups (p < 0.01).
","[{'ForeName': 'Lukasz M', 'Initials': 'LM', 'LastName': 'Mazur', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; School of Information and Library Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: lmazur@med.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Prithima R', 'Initials': 'PR', 'LastName': 'Mosaly', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; School of Information and Library Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nuamah', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Adapa', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Lawrence B', 'Initials': 'LB', 'LastName': 'Marks', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Practical radiation oncology,['10.1016/j.prro.2020.08.005']
751,32864685,Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis.,"OBJECTIVES


To examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercept in patients with PsA.
METHODS


The trial randomised 851 patients to receive weekly: MTX (20 mg/week), etanercept (50 mg/week) or MTX plus etanercept. Dichotomous composite measures examined included ACR 20/50/70 responses, minimal disease activity (MDA) and very low disease activity (VLDA). Continuous composite measures examined included Disease Activity Score (28 joints) using CRP (DAS28-CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS).
RESULTS


At week 24, etanercept-treated groups were significantly more effective than MTX monotherapy to achieve ACR 20 (primary end point) and MDA (key secondary end point). When examining score changes from baseline at week 24 across the five continuous composite measures, PASDAS demonstrated relatively greater changes in the etanercept-treated groups compared with MTX monotherapy and had the largest effect size and standardized response. Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments.
CONCLUSION


PASDAS was the most sensitive continuous composite measure examined with results that mirrored the protocol-defined primary and key secondary outcomes. Composite measures with multiple domains, such as PASDAS, may better quantify change in PsA disease burden.
TRAIL REGISTRATION


https://ClinicalTrials.gov, number NCT02376790.",2021,"Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments.
","['patients with PsA.\nMETHODS', 'psoriatic arthritis']","['MTX monotherapy', 'etanercept', 'MTX', 'MTX plus etanercept', 'MTX and etanercept', 'etanercept and methotrexate']","['Disease Activity Score (28 joints) using CRP (DAS28-CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS', 'ACR 20/50/70 responses, minimal disease activity (MDA) and very low disease activity (VLDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0442811', 'cui_str': 'Very low'}]",851.0,0.0455213,"Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments.
","[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Department of Dermatology and Department of Medicine, Division of Rheumatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Division of Rheumatology Clinical Research, Swedish Medical Center/Providence St. Joseph Health and the University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Division of Rheumatology and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Leonieke J J', 'Initials': 'LJJ', 'LastName': 'van Mens', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Lyrica', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Global Biostatistical Science, Amgen Inc., South San Francisco, USA.'}, {'ForeName': 'Priscilla K', 'Initials': 'PK', 'LastName': 'Yen', 'Affiliation': 'Global Biostatistical Science, Thousand Oaks, CA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Collier', 'Affiliation': 'US Medical Organization, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kricorian', 'Affiliation': 'US Medical Organization, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Chung', 'Affiliation': 'US Medical Organization, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa271']
752,32888788,"Lowering of hemoglobin A1C and risk of cardiovascular outcomes and all-cause mortality, a meta-regression analysis.","BACKGROUND


The management of type 2 diabetes predominantly focuses on reducing hemoglobin A1C (HbA1c). We examined the association between the magnitude of reduction in HbA1c and cardiovascular outcomes for new diabetes medications: sodium-glucose cotransporter-2 [SGLT2] inhibitors, glucagon-like peptide-1 [GLP1] agonists, and dipeptidyl peptidase-4 [DPP4] inhibitors.
METHODS


We reviewed all published, placebo-controlled, randomized cardiovascular outcome trials. Meta-regression was performed to evaluate the association between HbA1c reduction (i.e., [post-intervention HbA1c for active drug - pre-intervention HbA1c for active drug] - [post-intervention HbA1c for placebo - pre-intervention HbA1c for placebo]) and the composite cardiovascular outcome (i.e., stroke, myocardial infarction, or cardiovascular death).
RESULTS


We identified 14 cardiovascular outcome clinical trials, the median sample size was 9401, the median age was 64 years, the median time since diagnosis of diabetes was 12 years, and the median duration of trial follow-up was 120 weeks. Within individual medication classes, each additional 0.5% reduction in HbA1c in the active drug arm, relative to placebo, was associated with a lower incidence of cardiovascular events for GLP1 agonists (0.82, 0.68-0.98) but not for SGLT2 (0.97, 0.69-1.36) or DPP4 (1.03, 0.39-2.74) inhibitors.
DISCUSSION


Our study provides further support that reducing the risk of cardiovascular events for adults with diabetes is partly explained by a reduction in HbA1c.",2020,"Within individual medication classes, each additional 0.5% reduction in HbA1c in the active drug arm, relative to placebo, was associated with a lower incidence of cardiovascular events for GLP1 agonists (0.82, 0.68-0.98) but not for SGLT2 (0.97, 0.69-1.36) or DPP4 (1.03, 0.39-2.74) inhibitors.
","['adults with diabetes', 'new diabetes medications', 'median sample size was 9401, the median age was 64\u202fyears, the median time since diagnosis of diabetes was 12\u202fyears, and the median duration of trial follow-up was 120\u202fweeks']","['placebo', 'active drug - pre-intervention HbA1c for active drug] - [post-intervention HbA1c for placebo - pre-intervention HbA1c for placebo', 'sodium-glucose cotransporter-2']","['composite cardiovascular outcome (i.e., stroke, myocardial infarction, or cardiovascular death', 'Lowering of hemoglobin A1C and risk of cardiovascular outcomes', 'risk of cardiovascular events', 'hemoglobin A1C (HbA1c', 'cardiovascular events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.197082,"Within individual medication classes, each additional 0.5% reduction in HbA1c in the active drug arm, relative to placebo, was associated with a lower incidence of cardiovascular events for GLP1 agonists (0.82, 0.68-0.98) but not for SGLT2 (0.97, 0.69-1.36) or DPP4 (1.03, 0.39-2.74) inhibitors.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fralick', 'Affiliation': 'Sinai Health System and the Department of Medicine, University of Toronto, Toronto, ON, Canada; University of Toronto, Department of Medicine, General Internal Medicine, Toronto, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Colacci', 'Affiliation': 'University of Toronto, Department of Medicine, General Internal Medicine, Toronto, Canada. Electronic address: Michael.colacci@mail.utoronto.ca.'}, {'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Odutayo', 'Affiliation': ""University of Toronto, Department of Medicine, General Internal Medicine, Toronto, Canada; Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Reed', 'Initials': 'R', 'LastName': 'Siemieniuk', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107704']
753,32888906,The Relevance of Dual Tasking for Improving Trunk Muscle Endurance After Back Surgery.,"OBJECTIVE


To determine the effect of dual tasking on trunk muscle endurance in patients after lumbar diskectomy.
DESIGN


Cross-sectional study.
SETTING


Rehabilitation hospital setting.
PARTICIPANTS


Individuals (N=14) undergoing primary lumbar diskectomy.
INTERVENTION


Using a randomized design on 2 separate days, muscle endurance was evaluated during prone bridging and Biering-Sorensen tests. Each test was randomly performed under 2 cognitive conditions: single task without cognitive condition and self-regulated dual task (ie, mathematical task).
MAIN OUTCOME MEASURES


The primary outcomes were time to failure and pain assessed by the visual analog scale from 0 to 100 mm. The secondary outcomes were kinesiophobia assessed by the Tampa Scale and disability assessed by the Oswestry Disability Index. Associations were tested using a repeated measures analysis of variance with relevant interaction test.
RESULTS


A significant interaction between condition, endurance tests, and kinesiophobia (P=.005) was found. The post hoc comparison showed positive effects between cognitive conditions in both endurance tests (prone bridging test: mean difference, 15.7s; 95% confidence interval [CI], 7.5-24s; P=.001; Biering-Sorensen test: mean difference, 7.9s; 95% CI, 1.9-14s; P=.014). The linear regression analysis between the Tampa Scale for Kinesiophobia and the difference of time to failure between cognitive conditions showed a positive correlation only during the Biering-Sorensen test (r=0.80; P=.001).
CONCLUSIONS


A self-regulated dual task increases trunk muscle endurance in patients after lumbar diskectomy. The results suggest that the difference observed in time to failure between the single task and dual task is associated with fear avoidance, especially during back extension. This strategy seems especially relevant for patients with high levels of fear avoidance and may be used to improve trunk muscle endurance.",2021,A significant interaction between condition x endurance tests x kinesiophobia (p = 0.005) was found.,"['Rehabilitation hospital setting', 'patients after lumbar discectomy', 'trunk muscle endurance after back surgery', 'Fourteen people undergoing primary lumbar discectomy']","['dual tasking', 'self-regulated dual task', 'single task without cognitive condition and 2) self-regulated dual task (i.e., mathematical task']","['kinesiophobia assessed by the Tampa Scale and disability assessed by the Oswestry Disability Index', 'time to failure and pain assessed by the Visual Analog Scale (VAS', 'trunk muscle endurance']","[{'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0741419', 'cui_str': 'Back surgery'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0408633', 'cui_str': 'Primary lumbar discectomy'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}]","[{'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",14.0,0.0563876,A significant interaction between condition x endurance tests x kinesiophobia (p = 0.005) was found.,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cruz-Montecinos', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago, Chile; Laboratory of Biomechanics and Kinesiology, San José Hospital, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Núñez-Cortés', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago, Chile; Service of Physical Therapy, Hospital Clínico La Florida, Santiago, Chile.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Guzmán-González', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'García-Massó', 'Affiliation': 'Department of Teaching of Musical, Visual and Corporal Expression, University of Valencia, Valencia, Spain; Human Movement Analysis Group, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark; Exercise Intervention for Health Research Group, Department of Physiotherapy, University of Valencia, Valencia, Spain. Electronic address: joaquin.calatayud@uv.es.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.015']
754,32883567,Empagliflozin decreases the plasma concentration of plasminogen activator inhibitor-1 (PAI-1) in patients with type 2 diabetes: Association with improvement of fibrinolysis.,"AIMS


Elevation of the plasma concentration of plasminogen activator inhibitor-1 (PAI-1), a rapid-acting inhibitor of fibrinolysis, is associated with development of vascular thrombotic diseases, including coronary artery disease and stroke. We investigated the effects of empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, on the plasma concentration of PAI-1 and fibrinolytic activity in patients with type 2 diabetes.
METHODS


In a randomized, active-controlled, open-label trial, 51 patients with type 2 diabetes were randomly allocated at a 2:1 ratio to receive empagliflozin (10 mg/day, n = 31) or standard therapy (n = 18) for 12 weeks. We measured the plasma concentrations of PAI-1 and plasmin-α2-antiplasmin complex (PAP) as indicators of fibrinolytic activity. Serum leptin and high-molecular weight (HMW) adiponectin were also measured.
RESULTS


In 49 patients who completed the trial, baseline plasma PAI-1 showed a positive correlation with body weight, visceral fat area (VFA), γ-glutamyltranspeptidase (GGT), leptin, and the platelet count, while it showed a negative correlation with HDL cholesterol and PAP. Body weight and VFA decreased significantly in the empagliflozin group, but not in the control group. The serum level of GGT showed a significant decrease at 12 weeks in the empagliflozin group, while it was unchanged in the control group. Serum HMW adiponectin increased significantly in the empagliflozin group. Plasma PAI-1 decreased significantly by 25% in the empagliflozin group, but not in the control group. In the empagliflozin group, the change of plasma PAI-1 was positively correlated with the changes of body weight and leptin, but was negatively correlated with the change of PAP.
CONCLUSIONS


Empagliflozin reduced the plasma PAI-1 concentration through its synergistic actions of a glucose-lowering effect, VFA loss, and restoring the adipokine balance. (Clinical trial registry: UMIN000025418).",2020,"Plasma PAI-1 decreased significantly by 25% in the empagliflozin group, but not in the control group.","['patients with type 2 diabetes', '49 patients', '51 patients with type 2 diabetes']","['Empagliflozin', 'empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor', 'empagliflozin', 'standard therapy']","['change of plasma PAI-1', 'plasma PAI-1 concentration', 'body weight, visceral fat area (VFA), γ-glutamyltranspeptidase (GGT), leptin', 'Serum leptin and high-molecular weight (HMW) adiponectin', 'Body weight and VFA', 'body weight and leptin', 'plasma concentrations of PAI-1 and plasmin-α2-antiplasmin complex (PAP) as indicators of fibrinolytic activity', 'plasma concentration of PAI-1 and fibrinolytic activity', 'Serum HMW adiponectin', 'serum level of GGT', 'plasma concentration of plasminogen activator inhibitor-1 (PAI-1', 'Plasma PAI-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0016016', 'cui_str': 'Plasmin'}, {'cui': 'C0003410', 'cui_str': 'Antiplasmin'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",51.0,0.0384631,"Plasma PAI-1 decreased significantly by 25% in the empagliflozin group, but not in the control group.","[{'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Sakurai', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Jojima', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan. Electronic address: jojima@dokkyomed.ac.jp.'}, {'ForeName': 'Toshie', 'Initials': 'T', 'LastName': 'Iijima', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tomaru', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Usui', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Aso', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan. Electronic address: yaso@dokkyomed.ac.jp.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107703']
755,32888018,Population pharmacokinetics and dosing simulations of amoxicillin in obese adults receiving co-amoxiclav.,"BACKGROUND


Pneumonia, skin and soft tissue infections are more frequent in obese patients and are most often treated by co-amoxiclav, using similar dosing regimens to those used for non-obese subjects. No data are available on amoxicillin pharmacokinetics among obese subjects receiving co-amoxiclav.
MATERIALS AND METHODS


Prospective, single-centre, open-label, non-randomized, crossover pharmacokinetic trial having enrolled obese otherwise healthy adult subjects. A first dose of co-amoxiclav (amoxicillin/clavulanate 1000/200 mg) was infused IV over 30 min, followed by a second dose (1000/125 mg) administered orally, separated by a washout period of ≥24 h. We assayed concentrations of amoxicillin by a validated ultra HPLC-tandem MS technique. We estimated population pharmacokinetic parameters of amoxicillin by non-linear mixed-effect modelling using the SAEM algorithm developed by Monolix.
RESULTS


Twenty-seven subjects were included in the IV study, with 24 included in the oral part of the study. Median body weight and BMI were 109.3 kg and 40.6 kg/m2, respectively. Amoxicillin pharmacokinetics were best described by a two-compartment model with first-order elimination. Mean values for clearance, central volume, intercompartmental clearance and peripheral volume were, respectively, 14.6 L/h, 9.0 L, 4.2 L/h and 6.4 L for amoxicillin. Oral bioavailability of amoxicillin was 79.7%. Amoxicillin Cmax after oral administration significantly reduced with weight (P = 0.013). Dosing simulations for amoxicillin predicted that most of the population will achieve the pharmacodynamic target of fT>MIC ≥40% with the regimen of co-amoxiclav 1000/200 mg (IV) or 1000/125 mg (oral) q8h for MICs titrated up to 0.5 mg/L (IV) and 1 mg/L (oral).
CONCLUSIONS


Pharmacokinetic/pharmacodynamic goals for amoxicillin can be obtained in obese subjects.",2020,Amoxicillin Cmax after oral administration significantly reduced with weight (P = 0.013).,"['obese patients', 'obese subjects', 'Twenty-seven subjects were included in the IV study, with 24 included in the oral part of the study', 'enrolled obese otherwise healthy adult subjects', 'obese adults receiving co-amoxiclav', 'obese subjects receiving co-amoxiclav']","['Amoxicillin', 'co-amoxiclav (amoxicillin/clavulanate', 'amoxicillin']","['Amoxicillin Cmax', 'Median body weight and BMI', 'Mean values for clearance, central volume, intercompartmental clearance and peripheral volume', 'Oral bioavailability']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",27.0,0.0287644,Amoxicillin Cmax after oral administration significantly reduced with weight (P = 0.013).,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mellon', 'Affiliation': 'AP-HP, Tropical and Infectious Diseases department, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hammas', 'Affiliation': 'CIC-EC 1425, INSERM, F-75018 Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Burdet', 'Affiliation': 'CIC-EC 1425, INSERM, F-75018 Paris, France.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Duval', 'Affiliation': 'CIC-EC 1425, INSERM, F-75018 Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Carette', 'Affiliation': 'AP-HP, Nutrition department, Hôpital Georges-Pompidou, Paris, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'El-Helali', 'Affiliation': 'Microbiology Laboratory, Hôpital Paris Saint Joseph, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Massias', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mentré', 'Affiliation': 'CIC-EC 1425, INSERM, F-75018 Paris, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Czernichow', 'Affiliation': 'AP-HP, Nutrition department, Hôpital Georges-Pompidou, Paris, France.'}, {'ForeName': 'A-C', 'Initials': 'AC', 'LastName': 'Crémieux', 'Affiliation': 'AP-HP, Tropical and Infectious Diseases department, Hôpital Saint-Louis, Paris, France.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa368']
756,32888031,Effects of acetaminophen on risk taking.,"Acetaminophen, an analgesic and antipyretic available over-the-counter and used in over 600 medicines, is one of the most consumed drugs in the USA. Recent research has suggested that acetaminophen's effects extend to the blunting of negative as well as positive affect. Because affect is a determinant of risk perception and risk taking, we tested the hypothesis that acute acetaminophen consumption (1000 mg) could influence these important judgments and decisions. In three double-blind, placebo-controlled studies, healthy young adults completed a laboratory measure of risk taking (Balloon Analog Risk Task) and in Studies 1 and 2 completed self-report measures of risk perception. Across all studies (total n = 545), acetaminophen increased risk-taking behavior. On the more affectively stimulating risk perception measure used in Study 2, acetaminophen reduced self-reported perceived risk and this reduction statistically mediated increased risk-taking behavior. These results indicate that acetaminophen can increase risk taking, which may be due to reductions in risk perceptions, particularly those that are highly affect laden.",2020,"Across all studies (total n = 545), acetaminophen increased risk-taking behavior.",['healthy young adults'],"['acetaminophen', 'Acetaminophen', 'placebo']","['risk-taking behavior', 'risk taking', 'risk taking (Balloon Analog Risk Task']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}]",,0.0431866,"Across all studies (total n = 545), acetaminophen increased risk-taking behavior.","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Keaveney', 'Affiliation': 'Department of Psychology, The Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': 'School of Journalism and Communication, University of Oregon Eugene, OR 97403, USA.'}, {'ForeName': 'Baldwin', 'Initials': 'B', 'LastName': 'Way', 'Affiliation': 'Department of Psychology, The Ohio State University, Columbus, OH 43210, USA.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa108']
757,32894453,12 Months later: Motivational interviewing plus nutrition psychoeducation for weight loss in primary care.,"PURPOSE


Motivational interviewing (MI) weight-loss interventions have garnered much attention, particularly in primary care. Few studies, however, have examined long-term outcomes of MI for weight loss in primary care. This study sought to examine the longer-term outcomes of a combination approach comprising MI and nutrition psychoeducation (MINP) with a publically available web-support component (i.e., livestrong.com).
METHODS


Thirty-one adults with overweight/obesity were enrolled in a 3-month MINP treatment delivered in primary care by medical assistants. Weight, blood pressure, and depression (beck depression inventory) were assessed at baseline and 1-year following treatment cessation (i.e., 15 months total).
RESULTS


Participants' average BMI was significantly lower 12-months following treatment. Approximately one-third of participants (34.8%) maintained 5% or more weight loss. Participants also experienced significant decreases in diastolic blood pressure, resting heart rate, and depression symptoms, but not systolic blood pressure or waist circumference.
CONCLUSION


The scalable (2.5 h total) MINP intervention delivered in primary care by medical assistants resulted in significant weight (medium effect size) and psychological improvements 12 months later. These findings complement previous RCT findings that MI or nutrition psychoeducation interventions, delivered separately, resulted in small weight loss effects after 12 months, with 5% and 17% of participants, respectively, maintaining 5% weight loss. It remains unclear, however, if implementing MI in primary care for weight loss is cost effective beyond providing nutrition psychoeducation alone.
CLINICAL TRIAL REGISTRATION


The clinical trial registration number is NCT02578199.
LEVEL OF EVIDENCE


IV, uncontrolled trial.",2020,"Participants also experienced significant decreases in diastolic blood pressure, resting heart rate, and depression symptoms, but not systolic blood pressure or waist circumference.
",['Thirty-one adults with overweight/obesity were enrolled in a 3-month'],"['MINP treatment delivered in primary care by medical assistants', 'combination approach comprising MI and nutrition psychoeducation (MINP) with a publically available web-support component (i.e., livestrong.com', 'Motivational interviewing (MI) weight-loss interventions', 'Motivational interviewing plus nutrition psychoeducation']","['weight loss', 'diastolic blood pressure, resting heart rate, and depression symptoms', 'systolic blood pressure or waist circumference', 'small weight loss effects', 'average BMI', 'Weight, blood pressure, and depression (beck depression inventory']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",31.0,0.0384018,"Participants also experienced significant decreases in diastolic blood pressure, resting heart rate, and depression symptoms, but not systolic blood pressure or waist circumference.
","[{'ForeName': 'Rachel D', 'Initials': 'RD', 'LastName': 'Barnes', 'Affiliation': 'Division of General Internal Medicine, University of Minnesota Medical School, MMC 741 420 Delaware Street SE, Minneapolis, MN, 55455, USA. rdbarnes@umn.edu.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ivezaj', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}]",Eating and weight disorders : EWD,['10.1007/s40519-020-00994-5']
758,32890076,"Is Cooled Radiofrequency Ablation the Hot New Treatment for Knee Osteoarthritis?: Commentary on an article by Antonia F. Chen, MD, MBA, et al.: ""Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain. A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation"".",,2020,,[],"['Hyaluronic Acid', 'Cooled Radiofrequency Ablation']",[],[],"[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]",[],,0.0323513,,"[{'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Maletis', 'Affiliation': 'Department of Orthopedics, Kaiser Permanente Baldwin Park, Baldwin Park, California.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01209']
759,32892376,Developmental outcome of extremely preterm infants is improved after less invasive surfactant application: Developmental outcome after LISA.,"AIM


The aim of this study was to evaluate neurocognitive outcome at 24 months of corrected age after less invasive surfactant application (LISA) in preterm infants born at 23-26 weeks of gestational age.
METHODS


Surviving participants of a LISA trial conducted in 13 German level III neonatal intensive care units were reviewed for assessment of developmental outcome, hearing and vision problems, growth and rehospitalisation days. Maternal depression, breastfeeding rates and socio-economic factors were evaluated as potentially confounding factors.
RESULTS


In total, 156/182 infants took part in the study, 78 had received surfactant via LISA and 78 via endotracheal intubation. 22% of LISA infants compared to 42% of intubated infants had a psychomotor development index (PDI) <70 (0.012). A significant difference in mental development index (MDI) was observed in the stratum of more mature infants (25 and 26 weeks of GA). For this group, MDI < 70 was observed in 4% of LISA infants vs 21% of intubated infants (P = 0.008).
CONCLUSION


At 24 months of age, the LISA-treated infants scored less often PDI < 70 and had similar results in MDI. Infants born at 25 and 26 weeks treated with LISA had lower rates of severe disability. LISA is safe and may be superior.",2021,At 24 months of age the LISA treated infants scored less often PDI<70 and had similar results in MDI.,"['extremely preterm infants', 'p4reterm infants born at 23 - 26 weeks gestational age', 'Surviving participants of a LISA trial conducted in 13 German level III neonatal intensive care units were reviewed for assessment of developmental outcome, hearing and vision problems, growth and rehospitalization days', '156/182 infants took part in the study, 78 had received']","['surfactant via LISA', 'LISA', 'invasive surfactant application (LISA']","['mental development index (MDI', 'psychomotor development index', 'MDI', 'rates of severe disability', 'neurocognitive outcome', 'Maternal depression, breastfeeding rates and socioeconomic factors']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392358', 'cui_str': 'Psychomotor development'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]",,0.0626624,At 24 months of age the LISA treated infants scored less often PDI<70 and had similar results in MDI.,"[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Broer', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Roll', 'Affiliation': ""Department of Neonatology, Vest Children's Hospital Datteln, University Witten-Herdecke, Witten-Herdecke, Germany.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Göpel', 'Affiliation': 'Department of Pediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wieg', 'Affiliation': 'Department of Neonatology, Klinikum Aschaffenburg, Aschaffenburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jahn', 'Affiliation': ""Department of Neonatology, Children's Hospital Leverkusen, Leverkusen, Germany.""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Teig', 'Affiliation': ""Department of Neonatology, Children's Hospital, Ruhr-University Bochum, Bochum, Germany.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Höhn', 'Affiliation': 'Department of General Pediatrics, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Welzing', 'Affiliation': 'Department of Neonatology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vochem', 'Affiliation': 'Department of Neonatology, Olga Hospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hoppenz', 'Affiliation': ""Department of Neonatology and Pediatric Intensive Care Medicine, Children's Hospital, Cologne, Germany.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bührer', 'Affiliation': 'Department of Neonatology, Charité University Medical Center, Berlin, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Herting', 'Affiliation': 'Department of Pediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15565']
760,32892392,"Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close): multicentre, double-blind, randomised controlled superiority trial.","OBJECTIVE


To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.
DESIGN


Multicentre, double-blind, randomised controlled superiority trial.
SETTING


Thirty-two hospitals in the Netherlands.
POPULATION


A total of 2292 women aged ≥18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure.
METHODS


Single-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first.
MAIN OUTCOME MEASURES


Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS.
SECONDARY OUTCOMES


perioperative and menstrual characteristics; transvaginal ultrasound measurements.
RESULTS


A total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure.
CONCLUSIONS


The superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted.
TWEETABLE ABSTRACT


Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes.",2021,"Operative time was 3.9 minutes longer (95% CI 3.0 to 4.9, p<0.001) and niche prevalence was 4.8% higher (95% CI 0.01 to 0.09, p=0.027) after double-layer closure.
","['1144 women', '2292 women ≥ 18 years undergoing a first CS', ' 32 hospitals in the Netherlands', '774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group']","['Single-layer unlocked closure and double-layer unlocked closure with the second layer imbricating the first', 'double-layer uterine closure after a first caesarean section (CS', 'single- versus double-layer uterine closure during caesarean section']","['niche prevalence', 'Number of days with postmenstrual spotting during one menstrual cycle nine months after CS', 'drop-out and amenorrhoea', 'perioperative and menstrual characteristics, transvaginal ultrasound measurements', 'Operative time', 'Mean number of postmenstrual spotting days']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1144.0,0.775289,"Operative time was 3.9 minutes longer (95% CI 3.0 to 4.9, p<0.001) and niche prevalence was 4.8% higher (95% CI 0.01 to 0.09, p=0.027) after double-layer closure.
","[{'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Stegwee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'van der Voet', 'Affiliation': 'Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, the Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Ben', 'Affiliation': 'Department of Health Sciences, Amsterdam Public Health, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Universiteit van Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Research School Grow Maastricht University, Veldhoven, the Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cjm', 'Initials': 'C', 'LastName': 'de Groot', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jaf', 'Initials': 'J', 'LastName': 'Huirne', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16472']
761,32890575,"A 300 IR sublingual tablet is an effective, safe treatment for house dust mite-induced allergic rhinitis: An international, double-blind, placebo-controlled, randomized phase III clinical trial.","BACKGROUND


Allergic rhinitis induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It often has a negative impact on sleep, work, leisure activities, and health-related quality of life. Allergen immunotherapy is a proven, safe treatment for respiratory allergies.
OBJECTIVE


We sought to assess the efficacy and safety of a 300 index of reactivity (IR) sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged ≥12) and adults with moderate to severe HDM-induced allergic rhinitis.
METHODS


In a phase III, international, double-blind, placebo-controlled, randomized clinical trial, participants received approximately 12 months of treatment with placebo or the 300 IR tablet. The primary end point was the average total combined score during 4 weeks at the end of the treatment period.
RESULTS


A total of 1607 participants were randomized, and 1476 (including 555 [37.6%] with concomitant mild controlled asthma at inclusion) comprised the full analysis set. Over the primary evaluation period, the least squares mean average total combined score in the 300 IR group (3.62) was significantly lower (P < .0001) than in the placebo group (4.35), with a relative least squares mean difference of -16.9% (95% CI, -24.0% to -9.2%). All prespecified secondary end points were consistently improved in the 300 IR group, relative to placebo. The 300 IR tablet was generally well tolerated. Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300 IR group and 14.9% in the placebo group.
CONCLUSIONS


The 300 IR sublingual HDM tablet is an effective, safe treatment for HDM-induced allergic rhinitis.",2021,"Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300°IR group and 14.9% in the placebo group.
","['adolescents (aged ≥12) and adults with moderate-to-severe HDM-induced AR', '1,607 participants were randomized, and 1,476 (including 555 (37.6%) with concomitant mild controlled asthma at inclusion', 'moderate-to-severe house-dust-mite-induced allergic rhinitis', 'house-dust-mite-induced allergic rhinitis']","['placebo', 'Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract', 'Dermatophagoides pteronyssinus:Dermatophagoides farinae extract']","['least squares mean aTCS', 'average total combined score (aTCS', 'efficacy and safety', 'adverse events', 'tolerated', 'sleep, work, leisure activities, and health-related quality of life']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517810', 'cui_str': '555'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0323674', 'cui_str': 'Dermatophagoides'}, {'cui': 'C0323677', 'cui_str': 'Dermatophagoides farinae'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1445449', 'cui_str': 'Dermatophagoides farinae diagnostic allergen extract'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",1607.0,0.257438,"Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300°IR group and 14.9% in the placebo group.
","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Demoly', 'Affiliation': 'Department of Pulmonology and Addictology, Arnaud de Villeneuve Hospital, Montpellier University, Montpellier, France; Sorbonne Université, UMR-S 1136 INSERM, IPLESP, EPAR Team, Paris, France. Electronic address: pascal.demoly@inserm.fr.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'Departments of Medicine and Pediatrics, David Geffen School of Medicine at the University of California, Los Angeles, Calif.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Creticos', 'Affiliation': 'Division of Allergy & Clinical Immunology, Johns Hopkins Medicine, Baltimore, Md; Creticos Research Group with Charleston Allergy & Asthma, Charleston, SC.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'De Blay', 'Affiliation': 'Allergy Division, Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hellings', 'Affiliation': 'Department of Otorhinolaryngology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Kowal', 'Affiliation': 'Department of Experimental Allergology and Immunology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Le Gall', 'Affiliation': 'Global Clinical Development Department, Stallergenes Greer, Antony, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Nenasheva', 'Affiliation': 'Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Passalacqua', 'Affiliation': 'Allergy and Respiratory Diseases, IRCCS Policlinico S. Martino, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Pfaar', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Tortajada-Girbés', 'Affiliation': 'Pediatric Pulmonology and Allergy Unit, Department of Pediatrics, Dr Peset University Hospital, Valencia, Spain; Department of Pediatrics, Obstetrics and Gynecology. University of Valencia, Valencia, Spain; IVI Foundation, Valencia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vidal', 'Affiliation': 'Allergy Department, Complejo Hospitalario Universitario de Santiago, Faculty of Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Department of Dermatology, Allergy and Venerology, Charité, Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'Division of Allergy and Immunology, University of South Florida, Tampa, Fla.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.07.036']
762,32892222,"A randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1 study to determine the safety, pharmacokinetics and food and faecal microbiome effects of ibezapolstat administered orally to healthy subjects.","BACKGROUND


Clostridioides difficile infection is the most common cause of healthcare-associated infections in the USA, with limited treatment options. Ibezapolstat is a novel DNA polymerase IIIC inhibitor with in vitro activity against C. difficile.
OBJECTIVES AND METHODS


Randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of ibezapolstat in healthy volunteers. Microbiome changes associated with ibezapolstat were compared with vancomycin over a 10 day course using shotgun metagenomics.
RESULTS


A total of 62 subjects aged 31 ± 7 years (45% female; average BMI: 25 ± 3 kg/m2) were randomized. Ibezapolstat was well tolerated with a safety signal similar to placebo. Ibezapolstat had minimal systemic absorption with the majority of plasma concentrations less than 1 µg/mL. In the multiday, ascending dose study, ibezapolstat concentrations of 2000 µg/g of stool were observed by Day 2 and for the remainder of the dosing time period. In the multiday, multiple-dose arm, baseline microbiota was comparable between subjects that received ibezapolstat compared with vancomycin. At Day 10 of dosing, differential abundance analysis and β-diversity demonstrated a distinct difference between the microbiome in subjects given vancomycin compared with either dose of ibezapolstat (P = 0.006). α-Diversity changes were characterized as an increase in the Actinobacteria phylum in subjects that received ibezapolstat and an increase in Proteobacteria in subjects given vancomycin.
CONCLUSIONS


Ibezapolstat was shown to be safe and well tolerated, with minimal systemic exposure, high stool concentrations and a distinct microbiome profile compared with oral vancomycin. These results support further clinical development of ibezapolstat for patients with C. difficile infection.",2020,"α-Diversity changes were characterized as an increase in the Actinobacteria phylum in subjects that received ibezapolstat and an increase in Proteobacteria in subjects given vancomycin.
","['62 subjects aged 31\u2009±\u20097\u2009years (45% female; average BMI: 25\u2009±\u20093\u2009kg/m2', 'patients with C. difficile infection', 'healthy volunteers', 'healthy subjects']","['placebo', 'Ibezapolstat', 'vancomycin', 'ibezapolstat']","['minimal systemic absorption', 'safety, tolerability and pharmacokinetics', 'α-Diversity changes', 'safe and well tolerated', 'safety, pharmacokinetics and food and faecal microbiome effects']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C3850076', 'cui_str': 'Absorption, Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",62.0,0.388054,"α-Diversity changes were characterized as an increase in the Actinobacteria phylum in subjects that received ibezapolstat and an increase in Proteobacteria in subjects given vancomycin.
","[{'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Garey', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Khurshida', 'Initials': 'K', 'LastName': 'Begum', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lancaster', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gonzales-Luna', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Dinh', 'Initials': 'D', 'LastName': 'Bui', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mercier', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, KS, USA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Seng Yue', 'Affiliation': 'Learn and Confirm Inc., Montreal, Canada.'}, {'ForeName': 'Murray P', 'Initials': 'MP', 'LastName': 'Ducharme', 'Affiliation': 'Learn and Confirm Inc., Montreal, Canada.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, KS, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Silverman', 'Affiliation': 'Acurx Pharmaceuticals LLC, White Plains, NY, USA.'}, {'ForeName': 'M Jahangir', 'Initials': 'MJ', 'LastName': 'Alam', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kankam', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, KS, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa364']
763,32889846,"Head Rotation Reduces Oropharyngeal Leak Pressure of the i-gel and LMA® Supreme™ in Paralyzed, Anesthetized Patients: A Randomized Trial.","BACKGROUND


Second-generation supraglottic airway (SGA) devices are useful for airway management during positive pressure ventilation in general anesthesia and emergency medicine. In some clinical settings, such as the anesthetic management of awake craniotomy, SGAs are used in the head-rotated position, which is required for exposure of the surgical field, although this position sometimes worsens the efficiency of mechanical ventilation with SGAs. In this study, we investigated and compared the influence of head rotation on oropharyngeal leak pressures (OPLP) of the i-gel and LMA® Supreme™, which are second-generation SGA devices.
METHODS


Patients who underwent elective surgery under general anesthesia were enrolled in this study and randomly divided into i-gel or LMA Supreme groups. After induction of anesthesia with muscle relaxation, the i-gel or LMA Supreme was inserted according to computerized randomization. The primary outcome was the OPLP at 0°, 30°, and 60° head rotation. The secondary outcomes were the maximum airway pressure and expiratory tidal volume when patients were mechanically ventilated using a volume-controlled ventilation mode with a tidal volume of 10 mL/kg (ideal body weight), ventilation score, and fiber-optic views of vocal cords.
RESULTS


Thirty-four and 36 participants were included in the i-gel and LMA Supreme groups, respectively. The OPLPs of the i-gel and LMA Supreme significantly decreased as the head rotation angle increased (mean difference [95% confidence interval], P value: i-gel; 0° vs 30°: 3.5 [2.2-4.8], P < .001; 30° vs 60°: 2.0 [0.6-3.5], P = .002; 0° vs 60°: 5.5 [3.3-7.8], P < .001, LMA Supreme; 0° vs 30°: 4.1 [2.6-5.5], P < .001; 30° vs 60°: 2.4 [1.1-3.7], P < .001; 0° vs 60°: 6.5 [5.1-8.0], P < .001). There were statistically significant differences in expiratory tidal volume and ventilation score between 0° and 60° in the i-gel group and in ventilation score between 30° and 60° in the LMA Supreme group. There was no statistically significant difference between the 2 devices in all outcome measures. The incidences of adverse events, such as hoarseness or sore throat, were not significantly different between i-gel and LMA Supreme.
CONCLUSIONS


Head rotation to 30° and 60° reduces OPLP with both i-gel and LMA Supreme. There is no difference in OPLP between i-gel and LMA Supreme in the 3 head rotation positions.",2021,There were statistically significant differences in expiratory tidal volume and ventilation score between 0° and 60° in the i-gel group and in ventilation score between 30° and 60° in the LMA Supreme group.,"['Paralyzed, Anesthetized Patients', 'Thirty-four and 36 participants were included in the i-gel and LMA Supreme groups, respectively', 'Patients who underwent elective surgery under general anesthesia']","[' i-gel', 'Second-generation supraglottic airway ', 'Head Rotation', 'head rotation']","['ventilation score', 'maximum airway pressure and expiratory tidal volume', 'expiratory tidal volume and ventilation score', 'adverse events, such as hoarseness or sore throat', 'head rotation angle', 'tidal volume of 10 mL/kg (ideal body weight), ventilation score, and fiber-optic views of vocal cords', 'OPLP at 0°, 30°, and 60° head rotation', 'OPLP', 'Oropharyngeal Leak Pressure', 'oropharyngeal leak pressures (OPLP']","[{'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0015979', 'cui_str': 'Fiber Optic Technology'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.121973,There were statistically significant differences in expiratory tidal volume and ventilation score between 0° and 60° in the i-gel group and in ventilation score between 30° and 60° in the LMA Supreme group.,"[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Chaki', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Tachibana', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kumita', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Honami', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Hamada', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tokinaga', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005150']
764,32893049,Fermented infant formula (with Bifidobacterium breve C50 and Streptococcus thermophilus O65) with prebiotic oligosaccharides is safe and modulates the gut microbiota towards a microbiota closer to that of breastfed infants.,"BACKGROUND & AIMS


Microbiome-modulators can help positively steer early-life microbiota development but their effects on microbiome functionality and associated safety and tolerance need to be demonstrated. We investigated the microbiome impact of a new combination of bioactive compounds, produced by the food-grade microorganisms Bifidobacterium breve C50 and Streptococcus thermophilus ST065 during a fermentation process, and prebiotics in an infant formula. Tolerance and safety were also assessed.
METHODS


An exploratory prospective, randomized, double-blind, controlled, multi-centre study was designed to investigate the effect of bioactive compounds and prebiotics (short-chain galacto-oligosaccharides (scGOS)/long-chain fructo-oligosaccharides (lcFOS) 9:1). Experimental formulas containing these bioactive compounds and prebiotics (FERM/scGOS/lcFOS), prebiotics (scGOS/lcFOS), or bioactive compounds (FERM), were compared to a standard cow's milk-based control formula (Control). Exclusively breastfed infants were included as a reference arm since exclusive breastfeeding is considered as the optimal feeding for infants. The study lasted six months and included visits to health care professionals at baseline, two, four and six months of age. Stool SIgA concentration was the primary study outcome parameter.
RESULTS


There were 280 infants randomized over the experimental arms and 70 infants entered the breastfed-reference arm. Demographics were balanced, growth and tolerance parameters were according to expectation and adverse events were limited. At four months of age the median SIgA concentration in the FERM/scGOS/lcFOS group was significantly higher compared to the Control group (p = 0.03) and was more similar to the concentrations found in the breastfed-reference group. Bifidobacterium increased over time in all groups. The FERM/scGOS/lcFOS combination resulted in a microbiota composition and metabolic activity closer to the breastfed infants' microbiome.
CONCLUSION


The FERM/scGOS/lcFOS combination showed a significant positive effect on SIgA levels. All formulas tested were associated with normal growth and were well-tolerated. Additionally, at four months of age the FERM/scGOS/lcFOS formula brought the microbiome composition and metabolic activity closer towards that of breastfed infants.
CLINICAL TRIAL REGISTRY


Registration number NTR2726 (Netherlands Trial Register; www.trialregister.nl/).",2021,Bifidobacterium increased over time in all groups.,['280 infants randomized over the experimental arms and 70 infants entered the breastfed-reference arm'],"['prebiotic oligosaccharides', 'bioactive compounds and prebiotics (short-chain galacto-oligosaccharides (scGOS)/long-chain fructo-oligosaccharides (lcFOS']","['Tolerance and safety', 'bioactive compounds and prebiotics (FERM/scGOS/lcFOS), prebiotics (scGOS/lcFOS), or bioactive compounds (FERM', 'median SIgA concentration', 'SIgA levels', 'microbiota composition and metabolic activity', 'Bifidobacterium', 'tolerated', 'Stool SIgA concentration']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0238394', 'cui_str': 'Female pseudohermaphroditism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",280.0,0.0672141,Bifidobacterium increased over time in all groups.,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Béghin', 'Affiliation': 'Univ. Lille, CHU Lille, Clinical Investigation Center, CIC-1403-Inserm-CHU and U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000, Lille, France.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands. Electronic address: sebastian.tims@danone.com.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Roelofs', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Rougé', 'Affiliation': 'Laboratoire Gallia, Limonest, France.'}, {'ForeName': 'Raish', 'Initials': 'R', 'LastName': 'Oozeer', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands.'}, {'ForeName': 'Thameur', 'Initials': 'T', 'LastName': 'Rakza', 'Affiliation': ""Department of Neonatology, Lille University Jeanne de Flandre Children's Hospital and Faculty of Medicine, University of Lille, F-59000, Lille, France.""}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Chirico', 'Affiliation': 'Department of Neonatology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Guus', 'Initials': 'G', 'LastName': 'Roeselers', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Knol', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands; Laboratory of Microbiology, Wageningen University, the Netherlands.'}, {'ForeName': 'Jean Christophe', 'Initials': 'JC', 'LastName': 'Rozé', 'Affiliation': 'Department of Neonatal Medicine, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Turck', 'Affiliation': ""Univ. Lille, CHU Lille, Clinical Investigation Center, CIC-1403-Inserm-CHU and U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000, Lille, France; Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Lille University Jeanne de Flandre Children's Hospital and Faculty of Medicine, University of Lille, F-59000, Lille, France.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.024']
765,32897344,Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury.,"Importance


Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI.
Objective


To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI.
Design, Setting, and Participants


Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher.
Interventions


Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309).
Main Outcomes and Measures


The primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 [no disability] to 30 [death]), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events.
Results


Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month follow-up. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; [90% 1-sided confidence limit for benefit, -0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, -2.9% [95% CI, -7.9% to 2.1%]; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, -0.9 [95% CI, -2.5 to 0.7]; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, -5.4% [95% CI, -12.8% to 2.1%]; P = .16).
Conclusions and Relevance


Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale-Extended.
Trial Registration


ClinicalTrials.gov Identifier: NCT01990768.",2020,"The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%;","['patients with moderate or severe TBI', 'patients with TBI', 'Eligible participants (N\u2009=\u20091280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher', '1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants', 'Patients With Moderate or Severe Traumatic Brain Injury', '20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017', 'patients with moderate to severe TBI']","['Out-of-Hospital Tranexamic Acid vs Placebo', 'placebo', 'tranexamic acid', 'hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n\u2009=\u2009312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n\u2009=\u2009345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n\u2009=\u2009309']","['mean Glasgow Coma Scale score, 8', 'favorable neurologic function', '28-day mortality, 6-month Disability Rating Scale score (range, 0', '6-month Disability Rating Scale score', 'progression of intracranial hemorrhage', '28-day mortality', '6-month neurologic outcome', 'progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events', '6-Month Functional Neurologic Outcomes', 'neurologic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517706', 'cui_str': '312'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4305168', 'cui_str': 'Disability Rating Scale score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",96.0,0.74178,"The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%;","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Rowell', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland.'}, {'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Meier', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McKnight', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Delores', 'Initials': 'D', 'LastName': 'Kannas', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Sheehan', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Bulger', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Ahamed H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Christenson', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Morrison', 'Affiliation': ""Rescu, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Frascone', 'Affiliation': 'Department of Emergency Medicine, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Patrick L', 'Initials': 'PL', 'LastName': 'Bosarge', 'Affiliation': 'Department of Surgery, University of Alabama, Birmingham.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Johannigman', 'Affiliation': 'Department of Surgery, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Cotton', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center, Houston.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Callum', 'Affiliation': 'Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'McMullan', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Dries', 'Affiliation': 'Department of Surgery, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Tibbs', 'Affiliation': 'Trauma Surgery, Texas Health Presbyterian Hospital, Dallas.'}, {'ForeName': 'Neal J', 'Initials': 'NJ', 'LastName': 'Richmond', 'Affiliation': 'Department of Emergency Medicine, John Peter Smith Health Network, Ft Worth, Texas.'}, {'ForeName': 'Myron L', 'Initials': 'ML', 'LastName': 'Weisfeldt', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Tallon', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Garrett', 'Affiliation': 'Department of Emergency Medicine, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Zielinski', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Rajesh R', 'Initials': 'RR', 'LastName': 'Gandhi', 'Affiliation': 'Department of Surgery, John Peter Smith Health Network, Ft Worth, Texas.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Schlamp', 'Affiliation': 'British Columbia Emergency Health Services, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jui', 'Affiliation': 'Department of Emergency Medicine, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Klein', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Rizoli', 'Affiliation': ""Department of Surgery, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gamber', 'Affiliation': 'Department of Emergency Medicine, Medical City Plano, Plano, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fleming', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Vincent', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center, Houston.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, University of Alabama, Birmingham.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Hendrickson', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Simonson', 'Affiliation': 'Emergency Medicine, Methodist Dallas Medical Center, Dallas, Texas.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Klotz', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Witham', 'Affiliation': 'Trauma Surgery, Texas Health Harris Methodist Hospital, Ft Worth.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ferrara', 'Affiliation': 'Department of Emergency Medicine, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland.'}]",JAMA,['10.1001/jama.2020.8958']
766,32901283,Variation in the pharmacokinetics of glucosamine in healthy individuals.,"OBJECTIVES


Clinical trial data for the efficacy of glucosamine in OA are conflicting. Reportedly, Rotta-manufactured glucosamine products are more likely to be effective, and a possible explanation is greater bioavailability than other brands. Specifically, the aim was to compare the steady-state pharmacokinetics of Rotta- and non-Rotta-manufactured glucosamine products in healthy volunteers and examine the interindividual variability.
METHODS


In a crossover design, healthy adult participants ingested 1500 mg/day of a Rotta (DONA powder sachets; imported by Mylan Health, Carole Park, QLD, Australia) and a non-Rotta (glucosamine sulphate 1500 mg one-a-day tablet; Blackmores, Warriewood, NSW, Australia) glucosamine product/brand individually for 6 days. Blood samples were collected immediately before and for 12 h after the ingestion of the last dose of each brand and analysed to determine plasma levels of glucosamine. The pharmacokinetic parameters at steady state [including the minimum (Css min) and maximum (Css max) plasma concentration of glucosamine, time to reach Css max post-dosing (Tss max) and area under the plasma concentration vs time curve (AUCss 0-12)] for each brand were calculated and statistically compared.
RESULTS


Fourteen participants [mean age 35.5 years (s.d. 8.8)] were recruited (64.2% males). No significant differences were observed in the pharmacokinetic parameters between the two brands. However, for both brands, the coefficient of variation for Css min, Tss max and AUCss 0-12 exceeded 20%, indicating considerable differences in the parameters between participants. No significant association of the pharmacokinetic parameters was observed with various dosing- and participant-related variables.
CONCLUSION


Substantial interindividual differences in the absorption and elimination of glucosamine could be a cause of variable clinical outcomes in OA.
TRIAL REGISTRATION


The study was registered with the Australian New Zealand Clinical Trials Registry (http://www.ANZCTR.org.au/ACTRN12618000699268p.aspx), number ACTRN12618000699268p.",2021,No significant differences were observed in the pharmacokinetic parameters between the two brands.,"['healthy adult participants', 'healthy volunteers', 'Fourteen participants [mean age 35.5\u2009years (s.d', '8.8)] were recruited (64.2% males', 'healthy individuals']","['ingested 1500\u2009mg/day of a Rotta (DONA powder sachets; imported by Mylan Health, Carole Park, QLD, Australia) and a non-Rotta (glucosamine sulphate 1500\u2009mg one-a-day tablet; Blackmores, Warriewood, NSW, Australia) glucosamine product/brand individually for 6\u2009days', 'glucosamine', 'Rotta- and non-Rotta-manufactured glucosamine products']","['pharmacokinetic parameters', 'Blood samples', 'pharmacokinetic parameters at steady state [including the minimum (Css min) and maximum (Css max) plasma concentration of glucosamine, time to reach Css max post-dosing (Tss max) and area under the plasma concentration vs time curve']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1567628', 'cui_str': 'Dona S'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0474702', 'cui_str': 'Sulfate measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0438742,No significant differences were observed in the pharmacokinetic parameters between the two brands.,"[{'ForeName': 'Chhavi', 'Initials': 'C', 'LastName': 'Asthana', 'Affiliation': 'School of Pharmacy and Pharmacology, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Peterson', 'Affiliation': 'School of Pharmacy and Pharmacology, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Madhur D', 'Initials': 'MD', 'LastName': 'Shastri', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Rahul P', 'Initials': 'RP', 'LastName': 'Patel', 'Affiliation': 'School of Pharmacy and Pharmacology, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa418']
767,32901293,Highly sensitive serum cardiac troponin T and cardiovascular events in patients with systemic lupus erythematosus (TROPOPLUS study).,"OBJECTIVE


Identification of biological markers able to better stratify cardiovascular risks in SLE patients is needed. We aimed to determine whether serum cardiac troponin T (cTnT) levels measured with a highly sensitive assay [high sensitivity cTnT (HS-cTnT)] may predict cardiovascular events (CVEs) in SLE.
METHOD


All SLE patients included between 2007 and 2010 in the randomized, double-blind, placebo-controlled, multicentre PLUS trial were screened. Patients with no past history of CVE at inclusion and a follow-up period of >20 months were analysed. HS-cTnT concentration was measured using the electrochemiluminescence method on serum collected at PLUS inclusion. The primary outcome was the incident CVE. Factors associated with the primary outcome were identified and multivariate analysis was performed.
RESULTS


Overall, 442 SLE patients (of the 573 included in the PLUS study) were analysed for the primary outcome with a median follow up of 110 (interquartile range: 99-120) months. Among them, 29 (6.6%) experienced at least one CVE that occurred at a median of 67 (interquartile range: 31-91) months after inclusion. Six out of 29 patients had more than one CVE. In the multivariate analysis, dyslipidaemia, age and HS-cTnT were associated with the occurrence of CVE. Kaplan-Meier analysis showed that a concentration of HS-cTnT > 4.27 ng/l at inclusion increased by 2.7 [hazard ratio 2.7 (95% CI: 1.3, 5.6), P =0.0083] the risk of CVE in SLE.
CONCLUSION


HS-cTnT measured in serum is the first identified biomarker independently associated with incident CVE in SLE patients.",2021,"In the multivariate analysis, dyslipidaemia, age and HS-cTnT were associated with the occurrence of CVE.","['SLE patients', '29 patients had more than one CVE', 'Patients with no past history of CVE at inclusion and a follow-up period of >20\u2009months were analysed', '442 SLE patients (of the 573 included in the PLUS study', 'patients with systemic lupus erythematosus (TROPOPLUS study']",['placebo'],"['serum cardiac troponin T (cTnT', 'incident CVE', 'HS-cTnT concentration', 'Highly sensitive serum cardiac troponin T and cardiovascular events']","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332124', 'cui_str': 'No past history of'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439822', 'cui_str': 'Highly sensitive'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",442.0,0.562474,"In the multivariate analysis, dyslipidaemia, age and HS-cTnT were associated with the occurrence of CVE.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Chezel', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Costedoat-Chalumeau', 'Affiliation': 'Département de Médecine Interne, Hôpital Cochin, Centre de Reference Maladies Auto-immunes et Systémiques Rares, APHP, Université de Paris, CRESS, INSERM, INRA, France.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Laouénan', 'Affiliation': ""Departement d'Epidémiologie et de Recherche Clinique, Hôpital Bichat, France.""}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Rouzaud', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Chenevier-Gobeaux', 'Affiliation': 'Service de Diagnostic Biologique Automatisé, Département médico-universitaire BioPhyGen, Hôpital Cochin, APHP, Université de Paris, Paris, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Le Guern', 'Affiliation': 'Département de Médecine Interne, Hôpital Cochin, Centre de Reference Maladies Auto-immunes et Systémiques Rares, APHP, Université de Paris, CRESS, INSERM, INRA, France.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Mathian', 'Affiliation': 'Département de Médecine Interne 2, French National Referral Center for Systemic Lupus Erythematosus, Antiphospholipid Antibody Syndrome and Other Autoimmune Disorders, Groupement Hospitalier Pitié-Salpêtrière, APHP, Sorbonne Université, Paris, France.'}, {'ForeName': 'Drifa', 'Initials': 'D', 'LastName': 'Belhadi', 'Affiliation': ""Departement d'Epidémiologie et de Recherche Clinique, Hôpital Bichat, France.""}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'de Almeida Chaves', 'Affiliation': 'Département de Médecine Interne, Hôpital Purpan, Centre Hospitalo-Universitaire (CHU) de Toulouse, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Duhaut', 'Affiliation': ""Département de Médecine Interne, Hôpital Amiens Nord, CHU d'Amiens, Amiens, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fain', 'Affiliation': 'Département de Médecine Interne, Hôpital Saint Antoine, APHP, Université Pierre et Marie Curie, Paris, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Galicier', 'Affiliation': ""Département d'Immunologie Clinique, Hôpital Saint Louis, APHP, Université de Paris, Paris, France.""}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Ghillani-Dalbin', 'Affiliation': 'Département de Immunologie, Hôpital Pitié-Salpétrière, APHP, Université Pierre et Marie Curie, Paris, France.'}, {'ForeName': 'Jean Emmanuel', 'Initials': 'JE', 'LastName': 'Kahn', 'Affiliation': 'Département de Médecine Interne, Hôpital Ambroise Paré, APHP, Université de Versailles-Saint-Quentin en Yvelines, Versailles, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Morel', 'Affiliation': 'Département de Médecine Interne, Hôpital Cochin, Centre de Reference Maladies Auto-immunes et Systémiques Rares, APHP, Université de Paris, CRESS, INSERM, INRA, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Perard', 'Affiliation': 'Département de Médecine Interne, Hôpital St Joseph St Luc, Lyon, France.'}, {'ForeName': 'Micheline', 'Initials': 'M', 'LastName': 'Pha', 'Affiliation': 'Département de Médecine Interne 2, French National Referral Center for Systemic Lupus Erythematosus, Antiphospholipid Antibody Syndrome and Other Autoimmune Disorders, Groupement Hospitalier Pitié-Salpêtrière, APHP, Sorbonne Université, Paris, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Saidoune', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris, France.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Sarrot-Reynauld', 'Affiliation': 'Département de médecine interne, Hôpital Michallon, CHU de Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Aumaitre', 'Affiliation': 'Département de médecine interne, Hôpital Gabriel-Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Chasset', 'Affiliation': 'Département de médecine interne, Hôpital Tenon, APHP Université Pierre et Marie Curie, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Limal', 'Affiliation': 'Département de médecine interne, Hôpital Henri Mondor, APHP Université Paris-Est Créteil, Paris, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Desmurs-Clavel', 'Affiliation': 'Département de médecine interne, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ackermann', 'Affiliation': 'Département de médecine interne, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Zahir', 'Initials': 'Z', 'LastName': 'Amoura', 'Affiliation': 'Département de Médecine Interne 2, French National Referral Center for Systemic Lupus Erythematosus, Antiphospholipid Antibody Syndrome and Other Autoimmune Disorders, Groupement Hospitalier Pitié-Salpêtrière, APHP, Sorbonne Université, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Papo', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Sacre', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris, France.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa434']
768,32900519,"Long-term effects of resveratrol on cognition, cerebrovascular function and cardio-metabolic markers in postmenopausal women: A 24-month randomised, double-blind, placebo-controlled, crossover study.","Ageing and menopause contribute to endothelial dysfunction, causing impaired cerebral perfusion, which is in turn associated with accelerated cognitive decline. In a 14-week pilot study, we showed that supplementation with low-dose resveratrol, a phytoestrogen that can enhance endothelial function, improved cerebrovascular and cognitive functions in postmenopausal women. We sought to confirm these benefits in a larger, longer-term trial. A 24-month randomized, placebo-controlled crossover trial was undertaken in 125 postmenopausal women, aged 45-85 years, who took 75 mg trans-resveratrol or placebo twice-daily for 12 months and then crossover to the alternative treatment for another 12 months. We evaluated within individual differences between each treatment period in measures of cognition (primary outcome), cerebrovascular function in the middle cerebral artery (cerebral blood flow velocity: CBFV, cerebrovascular responsiveness: CVR) and cardio-metabolic markers as secondary outcomes. Subgroup analyses examined effects of resveratrol by life stages. Compared to placebo, resveratrol supplementation resulted a significant 33% improvement in overall cognitive performance (Cohen's d = 0.170, P = 0.005). Women ≥65 years of age showed a relative improvement in verbal memory with resveratrol compared to those younger than 65 years. Furthermore, resveratrol improved secondary outcomes including resting mean CBFV (d = 0.275, P = 0.001), CVR to hypercapnia (d = 0.307, P = 0.027), CVR to cognitive stimuli (d = 0.259, P = 0.032), fasting insulin (d = 0.174, P = 0.025) and insulin resistance index (d = 0.102, P = 0.034). Regular supplementation with low-dose resveratrol can enhance cognition, cerebrovascular function and insulin sensitivity in postmenopausal women. This may translate into a slowing of the accelerated cognitive decline due to ageing and menopause, especially in late-life women. Further studies are warranted to observe whether these cognitive benefits of resveratrol can reduce the risk of dementia.",2021,"Compared to placebo, resveratrol supplementation resulted a significant 33% improvement in overall cognitive performance (Cohen's d = 0.170, P = 0.005).","['125 postmenopausal women, aged 45-85 years, who took 75\xa0mg trans-resveratrol or placebo twice-daily for 12 months and then crossover to the alternative treatment for another 12 months', 'Women ≥65 years of age', 'postmenopausal women']","['placebo, resveratrol supplementation', 'Regular supplementation with low-dose resveratrol', 'placebo']","['CVR to cognitive stimuli ', 'cognition, cerebrovascular function and cardio-metabolic markers', 'cognition, cerebrovascular function and insulin sensitivity', 'overall cognitive performance', 'CVR to hypercapnia', 'cerebrovascular and cognitive functions', 'resting mean CBFV', 'verbal memory', 'insulin resistance index ', 'cognition (primary outcome), cerebrovascular function in the middle cerebral artery (cerebral blood flow velocity: CBFV, cerebrovascular responsiveness: CVR) and cardio-metabolic markers', 'fasting insulin']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",125.0,0.295164,"Compared to placebo, resveratrol supplementation resulted a significant 33% improvement in overall cognitive performance (Cohen's d = 0.170, P = 0.005).","[{'ForeName': 'Jay Jay', 'Initials': 'JJ', 'LastName': 'Thaung Zaw', 'Affiliation': 'University of Newcastle, School of Biomedical Sciences and Pharmacy, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Peter Rc', 'Initials': 'PR', 'LastName': 'Howe', 'Affiliation': 'University of Newcastle, School of Biomedical Sciences and Pharmacy, Callaghan, NSW, 2308, Australia; University of Southern Queensland, Institute for Resilient Regions, Springfield Central, QLD, 4300, Australia; University of South Australia, School of Health Sciences, Adelaide, SA, 5000, Australia.'}, {'ForeName': 'Rachel Hx', 'Initials': 'RH', 'LastName': 'Wong', 'Affiliation': 'University of Newcastle, School of Biomedical Sciences and Pharmacy, Callaghan, NSW, 2308, Australia; University of Southern Queensland, Institute for Resilient Regions, Springfield Central, QLD, 4300, Australia. Electronic address: Rachel.wong@newcastle.edu.au.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.025']
769,32900520,Dietary stearic acid and palmitic acid do not differently affect ABCA1-mediated cholesterol efflux capacity in healthy men and postmenopausal women: A randomized controlled trial.,"BACKGROUND


The saturated fatty acid stearic acid (C18:0) lowers HDL cholesterol compared with palmitic acid (C16:0). However, the ability of HDL particles to promote cholesterol efflux from macrophages (cholesterol efflux capacity; CEC) may better predict coronary heart disease (CHD) risk than HDL cholesterol concentrations.
OBJECTIVE


We examined effects of exchanging dietary palmitic acid for stearic acid on ATP-binding cassette transporter A1 (ABCA1)-mediated CEC, and other conventional and emerging cardiometabolic risk makers.
DESIGN


In a double-blind, randomized, crossover study with two 4-week isocaloric intervention periods, 34 healthy men and postmenopausal women (61.5 ± 5.7 years, BMI: 25.4 ± 2.5 kg/m 2 ) followed diets rich in palmitic acids or stearic acids. Difference in intakes was 6% of daily energy. ABCA1-mediated CEC was measured from J774 macrophages to apolipoprotein (apo)B-depleted serum.
RESULTS


Compared with the palmitic-acid diet, the stearic-acid diet lowered serum LDL cholesterol (-0.14 mmol/L; p = 0.010), HDL cholesterol (-0.09 mmol/L; p=<0.001), and apoA1 (-0.05 g/L; p < 0.001). ABCA1-mediated CEC did not differ between diets (p = 0.280). Cholesteryl ester transfer protein (CETP) mass was higher on stearic acid (0.11 mg/L; p = 0.003), but CETP activity was comparable. ApoB100 did not differ, but triacylglycerol concentrations tended to be higher on stearic acid (p = 0.100). Glucose concentrations were comparable. Effects on insulin and C-peptide were sex-dependent. In women, the stearic-acid diet increased insulin concentrations (1.57 μU/mL; p = 0.002), while in men, C-peptide concentrations were lower (-0.15 ng/mL; p = 0.037). Interleukin 6 (0.15 pg/mL; p = 0.039) and tumor necrosis factor alpha (0.18 pg/mL; p = 0.005), but not high-sensitivity C-reactive protein, were higher on stearic acid. Soluble intracellular adhesion molecule (9 ng/mL; p = 0.033), but not soluble vascular cell adhesion molecule and endothelial-selectin concentrations decreased after stearic-acid consumption.
CONCLUSIONS


As expected, stearic-acid intake lowered LDL cholesterol, HDL cholesterol, and apoA1. Insulin sensitivity in women and low-grade inflammation might be unfavorably affected by stearic-acid intake. However, palmitic-acid and stearic-acid intakes did not differently affect ABCA1-mediated CEC.
CLINICAL TRIAL REGISTRY


This trial was registered at clinicaltrials.gov as NCT02835651.",2021,"Soluble intracellular adhesion molecule (9 ng/mL; p = 0.033), but not soluble vascular cell adhesion molecule and endothelial-selectin concentrations decreased after stearic-acid consumption.
","['34 healthy men and postmenopausal women (61.5\xa0±\xa05.7 years, BMI: 25.4\xa0±\xa02.5\xa0kg/m 2 ) followed', 'healthy men and postmenopausal women']","['palmitic-acid diet, the stearic-acid diet', 'Dietary stearic acid and palmitic acid', 'saturated fatty acid stearic acid (C18:0', 'diets rich in palmitic acids or stearic acids', 'exchanging dietary palmitic acid', 'palmitic acid (C16:0']","['ABCA1-mediated cholesterol efflux capacity', 'tumor necrosis factor alpha', 'soluble vascular cell adhesion molecule and endothelial-selectin concentrations', 'Cholesteryl ester transfer protein (CETP) mass', 'CETP activity', 'triacylglycerol concentrations', 'HDL cholesterol', 'Soluble intracellular adhesion molecule', 'palmitic-acid and stearic-acid intakes', 'insulin concentrations', 'Insulin sensitivity', 'serum LDL cholesterol', 'LDL cholesterol, HDL cholesterol, and apoA1', 'Glucose concentrations', 'ABCA1-mediated CEC']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038229', 'cui_str': 'Octadecanoic acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol ester transfer protein'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0038229', 'cui_str': 'Octadecanoic acid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}]",34.0,0.26991,"Soluble intracellular adhesion molecule (9 ng/mL; p = 0.033), but not soluble vascular cell adhesion molecule and endothelial-selectin concentrations decreased after stearic-acid consumption.
","[{'ForeName': 'Merel A', 'Initials': 'MA', 'LastName': 'van Rooijen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM (School of Nutrition and Translational Research in Metabolism), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Jogchum', 'Initials': 'J', 'LastName': 'Plat', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM (School of Nutrition and Translational Research in Metabolism), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Wendy A M', 'Initials': 'WAM', 'LastName': 'Blom', 'Affiliation': 'Unilever Research and Development, Vlaardingen, the Netherlands.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Zock', 'Affiliation': 'Unilever Research and Development, Vlaardingen, the Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM (School of Nutrition and Translational Research in Metabolism), Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: r.mensink@maastrichtuniversity.nl.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.016']
770,32898024,"Acupuncture ameliorated vasomotor symptoms during menopausal transition: single-blind, placebo-controlled, randomized trial to test treatment efficacy.","OBJECTIVES


This study aimed to evaluate the effects of acupuncture on women with vasomotor symptoms during the menopausal transition with the aid of the Kupperman-Blatt Menopausal Index.
METHOD


Crossover, single-blind, sham-controlled trial with 100 women randomly divided into two groups of 50 participants each: G1 and G2. During the first 24 weeks of treatment, the G1 women received acupuncture and the G2 women were given sham acupuncture. The crossover was then applied: the G1 participants were given sham acupuncture, and the G2 participants received acupuncture for 24 more weeks.
RESULTS


The mean score of hot flashes of the group who first experienced acupuncture (G1) was statistically higher than that of the group that started with sham acupuncture (G2, P = 0.020). Also, both groups had similar mean scores in the middle of the study (both were receiving acupuncture). During the last 6 months of the study, after crossover, the values of G2 (acupuncture) were lower than those of G1 (sham acupuncture).
CONCLUSIONS


Acupuncture treatment may mitigate hot flashes and other climacteric symptoms during the menopausal transition.",2020,"The mean score of hot flashes of the group who first experienced acupuncture (G1) was statistically higher than that of the group that started with sham acupuncture (G2, P = 0.020).","['100 women randomly divided into two groups of 50 participants each: G1 and G2', 'women with vasomotor symptoms during the menopausal transition with the aid of the Kupperman-Blatt Menopausal Index']","['Acupuncture', 'sham acupuncture', ' Video Summary:http://links.lww.com/MENO/A641', 'acupuncture', 'placebo']","['climacteric symptoms', 'vasomotor symptoms', 'values of G2 (acupuncture', 'mean score of hot flashes']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1306878', 'cui_str': 'Climacteric discomfort'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}]",100.0,0.171546,"The mean score of hot flashes of the group who first experienced acupuncture (G1) was statistically higher than that of the group that started with sham acupuncture (G2, P = 0.020).","[{'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Soares', 'Affiliation': 'Disciplina de Ginecologia, Departamento de Obstetrícia e Ginecologia, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Branco-de-Luca', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'da Fonseca', 'Affiliation': ''}, {'ForeName': 'Ceci M', 'Initials': 'CM', 'LastName': 'Carvalho-Lopes', 'Affiliation': ''}, {'ForeName': 'Eduardo C', 'Initials': 'EC', 'LastName': 'Arruda-Veiga', 'Affiliation': ''}, {'ForeName': 'Cristiane L', 'Initials': 'CL', 'LastName': 'Roa', 'Affiliation': ''}, {'ForeName': 'Vicente R', 'Initials': 'VR', 'LastName': 'Bagnoli', 'Affiliation': ''}, {'ForeName': 'Edmund C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': ''}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001651']
771,32907792,Report from an effort to prevent type 2 diabetes development in primary care.,"BACKGROUND


In a clinical trial 2009-2012, individuals with prediabetes were randomised to a lifestyle intervention (LI) focused on physical activity or care as usual (CAU), with the aim of reducing development of type 2 diabetes (T2DM). At study termination after three years, there was a significantly less of an increase in insulin resistance in LI compared with the CAU group. The aim of this extended follow-up was to investigate whether positive results concerning metabolic variables remained five years after study termination.
METHOD


All participants from the original study were contacted for a new follow-up with an oral glucose tolerance test, anthropometric measurements, blood pressure and blood samples. Questionnaires about lifestyle were completed.
RESULTS


A total of 69 of the original 123 participants were examined, and personal data for another five participants were collected from the medical charts (n = 74). The LI group showed a decrease in diastolic blood pressure (-4 mmHg, CI 95% 0.8-6.8, p = 0.014) and body weight (-3 kg, CI 95% 1.2-4.9, p = 0.002) since base-line. Weight loss in the LI group was significantly greater compared with weight loss in the CAU group (-3 kg, CI 0.1-5.9, p = 0.044). Insulin resistance markers and incident T2DM were similar among the groups.
CONCLUSION


Although without modifying the incidence of diabetes or the level of insulin resistance, a physical activity intervention may be used to induce sustainable weight change in subjects with prediabetes at the primary care level.",2021,"The LI group showed a decrease in diastolic blood pressure (-4 mmHg, CI 95% 0.8-6.8, p = 0.014) and body weight (-3 kg, CI 95% 1.2-4.9, p = 0.002) since base-line.","['subjects with prediabetes at the primary care level', 'A total of 69 of the original 123 participants were examined, and personal data for another five participants were collected from the medical charts (n = 74', '2009-2012, individuals with prediabetes']","['lifestyle intervention (LI) focused on physical activity or care as usual (CAU', 'CAU']","['oral glucose tolerance test, anthropometric measurements, blood pressure and blood samples', 'weight loss', 'body weight', 'Insulin resistance markers and incident T2DM', 'Weight loss', 'diastolic blood pressure', 'insulin resistance in LI']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",123.0,0.0656996,"The LI group showed a decrease in diastolic blood pressure (-4 mmHg, CI 95% 0.8-6.8, p = 0.014) and body weight (-3 kg, CI 95% 1.2-4.9, p = 0.002) since base-line.","[{'ForeName': 'Margareta I', 'Initials': 'MI', 'LastName': 'Hellgren', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Sweden; The Skaraborg Institute, Skövde, Sweden. Electronic address: margareta.leonardsson-hellgren@vgregion.se.'}, {'ForeName': 'Per-Anders', 'Initials': 'PA', 'LastName': 'Jansson', 'Affiliation': 'The Wallenberg Laboratory, Department of Molecular and Clinical Medicine, The Sahlgrenska Academy at the University of Gothenburg, Sweden. Electronic address: per-anders.jansson@medic.gu.se.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Lindblad', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Sweden. Electronic address: ulf.lindblad@allmed.gu.se.'}]",Primary care diabetes,['10.1016/j.pcd.2020.08.019']
772,32910152,Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials.,"ABSTRACT OBJECTIVE


In the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials, the adjuvanted recombinant zoster vaccine (RZV) demonstrated ≥90% efficacy in preventing herpes zoster (HZ) in all age groups ≥50 years. Given the increased HZ risk associated with certain underlying autoimmune diseases or their treatment regimes, we conducted a post hoc analysis of RZV's efficacy against HZ and safety profile [specifically, the occurrence of serious adverse events (SAEs)] in ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies.
METHODS


Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomized to receive two doses of RZV or placebo 2 months apart. In this subgroup analysis of participants with at least one pIMD at enrolment, the efficacy was calculated for two-dose recipients who did not develop confirmed HZ before 30 days post-dose 2. SAE occurrence was evaluated for all participants who received at least one dose.
RESULTS


Of the 14 645 RZV and 14 660 placebo recipients from the ZOE-50/70 studies, 983 and 960, respectively, reported at least one pre-existing pIMD at enrolment and were included in these analyses. The most frequent pre-existing conditions were psoriasis, spondyloarthropathy and RA. Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70-79-year-old age group. SAEs and fatal SAEs were similar between RZV and placebo recipients.
CONCLUSION


In ZOE-50/70 participants with pre-existing pIMDs, RZV was highly efficacious against HZ and SAE incidence was similar between RZV and placebo recipients.
TRIAL REGISTRATION


ClinicalTrials.gov, https://clinicaltrials.gov, NCT01165177 (ZOE-50), NCT01165229 (ZOE-70).",2021,"Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70-79-year-old age group.","['adults with pre-existing potential immune-mediated diseases', 'herpes zoster (HZ) in all age groups ≥50\u2009years', 'ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies', 'Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years']","['RZV or placebo', 'adjuvanted recombinant zoster vaccine', 'recombinant zoster vaccine (RZV']","['SAEs and fatal SAEs', 'SAE occurrence', 'Efficacy against HZ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C4530095', 'cui_str': 'Varicella zoster virus glycoprotein E, recombinant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}]",,0.563023,"Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70-79-year-old age group.","[{'ForeName': 'Alemnew F', 'Initials': 'AF', 'LastName': 'Dagnew', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Rausch', 'Affiliation': 'GSK, Philadelphia, PA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hervé', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Toufik', 'Initials': 'T', 'LastName': 'Zahaf', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schuind', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa424']
773,32911009,Tooth replacement options for partially dentate older adults: a survival analysis.,"OBJECTIVES


To compare the success of two different tooth replacement strategies for partially dentate older adults; namely resin bonded bridgework (RBB) provided to restore patients according to the principles of the shortened dental arch concept (SDA) and conventional full-arch rehabilitation with removable dental prostheses (RDPs).
METHODS


A randomised controlled clinical trial (RCT) was conducted with partially dentate adults aged 65 years or older. Each patient from the RDP group had all missing natural teeth replaced with cobalt-chromium framework RDPs. Each patient from the SDA group was restored to 10 occluding pairs of natural and replacement teeth using RBB. Patients were followed-up at 6, 12, 24, 36 months. Success rates were generated according to defined success criteria. Log-rank tests and Cox's proportional hazard models were used to compare the success of the two treatment strategies.
RESULTS


After 36 months, 89 patients completed the RCT; n = 45 in the RDP group and n = 44 in the SDA group. The overall success rate of the SDA treatment was 90.4% compared to 73.0% for RDPs (p = 0.005). In the upper arch SDA treatment was 100% successful compared to 86.4% for RDPs (p = 0.019). In the lower arch, lower success rates were reported for both the SDA treatment (80.0%) and RDPs (60.0%) (p = 0.054). Further analyses with cox's proportional hazard models demonstrated that SDA treatment was significantly more successful than RDPs (Hazard Ratio: 2.47, p = 0.04).
CONCLUSIONS


After 36 months SDA treatment using RBB was significantly more successful than RDPs used for conventional full-arch rehabilitation in partially dentate older adults.
CLINICAL SIGNIFICANCE


Functionally orientated treatment according to the principles of the SDA is a feasible alternative to RDPs for partially dentate older patients. SDA treatment using RBB can achieve higher success rates compared to RDPs in this patient group.",2020,"After 36 months SDA treatment using RBB was significantly more successful than RDPs used for conventional full-arch rehabilitation in partially dentate older adults.
","['partially dentate older patients', 'partially dentate older adults', 'partially dentate adults aged 65\u2009years or older']","['resin bonded bridgework (RBB', 'shortened dental arch concept (SDA) and conventional full-arch rehabilitation with removable dental prostheses (RDPs']","['success rates', 'overall success rate', 'Success rates', 'RDPs']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0011325', 'cui_str': 'Dental arch structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}]",,0.0498701,"After 36 months SDA treatment using RBB was significantly more successful than RDPs used for conventional full-arch rehabilitation in partially dentate older adults.
","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McKenna', 'Affiliation': ""Centre for Public Health, Queen's University, Belfast, United Kingdom. Electronic address: g.mckenna@qub.ac.uk.""}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Tada', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore. Electronic address: sayaka.tada@nus.edu.sg.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'McLister', 'Affiliation': 'School of Dentistry, Belfast Health and Social Care Trust, Royal Victoria Hospital, Belfast, United Kingdom. Electronic address: conor.mclister@belfasttrust.hscni.net.'}, {'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'DaMata', 'Affiliation': 'Cork University Dental School and Hospital, University College Cork, Ireland. Electronic address: cristiane.damata@ucc.ie.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Hayes', 'Affiliation': 'Cork University Dental School and Hospital, University College Cork, Ireland. Electronic address: martina.hayes@ucc.ie.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cronin', 'Affiliation': 'School of Mathematical Sciences, University College Cork, Ireland. Electronic address: m.cronin@ucc.ie.'}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': ""Centre for Public Health, Queen's University, Belfast, United Kingdom. Electronic address: cmoore49@qub.ac.uk.""}, {'ForeName': 'Finbarr', 'Initials': 'F', 'LastName': 'Allen', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore. Electronic address: denpfa@nus.edu.sg.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103468']
774,32955643,Impact of music-based intervention on verbal memory: an experimental behavioral study with older adults.,"Normal age-related declines have been reported in different cognitive functions, such as episodic memory. Some environmental factors have the potential to reduce cognitive decline and promote healthy aging. In this research, we employed musical improvisation as a focal music-based intervention to explore its effects as a modulator of verbal memory. We evaluated two types of verbal memory: a neutral one, employing the Rey Auditory Verbal Learning Test (Study 1), and an emotional one, implementing the Spanish version of Affective Norms for English Words (Study 2) in a volunteer group of older adults. After the acquisition of neutral (Study 1) or emotional (Study 2) verbal information, the participants were exposed to musical improvisation (experimental condition) or two control conditions (rhythmic reproduction as a musically active control condition or a rest condition as a passive control condition) for 3 min. Then, memory was evaluated through two memory tasks (immediate and deferred free-recall and recognition tests). In both studies, we compared memory performance among musicians (with five or more years of music training) and non-musicians. We found a significant improvement in neutral verbal memory among participants involved in musical improvisation, who remembered more words than those in the control conditions. Differences were also found according to the musical experience of the sample, with musicians outperforming non-musicians. The current research supports the late-life cognitive benefits of music-based intervention and music training.",2021,"We found a significant improvement in neutral verbal memory among participants involved in musical improvisation, who remembered more words than those in the control conditions.","['older adults', 'volunteer group of older adults']","['verbal memory: a neutral one, employing the Rey Auditory Verbal Learning Test (Study 1), and an emotional one, implementing the Spanish version of Affective Norms for English Words (Study 2', 'music-based intervention', 'music-based intervention and music training', 'neutral (Study 1) or emotional (Study 2) verbal information, the participants were exposed to musical improvisation (experimental condition) or two control conditions (rhythmic reproduction as a musically active control condition or a rest condition as a passive control condition']","['verbal memory', 'neutral verbal memory']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",,0.0336298,"We found a significant improvement in neutral verbal memory among participants involved in musical improvisation, who remembered more words than those in the control conditions.","[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Diaz Abrahan', 'Affiliation': 'Lab. Interdisciplinario de Neurociencia Cognitiva (LINC), Centro de Estudios Multidisciplinarios en Sistemas Complejos y Ciencias del Cerebro (CEMSC3), Instituto de Ciencias Físicas (ICIFI), Escuela de Ciencia y Tecnología (ECyT), Universidad de San Martín (UNSAM), 25 de Mayo 1169, 1er piso, Of. 18, San Martin, 1650, Argentina. abrahanveronika@conicet.gov.ar.'}, {'ForeName': 'Favio', 'Initials': 'F', 'LastName': 'Shifres', 'Affiliation': 'Laboratorio para el Estudio de la Experiencia Musical (LEEM), Departamento de Música, Facultad de Bellas Artes (FBA), Universidad Nacional de La Plata (UNLP), La Plata, Argentina.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Justel', 'Affiliation': 'Lab. Interdisciplinario de Neurociencia Cognitiva (LINC), Centro de Estudios Multidisciplinarios en Sistemas Complejos y Ciencias del Cerebro (CEMSC3), Instituto de Ciencias Físicas (ICIFI), Escuela de Ciencia y Tecnología (ECyT), Universidad de San Martín (UNSAM), 25 de Mayo 1169, 1er piso, Of. 18, San Martin, 1650, Argentina.'}]",Cognitive processing,['10.1007/s10339-020-00993-5']
775,32919056,Exercise-induced changes in brain activity during memory encoding and retrieval after long-term bed rest.,"Episodic memory depends decisively on the hippocampus and the parahippocampal gyrus, brain structures that are also prone to exercise-induced neuroplasticity and cognitive improvement. We conducted a randomized controlled trial to investigate the effects of a high-intensity exercise program in twenty-two men resting in bed for 60 days on episodic memory and its neuronal basis. All participants were exposed to 60 days of uninterrupted bed rest. Eleven participants were additionally assigned to a high-intensity interval training that was performed five to six times weekly for 60 days. Episodic memory and its neural basis were determined four days prior to and on the 58th day of bed rest using functional magnetic resonance imaging (fMRI). We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly. These findings indicate a higher neuronal efficiency in the training group during memory encoding and retrieval and may suggest a dysfunctional mechanism in the non-exercising bed rest group induced by two months of physical inactivity. Our results provide further support for the modulating effects of physical exercise and adverse implications of a sedentary lifestyle and bedridden patients.",2020,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"['Eleven participants', 'twenty-two sedentary men resting in bed for 60 days on episodic memory and its neuronal basis']",['high-intensity exercise program'],"['BOLD signal', 'neuronal efficiency', 'brain activity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",22.0,0.0382575,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Friedl-Werner', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Université de Normandie, INSERM U 1075 COMETE, 14000 Caen, France.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Brauns', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Gunga', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany; Max-Planck-Institute for Human Development, Lise Meitner Group for Environmental Neuroscience, 14195 Berlin, Germany.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Stahn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Unit of Experimental Psychiatry, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: astahn@pennmedicine.upenn.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117359']
776,32921503,Reduced mortality risk in malnourished hospitalized older adult patients with COPD treated with a specialized oral nutritional supplement: Sub-group analysis of the NOURISH study.,"BACKGROUND


Hospitalized, malnourished older adults with chronic obstructive pulmonary disease (COPD) have an elevated risk of readmission and mortality.
OBJECTIVE


Post-hoc, sub-group analysis from the NOURISH study cohort examined the effect of a high-protein oral nutritional supplement (ONS) containing HMB (HP-HMB) in malnourished, hospitalized older adults with COPD and to identify predictors of outcomes.
METHODS


The NOURISH study (n = 652) was a multicenter, randomized, placebo-controlled, double-blind trial. The COPD subgroup (n = 214) included hospitalized, malnourished (based on Subjective Global Assessment), older adults (≥65 y), with admission diagnosis of COPD who received either standard-of-care plus HP-HMB (n = 109) or standard-of-care and a placebo supplement (n = 105) prescribed 2 servings/day from within 3 days of hospital admission (baseline) and up to 90 days after discharge. The primary study outcome was a composite endpoint of incidence of death or non-elective readmission up to 90-day post-discharge, while secondary endpoints included changes in hand-grip strength, body weight, and nutritional biomarkers over time. Categorical outcomes were analyzed using Cochran-Mantel-Haenszel tests, longitudinal data by repeated measures analysis of covariance; and changes from baseline by analysis of covariance. p-values ≤ 0.05 were considered statistically significant. Multivariate logistic regression was used to model predictors of the primary outcome and components.
RESULTS


In patients with COPD, 30, 60, and 90-day hospital readmission rate did not differ, but in contrast, 30, 60, and 90-day mortality risk was approximately 71% lower with HP-HMB supplementation relative to placebo (1.83%, 2.75%, 2.75% vs. 6.67%, 9.52% and 10.48%, p = 0.0395, 0.0193, 0.0113, resp.). In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. -0.01 kg, p < 0.05) and, improvements in blood nutritional biomarker concentrations. The multivariate logistic regression predictors of the death, readmission or composite endpoints in these COPD patients showed that participants who were severely malnourished (p = 0.0191) and had a Glasgow prognostic score (GPS) Score of 1 or 2 had statistically significant odds of readmission or death (p = 0.0227).
CONCLUSIONS


Among malnourished, hospitalized patients with COPD, supplementation with HP-HMB was associated with a markedly decreased mortality risk, and improved handgrip strength, body weight, and nutritional biomarkers within a 90-day period after hospital discharge. This post-hoc, subgroup analysis highlights the importance of early identification of nutritional risk and administration of high-protein ONS in older, malnourished patients with COPD after hospital admission and continuing after hospital discharge.",2021,"In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. ","['COPD subgroup (n\xa0=\xa0214) included hospitalized, malnourished (based on Subjective Global Assessment), older adults (≥65\xa0y), with admission diagnosis of COPD who received either', 'malnourished, hospitalized older adults with COPD', 'older, malnourished patients with COPD after hospital admission and continuing after hospital discharge', 'malnourished hospitalized older adult patients with COPD', 'malnourished, hospitalized patients with COPD, supplementation with HP-HMB', 'Hospitalized, malnourished older adults with chronic obstructive pulmonary disease (COPD']","['high-protein oral nutritional supplement (ONS) containing HMB (HP-HMB', 'placebo', 'standard-of-care plus HP-HMB (n\xa0=\xa0109) or standard-of-care and a placebo supplement']","['mortality risk', 'composite endpoint of incidence of death or non-elective readmission up to 90-day post-discharge, while secondary endpoints included changes in hand-grip strength, body weight, and nutritional biomarkers over time', 'hospital discharge', '90-day hospital readmission rate', 'GPS Score', 'handgrip strength', 'readmission or death', '90-day mortality risk', 'body weight', 'death, readmission or composite endpoints', 'mortality risk, and improved handgrip strength, body weight, and nutritional biomarkers', 'blood nutritional biomarker concentrations']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.272438,"In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. ","[{'ForeName': 'Nicolaas E', 'Initials': 'NE', 'LastName': 'Deutz', 'Affiliation': 'Texas A&M University, College Station, TX, USA. Electronic address: nep.deutz@ctral.org.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Ziegler', 'Affiliation': 'Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Matheson', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Matarese', 'Affiliation': 'Brody School of Medicine at East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Tappenden', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Geraldine E', 'Initials': 'GE', 'LastName': 'Baggs', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Nelson', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Menghua', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Refaat', 'Initials': 'R', 'LastName': 'Hegazi', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA; Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Satya S', 'Initials': 'SS', 'LastName': 'Jonnalagadda', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.031']
777,32943241,"Specialized oral nutritional supplement (ONS) improves handgrip strength in hospitalized, malnourished older patients with cardiovascular and pulmonary disease: A randomized clinical trial.","BACKGROUND & AIMS


Oral Nutritional Supplements (ONS) are used to treat malnutrition and improve clinical outcomes in malnourished patients. Poor handgrip strength (HGS) is associated with an increased risk of mortality, disability and other adverse health consequences. This analysis examined the effect of a specialized ONS on HGS and its relationship to nutritional status in hospitalized, older adults with malnutrition who were participants in the NOURISH trial.
METHODS


We enrolled older (≥65years), malnourished (Subjective Global Assessment [SGA] class B/C) adults hospitalized for cardiovascular and pulmonary events: congestive heart failure, acute myocardial infarction, pneumonia and/or chronic obstructive pulmonary disease exacerbation in a double-blind, randomized, placebo-controlled trial (NOURISH study). During hospitalization and until 90 days after discharge, participants received standard-of-care plus a high protein and beta-hydroxy-beta-methylbutyrate containing ONS (S-ONS; n = 328) or a placebo supplement (n = 324), aimed at 2 servings/day. HGS was evaluated by dynamometer at baseline, hospital discharge, day (d) 30, d60, and d90 post-discharge.
RESULTS


Post hoc, repeated measures analysis of data at discharge, d30, d60, and d90 showed significantly higher HGS in the S-ONS vs. the placebo group in the evaluable group (Least Squares Means ± Standard Error: (23.25 ± 0.25 vs. 22.63 ± 0.25, p = 0.043). At d90, there was a significant positive association between HGS and nutritional status (SGA) improvements in the entire cohort: 49% of participants with increased HGS from discharge had improved nutritional status versus 31% with unchanged or decreased HGS (p = 0.003). HGS and the scores on the Katz index of independence in activities of daily living (ADL) were positively associated at all visits including all ITT subjects (Pearson's r range: 0.24 to 0.34, all p < 0.0001).
CONCLUSIONS


S-ONS provided during hospitalization and up to 90 days post-discharge improves HGS in malnourished older adults following cardiovascular and pulmonary events and may contribute to improvement in patients' overall recovery.
CLINICAL TRIAL REGISTRATION


www.ClinicalTrials.gov NCT01626742.",2021,"HGS and the scores on the Katz index of independence in activities of daily living (ADL) were positively associated at all visits including all ITT subjects (Pearson's r range: 0.24 to 0.34, all p < 0.0001).
","['malnourished older adults', 'hospitalized, malnourished older patients with cardiovascular and pulmonary disease', 'enrolled older (≥65years), malnourished (Subjective Global Assessment [SGA] class B/C) adults hospitalized for cardiovascular and pulmonary events: congestive heart failure, acute myocardial infarction, pneumonia and/or chronic obstructive pulmonary disease exacerbation', 'hospitalized, older adults with malnutrition who were participants in the NOURISH trial', 'malnourished patients']","['specialized ONS', 'Specialized oral nutritional supplement (ONS', 'standard-of-care plus a high protein and beta-hydroxy-beta-methylbutyrate containing ONS (S-ONS; n\xa0=\xa0328) or a placebo supplement', 'placebo', 'Oral Nutritional Supplements (ONS']","['Katz index of independence in activities of daily living (ADL', 'HGS', 'handgrip strength', 'HGS and nutritional status (SGA) improvements', 'nutritional status', 'Poor handgrip strength (HGS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0053454', 'cui_str': '3-hydroxyisovaleric acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451239', 'cui_str': 'Katz activities of daily living'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",,0.541382,"HGS and the scores on the Katz index of independence in activities of daily living (ADL) were positively associated at all visits including all ITT subjects (Pearson's r range: 0.24 to 0.34, all p < 0.0001).
","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Matheson', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Nelson', 'Affiliation': 'Abbott Nutrition, Research and Development, Columbus, OH, USA. Electronic address: jeffrey.l.nelson@abbott.com.'}, {'ForeName': 'Geraldine E', 'Initials': 'GE', 'LastName': 'Baggs', 'Affiliation': 'Abbott Nutrition, Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Menghua', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Abbott Nutrition, Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Nicolaas E', 'Initials': 'NE', 'LastName': 'Deutz', 'Affiliation': 'Center for Translational Research in Aging & Longevity, Department of Health & Kinesiology, Texas A&M University, College Station, TX, USA.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.035']
778,32943381,Increased T2 signal intensity in the distal clavicle does not justify acromioclavicular resection arthroplasty during rotator cuff repair.,"INTRODUCTION


Acromioclavicular (AC) arthropathy can contribute to shoulder pain; it can be treated surgically by distal clavicle resection (DCR). The aim of this study was to determine whether increased T2 signal intensity in the clavicle on MRI is an argument in favour of AC resection arthroplasty by DCR during rotator cuff repair.
METHODS


The MRI images from 107 shoulders in 107 patients were analysed. We looked for statistical relationships and correlations between shoulders with T2 hyperintensity (HI+) and those without (HI-) before surgery and then in shoulders with T2 hyperintensity (HI+) that underwent AC resection arthroplasty (AC+) and those who did not (AC-).
RESULTS


On MRI, T2 hyperintensity in the AC joint was correlated with sex (more often found in men) and radiological signs of AC arthropathy. There was no statistical correlation before surgery, particularly with AC pain, or after surgery, with outcomes in shoulders undergoing DCR.
CONCLUSION


When repairing rotator cuff tears, the presence of T2 hyperintensity on MRI in the distal clavicle is not a predictor of better clinical outcomes after AC resection arthroplasty is done. The AC pain may be related to the rotator cuff tear instead.
LEVEL OF EVIDENCE


II, prospective randomised study.",2020,"On MRI, T2 hyperintensity in the AC joint was correlated with sex (more often found in men) and radiological signs of AC arthropathy.","['shoulders with T2 hyperintensity (HI+) and those without (HI-) before surgery and then in shoulders with T2 hyperintensity (HI+) that underwent AC resection arthroplasty (AC+) and those who did not (AC', '107 shoulders in 107 patients were analysed']",[],['T2 signal intensity'],"[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",107.0,0.0330461,"On MRI, T2 hyperintensity in the AC joint was correlated with sex (more often found in men) and radiological signs of AC arthropathy.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Métais', 'Affiliation': 'Hôpital privé La Châtaigneraie, ELSAN, 63110 Beaumont, France. Electronic address: pierremetais@mac.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gallinet', 'Affiliation': 'Centre épaule-main, 16, rue Madeleine Brès, 25000 Besançon, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Labattut', 'Affiliation': 'Service de chirurgie orthopédique, CHU de Dijon, 14, rue PaulGaffarel, 21000 Dijon, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Godenèche', 'Affiliation': 'Ramsay Santé, hôpital privé Jean Mermoz, centre orthopédique Santy, 69008 Lyon, France.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Centre ostéo-articulaire des Cèdres, Parc Sud Galaxie, 5, rue des Tropiques, 38130 Échirolles, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Collin', 'Affiliation': 'CHP Saint-Grégoire, 35760 Saint-Grégoire, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bonnevialle', 'Affiliation': 'Service de chirurgie orthopédique, CHU de Toulouse, place Baylac, 31059 Toulouse, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Garret', 'Affiliation': 'Clinique du Parc, 155, boulevard Stalingrad, 69006 Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Clavert', 'Affiliation': ""Service de chirurgie de l'épaule et du coude, Hautepierre 2, CHRU de Strasbourg, avenue Molière, 67098 Strasbourg cedex, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': '15, rue Ampère, 92500 Rueil Malmaison, France.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.08.010']
779,32943383,Benefits of distal clavicle resection during rotator cuff repair: Prospective randomized single-blind study.,"INTRODUCTION


Rotator cuff tears often occur in combination with acromioclavicular (AC) arthropathy. But it can be difficult to separate pain caused by the rotator cuff tear from pain caused by the AC joint, despite clinical and other examinations. Distal clavicle resection (DCR) is increasingly being done at the same time as arthroscopic rotator cuff repair. The aim of this study was to compare the functional outcomes 1 year after arthroscopic rotator cuff repair between patients who simultaneously undergo DCR and patients who do not. The primary hypothesis was that DCR improves the clinical outcomes.
MATERIAL AND METHODS


This was a prospective, multicenter, randomized, single-blind study of 200 patients who underwent isolated supraspinatus repair using the same technique. The patients were randomized into two groups: 97 patients who also underwent DCR and 103 patients who did not. The patients were followed until 1 year postoperative according to a standardized radiological and clinical review protocol.
RESULTS


At 1 year postoperative, all the clinical outcomes were worse in the DCR group, although only external rotation with elbow at side (53° vs. 59°, p=0.04) and the SSV (86.5 vs. 90.1, p=0.04) were statistically different. Overall shoulder pain was higher in the DCR group during the first 3 months postoperative (p=0.04). At 1 year, the DCR group had more residual pain; this pain was mainly located on the superior side of the shoulder (p=0.03), especially when more than 11 mm was resected (p=0.01). More of the shoulders in the DCR group had failures in rotator cuff healing based on ultrasonography (p=0.5).
CONCLUSION


Our hypothesis was not confirmed. We do not recommend doing routine DCR with arthroscopic rotator cuff repair.
LEVEL OF EVIDENCE


I, prospective randomized simple blind study.",2020,Overall shoulder pain was higher in the DCR group during the first 3 months postoperative (p=0.04).,"['97 patients who also underwent DCR and 103 patients who did not', 'rotator cuff repair', '200 patients who underwent isolated supraspinatus repair using the same technique', 'patients who simultaneously undergo DCR and patients who do not']","['distal clavicle resection', 'arthroscopic rotator cuff repair', 'Distal clavicle resection (DCR']","['external rotation with elbow at side', 'rotator cuff healing', 'residual pain; this pain', 'Overall shoulder pain', 'SSV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0186434', 'cui_str': 'Resection of clavicle'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0186434', 'cui_str': 'Resection of clavicle'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C3805255', 'cui_str': 'Residual pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0751995', 'cui_str': 'Genes, PDGFB'}]",200.0,0.0673519,Overall shoulder pain was higher in the DCR group during the first 3 months postoperative (p=0.04).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gallinet', 'Affiliation': 'Centre Épaule Main Besançon, 16, rue Madeleine Brès, 25000 Besançon, France. Electronic address: contact@docteurgallinet.com.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Centre ostéoarticulaire des Cèdres, Parc Sud Galaxie, 5, rue des Tropiques, 38130 Echirolles, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Labattut', 'Affiliation': 'Service de Chirurgie Orthopédique et Traumatologique, Hôpital François Mitterrand CHU de Dijon, 14, rue Gaffarel, BP 77908, 21079 Dijon cedex, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Collin', 'Affiliation': ""Institut locomoteur de l'ouest, 7, boulevard de la Boutière, 35760 Saint Grégoire, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Metais', 'Affiliation': 'Elsan Hôpital privé la Châtaigneraie, 63110 Beaumont, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bonnevialle', 'Affiliation': 'Hôpital Pierre Paul Riquet, CHRU de Toulouse, place Baylac, 31059 Toulouse, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Godeneche', 'Affiliation': 'Centre Orthopédique Santy, 24, avenue Paul Santy, 69008 Lyon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Garret', 'Affiliation': 'Clinique du Parc, 155, boulevard Stalingrad, 69006 Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Clavert', 'Affiliation': 'Service de chirurgie du membre supérieur, Hautepierre 2, CHRU Strasbourg, avenue Molière, 67200 Strasbourg, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': '15, rue Ampère, 92500 Rueil Malmaison, France.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.08.006']
780,32954927,"Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE).","PURPOSE


Many patients with HR+, HER2- early breast cancer (EBC) will not experience recurrence or have distant recurrence with currently available standard therapies. However, up to 30% of patients with high-risk clinical and/or pathologic features may experience distant recurrence, many in the first few years. Superior treatment options are needed to prevent early recurrence and development of metastases for this group of patients. Abemaciclib is an oral, continuously dosed, CDK4/6 inhibitor approved for HR+, HER2- advanced breast cancer (ABC). Efficacy and safety of abemaciclib in ABC supported evaluation in the adjuvant setting.
METHODS


This open-label, phase III study included patients with HR+, HER2-, high-risk EBC, who had surgery and, as indicated, radiotherapy and/or adjuvant/neoadjuvant chemotherapy. Patients with four or more positive nodes, or one to three nodes and either tumor size ≥ 5 cm, histologic grade 3, or central Ki-67 ≥ 20%, were eligible and randomly assigned (1:1) to standard-of-care adjuvant endocrine therapy (ET) with or without abemaciclib (150 mg twice daily for 2 years). The primary end point was invasive disease-free survival (IDFS), and secondary end points included distant relapse-free survival, overall survival, and safety.
RESULTS


At a preplanned efficacy interim analysis, among 5,637 randomly assigned patients, 323 IDFS events were observed in the intent-to-treat population. Abemaciclib plus ET demonstrated superior IDFS versus ET alone ( P  = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively. Safety data were consistent with the known safety profile of abemaciclib.
CONCLUSION


Abemaciclib when combined with ET is the first CDK4/6 inhibitor to demonstrate a significant improvement in IDFS in patients with HR+, HER2- node-positive EBC at high risk of early recurrence.",2020,"Abemaciclib plus ET demonstrated superior IDFS versus ET alone ( P  = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively.","['patients with HR+, HER2-, high-risk EBC, who had surgery and, as indicated', 'Patients with four or more positive nodes, or one to three\u202fnodes and either tumor size ≥ 5 cm, histologic grade 3, or central Ki-67 ≥ 20', 'patients with HR+, HER2- early breast cancer (EBC']","['CDK4/6 inhibitor', 'Abemaciclib Combined With Endocrine Therapy', 'standard-of-care adjuvant endocrine therapy (ET) with or without abemaciclib', 'radiotherapy and/or adjuvant/neoadjuvant chemotherapy']","['invasive disease-free survival (IDFS), and secondary end points included distant relapse-free survival, overall survival, and safety', 'Efficacy and safety', '2-year IDFS rates', 'IDFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0919553', 'cui_str': 'Histologic grade'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}]",5637.0,0.075697,"Abemaciclib plus ET demonstrated superior IDFS versus ET alone ( P  = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively.","[{'ForeName': 'Stephen R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of Obstetrics and Gynecology, Breast Center, LMU University Hospital, Munich, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Clinica Pesquisas e Centro São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Universidad Complutense, Ciberonc, GEICAM, Madrid, Spain.'}, {'ForeName': 'Zhi Min', 'Initials': 'ZM', 'LastName': 'Shao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qing Yuan', 'Initials': 'QY', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jorge Luis', 'Initials': 'JL', 'LastName': 'Martinez Rodriguez', 'Affiliation': 'Alivia Clinica de Alta Especialidad, Nuevo Leon, Mexico.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancérologie de l'Ouest Pays de la Loire, Saint Herblain-Angers, France.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'Department of Surgery, Oncology, and Gastroenterology, University of Padova, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Boyle', 'Affiliation': 'Mater Hospital Sydney, Patricia Ritchie Centre for Cancer Care and Research, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Universitaire Ziekenhuizen Leuven-Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""IOB Institute of Oncology, Quiron Group, Madrid, Barcelona, and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Breast Center, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wardley', 'Affiliation': 'NIHR Manchester Clinical Research Facility at The Christie, and Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Trakya University Faculty of Medicine, Edirne, Turkey.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Smith', 'Affiliation': 'Artios Pharma, Cambridge, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Frenzel', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Headley', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wei', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'San Antonio', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Hulstijn', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'University of Pittsburgh, NSABP Foundation, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02514']
781,32917417,"Effects of brown seaweeds on postprandial glucose, insulin and appetite in humans - A randomized, 3-way, blinded, cross-over meal study.","BACKGROUND & AIMS


Seaweed including brown seaweeds with rich bioactive components may be efficacious for a glycaemic management strategy and appetite control. We investigated the effects of two brown edible seaweeds, Laminaria digitata (LD) and Undaria pinnatifida (UP), on postprandial glucose metabolism and appetite following a starch load in a human meal study.
METHODS


Twenty healthy subjects were enrolled in a randomized, 3-way, blinded cross-over trial. The study was registered under ClinicalTrials.gov Identifier no. NCT00123456. At each test day, the subjects received one of three meals comprising 30 g of starch with 5 g of LD or UP or an energy-adjusted control meal containing pea protein. Fasting and postprandial blood glucose, insulin, C-peptide and glucagon-like peptide-1 (GLP-1) concentrations were measured. Subjective appetite sensations were scored using visual analogue scales (VAS).
RESULTS


Linear mixed model (LMM) analysis showed a lower blood glucose, insulin and C-peptide response following the intake of LD and UP, after correction for body weight. Participants weighing ≤ 63 kg had a reduced glucose response compared to control meal between 40 and 90 min both following LD and UP meals. Furthermore, LMM analysis for C-peptide showed a significantly lower response after intake of LD. Compared to the control meal, GLP-1 response was higher after the LD meal, both before and after the body weight adjustment. The VAS scores showed a decreased appetite sensation after intake of the seaweeds. Ad-libitum food intake was not different three hours after the seaweed meals compared to control.
CONCLUSIONS


Concomitant ingestion of brown seaweeds may help improving postprandial glycaemic and appetite control in healthy and normal weight adults, depending on the dose per body weight.
CLINICAL TRIAL REGISTRY NUMBER


Clinicaltrials.gov (ID# NCT02608372).",2021,"Fasting and postprandial blood glucose, insulin, C-peptide and glucagon-like peptide-1","['healthy and normal weight adults', 'Twenty healthy subjects']",['starch with 5\xa0g of LD or UP or an energy-adjusted control meal containing pea protein'],"['Laminaria digitata (LD) and Undaria pinnatifida (UP), on postprandial glucose metabolism and appetite', 'VAS scores', 'glucose response', 'appetite sensation', 'visual analogue scales (VAS', 'postprandial glycaemic and appetite control', 'GLP-1) concentrations', 'Subjective appetite sensations', 'GLP-1 response', 'postprandial glucose, insulin and appetite', 'Fasting and postprandial blood glucose, insulin, C-peptide and glucagon-like peptide-1', 'blood glucose, insulin and C-peptide response']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0751493', 'cui_str': 'Kelp'}, {'cui': 'C1030485', 'cui_str': 'Undaria pinnatifida'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3535674', 'cui_str': 'Pea Proteins'}]","[{'cui': 'C0751493', 'cui_str': 'Kelp'}, {'cui': 'C1030485', 'cui_str': 'Undaria pinnatifida'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003622', 'cui_str': 'Appetite control'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",20.0,0.129334,"Fasting and postprandial blood glucose, insulin, C-peptide and glucagon-like peptide-1","[{'ForeName': 'Nazikussabah', 'Initials': 'N', 'LastName': 'Zaharudin', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Faculty of Industrial Sciences and Technology, Universiti Malaysia Pahang, Gambang, Pahang, Malaysia.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Tullin', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ceyda Tugba', 'Initials': 'CT', 'LastName': 'Pekmez', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: ctp@nexs.ku.dk.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Sloth', 'Affiliation': 'Research Group for NanoBio Science, National Food Institute, Technical University of Denmark, Kgs Lyngby, Denmark.'}, {'ForeName': 'Rie R', 'Initials': 'RR', 'LastName': 'Rasmussen', 'Affiliation': 'Research Group for NanoBio Science, National Food Institute, Technical University of Denmark, Kgs Lyngby, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.027']
782,32928582,Blunted nutrient-response pathways in adipose tissue following high fat meals in men with metabolic syndrome: A randomized postprandial transcriptomic study.,"BACKGROUND


Excessive adipose tissue is central to disease burden posed by the Metabolic Syndrome (MetS). Whilst much is known of the altered transcriptomic regulation of adipose tissue under fasting conditions, little is known of the responses to high-fat meals.
METHODS


Nineteen middle-aged males (mean ± SD 52.0 ± 4.6 years), consumed two isocaloric high-fat, predominately dairy-based or soy-based, breakfast meals. Abdominal subcutaneous adipose biopsies were collected after overnight fast (0 h) and 4 h following each meal. Global gene expression profiling was performed by microarray (Illumina Human WG-6 v3).
RESULTS


In the fasted state, 13 genes were differently expressed between control and MetS adipose tissue (≥1.2 fold-difference, p < 0.05). In response to the meals, the control participants had widespread increases in genes related to cellular nutrient responses (≥1.2 fold-change, p < 0.05; 2444 & 2367 genes; dairy & soy, respectively). There was blunted response in the MetS group (≥1.2 fold-change, p < 0.05; 332 & 336 genes; dairy & soy, respectively).
CONCLUSIONS


In middle-aged males with MetS, a widespread suppression of the subcutaneous adipose tissue nutrient responsive gene expression suggests an inflexibility in the transcriptomic responsiveness to both high-fat meals.",2021,"There was blunted response in the MetS group (≥1.2 fold-change, p < 0.05; 332 & 336 genes; dairy & soy, respectively).
","['men with metabolic syndrome', 'Nineteen middle-aged males (mean\xa0±', 'middle-aged males with MetS']",[],"['Abdominal subcutaneous adipose biopsies', 'blunted response', 'cellular nutrient responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",[],"[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",13.0,0.03354,"There was blunted response in the MetS group (≥1.2 fold-change, p < 0.05; 332 & 336 genes; dairy & soy, respectively).
","[{'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'Dordevic', 'Affiliation': 'Department of Nutrition, Dietetics & Food, Monash University, Melbourne, Australia. Electronic address: aimee.dordevic@monash.edu.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Coort', 'Affiliation': 'Department of Bioinformatics - BiGCaT, NUTRIM School of Nutrition and Metabolism in Translational Research, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Chris T', 'Initials': 'CT', 'LastName': 'Evelo', 'Affiliation': 'Department of Bioinformatics - BiGCaT, NUTRIM School of Nutrition and Metabolism in Translational Research, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Murgia', 'Affiliation': 'School of Agriculture and Food, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Department of Nutrition, Dietetics & Food, Monash University, Melbourne, Australia; Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Maxine P', 'Initials': 'MP', 'LastName': 'Bonham', 'Affiliation': 'Department of Nutrition, Dietetics & Food, Monash University, Melbourne, Australia.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Larsen', 'Affiliation': 'Department of Physiology, Anatomy, and Microbiology, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Gran', 'Affiliation': 'Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand; The Riddet Institute, Massey University, Palmerston North, New Zealand; Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.024']
783,32925679,Radiation Exposure in Minimally Invasive Lumbar Fusion Surgery: A Randomized Controlled Trial Comparing Conventional Fluoroscopy and 3D Fluoroscopy-based Navigation.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


The aim of this study was to compare the dosemetrically determined radiation exposure of surgeon and patient during minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) using conventional 2D fluoroscopy (FLUORO) or 3D fluoroscopy-based navigation (NAV).
SUMMARY OF BACKGROUND DATA


MIS TLIF was shown to exhibit higher radiation exposures compared to open techniques. In particular, the routinely exposed surgeon encounters the risks of increased radiation doses. With the additional use of intraoperative 3D navigation, major steps of the operation can be performed without exposing the operating room staff to ionizing radiation.
METHODS


Forty-four patients undergoing monosegmental MIS TLIF were randomized into the two intraoperative imaging technique groups (FLUORO or NAV). The primary endpoint was the radiation exposure of the surgeon; the secondary endpoints were the radiation exposure of the patient and C-arm readings.
RESULTS


After exclusion of three patients, 41 patients were analyzed. In general, the average radiation exposure of the surgeon was lower in the NAV group without being statistically significant. The radiation exposure of the patient was significantly higher in the NAV group at all dosemeter sites. The average fluoroscopy time was 63 ± 36 versus 109 ± 31 sec (FLUORO versus NAV group, P < 0.001).
CONCLUSION


The additional use of intraoperative 3D fluoroscopy-based navigation compared to conventional 2D fluoroscopy alone showed a nonsignificant reduction of the radiation exposure of the surgeon in monosegmental MIS TLIF, while increasing the radiation exposure of the patient.
LEVEL OF EVIDENCE


1.",2021,"With the additional use of intraoperative 3D navigation, major steps of the operation can be performed without exposing the operating room staff to ionizing radiation.
","['Forty-four patients undergoing monosegmental MIS TLIF', 'Minimally Invasive Lumbar Fusion Surgery']","['Conventional Fluoroscopy and 3D Fluoroscopy-based Navigation', 'conventional 2D fluoroscopy (FLUORO) or 3D fluoroscopy-based navigation (NAV', 'intraoperative imaging technique groups (FLUORO or NAV', 'intraoperative 3D fluoroscopy-based navigation compared to conventional 2D fluoroscopy alone', 'Radiation Exposure', 'surgeon and patient during minimally invasive transforaminal lumbar interbody fusion (MIS TLIF']","['average fluoroscopy time', 'average radiation exposure of the surgeon', 'radiation exposure of the surgeon; the secondary endpoints were the radiation exposure of the patient and C-arm readings']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",44.0,0.0527076,"With the additional use of intraoperative 3D navigation, major steps of the operation can be performed without exposing the operating room staff to ionizing radiation.
","[{'ForeName': 'Jan-Helge', 'Initials': 'JH', 'LastName': 'Klingler', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Scholz', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Krüger', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Yashar', 'Initials': 'Y', 'LastName': 'Naseri', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Volz', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hohenhaus', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brönner', 'Affiliation': 'Helmholtz Zentrum München, German Research Center for Environmental Health, Individual Monitoring Service, Munich, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Hoedlmoser', 'Affiliation': 'Helmholtz Zentrum München, German Research Center for Environmental Health, Individual Monitoring Service, Munich, Germany.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Sircar', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hubbe', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}]",Spine,['10.1097/BRS.0000000000003685']
784,32940689,Circulating Tumor DNA Markers for Early Progression on Fulvestrant With or Without Palbociclib in ER+ Advanced Breast Cancer.,"BACKGROUND


There are no established molecular biomarkers for patients with breast cancer receiving combination endocrine and CDK4/6 inhibitor (CDK4/6i). We aimed to determine whether genomic markers in circulating tumor DNA (ctDNA) can identify patients at higher risk of early progression on fulvestrant therapy with or without palbociclib, a CDK4/6i.
METHODS


PALOMA-3 was a phase III, multicenter, double-blind randomized controlled trial of palbociclib plus fulvestrant (n = 347) vs placebo plus fulvestrant (n = 174) in patients with endocrine-pretreated estrogen receptor-positive (ER+) breast cancer. Pretreatment plasma samples from 459 patients were analyzed for mutations in 17 genes, copy number in 14 genes, and circulating tumor fraction. Progression-free survival (PFS) was compared in patients with circulating tumor fraction above or below a prespecified cutoff of 10% and with or without a specific genomic alteration. All statistical tests were 2-sided.
RESULTS


Patients with high ctDNA fraction had worse PFS on both palbociclib plus fulvestrant (hazard ratio [HR] = 1.62, 95% confidence interval [CI] = 1.17 to 2.24; P = .004) and placebo plus fulvestrant (HR = 1.77, 95% CI = 1.21 to 2.59; P = .004). In multivariable analysis, high-circulating tumor fraction was associated with worse PFS (HR = 1.20 per 10% increase in tumor fraction, 95% CI = 1.09 to 1.32; P < .001), as was TP53 mutation (HR = 1.84, 95% CI = 1.27 to 2.65; P = .001) and FGFR1 amplification (HR = 2.91, 95% CI = 1.61 to 5.25; P < .001). No interaction with treatment randomization was observed.
CONCLUSIONS


Pretreatment ctDNA identified a group of high-risk patients with poor clinical outcome despite the addition of CDK4/6 inhibition. These patients might benefit from inclusion in future trials of escalating treatment, with therapies that may be active in these genomic contexts.",2021,"In multivariable analysis, high-circulating tumor fraction was associated with worse PFS (HR = 1.20 per 10% increase in tumor fraction, 95% CI = 1.09 to 1.32; P < .001), as was TP53 mutation (HR = 1.84, 95% CI = 1.27 to 2.65; P = .001) and FGFR1 amplification (HR = 2.91, 95% CI = 1.61 to 5.25; P < .001).","['ER+ Advanced Breast Cancer', 'patients with breast cancer receiving combination endocrine and CDK4/6 inhibitor (CDK4/6i', 'patients with endocrine-pretreated estrogen receptor-positive (ER+) breast cancer', 'patients at higher risk of early progression on fulvestrant therapy with or without palbociclib, a CDK4/6i', '459 patients were analyzed for mutations in 17 genes, copy number in 14 genes, and circulating tumor fraction']","['palbociclib plus fulvestrant', 'placebo plus fulvestrant', 'Fulvestrant With or Without Palbociclib']","['Progression-free survival (PFS', 'FGFR1 amplification', 'PFS']","[{'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}]",459.0,0.302989,"In multivariable analysis, high-circulating tumor fraction was associated with worse PFS (HR = 1.20 per 10% increase in tumor fraction, 95% CI = 1.09 to 1.32; P < .001), as was TP53 mutation (HR = 1.84, 95% CI = 1.27 to 2.65; P = .001) and FGFR1 amplification (HR = 2.91, 95% CI = 1.61 to 5.25; P < .001).","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': ""O'Leary"", 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rosalind J', 'Initials': 'RJ', 'LastName': 'Cutts', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hrebien', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, Université Paris Sud, Villejuif, France.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Martin Behaim-Strasse 12, Neu-Isenburg, Germany.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Division of Research and Cancer Medicine, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Garcia-Murillas', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Centre, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Cynthia Huang', 'Initials': 'CH', 'LastName': 'Bartlett', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa087']
785,32940699,Association of altered folylpolyglutamate synthetase pre-mRNA splicing with methotrexate unresponsiveness in early rheumatoid arthritis.,"OBJECTIVES


An efficient pharmacological response to MTX treatment in RA patients relies on the retention and accumulation of intracellular MTX-polyglutamates catalysed by the enzyme folylpolyglutamate synthetase (FPGS). We recently identified a partial retention of FPGS intron 8 (8PR) as a prominent splice variant conferring FPGS dysfunction and decreased MTX polyglutamylation in acute lymphoblastic leukaemia. Here, we explored the association between FPGS 8PR levels and lack of MTX responsiveness in RA patients.
METHODS


Thirty-six patients undergoing MTX treatment were enrolled from the Combinatie behandeling Reumatoide Artritis (COBRA)-light trial. RNA was isolated from blood samples at baseline, 13 weeks and 26 weeks of therapy, from patients in either COBRA-light (n = 21) or COBRA (n = 15) treatment arms. RT-qPCR analysis was used to assess RNA levels of FPGS 8PR over wild-type FPGS (8WT).
RESULTS


In the COBRA-light treatment arm, higher baseline ratios of 8PR/8WT were significantly associated with higher 44-joint disease activity score (DAS44) at 13 and 26 weeks. Higher baseline ratios of 8PR/8WT also trended towards not obtaining low disease activity (DAS <1.6) and becoming a EULAR non-responder at 13 and 26 weeks. In the COBRA-treatment arm, a significant association was observed between high baseline 8PR/8WT ratios and higher DAS44 score at 26 weeks. Higher 8PR/8WT ratios were associated with non-response at week 26 based on both low disease activity and EULAR criteria.
CONCLUSION


This study is the first to associate alterations in FPGS pre-mRNA splicing levels with reduced responsiveness to MTX treatment in RA patients.
TRIAL REGISTRATION


ISRCTN55552928.",2021,"Higher 8PR/8WT ratios were associated with non-response at week 26 based on both low disease activity and EULAR criteria.
","['acute lymphoblastic leukaemia', 'RA patients', 'Thirty-six patients undergoing MTX treatment were enrolled from the Combinatie behandeling Reumatoide Artritis (COBRA)-light trial', 'early rheumatoid arthritis']","['MTX', 'COBRA']","['high baseline 8PR/8WT ratios and higher DAS44 score', 'FPGS 8PR levels and lack of MTX responsiveness', 'RNA levels of FPGS 8PR over wild-type FPGS (8WT', 'Higher 8PR/8WT ratios', '44-joint disease activity score (DAS44']","[{'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0060626', 'cui_str': 'Folylpolyglutamate synthase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",36.0,0.0627548,"Higher 8PR/8WT ratios were associated with non-response at week 26 based on both low disease activity and EULAR criteria.
","[{'ForeName': 'Ittai B', 'Initials': 'IB', 'LastName': 'Muller', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam, The Netherlands.'}, {'ForeName': 'Marry', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam, The Netherlands.'}, {'ForeName': 'Willem F', 'Initials': 'WF', 'LastName': 'Lems', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Marieke M', 'Initials': 'MM', 'LastName': 'Ter Wee', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wojtuszkiewicz', 'Affiliation': 'Department of Hematology, Amsterdam UMC, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Nurmohamed', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, location Reade, Amsterdam, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Department of Hematology, Amsterdam UMC, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Yehuda G', 'Initials': 'YG', 'LastName': 'Assaraf', 'Affiliation': 'The Fred Wyszkowski Cancer Research Laboratory, Department of Biology, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Jansen', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'de Jonge', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam, The Netherlands.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa428']
786,32962950,Correction of the knee coronal plane deformity using the screws plus reconstruction plate versus cannulated screws.,"INTRODUCTION


Knee angular deformity is a common finding occurring in the childhood that can cause gait disturbances and early compartment osteoarthritis. Despite various surgical approaches presented to correct the angular deformities of the knee, there is still a search for the best approach. Thus, the present study was conducted to compare the results of using cannulated screw (CS) versus screw plus reconstruction plate (SpRP) for correction of angular deformities through a two-year follow-up study.
HYPOTHESIS


Percutaneous CS implantation is as efficacious as SpRP implantation for the correction of angular deformities of the knee.
MATERIAL AND METHODS


This randomised clinical trial (RCT) was conducted on 63 patients with angular deformities who were randomly divided into two groups including treatment with cannulated screw (CS) (n=32) and treatment with screw plus reconstruction plate (SpRP) (n=31). All the patients underwent the alignment view radiography of both lower limbs before surgical procedure and then within 3, 6, 12, 18 months and 2 years following the surgery. Afterwards, the patients' mechanical axis of the knees, medial proximal tibial angle (MPTA), lateral distal femoral angle (LDFA), and varus/valgus angles were assessed and compared.
RESULTS


Results of the study showed that MPTA and LDFA significantly turned to the normal range during the 18 months follow-up in both treatment groups (p-value<0.001). Varus and valgus angles were corrected in both techniques as well postoperatively (p-value<0.001). Ultimate correction was achieved earlier in the CS treated group (12 months versus 18 months later).
DISCUSSION


Findings of the study revealed that the percutaneous CS implantation was successful similar to the SpRP implantation for correction of the angular deformity, while earlier ultimate angular correction and less pain complaint were among the superiorities of the CS.
LEVEL OF THE STUDY


II, comparative prospective study.",2020,Varus and valgus angles were corrected in both techniques as well postoperatively (p-value<0.001).,['63 patients with angular deformities'],"['screws plus reconstruction plate versus cannulated screws', 'cannulated screw (CS) versus screw plus reconstruction plate (SpRP', 'Percutaneous CS implantation', 'cannulated screw (CS', 'percutaneous CS implantation', 'screw plus reconstruction plate (SpRP']","['Varus and valgus angles', 'MPTA and LDFA', 'pain complaint', 'mechanical axis of the knees, medial proximal tibial angle (MPTA), lateral distal femoral angle (LDFA), and varus/valgus angles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",63.0,0.0217714,Varus and valgus angles were corrected in both techniques as well postoperatively (p-value<0.001).,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Tahririan', 'Affiliation': 'Department of Orthopedics, Kashani Hospital, Isfahan, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Mohammadsharifi', 'Affiliation': 'Department of Orthopedics, Kashani Hospital, Isfahan, Iran. Electronic address: iman.m.sharifi@gmail.com.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.04.020']
787,32925650,Outcomes of Secondary Intraocular Lens Implantation in the Infant Aphakia Treatment Study.,"PURPOSE


To report outcomes of secondary intraocular lens (IOL) implantation in the Infant Aphakia Treatment Study (IATS) SETTING:: Multicenter clinical practice DESIGN:: Secondary analysis of patients enrolled in a randomized clinical trial METHODS:: Details regarding all secondary IOL surgeries conducted in children enrolled in the IATS were compiled. We evaluated visual outcomes, refractive outcomes, and adverse events at age 10 ½ years. Comparisons were made to eyes that remained aphakic and to eyes randomized to primary IOL placement.
RESULTS


55/57 patients randomized to aphakia with contact lens correction were seen for the 10 ½ year study visit; 24/55 eyes (44%) had secondary IOL surgery. Median age at IOL surgery was 5.4 years (range 1.7 to 10.3 years). Mean absolute prediction error was 1.0 ± 0.7D. At age 10 ½ years, the median log MAR VA was 0.9 (range 0.2 to 1.7), similar to VA in the 31 eyes still aphakic (0.8, range 0.1 to 2.9); the number of eyes with stable or improved VA scores between the 4 ½ and 10 ½ year study visits was also similar (78% secondary IOL eyes, 84% aphakic eyes). For eyes undergoing IOL implantation after the 4.5 year study visit (n=22), the mean refraction at age 10 ½ years was -3.2 ±2.7D (range -9.9D to 1.1D), compared to -5.5 ±6.6 D (n=53, range -26.5 to 3.0D) in eyes with primary IOL (p=0.03).
CONCLUSIONS


Delayed IOL implantation allows a more predictable refractive outcome at age 10 ½ years, though the range of refractive error is still large.",2020,"For eyes undergoing IOL implantation after the 4.5 year study visit (n=22), the mean refraction at age 10 ½ years was -3.2 ±2.7D (range -9.9D to 1.1D), compared to -5.5 ±6.6 D (n=53, range -26.5 to 3.0D) in eyes with primary IOL (p=0.03).
","['55/57 patients randomized to', 'Median age at IOL surgery was 5.4 years (range 1.7 to 10.3 years', 'children enrolled in the IATS were compiled']","['aphakia with contact lens correction', 'Secondary Intraocular Lens Implantation', 'Delayed IOL implantation', 'secondary intraocular lens (IOL) implantation']","['mean refraction', 'visual outcomes, refractive outcomes, and adverse events', 'number of eyes with stable or improved VA scores', 'secondary IOL surgery', 'median log MAR VA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]",,0.0801868,"For eyes undergoing IOL implantation after the 4.5 year study visit (n=22), the mean refraction at age 10 ½ years was -3.2 ±2.7D (range -9.9D to 1.1D), compared to -5.5 ±6.6 D (n=53, range -26.5 to 3.0D) in eyes with primary IOL (p=0.03).
","[{'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'VanderVeen', 'Affiliation': ""Department of Ophthalmology, Boston Children's Hospital, Harvard Medical School, Boston MA.""}, {'ForeName': 'Carolyn D', 'Initials': 'CD', 'LastName': 'Drews-Botsch', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Nizam', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Erick D', 'Initials': 'ED', 'LastName': 'Bothun', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester MN.'}, {'ForeName': 'Lorri B', 'Initials': 'LB', 'LastName': 'Wilson', 'Affiliation': 'Department of Ophthalmology, Casey Eye Institute, Oregon Health & Science University School of Medicine, Portland, OR.'}, {'ForeName': 'M Edward', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': 'Department of Ophthalmology, Storm Eye Institute, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Lambert', 'Affiliation': 'Department of Ophthalmology, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000412']
788,32928070,A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial).,"OBJECTIVES


To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence.
METHOD


This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS).
RESULTS


Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT).
CONCLUSIONS


RFA plus compression is an excellent treatment for VLU because of its safety, effectiveness, and impact on ulcer recurrence reduction and clinical outcome. Registration:  Clinicaltrials.gov, NCT03293836, clinicaltrials.gov.",2021,"RESULTS


Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001).",['56 patients with VLU divided into'],"['compression alone (CR, N\u2009=\u200929) and RFA plus compression', 'saphenous and perforating veins radiofrequency ablation', 'radiofrequency endovenous ablation (RFA) of saphenous and perforating veins']","['venous leg ulcer (VLU) healing rates', 'ulcer recurrence rate', 'ulcer healing rates', 'healing rates', 'Healing velocity', 'ulcer healing velocity; and Venous Clinical Severity Score (VCSS', 'Recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C2242647', 'cui_str': 'Endovenous ablation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",56.0,0.0632548,"RESULTS


Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001).","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Puggina', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Igor Rafael', 'Initials': 'IR', 'LastName': 'Sincos', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Campos', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Rina Maria P', 'Initials': 'RMP', 'LastName': 'Porta', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Jorgete Barreto', 'Initials': 'JB', 'LastName': 'Dos Santos', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'De Luccia', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Puech-Leão', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Felipe Birchal', 'Initials': 'FB', 'LastName': 'Collares', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Erasmo Simão', 'Initials': 'ES', 'LastName': 'da Silva', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}]",Phlebology,['10.1177/0268355520951697']
789,32931545,Follow-up of a Wuqinxi exercise at home programme to reduce pain and improve function for knee osteoarthritis in older people: a randomised controlled trial.,"BACKGROUND


Exercise therapy is a key intervention in the management of knee osteoarthritis (KOA) and recommended in international guidelines on KOA management. An effective home-exercise programme for frail older adults with KOA was successful in achieving high adherence. This randomised controlled trial was to compare the adherence to the exercise and lasting effects of follow-up 3 months.
METHODS


Sixty-eight participants in the original Wuqinxi (WQX) exercise study were community dwelling older adults (age = 70.95 ± 9.85 years) with KOA were categorised into 34 controls group, 34 WQX group adherers. The Western Ontario and Mc Master Universities Osteoarthritis Index questionnaire score (WOMAC) pain and Berg Balance Scale, Timed Up and Go Test, 6-min Walk Test, 30-s chair stand test, isokinetic muscle strength testing of knee flexion and extension measured at pre-test and post-test of the intervention period and follow-up for two groups.
RESULTS


The WQX group maintained or improved in all nine measures from post-test to follow-up, whereas the control group significantly declined in WOMAC pain, Knee extensor strength and Knee flexor strength.
CONCLUSION


The WQX programme was an effective home-exercise programme that achieves high adherence in older adults with KOA who lived in these communities.",2021,The WQX programme was an effective home-exercise programme that achieves high adherence in older adults with KOA who lived in these communities.,"['Sixty-eight participants in the original Wuqinxi (WQX) exercise study were community dwelling older adults (age\u2009=\u200970.95\u2009±\u20099.85\xa0years) with KOA were categorised into 34 controls group, 34 WQX group adherers', 'frail older adults with KOA', 'older people', 'older adults with KOA who lived in these communities']","['WQX', 'Exercise therapy', 'Wuqinxi exercise']","['Western Ontario and Mc Master Universities Osteoarthritis Index questionnaire score (WOMAC) pain and Berg Balance Scale, Timed Up and Go Test, 6-min Walk Test, 30-s chair stand test, isokinetic muscle strength testing of knee flexion and extension', 'WOMAC pain, Knee extensor strength and Knee flexor strength']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",68.0,0.0535659,The WQX programme was an effective home-exercise programme that achieves high adherence in older adults with KOA who lived in these communities.,"[{'ForeName': 'Chun Mei', 'Initials': 'CM', 'LastName': 'Xiao', 'Affiliation': 'Department of Health Promotion and Physical Education, Beijing Institute of Graphic Communication, Beijing 102600, China.'}, {'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Department of Foreign Language Teaching, Beijing Institute of Graphic Communication, Beijing 102600, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Health Promotion and Physical Education, Beijing University Of Chemical Technology, Beijing 100029, China.'}, {'ForeName': 'Yong Chang', 'Initials': 'YC', 'LastName': 'Zhuang', 'Affiliation': 'Department of Wushu, Beijing Sport University, Beijing 100084, China.'}]",Age and ageing,['10.1093/ageing/afaa179']
790,32948397,Correction of anemia by dapagliflozin in patients with type 2 diabetes.,"AIMS


Anemia is common in type 2 diabetes (T2D), particularly in patients with kidney impairment, and often goes unrecognized. Dapagliflozin treatment increases hemoglobin and serum erythropoietin levels. We investigated the effect of dapagliflozin 10-mg/day on hemoglobin in T2D patients with and without anemia.
METHODS


Data from 5325 patients from 14 placebo-controlled, dapagliflozin-treatment studies of at least 24-weeks duration were pooled. Dapagliflozin's effects (vs. placebo) on hemoglobin, serum albumin, estimated glomerular filtration rate (eGFR), systolic blood pressure, body weight, and safety in patients with and without anemia were evaluated.
RESULTS


At baseline, 13% of all T2D patients and 28% of those with chronic kidney disease (eGFR <60 mL/min/1.73 m 2 ) had anemia. Hemoglobin increased continuously to at least week 8 and was sustained throughout 24-weeks follow-up in dapagliflozin-treated patients. Serum albumin increased in dapagliflozin-treated patients at week 4 and remained stable thereafter. Dapagliflozin was well tolerated and corrected anemia in 52% of patients with anemia at baseline (placebo: 26%). Incidences of new-onset anemia were lower in dapagliflozin-treated (2.3%) versus placebo-treated (6.5%) patients.
CONCLUSIONS


Treatment with dapagliflozin can correct and prevent anemia in T2D patients. A gradual increase in hemoglobin beyond week 4 may indicate an erythropoiesis-stimulating effect of sodium-glucose cotransporter 2 inhibition.",2020,"Dapagliflozin's effects (vs. placebo) on hemoglobin, serum albumin, estimated glomerular filtration rate (eGFR), systolic blood pressure, body weight, and safety in patients with and without anemia were evaluated.
","['patients with type 2 diabetes', 'T2D patients', 'T2D patients with and without anemia', 'patients with kidney impairment', 'Data from 5325 patients from 14 placebo-controlled, dapagliflozin-treatment studies of at least 24-weeks duration were pooled']","['placebo', 'Dapagliflozin', 'dapagliflozin']","['hemoglobin, serum albumin, estimated glomerular filtration rate (eGFR), systolic blood pressure, body weight, and safety in patients with and without anemia', 'Serum albumin', 'tolerated and corrected anemia', 'hemoglobin and serum erythropoietin levels', 'anemia', 'Hemoglobin', 'hemoglobin', 'Incidences of new-onset anemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",5325.0,0.0698855,"Dapagliflozin's effects (vs. placebo) on hemoglobin, serum albumin, estimated glomerular filtration rate (eGFR), systolic blood pressure, body weight, and safety in patients with and without anemia were evaluated.
","[{'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefánsson', 'Affiliation': 'Late-stage Development Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, the Netherlands; George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'George Institute for Global Health, Sydney, Australia; Department of Renal Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-stage Development Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Research and Early Development, Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sartipy', 'Affiliation': 'Late-stage Development Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Systems Biology Research Center, School of Bioscience, University of Skövde, Skövde, Sweden.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Cain', 'Affiliation': 'Bogier Clinical and IT Solutions, Raleigh, NC, United States.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. Electronic address: correarotter@gmail.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107729']
791,32960998,"Performance, acceptability, and validation of a phone application bowel diary.","AIMS


To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary).
METHODS


Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs).
RESULTS


Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper.
CONCLUSION


The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.",2020,Test-retest reliability was good,['Women reporting refractory accidental bowel leakage (ABL'],['phone application electronic bowel diary (PFDN Bowel eDiary'],"['Diary events', 'System usability scale (SUS) assessed eDiary usability', 'Performance, acceptability, and validation of a phone application bowel diary', 'urgency BMs per week ', 'performance, acceptability, external validity, and reliability', 'presence or absence of urgency and Bristol stool scale consistency', 'bowel movements (BM) and fecal incontinence episodes (FIE', 'mean SUS score', 'urgency FIE']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0331857,Test-retest reliability was good,"[{'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh/Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': ""Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women's and Infants Hospital, Providence, Rhode Island, USA.""}, {'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Arya', 'Affiliation': 'Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Department of Reproductive Medicine, UC San Diego Health Care System, San Diego, California, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Rahn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Durham, NC, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurourology and urodynamics,['10.1002/nau.24520']
792,32960999,"Which combination is most effective in women with idiopathic overactive bladder, including bladder training, biofeedback, and electrical stimulation? A prospective randomized controlled trial.","OBJECTIVE


To evaluate the efficacy of single and combined use of biofeedback (BF) and electrical stimulation (ES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB).
MATERIAL AND METHODS


Seventy women were randomized into four groups as follows: Group 1 received BT alone (n = 18), Group 2 received BT + BF (n = 17), Group 3 received BT + ES (n = 18), and Group 4 received BT + BF + ES (n = 17). BF and ES were performed 3 days a week, 20 min a day, a total of 24 sessions for 8 weeks. All women were evaluated in terms of incontinence severity (pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and number of pads), QoL (incontinence impact questionnaire), treatment success (positive response rate), cure/improvement rate, treatment satisfaction (Likert scale), and discomfort level (visual analog scale).
RESULTS


At the end of the treatment, severity of incontinence, frequency of voiding, incontinence episodes, and treatment satisfaction significantly improved in Group 3 and Group 4 compared with the other two groups. In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2. In Group 2 and Group 3, statistically significant improvements were seen in nocturia and QoL compared with Group 1. Moreover, statistically significant improvements in nocturia and QoL were found in Group 4 compared with the other three groups. There was no difference in the discomfort level of application between the groups.
CONCLUSION


We conclude that in the first-line conservative treatment of women with idiopathic OAB: (i) adding BF and/or ES to BT increases treatment effectiveness, (ii) clinical efficiency is greater when the combination includes ES, (iii) BT + BF + ES (triple combination) is the most effective treatment option in reducing nocturia and improving QoL.",2020,"In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2.","['women with idiopathic overactive bladder', 'women with idiopathic overactive bladder (OAB', 'women with idiopathic OAB', 'Seventy women were randomized into four groups as follows']","['biofeedback (BF) and electrical stimulation (ES) added to bladder training (BT', 'BT\xa0+\xa0BF', 'BT + BF + ES', 'BT alone', 'BT\xa0+\xa0ES']","['nocturia and QoL', 'severity of incontinence, frequency of voiding, incontinence episodes, and treatment satisfaction', 'nocturia and improving QoL', 'incontinence severity (pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and number of pads), QoL (incontinence impact questionnaire), treatment success (positive response rate), cure/improvement rate, treatment satisfaction (Likert scale), and discomfort level (visual analog scale', 'discomfort level of application', 'incontinence-related quality of life (QoL', 'cure/improvement and positive response rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}]","[{'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",70.0,0.0805382,"In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2.","[{'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Firinci', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Necmettin', 'Initials': 'N', 'LastName': 'Yildiz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Alkan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Zafer', 'Initials': 'Z', 'LastName': 'Aybek', 'Affiliation': 'Department of Urology, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}]",Neurourology and urodynamics,['10.1002/nau.24522']
793,32969040,"A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants.","AIM


To determine whether closed loop automated oxygen control resulted in a reduction in the duration and severity of desaturation episodes and the number of blood gases and chest radiographs in preterm, ventilated infants.
METHODS


Infants were studied on two consecutive days for 12 hours on each day. They were randomised to receive standard care (standard period) or standard care with a closed loop automated oxygen control system (automated oxygen control period) first.
RESULTS


Twenty-four infants with a median gestational age of 25.7 (range 23.1-32.6) weeks were studied at a median postconceptional age of 27.4 (range 24.3-34.9) weeks. During the automated oxygen control period, there were fewer desaturations that lasted >30 seconds (P = .032) or >60 seconds (P = .002), infants spent a higher proportion of the time within their target SpO 2  range during the automated oxygen control period (P < .001), and fewer manual adjustments were made to the inspired oxygen concentration (mean 0.58 vs mean 11.29) (P < .001). There were no significant differences in the number of blood gases (P = .872) or chest radiographs (P = .366) between the two periods.
CONCLUSION


Closed loop automated oxygen delivery resulted in fewer prolonged desaturations with more time spent in the targeted oxygen range.",2021,"There were no significant differences in the number of blood gases (p=0.872) or chest radiographs (p= 0.366) between the two periods.
","['Infants were studied on two consecutive days for 12 hours on each day', 'preterm, ventilated infants', 'Twenty-four infants with a median gestational age of 25.7 (range 23.1 - 32.6) weeks were studied at a median postconceptional age of 27.4 (range 24.3 - 34.9) weeks']","['standard care (standard period) or standard care with a closed loop automated oxygen control system (automated oxygen control period) first', 'closed loop automated oxygen control']","['inspired oxygen concentration', 'duration and severity of desaturation episodes and the number of blood gases and chest radiographs', 'number of blood gases (p=0.872) or chest radiographs']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5192328', 'cui_str': '27.4'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0428648', 'cui_str': 'Inspired oxygen concentration'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",24.0,0.161216,"There were no significant differences in the number of blood gases (p=0.872) or chest radiographs (p= 0.366) between the two periods.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sturrock', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Ambulkar', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'Williams', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sweeney', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Nadja F', 'Initials': 'NF', 'LastName': 'Bednarczuk', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Dassios', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15585']
794,32916063,Comparison of Glycemic Excursion Using Flash Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus Before and After Treatment with Voglibose.,"Purpose:  To determine the effect of Voglibose add-on therapy on daily glycemic excursions (using FreeStyle ®  Libre Pro™, a Flash glucose monitoring system) in Indian patients with type 2 diabetes mellitus (T2DM) receiving a stable dose of metformin (Met) or metformin+sulfonylurea (Met+SU).  Patients and Methods:  T2DM patients with glycosylated hemoglobin (HbA1c) ≥7.0% and at least two postprandial excursions ≥140 mg/dL (within 2 h of meal) during the screening phase (visit 1/day -14 ± 2) were enrolled in this prospective, multicenter interventional study. The patients were randomized at visit 2 (day 0 ± 2) to receive Voglibose 0.2 or 0.3 mg tablets (BID/TID) as add-on therapy to Met and Met+SU. All the patients were followed at day 14 ± 2 (visit 3), month 3 ± 14 days (visit 4), 14 weeks (i.e., visit 4 + 14 days) ±2 days (visit 5), and month 6 ± 14 days (visit 6). Continuous glucose monitoring was performed to study glycemic excursions at visits 2, 3, and 5. The study outcomes were: change in average number of glycemic excursions per day, percent time spent in glucose fluctuations, mean Postprandial glucose (PPG), Fasting plasma glucose (FPG), day and night time mean glucose levels from baseline to day 14 and week 14; change in mean amplitude of glycemic excursion (MAGE) from baseline to 14 weeks; and mean HbA1c level at 3 and 6 months.  Results:  Out of 110 patients enrolled, 101 patients (91.8%) (Met+SU+Voglibose: 73 and Met+Voglibose: 28) completed the study. There was a significant decrease in average number of glycemic excursions per day from baseline to day 14 in the Met+Sul+Voglibose group and to week 14 in the Met+Voglibose group. There was also a significant reduction in percent time spent above target glucose range from baseline to day 14 in both treatment groups and to week 14 in the Met+SU+Voglibose group. A significant reduction in mean PPG area under the curve, day and night time mean glucose levels, and mean FPG levels from baseline to day 14 was reported in both treatment groups. A significant reduction in night time glucose, and average MAGE and HbA1c levels was reported from baseline to week 14 in the Met+Voglibose group and the Met+SU+Voglibose group, respectively. At 6 months, body weight, glucose levels, cholesterol, low-density lipoprotein-cholesterol, and HbA1c were significantly lower, especially in the Met+SU+Voglibose arm.  Conclusion:  Voglibose was useful in reducing glycemic variability and improving glycemic control in Asian Indian adults with T2DM. (CTRI/2018/04/013074).",2021,There was also a significant reduction in percent time spent above target glucose range from baseline to day 14 in both treatment groups.,"['Indian patients with type 2 diabetes(T2DM) receiving a stable dose of metformin(Met)or metformin+sulfonylurea(Met+SU', '110 patients enrolled, 101 patients(91.8%)(Met+SU+Voglibose:73 and Met+Voglibose:28) completed the study', 'Patients with Type 2 Diabetes Mellitus Before and After Treatment with Voglibose', 'Asian Indian adults with T2DM.(CTRI/2018/04/013074', 'T2DM patients with glycosylated hemoglobin(HbA1c) >7.0% and at least two postprandial excursions>140 mg/dL during the screening phase(visit 1/day-14±2']","['Voglibose 0.2 mg or 0.3 mg tablets (BID/TID', 'Glycemic Excursion Using Flash Continuous Glucose Monitoring']","['average number of glycemic excursionsy,percent time spent in glucose fluctuations, mean postprandial glucose(PPG), fasting plasma glucose(FPG), day and night time mean glucose levels', 'mean PPG area under the curve and mean FPG levels', 'mean amplitude of glycemic excursion(MAGE', 'average number of glycemic excursions', 'daily glycemic excursions', 'percent time spent above target glucose range', 'mean HbA1c level', 'glycemic variability']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0532578', 'cui_str': 'voglibose'}, {'cui': 'C1524069', 'cui_str': 'Indian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0532578', 'cui_str': 'voglibose'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",110.0,0.0259508,There was also a significant reduction in percent time spent above target glucose range from baseline to day 14 in both treatment groups.,"[{'ForeName': 'Selvam', 'Initials': 'S', 'LastName': 'Kasthuri', 'Affiliation': 'Madras Diabetes Research Foundation, Gopalapuram, Chennai.'}, {'ForeName': 'Subramani', 'Initials': 'S', 'LastName': 'Poongothai', 'Affiliation': 'Madras Diabetes Research Foundation, Gopalapuram, Chennai.'}, {'ForeName': 'Ranjit Mohan', 'Initials': 'RM', 'LastName': 'Anjana', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre & Madras Diabetes Research Foundation, Gopalapuram, Chennai.""}, {'ForeName': 'Jayvel', 'Initials': 'J', 'LastName': 'Selvakumar', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre, Tambaram East, Chennai.""}, {'ForeName': 'Subramaniam', 'Initials': 'S', 'LastName': 'Muthukumar', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre, Anna Nagar, Chennai.""}, {'ForeName': 'Sengottuevel', 'Initials': 'S', 'LastName': 'Kayalvizhi', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre, Anna Nagar, Chennai.""}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Tariq', 'Affiliation': ""Dr. Mohan's Diabetes Specialties Centre, Avadi, Chennai.""}, {'ForeName': 'Evangelin', 'Initials': 'E', 'LastName': 'Honey', 'Affiliation': ""Dr. Mohan's Diabetes Specialties Centre, Porur, Chennai.""}, {'ForeName': 'Prasanna Kumar', 'Initials': 'PK', 'LastName': 'Gupta', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre, Tambaram East, Chennai.""}, {'ForeName': 'Ulagamathesan', 'Initials': 'U', 'LastName': 'Venkatesan', 'Affiliation': 'Madras Diabetes Research Foundation, Gopalapuram, Chennai.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre & Madras Diabetes Research Foundation, Gopalapuram, Chennai.""}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0484']
795,32919703,mTOR - Mediated protein synthesis by inhibiting protein catabolism in Chinese perch (Siniperca chuatsi).,"Activation of the mechanistic target of rapamycin (mTOR) pathway is known to promote protein synthesis by enhancing mRNA translation. However, there have been few literatures on the effect of mTOR on protein metabolism in non-mammals. The main source of ammonia in fish comes from protein catabolism. The key step of protein catabolism involves the deamination and/or transamination of amino acids. This study is aimed to explore the mechanism underlying mTOR pathway influencing protein retention from the perspective of protein catabolism. Chinese perch were fasted for 24 h and divided into 4 groups randomly before intracerebroventricular (ICV) injection: (1) control group for leucine; (2) leucine group; (3) control group for leucine and rapamycin; (4) leucine and rapamycin group. Food intake was equivalent between each control and treatment groups at each time point (0.5, 4, 12 and 24 h post-injection). Ammonia-N excretion rate, blood glucose, S6 phosphorylation level, and expression of relative genes of protein catabolism (GDH, AMPD, AST, ALT) were determined. The results indicated that the pS6 level was increased, and that the ammonia-N excretion rate, blood glucose, and mRNA level of protein catabolism genes (GDH and AMPD) were significantly decreased after injection with leucine, while those changes were reversed after injection with leucine and rapamycin. Our study not only reveals the mechanism by which mTOR mediates protein synthesis by inhibiting protein catabolism in Chinese perch, but also provides reference for improving the utilization of feed protein.",2020,"Food intake was equivalent between each control and treatment groups at each time point (0.5, 4, 12 and 24 h post-injection).",[],"['intracerebroventricular (ICV) injection: (1) control group for leucine; (2) leucine group; (3) control group for leucine and rapamycin; (4) leucine and rapamycin group', 'leucine and rapamycin', 'rapamycin']","['ammonia-N excretion rate, blood glucose, and mRNA level of protein catabolism genes (GDH and AMPD', 'pS6 level', 'Food intake', 'Ammonia-N excretion rate, blood glucose, S6 phosphorylation level, and expression of relative genes of protein catabolism (GDH, AMPD, AST, ALT']",[],"[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",,0.0135621,"Food intake was equivalent between each control and treatment groups at each time point (0.5, 4, 12 and 24 h post-injection).","[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Yanpeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Xu-Fang', 'Initials': 'XF', 'LastName': 'Liang', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China. Electronic address: xufang_liang@hotmail.com.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Shulin', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}]",Biochemical and biophysical research communications,['10.1016/j.bbrc.2020.08.107']
796,32919816,Effect of monthly vitamin D on diverticular disease hospitalization: Post-hoc analysis of a randomized controlled trial.,"BACKGROUND & AIMS


Some studies have linked low vitamin D status and high risk of diverticular disease, but the causal relationship between vitamin D and diverticular disease remains unclear; clinical trial data are warranted. The objective was to assess the efficacy of vitamin D 3  supplementation on diverticular disease hospitalization.
METHODS


Post-hoc analysis of a community-based randomized double-blind placebo-controlled trial (RCT) with 5108 participants randomized to receive monthly 100,000 IU vitamin D (n = 2558) or identical placebo (n = 2550). The outcome was time to first diverticular disease hospitalization from randomization to the end of intervention (July 2015), including a prespecified subgroup analysis in participants with baseline deseasonalized 25-hydroxyvitamin D (25(OH)D) levels < 50 nmol/L.
RESULTS


Over a median of 3.3 years follow-up, 74 participants had diverticular disease hospitalization. There was no difference in the risk of diverticular disease hospitalization between vitamin D supplementation (35/2558 = 1.4%) and placebo (39/2550 = 1.5%) groups (adjusted hazard ratio (HR) = 0.90; p = 0.65), although in participants with deseasonalized 25(OH)D < 50 nmol/L (n = 1272), the risk was significantly lower in the vitamin D group than placebo (HR = 0.08, p = 0.02).
DISCUSSION


Monthly 100,000 IU vitamin D 3  does not reduce the risk of diverticular disease hospitalization in the general population. Further RCTs are required to investigate the effect of vitamin D supplementation on the diverticular disease in participants with low 25(OH)D levels.",2021,"There was no difference in the risk of diverticular disease hospitalization between vitamin D supplementation (35/2558 = 1.4%) and placebo (39/2550 = 1.5%) groups (adjusted hazard ratio (HR) = 0.90; p = 0.65), although in participants with deseasonalized 25(OH)D ","['participants with low 25(OH)D levels', '5108 participants randomized to receive monthly 100,000']","['vitamin D supplementation', 'vitamin D 3  supplementation', 'placebo', 'IU vitamin D (n\xa0=\xa02558) or identical placebo', 'monthly vitamin D']","['diverticular disease hospitalization', 'time to first diverticular disease hospitalization', 'risk of diverticular disease hospitalization', 'baseline deseasonalized 25-hydroxyvitamin D (25(OH)D) levels']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1510475', 'cui_str': 'Diverticula of intestine'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",5108.0,0.680732,"There was no difference in the risk of diverticular disease hospitalization between vitamin D supplementation (35/2558 = 1.4%) and placebo (39/2550 = 1.5%) groups (adjusted hazard ratio (HR) = 0.90; p = 0.65), although in participants with deseasonalized 25(OH)D ","[{'ForeName': 'Zhenqiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand; Department of Geriatric Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Broad', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.030']
797,32919819,Six-month outcomes after individualized nutritional support during the hospital stay in medical patients at nutritional risk: Secondary analysis of a prospective randomized trial.,"BACKGROUND


Among medical inpatients at risk of malnutrition, the use of individualized nutritional support during the hospital stay was found to reduce complications and improve mortality at short-term. We evaluated clinical outcomes at 6-months follow-up.
METHODS


We randomly assigned 2028 patients to receive protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or hospital food as usual (control group) during the hospital stay. The intervention was discontinued at hospital discharge and further nutritional support was based on the discretion of the treating team. We had complete follow-up information of 1995 patients (98%), which were included in the final analysis. The primary endpoint was all-cause mortality at 6-months. Prespecified secondary end points included non-elective hospital readmissions, functional outcome and quality of life.
RESULTS


At 6-month, 231 of 994 (23.2%) intervention group patients had died compared to 246 of 999 (24.6%) control group patients, resulting in a hazard ratio for death of 0.90 (95%CI 0.76 to 1.08, p = 0.277). Compared to control patients, intervention group patients had similar rates of hospital readmission (27.3% vs. 27.6%, HR 1.00 (95%CI 0.84 to 1.18), p = 0.974), falls (11.2% vs. 10.9%, HR 0.96 (95%CI 0.72 to 1.27), p = 0.773) and similar quality of life and activities of daily living scores.
INTERPRETATION


While individualized nutritional support during the hospital stay significantly reduced short-term mortality, there was no legacy effect on longer term outcomes. Future trials should investigate whether continuation of nutritional support after hospital discharge reduces the high malnutrition-associated mortality rates in this vulnerable patient population.
TRIAL REGISTRATION


ClinicalTrials.gov number, NCT02517476.",2021,"Compared to control patients, intervention group patients had similar rates of hospital readmission (27.3% vs. 27.6%, HR 1.00 (95%CI 0.84 to 1.18), p = 0.974), falls (11.2% vs. 10.9%, HR 0.96 (95%CI 0.72 to 1.27), p = 0.773) and similar quality of life and activities of daily living scores.
","['2028 patients to receive', 'medical patients at nutritional risk', 'medical inpatients at risk of malnutrition']","['individualized nutritional support', 'protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or hospital food as usual (control group']","['hazard ratio for death', 'cause mortality', 'non-elective hospital readmissions, functional outcome and quality of life', 'quality of life and activities of daily living scores', 'died', 'rates of hospital readmission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2028.0,0.136654,"Compared to control patients, intervention group patients had similar rates of hospital readmission (27.3% vs. 27.6%, HR 1.00 (95%CI 0.84 to 1.18), p = 0.974), falls (11.2% vs. 10.9%, HR 0.96 (95%CI 0.72 to 1.27), p = 0.773) and similar quality of life and activities of daily living scores.
","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kaegi-Braun', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tribolet', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Department of Health Professions, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Gomes', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; The New York Academy of Sciences, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Fehr', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Baechli', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Geiser', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Deiss', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bregenzer', 'Affiliation': 'Internal Medicine, Spital Lachen, Switzerland.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hoess', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Switzerland.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Pavlicek', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bilz', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sigrist', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brändle', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Benz', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Henzen', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mattmann', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thomann', 'Affiliation': 'Internal Medicine, Bürgerspital Solothurn, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rutishauser', 'Affiliation': 'Internal Medicine, Kantonsspital Baselland, Switzerland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donzé', 'Affiliation': ""Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Division of Diabetology, Endocrinology, Nutritional Medicine & Metabolism, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland. Electronic address: schuetzph@gmail.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.019']
798,32949140,"A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren's syndrome.","OBJECTIVES


This phase 2 proof-of-concept study (NCT02610543) assessed efficacy, safety and effects on salivary gland inflammation of seletalisib, a potent and selective PI3Kδ inhibitor, in patients with moderate-to-severe primary Sjögren's syndrome (PSS).
METHODS


Adults with PSS were randomized 1:1 to seletalisib 45 mg/day or placebo, in addition to current PSS therapy. Primary end points were safety and tolerability and change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at week 12. Secondary end points included change from baseline at week 12 in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score and histological features in salivary gland biopsies.
RESULTS


Twenty-seven patients were randomized (seletalisib n = 13, placebo n = 14); 20 completed the study. Enrolment challenges led to early study termination with loss of statistical power (36% vs 80% planned). Nonetheless, a trend for improvement in ESSDAI and ESSPRI [difference vs placebo: -2.59 (95% CI: -7.30, 2.11; P=0.266) and -1.55 (95% CI: -3.39, 0.28), respectively] was observed at week 12. No significant changes were seen in saliva and tear flow. Serious adverse events (AEs) were reported in 3/13 of patients receiving seletalisib vs 1/14 for placebo and 5/13 vs 1/14 discontinued due to AEs, respectively. Serum IgM and IgG concentrations decreased in the seletalisib group vs placebo. Seletalisib demonstrated efficacy in reducing size and organisation of salivary gland inflammatory foci and in target engagement, thus reducing PI3K-mTOR signalling compared with placebo.
CONCLUSION


Despite enrolment challenges, seletalisib demonstrated a trend towards clinical improvement in patients with PSS. Histological analyses demonstrated encouraging effects of seletalisib on salivary gland inflammation and organisation.
TRIAL REGISTRATION


https://clinicaltrials.gov, NCT02610543.",2021,"Seletalisib demonstrated efficacy in reducing size and organisation of salivary gland inflammatory foci and in target engagement, thus reducing PI3K-mTOR signalling compared with placebo.
","[""primary Sjögren's syndrome"", 'patients with PSS', 'Twenty-seven patients were randomized (seletalisib n\u2009=\u200913, placebo n\u2009=\u200914); 20 completed the study', 'Adults with PSS', ""patients with moderate-to-severe primary Sjögren's syndrome (PSS""]","['seletalisib 45\u2009mg/day or placebo, in addition to current PSS therapy', 'placebo', 'oral seletalisib']","[""change from baseline at week 12 in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score and histological features in salivary gland biopsies"", ""safety and tolerability and change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score"", 'salivary gland inflammation and organisation', 'Serious adverse events (AEs', 'saliva and tear flow', 'ESSDAI and ESSPRI', 'Serum IgM and IgG concentrations']","[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C4507489', 'cui_str': 'seletalisib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4507489', 'cui_str': 'seletalisib'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0193303', 'cui_str': 'Biopsy of salivary gland'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037023', 'cui_str': 'Sialoadenitis'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",27.0,0.696523,"Seletalisib demonstrated efficacy in reducing size and organisation of salivary gland inflammatory foci and in target engagement, thus reducing PI3K-mTOR signalling compared with placebo.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Juarez', 'Affiliation': 'Translational Medicine, UCB Pharma, Slough, UK.'}, {'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Diaz', 'Affiliation': 'Translational Medicine, UCB Pharma, Slough, UK.'}, {'ForeName': 'Geoffrey I', 'Initials': 'GI', 'LastName': 'Johnston', 'Affiliation': 'Translational Medicine, UCB Pharma, Slough, UK.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Nayar', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Payne', 'Affiliation': 'Discovery Biology, Slough, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Helmer', 'Affiliation': 'Quantitative Clinical Pharmacology, Slough, UK.'}, {'ForeName': 'Dionne', 'Initials': 'D', 'LastName': 'Cain', 'Affiliation': 'Global Clinical Sciences and Operations, UCB Pharma, Slough, UK.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Statistical Science and Innovation, UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Devauchelle-Pensec', 'Affiliation': 'Department of Rheumatology, Brest University, Cavale Blanche Hospital, Brest, France.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Fisher', 'Affiliation': 'National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Giacomelli', 'Affiliation': ""Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Jacques-Eric', 'Initials': 'JE', 'LastName': 'Gottenberg', 'Affiliation': 'Department of Rheumatology, National Reference Centre For Rare Systemic Auto-Immune Diseases, Strasbourg University Hospital, University of Strasbourg, IBMC, CNRS UPR 3572, Strasbourg, France.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Guggino', 'Affiliation': 'Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, Rheumatology Section, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kvarnström', 'Affiliation': 'Department of Medicine, Rheumatology Unit, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Université Paris-Saclay, INSERM, CEA, Centre de recherche en Immunologie des Infections Virales et des Maladies auto-Immunes, AP-HP.Université Paris-Saclay, Hôpital Bicêtre, Rheumatology Department, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Wan Fai', 'Initials': 'WF', 'LastName': 'Ng', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University & NIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Rosas', 'Affiliation': 'Department of Rheumatology, Hospital Marina Baixa, Villajoyosa, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sánchez Bursón', 'Affiliation': 'Department of Rheumatology, Infanta Luisa Hospital, Sevilla, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Triolo', 'Affiliation': 'Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, Rheumatology Section, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Barone', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Bowman', 'Affiliation': 'National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa410']
799,32949144,Sialendoscopy increases saliva secretion and reduces xerostomia up to 60 weeks in Sjögren's syndrome patients: a randomized controlled study.,"OBJECTIVE


To assess the effect of sialendoscopy of the major salivary glands on salivary flow and xerostomia in patients with Sjögren's syndrome (SS).
METHODS


Forty-five patients with SS were randomly assigned to a control group (no irrigation, control, n = 15), to irrigation of the major salivary glands with saline (saline, n = 15) or to irrigation with saline followed by corticosteroid application (triamcinolone acetonide in saline, saline/TA, n = 15). Unstimulated whole saliva flow (UWSF), chewing-stimulated whole saliva flow (SWSF), citric acid-stimulated parotid flow, Clinical Oral Dryness Score (CODS), Xerostomia Inventory (XI) and EULAR SS Patient Reported Index (ESSPRI) scores were obtained 1 week before (T0), and 1, 8, 16, 24, 36, 48 and 60 weeks after sialendoscopy. Data were analysed using linear mixed models.
RESULTS


Irrespective of the irrigation protocol used, sialendoscopy resulted in an increased salivary flow during follow-up up to 60 weeks. Significant between-group differences in the longitudinal course of outcomes were found for UWSF, SWSF, XI and ESSPRI scores (P = 0.028, P = 0.001, P = 0.03, P = 0.021, respectively). UWSF at 60 weeks was higher compared with T0 in the saline group (median: 0.14 vs median: 0.10, P = 0.02) and in the saline/TA group (median: 0.20, vs 0.13, P = 0.035). In the saline/TA group SWSF at 48 weeks was higher compared with T0 (median: 0.74 vs 0.38, P = 0.004). Increase in unstimulated salivary flow was also reflected in improved CODS, XI and ESSPRI scores compared with baseline.
CONCLUSION


Irrigation of the major salivary glands in patients with SS increases salivary flow and reduces xerostomia.",2021,"Irrespective of the irrigation protocol used, sialendoscopy resulted in an increased salivary flow during follow-up up to 60 weeks.","['Forty-five patients with SS', ""Sjögren's syndrome patients"", ""patients with Sjögren's syndrome (SS""]","['Sialendoscopy', 'control group (no irrigation, control, n\u2009=\u200915), to irrigation of the major salivary glands with saline (saline, n\u2009=\u200915) or to irrigation with saline followed by corticosteroid application (triamcinolone acetonide in saline, saline/TA, n\u2009=\u200915', 'sialendoscopy']","['salivary flow', 'Unstimulated whole saliva flow (UWSF), chewing-stimulated whole saliva flow (SWSF), citric acid-stimulated parotid flow, Clinical Oral Dryness Score (CODS), Xerostomia Inventory (XI) and EULAR SS Patient', 'UWSF', 'CODS, XI and ESSPRI scores', 'saliva secretion and reduces xerostomia', 'salivary flow and reduces xerostomia', 'Index (ESSPRI', 'salivary flow and xerostomia', 'UWSF, SWSF, XI and ESSPRI scores', 'unstimulated salivary flow']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0930553', 'cui_str': 'Major salivary gland structure'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0030580', 'cui_str': 'Parotid gland structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",45.0,0.124481,"Irrespective of the irrigation protocol used, sialendoscopy resulted in an increased salivary flow during follow-up up to 60 weeks.","[{'ForeName': 'K Hakki', 'Initials': 'KH', 'LastName': 'Karagozoglu', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Vissink', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Forouzanfar', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan G A M', 'Initials': 'JGAM', 'LastName': 'de Visscher', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Floor', 'Initials': 'F', 'LastName': 'Maarse', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk S', 'Initials': 'HS', 'LastName': 'Brand', 'Affiliation': 'Department of Oral Biochemistry, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, The Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc), Amsterdam, The Netherlands.'}, {'ForeName': 'Derk H Jan', 'Initials': 'DHJ', 'LastName': 'Jager', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa284']
800,32956506,Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial.,"AIMS


Local anesthesia protocols for intradetrusor onabotulinum toxin A (BoNTA) injection lack standardization. We aimed to determine if an alkalinized lidocaine solution is more effective than lidocaine only.
METHODS


Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome) were included in a double-blinded randomized controlled trial after obtaining their informed consent. All participants filled a bladder diary and a urine culture was performed. Subjects were randomized 1:1 to Protocol A (20 ml 2% lidocaine + 10 ml 8.4% sodium bicarbonate) or Protocol B (20 ml 2% lidocaine + 10 ml 0.9% saline solution). A Numeric Rating Scale (0-10) was used to assess the level of pain immediately after the procedure (primary endpoint). Secondary endpoints included pain after 1 h, urinary tract infection, acute urinary retention, and hematuria related to the procedure.
RESULTS


A total of 116 patients were randomized. Baseline characteristics (age, sex, indication, and bladder diary parameters) of patients in Group A and B were similar. Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01). No differences were observed 1 h after treatment (Protocol A and B, respectively, 0.54 ± 0.17 vs. 0.69 ± 0.19, p = .487). The only adverse event reported was mild-to-moderate self-limited hematuria in 15.4% of patients.
CONCLUSIONS


The use of an alkalinized lidocaine solution has proven to be significantly superior to lidocaine only as local anesthesia before intradetrusor BoNTA injection, suggesting that this may be considered a first-line option.",2020,"Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01).","['Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome', '116 patients were randomized']","['Alkalinized lidocaine solution', 'lidocaine\u2009+\u200910\u2009ml 8.4% sodium bicarbonate) or Protocol B (20\u2009ml 2% lidocaine\u2009', 'lidocaine', 'alkalinized lidocaine solution']","['level of pain', 'Pain scores', 'pain after 1\u2009h, urinary tract infection, acute urinary retention, and hematuria related to the procedure', 'Numeric Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",116.0,0.555031,"Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01).","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pereira E Silva', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ponte', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Lopes', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Palma Dos Reis', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}]",Neurourology and urodynamics,['10.1002/nau.24519']
801,32928579,"Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study.","BACKGROUND & AIMS


Sarcopenia is defined as a syndrome characterized by declines in skeletal muscle mass and strength or an alteration in physical function. Although some studies showed nutritional supplementation alone might have health benefits for older sarcopenic patients, their results were inconsistent and remain controversial. The objective of this study was to evaluate if a diet with high protein supplementation (Supp) can lead to better improvement than additional protein intake via dietary counseling (Diet) in maintaining the muscle mass and strength among sarcopenic elders.
METHODS


This was an open-label, parallel-group (Supp vs. Diet) trial. In total, 56 sarcopenic elders completed this study. All subjects were advised to achieve adequate protein intake (1.2-1.5 g/kg body weight/day). This amount of protein is recommended for the elderly and is thought to prevent or retard muscle loss due to aging. The diet group (n = 28) was recommended to consume an ordinary protein-rich diet via counselling whereas the Supp group (n = 28) received a vitamin D- and leucine-enriched whey protein supplement for 12 weeks. The appendicular muscle mass index (AMMI), handgrip strength, gait speed, and calorie and macronutrients intake were evaluated after 4 and 12 weeks of the diet intervention.
RESULTS


Total energy and protein intake increased in both groups. The Supp group had higher intake than the Diet group. The AMMI increased in both groups, and handgrip strength improved in the Diet group. However, no significant differences in AMMI or handgrip strength were found between the two groups. Compared to the Diet group, the Supp group had better improvement in gait speed after 12 weeks of the supplement intervention especially in subjects younger than 75 years.
CONCLUSIONS


The AMMI can be improved as long as sufficient protein is consumed (1.2-1.5 g/kg body weight/day) in sarcopenic elders. Nutritional supplement allows the sarcopenic elderly to more conveniently meet their protein requirements. Supplementation with whey protein and vitamin D can further improve gait speed in elderly sarcopenic subjects, especially in the ""younger"" age group.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03860194.",2021,"The appendicular muscle mass index (AMMI), handgrip strength, gait speed, and calorie and macronutrients intake were evaluated after 4 and 12 weeks of the diet intervention.
","['older adults', 'sarcopenic elders', 'older sarcopenic patients', 'elderly sarcopenic subjects', '56 sarcopenic elders']","['additional protein intake via dietary counseling (Diet', 'vitamin D- and leucine-enriched whey protein supplement', 'Nutritional supplement', 'diet with high protein supplementation (Supp', 'adequate dietary protein with whey protein, leucine, and\xa0vitamin D supplementation', 'ordinary protein-rich diet via counselling whereas the Supp group', 'Supplementation with whey protein and vitamin D']","['appendicular muscle mass index (AMMI), handgrip strength, gait speed, and calorie and macronutrients intake', 'adequate protein intake', 'handgrip strength', 'Total energy and protein intake', 'AMMI', 'gait speed', 'AMMI or handgrip strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0331049', 'cui_str': 'Ammi'}]",56.0,0.0148331,"The appendicular muscle mass index (AMMI), handgrip strength, gait speed, and calorie and macronutrients intake were evaluated after 4 and 12 weeks of the diet intervention.
","[{'ForeName': 'Chih-Chien', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'School of Nutrition and Health Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan; Department of Family Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Ming-Hsiung', 'Initials': 'MH', 'LastName': 'Shih', 'Affiliation': 'Department of Family Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan; Department of Communications Engineering, Yuan Ze University, Taoyuan City, Taiwan.'}, {'ForeName': 'Chih-Dao', 'Initials': 'CD', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Sung-Ling', 'Initials': 'SL', 'LastName': 'Yeh', 'Affiliation': 'School of Nutrition and Health Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan. Electronic address: sangling@tmu.edu.tw.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.017']
802,32928580,"The effectiveness of a weight-loss Mediterranean diet/lifestyle intervention in the management of obstructive sleep apnea: Results of the ""MIMOSA"" randomized clinical trial.","BACKGROUND & AIMS


Although continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea (OSA), lifestyle interventions have also emerged as complementary therapeutic choices. We aimed to explore whether the addition of a weight-loss Mediterranean diet/lifestyle intervention to OSA standard care, i.e. CPAP prescription and brief written healthy lifestyle advice, has an incremental effect on improving OSA severity, over the effect of standard care alone.
METHODS


We designed a parallel, randomized, controlled, superiority clinical trial. Eligible participants were adult, overweight men and women, diagnosed with moderate-to-severe OSA [apnea-hypopnea index (AHI)≥ 15 events/h] through an attended overnight polysomnography. Participants were blindly randomized to a standard care group (SCG, n = 65), a Mediterranean diet group (MDG, n = 62) or a Mediterranean lifestyle group (MLG, n = 60). All three study groups were prescribed with CPAP. The SCG additionally received written healthy lifestyle advice, while intervention arms were subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet. The MLG also received counselling on physical activity and sleep habits. Polysomnographic data and OSA symptoms were evaluated pre- and post-intervention.
RESULTS


A total of 187 OSA patients were recruited. Seven patients were excluded post-randomization and 53/180 (29%) were lost to follow-up. No harms from the interventions applied were reported. According to intention-to-treat analysis (n = 180), mean (95% confidence interval) AHI change was -4.2 (-7.4, -1.0) for the SCG, -24.7 (-30.4, -19.1) for the MDG and -27.3 (-33.9, -20.6) for the MLG. Post-intervention age-, sex-, baseline- and CPAP use-adjusted AHI was significantly lower in the MDG and the MLG compared to the SCG (mean difference: -18.0, and -21.2, respectively, both P < 0.001), and the differences remained significant after further adjustment for body-weight change (P = 0.004 and 0.008, respectively). Other respiratory event indices, daytime sleepiness and insomnia were also significantly lower in both intervention arms compared to the SCG (all P < 0.05). The MLG only presented higher percent rapid-eye-movement sleep and lower daytime sleepiness compared to the MDG (both P < 0.05). Results were similar in the per-protocol analysis (n = 127).
CONCLUSIONS


A dietary/lifestyle intervention on top of standard care leads to greater improvements in OSA severity and symptomatology compared to standard care alone. Benefits are evident regardless of CPAP use and weight loss.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02515357, https://clinicaltrials.gov/ct2/show/NCT02515357.",2021,"Other respiratory event indices, daytime sleepiness and insomnia were also significantly lower in both intervention arms compared to the SCG (all P < 0.05).","['187 OSA patients were recruited', 'Eligible participants were adult, overweight men and women, diagnosed with moderate-to-severe OSA [apnea-hypopnea index (AHI)≥ 15 events/h] through an attended overnight polysomnography', 'obstructive sleep apnea']","['standard care group (SCG, n\xa0=\xa065), a Mediterranean diet group (MDG, n\xa0=\xa062) or a Mediterranean lifestyle group (MLG, n\xa0=\xa060', 'weight-loss Mediterranean diet/lifestyle intervention', 'continuous positive airway pressure (CPAP', 'baseline- and CPAP', 'CPAP']","['Polysomnographic data and OSA symptoms', 'OSA severity', 'OSA severity and symptomatology', 'AHI change', 'daytime sleepiness and insomnia', 'rapid-eye-movement sleep and lower daytime sleepiness', 'body-weight change', 'physical activity and sleep habits']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012694', 'cui_str': 'Cromolyn sodium'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0024443', 'cui_str': 'Madagascar'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0574375', 'cui_str': 'Malagasy language'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}]",187.0,0.0758424,"Other respiratory event indices, daytime sleepiness and insomnia were also significantly lower in both intervention arms compared to the SCG (all P < 0.05).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Georgoulis', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Yiannakouris', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kechribari', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Kallirroi', 'Initials': 'K', 'LastName': 'Lamprou', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Perraki', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Vagiakis', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Meropi D', 'Initials': 'MD', 'LastName': 'Kontogianni', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece. Electronic address: mkont@hua.gr.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.037']
803,32924568,Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting: The GoBolus Study.,"Background:  The GoBolus study investigated the real-world effectiveness of faster aspart in patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems.  Methods:  This 24-week, multicenter, single-arm, noninterventional study investigated adults with T1D (HbA 1c , 7.5%-9.5%) receiving multiple daily injections (MDI) of insulin and using iscCGM within local healthcare settings for ≥6 months before switching to faster aspart at study start (week 0; baseline). Primary endpoint was HbA 1c  change from baseline to week 24. Exploratory endpoint was change in iscCGM metrics from baseline to week 24.  Results:  Overall, 243 patients were included (55.6% male), with mean age/diabetes duration, 49.9/18.8 years; mean HbA 1c , 8.1%. By week 24, HbA 1c  had decreased by 0.19% (-2.1 mmol/mol,  P  < 0.0001) with no mean change in insulin doses or basal/bolus insulin ratios. For patients with sufficient available iscCGM data ( n  = 92): ""time in range"" (TIR; 3.9-10.0 mmol/L) increased from 46.9% to 50.1% ( P  = 0.01), corresponding to an increase of 46.1 min/day; time in hyperglycemia decreased from 49.1% to 46.1% (>10.0 mmol/L,  P  = 0.026) and 20.4% to 17.9% (>13.9 mmol/L,  P  = 0.013), corresponding to 43.5 ( P  = 0.024) and 35.6 ( P  = 0.015) fewer minutes per day on average spent in these ranges, respectively; no change for time in hypoglycemia (<3.9 and <3.0 mmol/L). Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L ( P  = 0.035) and 11.9 to 11.0 mmol/L ( P  = 0.002), respectively.  Conclusion:  Real-world switching to faster aspart in adults with T1D on MDI improved HbA 1c , increased TIR, and decreased time in hyperglycemia without affecting time in hypoglycemia. The GoBolus study: NCT03450863.",2021,"Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L (p=0.035) and 11.9 to 11.0 mmol/L (p=0.002), respectively.
","['Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting - The GoBolus Study', 'adults with T1D (HbA1c, 7.5-9.5%) receiving multiple daily insulin injections (MDI) and using iscCGM within local healthcare settings for ≥6 months prior to switching to faster aspart at study start (Week 0; baseline', '243 patients were included (55.6% male), with mean: age/diabetes duration, 49.9/18.8 years; HbA1c, 8.1', 'patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems']",['Fast-Acting Insulin Aspart'],"['iscCGM metrics', 'Mean interstitial and postprandial glucose', 'time in hyperglycemia', 'insulin doses or basal/bolus insulin ratios', 'MDI improved HbA1c, increased TIR, and decreased time in hyperglycemia', 'time in hypoglycemia', 'HbA1c change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",243.0,0.0333406,"Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L (p=0.035) and 11.9 to 11.0 mmol/L (p=0.002), respectively.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Diabetes Center for Children and Adolescents, Children's Hospital on the Bult, Hanover Medical School, Hanover, Germany.""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Axel Schweitzer', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Keuthage', 'Affiliation': 'Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Muenster, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kipper', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Kretzschmar', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Medizinisches Versorgungszentrum im Altstadt-Carree Fulda GmbH, Fulda, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Wiedenmann', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Ziegler', 'Affiliation': 'Diabetes Clinic for Children and Adolescents, Muenster, Germany.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0360']
804,32926803,Continuous Positive Airway Pressure Does Not Improve Nonalcoholic Fatty Liver Disease in Patients with Obstructive Sleep Apnea. A Randomized Clinical Trial.,"Rationale:  Obstructive sleep apnea (OSA) is associated with development of nonalcoholic fatty liver disease (NAFLD). The effects of continuous positive airway pressure (CPAP) on NAFLD in patients with concomitant OSA are unknown. Objectives:  To investigate the effects of autoadjusting CPAP versus subtherapeutic CPAP treatment over 6 months on NAFLD activities. Methods:  Patients with NAFLD and OSA, as defined by respiratory event index ≥5/h diagnosed by a validated level 3 Embletta device, were randomized into group A) autoadjusting CPAP (4-20 cm H 2 O) or group B) subtherapeutic CPAP (pressure fixed at 4 cm H 2 O). The primary endpoint was the difference in changes in intrahepatic triglyceride as measured by proton magnetic resonance spectroscopy after 6 months of therapy. Key secondary endpoints included changes in controlled attenuation parameter (CAP) and liver stiffness measurement measured with transient elastography, and serum cytokeratin-18 fragment. Measurements and Main Results:  A total of 120 patients were randomized equally into two groups. There were significant correlations between CAP and respiratory event index ( r  = 0.203,  P  = 0.026), percentage of total recording time with Sa O 2  < 90% ( r  = 0.265,  P  = 0.003), and oxygen desaturation index ( r  = 0.214,  P  = 0.019). After 6 months of treatment, there were no significant differences of changes in primary and secondary endpoints between the two treatment groups. Regression analysis showed that weight change over 6 months correlated with changes in both intrahepatic triglyceride and CAP ( P  < 0.001). Conclusions:  Despite significant correlations between hepatic steatosis and markers of severity of OSA, CPAP alone did not improve hepatic steatosis and fibrosis. However, the additional role of weight reduction through lifestyle modification deserves further investigation.",2021,"Following 6 months of treatment, there were no significant differences of changes in primary and secondary endpoints between the 2 treatment groups.","['Patients with NAFLD and OSA, as defined by respiratory event index (REI) ≥ 5/hr diagnosed by a validated level 3 Embletta device', 'Patients with Obstructive Sleep Apnea', 'Obstructive sleep apnea (OSA', 'A total of 120 patients', 'patients with concomitant OSA are unknown']","['autoCPAP', 'autoCPAP (4-20cmH2O) or group B) subtherapeutic CPAP (pressure fixed at 4cmH2O', 'continuous positive airway pressure (CPAP', 'CPAP', 'subtherapeutic CPAP']","['percentage of total recording time', 'changes in controlled attenuation parameter (CAP) and liver stiffness measurement measured with transient elastography, and serum cytokeratin-18 fragment', 'hepatic steatosis and fibrosis', 'oxygen desaturation index', 'Nonalcoholic Fatty Liver Disease', 'intrahepatic triglyceride (IHTG', 'hepatic steatosis and markers of severity of OSA', 'weight change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",120.0,0.124748,"Following 6 months of treatment, there were no significant differences of changes in primary and secondary endpoints between the 2 treatment groups.","[{'ForeName': 'Susanna S S', 'Initials': 'SSS', 'LastName': 'Ng', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'Vincent W S', 'Initials': 'VWS', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, and.'}, {'ForeName': 'Grace L H', 'Initials': 'GLH', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, and.'}, {'ForeName': 'Winnie C W', 'Initials': 'WCW', 'LastName': 'Chu', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Tat-On', 'Initials': 'TO', 'LastName': 'Chan', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'Kin-Wang', 'Initials': 'KW', 'LastName': 'To', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'Fanny W S', 'Initials': 'FWS', 'LastName': 'Ko', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'Ka-Pang', 'Initials': 'KP', 'LastName': 'Chan', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hui', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202005-1868OC']
805,32932401,Effects of combined 17β-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial.,"OBJECTIVE


To examine the impact of a single-capsule 17β-estradiol (E2)/progesterone (P4) on weight and blood pressure (BP) when treating moderate to severe vasomotor symptoms in postmenopausal women with a uterus.
METHODS


Healthy postmenopausal women with a uterus (aged 40-65, body mass index ≤34 kg/m2, BP ≤140/90 mm Hg) were randomized to daily E2/P4 (mg/mg; 1/100, 0.5/100, 0.5/50, 0.25/50) or placebo in the phase 3 REPLENISH trial (NCT01942668). Changes in weight and BP from baseline to month 12 were evaluated. Potentially clinically important changes were defined as increases or decreases from baseline in weight by ≥15% and ≥11.3 kg, systolic BP by ≥20 mm Hg (absolute value ≥160 or ≤90 mm Hg), and diastolic BP by ≥15 mm Hg (absolute value ≥90 or ≤60 mm Hg).
RESULTS


Overall mean changes in weight and BP from baseline to month 12 with E2/P4 were modest and generally not statistically or clinically significant versus placebo. Incidence of potentially clinically important changes was low for weight (E2/P4 vs placebo: 1.1-2.6% vs 2.2%), systolic BP (0.3-1.1% vs 1.1%), and diastolic BP (1.4-4.2% vs 3.2%). A small number of women had treatment-related, treatment-emergent adverse events of weight gain (1.4-2.6% vs 1.3%) or hypertension (0.2-1.2% vs 0%). Few women who discontinued E2/P4 had weight gain (1.6%) or hypertension (0.6%) as a primary reason. Efficacy profile on VMS was consistent with previous findings and not modified by body mass index.
CONCLUSIONS


Twelve-month use of E2/P4 had no clinically meaningful impact on weight or BP in postmenopausal women of the REPLENISH study.",2020,Overall mean changes in weight and BP from baseline to month 12 with E2/P4 were modest and generally not statistically or clinically significant versus placebo.,"['postmenopausal women with a uterus', 'Healthy postmenopausal women with a uterus (aged 40-65, body mass index ≤34\u200akg/m, BP ≤140/90 mm Hg', 'postmenopausal women']","['Combined 17β-estradiol and progesterone', 'placebo', 'VMS', 'single-capsule 17β-estradiol (E2)/progesterone (P4']","['systolic BP', 'weight gain', 'weight and BP', 'weight and blood pressure', 'weight and blood pressure (BP', 'hypertension', 'diastolic BP', 'weight or BP']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.302291,Overall mean changes in weight and BP from baseline to month 12 with E2/P4 were modest and generally not statistically or clinically significant versus placebo.,"[{'ForeName': 'Denise R', 'Initials': 'DR', 'LastName': 'Black', 'Affiliation': 'University of Manitoba, Winnipeg MB, Canada.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Minkin', 'Affiliation': 'School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001659']
806,32935270,A Multicenter Randomized Prospective Study of Early Cholecystectomy for Pediatric Patients with Biliary Colic.,"BACKGROUND


In patients with biliary colic, high-quality prospective data supporting the precise timing of cholecystectomy are lacking. The purpose of this study was to determine the effectiveness of early laparoscopic cholecystectomy in children with biliary colic.
METHODS


A multicenter, parallel-group, randomized study was conducted in patients with biliary colic at 5 hospitals in China. Pediatric patients with biliary colic were prospectively randomized to either the early cholecystectomy or conservative management strategy. The clinical outcomes within 6 months, including the number of biliary colic-free patients and gallstone-related complications, were compared (register number ChiCTR1900021830).
RESULTS


During the first 2 months of follow-up, 71 patients (59.2%, 71/120) receiving conservative management and 124 patients (97.6%, 124/127) in the early cholecystectomy group (p < 0.001) reported being entirely colic-free. The GIQLI measures were higher in the early cholecystectomy group than in the conservative management group (p = 0.032). Acute readmissions occurred in 7 (5.5%) of 127 patients in the early cholecystectomy group, compared with 23 (19.2%) of 120 patients in the conservative management group (risk ratio [RR] 0.25; 95% CI [0.10-0.60], p = 0.001) in the 6-month period.
CONCLUSIONS


Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.",2021,Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.,"['patients with biliary colic', 'patients with biliary colic at 5 hospitals in China', 'Pediatric patients with biliary colic', 'Pediatric Patients with Biliary Colic', 'children with biliary colic', 'A multicenter']","['laparoscopic cholecystectomy', 'Early Cholecystectomy', 'early cholecystectomy or conservative management strategy']","['number of biliary colic-free patients and gallstone-related complications', 'Acute readmissions', 'GIQLI measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151824', 'cui_str': 'Biliary colic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0151824', 'cui_str': 'Biliary colic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0970884,Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': ""Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopedics, Children's Hospital, Chongqing Medical University, Chongqing, 400014, People's Republic of China.""}, {'ForeName': 'Huanli', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China. guochunbao@cqmu.edu.cn.""}, {'ForeName': 'Chunbao', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': ""Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China. guochunbao@cqmu.edu.cn.""}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04700-9']
807,32936595,Not Just for Joints: The Associations of Moderate-to-Vigorous Physical Activity and Sedentary Behavior with Brain Cortical Thickness.,"INTRODUCTION


Cortical thinning is associated with aging; however, lifestyle factors can moderate this relationship. Two distinct lifestyle behaviors associated with brain health are regular moderate-to-vigorous physical activity (MVPA) and limited sedentary behavior (SB). However, it is unclear whether MVPA and SB levels contribute to cortical thickness independent of each other. We therefore investigated the independent relationships of MVPA and SB with cortical thickness using baseline data from a randomized controlled trial.
METHODS


At baseline, we measured MVPA and SB for 7 d using the SenseWear Mini. A subset of the randomized controlled trial participants (n = 30) underwent a 3T magnetic resonance imaging scan, wherein region-specific cortical surface morphometric analyses were performed using T1-weighted structural magnetic resonance imaging. We conducted regression analyses using a surface-based cluster size exclusion method for multiple comparisons within FreeSurfer neuroimaging software to determine if MVPA and SB are independently correlated with region-specific cortical thickness.
RESULTS


This subset of participants had a mean age of 61 yr (SD = 9 yr), and 80% were female. Higher MVPA was associated with greater cortical thickness in the temporal pole (cluster size, 855 mm; cortical thickness range, 2.59-3.72 mm; P < 0.05) and superior frontal gyrus (cluster size, 1204 mm; cortical thickness range, 2.41-3.15 mm; P < 0.05) of the left hemisphere, independent of SB. Sedentary behavior was not associated with greater cortical thickness in any region, independent of MVPA.
CONCLUSIONS


Our results indicate that adults with greater MVPA-independent of SB-are associated with greater cortical thickness in regions, which are susceptible to age-associated atrophy.",2020,"Higher MVPA was associated with greater cortical thickness in the temporal pole (cluster size, 855 mm; cortical thickness range, 2.59-3.72 mm; P < 0.05) and superior frontal gyrus (cluster size, 1204 mm; cortical thickness range, 2.41-3.15 mm; P < 0.05) of the left hemisphere, independent of SB.","['Joints', 'participants had a mean age of 61 yr (SD = 9 yr), and 80% were female']",['3T magnetic resonance imaging scan'],"['cortical thickness', 'MVPA and SB']","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",,0.158306,"Higher MVPA was associated with greater cortical thickness in the temporal pole (cluster size, 855 mm; cortical thickness range, 2.59-3.72 mm; P < 0.05) and superior frontal gyrus (cluster size, 1204 mm; cortical thickness range, 2.41-3.15 mm; P < 0.05) of the left hemisphere, independent of SB.","[{'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Falck', 'Affiliation': 'University of British Columbia, Faculty of Medicine, Aging, Mobility and Cognitive Neuroscience Laboratory, Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Health Research Institute, Vancouver, BC, CANADA.'}, {'ForeName': 'Chun L', 'Initials': 'CL', 'LastName': 'Hsu', 'Affiliation': 'University of British Columbia, Faculty of Medicine, Aging, Mobility and Cognitive Neuroscience Laboratory, Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Health Research Institute, Vancouver, BC, CANADA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Best', 'Affiliation': 'University of British Columbia, Faculty of Medicine, Aging, Mobility and Cognitive Neuroscience Laboratory, Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Health Research Institute, Vancouver, BC, CANADA.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': 'University of British Columbia, Faculty of Medicine, Arthritis Research Canada, Vancouver, BC, CANADA.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Egbert', 'Affiliation': 'University of British Columbia, Faculty of Medicine, Aging, Mobility and Cognitive Neuroscience Laboratory, Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Health Research Institute, Vancouver, BC, CANADA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'University of British Columbia, Faculty of Medicine, Aging, Mobility and Cognitive Neuroscience Laboratory, Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Health Research Institute, Vancouver, BC, CANADA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002374']
808,32946618,"Expression of HGF, pMet, and pAkt is related to benefit of radiotherapy after breast-conserving surgery: a long-term follow-up of the SweBCG91-RT randomised trial.","Experimental studies suggest that hepatocyte growth factor (HGF) and its transmembrane tyrosine kinase receptor, Met, in part also relying on Akt kinase activity, mediate radioresistance. We investigated the importance of these biomarkers for the risk of ipsilateral breast tumour recurrence (IBTR) after adjuvant radiotherapy (RT) in primary breast cancer. HGF, phosphorylated Met (pMet) and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT. HGF was evaluated in the stroma (HGF str  ); pMet in the membrane (pMet mem  ); HGF, pMet and pAkt in the cytoplasm (HGF cyt  , pMet cyt  , pAkt cyt  ); and pAkt in the nucleus (pAkt nuc  ). The prognostic and treatment predictive effects were evaluated to primary endpoint IBTR as first event during the first 5 years. Patients with tumours expressing low levels of HGF cyt  and pMet cyt  and high levels of pAkt nuc  derived a larger benefit from RT [hazard ratio (HR): 0.11 (0.037-0.30), 0.066 (0.016-0.28) and 0.094 (0.028-0.31), respectively] compared to patients with high expression of HGF cyt  and pMet cyt  , and low pAkt nuc  [HR: 0.36 (0.19-0.67), 0.35 (0.20-0.64) and 0.47 (0.32-0.71), respectively; interaction analyses: P = 0.052, 0.035 and 0.013, respectively]. These differences remained in multivariable analysis when adjusting for patient age, tumour size, histological grade, St Gallen subtype and systemic treatment (interaction analysis, P-values: 0.085, 0.027, and 0.023, respectively). This study suggests that patients with immunohistochemically low HGF cyt  , low pMet cyt  and high pAkt nuc  may derive an increased benefit from RT after breast-conserving surgery concerning the risk of developing IBTR.",2020,"HGF, phosphorylated Met (pMet), and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1,004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT.","['primary breast cancer', 'patients with immunohistochemically low HGF cyt  , low pMet cyt  , and high pAkt nuc']","['breast-conserving therapy, with or without adjuvant RT', 'radiotherapy', 'adjuvant radiotherapy (RT', 'hepatocyte growth factor (HGF']",['HGF'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}]","[{'cui': 'C0062534', 'cui_str': 'Scatter Factor'}]",,0.0359245,"HGF, phosphorylated Met (pMet), and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1,004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Veenstra', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Fredrika', 'Initials': 'F', 'LastName': 'Killander', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Niméus', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Stål', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}]",Molecular oncology,['10.1002/1878-0261.12803']
809,32985230,Caregiver Speaks Study Protocol: A Technologically-Mediated Storytelling Intervention for Hospice Family Caregivers of Persons Living With Dementia.,"OBJECTIVE


We present the protocol of a study aiming to examine the efficacy of a technologically-mediated storytelling intervention called Caregiver Speaks in reducing distress and grief intensity experienced by active and bereaved hospice family caregivers of persons living with dementia (PLWD).
DESIGN


The study is a mixed-method, 2-group, randomized controlled trial.
SETTING


This study takes place in 5 hospice agencies in the Midwest and Northeastern United States.
PARTICIPANTS


Participants include hospice family caregivers of PLWD.
INTERVENTION


Participants are randomized to usual hospice care or the intervention group. In the Caregiver Speaks intervention, caregivers engage in photo-elicitation storytelling (sharing photos that capture their thoughts, feelings, and reactions to caregiving and bereavement) via a privately facilitated Facebook group. This intervention will longitudinally follow caregivers from active caregiving into bereavement. The usual care group continues to receive hospice care but does not participate in the online group.
OUTCOMES MEASURED


We anticipate enrolling 468 participants. Our primary outcomes of interest are participant depression and anxiety, which are measured by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder screening (GAD-7). Our secondary outcomes of interest are participants' perceived social support, measured by the Perceived Social Support for Caregiving (PSSC) scale, and grief intensity, which is measured by the Texas Revised Inventory of Grief Present Subscale (TRIG-Present).",2021,"OBJECTIVE


We present the protocol of a study aiming to examine the efficacy of a technologically-mediated storytelling intervention called Caregiver Speaks in reducing distress and grief intensity experienced by active and bereaved hospice family caregivers of persons living with dementia (PLWD).
","['persons living with dementia (PLWD', 'enrolling 468 participants', 'Participants include hospice family caregivers of PLWD', '5 hospice agencies in the Midwest and Northeastern United States', 'Hospice Family Caregivers of Persons Living With Dementia']","['Technologically-Mediated Storytelling Intervention', 'technologically-mediated storytelling intervention called Caregiver Speaks']","['participant depression and anxiety, which are measured by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder screening (GAD-7', 'social support, measured by the Perceived Social Support for Caregiving (PSSC) scale, and grief intensity, which is measured by the Texas Revised Inventory of Grief Present Subscale (TRIG-Present']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",468.0,0.0535154,"OBJECTIVE


We present the protocol of a study aiming to examine the efficacy of a technologically-mediated storytelling intervention called Caregiver Speaks in reducing distress and grief intensity experienced by active and bereaved hospice family caregivers of persons living with dementia (PLWD).
","[{'ForeName': 'Abigail J', 'Initials': 'AJ', 'LastName': 'Rolbiecki', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'Debra Parker', 'Initials': 'DP', 'LastName': 'Oliver', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Teti', 'Affiliation': '14716University of Missouri, Department of Public Health, Columbia, MO, USA.'}, {'ForeName': 'Karla T', 'Initials': 'KT', 'LastName': 'Washington', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'Jacquelyn J', 'Initials': 'JJ', 'LastName': 'Benson', 'Affiliation': '14716University of Missouri, Department of Human Development and Family Science, Columbia, MO, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Kruse', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': '6572University of Pennsylvania, School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ersek', 'Affiliation': '6572University of Pennsylvania, School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mehr', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}]",The American journal of hospice & palliative care,['10.1177/1049909120960449']
810,32926247,The effect of intravenous golimumab on health-related quality of life and work productivity in adult patients with active ankylosing spondylitis: results of the phase 3 GO-ALIVE trial.,"INTRODUCTION/OBJECTIVES


The effect of intravenous (IV) golimumab on health-related quality of life (HRQoL) and productivity in patients with ankylosing spondylitis (AS) was evaluated.
METHOD


Patients were randomized to IV golimumab 2 mg/kg (n = 105) at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo (n = 103) at weeks 0, 4, 12, with crossover to golimumab 2 mg/kg at weeks 16, 20, then q8w through week 52. Changes from baseline in EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, Work Limitations Questionnaire (WLQ), and Ankylosing Spondylitis Quality of Life (ASQoL) were assessed. Correlations between these outcomes and disease activity and patient functioning outcomes were evaluated post hoc.
RESULTS


At week 16, changes from baseline (mean ± standard deviation) in EQ-5D-5L index (0.17 ± 0.16 vs 0.05 ± 0.14), EQ-VAS (20.3 ± 24.6 vs 4.8 ± 23.5), daily productivity VAS (- 2.9 ± - 2.9 vs - 1.1 ± - 2.5), WLQ productivity loss score (- 3.5 ± - 5.3 vs - 1.9 ± - 4.0), and ASQoL (- 5.4 ± - 5.0 vs - 1.8 ± - 4.5) were greater in the IV golimumab versus placebo group, respectively. At week 28, changes from baseline were similar between the IV golimumab and placebo-crossover groups (EQ-5D-5L index: 0.18 ± 0.17 and 0.16 ± 0.16, EQ-VAS: 20.5 ± 27.9 and 22.5 ± 23.1, daily productivity VAS: - 3.1 ± - 3.0 and - 3.1 ± - 2.8, WLQ productivity loss: - 3.9 ± - 5.5 and - 4.5 ± - 4.5, and ASQoL: - 5.3 ± - 5.2 and - 5.3 ± - 4.8, respectively); improvements were maintained through week 52. HRQoL and productivity outcomes were generally moderately correlated with disease activity and functioning outcomes.
CONCLUSIONS


In patients with AS, IV golimumab produced sustained improvements in HRQoL and productivity through 1 year, which correlated with improvements in disease activity and functioning. ClinicalTrials.gov registry number is NCT02186873. Key Points • Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.",2021,Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.,"['adult patients with active ankylosing spondylitis', 'patients with ankylosing spondylitis (AS', 'Patients']","['intravenous golimumab', 'placebo', 'Intravenous (IV) golimumab', 'intravenous (IV) golimumab']","['HRQoL and productivity', 'health-related quality of life (HRQoL) and productivity', 'disease activity and functioning', 'disease activity and patient functioning outcomes', 'disease activity and functioning outcomes', 'EQ-5D-5L index', 'daily productivity VAS', 'WLQ productivity loss score', 'EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, Work Limitations Questionnaire (WLQ), and Ankylosing Spondylitis Quality of Life (ASQoL', 'health-related quality of life and work productivity', 'HRQoL and productivity outcomes', 'general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.223187,Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Reveille', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, The University of Texas McGovern Medical School, 6431 Fannin, MSB 5.270, Houston, TX, USA. Reveille@uth.tmc.edu.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, The University of Texas McGovern Medical School, 6431 Fannin, MSB 5.270, Houston, TX, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Danve', 'Affiliation': 'Section of Rheumatology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Kafka', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'Janssen Global Services, LLC, Horsham, PA, USA.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Eric K H', 'Initials': 'EKH', 'LastName': 'Chan', 'Affiliation': 'Patient Reported Outcomes, Janssen Global Services, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05342-7']
811,32938555,"Reply to Letter to the Editor ""Outcomes of open ""crown"" type v. percutaneous Bunnell type repair of acute Achilles tendon ruptures. Randomized control study"".",,2020,,['acute Achilles tendon ruptures'],"['open ""crown"" type v. percutaneous Bunnell type repair']",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.0548507,,"[{'ForeName': 'Aleksas', 'Initials': 'A', 'LastName': 'Makulavicius', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania. Electronic address: makulaviciusa@gmail.com.'}, {'ForeName': 'Giedrius', 'Initials': 'G', 'LastName': 'Mazarevicius', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Klinga', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Matas', 'Initials': 'M', 'LastName': 'Urmanavicius', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Povilas', 'Initials': 'P', 'LastName': 'Masionis', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Valentinas', 'Initials': 'V', 'LastName': 'Uvarovas', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Narunas', 'Initials': 'N', 'LastName': 'Porvaneckas', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Xavier Martin', 'Initials': 'XM', 'LastName': 'Oliva', 'Affiliation': 'Barcelona University, Faculty of Medicine, Department of Embriology and Human Anatomy, Barcelona, Spain.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2020.09.002']
812,32941243,"We Don't Always Have to See the Bones to Know That They're Healing: Commentary on article by P. van Gerven, MD, et al.: ""Omitting Routine Radiography of Traumatic Ankle Fractures After Initial 2-Week Follow-up Does Not Affect Outcomes. The WARRIOR Trial: A Multicenter Randomized Controlled Trial"".",,2020,,['Traumatic Ankle Fractures'],[],[],"[{'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}]",[],[],,0.0971704,,"[{'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Harris', 'Affiliation': 'UCLA Harbor Medical Center, Los Angeles, California.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Pyle', 'Affiliation': 'UCLA Harbor Medical Center, Los Angeles, California.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01051']
813,32967439,The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study: A Pragmatic Randomized Trial.,"BACKGROUND


In-person clinic follow-up within 7 days after discharge from a heart failure hospitalization is associated with lower 30-day readmission. However, health systems and patients may find it difficult to complete an early postdischarge clinic visit, especially during the current pandemic. We evaluated the effect on 30-day readmission and death of follow-up within 7 days postdischarge guided by an initial structured nonphysician telephone visit compared with follow-up guided by an initial clinic visit with a physician.
METHODS AND RESULTS


We conducted a pragmatic randomized trial in a large integrated healthcare delivery system. Adults being discharged home after hospitalization for heart failure were randomly assigned to either an initial telephone visit with a nurse or pharmacist to guide follow-up or an initial in-person clinic appointment with primary care physicians providing usual care within the first 7 days postdischarge. Telephone appointments included a structured protocol enabling medication titration, laboratory ordering, and booking urgent clinic visits as needed under physician supervision. Outcomes included 30-day readmissions and death and frequency and type of completed follow-up within 7 days of discharge. Among 2091 participants (mean age 78 years, 44% women), there were no significant differences in 30-day heart failure readmission (8.6% telephone, 10.6% clinic,  P =0.11), all-cause readmission (18.8% telephone, 20.6% clinic,  P =0.30), and all-cause death (4.0% telephone, 4.6% clinic,  P =0.49). Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%,  P <0.001). Overall frequency of clinic visits during the first 7 days postdischarge was lower in participants assigned to nonphysician telephone guided follow-up (48%) compared with physician clinic-guided follow-up (77%,  P <0.001).
CONCLUSIONS


Early, structured telephone follow-up after hospitalization for heart failure can increase 7-day follow-up and reduce in-person visits with comparable 30-day clinical outcomes within an integrated care delivery framework. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03524534.",2020,"Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%,  P <0.001).","['Adults being discharged home after hospitalization for heart failure', '2091 participants (mean age 78 years, 44% women']","['initial telephone visit with a nurse or pharmacist to guide follow-up or an initial in-person clinic appointment with primary care physicians providing usual care within the first 7 days postdischarge', 'initial structured nonphysician telephone visit compared with follow-up guided by an initial clinic visit with a physician']","['30-day readmission and death', 'cause readmission', 'Overall frequency of clinic visits', '30-day heart failure readmission', '30-day readmissions and death and frequency and type of completed follow-up within 7 days of discharge', 'Heart Failure Readmission Intervention']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",2091.0,0.134487,"Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%,  P <0.001).","[{'ForeName': 'Keane K', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Kaiser Permanente Santa Clara Medical Center, CA (K.K.L., A.S.).'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Thomas', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}, {'ForeName': 'Thida C', 'Initials': 'TC', 'LastName': 'Tan', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Leong', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Steimle', 'Affiliation': 'Department of Cardiology, Kaiser Permanente Santa Clara Medical Center, CA (K.K.L., A.S.).'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Go', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006553']
814,32979521,Neural correlates of future weight loss reveal a possible role for brain-gastric interactions.,"Lifestyle dietary interventions are an essential practice in treating obesity, hence neural factors that may assist in predicting individual treatment success are of great significance. Here, in a prospective, open-label, three arms study, we examined the correlation between brain resting-state functional connectivity measured at baseline and weight loss following 6 months of lifestyle intervention in 92 overweight participants. We report a robust subnetwork composed mainly of sensory and motor cortical regions, whose edges correlated with future weight loss. This effect was found regardless of intervention group. Importantly, this main finding was further corroborated using a stringent connectivity-based prediction model assessed with cross-validation thus attesting to its robustness. The engagement of senso-motor regions in this subnetwork is consistent with the over-sensitivity to food cues theory of weight regulation. Finally, we tested an additional hypothesis regarding the role of brain-gastric interaction in this subnetwork, considering recent findings of a cortical network synchronized with gastric activity. Accordingly, we found a significant spatial overlap with the subnetwork reported in the present study. Moreover, power in the gastric basal electric frequency within our reported subnetwork negatively correlated with future weight loss. This finding was specific to the weight loss related subnetwork and to the gastric basal frequency. These findings should be further corroborated by combining direct recordings of gastric activity in future studies. Taken together, these intriguing results may have important implications for our understanding of the etiology of obesity and the mechanism of response to dietary intervention.",2021,This effect was found regardless of intervention group.,['92 overweight participants'],['Lifestyle dietary interventions'],['brain resting-state functional connectivity'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",92.0,0.0170556,This effect was found regardless of intervention group.,"[{'ForeName': 'Gidon', 'Initials': 'G', 'LastName': 'Levakov', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: gidonle@post.bgu.ac.il.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Yaskolka Meir', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Nachshon', 'Initials': 'N', 'LastName': 'Meiran', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shelef', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Diagnostic Imaging, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Avidan', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117403']
815,32978102,Randomized phase II study of a home-based walking intervention for radiation-related fatigue among older patients with breast cancer.,"BACKGROUND


Fatigue is a common side effect of radiation therapy and can dramatically affect the quality of life in older cancer patients. We compared a home-based graduated walking intervention with a fixed walking recommendation.recommendation to exercise to determine the effects of these interventions during adjuvant radiotherapy (RT) on older women with breast cancer.
METHODS


A randomized phase 2 trial in women ≥65 years, with stage 0-3 breast cancer. Prior to initiating breast RT, women were randomized to a Home-Based Graduated Walking Program (HBGWP) or a fixed walking recommendation. The primary outcome of fatigue was measured by the Total Disruption Index (TDI) of the Fatigue Symptom Inventory (FSI). Secondary outcomes including a short physical performance battery (SPPB) and questionnaires on exercise, physical function, fatigue (PROMIS Fatigue), and fatigue-related symptoms were collected at 3 time points. The primary goal was to compare the change in TDI between arms at the end of RT. Random coefficients models were used to determine the association between arm, fatigue, and exercise over time. Linear regression models were used to describe the change in outcome variables between visits.
RESULTS


Median age of the 54 participants (27 per arm) was 69 years (range 65-84). The baseline characteristics were similar between study arms. The number of minutes walking per week increased in both arms (mean 21 min/wk. baseline to 83 min/wk. end of RT, p < 0.01) and physical function improved over time in both arms (median 10.5 at baseline to 12 at end of RT, p < 0.01).There was no significant difference in change in TDI between arms (2.7 ± 9.9 vs. 1.8 ± 14.0, p = 0.61)between baseline and end of RT. However, in our linear regression model increasing walking over time was associated with statistically significant lower levels of fatigue (-2.44+/- 1.04, p = 0.04), but not in posthoc subgroup analyses.
CONCLUSION


The HBGWP did not decrease fatigue more than the fixed recommendation to exercise. Both the graduated intervention and fixed recommendation lead to increased walking which was associated with lower fatigue in this study of older adult breast cancer patients.",2021,"end of RT, p < 0.01) and physical function improved over time in both arms (median 10.5 at baseline to 12 at end of RT, p < 0.01).There was no significant difference in change in TDI between arms (2.7 ± ","['older cancer patients', 'older women with breast cancer', 'older adult breast cancer patients', 'Median age of the 54 participants (27 per arm) was 69\xa0years (range 65-84', 'women ≥65\xa0years, with stage 0-3 breast cancer']","['adjuvant radiotherapy (RT', 'Home-Based Graduated Walking Program (HBGWP) or a fixed walking recommendation', 'home-based graduated walking intervention with a fixed walking recommendation.recommendation to exercise', 'HBGWP', 'home-based walking intervention']","['levels of fatigue', 'short physical performance battery (SPPB) and questionnaires on exercise, physical function, fatigue (PROMIS Fatigue), and fatigue-related symptoms', 'change in TDI', 'Total Disruption Index (TDI) of the Fatigue Symptom Inventory (FSI', 'number of minutes walking per week', 'fatigue', 'quality of life', 'physical function']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1562039', 'cui_str': 'Number of minutes'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0748491,"end of RT, p < 0.01) and physical function improved over time in both arms (median 10.5 at baseline to 12 at end of RT, p < 0.01).There was no significant difference in change in TDI between arms (2.7 ± ","[{'ForeName': 'Noam A', 'Initials': 'NA', 'LastName': 'VanderWalde', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA; University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA. Electronic address: nvanderw@westclinic.com.'}, {'ForeName': 'Michelle Y', 'Initials': 'MY', 'LastName': 'Martin', 'Affiliation': 'University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Morningstar', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'University of North Carolina at Chapel Hill/Lineberger Comprehensive Cancer Center, 101 Manning Dr., Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Kirsten A', 'Initials': 'KA', 'LastName': 'Nyrop', 'Affiliation': 'University of North Carolina at Chapel Hill/Lineberger Comprehensive Cancer Center, 101 Manning Dr., Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farmer', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA; University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ballo', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA; University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'VanderWalde', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA; University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Hyman', 'Initials': 'H', 'LastName': 'Muss', 'Affiliation': 'University of North Carolina at Chapel Hill/Lineberger Comprehensive Cancer Center, 101 Manning Dr., Chapel Hill, NC 27514, USA.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2020.09.013']
816,32986498,Venetoclax Plus Rituximab in Relapsed Chronic Lymphocytic Leukemia: 4-Year Results and Evaluation of Impact of Genomic Complexity and Gene Mutations From the MURANO Phase III Study.,"PURPOSE


In previous analyses of the MURANO study, fixed-duration venetoclax plus rituximab (VenR) resulted in improved progression-free survival (PFS) compared with bendamustine plus rituximab (BR) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). At the 4-year follow-up, we report long-term outcomes, response to subsequent therapies, and the predictive value of molecular and genetic characteristics.
PATIENTS AND METHODS


Patients with CLL were randomly assigned to 2 years of venetoclax (VenR for the first six cycles) or six cycles of BR. PFS, overall survival (OS), peripheral-blood minimal residual disease (MRD) status, genomic complexity (GC), and gene mutations were assessed.
RESULTS


Of 389 patients, 194 were assigned to VenR and 195 to BR. Four-year PFS and OS rates were higher with VenR than BR, at 57.3% and 4.6% (hazard ratio [HR], 0.19; 95% CI, 0.14 to 0.25), and 85.3% and 66.8% (HR, 0.41; 95% CI, 0.26 to 0.65), respectively. Undetectable MRD (uMRD) at end of combination therapy (EOCT) was associated with superior PFS compared with low MRD positivity (HR, 0.50) and high MRD positivity (HR, 0.15). Patients in the VenR arm who received ibrutinib as their first therapy after progression (n = 12) had a reported response rate of 100% (10 of 10 evaluable patients); patients subsequently treated with a venetoclax-based regimen (n = 14) had a reported response rate of 55% (six of 11 evaluable patients). With VenR, the uMRD rate at end of treatment (EOT) was lower in patients with GC than in those without GC ( P  = .042); higher GC was associated with shorter PFS. Higher MRD positivity rates were seen with  BIRC3  and  BRAF  mutations at EOCT and with  TP53 ,  NOTCH1 ,  XPO1 , and  BRAF  mutations at EOT.
CONCLUSION


Efficacy benefits with fixed-duration VenR are sustained and particularly durable in patients who achieve uMRD. Salvage therapy with ibrutinib after VenR achieved high response rates. Genetic mutations and GC affected MRD rates and PFS.",2020,"Higher MRD positivity rates were seen with  BIRC3  and  BRAF  mutations at EOCT and with  TP53 ,  NOTCH1 ,  XPO1 , and  BRAF  mutations at EOT.
","['Relapsed Chronic Lymphocytic Leukemia', 'patients with relapsed or refractory chronic lymphocytic leukemia (CLL', '389 patients', 'patients who achieve uMRD', 'Patients with CLL']","['venetoclax (VenR', 'Venetoclax Plus Rituximab', 'bendamustine plus rituximab (BR']","['PFS, overall survival (OS), peripheral-blood minimal residual disease (MRD) status, genomic complexity (GC), and gene mutations', 'Higher MRD positivity rates', 'Undetectable MRD (uMRD', 'response rate', 'MRD rates and PFS', 'uMRD rate', 'OS rates', 'progression-free survival (PFS']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278791', 'cui_str': 'Chronic lymphocytic leukaemia refractory'}, {'cui': 'C4517752', 'cui_str': '389'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",389.0,0.127946,"Higher MRD positivity rates were seen with  BIRC3  and  BRAF  mutations at EOCT and with  TP53 ,  NOTCH1 ,  XPO1 , and  BRAF  mutations at EOT.
","[{'ForeName': 'Arnon P', 'Initials': 'AP', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Jenny Qun', 'Initials': 'JQ', 'LastName': 'Wu', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kipps', 'Affiliation': 'University of California School of Medicine, San Diego, CA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""D'Rozario"", 'Affiliation': 'The John Curtin School of Medical Research, Australian National University, Canberra, Australia.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Assouline', 'Affiliation': 'Segal Cancer Center, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Serna', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jaeger', 'Affiliation': 'Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cartron', 'Affiliation': 'Department of Clinical Hematology, University Hospital Montpellier, Montpellier, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Montillo', 'Affiliation': 'Department of Hematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dubois', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Eldering', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Mellink', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Van Der Kevie-Kersemaekers', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Su Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chyla', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Punnoose', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bolen', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Zoe June', 'Initials': 'ZJ', 'LastName': 'Assaf', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lefebure', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Humphrey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Royal Melbourne Hospital, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Victoria, Australia.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00948']
817,32985036,Impact of continuous passive motion on rehabilitation following total knee arthroplasty.,"BACKGROUND AND PURPOSE


There is an ongoing controversy in respect of the usage of continuous passive motion (CPM) following total knee arthroplasty (TKA). We analysed the impact of CPM on the early rehabilitation after TKA and the clinical outcome over the time.
METHODS


Forty patients were prospectively randomized to postoperative protocols following TKA. Half of them (n = 20) received the standard manual therapy alone and the others (n = 20) were treated additionally with CPM. Identical implants were used in all patients. Passive range of movement (PROM) was noted. Patient satisfaction and knee function was evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as well as the Knee Society Score (KSS) at time of discharge and 2 years postoperatively.
RESULTS


The patients in the solitary manual therapy group (MT) showed preoperatively a 7.2° greater PROM (p = .03) with 5.4° higher flexion (p = .05). Analogously, the KSS presented with 42.7 points a higher score result compared to the CPM group with 35.9 points (p = .03). Although the preoperative ability with 105.2° for flexion and 97.2° for the PROM were in favour of the group without CPM (99.8° resp. 90.0°), at time of discharge the patients with CPM reached with 111.0° a significant higher flexion and with 109.0° a higher PROM (MT group: 107.0° resp. 103.5°) (p = .04/.02). At 2 years follow-up both scores (WOMAC/KSS) and function (extension, flexion and PROM) were balanced (p > .05). Patella resurfacing showed no impact on the clinical results at discharge or at time of last follow-up (p > .05).
DISCUSSION


Although the addition of CPM did significantly improve knee flexion in the early postoperative stage, the difference might not represent a clinical relevance. Further, there were no notable effects on long-term clinical and functional results following TKA, so the routine application of CPM in the above stated setting might be ceased.",2020,"Patella resurfacing showed no impact on the clinical results at discharge or at time of last follow-up (p > .05).
","['total knee arthroplasty (TKA', 'Forty patients', 'total knee arthroplasty']","['continuous passive motion', 'standard manual therapy alone', 'CPM', 'continuous passive motion (CPM', 'TKA']","['knee flexion', 'Passive range of movement (PROM', 'Patient satisfaction and knee function', 'scores (WOMAC/KSS) and function (extension, flexion and PROM', 'PROM', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}]",40.0,0.0335773,"Patella resurfacing showed no impact on the clinical results at discharge or at time of last follow-up (p > .05).
","[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Wirries', 'Affiliation': 'Department of Orthopedic Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ezechieli', 'Affiliation': 'Department of Orthopedic Surgery, St. Josefs Hospital, Salzkotten, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Stimpel', 'Affiliation': 'Therapiezentrum Langenhagen, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Skutek', 'Affiliation': 'Department of Orthopedic Surgery, Hannover Medical School, Hannover, Germany.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1869']
818,32991513,Braces Designed Using CAD/CAM Combined or Not With Finite Element Modeling Lead to Effective Treatment and Quality of Life After 2 Years: A Randomized Controlled Trial.,"STUDY DESIGN


Single-center prospective randomized controlled trial.
OBJECTIVE


The aim of this study was to assess the computer-aided design/manufacturing (CAD/CAM) brace design approach, with and without added finite element modeling (FEM) simulations, after 2 years in terms of clinical outcomes, 3D correction, compliance, and quality of life (QoL).
SUMMARY OF BACKGROUND DATA


.: Previous studies demonstrated that braces designed using a combination of CAD/CAM and FEM induced promising in-brace corrections, were lighter, thinner, and covered less trunk surface. Yet, their long-term impact on treatment quality has not been evaluated.
METHODS


One-hundred twenty adolescent idiopathic scoliosis patients were recruited following Scoliosis Research Society standardized criteria for brace treatment; 61 patients in the first subgroup (CAD) were given braces designed using CAD/CAM; 59 in the second subgroup (CAD-FEM) received braces additionally simulated and refined using a patient-specific FEM built from 3D reconstructions of the spine, rib cage and pelvis. Main thoracic (MT) and thoraco-lumbar/lumbar (TL/L) Cobb angles, sagittal curves, and apical rotations were compared at the initial visit and after 2 years. Patient compliance and QoL were tracked respectively by using embedded temperature sensors and SRS-22r questionnaires.
RESULTS


Forty-four patients with CAD-FEM braces and 50 with CAD braces completed the study. Average in-brace correction was 9° MT (8° CAD-FEM, 10° CAD, P = 0.054) and 12° TL/L (same for both subgroups, P = 0.91). Out-of-brace 2-year progression from initial deformity was <4° for all 3D measurements. Sixty-six percent of all cases (30 CAD-FEM, 35 CAD) met the ≤5° curve progression criterion, 83% (38 CAD-FEM, 43 CAD) stayed <45°, and 6% (5 CAD-FEM, 1 CAD) underwent fusion surgery. 3D correction, compliance, and QoL were not significantly different between both subgroups (P > 0.05).
CONCLUSION


After 2 years, patients with braces designed using CAD/CAM with/without FEM had satisfying clinical outcomes (compared to the BrAIST study), 3D corrections, compliance and QoL. A more comprehensive optimization of brace treatment remains to be accomplished.
LEVEL OF EVIDENCE


2.",2021,"3D correction, compliance and QoL were not significantly different between both subgroups (p > 0.05).
","['Forty-four patients with CAD-FEM braces and 50 with CAD braces completed the study', 'One-hundred-twenty AIS patients were recruited following SRS standardized criteria for brace treatment; 61 patients in the first subgroup (CAD) were given']","['CAD/CAM and FEM', 'CAD/CAM Combined or Not with Finite Element Modeling Lead', 'braces designed using CAD/CAM; 59 in the second subgroup (CAD-FEM) received braces additionally simulated and refined using a patient-specific FEM built from 3D reconstructions of the spine, rib cage and pelvis', 'computer-aided design/manufacturing (CAD/CAM) brace design approach, with and without added finite element modeling (FEM) simulations']","['Main thoracic (MT) and thoraco-lumbar/lumbar (TL/L', 'Cobb angles, sagittal curves, and apical rotations', 'Quality of Life', '3D corrections, compliance and QoL', 'Patient compliance and QoL', '3D correction, compliance and QoL', 'clinical outcomes, 3D correction, compliance and quality of life (QoL']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0222762', 'cui_str': 'Thoracic cage structure'}, {'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",120.0,0.0870226,"3D correction, compliance and QoL were not significantly different between both subgroups (p > 0.05).
","[{'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Guy', 'Affiliation': 'Polytechnique Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Labelle', 'Affiliation': 'Sainte-Justine University Hospital Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Barchi', 'Affiliation': 'Sainte-Justine University Hospital Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Audet-Duchesne', 'Affiliation': 'Polytechnique Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Cobetto', 'Affiliation': 'Polytechnique Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Parent', 'Affiliation': 'Sainte-Justine University Hospital Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Raison', 'Affiliation': 'Polytechnique Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Carl-Éric', 'Initials': 'CÉ', 'LastName': 'Aubin', 'Affiliation': 'Polytechnique Montreal, Montreal, Quebec, Canada.'}]",Spine,['10.1097/BRS.0000000000003705']
819,32994202,Male serrate-legged treefrogs adjust competition strategies according to visual or chemical cues from females.,"There is increasing evidence that many anurans use multimodal cues to detect, discriminate and/or locate conspecifics and thus modify their behaviors. To date, however, most studies have focused on the roles of multimodal cues in female choice or male-male interactions. In the present study, we conducted an experiment to investigate whether male serrate-legged small treefrogs ( Kurixalus odontotarsus ) used visual or chemical cues to detect females and thus altered their competition strategies in different calling contexts. Three acoustic stimuli (advertisement calls, aggressive calls and compound calls) were broadcast in a randomized order after a spontaneous period to focal males in one of four treatment groups: combined visual and chemical cues of a female, only chemical cues, only visual cues and a control (with no females). We recorded the vocal responses of the focal males during each 3 min period. Our results demonstrate that males reduce the total number of calls in response to the presence of females, regardless of how they perceived the females. In response to advertisement calls and compound calls, males that perceived females through chemical cues produced relatively fewer advertisement calls but more aggressive calls. In addition, they produced relatively more aggressive calls during the playback of aggressive calls. Taken together, our study suggests that male  K   odontotarsus  adjust their competition strategies according to the visual or chemical cues of potential mates and highlights the important role of multisensory cues in male frogs' perception of females.",2020,"There is increasing evidence that many anurans use multimodal cues to detect, discriminate and/or locate conspecifics and thus modify their behaviors.","['female choice or male-male interactions', ""male frogs' perception of females""]","['male serrate-legged small treefrogs ( Kurixalus odontotarsus ) used visual or chemical cues', 'acoustic stimuli (advertisement calls, aggressive calls and compound calls) were broadcast', 'combined visual and chemical cues of a female, only chemical cues, only visual cues and a control (with no females']","['vocal responses', 'aggressive calls']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0003459', 'cui_str': 'Toads and Frogs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0327058', 'cui_str': 'Treefrog'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.0239534,"There is increasing evidence that many anurans use multimodal cues to detect, discriminate and/or locate conspecifics and thus modify their behaviors.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Deng', 'Affiliation': 'CAS Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization & Ecological Restoration and Biodiversity Conservation Key Laboratory of Sichuan Province, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu, 610041, China.'}, {'ForeName': 'Qiao-Ling', 'Initials': 'QL', 'LastName': 'He', 'Affiliation': 'College of Life Sciences, China West Normal University, Nanchong, 637000, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'CAS Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization & Ecological Restoration and Biodiversity Conservation Key Laboratory of Sichuan Province, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu, 610041, China.'}, {'ForeName': 'Bi-Cheng', 'Initials': 'BC', 'LastName': 'Zhu', 'Affiliation': 'CAS Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization & Ecological Restoration and Biodiversity Conservation Key Laboratory of Sichuan Province, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu, 610041, China.'}, {'ForeName': 'Tong-Liang', 'Initials': 'TL', 'LastName': 'Wang', 'Affiliation': 'Ministry of Education Key Laboratory for Ecology of Tropical Islands, College of Life Sciences, Hainan Normal University, Haikou, 570000, China.'}, {'ForeName': 'Ji-Chao', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': 'Ministry of Education Key Laboratory for Ecology of Tropical Islands, College of Life Sciences, Hainan Normal University, Haikou, 570000, China.'}, {'ForeName': 'Jian-Guo', 'Initials': 'JG', 'LastName': 'Cui', 'Affiliation': 'CAS Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization & Ecological Restoration and Biodiversity Conservation Key Laboratory of Sichuan Province, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu, 610041, China cuijg@cib.ac.cn.'}]",The Journal of experimental biology,['10.1242/jeb.229245']
820,33040610,Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial.,"OBJECTIVE


Does early treatment of spasticity with botulinum-toxin (BoNTA), in (hyper)acute stroke patients without arm-function, reduce contractures and improve function.
DESIGN


Randomised placebo-controlled-trial.
SETTING


Specialised stroke-unit.
PARTICIPANTS & INTERVENTION


Patients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke were randomised to receive injections of: 0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment).
OUTCOME-MEASURES


Spasticity, contractures, splint use and arm function (ARAT) were taken at baseline, 12-weeks post-injection and six-months after stroke. Additionally, spasticity and contractures were measured at weeks-two, four and six post-injection.
RESULTS


Ninety three patients were randomised. Mean time to intervention was 18-days (standard deviation = 9.3). Spasticity was lower in the treatment group with difference being significant between week-2 to 12 (elbow) and week-2 to 6 (wrist). Mean-difference (MD) varied between -8.5(95% CI -17 to 0) to -9.4(95% CI -14 to -5) µV.Contracture formation was slower in the treatment group. Passive range of motion was higher in the treatment group and was significant at week-12 (elbow MD6.6 (95% CI -0.7 to -12.6)) and week-6 (wrist MD11.8 (95% CI 3.8 to 19.8)). The use of splints was lower in the treatment group odds ratio was 7.2 (95% CI 1.5 to 34.1) and 4.2 (95% CI 1.3 to 14.0) at week-12 and month-6 respectively.Arm-function was not significantly different between the groups MD2.4 (95% CI -5.3 to 10.1) and 2.9 (95% CI -5.8 to 11.6) at week-12 and month-6 respectively.
CONCLUSION


BoNTA reduced spasticity and contractures after stroke and effects lasted for approximately 12-weeks. BoNTA reduced the need for concomitant contracture treatment and did not interfere with recovery of arm function.
TRIAL REGISTRATION


EudraCT (2010-021257-39) and ClinicalTrials.gov-Identifier: NCT01882556.",2021,Passive range of motion was higher in the treatment group and was significant at week-12,"['Specialised stroke-unit', 'Patients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke', 'Ninety three patients were randomised']","['botulinum toxin', 'botulinum-toxin (BoNTA', 'placebo', '0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment']","['µV.Contracture formation', 'Mean-difference (MD', 'Passive range of motion', 'Mean time', 'Arm-function', 'spasticity and contractures', 'Spasticity, contractures, splint use and arm function (ARAT', 'Spasticity']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}]",93.0,0.285423,Passive range of motion was higher in the treatment group and was significant at week-12,"[{'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Lindsay', 'Affiliation': 'School of Allied Health Professions, Keele University, Staffordshire, UK.'}, {'ForeName': 'Sissi', 'Initials': 'S', 'LastName': 'Ispoglou', 'Affiliation': 'Department of Elderly Medicine, Sandwell Hospital, West Bromwich, West Midlands, UK.'}, {'ForeName': 'Brinton', 'Initials': 'B', 'LastName': 'Helliwell', 'Affiliation': 'Ulster Hospital, South Eastern HSC Trust, Belfast.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Hicklin', 'Affiliation': 'Department of Elderly Medicine, Sandwell Hospital, West Bromwich, West Midlands, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Sturman', 'Affiliation': 'Neurology Department, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Pandyan', 'Affiliation': 'School of Allied Health Professions, Keele University, Staffordshire, UK.'}]",Clinical rehabilitation,['10.1177/0269215520963855']
821,33021871,Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of  EGFR -Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403.,"PURPOSE


The irreversible ErbB family tyrosine kinase inhibitor (TKI) afatinib plus the EGFR monoclonal antibody cetuximab was previously shown to overcome resistance to EGFR TKIs. We studied whether the combination of afatinib plus cetuximab compared with afatinib alone would improve progression-free survival (PFS) in patients with treatment-naive  EGFR -mutant non-small-cell lung cancer (NSCLC) by preventing or delaying resistance.
METHODS


Patients with  EGFR -mutant NSCLC without prior treatment of advanced disease were enrolled in this phase II, multicenter trial and randomly assigned to receive afatinib 40 mg orally daily plus cetuximab 500 mg/m 2  intravenously every 2 weeks or afatinib alone. The primary end point was PFS.
RESULTS


Between March 25, 2015 and April 23, 2018, 174 patients were randomly assigned, and 168 (83 on afatinib + cetuximab and 85 on afatinib) were eligible. There was no improvement in PFS in patients receiving afatinib plus cetuximab compared with afatinib alone (hazard ratio [HR], 1.01; 95% CI, 0.72 to 1.43;  P  = .94; median, 11.9 months  v  13.4 months). Similarly, there was no difference in response rate (67%  v  74%;  P  = .38) or overall survival (HR, 0.82; 95% CI, 0.50 to 1.36;  P  = .44). Toxicity was greater with the combination: grade ≥ 3 adverse events related to treatment occurred in 72% of patients receiving afatinib plus cetuximab compared with 40% of those receiving afatinib alone, most commonly rash and diarrhea. Dose reductions were more common in patients receiving the combination, and 30% of patients in this arm discontinued cetuximab due to toxicity. At interim analysis, there was insufficient evidence to support continued accrual, and the trial was closed.
CONCLUSIONS


The addition of cetuximab to afatinib did not improve outcomes in previously untreated  EGFR -mutant NSCLC, despite recognized activity in the acquired resistance setting.",2020,"Toxicity was greater with the combination: grade ≥ 3 adverse events related to treatment occurred in 72% of patients receiving afatinib plus cetuximab compared with 40% of those receiving afatinib alone, most commonly rash and diarrhea.","['Patients with  EGFR -mutant NSCLC without prior treatment of advanced disease', 'patients with treatment-naive  EGFR -mutant non-small-cell lung cancer (NSCLC) by preventing or delaying resistance', 'First-Line Treatment of', 'Non-Small-Cell Lung Cancer', '174 patients were randomly assigned, and 168 (83 on', 'Between March 25, 2015 and April 23, 2018']","['afatinib plus cetuximab', 'afatinib 40 mg orally daily plus cetuximab 500 mg/m 2  intravenously every 2 weeks or afatinib alone', 'EGFR -Mutant', 'afatinib + cetuximab and 85 on afatinib', 'Afatinib Plus Cetuximab Versus Afatinib Alone', 'afatinib alone']","['Toxicity', 'progression-free survival (PFS', 'toxicity', 'response rate', 'PFS', 'rash and diarrhea', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C3652037', 'cui_str': 'Afatinib 40 MG [Gilotrif]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",174.0,0.11611,"Toxicity was greater with the combination: grade ≥ 3 adverse events related to treatment occurred in 72% of patients receiving afatinib plus cetuximab compared with 40% of those receiving afatinib alone, most commonly rash and diarrhea.","[{'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Lilenbaum', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Politi', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Stinchcombe', 'Affiliation': 'Duke Cancer Center, Durham, NC.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Everett H', 'Initials': 'EH', 'LastName': 'Chen', 'Affiliation': 'Kaiser Permanente Medical Group/NCORP, Bellflower CA.'}, {'ForeName': 'Sandeep H', 'Initials': 'SH', 'LastName': 'Mashru', 'Affiliation': 'Kaiser Permanente Medical Group/NCORP, Portland, OR.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Gettinger', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Melnick', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Baumgart', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, CA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01149']
822,33032837,Randomized parallel-group pilot trial (Best foods for your heart) comparing the effects of a Mediterranean Portfolio diet with a low saturated fat diet on HIV dyslipidemia.,"BACKGROUND & AIMS


Mediterranean diets reduce the risk of cardiovascular disease (CVD). However, the effect is unknown in people living with HIV, who have an increased risk potentially due to the additional burdens of infection, inflammation and antiretroviral treatment (ART). We examined the feasibility of a 6-month dietary intervention in adults with HIV dyslipidemia using a sample size adequate to detect differences in LDL-cholesterol.
METHODS


Sixty adults with stable HIV infection on ART and LDL-cholesterol >3 mmol/l were recruited. Participants were randomized (1:1) to receive dietary advice to reduce saturated fat intake to <10% of energy intake (Diet1), or supported to adopt the Mediterranean Portfolio Diet (Diet2) with additional cholesterol-lowering foods (nuts, stanols, soya, oats, beans) for 6 months. Recruitment, retention and intervention fidelity were monitored. Measurements were conducted at baseline, 6 and 12 months. A secondary analysis examined between group differences in CVD risk factors at month 6 adjusted for baseline values and potential confounders.
RESULTS


Rates of recruitment, participation and attrition were 35%, 91%, and 12% respectively. Reported dietary adherence was 68% to Mediterranean foods and 59% to Portfolio components. At 6 months Diet2 participants (n = 29) had a significantly lower LDL-cholesterol (mean difference adjusted for baseline -0.4 mmol/l, 95%CI -0.7 to -0.1, P = 0.01), and systolic blood pressure (-7 mmHg, 95%CI -2 to -12, P = 0.008) compared to those in Diet1 (n = 31). These effects were not sustained at 1 year (LDL-cholesterol -0.05 mmol/l, 95%CI -0.33 to 0.23, P = 0.7; systolic blood pressure -3.5 mmHg, 95%CI -9.4 to 2.5, P = 0.2).
CONCLUSION


We showed the feasibility of adopting a Mediterranean Portfolio diet in people living with HIV. Our findings suggest this intervention might equate to short term improvements in diet quality, blood pressure, and LDL-cholesterol. Further definitive evaluations are required to determine if this is a viable strategy to facilitate cardiovascular risk reduction.
CLINICAL TRIAL REGISTRY


ISRCTN32090191 Best Foods For your heart trial.",2021,"These effects were not sustained at 1 year (LDL-cholesterol -0.05 mmol/l, 95%CI -0.33 to 0.23, P = 0.7; systolic blood pressure -3.5 ","['adults with HIV dyslipidemia using a sample size adequate to detect differences in LDL-cholesterol', 'Sixty adults with stable HIV infection on ART and LDL-cholesterol', 'people living with HIV']","['Best Foods', 'Mediterranean Portfolio diet', 'dietary intervention', 'dietary advice to reduce saturated fat intake to <10% of energy intake (Diet1), or supported to adopt the Mediterranean Portfolio Diet (Diet2) with additional cholesterol-lowering foods (nuts, stanols, soya, oats, beans', 'Mediterranean Portfolio diet with a low saturated fat diet']","['dietary adherence', 'HIV dyslipidemia', 'systolic blood pressure ', 'LDL-cholesterol', 'CVD risk factors', 'systolic blood pressure', 'risk of cardiovascular disease (CVD', 'Rates of recruitment, participation and attrition', 'Recruitment, retention and intervention fidelity', 'diet quality, blood pressure, and LDL-cholesterol']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0452298', 'cui_str': 'Low saturated fat diet'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",60.0,0.176734,"These effects were not sustained at 1 year (LDL-cholesterol -0.05 mmol/l, 95%CI -0.33 to 0.23, P = 0.7; systolic blood pressure -3.5 ","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Stradling', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK; Birmingham Heartlands HIV Service, Department of Infection and Immunology, University Hospitals Birmingham NHS Foundation Trust, UK. Electronic address: clare.stradling@gmail.com.'}, {'ForeName': 'G Neil', 'Initials': 'GN', 'LastName': 'Thomas', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Birmingham Heartlands HIV Service, Department of Infection and Immunology, University Hospitals Birmingham NHS Foundation Trust, UK.'}, {'ForeName': 'Shahrad', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Clinical Research Core and Department of Medicine, Weill Cornell Medicine in Qatar and New York, Doha, Qatar.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.038']
823,33010470,Effectiveness of Modalities to Teach Evidence Based Medicine to Pediatric Clerkship Students: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the effectiveness of a traditional didactic session (TDS) as compared to a self-paced, interactive, multimedia module (SPM) on the application of evidence-based medicine (EBM) skills among medical students during their inpatient pediatric rotation.
METHODS


We conducted a randomized controlled trial from June, 2017 to June, 2018 at a quaternary care children's hospital. Students were randomized to TDS or SPM during each 2-week block. All students completed a critical appraisal tool (CAT) of evidence related to a clinical question in a standardized appraisal form and self-reflected about the EBM process. The primary outcome was the numeric score of the CAT derived by using the validated Fresno tool. Secondary outcomes of knowledge, attitudes, confidence, and self-reported behaviors related to EBM were measured using validated surveys. Statistical analysis was performed using Student's t test for CAT scores and mixed-model procedure (PROC MIXED), with subject as random effect and time as repeated measure for the secondary outcomes.
RESULTS


One hundred twenty-seven clerkship students were included. Overall, there was no significant difference in mean CAT scores for TDS (n = 59) versus SPM (n = 66) groups (90.3 vs 92.0, P = .65). There were no significant differences between SPM and TDS groups for knowledge (P = .66), attitudes (P = .97), confidence (P  = .55), and accessing evidence (P = .27). Both groups showed significant gains in knowledge, attitudes, confidence, and accessing evidence from baseline to postcourse. Improvements in knowledge and confidence were sustained at 3-months.
CONCLUSION


A SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.",2021,A SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.,"['Pediatric Clerkship Students', ""6/2017 to 6/2018 at a quaternary care children's hospital"", 'medical students during their inpatient pediatric rotation', '127 clerkship students']","['SPM', 'traditional didactic session (TDS', 'TDS', 'self-paced, interactive, multimedia module (SPM', 'TDS or SPM']","['knowledge, attitudes, confidence, and accessing evidence', 'knowledge, attitudes, confidence, and self-reported behaviors related to EBM', 'mean CAT scores', 'numeric score of the CAT']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376537', 'cui_str': 'Medicine, Evidence-Based'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.166549,A SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.,"[{'ForeName': 'Teena', 'Initials': 'T', 'LastName': 'Hadvani', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex. Electronic address: tshadvan@texaschildrens.org.'}, {'ForeName': 'Ankhi', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Department of Pediatrics (A Dutta), Section of Pediatric Infectious Diseases, Baylor College of Medicine, The Woodlands, Tex.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Choy', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Department of Pediatrics (S Kumar), Center of Research, Innovation, and Scholarship for Medical Education, Baylor College of Medicine/Texas Children's Hospital, Houston, Tex.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Molleda', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Parikh', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Lopez', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Ban', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Sowdhamini S', 'Initials': 'SS', 'LastName': 'Wallace', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}]",Academic pediatrics,['10.1016/j.acap.2020.09.012']
824,33033956,Impact of aerosol box on intubation during COVID-19: a simulation study of normal and difficult airways.,"PURPOSE


Patients with coronavirus disease (COVID-19) are at risk of requiring mechanical ventilation, and concerns of protecting healthcare workers during aerosol-generating medical procedures has led to the design of the aerosol box.
METHODS


We conducted a randomized crossover mannequin-based simulation study to compare airway management with and without the aerosol box. Thirty-five anesthesiology participants and three critical care participants with more than 50 intubations with videolaryngoscopes were recruited. There were four airway simulations with and without the aerosol box (normal, pharyngeal swelling, cervical spine rigidity, and tongue edema). Each participant intubated the mannequin in eight consecutive simulations. The primary outcome of the study was time to intubation. Secondary outcomes included intubation attempts, optimization maneuvers, and personal protective equipment breaches.
RESULTS


Mean (standard deviation [SD]) time to intubation overall with the box was 30.9 (23.0) sec, while the time to intubation without the box was 25.1 (12.2) sec (mean difference, 5.8; 95% confidence interval [CI], -2.9 to 14.5). For the normal airway scenario, the mean (SD) time to intubation was 18.6 (3.5) sec for no box and 20.4 (3.3) sec for box (mean difference, 1.8; 95% CI, 0.2 to 3.4). During difficult airway scenarios only, the time to intubation was 34.4 (25.6) sec with the aerosol box and 27.3 (13.2) sec without the aerosol box (mean difference, 7.1; 95% CI, -2.5 to 16.7). There were more intubation attempts, personal protective equipment breaches, and optimization maneuvers during use of the aerosol box.
CONCLUSIONS


In this mannequin-based simulation study, the use of the aerosol box increased the time to intubation in some contexts but not others. Further studies in a clinical setting should be conducted to make appropriate modifications to the aerosol box to fully elicit its efficacy and safety prior to implementation in airway guidelines for managing patients with COVID-19.",2021,"During difficult airway scenarios only, the time to intubation was 34.4 (25.6) sec with the aerosol box and 27.3 (13.2) sec without the aerosol box (mean difference, 7.1; 95% CI, -2.5 to 16.7).","['Thirty-five anesthesiology participants and three critical care participants with more than 50 intubations with videolaryngoscopes were recruited', 'Patients with coronavirus disease (COVID-19']",['aerosol box'],"['aerosol box (normal, pharyngeal swelling, cervical spine rigidity, and tongue edema', 'mean (SD) time to intubation', 'time to intubation', 'intubation attempts, optimization maneuvers, and personal protective equipment breaches', 'Mean (standard deviation [SD]) time to intubation overall with the box', 'time to intubation without the box']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0151610', 'cui_str': 'Edema of the tongue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",35.0,0.0671134,"During difficult airway scenarios only, the time to intubation was 34.4 (25.6) sec with the aerosol box and 27.3 (13.2) sec without the aerosol box (mean difference, 7.1; 95% CI, -2.5 to 16.7).","[{'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Fong', 'Affiliation': 'Department of Anesthesia & Pain Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada. sfong1@ualberta.ca.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Faculty of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Efrem', 'Initials': 'E', 'LastName': 'Violato', 'Affiliation': 'Department of Educational Psychology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesia & Pain Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01825-y']
825,33031829,Effect of Age on the Efficacy and Safety of Once-Daily Single-Inhaler Triple-Therapy Fluticasone Furoate/Umeclidinium/Vilanterol in Patients With COPD: A Post Hoc Analysis of the Informing the Pathway of COPD Treatment Trial.,"BACKGROUND


In the Informing the Pathway of COPD Treatment (IMPACT) trial, single-inhaler triple-therapy fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI) reduced moderate/severe exacerbation rates vs FF/VI and UMEC/VI in patients with symptomatic COPD and a history of exacerbations, with a similar safety profile.
RESEARCH QUESTION


Are trial outcomes with single-inhaler triple-therapy FF/UMEC/VI vs FF/VI and UMEC/VI affected by age in patients with symptomatic COPD and a history of exacerbations?
STUDY DESIGN AND METHODS


IMPACT was a phase III, double-blind, 52-week trial. Patients ≥ 40 years of age with symptomatic COPD and ≥ 1 moderate/severe exacerbation in the previous year were randomly assigned 2:2:1 to FF/UMEC/VI 100/62.5/25 μg, FF/VI 100/25 μg, or UMEC/VI 62.5/25 μg. End points assessed by age included annual rate of moderate/severe exacerbations, change from baseline (CFB) in trough FEV 1 , proportion of St. George's Respiratory Questionnaire (SGRQ) responders (≥ 4 units decrease from baseline in SGRQ total score), and safety.
RESULTS


The intention-to-treat population comprised 10,355 patients; 4,724 (46%), 4,225 (41%), and 1,406 (14%) were ≤ 64, 65 to 74, and ≥ 75 years of age, respectively. FF/UMEC/VI reduced on-treatment moderate/severe exacerbation rates vs FF/VI (% reduction [95% CI]: ≤ 64 years, 8% [-1 to 16]; P = .070; 65-74 years, 22% [14-29]; P < .001; ≥ 75 years, 18% [3-31]; P = .021) and vs UMEC/VI (≤ 64 years, 16% [7-25]; P = .002; 65-74 years, 33% [25-41]; P < .001; ≥ 75 years, 24% [6-38]; P = .012), with greatest rate reduction seen in the 65 to 74 and ≥ 75 years subgroups. Post hoc analyses of CFB in trough FEV 1  and proportion of SGRQ responders at week 52 were significantly greater with FF/UMEC/VI than with FF/VI or UMEC/VI in all subgroups. No new safety signals were identified.
INTERPRETATION


FF/UMEC/VI reduced the rate of moderate/severe exacerbations and improved lung function and health status vs FF/VI and UMEC/VI irrespective of age for most end points, with a similar safety profile.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT02164513; URL: www.clinicaltrials.govCTT116855.",2021,"Post hoc analyses of CFB in trough FEV 1 , and proportion of SGRQ responders at Week 52 were significantly greater with FF/UMEC/VI than FF/VI or UMEC/VI in all subgroups.","['patients with symptomatic chronic obstructive pulmonary disease (COPD', 'Patients ≥40 years of age with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year', 'Patients With Chronic Obstructive Pulmonary Disease', '10,355 patients; 4724 (46%), 4225 (41%), and 1406 (14%) were ≤64, 65-74, and ≥75 years of age, respectively']","['Once-Daily Single-Inhaler Triple Therapy Fluticasone Furoate/Umeclidinium/Vilanterol', 'FF/UMEC/VI 100/62.5/25 mcg, FF/VI 100/25 mcg, or UMEC/VI 62.5/25 mcg', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI']","['FF/UMEC/VI reduced on-treatment moderate/severe exacerbation rates', ""annual rate of moderate/severe exacerbations, change from baseline (CFB) in trough forced expiratory volume in 1 second (FEV 1 ), proportion of St George's Respiratory Questionnaire (SGRQ) responders (≥4 units decrease from baseline in SGRQ total score) and safety"", 'rate of moderate/severe exacerbations and improved lung function and health status', 'Efficacy and Safety', 'CFB in trough FEV 1 , and proportion of SGRQ responders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0439211', 'cui_str': 'mcg'}]","[{'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.708903,"Post hoc analyses of CFB in trough FEV 1 , and proportion of SGRQ responders at Week 52 were significantly greater with FF/UMEC/VI than FF/VI or UMEC/VI in all subgroups.","[{'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Airways Clinical Research Center, Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX. Electronic address: hanania@bcm.edu.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Mannino', 'Affiliation': 'Department of Preventative Medicine and Environmental Health, University of Kentucky, College of Public Health, Lexington, KY; GSK, Research Triangle Park, NC.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Pulmonary & Critical Care, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GSK, Research Triangle Park, NC.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, England.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, England.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GSK, Brentford, Middlesex, England; University of Leicester, Leicester, England.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'University of Manchester, Manchester University NHS Foundation Trust, Manchester, England.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, England.'}, {'ForeName': 'Robson', 'Initials': 'R', 'LastName': 'Lima', 'Affiliation': 'GSK, Research Triangle Park, NC.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GSK, Collegeville, PA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",Chest,['10.1016/j.chest.2020.09.253']
826,33047687,Enhanced recovery after surgery in laparoscopic distal gastrectomy: Protocol for a prospective single-arm clinical trial.,"Background


The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections. However, a recent prospective, randomised, open, parallel-controlled trial (Chinese Laparoscopic Gastrointestinal Surgery Study-01 trial), initiated by our team, indicated that under conventional peri-operative management, the reduction of the post-operative hospital stay of laparoscopic distal gastrectomy (LDG) is quite limited compared with open gastrectomy. Thus, if we could provide valuable clinical evidence for demonstrating the efficacy of the ERAS programme for gastric cancer patients undergoing LDG, it would significantly enhance the peri-operative management of gastrectomy and benefit the patients.
Methods


In this prospective single-arm trial, patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study. All participants underwent LDG with peri-operative management under the ERAS programme. The primary outcome measures included the post-operative hospital stays and rehabilitative rate of the post-operative day 4. The secondary outcome measures are morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge.
Conclusion


With reasonable and scientific designing, the trial may be a great help to further discuss the benefit of ERAS programme and thus improving the peri-operative management of patients with gastrectomy.",2020,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","['All participants underwent LDG with peri-operative management under the ERAS programme', 'gastric cancer patients undergoing LDG', 'patients with gastrectomy', 'patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study']","['laparoscopic distal gastrectomy (LDG', 'ERAS programme', 'laparoscopic distal gastrectomy', 'surgery (ERAS) programme']","['morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge', 'post-operative hospital stays and rehabilitative rate of the post-operative day 4', 'length of hospital stay, overall complication rates and medical costs']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0800456,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","[{'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuehong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_35_19']
827,22707253,Testosterone induces off-line perceptual learning.,"RATIONALE


Perceptual learning operates on distinct timescales. How different neuromodulatory systems impact on learning across these different timescales is poorly understood.
OBJECTIVES


Here, we test the causal impact of a novel influence on perceptual learning, the androgen hormone testosterone, across distinct timescales.
METHODS


In a double-blind, placebo- controlled, cross-over study with testosterone, subjects undertook a simple contrast detection task during training sessions on two separate days.
RESULTS


On placebo, there was no learning either within training sessions or between days, except for a fast, rapidly saturating, improvement early on each testing day. However, testosterone caused ""off-line"" learning, with no learning seen within training sessions, but a marked performance improvement over the days between sessions. This testosterone-induced learning occurred in the absence of changes in subjective confidence or introspective accuracy.
CONCLUSIONS


Our findings show that testosterone influences perceptual learning on a timescale consistent with an influence on ""off-line"" consolidation processes.",2012,"On placebo, there was no learning either within training sessions or between days, except for a fast, rapidly saturating, improvement early on each testing day.",[],"['Testosterone', 'placebo', 'testosterone']",[],[],"[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.104835,"On placebo, there was no learning either within training sessions or between days, except for a fast, rapidly saturating, improvement early on each testing day.","[{'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Wright', 'Affiliation': 'Wellcome Trust Centre for Neuroimaging, Institute of Neurology, University College London, 12 Queen Square, London WC1N 3BG, UK. n.wright@ucl.ac.uk'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Edwards', 'Affiliation': ''}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Fleming', 'Affiliation': ''}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Dolan', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-012-2769-y']
828,33048581,Safety and Feasibility of the PEPPER Adaptive Bolus Advisor and Safety System: A Randomized Control Study.,"Background:  The Patient Empowerment through Predictive Personalized Decision Support (PEPPER) system provides personalized bolus advice for people with type 1 diabetes. The system incorporates an adaptive insulin recommender system (based on case-based reasoning, an artificial intelligence methodology), coupled with a safety system, which includes predictive glucose alerts and alarms, predictive low-glucose suspend, personalized carbohydrate recommendations, and dynamic bolus insulin constraint. We evaluated the safety and efficacy of the PEPPER system compared to a standard bolus calculator.  Methods:  This was an open-labeled multicenter randomized controlled crossover study. Following 4-week run-in, participants were randomized to PEPPER/Control or Control/PEPPER in a 1:1 ratio for 12 weeks. Participants then crossed over after a washout period. The primary end-point was percentage time in range (TIR, 3.9-10.0 mmol/L [70-180 mg/dL]). Secondary outcomes included glycemic variability, quality of life, and outcomes on the safety system and insulin recommender.  Results:  Fifty-four participants on multiple daily injections (MDI) or insulin pump completed the run-in period, making up the intention-to-treat analysis. Median (interquartile range) age was 41.5 (32.3-49.8) years, diabetes duration 21.0 (11.5-26.0) years, and HbA1c 61.0 (58.0-66.1) mmol/mol. No significant difference was observed for percentage TIR between the PEPPER and Control groups (62.5 [52.1-67.8] % vs. 58.4 [49.6-64.3] %, respectively,  P  = 0.27). For quality of life, participants reported higher perceived hypoglycemia with the PEPPER system despite no objective difference in time spent in hypoglycemia.  Conclusions:  The PEPPER system was safe, but did not change glycemic outcomes, compared to control. There is wide scope for integrating PEPPER into routine diabetes management for pump and MDI users. Further studies are required to confirm overall effectiveness.  Clinical trial registration:  ClinicalTrials.gov NCT03849755.",2021,The Patient Empowerment through Predictive Personalised Decision Support (PEPPER) system provides personalised bolus advice for people with Type 1 diabetes.,"['Median (interquartile range) age was 41.5 (32.3-49.8) years, diabetes duration 21.0 (11.5-26.0) years and HbA1c 61.0 (58.0-66.1) mmol/mol', 'people with Type 1 diabetes']","['PEPPER/Control or Control/PEPPER', 'Predictive Personalised Decision Support (PEPPER) system', 'PEPPER adaptive bolus advisor and safety system', 'PEPPER system', 'PEPPER']","['time spent in hypoglycaemia', 'percentage time in range (TIR, 3.9mmol/L-10.0mmol/L', 'glycaemic variability, quality of life, and outcomes on the safety system and insulin recommender', 'percentage TIR']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.10598,The Patient Empowerment through Predictive Personalised Decision Support (PEPPER) system provides personalised bolus advice for people with Type 1 diabetes.,"[{'ForeName': 'Parizad', 'Initials': 'P', 'LastName': 'Avari', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Yenny', 'Initials': 'Y', 'LastName': 'Leal', 'Affiliation': ""Diabetes, Endocrinology and Nutrition Unit, Hospital Universitari Dr. Josep Trueta, Institut d'Investigació Biomèdica de Girona, Girona, Spain.""}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'Department of Electrical and Electronic Engineering, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Wos', 'Affiliation': ""Diabetes, Endocrinology and Nutrition Unit, Hospital Universitari Dr. Josep Trueta, Institut d'Investigació Biomèdica de Girona, Girona, Spain.""}, {'ForeName': 'Narvada', 'Initials': 'N', 'LastName': 'Jugnee', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Arnoriaga-Rodríguez', 'Affiliation': ""Diabetes, Endocrinology and Nutrition Unit, Hospital Universitari Dr. Josep Trueta, Institut d'Investigació Biomèdica de Girona, Girona, Spain.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Chengyuan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Electrical and Electronic Engineering, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Quim', 'Initials': 'Q', 'LastName': 'Massana', 'Affiliation': ""eXiT Research Group, Institut d'Informàtica i Aplicacions, University of Girona, Girona, Spain.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lopez', 'Affiliation': ""eXiT Research Group, Institut d'Informàtica i Aplicacions, University of Girona, Girona, Spain.""}, {'ForeName': 'Lucian', 'Initials': 'L', 'LastName': 'Nita', 'Affiliation': 'Department of Research & Development, RomSoft SRL, Iasi, Romania.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'School of Engineering, Computing, and Mathematics, Oxford Brookes University, Oxford, United Kingdom.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Fernández-Real', 'Affiliation': ""Diabetes, Endocrinology and Nutrition Unit, Hospital Universitari Dr. Josep Trueta, Institut d'Investigació Biomèdica de Girona, Girona, Spain.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Oliver', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Fernández-Balsells', 'Affiliation': ""Diabetes, Endocrinology and Nutrition Unit, Hospital Universitari Dr. Josep Trueta, Institut d'Investigació Biomèdica de Girona, Girona, Spain.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Reddy', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0301']
829,33000715,Pilot of a novel theoretically derived intervention for cancer-related anxiety with patients with advanced or recurred disease.,"BACKGROUND


Treatments for cancer-related anxiety show modest benefits, but most have been trialled in patients with early stage disease or patients who are currently disease free. However, many patients with cancer have incurable disease, or their disease is slowly progressing or likely to recur. Treating anxiety in the context of realistic threat and ongoing uncertainty is particularly challenging. Based on a theoretical model of cancer-related anxiety, we developed a transdiagnostic intervention for patients with advanced or recurred disease who are experiencing clinically significant anxieties. The intervention was a novel integration of traditional and contemporary CBT.
AIMS


To evaluate the feasibility, acceptability and preliminary efficacy of the intervention in a pilot with patients with advanced or recurred cancer.
METHOD


Twelve patients with advanced or recurred cancer, who were experiencing anxiety, participated. Feasibility and acceptability were assessed with participant's ratings and adherence and retention rates. Psychological outcomes (anxiety, traumatic symptoms, fear of progression, depression, death anxiety and quality of life) were assessed pre-intervention, post-intervention and at 2-month follow-up.
RESULTS


Eleven of the 12 participants completed at least five therapy sessions of whom eight completed all nine sessions. Participants rated the intervention as having excellent face validity. Post-intervention, statistically significant improvements were demonstrated for anxiety, traumatic symptoms, fear of progression, depression and quality of life. These improvements were maintained at follow-up for anxiety, traumatic symptoms and depression.
CONCLUSIONS


This pilot provides preliminary evidence for the feasibility, acceptability and effectiveness of the novel intervention for cancer-related anxiety in the context of advanced disease.",2021,"Post-intervention, statistically significant improvements were demonstrated for anxiety, traumatic symptoms, fear of progression, depression and quality of life.","['patients with advanced or recurred cancer', 'Twelve patients with advanced or recurred cancer, who were experiencing anxiety, participated', 'Eleven of the 12 participants completed at least five therapy sessions of whom eight completed all nine sessions', 'patients with early stage disease or patients who are currently disease free', 'cancer-related anxiety with patients with advanced or recurred disease', 'patients with advanced or recurred disease who are experiencing clinically significant anxieties']",['novel intervention'],"['Feasibility and acceptability', ""participant's ratings and adherence and retention rates"", 'anxiety, traumatic symptoms, fear of progression, depression and quality of life', 'feasibility, acceptability and preliminary efficacy', 'Psychological outcomes (anxiety, traumatic symptoms, fear of progression, depression, death anxiety and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0522179', 'cui_str': 'Death anxiety'}]",12.0,0.0295766,"Post-intervention, statistically significant improvements were demonstrated for anxiety, traumatic symptoms, fear of progression, depression and quality of life.","[{'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Curran', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum Building A18, Manning Road, Camperdown, Sydney, New South Wales, NSW 2050, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Sharpe', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum Building A18, Manning Road, Camperdown, Sydney, New South Wales, NSW 2050, Australia.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Butow', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum Building A18, Manning Road, Camperdown, Sydney, New South Wales, NSW 2050, Australia.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000697']
830,33002924,"A Comparison of the Required Bronchial Cuff Volume Obtained by 2 Cuff Inflation Methods, Capnogram Waveform-Guided Versus Pressure-Guided: A Prospective Randomized Controlled Study.","BACKGROUND


Double-lumen endobronchial tubes (DLTs) are used for one-lung ventilation (OLV) during thoracic surgery. Overinflation into the bronchial cuff causes damage to the tracheobronchial mucosa, whereas underinflation leads to an incomplete collapse of the nonventilated lung or incomplete ventilation of the ventilated lung. However, how to determine the appropriate bronchial cuff volume and pressure during OLV is unclear. The objective of this study is to compare the required bronchial cuff volume for lung separation obtained by 2 different cuff inflation methods under closed- and open-chest conditions.
METHODS


A total of 64 patients scheduled to undergo elective thoracic surgery requiring OLV were recruited. Left DLTs were used for both right- and left-sided surgery. The patients were randomly assigned to 1 of 2 inflation-type groups to estimate the bronchial cuff volume. In the capnogram waveform-guided bronchial cuff inflation group (capno group, n = 27), the bronchial cuff was inflated until a capnometer sampling gas containing CO2 from the nonventilated lung displayed a flat line. The corresponding bronchial cuff volume and pressure were then recorded. In the pressure-guided bronchial cuff inflation group (pressure group, n = 29), the bronchial cuff was inflated by a cuff inflator to a pressure of 20 cm H2O. Lung separation was confirmed when a flat line of a capnometer was observed after gas sampling from the nonventilated lung.
RESULTS


Under closed-chest conditions, the bronchial cuff sealing volume for the capno group was significantly lower than that for the pressure group (mean [standard deviation {SD}], 1.00 [0.65] mL vs 1.44 [0.59] mL, mean difference, -0.44; 97.5% confidence interval [CI], -0.78 to -0.11; P = .010). Under open-chest conditions, the bronchial cuff sealing volume for the capno group was also significantly lower than that for the pressure group (mean [SD], 0.65 [0.66] mL vs 1.22 [0.45] mL, mean difference, -0.58; 97.5% CI, -0.88 to -0.27; P < .001).
CONCLUSIONS


The lowest cuff volume providing an air-tight bronchial seal was obtained by the capnogram waveform-guided bronchial cuff inflation method. Since the cuff volume required to achieve an air-tight seal decreases after opening the chest, readjustment of the bronchial cuff volume to prevent bronchial cuff damage to the tracheobronchial mucosa after opening the chest may be advisable.",2021,"Under open-chest conditions, the bronchial cuff sealing volume for the capno group was also significantly lower than that for the pressure group (mean [SD], 0.65 [0.66]",['64 patients scheduled to undergo elective thoracic surgery requiring OLV were recruited'],"['Guided Versus Pressure-Guided', 'Bronchial Cuff Volume Obtained by 2 Cuff Inflation Methods, Capnogram Waveform', 'Double-lumen endobronchial tubes (DLTs']","['lowest cuff volume providing an air-tight bronchial seal', 'bronchial cuff sealing volume', 'corresponding bronchial cuff volume and pressure']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4761260', 'cui_str': 'Capnogram'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",64.0,0.0167947,"Under open-chest conditions, the bronchial cuff sealing volume for the capno group was also significantly lower than that for the pressure group (mean [SD], 0.65 [0.66]","[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Nagase', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Ishihara', 'Affiliation': 'Gifu University Hospital Innovative and Clinical Research Promotion Center, Gifu University, Gifu, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Iida', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005179']
831,33003044,Electrolyte Beverage Intake to Promote Hydration and Maintain Kidney Function in Guatemalan Sugarcane Workers Laboring in Hot Conditions.,"OBJECTIVES


To evaluate impact of electrolyte supplementation on hydration status and health outcomes in Guatemalan agricultural workers performing heavy work under hot climatic conditions.
METHODS


A 3-week pragmatic trial was conducted with a group of 50 workers during the 2017 to 2018 sugarcane harvest. Workers received an electrolyte hydration intervention during 2 of the 3 weeks. Blood and urine samples were collected each week.
RESULTS


Increased electrolyte intake resulted in less muscle injury. Kidney function was maintained across the intervention period. Workers were adequately hydrated and average electrolyte levels remained in normal ranges. Mild indications of hyponatremia occurred at higher levels of fluid intake.
CONCLUSIONS


This trial demonstrates the feasibility of maintaining workers' electrolyte levels under extremely hot and humid conditions while mitigating muscle injury. Electrolyte supplementation should be added to standard workplace water, rest, and shade interventions to protect workers.",2020,Kidney function was maintained across the intervention period.,"['Guatemalan Sugarcane Workers', 'group of 50 workers during the 2017-18 sugarcane harvest', 'Guatemalan agricultural workers performing heavy work under hot climatic conditions']","['Electrolyte supplementation', 'electrolyte supplementation', 'electrolyte hydration intervention']","['electrolyte intake', 'Blood and urine samples', 'hyponatremia', 'hydration status and health outcomes', 'Kidney function']","[{'cui': 'C0997177', 'cui_str': 'Sugarcane'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.141553,Kidney function was maintained across the intervention period.,"[{'ForeName': 'Lyndsay', 'Initials': 'L', 'LastName': 'Krisher', 'Affiliation': 'Center for Health, Work, & Environment (Ms Krisher, Dr Butler-Dawson, Ms Dally, Ms Jaramillo, Dr Newman); Colorado Consortium on Climate Change and Human Health (Ms Krisher, Dr Butler-Dawson, Ms Dally, Ms Jaramillo, Dr Newman); Department of Environmental and Occupational Health (Ms Krisher, Dr Butler-Dawson, Ms Dally, Dr Newman), Colorado School of Public Health, University of Colorado Denver, Anschutz Medical Campus; Division of Kinesiology & Health, University of Wyoming, Laramie, Wyoming (Ms Yoder, Dr Johnson); Pantaleon, Guatemala (Dr Pilloni, Dr Cruz, Dr Asensio); Department of Epidemiology, Colorado School of Public Health (Dr Newman); Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, School of Medicine (Dr Newman), University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Butler-Dawson', 'Affiliation': ''}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Yoder', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pilloni', 'Affiliation': ''}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Dally', 'Affiliation': ''}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Jaramillo', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Cruz', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Asensio', 'Affiliation': ''}, {'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Newman', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000002033']
832,33006904,Glycemic Improvement Using Continuous Glucose Monitoring by Baseline Time in Range: Subgroup Analyses from the DIAMOND Type 1 Diabetes Study.,"The DIAMOND study demonstrated that real-time continuous glucose monitors (rtCGMs) improve glycemia for adults with type 1 diabetes using multiple daily injections. This analysis explores the relationship between baseline time in range (TIR) and improvement in TIR using rtCGMs or self-monitoring of blood glucose (SMBG). Baseline TIR was divided into three categories: <40% (9.6 h per day), <50% (12 h per day), and <60% (14.4 h per day). Compared with SMBG, use of rtCGMs increased mean TIR by an additional 16 min per day for participants with a baseline TIR <40%, 77 min per day for baseline TIR <50%, and 88 min per day for baseline TIR <60%. A greater percentage of participants increased TIR by >4 h per day using rtCGMs within the three baseline TIR groups. For participants with a baseline TIR <50%, 29% of rtCGM users improved their TIR by >4 h per day compared with no SMBG users ( P  < 0.001). Similar trends were found for improvement in mean glucose and time spent in hyper- and hypoglycemic ranges.",2021,A greater percentage of participants increased TIR by >4 h/day using rtCGM within the three baseline TIR groups.,['adults with T1D using multiple daily injections'],"['real-time continuous glucose monitors (rtCGM', 'rtCGM']","['mean glucose and time spent in hyper- and hypoglycemic ranges', 'baseline time in range (TIR) and improvement in TIR using rtCGM or self-monitoring of blood glucose (SMBG', 'Glycemic Improvement', 'mean TIR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]",,0.085825,A greater percentage of participants increased TIR by >4 h/day using rtCGM within the three baseline TIR groups.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Dexcom, Inc., San Diego, California, USA.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0471']
833,33010974,Androgens and hirsutism score of overweight women with polycystic ovary syndrome improved after vitamin D treatment: A randomized placebo controlled clinical trial.,"BACKGROUND & AIM


The objective of this study was to investigate the effect of vitamin D treatment on androgen levels and hirsutism scores in overweight women with PCOS.
METHODS


A prospective, randomized, double-blind, placebo-controlled clinical study was conducted at King Abdullah University Hospital in Irbid, Jordan. Overweight Jordanian females aged 18-49 years with vitamin D deficiency and PCOS (n = 60) were assigned to two groups: the treatment group (n = 30) who received 50,000 IU per week of vitamin D 3  and the control group (n = 30) who received a placebo.
RESULTS


After receiving the treatment for 12 consecutive weeks, the levels of total testosterone, parathyroid hormone, free androgen index, and hirsutism score were significantly decreased (P < 0.001), and the levels of 25-hydroxyvitamin D (25(OH)D), sex hormone binding globulin, and phosphorus were significantly increased (P < 0.05). Furthermore, significant changes were observed in ovarian volume and follicle numbers and size ultrasonography, and in the regularity of the menstrual cycle (P < 0.001). In the placebo group, no significant changes were observed in either androgen levels, hirsutism score, or menstrual regularity.
CONCLUSION


Vitamin D 3  at a treatment dose of 50,000 IU per week improved 25(OH)D levels and decreased the hirsutism scores and androgen levels of overweight women with PCOS. These results could mean increased fertility and better reproductive health for overweight women with PCOS; the use of vitamin D 3  as a treatment for these patients should be further investigated. CLINICALTRIALS.
GOV REGESTRATION NUMBER


NCT02328404.",2021,"In the placebo group, no significant changes were observed in either androgen levels, hirsutism score, or menstrual regularity.
","['overweight women with polycystic ovary syndrome', 'overweight women with PCOS', 'King Abdullah University Hospital in Irbid, Jordan', 'Overweight Jordanian females aged 18-49 years with vitamin D deficiency and PCOS (n\xa0=\xa060']","['vitamin D 3  and the control group (n\xa0=\xa030) who received a placebo', 'placebo', 'vitamin D treatment', 'vitamin D']","['levels of 25-hydroxyvitamin D (25(OH)D), sex hormone binding globulin, and phosphorus', '25(OH)D levels', 'levels of total testosterone, parathyroid hormone, free androgen index, and hirsutism score', 'fertility and better reproductive health', 'Androgens and hirsutism score', 'ovarian volume and follicle numbers and size ultrasonography, and in the regularity of the menstrual cycle', 'androgen levels, hirsutism score, or menstrual regularity', 'androgen levels and hirsutism scores', 'hirsutism scores and androgen levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0578772', 'cui_str': 'Hirsutism score'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}]",60.0,0.556511,"In the placebo group, no significant changes were observed in either androgen levels, hirsutism score, or menstrual regularity.
","[{'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Al-Bayyari', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Al-Huson University College, Al-Balqa Applied University, Al-Salt, Jordan. Electronic address: n.bayyari@bau.edu.jo.'}, {'ForeName': 'Hayder', 'Initials': 'H', 'LastName': 'Al-Domi', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University, Amman, Jordan.'}, {'ForeName': 'Faheem', 'Initials': 'F', 'LastName': 'Zayed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': ""Ra'ed"", 'Initials': 'R', 'LastName': 'Hailat', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Arieanna', 'Initials': 'A', 'LastName': 'Eaton', 'Affiliation': 'Department of Integrated Physiology and Health Sciences, Alma College, Alma, MI, USA.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.024']
834,33021870,Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial.,"PURPOSE


Maintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. Other options that complement the induction regimen with favorable toxicity are needed.
PATIENTS AND METHODS


The phase III, double-blind, placebo-controlled TOURMALINE-MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo on days 1, 8, and 15 of 28-day cycles as maintenance for 24 months. The primary endpoint was PFS since time of randomization.
RESULTS


Patients were randomly assigned to receive ixazomib (n = 425) or placebo (n = 281). TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4  v  9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801;  P  < .001; median follow-up, 21.1 months). Ixazomib significantly benefitted patients who achieved complete or very good partial response postinduction (median PFS, 25.6  v  12.9 months; HR, 0.586;  P  < .001). With ixazomib versus placebo, 36.6% versus 23.2% of patients had grade ≥ 3 treatment-emergent adverse events (TEAEs); 12.9% versus 8.0% discontinued treatment because of TEAEs. Common any-grade TEAEs included nausea (26.8%  v  8.0%), vomiting (24.2%  v  4.3%), and diarrhea (23.2%  v  12.3%). There was no increase in new primary malignancies (5.2%  v  6.2%); rates of on-study deaths were 2.6% versus 2.2%.
CONCLUSION


Ixazomib maintenance prolongs PFS with no unexpected toxicity in patients with NDMM not undergoing ASCT. To our knowledge, this is the first PI demonstrated in a randomized clinical trial to have single-agent efficacy for maintenance and is the first oral PI option in this patient population.",2020,"TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4  v  9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801;  P  < .001; median follow-up, 21.1 months).","['Patients', 'Patients With Newly Diagnosed Multiple Myeloma', 'patients with NDMM not undergoing ASCT', 'patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT', 'MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of']","['Ixazomib maintenance', 'Autologous Stem Cell Transplantation', 'standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo', 'placebo', 'ixazomib', 'ixazomib versus placebo', 'Ixazomib']","['diarrhea', 'risk of progression or death', 'nausea', 'complete or very good partial response postinduction', 'new primary malignancies', 'vomiting', 'PFS since time of randomization', 'rates of on-study deaths', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",,0.215654,"TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4  v  9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801;  P  < .001; median follow-up, 21.1 months).","[{'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology and Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Špička', 'Affiliation': 'First Department of Medicine, Department of Hematology, First Faculty of Medicine, Charles University and General Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""Department of Hematology, University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Oriol', 'Affiliation': ""Institut d'Investigació contra la Leucèmia Josep Carreras and Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hemato-oncology, University Hospital Ostrava, University of Ostrava, and Faculty of Medicine, Ostrava, Czech Republic.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Hematology, Leicester Royal Infirmary/University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bringhen', 'Affiliation': 'Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Katodritou', 'Affiliation': 'Department of Hematology, Theagenion Cancer Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Wee-Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, National University Health System, and Yong Loo Lin School of Medicine and Cancer Science Institute of Singapore, National University of Singapore, Singapore.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Pôle Régional de Cancérologie, Department of Haematology, Centre Hospitalier Universitaire La Milétrie-Poitiers, Poitiers, France.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'María-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, Centro de Investigación del Cáncer, Instituto de Biología Molecular y Celular del Cáncer, (Universitario de Salamanca Consejo Superior de Investigaciones Científicas), Salamanca, Spain.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, NY.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Vorog', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Bingxia', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palumbo', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02060']
835,33026940,How to Choose the Right Treatment for Patients With Advanced Squamous Cell Carcinoma in the Absence of a Comparative Randomized Clinical Trial.,,2020,,['Patients With Advanced Squamous Cell Carcinoma'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]",[],[],,0.0406972,,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Stefano Kim, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France; Dewi Vernerey, PhD, INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, and Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France; and Christophe Borg, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Stefano Kim, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France; Dewi Vernerey, PhD, INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, and Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France; and Christophe Borg, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Stefano Kim, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France; Dewi Vernerey, PhD, INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, and Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France; and Christophe Borg, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02137']
836,33000465,"Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2).","BACKGROUND


Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin-13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms.
OBJECTIVES


To evaluate the efficacy and safety of tralokinumab monotherapy in adults with moderate-to-severe AD who had an inadequate response to topical treatments.
METHODS


In two 52-week, randomized, double-blind, placebo-controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate-to-severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Primary endpoints were Investigator's Global Assessment (IGA) score of 0 or 1 at week 16 and ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16. Patients achieving an IGA score of 0 or 1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks. The trials were registered with ClinicalTrials.gov: NCT03131648 and NCT03160885.
RESULTS


At week 16, more patients who received tralokinumab vs. placebo achieved an IGA score of 0 or 1: 15·8% vs. 7·1% in ECZTRA 1 [difference 8·6%, 95% confidence interval (CI) 4·1-13·1; P = 0·002] and 22·2% vs. 10·9% in ECZTRA 2 (11·1%, 95% CI 5·8-16·4; P < 0·001) and EASI 75: 25·0% vs. 12·7% (12·1%, 95% CI 6·5-17·7; P < 0·001) and 33·2% vs. 11·4% (21·6%, 95% CI 15·8-27·3; P < 0·001). Early improvements in pruritus, sleep interference, Dermatology Life Quality Index, SCORing Atopic Dermatitis and Patient-Oriented Eczema Measure were observed from the first postbaseline measurements. The majority of week 16 tralokinumab responders maintained response at week 52 with continued tralokinumab treatment without any rescue medication (including topical corticosteroids). Adverse events were reported in 76·4% and 61·5% of patients receiving tralokinumab in ECZTRA 1 and ECZTRA 2, respectively, and in 77·0% and 66·0% of patients receiving placebo in ECZTRA 1 and ECZTRA 2, respectively, in the 16-week initial period.
CONCLUSIONS


Tralokinumab monotherapy was superior to placebo at 16 weeks of treatment and was well tolerated up to 52 weeks of treatment.",2021,Tralokinumab monotherapy was superior to placebo at 16 weeks of treatment and was well tolerated up to 52 weeks of treatment.,"['adults with moderate-to-severe AD', 'moderate-to-severe atopic dermatitis', 'adults with moderate-to-severe AD who had an inadequate response to topical treatments']","['Tralokinumab monotherapy', 'tralokinumab combined with topical corticosteroids', 'subcutaneous tralokinumab 300\xa0mg every 2\xa0weeks (Q2W), or placebo', 'tralokinumab monotherapy', 'placebo', 'Tralokinumab', 'tralokinumab vs. placebo', 'tralokinumab treatment without any rescue medication (including topical corticosteroids']","['pruritus, sleep interference, Dermatology Life Quality Index, SCORing Atopic Dermatitis and Patient-Oriented Eczema Measure', 'efficacy and safety', 'Adverse events', 'IGA score', 'AD signs and symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3658667', 'cui_str': 'tralokinumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C4304942', 'cui_str': 'POEM - Patient-Oriented Eczema Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",,0.499857,Tralokinumab monotherapy was superior to placebo at 16 weeks of treatment and was well tolerated up to 52 weeks of treatment.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology and the Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Department of Dermatology, Venereology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Lynde Dermatology, Probity Medical Research, Markham, ON, Canada.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spelman', 'Affiliation': 'Veracity Clinical Research, Brisbane, QLD, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katoh', 'Affiliation': 'Department of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Laval University and Centre Dermatologique du Québec Métropolitain and Centre de Recherche Dermatologique du Québec Métropolitain, Québec, QC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lesiak', 'Affiliation': 'Department of Dermatology and Pediatric and Oncologic Dermatology, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Dermatology, The Catholic University of Korea, Seoul, South Korea.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Herranz', 'Affiliation': 'Department of Dermatology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity, and Cardiovascular Disease, The University of Sheffield and Sheffield Teaching Hospitals NIHR Clinical Research Facility, Sheffield, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peris', 'Affiliation': 'Dermatology, Catholic University and Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Steffensen', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bang', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kuznetsova', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Jensen', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Østerdal', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.19574']
837,33000503,"Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial.","BACKGROUND


Tralokinumab is a fully human monoclonal antibody that specifically neutralizes interleukin-13, a key driver of atopic dermatitis (AD).
OBJECTIVES


To evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids (TCS) in patients with moderate-to-severe AD who were candidates for systemic therapy.
METHODS


This was a double-blind, placebo plus TCS controlled phase III trial. Patients were randomized 2 : 1 to subcutaneous tralokinumab 300 mg or placebo every 2 weeks (Q2W) with TCS as needed over 16 weeks. Patients who achieved an Investigator's Global Assessment (IGA) score of 0/1 and/or 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16 with tralokinumab were rerandomized 1 : 1 to tralokinumab Q2W or every 4 weeks (Q4W), with TCS as needed, for another 16 weeks.
RESULTS


At week 16, more patients treated with tralokinumab than with placebo achieved IGA 0/1: 38·9% vs. 26·2% [difference (95% confidence interval): 12·4% (2·9-21·9); P = 0·015] and EASI 75: 56·0% vs. 35·7% [20·2% (9·8-30·6); P < 0·001]. Of the patients who were tralokinumab responders at week 16, 89·6% and 92·5% of those treated with tralokinumab Q2W and 77·6% and 90·8% treated with tralokinumab Q4W maintained an IGA 0/1 and EASI 75 response at week 32, respectively. Among patients who did not achieve IGA 0/1 and EASI 75 with tralokinumab Q2W at 16 weeks, 30·5% and 55·8% achieved these endpoints, respectively, at week 32. The overall incidence of adverse events was similar across treatment groups.
CONCLUSIONS


Tralokinumab 300 mg in combination with TCS as needed was effective and well tolerated in patients with moderate-to-severe AD.",2021,"The overall incidence of adverse events (AEs) was similar across treatment groups.
","['patients with moderate-to-severe AD who were candidates for systemic therapy', ""Patients who achieved an Investigator's Global Assessment (IGA) score of 0/1 and/or 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16 with tralokinumab were rerandomized 1 : 1 to"", 'patients with moderate-to-severe AD', 'moderate-to-severe atopic dermatitis']","['Tralokinumab plus topical corticosteroids', 'tralokinumab Q2W or Q4W, with TCS', 'tralokinumab Q4W', 'subcutaneous tralokinumab 300 mg or placebo', 'TCS', 'Tralokinumab 300\xa0mg in combination with TCS', 'placebo', 'tralokinumab', 'tralokinumab Q2W']","['efficacy and safety', 'effective and well tolerated', 'overall incidence of adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3658667', 'cui_str': 'tralokinumab'}]","[{'cui': 'C3658667', 'cui_str': 'tralokinumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0242387', 'cui_str': 'Treacher Collins syndrome'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.550616,"The overall incidence of adverse events (AEs) was similar across treatment groups.
","[{'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Toth', 'Affiliation': 'XLR8 Medical Research and Probity Medical Research, Windsor, ON, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bieber', 'Affiliation': 'Department of Dermatology and Allergy, University Medical Center, Bonn, Germany.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Alexis', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Elewski', 'Affiliation': 'Department of Dermatology, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Pink', 'Affiliation': ""St John's Institute of Dermatology, Guy's and St Thomas' Hospitals, London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hijnen', 'Affiliation': 'Department of Dermatology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Jensen', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bang', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Olsen', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kurbasic', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Weidinger', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.19573']
838,33012603,Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial.,"Data on influenza vaccine immunogenicity in children are limited from tropical developing countries. We recently reported significant, moderate effectiveness of a trivalent inactivated influenza vaccine (IIV) in a controlled, cluster-randomized trial in children in rural Senegal during 2009, a year of H3N2 vaccine mismatch (NCT00893906). We report immunogenicity of IIV3 and inactivated polio vaccine (IPV) from that trial. We evaluated hemagglutination inhibition (HAI) and polio antibody titers in response to vaccination of three age groups (6 through 35 months, 3 through 5 years, and 6 through 8 years). As all children were IIV naïve, each received two vaccine doses, although titers were assessed after only the first dose for subjects aged 6 through 8 years. Seroconversion rates (4-fold titer rise or increase from <1:10 to ≥1:40) were 74-87% for A/H1N1, 76-87% for A/H3N2, and 54-79% for B/Yamagata. Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata. IIV responses were lowest in the youngest age group, and they were comparable between ages 3 through 5 years after two doses and 6 through 8 years after one dose. We found that baseline seropositivity (HAI titer ≥ 1:10) was an effect modifier of IIV response. Using a seroprotective titer (HAI titer ≥ 1:160) recommended for IIV evaluation in children, we found that among subjects who were seropositive at baseline, 69% achieved seroprotection for both A/H1N1 and A/H3N2, while among those who were seronegative at baseline, seroprotection was achieved in 11% for A/H1N1 and 22% for A/H3N2. The IPV group had high baseline polio antibody seropositivity and appropriate responses to vaccination. Our data emphasize the importance of a two-dose IIV3 series in vaccine naïve children. IIV and IPV vaccines were immunogenic in Senegalese children.",2020,"Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata.","['children are limited from tropical developing countries', 'children in rural Senegal during 2009, a year of H3N2 vaccine mismatch (NCT00893906', 'Senegalese children', 'vaccine naïve children', 'three age groups (6 through 35\xa0months, 3 through 5\xa0years, and 6 through 8\xa0years', 'children in Senegal']","['IIV3 and inactivated polio vaccine (IPV', 'trivalent inactivated influenza vaccine (IIV', 'seasonal inactivated influenza and inactivated polio vaccines']","['Seroprotection rates', 'hemagglutination inhibition (HAI) and polio antibody titers', 'Seroconversion rates', 'IIV responses', 'seroprotection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0337846', 'cui_str': 'Senegalese'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",,0.0885076,"Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata.","[{'ForeName': 'Mbayame', 'Initials': 'M', 'LastName': 'Niang', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Meagan E', 'Initials': 'ME', 'LastName': 'Deming', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA; Institute of Human Virology, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Goudiaby', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Ousmane M', 'Initials': 'OM', 'LastName': 'Diop', 'Affiliation': 'World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ndongo', 'Initials': 'N', 'LastName': 'Dia', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Aldiouma', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Doudou', 'Initials': 'D', 'LastName': 'Diop', 'Affiliation': 'PATH, Dakar, Senegal.'}, {'ForeName': 'Kristen D C', 'Initials': 'KDC', 'LastName': 'Lewis', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, Belgium; Division Global Health Protection, Centers for Disease Control and Prevention, Nairobi, Kenya.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA. Electronic address: kneuzil@som.umaryland.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.09.059']
839,33049392,"As-Needed Versus Regular Use of Fluticasone Furoate Nasal Spray in Patients with Moderate to Severe, Persistent, Perennial Allergic Rhinitis: A Randomized Controlled Trial.","BACKGROUND


Using intranasal corticosteroid (INCS) regularly is recommended for treating perennial allergic rhinitis. However, no studies have evaluated ""as-needed"" use.
OBJECTIVE


To compare the efficacy between as-needed and regular use of INCS in patients with moderate to severe perennial allergic rhinitis.
METHODS


In a 6-week randomized controlled trial, participants were assigned to either fluticasone furoate (FF) nasal spray, (27.5 μg) 2 sprays once daily for 1 week, followed by as-needed use (FF-as-needed) for 5 more weeks or 2 sprays once daily for 6 weeks (FF-regular). The primary outcome was a change in the total nasal symptom score (TNSS). The secondary outcomes were the change in nasal peak inspiratory flow, Rhinoconjunctivitis Quality of Life-36 Questionnaire score, and cumulative FF dose.
RESULTS


In total of 108 patients, 53 and 55 patients were randomized to the FF-as-needed and FF-regular group, respectively. The difference in mean change in TNSS between the 2 groups was not significant at week 6 (1.21 points; 95% CI, -0.08 to 2.49; P = .066). The FF-regular group tended toward a greater improvement in TNSS. The FF-regular group had a higher mean change in nasal peak inspiratory flow than the FF-as-needed group at week 6 (-19.21 L/min; 95% CI, -33.54 to -4.89; P = .009). Both groups had similar improvement in Rhinoconjunctivitis Quality of Life-36 Questionnaire. The mean cumulative FF dose in the FF-as-needed group was 51% that of the FF-regular group.
CONCLUSIONS


Both as-needed and regular use of INCS had similar improvement in TNSS and RCQ-36 score in patients with perennial allergic rhinitis. As-needed use had half of INCS exposure of the regular use.",2021,Both as-needed and regular use of INCS had similar improvement in TNSS and RCQ-36 in PAR patients.,"['Patients With Moderate to Severe, Persistent, Perennial Allergic Rhinitis', 'moderate-to-severe PAR patients', 'perennial allergic rhinitis (PAR', 'One hundred and three patients, 51 in FF-as-needed and 52 in FF-regular, completed the study']","['intranasal corticosteroid (INCS', 'INCS', 'fluticasone furoate (FF) nasal spray', 'Fluticasone Furoate Nasal Spray']","['mean change of NPIF', 'RCQ-36', 'change in nasal peak inspiratory flow (NPIF), Rhinoconjunctivitis Quality of Life-36 Questionnaire Score (RCQ-36), and cumulative FF dose', 'TNSS and RCQ-36', 'mean change of TNSS', 'TNSS', 'mean cumulative FF dose', 'total nasal symptom score (TNSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",103.0,0.192399,Both as-needed and regular use of INCS had similar improvement in TNSS and RCQ-36 in PAR patients.,"[{'ForeName': 'Torpong', 'Initials': 'T', 'LastName': 'Thongngarm', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chamard', 'Initials': 'C', 'LastName': 'Wongsa', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Phichayut', 'Initials': 'P', 'LastName': 'Phinyo', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Musculoskeletal Science and Translational Research (MSTR), Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Paraya', 'Initials': 'P', 'LastName': 'Assanasen', 'Affiliation': 'Division of Rhinology and Allergy, Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pongsakorn', 'Initials': 'P', 'LastName': 'Tantilipikorn', 'Affiliation': 'Division of Rhinology and Allergy, Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Mongkhon', 'Initials': 'M', 'LastName': 'Sompornrattanaphan', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. Electronic address: mongkhon.som@mahidol.ac.th.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.09.057']
840,33050728,Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial.,"Objective:  Several studies have shown that closed-loop automated insulin delivery (the artificial pancreas) improves glucose control compared with sensor-augmented pump therapy. We aimed to confirm these findings using our automated insulin delivery system based on the iPancreas platform.  Research Design and Methods:  We conducted a two-center, randomized crossover trial comparing automated insulin delivery with sensor-augmented pump therapy in 36 adults with type 1 diabetes. Each intervention lasted 12 days in outpatient free-living conditions with no remote monitoring. The automated insulin delivery system used a model predictive control algorithm that was a less aggressive version of our earlier dosing algorithm to emphasize safety. The primary outcome was time in the range 3.9-10.0 mmol/L.  Results:  The automated insulin delivery system was operational 90.2% of the time. Compared with the sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (interquartile range 53-74) to 69% (60-73;  P  = 0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30-49) to 45% (35-51;  P  = 0.011). Automated insulin delivery also reduced time spent below 3.9 and 3.3 mmol/L from 3.5% (0.8-5.4) to 1.6% (1.1-2.7;  P  = 0.0021) and from 0.9% (0.2-2.1) to 0.5% (0.2-1.1;  P  = 0.0122), respectively. Time spent below 2.8 mmol/L was 0.2% (0.0-0.6) with sensor-augmented pump therapy and 0.1% (0.0-0.4;  P  = 0.155) with automated insulin delivery.  Conclusions:  Our study confirms findings that automated insulin delivery improves glucose control compared with sensor-augmented pump therapy. ClinicalTrials.gov no. NCT02846831.",2021,"Compared to sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (IQR 53 to 74) to 69% (60 to 73; p=0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30 to 49) to 45% (35 to 51; p=0.011).",['36 adults with type 1 diabetes'],"['automated insulin delivery with sensor-augmented pump therapy', 'closed-loop insulin delivery system (the artificial pancreas) and sensor-augmented pump therapy']","['automated insulin delivery system', 'time in tight target range', 'time spent', 'Time spent']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}]","[{'cui': 'C0336563', 'cui_str': 'Artificial pancreas'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",36.0,0.0682118,"Compared to sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (IQR 53 to 74) to 69% (60 to 73; p=0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30 to 49) to 45% (35 to 51; p=0.011).","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Legault', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology and Metabolism, McGill University Health Centre, Montréal, Canada.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Raffray', 'Affiliation': 'Metabolic Diseases Research Unit, Institut de recherches cliniques de Montréal, Montréal, Canada.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Gouchie-Provencher', 'Affiliation': 'Centre for Translational Biology, Research Institute of McGill University Health Centre, Montréal, Canada.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Department of Biomedical Engineering, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'El-Fathi', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Messier', 'Affiliation': 'Metabolic Diseases Research Unit, Institut de recherches cliniques de Montréal, Montréal, Canada.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Rabasa-Lhoret', 'Affiliation': 'Metabolic Diseases Research Unit, Institut de recherches cliniques de Montréal, Montréal, Canada.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0365']
841,33053597,Blood Pressure Response to Muscle Metaboreflex Activation is Impaired in Men Living with HIV.,"We investigated the muscle metaboreflex contribution to blood pressure response during dynamic handgrip exercise in men living with HIV (MLHIV) vs. without HIV (Controls). Pressor and heart rate responses were evaluated during metaboreflex activation through post-exercise muscle ischemia (PEMI) method and control exercise session (CER) in 17 MLHIV and 21 Controls. Protocols were performed randomly on the same day, being both sessions composed of 12 min, as follows: a) 3 min at rest, b) 3 min of dynamic handgrip exercise at 30% of maximal voluntary contraction, c) 3 min of recovery post-exercise with vascular occlusion (occlusion only in PEMI), and d) 3 min of recovery post-exercise without vascular occlusion. To assess metaboreflex response, differences between PEMI and CER in recovery post-exercise were calculated for blood pressure and heart rate. Systolic and mean blood pressure (P<0.01) were superior in the last 2 min of recovery with vascular occlusion at PEMI in relation to CER for both groups. No difference was found between groups for blood pressure and heart rate (P>0.05). However, metaboreflex response for systolic blood pressure was lower in MLHIV vs. Controls (4.05±4.63 vs. 7.61±3.99 mmHg; P=0.01). In conclusion, pressor response during metaboreceptor stimulation was attenuated in men living with HIV, which may suggest loss of muscle metaboreflex sensibility.",2021,Systolic and mean blood pressure (P<0.01) were superior in the last 2 min of recovery with vascular occlusion at PEMI in relation to CER for both groups.,"['men living with HIV', '17 MLHIV and 21 Controls', 'men living with HIV (MLHIV) vs. without HIV (Controls', 'Men Living with HIV']","['dynamic handgrip exercise at 30% of maximal voluntary contraction, c) 3\u2009min of recovery post-exercise with vascular occlusion (occlusion only in PEMI), and d) 3\u2009min of recovery post-exercise without vascular occlusion', 'metaboreflex activation through post-exercise muscle ischemia (PEMI) method and control exercise session (CER', 'dynamic handgrip exercise']","['blood pressure and heart rate', 'metaboreflex response', 'pressor response', 'Pressor and heart rate responses', 'metaboreflex response for systolic blood pressure', 'Blood Pressure Response', 'Systolic and mean blood pressure']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237504', 'cui_str': 'CER'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.101859,Systolic and mean blood pressure (P<0.01) were superior in the last 2 min of recovery with vascular occlusion at PEMI in relation to CER for both groups.,"[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gama', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Farinatti', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Crisafulli', 'Affiliation': 'Department of Medical Science and Public Health, University of Cagliari, Italy.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Borges', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}]",International journal of sports medicine,['10.1055/a-1263-1124']
842,33055009,Effects of a health education program to promote healthy lifestyle and glycemic control in patients with type 2 diabetes: A randomized controlled trial.,"BACKGROUND


Type 2 diabetes mellitus (T2DM) is a common chronic disease with an increase in prevalence within developing countries. The aim of this study was to determine the efficacy of a structured educational program for improving lifestyle and health-related measures in Iranians with T2DM.
METHODS


A randomized controlled trial was conducted in 80 participants with T2DM who were randomly assigned to either the intervention or a control group. A demographic questionnaire along with the Health Promoting Lifestyle Profile-II and related laboratory tests were used to assess the efficacy of the program. The intervention consisted of six educational sessions held over 45 days. The control group received routine diabetic care at the clinic. Three months after the intervention, participants completed the measures again. Within-group and between-group comparisons were then made.
RESULTS


All subscales of lifestyle measure improved in the intervention group, whereas only the nutrition domain improved in the control group. After adjusting for baseline differences, physical activity and nutrition domains showed the greatest improvement in the intervention group compared to controls. All clinical measures were also significantly improved within intervention group from baseline to follow-up (p < 0.001), whereas HbA1c, fasting blood glucose, HDL, triglyceride, cholesterol, and weight also changed significantly in the control group. The frequency of HbA1c < 7% was increased from 27.5% at baseline to 37.5% at follow-up (10%) in the intervention group compared to only a 5% increase in the control group.
CONCLUSION


This educational health program significantly improved lifestyle changes and health-related clinical characteristics in persons with T2DM, compared to routine diabetic care in Iran. Further research is needed to better understand the usefulness of such programs in diabetics and other medical conditions among those in different cultural settings.",2021,"All clinical measures were also significantly improved within intervention group from baseline to follow-up (p < 0.001), whereas HbA1c, fasting blood glucose, HDL, triglyceride, cholesterol, and weight also changed significantly in the control group.","['80 participants with T2DM', 'patients with type 2 diabetes', 'persons with T2DM, compared to routine diabetic care in Iran', 'Iranians with T2DM']","['structured educational program', 'routine diabetic care', 'health education program']","['frequency of HbA1c', 'HbA1c, fasting blood glucose, HDL, triglyceride, cholesterol, and weight', 'healthy lifestyle and glycemic control', 'physical activity and nutrition domains', 'nutrition domain']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150544', 'cui_str': 'Diabetic care'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150544', 'cui_str': 'Diabetic care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",80.0,0.048797,"All clinical measures were also significantly improved within intervention group from baseline to follow-up (p < 0.001), whereas HbA1c, fasting blood glucose, HDL, triglyceride, cholesterol, and weight also changed significantly in the control group.","[{'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Sanaeinasab', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran; Health Education Department, Faculty of Health, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: sanaei1343@gmail.com.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Saffari', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran; Health Education Department, Faculty of Health, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: m.saffari@bmsu.ac.ir.'}, {'ForeName': 'Davoud', 'Initials': 'D', 'LastName': 'Yazdanparast', 'Affiliation': 'Health Education Department, Faculty of Health, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: hjch1400@gmail.com.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Karimi Zarchi', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran; Department of Epidemiology and Biostatistics, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: alikarimi_in@yahoo.com.'}, {'ForeName': 'Faten', 'Initials': 'F', 'LastName': 'Al-Zaben', 'Affiliation': 'Division of Psychiatry, Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia. Electronic address: faten_zaben@yahoo.com.'}, {'ForeName': 'Harold G', 'Initials': 'HG', 'LastName': 'Koenig', 'Affiliation': 'Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA; Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia; School of Public Health, Ningxia Medical University, Yinchuan, China. Electronic address: Harold.Koenig@duke.edu.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran; Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden. Electronic address: Pakpour_Amir@yahoo.com.'}]",Primary care diabetes,['10.1016/j.pcd.2020.09.007']
843,33263286,"Movement Matters, and So Does Context: Lessons Learned From Multisite Implementation of the Movement Matters Activity Program for Stroke in the Comprehensive Postacute Stroke Services Study.","The purpose of this Special Communication is to discuss the rationale and design of the Movement Matters Activity Program for Stroke (MMAP) and explore implementation successes and challenges in home health and outpatient therapy practices across the stroke belt state of North Carolina. MMAP is an interventional component of the Comprehensive Postacute Stroke Services Study, a randomized multicenter pragmatic trial of stroke transitional care. MMAP was designed to maximize survivor health, recovery, and functional independence in the community and to promote evidence-based rehabilitative care. MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care. MMAP implementation strategies were aligned with the Expert Recommendations for Implementing Change project, and MMAP site champion and facilitator survey feedback were thematically organized into the Consolidated Framework for Implementation Research domains. MMAP implementation was challenging, required modification and was affected by provider- and system-level factors. Program and study participation were limited and affected by practice priorities, productivity standards, and stroke patient volume. Sites with successful implementation appeared to have empowered MMAP champions in vertically integrated systems that embraced innovation. Findings from this broad evaluation can serve as a road map for the design and implementation of other comprehensive, complex interventions that aim to bridge the currently disconnected realms of acute care, postacute care, and community resources.",2021,"MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care.",['home health and outpatient therapy practices across the stroke belt state of North Carolina'],['MMAP'],[],"[{'cui': 'C1317851', 'cui_str': 'Home health care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",[],,0.0374604,"MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care.","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Pastva', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina. Electronic address: amy.pastva@duke.edu.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Coyle', 'Affiliation': 'University of Pittsburgh School of Health and Rehabilitation Science, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sylvia W', 'Initials': 'SW', 'LastName': 'Coleman', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Meghan D', 'Initials': 'MD', 'LastName': 'Radman', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Taylor', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Jones', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'University of Pittsburgh School of Health and Rehabilitation Science, Pittsburgh, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.09.386']
844,33006602,Sustained-release diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate) for knee osteoarthritis: a randomized phase 2 study.,"OBJECTIVE


To evaluate the efficacy and safety of diclofenac etalhyaluronate (DF-HA) (ONO-5704/SI-613), a novel DF-conjugated hyaluronate, in patients with knee OA in Japan.
METHODS


In this randomized, double-blind, placebo-controlled phase 2 study, patients were randomly assigned (1:1) to receive either 30 mg of DF-HA or placebo intra-articularly at weeks 0, 4 and 8 and were followed up for 24 weeks. The primary outcomes were changes from baseline in the WOMAC pain subscores, 50-foot walk test pain score and daily pain score. The secondary outcomes were the WOMAC physical function subscores, patient global assessment, responder rate and safety outcome.
RESULTS


Overall, 176 patients received the investigational drugs (87 received DF-HA and 89 received placebo). The mean changes in the WOMAC pain subscores and daily pain score from baseline over 12 weeks after the first injection were significantly higher in the DF-HA than placebo group; the mean difference was -7.0 mm [95% CI, -12.7, -1.2; P =0.018] and -0.61 (95% CI, -1.06, -0.16; P =0.008), respectively. The difference in the 50-foot walk test pain score was -5.0 mm (95% CI, -10.3, 0.3; P =0.065). Improvement of pain by DF-HA was observed at week 1 and maintained from week 12 to week 24. Significantly greater improvements in the secondary outcomes were also observed with DF-HA than with placebo. No clinically significant adverse events occurred.
CONCLUSION


DF-HA reduced pain in patients with knee OA without major safety concerns.
TRIAL REGISTRATION


UMIN Clinical Trials Registry, https://www.umin.ac.jp/ctr/index.htm, UMIN000015858.",2021,The mean changes in the WOMAC pain subscores and daily pain score from baseline over 12 weeks after the first injection were significantly higher in the DF-HA than placebo group; the mean difference was -7.0 ,"['patients with knee OA in Japan', 'patients with knee OA without major safety concerns', '176 patients received the investigational drugs (87 received DF-HA and 89 received', 'knee osteoarthritis']","['placebo', 'diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate', 'diclofenac etalhyaluronate (DF-HA) (ONO-5704/SI-613', '30\u2009mg of DF-HA or placebo']","['WOMAC pain subscores, 50-foot walk test pain score and daily pain score', 'WOMAC pain subscores and daily pain score', 'efficacy and safety', 'WOMAC physical function subscores, patient global assessment, responder rate and safety outcome', '50-foot walk test pain score', 'pain by DF-HA', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0178695', 'cui_str': 'hyaluronate'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]",,0.676109,The mean changes in the WOMAC pain subscores and daily pain score from baseline over 12 weeks after the first injection were significantly higher in the DF-HA than placebo group; the mean difference was -7.0 ,"[{'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nishida', 'Affiliation': 'Department of Rehabilitation, Orthopaedic Surgery, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kano', 'Affiliation': 'Research & Development Division, Clinical Development Department, Seikagaku Corporation, Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Nobuoka', 'Affiliation': 'Research & Development Division, Clinical Development Department, Seikagaku Corporation, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Seo', 'Affiliation': 'Research & Development Division, Clinical Development Department, Seikagaku Corporation, Tokyo, Japan.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa605']
845,33024237,The effect of aldosterone and aldosterone blockade on the progression of chronic kidney disease: a randomized placebo-controlled clinical trial.,"The progression of chronic kidney disease (CKD) cannot be completely inhibited. We first explored factors contributing to CKD progression in patients with CKD in a prospective observational study. In the next phase, we focused on the effects of aldosterone, conducting a single-blinded placebo-controlled study using the selective mineralocorticoid receptor antagonist (MRA), eplerenone (25 mg/day). We recruited patients with CKD stage 2 and 3 whose plasma aldosterone concentration was above 15 ng/dL based on the prior data of a prospective observational study. In the CKD cohort study (n = 141), baseline plasma aldosterone concentration was identified as an independent contributory factor for the future rate of change in estimated glomerular filtration rate (eGFR). When the cut-off value for aldosterone was set at 14.5 ng/dL, the decline rate was significantly higher in patients with higher plasma aldosterone concentration (- 1.22 ± 0.39 ml/min/1.73 m 2 /year vs. 0.39 ± 0.40 ml/min/1.73 m 2 /year, p = 0.0047). In the final intervention study, in the eplerenone group, eGFR dropped at 6 months after the initiation of the study, and thereafter eGFR was maintained until the end of the study. At 24 months and 36 months, eGFR was significantly higher in the eplerenone group than in the placebo group. In conclusion, MRA can be an effective strategy in preventing CKD progression, especially in patients with high plasma aldosterone.",2020,"At 24 months and 36 months, eGFR was significantly higher in the eplerenone group than in the placebo group.","['patients with CKD', 'patients with CKD stage 2 and 3 whose plasma aldosterone concentration was above 15\xa0ng/dL based on the prior data of a prospective observational study', 'patients with high plasma aldosterone', 'chronic kidney disease']","['aldosterone', 'MRA', 'eplerenone', 'placebo', 'aldosterone and aldosterone blockade', 'selective mineralocorticoid receptor antagonist (MRA), eplerenone']","['progression of chronic kidney disease (CKD', 'baseline plasma aldosterone concentration', 'eGFR', 'decline rate', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2316786', 'cui_str': 'Chronic kidney disease stage 2'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",,0.0289782,"At 24 months and 36 months, eGFR was significantly higher in the eplerenone group than in the placebo group.","[{'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Minakuchi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wakino', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. shuwakino@z8.keio.jp.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Urai', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Kurokochi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hirobumi', 'Initials': 'H', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}]",Scientific reports,['10.1038/s41598-020-73638-4']
846,33037261,Altered metabolomic profiling of overweight and obese adolescents after combined training is associated with reduced insulin resistance.,"Exercise training and a healthy diet are the main non-pharmacological strategies for treating chronic conditions, such as obesity and insulin resistance (IR), in adolescents. However, the isolated metabolic changes caused by exercise training without dietary intervention have not yet been established. We investigated how combined training (CT) without dietary intervention altered the concentrations of serum metabolites, biochemical, anthropometric and functional parameters in overweight and obese adolescents. Thirty-seven adolescents (14.6 ± 1.05 years), of both sexes, were randomly assigned to the control group (CG, n = 19) or the training group (TG, n = 18). The CT was composed by resistance training and aerobic training performed in the same session (~ 60 min), three times a week, for 12 weeks. All assessments were performed pre and post-intervention. Metabolomics analyses were conducted using nuclear magnetic resonance spectroscopy ( 1 H NMR) in a 600 MHz spectrometer. There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG. An increase in fat-free mass (FFM) was also observed in the CG. The metabolic changes were given mainly by changes in the levels of metabolites 2-oxoisocaproate (↓TG), 3-hydroxyisobutyrate (↑CG and ↓TG), glucose (↓TG), glutamine (↓CG and ↑TG) and pyruvate (↓TG). These findings demonstrate the positive effects of CT program without dietary intervention on metabolomic profile, body composition, biochemical markers, and glucose metabolism in overweight and obese adolescents.",2020,"There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG.","['Thirty-seven adolescents (14.6\u2009±\u20091.05\xa0years), of both sexes', 'overweight and obese adolescents']","['CT program without dietary intervention', 'Exercise training and a healthy diet', 'exercise training without dietary intervention', 'combined training (CT) without dietary intervention']","['levels of metabolites 2-oxoisocaproate (↓TG), 3-hydroxyisobutyrate (↑CG and ↓TG), glucose (↓TG), glutamine (↓CG and ↑TG) and pyruvate (↓TG', 'concentrations of serum metabolites, biochemical, anthropometric and functional parameters', 'fat-free mass (FFM', 'body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG', 'metabolomic profile, body composition, biochemical markers, and glucose metabolism']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4068754', 'cui_str': '1.05'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0368576', 'cui_str': '2-oxoisocaproate'}, {'cui': 'C0945804', 'cui_str': '3-hydroxyisobutyrate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0139828,"There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG.","[{'ForeName': 'Renata G', 'Initials': 'RG', 'LastName': 'Duft', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil. renataduft@gmail.com.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Ivan L P', 'Initials': 'ILP', 'LastName': 'Bonfante', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Wendell A', 'Initials': 'WA', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Larissa R', 'Initials': 'LR', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Education, University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Mara P T', 'Initials': 'MPT', 'LastName': 'Chacon-Mikahil', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Neiva', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Department of Physical Education, University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Cláudia R', 'Initials': 'CR', 'LastName': 'Cavaglieri', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil. cavaglieri@fef.unicamp.br.'}]",Scientific reports,['10.1038/s41598-020-73943-y']
847,33039647,Treatable Traits That Predict Health Status and Treatment Response in Airway Disease.,"BACKGROUND


A strategy based on the assessment and management of treatable traits (TTs) has been proposed as a new paradigm in airway disease. There is a potentially long list of TTs with likely different clinical impact.
OBJECTIVE


To identify TTs most strongly associated with poorer health-related quality of life (HRQOL) and treatments that most substantially improved HRQOL.
METHODS


We pooled data from 2 parallel-group clinical trials of multidimensional assessment and individualized management targeted to TTs versus usual care in patients with chronic obstructive pulmonary disease or severe asthma (intervention N = 45; control N = 46). Following multidimensional assessment, 22 TTs were identified and the intervention group received treatments tailored to their identified TT. We used Bayesian Model Averaging to examine associations between TTs and HRQOL (St George's Respiratory Questionnaire) at baseline, as well as between each TT treatment and the observed change in HRQOL postintervention.
RESULTS


TTs most substantially associated with poorer baseline HRQOL were frequent chest infections, breathing pattern disorder, inadequate inhaler technique, systemic inflammation (C-reactive protein >3 mg/L), and depression. In both trials, TT treatment led to a large, significant improvement in HRQOL compared with usual care (Cohen's d = 1.19; P < .001). Receiving a statin for systemic inflammation and oral corticosteroid for eosinophilic airway inflammation was associated with the largest HRQOL improvements. Treatments for exercise intolerance, anxiety, and obesity were associated with smaller improvements in HRQOL.
CONCLUSIONS


This study contributes to identifying clinically impactful TTs by showing that TTs across pulmonary, extrapulmonary, and behavioral domains were associated with HRQOL impairment and treatment response.",2021,"In both trials, TT treatment led to a large, significant improvement in HRQoL compared with usual care (Cohen's d=1.19, p<0.001).",['patients with COPD or severe asthma (intervention N=45; control N=46'],['multidimensional assessment and individualised management targeted to TT versus usual care'],"['poorer health-related quality of life (HRQoL', 'chest infections, breathing pattern disorder, inadequate inhaler technique, systemic inflammation (C-reactive protein>3mg/L) and depression', 'HRQoL', ""TT and HRQoL (St George's Respiratory Questionnaire"", 'exercise intolerance, anxiety, and obesity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.164122,"In both trials, TT treatment led to a large, significant improvement in HRQoL compared with usual care (Cohen's d=1.19, p<0.001).","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Hiles', 'Affiliation': 'Centre of Research Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'Centre of Research Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, NSW, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Alvar', 'Initials': 'A', 'LastName': 'Agusti', 'Affiliation': 'Respiratory Institute, Hospital Clinic, Universitat de Barcelona, IDIBAPS, CIBERES, Barcelona, Spain.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'McDonald', 'Affiliation': 'Centre of Research Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, NSW, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, New Lambton Heights, NSW, Australia. Electronic address: vanessa.mcdonald@newcastle.edu.au.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.09.046']
848,33039650,"Derepression of glomerular filtration, renal blood flow and antioxidant defence in patients with type 2 diabetes at high-risk of cardiorenal disease.","BACKGROUND


The role of antioxidant status on microvascular blood flow and glomerular filtration (eGFR) in patients with type 2 diabetes and hypertension whose risk of progressive renal disease varies by ethnicity is unknown.
METHODS


Adult, non-Caucasian (n = 101) and Caucasian (n = 69) patients with type 2 diabetes, hypertension and/or microalbuminuria and an eGFR > 45 mL/min/1.73 m 2  were randomised to receive 400 IU vitamin E and/or 20 μg selenium daily or matching placebo. eGFR (CKD-EPI) was measured at baseline, 3,6 and 12 months and renal blood flow by contrast-enhanced ultrasonography in a sub-group (n = 9) at baseline and 3 months by assessing the area under the time intensity curve (TIC). Circulating glutathione peroxidase 3 (GPx-3) activity was measured as a biomarker of oxidative defence status.
RESULTS


The time to change in eGFR was shortest with combined vitamin E and selenium than usual care (5.6 [4.0-7.0] vs 8.9 [6.8-10.9 months]; p = 0.006). Area under the TIC was reduced compared to baseline (38.52 [22.41-90.49] vs 123 [86.98-367.03]dB.s; P ≤ 0.05 and 347 [175.88-654.92] vs 928.03 [448.45-1683]dB.s; P ≤ 0.05, respectively] at 3 months suggesting an increase in rate of perfusion. The proportional change in eGFR at 12 months was greater in the group whose GPx-3 activity was above, compared with those below the cohort median (360 U/L) in the non-Caucasian and the Caucasian groups (19.1(12.5-25.7] % vs 6.5[-3.5 to 16.5] % and 12.8 [0.7 to 24] % vs 0.2 [-6.1 to 6.5] %).
CONCLUSION


In these patients with type 2 diabetes and early CKD, antioxidant treatment derepresses renal blood flow and a rise in eGFR correlated directly with GPx-3 activity.
SIGNIFICANCE


Diabetes mellitus is the world's leading cause of end-stage renal disease which has a predilection for black and minor ethnic groups compared with Caucasians. The differences in risk despite the benefits of conventional care may be related to oxidative stress. We found that glomerular filtration and renal blood flow is suppressed when renal function is preserved in high-risk patients with type 2 diabetes. Conventional care supplemented with selenium - the co-factor for glutathione peroxidase-3 (GPx-3) - improves renal perfusion and increase glomerular filtration according to host antioxidant defence determined by GPx-3 activity. Circulating GPx-3 activity warrants further investigation as a novel biomarker of reversible haemodynamic changes in early diabetic kidney disease to better enable targeting of renoprotective strategies.",2020,"Area under the TIC was reduced compared to baseline (38.52 [22.41- 90.49] vs 123 [86.98- 367.03]dB.s; P≤0.05 and 347 [175.88- 654.92] vs 928.03 [448.45-1683]dB.s; P≤0.05, respectively] at 3 months suggesting an increase in rate of perfusion.","['patients with type 2 diabetes at high-risk of cardiorenal disease', 'patients with type 2 diabetes and hypertension whose risk of progressive renal disease varies by ethnicity', 'high-risk patients with type 2 diabetes', 'Adult, non-Caucasian (n=101) and Caucasian (n=69) patients with type 2 diabetes, hypertension and/or microalbuminuria and an eGFR > 45 mL/min/1.73m 2', 'Diabetes mellitus']","['selenium daily or matching placebo', 'combined vitamin E and selenium', 'Conventional care supplemented with selenium - the co-factor for glutathione peroxidase-3 (GPx-3) ', '400 IU vitamin E']","['glomerular filtration and renal blood flow', 'renal blood flow and glomerular filtration', 'microvascular blood flow and glomerular filtration (eGFR', 'eGFR (CKD-EPI', 'rate of perfusion', 'Circulating glutathione peroxidase 3 (GPx-3) activity', 'renal blood flow', 'GPx-3 activity', 'proportional change in eGFR', 'time to change in eGFR', 'Derepression of glomerular filtration, renal blood flow and antioxidant defence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0155601', 'cui_str': 'Hypertensive heart AND renal disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1436542', 'cui_str': 'GPX3 protein, human'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1436542', 'cui_str': 'GPX3 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",,0.0397352,"Area under the TIC was reduced compared to baseline (38.52 [22.41- 90.49] vs 123 [86.98- 367.03]dB.s; P≤0.05 and 347 [175.88- 654.92] vs 928.03 [448.45-1683]dB.s; P≤0.05, respectively] at 3 months suggesting an increase in rate of perfusion.","[{'ForeName': 'Karima', 'Initials': 'K', 'LastName': 'Zitouni', 'Affiliation': 'St Georges University of London, Institute of Infection and Immunity, London, UK.'}, {'ForeName': 'M R C P', 'Initials': 'MRCP', 'LastName': 'Steyn', 'Affiliation': 'St Georges University Hospitals NHS Foundation Trust, Thomas Addison Unit, London, UK.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Lyka', 'Affiliation': 'St Georges University of London, Institute of Biomedical & Medical Education, London, UK.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Kelly', 'Affiliation': 'Kings College London, Analytical, Environmental and Forensic Sciences Department, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cook', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Trace Element Unit, Southampton, UK.'}, {'ForeName': 'Irina Chis', 'Initials': 'IC', 'LastName': 'Ster', 'Affiliation': 'St Georges University of London, Institute of Infection and Immunity, London, UK.'}, {'ForeName': 'Kenneth Anthony', 'Initials': 'KA', 'LastName': 'Earle', 'Affiliation': 'St Georges University Hospitals NHS Foundation Trust, Thomas Addison Unit, London, UK; St Georges University of London, Institute of Biomedical & Medical Education, London, UK. Electronic address: kearle@sgul.ac.uk.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.10.005']
849,33049054,Midostaurin in patients with acute myeloid leukemia and FLT3-TKD mutations: a subanalysis from the RATIFY trial.,"The results from the RATIFY trial (ClinicalTrials.gov: NCT00651261; CALGB 10603) showed that midostaurin combined with standard chemotherapy significantly improved outcomes in patients with FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML), compared with placebo. In this post hoc subgroup analysis from the trial, we evaluated the impact of midostaurin in 163 patients with FLT3-tyrosine kinase domain (TKD) mutations. At a median follow-up of 60.7 months (95% CI, 55.0-70.8), the 5-year event-free survival (EFS) rate was significantly higher in patients treated with midostaurin than in those treated with placebo (45.2% vs 30.1%; P = .044). A trend toward improved disease-free survival was also observed with midostaurin (67.3% vs 53.4%; P = .089), whereas overall survival (OS) was similar in the 2 groups. Patients with AML and NPM1mut/FLT3-TKDmut or core binding factor (CBF)-rearranged/FLT3-TKDmut genotypes had significantly prolonged OS with or without censoring at hematopoietic cell transplantation (HCT), compared with NPM1WT/CBF-negative AMLs. The multivariable model for OS and EFS adjusted for allogeneic HCT in first complete remission as a time-dependent covariable, revealed NPM1 mutations and CBF rearrangements as significant favorable factors. These data show that NPM1 mutations or CBF rearrangements identify favorable prognostic groups in patients with FLT3-TKD AMLs, independent of other factors, also in the context of midostaurin treatment.",2020,"A trend toward improved disease-free survival was also observed with midostaurin (67.3% vs 53.4%; P = .089), whereas overall survival (OS) was similar in the 2 groups.","['163 patients with FLT3-tyrosine kinase domain (TKD) mutations', 'patients with acute myeloid leukemia and FLT3-TKD mutations', 'patients with FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML']","['placebo', 'midostaurin combined with standard chemotherapy', 'Midostaurin', 'midostaurin']","['5-year event-free survival (EFS) rate', 'disease-free survival', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0287186', 'cui_str': 'Fetal Liver Kinase-2'}, {'cui': 'C0033681', 'cui_str': 'Protein-tyrosine kinase'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0526371', 'cui_str': 'midostaurin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",163.0,0.0988437,"A trend toward improved disease-free survival was also observed with midostaurin (67.3% vs 53.4%; P = .089), whereas overall survival (OS) was similar in the 2 groups.","[{'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Marcucci', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Prior', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Medical School, Hannover, Germany.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Lavorgna', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Nomdedeu', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu I Sant Pau and José Carreras Leukemia Research Institute, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Geyer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, NY.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'Department of Clinical Hematology, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sierra', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu I Sant Pau and José Carreras Leukemia Research Institute, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': 'Department of Hematology, Hospital Universitari i Politecnic La Fe, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brandwein', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Theo M', 'Initials': 'TM', 'LastName': 'de Witte', 'Affiliation': 'Department of Tumor Immunology, Nijmegen Centre of Life Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Joop H', 'Initials': 'JH', 'LastName': 'Jansen', 'Affiliation': 'Department of Tumor Immunology, Nijmegen Centre of Life Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Department of Hematology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Bruno C', 'Initials': 'BC', 'LastName': 'Medeiros', 'Affiliation': 'Division of Hematology, Stanford Comprehensive Cancer Center, Stanford University, Stanford, CA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Division of Hematologic Malignancies, Leukemia Service, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Medical School, Hannover, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'YinMiao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Pallaud', 'Affiliation': 'Novaremed AG, Basel, Switzerland.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Novartis Pharmaceuticals Corporation, Cambridge, MA.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Piciocchi', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany; and.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Byrd', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany; and.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Clara D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lo-Coco', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}]",Blood advances,['10.1182/bloodadvances.2020002904']
850,33052754,Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer.,"PURPOSE


Sentinel node (SN) biopsy is accurate in operable oral and oropharyngeal cT1-T2N0 cancer (OC), but, to our knowledge, the oncologic equivalence of SN biopsy and neck lymph node dissection (ND; standard treatment) has never been evaluated.
METHODS


In this phase III multicenter trial, 307 patients with OC were randomly assigned to (1) the ND arm or (2) the SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery). The primary outcome was neck node recurrence-free survival (RFS) at 2 years. Secondary outcomes were 5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS). Other outcomes were hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions during the 2 years after surgery.
RESULTS


Data on 279 patients (139 ND and 140 SN) could be analyzed. Neck node RFS was 89.6% (95% CI, 0.83% to 0.94%) at 2 years in the ND arm and 90.7% (95% CI, 0.84% to 0.95%) in the SN arm, confirming the equivalence with  P  < .01. The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms. The median hospital stay length was 8 days in the ND arm and 7 days in the SN arm ( P  < .01). The functional outcomes were significantly worse in the ND arm until 6 months after surgery.
CONCLUSION


This study demonstrated the oncologic equivalence of the SN and ND approaches, with lower morbidity in the SN arm during the first 6 months after surgery, thus establishing SN as the standard of care in OC.",2020,The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms.,"['Operable T1-T2N0 Oral and Oropharyngeal Cancer', '307 patients with OC', '279 patients (139 ND and 140 SN']","['SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery', 'Sentinel node (SN) biopsy', 'Sentinel Node Biopsy Versus Neck Node Dissection']","['hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions', '5-year RFS and the 2- and 5-year DSS and OS', 'Neck node RFS', 'median hospital stay length', 'neck node recurrence-free survival (RFS', '5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS']","[{'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}]","[{'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0011195', 'cui_str': 'Déjérine-Sottas disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",307.0,0.134481,The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms.,"[{'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Garrel', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Poissonnet', 'Affiliation': 'Head Neck Surgery Department, Antoine Lacassagne Center, Nice, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Moyà Plana', 'Affiliation': 'Head Neck Surgery Department, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Fakhry', 'Affiliation': 'Head Neck Surgery Department, Marseille University Hospital Center, Marseille, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dolivet', 'Affiliation': 'Head Neck Surgery Department, Alexis Vautrin Center, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lallemant', 'Affiliation': 'Head Neck Surgery Department, Nîmes University Hospital Center, Nîmes, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Sarini', 'Affiliation': 'Head Neck Surgery Department, Toulouse Oncopole, Toulouse, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Vergez', 'Affiliation': 'Head Neck Surgery Department, Toulouse Oncopole, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guelfucci', 'Affiliation': 'Head Neck Surgery Department, Toulon Hospital Center, Toulon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Choussy', 'Affiliation': 'Head Neck Surgery Department, Curie Institute, Paris, France.'}, {'ForeName': 'Vianney', 'Initials': 'V', 'LastName': 'Bastit', 'Affiliation': 'Head Neck Surgery Department, François Baclesse Center, Caen, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Richard', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Costes', 'Affiliation': 'Pathology Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Landais', 'Affiliation': 'Clinical Research University Institute, UPRES EA 2415, Montpellier, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Perriard', 'Affiliation': 'Clinical Research University Institute, UPRES EA 2415, Montpellier, France.'}, {'ForeName': 'Jean Pierre', 'Initials': 'JP', 'LastName': 'Daures', 'Affiliation': 'Clinical Research University Institute, UPRES EA 2415, Montpellier, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'de Verbizier', 'Affiliation': 'Nuclear Medicine Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Favier', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Boutray', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01661']
851,33052759,Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial.,"PURPOSE


SORCE is an international, randomized, double-blind, three-arm trial of sorafenib after surgical excision of primary renal cell carcinoma (RCC) found to be at intermediate or high risk of recurrence.
PATIENTS AND METHODS


We randomly assigned participants (2:3:3) to 3 years of placebo (arm A), 1 year of sorafenib followed by 2 years of placebo (arm B), or 3 years of sorafenib (arm C). The initial sorafenib dose was 400 mg twice per day orally, amended to 400 mg daily. The primary outcome analysis, which was revised as a result of external results, was investigator-reported disease-free survival (DFS) comparing 3 years of sorafenib versus placebo.
RESULTS


Between July 2007 and April 2013, we randomly assigned 1,711 participants (430, 642, and 639 participants in arms A, B, and C, respectively). Median age was 58 years, 71% of patients were men, 84% had clear cell histology, 53% were at intermediate risk of recurrence, and 47% were at high risk of recurrence. We observed no differences in DFS or overall survival in all randomly assigned patients, patients with high risk of recurrence, or patients with clear cell RCC only. Median DFS was not reached for 3 years of sorafenib or for placebo (hazard ratio, 1.01; 95% CI, 0.83 to 1.23;  P  = .95). We observed nonproportional hazards; the restricted mean survival time (RMST) was 6.81 years for 3 years of sorafenib and 6.82 years for placebo (RMST difference, 0.01 year; 95% CI, -0.49 to 0.48 year;  P  = .99). Despite offering treatment adaptations, more than half of participants stopped treatment by 12 months. Grade 3 hand-foot skin reaction was reported in 24% of participants on sorafenib.
CONCLUSION


Sorafenib should not be used as adjuvant therapy for RCC. Active surveillance remains the standard of care for patients at intermediate or high risk of recurrence after nephrectomy and is the appropriate control of our current international adjuvant RCC trial, RAMPART.",2020,"Median DFS was not reached for 3 years of sorafenib or for placebo (hazard ratio, 1.01; 95% CI, 0.83 to 1.23;  P  = .95).","['We randomly assigned participants (2:3:3) to 3 years of', 'Between July 2007 and April 2013, we randomly assigned 1,711 participants (430, 642, and 639 participants in arms A, B, and C, respectively', 'Renal Cell Carcinoma at Intermediate or High Risk of Relapse', 'primary renal cell carcinoma (RCC']","['sorafenib followed by 2 years of placebo', 'Adjuvant Sorafenib', 'Sorafenib', 'placebo', 'sorafenib']","['DFS or overall survival', 'disease-free survival (DFS', 'Median DFS', 'Grade 3 hand-foot skin reaction', 'mean survival time (RMST']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}]",1711.0,0.624039,"Median DFS was not reached for 3 years of sorafenib or for placebo (hazard ratio, 1.01; 95% CI, 0.83 to 1.23;  P  = .95).","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Eisen', 'Affiliation': 'Department of Oncology, Cambridge University Hospitals National Health Service (NHS) Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangou', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Bhavna', 'Initials': 'B', 'LastName': 'Oza', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Alastair W S', 'Initials': 'AWS', 'LastName': 'Ritchie', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Monash University and Eastern Health, Box Hill, Victoria, Australia.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Central Clinical School, Department of Medicine, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bex', 'Affiliation': 'Royal Free London NHS Foundation Trust UCL, Division of Surgery and Interventional Science, London, United Kingdom.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'Department of Development and Regeneration, Urogenital, Abdominal, and Plastic Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hancock', 'Affiliation': 'University of Sheffield, Academic Unit of Clinical Oncology, Weston Park Cancer Centre, Sheffield, United Kingdom.'}, {'ForeName': 'Gregers G', 'Initials': 'GG', 'LastName': 'Hermann', 'Affiliation': 'Urology Research Unit, Department of Urology, Herlev/Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Beth Israel Deaconess Medical Center-IMIM Research Lab, Boston, MA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hodgkinson', 'Affiliation': 'Pharmacy Department, Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Stewart', 'Affiliation': ""Department of Surgery, University of Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Barber', 'Affiliation': 'Velindre Cancer Centre, Cardiff, United Kingdom.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Academic Unit of Clinical Oncology, Weston Park Hospital, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Rhona', 'Initials': 'R', 'LastName': 'McMenemin', 'Affiliation': 'Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, United Kingdom.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pickering', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Meade', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01800']
852,33065218,The occlusal wear of ceramic fixed dental prostheses: 3-Year results in a randomized controlled clinical trial with split-mouth design.,"OBJECTIVES


This study's hypothesis was to evaluate differences of the occlusal wear rate for monolithically fabricated lithium disilicate and hand-veneered zirconia crowns in-vivo. Furthermore, a comparison of the materials' clinical performance according to CDA criteria was investigated.
METHODS


A total number of 15 patients in the need of full-coverage ceramic fixed dental prosthesis on molars were treated with two crowns each (n = 30), randomly assigned on the contralateral sides made of monolithic IPS e.max CAD (n = 15) and IPS e.max Ceram hand-veneered zirconia (n = 15). Clinical examination was conducted, silicone impressions were taken and plaster models fabricated at the day of crown insertion (baseline) and after 1, 2 and 3 years. The abrasion rate was digitally investigated: after model digitization with the industrial scanner Atos II, each follow-up model was superimposed with the baseline model. The wear was evaluated as the difference between two scans in terms of maximum vertical loss [mm], average decrease [mm] and volume loss [mm³]. For statistical analysis, the Mann-Whitney U test was performed and significance was set to less than 0.05.
RESULTS


IPS e.max CAD crowns showed a volume loss of -0.68 mm³ after three years, while IPS e.max Ceram hand-veneered zirconia crowns showed a volumetric wear of -0.75 mm³ at the same point of time. However, no significant differences were found between both materials regarding the 3 evaluated wear parameters. The survival rate for both materials was 100 % and the clinical performance outcome was good to excellent.
CONCLUSION


The two investigated materials for ceramic fixed dental prostheses showed similar wear rates and clinical performance over an in-vivo use of 3 years.
CLINICAL SIGNIFICANCE


Ceramic restorations are subject to occlusal wear over time due to the natural masticatory process. Both monolithic lithium disilicate and glass-ceramic veneered zirconia copings showed clinically satisfactory results over 3 years in-situ. In terms of abrasion, they are equally well suited for clinical use.",2020,"The two investigated materials for ceramic fixed dental prostheses showed similar wear rates and clinical performance over an in-vivo use of 3 years.
",['15 patients in the need of full-coverage ceramic fixed dental prosthesis on molars were treated with two crowns each (n\u2009=\u200930'],"['monolithic lithium disilicate and glass-ceramic veneered zirconia copings', 'monolithic IPS e.max CAD (n\u2009=\u200915) and IPS e.max Ceram hand-veneered zirconia']","['wear rates and clinical performance', 'volume loss', 'survival rate', 'abrasion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C4508100', 'cui_str': 'IPS e.max Ceram'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}]",,0.0308029,"The two investigated materials for ceramic fixed dental prostheses showed similar wear rates and clinical performance over an in-vivo use of 3 years.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Seidel', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany. Electronic address: anna.seidel@uk-erlangen.de.'}, {'ForeName': 'Renan', 'Initials': 'R', 'LastName': 'Belli', 'Affiliation': 'Laboratory of Dental Biomaterials, Department of Restorative Dentistry, University Hospital Erlangen of Friedrich-Alexander University Erlangen Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Breidebach', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wichmann', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Ragai Edward', 'Initials': 'RE', 'LastName': 'Matta', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103500']
853,33262048,Comparison of total hip arthroplasty with minimally invasive SuperPath approach vs. conventional posterolateral approach in elderly patients: A one-year follow-up randomized controlled research.,"OBJECTIVE


To compare difference between SuperPath approach and conventional posterolateral approach in total hip arthroplasty (THA) in elderly patients.
METHODS


The present prospective randomized controlled single blinded study enrolled a total of 96 elderly patients who received THA in our hospital during April 2015 to December 2018. All patients were randomly divided into the SuperPath group and the conventional group. General demographic characteristics and intraoperative data, as well as hospitalization time were recorded. Harris scores were used for measurement of hip function and visual analogue scale (VAS) was used for pain measurement. Serum levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and creatine phosphokinase (CK) were measured before and 24 h after surgery. Gait analysis was conducted by the method of footprints.
RESULTS


The mean surgical time was remarkably longer, the mean blood loss and incision length were significantly lower and the hospitalization time was also shorter in the SuperPath group compared with the conventional group. Both levels of CRP and CK were remarkably lower in the SuperPath group. At time points of 7 d and 1 mon after surgery, the VAS scores were significantly lower, and at 7 d, 1 mon and 3 mon the Harris scores were markedly higher in the SuperPath group compared with the conventional group. The step length and stride speed were significantly larger in the SuperPath group at 7 d and 1 mon after surgery than the conventional group. Joint dislocation was found in 2 cases of patients in the conventional group and no dislocation case was found in the SuperPath group. The angles of anteversion showed no significant difference, while the angles of abduction were significantly lower in the SuperPath group.
CONCLUSION


Patients with SuperPath approach had lower levels of CRP, ESR and CK, better hip function and less pain, as well as better gait condition than patients with conventional posterolateral approach in elderly patients.",2021,The step length and stride speed were significantly larger in the SuperPath group at 7 d and 1 mon after surgery than the conventional group.,"['96 elderly patients who received THA in our hospital during April 2015 to December 2018', 'elderly patients', 'total hip arthroplasty (THA) in elderly patients']","['total hip arthroplasty with minimally invasive SuperPath approach vs. conventional posterolateral approach', 'SuperPath approach and conventional posterolateral approach']","['Joint dislocation', 'lower levels of CRP, ESR and CK, better hip function and less pain', 'hospitalization time', 'hip function and visual analogue scale (VAS', 'mean blood loss and incision length', 'CRP and CK', 'step length and stride speed', 'VAS scores', 'angles of abduction', 'Serum levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and creatine phosphokinase (CK', 'mean surgical time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}]","[{'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",96.0,0.0270692,The step length and stride speed were significantly larger in the SuperPath group at 7 d and 1 mon after surgery than the conventional group.,"[{'ForeName': 'Xiaoliu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Minhang Hospital Affiliated to Fudan University, Shanghai, 201199, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiovascular Medicine, Tianyou Hospital, Wuhan University of Science and Technology, Wuhan, 430064, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiothoracic Surgery, Zhoupu Hospital Affiliated to Shanghai Medical College of Health, Shanghai, 201318, China. Electronic address: q_wang@21cn.com.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Rong', 'Affiliation': 'Department of Orthopedics, Minhang Hospital Affiliated to Fudan University, Shanghai, 201199, China. Electronic address: nhfip6@163.com.'}]",Asian journal of surgery,['10.1016/j.asjsur.2020.11.014']
854,33064669,Pre-operative tranexemic acid vs. etamsylate in reducing blood loss during elective cesarean section: randomized controlled trial.,"OBJECTIVES


To investigate whether etamsylate may be an alternative to tranexamic acid in reduction of blood loss during elective cesarean section.
METHODS


Prospective double-blinded multi-center randomized controlled trial involving 180 qualified women equally divided into three groups each containing 60 women received either tranexamic acid, etamsylate or placebo 20 min before elective cesarean section and blood loss was estimated.
RESULTS


Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo.
CONCLUSIONS


Etamsylate is an effective second-line therapy (after tranexamic acid) in reducing blood loss during elective cesarean section with low risk of side effects, therefore, it can be an effective alternative to tranexamic acid in cases with contraindications or anticipated to be at high-risk of developing side effects from tranexamic acid.",2021,"Results Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo.","['180 qualified women equally divided into three groups each containing 60 women received either', 'elective cesarean section']","['Pre-operative tranexemic acid vs. etamsylate', 'placebo', 'tranexamic acid', 'tranexamic acid, etamsylate or placebo']","['Mean blood loss, cases needing blood transfusion and cases needing further interventions', 'blood loss', 'mean postoperative hemoglobin and hematocrite']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0014968', 'cui_str': 'Ethamsylate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",180.0,0.260152,"Results Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo.","[{'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Torky', 'Affiliation': 'Department of Obstetrics and Gynecology, October 6th University, Giza, Egypt.'}, {'ForeName': 'El-Sayed', 'Initials': 'ES', 'LastName': 'El-Desouky', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abo-Elmagd', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Attia', 'Initials': 'A', 'LastName': 'Mohamed', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Abdalhamid', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Assuit, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'El-Shahat', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Sileem', 'Initials': 'S', 'LastName': 'Ahmed Sileem', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Assuit, Egypt.'}, {'ForeName': 'Mahmoud M', 'Initials': 'MM', 'LastName': 'Tawfick', 'Affiliation': 'Department of Microbiology, Faculty of Pharmacy Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Abo-Louz', 'Affiliation': 'Department of Obstetrics and Gynecology, October 6th University, Giza, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hussein', 'Affiliation': 'Department of Obstetrics and Gynecology, October 6th University, Giza, Egypt.'}]",Journal of perinatal medicine,['10.1515/jpm-2020-0271']
855,33273292,The Cost of Implementing and Sustaining the COMprehensive Post-Acute Stroke Services Model.,"BACKGROUND


The COMprehensive Post-Acute Stroke Services (COMPASS) model, a transitional care intervention for stroke patients discharged home, was tested against status quo postacute stroke care in a cluster-randomized trial in 40 hospitals in North Carolina. This study examined the hospital-level costs associated with implementing and sustaining COMPASS.
METHODS


Using an activity-based costing survey, we estimated hospital-level resource costs spent on COMPASS-related activities during approximately 1 year. We identified hospitals that were actively engaged in COMPASS during the year before the survey and collected resource cost estimates from 22 hospitals. We used median wage data from the Bureau of Labor Statistics and COMPASS enrollment data to estimate the hospital-level costs per COMPASS enrollee.
RESULTS


Between November 2017 and March 2019, 1582 patients received the COMPASS intervention across the 22 hospitals included in this analysis. Average annual hospital-level COMPASS costs were $2861 per patient (25th percentile: $735; 75th percentile: $3,475). Having 10% higher stroke patient volume was associated with 5.1% lower COMPASS costs per patient (P=0.016). About half (N=10) of hospitals reported postacute clinic visits as their highest-cost activity, while a third (N=7) reported case ascertainment (ie, identifying eligible patients) as their highest-cost activity.
CONCLUSIONS


We found that the costs of implementing COMPASS varied across hospitals. On average, hospitals with higher stroke volume and higher enrollment reported lower costs per patient. Based on average costs of COMPASS and readmissions for stroke patients, COMPASS could lower net costs if the model is able to prevent about 6 readmissions per year.",2021,Having 10% higher stroke patient volume was associated with 5.1% lower COMPASS costs per patient (P=0.016).,"['Between November 2017 and March 2019', 'stroke patients discharged home, was tested against status quo postacute stroke care in a cluster-randomized trial in 40 hospitals in North Carolina', '1582 patients received the', 'hospitals that were actively engaged in COMPASS during the year before the survey and collected resource cost estimates from 22 hospitals']",['COMPASS intervention'],"['stroke patient volume', 'Average annual hospital-level COMPASS costs', 'postacute clinic visits']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",,0.129731,Having 10% higher stroke patient volume was associated with 5.1% lower COMPASS costs per patient (P=0.016).,"[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Bayliss', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston Salem.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Halladay', 'Affiliation': 'Department of Family Medicine, UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Department of Family Medicine, UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, Pittsburgh, PA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kucharska-Newton', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Justin G', 'Initials': 'JG', 'LastName': 'Trogdon', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.'}]",Medical care,['10.1097/MLR.0000000000001462']
856,33273290,Evaluation of an Osteoporosis Outreach Program for Men With a Fragility Fracture and Their Physicians.,"BACKGROUND


Many health plans have outreach programs aimed at appropriately screening, evaluating, and treating women experiencing fragility fractures; however, few programs exist for men.
OBJECTIVE


The objective of this study was to develop, implement, and evaluate an osteoporosis outreach program for men with a recent fragility fracture and their physicians.
RESEARCH DESIGN AND SUBJECTS


A total of 10,934 male patients enrolled in a Medicare Advantage with Prescription Drug Plan with a recent fragility fracture were randomized to a program or control group. Patients and their physicians received letters followed by phone calls on osteoporosis and the importance of screening and treatment. The evaluation compared bone mineral density (BMD) test utilization and osteoporosis medication treatment (OPT) among patients who received the outreach versus no outreach at 12 months. The effect of the program was estimated through univariate and multivariable logistic regressions.
RESULTS


The program had a significant impact on BMD evaluation and OPT initiation. At 12 months, 10.7% of participants and 4.9% of nonparticipants received a BMD evaluation. The odds ratio (OR) (95% confidence interval) was 2.31 (1.94, 2.76), and the number needed to outreach to receive a BMD test was 18. OPT was initiated in 4.0% of participants and 2.5% of nonparticipants. The OR (95% confidence interval) of receiving OPT was 1.60 (1.24, 2.07), and the number needed to outreach was 69. Adjusted ORs were similar in magnitude and significance.
CONCLUSION


The program was highly effective by more than doubling the rate of BMD evaluation; however, more intensive interventions may yield an even higher screening rate.",2021,"The OR (95% confidence interval) of receiving OPT was 1.60 (1.24, 2.07), and the number needed to outreach was 69.","['patients who received the outreach versus no outreach at 12 months', 'women experiencing fragility fractures', 'Men With a Fragility Fracture and Their Physicians', 'men with a recent fragility fracture and their physicians', '10,934 male patients enrolled in a Medicare Advantage with Prescription Drug Plan with a recent fragility fracture']","['Osteoporosis Outreach Program', 'osteoporosis outreach program']","['odds ratio (OR', 'bone mineral density (BMD) test utilization and osteoporosis medication treatment (OPT', 'BMD evaluation and OPT initiation', 'OPT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2713369', 'cui_str': 'Medicare advantage coverage'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",10934.0,0.0454504,"The OR (95% confidence interval) of receiving OPT was 1.60 (1.24, 2.07), and the number needed to outreach was 69.","[{'ForeName': 'Margaret K', 'Initials': 'MK', 'LastName': 'Pasquale', 'Affiliation': 'Humana Healthcare Research Inc., Louisville, KY.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Sheer', 'Affiliation': 'Humana Healthcare Research Inc., Louisville, KY.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Yehoshua', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'McFadden', 'Affiliation': 'Humana Inc., Louisville, KY.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Caloyeras', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA.'}]",Medical care,['10.1097/MLR.0000000000001459']
857,33276294,Effect of non-sedation on physical function in survivors of critical illness - A substudy of the NONSEDA randomized trial.,"PURPOSE


Critical illness impairs physical function. The NONSEDA trial was a multicenter randomized trial, assessing non-sedation versus sedation during mechanical ventilation. The aim of this sub-study was to assess the effect of non-sedation on physical function.
METHODS


All patients from one NONSEDA trial site were included. At ICU discharge and three months thereafter, survivors were assessed for physical function.
RESULTS


205 patients were included, 118 survived to follow-up, 116 participated (98%).
PRIMARY OUTCOME


Three months after ICU-discharge, health-related quality of life (SF-36, physical component score) was similar (non-sedated 38.3 vs sedated 36.6, mean difference 1.7, 95% CI -1.7 to 5.1), as was function in activities of daily living (Barthel Index, non-sedated 19.5 vs sedated 18, median difference 1.5, 95% CI -0.2 to 3.2).
SECONDARY OUTCOMES


Non-sedated patients had a better Barthel Index at ICU-discharge (median 9 vs 4, median difference 5, 95% CI 2.5 to 7.5). At three months post-ICU discharge, the two groups did not differ regarding handgrip strength, walking distance, muscle size or biomechanical data.
CONCLUSION


Non-sedation did not lead to improved quality of life regarding physical function or better function in activities of everyday living. Non-sedated patients had a better physical recovery at ICU discharge.
TRIAL REGISTRATION


Clinicaltrials.govNCT02034942, registered January 14., 2014.",2021,"CONCLUSION


Non-sedation did not lead to improved quality of life regarding physical function or better function in activities of everyday living.","['survivors of critical illness', 'All patients from one NONSEDA trial site were included', '205 patients were included, 118 survived to follow-up, 116 participated (98']",['non-sedation'],"['handgrip strength, walking distance, muscle size or biomechanical data', 'health-related quality of life (SF-36, physical component score', 'physical function', 'function in activities of daily living (Barthel Index', 'better Barthel Index at ICU-discharge']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",205.0,0.307946,"CONCLUSION


Non-sedation did not lead to improved quality of life regarding physical function or better function in activities of everyday living.","[{'ForeName': 'Helene K', 'Initials': 'HK', 'LastName': 'Nedergaard', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Sygehusvej 24, 6000 Kolding, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløwsvej 19, 5000 Odense, Denmark. Electronic address: helene.korvenius.nedergaard@rsyd.dk.'}, {'ForeName': 'Hanne Irene', 'Initials': 'HI', 'LastName': 'Jensen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Sygehusvej 24, 6000 Kolding, Denmark; Department of Regional Health Research, University of Southern Denmark, J.B. Winsløwsvej 19, 5000 Odense, Denmark.'}, {'ForeName': 'Hanne Tanghus', 'Initials': 'HT', 'LastName': 'Olsen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, J.B. Winsløwsvej 19, 5000 Odense, Denmark; Department of Anesthesiology and Intensive Care, Odense University Hospital, Svendborg, Baagoees alle 15, 5700 Svendborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, J. B. Winsloevsvej 4, 5000 Odense, Denmark.'}, {'ForeName': 'Jørgen T', 'Initials': 'JT', 'LastName': 'Lauridsen', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sjøgaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, J. B. Winsloevsvej 4, 5000 Odense, Denmark.'}]",Journal of critical care,['10.1016/j.jcrc.2020.11.017']
858,33051743,"ASO Author Reflections: A Novel Technique for Single Layer Pancreatojejunostomy is not Inferior to Modified Blumgart Anastomosis in Robotic Pancreatoduodenectomy-Results of a Randomized, Controlled Trial.",,2021,,['ASO Author Reflections'],[],[],"[{'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}, {'cui': 'C3812881', 'cui_str': 'Author'}]",[],[],,0.0959316,,"[{'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China. Liurong301@126.com.""}]",Annals of surgical oncology,['10.1245/s10434-020-09237-4']
859,22717993,Cardiac examination and the effect of dual-processing instruction in a cardiopulmonary simulator.,"Use of dual-processing has been widely touted as a strategy to reduce diagnostic error in clinical medicine. However, this strategy has not been tested among medical trainees with complex diagnostic problems. We sought to determine whether dual-processing instruction could reduce diagnostic error across a spectrum of experience with trainees undertaking cardiac physical exam. Three experiments were conducted using a similar design to teach cardiac physical exam using a cardiopulmonary simulator. One experiment was conducted in each of three groups: experienced, intermediate and novice trainees. In all three experiments, participants were randomized to receive undirected or dual-processing verbal instruction during teaching, practice and testing phases. When tested, dual-processing instruction did not change the probability assigned to the correct diagnosis in any of the three experiments. Among intermediates, there was an apparent interaction between the diagnosis tested and the effect of dual-processing instruction. Among relative novices, dual processing instruction may have dampened the harmful effect of a bias away from the correct diagnosis. Further work is needed to define the role of dual-processing instruction to reduce cognitive error. This study suggests that it cannot be blindly applied to complex diagnostic problems such as cardiac physical exam.",2013,"When tested, dual-processing instruction did not change the probability assigned to the correct diagnosis in any of the three experiments.",['medical trainees with complex diagnostic problems'],"['undirected or dual-processing verbal instruction', 'dual-processing instruction']",[],"[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]",[],3.0,0.0283622,"When tested, dual-processing instruction did not change the probability assigned to the correct diagnosis in any of the three experiments.","[{'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Sibbald', 'Affiliation': 'Dr. Ho Ping Kong Center for Excellence in Education and Practice, University Health Network-Western Division, 399 Bathurst Street, 8 East 427B, Toronto, ON M5T 2S8, Canada. mattsibbald@gmail.com'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKinney', 'Affiliation': ''}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Cavalcanti', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'Parvathy', 'Initials': 'P', 'LastName': 'Nair', 'Affiliation': ''}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Eva', 'Affiliation': ''}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Hatala', 'Affiliation': ''}]",Advances in health sciences education : theory and practice,['10.1007/s10459-012-9388-6']
860,33260212,Impact of digitally acquired peer diagnostic input on diagnostic confidence in outpatient cases: A pragmatic randomized trial.,"OBJECTIVE


The study sought to evaluate if peer input on outpatient cases impacted diagnostic confidence.
MATERIALS AND METHODS


This randomized trial of a peer input intervention occurred among 28 clinicians with case-level randomization. Encounters with diagnostic uncertainty were entered onto a digital platform to collect input from ≥5 clinicians. The primary outcome was diagnostic confidence. We used mixed-effects logistic regression analyses to assess for intervention impact on diagnostic confidence.
RESULTS


Among the 509 cases (255 control; 254 intervention), the intervention did not impact confidence (odds ratio [OR], 1.46; 95% confidence interval [CI], 0.999-2.12), but after adjusting for clinician and case traits, the intervention was associated with higher confidence (OR, 1.53; 95% CI, 1.01-2.32). The intervention impact was greater in cases with high uncertainty (OR, 3.23; 95% CI, 1.09- 9.52).
CONCLUSIONS


Peer input increased diagnostic confidence primarily in high-uncertainty cases, consistent with findings that clinicians desire input primarily in cases with continued uncertainty.",2021,"The intervention impact was greater in cases with high uncertainty (OR, 3.23; 95% CI, 1.09- 9.52).
","['Encounters with diagnostic uncertainty', '28 clinicians with case-level randomization', 'outpatient cases']","['digitally acquired peer diagnostic input', 'peer input intervention']",['diagnostic confidence'],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.13942,"The intervention impact was greater in cases with high uncertainty (OR, 3.23; 95% CI, 1.09- 9.52).
","[{'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Khoong', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Valy', 'Initials': 'V', 'LastName': 'Fontil', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Rivadeneira', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Mekhala', 'Initials': 'M', 'LastName': 'Hoskote', 'Affiliation': 'Berkeley School of Public Health and UCSF School of Medicine, University of California, Berkeley-University of California, San Francisco Joint Medical Program, Berkeley, California, USA.'}, {'ForeName': 'Shantanu', 'Initials': 'S', 'LastName': 'Nundy', 'Affiliation': 'Milken Institute School of Public Health, Department of Health Policy and Management, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Lyles', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocaa278']
861,33277168,Lanolin and prenatal health education for prevention of nipple pain and trauma: Randomized clinical trial.,"OBJECTIVE


To investigate the effect of lanolin on nipple pain and trauma in breastfeeding after application of a health education.
METHOD


Randomized controlled clinical trial, with two arms, open, with 66 participants during prenatal care in the primary health care network in Goiania - Goias, Brazil. Participants were randomized (1:1) using computer generated numbers in both experimental group (EG) and control group (CG). The EG received lanolin and health education on breastfeeding at two different times with clinical demonstration using cloth didactic breast and illustrative album as the intervention, while the CG received standard health education. Health education was carried out by the same researchers in both groups. Measurement of pain, nipple trauma, and breastfeeding technique occurred on postpartum day eight. The analysis included descriptive statistics and inferential analysis by means chi-square or Fisher test, and Student's t-test, significance level set at 0.05.
RESULTS


A majority of the participants experienced no nipple trauma (59.1%) in both groups, and 60.6% of women experienced pain. In both groups, women showed favorable breastfeeding behaviors, except in the condition of the breasts. There were no significant differences between groups in pain prevention (p=0.61), nipple lesions (p=0.21), and breastfeeding technique (p>0.05).
CONCLUSION


It is not clear whether the intervention, lanolin combined with health education, has a positive effect on the prevention of nipple pain and trauma. Further research is needed to elucidate this question. Registration number: RBR-7tvhq8. Registry website: http://www.ensaiosclinicos.gov.br/.",2021,"There were no significant differences between groups in pain prevention (p=0.61), nipple lesions (p=0.21), and breastfeeding technique (p>0.05).
","['66 participants during prenatal care in the primary health care network in Goiania - Goias, Brazil']","['Lanolin and prenatal health education', 'computer generated numbers in both experimental group (EG) and control group (CG', 'lanolin']","['nipple trauma', 'pain prevention', 'favorable breastfeeding behaviors', 'Measurement of pain, nipple trauma, and breastfeeding technique', 'nipple lesions', 'pain']","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0023024', 'cui_str': 'Lanolin'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1319304', 'cui_str': 'Breastfeeding performance'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.075813,"There were no significant differences between groups in pain prevention (p=0.61), nipple lesions (p=0.21), and breastfeeding technique (p>0.05).
","[{'ForeName': 'Flávia Silva', 'Initials': 'FS', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Nursing, Federal University of Goias, Goiania, Goias, Brasil.'}, {'ForeName': 'Flaviana', 'Initials': 'F', 'LastName': 'Vieira', 'Affiliation': 'Faculty of Nursing, Federal University of Goias, Goiania, Goias, Brasil. Electronic address: flavianavieira@ufg.br.'}, {'ForeName': 'Janaína Valadares', 'Initials': 'JV', 'LastName': 'Guimarães', 'Affiliation': 'Faculty of Nursing, Federal University of Goias, Goiania, Goias, Brasil.'}, {'ForeName': ""Natalia Del'Angelo"", 'Initials': 'ND', 'LastName': 'Aredes', 'Affiliation': 'Faculty of Nursing, Federal University of Goias, Goiania, Goias, Brasil.'}, {'ForeName': 'Suzanne Hetzel', 'Initials': 'SH', 'LastName': 'Campbell', 'Affiliation': 'School of Nursing, University of British Columbia, Vancouver Campus, Canadá.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.10.030']
862,33259910,"The effect of Kneipp treatment hydrotherapy on secretory IgA in young children: A controlled, non-randomized clinical pilot study.","OBJECTIVES


This pilot study analyses the effect and feasibility of hydrotherapeutic Kneipp arm affusions on secretory immunoglobulin A (sIgA) and classic cold symptoms in children 3-6 years of age.
STUDY DESIGN


A controlled, non-randomized, clinical pilot study was undertaken.
INTERVENTION


This descriptive hydrotherapeutic intervention treated children aged 3-6 with Kneipp arm affusions over four weeks. The control group received no intervention. At baseline and after the intervention, secretory IgA was measured, cold symptoms were assessed by means of the Common Cold Questionnaire (CCQ), and a semi-structured follow-up qualitative interview of the parents in the intervention group was conducted on acceptance and susceptibility to infection of the respiratory tract.
RESULTS


Fifteen participants were included in the intervention group and 15 were in the control group. The Kneipp arm affusions intervention was conducted at home and well-accepted by the children. No differences developed between the groups regarding sIgA. Comparing the symptoms by means of CCQ did not show symptoms of respiratory tract infections. In the intervention group, rhinitis occurred less frequently (26.7 % vs. 66.7 %, p = 0.057). In the qualitative analysis, 9/13 parents described an improvement in susceptibility to infections of the respiratory tract.
CONCLUSION


Due to the pilot character of this study, home hydrotherapy (Kneipp arm affusions) in healthy children is feasible but did not influence sIgA levels. The influence on infections of the respiratory tract after the intervention phase should be interpreted carefully. In qualitative interviews, parents described less susceptibility to infections of the respiratory tract by their children.",2020,"In the intervention group, rhinitis occurred less frequently (26.7% vs. 66.7%, p = 0.057).","['children 3-6 years of age', 'healthy children', 'Fifteen participants were included in the intervention group and 15 were in the control group', 'young children', 'treated children aged 3-6 with Kneipp arm affusions over four weeks']","['Kneipp treatment hydrotherapy', 'hydrotherapeutic intervention', 'no intervention', 'hydrotherapeutic Kneipp']","['secretory immunoglobulin A (sIgA) and classic cold symptoms', 'susceptibility to infections of the respiratory tract', 'rhinitis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0863093', 'cui_str': 'Cold symptoms'}, {'cui': 'C0521978', 'cui_str': 'Susceptibility to infections'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}]",15.0,0.0432896,"In the intervention group, rhinitis occurred less frequently (26.7% vs. 66.7%, p = 0.057).","[{'ForeName': 'Klaudia', 'Initials': 'K', 'LastName': 'Schulte', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Blakeslee', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Stritter', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Eidenschink', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Gündling', 'Affiliation': 'Dean of Studies Naturopathy and Complementary Medicine, Carl Remigius Medical School, Idstein, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baumann', 'Affiliation': 'Chair of Medical Theory, Integrative and Anthroposophic Medicine, Faculty of Health, Witten/Herdecke University, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany; University of São Paulo, Faculty of Medicine, Department of Pediatrics São Paulo, Estado de Sao Paulo, Brazil.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102637']
863,33060632,Identifying a nasal gene expression signature associated with hyperinflation and treatment response in severe COPD.,"Hyperinflation contributes to dyspnea intensity in COPD. Little is known about the molecular mechanisms underlying hyperinflation and how inhaled corticosteroids (ICS) affect this important aspect of COPD pathophysiology. To investigate the effect of ICS/long-acting β 2 -agonist (LABA) treatment on both lung function measures of hyperinflation, and the nasal epithelial gene-expression profile in severe COPD. 117 patients were screened and 60 COPD patients entered a 1-month run-in period on low-dose ICS/LABA budesonide/formoterol (BUD/F) 200/6 one inhalation b.i.d. Patients were then randomly assigned to 3-month treatment with either a high dose BDP/F 100/6 two inhalations b.i.d. (n = 31) or BUD/F 200/6 two inhalations b.i.d. (n = 29). Lung function measurements and nasal epithelial gene-expression were assessed before and after 3-month treatment and validated in independent datasets. After 3-month ICS/LABA treatment, residual volume (RV)/total lung capacity (TLC)% predicted was reduced compared to baseline (p < 0.05). We identified a nasal gene-expression signature at screening that associated with higher RV/TLC% predicted values. This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients. Finally, this signature was increased in COPD patients compared to controls in nasal, bronchial and small airways brushings. Short-term ICS/LABA treatment improves RV/TLC% predicted in severe COPD. Furthermore, it decreases the expression of genes involved in the signal transduction by the p53 class mediator, which is a replicable COPD gene expression signature in the upper and lower airways.Trial registration: ClinicalTrials.gov registration number NCT01351792 (registration date May 11, 2011), ClinicalTrials.gov registration number NCT00848406 (registration date February 20, 2009), ClinicalTrials.gov registration number NCT00158847 (registration date September 12, 2005).",2020,"This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients.","['117 patients were screened and 60 COPD patients entered a 1-month run-in period on low-dose ICS', 'severe COPD']","['LABA budesonide/formoterol (BUD/F', 'LABA', 'ICS/long-acting β 2 -agonist (LABA']","['Lung function measurements and nasal epithelial gene-expression', 'p53 mediated apoptosis', 'residual volume (RV)/total lung capacity (TLC)% predicted', 'RV/TLC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0086571', 'cui_str': 'Lung Capacities'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}]",117.0,0.157791,"This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients.","[{'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Imkamp', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. k.imkamp@umcg.nl.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'van der Wiel', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Ilse M', 'Initials': 'IM', 'LastName': 'Boudewijn', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Gerard H', 'Initials': 'GH', 'LastName': 'Koppelman', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Corry-Anke', 'Initials': 'CA', 'LastName': 'Brandsma', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Timens', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Vroegop', 'Affiliation': 'Department of Pulmonary Diseases, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henk R', 'Initials': 'HR', 'LastName': 'Pasma', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Wim G', 'Initials': 'WG', 'LastName': 'Boersma', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Alkmaar, Alkmaar, The Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wielders', 'Affiliation': 'Department of Pulmonary Diseases, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van den Elshout', 'Affiliation': 'Department of Pulmonary Diseases, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mansour', 'Affiliation': 'Department of Pulmonary Diseases, Orbis Concern, Sittard, The Netherlands.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Steiling', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Avrum', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Lenburg', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Heijink', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dirkje S', 'Initials': 'DS', 'LastName': 'Postma', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Berge', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-72551-0']
864,33064852,A comparative study between preoperative rectal misoprostol and intraoperative intrauterine administration in the reduction of blood loss during and after cesarean delivery: A randomized controlled trial.,"OBJECTIVE


To compare the efficacy and safety of rectal misoprostol with intrauterine misoprostol in the reduction of blood loss during and after cesarean delivery.
METHODS


Ninety-eight pregnant women, all candidates for elective cesarean delivery, were equally randomized into two groups: the rectal group (received preoperative misoprostol rectally) and the intrauterine group (received intrauterine misoprostol after the delivery of the placenta). The primary outcome was the estimated blood loss (EBL) during cesarean delivery. Secondary outcomes included the occurrence of excessive blood loss (>1000 mL) within the first 24 hours postoperatively and the occurrence of any maternal or fetal side effects.
RESULTS


There were no statistically significant differences between the two groups regarding either the EBL (693.12 ± 139.09 vs 692.39 ± 132.83; P=0.979) or the occurrence of postpartum hemorrhage (>1000 mL) (6.1% vs 4.1%; P=0.99. Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group.
CONCLUSION


Insertion of intrauterine misoprostol is as effective as rectal insertion in reducing blood loss during and after cesarean delivery; however, it has a safer neonatal outcome and is more convenient when administered during cesarean delivery. ClinicalTrials.gov: NCT03723031.",2021,"Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group.
","['Ninety-eight pregnant women, all candidates for elective cesarean delivery', 'during and after cesarean delivery']","['preoperative rectal misoprostol and intraoperative intrauterine administration', 'rectal group (received preoperative misoprostol rectally', 'intrauterine misoprostol', 'intrauterine group (received intrauterine misoprostol', 'rectal misoprostol with intrauterine misoprostol']","['EBL', 'Apgar scores', 'blood loss', 'occurrence of postpartum hemorrhage', 'efficacy and safety', 'occurrence of excessive blood loss', 'occurrence of any maternal or fetal side effects', 'estimated blood loss (EBL']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",98.0,0.177543,"Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group.
","[{'ForeName': 'Moutaz M', 'Initials': 'MM', 'LastName': 'El-Sherbini', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Maged', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omneya M', 'Initials': 'OM', 'LastName': 'Helal', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mirna O', 'Initials': 'MO', 'LastName': 'Awad', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'El-Attar', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Jehan A', 'Initials': 'JA', 'LastName': 'Sadek', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'ElKomy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mariam A', 'Initials': 'MA', 'LastName': 'Dawoud', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13426']
865,33275819,Rapid eye movement sleep behavior disorder: A proof-of-concept neuroprotection study for prodromal synucleinopathies.,"BACKGROUND AND PURPOSE


To explore the feasibility of a neuroprotection trial in prodromal synucleinopathy, using idiopathic rapid eye movement sleep behavior disorder (iRBD) as the target population and  123  I-FP-CIT-SPECT as a biomarker of disease progression.
METHODS


Consecutive iRBD patients were randomly assigned to a treatment arm receiving selegiline and symptomatic rapid eye movement sleep behavior disorder treatment, or to a control arm receiving symptomatic treatment only. Selegiline was chosen because of a demonstrated neuroprotection effect in animal models. Patients underwent  123  I-FP-CIT-SPECT at baseline and after 30 months on average. The clinical outcome was the emergence of parkinsonism and/or dementia. A repeated-measures general linear model (GLM) was applied using group (control and treatment) as ""between"" factor, and both time (baseline and follow-up) and regions ( 123  I-FP-CIT-SPECT putamen and caudate uptake) as the ""within"" factors, adjusting for age.
RESULTS


Thirty iRBD patients completed the study (68.2 ± 6.9 years; 29 males; 21% dropout rate), 13 in the treatment arm, and 17 in the control arm. At follow-up (29.8 ± 9.0 months), three patients in the control arm developed dementia and one parkinsonism, whereas two patients in the treatment arm developed parkinsonism. Both putamen and caudate uptake decreased over time in the control arm. In the treatment arm, only the putamen uptake decreased over time, whereas caudate uptake remained stable. GLM analysis demonstrated an effect of treatment on the  123  I-FP-CIT-SPECT uptake change, with a significant interaction between the effect of group, time, and regions (p = 0.004).
CONCLUSIONS


A 30-months neuroprotection study for prodromal synucleinopathy is feasible, using iRBD as the target population and  123  I-FP-CIT-SPECT as a biomarker of disease progression.",2021,Both putamen and caudate uptake decreased over time in the control arm.,"['Consecutive iRBD patients', 'Thirty iRBD patients completed the study (68.2±6.9 years; 29 males; 21% drop-out rate), 13 in the treatment arm and 17 in the control arm']","['REMeDio', 'selegiline and symptomatic RBD treatment, or to a control arm, receiving symptomatic treatment only']","['dementia and one parkinsonism', 'emergence of parkinsonism and/or dementia']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036579', 'cui_str': 'Selegiline'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}]",123.0,0.025836,Both putamen and caudate uptake decreased over time in the control arm.,"[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Arnaldi', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Famà', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Girtler', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Brugnolo', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pardini', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Mattioli', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Meli', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Massa', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Orso', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'Department of Health Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Maria Isabella', 'Initials': 'MI', 'LastName': 'Donegani', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bauckneht', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Morbelli', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Nobili', 'Affiliation': 'Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.'}]",European journal of neurology,['10.1111/ene.14664']
866,33279459,Partial and Total Sleep Deprivation Interferes With Neural Correlates of Consolidation of Fear Extinction Memory.,"BACKGROUND


We assessed the impact of total and partial sleep loss on neural correlates of fear conditioning, extinction learning, and extinction recall in healthy young adults.
METHODS


Participants (56.3% female, age 24.8 ± 3.4 years) were randomized to a night of normal sleep (NS) (n = 48), sleep restriction (SR) (n = 53), or sleep deprivation (SD) (n = 53). All completed fear conditioning and extinction learning phases the following morning. Extinction recall was tested in the evening of the same day. Task-based contrasts were modeled at the beginning of, at the end of, and across the fear conditioning and extinction learning phases, and at the beginning of extinction recall. These contrasts were compared among the 3 groups by means of analysis of variance. Nonparametric permutation corrected analyses using a cluster-determining threshold of p < .005 and a familywise error of p < .05.
RESULTS


At the end of fear conditioning, NS activated medial prefrontal regions, SR activated motor areas, and participants in the SD group showed no significant activations. Across extinction learning, only NS activated both salience (fear) and extinction (regulatory) areas. For extinction recall, SD activated similar regions as NS across extinction learning, while SR activated salience and motor areas. During early fear conditioning, compared with NS, SD activated more medial prefrontal and SR activated more salience network areas. For extinction recall, NS activated more prefrontal areas and SD activated more of both salience- and extinction-related areas than SR.
CONCLUSIONS


Relative to NS, SR may enhance fear-related and diminish extinction-related activity, whereas SD may delay engagement of extinction learning. Findings may have clinical implications for populations and occupations in which sleep loss is common.",2021,"For extinction recall, NS activated more prefrontal areas and SD activated more of both salience- and extinction-related areas than SR.
","['healthy young adults', 'Participants (56.3% female, age 24.8 ± 3.4 years']","['sleep restriction (SR) (n\xa0= 53), or sleep deprivation (SD', 'night of normal sleep (NS']","['NS activated both salience (fear) and extinction (regulatory) areas', 'Partial and Total Sleep Deprivation Interferes With Neural Correlates of Consolidation of Fear Extinction Memory', 'Extinction recall']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",,0.0282372,"For extinction recall, NS activated more prefrontal areas and SD activated more of both salience- and extinction-related areas than SR.
","[{'ForeName': 'Jeehye', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Charlestown, Massachusetts; Department of Psychological and Brain Sciences, University of Massachusetts, Amherst, Massachusetts.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Pace-Schott', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Charlestown, Massachusetts; Department of Psychiatry, Harvard Medical School, Charlestown, Massachusetts; Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, Massachusetts. Electronic address: epace-schott@mgh.harvard.edu.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Department of Psychiatry, New York University Grossman School of Medicine, New York, New York; Nathan Kline Institute for Psychiatric Research, Rockland, New York.'}, {'ForeName': 'Huijin', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Biomedical Research Institute, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2020.09.013']
867,33279531,The effect of structured diabetes self-management education on type 2 diabetes patients attending a Primary Health Center in Kuwait.,"AIM


To evaluate the impact of diabetes self-management education (DSME) on diabetes control measured by glycated hemoglobin (HbA1c) in nationals and expatriates with type 2 diabetes mellitus (T2DM) in Kuwait.
METHOD


A total of 291 patients with T2DM (intervention = 150, control = 141) were assessed in a single-center, controlled study to compare the impact of DSME sessions on HbA1c levels as a measure of metabolic control of diabetes mellitus. Measurements of HbA1c were taken at baseline, 6-months, and 12-months. Multiple explorative association tests and regression models were constructed to examine the intervention effects.
RESULTS


Patients that received DSME sessions demonstrated better diabetes control with an average reduction of 1.3% (14 mmol/mol) HbA1c over 12-months compared to an average HbA1c increase of 1.1% (12 mmol/mol) in the control group (p < 0.001). Using pairwise comparisons, young, male, and expatriate patients and patients with HbA1c above 7% demonstrated the highest improvements in HbA1c with DSME sessions. In multivariate regressions, DSME intervention was associated with a 1.7% (18 mmol/mol) HbA1c reduction indicating better control of diabetes (p < 0.001).
CONCLUSION


DSME sessions were associated with better glycemic control in patients with T2DM over 12 months. This study establishes the effectiveness of DSME sessions for both Kuwaiti nationals and expatriates, which represent a significant portion of the population in Kuwait and the Arabian Gulf region. The favorable impact of DSME suggests a promising cost-effective approach to reduce the risk of complication associationed with diabetes suitable for the unique demographic characteristics in the region.",2021,"HbA1c reduction indicating better control of diabetes (p<0.001).
","['type 2 diabetes patients attending a Primary Health Center in Kuwait', '291 patients with T2DM (intervention= 150, control=141', 'patients with type 2 diabetes mellitus (T2DM) in Kuwaiti nationals and the expatriate population']","['diabetes self-management education (DSME', 'structured diabetes self-management education', 'DSME sessions', 'DSME']","['metabolic control of diabetes mellitus', 'glycemic control', 'glycated hemoglobin (HbA1c', 'diabetes control']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",291.0,0.0243273,"HbA1c reduction indicating better control of diabetes (p<0.001).
","[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alibrahim', 'Affiliation': 'Industrial & Management Systems Engineering Department, College of Engineering & Petroleum, Kuwait University, Kuwait.'}, {'ForeName': 'Dalal', 'Initials': 'D', 'LastName': 'AlRamadhan', 'Affiliation': 'Industrial & Management Systems Engineering Department, College of Engineering & Petroleum, Kuwait University, Kuwait.'}, {'ForeName': 'Susmy', 'Initials': 'S', 'LastName': 'Johny', 'Affiliation': 'Medical Research Department, Abdullah Al-Abdulhadi Primary Health Center (Al-Yarmouk), Capital Governorate, Ministry of Health, Kuwait.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Alhashemi', 'Affiliation': 'Medical Research Department, Abdullah Al-Abdulhadi Primary Health Center (Al-Yarmouk), Capital Governorate, Ministry of Health, Kuwait.'}, {'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Alduwaisan', 'Affiliation': 'Medical Research Department, Abdullah Al-Abdulhadi Primary Health Center (Al-Yarmouk), Capital Governorate, Ministry of Health, Kuwait.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Al-Hilal', 'Affiliation': 'Medical Research Department, Abdullah Al-Abdulhadi Primary Health Center (Al-Yarmouk), Capital Governorate, Ministry of Health, Kuwait. Electronic address: maryam.alhilal@gmail.com.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108567']
868,33289598,Selecting Children with Vesicoureteral Reflux Who are Most Likely to Benefit from Antibiotic Prophylaxis: Application of Machine Learning to RIVUR.,"PURPOSE


Continuous antibiotic prophylaxis reduces the risk of recurrent urinary tract infection by 50% in children with vesicoureteral reflux. However, there may be subgroups in whom continuous antibiotic prophylaxis could be used more selectively. We sought to develop a machine learning model to identify such subgroups.
MATERIALS AND METHODS


We used RIVUR data, randomly split into train/test in a 4:1 ratio. Two models were developed to predict recurrent urinary tract infection risk in scenario with and without continuous antibiotic prophylaxis. The test set was then used to validate recurrent urinary tract infection events and the effectiveness of continuous antibiotic prophylaxis. Predicted probabilities of recurrent urinary tract infection were generated from each model. Continuous antibiotic prophylaxis was assigned at various cutoffs of recurrent urinary tract infection risk reduction to evaluate continuous antibiotic prophylaxis effectiveness.
RESULTS


A total of 607 patients (558 female/49 male, median age 12 months) were included. Predictors included vesicoureteral reflux grade, serum creatinine, race/gender, prior urinary tract infection symptoms (fever/dysuria) and weight percentiles. The AUC of the prediction model of recurrent urinary tract infection (continuous antibiotic prophylaxis/placebo) was 0.82 (95% CI 0.74-0.87). Using 10% recurrent urinary tract infection risk reduction cutoff, minimal recurrent urinary tract infection per population level can be achieved by giving continuous antibiotic prophylaxis to 40% of patients with vesicoureteral reflux instead of everyone. In a test set (121), 51 patients had continuous antibiotic prophylaxis randomization consistent with model recommendation (continuous antibiotic prophylaxis if recurrent urinary tract infection risk reduction >10%). Recurrent urinary tract infection incidence was significantly lower among this group compared to those whose continuous antibiotic prophylaxis assignment differed from model suggestion (7.5% vs 19.4%, p=0.037).
CONCLUSIONS


Our predictive model identifies patients with vesicoureteral reflux who are more likely to benefit from continuous antibiotic prophylaxis, which would allow more selective, personalized use of continuous antibiotic prophylaxis with maximal benefit, while minimizing use in those with least need.",2021,The AUC of the prediction model of rUTI (CAP/placebo) was 0.82 (95% CI: 0.74-0.87).,"['Selecting Children with VUR', 'vesicoureteral reflux (VUR) children', '51 patients had CAP randomization consistent with model recommendation (CAP if rUTI risk reduction >10', '607 patients (558 female/49 male, median age 12 months) were included']","['rUTI (CAP/placebo', 'antibiotic prophylaxis (CAP']","['risk of recurrent urinary tract infection (rUTI', 'rUTI incidence', 'VUR grade, serum creatinine, race/sex, prior UTI symptoms (fever/dysuria), and weight percentiles']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteric reflux'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteric reflux'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]",607.0,0.0624457,The AUC of the prediction model of rUTI (CAP/placebo) was 0.82 (95% CI: 0.74-0.87).,"[{'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Bertsimas', 'Affiliation': 'Operations Research Center, Massachusetts Institute of Technology, Cambridge, Massachusetts.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Operations Research Center, Massachusetts Institute of Technology, Cambridge, Massachusetts.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Estrada', 'Affiliation': ""Department of Urology, Boston Children's Hospital (Advanced Analytics Group of Pediatric Urology), Boston, Massachusetts.""}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': ""Department of Urology, Boston Children's Hospital (Advanced Analytics Group of Pediatric Urology), Boston, Massachusetts.""}, {'ForeName': 'Hsin-Hsiao', 'Initials': 'HH', 'LastName': 'Scott Wang', 'Affiliation': ""Department of Urology, Boston Children's Hospital (Advanced Analytics Group of Pediatric Urology), Boston, Massachusetts.""}]",The Journal of urology,['10.1097/JU.0000000000001445']
869,33296526,Carvedilol is associated with improved survival in patients with cirrhosis: a long-term follow-up study.,"BACKGROUND


Primary prophylaxis of variceal haemorrhage with non-selective beta blockers (NSBB) or variceal band ligation (VBL) is now standard of care in patients with cirrhosis with portal hypertension. NSBB, and particularly carvedilol, may be associated with improved survival.
AIM


To assess mortality in a cohort of patients previously randomised to either carvedilol or VBL.
METHODS


We retrospectively analysed 152 patients recruited to a multi-centre randomised controlled trial between 7 April 2000 and 24 June 2006 designed to assess the efficacy of VBL versus carvedilol in preventing first variceal bleed. We used electronic records to undertake long-term follow-up (up to 20 years) with the primary outcome of all-cause mortality and secondary end points of liver-related mortality and decompensation events (ascites, encephalopathy, variceal bleeding).
RESULTS


We included 152 patients in analysis with baseline characteristics well matched between the carvedilol (n = 77) and VBL (n = 75) groups. In the intention-to-treat analysis, carvedilol offered a significant survival advantage with median survival of 7.8 years compared to 4.2 years in the VBL group (P = 0.03). This survival benefit was maintained in per-protocol analysis when patients who crossed between treatment arms were excluded (P = 0.02). Transplant-free survival, liver-related mortality and decompensation events were similar in both groups.
CONCLUSION


These data suggest that carvedilol offers a significant survival benefit for patients with cirrhosis and portal hypertension. The difference in all-cause and liver-related mortality suggests that this survival benefit may not be entirely liver-related. Prospective, studies are required to confirm these important findings.",2021,"Transplant-free survival, liver-related mortality and decompensation events were similar in both groups.
","['variceal haemorrhage with non', 'patients with cirrhosis with portal hypertension', '152 patients in analysis with baseline characteristics well matched between the carvedilol (n\xa0=\xa077) and VBL (n\xa0=\xa075) groups', 'patients with cirrhosis and portal hypertension', 'patients with cirrhosis', '152 patients recruited to a multi-centre randomised controlled trial between 7 April 2000 and 24 June 2006']","['carvedilol', 'VBL versus carvedilol', 'carvedilol or VBL', 'Carvedilol', 'selective beta blockers (NSBB) or variceal band ligation (VBL']","['survival', 'mortality', 'Transplant-free survival, liver-related mortality and decompensation events', 'survival benefit', 'mortality and secondary end points of liver-related mortality and decompensation events (ascites, encephalopathy, variceal bleeding', 'survival advantage with median survival']","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",152.0,0.269715,"Transplant-free survival, liver-related mortality and decompensation events were similar in both groups.
","[{'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'McDowell', 'Affiliation': 'Department of Hepatology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Cher Shiong', 'Initials': 'CS', 'LastName': 'Chuah', 'Affiliation': 'Department of Hepatology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Dhiraj', 'Initials': 'D', 'LastName': 'Tripathi', 'Affiliation': 'Liver Unit, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Stanley', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Ewan H', 'Initials': 'EH', 'LastName': 'Forrest', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Hayes', 'Affiliation': 'Department of Hepatology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16189']
870,33295965,Objective Risk Assessment vs Standard Care for Acute Coronary Syndromes: A Randomized Clinical Trial.,"Importance


Although international guidelines recommend use of the Global Registries of Acute Coronary Events (GRACE) risk score (GRS) to guide acute coronary syndrome (ACS) treatment decisions, the prospective utility of the GRS in improving care and outcomes is unproven.
Objective


To assess the effect of routine GRS implementation on guideline-indicated treatments and clinical outcomes of hospitalized patients with ACS.
Design, Setting, and Participants


Prospective cluster (hospital-level) randomized open-label blinded end point (PROBE) clinical trial using a multicenter ACS registry of acute care cardiology services. Fixed sampling of the first 10 patients within calendar month, with either ST-segment elevation or non-ST-segment elevation ACS. The study enrolled patients from June 2014 to March 2018, and data were analyzed between February 2020 and April 2020.
Interventions


Implementation of routine risk stratification using the GRS and guideline recommendations.
Main Outcomes and Measures


The primary outcome was a performance score based on receipt of early invasive treatment, discharge prescription of 4 of 5 guideline-recommended pharmacotherapies, and cardiac rehabilitation referral. Clinical outcomes included a composite of all-cause death and/or myocardial infarction (MI) within 1 year.
Results


This study enrolled 2318 patients from 24 hospitals and was stopped prematurely owing to futility. Of the patients enrolled, median age was 65 years (interquartile range, 56-74 years), 29.5% were women (n = 684), and 62.9% were considered high risk (n = 1433). Provision of all 3 measures among high-risk patients did not differ between the randomized arms (GRS: 424 of 717 [59.9%] vs control: 376 of 681 [55.2%]; odds ratio [OR], 1.04; 95% CI, 0.63-1.71; P = .88). The provision of early invasive treatment was increased compared with the control arm (GRS: 1042 of 1135 [91.8%] vs control: 989 of 1183 [83.6%]; OR, 2.26; 95% CI, 1.30-3.96; P = .004). Prescription of 4 of 5 guideline-recommended pharmacotherapies (GRS: 864 of 1135 [76.7%] vs control: 893 of 1183 [77.5%]; OR, 0.97; 95% CI, 0.68-1.38) and cardiac rehabilitation (GRS: 855 of 1135 [75.1%] vs control: 861 of 1183 [72.8%]; OR, 0.68; 95% CI, 0.32-1.44) were not different. By 12 months, GRS intervention was not associated with a significant reduction in death or MI compared with the control group (GRS: 96 of 1044 [9.2%] vs control: 146 of 1087 [13.4%]; OR, 0.66; 95% CI, 0.38-1.14).
Conclusions and Relevance


Routine GRS implementation in cardiology services with high levels of clinical care was associated with an increase in early invasive treatment but not other aspects of care. Low event rates and premature study discontinuation indicates the need for further, larger scale randomized studies.
Trial Registration


anzctr.org.au Identifier: ACTRN12614000550606.",2021,"By 12 months, GRS intervention was not associated with a significant reduction in death or MI compared with the control group (GRS: 96 of 1044 [9.2%] vs control: 146 of 1087 [13.4%]; OR, 0.66; 95% CI, 0.38-1.14).
","['2318 patients from 24 hospitals and was stopped prematurely owing to futility', 'Acute Coronary Syndromes', 'hospitalized patients with ACS', 'patients enrolled, median age was 65 years (interquartile range, 56-74 years), 29.5% were women (n\u2009=\u2009684), and 62.9% were considered high risk (n\u2009=\u20091433', 'study enrolled patients from June 2014 to March 2018, and data were analyzed between February 2020 and April 2020']","['GRS intervention', 'routine GRS implementation', 'GRS']","['cardiac rehabilitation', 'provision of early invasive treatment', 'composite of all-cause death and/or myocardial infarction (MI) within 1 year', 'performance score based on receipt of early invasive treatment, discharge prescription of 4 of 5 guideline-recommended pharmacotherapies, and cardiac rehabilitation referral', 'death or MI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",2318.0,0.0886714,"By 12 months, GRS intervention was not associated with a significant reduction in death or MI compared with the control group (GRS: 96 of 1044 [9.2%] vs control: 146 of 1087 [13.4%]; OR, 0.66; 95% CI, 0.38-1.14).
","[{'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Chew', 'Affiliation': 'College of Medicine and Public Health, Flinders University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Karice', 'Initials': 'K', 'LastName': 'Hyun', 'Affiliation': 'Westmead Applied Research Centre, Faulty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Morton', 'Affiliation': 'College of Medicine and Public Health, Flinders University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Horsfall', 'Affiliation': 'College of Medicine and Public Health, Flinders University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Hillis', 'Affiliation': 'School of Medicine, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Centre, Faulty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Quinn', 'Affiliation': 'Department of Health Science and Biostatistics, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': ""D'Souza"", 'Affiliation': 'Westmead Applied Research Centre, Faulty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Yan', 'Affiliation': ""St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Chris P', 'Initials': 'CP', 'LastName': 'Gale', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, England.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brieger', 'Affiliation': 'Cardiology Department, Concord Repatriation General Hospital, Sydney, Australia.'}]",JAMA cardiology,['10.1001/jamacardio.2020.6314']
871,33285097,"Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial.","BACKGROUND


First-line durvalumab plus etoposide with either cisplatin or carboplatin (platinum-etoposide) showed a significant improvement in overall survival versus platinum-etoposide alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) in the CASPIAN study. Here we report updated results, including the primary analysis for overall survival with durvalumab plus tremelimumab plus platinum-etoposide versus platinum-etoposide alone.
METHODS


CASPIAN is an ongoing, open-label, sponsor-blind, randomised, controlled phase 3 trial at 209 cancer treatment centres in 23 countries worldwide. Eligible patients were aged 18 years or older (20 years in Japan) and had treatment-naive, histologically or cytologically documented ES-SCLC, with a WHO performance status of 0 or 1. Patients were randomly assigned (1:1:1) in blocks of six, stratified by planned platinum, using an interactive voice-response or web-response system to receive intravenous durvalumab plus tremelimumab plus platinum-etoposide, durvalumab plus platinum-etoposide, or platinum-etoposide alone. In all groups, patients received etoposide 80-100 mg/m 2  on days 1-3 of each cycle with investigator's choice of either carboplatin area under the curve 5-6 mg/mL/min or cisplatin 75-80 mg/m 2  on day 1 of each cycle. Patients in the platinum-etoposide group received up to six cycles of platinum-etoposide every 3 weeks and optional prophylactic cranial irradiation (investigator's discretion). Patients in the immunotherapy groups received four cycles of platinum-etoposide plus durvalumab 1500 mg with or without tremelimumab 75 mg every 3 weeks followed by maintenance durvalumab 1500 mg every 4 weeks. The two primary endpoints were overall survival for durvalumab plus platinum-etoposide versus platinum-etoposide and for durvalumab plus tremelimumab plus platinum-etoposide versus platinum-etoposide in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. This study is registered at ClinicalTrials.gov, NCT03043872.
FINDINGS


Between March 27, 2017, and May 29, 2018, 972 patients were screened and 805 were randomly assigned (268 to durvalumab plus tremelimumab plus platinum-etoposide, 268 to durvalumab plus platinum-etoposide, and 269 to platinum-etoposide). As of Jan 27, 2020, the median follow-up was 25·1 months (IQR 22·3-27·9). Durvalumab plus tremelimumab plus platinum-etoposide was not associated with a significant improvement in overall survival versus platinum-etoposide (hazard ratio [HR] 0·82 [95% CI 0·68-1·00]; p=0·045); median overall survival was 10·4 months (95% CI 9·6-12·0) versus 10·5 months (9·3-11·2). Durvalumab plus platinum-etoposide showed sustained improvement in overall survival versus platinum-etoposide (HR 0·75 [95% CI 0·62-0·91]; nominal p=0·0032); median overall survival was 12·9 months (95% CI 11·3-14·7) versus 10·5 months (9·3-11·2). The most common any-cause grade 3 or worse adverse events were neutropenia (85 [32%] of 266 patients in the durvalumab plus tremelimumab plus platinum-etoposide group, 64 [24%] of 265 patients in the durvalumab plus platinum-etoposide group, and 88 [33%] of 266 patients in the platinum-etoposide group) and anaemia (34 [13%], 24 [9%], and 48 [18%]). Any-cause serious adverse events were reported in 121 (45%) patients in the durvalumab plus tremelimumab plus platinum-etoposide group, 85 (32%) in the durvalumab plus platinum-etoposide group, and 97 (36%) in the platinum-etoposide group. Treatment-related deaths occurred in 12 (5%) patients in the durvalumab plus tremelimumab plus platinum-etoposide group (death, febrile neutropenia, and pulmonary embolism [n=2 each]; enterocolitis, general physical health deterioration and multiple organ dysfunction syndrome, pneumonia, pneumonitis and hepatitis, respiratory failure, and sudden death [n=1 each]), six (2%) patients in the durvalumab plus platinum-etoposide group (cardiac arrest, dehydration, hepatotoxicity, interstitial lung disease, pancytopenia, and sepsis [n=1 each]), and two (1%) in the platinum-etoposide group (pancytopenia and thrombocytopenia [n=1 each]).
INTERPRETATION


First-line durvalumab plus platinum-etoposide showed sustained overall survival improvement versus platinum-etoposide but the addition of tremelimumab to durvalumab plus platinum-etoposide did not significantly improve outcomes versus platinum-etoposide. These results support the use of durvalumab plus platinum-etoposide as a new standard of care for the first-line treatment of ES-SCLC.
FUNDING


AstraZeneca.",2021,Durvalumab plus tremelimumab plus platinum-etoposide was not associated with a significant improvement in overall survival versus platinum-etoposide (hazard ratio [HR] 0·82,"['209 cancer treatment centres in 23 countries worldwide', 'extensive-stage small-cell lung cancer (CASPIAN', 'Between March 27, 2017, and May 29, 2018, 972 patients were screened and 805 were randomly assigned (268 to', 'Eligible patients were aged 18 years or older (20 years in Japan) and had treatment-naive, histologically or cytologically documented ES-SCLC, with a WHO performance status of 0 or 1', 'patients with extensive-stage small-cell lung cancer (ES-SCLC', 'group (cardiac arrest, dehydration, hepatotoxicity, interstitial lung disease, pancytopenia, and sepsis']","['durvalumab plus tremelimumab plus platinum-etoposide, 268 to durvalumab plus platinum-etoposide, and 269 to platinum-etoposide', 'Durvalumab plus tremelimumab plus platinum-etoposide', 'etoposide', 'Durvalumab plus platinum-etoposide', 'platinum-etoposide plus durvalumab 1500 mg with or without tremelimumab', 'planned platinum, using an interactive voice-response or web-response system to receive intravenous durvalumab plus tremelimumab plus platinum-etoposide, durvalumab plus platinum-etoposide, or platinum-etoposide alone', 'durvalumab plus tremelimumab plus platinum-etoposide versus platinum-etoposide alone', 'durvalumab plus platinum-etoposide versus platinum-etoposide and for durvalumab plus tremelimumab plus platinum-etoposide versus platinum-etoposide', 'Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone', 'platinum-etoposide alone', 'durvalumab plus platinum-etoposide', 'platinum-etoposide', 'durvalumab plus tremelimumab plus platinum-etoposide', 'carboplatin area under the curve 5-6 mg/mL/min or cisplatin', 'cisplatin or carboplatin (platinum-etoposide']","[' median overall survival', 'anaemia', 'overall survival improvement', 'median overall survival', 'deaths', 'Safety', 'death, febrile neutropenia, and pulmonary embolism [n=2 each]; enterocolitis, general physical health deterioration and multiple organ dysfunction syndrome, pneumonia, pneumonitis and hepatitis, respiratory failure, and sudden death', 'neutropenia', 'overall survival']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030312', 'cui_str': 'Pancytopenia'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0877211', 'cui_str': 'General physical health deterioration'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",972.0,0.0701171,Durvalumab plus tremelimumab plus platinum-etoposide was not associated with a significant improvement in overall survival versus platinum-etoposide (hazard ratio [HR] 0·82,"[{'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'BHI of Omsk Region Clinical Oncology Dispensary, Omsk, Russia.'}, {'ForeName': 'Yuanbin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cancer and Hematology Centers of Western Michigan, Grand Rapids, MI, USA.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Odessa Regional Oncological Dispensary, Odessa, Ukraine.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Statsenko', 'Affiliation': 'Omsk Regional Cancer Centre, Omsk, Russia.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': 'Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.'}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Voitko', 'Affiliation': 'Kyiv City Clinical Oncological Centre, Kiev, Ukraine.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Poltoratskiy', 'Affiliation': 'Petrov Research Institute of Oncology, St Petersburg, Russia.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Verderame', 'Affiliation': 'Azienda Ospedaliera Ospedali Riuniti PO Vincenzo Cervello, Palermo, Italy.'}, {'ForeName': 'Libor', 'Initials': 'L', 'LastName': 'Havel', 'Affiliation': 'Thomayer Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk Medical Academy, Dnipro, Ukraine.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Każarnowicz', 'Affiliation': 'Tuberculosis and Lung Disease Hospital, Olsztyn, Poland.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Losonczy', 'Affiliation': 'Department of Pulmonology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Nikolay V', 'Initials': 'NV', 'LastName': 'Conev', 'Affiliation': 'Clinic of Medical Oncology, University Multiprofile Hospital for Active Treatment St Marina, Varna, Bulgaria.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Armstrong', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Byrne', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Piruntha', 'Initials': 'P', 'LastName': 'Thiyagarajah', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain. Electronic address: lpazaresr@seom.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30539-8']
872,33285371,Early neuromuscular electrical stimulation reduces the loss of muscle mass in critically ill patients - A within subject randomized controlled trial.,"PURPOSE


To investigate the effect of Neuromuscular Electrical Stimulation (NMES) on muscle thickness, strength and morphological and molecular markers of the quadriceps.
MATERIALS AND METHODS


Adult critically ill patients with an expected prolonged stay received unilateral quadriceps NMES sessions for 7 consecutive days. Before and after the intervention period, quadriceps thickness was measured with ultrasound. After the intervention period, strength was assessed in cooperative patients and muscle biopsies were taken. Multivariable regression was performed to identify factors affecting muscle thickness loss.
RESULTS


Muscle thickness decreased less in the stimulated leg (-6 ± 16% versus -12 ± 15%, p = 0.014, n = 47). Strength was comparable. Opioid administration, minimal muscle contraction and more muscle thickness loss in the non-stimulated muscle were independently associated with better muscle thickness preservation. Stimulated muscles showed a shift towards larger myofibers and higher MyHC-I gene expression. NMES did not affect gene expression of other myofibrillary proteins, MuRF-1 or atrogin-1. Signs of myofiber necrosis and inflammation were comparable for both muscles.
CONCLUSIONS


NMES attenuated the loss of muscle mass, but not of strength, in critically ill patients. Preservation of muscle mass was more likely in patients receiving opioids, patients with a minimal muscle contraction during NMES and patients more prone to lose muscle mass.
TRIAL REGISTRATION


clinicaltrials.govNCT02133300.",2021,"NMES did not affect gene expression of other myofibrillary proteins, MuRF-1 or atrogin-1.","['Adult critically ill patients with an expected prolonged stay received', 'critically ill patients']","['unilateral quadriceps NMES sessions', 'NMES', 'Neuromuscular Electrical Stimulation (NMES', 'Early neuromuscular electrical stimulation']","['muscle thickness loss', 'loss of muscle mass', 'quadriceps thickness', 'muscle thickness, strength and morphological and molecular markers of the quadriceps']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0550959,"NMES did not affect gene expression of other myofibrillary proteins, MuRF-1 or atrogin-1.","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Segers', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium; Department of Intensive Care, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Langer', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Noppawan', 'Initials': 'N', 'LastName': 'Charususin', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium; Department of Physical therapy, Faculty of Allied Health Sciences, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium; Department of Respiratory and Critical Care, Tongji Hospital, Shangai, China.'}, {'ForeName': 'Bregje', 'Initials': 'B', 'LastName': 'Frickx', 'Affiliation': 'Medical Intensive Care Unit, Department of General Internal Medicine, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Demeyere', 'Affiliation': 'Department of Intensive Care, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Clerckx', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium; Department of Intensive Care, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Casaer', 'Affiliation': 'Department of Intensive Care, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium; Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Derese', 'Affiliation': 'Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Derde', 'Affiliation': 'Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Lies', 'Initials': 'L', 'LastName': 'Pauwels', 'Affiliation': 'Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Department of Intensive Care, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium; Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Hermans', 'Affiliation': 'Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium; Medical Intensive Care Unit, Department of General Internal Medicine, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Gosselink', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium; Department of Intensive Care, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Electronic address: Rik.Gosselink@kuleuven.be.'}]",Journal of critical care,['10.1016/j.jcrc.2020.11.018']
873,33290772,Epicutaneous immunotherapy for treatment of peanut allergy: Follow-up from the Consortium for Food Allergy Research.,"BACKGROUND


Consortium for Food Allergy Research investigators previously reported 52-week outcomes from a randomized controlled trial of peanut epicutaneous immunotherapy, observing modest and statistically significant induction of desensitization, highest in children ages 4 to 11 years.
OBJECTIVE


We sought to evaluate changes in efficacy, safety, and mechanistic parameters following extended open-label peanut epicutaneous immunotherapy.
METHODS


Peanut-allergic participants (4-25 years) received 52 weeks of placebo (PLB), Viaskin Peanut 100 μg (VP100) or 250 μg (VP250), and then crossed over to VP250 for PLB (PLB-VP250) and VP100 (VP100-VP250) participants and continued treatment for VP250 participants (total = 130 weeks of active epicutaneous immunotherapy). Efficacy was assessed by double-blind, placebo-controlled food challenge (5044 mg peanut protein), and adherence, safety, and mechanistic parameters were evaluated.
RESULTS


At week 130, desensitization success was achieved in 1 of 20 (5%) PLB-VP250, 5 of 24 (20.8%) VP100-VP250, and 9 of 25 (36%) VP250 participants, with median successfully consumed dose change from baseline of 11.5 mg, 141.5 mg, and 400 mg, respectively. Median age (years) for week 130 desensitization success was 6.2 years (interquartile range, 5.2-9.1) versus 9.4 years (interquartile range, 7.6-12.8) for failures (P < .001). Adherence was 96%. Adverse reactions were predominantly local patch-site reactions. Significant increases in peanut- and Ara h2-specific IgG 4  observed at week 52 persisted to week 130. By a post hoc analysis, there were no statistically significant increases from week 52 to week 130 in either desensitization success or successfully consumed dose.
CONCLUSIONS


Extended treatment with VP250 was well tolerated, and desensitization observed at week 52 persisted between weeks 52 and 130. Treatment success was observed predominantly in younger participants, with younger age at initiation of active therapy an important predictor of success.",2021,"By a post-hoc analysis, there were no statistically significant increases from week 52 to week 130 in either desensitization success or SCD.
CONCLUSION


Extended treatment with VP250 was well-tolerated and desensitization observed at week 52 persisted between weeks 52 and 130.","['Peanut-allergic participants (4-25 years', 'children ages 4-11 years']","['placebo (PLB), Viaskin Peanut 100 mcg (VP100) or 250 mcg (VP250), then crossover to VP250 for placebo (PLB-VP250) and VP100', 'DBPCFC', 'Epicutaneous Immunotherapy']","['Efficacy', 'adherence, safety and mechanistic parameters', 'Adherence', 'efficacy, safety, and mechanistic parameters', 'Adverse reactions', 'h2-specific', 'IgG4', 'desensitization success', 'peanut- and Ara']","[{'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020860', 'cui_str': 'Immunoglobulin IgG4'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0325983', 'cui_str': 'Genus Ara'}]",,0.241526,"By a post-hoc analysis, there were no statistically significant increases from week 52 to week 130 in either desensitization success or SCD.
CONCLUSION


Extended treatment with VP250 was well-tolerated and desensitization observed at week 52 persisted between weeks 52 and 130.","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Scurlock', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. Electronic address: ScurlockAmyM@uams.edu.""}, {'ForeName': 'A Wesley', 'Initials': 'AW', 'LastName': 'Burks', 'Affiliation': 'UNC School of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Sicherer', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Donald Y M', 'Initials': 'DYM', 'LastName': 'Leung', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'UNC School of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Henning', 'Affiliation': 'Emmes, Rockville, Bethesda.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, Bethesda.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Lindblad', 'Affiliation': 'Emmes, Rockville, Bethesda.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Berin', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Cho', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Wendy F', 'Initials': 'WF', 'LastName': 'Davidson', 'Affiliation': 'National Institutes of Health (National Institute of Allergy and Infectious Diseases), Bethesda, Md.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institutes of Health (National Institute of Allergy and Infectious Diseases), Bethesda, Md.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.11.027']
874,33300448,Effects of Virtual Reality on Pain During Venous Port Access in Pediatric Oncology Patients: A Randomized Controlled Study.,"PURPOSE


Needle procedures are one of the most distressing practices for pediatric oncology patients. Virtual reality (VR) is a distraction method which offers an extremely realistic and interactive virtual environment and helps reduce needle-related pain and distress. The aim of this study was to evaluate the effects of VR method on pain during venous port access in pediatric oncology patients aged 7 to 18 years.
METHOD


Children who had cancer and were between the ages of 7 and 18 years and undergoing a port-a-cath access were randomly assigned through blocked randomization to either the VR intervention group or control group. A commercially available VR headset was fitted to children in the intervention group. Immediately after the port access, pain scores were obtained from children's self-reports and parents' proxy reports, using the Wong-Baker FACES Pain Rating Scale.
RESULTS


Descriptive characteristics of the children ( n  = 71) showed a homogeneous distribution between groups. During the procedure, children in the control group ( n  = 36; 5.03 ± 3.35) experienced more pain than the children in VR group ( n  = 35; 2.34 ± 2.76;  p  < .001). Proxy reports of the parents in the experimental group (1.77 ± 2.46) were found to be lower than those in the control group (4.67 ± 2.56;  p  < .001).
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


VR method is effective for reducing pain during venous port access in pediatric oncology patients. VR should be used as a distraction method during venous port access.",2021,"Proxy reports of the parents in the experimental group (1.77 ± 2.46) were found to be lower than those in the control group (4.67 ± 2.56;  p  < .001).
","['pediatric oncology patients aged 7 to 18 years', 'Pediatric Oncology Patients', 'Children who had cancer and were between the ages of 7 and 18 years and undergoing a port-a-cath access', 'pediatric oncology patients']","['Virtual reality (VR', 'VR method', 'VR intervention group or control group', 'Virtual Reality']","['Pain', 'Baker FACES Pain Rating Scale', 'pain', 'pain scores']","[{'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3495140', 'cui_str': 'Port-A-Cath'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0302672,"Proxy reports of the parents in the experimental group (1.77 ± 2.46) were found to be lower than those in the control group (4.67 ± 2.56;  p  < .001).
","[{'ForeName': 'Remziye', 'Initials': 'R', 'LastName': 'Semerci', 'Affiliation': '37521Trakya University, Edirne, Turkey.'}, {'ForeName': 'Melahat', 'Initials': 'M', 'LastName': 'Akgün Kostak', 'Affiliation': '37521Trakya University, Edirne, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Eren', 'Affiliation': '37521Trakya University, Edirne, Turkey.'}, {'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Avci', 'Affiliation': '37521Trakya University, Edirne, Turkey.'}]",Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses,['10.1177/1043454220975702']
875,33305973,Impact of Nipple Shield Use on Milk Transfer and Maternal Nipple Pain.,"Background:  Nipple pain is a common cause of early cessation of breastfeeding. A nipple shield (shield) is often used to improve breastfeeding comfort. There are concerns that shield use may limit milk transfer. The aims of this study were to determine whether shield use reduces milk transfer and maternal nipple pain.  Methods:  A within-subject study of two groups of breastfeeding dyads (infants <6 months) was conducted; Control Group (CG): no breastfeeding difficulties; Pain Group (PG) shield used for nipple pain. There were two monitored sessions where shield use was randomized. Test weights and pain questionnaires were completed, and percentage of available milk removed (PAMR) was calculated.  Results:  Twenty-five PG (6 ± 4 postnatal weeks) and 34 CG (9 ± 6 postnatal weeks) had similar 24-hour milk production (PG: 676 ± 239 mL, CG: 775 ± 162 mL,  p  = 0.083). PG mean milk transfer volume and PAMR did not differ with shield use (no shield: 46 mL, 59%; shield: 40 mL, 53%, volume  p  = 0.38, PAMR  p  = 0.64). CG mean volume and PAMR were reduced with shield use (no shield: 65 mL, 64%; shield: 31 mL, 33%, volume  p  < 0.001, PAMR  p  < 0.001). PG pain scores were similar with and without shield use (Visual Analog Scale  p  = 0.44, McGill  p  = 0.97).  Conclusions:  Shield use did not impact either milk production or milk transfer in breastfeeding women experiencing nipple pain.",2021,"PG pain scores were similar with and without shield use (Visual Analog Scale  p  = 0.44, McGill  p  = 0.97).  ",['breastfeeding women experiencing nipple pain'],['Control Group (CG): no breastfeeding difficulties; Pain Group (PG) shield used for nipple pain'],"['Milk Transfer and Maternal Nipple Pain', 'milk transfer and maternal nipple pain', 'PG pain scores', 'percentage of available milk removed (PAMR', 'Test weights and pain questionnaires', '24-hour milk production', 'PG mean milk transfer volume and PAMR', 'milk production or milk transfer', 'CG mean volume and PAMR']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0240515', 'cui_str': 'Nipple pain'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0240515', 'cui_str': 'Nipple pain'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0240515', 'cui_str': 'Nipple pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0558187', 'cui_str': 'Lactation established'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0750484,"PG pain scores were similar with and without shield use (Visual Analog Scale  p  = 0.44, McGill  p  = 0.97).  ","[{'ForeName': 'Viviane S', 'Initials': 'VS', 'LastName': 'Coentro', 'Affiliation': 'Faculty of Science, School of Molecular Sciences, The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Perrella', 'Affiliation': 'Faculty of Science, School of Molecular Sciences, The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Ching Tat', 'Initials': 'CT', 'LastName': 'Lai', 'Affiliation': 'Faculty of Science, School of Molecular Sciences, The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Rea', 'Affiliation': 'Mathematics and Statistics, Murdoch University, Murdoch, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'Faculty of Health and Medical Sciences, Population and Global Health, School of Population and Global Health, The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Donna T', 'Initials': 'DT', 'LastName': 'Geddes', 'Affiliation': 'Faculty of Science, School of Molecular Sciences, The University of Western Australia, Crawley, Australia.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0110']
876,33301740,"Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial.","BACKGROUND


Systemic relapses remain a major problem in locally advanced rectal cancer. Using short-course radiotherapy followed by chemotherapy and delayed surgery, the Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation (RAPIDO) trial aimed to reduce distant metastases without compromising locoregional control.
METHODS


In this multicentre, open-label, randomised, controlled, phase 3 trial, participants were recruited from 54 centres in the Netherlands, Sweden, Spain, Slovenia, Denmark, Norway, and the USA. Patients were eligible if they were aged 18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, had a biopsy-proven, newly diagnosed, primary, locally advanced rectal adenocarcinoma, which was classified as high risk on pelvic MRI (with at least one of the following criteria: clinical tumour [cT] stage cT4a or cT4b, extramural vascular invasion, clinical nodal [cN] stage cN2, involved mesorectal fascia, or enlarged lateral lymph nodes), were mentally and physically fit for chemotherapy, and could be assessed for staging within 5 weeks before randomisation. Eligible participants were randomly assigned (1:1), using a management system with a randomly varying block design (each block size randomly chosen to contain two to four allocations), stratified by centre, ECOG performance status, cT stage, and cN stage, to either the experimental or standard of care group. All investigators remained masked for the primary endpoint until a prespecified number of events was reached. Patients allocated to the experimental treatment group received short-course radiotherapy (5 × 5 Gy over a maximum of 8 days) followed by six cycles of CAPOX chemotherapy (capecitabine 1000 mg/m 2  orally twice daily on days 1-14, oxaliplatin 130 mg/m 2  intravenously on day 1, and a chemotherapy-free interval between days 15-21) or nine cycles of FOLFOX4 (oxaliplatin 85 mg/m 2  intravenously on day 1, leucovorin [folinic acid] 200 mg/m 2  intravenously on days 1 and 2, followed by bolus fluorouracil 400 mg/m 2  intravenously and fluorouracil 600 mg/m 2  intravenously for 22 h on days 1 and 2, and a chemotherapy-free interval between days 3-14) followed by total mesorectal excision. Choice of CAPOX or FOLFOX4 was per physician discretion or hospital policy. Patients allocated to the standard of care group received 28 daily fractions of 1·8 Gy up to 50·4 Gy or 25 fractions of 2·0 Gy up to 50·0 Gy (per physician discretion or hospital policy), with concomitant twice-daily oral capecitabine 825 mg/m 2  followed by total mesorectal excision and, if stipulated by hospital policy, adjuvant chemotherapy with eight cycles of CAPOX or 12 cycles of FOLFOX4. The primary endpoint was 3-year disease-related treatment failure, defined as the first occurrence of locoregional failure, distant metastasis, new primary colorectal tumour, or treatment-related death, assessed in the intention-to-treat population. Safety was assessed by intention to treat. This study is registered with the EudraCT, 2010-023957-12, and ClinicalTrials.gov, NCT01558921, and is now complete.
FINDINGS


Between June 21, 2011, and June 2, 2016, 920 patients were enrolled and randomly assigned to a treatment, of whom 912 were eligible (462 in the experimental group; 450 in the standard of care group). Median follow-up was 4·6 years (IQR 3·5-5·5). At 3 years after randomisation, the cumulative probability of disease-related treatment failure was 23·7% (95% CI 19·8-27·6) in the experimental group versus 30·4% (26·1-34·6) in the standard of care group (hazard ratio 0·75, 95% CI 0·60-0·95; p=0·019). The most common grade 3 or higher adverse event during preoperative therapy in both groups was diarrhoea (81 [18%] of 460 patients in the experimental group and 41 [9%] of 441 in the standard of care group) and neurological toxicity during adjuvant chemotherapy in the standard of care group (16 [9%] of 187 patients). Serious adverse events occurred in 177 (38%) of 460 participants in the experimental group and, in the standard of care group, in 87 (34%) of 254 patients without adjuvant chemotherapy and in 64 (34%) of 187 with adjuvant chemotherapy. Treatment-related deaths occurred in four participants in the experimental group (one cardiac arrest, one pulmonary embolism, two infectious complications) and in four participants in the standard of care group (one pulmonary embolism, one neutropenic sepsis, one aspiration, one suicide due to severe depression).
INTERPRETATION


The observed decreased probability of disease-related treatment failure in the experimental group is probably indicative of the increased efficacy of preoperative chemotherapy as opposed to adjuvant chemotherapy in this setting. Therefore, the experimental treatment can be considered as a new standard of care in high-risk locally advanced rectal cancer.
FUNDING


Dutch Cancer Foundation, Swedish Cancer Society, Spanish Ministry of Economy and Competitiveness, and Spanish Clinical Research Network.",2021,"Treatment-related deaths occurred in four participants in the experimental group (one cardiac arrest, one pulmonary embolism, two infectious complications) and in four participants in the standard of care group (one pulmonary embolism, one neutropenic sepsis, one aspiration, one suicide due to severe depression).
","['locally advanced rectal cancer (RAPIDO', 'participants were recruited from 54 centres in the Netherlands, Sweden, Spain, Slovenia, Denmark, Norway, and the USA', 'Between June 21, 2011, and June 2, 2016, 920 patients were enrolled and randomly assigned to a treatment, of whom 912 were eligible (462 in the experimental group; 450 in the standard of care group', 'Patients were eligible if they were aged 18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, had a biopsy-proven, newly diagnosed, primary, locally advanced rectal adenocarcinoma, which was classified as high risk on pelvic MRI (with at least one of the following criteria: clinical tumour [cT] stage cT4a or cT4b, extramural vascular invasion, clinical nodal [cN] stage cN2, involved mesorectal fascia, or enlarged lateral lymph nodes), were mentally and physically fit for chemotherapy, and could be assessed for staging within 5 weeks before randomisation', 'Eligible participants', 'locally advanced rectal cancer']","['short-course radiotherapy followed by chemotherapy and delayed surgery, the Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation (RAPIDO', 'short-course radiotherapy', '28 daily fractions of 1·8 Gy up to 50·4 Gy or 25 fractions of 2·0 Gy up to 50·0 Gy (per physician discretion or hospital policy), with concomitant twice-daily oral capecitabine', 'CAPOX chemotherapy (capecitabine 1000 mg/m 2  orally twice daily on days 1-14, oxaliplatin 130 mg/m 2  intravenously on day 1, and a chemotherapy-free interval between days 15-21) or nine cycles of FOLFOX4 (oxaliplatin 85 mg/m 2  intravenously on day 1, leucovorin [folinic acid', 'fluorouracil 400 mg/m 2  intravenously and fluorouracil 600 mg/m 2  intravenously for 22 h on days 1 and 2, and a chemotherapy-free interval between days 3-14) followed by total mesorectal excision', 'CAPOX or FOLFOX4', 'Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy']","['cumulative probability of disease-related treatment failure', 'pulmonary embolism, one neutropenic sepsis, one aspiration, one suicide due to severe depression', '3-year disease-related treatment failure, defined as the first occurrence of locoregional failure, distant metastasis, new primary colorectal tumour, or treatment-related death, assessed in the intention-to-treat population', 'deaths', 'Safety', 'Serious adverse events', 'neurological toxicity', 'diarrhoea']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0203201', 'cui_str': 'MRI of pelvis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0877153', 'cui_str': 'Neutropenic sepsis'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",920.0,0.348632,"Treatment-related deaths occurred in four participants in the experimental group (one cardiac arrest, one pulmonary embolism, two infectious complications) and in four participants in the standard of care group (one pulmonary embolism, one neutropenic sepsis, one aspiration, one suicide due to severe depression).
","[{'ForeName': 'Renu R', 'Initials': 'RR', 'LastName': 'Bahadoer', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Esmée A', 'Initials': 'EA', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Corrie A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands; Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Annet G H', 'Initials': 'AGH', 'LastName': 'Roodvoets', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Iris D', 'Initials': 'ID', 'LastName': 'Nagtegaal', 'Affiliation': 'Department of Pathology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Regina G H', 'Initials': 'RGH', 'LastName': 'Beets-Tan', 'Affiliation': 'Department of Radiology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Lennart K', 'Initials': 'LK', 'LastName': 'Blomqvist', 'Affiliation': 'Department of Imaging and Physiology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Fokstuen', 'Affiliation': 'Department of Oncology and Pathology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': 'Department of Medical Oncology, Vall Hebron Institute of Oncology, Vall Hebron University Hospital, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, Netherlands.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Edhemovic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology Ljubljana, University of Ljubljana Faculty of Medicine, Ljubljana, Slovenia.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Biomedical Research Institute Incliva, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Per J', 'Initials': 'PJ', 'LastName': 'Nilsson', 'Affiliation': 'Department of Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Geke A P', 'Initials': 'GAP', 'LastName': 'Hospers', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands. Electronic address: sg.a.p.hospers@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30555-6']
877,33307206,Effects of Yoga in Daily Life program in rheumatoid arthritis: A randomized controlled trial.,"OBJECTIVES


To explore the feasibility and effectiveness of a yoga program in improving health-related quality of life (HQOL), physical and psychological functioning in rheumatoid arthritis (RA) patients.
DESIGN


Single-centre parallel-arms randomized controlled trial comparing yoga (n = 30) and education control group (n = 27).
SETTING


Tertiary care University hospital.
INTERVENTION


A 12-week yoga program, based on the Yoga in Daily Life system, included 2x weekly/90-minute sessions. The control group had 1xweekly/60-minute educational lectures on arthritis-related topics.
MAIN OUTCOME MEASURES


Assessments were performed at baseline, 12 (post-intervention) and 24 weeks (follow-up). The primary outcome was change in The Short Form-36 (SF-36) HQOL at 12 weeks. Linear regression analysis was adjusted for baseline scores.
RESULTS


No significant between-group differences were found for SF-36 (all p > 0.05). At 12 weeks the adjusted mean difference between groups favoured yoga for Functional Assessment of Chronic Illness Therapy-fatigue (5.08 CI 1.29 to 8.86; p = 0.009) and Hospital Anxiety and Depression Scale (HADS)-depression (-1.37 CI -2.38 to -0.36); p = 0.008) and at 24 weeks for HADS-anxiety (-1.79 CI -3.34 to - 0.23; p = 0.025), while the impact on fatigue was sustained (5.43 CI 1.33 to 9.54, p = 0.01). The program had no impact on RA disease activity. Feasibility outcomes included recruitment rate 16 %, retention 80.7 %, and adherence to yoga 87.5 vs 82.7 % for control. No serious adverse events were recorded.
CONCLUSIONS


Yoga in Daily Life program was not associated with change in health-related quality of life of RA patients. Significant improvements in fatigue and mood were observed at postintervention and follow-up. This yoga program was found feasible and safe for patients and may complement standard RA treat-to-target strategy.",2020,At 12 weeks the adjusted mean difference between groups favoured yoga for Functional Assessment of Chronic Illness Therapy-fatigue (5.08 CI 1.29 to 8.86; p = 0.009) and Hospital Anxiety and Depression Scale (HADS)-depression (,"['rheumatoid arthritis', 'rheumatoid arthritis (RA) patients', 'Tertiary care University hospital']","['Yoga in Daily Life program', 'yoga program', '1xweekly/60-minute educational lectures', 'trialcomparing yoga (n\u2009=\u200930) and education control group (n\u2009=\u200927']","['RA disease activity', 'serious adverse events', 'fatigue and mood', 'fatigue', 'recruitment rate 16 %, retention 80.7 %, and adherence', 'Functional Assessment of Chronic Illness Therapy-fatigue', 'health-related quality of life (HQOL), physical and psychological functioning', 'HADS-anxiety', 'health-related quality of life', 'Short Form-36 (SF-36) HQOL', 'SF-36', 'Hospital Anxiety and Depression Scale (HADS)-depression ']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.173808,At 12 weeks the adjusted mean difference between groups favoured yoga for Functional Assessment of Chronic Illness Therapy-fatigue (5.08 CI 1.29 to 8.86; p = 0.009) and Hospital Anxiety and Depression Scale (HADS)-depression (,"[{'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Pukšić', 'Affiliation': 'Department of Clinical Immunology, Allergology and Rheumatology, Department of Internal Medicine, School of Medicine University of Zagreb, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia. Electronic address: puksic.silva@gmail.com.'}, {'ForeName': 'Joško', 'Initials': 'J', 'LastName': 'Mitrović', 'Affiliation': 'Department of Clinical Immunology, Allergology and Rheumatology, Department of Internal Medicine, School of Medicine University of Zagreb, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Melanie-Ivana', 'Initials': 'MI', 'LastName': 'Čulo', 'Affiliation': 'Department of Clinical Immunology, Allergology and Rheumatology, Department of Internal Medicine, School of Medicine University of Zagreb, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Živković', 'Affiliation': 'Clinical Department of Laboratory Diagnostics, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Biserka', 'Initials': 'B', 'LastName': 'Orehovec', 'Affiliation': 'Clinical Department of Laboratory Diagnostics, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Dubravka', 'Initials': 'D', 'LastName': 'Bobek', 'Affiliation': 'Department of Physical Medicine and Rehabilitation with Rheumatology, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Jadranka', 'Initials': 'J', 'LastName': 'Morović-Vergles', 'Affiliation': 'Department of Clinical Immunology, Allergology and Rheumatology, Department of Internal Medicine, School of Medicine University of Zagreb, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102639']
878,33310174,"Intragastric administration of leucine and isoleucine does not reduce the glycaemic response to, or slow gastric emptying of, a carbohydrate-containing drink in type 2 diabetes.","AIMS


In healthy individuals, intragastric administration of the branched-chain amino acids, leucine and isoleucine, diminishes the glycaemic response to a mixed-nutrient drink, apparently by stimulating insulin and slowing gastric emptying, respectively. This study aimed to evaluate the effects of leucine and isoleucine on postprandial glycaemia and gastric emptying in type-2 diabetes mellitus (T2D).
METHODS


14 males with T2D received, on 3 separate occasions, in double-blind, randomised fashion, either 10 g leucine, 10 g isoleucine or control, intragastrically 30 min before a mixed-nutrient drink (500 kcal; 74 g carbohydrates, 18 g protein, 15 g fat). Plasma glucose, insulin and glucagon were measured from 30 min pre- until 120 min post-drink. Gastric emptying of the drink was also measured.
RESULTS


Leucine and isoleucine stimulated insulin, both before and after the drink (all P < 0.05; peak (mU/L): control: 70 ± 15; leucine: 88 ± 17; isoleucine: 74 ± 15). Isoleucine stimulated (P < 0.05), and leucine tended to stimulate (P = 0.078), glucagon before the drink, and isoleucine stimulated glucagon post-drink (P = 0.031; peak (pg/mL): control: 62 ± 5; leucine: 70 ± 9; isoleucine: 69 ± 6). Neither amino acid affected gastric emptying or plasma glucose (peak (mmol/L): control: 12.0 ± 0.5; leucine: 12.5 ± 0.7; isoleucine: 12.0 ± 0.6).
CONCLUSIONS


In contrast to health, in T2D, leucine and isoleucine, administered intragastrically in a dose of 10 g, do not lower the glycaemic response to a mixed-nutrient drink. This finding argues against a role for 'preloads' of either leucine or isoleucine in the management of T2D.",2021,"Isoleucine stimulated (P<0.05), and leucine tended to stimulate (P=0.078), glucagon before the drink, and isoleucine stimulated glucagon post-drink (P=0.031; peak (pg/mL):","['14 males with T2D', 'type-2 diabetes mellitus (T2D']","['10g leucine, 10g isoleucine or control, intragastrically 30 min before a mixed-nutrient drink', 'leucine and isoleucine', 'leucine or isoleucine']","['glycaemic response', 'Plasma glucose, insulin and glucagon', 'postprandial glycaemia and gastric emptying', 'gastric emptying or plasma glucose (peak (mmol/L', 'Gastric emptying']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0022192', 'cui_str': 'Isoleucine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]",14.0,0.128999,"Isoleucine stimulated (P<0.05), and leucine tended to stimulate (P=0.078), glucagon before the drink, and isoleucine stimulated glucagon post-drink (P=0.031; peak (pg/mL):","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Elovaris', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hajishafiee', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Sina S', 'Initials': 'SS', 'LastName': 'Ullrich', 'Affiliation': 'Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Penelope C E', 'Initials': 'PCE', 'LastName': 'Fitzgerald', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia. Electronic address: christine.feinle@adelaide.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108618']
879,33305626,The modulating effects of vitamin D on the activity of β-catenin in the endometrium of women with endometriosis: a randomized exploratory trial.,"AIMS


The aim of this prospective study was to investigate the effects of vitamin D on the expression and activity of β-catenin, as the key molecule of the Wnt/β-catenin signaling pathway, in endometriosis women.
MATERIALS AND METHODS


Thirty four infertile women with stage III or IV endometriosis were randomly divided to two groups. The control group received the routine treatment and the treatment group, beside the routine protocol, received 50000 IU vitamin D weekly for 12-14 weeks. Blood and endometrial tissue were collected from both groups before and after the intervention. Protein and Gene expression levels of β-catenin were assessed by Western blotting and Real-Time PCR, respectively.
RESULTS


Compared to before intervention, the expression of active form of β-catenin reduced significantly within treatment group ( p  = .000), in addition, the difference between control and treatment groups ( p  = .012) was significant after intervention, too. Also, the ratio of active/total form of β-catenin protein expression was significantly decreased within the treatment group at the end of intervention period ( p  = .000).
CONCLUSIONS


It seems vitamin D can change the activity of β-catenin protein in the endometrial cells of endometriosis patients. Further studies on the therapeutic potential of vitamin D in modifying the β-catenin activity in endometriosis patients are warranted.
CLINICAL TRIAL REGISTRATION NUMBER


IRCT2015081823678N1.
TRIAL REGISTRATION DATE


29 September 2015.",2021,"Also, the ratio of active/total form of β-catenin protein expression was significantly decreased within the treatment group at the end of intervention period ( p  = .000).
","['women with endometriosis', 'endometriosis patients', 'endometriosis women', 'Thirty four infertile women with stage III or IV endometriosis']",['vitamin D'],"['ratio of active/total form of β-catenin protein expression', 'Protein and Gene expression levels of β-catenin', 'Blood and endometrial tissue', 'activity of β-catenin', 'expression of active form of β-catenin']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",34.0,0.0330926,"Also, the ratio of active/total form of β-catenin protein expression was significantly decreased within the treatment group at the end of intervention period ( p  = .000).
","[{'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Pazhohan', 'Affiliation': 'Department of Midwifery, Urmia Branch, Islamic Azad University, Urmia, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaei-Mehrabad', 'Affiliation': 'Infertility Center, Academic Center for Education, Culture and Research, East Azarbaijan, Tabriz, Iran.'}, {'ForeName': 'Zhila', 'Initials': 'Z', 'LastName': 'Mohamad-Rezaeii', 'Affiliation': 'Department of Midwifery, Urmia Branch, Islamic Azad University, Urmia, Iran.'}, {'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Amidi', 'Affiliation': 'Department of Anatomy, School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahshad', 'Initials': 'M', 'LastName': 'Khodarahmian', 'Affiliation': ""Department of ART, Embryology Laboratory, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shabani Nashtaei', 'Affiliation': 'Department of Anatomy, School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Aligholi', 'Initials': 'A', 'LastName': 'Sobhani', 'Affiliation': 'Department of Anatomy, School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Ali', 'Initials': 'MA', 'LastName': 'Farajzadeh', 'Affiliation': 'Engineering Faculty, Near East University, Nicosia, Turkey.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1858780']
880,33309489,Comparing the effects of 12 months aerobic exercise and resistance training on glucose metabolism among prediabetes phenotype: A explorative randomized controlled trial.,"AIMS


The pathophysiology of each phenotype of prediabetes is unique that promotes different levels of diabetes and cardiovascular disease risks. Exercise guidelines for individuals with prediabetes including both aerobic and resistance training could improve metabolic control, but its effects on different prediabetes subtypes are unclear. The aim of this explorative randomized controlled trial was to evaluate the effects of aerobic training (AT) or resistance training (RT) on glucose metabolism and lipid profile by different prediabetes subtypes with.
METHODS


A randomized controlled trial in which 128 individuals with isolated impaired fasting glucose (i-IFG; n = 39), isolated impaired glucose tolerance (i-IGT; n = 29), combined glucose tolerance (CGI; n = 27) and isolated elevated HbA 1c  (n = 33) were randomly assigned to the control group, AT group and RT group, respectively. Supervised exercise training, including AT and RT were completed at moderate intensity for 60 min per day, three non-consecutive days per week for 12 months. The primary outcome was improvement in glucose metabolism. Secondary outcomes included measure of lipid profile and if these effects were moderated by the prediabetes phenotype.
RESULTS


Of the initial 128 participants, 118 finished the study, but all participants were included in the intention-to-treat analyses. The improvement in 2 h postprandial plasma glucose (2 hPG) between group difference (AT vs. RT) at 12 months was 0.87 (95% CI, -1.59 to-0.16; p < 0.05). Compared with RT group, AT significantly decreased the 2hPG in participants with i-IGT at 12 months (-1.66, 95% CI -3.04 to -0.28; p < 0.05).
CONCLUSIONS


AT program conferred benefits in improving 2 h PG and HbA 1c  compared with RT for prediabetes. These findings may moderate by prediabetes phenotype, and AT appeared more effective in i-IGT. A future trial with large sample size and long time follow up of prediabetes phenotype groups are needed.",2021,"Compared with RT group, AT significantly decreased the 2hPG in participants with i-IGT at 12 months (-1.66, 95% CI -3.04 to -0.28; p < 0.05).
","['118 finished the study, but all participants were included in the intention-to-treat analyses', 'different prediabetes subtypes with', 'individuals with prediabetes including both aerobic and resistance training', 'Of the initial 128 participants', 'prediabetes phenotype', '128 individuals with isolated impaired fasting glucose (i-IFG; n = 39), isolated impaired glucose tolerance (i-IGT; n = 29), combined glucose tolerance (CGI; n = 27) and isolated elevated HbA 1c  (n = 33']","['aerobic training (AT) or resistance training (RT', 'Supervised exercise training, including AT and RT', 'aerobic exercise and resistance training']","['glucose metabolism and lipid profile', 'lipid profile', 'glucose metabolism', '2 h postprandial plasma glucose']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",128.0,0.118141,"Compared with RT group, AT significantly decreased the 2hPG in participants with i-IGT at 12 months (-1.66, 95% CI -3.04 to -0.28; p < 0.05).
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Yangzhou University, 136 Jiangyang Road, Yangzhou, 225009 PR China. Electronic address: liulin163com@163.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Shaoyang University, Meizijing Campus, Xueyuan Road, Daxiang District, Shaoyang City, 422000 PR China. Electronic address: 821080836@qq.com.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Yangzhou University, 136 Jiangyang Road, Yangzhou, 225009 PR China; Nagano College of Nursing, Komagane, Nagano, 399-4117 Japan.'}, {'ForeName': 'Sijie', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'Central Hospital of Shaoyang, 36 Qianyuan Lane, Daxiang District, Shaoyang City, 422000 PR China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Jiangsu Province Academy of Traditional Chinese Medicine, #100 Hongshan Road, Qixia District Nanjing, 210028 PR China. Electronic address: Yuanxiaodan107@163.com.'}]",Primary care diabetes,['10.1016/j.pcd.2020.11.003']
881,33308429,Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in healthy adults: two clinical trials.,"BACKGROUND


Two novel type 2 oral poliovirus vaccine (OPV2) candidates, novel OPV2-c1 and novel OPV2-c2, designed to be more genetically stable than the licensed Sabin monovalent OPV2, have been developed to respond to ongoing polio outbreaks due to circulating vaccine-derived type 2 polioviruses.
METHODS


We did two randomised studies at two centres in Belgium. The first was a phase 4 historical control study of monovalent OPV2 in Antwerp, done before global withdrawal of OPV2, and the second was a phase 2 study in Antwerp and Ghent with novel OPV2-c1 and novel OPV2-c2. Eligible participants were healthy adults aged 18-50 years with documented history of at least three polio vaccinations, including OPV in the phase 4 study and either OPV or inactivated poliovirus vaccine (IPV) in the novel OPV2 phase 2 study, with no dose within 12 months of study start. In the historical control trial, participants were randomly assigned to either one dose or two doses of monovalent OPV2. In the novel OPV2 trial, participants with previous OPV vaccinations were randomly assigned to either one or two doses of novel OPV2-c1 or to one or two doses of novel OPV2-c2. IPV-vaccinated participants were randomly assigned to receive two doses of either novel OPV2-c1, novel OPV2-c2, or placebo. Vaccine administrators were unmasked to treatment; medical staff performing safety and reactogenicity assessments or blood draws for immunogenicity assessments were masked. Participants received the first vaccine dose on day 0, and a second dose on day 28 if assigned to receive a second dose. Primary objectives were assessments and comparisons of safety up to 28 days after each dose, including solicited adverse events and serious adverse events, and immunogenicity (seroprotection rates on day 28 after the first vaccine dose) between monovalent OPV2 and the two novel OPV2 candidates. Primary immunogenicity analyses were done in the per-protocol population. Safety was assessed in the total vaccinated population-ie, all participants who received at least one dose of their assigned vaccine. The phase 4 control study is registered with EudraCT (2015-003325-33) and the phase 2 novel OPV2 study is registered with EudraCT (2018-001684-22) and ClinicalTrials.gov (NCT04544787).
FINDINGS


In the historical control study, between Jan 25 and March 18, 2016, 100 volunteers were enrolled and randomly assigned to receive one or two doses of monovalent OPV2 (n=50 in each group). In the novel OPV2 study, between Oct 15, 2018, and Feb 27, 2019, 200 previously OPV-vaccinated volunteers were assigned to the four groups to receive one or two doses of novel OPV2-c1 or novel OPV2-c2 (n=50 per group); a further 50 participants, previously vaccinated with IPV, were assigned to novel OPV2-c1 (n=17), novel OPV2-c2 (n=16), or placebo (n=17). All participants received the first dose of assigned vaccine or placebo and were included in the total vaccinated population. All vaccines appeared safe; no definitely vaccine-related withdrawals or serious adverse events were reported. After first doses in previously OPV-vaccinated participants, 62 (62%) of 100 monovalent OPV2 recipients, 71 (71%) of 100 recipients of novel OPV2-c1, and 74 (74%) of 100 recipients of novel OPV2-c2 reported solicited systemic adverse events, four (monovalent OPV2), three (novel OPV2-c1), and two (novel OPV2-c2) of which were considered severe. In IPV-vaccinated participants, solicited adverse events occurred in 16 (94%) of 17 who received novel OPV2-c1 (including one severe) and 13 (81%) of 16 who received novel OPV2-c2 (including one severe), compared with 15 (88%) of 17 placebo recipients (including two severe). In previously OPV-vaccinated participants, 286 (97%) of 296 were seropositive at baseline; after one dose, 100% of novel OPV2 vaccinees and 97 (97%) of monovalent OPV2 vaccinees were seropositive.
INTERPRETATION


Novel OPV2 candidates were as safe, well tolerated, and immunogenic as monovalent OPV2 in previously OPV-vaccinated and IPV-vaccinated adults. These data supported the further assessment of the vaccine candidates in children and infants.
FUNDING


University of Antwerp and Bill & Melinda Gates Foundation.",2021,All vaccines appeared safe; no definitely vaccine-related withdrawals or serious adverse events were reported.,"['children and infants', 'IPV-vaccinated participants', 'Jan 25 and March 18, 2016, 100 volunteers', 'healthy adults', 'Eligible participants were healthy adults aged 18-50 years with documented history of at least three polio vaccinations, including OPV in the phase 4 study and either OPV or inactivated poliovirus vaccine (IPV) in the novel OPV2 phase 2 study, with no dose within 12 months of study start', 'participants with previous OPV vaccinations', '200 previously OPV-vaccinated volunteers', 'n=50 per group); a further 50 participants, previously vaccinated with IPV', 'We did two randomised studies at two centres in Belgium', '2015-003325-33) and the phase 2 novel OPV2 study is registered with EudraCT (2018-001684-22) and ClinicalTrials.gov (NCT04544787']","['monovalent OPV2', 'novel OPV2-c1 (n=17), novel OPV2-c2 (n=16), or placebo', 'novel OPV2-c1 or novel OPV2-c2 ', 'vaccine or placebo', 'novel OPV2-c1, novel OPV2-c2, or placebo', 'monovalent type 2 oral poliovirus vaccine', 'monovalent OPV2 ', 'EudraCT', 'novel OPV2-c1 or to one or two doses of novel OPV2-c2']","['solicited systemic adverse events', 'solicited adverse events', 'Safety and immunogenicity', 'solicited adverse events and serious adverse events, and immunogenicity (seroprotection rates', 'Safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0199809', 'cui_str': 'Poliomyelitis vaccination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C0282462', 'cui_str': 'Clinical Trials, Phase 4 as Topic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.204143,All vaccines appeared safe; no definitely vaccine-related withdrawals or serious adverse events were reported.,"[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'De Coster', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Ananda S', 'Initials': 'AS', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Kanchanamala', 'Initials': 'K', 'LastName': 'Withanage', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Steenackers', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'De Smedt', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Aerssens', 'Affiliation': 'Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'M Steven', 'Initials': 'MS', 'LastName': 'Oberste', 'Affiliation': 'Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Konopka-Anstadt', 'Affiliation': 'Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Weldon', 'Affiliation': 'Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Konz', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Rahnuma', 'Initials': 'R', 'LastName': 'Wahid', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Modlin', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA; PATH, Washington DC, USA; Dartmouth Geisel School of Medicine, Hanover, NH, USA.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Clemens', 'Affiliation': 'Global Research in Infectious Diseases, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sue Ann', 'Initials': 'SA', 'LastName': 'Costa Clemens', 'Affiliation': 'Institute for Global Health, Siena University, Siena, Italy.'}, {'ForeName': 'Novilia S', 'Initials': 'NS', 'LastName': 'Bachtiar', 'Affiliation': 'PT Bio Farma, Bandung, Indonesia.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium. Electronic address: pierre.vandamme@uantwerpen.be.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)32541-1']
882,33308425,"Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study.","BACKGROUND


Phase 3 clinical studies showed non-inferiority of long-acting intramuscular cabotegravir and rilpivirine dosed every 4 weeks to oral antiretroviral therapy. Important phase 2 results of every 8 weeks dosing, and supportive modelling, underpin further evaluation of every 8 weeks dosing in this trial, which has the potential to offer greater convenience. Our objective was to compare the week 48 antiviral efficacy of cabotegravir plus rilpivirine long-acting dosed every 8 weeks with that of every 4 weeks dosing.
METHODS


ATLAS-2M is an ongoing, randomised, multicentre (13 countries; Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the USA), open-label, phase 3b, non-inferiority study of cabotegravir plus rilpivirine long-acting maintenance therapy administered intramuscularly every 8 weeks (cabotegravir 600 mg plus rilpivirine 900 mg) or every 4 weeks (cabotegravir 400 mg plus rilpivirine 600 mg) to treatment-experienced adults living with HIV-1. Eligible newly recruited individuals must have received an uninterrupted first or second oral standard-of-care regimen for at least 6 months without virological failure and be aged 18 years or older. Eligible participants from the ATLAS trial, from both the oral standard-of-care and long-acting groups, must have completed the 52-week comparative phase with an ATLAS-2M screening plasma HIV-1 RNA less than 50 copies per mL. Participants were randomly assigned 1:1 to receive cabotegravir plus rilpivirine long-acting every 8 weeks or every 4 weeks. The randomisation schedule was generated by means of the GlaxoSmithKline validated randomisation software RANDALL NG. The primary endpoint at week 48 was HIV-1 RNA ≥50 copies per mL (Snapshot, intention-to-treat exposed), with a non-inferiority margin of 4%. The trial is registered at ClinicalTrials.gov, NCT03299049 and is ongoing.
FINDINGS


Screening occurred between Oct 27, 2017, and May 31, 2018. Of 1149 individuals screened, 1045 participants were randomised to the every 8 weeks (n=522) or every 4 weeks (n=523) groups; 37% (n=391) transitioned from every 4 weeks cabotegravir plus rilpivirine long-acting in ATLAS. Median participant age was 42 years (IQR 34-50); 27% (n=280) female at birth; 73% (n=763) white race. Cabotegravir plus rilpivirine long-acting every 8 weeks was non-inferior to dosing every 4 weeks (HIV-1 RNA ≥50 copies per mL; 2% vs 1%) with an adjusted treatment difference of 0·8 (95% CI -0·6-2·2). There were eight (2%, every 8 weeks group) and two (<1%, every 4 weeks group) confirmed virological failures (two sequential measures ≥200 copies per mL). For the every 8 weeks group, five (63%) of eight had archived non-nucleoside reverse transcriptase inhibitor resistance-associated mutations to rilpivirine at baseline. The safety profile was similar between dosing groups, with 844 (81%) of 1045 participants having adverse events (excluding injection site reactions); no treatment-related deaths occurred.
INTERPRETATION


The efficacy and safety profiles of dosing every 8 weeks and dosing every 4 weeks were similar. These results support the use of cabotegravir plus rilpivirine long-acting administered every 2 months as a therapeutic option for people living with HIV-1.
FUNDING


ViiV Healthcare and Janssen.",2021,"The safety profile was similar between dosing groups, with 844 (81%) of 1045 participants having adverse events (excluding injection site reactions); no treatment-related deaths occurred.
","['Eligible newly recruited individuals must have received an uninterrupted first or second oral standard-of-care regimen for at least 6 months without virological failure and be aged 18 years or older', 'adults with HIV-1 infection (ATLAS-2M', 'Of 1149 individuals screened, 1045 participants', 'multicentre (13 countries; Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the USA), open-label, phase 3b, non-inferiority study of', 'Median participant age was 42 years (IQR 34-50); 27% (n=280) female at birth; 73% (n=763) white race', 'Eligible participants from the ATLAS trial, from both the oral standard-of-care and long-acting groups, must have completed the 52-week comparative phase with an ATLAS-2M screening plasma HIV-1 RNA less than 50 copies per mL. Participants']","['Cabotegravir plus rilpivirine', 'rilpivirine long-acting in ATLAS', 'rilpivirine', 'cabotegravir plus rilpivirine long-acting maintenance therapy administered intramuscularly every 8 weeks (cabotegravir 600 mg plus rilpivirine 900 mg) or every 4 weeks (cabotegravir 400 mg plus rilpivirine 600 mg) to treatment-experienced adults living with HIV-1', 'cabotegravir plus rilpivirine']","['virological failures', 'HIV-1 RNA ≥50 copies per mL (Snapshot, intention-to-treat exposed', 'safety profile', 'adverse events', 'efficacy and safety profiles']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004170', 'cui_str': 'Bone structure of atlas'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439526', 'cui_str': '/mL'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1045.0,0.207308,"The safety profile was similar between dosing groups, with 844 (81%) of 1045 participants having adverse events (excluding injection site reactions); no treatment-related deaths occurred.
","[{'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: eoverton@uabmc.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Richmond', 'Affiliation': 'Nova Southeastern University, FL, USA.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Rizzardini', 'Affiliation': 'Fatebenefratelli Sacco Hospital, Milan, Italy; School of Clinical Medicine, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Jaeger', 'Affiliation': 'MVZ Karlsplatz, HIV Research and Clinical Care Centre, Munich, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Orrell', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.'}, {'ForeName': 'Firaya', 'Initials': 'F', 'LastName': 'Nagimova', 'Affiliation': 'Republic Center for the Prevention and Control of AIDS and Infectious Diseases, Russia.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Bredeek', 'Affiliation': 'Metropolis Medical, San Francisco, CA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'García Deltoro', 'Affiliation': 'General Hospital of Valencia, Valencia, Spain.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'University of Nebraska Medical Center, Omaha, USA.'}, {'ForeName': 'Jaime Federico', 'Initials': 'JF', 'LastName': 'Andrade-Villanueva', 'Affiliation': 'Hospital Civil ""Fray Antonio Alcalde"", Guadalajara, Mexico.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, University of Saskatchewan, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Khuong-Josses', 'Affiliation': 'CH - Hôpital Delafontaine, Saint-Denis, France.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Van Solingen-Ristea', 'Affiliation': 'Janssen Research and Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'van Eygen', 'Affiliation': 'Janssen Research and Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Herta', 'Initials': 'H', 'LastName': 'Crauwels', 'Affiliation': 'Janssen Research and Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ford', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Talarico', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Benn', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Krischan J', 'Initials': 'KJ', 'LastName': 'Hudson', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Chounta', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cutrell', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Shaefer', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Vanveggel', 'Affiliation': 'Janssen Research and Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Spreen', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)32666-0']
883,33314332,Prospective randomized clinical trial evaluating the effects of two different implant collar designs on peri-implant healing and functional osseointegration after 25 years.,"OBJECTIVES


Evaluate the effects of two different machined-collar lengths and designs on peri-implant healing.
MATERIAL AND METHODS


An implant with a microtextured surface and 3.6mm-long internal-connection machined collar was compared to two implants that had an identical 1.2mm-long external-connection machined collar, but one had the microtextured surface while the other's was machined. Participants received the three implants, with microgap at the crest, alternately at five sites between mental foramen, and a full-arch prosthesis. Peri-implant bone levels were measured after 23 to 26 years of function. Keratinized tissue height, plaque, probing depth, bleeding, and purulence were also evaluated. Descriptive and mixed models for repeated\measures analyses were used, with Bonferroni correction for pairwise comparisons.
RESULTS


Twenty-two participants (110 implants) were evaluated at the 25-year examination. Microtextured implants with the longer machined collar had significantly greater mean marginal bone loss (-1.77mm ± 0.18, mean ± SE) than machined (-0.85mm ± 0.18, p < .001) and microtextured (-1.00 ± 0.18mm, p < .001) implants with the shorter machined collar. Keratinized tissue height was greater for internal-connection (0.74mm ± 0.10) versus external-connection (0.51 ± 0.08, p =  0.01) microtextured implants. No differences were observed for plaque (p = 0.78), probing depth (p = 0.42), bleeding (p  = 0.07), and purulence (p = 1.00). Implant survival rate was 99%.
CONCLUSIONS


Implants with the 1.2mm machined collar limited bone loss to 1mm, while those with the longer machined collar showed > 1.5mm loss after 25 years of function with microgap at the crest. Internal-connection design and fixture surface microtexturing did not result in greater bone preservation. ClinicalTrials.gov Identifier: NCT03862482.",2021,"No differences were observed for plaque (p = 0 .78), probing depth (p = 0.42), bleeding (p = 0.07), and purulence (p = 1.00).",['after 25 Years'],['Two Different Implant Collar Designs'],"['probing depth', 'greater bone preservation', 'bleeding', 'Implant survival rate', 'mean marginal bone loss', 'Keratinized tissue height, plaque, probing depth, bleeding, and purulence', 'Peri-implant bone levels', 'Keratinized tissue height', 'Peri-Implant Healing and Functional Osseointegration']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0854358', 'cui_str': 'Purulence'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079949', 'cui_str': 'Osseointegration'}]",,0.0402446,"No differences were observed for plaque (p = 0 .78), probing depth (p = 0.42), bleeding (p = 0.07), and purulence (p = 1.00).","[{'ForeName': 'Aldo Joseph', 'Initials': 'AJ', 'LastName': 'Camarda', 'Affiliation': 'Département de stomatologie, Faculty of Dental Medicine, Université de Montréal, Pavillion Roger-Gaudry, Montreal, QC, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Durand', 'Affiliation': 'Département de santé buccale, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Benkarim', 'Affiliation': 'Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Pierre H', 'Initials': 'PH', 'LastName': 'Rompré', 'Affiliation': 'Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Guertin', 'Affiliation': 'Département de dentisterie de restauration, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Ciaburro', 'Affiliation': 'Département de dentisterie de restauration, Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}]",Clinical oral implants research,['10.1111/clr.13699']
884,33314183,Fructan-sensitive children with irritable bowel syndrome have distinct gut microbiome signatures.,"BACKGROUND


Dietary fructans may worsen gastrointestinal symptoms in children with irritable bowel syndrome (IBS).
AIM


To determine whether gut microbiome composition and function are associated with childhood IBS fructan-induced symptoms.
METHODS


Faecal samples were collected from 38 children aged 7-17 years with paediatric Rome III IBS, who previously completied a double-blind, randomised, placebo-controlled crossover (fructan vs maltodextrin) trial. Fructan sensitivity was defined as an increase of ≥30% in abdominal pain frequency during the fructan diet. Gut microbial composition was determined via 16Sv4 rDNA sequencing. LEfSe evaluated taxonomic composition differences. Tax4Fun2 predicted microbial fructan metabolic pathways.
RESULTS


At baseline, 17 fructan-sensitive (vs 21 fructan-tolerant) subjects had lower alpha diversity (q < 0.05) and were enriched in the genus Holdermania. In contrast, fructan-tolerant subjects were enriched in 14 genera from the class Clostridia. During the fructan diet, fructan-sensitive (vs tolerant) subjects were enriched in both Agathobacter (P = 0.02) and Cyanobacteria (P = 0.0001). In contrast, fructan-tolerant subjects were enriched in three genera from the Clostridia class. Comparing the fructan vs maltodextrin diet, fructan-sensitive subjects had a significantly increased relative abundance of Bifidobacterium (P = 0.02) while fructan-tolerant subjects had increased Anaerostipes (P = 0.03) during the fructan diet. Only fructan-sensitive subjects had a trend towards increased predicted β-fructofuranosidase during the fructan vs maltodextrin diet.
CONCLUSIONS


Fructan-sensitive children with IBS have distinct gut microbiome signatures. These microbiome signatures differ both at baseline and in response to a fructan challenge.",2021,"Only fructan-sensitive subjects had a trend towards increased predicted β-fructofuranosidase during the fructan vs maltodextrin diet.
","['children with irritable bowel syndrome (IBS', 'Faecal samples were collected from 38 children aged 7-17\xa0years with paediatric Rome III IBS, who previously completied a double-blind, randomised', 'Fructan-sensitive children with irritable bowel syndrome']",['placebo-controlled crossover (fructan vs maltodextrin'],"['Fructan sensitivity', 'alpha diversity', 'Gut microbial composition', 'β-fructofuranosidase', 'relative abundance of Bifidobacterium']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",38.0,0.049792,"Only fructan-sensitive subjects had a trend towards increased predicted β-fructofuranosidase during the fructan vs maltodextrin diet.
","[{'ForeName': 'Bruno P', 'Initials': 'BP', 'LastName': 'Chumpitazi', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Hoffman', 'Affiliation': 'Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Smith', 'Affiliation': 'Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'McMeans', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Musaad', 'Affiliation': ""Children's Nutrition Research Center, United States Department of Agriculture, Houston, TX, USA.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Versalovic', 'Affiliation': 'Department of Pathology and Immunology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Petrosino', 'Affiliation': 'Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Shulman', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16204']
885,33336834,Evaluation of an alcohol policy measure employing a randomised controlled trial design: Why was it possible?,"Some of the best evidence of effects of control policies on alcohol availability stems from controlled experimental studies in the Nordic state-owned alcohol monopolies. Publications from these studies do not, however, explain the process leading up to the implementation of changes in policy measures under controlled experimental conditions. In September 2020, the Norwegian state alcohol monopoly started the implementation of extended trading hours, employing a randomised controlled trial design. In this commentary, we give an account of the process leading up to this implementation and how the monopoly considered various pro- and contra-arguments in this regard. This case illustrates that willingness to contribute to strengthened scientific evidence on alcohol control policies can be embedded in the social responsibility of a state alcohol monopoly.",2021,"In September 2020, the Norwegian state alcohol monopoly started the implementation of extended trading hours, employing a randomised controlled trial design.",[],[],[],[],[],[],,0.0240892,"In September 2020, the Norwegian state alcohol monopoly started the implementation of extended trading hours, employing a randomised controlled trial design.","[{'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Rossow', 'Affiliation': 'Department of Alcohol, Tobacco and Drugs, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Maja Weemes', 'Initials': 'MW', 'LastName': 'Grøtting', 'Affiliation': 'Department of Alcohol, Tobacco and Drugs, Norwegian Institute of Public Health, Oslo, Norway.'}]",Drug and alcohol review,['10.1111/dar.13230']
886,33327043,Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia: A randomized controlled trial.,"OBJECTIVE


To evaluate the safety, efficacy and cost-effectiveness of holmium enucleation of the prostate and bipolar transurethral enucleation of the prostate.
METHODS


In our randomized controlled trial, 120 patients were allocated into two equal groups representing holmium enucleation of the prostate and bipolar enucleation of the prostate. Operative parameters were recorded according to operative, enucleation and resection time in addition to the intraoperative complications. Patients were followed up at 1, 3 and 12 months postoperative to assess the prostate size, post-voiding residual urine, International Prostate Symptom Score, peak urine flow rate and quality of life, and compared with the preoperative parameters. Cost analysis was evaluated for both procedures.
RESULTS


We evaluated 107 patients who finished our follow up and their data were analyzed. The prostate size was 135.2 ± 34.8 mL and 125 ± 26.9 mL for holmium enucleation of the prostate and bipolar enucleation of the prostate, respectively. Holmium enucleation of the prostate was associated with a shorter operative time of 83.43 ± 6.92 min compared with 94.7 ± 12.2 min in bipolar enucleation of the prostate groups. Holmium enucleation of the prostate was associated with an earlier catheter removal time and shorter hospital stay compared with bipolar enucleation of the prostate. Postoperative International Prostate Symptom Score, quality of life, post-voiding residual urine, peak urine flow rate, prostate-specific antigen and prostate volume reduction were comparable between both groups, and they both showed statistically significant improvement compared with their preoperative parameters. In the cost analysis, holmium enucleation of the prostate was more cost-effective than bipolar enucleation of the prostate.
CONCLUSION


Both holmium enucleation of the prostate and bipolar enucleation of the prostate are safe and effective in the surgical management of large prostatic adenomas. Holmium enucleation of the prostate has a shorter operative time and hospital stay with earlier catheter removal time, and is more cost-effective than bipolar enucleation of the prostate.",2021,"In the cost analysis, holmium enucleation of the prostate was more cost-effective than bipolar enucleation of the prostate.
","['107 patients who finished our follow up and their data were analyzed', 'benign prostatic hyperplasia', '120 patients', 'large prostatic adenomas']","['holmium enucleation of the prostate and bipolar enucleation of the prostate', 'Holmium laser enucleation of the prostate versus bipolar transurethral enucleation', 'holmium enucleation of the prostate and bipolar enucleation', 'holmium enucleation of the prostate and bipolar transurethral enucleation', 'Holmium enucleation', 'holmium enucleation']","['prostate size, post-voiding residual urine, International Prostate Symptom Score, peak urine flow rate and quality of life', 'operative time and hospital stay', 'safety, efficacy and cost-effectiveness', 'Postoperative International Prostate Symptom Score, quality of life, post-voiding residual urine, peak urine flow rate, prostate-specific antigen and prostate volume reduction', 'operative, enucleation and resection time in addition to the intraoperative complications', 'earlier catheter removal time and shorter hospital stay']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0520477', 'cui_str': 'Benign adenoma of prostate'}]","[{'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}]","[{'cui': 'C0426731', 'cui_str': 'Prostate size'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",120.0,0.029114,"In the cost analysis, holmium enucleation of the prostate was more cost-effective than bipolar enucleation of the prostate.
","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Higazy', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Tawfeek', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Hany Moustafa', 'Initials': 'HM', 'LastName': 'Abdalla', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Shorbagy', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Mousa', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ahmed I', 'Initials': 'AI', 'LastName': 'Radwan', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14462']
887,33327040,"Editorial Comment to Apalutamide for metastatic, castration-sensitive prostate cancer in the Japanese population: A subgroup analysis of the randomized, double-blind, placebo-controlled phase 3 TITAN study.",,2021,,['Japanese population'],['placebo'],[],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.442639,,"[{'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Urology, Chiba University Graduate School of Medicine, Chiba, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14470']
888,33317802,Perioperative use of physostigmine to reduce opioid consumption and peri-incisional hyperalgesia: a randomised controlled trial.,"BACKGROUND


Several studies have shown that cholinergic mechanisms play a pivotal role in the anti-nociceptive system by acting synergistically with morphine and reducing postoperative opioid consumption. In addition, the anti-cholinesterase drug physostigmine that increases synaptic acetylcholine concentrations has anti-inflammatory effects.
METHODS


In this randomised placebo-controlled trial including 110 patients undergoing nephrectomy, we evaluated the effects of intraoperative physostigmine 0.5 mg h -1  i.v. for 24 h on opioid consumption, hyperalgesia, pain scores, and satisfaction with pain control.
RESULTS


Physostigmine infusion did not affect opioid consumption compared with placebo. However, the mechanical pain threshold was significantly higher (2.3 [sd 0.3]) vs 2.2 [0.4]; P=0.0491), and the distance from the suture line of hyperalgesia (5.9 [3.3] vs 8.5 [4.6]; P=0.006), wind-up ratios (2.2 [1.5] vs 3.1 [1.5]; P=0.0389), and minimum and maximum postoperative pain scores at 24 h (minimum 1.8 [1.0] vs 2.4 [1.2]; P=0.0451; and maximum 3.2 [1.4] vs 4.2 [1.4]; P=0.0081) and 48 h (minimum 0.9 [1.0] vs 1.6 [1.1]; P=0.0101; and maximum 2.0 [1.5] vs 3.2 [1.6]; P=0.0029) were lower in the study group. Pain Disability Index was lower and satisfaction with pain control was higher after 3 months in the physostigmine group.
CONCLUSIONS


In contrast to previous trials, physostigmine did not reduce opioid consumption. As pain thresholds were higher and hyperalgesia and wind-up lower in the physostigmine group, we conclude that physostigmine has anti-hyperalgesic effects and attenuates sensitisation processes. Intraoperative physostigmine may be a useful and safe addition to conventional postoperative pain control.
CLINICAL TRIAL REGISTRATION


EudraCT number 2012-000130-19.",2021,"As pain thresholds were higher and hyperalgesia and wind-up lower in the physostigmine group, we conclude that physostigmine has anti-hyperalgesic effects and attenuates sensitisation processes.",['110 patients undergoing'],"['morphine', 'placebo', 'intraoperative physostigmine 0.5 mg h -1  i.v', 'Intraoperative physostigmine', 'nephrectomy', 'Physostigmine', 'physostigmine']","['opioid consumption', 'Pain Disability Index', 'mechanical pain threshold', 'synaptic acetylcholine concentrations', 'minimum and maximum postoperative pain scores', 'distance from the suture line of hyperalgesia', 'opioid consumption and peri-incisional hyperalgesia', 'opioid consumption, hyperalgesia, pain scores, and satisfaction with pain control', 'satisfaction with pain control']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0031849', 'cui_str': 'Physostigmine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1563019', 'cui_str': 'Suture line'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",110.0,0.329638,"As pain thresholds were higher and hyperalgesia and wind-up lower in the physostigmine group, we conclude that physostigmine has anti-hyperalgesic effects and attenuates sensitisation processes.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Klivinyi', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Rumpold-Seitlinger', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dorn', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Sampl', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Sivro', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Kordula', 'Initials': 'K', 'LastName': 'Lang-Illievich', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Fleck', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Farzi', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Helmar', 'Initials': 'H', 'LastName': 'Bornemann-Cimenti', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria. Electronic address: helmar.bornemann@medunigraz.at.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.10.039']
889,33326140,On the trail of blood doping-microRNA fingerprints to monitor autologous blood transfusions in vivo.,"Autologous blood doping refers to the illegal re-transfusion of any quantities of blood or blood components with blood donor and recipient being the same person. The re-transfusion of stored erythrocyte concentrates is particularly attractive to high-performance athletes as this practice improves their oxygen capacity excessively. However, there is still no reliable detection method available. Analyzing circulating microRNA profiles of human subjects that underwent monitored autologous blood transfusions seems to be a highly promising approach to develop novel biomarkers for autologous blood doping. In this exploratory study, we randomly divided 30 healthy males into two different treatment groups and one control group and sampled whole blood at several time points at baseline, after whole blood donation and after transfusion of erythrocyte concentrates. Hematological variables were recorded and analyzed following the adaptive model of the Athlete Biological Passport. microRNA profiles were examined by small RNA sequencing and comprehensive multivariate data analyses, revealing microRNA fingerprints that reflect the sampling time point and transfusion volume. Neither individual microRNAs nor a signature of transfusion-dependent microRNAs reached superior sensitivity at 100% specificity compared to the Athlete Biological Passport (≤11% 6 h after transfusion versus ≤44% 2 days after transfusion). However, the window of autologous blood doping detection was different. Due to the heterogenous nature of doping, with athletes frequently combining multiple medications in order to both gain a competitive advantage and interfere with known testing methods, the true applicability of the molecular signature remains to be validated in real anti-doping testings.",2021,Neither individual microRNAs nor a signature of transfusion-dependent microRNAs reached superior sensitivity at 100 % specificity compared to the Athlete Biological Passport (≤ 11 % six hours after transfusion versus ≤ 44 % two days after transfusion).,"['30 healthy males', 'human subjects']",[],['Hematological variables'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]",[],"[{'cui': 'C0439828', 'cui_str': 'Variable'}]",30.0,0.0121357,Neither individual microRNAs nor a signature of transfusion-dependent microRNAs reached superior sensitivity at 100 % specificity compared to the Athlete Biological Passport (≤ 11 % six hours after transfusion versus ≤ 44 % two days after transfusion).,"[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Mussack', 'Affiliation': 'Animal Physiology and Immunology, School of Life Sciences Weihenstephan, Technical University of Munich, Freising, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Wittmann', 'Affiliation': 'Department for Transfusion Medicine, Cell therapeutics and Haemostaseology, University Hospital LMU, Munich, Germany.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Pfaffl', 'Affiliation': 'Animal Physiology and Immunology, School of Life Sciences Weihenstephan, Technical University of Munich, Freising, Germany.'}]",American journal of hematology,['10.1002/ajh.26078']
890,33326122,Virtual reality rehabilitation in children with brain injury: a randomized controlled trial.,"AIM


To investigate the efficacy of a virtual reality rehabilitation system of wearable multi-inertial sensors to improve upper-limb function in children with brain injury.
METHOD


Eighty children (39 males, 41 females) with brain injury including cerebral palsy aged 3 to 16 years (mean age 5y 8mo, SD 2y 10mo) were assessed as part of a multicentre, single-blind, randomized controlled trial. The intervention group received a 30-minute virtual reality intervention and a 30-minute session of conventional occupational therapy while the control group received 60 minutes of conventional occupational therapy per session, with 20 sessions over 4 weeks. The virtual reality rehabilitation system consisted of games promoting wrist and forearm articular movements using wearable inertial sensors. The Melbourne Assessment of Unilateral Upper Limb Function-2 (MA-2), Upper Limb Physician's Rating Scale, Pediatric Evaluation of Disability Inventory Computer Adaptive Test, and computerized three-dimensional motion analysis were performed.
RESULTS


Both groups (virtual reality, n=40; control, n=38) significantly improved after treatment compared to baseline; however, the virtual reality group showed more significant improvements in upper-limb dexterity functions (MA-2, virtual reality group: Δ=10.09±10.50; control: Δ=3.65±6.92), performance of activities of daily living, and forearm supination by kinematic analysis (p<0.05). In the virtual reality group, children with more severe motor impairment showed significant improvements compared to those with less severe impairment.
INTERPRETATION


The virtual reality rehabilitation system used in this study, which consists of wearable inertial sensors and offers intensive, interactive, and repetitive motor training, is effective in children with brain injury.
WHAT THIS PAPER ADDS


Both virtual reality rehabilitation and conventional occupational therapy were effective for upper-limb training. Virtual reality training was superior in improving dexterity, performance of activities of daily living, and active forearm supination motion. The effect of virtual reality training was significant in children with more severe motor impairments.",2021,"Both groups (virtual reality, n=40; control, n=38) significantly improved after treatment compared to baseline; however, the virtual reality group showed more significant improvements in upper-limb dexterity functions (MA-2, virtual reality group: Δ=10.09±10.50; control: Δ=3.65±6.92), performance of activities of daily living, and forearm supination by kinematic analysis (p<0.05).","['children with brain injury', 'Eighty children (39 males, 41 females) with brain injury including cerebral palsy aged 3 to 16 years']","['30-minute virtual reality intervention and a 30-minute session of conventional occupational therapy while the control group received 60 minutes of conventional occupational therapy per session', 'virtual reality rehabilitation system consisted of games promoting wrist and forearm articular movements using wearable inertial sensors', 'virtual reality rehabilitation system of wearable multi-inertial sensors', 'Virtual reality rehabilitation']","[""Unilateral Upper Limb Function-2 (MA-2), Upper Limb Physician's Rating Scale, Pediatric Evaluation of Disability Inventory Computer Adaptive Test, and computerized three-dimensional motion analysis"", 'upper-limb dexterity functions', 'severe impairment', 'performance of activities of daily living, and forearm supination by kinematic analysis (p<0.05']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2732438', 'cui_str': 'Melbourne assessment of unilateral upper limb function'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",80.0,0.0787778,"Both groups (virtual reality, n=40; control, n=38) significantly improved after treatment compared to baseline; however, the virtual reality group showed more significant improvements in upper-limb dexterity functions (MA-2, virtual reality group: Δ=10.09±10.50; control: Δ=3.65±6.92), performance of activities of daily living, and forearm supination by kinematic analysis (p<0.05).","[{'ForeName': 'Ja Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Sook-Hee', 'Initials': 'SH', 'LastName': 'Yi', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul Rehabilitation Hospital, Seoul, Korea.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Ao', 'Affiliation': 'School of Rehabilitation, Kunming Medical University, Kunming, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'School of Rehabilitation, Kunming Medical University, Kunming, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'School of Rehabilitation, Kunming Medical University, Kunming, China.'}, {'ForeName': 'Dain', 'Initials': 'D', 'LastName': 'Shim', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beomki', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Park', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong-Wook', 'Initials': 'DW', 'LastName': 'Rha', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14762']
891,33338583,"Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers.","BACKGROUND


Ashwagandha (Withania somnifera) is a well-established and reputed herb in Ayurvedic medicine. It has been used as a ""Rasayana"" (rejuvenator), nootropic, and as a powerful natural adaptogen. The herb extract is extensively used for general wellbeing and in specific ailments. However, only a few studies have investigated the safety and tolerability of Ashwagandha in humans. This study evaluated the safety of Ashwagandha root extract consumption in healthy adults.
METHODS


In this randomized, double-blind, placebo-controlled, and parallel-group study, 80 healthy participants (40 males, 40 females) were randomized in a 1:1 ratio to receive either Ashwagandha 300 mg or a placebo of the same dosage, twice daily, orally for 8 weeks. The study was conducted at MV Hospital, and King George Medical University, Lucknow, India. The primary safety outcomes considered were laboratory assessment of hematological parameters, serum biochemistry analysis including hepatotoxicity evaluation, and thyroid function parameters. The secondary outcomes of this study were the clinical adverse events and the vital parameters. The within and between the groups' datasets were compared using the Wilcoxon signed-rank test and the Mann Whitney U test, respectively.
RESULTS


A detailed evaluation of the vital signs such as body weight, body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure, and Body Mass Index (BMI) were conducted for each participant at the baseline and the end of the study for treatment and placebo groups. Similarly, hematological and biochemical parameters were evaluated at the baseline and at the end of study. The outcome did not indicate any untoward effects in any of the treated volunteers. No statistically significant change or abnormality was observed in the considered parameters including thyroid hormonal profile in both the groups. No adverse events were reported by any of the participants in this study.
CONCLUSIONS


Ashwagandha is being consumed since time immemorial following the Ayurvedic medicine practices. Modern science requires evidence of the safety and efficacy of the Ashwagandha extract before mass consumption for various health issues and as a supplement. The present study revealed that the consumption of Ashwagandha root extract for 8 weeks was safe in both males and females volunteers. However, long term study and varying dosage ranges should be investigated in the future.",2020,No statistically significant change or abnormality was observed in the considered parameters including thyroid hormonal profile in both the groups.,"['males and females volunteers', '80 healthy participants (40 males, 40 females', 'Healthy Volunteers', 'healthy adults']","['placebo', 'Ashwagandha Root Extract', 'Ashwagandha root extract consumption', 'Placebo', 'Ashwagandha 300\u2009mg or a starch placebo']","['clinical adverse events and the vital parameters', 'safety and tolerability', 'hematological and biochemical parameters', 'thyroid hormonal profile', 'adverse events', 'body weight, body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure, and Body Mass Index (BMI', 'laboratory assessment of hematological parameters, serum biochemistry analysis including hepatotoxicity evaluation, and thyroid function parameters']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",80.0,0.0702887,No statistically significant change or abnormality was observed in the considered parameters including thyroid hormonal profile in both the groups.,"[{'ForeName': 'Narsing', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': ""King George's Medical University, Chowk, Lucknow, 226003, Uttar Pradesh, India.""}, {'ForeName': 'Sandeep Kumar', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'M V Hospital and Research Centre, 314/30 Mirza Mandi, Post Office, Chowk, Lucknow, 226003, Uttar Pradesh, India.'}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Tiwari', 'Affiliation': 'M V Hospital and Research Centre, 314/30 Mirza Mandi, Post Office, Chowk, Lucknow, 226003, Uttar Pradesh, India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Mishra', 'Affiliation': 'M V Hospital and Research Centre, 314/30 Mirza Mandi, Post Office, Chowk, Lucknow, 226003, Uttar Pradesh, India. Electronic address: akmishramvhr@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102642']
892,33317955,Using weighted blankets in an inpatient mental health hospital to decrease anxiety.,"OBJECTIVE


Patients who are involuntarily committed to a psychiatric facility often experience anxiety or increased anxiety in response to being placed in the institutional environment. The weighted blanket introduced a proactive treatment option. The purpose of this study was to evaluate patients' anxiety symptoms before and after weighted blanket, compared to a group that did not use a weighted blanket to control anxiety.
METHODS


This study was conducted in an inpatient mental health facility from June 10, 2019, through November 7, 2019, with psychiatric patients who were not actively psychotic. Participants were offered the choice of weighted or unweighted blankets for a 20-minute intervention. The treatment group was comprised of individuals who had opted to use a 14-pound weighted blanket, 20-pound weighted blanket or 5-pound weighted lap pad. Participants in the comparison group were active in a wider range of settings. Before application of the blankets, pulse rate was measured using a pulse oximeter, and anxiety was measured using the Spielberger State-Trait Anxiety Inventory shortened form (STAI: Y-6). Both measures were taken again after the intervention. A two-way mixed analysis of variance (ANOVA) was run to examine the interaction effects between time (pre/post) and group (comparison/weighted blanket). Simple main effects were then further examined for the comparison/weighted blanket groups using a repeated measures ANOVA. Within the weighted blanket group, additional two-way mixed ANOVA was run to determine if gender or blanket weight made a statistically significant difference.
RESULTS


There was a statistically significant difference (P < 0.05) among those who used weighted blankets (n = 61) and those who did not (n = 61) based on the pre/post data for both the STAI: Y-6 inventory and the patients' pulse rates. The results of two-way ANOVA indicated a significant interaction effect between intervention time and group (P < 0.001). Repeated measures ANOVA indicated a change between pre/post for the weighted blanket group only, and showed significant reductions in both the STAI: Y-6 (P < 0.001) and pulse rates (P = 0.040). Within the weighted blanket group, additional two-way mixed ANOVA showed that neither gender nor blanket weight had significant difference for either the STAI: Y-6 or the pulse measures.
CONCLUSION


The use of weighted blankets is a safe and potentially effective way to help individuals in a psychiatric facility manage anxiety. This study found a statistically significant drop in anxiety for adults at an inpatient facility, as shown by the STAI: Y-6 scores and drop in pulse rates among patients using weighted blankets. This study suggests a possible alternative to medications, seclusion and physical restraints, which are not patient-centered or trauma-supported.",2021,The results of two-way ANOVA indicated a significant interaction effect between intervention time and group (P < 0.001).,"['inpatient mental health facility from June 10, 2019, through November 7, 2019, with psychiatric patients who were not actively psychotic', 'Patients who are involuntarily committed to a psychiatric facility often experience anxiety or increased anxiety in response to being placed in the institutional environment']","['14-pound weighted blanket, 20-pound weighted blanket or 5-pound weighted lap pad', 'weighted blankets']","['anxiety', ""patients' anxiety symptoms"", 'pulse oximeter, and anxiety', 'Spielberger State-Trait Anxiety Inventory', 'pulse rates', 'pulse rate']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0332568', 'cui_str': 'Pad'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}]",,0.0380413,The results of two-way ANOVA indicated a significant interaction effect between intervention time and group (P < 0.001).,"[{'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Becklund', 'Affiliation': 'Annette L Becklund, MSW, LCSW & Associates LLC, PO Box 3870, Spring Hill, FL 34611, USA. Electronic address: annettelbecklund@gmail.com.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rapp-McCall', 'Affiliation': 'Saint Leo University, Saint Leo, FL 33574-6665, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Nudo', 'Affiliation': 'Saint Leo University, Saint Leo, FL 33574-6665, USA.'}]",Journal of integrative medicine,['10.1016/j.joim.2020.11.004']
893,33325793,Effectiveness and Safety of Coadministration of Intravitreal Dexamethasone Implant and Silicone Oil Endotamponade for Proliferative Diabetic Retinopathy with Tractional Diabetic Macular Edema.,"Purpose:  To investigate the efficacy and safety of coadministered intravitreal dexamethasone (IVD) implant and silicone oil endotamponade during pars plana vitrectomy (PPV) for the treatment of proliferative diabetic retinopathy (PDR) with tractional diabetic macular edema (DME).  Methods:  In this prospective, controlled, and randomized clinical study, the eyes with PDR and vitreomacular traction syndrome that underwent PPV with silicone oil endotamponade were divided into 2 groups. Group 1 was defined as the control group, and no other procedures were performed. IVD was implanted to the eyes in Group 2. In both groups, panretinal photocoagulation was completed to the missed areas during PPV. All cases followed for 6 months, postoperatively. Retinal findings were followed with optical coherence tomography and fluorescein fundus angiography.  Results:  A total of 52 eyes of 52 patients were included in the study. Twenty-six eyes of 23 patients were included in both groups. The improvement in best corrected visual acuity was statistically significantly higher in Group 2 ( P  > 0.05). In the postoperative period, the DME development rate and intravitreal ranibizumab (IVR) injection requirement were significantly higher in Group 1 ( P  > 0.05). There was no statistically significant difference in the proliferative vitroretinopathy development rate between the groups ( P  < 0.05).  Conclusion:  Coadministration of IVD implant and silicone oil endotamponade to the eyes with PDR during vitrectomy seems to be safe and effective application and may decrease the rate of DME and the requirement of IVR injection.",2021,There was no statistically significant difference in the proliferative vitroretinopathy development rate between the groups ( P  < 0.05).  ,"['eyes with PDR and vitreomacular traction syndrome that underwent PPV with silicone oil endotamponade', 'proliferative diabetic retinopathy (PDR) with tractional diabetic macular edema (DME', 'Twenty-six eyes of 23 patients were included in both groups', 'A total of 52 eyes of 52 patients were included in the study', 'Proliferative Diabetic Retinopathy with Tractional Diabetic Macular Edema']","['coadministered intravitreal dexamethasone (IVD) implant and silicone oil endotamponade during pars plana vitrectomy (PPV', 'Intravitreal Dexamethasone Implant and Silicone Oil Endotamponade', 'panretinal photocoagulation', 'IVD implant and silicone oil endotamponade']","['DME development rate and intravitreal ranibizumab (IVR) injection requirement', 'corrected visual acuity', 'rate of DME', 'efficacy and safety', 'proliferative vitroretinopathy development rate']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}, {'cui': 'C0730274', 'cui_str': 'Vitreomacular traction syndrome'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C2936394', 'cui_str': 'Endotamponade'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0058217', 'cui_str': 'dimethyl ether'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C2936394', 'cui_str': 'Endotamponade'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}]","[{'cui': 'C0058217', 'cui_str': 'dimethyl ether'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}]",52.0,0.0174515,There was no statistically significant difference in the proliferative vitroretinopathy development rate between the groups ( P  < 0.05).  ,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Altun', 'Affiliation': 'Department of Ophthalmology, Bahcesehir University, Istanbul, Turkey.'}, {'ForeName': 'Hatice Selen', 'Initials': 'HS', 'LastName': 'Kanar', 'Affiliation': 'Clinic of Ophthalmology, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Suat Fazil', 'Initials': 'SF', 'LastName': 'Aki', 'Affiliation': 'Clinic of Ophthalmology, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aysu', 'Initials': 'A', 'LastName': 'Arsan', 'Affiliation': 'Clinic of Ophthalmology, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aynur', 'Initials': 'A', 'LastName': 'Hacisalihoglu', 'Affiliation': 'Clinic of Ophthalmology, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2020.0079']
894,33331902,Intraoperative Oxygen Concentration and Neurocognition after Cardiac Surgery.,"BACKGROUND


Despite evidence suggesting detrimental effects of perioperative hyperoxia, hyperoxygenation remains commonplace in cardiac surgery. Hyperoxygenation may increase oxidative damage and neuronal injury leading to potential differences in postoperative neurocognition. Therefore, this study tested the primary hypothesis that intraoperative normoxia, as compared to hyperoxia, reduces postoperative cognitive dysfunction in older patients having cardiac surgery.
METHODS


A randomized double-blind trial was conducted in patients aged 65 yr or older having coronary artery bypass graft surgery with cardiopulmonary bypass. A total of 100 patients were randomized to one of two intraoperative oxygen delivery strategies. Normoxic patients (n = 50) received a minimum fraction of inspired oxygen of 0.35 to maintain a Pao2 above 70 mmHg before and after cardiopulmonary bypass and between 100 and 150 mmHg during cardiopulmonary bypass. Hyperoxic patients (n = 50) received a fraction of inspired oxygen of 1.0 throughout surgery, irrespective of Pao2 levels. The primary outcome was neurocognitive function measured on postoperative day 2 using the Telephonic Montreal Cognitive Assessment. Secondary outcomes included neurocognitive function at 1, 3, and 6 months, as well as postoperative delirium, mortality, and durations of mechanical ventilation, intensive care unit stay, and hospital stay.
RESULTS


The median age was 71 yr (interquartile range, 68 to 75), and the median baseline neurocognitive score was 17 (16 to 19). The median intraoperative Pao2 was 309 (285 to 352) mmHg in the hyperoxia group and 153 (133 to 168) mmHg in the normoxia group (P < 0.001). The median Telephonic Montreal Cognitive Assessment score on postoperative day 2 was 18 (16 to 20) in the hyperoxia group and 18 (14 to 20) in the normoxia group (P = 0.42). Neurocognitive function at 1, 3, and 6 months, as well as secondary outcomes, were not statistically different between groups.
CONCLUSIONS


In this randomized controlled trial, intraoperative normoxia did not reduce postoperative cognitive dysfunction when compared to intraoperative hyperoxia in older patients having cardiac surgery. Although the optimal intraoperative oxygenation strategy remains uncertain, the results indicate that intraoperative hyperoxia does not worsen postoperative cognition after cardiac surgery.
EDITOR’S PERSPECTIVE


",2021,"Neurocognitive function at 1, 3, and 6 months, as well as secondary outcomes, were not statistically different between groups.
","['100 patients', 'patients aged 65 yr or older having coronary artery bypass graft surgery with cardiopulmonary bypass', 'The median age was 71 yr (interquartile range, 68 to 75), and the median baseline neurocognitive score was 17 (16 to 19', 'Normoxic patients (n = 50', 'older patients having cardiac surgery', 'Hyperoxic patients (n = 50']","['intraoperative hyperoxia', 'minimum fraction of inspired oxygen of 0.35 to maintain a Pao2 above 70 mmHg before and after cardiopulmonary bypass and between 100 and 150 mmHg during cardiopulmonary bypass']","['neurocognitive function measured on postoperative day 2 using the Telephonic Montreal Cognitive Assessment', 'neurocognitive function at 1, 3, and 6 months, as well as postoperative delirium, mortality, and durations of mechanical ventilation, intensive care unit stay, and hospital stay', 'Neurocognitive function', 'postoperative cognitive dysfunction', 'median intraoperative Pao2', 'median Telephonic Montreal Cognitive Assessment score', 'Intraoperative Oxygen Concentration and Neurocognition']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}]",100.0,0.473072,"Neurocognitive function at 1, 3, and 6 months, as well as secondary outcomes, were not statistically different between groups.
","[{'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Shaefi', 'Affiliation': ''}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Shankar', 'Affiliation': ''}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': ""O'Gara"", 'Affiliation': ''}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Spear', 'Affiliation': ''}, {'ForeName': 'Kamal R', 'Initials': 'KR', 'LastName': 'Khabbaz', 'Affiliation': ''}, {'ForeName': 'Aranya', 'Initials': 'A', 'LastName': 'Bagchi', 'Affiliation': ''}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Banner-Goodspeed', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Leaf', 'Affiliation': ''}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Talmor', 'Affiliation': ''}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Marcantonio', 'Affiliation': ''}, {'ForeName': 'Balachundhar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003650']
895,33338437,"Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial.","BACKGROUND


Rimegepant is a calcitonin gene-related peptide receptor antagonist that has shown efficacy and safety in the acute treatment of migraine. We aimed to compare the efficacy of rimegepant with placebo for preventive treatment of migraine.
METHODS


We did a multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial at 92 sites in the USA. Adults with at least a 1-year history of migraine were recruited. After a 4-week observation period, eligible participants were randomised using an interactive web response system to oral rimegepant 75 mg or matching placebo every other day for 12 weeks (double-blind treatment phase). The primary efficacy endpoint was change from the 4-week observation period in the mean number of migraine days per month in the last 4 weeks of the double-blind treatment phase (weeks 9-12). Participants who received at least one dose of their assigned study medication and who had 14 days or more of data in the observation period and 14 days or more of data for at least one 4-week interval during the double-blind treatment phase were analysed for efficacy. Those who received at least one dose of study medication were analysed for safety. This study is registered with ClinicalTrials.gov, NCT03732638.
FINDINGS


Between Nov 14, 2018, and Aug 30, 2019, 1591 participants were recruited and assessed for eligibility, of whom 747 were randomly allocated either rimegepant (n=373) or placebo (n=374). 695 participants were included in the analysis for efficacy, of whom 348 were assigned rimegepant and 347 were allocated placebo. Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9-12. The change from the observation period in mean number of migraine days per month during weeks 9-12 was -4·3 days (95% CI -4·8 to -3·9) with rimegepant and -3·5 days (-4·0 to -3·0) with placebo (least squares mean difference -0·8 days, 95% CI -1·46 to -0·20; p=0·0099). 741 participants received study medication and were included in the safety analysis. 133 (36%) of 370 patients who received rimegepant reported an adverse event, compared with 133 (36%) of 371 who received placebo. Seven (2%) participants who received rimegepant and four (1%) who received placebo discontinued the study due to an adverse event; no patients died.
INTERPRETATION


Taken every other day, rimegepant was effective for preventive treatment of migraine. Tolerability was similar to that of placebo, and no unexpected or serious safety issues were noted.
FUNDING


Biohaven Pharmaceuticals.",2021,Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9-12.,"['695 participants were included in the analysis for efficacy, of whom 348 were assigned rimegepant and 347 were allocated', 'Adults with at least a 1-year history of migraine were recruited', 'Between Nov 14, 2018, and Aug 30, 2019, 1591 participants were recruited and assessed for eligibility, of whom 747 were randomly allocated either rimegepant (n=373) or', 'migraine', '741 participants received study medication and were included in the safety analysis']","['placebo', 'placebo (least squares', 'interactive web response system to oral rimegepant 75 mg or matching placebo', 'Oral rimegepant']","['mean number of migraine days per month', 'adverse event', 'mean number of migraine days', 'Tolerability']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0455512', 'cui_str': 'H/O: migraine'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",695.0,0.732802,Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9-12.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Croop', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA. Electronic address: robert.croop@biohavenpharma.com.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'California Medical Clinic for Headache, Santa Monica, CA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Stock', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kamen', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Conway', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Elyse G', 'Initials': 'EG', 'LastName': 'Stock', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Coric', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital/SLaM Biomedical Research Centre, King's College London, UK; University of California, Los Angeles, Los Angeles, CA, USA.""}]","Lancet (London, England)",['10.1016/S0140-6736(20)32544-7']
896,33340727,The Analgesic Efficacy of Erector Spinae Plane Blocks in Patients Undergoing Posterior Lumbar Spinal Surgery for Lumbar Fracture.,"OBJECTIVE


To investigate the postoperative analgesic efficacy of ultrasound-guided lumbar erector spinae plane (ESP) blocks in patients undergoing posterior lumbar spinal surgery for lumbar spinal fractures.
METHODS


A total of 80 patients who were scheduled for posterior internal fixation for lumbar spinal fractures were divided into a patient-controlled analgesia (PCA) group or a combined ESP-PCA group. Numeric rating scale at rest and during movement, postoperative sufentanil consumption, and accumulative and effective bolus presses of PCA were recorded at 6, 12, 24, and 48 hours postoperatively. Numeric rating scale at rest and during movement was the primary outcome. Incidence of postoperative nausea and vomiting during the first 24-48 hours, pruritus and chronic postoperative pain, and dose of pethidine for rescue analgesia were also recorded.
RESULTS


Numeric rating scale at rest and during movement at 6, 12, and 24 hours was lower in the ESP-PCA group (P < 0.001, P < 0.001, P = 0.0016 at rest; all P < 0.001 during movement). Lumbar ESP blocks diminished accumulative bolus presses and effective bolus presses of PCA at 6, 12, 24, and 48 hours postoperatively. Besides, patients in the ESP-PCA group had fewer demands for sufentanil and pethidine. The incidence of postoperative nausea and vomiting in the ESP-PCA group was lower than that in PCA group.
CONCLUSIONS


PCA combined with lumbar ESP blocks provided superior postoperative analgesia for patients with lumbar spinal fractures treated with posterior internal fixation. Lumbar ESP blocks decreased postoperative opioid consumption and incidence of postoperative nausea and vomiting, thereby enhancing postoperative recovery.",2021,"RESULTS


NRS at rest and during movement at 6, 12 and 24 h was lower in ESP-PCA group (p<0.001, p<0.001, p=0.0016, respectively for at rest; all p<0.001 for during movement).","['patients with lumbar spinal fractures treated with posterior internal fixation', 'Patients Undergoing Posterior Lumbar Spinal Surgery for Lumbar Fracture', 'Totally 80 patients, who scheduled for posterior internal fixation for lumbar spinal fractures', 'patients undergoing posterior lumbar spinal surgery for lumbar spinal fractures']","['Lumbar ESP blocks', 'ultrasound-guided lumbar erector spinae plane (ESP) blocks', 'PCA group (patient-controlled analgesia only) or ESP-PCA', 'pethidine', 'PCA combined with lumbar ESP blocks', 'Erector Spinae Plane Blocks']","['superior postoperative analgesia', 'postoperative opioid consumption', 'Numeric rating scale (NRS) at rest and during movement, postoperative sufentanil consumption, accumulative and effective bolus presses of PCA', 'Incidence of postoperative nausea and vomiting', 'postoperative nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0262544', 'cui_str': 'Fracture of lumbar spine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",80.0,0.0644209,"RESULTS


NRS at rest and during movement at 6, 12 and 24 h was lower in ESP-PCA group (p<0.001, p<0.001, p=0.0016, respectively for at rest; all p<0.001 for during movement).","[{'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Linhai, China.'}, {'ForeName': 'Mingcang', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Linhai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Ying', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Linhai, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Linhai, China.'}, {'ForeName': 'Hongzhu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Linhai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Linhai, China. Electronic address: 15867638325@sina.cn.'}]",World neurosurgery,['10.1016/j.wneu.2020.10.175']
897,33164553,"Patient Characteristics, Clinical Outcomes, and Effect of Dapagliflozin in Relation to Duration of Heart Failure: Is It Ever Too Late to Start a New Therapy?","BACKGROUND


The impact of heart failure (HF) duration on outcomes and treatment effect is largely unknown. We aim to compare baseline patient characteristics, outcomes, and the efficacy and safety of dapagliflozin, in relation to time from diagnosis of HF in DAPA-HF trial (Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure).
METHODS


HF duration was categorized as ≥2 to ≤12 months, >1 to 2 years, >2 to 5 years, and >5 years. Outcomes were adjusted for prognostic variables and analyzed using Cox regression. The primary end point was the composite of worsening HF or cardiovascular death. Treatment effect was examined within each duration category and by duration threshold.
RESULTS


The number of patients in each category was: 1098 (≥2-≤12 months), 686 (>1-2 years), 1105 (>2-5 years), and 1855 (>5 years). Longer-duration HF patients were older and more comorbid with worse symptoms. The rate of the primary outcome (per 100 person-years) increased with HF duration: 10.2 (95% CI, 8.7-12.0) for ≥2 to ≤12 months, 10.6 (8.7-12.9) >1 to 2 years, 15.5 (13.6-17.7) >2 to 5 years, and 15.9 (14.5-17.6) for >5 years. Similar trends were seen for all other outcomes. The benefit of dapagliflozin was consistent across HF duration and on threshold analysis. The hazard ratio for the primary outcome ≥2 to ≤12 months was 0.86 (0.63-1.18), >1 to 2 years 0.95 (0.64-1.42), >2 to 5 years 0.74 (0.57-0.96), and >5 years 0.64 (0.53-0.78),  P  interaction=0.26. The absolute benefit was greatest in longest-duration HF, with a number needed to treat of 18 for HF >5 years, compared with 28 for ≥2 to ≤12 months.
CONCLUSIONS


Longer-duration HF patients were older, had more comorbidity and symptoms, and higher rates of worsening HF and death. The benefits of dapagliflozin were consistent across HF duration. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03036124.",2020,"The absolute benefit was greatest in longest-duration HF, with a number needed to treat of 18 for HF >5 years, compared with 28 for ≥2 to ≤12 months.
","['Heart Failure', 'HF duration was categorized as ≥2 to ≤12 months, >1 to 2 years, >2 to 5 years, and >5 years', 'number of patients in each category was: 1098 (≥2-≤12 months), 686 (>1-2 years), 1105 (>2-5 years), and 1855 (>5 years']","['Dapagliflozin', 'dapagliflozin']","['Duration of Heart Failure', 'composite of worsening HF or cardiovascular death', 'hazard ratio']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191070', 'cui_str': '686'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.143976,"The absolute benefit was greatest in longest-duration HF, with a number needed to treat of 18 for HF >5 years, compared with 28 for ≥2 to ≤12 months.
","[{'ForeName': 'Su E', 'Initials': 'SE', 'LastName': 'Yeoh', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (S.E.Y., P.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (S.E.Y., P.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (S.E.Y., P.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark (L.K.).'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (M.N.K.).""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Argentina (F.A.M.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Poland (P.P.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""The TIMI Study Group (M.S.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division (S.D.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (O.B., M.S., A.M.L.).'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (O.B., M.S., A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (O.B., M.S., A.M.L.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (S.E.Y., P.D., P.S.J., J.J.V.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.120.007879']
898,33306283,Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19.,"BACKGROUND


Severe coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known.
METHODS


We conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15.
RESULTS


A total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P = 0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, -5.0 percentage points; 95% CI, -9.8 to -0.3; P = 0.03), as were new infections (5.9% vs. 11.2%; difference, -5.3 percentage points; 95% CI, -8.7 to -1.9; P = 0.003).
CONCLUSIONS


Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04401579.).",2021,"The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09).","['Hospitalized Adults with Covid-19', '1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control', 'hospitalized adults with Covid-19']","['Baricitinib plus Remdesivir', 'baricitinib (≤14 days) or placebo (control', 'placebo']","['serious adverse events', 'clinical status', 'new infections', '28-day mortality', 'time to recovery', 'recovery time', 'Serious adverse events', 'median time to recovery']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",1033.0,0.619885,"The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09).","[{'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Cameron R', 'Initials': 'CR', 'LastName': 'Wolfe', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Varduhi', 'Initials': 'V', 'LastName': 'Ghazaryan', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Iovine', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Hana M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Branche', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Justino', 'Initials': 'J', 'LastName': 'Regalado Pineda', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Uriel', 'Initials': 'U', 'LastName': 'Sandkovsky', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Cohen', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Patrick E H', 'Initials': 'PEH', 'LastName': 'Jackson', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Babafemi', 'Initials': 'B', 'LastName': 'Taiwo', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Catharine I', 'Initials': 'CI', 'LastName': 'Paules', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Arguinchona', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Erdmann', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Neera', 'Initials': 'N', 'LastName': 'Ahuja', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Frank', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Eu-Suk', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Seow Y', 'Initials': 'SY', 'LastName': 'Tan', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Mularski', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Nielsen', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Philip O', 'Initials': 'PO', 'LastName': 'Ponce', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Barbara S', 'Initials': 'BS', 'LastName': 'Taylor', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'LuAnn', 'Initials': 'L', 'LastName': 'Larson', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Nadine G', 'Initials': 'NG', 'LastName': 'Rouphael', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Saklawi', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Valeria D', 'Initials': 'VD', 'LastName': 'Cantos', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Ko', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Engemann', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Alpesh N', 'Initials': 'AN', 'LastName': 'Amin', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Billings', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Marie-Carmelle', 'Initials': 'MC', 'LastName': 'Elie', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ferreira', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Anabela', 'Initials': 'A', 'LastName': 'Cardoso', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'de Bono', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Proschan', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Deye', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Walla', 'Initials': 'W', 'LastName': 'Dempsey', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Seema U', 'Initials': 'SU', 'LastName': 'Nayak', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2031994']
899,33330899,Acute dose-response effect of coffee-derived chlorogenic acids on the human vasculature in healthy volunteers: a randomized controlled trial.,"BACKGROUND


Epidemiological studies have reported lower risk of cardiovascular disease with moderate coffee consumption. In addition, emerging evidence indicates that consumption of coffee beverages enriched in chlorogenic acids (CGAs) may influence blood pressure and endothelial function, suggesting that the beneficial cardiovascular effect of coffee may relate to its CGA content.
OBJECTIVES


We conducted a double-blind randomized crossover trial to test the effect of acute consumption of a decaffeinated green coffee extract (DGCE), rich in CGAs, on endothelial function in healthy subjects.
METHODS


We compared 3 different doses of DGCE (302, 604, and 906 mg, respectively) with a placebo. Endothelial function was defined as the percentage change in the internal diameter of the brachial artery in response to flow-mediated dilation (%FMD). In addition, we followed the plasma concentration-time profiles of 25 systemic CGA metabolites over 24 h after DGCE consumption and we explored the relation between systemic concentrations of CGAs and the effect on %FMD.
RESULTS


The DGCE formulations containing different amounts of CGAs resulted in dose-proportional increases in overall total polyphenol concentrations. The systemic appearance of total CGAs was biphasic, in agreement with previous results suggesting 2 sites of absorption in the gastrointestinal tract. Compared with the placebo group, a significant FMD increase (>1%) was observed 8.5, 10, and 24 h after consumption of 302 mg DGCE (∼156.4 mg CGAs). The differences with placebo observed in the other 2 groups were not statistically significant. Evaluation of the relation between phenolic exposure and %FMD showed a positive tendency toward a larger effect at higher concentrations and different behavior of CGA metabolites depending on the conjugated chemical position.
CONCLUSIONS


We demonstrated an acute improvement in %FMD over time after ingestion of a DGCE, explained at least partly by the presence in the blood circulation of CGAs and their metabolites. This trial was registered at clinicaltrials.gov as NCT03520452.",2021,The differences with placebo observed in the other 2 groups were not statistically significant.,"['healthy volunteers', 'healthy subjects']","['decaffeinated green coffee extract (DGCE), rich in CGAs', 'coffee-derived chlorogenic acids', 'placebo', 'DGCE']","['systemic appearance of total CGAs', 'overall total polyphenol concentrations', 'Endothelial function', 'FMD increase', 'blood pressure and endothelial function', 'plasma concentration-time profiles of 25 systemic CGA metabolites']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0008240', 'cui_str': 'Chlorogenic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008240', 'cui_str': 'Chlorogenic acid'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0055633', 'cui_str': 'Chromogranin A'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.458988,The differences with placebo observed in the other 2 groups were not statistically significant.,"[{'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'Cardiovascular Research Group, School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Zimmermann', 'Affiliation': 'Nestlé Research Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Guitard-Uldry', 'Affiliation': 'Nestlé Research Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Poquet', 'Affiliation': 'Nestlé Research Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lévêques', 'Affiliation': 'Nestlé Research Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Eriksen', 'Affiliation': 'Nestlé Research Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Rachid', 'Initials': 'R', 'LastName': 'Bel Rhlid', 'Affiliation': 'Nestlé Research Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Galaffu', 'Affiliation': 'Nestlé Research Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': ""D'Urzo"", 'Affiliation': 'Nestlé Research Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'De Castro', 'Affiliation': 'Nestlé Research Singapore, Singapore.'}, {'ForeName': 'Erno', 'Initials': 'E', 'LastName': 'Van Schaick', 'Affiliation': 'Calvagone, Liergues, France.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'Cardiovascular Research Group, School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Actis-Goretta', 'Affiliation': 'Nestlé Research Singapore, Singapore.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa312']
900,33332538,Individualized Aerobic Exercise in Neuromuscular Diseases: A Pilot Study on the Feasibility and Preliminary Effectiveness to Improve Physical Fitness.,"OBJECTIVE


Clear guidelines to prescribe aerobic exercise in neuromuscular diseases (NMD) are lacking, which hampers effective application in neuromuscular rehabilitation. This pilot study evaluated the feasibility and preliminary effectiveness of an individualized aerobic exercise program according to a recently developed training guide (B-FIT) to improve physical fitness in individuals with NMD.
METHODS


Thirty-one individuals who were ambulatory and had 15 different slowly progressive NMD participated in a 4-month, polarized, home-based, aerobic exercise program. The program included 2 low-intensity sessions and 1 high-intensity session per week. Feasibility outcomes were the following: completion rate, proportion of followed sessions, adverse events, and participant and therapist satisfaction based on a self-designed questionnaire. Submaximal incremental exercise tests were used to assess the effects on physical fitness.
RESULTS


Twenty-six participants (84%) completed the B-FIT program, and the proportion of followed sessions was >75%. Three adverse events were reported and resolved. Regarding satisfaction, participants (based on n = 9) reported feeling fitter, but training was considered insufficiently challenging. Physical therapists (n = 5) reported that B-FIT provides a clear, well-grounded guidance. They perceived the time investment for initiating the program and the carry-over to primary care as the main barriers. The mean (SD) submaximal heart rate (based on n = 20) reduced significantly by -6.5 beats per minute (95% CI = -11.8 to -1.2), from 121.7 (16.5) at baseline to 115.2 (14.3) after intervention. Submaximal ratings of perceived exertion, anaerobic threshold, and peak workload also improved significantly (P < .05).
CONCLUSION


The outcomes of this pilot study suggest that individualized aerobic exercise according to B-FIT is feasible and has potential to improve physical fitness in a wide variety of slowly progressive NMD. However, some barriers must be addressed before investigating the efficacy in a randomized controlled trial.
IMPACT


The outcomes of this study demonstrate the feasibility of individualized aerobic exercise according to the B-FIT training guide and the potential to improve physical fitness in NMD. Physical therapists indicated that the use of B-FIT provides a clear, well-grounded guidance. The training guide can support health care professionals in the application of aerobic exercise in adult neuromuscular rehabilitation.
LAY SUMMARY


Individualized exercise according to the B-FIT training guide is feasible in a wide variety of slowly progressive NMD and might help improve physical fitness.",2021,"Submaximal ratings of perceived exertion, anaerobic threshold, and peak workload also improved significantly (P < .05).
","['adult neuromuscular rehabilitation', 'NMD', 'individuals with NMD', 'Neuromuscular Diseases', 'Thirty-two individuals who were ambulatory and had 15 different slowly progressive NMD participated in a 4-month']","['polarized home-based aerobic exercise program', 'prescribe aerobic exercise', 'aerobic exercise', 'Individualized Aerobic Exercise', 'individualized aerobic exercise', 'individualized aerobic exercise program', 'Physical therapists']","['mean (SD) submaximal heart rate', 'completion rate, proportion of followed sessions, adverse events, and participant and therapist satisfaction based on a self-designed questionnaire', 'Submaximal ratings of perceived exertion, anaerobic threshold, and peak workload', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}]",32.0,0.034277,"Submaximal ratings of perceived exertion, anaerobic threshold, and peak workload also improved significantly (P < .05).
","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Voorn', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, the Netherlands.'}, {'ForeName': 'Fieke S', 'Initials': 'FS', 'LastName': 'Koopman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, the Netherlands.'}, {'ForeName': 'Merel-Anne', 'Initials': 'MA', 'LastName': 'Brehm', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, the Netherlands.'}]",Physical therapy,['10.1093/ptj/pzaa213']
901,33341402,Vulnerability in Executive Functions to Sleep Deprivation Is Predicted by Subclinical Attention-Deficit/Hyperactivity Disorder Symptoms.,"BACKGROUND


Sleep loss results in state instability of cognitive functioning. It is not known whether this effect is more expressed when there is an increased cognitive demand. Moreover, while vulnerability to sleep loss varies substantially among individuals, it is not known why some people are more affected than others. We hypothesized that top-down regulation was specifically affected by sleep loss and that subclinical inattention and emotional instability traits, related to attention-deficit/hyperactivity disorder symptoms, predict this vulnerability in executive function and emotion regulation, respectively.
METHODS


Healthy subjects (ages 17-45 years) rated trait inattention and emotional instability before being randomized to either a night of normal sleep (n = 86) or total sleep deprivation (n = 87). Thereafter, they performed a neutral and emotional computerized Stroop task, involving words and faces. Performance was characterized primarily by cognitive conflict reaction time and reaction time variability (RTV), mirroring conflict cost in top-down regulation.
RESULTS


Sleep loss led to increased cognitive conflict RTV. Moreover, a higher level of inattention predicted increased cognitive conflict RTV in the neutral Stroop task after sleep deprivation (r = .30, p = .0055) but not after normal sleep (r = .055, p = .65; interaction effect β = 6.19, p = .065). This association remained after controlling for cognitive conflict reaction time and emotional instability, suggesting domain specificity. Correspondingly, emotional instability predicted cognitive conflict RTV for the emotional Stroop task only after sleep deprivation, although this effect was nonsignificant after correcting for multiple comparisons.
CONCLUSIONS


Our findings suggest that sleep deprivation affects cognitive conflict variability and that less stable performance in executive functioning may surface after sleep loss in vulnerable individuals characterized by subclinical symptoms of inattention.",2021,"Moreover, a higher level of inattention predicted increased cognitive conflict RTV in the neutral Stroop task after sleep deprivation (r = .30, p = .0055) but not after normal sleep (r = .055, p = .65; interaction effect β = 6.19, p = .065).",['Healthy subjects (ages 17-45 years) rated'],['night of normal sleep (n\xa0= 86) or total sleep deprivation'],"['cognitive conflict reaction time and reaction time variability (RTV), mirroring conflict cost in top-down regulation', 'cognitive conflict reaction time and emotional instability', 'cognitive conflict RTV', 'trait inattention and emotional instability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}]",,0.153463,"Moreover, a higher level of inattention predicted increased cognitive conflict RTV in the neutral Stroop task after sleep deprivation (r = .30, p = .0055) but not after normal sleep (r = .055, p = .65; interaction effect β = 6.19, p = .065).","[{'ForeName': 'Orestis', 'Initials': 'O', 'LastName': 'Floros', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stress Research Institute, Stockholm, Sweden; Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Almeida', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stockholm University Brain Imaging Center, Stockholm, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Tigerström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stress Research Institute, Stockholm, Sweden; Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sundelin', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stress Research Institute, Stockholm, Sweden; Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Petrovic', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. Electronic address: predrag.petrovic@ki.se.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2020.09.019']
902,33351931,The Journey of Recovery: Caregivers' Perspectives From a Hip Fracture Telerehabilitation Clinical Trial.,"OBJECTIVE


The objective was to explore family caregivers' perspectives of the recovery process of older adults with hip fracture and describe experiences from caregivers who: (1) used the online intervention, or (2) received home-based care provided by the Andalusian Public Health Care System.
METHODS


This was an exploratory secondary study with informal family caregivers who had an older adult family member with hip fracture enrolled in a novel telerehabilitation (telerehab) clinical trial. Forty-four caregivers of older adults with hip fracture were interviewed at 6 to 9 months after their family member's hip fracture.
RESULTS


Caregivers shared concerns of family members' survival and recovery; they recounted increased stress and anxiety due to the uncertainty of new tasks associated with providing care and the impact on their lifestyle. Although most caregivers were satisfied with the health care received, they made suggestions for better organization of hospital discharge and requests for home support. The main reasons why caregivers and their family member chose the telerehab program were to enhance recovery after fracture, gain knowledge for managing at home, and because of the convenience of completing the exercises at home. There were more family caregivers in the control group who expressed a high level of stress and anxiety, and they also requested more social and health services compared with caregivers whose family member received telerehab.
CONCLUSION


Family caregivers are an essential component of recovery after hip fracture by providing emotional and physical support. However, future clinical interventions should evaluate person-centered interventions to mitigate possible stress and anxiety experienced by family caregivers.
IMPACT


Family caregivers' perspectives are necessary in the co-design of management strategies for older adults after hip fracture.",2021,"RESULTS


Caregivers shared concerns of family members' survival and recovery; they recounted increased stress and anxiety due to the uncertainty of new tasks associated with providing care and the impact on their lifestyle.","['Forty-four caregivers of older adults with hip fracture', 'informal family caregivers who had an older adult family member with hip fracture enrolled in a novel telerehabilitation (telerehab) clinical trial', 'older adults with hip fracture, and describe experiences from caregivers who (i) used the', 'older adults after hip fracture']",['online intervention or (ii) received home-based care provided by the Andalusian Public Health Care System'],['stress and anxiety'],"[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",44.0,0.0375264,"RESULTS


Caregivers shared concerns of family members' survival and recovery; they recounted increased stress and anxiety due to the uncertainty of new tasks associated with providing care and the impact on their lifestyle.","[{'ForeName': 'Patrocinio', 'Initials': 'P', 'LastName': 'Ariza-Vega', 'Affiliation': 'Physical Medicine and Rehabilitation Service, Virgen de las Nieves University Hospital, Biohealth Research Institute, Granada, Spain.'}, {'ForeName': 'Herminia', 'Initials': 'H', 'LastName': 'Castillo-Pérez', 'Affiliation': 'Ciudad de Berja Nursing Home, Almería, Spain.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Ortiz-Piña', 'Affiliation': 'Department of Physiotherapy, PA-HELP ""Physical Activity for HEaLth Promotion"" research group, University of Granada, Granada, Spain.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Ziden', 'Affiliation': 'Department of Health and Rehabilitation, The Sahlgrenska University Hospital, Gothenberg, Sweden; and Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Palomino-Vidal', 'Affiliation': 'Department of Physiotherapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Maureen C', 'Initials': 'MC', 'LastName': 'Ashe', 'Affiliation': 'Department of Family Practice, University of British Columbia, Vancouver, Canada.'}]",Physical therapy,['10.1093/ptj/pzaa220']
903,33370571,"The effect of Nigella sativa on appetite, anthropometric and body composition indices among overweight and obese women: A crossover, double-blind, placebo-controlled, randomized clinical trial.","OBJECTIVES


Obesity is a global concern which is associated with several complications and disease.
DESIGN


Present study is the first crossover, double-blind, placebo-controlled, randomized clinical trial aimed to evaluate the effect of Nigella Sativa (N. sativa) intervention on anthropometric and body composition parameters as well as dietary intake and appetite in a crossover design.
METHOD


Forty-five healthy women with obesity or overweight were randomized into two groups of intervention and placebo, and the study conducted in two 8-week periods of intervention separated by a 4-week washout period. Anthropometric and body composition indices and dietary intake were measured. Also, appetite sensation was evaluated via a standard visual analog scale (VAS) questionnaire. Pkcross procedure was performed for statistical analysis using STATA. Cohen's d effect size was estimated for all outcomes to determine the magnitude of the effects.
RESULTS


Supplementation with 2000 mg of N. sativa oil found to have a considerable increment in the measures of body mass index (P < 0.001, Cohen's d = 0.5), body weight (P < 0.001, Cohen's d = 0.6) and waist circumference (P = 0.020, Cohen's d = 0.4) with a medium effect size measure, and a significant decrease in body fat mass (P = 0.019, Cohen's d = 0.2), body fat percent (P < 0.001, Cohen's d = 0.2) and visceral fat area (P = 0.011, Cohen's d = 0.2) with a small effect size measure.
CONCLUSION


The overall improvements in anthropometric and body composition parameters and a significant decrease in appetite represents the beneficial effects of N. sativa supplements in the treatment of obesity. More studies with different dosages, a larger number of participants, and longer intervention duration are recommended to illustrate the exact effects of N. sativa as a complementary therapy for obesity.",2020,"RESULTS


Supplementation with 2000 mg of N. sativa oil found to have a considerable increment in the measures of body mass index (P < 0.001, Cohen's d = 0.5), body weight (P < 0.001, Cohen's d = 0.6) and waist circumference (P = 0.020, Cohen's d = 0.4) with a medium effect size measure, and a significant decrease in body fat mass (P = 0.019, Cohen's d = 0.2), body fat percent (P < 0.001, Cohen's d = 0.2) and visceral fat area (P = 0.011, Cohen's d = 0.2) with a small effect size measure.
","['Forty-five healthy women with obesity or overweight', 'Overweight and Obese Women']","['Placebo', 'Nigella Sativa (N. sativa) intervention', 'placebo', 'Nigella sativa']","['visceral fat area', 'body fat mass', 'body weight', 'Appetite, Anthropometric and Body Composition Indices', 'appetite sensation', 'appetite', 'body mass index', 'standard visual analog scale (VAS) questionnaire', 'waist circumference', 'Anthropometric and body composition indices and dietary intake']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",45.0,0.19204,"RESULTS


Supplementation with 2000 mg of N. sativa oil found to have a considerable increment in the measures of body mass index (P < 0.001, Cohen's d = 0.5), body weight (P < 0.001, Cohen's d = 0.6) and waist circumference (P = 0.020, Cohen's d = 0.4) with a medium effect size measure, and a significant decrease in body fat mass (P = 0.019, Cohen's d = 0.2), body fat percent (P < 0.001, Cohen's d = 0.2) and visceral fat area (P = 0.011, Cohen's d = 0.2) with a small effect size measure.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Safi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Razmpoosh', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossien', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Research Center of Prevention and Epidemiology of Non Communicable Disease, Department of Biostatistics and Epidemiology, Health Faculty, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahta', 'Initials': 'M', 'LastName': 'Mazaheri', 'Affiliation': 'Department of Medical Genetics, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Mother and Newborn, Health Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Nazari', 'Affiliation': 'Department of Medical Genetics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Nadjarzadeh', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: azadehnajarzadeh@gmail.com.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102653']
904,33330915,Dietary leucine requirement of older men and women is higher than current recommendations.,"BACKGROUND


Current national (34 mg . kg-1 . d-1) and international (39 mg kg-1 . d-1) recommendations for leucine in older adults are based on data from young adults. Evidence suggests that the leucine requirements of older adults are higher than those of young adults.
OBJECTIVE


The objective of the current study was to directly determine the leucine requirements in healthy older adult male and female study participants aged >60 y.
METHODS


Leucine requirement was determined using the indicator amino acid oxidation method (IAAO) with l-[1-13C]phenylalanine as the indicator. Sixteen older adults (n = 7 male and n = 9 female participants) were randomly assigned to receive 3 to 7 leucine intakes from 20 to 120 mg . kg-1 . d-1. The rate of release of 13CO2 from l-[1-13C]phenylalanine oxidation was measured, and breakpoint analysis was used to estimate the leucine requirement. The 95% CI was calculated using the parametric bootstrap method.
RESULTS


The mean leucine requirement for male participants was 77.8 mg . kg-1 . d-1 (upper 95% CI: 81.0) and for female participants, it was 78.2 mg . kg-1 . d-1 (upper 95% CI: 82.0) with no sex effect based on body weight. The data were therefore combined to yield a mean of 78.5 mg . kg-1 d-1 (upper 95% CI: 81.0 mg . kg-1 . d-1 ) for both sexes. On the basis of fat-free mass, the mean ± SEM leucine requirements were 115 ± 3.2 and 127 ± 2.4 mg . kg-1 . d-1 for male and female participants, respectively (P < 0.005).
CONCLUSIONS


The estimated leucine requirement of older adults is more than double the amount in current recommendations. These data suggest that leucine could be a limiting amino acid in the diet of older adults consuming the current RDA for protein and those consuming a plant-based diet. In view of the functional and structural role of leucine, especially its importance in muscle protein synthesis, current leucine recommendations of older adults should be revised. This trial was registered at clinicaltrials.gov as NCT03506126.",2021,d-1 (upper 95% CI: 82.0) with no sex effect based on body weight.,"['older men and women', 'healthy older adult male and female study participants aged ', 'older adults', 'Sixteen older adults (n\xa0=\xa07 male and n\xa0=\xa09 female participants']",['leucine'],"['mean leucine requirement', 'rate of release of 13CO2 from l-[1-13C]phenylalanine oxidation', 'leucine requirements']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0023401', 'cui_str': 'Leucine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",9.0,0.109616,d-1 (upper 95% CI: 82.0) with no sex effect based on body weight.,"[{'ForeName': 'Sylwia', 'Initials': 'S', 'LastName': 'Szwiega', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Mahroukh', 'Initials': 'M', 'LastName': 'Rafii', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Lebarron', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Department of Agriculture, Food, and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Dehan', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'Department of Statistical Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Libai', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Statistical Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Department of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa323']
905,33330913,"The effect of bovine colostrum/egg supplementation compared with corn/soy flour in young Malawian children: a randomized, controlled clinical trial.","BACKGROUND


Bovine colostrum with egg powder (BC/egg) is rich in essential amino acids and immunoactive compounds.
OBJECTIVES


This trial tested the hypothesis that a daily supplement of BC/egg would reduce linear growth faltering and environmental enteric dysfunction (EED) in Malawian infants when compared with an isoenergetic ration of corn/soy flour used as a control. EED was defined by a lactulose permeability test.
METHODS


This was a prospective, randomized, blinded, placebo-controlled clinical trial in which 9-mo-old infants received BC/egg or a control for 3 mo. The primary outcomes were change in length-for-age z-score (ΔLAZ) and urinary lactulose excretion (%L) at 12-mo-old. Secondary outcomes included episodes of diarrhea, stunting, EED, and the 16S configuration of the fecal microbiota.
RESULTS


Of the 277 children enrolled, 267 completed the intervention phase of the study. LAZ decreased in all children from 9 to 17 mo, although ΔLAZ was less in children receiving BC/egg from 9 to 12 mo (difference = 0.12 z-scores; P = 0.0011). This difference persisted after feeding was completed, with less ΔLAZ (difference = 0.09 z-scores). A lower prevalence of stunting was seen in the intervention group (n = 47/137) than the control group (n = 62/127) at 17 mo (RR = 0.70; 95% CI: 0.52, 0.94).The median %L at 12 mo of age in the children receiving BC/egg was 0.14%, compared with 0.17% in the control group (P = 0.74). In children with %L >0.45% at enrollment (severe EED), the BC/egg group had more children with normal %L at 12 mo of age (10/20, 50%) than was seen in controls (2/15, 13%; P = 0.024). Episodes of diarrhea and β-diversity of the 16S configuration of fecal microbiota did not differ between the 2 groups.
CONCLUSIONS


Addition of BC/egg to complementary feeding in Malawian infants resulted in less linear growth faltering. This trial was registered at clinicaltrials.gov as NCT03801317.",2021,"A lower prevalence of stunting was seen in the intervention group (n = 47/137) than the control group (n = 62/127) at 17 mo (RR = 0.70; 95% CI: 0.52, 0.94).The median %L at 12 mo of age in the children receiving BC/egg was 0.14%, compared with 0.17% in the control group (P = 0.74).","['Malawian infants', 'young Malawian children', '9-mo-old infants received BC/egg or a control for 3 mo', '277 children enrolled']","['isoenergetic ration of corn/soy flour', 'bovine colostrum/egg supplementation compared with corn/soy flour', 'placebo', 'ΔLAZ']","['linear growth faltering and environmental enteric dysfunction (EED', 'LAZ', 'episodes of diarrhea, stunting, EED, and the 16S configuration of the fecal microbiota', 'Episodes of diarrhea and β-diversity of the 16S configuration of fecal microbiota', 'change in length-for-age z-score (ΔLAZ) and urinary lactulose excretion', 'prevalence of stunting']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0452823', 'cui_str': 'Dried egg'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0771806', 'cui_str': 'Soya flour'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",277.0,0.278652,"A lower prevalence of stunting was seen in the intervention group (n = 47/137) than the control group (n = 62/127) at 17 mo (RR = 0.70; 95% CI: 0.52, 0.94).The median %L at 12 mo of age in the children receiving BC/egg was 0.14%, compared with 0.17% in the control group (P = 0.74).","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Bierut', 'Affiliation': 'Department of Pediatrics, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Duckworth', 'Affiliation': 'Department of Pediatrics, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Grabowsky', 'Affiliation': 'PanTheryx, Boulder, CO, USA.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Ordiz', 'Affiliation': 'Department of Pediatrics, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Marie L', 'Initials': 'ML', 'LastName': 'Laury', 'Affiliation': 'Genome Technology Access Center, Washington University in St Louis, MO, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Callaghan-Gillespie', 'Affiliation': 'Department of Pediatrics, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University in St Louis, St Louis, MO, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa325']
906,33357499,"Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial.","BACKGROUND


ANDHI was done to assess the efficacy of benralizumab, including onset of effect and impact on health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms.
METHODS


This phase 3b, randomised, double-blind, parallel-group, placebo-controlled ANDHI study was completed in adults (aged 18-75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per μL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more. Patients who met eligibility criteria were randomly assigned (2:1; stratified by previous exacerbation count [two, or three or more], maintenance oral corticosteroid use, and region), using an integrated web-based response system, to receive benralizumab at 30 mg every 8 weeks (first three doses given 4 weeks apart) or matched placebo for 24 weeks. Primary efficacy measure was annualised asthma exacerbation rate, with rate ratio (RR) calculated over the approximate 24-week follow-up. Secondary efficacy measures included change from baseline to end of treatment (week 24) in St George's Respiratory Questionnaire (SGRQ) total score (key secondary endpoint), FEV 1 , peak expiratory flow (PEF), ACQ-6, Predominant Symptom and Impairment Assessment (PSIA), Clinician Global Impression of Change (CGI-C), Patient Global Impression of Change (PGI-C), and Sino-Nasal Outcome Test-22 (SNOT-22). All efficacy analyses, except for SNOT-22, were summarised and analysed using the full analysis set on an intention-to-treat population (all randomly assigned patients receiving investigational product, regardless of protocol adherence or continued participation in the study). SNOT-22 was summarised for the subgroup of patients with physician-diagnosed nasal polyposis with informed consent. This study is registered with ClinicalTrials.gov, NCT03170271.
FINDINGS


Between July 7, 2017, and Sept 25, 2019, 656 patients received benralizumab (n=427) or placebo (n=229). Baseline characteristics were consistent with severe eosinophilic asthma. Benralizumab significantly reduced exacerbation risk by 49% compared with placebo (RR estimate 0·51, 95% CI 0·39-0·65; p<0·0001) over the 24-week treatment period and provided clinically meaningful and statistically significant improvement from baseline to week 24 in SGRQ total score versus placebo (least squares mean change from baseline -8·11 (95% CI -11·41 to -4·82; p<0·0001), with similar differences at earlier timepoints. Benralizumab improved FEV 1 , PEF, ACQ-6, CGI-C, PGI-C, PSIA, and SNOT-22 at week 24 versus placebo, with differences observed early (within weeks 1 to 4). Adverse events were reported for 271 (63%) of 427 patients on benralizumab versus 143 (62%) of 229 patients on placebo. The most commonly reported adverse events for the 427 patients receiving benralizumab (frequency >5%) were nasopharyngitis (30 [7%]), headache (37 [9%]), sinusitis (28 [7%]), bronchitis (22 [5%]), and pyrexia (26 [6%]). Fewer serious adverse events were reported for benralizumab (23 [5%]) versus placebo (25 [11%]), and the only common serious adverse event (experienced by >1% of patients) was worsening of asthma, which was reported for nine (2%) patients in the benralizumab group and nine (4%) patients in the placebo group.
INTERPRETATION


Our results extend the efficacy profile of benralizumab for patients with severe eosinophilic asthma, showing early clinical benefits in patient-reported outcomes, HRQOL, lung function, and nasal polyposis symptoms.
FUNDING


AstraZeneca.",2021,"Benralizumab significantly reduced exacerbation risk by 49% compared with placebo (RR estimate 0·51, 95% CI 0·39-0·65; p≤0·0001) over the 24-week treatment period and provided clinically meaningful and statistically significant improvement from baseline to week 24 in SGRQ total score versus placebo (least squares mean change from baseline -8·11","['Between July 7, 2017, and Sept 25, 2019', 'adults (aged 18-75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per μL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more', 'patients with severe eosinophilic asthma', 'patients with severe eosinophilic asthma treated with benralizumab (ANDHI', 'Patients who met eligibility criteria', '656 patients received']","['maintenance oral corticosteroid use, and region), using an integrated web-based response system, to receive benralizumab', 'benralizumab', 'placebo']","['FEV 1 , peak expiratory flow (PEF', 'annualised asthma exacerbation rate, with rate ratio (RR', 'FEV 1 , PEF, ACQ-6, CGI-C, PGI-C, PSIA, and SNOT-22', 'serious adverse events', 'nasopharyngitis', ""change from baseline to end of treatment (week 24) in St George's Respiratory Questionnaire (SGRQ) total score (key secondary endpoint"", 'health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms', 'ACQ-6, Predominant Symptom and Impairment Assessment (PSIA), Clinician Global Impression of Change (CGI-C), Patient Global Impression of Change (PGI-C), and Sino-Nasal Outcome Test-22 (SNOT-22', 'exacerbation risk', 'pyrexia', 'bronchitis', 'Adverse events', 'health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms', 'adverse events', 'sinusitis', 'headache']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",,0.713251,"Benralizumab significantly reduced exacerbation risk by 49% compared with placebo (RR estimate 0·51, 95% CI 0·39-0·65; p≤0·0001) over the 24-week treatment period and provided clinically meaningful and statistically significant improvement from baseline to week 24 in SGRQ total score versus placebo (least squares mean change from baseline -8·11","[{'ForeName': 'Tim W', 'Initials': 'TW', 'LastName': 'Harrison', 'Affiliation': 'Respiratory Research Unit, Nottingham National Institute for Health Research Biomedical Research Centre, University of Nottingham; Nottingham City Hospital, Nottingham, UK. Electronic address: tim.harrison@nottingham.ac.uk.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Chanez', 'Affiliation': 'Department of Respiratory Diseases CIC Nord INSERM, INRAE, C2VN, Aix Marseille University, Marseille, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Menzella', 'Affiliation': 'Pneumology Unit, Santa Maria Nuova Hospital, Azienda USL di Reggio Emilia-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Giorgio Walter', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Humanitas University & Research Hospital, IRCCS, Milano, Italy.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Louis', 'Affiliation': 'University and Centre Hospitalier Universitaire of Liège, Liège, Belgium.'}, {'ForeName': 'Borja G', 'Initials': 'BG', 'LastName': 'Cosio', 'Affiliation': 'Hospital Son Espases-IdISBa and Ciberes, Palma de Mallorca, Spain.'}, {'ForeName': 'Njira L', 'Initials': 'NL', 'LastName': 'Lugogo', 'Affiliation': 'University of Michigan Medical Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'East Carolina University Brody School of Medicine, Greenville, NC, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Burden', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'McDermott', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Garcia Gil', 'Affiliation': 'AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Zangrilli', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30414-8']
907,33359750,"Effect of yoga intervention on biochemical, oxidative stress markers, inflammatory markers and sleep quality among subjects with type 2 diabetes in South India: Results from the SATYAM project.","AIMS


The aim of this study was to investigate the effect of yoga intervention on the biochemical, oxidative stress markers and inflammatory markers and sleep quality among subjects with type 2 diabetes.
METHODS


Subjects with type 2 diabetes attending a tertiary care centre for diabetes during Feb 2017 to Oct 2019 in Chennai, India were randomly assigned to two different groups. Group1(non-Yoga) (n = 150) was advised on simple physical exercises whereas group2(Yoga) (n = 150) was trained and advised to do yogasanas with static loosening exercises for 50 min for 5 days in a week. Both the groups were followed up for a period of 3 months. Anthropometric, biochemical, oxidative stress markers, inflammatory markers and sleep quality were assessed at baseline and after follow up.
RESULTS


There was a significant reduction in BMI, blood glucose levels, HbA1c, lipid levels, IL6, TNFα and TBARS in Yoga group as compared to non-Yoga group. There was marked improvement in the levels of Adiponectin, PTGIS and sleep quality among subjects practising yogasanas.
CONCLUSION


Regular practice of yogasanas improved glycaemic control, oxidative stress, inflammatory response and sleep quality among subjects with type 2 diabetes. Hence, Yogasanas can be used as an adjuvant therapy for managing type 2 diabetes.",2021,"There was marked improvement in the levels of Adiponectin, PTGIS and sleep quality among subjects practising yogasanas.
","['subjects with type 2 diabetes', 'Subjects with type 2 diabetes attending a tertiary care centre for diabetes during Feb 2017 to Oct 2019 in Chennai, Tamil Nadu', 'subjects with type 2 diabetes in South India']","['simple physical exercises whereas group2(Yoga) (n=150) was trained and advised to do yogasanas with static loosening exercises', 'Yoga intervention', 'Group1(non-Yoga', 'yoga intervention']","['levels of Adiponectin, PTGIS and sleep quality', 'glycaemic control, oxidative stress, inflammatory response and sleep quality', 'Anthropometric, biochemical, oxidative stress markers, inflammatory markers and sleep quality', 'biochemical, oxidative stress markers, inflammatory markers and sleep quality', 'biochemical, oxidative stress markers and inflammatory markers and sleep quality', 'BMI, blood glucose levels, HbA1c, lipid levels, IL6, TNFα and TBARS']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0039285', 'cui_str': 'Tamil language'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}]",,0.0315702,"There was marked improvement in the levels of Adiponectin, PTGIS and sleep quality among subjects practising yogasanas.
","[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Diabetology, M.V. Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre (WHO Collaborating Centre for Research Education and Training in Diabetes) (IDF Centre for Excellence in Diabetes Care), Royapuram, Chennai, Tamil Nadu, India. Electronic address: drvijay@mvdiabetes.com.'}, {'ForeName': 'Sumathi', 'Initials': 'S', 'LastName': 'Sivakumar', 'Affiliation': 'Department of Yoga, M.V. Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre (WHO Collaborating Centre for Research Education and Training in Diabetes) (IDF Centre for Excellence in Diabetes Care), Royapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sai Prathiba', 'Affiliation': 'Department of Primary Prevention of Diabetes, M.V. Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre (WHO Collaborating Centre for Research Education and Training in Diabetes) (IDF Centre for Excellence in Diabetes Care), Royapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Arutselvi', 'Initials': 'A', 'LastName': 'Devarajan', 'Affiliation': 'Department of Epidemiology, M.V. Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre (WHO Collaborating Centre for Research Education and Training in Diabetes) (IDF Centre for Excellence in Diabetes Care), Royapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Leema', 'Initials': 'L', 'LastName': 'George', 'Affiliation': 'Department of Molecular Genetics, M.V. Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre (WHO Collaborating Centre for Research Education and Training in Diabetes) (IDF Centre for Excellence in Diabetes Care), Royapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Satyavani', 'Initials': 'S', 'LastName': 'Kumpatla', 'Affiliation': 'Department of Biochemistry, M.V. Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre (WHO Collaborating Centre for Research Education and Training in Diabetes) (IDF Centre for Excellence in Diabetes Care), Royapuram, Chennai, Tamil Nadu, India.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108644']
908,33358554,Response to Letter to the Editor re 'Effect of continuous antibiotic prophylaxis in children with postoperative JJ stents: A prospective randomized study'.,,2021,,['children with postoperative JJ stents'],['continuous antibiotic prophylaxis'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]",[],,0.0204975,,"[{'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Akinci', 'Affiliation': ""Department of Pediatric Urology, Ankara University School of Medicine, Cebeci Children's Hospital, Ankara, Turkey. Electronic address: aykut-akinci@hotmail.com.""}, {'ForeName': 'Berk', 'Initials': 'B', 'LastName': 'Burgu', 'Affiliation': ""Department of Pediatric Urology, Ankara University School of Medicine, Cebeci Children's Hospital, Ankara, Turkey.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.11.039']
909,33373715,Spectral Domain OCT Predictors of Visual Acuity in the Study of COmparative Treatments for REtinal Vein Occlusion 2: SCORE 2 Report 15.,"PURPOSE


To evaluate the association between baseline demographic and spectral domain OCT (SD-OCT) features with visual acuity (VA) in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) over 2 years.
DESIGN


Post hoc analysis of prospective clinical trial data.
PARTICIPANTS


A total of 362 SCORE2 participants with macular edema secondary to central retinal (CRVO) or hemiretinal vein occlusion (HRVO).
METHODS


Spectral domain OCT volume scans were assessed at the SCORE2 reading center at baseline, month 01 (M01), month 06 (M06), month 12 (M12), and month 24 (M24) for central subfield thickness (CST), subretinal fluid, intraretinal fluid, vitreoretinal interface abnormalities, disorganization of retinal inner layers (DRIL), and ellipsoid zone (EZ) within the central subfield (CSF).
MAIN OUTCOME MEASURES


Visual acuity at M06, M12, and M24.
RESULTS


Mean baseline age was 68.9 years. Mean VA at M01 was 63.2 letters, and CST was 299.7 μm. At M01, subretinal fluid was seen in 28.5% intraretinal fluid in 67.2%, DRIL was seen in 73.8%, mostly within the CSF, and the EZ was absent in 9.8 and patchy in 31.7%. In multivariate analysis including all M01 demographics and SD-OCT parameters and their association with VA at M06, M12, and M24, VA at M01 remained significant across all time points up to M24 (P < 0.001).
CONCLUSIONS


In this 2-year follow-up of eyes that were treated with both per protocol and off protocol for RVO, VA at M01 was an important predictor of long-term vision and change in vision. Establishing predictors of visual recovery helps identify causes for poor responders to treatment in patients with RVO.",2020,"At M01, subretinal fluid was seen in 28.5% intraretinal fluid in 67.2%, DRIL was seen in 73.8%, mostly within CSF and EZ was absent in 9.8 and patchy in 31.7%.","['patients with RVO', 'REtinal Vein Occlusion 2 (SCORE2) over 2 years', '362 SCORE2 participants with macular edema secondary to central retinal (CRVO) or hemi-retinal vein occlusion (HRVO']",[],"['central subfield thickness (CST), subretinal fluid, intraretinal fluid, vitreoretinal interface abnormalities, disorganization of retinal inner layers (DRIL), and ellipsoid zone (EZ) within the central subfield (CSF', 'DRIL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035328', 'cui_str': 'Retinal vein occlusion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}]",[],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}]",362.0,0.19349,"At M01, subretinal fluid was seen in 28.5% intraretinal fluid in 67.2%, DRIL was seen in 73.8%, mostly within CSF and EZ was absent in 9.8 and patchy in 31.7%.","[{'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Etheridge', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Blodi', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Oden', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Veldhuisen', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Eye Institute, University of California Los Angeles Stein Eye Institute, Los Angeles, California.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Mititelu', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Amitha', 'Initials': 'A', 'LastName': 'Domalpally', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. Electronic address: domalpally@wisc.edu.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.12.016']
910,33341369,Simultaneous bilateral endoscopic surgery in a pediatric patient: Description of a NOVEL technique.,"INTRODUCTION


Simultaneous bilateral endoscopic surgery (SBES) is the performance of a percutaneous nephrolithotomy (PCNL) on one side and a retrograde intrarenal surgery (RIRS) on the other kidney simultaneously.
OBJECTIVE


Our aim is to report through a video the surgical technique and the step-by-step details of a SBES performed in a pediatric patient.
PATIENTS AND METHODS


A 12-year-old male patient with bilateral upper tract urolithiasis.
RESULTS


Supine PCNL is performed in Galdakao-modified Valdivia position. Ureteroscopic surgeon performs retrograde pyelography on PCNL kidney. Percutaneous access under fluoroscopic guidance trough the lower calyx and dilated with Amplatz dilators to 17.5 Fr. Storz® 17.5 MIP Nephroscope is introduced and fragmentation with pneumatic lithotripter starts. On the other kidney, after introduction of ureteral sheet 12/14 Fr and digital flexible ureteroscope Flex Xc ® 9.5Fr, pulverization of the stone starts with Laser Holmium YAG (Oddysey®). Surgeons work simultaneously and share fluoro-scopic c-arm.
CONCLUSION


SBES can be reproduced in children. Proper planification and preparation of the involved team and OR set up are essential. Further prospective randomized studies are needed to establish safety and efficacy of SBES in pediatric patients.",2021,Percutaneous access under fluoroscopic guidance trough the lower calyx and dilated with Amplatz dilators to 17.5 Fr.,"['pediatric patients', 'A 12-year-old male patient with bilateral upper tract urolithiasis']","['Simultaneous bilateral endoscopic surgery', 'Laser Holmium YAG (Oddysey®', 'Simultaneous bilateral endoscopic surgery (SBES', 'SBES', 'percutaneous nephrolithotomy (PCNL', 'Storz® 17.5 MIP Nephroscope']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0181996', 'cui_str': 'Nephroscope'}]",[],,0.0382508,Percutaneous access under fluoroscopic guidance trough the lower calyx and dilated with Amplatz dilators to 17.5 Fr.,"[{'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Tessi', 'Affiliation': 'Pediatric Urology Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina. Electronic address: catalinatessi89@gmail.com.'}, {'ForeName': 'María Tatiana', 'Initials': 'MT', 'LastName': 'Szklarz', 'Affiliation': 'Pediatric Urology Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Felicitas López', 'Initials': 'FL', 'LastName': 'Imizcoz', 'Affiliation': 'Pediatric Urology Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ruiz', 'Affiliation': 'Pediatric Urology Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Weller', 'Affiliation': 'Pediatric Urology Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Sager', 'Affiliation': 'Pediatric Urology Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo Omar', 'Initials': 'PO', 'LastName': 'Agustin Schiavo', 'Affiliation': 'Telehealth Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina. Electronic address: pabloschiavo10@gmail.com.'}, {'ForeName': 'Pablo Horacio', 'Initials': 'PH', 'LastName': 'Lechuga', 'Affiliation': 'Telehealth Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Luna', 'Affiliation': 'Telehealth Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Corbetta', 'Affiliation': 'Pediatric Urology Department, Hospital ""Prof. Dr. Juan P. Garrahan"", Pichincha 1890, C1245 CABA, Buenos Aires, Argentina.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.11.042']
911,33338740,Feasibility and effect of a guided self-disclosure intervention designed to facilitate benefit finding in breast cancer patients: A pilot study.,"PURPOSE


This pilot study aimed to evaluate the feasibility and effect of a guided self-disclosure intervention (GSDI) promoting benefit finding (BF) for breast cancer patients.
METHODS


A total of 40 women with breast cancer were randomized either to a GSDI group, which included a 6-session face-to-face self-disclosure intervention, or to a control group. The Benefit Finding Scale (BFS) was used to measure BF, the Distress Disclosure Index (DDI) was used to measure self-disclosure, and the Impact of Event Scale-Revised (IES-R) was used to measure cognitive reappraisal. The outcomes were evaluated at baseline and the 3rd and 6th months.
RESULTS


The GSDI group had more satisfaction (t = 2.35, P = .02) than the control group and had significant group effects of higher BF (t = 2.214, P = .03) and a lower avoidance of the IES-R (t = -2.353, P = .024) at the 3rd month. There was a significant difference of BF (t = 2.036, P = .049) between the two groups at the 6th month, and other outcomes were not significant (P > .05). Intention-to treat (ITT) analysis showed significant time effects for all outcomes (P < .05); there were slightly significant time × group effects for BF (F = 4.15, P = .052) and disclosure (F = 2.719, P = .090). There were no time × group effects for the other outcomes (all P > .05).
CONCLUSION


This study suggests that the GSDI intervention may be feasible in the clinic and might improve BF for breast cancer patients. However, future research needs to further refine the intervention and expand the sample to carry out a full-scale randomized controlled trial.",2021,"The GSDI group had more satisfaction (t = 2.35, P = .02) than the control group and had significant group effects of higher BF (t = 2.214, P = .03) and a lower avoidance of the IES-R (t = ","['breast cancer patients', '40 women with breast cancer']","['guided self-disclosure intervention', 'GSDI intervention', 'guided self-disclosure intervention (GSDI', 'GSDI group, which included a 6-session face-to-face self-disclosure intervention, or to a control group']","['BF, the Distress Disclosure Index (DDI', 'higher BF', 'satisfaction', 'BF', 'Benefit Finding Scale (BFS']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036596', 'cui_str': 'Self Disclosure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0393341,"The GSDI group had more satisfaction (t = 2.35, P = .02) than the control group and had significant group effects of higher BF (t = 2.214, P = .03) and a lower avoidance of the IES-R (t = ","[{'ForeName': 'Mao-Mao', 'Initials': 'MM', 'LastName': 'Zhang', 'Affiliation': 'Oncology Nursing Care Research, School of Nursing, Anhui Medical University, Hefei, China; Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Juan-Juan', 'Initials': 'JJ', 'LastName': 'Chen', 'Affiliation': 'Oncology Nursing Care Research, School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Oncology Nursing Care Research, School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Quan-Lan', 'Initials': 'QL', 'LastName': 'Wang', 'Affiliation': 'Oncology Nursing Care Research, School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Hui-Ping', 'Initials': 'HP', 'LastName': 'Li', 'Affiliation': 'Research of Oncology Nursing Care & Nursing Education, School of Nursing, Anhui Medical University, Hefei, China. Electronic address: Lihuipinghl@163.com.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101879']
912,33359908,Ultrasound guided lateral quadratus lumborum block enhanced recovery in patients undergoing laparoscopic colorectal surgery.,"PURPOSE


This study aimed to evaluate the effects of lateral quadratus lumborum block (QLB) on postoperative pain and recovery in patients undergoing laparoscopic colorectal surgery.
MATERIALS AND METHODS


Patients between 18 and 70 years old, diagnosed with colon or rectal cancer, with American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for laparoscopic colorectal surgery were recruited. Patients were excluded if they were allergic to local anesthetics and unable to complete the procedure of puncture or follow-up evaluation. All included patients were randomly allocated to either QLB or Sham group. The primary outcome was perioperative cumulative sufentanil consumption.
RESULTS


There were no significant differences between the groups in anesthetic time, operation time, dosage of propofol, and remifentanil (P ​> ​0.05). Patients in the QLB group had significantly less sufentanil consumption both intraoperatively and postoperatively, compared with the Sham group (P ​< ​0.05). Postoperative VAS pain scores on coughing in the QLB group at 2 ​h, 6 ​h, 12 ​h, 24 ​h time points and VAS pain score at rest 2 ​h, 6 ​h after surgery were significantly lower than in the Sham group (P ​< ​0.05). Compared with the Sham group, time to first ambulation and anal flatus after surgery in the QLB group were significantly shorter (P ​< ​0.05). Significant differences of postoperative rescue analgesic usage and QoR-15 score at 48 ​h were found between the two groups (P ​< ​0.05).
CONCLUSIONS


Ultrasound-guided lateral QLB significantly reduced perioperative opioid consumption, alleviated postoperative pain, shortened the time to first ambulation and anal flatus, and enhanced postoperative recovery of the patients undergoing laparoscopic colorectal surgery.",2020,"Significant differences of postoperative rescue analgesic usage and QoR-15 score at 48 ​h were found between the two groups (P ​< ​0.05).
","['Patients were excluded if they were allergic to local anesthetics and unable to complete the procedure of puncture or follow-up evaluation', 'patients undergoing laparoscopic colorectal surgery', 'Patients between 18 and 70 years old, diagnosed with colon or rectal cancer, with American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for laparoscopic colorectal surgery were recruited']","['lateral quadratus lumborum block (QLB', 'QLB', 'Ultrasound guided lateral quadratus lumborum block']","['anesthetic time, operation time, dosage of propofol, and remifentanil', 'postoperative rescue analgesic usage and QoR-15 score', 'Postoperative VAS pain scores on coughing', 'perioperative opioid consumption, alleviated postoperative pain', 'postoperative pain and recovery', 'perioperative cumulative sufentanil consumption', 'sufentanil consumption', 'VAS pain score', 'time to first ambulation and anal flatus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",,0.0946569,"Significant differences of postoperative rescue analgesic usage and QoR-15 score at 48 ​h were found between the two groups (P ​< ​0.05).
","[{'ForeName': 'Danfeng', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Fujian Provincial Medical College, Fujian Medical University, Fuzhou, China; Division of Anesthesia, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Fujian Provincial Medical College, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Fujian Provincial Medical College, Fujian Medical University, Fuzhou, China; Division of Anesthesia, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Division of Anesthesia, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Division of Anesthesia, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Zenggui', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Fujian Provincial Medical College, Fujian Medical University, Fuzhou, China; Division of Anesthesia, Fujian Provincial Hospital, Fuzhou, China. Electronic address: yuzenggui0919@163.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.12.002']
913,33368951,Effect of early use of ivabradine on left ventricular remodeling after primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction: A pilot test.,"OBJECTIVE


To investigate the effect of early use of ivabradine on left ventricular remodeling after primary percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI).
METHODS


A total of 66 STEMI patients with sinus rhythm and the resting heart rate ≥80 bpm after successful emergency PCI were included. The patients in the test group were treated with ivabradine combined with metoprolol at 12 hr after PCI, while the control group was given only metoprolol orally. Their resting heart rate was controlled to <70 bpm at discharge and followed for 180 days. Heart rate and blood pressure were measured regularly. Echocardiogram was performed. N-terminal pro-B-type natriuretic peptide (NT-proBNP), high sensitivity troponin T, high sensitivity troponin I, and high sensitivity C-reactive protein were measured. The major adverse cardiovascular events during hospitalization and follow-up period were recorded.
RESULTS


Compared with the control group, the heart rate of the test group decreased significantly (p < .05). Compared with the control group, the left ventricular end-diastolic volume and left ventricular end-systolic volume were significantly decreased while left ventricular ejection fraction was significantly increased in the test group at 90 days after operation. NT-proBNP of the test group was significantly lower than that of the control group at 7 days after operation (p < .05).
CONCLUSION


For STEMI patients, early use of ivabradine combined with standard therapy such as β-blocker after successful reperfusion can achieve effective heart rate control, with great safety and tolerance. But the effect of ivabradine on left ventricular remodeling is uncertain.",2021,"Compared with the control group, the left ventricular end-diastolic volume and left ventricular end-systolic volume were significantly decreased while left ventricular ejection fraction was significantly increased in the test group at 90 days after operation.","['patients with acute ST-segment elevation myocardial infarction', 'patients with acute ST-segment elevation myocardial infarction (STEMI', '66 STEMI patients with sinus rhythm and the resting heart rate ≥80\xa0bpm after successful emergency PCI were included']","['primary percutaneous coronary intervention (PCI', 'metoprolol orally', 'ivabradine', 'ivabradine combined with standard therapy such as β-blocker', 'ivabradine combined with metoprolol']","['Heart rate and blood pressure', 'high sensitivity troponin', 'heart rate', 'left ventricular remodeling', 'resting heart rate', 'left ventricular end-diastolic volume and left ventricular end-systolic volume', 'NT-proBNP', 'left ventricular ejection fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1532297', 'cui_str': 'Emergency percutaneous coronary intervention'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",66.0,0.0263834,"Compared with the control group, the left ventricular end-diastolic volume and left ventricular end-systolic volume were significantly decreased while left ventricular ejection fraction was significantly increased in the test group at 90 days after operation.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, China.'}, {'ForeName': 'Xinbo', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Department of Echocardiography, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, China.'}, {'ForeName': 'Shaodi', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, China.'}, {'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, China.'}, {'ForeName': 'Xinlin', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, China.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12816']
914,33370370,The effect of an experiential learning program on motivations and activity involvement among dementia supporters in Japan.,"PURPOSE


The purpose of this study was to examine the effectiveness of an experiential learning program based on Kolb's theory in increasing dementia supporters' motivation and activity involvement within the community.
METHOD


In this interventional study, the sample was divided into two groups. The intervention group underwent dementia supporter training and participated in an experiential learning program, which was conducted two weeks after the initial training session. The control group underwent only the dementia supporter training.
RESULTS


Kolb's experiential learning model consists of four stages: concrete experience, reflective observation, conceptualization, and active experimentation. A total of 37 and 44 individuals constituted the intervention and control groups, respectively. The Wilcoxon signed-rank test revealed that there was a significant increase in motivation among the intervention group participants, when compared to the control group participants. Moreover, the activity rate was higher among the intervention group participants.
DISCUSSION


The experiential learning program was effective in increasing motivation levels and activity involvement among the dementia supporters.
CONCLUSIONS


The experiential learning program for dementia supporters can be used to improve other volunteer and professional programs. Moreover, Kolb's theory can be used to support individuals with dementia within the community.",2020,"The Wilcoxon signed-rank test revealed that there was a significant increase in motivation among the intervention group participants, when compared to the control group participants.","['dementia supporters in Japan', 'individuals with dementia within the community']","['experiential learning program', 'dementia supporter training and participated in an experiential learning program', 'dementia supporter training']","['motivation', 'activity rate']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0127384,"The Wilcoxon signed-rank test revealed that there was a significant increase in motivation among the intervention group participants, when compared to the control group participants.","[{'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Arakawa', 'Affiliation': 'Department of Nursing, International University of Health and Welfare, Ohtawara, Tochigi, Japan.'}, {'ForeName': 'Tokie', 'Initials': 'T', 'LastName': 'Anme', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}]",PloS one,['10.1371/journal.pone.0244337']
915,33373409,Estimating the impact of differential adherence on the comparative effectiveness of stool-based colorectal cancer screening using the CRC-AIM microsimulation model.,"BACKGROUND


Real-world adherence to colorectal cancer (CRC) screening strategies is imperfect. The CRC-AIM microsimulation model was used to estimate the impact of imperfect adherence on the relative benefits and burdens of guideline-endorsed, stool-based screening strategies.
METHODS


Predicted outcomes of multi-target stool DNA (mt-sDNA), fecal immunochemical tests (FIT), and high-sensitivity guaiac-based fecal occult blood tests (HSgFOBT) were simulated for 40-year-olds free of diagnosed CRC. For robustness, imperfect adherence was incorporated in multiple ways and with extensive sensitivity analysis. Analysis 1 assumed adherence from 0%-100%, in 10% increments. Analysis 2 longitudinally applied real-world first-round differential adherence rates (base-case imperfect rates = 40% annual FIT vs 34% annual HSgFOBT vs 70% triennial mt-sDNA). Analysis 3 randomly assigned individuals to receive 1, 5, or 9 lifetime (9 = 100% adherence) mt-sDNA tests and 1, 5, or 9 to 26 (26 = 100% adherence) FIT tests. Outcomes are reported per 1000 individuals compared with no screening.
RESULTS


Each screening strategy decreased CRC incidence and mortality versus no screening. In individuals screened between ages 50-75 and adherence ranging from 10%a-100%, the life-years gained (LYG) for triennial mt-sDNA ranged from 133.1-300.0, for annual FIT from 96.3-318.1, and for annual HSgFOBT from 99.8-320.6. At base-case imperfect adherence rates, mt-sDNA resulted in 19.1% more LYG versus FIT, 25.4% more LYG versus HSgFOBT, and generally had preferable efficiency ratios while offering the most LYG. Completion of at least 21 FIT tests is needed to reach approximately the same LYG achieved with 9 mt-sDNA tests.
CONCLUSIONS


Adherence assumptions affect the conclusions of CRC screening microsimulations that are used to inform CRC screening guidelines. LYG from FIT and HSgFOBT are more sensitive to changes in adherence assumptions than mt-sDNA because they require more tests be completed for equivalent benefit. At imperfect adherence rates, mt-sDNA provides more LYG than FIT or HSgFOBT at an acceptable tradeoff in screening burden.",2020,"At base-case imperfect adherence rates, mt-sDNA resulted in 19.1% more LYG versus FIT, 25.4% more LYG versus HSgFOBT, and generally had preferable efficiency ratios while offering the most LYG.","['In individuals screened between ages 50-75 and adherence ranging from 10%a-100%, the life-years gained (LYG) for triennial mt-sDNA ranged from 133.1-300.0, for annual FIT from 96.3-318.1, and for annual HSgFOBT from 99.8-320.6']",['stool-based colorectal cancer screening'],"['multi-target stool DNA (mt-sDNA), fecal immunochemical tests (FIT), and high-sensitivity guaiac-based fecal occult blood tests (HSgFOBT', 'CRC incidence and mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018302', 'cui_str': 'Guaiac'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018302', 'cui_str': 'Guaiac'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3.0,0.111189,"At base-case imperfect adherence rates, mt-sDNA resulted in 19.1% more LYG versus FIT, 25.4% more LYG versus HSgFOBT, and generally had preferable efficiency ratios while offering the most LYG.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Piscitello', 'Affiliation': 'EmpiriQA, LLC, Long Grove, IL, United States of America.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Saoud', 'Affiliation': 'Exact Sciences Corporation, Madison, WI, United States of America.'}, {'ForeName': 'A Mark', 'Initials': 'AM', 'LastName': 'Fendrick', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Bijan J', 'Initials': 'BJ', 'LastName': 'Borah', 'Affiliation': 'Department of Health Services Research, Mayo Clinic, Rochester, MN, United States of America.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Hassmiller Lich', 'Affiliation': 'Department of Health Policy & Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Matney', 'Affiliation': 'Exact Sciences Corporation, Madison, WI, United States of America.'}, {'ForeName': 'A Burak', 'Initials': 'AB', 'LastName': 'Ozbay', 'Affiliation': 'Exact Sciences Corporation, Madison, WI, United States of America.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Parton', 'Affiliation': 'Exact Sciences Corporation, Madison, WI, United States of America.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Limburg', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, United States of America.'}]",PloS one,['10.1371/journal.pone.0244431']
916,33386634,Test-guided dietary management of eczema in children: A randomized controlled feasibility trial (TEST).,"BACKGROUND


Parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain.
OBJECTIVE


To determine whether a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible.
METHODS


Children (>3 months and <5 years) with mild-to-severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed up for 24 weeks. A sample of doctors and parents was interviewed. Registration ISRCTN15397185.
RESULTS


From 1059 invitation letters sent to carers of potentially eligible children, 84 were randomized (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). Of the 42, 6 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4-6 weeks) - with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74%-100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT-related adverse events. During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission.
CONCLUSIONS


It is possible to recruit, randomize and retain children with eczema from primary care into a trial of food allergy screening and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds.",2021,"During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission.
","['children', 'From 1059 invitation letters sent to carers of potentially eligible children, 84 were randomised (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8', 'Children (>3 months and <5 years) with mild to severe eczema, recruited via primary care', 'By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4-6 weeks) - with 1/6 partially completing it']","[""structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish"", 'test-guided dietary advice versus usual care', 'Test-guided dietary management of eczema', 'intervention or usual care']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C4304942', 'cui_str': 'POEM - Patient-Oriented Eczema Measure'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C3810819', 'cui_str': 'Allergy clinic'}, {'cui': 'C0442750', 'cui_str': 'Distance vision 6/6'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0330953', 'cui_str': 'Anacardium occidentale'}, {'cui': 'C2702357', 'cui_str': 'codfish allergenic extract'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.112834,"During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission.
","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ridd', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Webb', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Roberts', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Santer', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gilbertson', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Deb', 'Initials': 'D', 'LastName': 'Marriage', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Turner', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Coast', 'Affiliation': 'Health Economics Bristol, Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy E', 'Initials': 'LE', 'LastName': 'Selman', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Clement', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alison R G', 'Initials': 'ARG', 'LastName': 'Shaw', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Muller', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Waddell', 'Affiliation': 'Nottingham City Care Partnership, Nottingham, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Angier', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Kai', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Boyle', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13816']
917,33341226,Multicentre randomised controlled clinical trial of electroacupuncture with usual care for patients with non-acute pain after back surgery.,"BACKGROUND


The purpose of this study was to investigate the effectiveness and safety between electroacupuncture (EA) combined with usual care (UC) and UC alone for pain reduction and functional improvement in patients with non-acute low back pain (LBP) after back surgery.
METHODS


In this multicentre, randomised, assessor-blinded active-controlled trial, 108 participants were equally randomised to either the EA with UC or the UC alone. Participants in the EA with UC group received EA treatment and UC treatment twice a week for 4 weeks; those allocated to the UC group received only UC. The primary outcome was the VAS pain intensity score. The secondary outcomes were functional improvement (Oswestry Disability Index [ODI]) and the quality of life (EuroQol-5-dimension questionnaire [EQ-5D]). The outcomes were measured at Week 5.
RESULTS


Significant reductions were observed in the VAS (mean difference [MD] -8.15; P=0.0311) and ODI scores (MD -3.98; P=0.0460) between two groups after 4 weeks of treatment. No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups. The reported AEs did not have a causal relationship with EA treatment.
CONCLUSIONS


The results showed that EA with UC treatment was more effective than UC alone and relatively safe in patients with non-acute LBP after back surgery. EA with UC treatment may be considered as an effective, integrated, conservative treatment for patients with non-acute LBP after back surgery.
CLINICAL TRIAL REGISTRATION


KCT0001939.",2021,No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups.,"['patients with non-acute pain after back surgery', 'patients with non-acute LBP after back surgery', 'patients with non-acute low back pain (LBP) after back surgery', '108 participants']","['electroacupuncture (EA) combined with usual care (UC) and UC alone', 'VAS', 'EA with UC or the UC alone', 'UC group received only UC', 'electroacupuncture']","['EQ-5D scores and incidence of adverse events (AEs', 'ODI scores', 'VAS pain intensity score', 'effectiveness and safety', 'functional improvement (Oswestry Disability Index [ODI]) and the quality of life (EuroQol-5-dimension questionnaire [EQ-5D', 'pain reduction and functional improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0741419', 'cui_str': 'Back surgery'}, {'cui': 'C0457950', 'cui_str': 'Acute low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",108.0,0.137784,No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups.,"[{'ForeName': 'In', 'Initials': 'I', 'LastName': 'Heo', 'Affiliation': 'Spine & Joint Center, Department of Korean Rehabilitation Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea; Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea.'}, {'ForeName': 'Byung-Cheul', 'Initials': 'BC', 'LastName': 'Shin', 'Affiliation': 'Spine & Joint Center, Department of Korean Rehabilitation Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea; Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea.'}, {'ForeName': 'Jae-Heung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, South Korea.'}, {'ForeName': 'Eui-Hyoung', 'Initials': 'EH', 'LastName': 'Hwang', 'Affiliation': 'Spine & Joint Center, Department of Korean Rehabilitation Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea; Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea.'}, {'ForeName': 'Jun-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea; University of Science & Technology, Korean Medicine Life Science, Campus of Korea Institute of Oriental Medicine, Daejeon, South Korea.'}, {'ForeName': 'Koh-Woon', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Me-Riong', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': 'Jaseng Hospital of Korean Medicine, Seoul, South Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.'}, {'ForeName': 'Ojin', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.'}, {'ForeName': 'Nam-Kwen', 'Initials': 'NK', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology & Otolaryngology and Dermatology, School of Korean Medicine, Pusan National University, Yangsan, South Korea.'}, {'ForeName': 'Dong-Wuk', 'Initials': 'DW', 'LastName': 'Son', 'Affiliation': 'Department of Neurosurgery, Yangsan Pusan National University Hospital, Yangsan, South Korea.'}, {'ForeName': 'Kyung-Min', 'Initials': 'KM', 'LastName': 'Shin', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea. Electronic address: kyungmin7221@kiom.re.kr.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.10.038']
918,33321461,"The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial.","PURPOSE


Port needle insertions are painful and distressing for Pediatric Hematology-Oncology patients. Virtual Reality (VR) can be used during needle-related procedures in these patients. This study aimed to investigate the effect of VR distraction during access to the venous port with a Huber needle in reducing needle-related pain, fear, and anxiety of children and adolescents with cancer.
METHODS


This randomized controlled study used a parallel trial design guided by the CONSORT checklist. The sample of children (n = 42) was allocated to the VR group (n = 21) and the control group (n = 21). Port needle-related pain was assessed using the Wong-Baker Faces Pain Rating Scale after the procedure. Before and after the port needle insertion procedure, anxiety and fear assessed using self- and parent-report using the Children's Anxiety Meter and Child Fear Scale. The primary outcome was the patient-reported pain scores after the procedure and fear and anxiety scores before and after the procedure. Pain, anxiety, and fear scores of the two groups and within groups were analyzed and also Spearman correlation analysis was used.
RESULTS


Self-reported pain scores of patients in the VR and control group were 2.4 ± 1.8 and 5.3 ± 1.8, respectively. This study found a statistically significant difference between groups in pain scores (p < .001). A statistically significant difference was found between groups according to the self- and parent-reported fear and anxiety scores after the procedure. Self-reported fear scores in the VR and control group were 0.8 ± 0.9, 2.0 ± 1.0, self-reported anxiety scores were 2.9 ± 2.0, 5.4 ± 2.0, respectively (p < .001).
CONCLUSION


Virtual reality is an effective distraction method in reducing port needle-related pain, fear, and anxiety in Pediatric Hematology-Oncology patients. ClinicalTrials.gov NCT04093154.",2021,A statistically significant difference was found between groups according to the self- and parent-reported fear and anxiety scores after the procedure.,"['children and adolescents with cancer', 'Pediatric Hematology-Oncology patients', 'pediatric hematology-oncology patients']","['VR distraction', 'virtual reality', 'Virtual Reality (VR']","[""anxiety and fear assessed using self- and parent-report using the Children's Anxiety Meter and Child Fear Scale"", 'Pain, anxiety, and fear scores', 'patient-reported pain scores after the procedure and fear and anxiety scores', 'anxiety scores', 'Baker Faces Pain Rating Scale', 'pain scores', 'pain, fear, and anxiety', 'fear and anxiety scores', 'Self-reported fear scores', 'Self-reported pain scores', 'needle-related pain, fear, and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1518927', 'cui_str': 'Pediatric hematology oncology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0424139', 'cui_str': 'Anxiety and fear'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0400774,A statistically significant difference was found between groups according to the self- and parent-reported fear and anxiety scores after the procedure.,"[{'ForeName': 'Gülçin Özalp', 'Initials': 'GÖ', 'LastName': 'Gerçeker', 'Affiliation': 'Pediatric Nursing Department, Dokuz Eylul University Faculty of Nursing, Izmir, 35340, Turkey. Electronic address: gulcinozalp@gmail.com.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bektaş', 'Affiliation': 'Pediatric Nursing Department, Dokuz Eylul University Faculty of Nursing, Izmir, 35340, Turkey. Electronic address: mbekta@gmail.com.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Aydınok', 'Affiliation': 'Ege University Hospital, Department of Paediatric Hematology-Oncology, Izmir, Turkey. Electronic address: yesim.aydinok@yahoo.com.'}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Ören', 'Affiliation': 'Dokuz Eylül University Hospital, Department of Paediatric Hematology, Izmir, Turkey. Electronic address: hale.oren@deu.edu.tr.'}, {'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Ellidokuz', 'Affiliation': 'Dokuz Eylül University Hospital, Institue of Oncology, Izmir, Turkey. Electronic address: hulya.ellidokuz@deu.edu.tr.'}, {'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Olgun', 'Affiliation': 'Dokuz Eylül University Hospital, Department of Paediatric Oncology, Izmir, Turkey. Electronic address: nur.olgun@deu.edu.tr.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101886']
919,33347829,"Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial.","BACKGROUND


Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations; however, there is scarce evidence of the effectiveness of the combinations in the Asian population. We evaluated camrelizumab plus chemotherapy against non-squamous NSCLC in China.
METHODS


We did a randomised, open-label, multicentre, phase 3 trial (CameL) in 52 hospitals in China for patients with non-squamous NSCLC without EGFR and ALK alteration. Eligible patients were aged 18-70 years and had no previous systemic chemotherapy, Eastern Cooperative Oncology Group performance status of 0 or 1, and at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (version 1.1). Patients were randomly assigned (1:1) to receive 4-6 cycles of carboplatin (area under curve 5 mg/mL per min) plus pemetrexed (500 mg/m 2 ) with or without camrelizumab (200 mg) every 3 weeks, followed by maintenance therapy with camrelizumab plus pemetrexed or pemetrexed alone. Medication was administered intravenously on day 1 of each 3-week treatment cycle. Randomisation was done using a centralised interactive web-response system with the block size randomly generated as four or six and stratified by sex and smoking history. The two primary endpoints were progression-free survival per blinded independent central review, in all patients and in patients who were PD-L1 positive. Primary analysis was done in the full analysis set that included all randomly assigned patients who received at least one dose of the study treatment. Herein, due to the primary endpoint being met at the interim analysis, we reported the findings of prespecified interim analysis, which only included confirmatory statistical testing for progression-free survival in all patients. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT03134872 (follow-up is ongoing).
FINDINGS


Between May 12, 2017, and June 6, 2018, of the 419 patients who were randomly assigned, seven did not receive assigned treatment and 412 received either camrelizumab plus chemotherapy (n=205) or chemotherapy alone (n=207). At interim analysis, median follow-up duration was 11·9 months (IQR 9·0-14·9). Progression-free survival in this interim analysis was significantly prolonged with camrelizumab plus chemotherapy than with chemotherapy alone (median 11·3 months [95% CI 9·6-15·4] vs 8·3 months [6·0-9·7]; hazard ratio 0·60 [0·45-0·79]; one-sided p=0·0001). Most common grade 3 or worse treatment-related adverse events were decreased neutrophil count (78 [38%] patients in the camrelizumab plus chemotherapy group vs 63 [30%] patients in the chemotherapy alone group), decreased white blood cell count (40 [20%] vs 30 [14%]), anaemia (38 [19%] vs 23 [11%]), and decreased platelet count (34 [17%] vs 24 [12%]). Serious treatment-related adverse events occurred in 74 (36%) patients in the camrelizumab plus chemotherapy group and 27 (13%) patients in the chemotherapy alone group.
INTERPRETATION


The primary endpoint was met at the interim analysis, showing a statistically significant and clinically meaningful improvement in progression-free survival with camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in all patients, supporting camrelizumab plus carboplatin and pemetrexed as a first-line treatment option for Chinese patients with advanced non-squamous NSCLC without EGFR and ALK alterations. The trial is being continued to collect long-term outcomes in all patients and carry out confirmatory statistical testing for progression-free survival in the PD-L1-positive population.
FUNDING


Jiangsu Hengrui Medicine.",2021,"The primary endpoint was met at the interim analysis, showing a statistically significant and clinically meaningful improvement in progression-free survival with camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in all patients, supporting camrelizumab plus carboplatin and pemetrexed as a first-line treatment option for Chinese patients with advanced non-squamous NSCLC without EGFR and ALK alterations.","['Eligible patients were aged 18-70 years and had no previous systemic chemotherapy, Eastern Cooperative Oncology Group performance status of 0 or 1, and at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (version 1.1', 'chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL', 'Between May 12, 2017, and June 6, 2018, of the 419 patients', '52 hospitals in China for patients with non-squamous NSCLC without EGFR and ALK alteration', 'Chinese patients with advanced non-squamous NSCLC without EGFR and ALK alterations', 'non-squamous NSCLC in China']","['camrelizumab plus pemetrexed or pemetrexed alone', 'Immunotherapy combined with chemotherapy', 'camrelizumab plus carboplatin and pemetrexed', 'carboplatin (area under curve 5 mg/mL per min) plus pemetrexed (500 mg/m 2 ) with or without camrelizumab', 'camrelizumab plus chemotherapy', 'Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone', 'camrelizumab plus chemotherapy (n=205) or chemotherapy alone', 'camrelizumab plus carboplatin and pemetrexed versus chemotherapy', 'camrelizumab plus chemotherapy against']","['platelet count', 'progression-free survival', 'anaemia', 'Progression-free survival', 'white blood cell count', 'Safety', 'neutrophil count', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0006801', 'cui_str': 'Camelus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.387338,"The primary endpoint was met at the interim analysis, showing a statistically significant and clinically meaningful improvement in progression-free survival with camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in all patients, supporting camrelizumab plus carboplatin and pemetrexed as a first-line treatment option for Chinese patients with advanced non-squamous NSCLC without EGFR and ALK alterations.","[{'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China. Electronic address: caicunzhoudr@163.com.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Yunchao', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Thoracic Surgery Oncology, Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center, Kunming, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Respiratory Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'LiZhu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Oncology Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Thoracic Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhehai', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory, Shandong Cancer Hospital & Institute, Jinan, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Oncology, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Oncology Department, General Hospital of Chinese People's Liberation Army, Beijing, China.""}, {'ForeName': 'QiMing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Respiratory Medicine, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Fengying', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology-Chest, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Oncology, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jianan', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Respiration, First Affiliated Hospital of Suzhou University, Suzhou, China.'}, {'ForeName': 'Jiuwei', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'Department of Medical Oncology, The First Bethune Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Lejie', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Pulmonary and Critical Care Medicine, The First Affiliated Hospital University of Science Technology of China, Hefei, China.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yueyin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Tumor Chemotherapy, The First Affiliated Hospital University of Science Technology of China, Hefei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Medical Oncology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'LiPing', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Fuzhou Pulmonary Hospital of Fujian, Fuzhou, China.'}, {'ForeName': 'Xiubao', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Department of Biotherapy, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Pneumology Department, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Oncology II, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Kangsheng', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'XiaoRong', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Clinical Research & Development, Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Clinical Research & Development, Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Clinical Research & Development, Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30365-9']
920,33358336,Propofol plus low-dose dexmedetomidine infusion and postoperative delirium in older patients undergoing cardiac surgery.,"BACKGROUND


Postoperative delirium (POD) is a frequent complication in older patients. Dexmedetomidine might be effective in decreasing the incidence of POD. We hypothesised that adding low-dose rate dexmedetomidine infusion to a propofol sedation regimen would have fewer side-effects and would counteract the possible delirium producing properties of propofol, resulting in a lower risk of POD than propofol with placebo.
METHODS


In this double-blind placebo-controlled trial, patients ≥60 yr old undergoing on-pump cardiac surgery were randomised 1:1 to the following postoperative sedative regimens: a propofol infusion and dexmedetomidine (0.4 μg kg -1  h -1 ) or a propofol infusion and saline 0.9% (placebo group). The study drug was started at chest closure and continued for 10 h. The primary endpoint was in-hospital POD, assessed using the Confusion Assessment Method and chart review method.
RESULTS


POD over the course of hospital stay occurred in 31/177 (18%) and 33/172 (19%) patients in the dexmedetomidine and placebo arm, respectively (P=0.687; odds ratio=0.89; 95% confidence interval, 0.52-1.54). The incidence of POD in the intensive care alone, or on the ward alone, was also not significantly different between the groups. Subjects in the dexmedetomidine group spent less median time in a delirious state (P=0.026). Median administered postoperative norepinephrine was significantly higher in the dexmedetomidine group (P<0.001). One patient in the dexmedetomidine group and 10 patients in the placebo group died in the hospital.
CONCLUSIONS


Adding low-dose rate dexmedetomidine to a sedative regimen based on propofol did not result in a different risk of in-hospital delirium in older patients undergoing cardiac surgery. With a suggestion of both harm and benefit in secondary outcomes, supplementing postoperative propofol with dexmedetomidine cannot be recommended based on this study.
CLINICAL TRIAL REGISTRATION


NCT03388541.",2021,Median administered postoperative norepinephrine was significantly higher in the dexmedetomidine group (P<0.001).,"['older patients undergoing cardiac surgery', 'older patients', 'patients ≥60 yr old undergoing on-pump cardiac surgery']","['dexmedetomidine', 'propofol infusion and saline 0.9% (placebo', 'Dexmedetomidine', 'placebo', 'Propofol plus low dose dexmedetomidine', 'propofol infusion and dexmedetomidine']","['median time in a delirious state', 'hospital', 'incidence of POD', 'hospital POD, assessed using the Confusion Assessment Method and chart review method', 'Median administered postoperative norepinephrine', 'hospital stay']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.537534,Median administered postoperative norepinephrine was significantly higher in the dexmedetomidine group (P<0.001).,"[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Momeni', 'Affiliation': 'Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium. Electronic address: mona.momeni@uclouvain.be.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Khalifa', 'Affiliation': 'Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lemaire', 'Affiliation': 'Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Watremez', 'Affiliation': 'Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tircoveanu', 'Affiliation': 'Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Van Dyck', 'Affiliation': 'Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kahn', 'Affiliation': 'Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rosal Martins', 'Affiliation': 'Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Mastrobuoni', 'Affiliation': 'Department of Cardiac Surgery; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'De Kerchove', 'Affiliation': 'Department of Cardiac Surgery; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'Serge Henri', 'Initials': 'SH', 'LastName': 'Zango', 'Affiliation': 'Department of Epidemiology and Statistics; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'Luc-Marie', 'Initials': 'LM', 'LastName': 'Jacquet', 'Affiliation': 'Department of Intensive Care Unit; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.10.041']
921,33367965,Effect of Preoperative Infusion of Levosimendan on Biomarkers of Myocardial Injury and Haemodynamics After Paediatric Cardiac Surgery: A Randomised Controlled Trial.,"OBJECTIVE


The aim was to test the hypothesis that preoperative infusion of levosimendan would decrease patients' cardiac biomarker profiles during the immediate postoperative stage (troponin I and B-type natriuretic peptide levels) more efficiently than placebo after cardiopulmonary bypass.
METHODS


In a randomised, placebo-controlled, double-blinded study, 30 paediatric patients were scheduled for congenital heart disease surgery. 15 patients (50%) received prophylactic levosimendan and 15 patients (50%) received placebo from 12 h before cardiopulmonary bypass to 24 h after surgery.
RESULTS


Troponin I levels were higher in the placebo group at 0, 12, and 24 h after cardiopulmonary bypass, although the mean differences between the study groups and the 95% confidence intervals (CIs) for troponin I levels did not present statistically significant differences at any of the three time points considered (mean differences [95% CIs] - 3.32 pg/ml [- 19.34 to 12.70], - 2.42 pg/ml [- 19.78 to 13.95], and - 79.94 pg/ml [- 266.99 to 16.39] at 0, 12, and 24 h, respectively). A similar lack of statistically significant difference was observed for B-type natriuretic peptide (mean differences [95% CIs] 36.86 pg/dl [- 134.16 to 225.64], - 350.79 pg/dl [- 1459.67 to 557.45], and - 310.35 pg/dl [- 1505.76 to 509.82]). Lactic acid levels were significantly lower with levosimendan; the mean differences between the study groups and the 95% CIs for lactate levels present statistically significant differences at 0 h (- 1.52 mmol/l [- 3.19 to - 0.25]) and 12 h (- 1.20 mmol/l [- 2.53 to - 0.10]) after cardiopulmonary bypass. Oxygen delivery (DO 2 ) was significantly higher at 12 h and 24 h after surgery (mean difference [95% CI] 627.70 ml/min/m 2  [122.34-1162.67] and 832.35 ml/min/m 2  [58.15 to 1651.38], respectively).
CONCLUSIONS


Levosimendan does not significantly improve patients' postoperative troponin I and B-type natriuretic peptide profiles during the immediate postoperative stage in comparison with placebo, although both were numerically higher with placebo. Levosimendan, however, significantly reduced lactic acid levels and improved patients' DO 2  profiles. These results highlight the importance of this new drug and its possible benefit with regard to myocardial injury; however, evaluation in larger, adequately powered trials is needed to determine the efficacy of levosimendan. Trial registry number: EudraCT 2012-005310-19.",2021,"CONCLUSIONS


Levosimendan does not significantly improve patients' postoperative troponin","['After Paediatric Cardiac Surgery', 'Trial registry number: EudraCT 2012-005310-19', '30 paediatric patients were scheduled for congenital heart disease surgery']","['placebo', 'troponin', 'Levosimendan', 'levosimendan', 'prophylactic levosimendan']","[""patients' postoperative troponin"", 'Oxygen\xa0delivery (DO 2 ', 'lactic acid levels', 'Troponin I levels', 'Lactic acid levels', 'Myocardial Injury and Haemodynamics', 'B-type natriuretic peptide']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",30.0,0.632139,"CONCLUSIONS


Levosimendan does not significantly improve patients' postoperative troponin","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Abril-Molina', 'Affiliation': 'Pediatric Intensive Care Unit, Hospital Universitario Virgen de las Nieves, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Gómez-Luque', 'Affiliation': 'Pediatric Intensive Care Unit, Hospital Universitario Virgen de las Nieves, University of Granada, Granada, Spain. pepegomezluque@gmail.com.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Perin', 'Affiliation': 'Paediatric Cardiology Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Esteban-Molina', 'Affiliation': 'Paediatric Cardiac Surgery Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferreiro-Marzal', 'Affiliation': 'Paediatric Cardiac Surgery Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernandez-Guerrero', 'Affiliation': 'Pediatric Anesthesia Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Ocete-Hita', 'Affiliation': 'Pediatric Intensive Care Unit, Hospital Universitario Virgen de las Nieves, University of Granada, Granada, Spain.'}]",Drugs in R&D,['10.1007/s40268-020-00332-1']
922,33306873,Performance of different criteria for refractory myasthenia gravis.,"BACKGROUND AND PURPOSE


Defining refractory myasthenia gravis is important, as this can drive clinical decision making, for example, by escalating treatments in refractory individuals. There are several definitions of refractory myasthenia, and their performances have not been compared. Having valid and reliable criteria can help select patients in whom more aggressive treatments may be needed.
METHODS


We applied five different refractory myasthenia criteria (Drachman, Mantegazza, Suh, the International Consensus Guideline (ICG), and the randomised controlled trial of eculizumab in refractory, anti-acetylcholine receptor positive, generalised myasthenia gravis (REGAIN), to a cohort of 237 patients. We compared the proportion of refractory patients among different criteria and their scores on disease severity, fatigue, and quality-of-life (QoL) scales. We also assessed the agreement for each criterion between two trained assessors.
RESULTS


The Drachman, Mantegazza, and Suh criteria resulted in high proportions of refractory individuals (40.1%, 39.2%, and 38.8%, respectively), compared with the ICG and REGAIN criteria (9.7% and 3.0%, respectively). Refractory patients by the ICG and REGAIN criteria had worse disease severity, QoL, and fatigue scores, compared with patients classified as refractory by other criteria. All criteria had high agreement between raters (between 70% and 100%).
CONCLUSIONS


There is high variability in the proportion of refractory myasthenia gravis patients depending on the criteria used, with ICG and REGAIN criteria capturing patients with worse disease severity. This reflects conceptual differences as to what refractory means. Further multicenter studies are needed to determine appropriate criteria for refractory myasthenia gravis.",2021,"Refractory patients by the ICG and REGAIN criteria had worse disease severity, QoL, and fatigue scores, compared with patients classified as refractory by other criteria.",['237 patients'],['eculizumab'],"['disease severity, fatigue, and quality-of-life (QoL) scales', 'disease severity, QoL, and fatigue scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1541483', 'cui_str': 'eculizumab'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",237.0,0.129347,"Refractory patients by the ICG and REGAIN criteria had worse disease severity, QoL, and fatigue scores, compared with patients classified as refractory by other criteria.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tran', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Aishani', 'Initials': 'A', 'LastName': 'Biswas', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Mendoza', 'Affiliation': 'Division of Neurology, Department of Medicine, The Ellen and Prosserman Centre for Neuromuscular Diseases, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Katzberg', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Barnett', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",European journal of neurology,['10.1111/ene.14675']
923,33357793,Towards safe blood-transfusion practice for nurses: Effectiveness of comic-based learning tool.,"Comic has been used to support education for nurses. This learning approach needs to be explored further because it supports nurses to continue learning during their professional phase. The purpose of this study is to examine the effectiveness of comic in supporting the training of safety blood transfusions administration among nurses. The research design is a controlled trial. The respondents are nurses assigned into control and intervention groups. The intervention group received blood transfusion with comic approach and the control group received conventional standard operational procedure. After two weeks, the safety blood transfusion knowledge of the two groups was measured by using a questionnaire. The data was analyzed by using independent t tests. The result shows that there is a significant mean difference in knowledge between the two groups (p value:0.00), thus comic is an effective learning tool to support a safe blood transfusion administration among nurses.",2020,"The result shows that there is a significant mean difference in knowledge between the two groups (p value:0.00), thus comic is an effective learning tool to support a safe blood transfusion administration among nurses.",['nurses'],['blood transfusion with comic approach and the control group received conventional standard operational procedure'],['safety blood transfusion knowledge'],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.018285,"The result shows that there is a significant mean difference in knowledge between the two groups (p value:0.00), thus comic is an effective learning tool to support a safe blood transfusion administration among nurses.","[{'ForeName': 'Indah Mei', 'Initials': 'IM', 'LastName': 'Rahajeng', 'Affiliation': 'Department of Nursing, Faculty of Medicine, Universitas Udayana, Denpasar, Indonesia. Electronic address: indah.mei@unud.ac.id.'}, {'ForeName': 'Faridatul', 'Initials': 'F', 'LastName': 'Muslimah', 'Affiliation': 'Intensive Care Unit, Abdoer Rahem Public Hospital, Situbondo, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.07.026']
924,33357792,"The effect of progressive muscle relaxation on anxiety and blood pressure among hypertension patients in east Kalimantan, Indonesia.","Hypertension remains a major problem in the health sector and affects both physical and psychological. Hypertension is a chronic disease that may lead to other serious illnesses and anxiety if it is treated improperly. One of the non-pharmacological treatment for lowering blood pressure and anxiety is by relaxation technique, specifically with progressive muscle relaxation technique (PMR). It is to determine the effect of progressive muscle relaxation on anxiety and blood pressure among hypertension patients in A.W. Sjahranie General Hospital, East Kalimantan. This study was conducted using a non-equivalent control group pretest-posttest design. The sampling technique used was the simple random sampling technique. This study involved 91 respondents in A.W. Sjahranie General Hospital, East Kalimantan. They were divided into two groups. The respondents of 71 people were in the intervention group health education and PMR, they exercised 2 times a week for 8 weeks and 20 respondents in the control group were given health education. The research instruments used were questionnaires and blood pressure observation sheets. Measurement of blood pressure (systolic and diastolic) and anxiety was carried out on the fourth week and eighth week. This study used the Paired t-test and Pearson Correlation Test as the data analysis technique. These findings showed that there was a significant difference before and after the fourth and eighth weeks of intervention on systolic and diastolic blood pressure and anxiety (p=0.000). The results showed significant differences between the intervention group and the control group in systolic blood pressure (p=0.001) and diastolic (p=0.000), anxiety (p=0.000). Intervention PMR provides the most powerful influence on systolic and diastolic blood pressure, and anxiety (p=0.000). This study recommends the need for PMR exercises for 8 weeks to control blood pressure and anxiety in patients with primary hypertension, and for the hospital, it was suggested to develop PMR as a part of independent nursing practices.",2020,"Intervention PMR provides the most powerful influence on systolic and diastolic blood pressure, and anxiety (p=0.000).","['patients with primary hypertension', 'hypertension patients in A.W. Sjahranie General Hospital, East Kalimantan', 'hypertension patients in east Kalimantan, Indonesia', '91 respondents in A.W. Sjahranie General Hospital, East Kalimantan']","['PMR exercises', 'control group were given health education', 'progressive muscle relaxation']","['systolic and diastolic blood pressure and anxiety', 'systolic blood pressure', 'anxiety and blood pressure', 'systolic and diastolic blood pressure, and anxiety', 'blood pressure (systolic and diastolic) and anxiety', 'diastolic (p=0.000), anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}]",91.0,0.0127437,"Intervention PMR provides the most powerful influence on systolic and diastolic blood pressure, and anxiety (p=0.000).","[{'ForeName': 'Made', 'Initials': 'M', 'LastName': 'Ermayani', 'Affiliation': 'Department of Nursing, Dirgahayu School of Health Sciences, Indonesia. Electronic address: ermayani.made@gmail.com.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Prabawati', 'Affiliation': 'Department of Nursing, Sint Carolus School of Health Sciences, Indonesia.'}, {'ForeName': 'Wilhelmus Hary', 'Initials': 'WH', 'LastName': 'Susilo', 'Affiliation': 'Faculty of Economics University of Persada Indonesia Y.A.I, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.07.025']
925,33354149,Comparative study of the efficacy and safety of intranasal azelastine hydrochloride and fluticasone furoate in the treatment of allergic rhinitis.,"BACKGROUND


Allergic rhinitis (AR) is characterized by nasal itch, sneezing, watery or mucous rhinorrhea, nasal obstruction, and nasal or pharyngeal irritation. If untreated, AR can impair patients' quality of life (QOL). Azelastine hydrochloride (AH), histamine receptor antagonists, has anti-inflammatory and mast cell stabilizing properties. Fluticasone furoate (FF) is an anti-inflammatory agent with action on mast cells, eosinophils, neutrophils, macrophages, and lymphocytes. This study compares the efficacy and safety of these medications in AR.
MATERIALS AND METHODS


Patients in the study had been clinically diagnosed with AR. In each group, there were 75 randomized patients who were to receive either FF (27.5 μg/spray) or AH (0.10%) intranasally twice daily. Assessment in terms of symptoms (total nasal symptom score), signs (endoscopic staging), QOL, eosinophil count, and sensory attributes was done at baseline, day 7, and day 15. Adverse effects were recorded, and the cost incurred was analyzed. Paired and umpaired  t -test were used to compare symptom scores, QOL scores, and absolute eosinophil count within and between the groups, respectively.
RESULTS


The total number of patients was 150 (76 males and 74 females); the mean age for FF group was 26.23 ± 5.2 years, and 26.96 ± 4.8 years for AH group. By day 7, there was a reduction of all scores in both medications, but the reduction in reduction was highly significant with FF ( P  = 0.001). There was a significant reduction ( P  = 0.001) in absolute eosinophil count both in blood and nasal smears by day 15 in both the groups; the reduction was significant ( P  = 0.001) with fluticasone. Adverse reactions were reported by 33.3% of patients receiving FF and 28% patients receiving AH.
CONCLUSION


Fluticasone furoate produced sustained relief of symptoms, signs, and sensory attributes with a greater reduction in eosinophil count in comparison with AH in patients with allergic rhinitis.",2020,There was a significant reduction ( P  = 0.001) in absolute eosinophil count both in blood and nasal smears by day 15 in both the groups; the reduction was significant ( P  = 0.001) with fluticasone.,"['Allergic rhinitis (AR', 'total number of patients was 150 (76 males and 74 females); the mean age for FF group was 26.23 ± 5.2 years, and 26.96 ± 4.8 years for AH group', 'allergic rhinitis', 'Patients in the study had been clinically diagnosed with AR', 'patients with allergic rhinitis']","['fluticasone', 'Azelastine hydrochloride (AH), histamine receptor antagonists', 'intranasal azelastine hydrochloride and fluticasone furoate', 'Fluticasone furoate', 'FF', 'Fluticasone furoate (FF']","['Adverse effects', 'symptoms (total nasal symptom score), signs (endoscopic staging), QOL, eosinophil count, and sensory attributes', 'symptom scores, QOL scores, and absolute eosinophil count', 'absolute eosinophil count both in blood and nasal smears', 'Adverse reactions', 'eosinophil count', ""patients' quality of life (QOL"", 'efficacy and safety']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0771004', 'cui_str': 'Azelastine hydrochloride'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0771004', 'cui_str': 'Azelastine hydrochloride'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",75.0,0.0232111,There was a significant reduction ( P  = 0.001) in absolute eosinophil count both in blood and nasal smears by day 15 in both the groups; the reduction was significant ( P  = 0.001) with fluticasone.,"[{'ForeName': 'Nandish', 'Initials': 'N', 'LastName': 'Chennakeshavaraju', 'Affiliation': 'Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India.'}, {'ForeName': 'Sarala', 'Initials': 'S', 'LastName': 'Narayana', 'Affiliation': 'Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India.'}, {'ForeName': 'Azeem S M', 'Initials': 'ASM', 'LastName': 'Mohiyuddin', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India.'}]",Journal of family & community medicine,['10.4103/jfcm.JFCM_103_20']
926,33360753,Open Versus Ultrasound Guided Tunneled Central Venous Access in children: A Randomized Controlled Study.,"BACKGROUND


The purpose of this study was to compare open insertion to ultrasound guided percutaneous insertion of central access catheters performed in a tertiary pediatric hospital in terms of its safety and complication rates.
METHODS


This was an ethics approved prospective randomized trial of children under 16 y of age. Procedure was performed by surgeons with varying experience with percutaneous and open insertion. Primary outcome studied was complications-immediate and late. Secondary outcomes were time taken to complete procedure, conversion rates, duration of line use.
RESULTS


A total of 108 patients were analyzed. Sixty-four were male. Right internal jugular vein was accessed in 97. Eighty-one lines were double lumen, 23 implantable access devices, and the rest were single lumen catheters. More than one needle puncture was needed in 22% of the cases but there were no conversions in the ultrasound group. Twelve patients needed more than one insertion to achieve optimal position of the tip. Eleven patients had immediate and late complications. Percutaneous lines lasted 45 d longer though this was not statistically significant. Operating time was 20.6% shorter with percutaneous access. Post-removal measurement of vein size by ultrasound demonstrated significant decrease in size in the open group.
CONCLUSIONS


Ultrasound guided percutaneous insertion was safe. The study also demonstrated a decrease in operating times, preservation of vein size, and no increase in complication rates in the US group when performed by operators of varying expertise.",2021,More than one needle puncture was needed in 22% of the cases but there were no conversions in the ultrasound group.,"['children', 'children under 16\xa0y of age', 'A total of 108 patients were analyzed', 'Twelve patients needed more than one insertion to achieve optimal position of the tip', 'Sixty-four were male']","['Open Versus Ultrasound Guided Tunneled Central Venous Access', 'ultrasound guided percutaneous insertion of central access catheters']","['Operating time', 'size', 'complications-immediate and late', 'complication rates', 'immediate and late complications', 'operating times, preservation of vein size', 'time taken to complete procedure, conversion rates, duration of line use']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",108.0,0.0754897,More than one needle puncture was needed in 22% of the cases but there were no conversions in the ultrasound group.,"[{'ForeName': 'Soundappan S V', 'Initials': 'SSV', 'LastName': 'Soundappan', 'Affiliation': ""Department of Surgery, The Children's Hospital at Westmead, Sydney, New South Wales, Australia; Division of Child and Adolescent health, Sydney Medical School, University of Sydney, NSW, Australia. Electronic address: s.soundappan@health.nsw.gov.au.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'Tung Wah College, Hong Kong.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Cass', 'Affiliation': ""Department of Surgery, The Children's Hospital at Westmead, Sydney, New South Wales, Australia; Division of Child and Adolescent health, Sydney Medical School, University of Sydney, NSW, Australia.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Karpelowsky', 'Affiliation': ""Department of Surgery, The Children's Hospital at Westmead, Sydney, New South Wales, Australia; Division of Child and Adolescent health, Sydney Medical School, University of Sydney, NSW, Australia.""}]",The Journal of surgical research,['10.1016/j.jss.2020.11.065']
927,33369683,Effect of a comprehensive eRehabilitation intervention alongside conventional stroke rehabilitation on disability and health-related quality of life: A pre-post comparison.,"OBJECTIVE


To compare the effect on disability and quality of life, of conventional rehabilitation (control group) with individualized, tailored eRehabilitation intervention alongside conventional rehabilitation (Fast@home; intervention group), for people with stroke.
METHODS


Pre-post design. The intervention comprised cognitive (Braingymmer®) and physical (Telerevalidatie®/Physitrack®) exercises, activity-tracking (Activ8®) and psycho-education. Assessments were made at admission (T0) and after 3 (T3) and 6 months (T6). The primary outcome concerned disability (Stroke Impact Scale; SIS). Secondary outcomes were: health-related quality of life, fatigue, self-management, participation and physical activity. Changes in scores between T0-T3, T3-T6, and T0-T6 were compared by analysis of variance and linear mixed models.
RESULTS


The study included 153 and 165 people with stroke in the control and intervention groups, respectively. In the intervention group, 82 (50%) people received the intervention, of whom 54 (66%) used it. Between T3 and T6, the change in scores for the SIS subscales Communication (control group/intervention group -1.7/-0.3) and Physical strength (-5.7/3.3) were significantly greater in the total intervention group (all mean differences< minimally clinically important differences). No significant differences were found for other SIS subscales or secondary outcomes, or between T0-T3 and T0-T6.
CONCLUSION


eRehabilitation alongside conventional stroke rehabilitation had a small positive effect on communication and physical strength on the longer term, compared to conventional rehabilitation only.",2021,"No significant differences were found for other SIS subscales or secondary outcomes, or between T0-T3 and T0-T6.
CONCLUSION


eRehabilitation alongside conventional stroke rehabilitation had a small effect on communication and physical strength on the longer term.","['people with stroke', '153 and 165 people with stroke in the control and intervention groups, respectively']","['conventional rehabilitation (control group) with individualized, tailored eRehabilitation intervention alongside conventional rehabilitation (Fast@home; intervention', 'cognitive (Braingymmer®) and physical (Telerevalidatie®/Physitrack®) exercises, activity-tracking (Activ8®) and psycho-education', 'comprehensive eRehabilitation intervention alongside conventional stroke rehabilitation']","['health-related quality of life, fatigue, self-management, participation and physical activity', 'disability and quality of life', 'communication and physical strength', 'disability (Stroke Impact Scale; SIS', 'Physical strength ', 'disability and health-related quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0902446,"No significant differences were found for other SIS subscales or secondary outcomes, or between T0-T3 and T0-T6.
CONCLUSION


eRehabilitation alongside conventional stroke rehabilitation had a small effect on communication and physical strength on the longer term.","[{'ForeName': 'Berber', 'Initials': 'B', 'LastName': 'Brouns', 'Affiliation': 'Basalt Rehabilitation Centre, The Hague and Leiden, Department of Innovation, Quality + Research, Haag, The Netherlands. b.brouns@lumc.nl, b.brouns@basaltrevalidatie.nl.'}, {'ForeName': 'Leti', 'Initials': 'L', 'LastName': 'van Bodegom-Vos', 'Affiliation': ''}, {'ForeName': 'Arend J', 'Initials': 'AJ', 'LastName': 'de Kloet', 'Affiliation': ''}, {'ForeName': 'Sietske J', 'Initials': 'SJ', 'LastName': 'Tamminga', 'Affiliation': ''}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Volker', 'Affiliation': ''}, {'ForeName': 'Monique A M', 'Initials': 'MAM', 'LastName': 'Berger', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Fiocco', 'Affiliation': ''}, {'ForeName': 'Paulien H', 'Initials': 'PH', 'LastName': 'Goossens', 'Affiliation': ''}, {'ForeName': 'Thea P M', 'Initials': 'TPM', 'LastName': 'Vliet Vlieland', 'Affiliation': ''}, {'ForeName': 'Jorit J L', 'Initials': 'JJL', 'LastName': 'Meesters', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2785']
928,33373701,Parecoxib Vs Paracetamol for Treatment of Acute Renal Colic Due to Ureteric Calculi: A Randomized Controlled Trial.,"OBJECTIVE


To compare efficacy and safety of parecoxib and paracetamol for treatment of acute renal colic due to ureteric stones.
MATERIALS AND METHODS


A randomized, double blinded, controlled trial included adult patients presented to emergency department with acute renal colic due to ureteric calculi between June 2019 and August 2020. Patients with hypersensitivity to either drug, peptic ulcer, coronary ischemia, peripheral vascular or cerebrovascular disease, hepatic impairment (Child-Pugh score >10) or chronic kidney disease stage 4 or 5 were excluded. Eligible patients were randomized to group 1 who received 1g intravenous Paracetamol infusion or group 2 who received 40mg intravenous Parecoxib infusion. Pain analogue score was evaluated before treatment and 30 minutes afterwards. The primary endpoint was the need for rescue analgesia for persistent pain. Safety was evaluated by the incidence of adverse events.
RESULTS


The study included 203 patients (102 in group 1 and 101 in group 2). Pretreatment patients' data were comparable for both groups. The mean pain analogue score decrease from 7.6 to 3.8 in paracetamol group (P <.001) and from 7.8 to 3.4 in parecoxib group (P <.001). Rescue analgesia were needed in 36 patients (35.3%) in paracetamol group and 27 patients (26.7%) in parecoxib group (P = .187). Minor adverse events developed in 2 patients (2%) in paracetamol group and 3 patients (3%) in parecoxib group (P=0.683).
CONCLUSION


Paracetamol and Parecoxib were effective for treatment for patient with acute renal colic. Both treatments showed comparable results in reduction of pain and need for rescue analgesia with minimal adverse events.",2021,The mean PAS decrease from 7.6 to 3.8 in paracetamol group (P<0.001) and from 7.8 to 3.4 in parecoxib group (P<0.001).,"['Patients with hypersensitivity to either drug, peptic ulcer, coronary ischemia, peripheral vascular or cerebrovascular disease, hepatic impairment (Child', 'adult patients presented to emergency department with acute renal colic due to ureteric calculi between June 2019 and August 2020', 'Pugh score >10) or chronic kidney disease stage 4 or 5 were excluded', 'acute renal colic due to ureteric stones', 'Eligible patients', '203 patients (102 in group 1 and 101 in group 2', 'patient with acute renal colic', 'Acute Renal Colic due to Ureteric Calculi']","['parecoxib', 'Paracetamol', 'parecoxib and paracetamol', 'Paracetamol infusion or group 2 who received 40mg intravenous Parecoxib infusion', 'Parecoxib', 'paracetamol', 'Paracetamol and Parecoxib']","['need for rescue analgesia for persistent pain', 'Minor adverse events', 'mean PAS decrease', 'Pain analogue score (PAS', 'Rescue analgesia', 'efficacy and safety', 'reduction of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2317473', 'cui_str': 'Chronic kidney disease stage 4'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",203.0,0.256009,The mean PAS decrease from 7.6 to 3.8 in paracetamol group (P<0.001) and from 7.8 to 3.4 in parecoxib group (P<0.001).,"[{'ForeName': 'Abdullatif', 'Initials': 'A', 'LastName': 'Al-Terki', 'Affiliation': 'Urology Unit, Department of Surgery, Al-Amiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Jaffar', 'Initials': 'J', 'LastName': 'Hussain', 'Affiliation': 'Urology Unit, Department of Surgery, Al-Amiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Ahmed R', 'Initials': 'AR', 'LastName': 'El-Nahas', 'Affiliation': 'Urology Unit, Department of Surgery, Al-Amiri Hospital, Kuwait City, Kuwait; Urology and Nephrology Center, Mansoura University, Mansoura, Egypt. Electronic address: ar_el_nahas@yahoo.com.'}, {'ForeName': 'Abdullatif', 'Initials': 'A', 'LastName': 'Aloumi', 'Affiliation': 'Emergency Department, Al-Amiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Monira', 'Initials': 'M', 'LastName': 'Al-Asfoor', 'Affiliation': 'Emergency Department, Al-Amiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Abbas Amt', 'Initials': 'AA', 'LastName': 'Altamimi', 'Affiliation': 'Emergency Department, Al-Amiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Usama', 'Initials': 'U', 'LastName': 'Abdelhamid', 'Affiliation': 'Urology Unit, Department of Surgery, Al-Amiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Majd', 'Initials': 'M', 'LastName': 'Alkabbani', 'Affiliation': 'Urology Unit, Department of Surgery, Al-Amiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Tariq F', 'Initials': 'TF', 'LastName': 'Al-Shaiji', 'Affiliation': 'Urology Unit, Department of Surgery, Al-Amiri Hospital, Kuwait City, Kuwait.'}]",Urology,['10.1016/j.urology.2020.12.017']
929,33381795,"Eucaloric diets enriched in palm olein, cocoa butter, and soybean oil did not differentially affect liver fat concentration in healthy participants: a 16-week randomized controlled trial.","BACKGROUND


Effects of dietary fat quality on liver fat remain to be elucidated. Inconsistent evidence may be influenced by fatty acid saturation, chain-length, and regio-specificity within triacylglycerol (TAG) molecules.
OBJECTIVES


We aimed to compare eucaloric diets enriched in palm olein (POo), cocoa butter (COB), and soybean oil (SBO) on liver fat concentration in healthy participants. Secondary outcomes included visceral (VAT) and abdominal subcutaneous (aSCAT) adipose tissue, plus other obesity and cardiometabolic health outcomes.
METHODS


Eighty-three healthy participants (20-45 y, BMI 18.5-27.5 kg/m2) commenced and 64 completed a 16-wk randomized parallel intervention, preceded by a 2-wk run-in. Participants consumed identical eucaloric background diets differing in test fats [contributing 20% total energy intake (%E)], providing 33%E total fat with the following ratios for PUFAs/SFAs/MUFAs: POo, 4.2/13.5/15%E; SBO, 14.4/8.8/9.4%E; COB, 2.3/19.5/11%E. Liver fat and abdominal adiposity were measured at weeks 0 and 16 using 1H-magnetic resonance spectroscopy/imaging; all other outcomes were measured at 0, 4, 8, 12, and 16 wk.
RESULTS


Fat quality did not affect liver fat concentration, VAT, aSCAT, obesity indexes, blood pressure, liver enzymes, leptin, or fasting glucose. Body fat mass decreased with SBO and COB compared with POo. SBO decreased serum total cholesterol (TC), LDL cholesterol, and TC:HDL cholesterol relative to POo [estimated marginal mean (95% CI) differences: -0.57 (-0.94, -0.20) mmol/L; -0.37 (-0.68, -0.07) mmol/L; and -0.42 (-0.73, -0.11) mmol/L, respectively]. No diet differences were observed on HDL cholesterol, TAG, apoA1, apoB, apoB:apoA1, or fecal free fatty acids (FFAs), except for lower FFA pentadecanoic acid (15:0) with COB than with SBO and POo.
CONCLUSIONS


In healthy adults, when consumed as part of eucaloric typical Australian diets, 3 different dietary fat sources did not differentially affect liver fat concentration and amounts of adipose tissue. Effects on serum lipids were inconsistent across lipid profiles. The findings must be confirmed in metabolically impaired individuals before recommendations can be made.",2021,"No diet differences were observed on HDL cholesterol, TAG, apoA1, apoB, apoB:apoA1, or fecal free fatty acids (FFAs), except for lower FFA pentadecanoic acid (15:0) with COB than with SBO and POo.
","['Eighty-three healthy participants (20-45 y, BMI 18.5-27.5 kg/m2) commenced and 64 completed a 16-wk randomized parallel intervention, preceded by a 2-wk run-in', 'healthy adults', 'healthy participants']","['eucaloric diets enriched in palm olein (POo), cocoa butter (COB), and soybean oil (SBO', 'Eucaloric diets enriched in palm olein, cocoa butter, and soybean oil']","['SBO decreased serum total cholesterol (TC), LDL cholesterol, and TC:HDL cholesterol relative to POo', 'visceral (VAT) and abdominal subcutaneous (aSCAT) adipose tissue, plus other obesity and cardiometabolic health outcomes', 'liver fat concentration', 'Body fat mass', 'liver fat concentration, VAT, aSCAT, obesity indexes, blood pressure, liver enzymes, leptin, or fasting glucose', 'liver fat concentration and amounts of adipose tissue', 'HDL cholesterol, TAG, apoA1, apoB, apoB:apoA1, or fecal free fatty acids (FFAs), except for lower FFA pentadecanoic acid (15:0) with COB', 'Fat quality', 'serum lipids']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0056057', 'cui_str': 'cocoa butter'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}]","[{'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C1563741', 'cui_str': 'Fat, Abdominal Subcutaneous'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348480', 'cui_str': 'Other obesity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0762868', 'cui_str': 'pentadecanoic acid'}, {'cui': 'C0056057', 'cui_str': 'cocoa butter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",83.0,0.177552,"No diet differences were observed on HDL cholesterol, TAG, apoA1, apoB, apoB:apoA1, or fecal free fatty acids (FFAs), except for lower FFA pentadecanoic acid (15:0) with COB than with SBO and POo.
","[{'ForeName': 'Welma', 'Initials': 'W', 'LastName': 'Stonehouse', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Sergi', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Benassi-Evans', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'James-Martin', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mahinda', 'Initials': 'M', 'LastName': 'Abeywardena', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa347']
930,33401223,Drug-drug interactions between salvianolate injection and aspirin based on their metabolic enzymes.,"BACKGROUND


It is unclear whether the combination of traditional Chinese medicine and Western medicine leads to interactions in pharmacokinetics (PKs) and pharmacodynamics (PDs). In this study, the influence of salvianolate and aspirin on metabolic enzymes, and the relationship between the blood concentration and pharmacodynamic indexes, were determined.
METHOD


In this, randomized, parallel-grouped, single-center clinical trial, 18 patients with coronary heart disease were randomly allocated into three groups: aspirin (AP) group, salvianolate (SV) group, and combination (A + S) group. All treatment courses lasted for 10 days, and blood samples were acquired before and after administration at different timepoints. The expression of catechol-O-methyltransferase (COMT), CD62p, procaspase-activating compound 1 (PAC-1), P2Y12, phosphodiesterase, and mitogen-activated protein kinase 8 (MAPK8) were compared with variance analysis The blood concentrations were analyzed by ultra-performance liquid chromatography-tandem mass spectrometry.
RESULTS


Sixteen subjects completed the study. No significant difference in COMT was found among groups, although there was a decrease in the SV group. The PK results indicated that the absorption time of salicylic acid was shortened and the AUC 0-∞  decreased and the elimination time of salvianolic acid B was prolonged and the AUC 0-∞  decreased. The PD results declined after administration. A significant difference was found in MAPK8, CD62p, and P2Y12 expression. Compared with the SV group, a significant difference in P2Y12 in the A + S group was found.
CONCLUSION


A pharmacokinetic drug-drug interaction was found in the aspirin and salvianolate combination. Pharmacodynamically, there was no difference between the A + S and AP groups. However, P2Y12 expression in the combination group was superior to that in the SV group.
TRIAL REGISTRATION NUMBERS


The trial was registered on October 9, 2017, ClinicalTrials.gov, NCT03306550. https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0007D8H&selectaction=Edit&uid=U0003QY8&ts=2&cx=oiuc9g.",2021,"The expression of catechol-O-methyltransferase (COMT), CD62p, procaspase-activating compound 1","['18 patients with coronary heart disease', 'Sixteen subjects completed the study']","['salvianolate and aspirin', 'salvianolate injection and aspirin', 'aspirin (AP) group, salvianolate (SV) group, and combination (A\u2009+\u2009S']","['PAC-1), P2Y12, phosphodiesterase, and mitogen-activated protein kinase 8 (MAPK8', 'MAPK8, CD62p, and P2Y12 expression', 'expression of catechol-O-methyltransferase (COMT), CD62p, procaspase-activating compound 1', 'absorption time of salicylic acid', 'COMT', 'blood concentrations', 'elimination time of salvianolic acid B']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3252125', 'cui_str': 'salvianolate'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0031640', 'cui_str': 'Phosphoric diester hydrolase'}, {'cui': 'C0380051', 'cui_str': 'Stress-Activated Protein Kinase 1'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0654158', 'cui_str': 'salvianolic acid B'}]",18.0,0.0405935,"The expression of catechol-O-methyltransferase (COMT), CD62p, procaspase-activating compound 1","[{'ForeName': 'Weiyi', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Qiaoning', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Wantong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Yonggang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Shuge', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Zhongning', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. Electronic address: crystal005@163.com.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.111203']
931,33401219,Effect of atorvastatin versus rosuvastatin on inflammatory biomarkers and LV function in type 2 diabetic patients with dyslipidemia.,"BACKGROUND


Statins are potential drugs for decreasing risk of atherosclerotic cardiovascular complications in type 2 diabetic (T2D) patients.
PURPOSE


To examine the efficacy of both rosuvastatin (ROSUVA) and atorvastatin (ATORVA) on LV function and markers of inflammation in T2D patients with dyslipidemia.
METHODS


One hundred-sixty T2D patients were assigned to receive either atorvastatin (ATORVA group, n = 80, 40 mg) or rosuvastatin (ROSUVA group, n = 80, 10 mg), daily for 6 months. Blood was collected for biochemical analysis. The prevalence of left ventricular abnormalities was determined by echocardiography and two-dimensional Speckle-Strain to assess Global Longitudinal Strain (GLS).
RESULTS


ROSUVA vs. ATORVA resulted in significant (p < 0.001) reduction in HbA1c % (9.13 vs 2.35%), LDL-C (22.23% vs. 14.75%), triglycerides (13.56 % vs. 8.21 %), total cholesterol (16.10 % vs. 10.81 %), atherogenic index (18.08. % vs. 10.97%), hs-CRP (23.51 % vs.18.96%), sortilin (33.33 % % vs. 15.08 %), and leptin (31.81 % vs. 23.17 %) but increased adiponectin (97.99 % vs.76.47.1 %) and HDL-C (76.47 % vs. 0.21 %) compared with baseline, respectively. Negative correlations between adiponectin and each of hs-CRP, HbA1c%, total cholesterol, LDL-C, atherogenic index and leptin were found. Also, left ventricular functions were correlated with adiponectin, lipids, HbA1c% and hs-CRP. The areas under receiver operating characteristic curve (AUC) showed that hs-CRP, leptin, sortlin, leptin, and adiponectin were good predictors for cardiovascular events.
CONCLUSION


ROSUVA is more efficacious in improving lipid profile, atherogenic index and modulation of inflammatory biomarkers in dyslipidemic T2D patients compared with ATROVA. However, both statins are equivalent as cardioprotective agents in dyslipidemic T2D patients.",2021,"RESULTS


ROSUVA vs. ATORVA resulted in significant (p < 0.001) reduction in HbA1c % (9.13 vs 2.35%), LDL-C (22.23% vs. 14.75%), triglycerides (13.56 % vs. 8.21 %), total cholesterol (16.10 % vs. 10.81 %), atherogenic index (18.08.","['dyslipidemic T2D patients', 'type 2 diabetic patients with dyslipidemia', 'type 2 diabetic (T2D) patients', 'hundred-sixty T2D', 'T2D patients with dyslipidemia', 'One']","['atorvastatin (ATORVA group, n\u202f=\u202f80, 40\u202fmg) or rosuvastatin (ROSUVA', 'atorvastatin versus rosuvastatin', 'rosuvastatin (ROSUVA) and atorvastatin (ATORVA']","['LV function and markers of inflammation', 'adiponectin', 'LDL-C', 'HDL-C', 'leptin', 'adiponectin, lipids, HbA1c% and hs-CRP', 'triglycerides', 'atherogenic index', 'hs-CRP', 'prevalence of left ventricular abnormalities', 'adiponectin and each of hs-CRP, HbA1c%, total cholesterol, LDL-C, atherogenic index and leptin', 'hs-CRP, leptin, sortlin, leptin, and adiponectin', 'lipid profile, atherogenic index and modulation of inflammatory biomarkers', 'inflammatory biomarkers and LV function', 'total cholesterol', 'atherosclerotic cardiovascular complications']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0344905', 'cui_str': 'Left ventricular abnormality'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}]",160.0,0.0215157,"RESULTS


ROSUVA vs. ATORVA resulted in significant (p < 0.001) reduction in HbA1c % (9.13 vs 2.35%), LDL-C (22.23% vs. 14.75%), triglycerides (13.56 % vs. 8.21 %), total cholesterol (16.10 % vs. 10.81 %), atherogenic index (18.08.","[{'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Werida', 'Affiliation': 'Faculty of Pharmacy, Clinical Pharmacy Department, Damanhur University, El- Bahiara, Egypt. Electronic address: rehabwrieda@pharm.dmu.edu.eg.'}, {'ForeName': 'Ibtsam', 'Initials': 'I', 'LastName': 'Khairat', 'Affiliation': 'Faculty of Medicine, Cardiology Department, Tanta University, El-Gharbia, Egypt. Electronic address: ebtesam.abdelhai@med.tanta.edu.eg.'}, {'ForeName': 'Naglaa F', 'Initials': 'NF', 'LastName': 'Khedr', 'Affiliation': 'Faculty of Pharmacy, Department of Biochemistry, Tanta University, El-Gharbia, Egypt. Electronic address: naglaa.khedr@pharm.tanta.edu.eg.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.111179']
932,33358113,Comment to: Effect of continuous antibiotic prophylaxis in children with postoperative JJ stents: A prospective randomized study.,,2021,,['children with postoperative JJ stents'],['continuous antibiotic prophylaxis'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]",[],,0.0252662,,"[{'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Jayakumar', 'Affiliation': 'Department of Pediatric Surgery, All India Institute of Medical Sciences (AIIMS), Jodhpur, India. Electronic address: doctortkjayakumar@gmail.com.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Department of Pediatric Surgery, All India Institute of Medical Sciences (AIIMS), Jodhpur, India.'}, {'ForeName': 'Kirtikumar J', 'Initials': 'KJ', 'LastName': 'Rathod', 'Affiliation': 'Department of Pediatric Surgery, All India Institute of Medical Sciences (AIIMS), Jodhpur, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Department of Pediatric Surgery, All India Institute of Medical Sciences (AIIMS), Jodhpur, India.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.11.036']
933,33356445,Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy from a Double-Blind Extension Study of the International Phase 3 Trial (EMPOWUR).,"PURPOSE


The long-term safety, tolerability and efficacy of vibegron in adults with overactive bladder were evaluated in the 40-week phase 3 EMPOWUR extension study.
MATERIALS AND METHODS


Patients who completed 12 weeks of once-daily vibegron 75 mg or tolterodine 4 mg extended release in EMPOWUR continued double-blind treatment; patients who completed 12 weeks of placebo were randomly assigned 1:1 to receive double-blind vibegron or tolterodine. The primary outcome was safety, measured by incidence of adverse events. Secondary outcomes included change from baseline at week 52 in average daily number of micturitions and urgency episodes (all patients), and urge and total urinary incontinence episodes (patients with overactive bladder wet) based on 7-day diary data.
RESULTS


Of 506 patients randomized 505 received ≥1 dose of medication, and 430 (85%) completed the study. A total of 12 patients (2.4%) discontinued owing to adverse events. The most common adverse events with vibegron/tolterodine (>5% in either group) were hypertension (8.8%/8.6%), urinary tract infection (6.6%/7.3%), headache (5.5%/3.9%), nasopharyngitis (4.8%/5.2%) and dry mouth (1.8%/5.2%). Improvements in efficacy end points were maintained for patients receiving vibegron for 52 weeks; least squares mean change from baseline to week 52 in micturitions was ‒2.4 for vibegron vs ‒2.0 for tolterodine; in urge urinary incontinence episodes ‒2.2 vs ‒1.7 (p <0.05); in urgency episodes ‒3.4 vs ‒3.2; and in total incontinence episodes ‒2.5 vs ‒1.9 (p <0.05). Among patients with overactive bladder wet 61.0% receiving vibegron experienced ≥75% reduction in urge urinary incontinence episodes after 52 weeks of treatment vs 54.4% with tolterodine, while 40.8% vs 34.2% experienced a 100% reduction.
CONCLUSIONS


Vibegron demonstrated favorable long-term safety, tolerability and efficacy in patients with overactive bladder, consistent with results of the 12-week study.",2020,"Improvements in efficacy endpoints were maintained for patients receiving vibegron for 52 weeks; least squares mean change from baseline to week 52 in micturitions was ‒2.4 for vibegron and ‒2.0 for tolterodine; in urge urinary incontinence episodes was ‒2.2 and ‒1.7, respectively (p <0.05); in urgency episodes was ‒3.4 and ‒3.2; and in total incontinence episodes was ‒2.5 and ‒1.9 (p <0.05).","['adults with overactive bladder', 'Patients who completed 12 weeks of once', 'patients with overactive bladder', '506 patients randomized']","['daily vibegron 75 mg or tolterodine', 'vibegron/tolterodine', 'placebo', 'tolterodine', 'double-blind vibegron or tolterodine', 'vibegron']","['favorable long-term safety, tolerability, and efficacy', 'total incontinence episodes', 'nasopharyngitis', 'urge urinary incontinence episodes', 'efficacy endpoints', 'hypertension', 'safety, measured by incidence of adverse events', 'urinary tract infection', 'urgency episodes', 'average daily number of micturitions and urgency episodes (all patients) and urge and total urinary incontinence episodes', 'headache']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150044', 'cui_str': 'Total urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",506.0,0.24774,"Improvements in efficacy endpoints were maintained for patients receiving vibegron for 52 weeks; least squares mean change from baseline to week 52 in micturitions was ‒2.4 for vibegron and ‒2.0 for tolterodine; in urge urinary incontinence episodes was ‒2.2 and ‒1.7, respectively (p <0.05); in urgency episodes was ‒3.4 and ‒3.2; and in total incontinence episodes was ‒2.5 and ‒1.9 (p <0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Frankel', 'Affiliation': 'Seattle Urology Research Center, Seattle, Washington.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Varano', 'Affiliation': 'Clinical Research Consulting, Milford, Connecticut.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Shortino', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jankowich', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mudd', 'Affiliation': 'Urovant Sciences, Irvine, California.'}]",The Journal of urology,['10.1097/JU.0000000000001574']
934,33356418,Defining the Optimal Total Number of Chemotherapy Courses in Younger Patients With Acute Myeloid Leukemia: A Comparison of Three Versus Four Courses.,"PURPOSE


The optimum number of treatment courses for younger patients with acute myeloid leukemia (AML) is uncertain. The United Kingdom National Cancer Research Institute AML17 trial randomly assigned patients who were not high risk to a total of three versus four courses.
PATIENTS AND METHODS


Patients received two induction courses based on daunorubicin and cytarabine (Ara-C), usually with gemtuzumab ozogamicin. Following remission, 1,017 patients were randomly assigned to a third course, MACE (amsacrine, Ara-C, and etoposide), plus a fourth course of MidAc (mitoxantrone and Ara-C) and following an amendment to one or two courses of high-dose Ara-C. Primary end points were cumulative incidence of relapse (CIR), relapse-free survival (RFS), and overall survival (OS). Outcomes were correlated with patient characteristics, mutations, cytogenetics, induction treatments, and measurable residual disease (MRD) postinduction.
RESULTS


In logrank analyses, CIR and RFS at 5 years were improved in recipients of four courses (50%  v  58%: hazard ratio [HR] 0.81 [0.69-0.97],  P  = .02 and 43%  v  36%: HR 0.83 [0.71-0.98],  P  = .03, respectively). While OS was not significantly better (63%  v  57%: HR 0.84 [0.69-1.03],  P  = .09), the noninferiority of three courses to four courses was not established. The impact on relapse was only significant when the fourth course was Ara-C. In exploratory analyses, although MRD impacted survival, a fourth course had no effect in either MRD-positive or MRD-negative patients. A fourth course was beneficial in patients who lacked a mutation of  FLT3  or  NPM1 , had < 3 mutations in other genes, or had a presenting WBC of < 10 × 10 9  L -1 .
CONCLUSION


Although a fourth course of high-dose Ara-C reduced CIR and improved RFS, it did not result in a significant OS benefit. Subsets including those with favorable cytogenetics, those lacking a mutation of  FLT3 or NPM1 , or those with < 3 other mutations may derive survival benefit.",2021,"While OS was not significantly better (63%  v  57%: HR 0.84 [0.69-1.03],  P  = .09), the noninferiority of three courses to four courses was not established.","['With Acute Myeloid Leukemia', 'Younger Patients', 'Patients received two induction courses based on', 'younger patients with acute myeloid leukemia (AML']","['MACE (amsacrine, etoposide, and Ara-C), plus a fourth course of MidAc (mitoxantrone and Ara-C', 'daunorubicin and cytarabine (Ara-C), usually with gemtuzumab ozogamicin']","['MRD impacted survival', 'cumulative incidence of relapse (CIR), relapse-free survival (RFS), and overall survival (OS', 'CIR and improved RFS', 'survival benefit', 'relapse', 'patient characteristics, mutations, cytogenetics, induction treatments, and measurable residual disease (MRD) postinduction', 'CIR and RFS']","[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0002699', 'cui_str': 'Amsacrine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0068899', 'cui_str': 'NOAC protocol'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0876099', 'cui_str': 'Mylotarg'}]","[{'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",1017.0,0.297208,"While OS was not significantly better (63%  v  57%: HR 0.84 [0.69-1.03],  P  = .09), the noninferiority of three courses to four courses was not established.","[{'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Burnett', 'Affiliation': 'Department of Haematology, Cardiff University School of Medicine, Cardiff, United Kingdom.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Russell', 'Affiliation': 'Department of Haematology, Nottingham University Hospital NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Hills', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Knapper', 'Affiliation': 'Department of Haematology, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Freeman', 'Affiliation': 'Department of Clinical Immunology, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Huntly', 'Affiliation': 'Department of Haematology, and Wellcome Trust-MRC Cambridge Stem Cell Institute, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'Department of Haematology, Royal Liverpool University Hospital, Liverpool, United Kingdom.'}, {'ForeName': 'Ian F', 'Initials': 'IF', 'LastName': 'Thomas', 'Affiliation': 'Centre for Trials Research, Cardiff University School of Medicine, Cardiff, United Kingdom.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mary Frances', 'Initials': 'MF', 'LastName': 'McMullin', 'Affiliation': ""Department of Haematology, Centre for Medical Education, Queen's University, Belfast City Hospital, Belfast, United Kingdom.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drummond', 'Affiliation': 'Department of Haematology, Beatson Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kell', 'Affiliation': 'Department of Haematology, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Spearing', 'Affiliation': 'Canterbury District Health Board, Canterbury, New Zealand.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01170']
935,33359573,The impact of periodontal treatment on healthcare costs in newly diagnosed diabetes patients: Evidence from a German claims database.,"AIMS


There is sufficient scientific evidence for the bidirectional association between periodontal diseases and diabetes. In this context, we hypothesized that periodontal treatment leads to lower healthcare costs in newly diagnosed diabetes patients by promoting a milder disease course.
METHODS


A total of 23,771 persons were investigated who were continuously insured by German health insurances between 2011 and 2016, 18 years or older, and newly diagnosed with diabetes in 2013. The study population was divided into a periodontal treatment and control group (no periodontal treatment). The average treatment effect of a periodontal treatment on various types of healthcare costs (inpatient, outpatient, drug costs) was analyzed by a doubly robust method.
RESULTS


Finally, 5.3% of the study population could be assigned to the treatment group. In newly diagnosed diabetes patients with periodontal treatment, a reduction in total healthcare costs (0.96, 95%CI 0.89; 1.04), inpatient costs (0.87, 95%CI 0.69; 1.08), diabetes-related drug costs (0.93, 95%CI 0.84; 1.03) and other drug costs (0.97, 95%CI 0.89; 1.05) could be shown compared to the control group.
CONCLUSIONS


This study provides evidence that periodontal treatment for diabetes patients reduces healthcare costs. Fewer diabetes-specific complications and hospitalizations are expected.",2021,"In newly diagnosed diabetes patients with periodontal treatment, a reduction in total healthcare costs (0.96, 95%CI 0.89; 1.04), inpatient costs (0.87, 95%CI 0.69; 1.08), diabetes-related drug costs (0.93, 95%CI 0.84; 1.03) and other drug costs (0.97, 95%CI 0.89; 1.05) could be shown compared to the control group.
","['diabetes patients', 'newly diagnosed diabetes patients', '23,771 persons were investigated who were continuously insured by German health insurances between 2011 and 2016, 18 years or older, and newly diagnosed with diabetes in 2013', 'newly diagnosed diabetes patients with periodontal treatment']",['periodontal treatment'],"['diabetes-related drug costs', 'total healthcare costs', 'drug costs', 'inpatient costs', 'healthcare costs (inpatient, outpatient, drug costs', 'healthcare costs']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0085123', 'cui_str': 'Drug Costs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]",23771.0,0.046801,"In newly diagnosed diabetes patients with periodontal treatment, a reduction in total healthcare costs (0.96, 95%CI 0.89; 1.04), inpatient costs (0.87, 95%CI 0.69; 1.08), diabetes-related drug costs (0.93, 95%CI 0.84; 1.03) and other drug costs (0.97, 95%CI 0.89; 1.05) could be shown compared to the control group.
","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Blaschke', 'Affiliation': 'PMV Research Group, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. Electronic address: katja.blaschke@uk-koeln.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. Electronic address: martin.hellmich@uni-koeln.de.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Samel', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. Electronic address: christina.samel@uni-koeln.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Listl', 'Affiliation': 'Department of Dentistry - Quality and Safety of Oral Healthcare, Radboud University - Radboudumc (RIHS), Nijmegen, the Netherlands; Medical Faculty, Department of Conservative Dentistry, Section for Translational Health Economics, Heidelberg University, Heidelberg, Germany. Electronic address: Stefan.Listl@radboudumc.nl.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Schubert', 'Affiliation': 'PMV Research Group, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. Electronic address: ingrid.schubert@uk-koeln.de.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108641']
936,33389369,Effect of antiglaucoma agents on short-term intraocular pressure fluctuations after intravitreal bevacizumab injections.,"PURPOSE


To evaluate the effect of prophylactic pressure-lowering medications on intraocular pressure (IOP) spikes after intravitreal injections (IVIs) METHODS: In this randomized double-blind clinical trial, 74 eyes that were candidates for intravitreal anti-vascular endothelial growth factor (VEGF) injection (IVI) (0.05 mL, 1.25 mg of bevacizumab) were enrolled and sorted randomly into five groups, group 1: topical timolol 0.5% (n = 16); group 2: topical brimonidin (n = 15); group 3: oral acetazolamide 250 mg (n = 14); group 4: intravenous mannitol (1.5 gr/kg) (n = 16); group 5: no intraocular pressure-lowering medication (n = 13). Medications were administered 30-60 min prior to injection. None of the patients had history of glaucoma. Intraocular pressure was measured before (baseline), 5 min after (T5), 10 min after (T10), 15 min after (T15) and 30 min after (T30) IVI using Goldmann Tonometer.
RESULTS


There was a statistically significant, but relatively weak negative correlation between the amount of vitreous reflux post-IVI intraocular pressure elevation (Spearman's rho = -0.315, p = 0.006). There was no difference of the amount of vitreous reflux (P = 0.196) between study groups. The baseline mean IOP for Groups 1, 2, 3,4 and 5 were 11.19 ± 3.7, 10.07 ± 2.19, 11 ± 2.98, 10.13 ± 3.48 and12.54 ± 2.60 mmHg, respectively. (P = 0.214) There was no difference of peak IOP spike between groups at T5: 37 ± 19.7, 34.80 ± 15.76, 33.43 ± 18.29, 33.56 ± 16.88, 34.92 ± 9.99 mmHg (P = 0.977). There was also no difference of IOP at T10, T15 and T30 between study groups: P = 0.979, P = 0.994 and P = 0.692, respectively.
CONCLUSION


Although it is advisable to prevent IOP spikes, our study showed that use of prophylactic pressure-lowering medications with every mechanism of action has no effect in IOP spikes following intravitreal bevacizumab injections in non-glaucomatous eyes. Trial registrationThe study was registered with clinicaltrails.gov (ID# NCT02140450). Trial registration date: 05.09.2014.",2021,"There was also no difference of IOP at T10, T15 and T30 between study groups: P = 0.979, P = 0.994 and P = 0.692, respectively.
",['74 eyes that were candidates for'],"['bevacizumab injections', 'antiglaucoma agents', 'oral acetazolamide 250\xa0mg (n\u2009=\u200914); group 4: intravenous mannitol (1.5 gr/kg) (n\u2009=\u200916); group 5: no intraocular pressure-lowering medication', 'topical brimonidin', 'intravitreal anti-vascular endothelial growth factor (VEGF) injection (IVI) (0.05\xa0mL, 1.25\xa0mg of bevacizumab', 'topical timolol', 'prophylactic pressure-lowering medications']","['intraocular pressure (IOP) spikes', 'IOP', 'Intraocular pressure', 'peak IOP spike', 'baseline mean IOP', 'vitreous reflux post-IVI intraocular pressure elevation', 'vitreous reflux', 'short-term intraocular pressure fluctuations']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C4019040', 'cui_str': 'bevacizumab Injection'}, {'cui': 'C1515995', 'cui_str': 'Antiglaucoma agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0982981', 'cui_str': 'Acetazolamide 250 MG'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2363846', 'cui_str': 'Intraocular pressure fluctuation'}]",74.0,0.365224,"There was also no difference of IOP at T10, T15 and T30 between study groups: P = 0.979, P = 0.994 and P = 0.692, respectively.
","[{'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Shoeibi', 'Affiliation': 'Associate Professor of Ophthalmology, Khatam Eye Hospital, Mashhad University of Medical Sciences, eye research center, Mashhad, Iran.'}, {'ForeName': 'Zina', 'Initials': 'Z', 'LastName': 'Ghosi', 'Affiliation': 'Resident of Ophthalmology, Khatam Eye Hospital, Mashhad University of Medical Sciences, eye research center, Mashhad, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Jafari', 'Affiliation': 'Anterior Segment Fellow in Ophthalmology, Khatam Eye Hospital, Mashhad University of Medical Sciences, eye research center, Mashhad, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Omidtabrizi', 'Affiliation': 'Vitreoretina Fellowship Student, Khatam Al Anbia Eye Hospital, Mashhad University of Medical Sciences, eye research centerAbutalib crossroad, Ghareni Blvd, Mashhad, Iran. arash_omid2001@yahoo.com.'}]",International ophthalmology,['10.1007/s10792-020-01667-z']
937,33416886,Assessment of Mortality Among Durable Left Ventricular Assist Device Recipients Ineligible for Clinical Trials.,"Importance


While wide-scale adoption of durable left ventricular assist devices (LVADs) can be attributed to favorable randomized clinical trial outcomes, restrictive selection criteria may be associated with a lack of generalizability to real-world experience.
Objective


To estimate the proportion of LVAD recipients who are eligible for clinical trials and to assess whether an association exists between trial eligibility and mortality.
Design, Setting, and Participants


This cohort study examined 14 679 patients undergoing primary, intracorporeal continuous-flow LVAD implantation (with or without a right ventricular assist device) in 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). To simulate a trial population, trial criteria from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) were mapped to INTERMACS variables. Patients were categorized as eligible for trial inclusion or ineligible for trial inclusion and by number of ineligibility criteria met. Follow-up in INTERMACS was complete for all patients through October 31, 2017. Data were analyzed from July 2019 through November 2020.
Exposures


Undergoing durable LVAD implantation.
Main Outcomes and Measures


Trial eligibility and postimplant mortality were analyzed using Kaplan-Meier estimates and Cox proportional hazards models.
Results


Among 14 679 recipients, mean (SD) age was 57 (13) years, 11 503 individuals (78.4%) were men, and 11 406 individuals (77.7%) presented with New York Heart Association class IV heart failure. A total of 6429 recipients (43.8%) were ineligible for trial inclusion, of whom 4226 individuals (65.7%) met 1 ineligibility criterion, 1442 individuals (22.4%) met 2 criteria, and 761 individuals (11.8%) met 3 or more criteria. Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (1-year mortality: 25.3% [95% CI, 24.2%-26.5%] vs 16.2% [95% CI, 15.4%-17.1%]; 3-year mortality: 42.8% [95% CI, 41.3%-44.4%] vs 36.4% [95% CI, 35.0%-37.8%]; log-rank P < .001 for both). Patients who were trial-ineligible had increased risk of mortality compared with patients who were trial-eligible if they met 1 trial ineligibility criterion (hazard ratio [HR], 1.16 [95% CI, 1.08-1.24]; P < .001), 2 trial ineligibility criteria (HR, 1.51 [95% CI, 1.36-1.67]; P < .001), or 3 or more trial ineligibility criteria (HR, 2.09 [95% CI, 1.84-2.39]; P < .001). Among patients meeting only 1 ineligibility criterion, 4 criteria were independently associated with mortality: prior or ongoing mechanical circulatory support (HR, 1.63 [95% CI, 1.23-2.16]; P = .001), elevated creatinine level (HR, 1.42 [95% CI, 1.17-1.72]; P < .001), elevated bilirubin level (HR, 1.39 [95% CI, 1.17-1.66]; P < .001), and low albumin or prealbumin level (HR, 1.18 [95% CI, 1.05-1.33]; P = .007).
Conclusions and Relevance


These findings suggest that while treatment for patients who are ineligible for LVAD trial inclusion should be weighed against medical management, more consideration could be given to designing trials with eligibility criteria that reflect real-world experience.",2021,"Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (1-year mortality: 25.3% [95% CI, 24.2%-26.5%] vs 16.2% [95% CI, 15.4%-17.1%]; 3-year mortality: 42.8% [95% CI, 41.3%-44.4%] vs 36.4% [95% CI, 35.0%-37.8%]; log-rank P < .001 for both).","['Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3', 'Patients were categorized as eligible for trial inclusion or ineligible for trial inclusion and by number of ineligibility criteria met', 'Among 14\u202f679 recipients, mean (SD) age was 57 (13) years, 11\u202f503 individuals (78.4%) were men, and 11\u202f406 individuals (77.7%) presented with New York Heart Association class IV heart failure', 'in 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS', '14\u202f679 patients undergoing primary', '6429 recipients (43.8%) were ineligible for trial inclusion, of whom 4226 individuals (65.7%) met 1 ineligibility criterion, 1442 individuals (22.4%) met 2 criteria, and 761 individuals (11.8%) met 3 or more criteria']","['MagLev Technology', 'intracorporeal continuous-flow LVAD implantation (with or without a right ventricular assist device', 'durable left ventricular assist devices (LVADs']","['elevated creatinine level', 'Measures\n\n\nTrial eligibility and postimplant mortality', 'elevated bilirubin level', 'Estimated mortality', 'Mortality', '3-year mortality', 'mortality: prior or ongoing mechanical circulatory support', 'low albumin or prealbumin level', 'risk of mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0183046', 'cui_str': 'Right ventricular assist device'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}]","[{'cui': 'C0151578', 'cui_str': 'Creatinine increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0311468', 'cui_str': 'Increased bilirubin level'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0860864', 'cui_str': 'Decreased albumin'}, {'cui': 'C0337441', 'cui_str': 'Transthyretin measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",14679.0,0.474677,"Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (1-year mortality: 25.3% [95% CI, 24.2%-26.5%] vs 16.2% [95% CI, 15.4%-17.1%]; 3-year mortality: 42.8% [95% CI, 41.3%-44.4%] vs 36.4% [95% CI, 35.0%-37.8%]; log-rank P < .001 for both).","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Brescia', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Tessa M F', 'Initials': 'TMF', 'LastName': 'Watt', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Francis D', 'Initials': 'FD', 'LastName': 'Pagani', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Cascino', 'Affiliation': 'Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'McCullough', 'Affiliation': 'Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Shore', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Likosky', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Aaronson', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Thompson', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.32865']
938,33381794,Effects of fructose restriction on liver steatosis (FRUITLESS); a double-blind randomized controlled trial.,"BACKGROUND


There is an ongoing debate on whether fructose plays a role in the development of nonalcoholic fatty liver disease.
OBJECTIVES


The aim of this study was to investigate the effects of fructose restriction on intrahepatic lipid (IHL) content in a double-blind randomized controlled trial using an isocaloric comparator.
METHODS


Between March 2017 and October 2019, 44 adult overweight individuals with a fatty liver index ≥ 60 consumed a 6-wk fructose-restricted diet (<7.5 g/meal and <10 g/d) and were randomly assigned to supplementation with sachets of glucose (= intervention group) or fructose (= control group) 3 times daily. Participants and assessors were blinded to the allocation. IHL content, assessed by proton magnetic resonance spectroscopy, was the primary outcome and glucose tolerance and serum lipids were the secondary outcomes. All measurements were conducted in Maastricht University Medical Center.
RESULTS


Thirty-seven participants completed the study protocol. After 6 wk of fructose restriction, dietary fructose intake and urinary fructose excretion were significantly lower in the intervention group (difference: -57.0 g/d; 95% CI: -77.9, -39.5 g/d; and -38.8 μmol/d; 95% CI: -91.2, -10.7 μmol/d, respectively). Although IHL content decreased in both the intervention and control groups (P < 0.001 and P = 0.003, respectively), the change in IHL content was more pronounced in the intervention group (difference: -0.7% point, 95% CI: -2.0, -0.03% point). The changes in glucose tolerance and serum lipids were not significantly different between groups.
CONCLUSIONS


Six weeks of fructose restriction per se led to a small, but statistically significant, decrease in IHL content in comparison with an isocaloric control group.This trial was registered at clinicaltrials.gov as NCT03067428.",2021,"Although IHL content decreased in both the intervention and control groups (P < 0.001 and P = 0.003, respectively), the change in IHL content was more pronounced in the intervention group (difference: -0.7% point, 95% CI: -2.0, -0.03% point).","['Between March 2017 and October 2019, 44 adult overweight individuals with a fatty liver index\xa0≥\xa060 consumed a 6-wk fructose-restricted diet (<7.5 g/meal and <10 g/d', 'Maastricht University Medical Center', 'Thirty-seven participants completed the study protocol']","['fructose restriction', 'isocaloric comparator', 'supplementation with sachets of glucose (= intervention group) or fructose (= control group) 3 times daily']","['IHL content', 'intrahepatic lipid (IHL) content', 'glucose tolerance and serum lipids', 'liver steatosis', 'change in IHL content', 'dietary fructose intake and urinary fructose excretion']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0560724', 'cui_str': 'g/meal'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0556134', 'cui_str': 'Fructose intake'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",44.0,0.552207,"Although IHL content decreased in both the intervention and control groups (P < 0.001 and P = 0.003, respectively), the change in IHL content was more pronounced in the intervention group (difference: -0.7% point, 95% CI: -2.0, -0.03% point).","[{'ForeName': 'Nynke', 'Initials': 'N', 'LastName': 'Simons', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Pandichelvam', 'Initials': 'P', 'LastName': 'Veeraiah', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Pomme I H G', 'Initials': 'PIHG', 'LastName': 'Simons', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Nicolaas C', 'Initials': 'NC', 'LastName': 'Schaper', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'M Eline', 'Initials': 'ME', 'LastName': 'Kooi', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Edith J M', 'Initials': 'EJM', 'LastName': 'Feskens', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'E M C Liesbeth', 'Initials': 'EMCL', 'LastName': 'van der Ploeg', 'Affiliation': 'Department of Dietetics, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Mathias D G', 'Initials': 'MDG', 'LastName': 'Van den Eynde', 'Affiliation': 'Laboratory for Metabolism and Vascular Medicine, Division of General Internal Medicine, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Casper G', 'Initials': 'CG', 'LastName': 'Schalkwijk', 'Affiliation': 'Laboratory for Metabolism and Vascular Medicine, Division of General Internal Medicine, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Coen D A', 'Initials': 'CDA', 'LastName': 'Stehouwer', 'Affiliation': 'Laboratory for Metabolism and Vascular Medicine, Division of General Internal Medicine, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Martijn C G J', 'Initials': 'MCGJ', 'LastName': 'Brouwers', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa332']
939,33373852,The Effects of Volatile Anesthetics on Lung Ischemia-Reperfusion Injury: Basic to Clinical Studies.,"Case reports from as early as the 1970s have shown that intravenous injection of even a small dose of volatile anesthetics result in fatal lung injury. Direct contact between volatile anesthetics and pulmonary vasculature triggers chemical damage in the vessel walls. A wide variety of factors are involved in lung ischemia-reperfusion injury (LIRI), such as pulmonary endothelial cells, alveolar epithelial cells, alveolar macrophages, neutrophils, mast cells, platelets, proinflammatory cytokines, and surfactant. With a constellation of factors involved, the assessment of the protective effect of volatile anesthetics in LIRI is difficult. Multiple animal studies have reported that with regards to LIRI, sevoflurane demonstrates an anti-inflammatory effect in immunocompetent cells and an anti-apoptotic effect on lung tissue. Scattered studies have dismissed a protective effect of desflurane against LIRI. While a single-center randomized controlled trial (RCT) found that volatile anesthetics including desflurane demonstrated a lung-protective effect in thoracic surgery, a multicenter RCT did not demonstrate a lung-protective effect of desflurane. LIRI is common in lung transplantation. One study, although limited due to its small sample size, found that the use of volatile anesthetics in organ procurement surgery involving ""death by neurologic criteria"" donors did not improve lung graft survival. Future studies on the protective effect of volatile anesthetics against LIRI must examine not only the mechanism of the protective effect but also differences in the effects of different types of volatile anesthetics, their optimal dosage, and the appropriateness of their use in the event of marked alveolar capillary barrier damage.",2021,"Future studies on the protective effect of volatile anesthetics against LIRI must examine not only the mechanism of the protective effect but also differences in the effects of different types of volatile anesthetics, their optimal dosage, and the appropriateness of their use in the event of marked alveolar capillary barrier damage.",['Lung Ischemia-Reperfusion Injury'],"['Volatile Anesthetics', 'sevoflurane', 'desflurane']",['lung graft survival'],"[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}]","[{'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",1.0,0.0444939,"Future studies on the protective effect of volatile anesthetics against LIRI must examine not only the mechanism of the protective effect but also differences in the effects of different types of volatile anesthetics, their optimal dosage, and the appropriateness of their use in the event of marked alveolar capillary barrier damage.","[{'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Oshima', 'Affiliation': 'Department of Anesthesiology, Yonago Medical Center, Yonago, Tottori, Japan. Electronic address: yoshimatomo@gmail.com.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Otsuki', 'Affiliation': 'Division of Anesthesiology and Critical Care Medicine, Department of Surgery, Tottori University Faculty of Medicine, Yonago, Tottori, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Endo', 'Affiliation': 'Division of Anesthesiology and Critical Care Medicine, Department of Surgery, Tottori University Faculty of Medicine, Yonago, Tottori, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakasone', 'Affiliation': 'Division of Anesthesiology and Critical Care Medicine, Department of Surgery, Tottori University Faculty of Medicine, Yonago, Tottori, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Division of Anesthesiology and Critical Care Medicine, Department of Surgery, Tottori University Faculty of Medicine, Yonago, Tottori, Japan.'}, {'ForeName': 'Shunsaku', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Division of Anesthesiology and Critical Care Medicine, Department of Surgery, Tottori University Faculty of Medicine, Yonago, Tottori, Japan.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Inagaki', 'Affiliation': 'Division of Anesthesiology and Critical Care Medicine, Department of Surgery, Tottori University Faculty of Medicine, Yonago, Tottori, Japan.'}]",The Journal of surgical research,['10.1016/j.jss.2020.11.042']
940,33403821,Reassessing the Cardiovascular Safety of Febuxostat: Implications of the Febuxostat versus Allopurinol Streamlined Trial.,,2021,"The US FDA-mandated CARES trial, published in 2018, reported increased all-cause and cardiovascular (CV) death in participants randomized to febuxostat compared with allopurinol.",[],"['febuxostat', 'allopurinol']","['cause and cardiovascular (CV) death', 'risk of composite CV events, CV mortality']",[],"[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0692838,"The US FDA-mandated CARES trial, published in 2018, reported increased all-cause and cardiovascular (CV) death in participants randomized to febuxostat compared with allopurinol.","[{'ForeName': 'Hyon K', 'Initials': 'HK', 'LastName': 'Choi', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Tuhina', 'Initials': 'T', 'LastName': 'Neogi', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Stamp', 'Affiliation': 'University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Terkeltaub', 'Affiliation': 'VA San Diego Healthcare System and University of California San Diego.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41638']
941,33385511,"Medicinal seeds Ziziphus spinosa for insomnia: A randomized, placebo-controlled, cross-over, feasibility clinical trial.","OBJECTIVES


To evaluate the feasibility of implementing a clinical trial protocol of the herbal seeds Ziziphus spinosa (ZS) for people with insomnia.
DESIGN AND SETTING


A randomized, double-blind, placebo controlled, cross-over feasibility trial in Melbourne, Australia.
INTERVENTIONS


After two-week run-in participants were randomized to either ZS (encapsulated granules; 2 g daily) or placebo for four weeks. After four-weeks wash-out, participants swapped to the other treatment for four weeks.
MAIN OUTCOME MEASURES


Sleep quality assessed by the Insomnia Severity Index and Pittsburgh Sleep Quality Index (PSQI). Quality of life, mood, functional impairment and sleep parameters were also assessed.
RESULTS


Twelve participants were randomized and completed both periods of cross-over (six in each sequence). Feasibility endpoints were acceptable. Improvements for sleep quality measured on the PSQI were statistically significant during the ZS treatment periods compared to placebo (t = -2.276, df = 10, 95 % CI -3.3 to -0.04, p = 0.046). There was no evidence of any significant carryover effects. However, there were period effects. Other outcomes showed no statistically significant difference between the treatments. Subjective sleep parameters measured on sleep diaries showed improvements after ZS in terms of total sleep time, sleep efficiency and sleep onset latency, but not after placebo. ZS was well tolerated with only minor adverse events.
CONCLUSIONS


ZS is an acceptable and well-tolerated herbal candidate for the treatment of insomnia. The feasibility objectives of this study were achieved and ZS improved both subjective sleep quality and quantity compared to placebo. ZS should be explored in future clinical trials.",2020,"Subjective sleep parameters measured on sleep diaries showed improvements after ZS in terms of total sleep time, sleep efficiency and sleep onset latency, but not after placebo.","['Medicinal seeds Ziziphus spinosa for insomnia', 'people with insomnia']","['ZS (encapsulated granules; 2\u2009g daily) or placebo', 'herbal seeds Ziziphus spinosa (ZS', 'placebo']","['Subjective sleep parameters', 'sleep quality', 'total sleep time, sleep efficiency and sleep onset latency', 'Quality of life, mood, functional impairment and sleep parameters', 'Sleep quality assessed by the Insomnia Severity Index and Pittsburgh Sleep Quality Index (PSQI', 'subjective sleep quality and quantity']","[{'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C1029148', 'cui_str': 'Zizyphus'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1029148', 'cui_str': 'Zizyphus'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",12.0,0.474806,"Subjective sleep parameters measured on sleep diaries showed improvements after ZS in terms of total sleep time, sleep efficiency and sleep onset latency, but not after placebo.","[{'ForeName': 'Johannah L', 'Initials': 'JL', 'LastName': 'Shergis', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: johannah.shergis@rmit.edu.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hyde', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: anna.hyde@rmit.edu.au.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Meaklim', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: hailey.meaklim@rmit.edu.au.'}, {'ForeName': 'Prerna', 'Initials': 'P', 'LastName': 'Varma', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: prerna.varma@rmit.edu.au.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Da Costa', 'Affiliation': 'School of Science, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: cliff.dacosta@rmit.edu.au.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Jackson', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria 3800, Australia. Electronic address: melinda.jackson@monash.edu.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102657']
942,33388390,A qualitative study on participants' experiences with a community-based mindful walking intervention and mobile device activity measurement.,"BACKGROUND


Mindful walking (MW) interventions employ mindfulness training combined with physical activity. Wearable mobile devices have been increasingly used to measure outcomes of physical activity interventions. The purpose of this study was to understand MW participants' attitudes towards MW and the use of mobile devices in health promotion interventions, including barriers and facilitators of intervention engagement and adherence. Few qualitative studies have documented participant experience with these two types of interventions.
METHOD


The pilot study involved a randomized MW intervention including 38 participants with self-reported inadequate physical activity. Half of them were randomized to receive MW intervention plus a FitBit device and the other received the FitBit device only. We used a qualitative thematic analysis of the narrative data collected through open-ended survey questions at three time points. Participants in the MW intervention were asked to describe their experiences with MW, while all participants were asked to describe their experience with wearing the FitBit to track their step counts.
RESULTS


Participants reported a broad range of perceived benefits and challenges related to adopting the MW intervention and using the mobile device. Participants were generally willing to try to adopt the recommended MW practice and to see value of MW in increasing physical activity and improving overall health. Participants reported using a variety of additional device features beyond goal setting and step counts, indicating using the devices may have been effective in providing additional motivation for participants in meeting physical activity goals in both the control and intervention groups. While most of the feedback about MW (in the intervention group) and the device (all participants) was overwhelmingly positive, a minority of participants reported barriers such as lack of patience with meditation and discomfort with wearing the device.
CONCLUSION


Most participants in the MW intervention see the health benefits of this program and most participants using the wearable physical activity tracking device reported the motivational benefits of this device. Issues with the MW intervention (e.g., lack of patience) and the wearable device (e.g., discomfort with wearing) need to be addressed in future interventions.",2020,Most participants in the MW intervention see the health benefits of this program and most participants using the wearable physical activity tracking device reported the motivational benefits of this device.,"['38 participants with self-reported inadequate physical activity', ""participants' experiences with a"", ""MW participants' attitudes towards MW""]","['MW intervention', 'Mindful walking ', 'community-based mindful walking intervention and mobile device activity measurement', 'MW intervention plus a FitBit device']",['health benefits'],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086387', 'cui_str': 'Health Benefits'}]",38.0,0.0725935,Most participants in the MW intervention see the health benefits of this program and most participants using the wearable physical activity tracking device reported the motivational benefits of this device.,"[{'ForeName': 'Karyn O', 'Initials': 'KO', 'LastName': 'Jones', 'Affiliation': 'School of Nursing, Clemson University, USA. Electronic address: karynj@clemson.edu.'}, {'ForeName': 'Snehal S', 'Initials': 'SS', 'LastName': 'Lopes', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}, {'ForeName': 'Ralph S', 'Initials': 'RS', 'LastName': 'Welsh', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}, {'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Jindal', 'Affiliation': 'Internal Medicine Clinic, Prisma Health System, USA; Department of Medicine, School of Medicine Greenville, University of South Carolina, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Zinzow', 'Affiliation': 'Department of Psychology, Clemson University, USA.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102640']
943,33389422,Xanthine oxidase enzyme activity in keratoconic corneal epithelium.,"PURPOSE


To assess the activity of xanthine oxidase (XO) enzyme in keratoconic corneal epithelium and to evaluate its relationship with the keratoconus (KC) severity.
METHODS


This prospective and randomized study included 66 eyes of 54 KC patients who received corneal collagen cross-linking treatment and 43 eyes of 32 patients who underwent photorefractive keratectomy due to their refractive error. During surgical procedures, the corneal epithelium was mechanically scraped and gathered to analyze the XO enzyme activity spectrophotometrically. The KC group was subdivided into three groups (stages 1, 2, and 3) according to the Amsler-Krumeich classification. The results were compared between the KC and the control group and in between KC subgroups.
RESULTS


No significant differences in age and gender were found between the KC and control groups (p = 0.064 and p = 0.296, respectively). The mean XO activity levels of the KC and control groups were 173.57 ± 87.61 and 223.70 ± 99.52 mIU/mg, respectively (p < 0.001). In KC group, 33 eyes were at stage 1, 19 were at stage 2, and 14 were at stage 3. No significant difference was observed between KC subgroups regarding XO activity levels (p = 0.681).
CONCLUSION


In this study, our findings revealed that ultraviolet-related pro-oxidant XO enzyme may have a role in the etiopathogenesis of KC. Further studies are needed to support our result.
CLINICAL TRIALS REGISTRATION


When we started this study in 2018, we did not have a ""Clinical Trials Registration."" However, we have ethics committee approval (date: 21. 02. 2018/No: 22).",2021,"No significant differences in age and gender were found between the KC and control groups (p = 0.064 and p = 0.296, respectively).","['and 43 eyes of 32 patients who underwent photorefractive keratectomy due to their refractive error', 'keratoconic corneal epithelium', '66 eyes of 54 KC patients who received']","['xanthine oxidase (XO) enzyme', 'corneal collagen cross-linking treatment', 'Xanthine oxidase enzyme activity']","['XO activity levels', 'mean XO activity levels']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0459875', 'cui_str': 'Structure of corneal epithelium'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}]","[{'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}]","[{'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",33.0,0.0264729,"No significant differences in age and gender were found between the KC and control groups (p = 0.064 and p = 0.296, respectively).","[{'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Tanriverdi', 'Affiliation': 'Hulusi Alatas Elmadag State Hospital, Ankara, Turkey. drburak23@gmail.com.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sarac', 'Affiliation': 'Department of Ophthalmology, Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Hikmet Can', 'Initials': 'HC', 'LastName': 'Cubukcu', 'Affiliation': 'Department of Medical Biochemistry, Maresal Cakmak State Hospital, Erzurum, Turkey.'}, {'ForeName': 'Mehtap', 'Initials': 'M', 'LastName': 'Caglayan', 'Affiliation': 'Gazi Yasargil Training and Research Hospital, Diyarbakir, Turkey.'}, {'ForeName': 'Zahide Esra', 'Initials': 'ZE', 'LastName': 'Durak', 'Affiliation': 'The Laboratory of Turkish Public Health Institution, Ankara, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Durak', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, Ankara University, Morphology Building, Ankara, Turkey.'}, {'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Cagil', 'Affiliation': 'Department of Ophthalmology, Yildirim Beyazit University, Ankara, Turkey.'}]",International ophthalmology,['10.1007/s10792-020-01665-1']
944,33388816,When the non-dominant arm dominates: the effects of visual information and task experience on speed-accuracy advantages.,"Speed accuracy trade-off, the inverse relationship between movement speed and task accuracy, is a ubiquitous feature of skilled motor performance. Many previous studies have focused on the dominant arm, unimanual performance in both simple tasks, such as target reaching, and complex tasks, such as overarm throwing. However, while handedness is a prominent feature of human motor performance, the effect of limb dominance on speed-accuracy relationships is not well-understood. Based on previous research, we hypothesize that dominant arm skilled performance should depend on visual information and prior task experience, and that the non-dominant arm should show greater skill when no visual information nor prior task information is available. Forty right-handed young adults reached to 32 randomly presented targets across a virtual reality workspace with either the left or the right arm. Half of the participants received no visual feedback about hand position throughout each reach. Sensory information and task experience were lowest during the first cycle of exposure (32 reaches) in the no-vision condition, in which visual information about motion was not available. Under this condition, we found that the left arm group showed greater skill, measured in terms of position error normalized to speed, and by error variability. However, as task experience and sensory information increased, the right arm group showed substantial improvements in speed-accuracy relations, while the left arm group maintained, but did not improve, speed-accuracy relations throughout the task. These differences in performance between dominant and non-dominant arm groups during the separate stages of the task are consistent with complimentary models of lateralization, which propose different proficiencies of each hemisphere for different features of control. Our results are incompatible with global dominance models of handedness that propose dominant arm advantages under all performance conditions.",2021,"Sensory information and task experience were lowest during the first cycle of exposure (32 reaches) in the no-vision condition, in which visual information about motion was not available.",['Forty right-handed young adults'],[],"['task experience and sensory information', 'speed-accuracy relations', 'position error normalized to speed, and by error variability']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",40.0,0.0234146,"Sensory information and task experience were lowest during the first cycle of exposure (32 reaches) in the no-vision condition, in which visual information about motion was not available.","[{'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Dexheimer', 'Affiliation': 'Department of Kinesiology, College of Health and Human Development, The Pennsylvania State University, 27 Rec Hall, University Park, PA, 16802, USA. brooke.dexheimer@psu.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sainburg', 'Affiliation': 'Department of Kinesiology, College of Health and Human Development, The Pennsylvania State University, 27 Rec Hall, University Park, PA, 16802, USA.'}]",Experimental brain research,['10.1007/s00221-020-06011-6']
945,33388813,Enhancing creativity by altering the frontoparietal control network functioning using transcranial direct current stimulation.,"The left angular gyrus (AG), part of the frontotemporal network, is implicated in creative thinking, including verbal creativity tasks such as novel metaphor generation. The current study tested the effects of tDCS over the left AG on two metaphor generation tasks. The study was a randomized, double-blind, sham-controlled, crossover study of anodal vs. cathodal stimulation by tDCS. Compared to sham, cathodal stimulation resulted in significantly increased novel metaphor generation, while anodal stimulation increased conventional metaphor generation. Higher motivation (behavioral approach system's ""fun-seeking"") was associated with greater metaphor creativity in the sham condition, and lower fun seeking was associated with producing a greater quantity of conventional metaphors. Following active stimulation, motivation traits no longer contributed to creative metaphor generation. Thus, the beneficial effect of cathodal tDCS over the left AG in generation of novel metaphors is through restraining the control network. The current study gives a glimpse into the neural basis for creative thinking.",2021,"Compared to sham, cathodal stimulation resulted in significantly increased novel metaphor generation, while anodal stimulation increased conventional metaphor generation.",[],"['anodal vs. cathodal stimulation by tDCS', 'tDCS', 'cathodal tDCS']","['metaphor creativity', 'Enhancing creativity', 'anodal stimulation increased conventional metaphor generation', 'novel metaphor generation']",[],"[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0302829', 'cui_str': 'Metaphor'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205314', 'cui_str': 'New'}]",2.0,0.133268,"Compared to sham, cathodal stimulation resulted in significantly increased novel metaphor generation, while anodal stimulation increased conventional metaphor generation.","[{'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Lifshitz-Ben-Basat', 'Affiliation': 'Department of Communication Disorders, Faculty of Health Sciences, Ariel University, Kiryat Hamada, 40700, Ariel, Israel. adilb@ariel.ac.il.'}, {'ForeName': 'Nira', 'Initials': 'N', 'LastName': 'Mashal', 'Affiliation': 'School of Education, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.'}]",Experimental brain research,['10.1007/s00221-020-06023-2']
946,33407599,"Improvement of urinary tract symptoms and quality of life in benign prostate hyperplasia patients associated with consumption of a newly developed whole tomato-based food supplement: a phase II prospective, randomized double-blinded, placebo-controlled study.","BACKGROUND


Benign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients' quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH.
METHODS


Forty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for 2 months a sachet (5 g) of a newly developed whole tomato food supplement (WTFS) (treatment = Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score (IPSS) questionnaire before and after treatment.
RESULTS


All but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (P < 0.0002) LUTS since mean IPSS decreased from 9.05 ± 1.15 to 7.15 ± 1.04 (paired t-test, two-tailed P-value < 0.001), and improved life quality (P < 0.0001). A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/mL ± 1.52 vs 6.95 ± 0.76, P = 0.065), with changes being statistically significant only in the subgroup of patients with baseline levels above 10 ng/mL (18.5 ng/mL ± 2.7 vs 10.3 ± 2.1, P = 0.009).
CONCLUSIONS


The new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients.",2021,"Unlike placebo, treatment significantly reduced (P < 0.0002)","['symptomatic BPH patients', 'Benign prostatic hyperplasia (BPH', 'patients diagnosed with BPH', 'elderly men', 'benign prostate hyperplasia patients associated with consumption of a newly developed whole tomato-based food supplement', 'Forty consecutive patients with histologically proved BPH']","['sachet (5\xa0g) of a newly developed whole tomato food supplement (WTFS) (treatment\u2009=\u2009Group A) or placebo', 'novel whole tomato-based food supplement', 'LUTS', 'placebo']","['since mean IPSS', 'life quality', 'side effects', 'efficacy and safety', 'total PSA levels', 'International Prostatic Symptom Score (IPSS) questionnaire', 'urinary tract symptoms and quality of life']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242772', 'cui_str': 'Tomato'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}]","[{'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0242772', 'cui_str': 'Tomato'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}]",40.0,0.392899,"Unlike placebo, treatment significantly reduced (P < 0.0002)","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Cormio', 'Affiliation': 'Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Beppe', 'Initials': 'B', 'LastName': 'Calò', 'Affiliation': 'Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Falagario', 'Affiliation': 'Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Iezzi', 'Affiliation': ""Department of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d'Annunzio University, Chieti, Italy.""}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Lamolinara', 'Affiliation': ""Department of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d'Annunzio University, Chieti, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural Sciences, University of Naples, Portici, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Silecchia', 'Affiliation': 'Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Carrieri', 'Affiliation': 'Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Fogliano', 'Affiliation': 'Department of Agrotechnology and Food Science, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Iacobelli', 'Affiliation': 'Janus Pharma S.r.l., Via Giacomo Peroni 386, 00131, Roma, Italy.'}, {'ForeName': 'Pier Giorgio', 'Initials': 'PG', 'LastName': 'Natali', 'Affiliation': ""Department of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d'Annunzio University, Chieti, Italy. natalipg2002@yahoo.it.""}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Piantelli', 'Affiliation': ""Department of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d'Annunzio University, Chieti, Italy.""}]",Journal of translational medicine,['10.1186/s12967-020-02684-3']
947,33395602,Reappraisal of disgust: Self-report and behavioural assessment of individuals with moderate to high contamination fears.,"Previous research has linked certain psychological disorders, including obsessive-compulsive disorder (OCD), to the experience of disgust and how it is interpreted/appraised. Therefore, the present study examined whether targeting primary and secondary disgust appraisals (i.e., cognitive reappraisal) in individuals with moderate to high OCD-relevant contamination fears can effectively reduce disgust. Fifty-two participants were randomly assigned to one of three conditions; two of which involved reading a brief script modifying either a primary disgust appraisal (i.e., likelihood of a feared outcome) or a secondary disgust appraisal (i.e., the individual's ability to cope), and a third control condition with no reappraisal script. Following this experimental manipulation of disgust appraisal, participants completed two contamination-relevant behavioural approach tasks which involved 1) increasing proximity to, and eventually touching, a dead cockroach, and 2) drinking apple juice from an unused urine sample collection container. Results indicated that the interventions successfully modified their intended appraisal targets. Furthermore, on the second behavioural approach task, the secondary reappraisal condition demonstrated significantly less disgust-related avoidance relative to the control condition and reported significantly less disgust relative to the primary reappraisal condition. Our results incrementally add to the existing literature that emphasises the potential advantages of modifying disgust appraisals and specifically secondary disgust appraisals when treating disgust-based psychological disorders.",2021,"Furthermore, on the second behavioural approach task, the secondary reappraisal condition demonstrated significantly less disgust-related avoidance relative to the control condition and reported significantly less disgust relative to the primary reappraisal condition.","['individuals with moderate to high contamination fears', 'individuals with moderate to high OCD-relevant contamination fears', 'Fifty-two participants']","[""brief script modifying either a primary disgust appraisal (i.e., likelihood of a feared outcome) or a secondary disgust appraisal (i.e., the individual's ability to cope), and a third control condition with no reappraisal script""]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C4319570', 'cui_str': '52'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],52.0,0.0138854,"Furthermore, on the second behavioural approach task, the secondary reappraisal condition demonstrated significantly less disgust-related avoidance relative to the control condition and reported significantly less disgust relative to the primary reappraisal condition.","[{'ForeName': 'Shiu F', 'Initials': 'SF', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, Concordia University, Canada. Electronic address: shiu.wong@concordia.ca.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Department of Psychology, Concordia University, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marishel', 'Affiliation': 'School of Psychology, University of New South Wales, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Grisham', 'Affiliation': 'School of Psychology, University of New South Wales, Australia. Electronic address: jessicag@unsw.edu.au.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102346']
948,33401019,"Developing evidence-based guidance for the treatment of dry eye disease with artificial tear supplements: A six-month multicentre, double-masked randomised controlled trial.","PURPOSE


To assess the six-month therapeutic profiles of lipid and non-lipid-based artificial tear supplements in managing dry eye disease (DED).
METHODS


Ninety-nine participants fulfilling the TFOS DEWS II diagnostic criteria for DED (64% females; mean ± SD age, 44 ± 16 years) were enrolled in a prospective, multicentre, double-masked, parallel group, randomised controlled trial. Participants instilled lipid-based nanoemulsion drops or non-lipid-based aqueous drops for six months, at least four times daily. Symptomology, tear film and ocular surface characteristics were assessed at Days 0, 30, 60, 90, 120, 150 and 180.
RESULTS


Sustained reductions in OSDI, DEQ-5, and SANDE symptom scores from baseline were observed from Day 30 onwards in both groups (all p < 0.05) and decreased superior lid wiper epitheliopathy grades from Day 60 onwards (all p ≤ 0.01). Improvements in non-invasive tear film breakup time, and sodium fluorescein and lissamine green staining scores followed from Day 120 onwards in both groups (all p < 0.05). Tear lipid layer grades increased from Day 90 onwards only with the lipid-based drops, and with significantly greater improvement in those with suboptimal lipid layer thickness at baseline (grade ≤3; p = 0.02). By Day 180, 19% of participants no longer fulfilled the diagnostic criteria for DED.
CONCLUSIONS


Over a six-month treatment period, improvements in dry eye symptomology preceded tear film and ocular surface changes with regular use of both lipid and non-lipid-based artificial tear supplements. Both formulations addressed most mild-to-moderate forms of aqueous deficient and evaporative DED, while evaporative cases benefitted preferentially from lipid-based supplementation. This represents a first step towards mapping DED therapeutic strategies according to disease subtype and severity.",2021,"Improvements in non-invasive tear film breakup time, sodium fluorescein and lissamine green staining scores followed from Day 120 onwards in both groups (all p < 0.05).","['Ninety-nine participants fulfilling the TFOS DEWS II diagnostic criteria for DED (64% females; mean\u202f±\u202fSD age, 44\u202f±\u202f16 years', 'dry eye disease with artificial tear supplements']","['lipid and non-lipid-based artificial tear supplements', 'lipid-based nano-emulsion drops or non-lipid-based aqueous drops']","['suboptimal lipid thickness', 'superior lid wiper epitheliopathy grades', 'Symptomology, tear film and ocular surface characteristics', 'OSDI, DEQ-5, and SANDE symptom scores', 'non-invasive tear film breakup time, sodium fluorescein and lissamine green staining scores', 'Tear lipid layer grades']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449588', 'cui_str': 'Surface characteristics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0147866', 'cui_str': 'Fluorescein sodium stain'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0038128', 'cui_str': 'Stain'}]",99.0,0.125786,"Improvements in non-invasive tear film breakup time, sodium fluorescein and lissamine green staining scores followed from Day 120 onwards in both groups (all p < 0.05).","[{'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Craig', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, Canada; Optometry and Vision Science Research Group, Aston University, Birmingham, UK. Electronic address: jp.craig@auckland.ac.nz.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Muntz', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Doerte', 'Initials': 'D', 'LastName': 'Luensmann', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, Canada.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Trave Huarte', 'Affiliation': 'Optometry and Vision Science Research Group, Aston University, Birmingham, UK.'}, {'ForeName': 'Ally L', 'Initials': 'AL', 'LastName': 'Xue', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Lyndon', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, Canada; School of Optometry and Vision Science, UNSW Sydney, Australia; Centre for Eye & Vision Research (CEVR), Hong Kong.'}, {'ForeName': 'Mark D P', 'Initials': 'MDP', 'LastName': 'Willcox', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Australia.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Optometry and Vision Science Research Group, Aston University, Birmingham, UK.'}]",The ocular surface,['10.1016/j.jtos.2020.12.006']
949,33404620,Effect of Machine Learning on Dispatcher Recognition of Out-of-Hospital Cardiac Arrest During Calls to Emergency Medical Services: A Randomized Clinical Trial.,"Importance


Emergency medical dispatchers fail to identify approximately 25% of cases of out-of-hospital cardiac arrest (OHCA), resulting in lost opportunities to save lives by initiating cardiopulmonary resuscitation.
Objective


To examine how a machine learning model trained to identify OHCA and alert dispatchers during emergency calls affected OHCA recognition and response.
Design, Setting, and Participants


This double-masked, 2-group, randomized clinical trial analyzed all calls to emergency number 112 (equivalent to 911) in Denmark. Calls were processed by a machine learning model using speech recognition software. The machine learning model assessed ongoing calls, and calls in which the model identified OHCA were randomized. The trial was performed at Copenhagen Emergency Medical Services, Denmark, between September 1, 2018, and December 31, 2019.
Intervention


Dispatchers in the intervention group were alerted when the machine learning model identified out-of-hospital cardiac arrest, and those in the control group followed normal protocols without alert.
Main Outcomes and Measures


The primary end point was the rate of dispatcher recognition of subsequently confirmed OHCA.
Results


A total of 169 049 emergency calls were examined, of which the machine learning model identified 5242 as suspected OHCA. Calls were randomized to control (2661 [50.8%]) or intervention (2581 [49.2%]) groups. Of these, 336 (12.6%) and 318 (12.3%), respectively, had confirmed OHCA. The mean (SD) age among of these 654 patients was 70 (16.1) years, and 419 of 627 patients (67.8%) with known gender were men. Dispatchers in the intervention group recognized 296 confirmed OHCA cases (93.1%) with machine learning assistance compared with 304 confirmed OHCA cases (90.5%) using standard protocols without machine learning assistance (P = .15). Machine learning alerts alone had a significantly higher sensitivity than dispatchers without alerts for confirmed OHCA (85.0% vs 77.5%; P < .001) but lower specificity (97.4% vs 99.6%; P < .001) and positive predictive value (17.8% vs 55.8%; P < .001).
Conclusions and Relevance


This randomized clinical trial did not find any significant improvement in dispatchers' ability to recognize cardiac arrest when supported by machine learning even though artificial intelligence did surpass human recognition.
Trial Registration


ClinicalTrials.gov Identifier: NCT04219306.",2021,"Conclusions and Relevance


This randomized clinical trial did not find any significant improvement in dispatchers' ability to recognize cardiac arrest when supported by machine learning even though artificial intelligence did surpass human recognition.
","['emergency number 112 (equivalent to 911) in Denmark', '654 patients was 70 (16.1) years, and 419 of 627 patients (67.8%) with known gender were men', 'Copenhagen Emergency Medical Services, Denmark, between September 1, 2018, and December 31, 2019', 'A total of 169\u202f049 emergency calls']","['machine learning model identified out-of-hospital cardiac arrest, and those in the control group followed normal protocols without alert', 'Machine Learning']","['Dispatcher Recognition of Out-of-Hospital Cardiac Arrest', 'positive predictive value', 'sensitivity', 'rate of dispatcher recognition of subsequently confirmed OHCA']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]",169049.0,0.0524208,"Conclusions and Relevance


This randomized clinical trial did not find any significant improvement in dispatchers' ability to recognize cardiac arrest when supported by machine learning even though artificial intelligence did surpass human recognition.
","[{'ForeName': 'Stig Nikolaj', 'Initials': 'SN', 'LastName': 'Blomberg', 'Affiliation': 'Copenhagen Emergency Medical Services, Copenhagen, Denmark.'}, {'ForeName': 'Helle Collatz', 'Initials': 'HC', 'LastName': 'Christensen', 'Affiliation': 'Copenhagen Emergency Medical Services, Copenhagen, Denmark.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Lippert', 'Affiliation': 'Copenhagen Emergency Medical Services, Copenhagen, Denmark.'}, {'ForeName': 'Annette Kjær', 'Initials': 'AK', 'LastName': 'Ersbøll', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Petersen', 'Affiliation': 'Department of Clinical Investigation, Nordsjællands Hospital, Hillrød, Denmark.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Sayre', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kudenchuk', 'Affiliation': 'Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Folke', 'Affiliation': 'Copenhagen Emergency Medical Services, Copenhagen, Denmark.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.32320']
950,33411545,A clustered-randomized controlled trial of a self-reflection resilience-strengthening intervention and novel mediators.,"This study tests the efficacy of a unique resilience-strengthening intervention using a clustered-randomized controlled trial. It was hypothesized that the training, which encourages adaptive self-reflection on stressor events and the effectiveness of coping strategies and resources, would exert a positive effect on mental health outcomes via increased reflection and decreased brooding. The trial was conducted during a significant stressor period with a final sample of 204 second-class Officer Cadets from the Royal Military College, Australia. Platoons of Cadets were randomly allocated to either Self-Reflection Resilience Training (SRT;  n  = 96) or an exposure-matched active control group that received training as usual (i.e., cognitive-behavioral skill development training) and communication skills seminars ( n  = 108). Compared to the active control group, SRT was more effective at preventing the onset of depression symptoms and promoting stable levels of perceived stress during a period of increased exposure to training stressors, consistent with a resilient trajectory. The Self-Reflection group unexpectedly demonstrated higher anxiety symptoms than the Control group at immediate follow-up, but these symptoms returned to baseline levels at longer term follow-up. In contrast, the Control group experienced increasing anxiety symptoms between immediate and longer term follow-up. Mediation analyses supported an indirect effect of SRT on all three outcome measures via brooding, but not via reflection. This study provides support for the capacity of a practical, sustainable, and scalable intervention based on self-reflection to strengthen resilience in the military training setting. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Compared to the active control group, SRT was more effective at preventing the onset of depression symptoms and promoting stable levels of perceived stress during a period of increased exposure to training stressors, consistent with a resilient trajectory.","['204 second-class Officer Cadets from the Royal Military College, Australia']","['Self-Reflection Resilience Training (SRT;  n  = 96) or an exposure-matched active control group that received training as usual (i.e., cognitive-behavioral skill development training) and communication skills seminars', 'SRT', 'self-reflection resilience-strengthening intervention and novel mediators', 'unique resilience-strengthening intervention']",['anxiety symptoms'],"[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0237758', 'cui_str': 'Non-commissioned officer'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0624889,"Compared to the active control group, SRT was more effective at preventing the onset of depression symptoms and promoting stable levels of perceived stress during a period of increased exposure to training stressors, consistent with a resilient trajectory.","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Falon', 'Affiliation': 'Department of Psychology, Macquarie University.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Karin', 'Affiliation': 'Department of Psychology, Macquarie University.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Boga', 'Affiliation': 'Department of Psychology, Macquarie University.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Griffin', 'Affiliation': 'Department of Psychology, Macquarie University.'}, {'ForeName': 'Monique F', 'Initials': 'MF', 'LastName': 'Crane', 'Affiliation': 'Department of Psychology, Macquarie University.'}]",Journal of occupational health psychology,['10.1037/ocp0000268']
951,33417279,Single versus two-implant mandibular overdentures using early-loaded titanium-zirconium implants with hydrophilic surface and ball attachments: 1-year randomized clinical trial.,"OBJECTIVE


This randomized clinical trial aimed to compare the outcomes of the mandibular overdenture retained by one (1-IOD) or two (2-IOD) implants.
MATERIALS AND METHODS


Participants received new complete dentures, were assessed at baseline and randomly assigned to groups. Early loaded single midline implant (1-IOD) or two implants in the canine regions bilaterally (2-IOD). Ball attachments were used for overdenture retention. Post-treatment outcomes (6- and 12-month follow-ups) included patient satisfaction, oral health-related quality of life measures, and chewing function. Data analysis included within- and between-group comparisons, and Generalized Estimating Equations. Both superiority and non-inferiority hypotheses were tested.
RESULTS


Forty-seven participants were included (1-IOD = 23; 2-IOD = 24). Significant improvements in OHIP-Edent were observed after insertion of new dentures and at the 1-year follow-up compared with baseline. No differences were found between the 1- and 2-IOD groups for the OHIP-Edent and QoLFAST scores. Patient satisfaction with the mandibular denture improved significantly from baseline to the 6-month follow-up and remained unaltered until 1 year, with no differences between groups. The magnitudes of treatment effect sizes were moderate to large for patient-reported outcomes. Progressive improvement in chewing function occurred in both groups. Non-inferiority testing based on a 15% non-inferiority margin showed inconclusive results for patient-reported outcomes, whilst chewing function in the 1-IOD group was concluded to be not inferior to the 2-IOD group.
CONCLUSIONS


Results support the use of both 1- and 2-IOD. The 1-IOD was also an acceptable alternative to the 2-IOD as a secondary option for the treatment of the edentulous mandible.",2021,No differences were found between the 1- and 2-IOD groups for the OHIP-Edent and QoLFAST scores.,"['Participants received new complete dentures', 'Forty-seven participants were included (1-IOD=23; 2-IOD=24']","['Single versus two-implant mandibular overdentures using early-loaded titanium-zirconium implants with hydrophilic surface and ball attachments', 'mandibular overdenture retained by one (1-IOD) or two (2-IOD) implants']","['patient satisfaction, oral health-related quality of life measures, and chewing function', 'Patient satisfaction with the mandibular denture', 'OHIP-Edent and QoLFAST scores', 'chewing function', 'OHIP-Edent']","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0043506', 'cui_str': 'Zirconium'}, {'cui': 'C0475370', 'cui_str': 'Hydrophilic'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0333118', 'cui_str': 'Retained'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.136184,No differences were found between the 1- and 2-IOD groups for the OHIP-Edent and QoLFAST scores.,"[{'ForeName': 'Gabriela Pereira', 'Initials': 'GP', 'LastName': 'de Resende', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Lídia Moraes Ribeiro', 'Initials': 'LMR', 'LastName': 'Jordão', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'João Antônio Chaves', 'Initials': 'JAC', 'LastName': 'de Souza', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schimmel', 'Affiliation': 'Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Cláudio Rodrigues', 'Initials': 'CR', 'LastName': 'Leles', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiania, Brazil.'}]",Clinical oral implants research,['10.1111/clr.13707']
952,33418483,tDCS-Augmented in vivo exposure therapy for specific fears: A randomized clinical trial.,"Exposure therapy is highly effective for anxiety-related disorders, but there is a need for enhancement. Recent trials of adjunctive neuromodulation have shown promise, warranting evaluation of transcranial direct current stimulation (tDCS) as an augmentation. In a double-blind, placebo-controlled trial, contamination- and animal-phobic participants (N = 49) were randomized to active tDCS (1.7 mA, 20 min; n = 27), or sham tDCS (1.7 mA, 30 s; n = 22), followed by 30 min of in-vivo exposure. Active tDCS targeted excitation of the left mPFC and inhibition of the right dlPFC; polarity was counterbalanced for controls. We predicted tDCS would result in accelerated and better maintained gains, contingent on the subsequent in-session response, and baseline negative prognostic indicators. Consistent with predictions, tDCS promoted engagement and reductions in threat appraisals during exposure, and greater reductions in distress and threat appraisals through 1-month, although effects did not uniformly generalize. tDCS was most beneficial given high phobic severity, anxiety sensitivity, and a suboptimal early response. tDCS may promote engagement and response among individuals who are resistant or refractory to standard treatment. tDCS should be applied to more severe anxiety-related disorders, with parameters yoked to individual differences to improve outcomes in exposure-based interventions.",2021,"Consistent with predictions, tDCS promoted engagement and reductions in threat appraisals during exposure, and greater reductions in distress and threat appraisals through 1-month, although effects did not uniformly generalize.","['individuals who are resistant or refractory to standard treatment', 'and animal-phobic participants (N = 49']","['tDCS-Augmented in vivo exposure therapy', 'contamination', 'placebo', 'active tDCS', 'tDCS', 'sham tDCS', 'Exposure therapy', 'transcranial direct current stimulation (tDCS']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],49.0,0.175303,"Consistent with predictions, tDCS promoted engagement and reductions in threat appraisals during exposure, and greater reductions in distress and threat appraisals through 1-month, although effects did not uniformly generalize.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Cobb', 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States; Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, National Crime Victims Research and Treatment Center, Brain Stimulation Laboratory, Charleston, SC, United States; Ralph H. Johnson VA Medical Center, PTSD Clinical Team, Charleston, SC, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': ""O'Connor"", 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zaizar', 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Caulfield', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, National Crime Victims Research and Treatment Center, Brain Stimulation Laboratory, Charleston, SC, United States.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gonzalez-Lima', 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Telch', 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States. Electronic address: telch@austin.utexas.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102344']
953,33417474,Risk-Adapted Preemptive Tocilizumab to Prevent Severe Cytokine Release Syndrome After CTL019 for Pediatric B-Cell Acute Lymphoblastic Leukemia: A Prospective Clinical Trial.,"PURPOSE


To prospectively evaluate the effectiveness of risk-adapted preemptive tocilizumab (PT) administration in preventing severe cytokine release syndrome (CRS) after CTL019, a CD19 chimeric antigen receptor T-cell therapy.
METHODS


Children and young adults with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia were assigned to high- (≥ 40%) or low- (< 40%) tumor burden cohorts (HTBC or LTBC) based on a bone marrow aspirate or biopsy before infusion. HTBC patients received a single dose of tocilizumab (8-12 mg/kg) after development of high, persistent fevers. LTBC patients received standard CRS management. The primary end point was the frequency of grade 4 CRS (Penn scale), with an observed rate of ≤ 5 of 15 patients in the HTBC pre-defined as clinically meaningful. In post hoc analyses, the HTBC was compared with a historical cohort of high-tumor burden patients from the initial phase I CTL019 trial.
RESULTS


The primary end point was met. Seventy patients were infused with CTL019, 15 in the HTBC and 55 in the LTBC. All HTBC patients received the PT intervention. The incidence of grade 4 CRS was 27% (95% CI, 8 to 55) in the HTBC and 3.6% (95% CI, 0.4 to 13) in the LTBC. The best overall response rate was 87% in the HTBC and 100% in the LTBC. Initial CTL019 expansion was greater in the HTBC than the LTBC ( P  < .001), but persistence was not different ( P  = .73). Event-free and overall survival were worse in the HTBC ( P  = .004,  P  < .001, respectively). In the post hoc analysis, grade 4 CRS was observed in 27% versus 50% of patients in the PT and prior phase I cohorts, respectively ( P  = .18).
CONCLUSION


Risk-adapted PT administration resulted in a decrease in the expected incidence of grade 4 CRS, meeting the study end point, without adversely impacting the antitumor efficacy or safety of CTL019.",2021,"Event-free and overall survival were worse in the HTBC ( P  = .004,  P  < .001, respectively).","['Pediatric B-Cell Acute Lymphoblastic Leukemia', 'Seventy patients were infused with CTL019, 15 in the HTBC and 55 in the LTBC', 'Children and young adults with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia were assigned to high- (≥ 40%) or low- (< 40']","['HTBC', 'standard CRS management', 'Tocilizumab', 'risk-adapted preemptive tocilizumab (PT', 'tocilizumab', 'LTBC', 'CTL019']","['Initial CTL019 expansion', 'incidence of grade 4 CRS', 'overall response rate', 'frequency of grade 4 CRS (Penn scale', 'grade 4 CRS', 'Event-free and overall survival']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C3640939', 'cui_str': 'tisagenlecleucel'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3640939', 'cui_str': 'tisagenlecleucel'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C3640939', 'cui_str': 'tisagenlecleucel'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",70.0,0.084799,"Event-free and overall survival were worse in the HTBC ( P  = .004,  P  < .001, respectively).","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kadauke', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Myers', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Yimei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Aplenc', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Baniewicz', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Barrett', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Barz Leahy', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Callahan', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Dolan', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Fitzgerald', 'Affiliation': ""Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Gladney', 'Affiliation': 'Center for Cellular Immunotherapies, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Simon F', 'Initials': 'SF', 'LastName': 'Lacey', 'Affiliation': 'Abramson Cancer Center and Center for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Maude', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'McGuire', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Motley', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Teachey', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Gerald B', 'Initials': 'GB', 'LastName': 'Wertheim', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wray', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'DiNofia', 'Affiliation': ""Cellular Therapy and Transplant Section and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Grupp', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02477']
954,33482949,Refill Reminder Preference and Inhaled Corticosteroid Adherence Among Patients with Asthma.,"CONTEXT


Refill reminders can help patients improve adherence to inhaled corticosteroid (ICS) therapy. However, little is known about patient preferences for reminder type or whether patients who express a preference differ from patients who do not.
OBJECTIVES


To describe patient preferences for ICS prescription refill reminder type and to compare baseline ICS therapy adherence, measured as proportion of days covered (PDC) 1 year before initiating preference-based reminders, between patients who did and did not express a preference.
DESIGN


This substudy within a randomized multi-intervention study was conducted at Kaiser Permanente Colorado. Adults with asthma randomized to intervention were offered the opportunity to choose text, telephone, or email reminders. Patients who did and did not provide a preference were compared by baseline characteristics using log-binomial models.
MAIN OUTCOME MEASURE(S)


The primary outcomes were reminder preference and type.
RESULTS


A total of 1497 of 4545 patients (32.9%) expressed a preference; 789 (52.7%) chose text. The adjusted relative risk (aRR) of not providing a preference increased with decreasing PDC (PDC of 0.50 to < 0.80: aRR, 1.14; 95% confidence interval [CI], 1.04-1.25; PDC < 0.5: aRR, 1.76; 95% CI, 1.59-1.95) compared with patients with a PDC of 0.80 or greater.
CONCLUSION


Among patients who expressed a preference, text reminders were preferred. Patients who expressed a preference had higher baseline adherence. Further research is needed to determine whether expressing a preference for a refill reminder type is itself associated with adherence. Given that offering the opportunity to choose a reminder type only engaged a subset of patients, further work is needed to understand how best to leverage technology-enabled communication outreach to help patients optimize adherence.",2020,A total of 1497 of 4545 patients (32.9%) expressed a preference; 789 (52.7%) chose text.,"['Adults with asthma', 'A total of 1497 of 4545 patients (32.9%) expressed a preference; 789 (52.7%) chose text', 'patients who expressed a preference', 'Patients with Asthma']",[],"['Refill Reminder Preference and Inhaled Corticosteroid Adherence', 'baseline ICS therapy adherence', 'reminder preference and type', 'adjusted relative risk (aRR', 'baseline adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],"[{'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",4545.0,0.203329,A total of 1497 of 4545 patients (32.9%) expressed a preference; 789 (52.7%) chose text.,"[{'ForeName': 'Marsha A', 'Initials': 'MA', 'LastName': 'Raebel', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Shetterly', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO.'}, {'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Goodrich', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO.'}, {'ForeName': 'Courtney B', 'Initials': 'CB', 'LastName': 'Anderson', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Bender', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, CO.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO.'}]",The Permanente journal,['10.7812/TPP/19.199']
955,33450831,Effects of Meditation on Mental Health and Cardiovascular Balance in Caregivers.,"BACKGROUND


Caring for a loved one can be rewarding but is also associated with substantial caregiver burden, developing mental outcomes and affecting happiness. The aim of this study was to determine the effects of a four-week, 16-h presential meditation program on physiological and psychological parameters and vagal nerve activity in high-burden caregivers, as compared to a control group.
METHODS


A non-randomized repeated-measures controlled clinical trial was conducted.
RESULTS


According to the ANCOVA results, the global happiness score (F = 297.42,  p  < 0.001) and the scores for all subscales were significantly higher in the experimental group than in the control group at 5 weeks. Anxiety levels were also significantly reduced in the experimental group (F = 24.92,  p  < 0.001), systolic (F = 16.23,  p  < 0.001) and diastolic blood (F = 34.39,  p  < 0.001) pressures, and the resting heart rate (F = 17.90,  p  < 0.05). HRV results revealed significant between-group differences in the HRV Index (F = 8.40,  p  < 0.05), SDNN (F = 13.59,  p  < 0.05), and RMSSD (F = 10.72,  p  < 0.05) in the time domain, and HF (F = 4.82  p  < 0.05)) in the frequency domain, which were all improved in the experimental group after the meditation program.
CONCLUSIONS


Meditation can be a useful therapy to enhance the mental health and autonomic nervous system balance of informal caregivers, improving symptoms of physical and mental overload.",2021,"Anxiety levels were also significantly reduced in the experimental group (F = 24.92,  p  < 0.001), systolic (F = 16.23,  p  < 0.001) and diastolic blood (F = 34.39,  ",['Caregivers'],"['Meditation', 'presential meditation program']","['systolic', 'HRV Index', 'global happiness score', 'resting heart rate', 'RMSSD', 'physiological and psychological parameters and vagal nerve activity', 'diastolic blood', 'Mental Health and Cardiovascular Balance', 'Anxiety levels']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",,0.0476937,"Anxiety levels were also significantly reduced in the experimental group (F = 24.92,  p  < 0.001), systolic (F = 16.23,  p  < 0.001) and diastolic blood (F = 34.39,  ","[{'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Díaz-Rodríguez', 'Affiliation': 'Research Group CTS1068, Andalusia Research Plan, Junta de Andalucía, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain.'}, {'ForeName': 'Keyla', 'Initials': 'K', 'LastName': 'Vargas-Román', 'Affiliation': 'Research Group CTS1068, Andalusia Research Plan, Junta de Andalucía, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Sanchez-Garcia', 'Affiliation': 'Research Group CTS1068, Andalusia Research Plan, Junta de Andalucía, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Rodríguez-Blanque', 'Affiliation': 'Research Group CTS1068, Andalusia Research Plan, Junta de Andalucía, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain.'}, {'ForeName': 'Guillermo Arturo', 'Initials': 'GA', 'LastName': 'Cañadas-De la Fuente', 'Affiliation': 'Department of Nursing, School of Health Sciences, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Emilia I', 'Initials': 'EI', 'LastName': 'De La Fuente-Solana', 'Affiliation': 'Methodology of Behavioral Sciences Department, School of Psychology, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18020617']
956,33400421,"A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair.","Hair loss is a complex and multi-factorial problem that is associated with significant psychological morbidity in women. Menopausal women represent a significant percentage of those affected, since the menopausal hormonal transition can be a contributing factor. A novel nutraceutical supplement has been specifically formulated with phytoactives to improve hair growth and quality in menopausal women (Nutrafol&reg; Women&rsquo;s Balance Capsules). The objective of this 6-month, randomized, double-blind, placebo-controlled study was to assess the safety and efficacy of this oral supplement to promote hair growth in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning. Subjects were randomized to the study supplement (n=40) or placebo (n=30). The primary endpoint was a statistically significant increase in the number of terminal and vellus hairs based on phototrichogram analysis. Daily intake of the nutraceutical supplement resulted in progressive and significant increase in terminal and total hair counts on days 90 (P&lt;0.01) and 180 (P&lt;0.01) compared to placebo. The vellus hair counts significantly increased for the active treatment group (P&lt;0.05) by day 180 while significantly decreasing for the placebo group subjects. Hair shedding progressively and significantly decreased for the active group compared to placebo, culminating in a reduction of 32.41% by day 180 (P&lt;0.01). The study supplement was well-tolerated. ClinicalTrials.gov Identifier: NCT04048031 

J Drugs Dermatol. 2021;20(1):55-61. doi:10.36849/JDD.5701

THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.",2021,The vellus hair counts significantly increased for the active treatment group (P&lt;0.05) by day 180 while significantly decreasing for the placebo group subjects.,"['Menopausal women', 'women', 'perimenopausal, menopausal, and postmenopausal women with self-perceived thinning', 'Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair']","['placebo', 'Placebo', 'Nutraceutical Supplement']","['Hair shedding progressively', 'safety and efficacy', 'hair growth and quality', 'vellus hair counts', 'terminal and total hair counts', 'Hair loss', 'number of terminal and vellus hairs based on phototrichogram analysis', 'tolerated', 'psychological morbidity']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232407', 'cui_str': 'Hair growth'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0221959', 'cui_str': 'Structure of vellus hair'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.607194,The vellus hair counts significantly increased for the active treatment group (P&lt;0.05) by day 180 while significantly decreasing for the placebo group subjects.,"[{'ForeName': 'Glynis', 'Initials': 'G', 'LastName': 'Ablon', 'Affiliation': ''}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Kogan', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.5701']
957,33484864,Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia.,"OBJECTIVE


Community-acquired bacterial pneumonia (CABP) is a major clinical burden worldwide. In the phase III OPTIC study (NCT02531438) in CABP, omadacycline was found to be non-inferior to moxifloxacin for investigator-assessed clinical response (IACR) at post-treatment evaluation (PTE, 5-10 days after last dose). This article reports the efficacy findings, as specified in the European Medicines Agency (EMA) guidance.
METHODS


Patients were randomized 1:1 to omadacycline 100 mg intravenously (every 12 h for two doses, then every 24 h) with optional transition to 300 mg orally after 3 days, or moxifloxacin 400 mg intravenously (every 24 h) with optional transition to 400 mg orally after 3 days. The total treatment duration was 7-14 days. The primary endpoint for EMA efficacy analysis was IACR at PTE in patients with Pneumonia Patient Outcomes Research Team (PORT) risk class III and IV.
RESULTS


In total, 660 patients were randomized as PORT risk class III and IV. Omadacycline was non-inferior to moxifloxacin at PTE. The clinical success rates were 88.4% and 85.2%, respectively [intent-to-treat population; difference 3.3; 97.5% confidence interval (CI) -2.7 to 9.3], and 92.5% and 90.5%, respectively (clinically evaluable population; difference 2.0; 97.5% CI 3.2-7.4). Clinical success rates with omadacycline and moxifloxacin were similar against identified pathogens and across key subgroups.
CONCLUSIONS


Omadacycline was non-inferior to moxifloxacin for IACR at PTE, with high clinical success across pathogen types and patient subgroups.",2021,"Clinical success rates with omadacycline and moxifloxacin were similar against identified pathogens, and across key subgroups.
","['adults with community-acquired bacterial pneumonia', 'Patients', '660 patients']","['Omadacycline versus moxifloxacin', 'Omadacycline', 'omadacycline', 'omadacycline and moxifloxacin', 'moxifloxacin']",['EMA efficacy analysis was IACR at PTE in Pneumonia Patient Outcomes Research Team (PORT) risk class III/IV patients'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456394', 'cui_str': 'Community acquired'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517845', 'cui_str': '660'}]","[{'cui': 'C2983838', 'cui_str': 'omadacycline'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]",660.0,0.124849,"Clinical success rates with omadacycline and moxifloxacin were similar against identified pathogens, and across key subgroups.
","[{'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': 'Servei de Pneumologia, Hospital Clinic, Barcelona, Universitat de Barcelona, Spain. Electronic address: atorres@clinic.cat.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Garrity-Ryan', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Kirsch', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.'}, {'ForeName': 'Judith N', 'Initials': 'JN', 'LastName': 'Steenbergen', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Eckburg', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'AD Stats Consulting, Guerneville, CA, USA.'}, {'ForeName': 'Marla', 'Initials': 'M', 'LastName': 'Curran', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manley', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Tzanis', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'McGovern', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.01.032']
958,33451086,The Effect of Eight-Week Sprint Interval Training on Aerobic Performance of Elite Badminton Players.,"This study was aimed to: (1) investigate the effects of physiological functions of sprint interval training (SIT) on the aerobic capacity of elite badminton players; and (2) explore the potential mechanisms of oxygen uptake, transport and recovery within the process. Thirty-two elite badminton players volunteered to participate and were randomly divided into experimental (Male-SIT and Female-SIT group) and control groups (Male-CON and Female-CON) within each gender. During a total of eight weeks, SIT group performed three times of SIT training per week, including two power bike trainings and one multi-ball training, while the CON group undertook two Fartlek runs and one regular multi-ball training. The distance of YO-YO IR2 test (which evaluates player's ability to recover between high intensity intermittent exercises) for Male-SIT and Female-SIT groups increased from 1083.0 ± 205.8 m to 1217.5 ± 190.5 m, and from 725 ± 132.9 m to 840 ± 126.5 m ( p  < 0.05), respectively, which were significantly higher than both CON groups ( p  < 0.05). For the Male-SIT group, the ventilatory anaerobic threshold and ventilatory anaerobic threshold in percentage of VO 2 max significantly increased from 3088.4 ± 450.9 mL/min to 3665.3 ± 263.5 mL/min ( p  < 0.05),and from 74 ± 10% to 85 ± 3% ( p  < 0.05) after the intervention, and the increases were significantly higher than the Male-CON group ( p  < 0.05); for the Female-SIT group, the ventilatory anaerobic threshold and ventilatory anaerobic threshold in percentage of VO 2 max were significantly elevated from 1940.1 ± 112.8 mL/min to 2176.9 ± 78.6 mL/min, and from 75 ± 4% to 82 ± 4% ( p  < 0.05) after the intervention, which also were significantly higher than those of the Female-CON group ( p  < 0.05). Finally, the lactate clearance rate was raised from 13 ± 3% to 21 ± 4% ( p  < 0.05) and from 21 ± 5% to 27 ± 4% for both Male-SIT and Female-SIT groups when compared to the pre-test, and this increase was significantly higher than the control groups ( p  < 0.05). As a training method, SIT could substantially improve maximum aerobic capacity and aerobic recovery ability by improving the oxygen uptake and delivery, thus enhancing their rapid repeated sprinting ability.",2021,"Finally, the lactate clearance rate was raised from 13 ± 3% to 21 ± 4% ( p  < 0.05) and from 21 ± 5% to 27 ± 4% for both Male-SIT and Female-SIT groups when compared to the pre-test, and this increase was significantly higher than the control groups ( p  < 0.05).","['Thirty-two elite badminton players volunteered to participate and were', 'Elite Badminton Players', 'elite badminton players']","['sprint interval training (SIT', 'Eight-Week Sprint Interval Training', 'SIT training per week, including two power bike trainings and one multi-ball training, while the CON group undertook two Fartlek runs and one regular multi-ball training', 'randomly divided into experimental (Male-SIT and Female-SIT group) and control groups (Male-CON and Female-CON']","['ventilatory anaerobic threshold and ventilatory anaerobic threshold in percentage of VO 2 max', 'maximum aerobic capacity and aerobic recovery ability', 'distance of YO-YO IR2 test', 'lactate clearance rate']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C4076913', 'cui_str': ""bis(2,(2'-benzothienyl)-pyridinato-N,C3')(acetylacetonate)Ir(III)""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",2.0,0.0118917,"Finally, the lactate clearance rate was raised from 13 ± 3% to 21 ± 4% ( p  < 0.05) and from 21 ± 5% to 27 ± 4% for both Male-SIT and Female-SIT groups when compared to the pre-test, and this increase was significantly higher than the control groups ( p  < 0.05).","[{'ForeName': 'Haochong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'China Institute of Sport and Health Science, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Leng', 'Affiliation': 'Sports Coaching College, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Sports Coaching College, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'China Institute of Sport and Health Science, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Dapeng', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'China Institute of Sport and Health Science, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Yixiong', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'AI Sports Engineering Lab, School of Sports Engineering, Beijing Sport University, Beijing 100084, China.'}]",International journal of environmental research and public health,['10.3390/ijerph18020638']
959,33410758,Usability and Preliminary Effectiveness of a Preoperative mHealth App for People Undergoing Major Surgery: Pilot Randomized Controlled Trial.,"BACKGROUND


Major surgery is associated with negative postoperative outcomes such as complications and delayed or poor recovery. Multimodal prehabilitation can help to reduce the negative effects of major surgery. Offering prehabilitation by means of mobile health (mHealth) could be an effective new approach.
OBJECTIVE


The objectives of this pilot study were to (1) evaluate the usability of the Be Prepared mHealth app prototype for people undergoing major surgery, (2) explore whether the app was capable of bringing about a change in risk behaviors, and (3) estimate a preliminary effect of the app on functional recovery after major surgery.
METHODS


A mixed-methods pilot randomized controlled trial was conducted in two Dutch academic hospitals. In total, 86 people undergoing major surgery participated. Participants in the intervention group received access to the Be Prepared app, a smartphone app using behavior change techniques to address risk behavior prior to surgery. Both groups received care as usual. Usability (System Usability Scale), change in risk behaviors 3 days prior to surgery, and functional recovery 30 days after discharge from hospital (Patient-Reported Outcomes Measurement Information System physical functioning 8-item short form) were assessed using online questionnaires. Quantitative data were analyzed using descriptive statistics, chi-square tests, and multivariable linear regression. Semistructured interviews about the usability of the app were conducted with 12 participants in the intervention group. Thematic analysis was used to analyze qualitative data.
RESULTS


Seventy-nine people-40 in the intervention group and 39 in the control group-were available for further analysis. Participants had a median age of 61 (interquartile range 51.0-68.0) years. The System Usability Scale showed that patients considered the Be Prepared app to have acceptable usability (mean 68.2 [SD 18.4]). Interviews supported the usability of the app. The major point of improvement identified was further personalization of the app. Compared with the control group, the intervention group showed an increase in self-reported physical activity and muscle strengthening activities prior to surgery. Also, 2 of 2 frequent alcohol users in the intervention group versus 1 of 9 in the control group drank less alcohol in the run-up to surgery. No difference was found in change of smoking cessation. Between-group analysis showed no meaningful differences in functional recovery after correction for baseline values (β=-2.4 [95% CI -5.9 to 1.1]).
CONCLUSIONS


The Be Prepared app prototype shows potential in terms of usability and changing risk behavior prior to major surgery. No preliminary effect of the app on functional recovery was found. Points of improvement have been identified with which the app and future research can be optimized.
TRIAL REGISTRATION


Netherlands Trial Registry NL8623; https://www.trialregister.nl/trial/8623.",2021,"Between-group analysis showed no meaningful differences in functional recovery after correction for baseline values (β=-2.4 [95% CI -5.9 to 1.1]).
","['Participants had a median age of 61 (interquartile range 51.0-68.0) years', 'People Undergoing Major Surgery', 'people undergoing major surgery, (2', 'two Dutch academic hospitals', '86 people undergoing major surgery participated']","['Preoperative mHealth App', 'smartphone app using behavior change techniques to address risk behavior prior to surgery']","['functional recovery', 'change of smoking cessation', 'Usability (System Usability Scale), change in risk behaviors 3 days prior to surgery, and functional recovery', 'self-reported physical activity and muscle strengthening activities']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",86.0,0.142197,"Between-group analysis showed no meaningful differences in functional recovery after correction for baseline values (β=-2.4 [95% CI -5.9 to 1.1]).
","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'van der Velde', 'Affiliation': 'Innovation of Human Movement Care Research Group, HU University of Applied Sciences, Utrecht, Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Valkenet', 'Affiliation': 'Innovation of Human Movement Care Research Group, HU University of Applied Sciences, Utrecht, Netherlands.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Geleijn', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marjoke', 'Initials': 'M', 'LastName': 'Kruisselbrink', 'Affiliation': 'Clinical Health Sciences, Program Physiotherapy Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Marsman', 'Affiliation': 'Department of Anesthesiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Liedewij Mj', 'Initials': 'LM', 'LastName': 'Janssen', 'Affiliation': 'Department of Anesthesiology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jelle P', 'Initials': 'JP', 'LastName': 'Ruurda', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'van der Peet', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jesse J', 'Initials': 'JJ', 'LastName': 'Aarden', 'Affiliation': 'European School of Physiotherapy, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Veenhof', 'Affiliation': 'Innovation of Human Movement Care Research Group, HU University of Applied Sciences, Utrecht, Netherlands.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'van der Leeden', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",JMIR mHealth and uHealth,['10.2196/23402']
960,33418095,Cognitive effects of theta frequency bilateral subthalamic nucleus stimulation in Parkinson's disease: A pilot study.,"BACKGROUND


There is significant evidence for cognitive decline following deep brain stimulation (DBS). Current stimulation paradigms utilize gamma frequency stimulation for optimal motor benefits; however, little has been done to optimize stimulation parameters for cognition. Recent evidence implicates subthalamic nucleus (STN) theta oscillations in executive function, and theta oscillations are well-known to relate to episodic memory, suggesting that theta frequency stimulation could potentially improve cognition in Parkinson's disease (PD).
OBJECTIVE


To evaluate the acute effects of theta frequency bilateral STN stimulation on executive function in PD versus gamma frequency and off, as well as investigate the differential effects on episodic versus nonepisodic verbal fluency.
METHODS


Twelve patients (all males, mean age 60.8) with bilateral STN DBS for PD underwent a double-blinded, randomized cognitive testing during stimulation at (1) 130-135 Hz (gamma), (2) 10 Hz (theta) and (3) off. Executive functions and processing speed were evaluated using verbal fluency tasks (letter, episodic category, nonepisodic category, and category switching), color-word interference task, and random number generation task. Performance at each stimulation frequency was compared within subjects.
RESULTS


Theta frequency significantly improved episodic category fluency compared to gamma, but not compared to off. There were no significant differences between stimulation frequencies in other tests.
CONCLUSION


In this pilot trial, our results corroborate the role of theta oscillations in episodic retrieval, although it is unclear whether this reflects direct modulation of the medial temporal lobe and whether similar effects can be found with more canonical memory paradigms. Further work is necessary to corroborate our findings and investigate the possibility of interleaving theta and gamma frequency stimulation for concomitant motor and cognitive effects.",2021,"RESULTS


Theta frequency significantly improved episodic category fluency compared to gamma, but not compared to off.","[""Parkinson's Disease"", 'Twelve patients (all males, mean age 60.8) with bilateral STN DBS for PD underwent a double-blinded, randomized cognitive testing during stimulation at (1) 130-135Hz (gamma), (2) 10Hz (theta) and (3) off']","['theta frequency bilateral STN stimulation', 'Theta Frequency Bilateral Subthalamic Nucleus Stimulation']","['Executive functions and processing speed', 'stimulation frequencies', 'episodic category fluency', 'executive function', 'verbal fluency tasks (letter, episodic category, nonepisodic category, and category switching), color-word interference task, and random number generation task']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1174074', 'cui_str': 'AT 130'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]",,0.173535,"RESULTS


Theta frequency significantly improved episodic category fluency compared to gamma, but not compared to off.","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lam', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': ""King's College London Medical School, London, United Kingdom.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cohn', 'Affiliation': 'Department of Psychology, University of Toronto, Toronto, Canada; Krembil Brain Institute, University Health Network, Toronto, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mark', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Esnaashari', 'Affiliation': 'Department of Neurology, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Petkus', 'Affiliation': 'Department of Neurology, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Department of Neurology, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Feigenbaum', 'Affiliation': 'Department of Neurology, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Liker', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Charles Y', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Darrin J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States. Electronic address: Darrin.lee@med.usc.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.12.014']
961,33482247,"Final analysis of the randomized trial on imatinib as an adjuvant in localized gastrointestinal stromal tumors (GIST) from the EORTC Soft Tissue and Bone Sarcoma Group (STBSG), the Australasian Gastro-Intestinal Trials Group (AGITG), UNICANCER, French Sarcoma Group (FSG), Italian Sarcoma Group (ISG), and Spanish Group for Research on Sarcomas (GEIS) ☆ .","BACKGROUND


In 2004, we started an intergroup randomized trial of adjuvant imatinib versus no further therapy after R0-R1 surgery in localized, high/intermediate-risk gastrointestinal stromal tumors (GIST) patients. Interim analysis results were published in 2015 upon recommendation from an independent data review committee. We report the final outcome of the study.
PATIENTS AND METHODS


This was a randomized, open-label, multicenter phase III trial carried out at 112 hospitals in 12 countries. Patients were randomized to 2 years of imatinib, 400 mg daily, or no further therapy after surgery. The primary endpoint was imatinib failure-free survival (IFFS), while relapse-free survival (RFS), relapse-free interval (RFI), overall survival (OS) and toxicity were secondary endpoints. Adjusting for the interim analyses, results on IFFS were assessed on a 4.3% significance level; for the other endpoints, 5% was used.
RESULTS


Nine hundred and eight patients were randomized between January 2005 and October 2008: 454 to imatinib and 454 to observation; 835 patients were eligible. With a median follow-up of 9.1 years, 5 (10)-year IFFS was 87% (75%) in the imatinib arm versus 83% (74%) in the control arm [hazard ratio (HR) = 0.87, 95.7% confidence interval (CI) (0.65; 1.15), P = 0.31]; RFS was 70% versus 63% at 5 years and 63% versus 61% at 10 years, [HR = 0.71, 95% CI (0.57; 0.89), P = 0.002]; OS was 93% versus 92% at 5 years and 80% versus 78% at 10 years [HR = 0.88, 95% CI (0.65; 1.21), P = 0.43]. Among 526 patients with high-risk GIST by local pathology, 10-year IFFS and RFS were 69% versus 61%, and 48% versus 43%, respectively.
CONCLUSIONS


With 9.1 years of follow-up, a trend toward better long-term IFFS in imatinib-treated patients was observed in the high-risk subgroup. Although the difference was not statistically significant and the surrogacy value of such an endpoint is not validated, this may be seen as supporting the results reported by the Scandinavian/German trial, showing a sustained small but significant long-term OS benefit in high-risk GIST patients treated with 3 years of adjuvant imatinib.",2021,"With 9.1 years of follow-up, a trend toward better long-term IFFS in imatinib-treated patients was observed in the high-risk subgroup.","['R0-R1 surgery in localized, high/intermediate-risk GIST patients', 'localized gastrointestinal stromal tumors (GIST', '835 patients were eligible', '526 patients with high-risk GIST by', '908 patients were randomized between January 2005 and October 2008, 454 to imatinib and 454 to observation', '112 hospitals in 12 countries']","['adjuvant imatinib', 'imatinib']","['imatinib failure-free survival (IFFS), while relapse-free survival (RFS), relapse-free interval (RFI), overall survival (OS) and toxicity', 'better long-term IFFS', 'IFFS', 'RFS', 'local pathology, 10-year IFFS and RFS']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1321660', 'cui_str': 'Fosamprenavir calcium'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0439234', 'cui_str': 'year'}]",835.0,0.18394,"With 9.1 years of follow-up, a trend toward better long-term IFFS in imatinib-treated patients was observed in the high-risk subgroup.","[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Casali', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori, and University of Milan, Milano, Italy; Gustave Roussy, Villejuif, France. Electronic address: paolo.casali@istitutotumori.mi.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Instituto Valenciano De Oncologia, Valencia, Spain.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Velasco', 'Affiliation': 'Adelaide Cancer Centre, Kurralta Park, and Division of Medicine, University of Adelaide, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kotasek', 'Affiliation': 'Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Mannheim University Medical Center, Mannheim, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fumagalli', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori, and University of Milan, Milano, Italy; Gustave Roussy, Villejuif, France.'}, {'ForeName': 'I R', 'Initials': 'IR', 'LastName': 'Judson', 'Affiliation': 'Institut Bergonie, Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Institut Bergonie, Bordeaux, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Hartmann', 'Affiliation': 'Medizinische Universitätsklinik II, Tübingen, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Duffaud', 'Affiliation': 'Hôpital de La Timone, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Martin-Broto', 'Affiliation': 'Hospital Universitari Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori, and University of Milan, Milano, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wardelmann', 'Affiliation': 'University Hospital Münster, Münster, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marréaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Zalcberg', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Litière', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, NetSARC and LYRIC, Centre Leon Berard, Lyon, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.01.004']
962,33485895,"Subgroup analysis of nelipepimut-S plus GM-CSF combined with trastuzumab versus trastuzumab alone to prevent recurrences in patients with high-risk, HER2 low-expressing breast cancer.","HER2-targeted therapy has not benefited patients with low levels of HER2 expression; however, combination therapy may be effective. Primary analysis of a phase IIb trial investigating the HER2-derived vaccine nelipepimut-S (NPS) did not benefit the intention-to-treat population, but subset analysis showed a benefit in triple-negative breast cancer (TNBC) patients. The subset analysis of this multicenter, randomized, single-blind, phase IIb trial identified significant improvement in 36-month disease-free survival (DFS) between NPS (n = 55) and placebo (n = 44) in TNBC (HR 0.25, p = 0.01) and those who express HLA-A24 (HR 0.41, p = 0.05). The TNBC cohort demonstrated improved 36-month DFS in those with HER2 1+ expression (HR 0.17, p = 0.01), HLA-A24 positivity (HR 0.08, p < 0.01), or in those who received neoadjuvant chemotherapy (HR 0.21, p < 0.01). NPS vaccination with trastuzumab was associated with improved 36-month DFS among patients with TNBC. The observed benefit to this high-risk subgroup warrants confirmation in a phase III trial.",2021,"The TNBC cohort demonstrated improved 36-month DFS in those with HER2 1+ expression (HR 0.17, p = 0.01), HLA-A24 positivity (HR 0.08, p < 0.01), or in those who received neoadjuvant chemotherapy (HR 0.21, p < 0.01).","['patients with TNBC', 'patients with high-risk, HER2 low-expressing breast cancer']","['HER2-targeted therapy', 'placebo', 'HER2-derived vaccine nelipepimut-S (NPS', 'trastuzumab', 'nelipepimut-S plus GM-CSF combined with trastuzumab versus trastuzumab alone']","['36-month disease-free survival (DFS', '36-month DFS', 'HLA-A24 positivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0062802', 'cui_str': 'HLA-A24 antigen'}]",,0.0646247,"The TNBC cohort demonstrated improved 36-month DFS in those with HER2 1+ expression (HR 0.17, p = 0.01), HLA-A24 positivity (HR 0.08, p < 0.01), or in those who received neoadjuvant chemotherapy (HR 0.21, p < 0.01).","[{'ForeName': 'R Connor', 'Initials': 'RC', 'LastName': 'Chick', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'G Travis', 'Initials': 'GT', 'LastName': 'Clifton', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Diane F', 'Initials': 'DF', 'LastName': 'Hale', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Vreeland', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Annelies T', 'Initials': 'AT', 'LastName': 'Hickerson', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Phillip M', 'Initials': 'PM', 'LastName': 'Kemp Bohan', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'McCarthy', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA. Electronic address: p.m.mccarthy.0@gmail.com.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1354, P.O. Box 30149, Houston, TX, 77230, USA.'}, {'ForeName': 'Gheath', 'Initials': 'G', 'LastName': 'Alatrash', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 900, Houston, TX 77030, USA.'}, {'ForeName': 'Rashmi K', 'Initials': 'RK', 'LastName': 'Murthy', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1354, P.O. Box 30149, Houston, TX, 77230, USA.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Qiao', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Unit 1434, P.O. Box 301439, Houston, TX 77230, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Philips', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Unit 1434, P.O. Box 301439, Houston, TX 77230, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lukas', 'Affiliation': 'Department of Medicine, Division of Oncology, University of Washington, 825 Eastlake Ave E., Seattle, WA 98109, USA.'}, {'ForeName': 'Jarrod P', 'Initials': 'JP', 'LastName': 'Holmes', 'Affiliation': 'Department of Medical Oncology, St. Joseph Health Cancer Center, 3555 Round Barn Circle, Suite A, Santa Rosa, CA 95403, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': ""Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, 450 Brookline Ave, Boston, MA 02215, USA; Breast Oncology Program, Dana-Farber/Brigham and Women's Hospital, 450 Brookline Ave, Boston, MA 02215, USA.""}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Peoples', 'Affiliation': 'Cancer Vaccine Development Program, 1422 E. Grayson, 3rd Floor, San Antonio, TX 78208, USA.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2021.108679']
963,33485464,"First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial.","BACKGROUND


Approved systemic treatments for malignant pleural mesothelioma (MPM) have been limited to chemotherapy regimens that have moderate survival benefit with poor outcomes. Nivolumab plus ipilimumab has shown clinical benefit in other tumour types, including first-line non-small-cell lung cancer. We hypothesised that this regimen would improve overall survival in MPM.
METHODS


This open-label, randomised, phase 3 study (CheckMate 743) was run at 103 hospitals across 21 countries. Eligible individuals were aged 18 years and older, with previously untreated, histologically confirmed unresectable MPM, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Eligible participants were randomly assigned (1:1) to nivolumab (3 mg/kg intravenously once every 2 weeks) plus ipilimumab (1 mg/kg intravenously once every 6 weeks) for up to 2 years, or platinum plus pemetrexed chemotherapy (pemetrexed [500 mg/m 2  intravenously] plus cisplatin [75 mg/m 2  intravenously] or carboplatin [area under the concentration-time curve 5 mg/mL per min intravenously]) once every 3 weeks for up to six cycles. The primary endpoint was overall survival among all participants randomly assigned to treatment, and safety was assessed in all participants who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT02899299, and is closed to accrual.
FINDINGS


Between Nov 29, 2016, and April 28, 2018, 713 patients were enrolled, of whom 605 were randomly assigned to either nivolumab plus ipilimumab (n=303) or chemotherapy (n=302). 467 (77%) of 605 participants were male and median age was 69 years (IQR 64-75). At the prespecified interim analysis (database lock April 3, 2020; median follow-up of 29·7 months [IQR 26·7-32·9]), nivolumab plus ipilimumab significantly extended overall survival versus chemotherapy (median overall survival 18·1 months [95% CI 16·8-21·4] vs 14·1 months [12·4-16·2]; hazard ratio 0·74 [96·6% CI 0·60-0·91]; p=0·0020). 2-year overall survival rates were 41% (95% CI 35·1-46·5) in the nivolumab plus ipilimumab group and 27% (21·9-32·4) in the chemotherapy group. Grade 3-4 treatment-related adverse events were reported in 91 (30%) of 300 patients treated with nivolumab plus ipilimumab and 91 (32%) of 284 treated with chemotherapy. Three (1%) treatment-related deaths occurred in the nivolumab plus ipilimumab group (pneumonitis, encephalitis, and heart failure) and one (<1%) in the chemotherapy group (myelosuppression).
INTERPRETATION


Nivolumab plus ipilimumab provided significant and clinically meaningful improvements in overall survival versus standard-of-care chemotherapy, supporting the use of this first-in-class regimen that has been approved in the USA as of October, 2020, for previously untreated unresectable MPM.
FUNDING


Bristol Myers Squibb.",2021,2-year overall survival rates were 41% (95% CI 35·1-46·5) in the nivolumab plus ipilimumab group and 27% (21·9-32·4) in the chemotherapy group.,"['Eligible participants', 'Between Nov 29, 2016, and April 28, 2018, 713 patients were enrolled, of whom 605', 'n=303) or chemotherapy (n=302', 'malignant pleural mesothelioma (MPM', 'Eligible individuals were aged 18 years and older, with previously untreated, histologically confirmed unresectable MPM, and an Eastern Cooperative Oncology Group performance status of 0 or 1', '467 (77%) of 605 participants were male and median age was 69 years (IQR 64-75', 'unresectable malignant pleural mesothelioma (CheckMate 743']","['nivolumab', 'First-line nivolumab plus ipilimumab', 'Nivolumab plus ipilimumab', 'ipilimumab', 'chemotherapy', 'platinum plus pemetrexed chemotherapy (pemetrexed [500 mg/m 2  intravenously] plus cisplatin [75 mg/m 2  intravenously] or carboplatin', 'nivolumab plus ipilimumab']","['deaths', '2-year overall survival rates', 'overall survival', 'adverse events']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",713.0,0.402226,2-year overall survival rates were 41% (95% CI 35·1-46·5) in the nivolumab plus ipilimumab group and 27% (21·9-32·4) in the chemotherapy group.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': 'The Netherlands Cancer Institute and Leiden University Medical Center, Amsterdam, Netherlands. Electronic address: p.baas@nki.nl.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Scherpereel', 'Affiliation': 'Pulmonary and Thoracic Oncology, University of Lille, CHU Lille, INSERM U1189, OncoThAI, Lille, France.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'Medical School, University of Western Australia Perth, WA, Australia; Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Fujimoto', 'Affiliation': 'Okayama Rosai Hospital, Okayama, Japan.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Mansfield', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Royal Marsden Hospital, London, UK; Institute of Cancer Research, London, UK.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Jahan', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Antonia', 'Affiliation': 'H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Oulkhouir', 'Affiliation': 'Hôpital Côte de Nacre CHU de Caen, Caen, France.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Bautista', 'Affiliation': 'Centro Médico Nacional Siglo XXI, Mexico City, Mexico.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Cornelissen', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Aix Marseille University, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Grossi', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Kowalski', 'Affiliation': 'Department of Lung Cancer and Chest Tumours, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Rodríguez-Cid', 'Affiliation': 'Centro Oncológico, Médica Sur-Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Aanur', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Oukessou', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Baudelet', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': 'Bichat-Claude Bernard University Hospital, AP-HP, Université de Paris, Paris, France.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)32714-8']
964,33465546,A single oral dose of cannabidiol did not reduce upper limb tremor in patients with essential tremor.,"Essential tremor (ET) is a common clinical syndrome characterized by action tremors affecting both upper limbs that can compromise manual tasks' execution and impair functional and social performance. The primary pharmacological treatment is symptomatic, but effective medicines are somewhat limited. There is a clear need to find new effective therapies for the treatment of ET. Cannabidiol (CBD) is a modulator of CB1 receptor and CB1 agonists can reduce tremors in experimental models. We hypothesized that a single acute CBD intake would reduce tremors in ET patients. We performed a randomized, controlled, double-blind, crossover study on 19 patients with ET. They were 10 males and 9 females, had mean 63 years of age, and mean 23 years of disease duration and had insufficient control of their tremors with the usual pharmacological treatment. They ingested a single oral dose of CBD (300 mg) or placebo in two experimental sessions performed 2-weeks apart. Patients were evaluated immediately before and after oral ingestion (60 min and 210 min), using the Fahn-Tolosa-Marin clinical scale. There was no carryover effect. There were no significant differences in upper limb tremors score, specific motor task tremor scores (writing and drawing/pouring) or clinical impression of change after treatment with placebo or CBD. In conclusion, a single 300 mg oral dose of CBD had no significant effect on the severity of upper limb tremors of ET patients. Our findings did not exclude the possibility that chronic treatment with CBD could have a symptomatic effect.",2021,"There were no significant differences in upper limb tremors score, specific motor task tremor scores (writing and drawing/pouring) or clinical impression of change after treatment with placebo or CBD.","['patients with essential tremor', 'They were 10 males and 9 females, had mean 63 years of age, and mean 23 years of disease duration and had insufficient control of their tremors with the usual pharmacological treatment', '19 patients with ET']","['CBD', 'placebo', 'Cannabidiol (CBD']","['severity of upper limb tremors', 'upper limb tremors score, specific motor task tremor scores (writing and drawing/pouring) or clinical impression of change', 'upper limb tremor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270736', 'cui_str': 'Essential tremor'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",19.0,0.0568786,"There were no significant differences in upper limb tremors score, specific motor task tremor scores (writing and drawing/pouring) or clinical impression of change after treatment with placebo or CBD.","[{'ForeName': 'Stela', 'Initials': 'S', 'LastName': 'Santos de Alencar', 'Affiliation': 'Ribeirão Preto Medical School Hospital, University of São Paulo, Brazil. Electronic address: stelaalencar@yahoo.com.br.'}, {'ForeName': 'José Alexandre S', 'Initials': 'JAS', 'LastName': 'Crippa', 'Affiliation': 'Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo, Brazil. Electronic address: jcrippa@fmrp.usp.br.'}, {'ForeName': 'Manuelina C M', 'Initials': 'MCM', 'LastName': 'Brito', 'Affiliation': 'Ribeirão Preto Medical School Hospital, University of São Paulo, Brazil. Electronic address: manuelinamacruz@gmail.com.'}, {'ForeName': 'Ângela V', 'Initials': 'ÂV', 'LastName': 'Pimentel', 'Affiliation': 'Ribeirão Preto Medical School Hospital, University of São Paulo, Brazil. Electronic address: avpimentel@hcrp.usp.br.'}, {'ForeName': 'Jaime Eduardo', 'Initials': 'JE', 'LastName': 'Cecilio Hallak', 'Affiliation': 'Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo, Brazil. Electronic address: jhallak@fmrp.usp.br.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Tumas', 'Affiliation': 'Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo, Brazil. Electronic address: tumasv@fmrp.usp.br.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2021.01.001']
965,33417682,The neutrophil-lymphocyte ratio and incident atherosclerotic events: analyses from five contemporary randomized trials.,"AIMS


The neutrophil-lymphocyte ratio (NLR) is a readily available inflammatory biomarker that may associate with atherosclerosis and predict cardiovascular (CV) events. The aims of this study are to determine whether the NLR predicts incident major adverse cardiovascular events (MACE) and is modified by anti-inflammatory therapy.
METHODS AND RESULTS


Baseline and on-treatment NLRs were calculated from complete blood counts among 60 087 participants randomized in the CANTOS, JUPITER, SPIRE-1, SPIRE-2, and CIRT trials to receive placebo or canakinumab, rosuvastatin, bococizumab, or methotrexate, respectively, and followed up for MACE. All analyses were performed first in CANTOS, and then externally validated in the other four trials. For the five trials, hazard ratios for major CV events and mortality comparing NLR quartiles were computed using Cox proportional hazards models, and the effect of each randomized intervention on the NLR was evaluated in comparison to placebo. The NLR modestly correlated with interleukin-6, C-reactive protein, and fibrinogen levels but minimally with lipids. In all five randomized trials, baseline NLR predicted incident CV events and death; the per-quartile increase in risk of MACE was 20% in CANTOS [95% confidence interval (CI) 14-25%, P < 0.0001], 31% in SPIRE-1 (95% CI 14-49%, P = 0.00007), 27% in SPIRE-2 (95% CI 12-43%, P = 0.0002), 9% in CIRT (95% CI 0.2-20%, P = 0.045), and 11% in JUPITER (95% CI 1-22%, P = 0.03). While lipid-lowering agents had no significant impact on the NLR, anti-inflammatory therapy with canakinumab lowered the NLR (P < 0.0001).
CONCLUSION


The NLR, an easily obtained inflammatory biomarker, independently predicts CV risk and all-cause mortality, and is reduced by interleukin-1β blockade with canakinumab.",2021,"The NLR, an easily obtained inflammatory biomarker, independently predicts CV risk and all-cause mortality, and is reduced by interleukin-1β blockade with canakinumab.",[],"['placebo or canakinumab, rosuvastatin, bococizumab, or methotrexate, respectively, and followed up for MACE', 'placebo']","['neutrophil-lymphocyte ratio and incident atherosclerotic events', 'neutrophil-lymphocyte ratio (NLR', 'risk of MACE', 'incident CV events and death', 'interleukin-6, C-reactive protein, and fibrinogen levels']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4043705', 'cui_str': 'bococizumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}]",60087.0,0.295705,"The NLR, an easily obtained inflammatory biomarker, independently predicts CV risk and all-cause mortality, and is reduced by interleukin-1β blockade with canakinumab.","[{'ForeName': 'Nicholas H', 'Initials': 'NH', 'LastName': 'Adamstein', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Divisions of Preventive Medicine and Cardiovascular Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Divisions of Preventive Medicine and Cardiovascular Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Lynda M', 'Initials': 'LM', 'LastName': 'Rose', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Divisions of Preventive Medicine and Cardiovascular Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Divisions of Preventive Medicine and Cardiovascular Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Dey', 'Affiliation': 'Division of Intramural Research, Cardiovascular Branch, Lab of Inflammation and Cardiometabolic Diseases, National Heart Lung and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Divisions of Preventive Medicine and Cardiovascular Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Ira A', 'Initials': 'IA', 'LastName': 'Tabas', 'Affiliation': 'Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'Division of Intramural Research, Cardiovascular Branch, Lab of Inflammation and Cardiometabolic Diseases, National Heart Lung and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Divisions of Preventive Medicine and Cardiovascular Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}]",European heart journal,['10.1093/eurheartj/ehaa1034']
966,33482298,Implementation of daily chlorhexidine bathing in intensive care units for reduction of central line-associated bloodstream infections.,"BACKGROUND


Daily chlorhexidine bathing has been associated with a reduction in central line-associated bloodstream infections (CLABSI). In the setting of an already established CLABSI surveillance system and an implemented CLABSI prevention bundle, we analysed the effect of daily chlorhexidine bathing in ICU patients on CLABSI incidence and its causative pathogens.
METHODS


This was a before-and-after study in intensive care units (ICUs) at a tertiary-care centre in Switzerland. Prospective surveillance of CLABSIs and their aetiologies was established. The intervention consisted of daily chlorhexidine bathing of ICU patients with a central venous catheter. A baseline period of 19 months was followed by an intervention period of 9 months.
FINDINGS


A total of 5008 patients were included. In the baseline period a mean CLABSI rate of 2.45/1000 catheter days (95% confidence interval (CI) 1.93-3.07) was observed, followed by 1.00/1000 catheter days (95% CI 0.55-1.67; P<0.001) in the intervention period. Introduction of chlorhexidine bathing was independently associated with a reduced risk of CLABSI (adjusted odds ratio 0.47, 95% CI 0.26-0.84, P=0.011). We did not observe a significant change in aetiology except for an increase of Serratia marcescens in the intervention period.
CONCLUSIONS


Introduction of daily chlorhexidine bathing resulted in a decline in CLABSI incidence on ICUs. Starting from a baseline CLABSI rate that can be considered standard in a high-income setting and several measures for CLABSI prevention implemented, chlorhexidine bathing proved helpful for a further reduction.",2021,"We did not observe a significant change in etiology except for an increase of Serratia marcescens in the intervention period.
","['A total of 5008 patients were included', 'Before-and-after study in intensive care units (ICU) at a tertiary care centre in Switzerland']","['chlorhexidine', 'chlorhexidine bathing of ICU patients with a central venous catheter']","['CLABSI incidence on ICUs', 'reduced risk of CLABSI', 'Serratia marcescens', 'mean CLABSI rate', 'central line-associated bloodstream infections']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}]","[{'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036766', 'cui_str': 'Serratia marcescens'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",5008.0,0.0999113,"We did not observe a significant change in etiology except for an increase of Serratia marcescens in the intervention period.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Scheier', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Saleschus', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dunic', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Clinical Nursing Science & Department of Perioperative Medicine, Kantonsspital Aarau, Aaurau, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schüpbach', 'Affiliation': 'Institute for Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Falk', 'Affiliation': 'Information and Communication Technology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sax', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Kuster', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Schreiber', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland. Electronic address: peterwerner.schreiber@usz.ch.'}]",The Journal of hospital infection,['10.1016/j.jhin.2021.01.007']
967,33482947,Clinical Implications of the Association of Race With Body Satisfaction and Perceived Control Over Eating in Women Initiating a Behavioral Obesity Treatment.,"OBJECTIVE


An improved understanding of the implications of race on body satisfaction might optimize the weight loss process and quality of life in women with obesity.
METHODS


Women with obesity (mean [standard deviation] age, 33.0 [13.8] years) of black (n = 32) and white (n = 38) racial groups volunteered for a cognitive-behavioral weight management program.
RESULTS


Body satisfaction scores at baseline and month 3 were significantly higher in the black group; however, the significant within-group improvements in that variable and on weight, physical activity, fruit and vegetable consumption, sweets intake, perceived ability to control eating, and emotional eating did not significantly differ by racial group. Neither weight nor age significantly added to the strength of the association between race and body satisfaction. Perceived ability to control eating mediated the associations between race and body satisfaction as well as change in weight and change in body satisfaction. In post hoc analyses, inverse associations between body satisfaction and emotional eating were detected regardless of race.
CONCLUSION


The findings of this study increased understanding of body satisfaction in women with obesity and have implications for addressing psychosocial factors within weight loss treatments across racial and at-risk groups.",2020,Perceived ability to control eating mediated the associations between race and body satisfaction as well as change in weight and change in body satisfaction.,"['Women with obesity (mean [standard deviation] age, 33.0 [13.8] years) of black (n = 32) and white (n = 38) racial groups volunteered for a cognitive-behavioral weight management program', 'Women', 'women with obesity']",[],"['body satisfaction', 'weight, physical activity, fruit and vegetable consumption, sweets intake, perceived ability to control eating, and emotional eating', 'Body satisfaction scores', 'body satisfaction and emotional eating']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]",[],"[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",38.0,0.0207877,Perceived ability to control eating mediated the associations between race and body satisfaction as well as change in weight and change in body satisfaction.,"[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Annesi', 'Affiliation': 'School of Health Professions, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Ping H', 'Initials': 'PH', 'LastName': 'Johnson', 'Affiliation': 'Department of Health Promotion, Kennesaw State University, Kennesaw, GA.'}]",The Permanente journal,['10.7812/TPP/19.189']
968,33482946,High Remission Rate with Infliximab and Plant-Based Diet as First-Line (IPF) Therapy for Severe Ulcerative Colitis: Single-Group Trial.,"INTRODUCTION


About one-third of patients with severe ulcerative colitis (UC) do not respond to corticosteroid therapy and receive rescue therapy with infliximab or cyclosporine. Up to 20% of such patients fail to respond to rescue therapy and undergo colectomy.
OBJECTIVE


We investigated the outcomes of infliximab and a plant-based diet (PBD) as first-line therapy for severe UC.
METHODS


Patients with severe UC defined by the Truelove and Witts criteria were admitted and given standard induction therapy with infliximab (5.0 mg/kg-7.5 mg/kg) at 0, 2, and 6 weeks. Additionally, they received a PBD. The primary endpoint was remission or colectomy in the induction phase and 1 year after discharge. Secondary endpoints were changes in inflammatory markers in the induction phase and the PBD score at baseline and follow-up. A higher PBD score indicates greater adherence to a PBD.
RESULTS


Infliximab and PBD as first-line therapy was administered in 17 cases. The remission rate was 76% (13/17), and the colectomy rate was 6% (1/17) in the induction phase. C-reactive protein values and the erythrocyte sedimentation rate significantly decreased at week 6 from 9.42 mg/dL to 0.33 mg/dL and from 59 to 17 mm/h, respectively (p < 0.0001). At 1-year follow-up, the cumulative relapse rate was 25%, and there were no additional colectomy cases. Mean PBD scores of 27.7 at 1 year and 23.8 at 4 years were significantly higher than baseline scores of 8.3 and 9.9, respectively (p < 0.0001 and p = 0.0391).
CONCLUSION


This new first-line therapy for severe UC demonstrated a higher remission rate and lower colectomy rate than with the current modality.",2020,"Mean PBD scores of 27.7 at 1 year and 23.8 at 4 years were significantly higher than baseline scores of 8.3 and 9.9, respectively (p < 0.0001 and p = 0.0391).
","['Patients with severe UC defined by the Truelove and Witts criteria were admitted and given', 'Severe Ulcerative Colitis', 'patients with severe ulcerative colitis (UC']","['infliximab or cyclosporine', 'infliximab and a plant-based diet (PBD', 'standard induction therapy with infliximab', 'Infliximab and Plant-Based Diet as First-Line (IPF) Therapy']","['remission rate', 'colectomy rate', 'cumulative relapse rate', 'High Remission Rate', 'erythrocyte sedimentation rate', 'remission rate and lower colectomy rate', 'changes in inflammatory markers in the induction phase and the PBD score', 'Mean PBD scores', 'remission or colectomy in the induction phase and 1 year after discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C5197846', 'cui_str': 'Diet, Plant-Based'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009274', 'cui_str': 'Excision of colon'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C5197846', 'cui_str': 'Diet, Plant-Based'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0439286,"Mean PBD scores of 27.7 at 1 year and 23.8 at 4 years were significantly higher than baseline scores of 8.3 and 9.9, respectively (p < 0.0001 and p = 0.0391).
","[{'ForeName': 'Mitsuro', 'Initials': 'M', 'LastName': 'Chiba', 'Affiliation': 'Gastroenterology Division, Akita City Hospital, Akita, Japan.'}, {'ForeName': 'Tsuyotoshi', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Gastroenterology Division, Akita City Hospital, Akita, Japan.'}, {'ForeName': 'Kunio', 'Initials': 'K', 'LastName': 'Nakane', 'Affiliation': 'Gastroenterology Division, Akita City Hospital, Akita, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Tsuda', 'Affiliation': 'Gastroenterology Division, Akita City Hospital, Akita, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Gastroenterology Division, Akita City Hospital, Akita, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Ohno', 'Affiliation': 'Gastroenterology Division, Akita City Hospital, Akita, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Obara', 'Affiliation': 'Gastroenterology Division, Akita City Hospital, Akita, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Komatsu', 'Affiliation': 'Gastroenterology Division, Akita City Hospital, Akita, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Tozawa', 'Affiliation': 'Gastroenterology Division, Nakadori General Hospital, Akita, Japan.'}]",The Permanente journal,['10.7812/TPP/19.166']
969,33472641,Distinct osmoregulatory responses to sodium loading in patients with altered glycosaminoglycan structure: a randomized cross-over trial.,"BACKGROUND


By binding to negatively charged polysaccharides called glycosaminoglycans, sodium can be stored in the body-particularly in the skin-without concurrent water retention. Concordantly, individuals with changed glycosaminoglycan structure (e.g. type 1 diabetes (DM1) and hereditary multiple exostosis (HME) patients) may have altered sodium and water homeostasis.
METHODS


We investigated responses to acute (30-min infusion) and chronic (1-week diet) sodium loading in 8 DM1 patients and 7 HME patients in comparison to 12 healthy controls. Blood samples, urine samples, and skin biopsies were taken to investigate glycosaminoglycan sulfation patterns and both systemic and cellular osmoregulatory responses.
RESULTS


Hypertonic sodium infusion increased plasma sodium in all groups, but more in DM1 patients than in controls. High sodium diet increased expression of nuclear factor of activated t-cells 5 (NFAT5)-a transcription factor responsive to changes in osmolarity-and moderately sulfated heparan sulfate in skin of healthy controls. In HME patients, skin dermatan sulfate, rather than heparan sulfate, increased in response to high sodium diet, while in DM1 patients, no changes were observed.
CONCLUSION


DM1 and HME patients show distinct osmoregulatory responses to sodium loading when comparing to controls with indications for reduced sodium storage capacity in DM1 patients, suggesting that intact glycosaminoglycan biosynthesis is important in sodium and water homeostasis. Trial registration These trials were registered with the Netherlands trial register with registration numbers: NTR4095 ( https://www.trialregister.nl/trial/3933 at 2013-07-29) and NTR4788 ( https://www.trialregister.nl/trial/4645 at 2014-09-12).",2021,High sodium diet increased expression of nuclear factor of activated t-cells 5 (NFAT5)-a transcription factor responsive to changes in osmolarity-and moderately sulfated heparan sulfate in skin of healthy controls.,"['individuals with changed glycosaminoglycan structure (e.g. type 1 diabetes (DM1) and hereditary multiple exostosis (HME) patients', 'DM1 patients', 'patients with altered glycosaminoglycan structure', '8 DM1 patients and 7 HME patients in comparison to 12 healthy controls']","['High sodium diet', 'sodium loading', 'Hypertonic sodium', 'acute (30-min infusion) and chronic (1-week diet) sodium loading']","['plasma sodium', 'Blood samples, urine samples, and skin biopsies', 'skin dermatan sulfate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017973', 'cui_str': 'Mucopolysaccharide'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0015306', 'cui_str': 'Multiple congenital exostosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0115685', 'cui_str': 'elliptinium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0452340', 'cui_str': 'High sodium diet'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0858175', 'cui_str': 'Plasma sodium'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0011602', 'cui_str': 'dermatan sulfate'}]",,0.0207252,High sodium diet increased expression of nuclear factor of activated t-cells 5 (NFAT5)-a transcription factor responsive to changes in osmolarity-and moderately sulfated heparan sulfate in skin of healthy controls.,"[{'ForeName': 'Eliane F E', 'Initials': 'EFE', 'LastName': 'Wenstedt', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Jetta J', 'Initials': 'JJ', 'LastName': 'Oppelaar', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Besseling', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Nienke M G', 'Initials': 'NMG', 'LastName': 'Rorije', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Rik H G', 'Initials': 'RHG', 'LastName': 'Olde Engberink', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Oosterhof', 'Affiliation': 'Department of Biochemistry, Radboud UMC, Geert Grooteplein Zuid 10, Nijmegen, The Netherlands.'}, {'ForeName': 'Toin H', 'Initials': 'TH', 'LastName': 'van Kuppevelt', 'Affiliation': 'Department of Biochemistry, Radboud UMC, Geert Grooteplein Zuid 10, Nijmegen, The Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Internal Medicine, Section of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aten', 'Affiliation': 'Department of Pathology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. l.vogt@amsterdamumc.nl.'}]",Journal of translational medicine,['10.1186/s12967-021-02700-0']
970,33466699,Effects of Motor Imagery Training on Balance and Gait in Older Adults: A Randomized Controlled Pilot Study.,"The aim of this study was to demonstrate the effects of motor imagery training on balance and gait abilities in older adults and to investigate the possible application of the training as an effective intervention against fall prevention. Subjects (n = 34) aged 65 years and over who had experienced falls were randomly allocated to three groups: (1) motor imagery training group (MITG, n = 11), (2) task-oriented training group (TOTG, n = 11), and (3) control group (CG, n = 12). Each group performed an exercise three times a week for 6 weeks. The dependent variables included Path Length of center of pressure (COP)-based static balance, Berg Balance Scale (BBS) score, Timed Up and Go Test (TUG) score, which assesses a person's mobility based on changes in both static and dynamic balance, Falls Efficacy Scale (FES) score, which evaluates changes in fear of falls, and gait parameters (velocity, cadence, step length, stride length, and H-H base support) to evaluate gait. After the intervention, Path Length, BBS, TUG, velocity, cadence, step length, and stride length showed significant increases in MITG and TOTG compared to CG ( p  < 0.05). Post hoc test results showed a significantly greater increase in BBS, TUG, and FES in MITG compared with TOTG and CG ( p  < 0.05). Our results suggest that motor imagery training combined with functional training has positive effects on balance, gait, and fall efficacy for fall prevention in the elderly.",2021,"After the intervention, Path Length, BBS, TUG, velocity, cadence, step length, and stride length showed significant increases in MITG and TOTG compared to CG ( p  < 0.05).","['older adults', 'Subjects (n = 34) aged 65 years and over who had experienced falls', 'Older Adults']","['motor imagery training group (MITG, n = 11), (2) task-oriented training', 'motor imagery training', 'Motor Imagery Training', 'motor imagery training combined with functional training']","['Balance and Gait', ""Path Length of center of pressure (COP)-based static balance, Berg Balance Scale (BBS) score, Timed Up and Go Test (TUG) score, which assesses a person's mobility based on changes in both static and dynamic balance, Falls Efficacy Scale (FES) score, which evaluates changes in fear of falls, and gait parameters (velocity, cadence, step length, stride length, and H-H base support) to evaluate gait"", 'balance and gait abilities', 'BBS, TUG, and FES', 'Path Length, BBS, TUG, velocity, cadence, step length, and stride length', 'balance, gait, and fall efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",34.0,0.0127174,"After the intervention, Path Length, BBS, TUG, velocity, cadence, step length, and stride length showed significant increases in MITG and TOTG compared to CG ( p  < 0.05).","[{'ForeName': 'Dong Sik', 'Initials': 'DS', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Division of Health Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Jong Duk', 'Initials': 'JD', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Daejeon 34520, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph18020650']
971,33486048,Effects of non-supervised aerobic exercise on sleep quality and maternal-fetal attachment in pregnant women: A randomized controlled trial.,"OBJECTIVES


This study was designed to evaluate the effect in pregnant women of a non-supervised aerobic exercise intervention on sleep quality and maternal-fetal attachment.
DESIGN


Pretest-posttest randomized controlled trial.
SETTING


Prenatal clinic of a medical center in southern Taiwan.
PARTICIPANTS


One hundred and forty eligible, pregnant women were assigned systematically, at a random starting point, to either the experimental group (n = 70) or the control group (n = 70).
INTERVENTION


Participants in the experimental group received a 20-minute, low-impact aerobic exercise video on DVD and were instructed to exercise at home at least three times per week for a period of three months. Participants in the control group received routine prenatal care only.
MAIN OUTCOME MEASURES


The Pittsburgh Sleep Quality Index and Modified Maternal-Fetal Attachment Scale were used to assess outcome measures before the intervention and at four and 12-weeks post-intervention.
RESULTS


The paired-sample t-tests revealed a significant improvement in sleep quality in the experimental group at 4-weeks posttest, which persisted through 12-weeks posttest. In addition, the experimental group reported a significantly higher mean score for maternal-fetal attachment at 4-weeks posttest than the control group.
CONCLUSION


The results of this study indicate that performing aerobic exercise ameliorates the decline in sleep quality and improves maternal-fetal attachment in women who are pregnant. These findings may be used to encourage pregnant women to regularly perform low-impact aerobic exercise.",2021,"In addition, the experimental group reported a significantly higher mean score for maternal-fetal attachment at 4-weeks posttest than the control group.
","['pregnant women', 'One hundred and forty eligible', 'pregnant women of a non', 'women who are pregnant', 'Prenatal clinic of a medical center in southern Taiwan']","['supervised aerobic exercise intervention', 'aerobic exercise', 'routine prenatal care only', 'non-supervised aerobic exercise', 'low-impact aerobic exercise video on DVD and were instructed to exercise']","['mean score for maternal-fetal attachment', 'sleep quality', 'Pittsburgh Sleep Quality Index and Modified Maternal-Fetal Attachment Scale', 'sleep quality and improves maternal-fetal attachment', 'sleep quality and maternal-fetal attachment']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",140.0,0.0965548,"In addition, the experimental group reported a significantly higher mean score for maternal-fetal attachment at 4-weeks posttest than the control group.
","[{'ForeName': 'Wen-Chun', 'Initials': 'WC', 'LastName': 'Shen', 'Affiliation': 'Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, and Case Manager, Department of Neurology, National Cheng Kung University Hospital, Tainan, Taiwan. Electronic address: nckuwenchun@gmail.com.'}, {'ForeName': 'Chung-Hey', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Hungkuang University, Taichung, and Adjunct Professor, Department of Nursing & Institute of Allied Health Sciences, National Cheng Kung University, Tainan, Taiwan. Electronic address: chunghey@ncku.edu.tw.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102671']
972,33492568,A Randomized Phase I Study of Abemaciclib in Chinese Patients with Advanced and/or Metastatic Cancers.,"BACKGROUND


Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, is approved in combination with endocrine therapy or as monotherapy for hormone receptor-positive and human epidermal growth factor receptor-2-negative (HR+/HER2-) advanced breast cancer outside of China.
OBJECTIVE


To evaluate the safety, tolerability, and pharmacokinetic (PK) profile of abemaciclib in Chinese patients with advanced and/or metastatic cancers.
PATIENTS AND METHODS


A multicenter, open-label, phase I trial of abemaciclib in Chinese patients with advanced and/or metastatic cancers was conducted. Patients were randomized (1:1) to oral abemaciclib 150 or 200 mg every 12 h on a 28-day cycle. Safety analyses (primary outcome) included all patients receiving at least one dose of abemaciclib. PK and antitumor activity were also assessed.
RESULTS


Of the 26 patients randomized, 25 received abemaciclib 150 mg (n = 12) or 200 mg (n = 13). All 25 patients reported ≥ 1 treatment-emergent adverse event (TEAE). The majority of TEAEs were Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or 2 in severity. The most frequent TEAEs of Grade ≥ 3 were neutropenia (32%) and thrombocytopenia (24%). Four patients (16%) discontinued treatment due to AEs. Abemaciclib exhibited slow absorption and clearance at single dose, with maximum concentrations achieved after around 6 h and an elimination half-life of approximately 24 h. No complete response was observed, two patients (8%) achieved partial response, with one confirmed responder, and the disease control rate was 68% (n = 17).
CONCLUSIONS


Abemaciclib was well tolerated and the safety and PK profiles in Chinese patients were comparable to those previously reported in non-Chinese populations. Preliminary antitumor activity was observed. CLINICALTRIALS.
GOV IDENTIFIER


NCT02919696.",2021,"No complete response was observed, two patients (8%) achieved partial response, with one confirmed responder, and the disease control rate was 68% (n = 17).
","['Chinese Patients with Advanced and/or Metastatic Cancers', 'Chinese patients', '26 patients randomized', 'Chinese patients with advanced and/or metastatic cancers']","['oral abemaciclib', 'abemaciclib', 'Abemaciclib', 'endocrine therapy']","['tolerated and the safety and PK profiles', 'thrombocytopenia', '≥\u20091 treatment-emergent adverse event (TEAE', 'antitumor activity', 'disease control rate', 'complete response', 'PK and antitumor activity', 'safety, tolerability, and pharmacokinetic (PK) profile of abemaciclib', 'partial response', 'neutropenia']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",26.0,0.0658188,"No complete response was observed, two patients (8%) achieved partial response, with one confirmed responder, and the disease control rate was 68% (n = 17).
","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Ji', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Rubing', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Haoxun', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Sonya C', 'Initials': 'SC', 'LastName': 'Chapman', 'Affiliation': 'Eli Lilly and Company, Windlesham, UK.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Sykes', 'Affiliation': 'Eli Lilly and Company, Windlesham, UK.'}, {'ForeName': 'Wanli', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. xchu2009@hotmail.com.'}]",Targeted oncology,['10.1007/s11523-020-00789-9']
973,33486403,Living with severe multiple sclerosis: Cost-effectiveness of a palliative care intervention and cost of illness study.,"BACKGROUND


Little is known about the economic consequences of living with severe multiple sclerosis (SMS).
AIMS


To assess the cost-effectiveness of a home-based palliative approach (HPA) for people with SMS (pwSMS). To assess direct healthcare costs in this population.
METHODS


PwSMS from three Italian centers received (2:1 ratio) HPA or usual care over six months. Direct healthcare costs were collected on a monthly basis. Incremental cost-effectiveness was gauged from a national healthcare system (NHS) and a personal perspective, considering the Palliative Outcome Scale-Symptoms-MS (POS-S-MS) and the EuroQol five-dimension descriptive system quality-adjusted life years (EQ-5D-3L QALYs), both completed at baseline, after three and six months.
RESULTS


Of 78 randomized pwSMS, 76 (50 HPA, 26 usual care) were analyzed. Mean QALYs were close to zero, and the mean group difference was -0.006 (95% CI -0.057 to 0.044). The mean baseline-adjusted cost difference was € -394 (95% confidence interval, CI -3,532 to 2,743). POS-S-MS cost-effectiveness showed a slight mean reduction of symptom burden (-1.9; 95% CI -1.1 to 5.0) with unchanged costs. Mean direct costs due to MS were € 23,195/year, almost equally distributed between NHS (€ 13,108) and pwSMS (€ 10,087). Personal care, medications and home rehabilitation accounted for 80% of total expenditures. Most personal care costs were covered by pwSMS, and these costs were 3/4 of pwSMS out-of-pocket.
CONCLUSIONS


The slight reduction of symptom burden produced by the HPA was not associated with an increase in costs. NHS and pwSMS almost equally sustained these costs.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN73082124.",2021,"Mean QALYs were close to zero, and the mean group difference was -0.006","['people with SMS (pwSMS', 'PwSMS from three Italian centers received (2:1 ratio) HPA or usual care over six months', 'Living with severe multiple sclerosis']","['home-based palliative approach (HPA', 'palliative care intervention']","['Mean direct costs', 'costs', 'Direct healthcare costs', 'cost-effectiveness', 'symptom burden', 'POS-S-MS cost-effectiveness', 'Palliative Outcome Scale-Symptoms-MS (POS-S-MS) and the EuroQol five-dimension descriptive system quality-adjusted life years (EQ-5D-3L QALYs', 'Incremental cost-effectiveness', 'Mean QALYs', 'direct healthcare costs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0881442,"Mean QALYs were close to zero, and the mean group difference was -0.006","[{'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Rosato', 'Affiliation': 'Department of Psychology, University of Turin, Turin, Italy; Unit of Clinical Epidemiology, ""Città della Salute e della Scienza"" Hospital, Turin, Italy and CPO Piemonte, Turin, Italy. Electronic address: rosalba.rosato@unito.it.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Pagano', 'Affiliation': 'Unit of Clinical Epidemiology, ""Città della Salute e della Scienza"" Hospital, Turin, Italy and CPO Piemonte, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giordano', 'Affiliation': 'Department of Psychology, University of Turin, Turin, Italy; Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milan, Italy. Electronic address: andrea.giordano@istituto-besta.it.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Farinotti', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milan, Italy. Electronic address: mariangela.farinotti@istituto-besta.it.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Ponzio', 'Affiliation': 'Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Via Operai 40, 16149 Genoa, Italy. Electronic address: michela.ponzio@aism.it.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Veronese', 'Affiliation': 'Fondazione FARO, Via Morgari 12, 10125 Turin, Italy. Electronic address: simone.veronese@fondazionefaro.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Confalonieri', 'Affiliation': 'Multiple Sclerosis Center, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milan, Italy. Electronic address: paolo.confalonieri@istituto-besta.it.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Grasso', 'Affiliation': 'Multiple Sclerosis Unit, IRCCS S. Lucia Foundation, Via Ardeatina 306, 00179 Rome, Italy. Electronic address: mg.grasso@hsantalucia.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Multiple Sclerosis Center, Neurology Clinic, University Hospital Policlinico Vittorio Emanuele, Via S. Sofia 78, 95123 Catania, Italy. Electronic address: patti@unict.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Solari', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milan, Italy. Electronic address: alessandra.solari@istituto-besta.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102756']
974,33486385,Reductions in social anxiety during treatment predict lower levels of loneliness during follow-up among individuals with social anxiety disorder.,"INTRODUCTION


Individuals with social anxiety disorder (SAD) are at elevated risk of loneliness, yet little research has examined loneliness in this population. Cognitive-behavioral group therapy (CBGT) and mindfulness-based stress reduction (MBSR) have demonstrated efficacy in treating SAD, yet research has not examined whether they lead to reductions in loneliness.
METHODS


This sample comprised 108 individuals with SAD who were randomized to CBGT, MBSR, or a waitlist control (WL); WL participants were re-randomized to CBGT or MBSR following WL. Assessments were completed pre- and post-treatment, and 3-, 6-, 9-, and 12-month follow-up assessments.
RESULTS


Compared to WL, individuals in CBGT and MBSR were less lonely at post-treatment; there was no difference between treatments after treatment or during follow-up. Greater reductions in social anxiety from pre- to post-treatment predicted lower levels of loneliness during follow-up. Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up.
DISCUSSION


Individuals who experience reductions in their social anxiety during treatment may also feel less lonely following treatment. Reductions in loneliness also lead to improvements in social anxiety. Future research should continue to examine the relationship between social anxiety and loneliness and how interventions for SAD may help reduce loneliness.",2021,"Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up.
","['Individuals with social anxiety disorder (SAD', '108 individuals with SAD who were randomized to CBGT, MBSR, or a waitlist control (WL); WL participants were re-randomized to', 'individuals with social anxiety disorder']","['CBGT or MBSR', 'Cognitive-behavioral group therapy (CBGT) and mindfulness-based stress reduction (MBSR']",['social anxiety'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}]",108.0,0.0170514,"Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up.
","[{'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': ""O'Day"", 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Butler', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychology, California State University, East Bay, Hayward, CA 94542, USA.'}, {'ForeName': 'Philippe R', 'Initials': 'PR', 'LastName': 'Goldin', 'Affiliation': 'UC Davis Medical Center, University of California, Davis, Davis, CA, 95616, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gross', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Heimberg', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, 19122, USA. Electronic address: heimberg@temple.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2021.102362']
975,33422683,Neuro-cardiac coupling predicts transcutaneous auricular vagus nerve stimulation effects.,"BACKGROUND


Transcutaneous auricular Vagus Nerve Stimulation (taVNS) is a non-invasive neuromodulation technique that may constitute an effective treatment for a wide range of neurological, psychiatric, and medical conditions. One key challenge in taVNS research is the high interindividual response variability. To gain an understanding of this variability, reliable biomarkers for taVNS responsiveness would be highly desirable. In this study, we investigated physiological candidate biomarkers while systematically varying stimulation conditions and observing physiological state characteristics.
METHODS


Forty-four healthy young adults received taVNS and sham-stimulation. Subjects were pseudo-randomly assigned to stimulation of the left or right ear. Each subject underwent six blocks of stimulation. Across blocks, respiration-locking (inhalation-locked taVNS vs. exhalation-locked taVNS vs. sham) and the electrode location (tragus vs. cymba conchae) were varied. We analyzed heart rate (HR), various heart rate variability (HRV) scores, and neuro-cardiac coupling (NCC), indexed by the relationship between electroencephalographic delta power and heartbeat length.
RESULTS


We observed an effect of taVNS on HR and HRV scores during, but not after stimulation. The direction of the effects was consistent with parasympathetic activation. We did not observe any systematic influence of the stimulation conditions that we varied. However, we found baseline NCC scores to be significant predictors for the individual effect of taVNS on HRV scores.
CONCLUSION


Cardiac effects of taVNS indicate parasympathetic activation. These effects were short lived, which might explain that some previous studies were unable to detect them. We propose NCC as a novel candidate biomarker for responsiveness to taVNS.",2021,We did not observe any systematic influence of the stimulation conditions that we varied.,['Forty-four healthy young adults'],"['respiration-locking (inhalation-locked taVNS vs. exhalation-locked taVNS vs. sham', 'Transcutaneous auricular Vagus Nerve Stimulation (taVNS', 'taVNS', 'NCC', 'taVNS and sham-stimulation']","['heart rate (HR), various heart rate variability (HRV) scores, and neuro-cardiac coupling (NCC), indexed by the relationship between electroencephalographic delta power and heartbeat length', 'HR and HRV scores', 'HRV scores']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",44.0,0.102139,We did not observe any systematic influence of the stimulation conditions that we varied.,"[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Keute', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany. Electronic address: marius.keute@uni-tuebingen.de.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Machetanz', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Levan', 'Initials': 'L', 'LastName': 'Berelidze', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Guggenberger', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Gharabaghi', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany. Electronic address: alireza.gharabaghi@uni-tuebingen.de.'}]",Brain stimulation,['10.1016/j.brs.2021.01.001']
976,33427861,Effect of Family Navigation on Diagnostic Ascertainment Among Children at Risk for Autism: A Randomized Clinical Trial From DBPNet.,"Importance


Early identification of autism spectrum disorder (ASD) is associated with improved cognitive and behavioral outcomes. Targeted strategies are needed to support equitable access to diagnostic services to ensure that children from low-income and racial/ethnic minority families receive the benefits of early ASD identification and treatment.
Objective


To test the efficacy of family navigation (FN), an individually tailored, culturally informed care management strategy, to increase the likelihood of achieving diagnostic ascertainment among young children at risk for ASD.
Design, Setting, and Participants


This randomized clinical trial of 249 families of children aged 15 to 27 months who had positive screening results for possible ASD was conducted in 11 urban primary care sites in 3 cities. Data collection occurred from February 24, 2015, through November 5, 2018. Statistical analysis was performed on an intent-to-treat basis from November 5, 2018, to July 27, 2020.
Interventions


Families were randomized to FN or conventional care management (CCM). Families receiving FN were assigned a navigator who conducted community-based outreach to families to address structural barriers to care and support engagement in recommended services. Families receiving CCM were assigned to a care manager, who did limited telephone outreach. Families received FN or CCM after positive initial screening results and for 100 days after diagnostic ascertainment.
Main Outcomes and Measures


The primary outcome, diagnostic ascertainment, was measured as the number of days from randomization to completion of the child's clinical developmental evaluation, when a diagnosis of ASD or other developmental disorder was determined.
Results


Among 250 families randomized, 249 were included in the primary analysis (174 boys [69.9%]; mean [SD] age, 22.0 [3.5] months; 205 [82.3%] publicly insured; 233 [93.6%] non-White). Children who received FN had a greater likelihood of reaching diagnostic ascertainment over the course of 1 year (FN, 108 of 126 [85.7%]; CCM, 94 of 123 [76.4%]; unadjusted hazard ratio [HR], 1.39 [95% CI, 1.05-1.84]). Site (Boston, New Haven, and Philadelphia) and ethnicity (Hispanic vs non-Hispanic) moderated the effect of FN (treatment × site interaction; P = .03; Boston: HR, 2.07 [95% CI, 1.31-3.26]; New Haven: HR, 1.91 [95% CI, 0.94-3.89]; and Philadelphia: HR, 0.91 [95% CI, 0.60-1.37]) (treatment × ethnicity interaction; P < .001; Hispanic families: HR, 2.81 [95% CI, 2.23-3.54] vs non-Hispanic families: HR, 1.49 [95% CI, 1.45-1.53]). The magnitude of FN's effect was significantly greater among Hispanic families than among non-Hispanic families (diagnostic ascertainment among Hispanic families: FN, 90.9% [30 of 33], and CCM, 53.3% [16 of 30]; vs non-Hispanic families: FN, 89.7% [35 of 39], and CCM, 77.5% [31 of 40]).
Conclusions and Relevance


Family navigation improved the likelihood of diagnostic ascertainment among children from racial/ethnic minority, low-income families who were detected as at risk for ASD in primary care. Results suggest differential effects of FN by site and ethnicity.
Trial Registration


ClinicalTrials.gov Identifier: NCT02359084.",2021,"To test the efficacy of family navigation (FN), an individually tailored, culturally informed care management strategy, to increase the likelihood of achieving diagnostic ascertainment among young children at risk for ASD.
","['249 families of children aged 15 to 27 months who had positive screening results for possible ASD was conducted in 11 urban primary care sites in 3 cities', 'autism', 'Families receiving FN', 'Families receiving', 'young children at risk for ASD', 'Children at Risk for Autism', '250 families randomized, 249 were included in the primary analysis (174 boys [69.9%]; mean [SD] age, 22.0 [3.5] months; 205 [82.3%] publicly insured; 233 [93.6%] non-White', 'spectrum disorder (ASD']","['CCM', 'navigator who conducted community-based outreach to families to address structural barriers to care and support engagement in recommended services', 'family navigation (FN', 'FN or conventional care management (CCM', 'FN', 'Family Navigation', 'FN or CCM']","['Diagnostic Ascertainment', 'likelihood of reaching diagnostic ascertainment', 'diagnostic ascertainment', ""number of days from randomization to completion of the child's clinical developmental evaluation, when a diagnosis of ASD or other developmental disorder"", ""magnitude of FN's effect""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",250.0,0.165169,"To test the efficacy of family navigation (FN), an individually tailored, culturally informed care management strategy, to increase the likelihood of achieving diagnostic ascertainment among young children at risk for ASD.
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Augustyn', 'Affiliation': 'Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Sarabeth', 'Initials': 'S', 'LastName': 'Broder-Fingert', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': ""Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Weitzman', 'Affiliation': 'Developmental and Behavioral Pediatrics, Division of General Pediatrics, Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Kuhn', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hickey', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chu', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Levinson', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Sandler Eilenberg', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Cabral', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Patts', 'Affiliation': 'Biostatistics, Epidemiology, and Data Analytics Center, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Yaminette', 'Initials': 'Y', 'LastName': 'Diaz-Linhart', 'Affiliation': 'The Heller School for Social Policy and Management, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Ivys', 'Initials': 'I', 'LastName': 'Fernandez-Pastrana', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Miller', 'Affiliation': 'Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, The Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Guevara', 'Affiliation': 'Department of Pediatrics, The Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ada M', 'Initials': 'AM', 'LastName': 'Fenick', 'Affiliation': 'Developmental and Behavioral Pediatrics, Division of General Pediatrics, Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Blum', 'Affiliation': 'Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, The Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.5218']
977,33428461,"Pre-Post Effects of the Psychoeducational, Autism-Specific Parent Training FAUT-E.","Objective:  Psychoeducational parent training is an economic way to provide care for parents of children newly diagnosed with an autism spectrum disorder (ASD). This study explores pre-post effect sizes of the manualized autism-specific parent training FAUT-E (Frankfurter Autismus-Elterntraining).  Method:  Two behaviorally trained therapists worked with 6-10 parents in eight group sessions. Twenty-four parents of 24 children with ASD participated in the study. Outcomes were child- and parent-related measures obtained at T0 (first measurement), T1 (second measurement), T2 (postintervention), and T3 (3 months after intervention).  Results:  Children showed improved behavior in the parent-rated Aberrant Behavior Checklist (ABC) total score after therapy ( p  = .001; ES T1T2 = .73) and at T3 ( p  = .018; ES T1-T3 = -.51), and a lower intensity of parent-rated problem behavior at T3 ( p  = .031; ES T1-T3 = -.46). Parental measures did not change.  Conclusions:  This study found medium pre-post effects on the child's behavior by FAUT-E between T1 and T2/T3; these were not observed between the measurements T0-T1. FAUT-E was easy to implement and did not increase parental stress. This is in line with results of studies on other training programs to teach parents to use effective behavioral strategies with ASD.",2021,Psychoeducational parent training is an economic way to provide care for parents of children newly diagnosed with an autism spectrum disorder (ASD).,"['parents of children newly diagnosed with an autism spectrum disorder (ASD', 'Twenty-four parents of 24 children with ASD participated in the study']","['Psychoeducational parent training', 'Psychoeducational, Autism-Specific Parent Training FAUT-E', 'manualized autism-specific parent training FAUT-E (Frankfurter Autismus-Elterntraining']","['total score', 'behavior in the parent-rated Aberrant Behavior Checklist (ABC']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0452946', 'cui_str': 'Frankfurter'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}]",24.0,0.0341319,Psychoeducational parent training is an economic way to provide care for parents of children newly diagnosed with an autism spectrum disorder (ASD).,"[{'ForeName': 'Juliane E', 'Initials': 'JE', 'LastName': 'Medda', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Autism Research and Intervention Centre of Excellence, University Hospital Frankfurt, University of Frankfurt/Main.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Kitzerow', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Autism Research and Intervention Centre of Excellence, University Hospital Frankfurt, University of Frankfurt/Main.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schlitt', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Autism Research and Intervention Centre of Excellence, University Hospital Frankfurt, University of Frankfurt/Main.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Berndt', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Autism Research and Intervention Centre of Excellence, University Hospital Frankfurt, University of Frankfurt/Main.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schwenck', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Autism Research and Intervention Centre of Excellence, University Hospital Frankfurt, University of Frankfurt/Main.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Uhlmann', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Freitag', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Autism Research and Intervention Centre of Excellence, University Hospital Frankfurt, University of Frankfurt/Main.'}]",Zeitschrift fur Kinder- und Jugendpsychiatrie und Psychotherapie,['10.1024/1422-4917/a000781']
978,33433597,Effect of Exposure to e-Cigarettes With Salt vs Free-Base Nicotine on the Appeal and Sensory Experience of Vaping: A Randomized Clinical Trial.,"Importance


Alkaline free-base nicotine is bitter and a respiratory irritant. High-nicotine electronic cigarette (e-cigarette) products contain acid additives that change nicotine from a free-base to a protonated salt chemical form, which could improve the sensory experience of vaping, particularly among never smokers unaccustomed to inhaling free-base nicotine.
Objective


To determine whether exposure to e-cigarettes with salt vs free-base nicotine formulations improves the appeal and sensory experience of vaping e-cigarettes and whether nicotine formulation effects differ by e-cigarette flavor and ever combustible cigarette smoking status.
Design, Setting, and Participants


Single-visit double-blind within-participant randomized clinical trial was conducted in an academic medical center outpatient clinical research facility in Southern California. Participants were 119 individuals with past 30-day e-cigarette or combustible cigarette use aged 21 years or older recruited from November 2019 to March 2020.
Interventions


Participants self-administered standardized puffs of each 10 differently flavored e-cigarette solutions using a pod-style device. Each flavor was administered in salt (benzoic acid added) and free-base (no benzoic acid) nicotine formulations with commensurate nicotine concentrations (mean, 23.6 mg/mL). The 20 solutions were administered in randomly assigned sequences. Immediately after puffing each solution, participants rated appeal and sensory attributes.
Main Outcomes and Measures


Self-reported appeal (mean of like, dislike [reverse-scored], and willingness to use again ratings) and 4 sensory attributes (sweetness, smoothness, bitterness, and harshness; analyzed individually) on visual analog scales with not at all and extremely anchors (range, 0-100).
Results


Of the 119 participants; 39 (32.8%) were female. The mean (SD) age was 42.1 (14.4) years; 105 (88.2%) were ever combustible cigarette smokers, and 66 (55.5%) were current e-cigarette users. Salt vs free-base nicotine formulations produced higher ratings of appeal (salt vs free-base mean difference effect estimate: b = 12.0; 95% CI, 9.9-14.1; P < .001), sweetness (b = 9.3; 95% CI, 7.1-11.4; P < .001), and smoothness (b = 17.4; 95% CI, 15.2-19.6; P < .001) and lower ratings of bitterness (b = -13.3; 95% CI, -15.4 to -11.2; P < .001) and harshness (b = -21.0; 95% CI, -23.2 to -18.7; P < .001). Nicotine formulation effects largely generalized across different flavors and the smoothness-enhancing and harshness-reducing effects of nicotine salt were stronger in never vs ever cigarette smokers.
Conclusions and Relevance


In this randomized clinical trial of adult current nicotine or tobacco product users, controlled exposure to e-cigarette puffs with salt vs free-base nicotine formulations appeared to increase product appeal and improve the sensory experience of vaping, particularly among never smokers. Regulatory policies limiting acid additives in e-cigarettes might reduce the appeal of high-nicotine e-cigarettes among populations deterred from vaping e-cigarettes that emit harsh aerosol.
Trial Registration


ClinicalTrials.gov Identifier: NCT04399031.",2021,"Salt vs free-base nicotine formulations produced higher ratings of appeal (salt vs free-base mean difference effect estimate: b = 12.0; 95% CI, 9.9-14.1; P < .001), sweetness (b = 9.3; 95% CI, 7.1-11.4; P < .001), and smoothness (b = 17.4; 95% CI, 15.2-19.6; P < .001) and lower ratings of bitterness (b = -13.3; 95% CI, -15.4 to -11.2; P < .001) and harshness (b = -21.0; 95% CI, -23.2 to -18.7; P < .001).","['The mean (SD) age was 42.1 (14.4) years; 105 (88.2%) were ever combustible cigarette smokers, and 66 (55.5%) were current e-cigarette users', '119 participants', 'academic medical center outpatient clinical research facility in Southern California', 'Participants were 119 individuals with past 30-day e-cigarette or combustible cigarette use aged 21 years or older recruited from November 2019 to March 2020', '39 (32.8%) were female', 'Appeal and Sensory Experience of Vaping']","['Exposure to e-Cigarettes With Salt vs Free-Base Nicotine', 'Nicotine', 'exposure to e-cigarettes with salt vs free-base nicotine formulations', 'Interventions\n\n\nParticipants self-administered standardized puffs of each 10 differently flavored e-cigarette solutions using a pod-style device', 'nicotine', 'High-nicotine electronic cigarette (e-cigarette', 'salt (benzoic acid added) and free-base (no benzoic acid) nicotine formulations']","['Measures\n\n\nSelf-reported appeal (mean of like, dislike [reverse-scored], and willingness to use again ratings) and 4 sensory attributes (sweetness, smoothness, bitterness, and harshness; analyzed individually) on visual analog scales']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}]","[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0449897', 'cui_str': 'Solution used'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0053225', 'cui_str': 'Benzoic acid'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0234804', 'cui_str': 'Harsh voice quality'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",119.0,0.157904,"Salt vs free-base nicotine formulations produced higher ratings of appeal (salt vs free-base mean difference effect estimate: b = 12.0; 95% CI, 9.9-14.1; P < .001), sweetness (b = 9.3; 95% CI, 7.1-11.4; P < .001), and smoothness (b = 17.4; 95% CI, 15.2-19.6; P < .001) and lower ratings of bitterness (b = -13.3; 95% CI, -15.4 to -11.2; P < .001) and harshness (b = -21.0; 95% CI, -23.2 to -18.7; P < .001).","[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Madden', 'Affiliation': 'Institute for Addiction Science, University of Southern California, Los Angeles.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Peraza', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Schiff', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Lebovitz', 'Affiliation': 'Institute for Addiction Science, University of Southern California, Los Angeles.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whitted', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Barrington-Trimis', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles.'}, {'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Mason', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles.'}, {'ForeName': 'Marissa K', 'Initials': 'MK', 'LastName': 'Anderson', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles.'}, {'ForeName': 'Alayna P', 'Initials': 'AP', 'LastName': 'Tackett', 'Affiliation': 'Department of Pediatrics, University of Oklahoma, Oklahoma City.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.32757']
979,33486139,Long-term safety and efficacy of apomorphine infusion in Parkinson's disease patients with persistent motor fluctuations: Results of the open-label phase of the TOLEDO study.,"INTRODUCTION


The randomized, double-blind phase (DBP) of the TOLEDO study confirmed the efficacy of apomorphine infusion (APO) in reducing OFF time in PD patients with persistent motor fluctuations despite optimized oral/transdermal therapy. Here we report safety and efficacy results including the 52-week open-label phase (OLP).
METHODS


All patients completing the 12-week DBP (including those switching early to open-label treatment) were offered OLP entry. The primary objective was the evaluation of long-term safety of APO.
RESULTS


Eighty-four patients entered the OLP (40 previously on APO, 44 on placebo) and 59 patients (70.2%) completed the study. The safety profile of APO was consistent with experience from extensive clinical use. Common treatment-related adverse events (AEs) were mild or moderate infusion site nodules, somnolence and nausea. Fourteen (16.7%) patients discontinued the OLP due to AEs, those involving >1 patient were infusion site reactions (n = 4) and fatigue (n = 2); hemolytic anemia occurred in one case. Reduction in daily OFF time and improvement in ON time without troublesome dyskinesia were sustained for up to 64 weeks. Pooled data for week 64 (n = 55) showed a mean (SD) change from DBP baseline in daily OFF time of -3.66 (2.72) hours and in ON time without troublesome dyskinesia of 3.31 (3.12) hours. Mean (±SD) daily levodopa-equivalent dose decreased from DBP baseline to week 64 by 543 mg (±674) and levodopa dose by 273 mg (±515).
CONCLUSIONS


The safety and efficacy of APO infusion were demonstrated with long-term use for persistent motor fluctuations, allowing substantial reductions in oral PD medication.",2021,Reduction in daily OFF time and improvement in ON time without troublesome dyskinesia were sustained for up to 64 weeks.,"['PD patients with persistent motor fluctuations despite optimized oral/transdermal therapy', 'Eighty-four patients entered the OLP (40 previously on APO, 44 on placebo) and 59 patients (70.2%) completed the study', ""Parkinson's disease patients with persistent motor fluctuations""]","['levodopa', 'apomorphine infusion', 'apomorphine infusion (APO', 'APO']","['OFF time', 'mean (SD) change from DBP baseline in daily OFF time', 'daily OFF time and improvement in ON time without troublesome dyskinesia', 'somnolence and nausea', 'hemolytic anemia', 'Mean (±SD) daily levodopa-equivalent dose', 'evaluation of long-term safety of APO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1868976', 'cui_str': 'Motor fluctuations'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002878', 'cui_str': 'Hemolytic anemia'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",,0.0657878,Reduction in daily OFF time and improvement in ON time without troublesome dyskinesia were sustained for up to 64 weeks.,"[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Katzenschlager', 'Affiliation': 'Department of Neurology and Karl Landsteiner Institute for Neuroimmunological and Neurodegenerative Disorders, Klinik Donaustadt, Vienna, Austria. Electronic address: regina.katzenschlager@gesundheitsverbund.at.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria. Electronic address: Werner.Poewe@i-med.ac.at.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rascol', 'Affiliation': ""Université de Toulouse 3, INSERM, CHU de Toulouse, Centre D'Investigation Clinique CIC1436, Réseau NS-PARK/F-CRIN, Centre Expert Parkinson de Toulouse, Centre COEN NeuroToul, Department of Clinical Pharmacology and Neurosciences, Toulouse University Hospital, Toulouse, France. Electronic address: olivier.rascol@univ-tlse3.fr.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Trenkwalder', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Goettingen and Centre of Parkinsonism and Movement Disorders, Elena Hospital, Kassel, Germany. Electronic address: claudia.trenkwalder@med.uni-goettingen.de.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Deuschl', 'Affiliation': 'Department of Neurology, University Hospital Schleswig-Holstein, Kiel, Christian-Albrechts University, Kiel, Germany. Electronic address: g.deuschl@neurologie.uni-kiel.de.'}, {'ForeName': 'K Ray', 'Initials': 'KR', 'LastName': 'Chaudhuri', 'Affiliation': 'Parkinson Foundation Centre of Excellence, Kings College Hospital, Denmark Hill Campus, London, UK. Electronic address: ray.chaudhuri@kcl.ac.uk.'}, {'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Henriksen', 'Affiliation': 'Movement Disorder Clinic, Bispebjerg Hospital, Copenhagen, Denmark. Electronic address: tovehenriksen@dadlnet.dk.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, University Medical Centre, Groningen, the Netherlands. Electronic address: t.van.laar@umcg.nl.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lockhart', 'Affiliation': 'Britannia Pharmaceuticals Limited, Reading, UK. Electronic address: donnamcvey@hurstgrangeassociates.co.uk.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Staines', 'Affiliation': 'Sigma Statistical Services, Balmullo, UK. Electronic address: harry.staines@britannia-pharm.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lees', 'Affiliation': 'University College London Institute of Neurology, Queen Square, London, UK. Electronic address: andrew.lees@ucl.ac.uk.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.12.024']
980,33429063,Liraglutide and sitagliptin have no effect on intestinal microbiota composition: A 12-week randomized placebo-controlled trial in adults with type 2 diabetes.,"AIM


Preclinical data suggest that treatment with either glucagon-like peptide (GLP)-1 receptor agonists or dipeptidyl peptidase (DPP)-4 inhibitors could change the intestinal microbiome and thereby contribute to their beneficial (cardio)metabolic effects. Therefore, our study aimed to investigate the effects of these agents on microbiota composition in adults with type 2 diabetes (T2D).
METHODS


A total of 51 adults with T2D (mean ± SD: age 62.8 ± 6.9 years, BMI 31.8 ± 4.1 kg/m 2 , HbA 1c  7.3 ± 0.6%) treated with metformin and/or sulphonylureas were included in the 12-week randomized, double-blind trial. Patients were given the GLP-1 receptor agonist liraglutide (1.8 mg sc) or the DPP-4 inhibitor sitagliptin (100 mg), or matching placebos, once daily for 12 weeks. Faecal samples were collected at baseline and at 12 weeks after the start of the intervention. Microbiota analyses were performed by 16S rRNA gene-sequencing analysis. Bile acids were measured in faeces and plasma.
RESULTS


Liraglutide decreased HbA 1c  by 1.3% (95% CI: -1.7 to -0.9) and tended to reduce body weight (-1.7 kg, 95% CI: -3.6 to 0.3), but increased faecal secondary bile acid deoxycholic acid. Sitagliptin lowered HbA 1c  by 0.8% (95% CI: -1.4 to -0.4) while body weight remained stable (-0.8 kg, 95% CI: -2.7 to 1.0), but increased faecal levels of cholic acid, chenodeoxycholic acid and ursodeoxycholic acid. However, neither liraglutide nor sitagliptin affected either alpha or beta diversity of the intestinal microbiota, nor were changes in microbial composition related to clinical parameters.
CONCLUSION


These data suggest that the beneficial effects of liraglutide and sitagliptin on glucose metabolism, body weight and bile acids, when used as add-on therapies to metformin or sulphonylureas, are not linked to changes in the intestinal microbiota (NCT01744236).",2021,"Sitagliptin lowered HbA 1c  by 0.8% (95% CI: -1.4 to -0.4) while body weight remained stable (-0.8 kg, 95% CI: -2.7 to 1.0), but increased faecal levels of cholic acid, chenodeoxycholic acid and ursodeoxycholic acid.","['51 adults with T2D (mean\u2009±\u2009SD: age 62.8\u2009±\u20096.9 years, BMI 31.8\u2009±\u20094.1\u2009kg/m 2 , HbA 1c  7.3\u2009±\u20090.6%) treated with', 'adults with type 2 diabetes', 'adults with type 2 diabetes (T2D']","['liraglutide', 'placebo', 'DPP-4 inhibitor sitagliptin', 'Liraglutide', 'liraglutide and sitagliptin', 'metformin and/or sulphonylureas', 'glucagon-like peptide (GLP)-1 receptor agonists or dipeptidyl peptidase (DPP)-4 inhibitors', 'Liraglutide and sitagliptin', 'GLP-1 receptor agonist liraglutide']","['intestinal microbiota composition', 'microbiota composition', 'faecal secondary bile acid deoxycholic acid', 'body weight', 'Sitagliptin lowered HbA 1c', 'faecal levels of cholic acid, chenodeoxycholic acid and ursodeoxycholic acid', 'Bile acids', 'glucose metabolism, body weight and bile acids', 'Faecal samples']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0014361', 'cui_str': 'Glucagon-Like Polypeptides'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0012515', 'cui_str': 'Dipeptidylpeptide hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0011479', 'cui_str': 'deoxycholic acid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008404', 'cui_str': 'Cholalic Acids'}, {'cui': 'C0008024', 'cui_str': 'chenodeoxycholic acid'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",51.0,0.0612314,"Sitagliptin lowered HbA 1c  by 0.8% (95% CI: -1.4 to -0.4) while body weight remained stable (-0.8 kg, 95% CI: -2.7 to 1.0), but increased faecal levels of cholic acid, chenodeoxycholic acid and ursodeoxycholic acid.","[{'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Location VUmc, Amsterdam, The Netherlands. Electronic address: mm.smits1@amsterdamumc.nl.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Fluitman', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Herrema', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Davids', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Albert K', 'Initials': 'AK', 'LastName': 'Groen', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Belzer', 'Affiliation': 'Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'de Vos', 'Affiliation': 'Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands; Department of Veterinary Biosciences, and RPU Immunobiology, Department of Bacteriology and Immunology, Haartman Institute, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Djuna L', 'Initials': 'DL', 'LastName': 'Cahen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Location VUmc, Amsterdam, The Netherlands; Department of Vascular Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Location VUmc, Amsterdam, The Netherlands.'}]",Diabetes & metabolism,['10.1016/j.diabet.2021.101223']
981,33434087,A Randomized Controlled Trial of the Effect of Music During Cesarean Sections and the Early Postpartum Period on Breastfeeding Rates.,"Objective:  The objective of this research was to study the role of music listening by mothers during a cesarean section and the postpartum period to achieve exclusive breastfeeding in the first 6 months.  Methods and Study Design:  This was a prospective, observational, randomized controlled trial study. A total of 185 singleton pregnant women, in at least 37 weeks of gestation, who were appointed for elective cesarean sections, were recruited. They were randomized into three groups, including pregnant women who did not listen to music (Group 1), listened to music during cesarean section (Group 2), and listened to music during cesarean section and the postpartum room for the first 2 days (Group 3). The breastfeeding results of all three groups were followed up at 7 days, 14 days, and then at months 1, 2, 3, and 6.  Results:  Success in exclusive breastfeeding among Groups 1, 2, and 3 and Groups 1 and 2 + 3 was not different in every lactating period (7 days-6 months). From subgroup analysis, mothers who listened to music in a private ward had more success in exclusive breastfeeding than those in a common ward. Mothers who listened to music and had an income of <20,000 baht, an educational level lower than university, planned the pregnancy, had their first pregnancy, and stayed in a private ward had more successful exclusive breastfeeding in a 6-month period than those mothers who did not listen to music, and the difference was statistically significant.  Conclusions:  Music listening by mothers during a cesarean section and in the postpartum ward did not enhance exclusive breastfeeding during the first 6 months of the postpartum period. However, from subgroup analysis, mothers who listened to music in a private ward had more success in exclusive breastfeeding than those in a common ward. Thai Clinical Trials Registry number was TCTR20180712001.",2021,"A total of 185 singleton pregnant women, in at least 37 weeks of gestation, who were appointed for elective cesarean sections, were recruited.","['185 singleton pregnant women, in at least 37 weeks of gestation, who were appointed for elective cesarean sections, were recruited', 'pregnant women who did not listen to music (Group 1']","['Music listening', 'listened to music during cesarean section (Group 2), and listened to music during cesarean section', 'music listening', 'Music During Cesarean Sections']","['Breastfeeding Rates', 'successful exclusive breastfeeding']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",185.0,0.135994,"A total of 185 singleton pregnant women, in at least 37 weeks of gestation, who were appointed for elective cesarean sections, were recruited.","[{'ForeName': 'Saifon', 'Initials': 'S', 'LastName': 'Chawanpaiboon', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynaecology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Vitaya', 'Initials': 'V', 'LastName': 'Titapant', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynaecology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Julaporn', 'Initials': 'J', 'LastName': 'Pooliam', 'Affiliation': 'Clinical Epidemiological Unit, Office for Research and Development, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0299']
982,33434080,Effect of low-fat dairy products fortified with 1500IU nano encapsulated vitamin D 3  on cardiometabolic indicators in adults with abdominal obesity: a total blinded randomized controlled trial.,"BACKGROUND & AIMS


Vitamin D deficiency is widespread worldwide. In this study, we aimed to evaluate the effect of a nano encapsulated form of vitamin D used for fortifying low-fat dairy products (milk and yogurt) on anthropometric indices, glycemic status, and lipid profile in subjects with abdominal obesity.
METHODS


In a totally (quadruple) blinded, randomized, and parallel-controlled trial, 306 individuals with abdominal obesity were randomly allocated to one of four groups: fortified low-fat yogurt (FY, 1500 IU nano encapsulated vitamin D 3  per 150 g/d), non-fortified low-fat yogurt (nFY), fortified low-fat milk (FM, 1500 IU nano encapsulated vitamin D 3  per 200 g/d), non-fortified low-fat milk (nFM), for 10 weeks (nFM and nFY, were considered as the control groups). Anthropometric and biochemical parameters were measured at baseline and after a ten-week trial in Mashhad, Iran.
RESULTS


After the ten-week intervention, we found a significant increase in serum concentration of 25(OH)D in both the FM and FY groups compared to the respective control groups (19.10 ± 5.69 ng/mL and 20.88 ± 5.76 ng/mL respectively,  p  < .001). We observed a significant reduction in weight to hip ratio ( p  = .04) and a significant improvement in triglyceride ( p  < .001) and HDL-C ( p  = .01) only in FM group compared to nFM group. Also, we found a significant reduction in fasting serum insulin ( p  < .001), and a significant improvement of HOMA-IR ( p  < .001) and QUICKI ( p  < .001) in both intervention groups compared to their placebos.
CONCLUSIONS


An intake of fortified dairy products containing nano-encapsulated vitamin D 3  was associated with an improvement in some measures of anthropometric indices, glucose homeostasis, and lipid profiles, particularly in individuals receiving fortified milk. Hence, along with other benefits, fortification of dairy products with vitamin D may be an effective approach to improve some cardiometabolic indicators, such as insulin resistance.
TRIAL REGISTRATION NUMBER


IRCT20101130005280N27.",2021,We observed a significant reduction in weight to hip ratio (p = 0.04) and a significant improvement in triglyceride (p < 0.001) and HDL-C (p = 0.01) only in FM group compared to nFM group.,"['adults with abdominal obesity', '306 individuals with abdominal obesity', 'subjects with abdominal obesity', 'individuals receiving fortified milk']","['low-fat dairy products fortified with 1500IU nano encapsulated vitamin D 3', 'fortified low-fat yogurt (FY, 1500\u2009IU nano encapsulated vitamin D 3  per 150\u2009g/d), non-fortified low-fat yogurt (nFY), fortified low-fat milk (FM, 1500\u2009IU nano encapsulated vitamin D 3  per 200\u2009g/d), non-fortified low-fat milk (nFM', 'nano encapsulated form of vitamin D', 'vitamin D', 'fortified dairy products containing nano-encapsulated vitamin D']","['HOMA-IR', 'triglyceride', 'serum concentration of 25(OH)D', 'anthropometric indices, glycemic status, and lipid profile', 'fasting serum insulin', 'Anthropometric and biochemical parameters', 'anthropometric indices, glucose homeostasis, and lipid profiles', 'weight to hip ratio', 'cardiometabolic indicators', 'QUICKI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1532525', 'cui_str': 'Fortified milk'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0452814', 'cui_str': 'Low fat yogurt'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",306.0,0.188861,We observed a significant reduction in weight to hip ratio (p = 0.04) and a significant improvement in triglyceride (p < 0.001) and HDL-C (p = 0.01) only in FM group compared to nFM group.,"[{'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Sharifan', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Ziaee', 'Affiliation': 'Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Darroudi', 'Affiliation': 'International UNESCO Center for Health Related Basic Sciences and Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Rezaie', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Safarian', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Eslami', 'Affiliation': 'Department of Medical Informatics, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Khadem-Rezaiyan', 'Affiliation': 'Clinical Research Development Unit of Akbar Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tayefi', 'Affiliation': 'Norwegian Center for e-health Research, University hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mohammadi Bajgiran', 'Affiliation': 'International UNESCO Center for Health Related Basic Sciences and Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Ghazizadeh', 'Affiliation': 'Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khorasanchi', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bagherniya', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Sardar', 'Affiliation': 'Department of General Courses, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Ferns', 'Affiliation': 'Brighton & Sussex Medical School, Division of Medical Education, Brighton, UK.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Vatanparast', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghayour Mobarhan', 'Affiliation': 'International UNESCO Center for Health Related Basic Sciences and Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Current medical research and opinion,['10.1080/03007995.2021.1874324']
983,33492374,Effect of Text Messaging on Bowel Preparation and Appointment Attendance for Outpatient Colonoscopy: A Randomized Clinical Trial.,"Importance


Outpatient colonoscopy is important for colorectal cancer screening. However, nonadherence and poor bowel preparation are common.
Objective


To determine if an automated text messaging intervention with a focus on informational and reminder functions could improve attendance rates and bowel preparation quality for outpatient colonoscopy.
Design, Setting, and Participants


This randomized clinical trial was conducted in an endoscopy center at an urban academic medical center. Adult patients scheduled for outpatient colonoscopy between January and September 2019 were enrolled by telephone call (early phase) or by automated text message (late phase). Data were analyzed from October 2019 to January 2020.
Interventions


After enrollment, patients were randomized in a 1:1 ratio to usual care (ie, written instructions and nurse telephone call) or to the intervention (ie, usual care plus an automated series of 9 educational or reminder text messages in the week prior to scheduled colonoscopy).
Main Outcomes and Measures


The primary outcome was appointment attendance rate with good or excellent bowel preparation. Secondary outcomes included appointment attendance rate, bowel preparation quality (poor or inadequate, fair or adequate, and good or excellent), and cancellation lead time (in days).
Results


Among 753 patients included and randomized in the trial (median [interquartile range] age, 56 [49-64] years; 364 [48.3%] men; 429 [57.2%] Black), 367 patients were randomized to the intervention group and 386 patients were randomized to the control group. There was no significant difference in the primary outcome between groups (patients attending appointments with good or excellent bowel preparation: intervention, 195 patients [53.1%]; control, 210 patients [54.4%]; P = .73), including when stratified by early or late phase enrollment groups. Similarly, there were no significant differences in secondary outcomes.
Conclusions and Relevance


This randomized clinical trial found no significant difference in appointment attendance or bowel preparation quality with an automated text messaging intervention compared with the usual care control. Future work could optimize the content and delivery of text message interventions or identify patient subgroups that may benefit from this approach.
Trial Registration


ClinicalTrials.gov Identifier: NCT03710213.",2021,"Conclusions and Relevance


This randomized clinical trial found no significant difference in appointment attendance or bowel preparation quality with an automated text messaging intervention compared with the usual care control.","['Adult patients scheduled for outpatient colonoscopy between January and September 2019 were enrolled by telephone call (early phase) or by automated text message (late phase', '364 [48.3%] men; 429 [57.2%] Black), 367 patients were randomized to the intervention group and 386 patients', 'Outpatient Colonoscopy', 'endoscopy center at an urban academic medical center', '753 patients included and randomized in the trial (median [interquartile range] age, 56 [49-64] years']","['Text Messaging', 'usual care (ie, written instructions and nurse telephone call) or to the intervention (ie, usual care plus an automated series of 9 educational or reminder text messages in the week prior to scheduled colonoscopy', 'automated text messaging intervention']","['appointment attendance rate with good or excellent bowel preparation', 'Bowel Preparation and Appointment Attendance', 'appointment attendance rate, bowel preparation quality (poor or inadequate, fair or adequate, and good or excellent), and cancellation lead time (in days', 'attendance rates and bowel preparation quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",367.0,0.20255,"Conclusions and Relevance


This randomized clinical trial found no significant difference in appointment attendance or bowel preparation quality with an automated text messaging intervention compared with the usual care control.","[{'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Mahmud', 'Affiliation': 'Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sung', 'Affiliation': 'Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Coniglio', 'Affiliation': 'Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': 'Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Bernard', 'Affiliation': 'Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.34553']
984,33422558,"Age Effect on Treatment Responses to 0.05%, 0.025%, and 0.01% Atropine: Low-Concentration Atropine for Myopia Progression Study.","PURPOSE


To investigate the effect of age at treatment and other factors on treatment response to atropine in the Low-Concentration Atropine for Myopia Progression (LAMP) Study.
DESIGN


Secondary analysis from a randomized trial.
PARTICIPANTS


Three hundred fifty children aged 4 to 12 years who originally were assigned to receive 0.05%, 0.025%, or 0.01% atropine or placebo once daily, and who completed 2 years of the LAMP Study, were included. In the second year, the placebo group was switched to the 0.05% atropine group.
METHODS


Potential predictive factors for change in spherical equivalent (SE) and axial length (AL) over 2 years were evaluated by generalized estimating equations in each treatment group. Evaluated factors included age at treatment, gender, baseline refraction, parental myopia, time outdoors, diopter hours of near work, and treatment compliance. Estimated mean values and 95% confidence intervals (CIs) of change in SE and AL over 2 years also were generated.
MAIN OUTCOME MEASURES


Factors associated with SE change and AL change over 2 years were the primary outcome measures. Associated factors during the first year were secondary outcome measures.
RESULTS


In 0.05%, 0.025%, and 0.01% atropine groups, younger age was the only factor associated with SE progression (coefficient of 0.14, 0.15, and 0.20, respectively) and AL elongation (coefficient of -0.10, -0.11, and -0.12, respectively) over 2 years; the younger the age, the poorer the response. At each year of age from 4 to 12 years across the treatment groups, higher-concentration atropine showed a better treatment response, following a concentration-dependent effect (P trend  <0.05 for each age group). In addition, the mean SE progression in 6-year-old children receiving 0.05% atropine (-0.90 diopter [D]; 95% CI, -0.99 to -0.82) was similar to that of 8-year-old children receiving 0.025% atropine (-0.89 D; 95% CI, -0.94 to -0.83) and 10-year-old children receiving 0.01% atropine (-0.92 D; 95% CI, -0.99 to -0.85). All concentrations were well tolerated in all age groups.
CONCLUSIONS


Younger age is associated with poor treatment response to low-concentration atropine at 0.05%, 0.025%, and 0.01%. Among concentrations studied, younger children required the highest 0.05% concentration to achieve similar reduction in myopic progression as older children receiving lower concentrations.",2021,"All concentrations were well tolerated at all age groups.
","['once daily in both eyes who completed 2 years of the LAMP study were included in this study', '350 children, aged 4 to 12 years, randomization stratified by age and gender, originally assigned to receive 0.05%, 0.025%, 0.01']","['placebo', 'atropine, or placebo', 'atropine (-0.89D, 95%CI', 'atropine', 'atropine: Low-concentration Atropine']","['SE progression', 'spherical equivalent (SE) and axial length (AL', 'myopic progression', 'mean SE progression']","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C4517400', 'cui_str': '0.025'}, {'cui': 'C4517393', 'cui_str': '0.01'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",350.0,0.238738,"All concentrations were well tolerated at all age groups.
","[{'ForeName': 'Fen Fen', 'Initials': 'FF', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yuzhou', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Benjamin Hon Kei', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'Shu Min', 'Initials': 'SM', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Ka Wai', 'Initials': 'KW', 'LastName': 'Kam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alvin L', 'Initials': 'AL', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Li Jia', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Clement C', 'Initials': 'CC', 'LastName': 'Tham', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong SAR, China; Hong Kong Eye Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Chi Pui', 'Initials': 'CP', 'LastName': 'Pang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Hong Kong Eye Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Yam', 'Affiliation': ""Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong SAR, China; Hong Kong Eye Hospital, Hong Kong SAR, China; Department of Ophthalmology, Hong Kong Children's Hospital, Hong Kong SAR, China. Electronic address: yamcheuksing@cuhk.edu.hk.""}]",Ophthalmology,['10.1016/j.ophtha.2020.12.036']
985,33439284,Improved transition to adult care in youth with type 1 diabetes: a pragmatic clinical trial.,"AIMS/HYPOTHESIS


Youth with type 1 diabetes are at high risk for loss to follow-up during the transition from paediatric to adult diabetes care. Our aim was to assess the effect of a communication technology enhanced transition coordinator intervention compared with usual care on clinic attendance among transitioning youth with type 1 diabetes.
METHODS


In this open label, pragmatic clinical trial of youth with type 1 diabetes, aged 17-18 years, transitioning from paediatric to adult diabetes care, the intervention group received support from a transition coordinator who used communication technology and the control group received usual care. The primary outcome was the proportion of individuals that did not attend at least one routine clinic visit in adult diabetes care within 1 year after transfer. Secondary outcomes included diabetes-related clinical outcomes and quality of life measures.
RESULTS


There were no baseline differences in age, sex, HbA 1c  and number of follow-up visits, emergency department visits and diabetic ketoacidosis admissions in the 1 year prior to transition between the usual care (n = 101) and intervention (n = 102) groups. In the year following transfer, 47.1% in the usual care group vs 11.9% in the intervention group did not attend any outpatient diabetes appointments (p < 0.01). There were no differences in glycaemic control or diabetic ketoacidosis post transfer.
CONCLUSIONS/INTERPRETATION


Our intervention was successful in improving clinic attendance among transitioning youth with type 1 diabetes. Importantly, this programme used simple, readily accessible communication technologies, which increases the sustainability and transferability of this strategy.
TRIAL REGISTRATION


isrctn.org ISRCTN13459962.",2021,"There were no baseline differences in age, sex, HbA 1c  and number of follow-up visits, emergency department visits and diabetic ketoacidosis admissions in the 1 year prior to transition between the usual care (n = 101) and intervention (n = 102) groups.","['Youth with type 1 diabetes', 'transitioning youth with type 1 diabetes', 'youth with type 1 diabetes', 'youth with type 1 diabetes, aged 17-18\xa0years, transitioning from paediatric to adult diabetes care, the intervention group received']","['usual care', 'support from a transition coordinator who used communication technology and the control group received usual care', 'communication technology enhanced transition coordinator intervention']","['diabetes-related clinical outcomes and quality of life measures', 'proportion of individuals that did not attend at least one routine clinic visit in adult diabetes care within 1\xa0year after transfer', 'glycaemic control or diabetic ketoacidosis post transfer', 'clinic attendance']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0559294', 'cui_str': 'Did not attend'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0757514,"There were no baseline differences in age, sex, HbA 1c  and number of follow-up visits, emergency department visits and diabetic ketoacidosis admissions in the 1 year prior to transition between the usual care (n = 101) and intervention (n = 102) groups.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Butalia', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. sbutalia@ucalgary.ca.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Crawford', 'Affiliation': 'Alberta Health Services, Calgary, AB, Canada.'}, {'ForeName': 'K Ashlee', 'Initials': 'KA', 'LastName': 'McGuire', 'Affiliation': 'Provincial Primary Health Care, Alberta Health Services, Calgary, AB, Canada.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Dyjur', 'Affiliation': 'Diabetes Centre Calgary, Alberta Health Services, Calgary, AB, Canada.'}, {'ForeName': 'Julia R', 'Initials': 'JR', 'LastName': 'Mercer', 'Affiliation': ""Alberta Children's Hospital, Diabetes Clinic, Alberta Health Services, Calgary, AB, Canada.""}, {'ForeName': 'Danièle', 'Initials': 'D', 'LastName': 'Pacaud', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}]",Diabetologia,['10.1007/s00125-020-05368-1']
986,33450656,"A carbohydrate-restricted diet for patients with irritable bowel syndrome lowers serum C-peptide, insulin, and leptin without any correlation with symptom reduction.","Alterations in gut endocrine cells and hormone levels have been measured in patients with irritable bowel syndrome (IBS). The hypothesis of the present study was that hormone levels would change after 4 weeks of a starch- and sucrose-reduced diet (SSRD) intervention corresponding to decreased carbohydrate intake and symptoms. Among 105 IBS patients from primary and tertiary healthcare, 80 were randomized to SSRD, while 25 followed their ordinary diet. Food diaries, Rome IV, and IBS-symptom severity score (IBS-SSS) questionnaires were completed, and blood samples were collected at baseline and after the intervention. Serum C-peptide, gastric inhibitory peptide, glucagon, glucagon-like peptide-1, insulin, leptin, luteinizing hormone, polypeptide YY, and glucose were measured, along with the prevalence of autoantibodies against gonadotropin-releasing hormone; its precursor, progonadoliberin-2, and receptor; and tenascin C. Carbohydrate intake was lower in the intervention group than in controls at week 4 (median: 88 [66-128] g vs 182 [89-224] g; P < .001). The change in carbohydrate intake, adjusted for weight, was associated with a decrease in C-peptide (β: 14.43; 95% confidence interval [CI]: 4.12-24.75) and insulin (β: 0.18; 95% CI: 0.04-0.32) levels. Glucose levels remained unchanged. The IBS-SSS scores were lower in the intervention group but not in controls (P < .001), without any association with changes in hormone concentrations. There was no difference in autoantibody prevalence between patients and healthy controls. In conclusion, the hypothesis that reduced carbohydrate intake corresponded to altered hormonal levels in IBS was accepted; however, there was no relationship between hormonal concentrations and symptoms.",2021,"The IBS-SSS scores were lower in the intervention group but not in controls (P < .001), without any association with changes in hormone concentrations.","['patients with irritable bowel syndrome (IBS', '105 IBS patients from primary and tertiary healthcare, 80 were randomized to', 'patients with irritable bowel syndrome']","['carbohydrate-restricted diet', 'starch- and sucrose-reduced diet (SSRD) intervention', 'SSRD']","['Glucose levels', 'autoantibody prevalence', 'IBS-SSS scores', 'carbohydrate intake', 'carbohydrate intake and symptoms', 'change in carbohydrate intake', 'Serum C-peptide, gastric inhibitory peptide, glucagon, glucagon-like peptide-1, insulin, leptin, luteinizing hormone, polypeptide YY, and glucose', 'Food diaries, Rome IV, and IBS-symptom severity score (IBS-SSS) questionnaires', 'tenascin C. Carbohydrate intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1305923', 'cui_str': 'Polypeptide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0068613', 'cui_str': 'neuronectin'}]",105.0,0.0493291,"The IBS-SSS scores were lower in the intervention group but not in controls (P < .001), without any association with changes in hormone concentrations.","[{'ForeName': 'Khadija', 'Initials': 'K', 'LastName': 'Saidi', 'Affiliation': 'Lund University, Skåne University Hospital Malmö, Department of Internal Medicine, Malmö, Sweden. Electronic address: kh7102sa-s@student.lu.se.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Nilholm', 'Affiliation': 'Lund University, Skåne University Hospital Malmö, Department of Internal Medicine, Malmö, Sweden. Electronic address: clara.nilholm@med.lu.se.'}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': 'Lund University, Skåne University Hospital Malmö, Department of Internal Medicine, Malmö, Sweden. Electronic address: bodil.roth@med.lu.se.'}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Ohlsson', 'Affiliation': 'Lund University, Skåne University Hospital Malmö, Department of Internal Medicine, Malmö, Sweden. Electronic address: bodil.ohlsson@med.lu.se.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.12.001']
987,33350762,Effectiveness of dose-escalated topiramate monotherapy and add-on therapy in neurosurgery-related epilepsy: A prospective study.,"BACKGROUND


Lesional and symptomatic causes of epilepsy are the most common neurological disorders of the brain. Topiramate effectively controls newly diagnosed epilepsy and refractory focal seizures, but high-dose topiramate does not improve seizure control. This study aimed to evaluate the clinical efficacy and safety of dose-escalated topiramate as first-line monotherapy and add-on therapy in patients with neurosurgery-related epilepsy.
MATERIAL AND METHODS


A total of 55 neurosurgical patients with epilepsy were divided into monotherapy and add-on therapy groups and both groups received topiramate via the dose-escalation method. The primary efficacy outcomes were seizure-free rate and seizure response rate. Adverse events and seizure frequency were recorded.
RESULTS


The seizure response rate in the first month of monotherapy was significantly better than that of add-on therapy (89% vs 65%, P < .05), but no significant differences were found in seizure response rates between the 2 groups after 2 months of treatment. Both monotherapy and add-on therapy were effective in controlling seizures, with mean seizure frequency of 0.725 vs 0.536 and seizure-free rate of 88% vs 78.6%. Both treatments showed good improvement of seizure frequency in patients without tumor. The efficacy of monotherapy was better than that of add-on therapy (80% vs 29.2%) in patients with body mass index (BMI) ≤24. However, add-on therapy was better than monotherapy (76.7% vs 21.4%) in patients with BMI > 24. Dizziness (25.5%) and headache (16.4%) were the most common adverse events. No severe adverse event such as cognitive impairment was observed.
CONCLUSIONS


Dose-escalated topiramate monotherapy and add-on therapy demonstrate good efficacy and safety, with fewer adverse events in seizure control in neurosurgical patients.",2020,Dizziness (25.5%) and headache (16.4%) were the most common adverse events.,"['neurosurgical patients', 'neurosurgery-related epilepsy', 'patients with neurosurgery-related epilepsy', '55 neurosurgical patients with epilepsy']","['dose-escalated topiramate monotherapy', 'topiramate', 'Topiramate', 'monotherapy']","['seizure response rate', 'Adverse events and seizure frequency', 'seizure control', 'clinical efficacy and safety', 'seizure-free rate and seizure response rate', 'seizure frequency', 'Dizziness', 'seizure response rates', 'headache', 'severe adverse event such as cognitive impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",55.0,0.077837,Dizziness (25.5%) and headache (16.4%) were the most common adverse events.,"[{'ForeName': 'Yu-Tse', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Linkou Branch and school of medicine.'}, {'ForeName': 'Guo-Tai', 'Initials': 'GT', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Chiayi Branch and school of medicine, Chang Gung University, Taiwan.'}, {'ForeName': 'Yin-Cheng', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Linkou Branch and school of medicine.'}, {'ForeName': 'Jih-Tsun', 'Initials': 'JT', 'LastName': 'Ho', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Kaohsiung Branch and school of medicine.'}, {'ForeName': 'Cheng-Chi', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Linkou Branch and school of medicine.'}, {'ForeName': 'Cheng-Chia', 'Initials': 'CC', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Chiayi Branch and school of medicine, Chang Gung University, Taiwan.'}, {'ForeName': 'Chen-Nen', 'Initials': 'CN', 'LastName': 'Chang', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Chiayi Branch and school of medicine, Chang Gung University, Taiwan.'}]",Medicine,['10.1097/MD.0000000000023771']
988,33422263,"Continuation versus discontinuation of renin-angiotensin system inhibitors in patients admitted to hospital with COVID-19: a prospective, randomised, open-label trial.","BACKGROUND


Biological considerations suggest that renin-angiotensin system inhibitors might influence the severity of COVID-19. We aimed to evaluate whether continuing versus discontinuing renin-angiotensin system inhibitors (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) affects outcomes in patients admitted to hospital with COVID-19.
METHODS


The REPLACE COVID trial was a prospective, randomised, open-label trial done at 20 large referral hospitals in seven countries worldwide. Eligible participants were aged 18 years and older who were admitted to hospital with COVID-19 and were receiving a renin-angiotensin system inhibitor before admission. Individuals with contraindications to continuation or discontinuation of renin-angiotensin system inhibitor therapy were excluded. Participants were randomly assigned (1:1) to continuation or discontinuation of their renin-angiotensin system inhibitor using permuted block randomisation, with allocation concealed using a secure web-based randomisation system. The primary outcome was a global rank score in which participants were ranked across four hierarchical tiers incorporating time to death, duration of mechanical ventilation, time on renal replacement or vasopressor therapy, and multiorgan dysfunction during the hospitalisation. Primary analyses were done in the intention-to-treat population. The REPLACE COVID trial is registered with ClinicalTrials.gov, NCT04338009.
FINDINGS


Between March 31 and Aug 20, 2020, 152 participants were enrolled and randomly assigned to either continue or discontinue renin-angiotensin system inhibitor therapy (continuation group n=75; discontinuation group n=77). Mean age of participants was 62 years (SD 12), 68 (45%) were female, mean body-mass index was 33 kg/m 2  (SD 8), and 79 (52%) had diabetes. Compared with discontinuation of renin-angiotensin system inhibitors, continuation had no effect on the global rank score (median rank 73 [IQR 40-110] for continuation vs 81 [38-117] for discontinuation; β-coefficient 8 [95% CI -13 to 29]). There were 16 (21%) of 75 participants in the continuation arm versus 14 (18%) of 77 in the discontinuation arm who required intensive care unit admission or invasive mechanical ventilation, and 11 (15%) of 75 participants in the continuation group versus ten (13%) of 77 in the discontinuation group died. 29 (39%) participants in the continuation group and 28 (36%) participants in the discontinuation group had at least one adverse event (χ 2  test of adverse events between treatment groups p=0·77). There was no difference in blood pressure, serum potassium, or creatinine during follow-up across the two groups.
INTERPRETATION


Consistent with international society recommendations, renin-angiotensin system inhibitors can be safely continued in patients admitted to hospital with COVID-19.
FUNDING


REPLACE COVID Investigators, REPLACE COVID Trial Social Fundraising Campaign, and FastGrants.",2021,"Compared with discontinuation of renin-angiotensin system inhibitors, continuation had no effect on the global rank score (median rank 73 [IQR 40-110] for continuation vs 81","['Between March 31 and Aug 20, 2020', 'Mean age of participants was 62 years (SD 12), 68 (45%) were female, mean body-mass index was 33 kg/m 2', '20 large referral hospitals in seven countries worldwide', 'Eligible participants were aged 18 years and older who were admitted to hospital with COVID-19 and were receiving a renin-angiotensin system inhibitor before admission', 'Individuals with contraindications to continuation or discontinuation of renin-angiotensin system inhibitor therapy were excluded', 'patients admitted to hospital with COVID-19', '152 participants']","['continuation or discontinuation of their renin-angiotensin system inhibitor using permuted block randomisation, with allocation concealed using a secure web-based randomisation system', 'continue or discontinue renin-angiotensin system inhibitor therapy ', 'discontinuing renin-angiotensin system inhibitors (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers', 'renin-angiotensin system inhibitors']","['blood pressure, serum potassium, or creatinine', 'time to death, duration of mechanical ventilation, time on renal replacement or vasopressor therapy, and multiorgan dysfunction during the hospitalisation', 'intensive care unit admission or invasive mechanical ventilation', 'global rank score']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",152.0,0.158106,"Compared with discontinuation of renin-angiotensin system inhibitors, continuation had no effect on the global rank score (median rank 73 [IQR 40-110] for continuation vs 81","[{'ForeName': 'Jordana B', 'Initials': 'JB', 'LastName': 'Cohen', 'Affiliation': 'Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Hanff', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'William', 'Affiliation': 'Division of Cardiology, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sweitzer', 'Affiliation': 'Division of Cardiology, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Nelson R', 'Initials': 'NR', 'LastName': 'Rosado-Santander', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, Arequipa, Peru.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Medina', 'Affiliation': 'Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, Lima, Peru.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Rodriguez-Mori', 'Affiliation': 'Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, Lima, Peru.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Renna', 'Affiliation': 'Hypertension Unit, Department of Pathology, Hospital Español de Mendoza, National University of Cuyo, IMBECU-CONICET, Mendoza, Argentina.'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Corrales-Medina', 'Affiliation': 'Division of Infectious Diseases, University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Jaime F', 'Initials': 'JF', 'LastName': 'Andrade-Villanueva', 'Affiliation': 'Unidad de VIH, Hospital Civil de Guadalajara and Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Barbagelata', 'Affiliation': 'Universidad Católica de Buenos Aires, Buenos Aires, Argentina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cristodulo-Cortez', 'Affiliation': 'Departamento de Medicina Interna, Hospital Obrero number 3 Caja Nacional de Salud, Santa Cruz de la Sierra, Bolivia.'}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'Díaz-Cucho', 'Affiliation': 'Departamento de Medicina, Hospital Alberto Barton Thompson, Callao, Peru.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Spaak', 'Affiliation': 'Department of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Alfonso', 'Affiliation': 'Division of Cardiology, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Valdivia-Vega', 'Affiliation': 'Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, Lima, Peru.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Villavicencio-Carranza', 'Affiliation': 'Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, Lima, Peru.'}, {'ForeName': 'Ricardo J', 'Initials': 'RJ', 'LastName': 'Ayala-García', 'Affiliation': 'Departamento de Emergencia, Hospital Nacional Edgardo Rebagliati Martins, Lima, Peru.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Castro-Callirgos', 'Affiliation': 'Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, Lima, Peru.'}, {'ForeName': 'Luz A', 'Initials': 'LA', 'LastName': 'González-Hernández', 'Affiliation': 'Unidad de VIH, Hospital Civil de Guadalajara and Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Eduardo F', 'Initials': 'EF', 'LastName': 'Bernales-Salas', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, Arequipa, Peru.'}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Coacalla-Guerra', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, Arequipa, Peru.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Salinas-Herrera', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, Arequipa, Peru.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Nicolosi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Hospital Español, Buenos Aires, Argentina.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Basconcel', 'Affiliation': 'Division of Cardiology, Department of Medicine, Hospital Español, Buenos Aires, Argentina.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Byrd', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Sharkoski', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Bendezú-Huasasquiche', 'Affiliation': 'Departamento de Medicina, Hospital Alberto Barton Thompson, Callao, Peru.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edmonston', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Vasquez', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Surgery, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: julio.chirinos@uphs.upenn.edu.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30558-0']
989,33442924,"Right unilateral versus bilateral formula-based electroconvulsive therapy in the treatment of major depression in elderly patients: a randomised, open label, pilot controlled trial.","BACKGROUND


Electroconvulsive therapy (ECT) remains the most effective treatment of depression in the elderly population; however, it is still unclear which type of ECT is most beneficial in this population. The aims of this study were: (i) to assess the feasibility of a randomised controlled trial in elderly depressed patients treated with right unilateral (RUL) or fronto-temporal bilateral (BT) formula-based ECT; (ii) to compare formula-based RUL and BT ECT in terms of efficacy, safety and tolerability in this population.
METHODS


The study lasted 3 years and managed to randomise 29 patients over 65 years old to receive either BT (n = 14) or RUL (n = 15) ECT. Brief pulse width (0.5 ms) and age-based dosing method were applied. The clinical efficacy was assessed using Hamilton Depression Rating Scale, somatic state was monitored throughout the ECT course. In neuropsychological examination general cognitive performance, executive functions, verbal fluency, memory, autobiographical memory were evaluated.
RESULTS


The recruitment was poor due to small number of patients able to give informed consent. ECT proved to be a highly effective and safe method of treatment among elders. Formula-based RUL ECT did not differ from BT in antidepressant efficacy and had cognitive advantages - the indices of general cognitive performance, verbal fluency and memory were significantly better than before the treatment in the RUL group. Decline in retrieval consistency of autobiographical memory was more pronounced in the BT group, although it was observed across both groups.
CONCLUSIONS


Formula-based RUL ECT might not differ from BT in antidepressant efficacy and has an advantage in terms of tolerability.",2021,"Formula-based RUL ECT did not differ from BT in antidepressant efficacy and had cognitive advantages - the indices of general cognitive performance, verbal fluency and memory were significantly better than before the treatment in the RUL group.","['elderly depressed patients treated with', '29 patients over 65\u2009years old to receive either', 'major depression in elderly patients']","['right unilateral (RUL) or fronto-temporal bilateral (BT) formula-based ECT; (ii) to compare formula-based RUL and BT ECT', 'ECT', 'Formula-based RUL ECT', 'Electroconvulsive therapy (ECT', 'RUL (n =\u200915) ECT', 'Right unilateral versus bilateral formula-based electroconvulsive therapy', 'BT']","['retrieval consistency of autobiographical memory', 'Hamilton Depression Rating Scale, somatic state', 'efficacy, safety and tolerability', 'tolerability', 'general cognitive performance, verbal fluency and memory', 'neuropsychological examination general cognitive performance, executive functions, verbal fluency, memory, autobiographical memory']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0562343', 'cui_str': 'Bilateral electroconvulsive therapy'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.036837,"Formula-based RUL ECT did not differ from BT in antidepressant efficacy and had cognitive advantages - the indices of general cognitive performance, verbal fluency and memory were significantly better than before the treatment in the RUL group.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Dominiak', 'Affiliation': 'Department of Pharmacology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Zuzanna', 'Initials': 'Z', 'LastName': 'Goetz', 'Affiliation': 'Department of Affective Disorders, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Anna Z', 'Initials': 'AZ', 'LastName': 'Antosik-Wojcinska', 'Affiliation': 'Department of Psychiatry, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Swiecicki', 'Affiliation': 'Department of Affective Disorders, Institute of Psychiatry and Neurology, Warsaw, Poland.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12652']
990,33453450,Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis.,"BACKGROUND


Dupilumab has demonstrated efficacy with acceptable safety in clinical trials in patients with moderate to severe atopic dermatitis (AD).
OBJECTIVE


To assess dupilumab's impact on asthma and sinonasal conditions in adult patients with moderate to severe AD in four randomized, double-blinded, placebo-controlled trials.
METHODS


In LIBERTY AD SOLO 1 (NCT02277743), SOLO 2 (NCT02755649), CHRONOS (NCT02260986), and CAFÉ (NCT02755649), patients received placebo, dupilumab 300 mg every 2 weeks (q2w), or dupilumab 300 mg weekly (qw). In CHRONOS and CAFÉ, patients received concomitant topical corticosteroids. This post hoc analysis assessed Asthma Control Questionnaire-5 (ACQ-5) scores in patients with asthma, Sino-Nasal Outcome Test-22 (SNOT-22) scores in patients with sinonasal conditions, and AD signs and symptoms in all patients.
RESULTS


Of the 2444 patients, 463 had asthma with baseline ACQ-5 ≥ 0.5 (19%); 1171 had sinonasal conditions (48%); and 311 had both (13%). At week 16, ACQ-5 scores (least squares mean change from baseline [standard error]) improved by 0.27 (0.07), 0.59 (0.08), and 0.56 (0.07) in placebo-, q2w-, and qw-treated patients with asthma, respectively, whereas SNOT-22 scores improved by 5.1 (0.8), 9.9 (0.9), and 10.8 (0.8) in patients with sinonasal conditions (P < .01 for all dupilumab vs placebo). Improvements in ACQ-5 and SNOT-22 were also seen in patients with both conditions. Dupilumab also significantly improved AD signs and symptoms among all subgroups.
CONCLUSIONS


In this first analysis of patients with comorbid moderate to severe AD, asthma, and/or chronic sinonasal conditions, dupilumab improved all three diseases in a clinically meaningful and statistically significant manner (vs placebo), based on validated outcome measures.",2021,Improvements in ACQ-5 and SNOT-22 were also seen in patients with both conditions.,"['Of the 2,444 patients, 463 (19%) had asthma with baseline ACQ-5 ≥ 0.5; 1,171 (48%) had sinonasal conditions; and 311 (13%) had both', 'Adults with Moderate-to-Severe Atopic Dermatitis', 'patients with moderate-to-severe atopic dermatitis (AD', 'adult patients with moderate-to-severe AD']","['placebo, dupilumab', 'Dupilumab', 'concomitant topical corticosteroids', 'placebo']","['AD signs and symptoms', 'Asthma Control Questionnaire-5 (ACQ-5) scores', 'ACQ-5 and SNOT-22', 'SNOT-22 scores', 'ACQ-5 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}]",2444.0,0.197664,Improvements in ACQ-5 and SNOT-22 were also seen in patients with both conditions.,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boguniewicz', 'Affiliation': 'National Jewish Health, Denver, Colo; University of Colorado School of Medicine, Denver, Colo. Electronic address: boguniewiczm@njhealth.org.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates, Calif.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai Medical Center, New York, NY; Laboratory for Investigative Dermatology, Rockefeller University, New York, NY.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, Ore.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Allergy Center Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, Calif.'}, {'ForeName': 'Weily', 'Initials': 'W', 'LastName': 'Soong', 'Affiliation': 'Alabama Allergy and Asthma Center, Birmingham, Ala.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lio', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Ill.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme, Cambridge, Mass.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, Mass.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Leda P', 'Initials': 'LP', 'LastName': 'Mannent', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.12.059']
991,33453418,GLP-1 and hunger modulate incentive motivation depending on insulin sensitivity in humans.,"OBJECTIVE


To regulate food intake, our brain constantly integrates external cues, such as the incentive value of a potential food reward, with internal state signals, such as hunger feelings. Incentive motivation refers to the processes that translate an expected reward into the effort spent to obtain the reward; the magnitude and probability of a reward involved in prompting motivated behaviour are encoded by the dopaminergic (DA) midbrain and its mesoaccumbens DA projections. This type of reward circuity is particularly sensitive to the metabolic state signalled by peripheral mediators, such as insulin or glucagon-like peptide 1 (GLP-1). While in rodents the modulatory effect of metabolic state signals on motivated behaviour is well documented, evidence of state-dependent modulation and the role of incentive motivation underlying overeating in humans is lacking.
METHODS


In a randomised, placebo-controlled, crossover design, 21 lean (body mass index [BMI] < 25 kg/m 2 ) and 16 obese (BMI³ 30 kg/m 2 ) volunteer participants received either liraglutide as a GLP-1 analogue or placebo on two separate testing days. Incentive motivation was measured using a behavioural task in which participants were required to exert physical effort using a handgrip to win different amounts of food and monetary rewards. Hunger levels were measured using visual analogue scales; insulin, glucose, and systemic insulin resistance as assessed by the homeostasis model assessment of insulin resistance (HOMA-IR) were quantified at baseline.
RESULTS


In this report, we demonstrate that incentive motivation increases with hunger in lean humans (F (1,42)  = 5.31, p = 0.026, β = 0.19) independently of incentive type (food and non-food reward). This effect of hunger is not evident in obese humans (F (1,62)  = 1.93, p = 0.17, β = -0.12). Motivational drive related to hunger is affected by peripheral insulin sensitivity (two-way interaction, F (1, 35)  = 6.23, p = 0.017, β = -0.281). In humans with higher insulin sensitivity, hunger increases motivation, while poorer insulin sensitivity dampens the motivational effect of hunger. The GLP-1 analogue application blunts the interaction effect of hunger on motivation depending on insulin sensitivity (three-way interaction, F (1, 127)  = 5.11, p = 0.026); no difference in motivated behaviour could be found between humans with normal or impaired insulin sensitivity under GLP-1 administration.
CONCLUSION


We report a differential effect of hunger on motivation depending on insulin sensitivity. We further revealed the modulatory role of GLP-1 in adaptive, motivated behaviour in humans and its interaction with peripheral insulin sensitivity and hunger. Our results suggest that GLP-1 might restore dysregulated processes of midbrain DA function and hence motivational behaviour in insulin-resistant humans.",2021,"Hunger levels were measured using visual analogue scales; insulin, glucose and systemic insulin resistance as assessed by the homeostasis model assessment of insulin resistance (HOMA-IR) were quantified at baseline.
","['21 lean (body mass index, BMI, < 25 kg/m 2 ) and 16 obese (BMI ≥ 30 kg/m 2 ) volunteer participants received either', 'humans']","['liraglutide as GLP-1 analogue or placebo', 'placebo']","['Hunger levels', 'incentive motivation increases with hunger in lean humans', 'peripheral insulin sensitivity', 'visual analogue scales; insulin, glucose and systemic insulin resistance as assessed by the homeostasis model assessment of insulin resistance (HOMA-IR', 'Incentive motivation', 'midbrain DA function and hence motivational behaviour', 'insulin sensitivity']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0025462', 'cui_str': 'Midbrain structure'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.118576,"Hunger levels were measured using visual analogue scales; insulin, glucose and systemic insulin resistance as assessed by the homeostasis model assessment of insulin resistance (HOMA-IR) were quantified at baseline.
","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Hanssen', 'Affiliation': 'Max Planck Institute for Metabolism Research, Gleueler Str. 50, 50931, Cologne, Germany; Policlinic for Endocrinology, Diabetes and Preventive Medicine (PEPD), University Hospital Cologne, Kerpener Str. 62, 50937 Cologne, Germany. Electronic address: ruth.hanssen@sf.mpg.de.'}, {'ForeName': 'Alina Chloé', 'Initials': 'AC', 'LastName': 'Kretschmer', 'Affiliation': 'Max Planck Institute for Metabolism Research, Gleueler Str. 50, 50931, Cologne, Germany; Policlinic for Endocrinology, Diabetes and Preventive Medicine (PEPD), University Hospital Cologne, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Rigoux', 'Affiliation': 'Max Planck Institute for Metabolism Research, Gleueler Str. 50, 50931, Cologne, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Albus', 'Affiliation': 'Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Joseph-Stelzmann-Straße 26, 50931 Cologne, Germany; Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM), University Hospital Cologne, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Sharmili', 'Initials': 'S', 'LastName': 'Edwin Thanarajah', 'Affiliation': 'Max Planck Institute for Metabolism Research, Gleueler Str. 50, 50931, Cologne, Germany; Department of Psychiatry, Psychosomatic Medicine, and Psychotherapy, University Hospital Frankfurt, Heinrich-Hoffmann-Strasse 10, 60528, Frankfurt am Main, Germany.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Sitnikow', 'Affiliation': 'Max Planck Institute for Metabolism Research, Gleueler Str. 50, 50931, Cologne, Germany.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Melzer', 'Affiliation': 'Max Planck Institute for Metabolism Research, Gleueler Str. 50, 50931, Cologne, Germany.'}, {'ForeName': 'Oliver A', 'Initials': 'OA', 'LastName': 'Cornely', 'Affiliation': 'Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Joseph-Stelzmann-Straße 26, 50931 Cologne, Germany; University of Cologne Faculty of Medicine, University Hospital Cologne Chair Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Joseph-Stelzmann-Straße 26, 50931, Cologne, Germany; Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM), University Hospital Cologne, Kerpener Str. 62, 50937 Cologne, Germany; Clinical Trials Centre Cologne (ZKS Köln), University Hospital Cologne, Gleueler Str. 269, 50935 Cologne, Germany.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Brüning', 'Affiliation': 'Max Planck Institute for Metabolism Research, Gleueler Str. 50, 50931, Cologne, Germany; Policlinic for Endocrinology, Diabetes and Preventive Medicine (PEPD), University Hospital Cologne, Kerpener Str. 62, 50937 Cologne, Germany; Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Joseph-Stelzmann-Straße 26, 50931 Cologne, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Tittgemeyer', 'Affiliation': 'Max Planck Institute for Metabolism Research, Gleueler Str. 50, 50931, Cologne, Germany; Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Joseph-Stelzmann-Straße 26, 50931 Cologne, Germany.'}]",Molecular metabolism,['10.1016/j.molmet.2021.101163']
992,33439265,Effect of Bimagrumab vs Placebo on Body Fat Mass Among Adults With Type 2 Diabetes and Obesity: A Phase 2 Randomized Clinical Trial.,"Importance


Antibody blockade of activin type II receptor (ActRII) signaling stimulates skeletal muscle growth. Previous clinical studies suggest that ActRII inhibition with the monoclonal antibody bimagrumab also promotes excess adipose tissue loss and improves insulin resistance.
Objective


To evaluate the efficacy and safety of bimagrumab on body composition and glycemic control in adults with type 2 diabetes and overweight and obesity.
Design, Setting, and Participants


This double-masked, placebo-controlled, 48-week, phase 2 randomized clinical trial was conducted among adults with type 2 diabetes, body mass index between 28 and 40, and glycated hemoglobin (HbA1c) levels between 6.5% and 10.0% at 9 US and UK sites. The trial was conducted from February 2017 to May 2019. Only participants who completed a full treatment regimen were included in analysis.
Interventions


Patients were randomized to intravenous infusion of bimagrumab (10 mg/kg up to 1200 mg in 5% dextrose solution) or placebo (5% dextrose solution) treatment every 4 weeks for 48 weeks; both groups received diet and exercise counseling.
Main Outcomes and Measures


The primary end point was least square mean change from baseline to week 48 in total body fat mass (FM); secondary and exploratory end points were lean mass (LM), waist circumference (WC), HbA1c level, and body weight (BW) changes from baseline to week 48.
Results


A total of 75 patients were randomized to bimagrumab (n = 37; 23 [62.2%] women) or placebo (n = 38; 12 [31.6%] women); 58 (77.3%) completed the 48-week study. Patients at baseline had a mean (SD) age of 60.4 (7.7) years; mean (SD) BMI of 32.9 (3.4); mean (SD) BW of 93.6 (14.9) kg; mean (SD) FM of 35.4 (7.5) kg; and mean (SD) HbA1c level of 7.8% (1.0%). Changes at week 48 for bimagrumab vs placebo were as follows: FM, -20.5% (-7.5 kg [80% CI, -8.3 to -6.6 kg]) vs -0.5% (-0.18 kg [80% CI, -0.99 to 0.63 kg]) (P < .001); LM, 3.6% (1.70 kg [80% CI, 1.1 to 2.3 kg]) vs -0.8% (-0.4 kg [80% CI, -1.0 to 0.1 kg]) (P < .001); WC, -9.0 cm (80% CI, -10.3 to -7.7 cm) vs 0.5 cm (80% CI, -0.8 to 1.7 cm) (P < .001); HbA1c level, -0.76 percentage points (80% CI, -1.05 to -0.48 percentage points) vs -0.04 percentage points (80% CI, -0.23 to 0.31 percentage points) (P = .005); and BW, -6.5% (-5.9 kg [80% CI, -7.1 to -4.7 kg]) vs -0.8% (-0.8 kg [80% CI, -1.9 to 0.3 kg]) (P < .001). Bimagrumab's safety and tolerability profile was consistent with prior studies.
Conclusions and Relevance


In this phase 2 randomized clinical trial, ActRII blockade with bimagrumab led to significant loss of FM, gain in LM, and metabolic improvements during 48 weeks in patients with overweight or obesity who had type 2 diabetes. ActRII pathway inhibition may provide a novel approach for the pharmacologic management of excess adiposity and accompanying metabolic disturbances.
Trial Registration


ClinicalTrials.gov number: NCT03005288.",2021,"HbA1c level, -0.76 percentage points (80% CI, -1.05 to -0.48 percentage points) vs -0.04 percentage points (80% CI, -0.23 to 0.31 percentage points) (P = .005); and BW, -6.5% (-5.9 kg [80% CI, -7.1 to -4.7 kg]) vs -0.8% (-0.8 kg [80% CI, -1.9 to 0.3 kg])","['Patients at baseline had a mean (SD) age of 60.4 (7.7) years; mean (SD) BMI of 32.9 (3.4); mean (SD) BW of 93.6 (14.9) kg; mean', 'A total of 75 patients were randomized to bimagrumab (n\u2009=\u200937; 23 [62.2%] women) or', 'Adults With Type 2 Diabetes and Obesity', 'February 2017 to May 2019', 'adults with type 2 diabetes, body mass index between 28 and 40, and glycated hemoglobin (HbA1c) levels between 6.5% and 10.0% at 9 US and UK sites', 'patients with overweight or obesity who had type 2 diabetes', 'adults with type 2 diabetes and overweight and obesity', 'n\u2009=\u200938; 12 [31.6%] women); 58 (77.3%) completed the 48-week study']","['intravenous infusion of bimagrumab (10 mg/kg up to 1200 mg in 5% dextrose solution) or placebo', 'placebo', 'diet and exercise counseling', 'Bimagrumab vs Placebo', 'bimagrumab', 'activin type II receptor (ActRII']","['Body Fat Mass', ""Bimagrumab's safety and tolerability profile"", 'least square mean change', 'adipose tissue loss and improves insulin resistance', 'total body fat mass (FM); secondary and exploratory end points were lean mass (LM), waist circumference (WC), HbA1c level, and body weight (BW) changes', 'body composition and glycemic control', 'efficacy and safety', 'FM, gain in LM, and metabolic improvements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0985452', 'cui_str': 'Glucose 50 MG/ML'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0418878', 'cui_str': 'Recommendation to exercise'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",75.0,0.613049,"HbA1c level, -0.76 percentage points (80% CI, -1.05 to -0.48 percentage points) vs -0.04 percentage points (80% CI, -0.23 to 0.31 percentage points) (P = .005); and BW, -6.5% (-5.9 kg [80% CI, -7.1 to -4.7 kg]) vs -0.8% (-0.8 kg [80% CI, -1.9 to 0.3 kg])","[{'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Heymsfield', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Coleman', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Miller', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Rooks', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Laurent', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Petricoul', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Praestgaard', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Swan', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wade', 'Affiliation': 'QPS-Miami Research Associates, Miami, Florida.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Perry', 'Affiliation': 'Panax Clinical Research, Miami, Florida.'}, {'ForeName': 'Bret H', 'Initials': 'BH', 'LastName': 'Goodpaster', 'Affiliation': 'Advent Health Research Institute, Orlando, Florida.'}, {'ForeName': 'Ronenn', 'Initials': 'R', 'LastName': 'Roubenoff', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.33457']
993,33432422,High-security closed devices are efficient and safe to protect human oocytes from potential risk of viral contamination during vitrification and storage especially in the COVID-19 pandemic.,"PURPOSE


The main purpose and research question of the study are to compare the efficacy of high-security closed versus open devices for human oocytes' vitrification.
METHODS


A prospective randomized study was conducted. A total of 737 patients attending the Infertility and IVF Unit at S.Orsola University Hospital (Italy) between October 2015 and April 2020 were randomly assigned to two groups. A total of 368 patients were assigned to group 1 (High-Security Vitrification™ - HSV) and 369 to group 2 (Cryotop® open system). Oocyte survival, fertilization, cleavage, pregnancy, implantation, and miscarriage rate were compared between the two groups.
RESULTS


No statistically significant differences were observed on survival rate (70.3% vs. 73.3%), fertilization rate (70.8% vs. 74.9%), cleavage rate (90.6% vs. 90.3%), pregnancy/transfer ratio (32.0% vs. 31.8%), implantation rate (19.7% vs. 19.9%), nor miscarriage rates (22.1% vs. 21.5%) between the two groups. Women's mean age in group 1 (36.18 ± 3.92) and group 2 (35.88 ± 3.88) was not significantly different (P = .297). A total of 4029 oocytes were vitrified (1980 and 2049 in groups 1 and 2 respectively). A total of 2564 were warmed (1469 and 1095 in groups 1 and 2 respectively). A total of 1386 morphologically eligible oocytes were inseminated by intracytoplasmic sperm injection (792 and 594 respectively, P = .304).
CONCLUSIONS


The present study shows that the replacement of the open vitrification system by a closed one has no impact on in vitro and in vivo survival, development, pregnancy and implantation rate. Furthermore, to ensure safety, especially during the current COVID-19 pandemic, the use of the closed device eliminates the potential samples' contamination during vitrification and storage.",2021,"No statistically significant differences were observed on survival rate (70.3% vs. 73.3%), fertilization rate (70.8% vs. 74.9%), cleavage rate (90.6% vs. 90.3%), pregnancy/transfer ratio (32.0% vs. 31.8%), implantation rate (19.7% vs. 19.9%), nor miscarriage rates (22.1% vs. 21.5%) between the two groups.","['368 patients were assigned to group 1 (High-Security Vitrification™ - HSV) and 369 to group 2', '737 patients attending the Infertility and IVF Unit at S.Orsola University Hospital (Italy) between October 2015 and April 2020']",['high-security closed versus open devices'],"['implantation rate', 'fertilization rate', 'vivo survival, development, pregnancy and implantation rate', 'cleavage rate', 'miscarriage rates', 'survival rate', 'pregnancy/transfer ratio', 'Oocyte survival, fertilization, cleavage, pregnancy, implantation, and miscarriage rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2936610', 'cui_str': 'Glass Transition'}, {'cui': 'C0019348', 'cui_str': 'Herpes simplex'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]",4029.0,0.0697989,"No statistically significant differences were observed on survival rate (70.3% vs. 73.3%), fertilization rate (70.8% vs. 74.9%), cleavage rate (90.6% vs. 90.3%), pregnancy/transfer ratio (32.0% vs. 31.8%), implantation rate (19.7% vs. 19.9%), nor miscarriage rates (22.1% vs. 21.5%) between the two groups.","[{'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Porcu', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy. eleonora.porcu@unibo.it.""}, {'ForeName': 'Maria Lucrezia', 'Initials': 'ML', 'LastName': 'Tranquillo', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Notarangelo', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}, {'ForeName': 'Patrizia Maria', 'Initials': 'PM', 'LastName': 'Ciotti', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}, {'ForeName': 'Nilla', 'Initials': 'N', 'LastName': 'Calza', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Zuffa', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mori', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Nardi', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dirodi', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cipriani', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}, {'ForeName': 'Francesca Sonia', 'Initials': 'FS', 'LastName': 'Labriola', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Damiano', 'Affiliation': ""Infertility and IVF Unit, University of Bologna, Sant'Orsola University Hospital, Bologna, Italy.""}]",Journal of assisted reproduction and genetics,['10.1007/s10815-021-02062-y']
994,33444116,Randomized Phase II Study of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma.,"PURPOSE


Mucosal melanoma (MM) is a highly vascularized tumor with an extremely poor prognosis. In this randomized, open-label, phase II study, we characterized the efficacy and safety of bevacizumab in combination with carboplatin plus paclitaxel (CPB) in patients with previously untreated advanced MM.
PATIENTS AND METHODS


Patients were randomly assigned in a 2:1 ratio to receive carboplatin (area under the curve, 5) plus paclitaxel (175 mg/m 2 ) once every 4 weeks in combination with (CPB arm, 5 mg/kg) or without (CP arm) bevacizumab once every 2 weeks. Progression-free survival (PFS) was the primary end point. Secondary end points included overall survival (OS), objective response rate, and adverse events.
RESULTS


We recruited 114 patients to our study. The median PFS was significantly longer in the CPB arm (4.8 months; 95% CI, 3.6 to 6.0 months) than in the CP arm (3.0 months; 95% CI, 1.7 to 4.3 months) (hazard ratio, 0.461; 95% CI, 0.306 to 0.695;  P  < .001). Objective response rates were 19.7% and 13.2%, respectively ( P  = .384). The median OS was also significantly longer in the CPB arm than in the CP arm (13.6  v  9.0 months; hazard ratio, 0.611; 95% CI, 0.407 to 0.917;  P  = .017). No new safety signals were observed.
CONCLUSION


PFS and OS were significantly better in patients with metastatic MM who received bevacizumab in addition to CPB than in those who received CPB alone. A phase III study should be performed to confirm these benefits (ClinicalTrials.gov identifier: NCT02023710).",2021,"Objective response rates were 19.7% and 13.2%, respectively ( P  = .384).","['patients with previously untreated advanced MM', '114 patients to our study', 'Patients', 'Patients With Previously Untreated Advanced Mucosal Melanoma']","['combination with (CPB arm, 5 mg/kg) or without (CP arm) bevacizumab', 'bevacizumab', 'carboplatin (area under the curve, 5) plus paclitaxel', 'Bevacizumab', 'Carboplatin Plus Paclitaxel', 'carboplatin plus paclitaxel (CPB']","['Progression-free survival (PFS', 'median PFS', 'overall survival (OS), objective response rate, and adverse events', 'efficacy and safety', 'Objective response rates', 'median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.164051,"Objective response rates were 19.7% and 13.2%, respectively ( P  = .384).","[{'ForeName': 'Xieqiao', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Xinan', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Chi', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Bixia', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lian', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Siming', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Cancer Biotherapy, Third Affiliated Hospital of Kunming School of Medicine, Kunming, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital and Institute, Beijing, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00902']
995,33444178,Protocol for the REPAT study: role of emotional processing in art therapy for breast cancer palliative care patients.,"INTRODUCTION


Patients with breast cancer (BC) cope with depression which is linked to functional limitations in survivorship and to physical symptoms. Pain and fatigue are prominent symptoms that affect the well-being of cancer survivors. Emotional processing has been associated with improved physical and psychological health in survivors. Art therapy is a form of psychotherapy that involves the use of visual art-making for expression and communication. It encourages emotional processing and has been linked to symptom reduction in patients with cancer. This protocol is designed to examine two mechanistic changes: emotional processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (heart rate variability and cytokine expression) through which an art therapy intervention may reduce depression, pain and fatigue. In addition, we will examine ethnocultural differences in the effect of art therapy in women from different ethnocultural backgrounds.
METHODS AND ANALYSIS


A randomised controlled study with careful controls will randomise 240 patient with BC (50% Jewish and 50% Arab) to an 8-week group art therapy intervention or an 8-week Mandala colouring comparison group. This design will test the mechanisms of art therapy on the targeted outcomes beyond the effects of time with a group, focus on a task and engagement with art materials. We will examine two potential mechanisms: emotional processing and cholinergic anti-inflammatory processes; of the intervention effects on depression, pain and fatigue and compare these effects in Arab versus Jewish women.
ETHICS AND DISSEMINATION


Participants will sign informed consent before participation and will be informed that they can leave the study at any point in time without effect on their medical treatment. The Helsinki committees of each participating hospital have approved the study. Data collected in this study will be published in peer-review journals, and we will use the platform of the study website (http://repat.haifa.ac.il/en/) for further dissemination to the general public.
TRIAL REGISTRATION NUMBER


The study is registered in ClinicalTrials.gov: NCT03377816; Pre-results.",2020,Emotional processing has been associated with improved physical and psychological health in survivors.,"['breast cancer palliative care patients', 'Patients with breast cancer (BC', 'patients with cancer', 'women from different ethnocultural backgrounds', 'careful controls will randomise 240 patient with BC (50% Jewish and 50% Arab) to an', 'Arab versus Jewish women']","['emotional processing', '8-week group art therapy intervention or an 8-week Mandala colouring comparison group']","['Pain and fatigue', 'depression, pain and fatigue']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0022422', 'cui_str': 'Judaism'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003827', 'cui_str': 'Art therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009393', 'cui_str': 'Color'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.129141,Emotional processing has been associated with improved physical and psychological health in survivors.,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Czamanski-Cohen', 'Affiliation': 'School of Creative Arts Therapies, University of Haifa, Haifa, Israel joczamanski@gmail.com.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Wiley', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Weihs', 'Affiliation': 'The Department of Psychiatry College of Medicine, University of Arizona, Tucson, Arizona, USA.'}]",BMJ open,['10.1136/bmjopen-2020-037521']
996,33464318,Cost-effectiveness of Pembrolizumab as a Second-Line Therapy for Hepatocellular Carcinoma.,"Importance


Immune checkpoint inhibitors have been approved for use as a second-line therapy for hepatocellular carcinoma (HCC) in patients who previously received sorafenib. Pembrolizumab has shown substantial antitumor activity and a favorable toxicity profile as a second-line treatment of HCC. However, considering the high cost of pembrolizumab, there is a need to assess its value by considering both the clinical efficacy and cost.
Objective


To evaluate the cost-effectiveness of pembrolizumab vs placebo as second-line therapy in patients with HCC from the US payer perspective.
Design, Setting, and Participants


A Markov model was developed to compare the lifetime cost and efficacy of pembrolizumab as a second-line treatment of HCC with those of placebo using outcome data from the KEYNOTE-240 randomized placebo-controlled trial, which included 413 patients with advanced HCC previously treated with sorafenib and randomized patients to receive pembrolizumab plus best supportive care or placebo plus best supportive care in a 2:1 ratio.
Main Outcomes and Measures


Life-years, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER) were estimated at a willingness-to-pay threshold of $150 000 per QALY. One-way and probabilistic sensitivity analyses were performed to account for the parameter of uncertainty. A cost-threshold analysis was also performed. The study was conducted from January 31 to July 29, 2020.
Results


The base-case model found that treatment with pembrolizumab was associated with increased overall cost by $47 057 and improved effectiveness by 0.138 QALYs compared with placebo, leading to an ICER of $340 409 per QALY. The model was most sensitive to the hazard ratio of overall survival (range, 0.61-1.00), health utility of placebo (range, 0.59-0.93), price of pembrolizumab (range, $5531-$8297), and price of postprogression therapies (range, $5596-$7944 for pembrolizumab and $4770-$7156 for placebo). The ICER of pembrolizumab was larger than $150 000 per QALY in most of the sensitivity and subgroup analyses. The price of pembrolizumab needed to be reduced by 57.7% to $2925 per cycle to achieve cost-effectiveness.
Conclusions and Relevance


The findings of this cost-effectiveness analysis suggest that, at its current price, pembrolizumab is not a cost-effective second-line therapy for HCC in the US, with a willingness-to-pay threshold of $150 000 per QALY.",2021,"The model was most sensitive to the hazard ratio of overall survival (range, 0.61-1.00), health utility of placebo (range, 0.59-0.93), price of pembrolizumab (range, $5531-$8297), and price of postprogression therapies (range, $5596-$7944 for pembrolizumab and $4770-$7156 for placebo).","['413 patients with advanced HCC previously treated with', 'January 31 to July 29, 2020', 'hepatocellular carcinoma (HCC) in patients who previously received', 'Hepatocellular Carcinoma', 'patients with HCC from the US payer perspective']","['Pembrolizumab', 'placebo', 'pembrolizumab vs placebo', 'pembrolizumab plus best supportive care or placebo', 'pembrolizumab', 'sorafenib']","['cost-effectiveness', 'price of pembrolizumab (range, $5531-$8297), and price of postprogression therapies', 'overall cost', 'hazard ratio of overall survival', 'ICER of pembrolizumab', 'Measures\n\n\nLife-years, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER', 'health utility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0098700', 'cui_str': '5531'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",413.0,0.136497,"The model was most sensitive to the hazard ratio of overall survival (range, 0.61-1.00), health utility of placebo (range, 0.59-0.93), price of pembrolizumab (range, $5531-$8297), and price of postprogression therapies (range, $5596-$7944 for pembrolizumab and $4770-$7156 for placebo).","[{'ForeName': 'Chi-Leung', 'Initials': 'CL', 'LastName': 'Chiang', 'Affiliation': 'Department of Clinical Oncology, University of Hong Kong, Hong Kong (SAR), China.'}, {'ForeName': 'Sik-Kwan', 'Initials': 'SK', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, University of Hong Kong, Hong Kong (SAR), China.'}, {'ForeName': 'Shing-Fung', 'Initials': 'SF', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong (SAR), China.'}, {'ForeName': 'Irene Oi-Ling', 'Initials': 'IO', 'LastName': 'Wong', 'Affiliation': 'School of Public Health, University of Hong Kong, Hong Kong (SAR), China.'}, {'ForeName': 'Horace Cheuk-Wai', 'Initials': 'HC', 'LastName': 'Choi', 'Affiliation': 'Department of Clinical Oncology, University of Hong Kong, Hong Kong (SAR), China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.33761']
997,33471039,Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial.,"BACKGROUND


Weight loss is critical for preventing and managing obesity-related diseases. There is a notable lack of valid and reliable means to manage patients with overweight/obesity and knee osteoarthritis (KOA).
OBJECTIVE


To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA.
METHODS


The trial was designed as a randomized controlled trial including patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2).Patients underwent a pre-random assignment diet intervention (week -8 to 0). At week 0, patients having lost >5% of their body weight were randomly assigned to liraglutide 3 mg/d or placebo for 52 wk. The coprimary outcomes were changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale from week 0 to 52.
RESULTS


In total, 168 patients enrolled and 156 were randomly assigned to receive liraglutide or placebo. Patients experienced a significant reduction in body weight and KOOS pain during the pre-random assignment dietary intervention period (week -8 to 0). From week 0 to 52 there was a significant difference in body weight between the liraglutide and placebo group (mean changes: -2.8 and +1.2 kg, respectively; group difference, 3.9 kg; 95% CI: -6.9, -1.0; P = 0.008). There was, however, no group difference in KOOS pain (mean changes: 0.4 and -0.6 points, respectively; group difference, 0.9 points; 95% CI: -3.9, 5.7; P = 0.71). Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively.
CONCLUSIONS


In patients with KOA and overweight/obesity liraglutide added after an 8-wk pre-random assignment diet induced a significant weight loss at >52 wk but did not reduce knee pain compared to placebo. This trial was registered at clinicaltrials.gov as NCT02905864.",2021,"Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively.
","['168 patients enrolled and 156', 'patients having lost >5% of their body weight', 'patients with KOA and overweight/obesity', 'patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2).Patients underwent a', 'knee osteoarthritis', 'patients with overweight/obesity and knee osteoarthritis (KOA', 'patients with overweight/obesity and KOA']","['liraglutide 3 mg/d or placebo', 'liraglutide', 'placebo', 'liraglutide and placebo', 'liraglutide or placebo', 'Liraglutide', 'pre-random assignment diet intervention']","['weight loss', 'KOOS pain', 'body weight', 'body weight and KOOS pain', 'efficacy and safety', 'changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale', 'knee pain']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]",168.0,0.207837,"Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively.
","[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Gudbergsen', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Overgaard', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Henriksen', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Eva Ejlersen', 'Initials': 'EE', 'LastName': 'Wæhrens', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bliddal', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Sabrina Mai', 'Initials': 'SM', 'LastName': 'Nielsen', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Boesen', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Filip Krag', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'NNF Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marianne Uggen', 'Initials': 'MU', 'LastName': 'Rasmussen', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Bartholdy', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Cecilie Laubjerg', 'Initials': 'CL', 'LastName': 'Daugaard', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ellegaard', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Berit Lilienthal', 'Initials': 'BL', 'LastName': 'Heitmann', 'Affiliation': 'Research Unit for Dietary Studies at The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Else Marie', 'Initials': 'EM', 'LastName': 'Bartels', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Danneskiold-Samsøe', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Lars Erik', 'Initials': 'LE', 'LastName': 'Kristensen', 'Affiliation': 'The Parker Institute, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Frederiksberg, Denmark.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa328']
998,33467392,Responses to Low- and High-Intensity Exercise in Adolescents with Type 1 Diabetes in Relation to Their Level of VO 2  Max.,"The purpose of this study was to investigate the influence of maximal oxygen uptake (VO 2  max) on the glycemic changes during low and high intensity exercises in young type 1 diabetic patients. Twenty boys (age: 14.3 ± 1.6 years; height: 171.0 ± 11.3 cm; weight; 59.5 ± 12.8 kg) were divided into low-fit group (LFG,  n  = 10) and high-fit group (HFG,  n  = 10). According to the experimental design, participants performed three physical efforts (VO 2  max test, mixed aerobic-anaerobic effort and aerobic effort) on the cycloergometer, during which real-time glycemia was measured. Mixed aerobic-anaerobic exercise demanded significantly smaller carbohydrate supplementation (0.2 ± 0.2 g/kg during exercise) than the aerobic test session (0.4 ± 0.3 g/kg during exercise). Moreover, patients with higher VO 2  max had lower tendency for glycemic changes during the aerobic effort. The results of the current study suggest that young type 1 diabetic patients should perform different intensity activities using continuous glycemic monitoring system to avoid acute and chronic complications of the disease.",2021,Mixed aerobic-anaerobic exercise demanded significantly smaller carbohydrate supplementation (0.2 ± 0.2 g/kg during exercise) than the aerobic test session (0.4 ± 0.3 g/kg during exercise).,"['young type 1 diabetic patients', 'Adolescents with Type 1 Diabetes in Relation to Their Level of VO 2  Max', 'Twenty boys (age: 14.3 ± 1.6 years; height: 171.0 ± 11.3 cm; weight; 59.5 ± 12.8 kg']","['maximal oxygen uptake (VO 2  max', 'Low- and High-Intensity Exercise', 'Mixed aerobic-anaerobic exercise']","['smaller carbohydrate supplementation', 'glycemic changes']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517547', 'cui_str': '12.8'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0556103', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",3.0,0.0129232,Mixed aerobic-anaerobic exercise demanded significantly smaller carbohydrate supplementation (0.2 ± 0.2 g/kg during exercise) than the aerobic test session (0.4 ± 0.3 g/kg during exercise).,"[{'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Myśliwiec', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Skalska', 'Affiliation': 'Department of Pediatrics, Diabetology and Endocrinology, Gdansk Medical University, 80-210 Gdansk, Poland.'}, {'ForeName': 'Arkadiusz', 'Initials': 'A', 'LastName': 'Michalak', 'Affiliation': 'Department of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, 91-738 Lodz, Poland.'}, {'ForeName': 'Jędrzej', 'Initials': 'J', 'LastName': 'Chrzanowski', 'Affiliation': 'Department of Biostatistics and Translational Medicine, Medical University of Lodz, 92-215 Lodz, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Szmigiero-Kawko', 'Affiliation': 'Department of Pediatrics, Diabetology and Endocrinology, Gdansk Medical University, 80-210 Gdansk, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Lejk', 'Affiliation': 'Department of Pediatrics, Diabetology and Endocrinology, Gdansk Medical University, 80-210 Gdansk, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jastrzębska', 'Affiliation': 'Department of Pediatrics, Diabetology and Endocrinology, Gdansk Medical University, 80-210 Gdansk, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Radzimiński', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Guillermo F', 'Initials': 'GF', 'LastName': 'López-Sánchez', 'Affiliation': 'Faculty of Health, Education, Medicine and Social Care, Anglia Ruskin University-Cambridge Campus, Cambridge CB1 PT1, UK.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Gawrecki', 'Affiliation': 'Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences, 61-701 Poznan, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Jastrzębski', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph18020692']
999,33439974,Intravenous versus Volatile Anesthetic Effects on Postoperative Cognition in Elderly Patients Undergoing Laparoscopic Abdominal Surgery.,"BACKGROUND


Delayed neurocognitive recovery after surgery is associated with poor outcome. Most surgeries require general anesthesia, of which sevoflurane and propofol are the most commonly used inhalational and intravenous anesthetics. The authors tested the primary hypothesis that patients with laparoscopic abdominal surgery under propofol-based anesthesia have a lower incidence of delayed neurocognitive recovery than patients under sevoflurane-based anesthesia. A second hypothesis is that there were blood biomarkers for predicting delayed neurocognitive recovery to occur.
METHODS


A randomized, double-blind, parallel, controlled study was performed at four hospitals in China. Elderly patients (60 yr and older) undergoing laparoscopic abdominal surgery that was likely longer than 2 h were randomized to a propofol- or sevoflurane-based regimen to maintain general anesthesia. A minimum of 221 patients was planned for each group to detect a one-third decrease in delayed neurocognitive recovery incidence in propofol group compared with sevoflurane group. The primary outcome was delayed neurocognitive recovery incidence 5 to 7 days after surgery.
RESULTS


A total of 544 patients were enrolled, with 272 patients in each group. Of these patients, 226 in the propofol group and 221 in the sevoflurane group completed the needed neuropsychological tests for diagnosing delayed neurocognitive recovery, and 46 (20.8%) in the sevoflurane group and 38 (16.8%) in the propofol group met the criteria for delayed neurocognitive recovery (odds ratio, 0.77; 95% CI, 0.48 to 1.24; P = 0.279). A high blood interleukin-6 concentration at 1 h after skin incision was associated with an increased likelihood of delayed neurocognitive recovery (odds ratio, 1.04; 95% CI, 1.01 to 1.07; P = 0.007). Adverse event incidences were similar in both groups.
CONCLUSIONS


Anesthetic choice between propofol and sevoflurane did not appear to affect the incidence of delayed neurocognitive recovery 5 to 7 days after laparoscopic abdominal surgery. A high blood interleukin-6 concentration after surgical incision may be an independent risk factor for delayed neurocognitive recovery.
EDITOR’S PERSPECTIVE


",2021,"A high blood interleukin-6 concentration at 1 h after skin incision was associated with an increased likelihood of delayed neurocognitive recovery (odds ratio, 1.04; 95% CI, 1.01 to 1.07; P = 0.007).","['Elderly patients (60 yr and older) undergoing laparoscopic abdominal surgery that was likely longer than 2 h', 'Elderly Patients Undergoing Laparoscopic Abdominal Surgery', '544 patients were enrolled, with 272 patients in each group', 'patients with laparoscopic abdominal surgery under', 'four hospitals in China']","['Intravenous versus Volatile Anesthetic', 'propofol-based anesthesia', 'propofol- or sevoflurane-based regimen to maintain general anesthesia', 'sevoflurane-based anesthesia', 'propofol', 'sevoflurane', 'propofol and sevoflurane', 'sevoflurane and propofol']","['delayed neurocognitive recovery incidence', 'Adverse event incidences', 'Postoperative Cognition', 'needed neuropsychological tests for diagnosing delayed neurocognitive recovery', 'blood interleukin-6 concentration', 'delayed neurocognitive recovery']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",544.0,0.473751,"A high blood interleukin-6 concentration at 1 h after skin incision was associated with an increased likelihood of delayed neurocognitive recovery (odds ratio, 1.04; 95% CI, 1.01 to 1.07; P = 0.007).","[{'ForeName': 'Yujuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Dongtai', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hanbing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Furong', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': ''}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Chuwen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ''}, {'ForeName': 'Weixing', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': ''}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Ziqing', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Shuling', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': ''}, {'ForeName': 'Weian', 'Initials': 'W', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zuo', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003680']
1000,33443580,"Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial.","Importance


Trivalent adjuvanted inactivated influenza vaccine (aIIV3) and trivalent high-dose inactivated influenza vaccine (HD-IIV3) are US-licensed for adults aged 65 years and older. Data are needed on the comparative safety, reactogenicity, and health-related quality of life (HRQOL) effects of these vaccines.
Objective


To compare safety, reactogenicity, and changes in HRQOL scores after aIIV3 vs HD-IIV3.
Design, Setting, and Participants


This randomized blinded clinical trial was a multicenter US study conducted during the 2017 to 2018 and 2018 to 2019 influenza seasons. Among 778 community-dwelling adults aged at least 65 years and assessed for eligibility, 13 were ineligible and 8 withdrew before randomization. Statistical analysis was performed from August 2019 to August 2020.
Interventions


Intramuscular administration of aIIV3 or HD-IIV3 after age-stratification (65-79 years; ≥80 years) and randomization.
Main Outcomes and Measures


Proportions of participants with moderate-to-severe injection-site pain and 14 other solicited reactions during days 1 to 8, using a noninferiority test (5% noninferiority margin), and serious adverse events (SAE) and adverse events of clinical interest (AECI), including new-onset immune-mediated conditions, during days 1 to 43. Changes in HRQOL scores before and after vaccination (days 1, 3) were also compared between study groups.
Results


A total of 757 adults were randomized, 378 to receive aIIV3 and 379 to receive HD-IIV3. Of these participants, there were 420 women (55%) and 589 White individuals (78%) with a median (range) age of 72 (65-97) years. The proportion reporting moderate-to-severe injection-site pain, limiting or preventing activity, after aIIV3 (12 participants [3.2%]) (primary outcome) was noninferior compared with HD-IIV3 (22 participants [5.8%]) (difference -2.7%; 95% CI, -5.8 to 0.4). Ten reactions met noninferiority criteria for aIIV3; 4 (moderate-to-severe injection-site tenderness, arthralgia, fatigue, malaise) did not. It was inconclusive whether these 4 reactions occurred in higher proportions of participants after aIIV3. No participant sought medical care for a vaccine reaction. No AECI was observed. Nine participants had at least SAE after aIIV3 (2.4%; 95% CI,1.1% to 4.5%); 3 had at least 1 SAE after HD-IIV3 (0.8%; 95% CI, 0.2% to 2.2%). No SAE was associated with vaccination. Changes in prevaccination and postvaccination HRQOL scores were not clinically meaningful and not different between the groups.
Conclusions and Relevance


Overall safety and HRQOL findings were similar after aIIV3 and HD-IIV3, and consistent with prelicensure data. From a safety standpoint, this study's results support using either vaccine to prevent influenza in older adults.
Trial Registration


ClinicalTrials.gov Identifier: NCT03183908.",2021,"Changes in prevaccination and postvaccination HRQOL scores were not clinically meaningful and not different between the groups.
","['2017 to 2018 and 2018 to 2019 influenza seasons', '778 community-dwelling adults aged at least 65 years and assessed for eligibility, 13 were ineligible and 8 withdrew before randomization', '420 women (55%) and 589 White individuals (78%) with a median (range) age of 72 (65-97) years', 'A total of 757 adults were randomized, 378 to receive aIIV3 and 379 to receive HD-IIV3', 'older adults', 'Older Adults', 'Participants', 'adults aged 65 years and older']","['Importance\n\n\nTrivalent adjuvanted inactivated influenza vaccine (aIIV3) and trivalent high-dose inactivated influenza vaccine (HD-IIV3', 'Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines', 'vaccine']","['safety, reactogenicity, and changes in HRQOL scores', 'Safety, Reactogenicity, and Health-Related Quality of Life', 'comparative safety, reactogenicity, and health-related quality of life (HRQOL) effects', 'Measures\n\n\nProportions of participants with moderate-to-severe injection-site pain and 14 other solicited reactions', 'HRQOL scores', 'prevaccination and postvaccination HRQOL scores', 'serious adverse events (SAE) and adverse events of clinical interest (AECI), including new-onset immune-mediated conditions']","[{'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",757.0,0.341616,"Changes in prevaccination and postvaccination HRQOL scores were not clinically meaningful and not different between the groups.
","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Schmader', 'Affiliation': 'Center for the Study of Aging, Division of Geriatrics, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Liu', 'Affiliation': 'Section of Geriatrics, Division of Primary Care and Population Health, Stanford University, Stanford, California.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Harrington', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Wes', 'Initials': 'W', 'LastName': 'Rountree', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Auerbach', 'Affiliation': 'Geriatrics Section, Boston Medical Center, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Barnett', 'Affiliation': 'Section of Pediatric Infectious Diseases, Boston Medical Center, Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Schlaudecker', 'Affiliation': ""Cincinnati Children's Hospital and Medical Center, Department of Pediatrics Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Todd', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Poniewierski', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Staat', 'Affiliation': ""Cincinnati Children's Hospital and Medical Center, Department of Pediatrics Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wodi', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Broder', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.31266']
1001,33450473,The impact of a cardiopulmonary resuscitation video on reducing surrogates' anxiety: A pilot randomized controlled trial.,"PURPOSE


To test the primary hypothesis that a CPR video will reduce ICU patients' surrogates' anxiety when deciding code status, as measured by the Hamilton Anxiety Rating (HAM-A) Scale, as compared to the no video group.
MATERIALS AND METHODS


This is a prospective randomized control trial. Twenty-seven ICU patients' surrogates were enrolled in the study after receiving an ICU team-led code status discussion. After the enrollment, twelve surrogates were randomized to the video group and fifteen to the no video group. The primary outcome of anxiety was quantified using the HAM-A Scale. Demographic information, clinical data, and patients' provenance information (Home vs. Not Home) were collected. The patients' severity of illness was calculated using the Sequential Organ Failure Assessment (SOFA) Score.
RESULTS


The HAM-A score in the video group was 5.65 points lower than in the no video group ([β = -5.65, 95% CI -11.12 -0.18] P = 0.04). The statistically significant difference was maintained when adjusting for patients' SOFA Score and patients' provenance (P = 0.03).
CONCLUSION


CPR video used to supplement ICU team-led code status discussions reduced surrogates' anxiety, as compared to no video.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03630965.",2021,"The HAM-A score in the video group was 5.65 points lower than in the no video group ([β = -5.65, 95% CI -11.12 -0.18] P = 0.04).","[""Twenty-seven ICU patients' surrogates were enrolled in the study after receiving an ICU team-led code status discussion""]","['cardiopulmonary resuscitation video', 'CPR video']","['anxiety', 'Hamilton Anxiety Rating (HAM-A) Scale', 'Sequential Organ Failure Assessment (SOFA) Score', ""surrogates' anxiety"", 'HAM-A score', 'HAM-A Scale']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",27.0,0.0789998,"The HAM-A score in the video group was 5.65 points lower than in the no video group ([β = -5.65, 95% CI -11.12 -0.18] P = 0.04).","[{'ForeName': 'Tirsa M', 'Initials': 'TM', 'LastName': 'Ferrer Marrero', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.. Electronic address: tferrermarre@mcw.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Barash', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Besma', 'Initials': 'B', 'LastName': 'Jaber', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Nothem', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Weber', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Zellner Jones', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kennedy', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Graf', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Broaddrick', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Zhuping', 'Initials': 'Z', 'LastName': 'Garacci', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Anjishnu', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': 'Division of Biostatistics, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kryworuchko', 'Affiliation': 'School of Nursing, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jayshil', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}]",Journal of critical care,['10.1016/j.jcrc.2020.11.001']
1002,33463794,Injury prevention effects of stretching exercise intervention by physical therapists in male high school soccer players.,"We aimed to examine the prevalence of injury after physical therapy intervention for muscle tightness and injury prevention in male high school soccer players. A randomized controlled trial was conducted. Participants comprised 124 players from two high schools who competed in national tournament soccer games held from April 2018 to March 2019. Players were randomly divided into intervention (with a 12-week stretching intervention by physical therapists) and control groups (without the intervention). Players and coaches provided written information regarding injuries and daily training and match times; physical therapists visited each team weekly to collect data and review documentation. Muscle tightness and injury incidence, number, type, location, circumstances, situations, severity, and contents during the 12-week intervention period and a subsequent 40-week observation period were compared between groups. Injuries were significantly lower with intervention during the 40-week observation period (P < .01) but not during the 12-week intervention period (P = .44). Injury types mainly included disorder, non-contact, lower-limb/trunk, and muscle/tendon injuries. Significant interactions were observed for all tightness-test measurement items. The intervention group showed significant improvements in heel-buttock distance, and straight leg-raise and hip rotation angles (pre-intervention < 12 weeks < 52 weeks), as well as significant improvements in ankle dorsiflexion angles at 12 and 52 weeks (relative to pre-intervention values). Instructed stretching exercises, personally designed by physical therapists to address muscle tightness, improved the range of motion and trunk flexibility, with a positive effect on the injury rate in male high school soccer players, especially for non-contact disorder injuries during training.",2020,"The intervention group showed significant improvements in heel-buttock distance, and straight leg-raise and hip rotation angles","['Participants comprised 124 players from two high schools who competed in national tournament soccer games held from April 2018 to March 2019', 'male high school soccer players', 'male high school soccer players, especially for non-contact disorder injuries during training', 'Injury types mainly included disorder, non-contact, lower-limb/trunk, and muscle/tendon injuries']","['stretching exercise intervention', 'stretching intervention by physical therapists) and control groups (without the intervention', 'physical therapy intervention', 'Instructed stretching exercises']","['Muscle tightness and injury incidence, number, type, location, circumstances, situations, severity, and contents', 'heel-buttock distance, and straight leg-raise and hip rotation angles', 'ankle dorsiflexion angles', 'Injuries']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449499', 'cui_str': 'Type of injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039504', 'cui_str': 'Tendon injury'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0006497', 'cui_str': 'Buttock structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}]",,0.0164047,"The intervention group showed significant improvements in heel-buttock distance, and straight leg-raise and hip rotation angles","[{'ForeName': 'Nobuhide', 'Initials': 'N', 'LastName': 'Azuma', 'Affiliation': 'Department of Rehabilitation Physical Therapy, Faculty of Health Science, Fukui Health Science University, Fukui City, Japan.'}, {'ForeName': 'Fujiko', 'Initials': 'F', 'LastName': 'Someya', 'Affiliation': 'School of Health Sciences, Kanazawa University, Kanazawa City, Japan.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13777']
1003,33466606,Comparison of Interventional Strategies to Improve Recovery after Eccentric Exercise-Induced Muscle Fatigue.,"The aim of this study was to compare the effects of various recovery techniques on muscle tissue after eccentric exercise-induced muscle fatigue (EIMF). Forty subjects (24.3 ± 2.6 years; 77.45 ± 8.3 kg; 177.0 ± 6.4 cm; 24.66 ± 1.6 kg∙m -2 ) were randomly assigned to one of the following groups: manual therapy ( n  =10, MT), mechanical vibration ( n  = 10, MV), percussion therapy ( n  = 10, PT) or foam roller ( n  = 10, FR). The contraction time (Tc) and the radial displacement (Dm) of the gastrocnemius was evaluated through tensiomyography (TMG). The application of the different techniques had positive effects for Tc and Dm in the treated leg compared to the untreated leg (F = 50.01,  p  < 0.01, η 2 p = 0.58 and F = 27.58,  p  < 0.01, η 2 p = 0.43, respectively) and for the interaction of the factors (Time x Leg x Therapy: F = 5.76,  p  < 0.01, η 2 p = 0.32 and F = 5.93,  p  < 0.01, η 2 p = 0.33, respectively). The results of the various methods used were similar: Tc (F = 0.17,  p  = 0.917; η 2 p = 0.01) and Dm (F = 3.30,  p  = 0.031, η 2 p = 0.22). PT interventions show potential for restoring muscle compliance and reducing stiffness, similar to MT and possibly more effective (cost-time relationship) compared to MV or FR.",2021,"The results of the various methods used were similar: Tc (F = 0.17,  p  = 0.917; η 2 p = 0.01) and Dm (F = 3.30,  p  = 0.031, η 2 p = 0.22).",['Forty subjects (24.3 ± 2.6 years; 77.45 ± 8.3 kg; 177.0 ± 6.4 cm; 24.66 ± 1.6 kg∙m -2 '],"['manual therapy ( n  =10, MT), mechanical vibration ( n  = 10, MV), percussion therapy ( n  = 10, PT) or foam roller', 'eccentric exercise-induced muscle fatigue (EIMF']",['contraction time (Tc) and the radial displacement (Dm) of the gastrocnemius was evaluated through tensiomyography (TMG'],"[{'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C4517508', 'cui_str': '1.6'}]","[{'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0556838', 'cui_str': 'Percussion therapy'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]","[{'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}]",40.0,0.0202492,"The results of the various methods used were similar: Tc (F = 0.17,  p  = 0.917; η 2 p = 0.01) and Dm (F = 3.30,  p  = 0.031, η 2 p = 0.22).","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'García-Sillero', 'Affiliation': 'Faculty of Sport Sciences, EADE-University of Wales Trinity Saint David, 29018 Málaga, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Benítez-Porres', 'Affiliation': 'Faculty of Medicine, University of Málaga, 29071 Málaga, Spain.'}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'García-Romero', 'Affiliation': 'Faculty of Medicine, University of Málaga, 29071 Málaga, Spain.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Bonilla', 'Affiliation': 'Research Division, DBSS International SAS, 110861 Bogotá, Colombia.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Petro', 'Affiliation': 'Research Division, DBSS International SAS, 110861 Bogotá, Colombia.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Vargas-Molina', 'Affiliation': 'Faculty of Sport Sciences, EADE-University of Wales Trinity Saint David, 29018 Málaga, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18020647']
1004,33470195,Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance.,"Although statins play a pivotal role in the prevention of atherosclerotic cardiovascular disease, many patients fail to achieve recommended lipid levels due to statin-associated muscle symptoms. Bempedoic acid is an oral pro-drug that is activated in the liver and inhibits cholesterol synthesis in hepatocytes, but is not activated in skeletal muscle which has the potential to avoid muscle-related adverse events. Accordingly, this agent effectively lowers atherogenic lipoproteins in patients who experience statin-associated muscle symptoms. However, the effects of bempedoic acid on cardiovascular morbidity and mortality have not been studied. STUDY DESIGN: Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes is a randomized, double-blind, placebo-controlled clinical trial. Included patients must have all of the following: (i) established atherosclerotic cardiovascular disease or have a high risk of developing atherosclerotic cardiovascular disease, (ii) documented statin intolerance, and (iii) an LDL-C ≥100 mg/dL on maximally-tolerated lipid-lowering therapy. The study randomized 14,014 patients to treatment with bempedoic acid 180 mg daily or matching placebo on a background of guideline-directed medical therapy. The primary outcome is a composite of the time to first cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. The trial will continue until 1620 patients experience a primary endpoint, with a minimum of 810 hard ischemic events (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) and minimum treatment duration of 36 months and a projected median treatment exposure of 42 months. CONCLUSIONS: CLEAR Outcomes will determine whether bempedoic acid 180 mg daily reduces the incidence of adverse cardiovascular events in high vascular risk patients with documented statin intolerance and elevated LDL-C levels.",2020,"The trial will continue until 1620 patients experience a primary endpoint, with a minimum of 810 hard ischemic events (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) and minimum treatment duration of 36months and a projected median treatment exposure of 42months.
","['Included patients must have all of the following: (i) established atherosclerotic cardiovascular disease or have a high risk of developing atherosclerotic cardiovascular disease, (ii) documented statin intolerance, and (iii) an LDL-C≥100mg/dL on maximally-tolerated lipid-lowering therapy', 'patients with statin intolerance', 'patients who experience statin-associated muscle symptoms', 'high vascular risk patients with documented statin intolerance and elevated LDL-C levels', '14,014 patients to treatment with', '1620 patients experience a primary endpoint, with a minimum of 810 hard ischemic events (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) and minimum treatment duration of 36months and a projected median treatment exposure of 42months']","['placebo', 'Bempedoic acid', 'bempedoic acid 180mg daily or matching placebo', 'bempedoic acid', 'ACL-Inhibiting Regimen (CLEAR']","['composite of the time to first cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization', 'cardiovascular events', 'atherogenic lipoproteins', 'cardiovascular morbidity and mortality']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",14014.0,0.257617,"The trial will continue until 1620 patients experience a primary endpoint, with a minimum of 810 hard ischemic events (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) and minimum treatment duration of 36months and a projected median treatment exposure of 42months.
","[{'ForeName': 'StephenJ', 'Initials': 'S', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University, Melbourne, Australia. Electronic address: stephen.nicholls@monash.edu.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic Coordinating Center for Clinical Research.'}, {'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic Coordinating Center for Clinical Research.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'University Medical Center Utrecht, Julius Center, Utrecht, Netherlands.'}, {'ForeName': 'John Jp', 'Initials': 'JJ', 'LastName': 'Kastelein', 'Affiliation': 'Department of Vascular Medicine, University of Amsterdam Academic Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'Clinical Pharmacology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Plutzky', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Department of Primary Care & Public Health, Imperial College London, London, England.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Thompson', 'Affiliation': 'Division of Cardiology, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sasiela', 'Affiliation': 'Esperion Therapeutics, Ann Arbor, MI.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Mason', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic Coordinating Center for Clinical Research.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'McCluskey', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic Coordinating Center for Clinical Research.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Davey', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic Coordinating Center for Clinical Research.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic Coordinating Center for Clinical Research.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic Coordinating Center for Clinical Research.'}]",American heart journal,['10.1016/j.ahj.2020.10.060']
1005,33427884,Outcomes After Elective Inguinal Hernia Repair Performed by Associate Clinicians vs Medical Doctors in Sierra Leone: A Randomized Clinical Trial.,"Importance


Task sharing of surgical duties with medical doctors (MDs) without formal surgical training and associate clinicians (ACs; health care workers corresponding to an educational level between that of a nurse and an MD) is practiced to provide surgical services to people in low-resource settings. The safety and effectiveness of this has not been fully evaluated through a randomized clinical trial.
Objective


To determine whether task sharing with MDs and ACs is safe and effective in mesh hernia repair in Sierra Leone.
Design, Setting, and Participants


This single-blind, noninferiority randomized clinical trial included adult, healthy men with primary inguinal hernia randomized to receiving surgical treatment from an MD or an AC. In Sierra Leone, ACs practicing surgery have received 2 years of surgical training and completed a 1-year internship. The study was conducted between October 2017 and February 2019. Patients were followed up at 2 weeks and 1 year after operations. Observers were blinded to the study arm of the patients. The study was carried out in a first-level hospital in rural Sierra Leone. Data were analyzed from March to June 2019.
Interventions


All patients received an open mesh inguinal hernia repair under local anesthesia. The control group underwent operations performed by MDs, and the intervention group underwent operations performed by ACs.
Main Outcomes and Measures


The primary end point was hernia recurrence at 1 year. Outcomes were assessed by blinded observers at 2 weeks and 1 year after operations.
Results


A total of 230 patients were recruited (mean [SD] age, 43.0 [13.5] years), and all but 1 patient underwent inguinal hernia repair between October 23, 2017, and February 2, 2018, performed by 5 MDs and 6 ACs. A total of 114 patients were operated on by MDs, and 115 patients were operated on by ACs. There were no crossovers between the study arms. The follow-up rate was 100% at 2 weeks and 94.1% at 1 year. At 1 year, hernia recurrence occurred in 7 patients (6.9%) operated on by MDs and 1 patient (0.9%) operated on by ACs (absolute difference, -6.0 [95% CI, -11.2 to 0.7] percentage points; P < .001).
Conclusions and Relevance


These findings demonstrate that task sharing of elective mesh inguinal hernia repair with ACs was safe and effective. The task sharing debate should progress to focus on optimizing surgical training programs for nonsurgeons and building capacity for elective surgical care in low- and middle-income countries.
Trial Registration


isrctn.org Identifier: ISRCTN63478884.",2021,"At 1 year, hernia recurrence occurred in 7 patients (6.9%) operated on by MDs and 1 patient (0.9%) operated on by ACs (absolute difference, -6.0 [95% CI, -11.2 to 0.7] percentage points; P < .001).
","['first-level hospital in rural Sierra Leone', 'October 2017 and February 2019', '114 patients were operated on by MDs, and 115 patients were operated on by ACs', 'mesh hernia repair in Sierra Leone', 'in Sierra Leone', 'A total of 230 patients were recruited (mean [SD] age, 43.0 [13.5] years), and all but 1 patient underwent inguinal hernia repair between October 23, 2017, and February 2, 2018, performed by 5 MDs and 6 ACs', 'adult, healthy men with primary inguinal hernia randomized to receiving surgical treatment from an MD or an AC']","['medical doctors (MDs) without formal surgical training', 'Elective Inguinal Hernia Repair Performed by Associate Clinicians vs Medical Doctors', 'task sharing with MDs and ACs', 'operations performed by MDs, and the intervention group underwent operations performed by ACs', 'open mesh inguinal hernia repair under local anesthesia']","['safety and effectiveness', 'hernia recurrence']","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037063', 'cui_str': 'Sierra Leone'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0450010', 'cui_str': 'Operation performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",230.0,0.123436,"At 1 year, hernia recurrence occurred in 7 patients (6.9%) operated on by MDs and 1 patient (0.9%) operated on by ACs (absolute difference, -6.0 [95% CI, -11.2 to 0.7] percentage points; P < .001).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ashley', 'Affiliation': 'Kamakwie Wesleyan Hospital, Kamakwie, Sierra Leone.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Ashley', 'Affiliation': 'The Lakes Medical Practice, Penrith, United Kingdom.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wladis', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Håkon A', 'Initials': 'HA', 'LastName': 'Bolkan', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'van Duinen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Jessica H', 'Initials': 'JH', 'LastName': 'Beard', 'Affiliation': 'Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Hertta', 'Initials': 'H', 'LastName': 'Kalsi', 'Affiliation': 'Skåne University Hospital, Skåne, Sweden.'}, {'ForeName': 'Juuli', 'Initials': 'J', 'LastName': 'Palmu', 'Affiliation': 'Kiruna Hospital, Kiruna, Sweden.'}, {'ForeName': 'Pär', 'Initials': 'P', 'LastName': 'Nordin', 'Affiliation': 'Department of Surgery and Perioperative Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Holm', 'Affiliation': 'Mälarsjukhuset, Eskilstuna, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ohene-Yeboah', 'Affiliation': 'Department of Surgery, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Löfgren', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.32681']
1006,33466200,Optimal intervention time and risk of the activating blood and removing stasis method in acute cerebral hemorrhage patients: A randomized placebo-controlled trial.,"INTRODUCTION


Stroke is the leading cause of disability-adjusted life years in neurological diseases and has become one of the top 3 fatal diseases in the world. Cerebral hemorrhage accounts for approximately 18% to 24% of all strokes in Asian countries. Cerebral hemorrhage is one of the most destructive subtypes of stroke and has high morbidity and mortality. Based on the current research, it has been confirmed that neither surgical treatment nor current drug treatment is the most preferred treatment. Traditional Chinese medicine (TCM) is increasingly being used to treat cerebral hemorrhage, and the activating blood and removing stasis (ABRS) method has received more attention. At present, there is still a lack of high-quality clinical research on the treatment of acute cerebral hemorrhage.
METHOD


We designed a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. We aim to recruit 312 cerebral hemorrhage patients aged 18 to 80 years within 24 to 72 hours after onset. In addition to routine treatment, participants will randomly receive ABRS granules or placebo for 14 days. Those enrolled within 24 to 48 hours after onset will enter strata A, and those enrolled within 49 to 72 hours (including 48-49 hours) after onset will enter strata B. The strata sample size ratio will be 1:1. The primary outcome is the disability degree (modified Rankin Scale score, mRS) at 6 months after onset. The secondary outcomes include the percentage of hematoma enlargement after treatment, Barthel index (BI), National Institutes of Health stroke scale (NIHSS) score, mortality rate, all-cause mortality rate, TCM stroke syndrome evaluation scale score, and adverse events.
DISCUSSION


The study is expected to confirm the safety and effect of acute cerebral hemorrhage within 24 to 72 hours treated with the ABRS method and to determine the optimal time for intervention in this period.
TRIAL REGISTRATION NUMBER


ChiCTR1900022627.",2021,"The secondary outcomes include the percentage of hematoma enlargement after treatment, Barthel index (BI), National Institutes of Health stroke scale (NIHSS) score, mortality rate, all-cause mortality rate, TCM stroke syndrome evaluation scale score, and adverse events.
","['acute cerebral hemorrhage patients', 'Those enrolled within 24 to 48\u200ahours after onset will enter strata A, and those enrolled within 49 to 72\u200ahours (including 48-49\u200ahours) after onset will enter strata B', '312 cerebral hemorrhage patients aged 18 to 80 years within 24 to 72\u200ahours after onset']","['Traditional Chinese medicine (TCM', 'placebo']","['disability degree (modified Rankin Scale score, mRS', 'percentage of hematoma enlargement after treatment, Barthel index (BI), National Institutes of Health stroke scale (NIHSS) score, mortality rate, all-cause mortality rate, TCM stroke syndrome evaluation scale score, and adverse events', 'Cerebral hemorrhage accounts', 'Cerebral hemorrhage']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}]",,0.200681,"The secondary outcomes include the percentage of hematoma enlargement after treatment, Barthel index (BI), National Institutes of Health stroke scale (NIHSS) score, mortality rate, all-cause mortality rate, TCM stroke syndrome evaluation scale score, and adverse events.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'College of Traditional Chinese Medicine, Changchun University of Chinese Medicine.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Scientific Research Office.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': 'Department of Encephalopathy, The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun.'}, {'ForeName': 'Yabin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Encephalopathy, The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun.'}, {'ForeName': 'Yutong', 'Initials': 'Y', 'LastName': 'Fei', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Tianying', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': 'GCP Department.'}, {'ForeName': 'Mingkun', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'College of Traditional Chinese Medicine, Changchun University of Chinese Medicine.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'College of Traditional Chinese Medicine, Changchun University of Chinese Medicine.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Encephalopathy, The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Department of Encephalopathy, The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun.'}, {'ForeName': 'Tianye', 'Initials': 'T', 'LastName': 'Lan', 'Affiliation': 'Department of Encephalopathy, The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Encephalopathy, The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun.'}]",Medicine,['10.1097/MD.0000000000024214']
1007,33466190,Comparison of polyurethane foam dressing and hydrocolloid dressing in patients with pressure ulcers: A randomized controlled trial protocol.,,2021,,['patients with pressure ulcers'],['polyurethane foam dressing and hydrocolloid dressing'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]","[{'cui': 'C0460852', 'cui_str': 'Polyurethane foam dressing'}, {'cui': 'C0122734', 'cui_str': 'Hydrocolloid dressing'}]",[],,0.103716,,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Diagnosis and Treatment Center for Chronic Wounds, Hangzhou Geriatric Hospital.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, Community Health Service Center, Yuhang District.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Diagnosis and Treatment Center for Chronic Wounds, Hangzhou Geriatric Hospital, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Diagnosis and Treatment Center for Chronic Wounds, Hangzhou Geriatric Hospital, Hangzhou, Zhejiang, China.'}]",Medicine,['10.1097/MD.0000000000024165']
1008,33466183,"Dexamethasone and post-adenotonsillectomy pain in children: Double-blind, randomized controlled trial.","OBJECTIVE


To assess the impact of intraoperative intravenous dexamethasone on the reduction of postoperative morbidity in children undergoing adenotonsillectomy.
METHODS


A double blind randomized controlled trial conducted among children undergoing adenotonsillectomy at a tertiary hospital in Korea from November 2018 to June 2019. Children were randomly assigned to receive dexamethasone (0.5 mg/kg, maximum dose 24 mg) or placebo intravenously after induction of anesthesia. The primary endpoint was the reduction of postoperative pain and postoperative nausea and vomiting (PONV); secondary endpoints were adverse effects like postoperative hemorrhage.
RESULTS


The study included 105 children, and 67 were male. Their mean age was 6.2 ± 2.1 years. There was no significant difference between the groups in terms of demographic data or the operation time. The pain scores of the dexamethasone group were lower than those of the control group, but no significant difference was found (all P > .05). The average pain visual analog scale (VAS) during the study period (day 0-7) was 3.67 ± 1.59 and 4.40 ± 2.01 in the dexamethasone group and control group, respectively (P-value = .107). When we compared early pain VAS (day 0-2) and late pain VAS (day 5-7), the dexamethasone group showed significantly lower early mean VAS compared to the control group (4.55 ± 1.78 vs 5.40 ± 2.05, P-value = .046). The mean VAS for PONV was significantly lower in the dexamethasone group than in the control group (1.89 ± 2.22 vs 3.00 ± 2.37, P value = .044).
CONCLUSION


In children undergoing adenotonsillectomy, dexamethasone decreased the early postoperative pain and PONV without increasing postoperative hemorrhage.",2021,"In children undergoing adenotonsillectomy, dexamethasone decreased the early postoperative pain and PONV without increasing postoperative hemorrhage.","['children', 'children undergoing adenotonsillectomy', '105 children, and 67 were male', 'children undergoing', 'Their mean age was 6.2\u200a±\u200a2.1 years', 'children undergoing adenotonsillectomy at a tertiary hospital in Korea from November 2018 to June 2019']","['adenotonsillectomy, dexamethasone', 'Dexamethasone', 'placebo', 'dexamethasone']","['adverse effects like postoperative hemorrhage', 'postoperative morbidity', 'early mean VAS', 'mean VAS for PONV', 'reduction of postoperative pain and postoperative nausea and vomiting (PONV', 'postoperative hemorrhage', 'early pain VAS', 'late pain VAS', 'average pain visual analog scale (VAS', 'pain scores', 'demographic data or the operation time', 'early postoperative pain and PONV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",105.0,0.45929,"In children undergoing adenotonsillectomy, dexamethasone decreased the early postoperative pain and PONV without increasing postoperative hemorrhage.","[{'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery.'}, {'ForeName': 'Eu Jeong', 'Initials': 'EJ', 'LastName': 'Ku', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University College of Medicine, Chungbuk National University Hospital, Cheongju, Korea.'}, {'ForeName': 'Il Gu', 'Initials': 'IG', 'LastName': 'Jung', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery.'}, {'ForeName': 'Min Hyuck', 'Initials': 'MH', 'LastName': 'Kang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery.'}, {'ForeName': 'Young-Seok', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery.'}, {'ForeName': 'Hahn Jin', 'Initials': 'HJ', 'LastName': 'Jung', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery.'}]",Medicine,['10.1097/MD.0000000000024122']
1009,33466137,The efficacy of continuous nursing care for patients with chronic obstructive pulmonary disease: A randomized controlled trial protocol.,,2021,,['patients with chronic obstructive pulmonary disease'],['continuous nursing care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]",[],,0.126325,,"[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Respiratory and Critical Care Medicine.'}, {'ForeName': 'Fengmin', 'Initials': 'F', 'LastName': 'Men', 'Affiliation': 'Department of Internal Medicine.'}, {'ForeName': 'Xingfen', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Office of Health Care.'}, {'ForeName': 'Zhenying', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Respiratory Care Unit, Shandong Chest Hospital, Shandong, 250013, China.'}]",Medicine,['10.1097/MD.0000000000023974']
1010,33466136,The effectiveness of specialized nursing interventions for patients with Parkinson disease: A randomized controlled study protocol.,"BACKGROUND


The purpose of this experiment is to evaluate the impact of the care of Parkinson disease nurse specialist on improving motor symptoms and life quality for patients with Parkinson disease (PD).
METHOD


This is a randomized controlled research, and it will be conducted from April 2021 to October 2021 at Sichuan Provincial People's Hospital. The experiment was granted through the Research Ethics Committee of Sichuan Provincial People's Hospital (004510293). All the patients suffer from PD, age 18 years or older, both female and male, regardless of the duration or severity of this disease are eligible. The exclusion criteria contains: lack sufficient knowledge to complete questionnaires, serious physical comorbidities or refuse to take part in the program. In our experiment, the major result measures are motor symptoms and life quality. For the measurement of life quality, we will utilize Parkinson disease Questionnaire-39, the most extensively utilized the scale of life quality in PD. The evaluation of motor symptoms severity is carried out with the revision of Unified Parkinson Disease Rating Scale sponsored by Movement Disorder Society.
RESULTS


Table 1 indicates clinical outcomes at different time points.
CONCLUSION


The Parkinson's disease nurse specialist care may promote the life quality in the PD patients.
TRIAL REGISTRATION NUMBER


researchregistry 6284.",2021,"The evaluation of motor symptoms severity is carried out with the revision of Unified Parkinson Disease Rating Scale sponsored by Movement Disorder Society.
","['patients with Parkinson disease', ""April 2021 to October 2021 at Sichuan Provincial People's Hospital"", 'patients with Parkinson disease (PD', 'patients suffer from PD, age 18 years or older, both female and male, regardless of the duration or severity of this disease are eligible']",['specialized nursing interventions'],"['life quality', 'motor symptoms and life quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}]",,0.038558,"The evaluation of motor symptoms severity is carried out with the revision of Unified Parkinson Disease Rating Scale sponsored by Movement Disorder Society.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Cardiology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Sichuan, China.""}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology.'}]",Medicine,['10.1097/MD.0000000000023972']
1011,33477316,Effects of the Manual Therapy Approach of Segments C0-1 and C2-3 in the Flexion-Rotation Test in Patients with Chronic Neck Pain: A Randomized Controlled Trial.,"Background : Flexion-rotation test predominantly measures rotation in C1-2 segment. Restriction in flexion-rotation may be due to direct limitation in C1-2, but also to a premature tightening of the alar ligament as a result of lack of movement in C0-1 or C2-3. The aim of this study was to compare the effect of a 20-min single cervical exercise session, with or without manual therapy of C0-1 and C2-3 segment in flexion-rotation test, in patients with chronic neck pain and positive flexion-rotation test.  Methods : Randomized controlled clinical trial in 48 subjects (24 manual therapy+exercise/24 exercise). Range of motion and pain during flexion-rotation test, neck pain intensity and active cervical range of motion were measured before and after the intervention.  Results : Significant differences were found in favour of the manual therapy group in the flexion-rotation test: right ( p  < 0.001) and left rotation ( p  < 0.001); pain during the flexion-rotation test: right ( p  < 0.001) and left rotation ( p  < 0.001); neck pain intensity: ( p  < 0.001); cervical flexion ( p  < 0.038), extension ( p  < 0.010), right side-bending ( p  < 0.035), left side-bending ( p  < 0.002), right rotation ( p  < 0.001), and left rotation ( p  < 0.006).  Conclusions : Addition of one C0-C1 and C2-C3 manual therapy session to cervical exercise can immediately improve flexion-rotation test and cervical range of motion and reduce pain intensity.",2021,Significant differences were found in favour of the manual therapy group in the flexion-rotation test:,"['C1-2 segment', 'Patients with Chronic Neck Pain', '48 subjects (24 manual therapy+exercise/24 exercise', 'patients with chronic neck pain and positive flexion-rotation test']","['20-min single cervical exercise session, with or without manual therapy of C0-1 and C2-3 segment in flexion-rotation test', 'Manual Therapy Approach of Segments C0-1 and C2-3 in the Flexion-Rotation Test']","['flexion-rotation test and cervical range of motion and reduce pain intensity', 'right rotation', 'flexion-rotation test', 'cervical flexion', 'Range of motion and pain during flexion-rotation test, neck pain intensity and active cervical range of motion', 'left rotation', 'right side-bending', 'neck pain intensity', 'pain']","[{'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0011119', 'cui_str': 'Bends'}]",48.0,0.0759654,Significant differences were found in favour of the manual therapy group in the flexion-rotation test:,"[{'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, C/Josep Trueta s/n, Sant Cugat del Vallés, 08195 Barcelona, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Malo-Urriés', 'Affiliation': 'Departamento de Fisiatría y Enfermería, Unidad de Investigación en Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Zaragoza, C/Domingo Miral, s/n, 50009 Zaragoza, Spain.'}, {'ForeName': 'María Orosia', 'Initials': 'MO', 'LastName': 'Lucha-López', 'Affiliation': 'Departamento de Fisiatría y Enfermería, Unidad de Investigación en Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Zaragoza, C/Domingo Miral, s/n, 50009 Zaragoza, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Pérez-Bellmunt', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, C/Josep Trueta s/n, Sant Cugat del Vallés, 08195 Barcelona, Spain.'}, {'ForeName': 'Andoni', 'Initials': 'A', 'LastName': 'Carrasco-Uribarren', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, C/Josep Trueta s/n, Sant Cugat del Vallés, 08195 Barcelona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Fanlo-Mazas', 'Affiliation': 'Departamento de Fisiatría y Enfermería, Unidad de Investigación en Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Zaragoza, C/Domingo Miral, s/n, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral-de-Toro', 'Affiliation': 'Departamento de Fisiatría y Enfermería, Unidad de Investigación en Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Zaragoza, C/Domingo Miral, s/n, 50009 Zaragoza, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Hidalgo-García', 'Affiliation': 'Departamento de Fisiatría y Enfermería, Unidad de Investigación en Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Zaragoza, C/Domingo Miral, s/n, 50009 Zaragoza, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18020753']
1012,33476880,Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years.,"BACKGROUND


Alemtuzumab significantly improved clinical and MRI outcomes vs. subcutaneous interferon beta-1a (SC IFNB-1a) in the CARE-MS trials (NCT00530348, NCT00548405), with sustained efficacy in 2 consecutive extensions (NCT00930553, NCT02255656 [TOPAZ]).
METHODS


Post hoc analysis of 8-year alemtuzumab efficacy and safety in pooled CARE-MS patients (N=811) stratified by baseline age (≥18 to ≤25, >25 to ≤35, >35 to ≤45, >45 to ≤55 years).
RESULTS


Compared with SC IFNB-1a over 2 years across age cohorts, alemtuzumab lowered annualized relapse rates (ARR; 0.22-0.24 vs. 0.38-0.51), improved or stabilized disability (freedom from 6-month confirmed disability worsening [CDW]: 85%-92% vs. 62%-88%; achievement of 6-month confirmed disability improvement [CDI]: 20%-31% vs. 13%-25%), increased proportions free of MRI disease activity (70%-86% vs. 42%-63% per year), and slowed brain volume loss (BVL; -0.45% to -0.87% vs. -0.50% to -1.39%). Through Year 2, the treatment effect with alemtuzumab did not significantly differ among age groups for ARR (p-interaction=0.6325), 6-month CDW-free (p-interaction=0.4959), 6-month CDI (p-interaction=0.9268), MRI disease activity-free (p-interaction=0.6512), and BVL (p-interaction=0.4970). Alemtuzumab remained effective on outcomes through Year 8 across age groups. Age-related increases in malignancies (≤45 years: 0.9%-2.2% vs. >45 years: 8.1%) and deaths (0%-1.7% vs. 7.0%) were observed. Serious infections also increased from the youngest (5.1%) to oldest (12.8%) age cohorts.
CONCLUSIONS


Alemtuzumab had greater efficacy than SC IFNB-1a over 2 years across comparable age groups, with no significant differences between alemtuzumab-treated age groups. Efficacy on relapse, disability, and MRI outcomes continued through Year 8 across age groups. Age-related increases in serious infections, malignancies, and deaths were observed.",2020,"Compared with SC IFNB-1a over 2 years across age cohorts, alemtuzumab lowered annualized relapse rates (ARR; 0.22-0.24 vs. 0.38-0.51), improved or stabilized disability (freedom from 6-month confirmed disability worsening [CDW]: 85%-92% vs. 62%-88%; achievement of 6-month confirmed disability improvement [CDI]: 20%-31% vs. 13%-25%), increased proportions free of MRI disease activity (70%-86% vs. 42%-63% per year), and slowed brain volume loss (BVL; -0.45% to -0.87%","['pooled CARE-MS patients (N=811) stratified by baseline age (≥18 to ≤25, >25 to ≤35, >35 to ≤45, >45 to ≤55 years', 'age']","['Alemtuzumab', 'alemtuzumab']","['serious infections, malignancies, and deaths', 'MRI disease activity', 'Serious infections', 'slowed brain volume loss', 'deaths', 'MRI disease activity-free', 'annualized relapse rates', '6-month CDW-free', 'stabilized disability', 'relapse, disability, and MRI outcomes']","[{'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0383429', 'cui_str': 'alemtuzumab'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0452673,"Compared with SC IFNB-1a over 2 years across age cohorts, alemtuzumab lowered annualized relapse rates (ARR; 0.22-0.24 vs. 0.38-0.51), improved or stabilized disability (freedom from 6-month confirmed disability worsening [CDW]: 85%-92% vs. 62%-88%; achievement of 6-month confirmed disability improvement [CDI]: 20%-31% vs. 13%-25%), increased proportions free of MRI disease activity (70%-86% vs. 42%-63% per year), and slowed brain volume loss (BVL; -0.45% to -0.87%","[{'ForeName': 'Ann D', 'Initials': 'AD', 'LastName': 'Bass', 'Affiliation': 'Neurology Center of San Antonio, 1314 East Sonterra Blvd #601, San Antonio, TX, USA. Electronic address: annofb@hotmail.com.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Arroyo', 'Affiliation': 'Hospital Universitario Quirónsalud Madrid (RA), c/ Diego de Velázquez, 1 28223 Pozuelo de Alarcón, Madrid, Spain.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Boster', 'Affiliation': 'Boster MS Center, 8000 Ravines Edge Court, Suite 200, Columbus, OH, USA.'}, {'ForeName': 'Alexey N', 'Initials': 'AN', 'LastName': 'Boyko', 'Affiliation': 'Pirogov Russian National Research University, Department of Neuroimmunology of the Federal Center of Brain and Neurosciences, Moscow, Russia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Eichau', 'Affiliation': 'Hospital Universitario Virgen Macarena, Avda. Dr. Fedriani, No. 3. 41009, Seville, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ionete', 'Affiliation': 'University of Massachusetts Memorial Medical Center, 55 Lake Avenue North, Worcester, MA, USA.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Limmroth', 'Affiliation': 'Klinik für Neurologie und Palliativmedizin, Ostmerheimer Str. 200, 51109 Cologne, Germany.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Navas', 'Affiliation': 'Clínica Universitaria Colombia, Cl. 22b ## 66-46, Bogota, Colombia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pelletier', 'Affiliation': 'Keck School of Medicine of University of Southern California, 1520 San Pablo St, Los Angeles, CA, USA.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pozzilli', 'Affiliation': 'Department of Human Neuroscience, Sapienza University, University Avenue 30, Rome, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ravenscroft', 'Affiliation': 'Kansas City MS Center, 10600 Mastin Street, Entrance C, Overland Park, KS, USA.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Sousa', 'Affiliation': 'Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3000-075, Coimbra, Portugal.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Tintoré', 'Affiliation': ""University Hospital Vall d'Hebron, Passeig de la Vall d'Hebron, 119, 129, 08035 Barcelona, Spain.""}, {'ForeName': 'Bernard M J', 'Initials': 'BMJ', 'LastName': 'Uitdehaag', 'Affiliation': 'Amsterdam University Medical Centers, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Darren P', 'Initials': 'DP', 'LastName': 'Baker', 'Affiliation': 'Sanofi, 50 Binney Street, Cambridge, MA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Sanofi, 50 Binney Street, Cambridge, MA, USA.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Choudhry', 'Affiliation': 'Sanofi, 50 Binney Street, Cambridge, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rog', 'Affiliation': 'Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102717']
1013,33480852,A Mobile App-Based Intervention Program for Nonprofessional Caregivers to Promote Positive Mental Health: Randomized Controlled Trial.,"BACKGROUND


While nonprofessional caregivers often experience a sense of fulfillment when they provide care, there is also a significant risk of emotional and physical burnout. Consequently, this can negatively affect both the caregiver and the person being cared for. Intervention programs can help empower nonprofessional caregivers of people with chronic diseases and develop solutions to decrease the physical and psychological consequences resulting from caregiving. However, most clinically tested intervention programs for nonprofessional caregivers require face-to-face training, and many caregivers encounter obstacles that hinder their participation in such programs. Consequently, it is necessary to design internet-based intervention programs for nonprofessional caregivers that address their needs and test the efficacy of the programs.
OBJECTIVE


The aim of this study was to evaluate the effectiveness of a smartphone app-based intervention program to increase positive mental health for nonprofessional caregivers.
METHODS


This study was a randomized controlled trial of 3 months' duration. A total of 152 caregivers over 18 years of age with a minimum of 4 months' experience as nonprofessional caregivers were recruited from primary health care institutions. Nonprofessional caregivers were randomized into two groups. In the intervention group, each caregiver installed a smartphone app and used it for 28 days. This app offered them daily activities that were based on 10 recommendations to promote positive mental health. The level of positive mental health, measured using the Positive Mental Health Questionnaire (PMHQ), and caregiver burden, measured using the 7-item short-form version of the Zarit Caregiver Burden Interview (ZBI-7), were the primary outcomes. Users' satisfaction was also measured.
RESULTS


In all, 113 caregivers completed the study. After the first month of the intervention, only one factor of the PMHQ, F1-Personal satisfaction, showed a significant difference between the groups, but it was not clinically relevant (0.96; P=.03). However, the intervention group obtained a higher mean change for the overall PMHQ score (mean change between groups: 1.40; P=.24). The results after the third month of the intervention showed an increment of PMHQ scores. The mean difference of change in the PMHQ score showed a significant difference between the groups (11.43; P<.001; d=0.82). Significant changes were reported in 5 of the 6 factors, especially F5-Problem solving and self-actualization (5.69; P<.001; d=0.71), F2-Prosocial attitude (2.47; P<.001; d=1.18), and F3-Self-control (0.76; P=.03; d=0.50). The results of the ZBI-7 showed a decrease in caregiver burden in the intervention group, although the results were inconclusive. Approximately 93.9% (46/49) of the app users indicated that they would recommend the app to other caregivers and 56.3% (27/49) agreed that an extension of the program's duration would be beneficial.
CONCLUSIONS


The app-based intervention program analyzed in this study was effective in promoting positive mental health and decreasing the burden of caregivers and achieved a high range of user satisfaction. This study provides evidence that mobile phone app-based intervention programs may be useful tools for increasing nonprofessional caregivers' well-being. The assessment of the effectiveness of intervention programs through clinical trials should be a focus to promote internet-based programs in health policies.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN14818443; http://www.isrctn.com/ISRCTN14818443.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12889-019-7264-5.",2021,The app-based intervention program analyzed in this study was effective in promoting positive mental health and decreasing the burden of caregivers and achieved a high range of user satisfaction.,"['Nonprofessional caregivers', ""152 caregivers over 18 years of age with a minimum of 4 months' experience as nonprofessional caregivers were recruited from primary health care institutions"", 'Nonprofessional Caregivers to Promote Positive Mental Health', '113 caregivers completed the study']","['mobile phone app-based intervention programs', 'Mobile App-Based Intervention Program', 'smartphone app-based intervention program']","['PMHQ, F1-Personal satisfaction', 'overall PMHQ score', 'positive mental health', 'PMHQ score', 'F5-Problem solving and self-actualization', 'PMHQ scores', 'caregiver burden', ""Users' satisfaction"", 'F2-Prosocial attitude', 'Positive Mental Health Questionnaire (PMHQ), and caregiver burden, measured using the 7-item short-form version of the Zarit Caregiver Burden Interview (ZBI-7', 'level of positive mental health']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031206', 'cui_str': 'Personal wellbeing status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.138201,The app-based intervention program analyzed in this study was effective in promoting positive mental health and decreasing the burden of caregivers and achieved a high range of user satisfaction.,"[{'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Ferré-Grau', 'Affiliation': 'Department of Nursing, Universitat Rovira i Virgili, Tarragona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Raigal-Aran', 'Affiliation': 'Department of Nursing, Universitat Rovira i Virgili, Tarragona, Spain.'}, {'ForeName': 'Jael', 'Initials': 'J', 'LastName': 'Lorca-Cabrera', 'Affiliation': 'Department of Nursing, Universitat Rovira i Virgili, Tortosa, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lluch-Canut', 'Affiliation': 'Department of Public Health, Mental Health and Maternal-Child Nursing, School of Nursing, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ferré-Bergadà', 'Affiliation': 'Department of Computer Engineering and Mathematics, Universitat Rovira i Virgili, Tarragona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Lleixá-Fortuño', 'Affiliation': ""Territorial Health Services of Terres de l'Ebre, Catalan Health Institute, Tortosa, Spain.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Puig-Llobet', 'Affiliation': 'Department of Public Health, Mental Health and Maternal-Child Nursing, School of Nursing, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Miguel-Ruiz', 'Affiliation': 'Department of Mental Health, Campus Docent Sant Joan de Déu--Fundació Privada, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Albacar-Riobóo', 'Affiliation': 'Department of Nursing, Universitat Rovira i Virgili, Tortosa, Spain.'}]",JMIR mHealth and uHealth,['10.2196/21708']
1014,33446472,"Pingchan granule for depressive symptoms in parkinson's disease: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Depression in Parkinson's disease (dPD) is closely related to quality of life. Current studies have suggested that Pingchan Granule (PCG) might be effective for treating dPD.
OBJECTIVE


This study determines the efficacy of PCG for depressive symptoms in Parkinson's disease (PD).
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS


This was a randomized, double-blind, placebo-controlled trial, conducted in Longhua Hospital, Shanghai, China. Patients diagnosed with idiopathic PD and clinically significant depressive symptoms (defined by a 24-item Hamilton Rating Scale for Depression [HAM-D] score ≥ 8) were included in this study, randomly assigned to PCG or placebo group in a 1:1 ratio and followed for 24 weeks.
MAIN OUTCOME MEASURES


The primary outcome was the change from baseline to week 24 in HAM-D score among the set of patients who completed the study following the treatment protocol (per-protocol set). Secondary outcomes included changes in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) part 2 (UPDRS-II), UPDRS part 3 (UPDRS-III), Parkinson's Disease Sleep Scale (PDSS) and Hamilton Rating Scale for Anxiety (HAM-A), between baseline and week 24.
RESULTS


Eighty-six patients were enrolled, and 85 patients were included in the per-protocol set. HAM-D scores decreased by an adjusted mean of 11.77 (standard error [SE] 0.25) in the PCG group and 3.86 (SE 0.25) in the placebo group (between-group difference = 7.91, 95% confidence interval [7.22, 8.80], P < 0.001), in the multivariable linear regression. Improvements in scores on the UPDRS-II, UPDRS-III, PDSS, and HAM-A scales were also observed.
CONCLUSION


Treatment with PCG was well tolerated and improved depressive symptoms and motor and other non-motor symptoms in PD.
TRIAL REGISTRATION


Chinese Clinical Trial Register: ChiCTR-INR-17011949.",2021,"Improvements in scores on the UPDRS-II, UPDRS-III, PDSS, and HAM-A scales were also observed.
","['Longhua Hospital, Shanghai, China', 'HAM-D] score\xa0≥\xa08', ""Parkinson's disease (PD"", 'Eighty-six patients were enrolled, and 85 patients were included in the per-protocol set', ""Parkinson's disease (dPD"", ""parkinson's disease""]","['PCG or placebo', 'Pingchan Granule (PCG', 'PCG', 'placebo']","['tolerated and improved depressive symptoms and motor and other non-motor symptoms', '24-item Hamilton Rating Scale for Depression', 'depressive symptoms', 'HAM-D scores', 'HAM-D score', 'UPDRS-II, UPDRS-III, PDSS, and HAM-A scales', ""changes in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) part 2 (UPDRS-II), UPDRS part 3 (UPDRS-III), Parkinson's Disease Sleep Scale (PDSS) and Hamilton Rating Scale for Anxiety""]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",86.0,0.648952,"Improvements in scores on the UPDRS-II, UPDRS-III, PDSS, and HAM-A scales were also observed.
","[{'ForeName': 'Si-Chun', 'Initials': 'SC', 'LastName': 'Gu', 'Affiliation': 'Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. Electronic address: yeqing1982889@163.com.'}, {'ForeName': 'Can-Xing', 'Initials': 'CX', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. Electronic address: cxyuan1964@163.com.'}]",Journal of integrative medicine,['10.1016/j.joim.2020.12.006']
1015,33461636,"Divergence of dose-response with asenapine: a cluster analysis of randomized, double-blind, and placebo control study.","BACKGROUND


Differences in psychiatric background and dose-response to asenapine in patients with schizophrenia were examined based on efficacy and safety, using data obtained in a double-blind, placebo-controlled trial.
METHODS


Patients with schizophrenia were classified into three clusters by a cluster analysis based on the Positive and Negative Symptom Scale (PANSS) subscores at baseline, using the data from a 6-week, double-blind, placebo-controlled trial. PANSS Marder factor scores were calculated for each cluster. The efficacy of 10 or 20 mg/day of asenapine on PANSS score was used as the primary endpoint, with the incidence of adverse events evaluated as the secondary endpoint.
RESULTS


A total of 529 asenapine-treated patients were classified into 3 clusters: Cluster-P with the higher scores in positive symptoms, disorganized thoughts, and hostility/excitement, Cluster-N with higher scores in negative symptoms, and Cluster-L with overall lower scores. In Cluster-N and Cluster-L, both 10 and 20 mg/day groups showed significant improvement in PANSS scores, while only the 20 mg/day group showed a significant difference in Cluster-P. Cluster-N and Cluster-L had differences in the incidence of adverse events, but this was not seen in Cluster-P.
CONCLUSIONS


The efficacy and safety of asenapine 10 and 20 mg/day differed between the 3 clusters of patients. This suggests that background information regarding baseline psychiatric symptoms may affect the therapeutic response in patients with schizophrenia.",2021,,[],"['placebo', 'asenapine']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2000088', 'cui_str': 'Asenapine'}]",[],,0.474815,,"[{'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Takekita', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hiraoka', 'Affiliation': 'Medical Science Section, Pharmaceutical Research & Development Division, Meiji Seika Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Iwama', 'Affiliation': 'Regulatory & Datascience Department, Pharmaceutical Research & Development Division, Meiji Seika Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Naotaka', 'Initials': 'N', 'LastName': 'Sunada', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Nobuatsu', 'Initials': 'N', 'LastName': 'Aoki', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Funatsuki', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Chikashi', 'Initials': 'C', 'LastName': 'Takano', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Tomoyo', 'Initials': 'T', 'LastName': 'Yanagida', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Koshikawa', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Minami', 'Initials': 'M', 'LastName': 'Naito', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}]",CNS spectrums,['10.1017/S1092852921000043']
1016,33464924,Effects of Anterolateral Structure Augmentation on the In Vivo Kinematics of Anterior Cruciate Ligament-Reconstructed Knees.,"BACKGROUND


Double-bundle anterior cruciate ligament (ACL) reconstruction (ACLR) is a well-known treatment that restores the stability of ACL-deficient knees. However, some isolated ACL-reconstructed knees ultimately show rotatory laxity and develop osteoarthritis. Whether combined ACLR with anterolateral structure (ALS) augmentation (ALSA) can provide better improvement in the in vivo knee rotational kinematics remains unknown.
HYPOTHESIS


When compared with isolated double-bundle ACLR, combined double-bundle ACLR with ALSA can improve knee in vivo rotational kinematics and provide better restoration of knee kinematics.
STUDY DESIGN


Controlled laboratory study.
METHODS


Sixteen patients with unilateral ACL injury were randomly divided into 2 groups to receive either combined double-bundle ACLR and ALSA (ALSA group) or isolated double-bundle ACLR (ACLR group). All patients performed a single-leg lunge using the operative and nonoperative/contralateral legs under dual-fluoroscopic imaging system surveillance during a hospital visit at a minimum 1 year (12-13 months) of follow-up to assess the 6 degrees of freedom knee kinematics. Functional evaluation using the Lysholm and Marx rating scales and clinical examinations were also performed.
RESULTS


From full extension to approximately 90° of knee flexion at 5° intervals, the mean ± SD internal rotation of the reconstructed knees in the ALSA group (1.5°± 0.9°) was significantly smaller than that of the contralateral knees (8.2°± 1.9°;  P  = .008). The ALSA group knees also showed significantly ( P  = .045) more medial translation than the contralateral knees. In the ACLR group, the mean internal rotation of the reconstructed knee (6.0°± 2.1°) was significantly smaller than that of the contralateral knees (8.9°± 0.6°;  P  < .001). At full extension, the tibia was significantly more externally rotated than that of the contralateral legs (0.5°± 7.4° vs 7.6°± 3.4°,  P  = .049).
CONCLUSION


When compared with isolated double-bundle ACLR, double-bundle ACLR augmented with ALS reconstruction resulted in anterolateral rotatory overconstraint during the lunge motion.
CLINICAL RELEVANCE


Additional ALSA of double-bundle ACL-reconstructed knees overconstrained rotatory stability. Therefore, the use of ALSA for ACL-reconstructed knees should be considered with caution for patients with ACL deficiency and anterolateral rotatory instability. Longer-term follow-up to evaluate long-term outcomes and altered kinematics over time is recommended.",2021,The ALSA group knees also showed significantly ( P  = .045) more medial translation than the contralateral knees.,"['Anterior Cruciate Ligament-Reconstructed Knees', 'Sixteen patients with unilateral ACL injury', 'patients with ACL deficiency and anterolateral rotatory instability']","['combined double-bundle ACLR and ALSA (ALSA group) or isolated double-bundle ACLR (ACLR group', 'isolated double-bundle ACLR, double-bundle ACLR augmented with ALS reconstruction', 'combined ACLR with anterolateral structure (ALS) augmentation (ALSA', 'single-leg lunge using the operative and nonoperative/contralateral legs under dual-fluoroscopic imaging system surveillance', 'Double-bundle anterior cruciate ligament (ACL) reconstruction (ACLR', 'Anterolateral Structure Augmentation', 'ALSA', 'isolated double-bundle ACLR, combined double-bundle ACLR with ALSA']","['anterolateral rotatory overconstraint', 'medial translation', 'mean internal rotation of the reconstructed knee', 'rotatory laxity and develop osteoarthritis', 'mean ± SD internal rotation']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}]","[{'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]",16.0,0.0214788,The ALSA group knees also showed significantly ( P  = .045) more medial translation than the contralateral knees.,"[{'ForeName': 'Jiebo', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Sports Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'School of Biomedical Engineering and Med-X Research Institute, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Caiqi', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Department of Sports Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': ""Department of Sports Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Sports Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Tsung-Yuan', 'Initials': 'TY', 'LastName': 'Tsai', 'Affiliation': 'School of Biomedical Engineering and Med-X Research Institute, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jinzhong', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Sports Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}]",The American journal of sports medicine,['10.1177/0363546520981743']
1017,33467603,Acute Effects of Global Postural Re-Education on Non-Specific Low Back Pain. Does Time-of-Day Play a Role?,"Low back pain is one the most common forms of musculoskeletal disorders. Thus, several physiotherapeutic strategies (e.g., global postural re-education therapy) have been used for reducing low back pain. The aim of this study was to determinate if acute application of global postural re-education session associated effects are influenced by the time-of-day when this physical therapy is applied. Eight participants in a randomized, counterbalanced order were acutely tested both before and 24 h after a global postural re-education therapy session (10 min session) in three different time-of-day points; morning (i.e., AM; 7:00-9:00 h), midday (i.e., AM; 12:00-14:00 h) and afternoon (i.e., PM; 18:00-20:00 h). In each session, low back pain Visual Analogue Pain Scale [VAS]), flexibility, function capacity (Roland Morris Questionnaire [RMQ], and physical functioning Oswestry Disability Index [ODI]) were recorded. Results showed a pain reduction (VAS Scale) 24 h post Global postural re-education [GPR] session ( p  = 0.001) and increasing of flexibility pre-post GPR session in all the time-of-day points (morning, midday, and afternoon) ( p  = 0.001) while no differences were reported in RMQ ( p  = 0.969) and ODI ( p  = 0.767). Thus, acute GPR session produces the same effects on flexibility, low back pain, function capacity, and physical functioning values independently of time-of-day when it is applied.",2021,"24 h post Global postural re-education [GPR] session ( p  = 0.001) and increasing of flexibility pre-post GPR session in all the time-of-day points (morning, midday, and afternoon) ( p  = 0.001) while no differences were reported in RMQ ( p  = 0.969) and ODI ( p  = 0.767).",['Non-Specific Low Back Pain'],"['global postural re-education therapy session', 'Global Postural Re-Education', 'global postural re-education session']","['pain reduction (VAS Scale', 'flexibility, low back pain, function capacity, and physical functioning values', 'low back pain Visual Analogue Pain Scale [VAS]), flexibility, function capacity (Roland Morris Questionnaire [RMQ], and physical functioning Oswestry Disability Index [ODI', 'flexibility pre-post GPR session', 'RMQ']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0454282', 'cui_str': 'Posture training'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0085498', 'cui_str': 'Gram-positive bacillus'}]",,0.031419,"24 h post Global postural re-education [GPR] session ( p  = 0.001) and increasing of flexibility pre-post GPR session in all the time-of-day points (morning, midday, and afternoon) ( p  = 0.001) while no differences were reported in RMQ ( p  = 0.969) and ODI ( p  = 0.767).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Merinero', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Aragón', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Álvarez-González', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'López-Samanes', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'López-Pascual', 'Affiliation': 'Departamento de Economía de la Empresa, Universidad Rey Juan Carlos, Vicálvaro, 28032 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18020713']
1018,33445133,Anakinra compared to prednisone in the treatment of acute CPPD crystal arthritis: A randomized controlled double-blinded pilot study.,,2021,,['acute CPPD crystal arthritis'],['prednisone'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1739045', 'cui_str': ""N-CYCLOHEXYL-N'-PHENYL-1,4-PHENYLENEDIAMINE""}, {'cui': 'C0152087', 'cui_str': 'Crystal arthropathy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],,0.551721,,"[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dumusc', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland. Electronic address: alexandre.dumusc@chuv.ch.'}, {'ForeName': 'Borbala', 'Initials': 'B', 'LastName': 'Pazar Maldonado', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Benaim', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Lausanne University Hospital, 1005 Lausanne, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Zufferey', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland.'}, {'ForeName': 'Bérengère', 'Initials': 'B', 'LastName': 'Aubry-Rozier', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'So', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland.'}]",Joint bone spine,['10.1016/j.jbspin.2020.105088']
1019,33478179,The Effect of a Personalized Oral Health Education Program on Periodontal Health in an At-Risk Population: A Randomized Controlled Trial.,"While periodontal disease is associated with many risk factors, socioeconomically disadvantaged communities experience the highest disease burden. The aim of this study was to evaluate the effectiveness of a personalized oral health education program, in combination with routine dental treatment, in participants from a low socioeconomic community. We used a randomized, controlled, examiner-blinded clinical trial. A total of 579 participants (aged 18-60 years) were randomly grouped: the intervention group (n = 292) received a personalized oral health education program in combination with routine dental care and the control group (n = 287) received routine dental care. All participants were assessed for improvement in oral health care behaviors, dental plaque, and periodontal status at baseline, 12 months, and 24 months. We found a significant drop ( p  < 0.001) in the plaque indices, Periodontal Probing Depths (PPD) and Bleeding on Probing (BOP) between baseline and the 12-month follow-up for both groups. For BOP, the number of sites positive was significantly different between baseline and the 24-month follow-up ( p  = 0.037). No differences were found between the two groups for any evaluated clinical outcome. The personalized oral health education program used in the current study did not appear to add significant improvement to clinical outcomes of periodontal health compared with routine restorative dental care per se.",2021,"We found a significant drop ( p  < 0.001) in the plaque indices, Periodontal Probing Depths (PPD) and Bleeding on Probing (BOP) between baseline and the 12-month follow-up for both groups.","['Periodontal Health in an At-Risk Population', 'participants from a low socioeconomic community', '579 participants (aged 18-60 years']","['personalized oral health education program in combination with routine dental care and the control group', 'Personalized Oral Health Education Program', 'personalized oral health education program', 'routine dental care']","['plaque indices, Periodontal Probing Depths (PPD) and Bleeding on Probing (BOP', 'oral health care behaviors, dental plaque, and periodontal status', 'number of sites positive']","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0242444', 'cui_str': 'Populations at Risk'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445108', 'cui_str': 'Number of sites'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",579.0,0.0620985,"We found a significant drop ( p  < 0.001) in the plaque indices, Periodontal Probing Depths (PPD) and Bleeding on Probing (BOP) between baseline and the 12-month follow-up for both groups.","[{'ForeName': 'Eman S', 'Initials': 'ES', 'LastName': 'Almabadi', 'Affiliation': 'School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Camperdown, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': 'Prevention Research Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Rahena', 'Initials': 'R', 'LastName': 'Akhter', 'Affiliation': 'School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Camperdown, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gugusheff', 'Affiliation': 'Prevention Research Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Van Buskirk', 'Affiliation': 'Prevention Research Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Sankey', 'Affiliation': 'Oral Health Clinic, Logan Hospital, Meadowbrook, Queensland, QLD 4131, Australia.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Palmer', 'Affiliation': 'School of Dentistry, The University of Queensland, Herston, QLD 4072, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kavanagh', 'Affiliation': ""Centre for Children's Health Research and School of Psychology & Counselling, Queensland University of Technology (QUT), South Brisbane, QLD 4072, Australia.""}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Seymour', 'Affiliation': 'School of Dentistry, The University of Queensland, Herston, QLD 4072, Australia.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Cullinan', 'Affiliation': 'School of Dentistry, The University of Queensland, Herston, QLD 4072, Australia.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Eberhard', 'Affiliation': 'School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Camperdown, Sydney, NSW 2006, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph18020846']
1020,33493803,Coffee and cigarette smoking interactions with lamotrigine.,"The objective of this analysis was to determine possible interactions between lamotrigine (LTG) and coffee or cigarette use. As part of the statistical analysis of factors influencing LTG pharmacokinetics (PK) in the Equigen chronic dose study, we collected prospective data from enrolled patients on their use of coffee and cigarettes. Subjects were part of a crossover replication study of generic LTG products with rigorous blood sampling and were instructed to not change their typical consumption of these products for the duration of the study. A total of 35 subjects were enrolled, with 33 subjects having sufficient data for analysis. Higher consumption of coffee was associated with a significantly lower area under the curve (AUC) and maximum concentration (Cmax) of lamotrigine (LTG). Higher cigarette use did not result in a significant change in AUC or Cmax. Coffee, but not cigarette use, either induces LTG metabolism or inhibits LTG absorption.",2021,Higher consumption of coffee was associated with a significantly lower area under the curve (AUC) and maximum concentration (Cmax) of lamotrigine (LTG).,"['35 subjects were enrolled, with 33 subjects having sufficient data for analysis', 'enrolled patients on their use of coffee and cigarettes']","['lamotrigine (LTG', 'generic LTG products with rigorous blood sampling', 'lamotrigine']","['AUC or Cmax', 'lower area under the curve (AUC) and maximum concentration (Cmax) of lamotrigine (LTG', 'Higher consumption of coffee']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}]",35.0,0.0222585,Higher consumption of coffee was associated with a significantly lower area under the curve (AUC) and maximum concentration (Cmax) of lamotrigine (LTG).,"[{'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Welty', 'Affiliation': 'College of Pharmacy and Health Sciences, Drake University, Des Moines, IA, USA. Electronic address: timothy.welty@drake.edu.'}, {'ForeName': 'Barry E', 'Initials': 'BE', 'LastName': 'Gidal', 'Affiliation': 'School of Pharmacy, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Privitera', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Michel J', 'Initials': 'MJ', 'LastName': 'Berg', 'Affiliation': 'School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Krebill', 'Affiliation': 'School of Medicine, University of Kansas Medical Center, Kansas City, KA, USA.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Szaflarski', 'Affiliation': 'School of Medicine, University of Alabama Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Diaz', 'Affiliation': 'School of Medicine, University of Kansas Medical Center, Kansas City, KA, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107741']
1021,33497850,Does cognitive training improve attention/working memory in persons with MS? A pilot study using the Cogmed Working Memory Training program.,"BACKGROUND


Cognitive deficits, especially in attention, are common in persons with MS (PwMS) and are associated with clinically meaningful outcomes, such as work disability and lower quality of life (QOL). In this study, we aimed to determine whether Cogmed Working Memory Training (CWMT) improves attention/working memory in PwMS displaying impairment in these domains.
METHODS


This single blind, randomized controlled, pilot study compared the effects of CWMT, a five-week evidenced-based computer-assisted training program that is supported by weekly meetings with a coach, to standard medical care (treatment as usual). We recruited PwMS from one MS center (London (ON) Canada), aged 18-64, with an Expanded Disability Status Scale (EDSS) score of ≤ 7.0, and a visual acuity (corrected) of at least 20/70. Potential subjects had to demonstrate impaired attention on at least two of three measures (Paced Auditory Serial Addition Test [PASAT], Symbol Digit Modalities Test [SDMT], and/or DKEFS Color-Word Interference Test); these measures also served as the primary study outcomes. Subjects were randomized to either the CWMT or treatment as usual. Secondary cognitive outcomes included other measures of attention, memory, as well as a self-reported cognitive function measure. Self-reported measures of mood (depression and anxiety), pain, and QOL were also included as other secondary outcomes. Subjects received assessments at baseline, post-treatment, and 6-month follow-up, or an equivalent time period for the treatment as usual group. The two groups were compared at baseline on background measures using independent samples t-tests, Chi-Square tests, and Mann-Whitney U tests. To analyze primary and secondary outcomes, a non-parametric approach was used due the small sample size and that many of our outcomes did not meet assumptions for parametric analyses. Friedman's test was conducted followed by post hoc pairwise comparisons within each group using Wilcoxon Signed-Rank tests with Bonferroni corrected post hoc contrasts, which allowed us to examine for differences between time points.
RESULTS


Of 30 subjects, 15 were assigned to CWMT. Significant training effects were noted in 1 of 3 primary attentional outcomes (DKEFS Color-Word Interference Test), 2 of 3 secondary attentional outcomes (Letter-Number Sequencing, Digit Span), and 1 mood scale (Hospital Anxiety and Depression scale (HADS) - Depression Subscale), ps < .025. No significant changes were observed in the treatment as usual group.
CONCLUSION


This pilot study demonstrates that cognitive training with CWMT has the potential to improve attention/working memory in PwMS, as well as a potential positive effect on mood, in PwMS. Further exploration of this intervention in PwMS with attention/working memory impairment is warranted.",2021,"Significant training effects were noted in 1 of 3 primary attentional outcomes (DKEFS Color-Word Interference Test), 2 of 3 secondary attentional outcomes (Letter-Number Sequencing, Digit Span), and 1 mood scale (Hospital Anxiety and Depression scale (HADS) - Depression Subscale), ps < .025.","['We recruited PwMS from one MS center (London (ON) Canada), aged 18-64, with an Expanded Disability Status Scale (EDSS) score of ≤ 7.0, and a visual acuity (corrected) of at least 20/70', 'persons with MS (PwMS', '30 subjects', 'persons with MS']","['CWMT', 'cognitive training with CWMT', 'cognitive training', 'Cogmed Working Memory Training program', 'Cogmed Working Memory Training (CWMT']","['measures (Paced Auditory Serial Addition Test [PASAT], Symbol Digit Modalities Test [SDMT], and/or DKEFS Color-Word Interference Test', '3 primary attentional outcomes (DKEFS Color-Word Interference Test), 2 of 3 secondary attentional outcomes (Letter-Number Sequencing, Digit Span), and 1 mood scale (Hospital Anxiety and Depression scale (HADS) - Depression Subscale', 'measures of attention, memory, as well as a self-reported cognitive function measure', 'mood (depression and anxiety), pain, and QOL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0461683,"Significant training effects were noted in 1 of 3 primary attentional outcomes (DKEFS Color-Word Interference Test), 2 of 3 secondary attentional outcomes (Letter-Number Sequencing, Digit Span), and 1 mood scale (Hospital Anxiety and Depression scale (HADS) - Depression Subscale), ps < .025.","[{'ForeName': 'Mervin', 'Initials': 'M', 'LastName': 'Blair', 'Affiliation': 'Lawson Health Research Institute, Clinical Neuropsychiatry & Therapeutic Brain Stimulation Research, Ontario Shores Centre for Mental Health Sciences, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Goveas', 'Affiliation': 'Lawson Health Research Institute, Clinical Neuropsychiatry & Therapeutic Brain Stimulation Research, Ontario Shores Centre for Mental Health Sciences, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Ajmal', 'Initials': 'A', 'LastName': 'Safi', 'Affiliation': 'Lawson Health Research Institute, Clinical Neuropsychiatry & Therapeutic Brain Stimulation Research, Ontario Shores Centre for Mental Health Sciences, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Marshall', 'Affiliation': 'Parkwood Institute, Rehabilitation Program, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rosehart', 'Affiliation': 'Western University, Department of Clinical Neurological Sciences and, Parkwood Institute, Department of Cognitive Neurology London Health Sciences Center, London, ON Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Orenczuk', 'Affiliation': 'Parkwood Institute, Veterans Care Program, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Morrow', 'Affiliation': 'Western University, Department of Clinical Neurological Sciences and, Parkwood Institute, Department of Cognitive Neurology London Health Sciences Center, London, ON Canada. Electronic address: Sarah.morrow@lhsc.on.ca.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102770']
1022,33429174,Corticosteroid nasal spray for recovery of smell sensation in COVID-19 patients: A randomized controlled trial.,"OBJECTIVES


To evaluate the role of the topical corticosteroid, mometasone furoate, nasal spray in the treatment of post COVID-19 anosmia.
METHODS


A prospective, randomized, controlled trial was conducted among patients with post COVID-19 anosmia. One hundred patients were randomly assigned to two groups; group I included 50 patients received mometasone furoate nasal spray in an appropriate dose of 2 puff (100 μg) once daily in each nostril for 3 weeks with olfactory training, group II included 50 patients were advised to keep on olfactory training only. The assessment of smell was done using (Visual Analog Scale from 0 to 10). All patients were initially evaluated after their recovery from COVID-19 and followed up for 3 weeks. The smell scores were recorded weekly and the duration of smell loss was recorded from the onset of anosmia till the full recovery.
RESULTS


In both groups, the smell scores significantly improved by the end of the third week (P < 0.001). By comparing smell scores between both groups after 1 week, 2 weeks, and 3 weeks of treatment, there were no statistically significant differences between both groups. In group I, (62%) of patients completely recovered their sense of smell after 3 weeks of treatment, compared to (52%) of patients in group II (P = 0.31).
CONCLUSION


The results suggested that using mometasone furoate nasal spray as a topical corticosteroid in the treatment of post COVID-19 anosmia offers no superiority benefits over the olfactory training, regarding smell scores, duration of anosmia, and recovery rates.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT04484493.",2021,"In both groups, the smell scores significantly improved by the end of the third week (P < 0.001).","['COVID-19 patients', 'patients with post COVID-19 anosmia', 'One hundred patients']","['mometasone furoate nasal spray', 'topical corticosteroid, mometasone furoate, nasal spray', 'mometasone furoate nasal spray in an appropriate dose of 2 puff (100\xa0μg) once daily in each nostril for 3\xa0weeks with olfactory training, group II included 50 patients were advised to keep on olfactory training only', 'Corticosteroid nasal spray']","['smell scores', 'duration of smell loss', 'smell sensation', 'sense of smell', 'smell scores, duration of anosmia, and recovery rates']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",100.0,0.123019,"In both groups, the smell scores significantly improved by the end of the third week (P < 0.001).","[{'ForeName': 'Abdelrahman Ahmed', 'Initials': 'AA', 'LastName': 'Abdelalim', 'Affiliation': 'Department of Otorhinolaryngology, Benha Faculty of Medicine, Benha University, Egypt. Electronic address: abdelrahman.ahmed@fmed.bu.edu.eg.'}, {'ForeName': 'Ayman Abdelaal', 'Initials': 'AA', 'LastName': 'Mohamady', 'Affiliation': 'Department of Otorhinolaryngology, Benha Faculty of Medicine, Benha University, Egypt.'}, {'ForeName': 'Rasha Abdelhamid', 'Initials': 'RA', 'LastName': 'Elsayed', 'Affiliation': 'Department of Medical Microbiology and Immunology, Benha Faculty of Medicine, Benha University, Egypt.'}, {'ForeName': 'Mona Ahmed', 'Initials': 'MA', 'LastName': 'Elawady', 'Affiliation': 'Department of Public Health, Benha Faculty of Medicine, Benha University, Egypt.'}, {'ForeName': 'Abdelhakim Fouad', 'Initials': 'AF', 'LastName': 'Ghallab', 'Affiliation': 'Department of Otorhinolaryngology, Benha Faculty of Medicine, Benha University, Egypt.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102884']
1023,33459692,Effect of resistance exercises applying maximum expiration on the respiratory muscle strength of elderly women.,"BACKGROUND


Respiratory-muscle weakness is an important clinical problem. The respiratory system's health is a decisive factor in the physical and social life of the elderly. Changes in respiratory muscular strength and function activate the torso's adjustment ability, which affects daily activities.
OBJECTIVE


This study aimed to investigate the effects of resistance exercises combined with breathing exercises on the respiratory-muscle strength of elderly women.
METHOD


This study included 26 elderly woman, who were randomly divided into two sub-groups of 13 participants each. The experimental group performed breathing exercises and dynamic upper- and lower-extremity exercises, and the control group practiced only dynamic upper- and lower-extremity exercises. The maximum expiratory pressure (MEP) and maximum inspiratory pressure (MIP) were measured both before and at the end of the six-week study.
RESULTS


In both groups, both the post-test MIPs and MEPs were significantly higher than the pre-intervention ones (p< 0.05). For MIPs, the between-group difference was not statistically significant, either before the intervention or post-test (p> 0.05). For MEPs, the between-group difference was statistically significant at post-intervention points (p< 0.05).
CONCLUSION


The results showed that resistance exercises applying maximum expiration improved the respiratory-muscle strength of elderly women. These findings indicate that resistance exercises applying maximum expiration as described here in should be considered in patients who require breathing therapy, because the combination seems to significantly increase the strength of the respiratory muscles.",2020,"In both groups, both the post-test MIPs and MEPs were significantly higher than the pre-intervention ones (p< 0.05).","['elderly women', '26 elderly woman, who were randomly divided into two sub-groups of 13 participants each']","['resistance exercises applying maximum expiration', 'breathing exercises and dynamic upper- and lower-extremity exercises, and the control group practiced only dynamic upper- and lower-extremity exercises', 'resistance exercises combined with breathing exercises']","['respiratory-muscle strength', 'maximum expiratory pressure (MEP) and maximum inspiratory pressure (MIP']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}]",26.0,0.0180069,"In both groups, both the post-test MIPs and MEPs were significantly higher than the pre-intervention ones (p< 0.05).","[{'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Young Mi', 'Initials': 'YM', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Kyoung', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181166']
1024,33464545,Effect of Food on the Pharmacokinetics of the Oral Docetaxel Tablet Formulation ModraDoc006 Combined with Ritonavir (ModraDoc006/r) in Patients with Advanced Solid Tumours.,"INTRODUCTION


ModraDoc006 is a novel docetaxel tablet formulation that is co-administrated with the cytochrome P450 3A4 and P-glycoprotein inhibitor ritonavir (r): ModraDoc006/r.
OBJECTIVES


This study evaluated the effect of food consumed prior to administration of ModraDoc006/r on the pharmacokinetics of docetaxel and ritonavir.
METHODS


Patients with advanced solid tumours were enrolled in this randomized crossover study to receive ModraDoc006/r in a fasted state in week 1 and after a standardized high-fat meal in week 2 and vice versa. Pharmacokinetic sampling was conducted until 48 h after both study drug administrations. Docetaxel and ritonavir plasma concentrations were determined using liquid chromatography with tandem mass spectrometry. Safety was evaluated with the Common Terminology Criteria for Adverse Events, version 4.03.
RESULTS


In total, 16 patients completed the food-effect study. The geometric mean ratio (GMR) for the docetaxel area under the plasma concentration-time curve (AUC) 0-48 , AUC 0-inf  and maximum concentration (C max ) were 1.11 (90% confidence interval [CI] 0.93-1.33), 1.19 (90% CI 1.00-1.41) and 1.07 (90% CI 0.81-1.42) in fed versus fasted conditions, respectively. For the ritonavir C max , the GMR was 0.79 (90% CI 0.69-0.90), whereas the AUC 0-48  and AUC 0-inf  were bioequivalent. The most frequent treatment-related toxicities were grade ≤ 2 diarrhoea and fatigue. Hypokalaemia was the only observed treatment-related grade 3 toxicity.
CONCLUSIONS


The docetaxel and ritonavir exposure were not bioequivalent, as consumption of a high-fat meal prior to administration of ModraDoc006/r resulted in a slightly higher docetaxel exposure and lower ritonavir C max . Since docetaxel exposure is the only clinically relevant parameter in our patient population, the overall conclusion is that combined ModraDoc006 and ritonavir treatment may be slightly affected by concomitant intake of a high-fat meal. In view of the small effect, it is most likely that the intake of a light meal will not affect the systemic exposure to docetaxel. CLINICALTRIALS.
GOV IDENTIFIER


NCT03147378, date of registration: May 10 2017.",2021,"For the ritonavir C max , the GMR was 0.79 (90% CI 0.69-0.90), whereas the AUC 0-48  and AUC 0-inf  were bioequivalent.","['Patients with Advanced Solid Tumours', 'Patients with advanced solid tumours']","['ModraDoc006/r', 'Oral Docetaxel Tablet Formulation ModraDoc006', 'glycoprotein inhibitor ritonavir (r', 'Ritonavir (ModraDoc006/r', 'docetaxel and ritonavir']","['geometric mean ratio (GMR', 'Docetaxel and ritonavir plasma concentrations', 'Hypokalaemia', 'plasma concentration-time curve (AUC) 0-48 , AUC 0-inf  and maximum concentration (C max ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",16.0,0.0622561,"For the ritonavir C max , the GMR was 0.79 (90% CI 0.69-0.90), whereas the AUC 0-48  and AUC 0-inf  were bioequivalent.","[{'ForeName': 'Marit A C', 'Initials': 'MAC', 'LastName': 'Vermunt', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066CX, Amsterdam, The Netherlands. m.vermunt@nki.nl.'}, {'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'de Weger', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Janssen', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Lopez-Yurda', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Keessen', 'Affiliation': 'Modra Pharmaceuticals BV, Amsterdam, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Thijssen', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Rosing', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Alwin D R', 'Initials': 'ADR', 'LastName': 'Huitema', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Jos H', 'Initials': 'JH', 'LastName': 'Beijnen', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Marchetti', 'Affiliation': 'Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}]",Drugs in R&D,['10.1007/s40268-020-00336-x']
1025,33433595,Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial.,"Importance


It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations. Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation.
Objective


To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial.
Design, Setting, and Participants


This survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020.
Exposure


Parental choice of enrollment in neonatal clinical trial.
Main Outcomes and Measures


Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers.
Results


Of a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment.
Conclusions and Relevance


In this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and reported income), perception of illness, and trust in medical researchers. Future work to confirm these findings and explore the reasons behind them may lead to strategies for better engaging underrepresented groups in neonatal clinical research to reduce enrollment disparities.",2021,"Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73).","['This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents', 'Participants\n\n\nThis survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment', ""parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers"", 'parents from racial or ethnic minority populations', 'parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial', 'Results\n\n\nOf a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis']",[],"[""Measures\n\n\nPercentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers"", 'enrollment rates', 'rates of Medicaid participation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0004044', 'cui_str': 'Asphyxiation'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}]",387.0,0.23368,"Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73).","[{'ForeName': 'Elliott Mark', 'Initials': 'EM', 'LastName': 'Weiss', 'Affiliation': ""Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Aleksandra E', 'Initials': 'AE', 'LastName': 'Olszewski', 'Affiliation': ""Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Katherine F', 'Initials': 'KF', 'LastName': 'Guttmann', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Brooke E', 'Initials': 'BE', 'LastName': 'Magnus', 'Affiliation': 'Department of Psychology and Neuroscience, Boston College, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of Washington School of Public Health, Seattle.'}, {'ForeName': 'Anita R', 'Initials': 'AR', 'LastName': 'Shah', 'Affiliation': ""Division of Neonatology, Children's Hospital of Orange County, Orange, California.""}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Yvonne W', 'Initials': 'YW', 'LastName': 'Wu', 'Affiliation': 'Departments of Neurology and Pediatrics, University of California San Francisco School of Medicine, San Francisco.'}, {'ForeName': 'Kaashif A', 'Initials': 'KA', 'LastName': 'Ahmad', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, San Antonio, Texas.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bendel-Stenzel', 'Affiliation': 'Department of Pediatrics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Natalia A', 'Initials': 'NA', 'LastName': 'Isaza', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Children's National Hospital, George Washington University School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Lampland', 'Affiliation': ""Department of Neonatology, Children's Minnesota Hospital, Minneapolis.""}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Mathur', 'Affiliation': 'Department of Pediatrics, St Louis University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Riley', 'Affiliation': ""Department of Pediatrics, Cook Children's Medical Center, Fort Worth, Texas.""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Russell', 'Affiliation': ""Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Zeynep N I', 'Initials': 'ZNI', 'LastName': 'Salih', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Torr', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Joern-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Uchenna E', 'Initials': 'UE', 'LastName': 'Anani', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': ""Department of Neurology, Children's National Hospital, George Washington University School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': 'Juanita', 'Initials': 'J', 'LastName': 'Dudley', 'Affiliation': ""Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Flibotte', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Havrilla', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Charmaine M', 'Initials': 'CM', 'LastName': 'Kathen', 'Affiliation': 'Pediatrix Medical Group, San Antonio, Texas.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': ""O'Kane"", 'Affiliation': ""Department of Neurology, Children's National Hospital, George Washington University School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': 'Krystle', 'Initials': 'K', 'LastName': 'Perez', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Brenda J', 'Initials': 'BJ', 'LastName': 'Stanley', 'Affiliation': 'Pediatrix Medical Group, San Antonio, Texas.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Wilfond', 'Affiliation': ""Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Seema K', 'Initials': 'SK', 'LastName': 'Shah', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.32106']
1026,33433351,"Bioequivalence study of two perindopril tert-butylamine tablet formulations in healthy Chinese subjects under fasting and fed conditions: A randomized, open-label, single-dose, crossover trial.","BACKGROUND


To evaluate the bioequivalence between test and reference formulations of perindopril tert-butylamine under fasting and fed conditions and to assess their pharmacokinetic (PK) and safety profiles.
METHOD


A randomized, open-label, single-dose, crossover trial was conducted in healthy Chinese subjects. Test or reference perindopril tert-butylamine tablets (4 mg) were randomly given to subjects under fasting (2-period crossover, with an administration sequence of test tablet (T), reference tablet (R) or RT) and fed (4-period crossover, with an administration sequence of TRTR or RTRT) conditions, while each single administration was followed by a 14-day washout period. The plasma concentrations and corresponding non-compartmental PK parameters of perindopril and perindoprilat were determined. The two formulations were considered to be bioequivalent if the 90 % confidence intervals (CIs) of the geometric mean (GM) ratio (test/reference) for C max , AUC 0-t , and AUC 0-∞  (perindopril) was both within the range of 80-125 %. Safety assessments including vital signs, physical examination, laboratory examination, 12-lead ECG and reports of treatment emergent adverse events (TEAEs) were carefully documented.
RESULTS


A total of 64 subjects (32 in each trial) were randomized and all completed the trials. Regardless of fasting or fed trials, the PK characteristics of perindopril and perindoprilat for the test formulation were similar to those of the reference formulation (all P > 0.05). The 90 % CIs of the geometric mean (GM) ratio for C max , AUC 0-t,  and AUC 0-∞ , respectively, were 92.86-106.81 %, 98.44-102.88 % and 98.48-103.02 % under the fasting condition and 90.64-110.04 %, 96.95-101.90 % and 96.83-101.78 % under the fed condition, which were both within the pre-specified range of 80-125 %. A total of 10 (31.3 %) fasted subjects and 11 (34.4 %) fed subjects experienced 11 and 24 TEAEs, respectively, all of which were within the severity of grade 1. The incidence of TEAEs and drug-related TEAEs were similar between test and reference formulations (all P > 0.05) and no serious TEAEs or deaths occurred during the trials.
CONCLUSIONS


The test and reference formulations of perindopril tert-butylamine tablets (4 mg) were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions.",2021,"The incidence of TEAEs and drug-related TEAEs were similar between test and reference formulations (all P > 0.05) and no serious TEAEs or deaths occurred during the trials.
","['healthy Chinese subjects under fasting and fed conditions', '64 subjects (32 in each trial', 'healthy Chinese subjects']","['perindopril and perindoprilat', 'perindopril tert-butylamine tablets', 'subjects under fasting (2-period crossover, with an administration sequence of test tablet (T), reference tablet (R) or RT) and fed (4-period crossover, with an administration sequence of TRTR or RTRT', 'perindopril tert-butylamine tablet formulations', 'perindopril tert-butylamine']","['pharmacokinetic (PK) and safety profiles', 'geometric mean (GM) ratio for C max , AUC 0-t,  and AUC', 'geometric mean (GM) ratio (test/reference) for C max , AUC 0-t , and AUC 0-∞  (perindopril', 'vital signs, physical examination, laboratory examination, 12-lead ECG and reports of treatment emergent adverse events (TEAEs', 'plasma concentrations', 'incidence of TEAEs and drug-related TEAEs']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0070426', 'cui_str': 'perindoprilat'}, {'cui': 'C0244718', 'cui_str': 'Perindopril erbumine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",64.0,0.076156,"The incidence of TEAEs and drug-related TEAEs were similar between test and reference formulations (all P > 0.05) and no serious TEAEs or deaths occurred during the trials.
","[{'ForeName': 'Qiuying', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Unit, General Hospital of Northern Theater Command, Shenyang, 110840, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Hao', 'Affiliation': 'Phase I Clinical Trial Unit, General Hospital of Northern Theater Command, Shenyang, 110840, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Phase I Clinical Trial Unit, General Hospital of Northern Theater Command, Shenyang, 110840, China.'}, {'ForeName': 'Yunbiao', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Phase I Clinical Trial Unit, General Hospital of Northern Theater Command, Shenyang, 110840, China. Electronic address: tangyb99@163.com.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2021.111221']
1027,33477587,Chronic Effects of a Training Program Using a Nasal Inspiratory Restriction Device on Elite Cyclists.,"This study compared the response of a 9-week cycling training on ventilatory efficiency under two conditions: (i) Combined with respiratory muscle training (RMT) using a new nasal restriction device (FeelBreathe) (FB group) and (ii) without RMT (Control group). Eighteen healthy elite cyclists were randomly separated into the FB group ( n  = 10) or Control group ( n  = 8). Gas exchange was measured breath by breath to measure ventilatory efficiency during an incremental test on a cycloergometer before (Pre) and after (Post) the nine weeks of training. The FB group showed higher peak power (Δ (95%HDI) (0.82 W/kg (0.49, 1.17)), VO 2 max (5.27 mL/kg/min (0.69, 10.83)) and VT 1  (29.3 W (1.8, 56.7)) compared to Control at Post FINAL . The FB group showed lower values from Pre to Post PRE  in minute ventilation (VE) (-21.0 L/min (-29.7, -11.5)), Breathing frequency (BF) (-5.1 breaths/min (-9.4, -0.9)), carbon dioxide output (VCO 2 ) (-0.5 L/min (-0.7, -0.2)), respiratory equivalents for oxygen (EqO 2 ) (-0.8 L/min (-2.4, 0.8)), heart rate (HR) (-5.9 beats/min (-9.2, -2.5)),, respiratory exchange ratio (RER) (-0.1 (-0.1, -0.0) and a higher value in inspiratory time (Tin) (0.05 s (0.00, 0.10)), expiratory time (Tex) (0.11 s (0.05, 0.17)) and end-tidal partial pressure of CO 2  ( PETCO 2 ) (0.3 mmHg (0.1, 0.6)). In conclusion, RMT using FB seems to be a new and easy alternative ergogenic tool which can be used at the same time as day-to-day training for performance enhancement.",2021,"The FB group showed higher peak power (Δ (95%HDI) (0.82 W/kg (0.49, 1.17)), VO 2 max (5.27 mL/kg/min (0.69, 10.83)) and VT 1  (29.3 W (1.8, 56.7)) compared to Control at Post FINAL .","['Elite Cyclists', 'Eighteen healthy elite cyclists']","['conditions: (i) Combined with respiratory muscle training (RMT) using a new nasal restriction device (FeelBreathe) (FB group) and (ii) without RMT (Control group', 'Training Program Using a Nasal Inspiratory Restriction Device', '9-week cycling training']","['carbon dioxide output (VCO 2 ', 'ventilatory efficiency', 'respiratory equivalents for oxygen (EqO 2 ', 'respiratory exchange ratio (RER', 'inspiratory time (Tin', 'Breathing frequency (BF', 'higher peak power', 'expiratory time (Tex', 'heart rate (HR', 'end-tidal partial pressure of CO']","[{'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0429247', 'cui_str': 'Carbon dioxide output'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428687', 'cui_str': 'Expiratory time'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}]",18.0,0.018187,"The FB group showed higher peak power (Δ (95%HDI) (0.82 W/kg (0.49, 1.17)), VO 2 max (5.27 mL/kg/min (0.69, 10.83)) and VT 1  (29.3 W (1.8, 56.7)) compared to Control at Post FINAL .","[{'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Gonzalez-Montesinos', 'Affiliation': 'Department of Physical Education, Faculty of Education Sciences, University of Cádiz, Puerto Real, 11003 Cádiz, Spain.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Fernandez-Santos', 'Affiliation': 'Galeno Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Cádiz, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vaz-Pardal', 'Affiliation': 'Bahía Sur Andalusian Center for Sports Medicine, 11100 Cádiz, Spain.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Aragon-Martin', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, Puerta del Mar University Hospital University of Cádiz, 11009 Cádiz, Spain.'}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Arnedillo-Muñoz', 'Affiliation': 'Allergy and Thoracic Surgery Department, University Hospital Puerta del Mar. Pneumology, 11009 Cádiz, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Reina-Novo', 'Affiliation': 'National Cycling Coach, IES, Stadium Path 2504, Hong Kong.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Orantes-Gonzalez', 'Affiliation': 'Department of Physical Education & Sports, University of Granada, 18010 Granada, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Heredia-Jimenez', 'Affiliation': 'Department of Physical Education & Sports, University of Granada, 18010 Granada, Spain.'}, {'ForeName': 'Jesus G', 'Initials': 'JG', 'LastName': 'Ponce-Gonzalez', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, Puerta del Mar University Hospital University of Cádiz, 11009 Cádiz, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18020777']
1028,33462851,A Bayesian-bandit adaptive design for N-of-1 clinical trials.,"N-of-1 trials, which are randomized, double-blinded, controlled, multiperiod, crossover trials on a single subject, have been applied to determine the heterogeneity of the individual's treatment effect in precision medicine settings. An aggregated N-of-1 design, which can estimate the population effect from these individual trials, is a pragmatic alternative when a randomized controlled trial (RCT) is infeasible. We propose a Bayesian adaptive design for both the individual and aggregated N-of-1 trials using a multiarmed bandit framework that is estimated via efficient Markov chain Monte Carlo. A Bayesian hierarchical structure is used to jointly model the individual and population treatment effects. Our proposed adaptive trial design is based on Thompson sampling, which randomly allocates individuals to treatments based on the Bayesian posterior probability of each treatment being optimal. While we use a subject-specific treatment effect and Bayesian posterior probability estimates to determine an individual's treatment allocation, our hierarchical model facilitates these individual estimates to borrow strength from the population estimates via shrinkage to the population mean. We present the design's operating characteristics and performance via a simulation study motivated by a recently completed N-of-1 clinical trial. We demonstrate that from a patient-centered perspective, subjects are likely to benefit from our adaptive design, in particular, for those individuals that deviate from the overall population effect.",2021,"Our proposed adaptive trial design is based on Thompson sampling, which randomly allocates individuals to treatments based on the Bayesian posterior probability of each treatment being optimal.",[],[],[],[],[],[],,0.300841,"Our proposed adaptive trial design is based on Thompson sampling, which randomly allocates individuals to treatments based on the Bayesian posterior probability of each treatment being optimal.","[{'ForeName': 'Sama', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Biostatistics Research Center, Herbert Wertheim School of Public Health, University of California, San Diego, California, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Biostatistics Research Center, Herbert Wertheim School of Public Health, University of California, San Diego, California, USA.'}]",Statistics in medicine,['10.1002/sim.8873']
1029,33464316,Assessment of Racial Differences in Pharmacotherapy Efficacy for Smoking Cessation: Secondary Analysis of the EAGLES Randomized Clinical Trial.,"Importance


Understanding Black vs White differences in pharmacotherapy efficacy and the underlying reasons is critically important to reducing tobacco-related health disparities.
Objective


To compare pharmacotherapy efficacy and examine variables to explain Black vs White differences in smoking abstinence.
Design, Setting, and Participants


This study is a secondary analysis of the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) double-blind, placebo-controlled, randomized clinical trial, which took place at clinical trial centers, academic centers, and outpatient clinics in 29 states in the US. US Black and White smokers who smoked 10 or more cigarettes per day with and without psychiatric comorbidity were enrolled between November 2011 and January 2015. Data analysis was performed from July 2019 to January 2020.
Interventions


Participants were randomized (1:1:1:1) in a double-blind, triple-dummy, placebo- and active-controlled (nicotine patch) trial of varenicline and bupropion for 12 weeks with follow-up through week 24.
Main Outcomes and Measures


Biochemically verified continuous cigarette abstinence rate (CAR) from weeks 9 to 24. Baseline, postbaseline treatment, and safety characteristics were examined as variables to explain race differences in abstinence.
Results


Of the 1065 Black smokers enrolled, 255 were randomized to receive varenicline, 259 received bupropion, 286 received nicotine replacement therapy (NRT [ie, nicotine patch]), and 265 received placebo. Among the 3044 White smokers enrolled, 778 were randomized to receive varenicline, 769 received bupropion, 738 received NRT, and 759 received placebo. Participants were predominantly female (614 Black [57.7%] and 1786 White [58.7%] women) and heavy smokers (mean [SD] cigarettes per day, 18.2 [7.9] for Black and 20.0 [7.5] for White smokers), with a mean (SD) age of 47.2 (11.2) years for Black and 46.5 (12.7) years for White participants. Treatment and race were associated with CAR for weeks 9 to 24. The CAR was 4.9% lower for Black vs White participants (odds ratio [OR], 0.53; 95% CI, 0.41-0.69; P < .001); differences were found across all treatments. Pooling psychiatric and nonpsychiatric cohorts, varenicline (OR, 2.63; 95% CI, 1.90-3.63; P < .001), bupropion (OR, 1.75; 95% CI, 1.25-2.46; P = .001), and NRT (OR, 1.52; 95% CI, 1.07-2.16; P = .02) had greater efficacy than placebo for White participants. Only varenicline (OR, 2.63; 95% CI, 1.26-5.48; P = .01) had greater efficacy than placebo for Black participants. Baseline, postbaseline, and safety characteristics differed by race, but these variables did not eliminate the association of race with CAR. Black participants had 49% reduced odds of CAR for weeks 9 to 24 compared with White participants in the adjusted model (OR, 0.51; 95% CI, 0.39-0.66; P < .001).
Conclusions and Relevance


Black and White smokers achieved the highest rate of abstinence while taking varenicline, suggesting that it is the best first-line therapy for these groups. However, Black smokers were less responsive to all therapies, including placebo. Understanding variables (eg, socioeconomic or biological) beyond those may lead to improved treatment outcomes for Black smokers.
Trial Registration


ClinicalTrials.gov Identifier: NCT01456936.",2021,"Only varenicline (OR, 2.63; 95% CI, 1.26-5.48; P = .01) had greater efficacy than placebo for Black participants.","['US Black and White smokers who smoked 10 or more cigarettes per day with and without psychiatric comorbidity were enrolled between November 2011 and January 2015', '3044 White smokers enrolled, 778 were randomized to receive', 'Smoking Cessation', 'academic centers, and outpatient clinics in 29 states in the US', 'Black smokers', 'Participants were predominantly female (614 Black [57.7%] and 1786 White [58.7%] women) and heavy smokers (mean [SD] cigarettes per day, 18.2\u2009[7.9] for Black and 20.0\u2009[7.5] for White smokers), with a mean (SD) age of 47.2\u2009(11.2) years for Black and 46.5\u2009(12.7) years for White participants', '1065 Black smokers enrolled, 255 were randomized to receive']","['placebo', 'bupropion', 'placebo- and active-controlled (nicotine patch) trial of varenicline and bupropion', 'bupropion, 738 received NRT', 'varenicline', 'nicotine replacement therapy (NRT [ie, nicotine patch']","['odds of CAR', 'continuous cigarette abstinence rate (CAR']","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517546', 'cui_str': '12.7'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",1065.0,0.504721,"Only varenicline (OR, 2.63; 95% CI, 1.26-5.48; P = .01) had greater efficacy than placebo for Black participants.","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': 'Alpert Medical School, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sanderson Cox', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Kolawole', 'Initials': 'K', 'LastName': 'Okuyemi', 'Affiliation': 'Department of Family and Preventive Medicine, The University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': 'Retired from Pfizer, New York, New York.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Samuels', 'Affiliation': 'Retired from Pfizer, New York, New York.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, Bioengineering, and Therapeutic Sciences, University of California, San Francisco.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.32053']
1030,33472754,Investigating the Use of Denosumab in the Treatment of Acute Charcot Neuroarthropathy.,"Charcot neuroarthropathy is a devastating condition, most commonly affecting poorly controlled diabetic patients with peripheral neuropathy. Pharmacological options for the condition are currently limited. The purpose of this study was to investigate the potential of Prolia® (denosumab) as a safe and feasible option in the treatment of acute Charcot neuroarthropathy. A total of 7 consecutive subjects were enrolled and followed for 1 year. Subjects received a single one-time injection of denosumab 60 mg. Subjects also received standard of care treatment, which included total contact casting, restricted weightbearing status, and biweekly office visits until normalization of the skin temperature gradient. Overall, the pharmaceutical treatment was generally well-tolerated. One subject developed a diabetic foot infection with cellulitis of the contralateral lower extremity, which occurred following the 6-month follow-up visit and which resolved with oral antibiotics One subject identified transient muscle pain in the same upper extremity which received the injection. Subjects were found to exit the acute phase of the condition at an average of 52.00 ± 17.89 days after their injection, which was defined by normalization of skin temperature to within 2°C of the contralateral foot. Treatment of acute Charcot neuroarthropathy with denosumab was well-tolerated in this open-label, pilot study. The clinical outcomes suggest that the medication may be efficacious, though a larger sample size would be needed to confirm these preliminary results. An adequately-powered, randomized, controlled study may be an appropriate follow-up.",2021,"Treatment of acute Charcot neuroarthropathy with denosumab was well-tolerated in this open-label, pilot study.","['acute Charcot neuroarthropathy', 'A total of 7 consecutive subjects were enrolled and followed for 1 year', 'Acute Charcot Neuroarthropathy', 'diabetic patients with peripheral neuropathy']","['Prolia (Denosumab', 'Charcot neuroarthropathy', 'denosumab', 'Prolia (denosumab', 'denosumab 60 mg']",['tolerated'],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C2917754', 'cui_str': 'Prolia'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]",[],7.0,0.0226178,"Treatment of acute Charcot neuroarthropathy with denosumab was well-tolerated in this open-label, pilot study.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shofler', 'Affiliation': 'Assistant Professor, Department of Podiatric Medicine, Surgery, and Biomechanics, Western University College of Podiatric Medicine, Pomona, CA. Electronic address: dshofler@westernu.edu.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Hamedani', 'Affiliation': 'Podiatric Medical Student, Department of Podiatric Medicine, Surgery, and Biomechanics, Western University College of Podiatric Medicine, Pomona, CA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Seun', 'Affiliation': 'Podiatric Medical Student, Department of Podiatric Medicine, Surgery, and Biomechanics, Western University College of Podiatric Medicine, Pomona, CA.'}, {'ForeName': 'Airani', 'Initials': 'A', 'LastName': 'Sathananthan', 'Affiliation': 'Associate Professor, Department of Internal Medicine, Western University College of Osteopathic Medicine of the Pacific, Pomona, CA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Katsaros', 'Affiliation': 'Associate Professor, Department of Internal Medicine, Western University College of Osteopathic Medicine of the Pacific, Pomona, CA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Liggan', 'Affiliation': 'Assistant Professor, Department of Physical Therapy Education, College of Osteopathic Medicine of the Pacific-Northwest, Lebanon, OR.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Assistant Professor, Western University College of Dental Medicine, Pomona, CA.'}, {'ForeName': 'Christal', 'Initials': 'C', 'LastName': 'Pham', 'Affiliation': 'Assistant Director of Clinical Pharmacy Services, WesternU Health, Western University of Health Sciences, Pomona, CA.'}]",The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons,['10.1053/j.jfas.2020.09.018']
1031,33474583,Growth and development of islet autoimmunity and type 1 diabetes in children genetically at risk.,"AIMS/HYPOTHESIS


We aimed to evaluate the relationship between childhood growth measures and risk of developing islet autoimmunity (IA) and type 1 diabetes in children with an affected first-degree relative and increased HLA-conferred risk. We hypothesised that being overweight or obese during childhood is associated with a greater risk of IA and type 1 diabetes.
METHODS


Participants in a randomised infant feeding trial (N = 2149) were measured at 12 month intervals for weight and length/height and followed for IA (at least one positive out of insulin autoantibodies, islet antigen-2 autoantibody, GAD autoantibody and zinc transporter 8 autoantibody) and development of type 1 diabetes from birth to 10-14 years. In this secondary analysis, Cox proportional hazard regression models were adjusted for birthweight and length z score, sex, HLA risk, maternal type 1 diabetes, mode of delivery and breastfeeding duration, and stratified by residence region (Australia, Canada, Northern Europe, Southern Europe, Central Europe and the USA). Longitudinal exposures were studied both by time-varying Cox proportional hazard regression and by joint modelling. Multiple testing was considered using family-wise error rate at 0.05.
RESULTS


In the Trial to Reduce IDDM in the Genetically at Risk (TRIGR) population, 305 (14.2%) developed IA and 172 (8%) developed type 1 diabetes. The proportions of children overweight (including obese) and obese only were 28% and 9% at 10 years, respectively. Annual growth measures were not associated with IA, but being overweight at 2-10 years of life was associated with a twofold increase in the development of type 1 diabetes (HR 2.39; 95% CI 1.46, 3.92; p < 0.001 in time-varying Cox regression), and similarly with joint modelling.
CONCLUSIONS/INTERPRETATION


In children at genetic risk of type 1 diabetes, being overweight at 2-10 years of age is associated with increased risk of progression from multiple IA to type 1 diabetes and with development of type 1 diabetes, but not with development of IA. Future studies should assess the impact of weight management strategies on these outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00179777.",2021,"Annual growth measures were not associated with IA, but being overweight at 2-10 years of life was associated with a twofold increase in the development of type 1 diabetes (HR 2.39; 95% CI 1.46, 3.92; p < 0.001 in time-varying Cox regression), and similarly with joint modelling.
","['Participants in a randomised infant feeding trial', 'children genetically at risk', 'children with an affected first-degree relative and increased HLA-conferred risk']",[],"['Annual growth measures', 'IDDM']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",[],"[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}]",2149.0,0.066552,"Annual growth measures were not associated with IA, but being overweight at 2-10 years of life was associated with a twofold increase in the development of type 1 diabetes (HR 2.39; 95% CI 1.46, 3.92; p < 0.001 in time-varying Cox regression), and similarly with joint modelling.
","[{'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Nucci', 'Affiliation': 'Department of Nutrition, Georgia State University, Atlanta, GA, USA. anucci@gsu.edu.'}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': 'Welfare and Health Promotion Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cuthbertson', 'Affiliation': 'Pediatrics Epidemiology Center, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Ludvigsson', 'Affiliation': ""Crown Princess Victoria Children's Hospital and Division of Pediatrics, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Ulle', 'Initials': 'U', 'LastName': 'Einberg', 'Affiliation': ""Tallinn Children's Hospital, Tallinn, Estonia.""}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Huot', 'Affiliation': 'CHU Ste. Justine, Montreal, QC, Canada.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Castano', 'Affiliation': 'Cruces, University Hospital, Biocruces Bizkaia Research Institute, UPV/EHU, CIBERDEM, CIBERER, Endo-ERN, Bilbao, Bizkaia, Spain.'}, {'ForeName': 'Bärbel', 'Initials': 'B', 'LastName': 'Aschemeier', 'Affiliation': ""Diabetes Centre for Children and Adolescents, Children's and Adolescent's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Dorothy J', 'Initials': 'DJ', 'LastName': 'Becker', 'Affiliation': ""Division of Endocrinology, University of Pittsburgh and UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': ""Pediatric Research Center, Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'Pediatrics Epidemiology Center, University of South Florida, Tampa, FL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-020-05358-3']
1032,33466131,A randomized study protocol comparing the platelet-rich plasma with hyaluronic acid in the treatment of symptomatic knee osteoarthritis.,"BACKGROUND


In recent years, intra articular injection of platelet rich plasma has attracted increasing attention. The major aim of our current randomized controlled double-blind study was to compare long-term outcomes of intra-articular injection of hyaluronic acid or platelet rich plasma in the treatment of the patients with knee osteoarthritis.
METHODS


This is a kind of double-blind, randomized, prospective, and comparative clinical investigation with the allocation ratio of 1:1 and was approved by our institutional review Committee. Between 2020 and 2021, altogether 2 hundred patients will be selected to participate in our present study. We will report the randomized experiments in accordance with the guidelines of Consolidated Standards of Reporting Trials and then offer the Consolidated Standards of Reporting Trials flow chart. The inclusion criteria were: patients aged from 40 to 70 years old, patients with chief complaint history of at least 1 month and knee joint pain for nearly 6 months, need the analgesic drug treatment, and radiology confirmed knee osteoarthritis. The eligible patients would be randomly divided into 2 groups through applying the random numbers generated by computer before surgery. Outcomes after treatment were assessed using the Western Ontario and McMaster University and the scoring systems of visual analogue scale which were recorded through questionnaires accomplished via the patients prior to the first injection and then at three and six months, 1 and 2 years follow-up. Any adverse events occurred within 1 year after surgery were recorded during follow-up.
RESULTS


This should suggest whether biological methods can offer more lasting outcomes than the viscosification.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry6265).",2021,"Outcomes after treatment were assessed using the Western Ontario and McMaster University and the scoring systems of visual analogue scale which were recorded through questionnaires accomplished via the patients prior to the first injection and then at three and six months, 1 and 2 years follow-up.","['The inclusion criteria were: patients aged from 40 to 70 years old, patients with chief complaint history of at least 1 month and knee joint pain for nearly 6 months, need the analgesic drug treatment, and radiology confirmed knee osteoarthritis', 'Between 2020 and 2021, altogether 2 hundred patients will be selected to participate in our present study', 'patients with knee osteoarthritis', 'symptomatic knee osteoarthritis']","['platelet-rich plasma with hyaluronic acid', 'hyaluronic acid or platelet rich plasma']","['Western Ontario and McMaster University and the scoring systems of visual analogue scale', 'adverse events']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",0.0,0.0951808,"Outcomes after treatment were assessed using the Western Ontario and McMaster University and the scoring systems of visual analogue scale which were recorded through questionnaires accomplished via the patients prior to the first injection and then at three and six months, 1 and 2 years follow-up.","[{'ForeName': 'Deyan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Neurorehabilitation, Anhui Wannan Rehabilitation Hospital, Anhui, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023881']
1033,33477909,The Effect of Two Bed Bath Practices in Cost and Vital Signs of Critically Ill Patients.,"By promoting personal hygiene and improving comfort, bed baths can decrease the risk of infection and help maintain skin integrity in critically ill patients. Current bed-bathing practices commonly involve the use of either soap and water (SAW) or disposable wipes (DWs). Previous research has shown both bed-bathing methods are equally effective in removing dirt, oil, and microorganisms. This experimental study compared the cost, staff satisfaction, and effects of two bed-bathing practices on critically ill patients' vital signs. We randomly assigned 138 participants into 2 groups: an experimental group that received bed baths using DWs and a control group that received bed baths using SAW. We compared the bath duration, cost, vital sign trends, and nursing staff satisfaction between the two groups. We used the chi-square test and  t -test for the statistical analysis, and we expressed the quantitative data as mean and standard deviation. Our results showed the bed baths using DWs had a shorter duration and lower cost than those using SAW. There were no significant differences in the vital sign trends between the two groups. The nursing staff preferred to use DWs over SAW. This study can help clinical nursing staff decide which method to use when assisting patients with bed baths.",2021,There were no significant differences in the vital sign trends between the two groups.,"[""critically ill patients' vital signs"", 'critically ill patients', 'Critically Ill Patients']","['bed baths using DWs and a control group that received bed baths using SAW', 'soap and water (SAW) or disposable wipes (DWs', 'Two Bed Bath Practices']","['vital sign trends', 'Cost and Vital Signs', 'shorter duration and lower cost', 'bath duration, cost, vital sign trends, and nursing staff satisfaction']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]","[{'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",138.0,0.0392287,There were no significant differences in the vital sign trends between the two groups.,"[{'ForeName': 'Chia-Hui', 'Initials': 'CH', 'LastName': 'Tai', 'Affiliation': 'Department of Nursing, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien 970473, Taiwan.'}, {'ForeName': 'Tsung-Cheng', 'Initials': 'TC', 'LastName': 'Hsieh', 'Affiliation': 'Institute of Medical Sciences, Tzu Chi University, Hualien 970374, Taiwan.'}, {'ForeName': 'Ru-Ping', 'Initials': 'RP', 'LastName': 'Lee', 'Affiliation': 'Institute of Medical Sciences, Tzu Chi University, Hualien 970374, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph18020816']
1034,33477722,Preliminary Results of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Single-School Randomized Controlled Trial.,"School-based obesity prevention programs are key to promoting healthy habits. The aim of this study was to evaluate the effect of the Planet Nutrition program on BMI z-score and other parameters compared to a control group of Mexican schoolchildren after 9 weeks of intervention. The effect of the summer holidays on the BMI z-score was also evaluated at 23 weeks. A pilot randomized controlled trial design was used and 41 schoolchildren were randomized (21 intervention group and 20 control). The program included 18 nutrition education sessions, 20 physical activity classes and six brochures for parents. At 9 weeks, no significant differences were found between the intervention and control groups in the change in BMI z-score (-0.11, 95% CI -0.23, 0.01). Significant differences were observed in some secondary outcomes: body fat percentage (-1.72, 95% CI -3.42, -0.02), waist circumference (-3.45, 95% CI -5.55, -1.36), physical activity (0.44, 95% CI 0.01, 0.88) and nutrition knowledge (1.15, 95% CI 0.27, 2.03). Summer holidays negatively affected the BMI z-score in both groups, reducing the difference observed between groups at 9 weeks (-0.07, 95% CI -0.22, 0.07). The Planet Nutrition program showed favorable effects in some obesity and lifestyle parameters in the short term.",2021,"At 9 weeks, no significant differences were found between the intervention and control groups in the change in BMI z-score (-0.11, 95% CI -0.23, 0.01).","['41 schoolchildren', 'Mexican Schoolchildren', 'Mexican schoolchildren after 9 weeks of intervention']","['Planet Nutrition Program', '18 nutrition education sessions, 20 physical activity classes and six brochures for parents', 'Planet Nutrition program', 'School-based obesity prevention programs']","['physical activity', 'obesity and lifestyle parameters', 'BMI z-score', 'nutrition knowledge', 'waist circumference', 'Obesity Parameters']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0080026', 'cui_str': 'Planets'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",,0.0605901,"At 9 weeks, no significant differences were found between the intervention and control groups in the change in BMI z-score (-0.11, 95% CI -0.23, 0.01).","[{'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Ramírez-Rivera', 'Affiliation': 'Centro de Promoción de Salud Nutricional, Departamento de Ciencias Químico Biológicas, Universidad de Sonora, Hermosillo, Sonora 83000, Mexico.'}, {'ForeName': 'Teresita', 'Initials': 'T', 'LastName': 'Martínez-Contreras', 'Affiliation': 'Centro de Promoción de Salud Nutricional, Departamento de Ciencias Químico Biológicas, Universidad de Sonora, Hermosillo, Sonora 83000, Mexico.'}, {'ForeName': 'Rosa C', 'Initials': 'RC', 'LastName': 'Villegas-Valle', 'Affiliation': 'Departamento de Ciencias Químico Biológicas, Universidad de Sonora, Hermosillo, Sonora 83000, Mexico.'}, {'ForeName': 'Gricelda', 'Initials': 'G', 'LastName': 'Henry-Mejia', 'Affiliation': 'Departamento de Ciencias del Deporte y la Actividad Física, Universidad de Sonora, Hermosillo, Sonora 83000, Mexico.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Quizán-Plata', 'Affiliation': 'Departamento de Ciencias Químico Biológicas, Universidad de Sonora, Hermosillo, Sonora 83000, Mexico.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Haby', 'Affiliation': 'Departamento de Ciencias Químico Biológicas, Universidad de Sonora, Hermosillo, Sonora 83000, Mexico.'}, {'ForeName': 'Rolando G', 'Initials': 'RG', 'LastName': 'Díaz-Zavala', 'Affiliation': 'Centro de Promoción de Salud Nutricional, Departamento de Ciencias Químico Biológicas, Universidad de Sonora, Hermosillo, Sonora 83000, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph18020790']
1035,33513520,Improving MS patients' understanding of treatment risks and benefits in clinical consultations: A randomised crossover trial.,"BACKGROUND


Multiple Sclerosis (MS) patients find it difficult to understand the complex risk-benefit profiles of disease-modifying drugs. An evidence-based protocol was designed to improve patient's understanding of treatment information: Benefit and Risk Information for Medication in Multiple Sclerosis (BRIMMS).
OBJECTIVE


A feasibility study to evaluate whether the BRIMMS protocol can improve MS patients' treatment understanding and reduce conflict in treatment decisions compared to consultation as usual.
DESIGN


Single-blind 4-condition 4-period randomised crossover trial. Hypothetical treatment information was presented to MS patients in a faux 20 minute consultation session using the BRIMMS protocol (aural and visual) or as a usual consultation (aural and visual). Patients were randomised to the order in which they received the four consultation styles.
PARTICIPANTS


24 patients diagnosed with relapsing-remitting MS.
MEASURES


Patients were assessed on their comprehension of treatment information, decisional conflict and feedback on consultation styles. Disease and demographic information was also collected.
RESULTS


Treatment understanding was greater for both BRIMMS visual and BRIMMS aural, compared to usual consultations in visual or aural format. Similarly, BRIMMS visual and BRIMMS aural reduced decisional conflict compared to usual consultations in visual or aural formats. All comparisons were p<0.001. Cognitive status was not related to understanding in the BRIMMS protocol, but was negatively related with usual consultation. Conversely, mood influenced understanding on the BRIMMS protocol but not for usual consultation.
CONCLUSIONS


BRIMMS protocol offers an effective, evidence-based tool for presenting treatment information in consultations with MS patients and is not influenced by cognition.
TRIAL REGISTRATION


ISRCTN17318966.",2021,"RESULTS


Treatment understanding was greater for both BRIMMS visual and BRIMMS aural, compared to usual consultations in visual or aural format.",['24 patients diagnosed with relapsing-remitting MS'],[],"['comprehension of treatment information, decisional conflict and feedback on consultation styles', 'Cognitive status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]",[],"[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",24.0,0.0803882,"RESULTS


Treatment understanding was greater for both BRIMMS visual and BRIMMS aural, compared to usual consultations in visual or aural format.","[{'ForeName': 'Gurpreet K', 'Initials': 'GK', 'LastName': 'Reen', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London, Egham, UK; Department of Experimental Psychology, University of Oxford, Oxford, UK. Electronic address: Gurpreet.reen@psy.ox.ac.uk.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Silber', 'Affiliation': ""Department of Psychology, Royal Holloway, University of London, Egham, UK; Department of Neurology, King's College Hospital NHS Foundation Trust, Denmark Hill, London, UK.""}, {'ForeName': 'Dawn W', 'Initials': 'DW', 'LastName': 'Langdon', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London, Egham, UK; Department of Experimental Psychology, University of Oxford, Oxford, UK.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102737']
1036,33514274,Rivastigmine Transdermal Patch Treatment for Moderate to Severe Cognitive Impairment in Veterans with Traumatic Brain Injury (RiVET Study): A Randomized Clinical Trial.,"Cognitive impairment is common in veterans with histories of traumatic brain injury (TBI). Cholinergic deficits have been hypothesized as contributors to this impairment. We report the effects of cholinesterase inhibitor rivastigmine transdermal patch treatment in veterans with TBI and post-traumatic memory impairment. Our objective was to evaluate the efficacy and safety of a 9.5 mg/24 h (10 cm 2 ) rivastigmine patch in veterans of military conflicts with persistent moderate to severe memory impairment at least 12 weeks after TBI. This randomized, outpatient, double-blind, placebo-controlled 12-week trial with an exploratory double-blind phase of an additional 14 weeks was conducted at 5 VA Medical Centers, among veterans with closed, non-penetrating TBI who met or exceeded modified American Congress of Rehabilitation Medicine criteria for mild TBI with verbal memory deficits, as assessed by the Hopkins Verbal Learning Test, Revised (HVLT-R). Patients were randomized 1:1 to rivastigmine or matching placebo patches after a 1-week single-blind, placebo run-in phase. At randomization, patients received 4.6 mg/24 h rivastigmine patches or matching placebo increased to a 9.5 mg/24 h patch after 4 weeks. The primary efficacy outcome measure was the proportion of participants who had at least a five-word improvement on the HVLT-R Total Recall Index (Trials 1-3). A total of 3671 participants were pre-screened, of whom 257 (7.0%) were screened; 96 (37%) randomized, and 94 included in study analyses. Responder rates were 40.8% (20 of 49) and 51.1% (23 of 45) in the rivastigmine and placebo groups, respectively ( p  = 0.41). A mixed-effect model including treatment, time, and treatment-by-time interaction indicated no significant difference in treatment effect over time between the groups ( p  = 0.24). Overall, there were no significant differences in changes for all secondary outcomes between the rivastigmine and placebo groups. The most commonly observed adverse events were application site reactions. This trial provides the largest sample to date of veterans with TBI and post-traumatic memory deficits enrolled in a pharmacological trial. Trial Registration: clinicaltrials.gov Identifier: NCT01670526.",2021,The responder rates were 40.8% (20/49) and 51.1% (23/45) in rivastigmine and placebo groups respectively (p=0.41).,"['A total 3671 participants were pre-screened, of whom 257 (7.0%) were screened; 96 (37%) randomized and 94 included in study analyses', 'veterans with TBI and post-traumatic memory impairment', 'veterans of military conflicts with persistent moderate to severe memory impairment at least 12 weeks following TBI', 'additional 14 weeks was conducted at 5 VA Medical Centers, among veterans with closed, non-penetrating TBI who met or exceeded modified ACRM criteria for mild TBI with verbal memory deficits, as assessed by the Hopkins Verbal Learning Test, Revised (HVLT-R', 'Veterans with Traumatic Brain Injury (RiVET Study', 'veterans with histories of traumatic brain injury (TBI', 'veterans with TBI and posttraumatic memory deficits enrolled in a pharmacological trial']","['rivastigmine patches or matching placebo', 'placebo', 'rivastigmine patch', 'rivastigmine or matching placebo', 'Rivastigmine Transdermal Patch Treatment', 'cholinesterase inhibitor rivastigmine transdermal patch treatment']","['proportion of participants who had at least 5-word improvement on HVLT-R Total Recall Index', 'efficacy and safety', 'responder rates']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0233794', 'cui_str': 'Memory impairment'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2712539', 'cui_str': 'History of traumatic brain injury'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008425', 'cui_str': 'Cholinesterase inhibitor'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3671.0,0.616982,The responder rates were 40.8% (20/49) and 51.1% (23/45) in rivastigmine and placebo groups respectively (p=0.41).,"[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Brawman-Mintzer', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'X Charlene', 'Initials': 'XC', 'LastName': 'Tang', 'Affiliation': 'Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, USA.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bizien', 'Affiliation': 'Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': 'Miami VA Healthcare System, Miami, Florida, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Horner', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Arciniegas', 'Affiliation': 'University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Raskind', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle, Washington, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Johnson-Greene', 'Affiliation': 'Miami VA Healthcare System, Miami, Florida, USA.'}, {'ForeName': 'R Jared', 'Initials': 'RJ', 'LastName': 'Martineau', 'Affiliation': 'VA Salt Lake City Health Care System, Salt Lake City, Utah, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamner', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rodriguez-Suarez', 'Affiliation': 'Miami VA Healthcare System, Miami, Florida, USA.'}, {'ForeName': 'Ricardo E', 'Initials': 'RE', 'LastName': 'Jorge', 'Affiliation': 'Michael E. DeBakey VA Health System, Houston, Texas, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGarity', 'Affiliation': ""James A. Haley Veterans' Hospital, Tampa, Florida, USA.""}, {'ForeName': 'Hal S', 'Initials': 'HS', 'LastName': 'Wortzel', 'Affiliation': 'Rocky Mountain MIRECC for Suicide Prevention, Denver, Colorado, USA.'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Sindowski', 'Affiliation': 'Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, USA.'}, {'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Mintzer', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Arianne Z', 'Initials': 'AZ', 'LastName': 'Kindy', 'Affiliation': 'Roper St. Francis Healthcare, Charleston, South Carolina, USA.'}, {'ForeName': 'Keaveny', 'Initials': 'K', 'LastName': 'Donovan', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Domenic', 'Initials': 'D', 'LastName': 'Reda', 'Affiliation': 'Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, USA.'}]",Journal of neurotrauma,['10.1089/neu.2020.7146']
1037,33514270,Does rTMS Targeting Contralesional S1 Enhance Upper Limb Somatosensory Function in Chronic Stroke? A Proof-of-Principle Study.,"BACKGROUND


Somatosensory deficits are prevalent after stroke, but effective interventions are limited. Brain stimulation of the contralesional primary somatosensory cortex (S1) is a promising adjunct to peripherally administered rehabilitation therapies.
OBJECTIVE


To assess short-term effects of repetitive transcranial magnetic stimulation (rTMS) targeting contralesional (S1) of the upper extremity.
METHODS


Using a single-session randomized crossover design, stroke survivors with upper extremity somatosensory loss participated in 3 rTMS treatments targeting contralesional S1: Sham, 5 Hz, and 1 Hz. rTMS was delivered concurrently with peripheral of sensory electrical stimulation and vibration of the affected hand. Outcomes included 2-point discrimination (2PD), proprioception, vibration perception threshold, monofilament threshold (size), and somatosensory evoked potential (SEP). Measures were collected before, immediately after treatment, and 1 hour after treatment. Mixed models were fit to analyze the effects of the 3 interventions.
RESULTS


Subjects were 59.8 ± 8.1 years old and 45 ± 39 months poststroke. There was improvement in 2PD after 5-Hz rTMS for the stroke-affected ( F (2, 76.163) = 3.5,  P  = .035) and unaffected arm ( F (2, 192.786) = 10.6,  P  < .0001). Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45 ( F (2, 133.027) = 3.518,  P  = .032) and N45-P60 ( F (2, 67.353) = 3.212,  P  = .047). Latencies shortened after 5-Hz rTMS for N20 ( F (2, 69.64) = 3.37,  P  = .04), N60 ( F (2, 47.343) = 4.375,  P  = .018), and P100 ( F (2, 37.608) = 3.537,  P  = .039) peaks. There were no differences between changes immediately after the intervention and an hour later.
CONCLUSIONS


Short-term application of facilitatory high-frequency rTMS (5Hz) to contralesional S1 combined with peripheral somatosensory stimulation may promote somatosensory function. This intervention may serve as a useful adjunct in somatosensory rehabilitation after stroke.",2021,Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45,"['Subjects were 59.8 ± 8.1 years old and 45 ± 39 months poststroke', 'stroke survivors with upper extremity somatosensory loss participated in 3']","['rTMS treatments targeting contralesional S1: Sham, 5 Hz, and 1 Hz', '5-Hz rTMS', 'contralesional primary somatosensory cortex (S1', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '5-Hz rTMS for N33-P45']","['Peak-to-peak SEP amplitudes', '2PD', '2-point discrimination (2PD), proprioception, vibration perception threshold, monofilament threshold (size), and somatosensory evoked potential (SEP']","[{'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3496281', 'cui_str': 'Primary Somatic Sensory Area'}, {'cui': 'C1334860', 'cui_str': 'N33 protein, human'}, {'cui': 'C0381943', 'cui_str': 'Skp2 Protein'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0429277', 'cui_str': 'Two point static discrimination response'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.057305,Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45,"[{'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Pundik', 'Affiliation': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Skelly', 'Affiliation': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McCabe', 'Affiliation': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Akbari', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Tatsuoka', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ela B', 'Initials': 'EB', 'LastName': 'Plow', 'Affiliation': 'Lerner College of Medicine, Cleveland Clinic, Cleveland, OH, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968321989338']
1038,33465382,"The effects of abdominal ""I LOV U"" massage along with lifestyle training on constipation and distension in the elderly with stroke.","INTRODUCTION


Constipation and distension are dominant gastrointestinal problems after stroke in the elderly. Always they are treated by the use of laxatives and fibers. Abdominal massage along with a healthy lifestyle can be a solution.
PURPOSE


This study aimed to investigate the effect of abdominal massage and lifestyle training on constipation and distention of the elderly with stroke.
METHOD


This study was a randomized clinical trial that was conducted on elderly patients with stroke at Qaem hospital of Mashhad, Iran. 68 patients were randomly allocated into control (n = 34) and intervention (n = 34) groups in 2017-2018. Finally 29 elderly in the intervention and 34 in the control group completed the study. Intervention included the abdominal massage by using ""I LOV U"" method along with lifestyle education. Each abdominal massage lasted for 15 min, twice daily for ten days that was performed at first session by the researcher and then continued by the key care giver. Data were collected by the demographic form, constipation assessment score (CAS), distension measurement tool (meter), and food tolerance evaluation checklist.
RESULTS


The results indicated that both groups were homogeneous in demographic variables (P > 0.05). The repeated ANOVA showed a more significant decrease in abdominal circumference of the intervention group during the 10- days study (P = 0.029).The Friedman test showed a significant difference in frequency of defecation in two groups in 10- day study (P < 0.0001). Therefore the CAS Score was significantly decreased in intervention group more than the control group (0.30 < 0.98 < 1.59, P = 0.001, EF = 0.44). The food tolerance frequencies through Gavage (P = 0.20), and also orally (P < 0.001) were significantly improved in the intervention group.
CONCLUSION


According to results, the abdominal massage along with lifestyle training could improve constipation and distension and also increase food intake tolerance in the elderly patients with stroke.",2021,"Therefore the CAS Score was significantly decreased in intervention group more than the control group (0.30 < 0.98 < 1.59, P = 0.001, EF = 0.44).","['Finally 29 elderly in the intervention and 34 in the control group completed the study', 'Elderly with Stroke', 'constipation and distention of the elderly with stroke', '68 patients', 'elderly patients with stroke', 'elderly patients with stroke at Qaem hospital of Mashhad, Iran']","['Lifestyle Training', 'lifestyle training', 'abdominal massage by using ""I LOV U"" method along with lifestyle education', 'Abdominal massage', 'abdominal massage and lifestyle training', 'Abdominal ""I LOV U"" Massage']","['constipation and distension', 'frequency of defecation', 'food intake tolerance', 'abdominal circumference', 'Constipation and Distension', 'CAS Score', 'demographic form, constipation assessment score (CAS), distension measurement tool (meter), and food tolerance evaluation checklist']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0581872', 'cui_str': 'Frequency of defecation'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",68.0,0.0244849,"Therefore the CAS Score was significantly decreased in intervention group more than the control group (0.30 < 0.98 < 1.59, P = 0.001, EF = 0.44).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fekri', 'Affiliation': 'Department of Medical Surgical nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Aghebati', 'Affiliation': 'Department of Medical Surgical nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran; Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: aghebatin@mums.ac.ir.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Sadeghi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammd Taghi', 'Initials': 'MT', 'LastName': 'Farzadfard', 'Affiliation': 'Medical School, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102665']
1039,33475735,Restrictive Transfusion Strategy after Cardiac Surgery.,"BACKGROUND


Recent guidelines on transfusion in cardiac surgery suggest that hemoglobin might not be the only criterion to trigger transfusion. Central venous oxygen saturation (Svo2), which is related to the balance between tissue oxygen delivery and consumption, may help the decision process of transfusion. We designed a randomized study to test whether central Svo2-guided transfusion could reduce transfusion incidence after cardiac surgery.
METHODS


This single center, single-blinded, randomized controlled trial was conducted on adult patients after cardiac surgery in the intensive care unit (ICU) of a tertiary university hospital. Patients were screened preoperatively and were assigned randomly to two study groups (control or Svo2) if they developed anemia (hemoglobin less than 9 g/dl), without active bleeding, during their ICU stay. Patients were transfused at each anemia episode during their ICU stay except the Svo2 patients who were transfused only if the pretransfusion central Svo2 was less than or equal to 65%. The primary outcome was the proportion of patients transfused in the ICU. The main secondary endpoints were (1) number of erythrocyte units transfused in the ICU and at study discharge, and (2) the proportion of patients transfused at study discharge.
RESULTS


Among 484 screened patients, 100 were randomized, with 50 in each group. All control patients were transfused in the ICU with a total of 94 transfused erythrocyte units. In the Svo2 group, 34 (68%) patients were transfused (odds ratio, 0.031 [95% CI, 0 to 0.153]; P < 0.001 vs. controls), with a total of 65 erythrocyte units. At study discharge, eight patients of the Svo2 group remained nontransfused and the cumulative count of erythrocyte units was 96 in the Svo2 group and 126 in the control group.
CONCLUSIONS


A restrictive transfusion strategy adjusted with central Svo2 may allow a significant reduction in the incidence of transfusion.
EDITOR’S PERSPECTIVE


",2021,"In the Svo2 group, 34 (68%) patients were transfused (odds ratio, 0.031 [95% CI, 0 to 0.153]; P < 0.001 vs. controls), with a total of 65 erythrocyte units.","['adult patients after cardiac surgery in the intensive care unit (ICU) of a tertiary university hospital', '484 screened patients, 100 were randomized, with 50 in each group']","['central Svo2-guided transfusion', 'Central venous oxygen saturation (Svo2']","['number of erythrocyte units transfused in the ICU and at study discharge, and (2) the proportion of patients transfused at study discharge', 'cumulative count of erythrocyte units', 'proportion of patients transfused in the ICU', 'transfusion incidence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0428176', 'cui_str': 'Venous oxygen saturation measurement'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",94.0,0.122317,"In the Svo2 group, 34 (68%) patients were transfused (odds ratio, 0.031 [95% CI, 0 to 0.153]; P < 0.001 vs. controls), with a total of 65 erythrocyte units.","[{'ForeName': 'Norddine', 'Initials': 'N', 'LastName': 'Zeroual', 'Affiliation': ''}, {'ForeName': 'Cinderella', 'Initials': 'C', 'LastName': 'Blin', 'Affiliation': ''}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Saour', 'Affiliation': ''}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'David', 'Affiliation': ''}, {'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Aouinti', 'Affiliation': ''}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': ''}, {'ForeName': 'Pascal H', 'Initials': 'PH', 'LastName': 'Colson', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudard', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003682']
1040,33478173,Effects of an African Circle Dance Programme on Internally Displaced Persons with Depressive Symptoms: A Quasi-Experimental Study.,"Background : Internally Displaced Persons (IDPs) are people who have been forced to flee their homes due to disasters. Depressive symptoms, at over 31-67%, are prevalent in IDPs in Africa. Despite the evidence for the benefits of the promotion of dance interventions on psychological health, supporting information is needed to outline the benefits of an African Circle Dance (ACD) intervention for IDPs in Africa.  Methods : A quasi-experimental design (pre-/post-test) was employed. Two IDP camps were randomized into the intervention group (psychoeducation and ACD intervention) and the control group (psychoeducation). Adults aged ≥18 years, living in an IDP camp, able to perform brisk walking, and who scored ≥10 on a depressive symptoms subscale were recruited. The intervention group received an 8-week ACD dance intervention and two 1-h psychoeducation sessions on stress management; the controls only received the psychoeducation sessions. Outcomes were depressive symptoms, stress, and anxiety. Data were collected at baseline (T0), immediately after the intervention at week 8 (T1), and at week 12 (T2) at the post-intervention and follow-up session. A generalized estimating equation was used to test the effects of the ACD intervention, with a 0.05 significance level.  Results : 198 IDPs completed the study (n control  = 98; n intervention  = 100). The intervention group reported significantly greater improvements in depressive symptoms ( v  = 0.33,  p  < 0.001) and stress ( v  = 0.15, 0.008) than did the control group.  Conclusions : ACD could be a valuable complementary intervention in health promotion but more research is needed.",2021,"The intervention group reported significantly greater improvements in depressive symptoms ( v  = 0.33,  p  < 0.001) and stress ( v  = 0.15, 0.008) than did the control group.  ","['Two IDP camps', 'Adults aged ≥18 years, living in an IDP camp, able to perform brisk walking, and who scored ≥10 on a depressive symptoms subscale were recruited', 'Internally Displaced Persons with Depressive Symptoms', '198 IDPs completed the study (n control  = 98; n intervention  = 100']","['intervention group (psychoeducation and ACD intervention) and the control group (psychoeducation', 'ACD', '8-week ACD dance intervention and two 1-h psychoeducation sessions on stress management; the controls only received the psychoeducation sessions', ' ', 'African Circle Dance Programme']","['depressive symptoms, stress, and anxiety', 'depressive symptoms', 'Depressive symptoms', 'stress']","[{'cui': 'C0021532', 'cui_str': 'Inosine diphosphate'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C5197839', 'cui_str': 'Internally Displaced Persons'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0323553,"The intervention group reported significantly greater improvements in depressive symptoms ( v  = 0.33,  p  < 0.001) and stress ( v  = 0.15, 0.008) than did the control group.  ","[{'ForeName': 'Dauda', 'Initials': 'D', 'LastName': 'Salihu', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Eliza M L', 'Initials': 'EML', 'LastName': 'Wong', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Rick Y C', 'Initials': 'RYC', 'LastName': 'Kwan', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}]",International journal of environmental research and public health,['10.3390/ijerph18020843']
1041,33478112,Toothpastes with Enzymes Support Gum Health and Reduce Plaque Formation.,"Enzymes in toothpastes can support host immune responses, and thus maintain oral health. This study aimed to investigate gingival health and the plaque-reducing effects of enzyme-containing toothpastes. A laboratory study tested the antimicrobial potential of different enzyme-containing toothpaste formulations. Two promising formulations (enzyme-containing toothpastes with glucose oxidase and D-glucose with (C+) and without Citrox (C-) Citrox) were investigated in a clinical crossover trial (two slurries: sodium lauryl sulfate-containing (SLS), a toothpaste without SLS (reference), and water). Subjects ( n  = 20) abstained from toothbrushing for four days and rinsed with a toothpaste slurry. Bleeding on probing (BOP) and plaque indices (PI) were measured. A mixed linear model was used to statistically compare the slurries with respect to BOP and PI change. The in vitro bacterial growth-inhibiting evaluation showed the best results for SLS, followed by C+ and C-. The change in BOP and PI exhibited statistically significant differences to water rinsing (BOP; PI changes in % points (difference of the baseline and post-rinse values: water = 8.8%; 90.0%; C+ = -1.4%; 80.4%; SLS = 1.5%; 72.1%; reference = 0.8%; 77.5%; C- = -1.8%; 75.1%). All slurries exhibited anti-gingivitis and anti-plaque effects, resulting in a prophylactic benefit for limited-access regions during brushing.",2021,The change in BOP and PI exhibited statistically significant differences to water rinsing (BOP; PI changes in % points (difference of the baseline and post-rinse values: water = 8.8%; 90.0%; C+ = -1.4%; 80.4%; SLS = 1.5%; 72.1%; reference = 0.8%; 77.5%; C- = -1.8%; 75.1%).,[],"['formulations (enzyme-containing toothpastes with glucose oxidase and D-glucose with (C+) and without Citrox (C-) Citrox', 'toothpaste slurry', 'sodium lauryl sulfate-containing (SLS), a toothpaste without SLS (reference), and water', 'enzyme-containing toothpastes']","['Bleeding on probing (BOP) and plaque indices (PI', 'BOP and PI change', 'change in BOP', 'Plaque Formation']",[],"[{'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0017735', 'cui_str': 'GLUCOSE OXIDASE'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0383452,The change in BOP and PI exhibited statistically significant differences to water rinsing (BOP; PI changes in % points (difference of the baseline and post-rinse values: water = 8.8%; 90.0%; C+ = -1.4%; 80.4%; SLS = 1.5%; 72.1%; reference = 0.8%; 77.5%; C- = -1.8%; 75.1%).,"[{'ForeName': 'Pune N', 'Initials': 'PN', 'LastName': 'Paqué', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Schmidlin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Wiedemeier', 'Affiliation': 'Statistical Services, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}, {'ForeName': 'Florian J', 'Initials': 'FJ', 'LastName': 'Wegehaupt', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}, {'ForeName': 'Phoebe D', 'Initials': 'PD', 'LastName': 'Burrer', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Körner', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}, {'ForeName': 'Shengjile', 'Initials': 'S', 'LastName': 'Deari', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}, {'ForeName': 'Michel-Angelo', 'Initials': 'MA', 'LastName': 'Sciotti', 'Affiliation': 'School of Life Sciences, Institute for Chemistry and Bioanalytics, University of Applied Sciences Northern Switzerland, Hofackerstrasse 30, 4132 Muttenz, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}]",International journal of environmental research and public health,['10.3390/ijerph18020835']
1042,33496081,Re: Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy - a multicentre randomised controlled trial (LAVA trial).,,2021,,['uterine prolapse stage 2 or higher'],['laparoscopic sacrohysteropexy'],[],"[{'cui': 'C0042140', 'cui_str': 'Uterine prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C3164185', 'cui_str': 'Sacrohysteropexy'}]",[],,0.387829,,"[{'ForeName': 'M-S', 'Initials': 'MS', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Z-X', 'Initials': 'ZX', 'LastName': 'Loo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'K-L', 'Initials': 'KL', 'LastName': 'Lin', 'Affiliation': 'Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'C-Y', 'Initials': 'CY', 'LastName': 'Long', 'Affiliation': 'Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16644']
1043,33493624,A direct comparison of neuronavigated and non-neuronavigated intermittent theta burst stimulation in the treatment of depression.,"OBJECTIVE


To investigate whether a four-week course of neuronavigated intermittent theta burst stimulation (iTBS) of the left dorsolateral prefrontal cortex is superior to the non-neuronavigated F3-EEG method of positioning.
METHODS


We conducted a single-center, two-arm, randomized and double-blinded study (clinicaltrials.gov NCT03953521). 37 inpatients with an at least moderate depressive episode were randomized to receive either neuronavigated or 10-20-EEG-system based F3 guided iTBS. Both groups received twenty week daily sessions of iTBS while continuing to receive standard-of-care treatment by their ward physicians. For navigated iTBS, we used magnetic resonance imaging to target the border between the anterior and middle third of the middle frontal gyrus considered to represent the left dorsolateral prefrontal cortex (lDLPFC). Differences in the treatment arms were blinded by completely mimicking the procedures of the respective other treatment group. Rating physicians were not involved in the treatment procedure. Primary outcome was defined as the change of the 21-item version of the Hamilton Depression Score (HAMD) from baseline to end of treatment at week 4. Secondary outcomes included HAMD score during the treatment, Patient Health Questionnaire-9, WHO Quality of Life-BREF and Clinical Global Impression. For primary outcome, we used a planned group comparison for the absolute change in the HAMD. For secondary outcome measures we calculated analyses of variance (ANOVAs) with the within-subjects factor time (primary: baseline vs. week 4; secondary: all visits) and the between-subjects factor group (navigated vs. F3 guided group). We also did planned contrasts between both groups for all variables and all treatment and follow-up visits with the aim not to oversee any group differences. For group contrasts we used Student T-tests for metric and chi-square tests for categorial variables. Significance threshold was set to 5% uncorrected for multiple comparisons.
RESULTS


Enrolment of 80 patients with interim analysis was planned. Interim analysis was performed after 37 patients (intention to treat). 6 patients dropped out, leaving 31 for analysis. With respect to primary outcome criteria, absolute change in the HAMD did not differ significantly between groups. In accordance, relative change and number of responders and remitters were not significantly different. Overall number of responders was 53% and of remitters was 60%. On a descriptive level, the results favor the clinical effects of the F3 group for the absolute and relative change in the HAMD and the number of responders. Number of remitters were exactly the same for both groups. Therefore, we decided to stop the trial due to the added burden of magnetic resonance imaging and neuronavigated treatment in relation to the effect. Secondary outcomes did also not differ significantly between groups. Patients did not differ in their baseline characteristics nor with respect to intake of medication during the trial period and all had access to the same therapeutic interventions.
CONCLUSION


We noticed a high antidepressive effect of add-on iTBS treatment to standard inpatient treatment but failed to demonstrate a clinical superiority of neuronavigated localization. The non-navigated, F3 guided iTBS treatment used as a control group may be sophisticated enough to dilute potential added benefits, and the difference between the localization approaches is either negligible or too small to justify the additional efforts of navigation. The effects of concomitant treatment may mask effects, but our patient population reflects clinical reality in an inpatient setting. Further prospective studies are warranted to compare neuronavigated with surface-based approaches.",2021,"Patients did not differ in their baseline characteristics nor with respect to intake of medication during the trial period and all had access to the same therapeutic interventions.
","['80 patients with interim analysis was planned', '37 inpatients with an at least moderate depressive episode']","['neuronavigated or 10-20-EEG-system based F3 guided iTBS', 'neuronavigated intermittent theta burst stimulation', 'neuronavigated and non-neuronavigated intermittent theta burst stimulation', 'intermittent theta burst stimulation while continuing to receive standard-of-care treatment by their ward physicians']","['absolute change in the HAMD', 'Overall number of responders', 'HAMD score during the treatment, Patient Health Questionnaire-9, WHO Quality of Life-BREF and Clinical Global Impression', 'change of the 21-item version of the Hamilton Depression Score (HAMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0494398', 'cui_str': 'Moderate depressive episode'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",80.0,0.0960668,"Patients did not differ in their baseline characteristics nor with respect to intake of medication during the trial period and all had access to the same therapeutic interventions.
","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hebel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany. Electronic address: tobias.hebel@medbo.de.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Göllnitz', 'Affiliation': 'Faculty of Medicine, University of Regensburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schoisswohl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Franziska C', 'Initials': 'FC', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelnaim', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Wetter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rupprecht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}]",Brain stimulation,['10.1016/j.brs.2021.01.013']
1044,33507012,A multilevel intervention to reduce stigma among alcohol consuming men living with HIV receiving antiretroviral therapy: findings from a randomized control trial in India: Erratum.,,2021,,['consuming men living with HIV receiving antiretroviral therapy'],['alcohol'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}]",[],,0.0675811,,[],"AIDS (London, England)",['10.1097/01.aids.0000733060.19591.47']
1045,33515859,Up-regulation of proactive control is associated with beneficial effects of a childhood gymnastics program on response preparation and working memory.,"The current study focused on the effects of an 8-week motor skill-based physical activity (i.e., gymnastics) program on the contingent negative variation derived from event-related brain potentials (CNV-ERP) during a working memory task in children. Children aged 7-10 years old were assigned to a gymnastics group (n = 26) or a wait-list control group (n = 24). The gymnastics group engaged in a gymnastics program whereas children in the control group were asked to maintain their typical routine during the intervention period. Working memory performance was measured by a delayed-matching working memory task, accompanied by CNV-ERP collection. The results revealed significant improvement of response accuracy from pre-test to post-test in the gymnastic group regardless of memory demands. Moreover, significant increase from pre-test to post-test in the initial CNV was observed in the gymnastic group regardless of memory demands. Bivariate correlations further indicated that, in the gymnastic group, increases in response accuracy from pre-test to post-test were correlated with increases in initial CNV from pre-test to post-test in task conditions with lower and higher memory loads. Overall, the current findings suggest that up-regulation of proactive control may characterize the beneficial effects of childhood motor skill-based physical activity on working memory.",2021,The results revealed significant improvement of response accuracy from pre-test to post-test in the gymnastic group regardless of memory demands.,"['Children aged 7-10\xa0years old', 'children']","['8-week motor skill-based physical activity (i.e., gymnastics) program', 'gymnastics group (n\xa0=\xa026) or a wait-list control group']","['response accuracy', 'Working memory performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0168873,The results revealed significant improvement of response accuracy from pre-test to post-test in the gymnastic group regardless of memory demands.,"[{'ForeName': 'Chih-Chien', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Shu-Shih', 'Initials': 'SS', 'LastName': 'Hsieh', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, United States.'}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Chung-Ju', 'Initials': 'CJ', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Sports Pedagogy, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, United States; Department of Physical Therapy, Movement, and Rehabilitation Sciences, Northeastern University, Boston, United States.'}, {'ForeName': 'Tsung-Min', 'Initials': 'TM', 'LastName': 'Hung', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan; Institute in Research Excellence and Learning Science, National Taiwan Normal University, Taipei, Taiwan. Electronic address: ernesthungkimo@yahoo.com.tw.'}]",Brain and cognition,['10.1016/j.bandc.2021.105695']
1046,33515786,Improving care coordination for patients with cardiac disease: Study protocol of the randomised controlled new healthcare programme (Cardiolotse).,"INTRODUCTION


A lack of effective coordination and communication between ambulatory care physicians and hospitals, including the lack of follow-up care, poses a challenge to the recovery process of patients suffering from cardiac disease, often resulting in rehospitalisation and adverse outcomes. This innovative care programme aims to bridge the gap between ambulatory and hospital care. A key element of this programme is specifically trained care managers (Cardiolotse) who provide post-discharge support, access to additional resources and help the patient to navigate successfully through the healthcare system.
MATERIAL AND METHODS


The study is set up as a prospective, randomised, controlled trial. Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation. Sample size calculations resulted in 1454patients per group after adjusting for potential non-compliance. All participants are surveyed at discharge, after 3 and 12 months. The primary outcome of the study is the 12-month rehospitalisation rate. Secondary outcomes include differences in length of hospital stay, mortality, quality-adjusted life years, costs and patient satisfaction. Statistical analysis and economic evaluation will be complemented by a process evaluation.
DISCUSSION


The new healthcare programme is designed to support patients when leaving hospital with cardiac conditions by easing the transition between sectors through access to Cardiolotses and individualised care plans. We hypothesise that the programme reduces rehospitalisation and improves clinically relevant patient outcomes.
TRIAL REGISTRATION


German Clinical Trial Register, DRKS00020424. Registered 2020-06-18, http://www.drks.de/DRKS00020424.",2021,Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation.,"['patients with cardiac disease', 'patients suffering from cardiac disease']",[],"['12-month rehospitalisation rate', 'length of hospital stay, mortality, quality-adjusted life years, costs and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}]",[],"[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.137016,Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation.,"[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Geiger', 'Affiliation': 'LMU Munich, Department of Health Services Management, Schackstraße 4, 80539 Munich, Germany. Electronic address: geiger@bwl.lmu.de.'}, {'ForeName': 'Katrin C', 'Initials': 'KC', 'LastName': 'Reber', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Darius', 'Affiliation': 'Vivantes - Netzwerk für Gesundheit GmbH, Aroser Allee 72-76, 13407 Berlin, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Holzgreve', 'Affiliation': 'Vivantes - Netzwerk für Gesundheit GmbH, Aroser Allee 72-76, 13407 Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Karmann', 'Affiliation': 'Vivantes - Netzwerk für Gesundheit GmbH, Aroser Allee 72-76, 13407 Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Liersch', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Anica', 'Initials': 'A', 'LastName': 'Stürtz', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Riesner', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Sundmacher', 'Affiliation': 'Chair of Health Economics, Technical University of Munich, Georg-Brauchle-Ring 60/62, 80992, Germany.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106297']
1047,33515785,"A randomized, controlled trial of the safety planning intervention: Research design and methods.","BACKGROUND


Brief interventions for suicide risk among patients treated in acute care settings like the emergency department are needed. The Safety Planning Intervention is a promising approach but has yet to undergo a high quality, individual level randomized controlled trial.
PURPOSE


This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs.
METHODS


The sample comprised patients 18 years and older presenting to one of three different emergency departments with suicide related emergencies (target n = 484). Eligible patients were approached, consented, and randomized to the intervention (Safety Planning Intervention) or control (risk factors and warning signs). They were assessed at 1, 3 and 6 months after their index visit. The primary outcome is suicidal behavior. The study also assessed mechanisms of action. Data analyses are pending.
CONCLUSIONS


We identified and addressed key challenges to studying suicidal patients in the emergency department, including difficulty enrolling during the emergency department visit, ascertaining outcomes in patients that are historically very difficult to follow, and addressing the ambiguity of suicidal behavior. ClinicalTrials.gov Identifier: NCT03227991.",2021,"This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs.
","['Eligible patients', 'patients 18\u202fyears and older presenting to one of three different emergency departments with suicide related emergencies (target n\u202f=\u202f484', 'suicidal patients in the emergency department, including difficulty enrolling during the emergency department visit']","['Safety Planning Intervention', 'intervention (Safety Planning Intervention) or control (risk factors and warning signs']",['suicidal behavior'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0220912', 'cui_str': 'signs'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",484.0,0.148182,"This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs.
","[{'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Boudreaux', 'Affiliation': 'Departments of Emergency Medicine, Psychiatry, and Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA. Electronic address: Edwin.Boudreaux@umassmed.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA. Electronic address: bhs2@cumc.columbia.edu.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA. Electronic address: kelgreen@pennmedicine.upenn.edu.'}, {'ForeName': 'Hanga', 'Initials': 'H', 'LastName': 'Galfalvy', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA. Electronic address: hanga.galfalvy@nyspi.columbia.edu.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA. Electronic address: gregbrow@pennmedicine.upenn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106291']
1048,33515784,Promoting physical activity in young adult cancer survivors using mHealth and adaptive tailored feedback strategies: Design of the Improving Physical Activity after Cancer Treatment (IMPACT) randomized controlled trial.,"INTRODUCTION


Despite the health benefits of physical activity for cancer survivors, nearly 60% of young adult cancer survivors (YACS) are physically inactive. Few physical activity interventions have been designed specifically for YACS.
PURPOSE


To describe the rationale and design of the IMPACT (IMproving Physical Activity after Cancer Treatment) trial, which tests the efficacy of a theory-based, mobile physical activity intervention for YACS.
METHODS


A total of 280 physically inactive YACS (diagnosed at ages 18-39) will be randomized to a self-help control or intervention condition. All participants will receive an activity tracker and companion mobile app, cellular-enabled scale, individual videochat session, and access to a Facebook group. Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques. The program includes: behavioral lessons; adaptive goal-setting in response to individuals' changing activity patterns; tailored feedback based on objective data and self-report measures; tailored text messages; and Facebook prompts encouraging peer support. Assessments occur at baseline, 3, 6, and 12 months. The primary outcome is total physical activity min/week at 6 months (assessed via accelerometry); secondary outcomes include total physical activity at 12 months, sedentary behavior, weight, and psychosocial measures.
CONCLUSIONS


IMPACT uniquely focuses on physical activity in YACS using an automated tailored mHealth program. Study findings could result in a high-reach, physical activity intervention for YACS that has potential to be adopted on a larger scale and reduce cancer-related morbidity. ClinicalTrials.gov Identifier: NCT03569605.",2021,"Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques.","['young adult cancer survivors', '280 physically inactive YACS (diagnosed at ages 18-39']","['mobile intervention based on social cognitive theory', 'activity tracker and companion mobile app, cellular-enabled scale, individual videochat session, and access to a Facebook group', 'self-help control or intervention condition', 'theory-based, mobile physical activity intervention']","['behavioral capability, self-regulation, self-efficacy, and social support', 'total physical activity minutes/week at 6\u202fmonths (assessed via accelerometry); secondary outcomes include total physical activity at 12\u202fmonths, sedentary behavior, weight, and psychosocial measures']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",280.0,0.0428451,"Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques.","[{'ForeName': 'Carmina G', 'Initials': 'CG', 'LastName': 'Valle', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: carmina.valle@unc.edu.'}, {'ForeName': 'Bernardine M', 'Initials': 'BM', 'LastName': 'Pinto', 'Affiliation': 'School of Nursing, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Diamond', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lindsey N', 'Initials': 'LN', 'LastName': 'Horrell', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Brooke T', 'Initials': 'BT', 'LastName': 'Nezami', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Hatley', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Coffman', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Polzien', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Hales', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Rini', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Departments of Psychiatry and Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106293']
1049,33523036,Effects of autogenic and reciprocal inhibition muscle energy techniques on isometric muscle strength in neck pain: A randomized controlled trial.,"BACKGROUND


The neck is one of the most common sites of musculoskeletal symptoms, and muscle shortening and weakness is observed to be a common cause of neck pain and disability.
OBJECTIVE


To compare the immediate and short term effects of static stretching (SS), autogenic inhibition (AI) and reciprocal inhibition (RI) muscle energy techniques (MET) on isometric muscle strength in the management of mechanical neck pain.
METHODS


A randomized controlled trial was conducted on 78 participants with neck pain randomly allocated to SS, AI-MET and RI-MET groups. All the participants received Trans Cutaneous Electrical Nerve Stimulation (TENS), hot pack and unilateral postero-anterior glide, followed by 3-5 repetitions of either SS, AI-MET or RI-MET for five consecutive sessions. Numeric pain rating scale (NPRS) and Modified Sphygmomanometer Dynamometry (MSD) were used as outcome measurement tools. One way ANOVA and repeated measures ANOVA were used for inter-group and intra-group comparison.
RESULT


In terms of MSD scores, a significant difference (p< 0.05) was observed between the groups. Both AI-MET and RI-MET were found to be comparatively more effective than SS, however AI-MET was found to be the most effective.
CONCLUSION


AI-MET is more effective than SS and RI-MET in terms of improving isometric muscle strength in patients with mechanical neck pain.",2021,"In terms of MSD scores, a significant difference (p< 0.05) was observed between the groups.","['neck pain', 'patients with mechanical neck pain', '78 participants with neck pain randomly allocated to SS, AI-MET and RI-MET groups']","['autogenic and reciprocal inhibition muscle energy techniques', 'static stretching (SS), autogenic inhibition (AI) and reciprocal inhibition (RI) muscle energy techniques (MET', 'Trans Cutaneous Electrical Nerve Stimulation (TENS), hot pack and unilateral postero-anterior glide, followed by 3-5 repetitions of either SS, AI-MET or RI-MET']","['Numeric pain rating scale (NPRS) and Modified Sphygmomanometer Dynamometry (MSD', 'MSD scores', 'isometric muscle strength']","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0683266', 'cui_str': 'Reciprocal inhibition'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0683266', 'cui_str': 'Reciprocal inhibition'}, {'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0183427', 'cui_str': 'Sphygmomanometer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",78.0,0.0493885,"In terms of MSD scores, a significant difference (p< 0.05) was observed between the groups.","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Osama', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200002']
1050,33529381,Flapless application of enamel matrix derivative in periodontal retreatment: A multicentre randomized feasibility trial.,"AIM


To investigate the potential benefit of enamel matrix derivative (EMD) as adjunct to re-instrumentation of residual pockets persisting after steps 1 and 2 of periodontal therapy.
MATERIAL AND METHODS


44 adult patients participated in a multicentre feasibility randomized clinical trial with split-mouth design. They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥5 and ≤8 mm, with bleeding on probing (BOP). Two teeth with similar PPD were randomized to receive re-instrumentation either with (test) or without (control) adjunctive flapless administration of EMD. Differences in the changes of PPD and BOP from baseline to 6 and 12 months were analysed, and the frequencies of pocket closure (PPD ≤4 mm and no BOP) compared.
RESULTS


For the primary outcome ""change of mean PPD after 6 months,"" a significant additional benefit of 0.79 ± 1.3 mm (p < .0001) could be observed for the test group. At 12 months, this difference could be maintained (0.85 ± 1.1 mm; p < .0001). The frequency of pocket closure in the test group was 69% at 6 and 80% at 12 months and significantly higher than in the control group with 34% and 42%, respectively (p < .01).
CONCLUSIONS


The results of the present feasibility study indicate a benefit of adjunctive EMD during non-surgical retreatment (step 3 of periodontal therapy) of residual deep pockets.",2021,"The frequency of pocket closure in the test group was 69% at 6 and 80% at 12 months and significantly higher than in the control group with 34% and 42%, respectively (p < 0.01).
","['44 adult patients participated in a multicenter feasibility randomized clinical trial with split-mouth design', 'Two teeth with similar PPD', 'periodontal retreatment', 'They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥ 5 and ≤ 8 mm, with bleeding on probing (BOP']","['enamel matrix derivative (EMD', 're-instrumentation either with (test) or without (control) adjunctive flapless administration of EMD', 'adjunctive EMD']","['PPD and BOP', 'mean PPD', 'frequency of pocket closure', 'frequencies of pocket closure (PPD ≤ 4 mm and no BOP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1301776', 'cui_str': 'Step 1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",44.0,0.228622,"The frequency of pocket closure in the test group was 69% at 6 and 80% at 12 months and significantly higher than in the control group with 34% and 42%, respectively (p < 0.01).
","[{'ForeName': 'Holger F R', 'Initials': 'HFR', 'LastName': 'Jentsch', 'Affiliation': 'Centre of Periodontology, Department for Cariology, Endodontology and Periodontology, University Hospital of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Roccuzzo', 'Affiliation': 'Private Practice, Torino, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pilloni', 'Affiliation': 'Sapienza, Department of Dental and Maxillo-Facial Sciences - Section of Periodontology, University of Rome, Rome, Italy.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Kasaj', 'Affiliation': 'Department of Periodontology and Conservative Dentistry, University of Mainz, Mainz, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Jepsen', 'Affiliation': 'Department of Periodontology, Operative and Preventive Dentistry, University of Bonn, Bonn, Germany.'}]",Journal of clinical periodontology,['10.1111/jcpe.13438']
1051,33445037,A more secure and effective method for throat swab collection: The importance of adequate exposure of oral cavity in COVID-19 specimen collection.,"OBJECTIVES


This study aims to propose a novel and effective throat swab collection method for coronavirus disease 2019 (COVID-19).
METHODS


The subjects were randomly divided into two groups. The subjects were asked to open their mouth to make ""ah"" sound (traditional method) or simulate yawn (improved method) for throat swab collection. The usage of tongue depressor, collection time, adverse reactions and subjective discomfort (VAS score) were compared. The collection time, comprehensive indicators of adverse reactions and VAS score were also compared among three collectors.
RESULTS


The tongue depressor was less used in the improved group (χ 2  = 40.186, P < 0.01). The average collection time of the traditional group was 5.44 ± 2.97 and that of the improved group was 4.00 ± 2.31 (P < 0.01). The subjects in the improved group had fewer and milder adverse reactions. The VAS score of subjects in the improved group was lower than that in the traditional group (P < 0.01). Among different collectors, the collection time, comprehensive indicators of adverse reactions and VAS were the same as the overall trend.
CONCLUSION


Simulating yawn is a safer and faster throat swab collection method.",2021,"The tongue depressor was less used in the improved group (χ 2  = 40.186, P < 0.01).",['coronavirus disease 2019 (COVID-19'],"['open their mouth to make ""ah"" sound (traditional method) or simulate yawn (improved method) for throat swab collection']","['collection time, comprehensive indicators of adverse reactions and VAS', 'usage of tongue depressor, collection time, adverse reactions and subjective discomfort (VAS score', 'collection time, comprehensive indicators of adverse reactions and VAS score', 'milder adverse reactions', 'average collection time', 'VAS score']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043387', 'cui_str': 'Yawning'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]","[{'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0183967', 'cui_str': 'Tongue blade'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.021042,"The tongue depressor was less used in the improved group (χ 2  = 40.186, P < 0.01).","[{'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Tianjin Third Central Hospital, Tianjin 300170, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Tianjin Third Central Hospital, Tianjin 300170, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Qu', 'Affiliation': 'Admin Office, Tianjin Third Central Hospital, Tianjin 300170, China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of General Surgery, Tianjin Third Central Hospital, Tianjin 300170, China.'}, {'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Department of General Surgery, Tianjin Third Central Hospital, Tianjin 300170, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'Department of General Surgery, Tianjin Third Central Hospital, Tianjin 300170, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Director of Nursing, Tianjin Third Central Hospital, Tianjin 300170, China.'}, {'ForeName': 'Fangmin', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Tianjin Third Central Hospital, Tianjin 300170, China. Electronic address: Chengfangming01511@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102896']
1052,33476774,"The primary care assessment and research of a telephone intervention for neuropsychiatric conditions with education and resources study: Design, rationale, and sample of the PARTNERs randomized controlled trial.","While most patients with depression, anxiety, or at-risk drinking receive care exclusively in primary care settings, primary care providers experience challenges in diagnosing and treating these common problems. Over the past two decades, the collaborative care model has addressed these challenges. However, this model has been adopted very slowly due to the high costs of care managers; inability to sustain their role in small practices; and the perceived lack of relevance of interventions focused on a specific psychiatric diagnosis. Thus, we designed an innovative randomized clinical trial (RCT), the Primary Care Assessment and Research of a Telephone Intervention for Neuropsychiatric Conditions with Education and Resources study (PARTNERs). This RCT compared the outcomes of enhanced usual care and a novel model of collaborative care in primary care patients with depressive disorders, generalized anxiety, social phobia, panic disorder, at-risk drinking, or alcohol use disorders. These conditions were selected because they are present in almost a third of patients seen in primary care settings. Innovations included assigning the care manager role to trained lay providers supported by computer-based tools; providing all care management centrally by phone - i.e., the intervention was delivered without any face-to-face contact between the patient and the care team; and basing patient eligibility and treatment selection on a transdiagnostic approach using the same eligibility criteria and the same treatment algorithms regardless of the participants' specific psychiatric diagnosis. This paper describes the design of this RCT and discusses the rationale for its main design features.",2021,"This RCT compared the outcomes of enhanced usual care and a novel model of collaborative care in primary care patients with depressive disorders, generalized anxiety, social phobia, panic disorder, at-risk drinking, or alcohol use disorders.","['primary care patients with depressive disorders, generalized anxiety, social phobia, panic disorder, at-risk drinking, or alcohol use disorders', 'neuropsychiatric conditions with education and resources']","['telephone intervention', 'Telephone Intervention']",[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0251913,"This RCT compared the outcomes of enhanced usual care and a novel model of collaborative care in primary care patients with depressive disorders, generalized anxiety, social phobia, panic disorder, at-risk drinking, or alcohol use disorders.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Rodie', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Fitzgibbon', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Perivolaris', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Crawford', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Geist', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Levinson', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mitchell', 'Affiliation': 'Group Health Centre, Sault Ste. Marie, ON, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oslin', 'Affiliation': 'University of Pennsylvania and the Department of Veteran Affairs, Philadelphia, PA, United States of America.'}, {'ForeName': 'Nadiya', 'Initials': 'N', 'LastName': 'Sunderji', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Waypoint Centre for Mental Health Care, Penetanguishene, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Electronic address: benoit.mulsant@utoronto.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106284']
1053,33476675,Endocrinological effects of social exclusion and inclusion: Experimental evidence for adaptive regulation of female fecundity.,"When current conditions are probabilistically less suitable for successful reproduction than future conditions, females may prevent or delay reproduction until conditions improve. Throughout human evolution, social support was likely crucial to female reproductive success. Women may thus have evolved fertility regulation systems sensitive to cues from the social environment. However, current understanding of how psychological phenomena might affect female ovarian function is limited. In this study, we examined whether cues of reduced social support-social ostracism-impact women's hormone production. Following an in-lab group bonding task, women were randomly assigned to a social exclusion (n = 88) or social inclusion (n = 81) condition. After social exclusion, women with low background levels of social support experienced a decrease in estradiol relative to progesterone. In contrast, socially-included women with low background social support experienced an increase in estradiol relative to progesterone. Hormonal changes in both conditions occurred specifically when women were in their mid-to-late follicular phase, when baseline estradiol is high and progesterone is low. Follow-up analyses revealed that these changes were primarily driven by changes in progesterone, consistent with existing evidence for disruption of ovarian function following adrenal release of follicular-phase progesterone. Results offer support for a potential mechanism by which fecundity could respond adaptively to the loss or lack of social support.",2021,"Follow-up analyses revealed that these changes were primarily driven by changes in progesterone, consistent with existing evidence for disruption of ovarian function following adrenal release of follicular-phase progesterone.",['female fecundity'],['social exclusion (n\u202f=\u202f88) or social inclusion'],['estradiol relative to progesterone'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}]","[{'cui': 'C0237827', 'cui_str': 'Social exclusion'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]",,0.0216004,"Follow-up analyses revealed that these changes were primarily driven by changes in progesterone, consistent with existing evidence for disruption of ovarian function following adrenal release of follicular-phase progesterone.","[{'ForeName': 'Tran', 'Initials': 'T', 'LastName': 'Dinh', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: trandinh@unm.edu.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Gangestad', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Melissa Emery', 'Initials': 'ME', 'LastName': 'Thompson', 'Affiliation': 'Department of Anthropology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'A Janet', 'Initials': 'AJ', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA; Bedari Kindness Institute, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Daniel M T', 'Initials': 'DMT', 'LastName': 'Fessler', 'Affiliation': 'Department of Anthropology, University of California, Los Angeles, Los Angeles, CA, USA; Bedari Kindness Institute, University of California, Los Angeles, Los Angeles, CA, USA; Center for Behavior, Evolution, & Culture, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Theresa E', 'Initials': 'TE', 'LastName': 'Robertson', 'Affiliation': 'Department of Management, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Martie G', 'Initials': 'MG', 'LastName': 'Haselton', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA; Department of Communication, University of California, Los Angeles, CA, USA.'}]",Hormones and behavior,['10.1016/j.yhbeh.2021.104934']
1054,33493530,"A Phase 1b, Randomized, Single-Center Trial of Topical Cerdulatinib (DMVT-502) in Patients with Mild-to-Moderate Atopic Dermatitis.",,2021,,['Patients with Mild-to-Moderate Atopic Dermatitis'],['Topical Cerdulatinib (DMVT-502'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4045924', 'cui_str': 'cerdulatinib'}]",[],,0.0415831,,"[{'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Piscitelli', 'Affiliation': 'Dermavant Sciences, Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Department of Biomedical Engineering, The University of Mississippi, Oxford, Mississippi, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'McHale', 'Affiliation': 'Dermavant Sciences, Inc, Durham, North Carolina, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Jett', 'Affiliation': 'Dermavant Sciences, Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': 'Immunovant, Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Gillmor', 'Affiliation': 'Enzyvant, Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Tabolt', 'Affiliation': 'Dermavant Sciences, Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Tallman', 'Affiliation': 'Dermavant Sciences, Inc, New York, New York, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: emma.guttman@mountsinai.org.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2020.11.031']
1055,33493450,Effect of anakinra versus usual care in adults in hospital with COVID-19 and mild-to-moderate pneumonia (CORIMUNO-ANA-1): a randomised controlled trial.,"BACKGROUND


Patients with COVID-19 pneumonia have an excess of inflammation and increased concentrations of cytokines including interleukin-1 (IL-1). We aimed to determine whether anakinra, a recombinant human IL-1 receptor antagonist, could improve outcomes in patients in hospital with mild-to-moderate COVID-19 pneumonia.
METHODS


In this multicentre, open-label, Bayesian randomised clinical trial (CORIMUNO-ANA-1), nested within the CORIMUNO-19 cohort, we recruited patients from 16 University hospitals in France with mild-to-moderate COVID-19 pneumonia, severe acute respiratory syndrome coronavirus 2 infection confirmed by real-time RT-PCR, requiring at least 3 L/min of oxygen by mask or nasal cannula but without ventilation assistance, a score of 5 on the WHO Clinical Progression Scale (WHO-CPS), and a C-reactive protein serum concentration of more than 25 mg/L not requiring admission to the intensive care unit at admission to hospital. Eligible patients were randomly assigned (1:1) using a web-based secure centralised system, stratified by centre and blocked with varying block sizes (randomly of size two or four), to either usual care plus anakinra (200 mg twice a day on days 1-3, 100 mg twice on day 4, 100 mg once on day 5) or usual care alone. Usual care was provided at the discretion of the site clinicians. The two coprimary outcomes were the proportion of patients who had died or needed non-invasive or mechanical ventilation by day 4 (ie, a score of >5 on the WHO-CPS) and survival without need for mechanical or non-invasive ventilation (including high-flow oxygen) at day 14. All analyses were done on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT04341584, and is now closed to accrual.
FINDINGS


Between April 8 and April 26, 2020, we screened 153 patients. The study was stopped early following the recommendation of the data and safety monitoring board, after the recruitment of 116 patients: 59 were assigned to the anakinra group, and 57 were assigned to the usual care group. Two patients in the usual care group withdrew consent and were not analysed. In the analysable population, the median age was 66 years (IQR 59 to 76) and 80 (70%) participants were men. In the anakinra group, 21 (36%) of 59 patients had a WHO-CPS score of more than 5 at day 4 versus 21 (38%) of 55 in the usual care group (median posterior absolute risk difference [ARD] -2·5%, 90% credible interval [CrI] -17·1 to 12·0), with a posterior probability of ARD of less than 0 (ie, anakinra better than usual care) of 61·2%. At day 14, 28 (47%; 95% CI 33 to 59) patients in the anakinra group and 28 (51%; 95% CI 36 to 62) in the usual care group needed ventilation or died, with a posterior probability of any efficacy of anakinra (hazard ratio [HR] being less than 1) of 54·5% (median posterior HR 0·97; 90% CrI 0·62 to 1·52). At day 90, 16 (27%) patients in the anakinra group and 15 (27%) in the usual care group had died. Serious adverse events occurred in 27 (46%) patients in the anakinra group and 21 (38%) in the usual care group (p=0·45).
INTERPRETATION


Anakinra did not improve outcomes in patients with mild-to-moderate COVID-19 pneumonia. Further studies are needed to assess the efficacy of anakinra in other selected groups of patients with more severe COVID-19.
FUNDING


The Ministry of Health, Programme Hospitalier de Recherche Clinique, Foundation for Medical Research, and AP-HP Foundation.",2021,"At day 14, 28 (47%; 95% CI 33 to 59) patients in the anakinra group and 28 (51%; 95% CI 36 to 62) in the usual care group needed ventilation or died, with a posterior probability of any efficacy of anakinra (hazard ratio [HR] being less than 1) of 54·5% (median posterior HR 0·97; 90% CrI 0·62 to 1·52).","['patients with mild-to-moderate COVID-19 pneumonia', 'recruited patients from 16 University hospitals in France with mild-to-moderate COVID-19 pneumonia, severe acute respiratory syndrome coronavirus 2 infection confirmed by real-time RT-PCR, requiring at least 3 L/min of oxygen by mask or nasal cannula but without ventilation assistance, a score of 5 on the WHO Clinical Progression Scale (WHO-CPS), and a C-reactive protein serum concentration of more than 25 mg/L not requiring admission to the intensive care unit at admission to hospital', 'Eligible patients', 'Patients with COVID-19 pneumonia', 'adults in hospital with COVID-19 and mild-to-moderate pneumonia (CORIMUNO-ANA-1', 'Between April 8 and April 26, 2020', '116 patients: 59 were assigned to the anakinra group, and 57 were assigned to the usual care group', 'patients in hospital with mild-to-moderate COVID-19 pneumonia', '153 patients', 'In the analysable population, the median age was 66 years (IQR 59 to 76) and 80 (70%) participants were men']","['usual care plus anakinra', 'recombinant human IL-1 receptor antagonist', 'anakinra versus usual care', 'usual care alone']","['died', 'survival without need for mechanical or non-invasive ventilation', 'ventilation or died', 'Serious adverse events', 'proportion of patients who had died or needed non-invasive or mechanical ventilation', 'WHO-CPS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003243', 'cui_str': 'Antinuclear antibody'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704264', 'cui_str': 'Interleukin 1 Inhibitor, Urine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.165209,"At day 14, 28 (47%; 95% CI 33 to 59) patients in the anakinra group and 28 (51%; 95% CI 36 to 62) in the usual care group needed ventilation or died, with a posterior probability of any efficacy of anakinra (hazard ratio [HR] being less than 1) of 54·5% (median posterior HR 0·97; 90% CrI 0·62 to 1·52).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30556-7']
1056,33508442,Potential impacts of Acu-TENS in the treatment of adolescents with moderate to severe bronchial asthma: A randomized clinical study.,"OBJECTIVE


The purpose of this study was to evaluate the efficacy of transcutaneous electrical nerve stimulation over the acupuncture points (Acu-TENS) on total serum immunoglobulin E (IgE total ), pulmonary function, and quality of life in adolescents with asthma.
METHODS


In a double-blind randomized clinical trial, 32 adolescents (age; 12-16 years) with asthma participated and were assigned randomly to receive either the breathing retraining program (control group) or the breathing retraining program plus Acu-TENS application (Acu-TENS group). Acu-TENS was applied for 40 min' day-after-day session for two successive months, with no side-effects reported. Serum IgE total , pulmonary function [forced vital capacity (FVC), forced expiratory volume at one second (FEV 1 ), and FEV 1 /FVC], and quality of life were evaluated pre- and post-treatment.
RESULTS


Serum IgE total  (P = 0.028, η p 2  = 0.15), Pulmonary function [FVC (P = 0.043, η p 2  = 0.13), FEV 1  (P = .046, η p 2  = 0.12)], and quality of life (P < .001, η p 2  = 0.17) increased significantly in the Acu-TENS group when compared to the control group.
CONCLUSION


This study demonstrates that the Acu-TENS is an impending asthma treatment that may be used to reinforce the immune system response, ameliorate lung function, and increase the quality of life in adolescents with asthma.",2021,"total  (P = 0.028, η p 2  = 0.15), Pulmonary function [FVC (P =  0.043, η p 2  = 0.13), FEV 1  (P =  .046, η p 2  = 0.12)], and quality of life (P <  .001, η p 2  = 0.17) increased significantly in the Acu-TENS group when compared to the control group.
","['adolescents with moderate to severe bronchial asthma', '32 adolescents (age; 12-16 years) with asthma participated', 'adolescents with asthma']","['Acu-TENS', 'breathing retraining program (control group) or the breathing retraining program plus Acu-TENS application (Acu-TENS group', 'transcutaneous electrical nerve stimulation over the acupuncture points (Acu-TENS']","['Serum IgE', 'Pulmonary function [FVC', 'total serum immunoglobulin E (IgE total ), pulmonary function, and quality of life', 'Serum IgE total , pulmonary function [forced vital capacity (FVC), forced expiratory volume at one second (FEV 1 ), and FEV 1 /FVC], and quality of life', 'quality of life']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}]",32.0,0.0221138,"total  (P = 0.028, η p 2  = 0.15), Pulmonary function [FVC (P =  0.043, η p 2  = 0.13), FEV 1  (P =  .046, η p 2  = 0.12)], and quality of life (P <  .001, η p 2  = 0.17) increased significantly in the Acu-TENS group when compared to the control group.
","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia. Electronic address: rke_pt2001@yahoo.com.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Shaimaa E', 'Initials': 'SE', 'LastName': 'Ali', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Abeer M', 'Initials': 'AM', 'LastName': 'Yousef', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Azab', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102673']
1057,33515494,Is it cost effective to use a 2% chlorhexidine wipes bath to reduce central-line associated blood stream infection? A quasi-experimental study.,"BACKGROUND


Bathing with 2% chlorhexidine (CHG) wipes is an important measure regarding infection prevention in critically ill patients. The aim of this study was to evaluate the impact of CHG wipes bath to prevent central-line associated bloodstream infection (CLABSI) in critically ill patients and determine if such measure is cost-saving.
METHODS


a quasi-experimental study, conducted from July 2017 to April 2019. Daily bath with 2% CHG was used in all patients at the unit in the intervention period. The following were evaluated: CLABSI incidence density in both periods, 30- day mortality, guided antimicrobials used to treat CLABSI and 2% CHG costs.
RESULTS


CLABSI incidence density dropped from 8.69 to 1.83 per 1.000 central line-days (p = 0.001), mainly by Klebsiella pneumoniae Carbapenen Resistant (Kp-KPC) (p = 0.05). Costs with guided antimicrobials for the treatment in pre-intervention were US$ 46,114.36, and in the intervention period, US$ 4,177.50. The 2% CHG monthly cost was US$ 2,698.00, achieving 30% savings when comparing both periods.
DISCUSSION


An expressive reduction of 79% in CLABSI incidence density was observed, mainly due to Kp-KPC infection and also a reduction in guided antimicrobial costs.
CONCLUSIONS


Bathing with 2% CHG led to evident CLABSI reduction.",2021,"RESULTS


CLABSI incidence density dropped from 8.69 to 1.83 per 1.000 central line-days (p = 0.001), mainly by Klebsiella pneumoniae Carbapenen Resistant (Kp-KPC) (p = 0.05).","['a quasi-experimental study, conducted from July 2017 to April 2019', 'critically ill patients']","['chlorhexidine', 'chlorhexidine (CHG', 'Daily bath with 2% CHG']",['CLABSI incidence density'],"[{'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0008586', 'cui_str': 'Chromogranin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",,0.0210131,"RESULTS


CLABSI incidence density dropped from 8.69 to 1.83 per 1.000 central line-days (p = 0.001), mainly by Klebsiella pneumoniae Carbapenen Resistant (Kp-KPC) (p = 0.05).","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Feriani', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, Departmento de Infectologia, São Paulo, SP, Brazil.'}, {'ForeName': 'Ercilia Evangelista', 'Initials': 'EE', 'LastName': 'Souza', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, Departmento de Infectologia, São Paulo, SP, Brazil.'}, {'ForeName': 'Larissa Gordilho Mutti', 'Initials': 'LGM', 'LastName': 'Carvalho', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, Departmento de Infectologia, São Paulo, SP, Brazil.'}, {'ForeName': 'Aline Santos', 'Initials': 'AS', 'LastName': 'Ibanes', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, Departmento de Infectologia, São Paulo, SP, Brazil.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Vasconcelos', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, Departmento de Infectologia, São Paulo, SP, Brazil.'}, {'ForeName': 'Vera Lucia', 'Initials': 'VL', 'LastName': 'Barbosa', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, Departmento de Infectologia, São Paulo, SP, Brazil.'}, {'ForeName': 'Sandra Kiyomi', 'Initials': 'SK', 'LastName': 'Kondo', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, Departmento de Farmácia, São Paulo, SP, Brazil.'}, {'ForeName': 'Cely S', 'Initials': 'CS', 'LastName': 'Abboud', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, Departmento de Infectologia, São Paulo, SP, Brazil. Electronic address: cely.saad@dantepazzanese.org.br.'}]",The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases,['10.1016/j.bjid.2021.101538']
1058,33517953,Bag-Valve-Mask versus Laryngeal Mask Airway Ventilation in Cardiopulmonary Resuscitation with Continuous Compressions: A Simulation Study.,"INTRODUCTION


The 2017 International Liaison Committee on Resuscitation (ILCOR) guideline recommends that Emergency Medical Service (EMS) providers can perform cardiopulmonary resuscitation (CPR) with synchronous or asynchronous ventilation until an advanced airway has been placed. In the current literature, limited data on CPR performed with continuous compressions and asynchronous ventilation with bag-valve-mask (BVM) are available.
STUDY OBJECTIVE


In this study, researchers aimed to compare the effectiveness of asynchronous BVM and laryngeal mask airway (LMA) ventilation during CPR with continuous chest compressions.
METHODS


Emergency medicine residents and interns were included in the study. The participants were randomly assigned to resuscitation teams with two rescuers. The cross-over simulation study was conducted on two CPR scenarios: asynchronous ventilation via BVM during a continuous chest compression and asynchronous ventilation via LMA during a continuous chest compression in cardiac arrest patient with asystole. The primary endpoints were the ventilation-related measurements.
RESULTS


A total of 92 volunteers were included in the study and 46 CPRs were performed in each group. The mean rate of ventilations of the LMA group was significantly higher than that of the BVM group (13.7 [11.7-15.7] versus 8.9 [7.5-10.3] breaths/minute; P <.001). The mean volume of ventilations of the LMA group was significantly higher than that of the BVM group (358.4 [342.3-374.4] ml versus 321.5 [303.9-339.0] ml; P = .002). The mean minute ventilation volume of the LMA group was significantly higher than that of the BVM group (4.88 [4.15-5.61] versus 2.99 [2.41-3.57] L/minute; P <.001). Ventilations exceeding the maximum volume limit occurred in two (4.3%) CPRs in the BVM group and in 11 (23.9%) CPRs in the LMA group (P = .008).
CONCLUSION


The results of this study show that asynchronous BVM ventilation with continuous chest compressions is a reliable and effective strategy during CPR under simulation conditions. The clinical impact of these findings in actual cardiac arrest patients should be evaluated with further studies at real-life scenes.",2021,"Ventilations exceeding the maximum volume limit occurred in two (4.3%) CPRs in the BVM group and in 11 (23.9%) CPRs in the LMA group (P = .008).
","['Emergency medicine residents and interns were included in the study', '92 volunteers were included in the study and 46 CPRs were performed in each group', 'Cardiopulmonary Resuscitation with Continuous Compressions', 'cardiac arrest patient with asystole']","['BVM', 'asynchronous BVM and laryngeal mask airway (LMA) ventilation', 'cardiopulmonary resuscitation (CPR) with synchronous or asynchronous ventilation', 'Bag-Valve-Mask versus Laryngeal Mask Airway Ventilation']","['mean volume of ventilations', 'mean rate of ventilations', 'maximum volume limit', 'ventilation-related measurements', 'mean minute ventilation volume']","[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}]",92.0,0.0238832,"Ventilations exceeding the maximum volume limit occurred in two (4.3%) CPRs in the BVM group and in 11 (23.9%) CPRs in the LMA group (P = .008).
","[{'ForeName': 'Zerrin Defne', 'Initials': 'ZD', 'LastName': 'Dundar', 'Affiliation': 'Emergency Medicine Department, Necmettin Erbakan University Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Mustafa Kursat', 'Initials': 'MK', 'LastName': 'Ayranci', 'Affiliation': 'Emergency Medicine Department, Necmettin Erbakan University Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Kocak', 'Affiliation': 'Emergency Medicine Department, Necmettin Erbakan University Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Abdullah Sadik', 'Initials': 'AS', 'LastName': 'Girisgin', 'Affiliation': 'Emergency Medicine Department, Necmettin Erbakan University Meram Faculty of Medicine, Konya, Turkey.'}]",Prehospital and disaster medicine,['10.1017/S1049023X21000054']
1059,33517032,The Effects of Combining Transcranial Direct Current Stimulation and Gait Training with Functional Electrical Stimulation on Trunk Acceleration During Walking in Patients with Subacute Stroke.,"OBJECTIVES


This study aimed to investigate whether the combination of transcranial direct current stimulation (tDCS) and gait training with FES affected walking speed and trunk accelerometry-based gait characteristics in patients with subacute stroke, compared with FES or tDCS gait training only.
MATERIALS AND METHODS


Stroke patients (n = 34; female 15; mean age, 72.5 ± 11.2 years; mean days poststroke, 38.7) with resultant paresis in the lower extremity (mean Fugl-Meyer score, 25.5) were enrolled. Patients were randomly assigned to one of three groups: combined anodal tDCS and gait training with FES (tDCS+FES, n = 11), anodal tDCS with gait training (tDCS, n = 11), or combined sham tDCS and gait training with FES (FES, n = 12). Participants received the intervention for 20 minutes and a 40-minute conventional rehabilitative intervention daily for a week. Patients' walking ability was evaluated using walking speed, harmonic ratio (HR), autocorrelation coefficient (AC), and root mean square (RMS) along each axis using a wearable trunk accelerometer.
RESULTS


The tDCS+FES group had a significantly greater change in AC in the anteroposterior axis and mediolateral axis than the FES and tDCS groups and FES group, respectively. There were no significant effects on walking speed or other parameters (HR and RMS) among the groups.
CONCLUSIONS


The combination of anodal tDCS and gait training with FES improved the post-stroke patients' gait regularity than FES gait training intervention only. Thus, combined tDCS and FES gait training, as a novel intervention, could be an important therapeutic tool in improving walking performance.",2021,"The tDCS+FES group had a significantly greater change in AC in the anteroposterior axis and mediolateral axis than the FES and tDCS groups and FES group, respectively.","['patients with subacute stroke, compared with FES or tDCS gait training only', 'Patients with Subacute Stroke', 'mean days poststroke, 38.7) with resultant paresis in the lower extremity (mean Fugl-Meyer score, 25.5) were enrolled', 'Stroke patients (n\u202f=\u202f34; female 15; mean age, 72.5 ± 11.2 years']","['combined anodal tDCS and gait training with FES (tDCS+FES, n\u202f=\u202f11), anodal tDCS with gait training (tDCS, n\u202f=\u202f11), or combined sham tDCS and gait training with FES (FES, n\u202f=\u202f12', 'anodal tDCS and gait training with FES', 'tDCS+FES', 'transcranial direct current stimulation (tDCS) and gait training with FES affected walking speed and trunk accelerometry-based gait characteristics', 'Transcranial Direct Current Stimulation and Gait Training with Functional Electrical Stimulation', '40-minute conventional rehabilitative intervention']","['walking speed or other parameters (HR and RMS', 'Trunk Acceleration', 'change in AC in the anteroposterior axis and mediolateral axis', 'walking speed, harmonic ratio (HR), autocorrelation coefficient (AC), and root mean square (RMS) along each axis using a wearable trunk accelerometer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}]",,0.0204706,"The tDCS+FES group had a significantly greater change in AC in the anteroposterior axis and mediolateral axis than the FES and tDCS groups and FES group, respectively.","[{'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Mitsutake', 'Affiliation': 'Department of Physical Therapy, Faculty of Medical Science, Fukuoka International University of Health and Welfare, Fukuoka, Japan; Education and Research Centre for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan. Electronic address: mitutuba1012@gmail.com.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Sakamoto', 'Affiliation': 'Education and Research Centre for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Nakazono', 'Affiliation': 'Department of Occupational Therapy, Faculty of Medical Science, Fukuoka International University of Health and Welfare, Fukuoka, Japan.'}, {'ForeName': 'Etsuo', 'Initials': 'E', 'LastName': 'Horikawa', 'Affiliation': 'Department of Orthoptics, Faculty of Medical Science, Fukuoka International University of Health and Welfare, Fukuoka, Japan.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2021.105635']
1060,33516859,Pinging the brain with transcranial magnetic stimulation reveals cortical reactivity in time and space.,"BACKGROUND


Single-pulse transcranial magnetic stimulation (TMS) elicits an evoked electroencephalography (EEG) potential (TMS-evoked potential, TEP), which is interpreted as direct evidence of cortical reactivity to TMS. Thus, combining TMS with EEG can be used to investigate the mechanism underlying brain network engagement in TMS treatment paradigms. However, controversy remains regarding whether TEP is a genuine marker of TMS-induced cortical reactivity or if it is confounded by responses to peripheral somatosensory and auditory inputs. Resolving this controversy is of great significance for the field and will validate TMS as a tool to probe networks of interest in cognitive and clinical neuroscience.
OBJECTIVE


Here, we delineated the cortical origin of TEP by spatially and temporally localizing successive TEP components, and modulating them with transcranial direct current stimulation (tDCS) to investigate cortical reactivity elicited by single-pulse TMS and its causal relationship with cortical excitability.
METHODS


We recruited 18 healthy participants in a double-blind, cross-over, sham-controlled design. We collected motor-evoked potentials (MEPs) and TEPs elicited by suprathreshold single-pulse TMS targeting the left primary motor cortex (M1). To causally test cortical and corticospinal excitability, we applied tDCS to the left M1.
RESULTS


We found that the earliest TEP component (P25) was localized to the left M1. The following TEP components (N45 and P60) were largely localized to the primary somatosensory cortex, which may reflect afferent input by hand-muscle twitches. The later TEP components (N100, P180, and N280) were largely localized to the auditory cortex. As hypothesized, tDCS selectively modulated cortical and corticospinal excitability by modulating the pre-stimulus mu-rhythm oscillatory power.
CONCLUSION


Together, our findings provide causal evidence that the early TEP components reflect cortical reactivity to TMS.",2021,"The later TEP components (N100, P180, and N280) were largely localized to the auditory cortex.","['18 healthy participants in a double-blind, cross-over, sham-controlled design']","['collected motor-evoked potentials (MEPs) and TEPs elicited by suprathreshold single-pulse TMS', 'Transcranial Magnetic Stimulation', 'TEP', 'transcranial direct current stimulation (tDCS', 'pulse transcranial magnetic stimulation (TMS']",['cortical and corticospinal excitability'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",18.0,0.0660331,"The later TEP components (N100, P180, and N280) were largely localized to the auditory cortex.","[{'ForeName': 'Sangtae', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'School of Electronics Engineering, Kyungpook National University, Daegu, 41566, South Korea; School of Electronic and Electrical Engineering, Kyungpook National University, Daegu, 41566, South Korea; Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Neurology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Cell Biology and Physiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Neuroscience Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA. Electronic address: flavio_frohlich@med.unc.edu.'}]",Brain stimulation,['10.1016/j.brs.2021.01.018']
1061,33524208,The Effect of Mobile Learning on Student Success and Anxiety in Teaching Genital System Anatomy.,"The widespread use of smartphones has led to the emergence of new mobile learning tools. The aim of this study was to compare traditional methods to mobile learning applications, and their effect on the academic achievement and anxiety levels of students learning genital system anatomy. This research study was a randomized controlled study conducted with students who took anatomy between November and December 2018. The cohort consisted of 63 students who met the sampling criteria. Groups (control = 31, experimental = 32) were randomly selected using a simple number table. The mobile application developed for the experimental group was installed on the students' mobile devices with the extension ""genitalsystem.apk."" The anatomy of the genital system was taught to the control group using the standard curriculum and to the experimental group using the mobile application. After teaching the anatomy of the genital system, the state anxiety levels of the students in the control group were determined to be higher at 45.6 (±8.7) than the experimental group at 40.4 (±8.3) as measured by the 20-80 point STAI scale. The posttest examination average of the control group was 8.9 (±6.9) out of 22 or 40.4 (±6.9)% and the posttest average of the experimental group using mobile application was 14.9 (±5.5) or 67.7 (±5.5)%. State anxiety levels and examination grades showed a highly significant difference in favor of the experimental group. These results indicate that using mobile applications when teaching anatomy may be an effective method to enhance learning and reduce anxiety levels when compared to the traditional teaching methods.",2021,State anxiety levels and examination grades showed a highly significant difference in favor of the experimental group.,"['63 students who met the sampling criteria', 'students learning genital system anatomy', 'students who took anatomy between November and December 2018']",['mobile learning'],"['state anxiety levels', 'State anxiety levels', 'anxiety levels', 'academic achievement and anxiety levels']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",,0.019727,State anxiety levels and examination grades showed a highly significant difference in favor of the experimental group.,"[{'ForeName': 'Güneş', 'Initials': 'G', 'LastName': 'Bolatli', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, Siirt University, Siirt, Turkey.'}, {'ForeName': 'Hamiyet', 'Initials': 'H', 'LastName': 'Kizil', 'Affiliation': 'Department of Nursing, School of Health Sciences, Beykent University, İstanbul, Turkey.'}]",Anatomical sciences education,['10.1002/ase.2059']
1062,33274479,Cyclosporine A plus low-dose steroid treatment in COVID-19 improves clinical outcomes in patients with moderate to severe disease: A pilot study.,"BACKGROUND


COVID-19 pandemic causes high global morbidity and mortality and better medical treatments to reduce mortality are needed.
OBJECTIVE


To determine the added benefit of cyclosporine A (CsA), to low-dose steroid treatment, in patients with COVID-19.
METHODS


Open-label, non randomized pilot study of patients with confirmed infection of SARS-CoV-2 hospitalized from April to May 2020 at a single centre in Puebla, Mexico. Patients were assigned to receive either steroids or CsA plus steroids. Pneumonia severity was assessed by clinical, laboratory, and lung tomography. The death rate was evaluated at 28 days.
RESULTS


A total of 209 adult patients were studied, 105 received CsA plus steroids (age 55.3 ± 13.3; 69% men), and 104 steroids alone (age 54.06 ± 13.8; 61% men). All patients received clarithromycin, enoxaparin and methylprednisolone or prednisone up to 10 days. Patient's death was associated with hypertension (RR = 3.5) and diabetes (RR = 2.3). Mortality was 22 and 35% for CsA and control groups (P = 0.02), respectively, for all patients, and 24 and 48.5% for patients with moderate to severe disease (P = 0.001). Higher cumulative clinical improvement was seen for the CsA group (Nelson Aalen curve, P = 0.001, log-rank test) in moderate to severe patients. The Cox proportional hazard analysis showed the highest HR improvement value of 2.15 (1.39-3.34, 95%CI, P = 0.0005) for CsA treatment in moderate to severe patients, and HR = 1.95 (1.35-2.83, 95%CI, P = 0.0003) for all patients.
CONCLUSION


CsA used as an adjuvant to steroid treatment for COVID-19 patients showed to improve outcomes and reduce mortality, mainly in those with moderate to severe disease. Further investigation through controlled clinical trials is warranted.",2020,"Mortality was 22 and 35% for CsA and control groups (P = 0.02), respectively, for all patients, and 24 and 48.5% for patients with moderate to severe disease (P = 0.001).","['patients with confirmed infection of SARS-CoV-2 hospitalized from April to May 2020 at a single centre in Puebla, Mexico', 'patients with moderate to severe disease', 'patients with COVID-19', '209 adult patients were studied, 105 received CsA plus steroids (age 55.3\xa0±\xa013.3; 69% men), and 104 steroids alone (age 54.06\xa0±\xa013.8; 61% men']","['Cyclosporine A plus low-dose steroid', 'cyclosporine A (CsA', 'steroids or CsA plus steroids', 'clarithromycin, enoxaparin and methylprednisolone or prednisone']","[""Patient's death"", 'death rate', 'cumulative clinical improvement', 'Mortality', 'Pneumonia severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4517561', 'cui_str': '13.8'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",209.0,0.0726132,"Mortality was 22 and 35% for CsA and control groups (P = 0.02), respectively, for all patients, and 24 and 48.5% for patients with moderate to severe disease (P = 0.001).","[{'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Gálvez-Romero', 'Affiliation': 'From the, Departamento de investigación, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Palmeros-Rojas', 'Affiliation': 'Área de Matemáticas, Departamento de Preparatoria Agrícola, Universidad Autónoma Chapingo, Texcoco, México.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Real-Ramírez', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sánchez-Romero', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tome-Maxil', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Ramírez-Sandoval', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Olivos-Rodríguez', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Flores-Encarnación', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Cabrera-Estrada', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ávila-Morales', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cortés-Sánchez', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sarmiento-Padilla', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Tezmol-Ramírez', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aparicio-Hernández', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Urbina-Sánchez', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'M Á', 'Initials': 'MÁ', 'LastName': 'Gómez-Pluma', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cisneros-Méndez', 'Affiliation': 'Departamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Rodríguez-Rivas', 'Affiliation': 'Departamento de Radiología, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Reyes-Inurrigarro', 'Affiliation': 'Departamento del Servicio de Urgencias y Terapia Intensiva, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cortés-Díaz', 'Affiliation': 'Departamento del Servicio de Urgencias y Terapia Intensiva, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cruz-Delgado', 'Affiliation': 'Departamento del Servicio de Urgencias y Terapia Intensiva, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Navarro-González', 'Affiliation': 'Departamento del Servicio de Epidemiología, Hospital Regional, ISSSTE, Puebla, México.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Deveaux-Homs', 'Affiliation': 'Director Médico, Hospital Regional, Hospital Regional ISSSTE, Puebla, México.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pedraza-Sánchez', 'Affiliation': 'Unidad de Bioquímica, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), and Facultad de Ciencias, Universidad Nacional Autónoma de México (UNAM), Ciudad de México, México.'}]",Journal of internal medicine,['10.1111/joim.13223']
1063,33525212,Efficacy and safety of sofosbuvir/ ledipasvir in treatment of patients with COVID-19; A randomized clinical trial.,"BACKGROUND


There is no study regarding the use of SOF/LDP in treatment of COVID-19.  Objectives: In this study, the efficacy and safety of SOF/LDP were assessed in treatment of patients with mild to moderate COVID-19.
METHODS


Among an open-label randomized clinical trial, 82 patients with mild to moderated COVID-19 were assigned to receive either SOF/LDP 400/100 mg daily plus the standard of care (SOF/LDP group, n=42) or the standard of care alone (control group, n=40) for 10 days. Time to clinical response, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were assessed.
RESULTS


Clinical response occurred in 91.46% of patients. Although rates of clinical response were comparable between the groups but it occurred faster in the SOF/LDP group than the control group (2 vs. 4 days respectively, P= 0.02). Supportive cares were provided in the medical wards for most patients but 17.07% of patients were transferred to ICU during the hospitalization course. However, durations of hospital and ICU stay were comparable between the groups.  14--day mortality rate was 7.14% and 7.5% in the SOF/ LDP and control groups respectively. No adverse effects leading to drug discontinuation occurred. Gastrointestinal events (nausea, vomiting and diarrhea) were the most common side effects (15.85%).
CONCLUSION


Added to the standard of care, SOF/LDP accelerated time to the clinical response. However, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were not different. No significant adverse event was detected.  More randomized clinical trials with larger sample sizes are needed to confirm the efficacy and safety of SOF/LDP in the treatment of COVID-19.",2020,"Although rates of clinical response were comparable between the groups but it occurred faster in the SOF/LDP group than the control group (2 vs. 4 days respectively, P= 0.02).","['82 patients with mild to moderated COVID-19', 'patients with COVID-19', 'patients with mild to moderate COVID-19']","['SOF/LDP 400/100', 'sofosbuvir/ ledipasvir', 'SOF/LDP', 'standard of care alone (control']","['Gastrointestinal events (nausea, vomiting and diarrhea', '14--day mortality rate', 'durations of hospital and ICU stay', 'Time to clinical response, rate of clinical response, duration of hospital and ICU stay and 14-day mortality', 'adverse event', 'Efficacy and safety', 'rates of clinical response', 'rate of clinical response, duration of hospital and ICU stay and 14-day mortality', 'efficacy and safety of SOF/LDP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C3851350', 'cui_str': 'ledipasvir'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0151791', 'cui_str': 'Nausea, vomiting and diarrhea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",82.0,0.0630775,"Although rates of clinical response were comparable between the groups but it occurred faster in the SOF/LDP group than the control group (2 vs. 4 days respectively, P= 0.02).","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Array. khalilih@tums.ac.ir.'}, {'ForeName': 'Anahid', 'Initials': 'A', 'LastName': 'Nourian', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.. anahid.nouriam@gmail.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Ahmadinejad', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran. ahmadiz@tums.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Emadi Kouchak', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran. dr_emady@yahoo.com.'}, {'ForeName': 'Sirous', 'Initials': 'S', 'LastName': 'Jafari', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran. jafari_sirous@yahoo.com.'}, {'ForeName': 'Sayed Ali', 'Initials': 'SA', 'LastName': 'Dehghan Manshadi', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran. sealdema@yahoo.com.'}, {'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Rasolinejad', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran. mehrnaz.rn@gmail.com.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Kebriaeezadeh', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.. kebriaee@tums.ac.ir.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v91i4.10877']
1064,33540112,The effects of offline and online prefrontal vs parietal transcranial direct current stimulation (tDCS) on verbal and spatial working memory.,"Working memory (WM) is a limited-capacity system or set of processes that enables temporary storage and manipulation of information essential for complex cognitive processes. The WM performance is supported by a widespread neural network in which fronto-parietal functional connections have a pivotal role. Transcranial direct current stimulation (tDCS) is rapidly emerging as a promising tool for understanding the role of various cortical areas and their functional networks on cognitive performance. Here we comprehensively evaluated the effects of tDCS on WM by conducting three cross-over counterbalanced sham-controlled experiments in which we contrasted the effects and interactions of the anodal (i.e. facilitatory) tDCS across anterior-posterior (i.e. DLPFC vs PPC) and left-right (i.e. the lateralization) axes, and across online and offline protocols using both verbal and spatial WM (3-back) tasks as outcomes. In the offline protocols, left DLPFC stimulation affected neither verbal nor spatial WM, while left PPC stimulation increased spatial WM. When applied offline over right DLPFC, tDCS improved verbal WM task and marginally enhanced spatial WM; while when tDCS was applied over the right PPC, facilitatory effects were observed on verbal WM. In the online protocol, tDCS did not modulate WM regardless of the task modality or stimulation loci. In summary, the study did not replicate the left DLPFC tDCS effect on WM, found in some of the previous studies, but demonstrated positive effects of stimulation of the right DLPFC as well as PPC bilaterally. The observed effects varied across modality of the 3-back task, and tDCS protocol applied. The results of this study argue for moving towards targeting the lesser-explored stimulation sites within the fronto-parietal network, such as PPC, to gain a better understanding of the usefulness of tDCS for WM neuromodulation.",2021,"In the offline protocols, left DLPFC stimulation affected neither verbal nor spatial WM, while left PPC stimulation increased spatial WM.",[],"['Transcranial direct current stimulation (tDCS', 'tDCS', 'Working memory (WM', 'Offline and Online Prefrontal vs Parietal Transcranial Direct Current Stimulation (tDCS']","['Verbal and Spatial Working Memory', 'verbal WM task and marginally enhanced spatial WM', 'verbal WM', 'verbal nor spatial WM, while left PPC stimulation increased spatial WM']",[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0320841,"In the offline protocols, left DLPFC stimulation affected neither verbal nor spatial WM, while left PPC stimulation increased spatial WM.","[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Živanović', 'Affiliation': 'University of Belgrade Faculty of Philosophy, Department of Psychology, Serbia.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Paunović', 'Affiliation': 'University of Belgrade Institute for Medical Research, Human Neuroscience Group, Serbia.'}, {'ForeName': 'Uroš', 'Initials': 'U', 'LastName': 'Konstantinović', 'Affiliation': 'University of Belgrade Institute for Medical Research, Human Neuroscience Group, Serbia.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Vulić', 'Affiliation': 'University of Belgrade Institute for Medical Research, Human Neuroscience Group, Serbia.'}, {'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Bjekić', 'Affiliation': 'University of Belgrade Institute for Medical Research, Human Neuroscience Group, Serbia. Electronic address: jovana.bjekic@imi.bg.ac.rs.'}, {'ForeName': 'Saša R', 'Initials': 'SR', 'LastName': 'Filipović', 'Affiliation': 'University of Belgrade Institute for Medical Research, Human Neuroscience Group, Serbia.'}]",Neurobiology of learning and memory,['10.1016/j.nlm.2021.107398']
1065,33530156,Effects of progressive neuromuscular stabilization exercise on the support surface on patients with high obesity with lumbar instability: A double-blinded randomized controlled trial.,"BACKGROUND


Intensive neuromuscular stabilization exercise on highly obese patients with low back pain results in positive effects of body fat decline and prevention of complications. The purpose of this study is to investigate the effects of progressive neuromuscular stabilization exercise on unstable surface on pain, motor function, psychosocial factors, balance, and abdominal contraction with highly obese patients with lumbar instability.
METHODS


This study is a double-blinded randomized controlled trial. A total of 46 highly obese patients (body mass index [BMI] ≥ 30 kg/m2) with lumbar instability were assigned randomly to experimental group (n = 23) and control group (n = 23). The control group performed the intensive progressive exercise on a stable surface and the experimental group on an unstable surface.
RESULT


Significant differences were shown for BMI, QVAS, K-ODI, FABQ, and balance ability for both groups before and after the intervention (P < .05), and only the experimental group showed significant difference for transverse abdominis muscle thickness in contraction and contraction rate (P < .05). Compared to the control group, the experimental group showed significant difference (P < .05) in the amount of changes for QVAS, K-ODI, balance ability, transverse abdominis muscle thickness in contraction, and contraction rate.
CONCLUSION


Progressive neuromuscular stabilization exercise program on unstable surfaces demonstrated to be an effective and clinically useful method to decrease pain level, increase motor function, balance, and transverse abdominis muscle thickness in contraction and contraction rate for highly obese patients with lumbar instability.",2021,"Compared to the control group, the experimental group showed significant difference (P < .05) in the amount of changes for QVAS, K-ODI, balance ability, transverse abdominis muscle thickness in contraction, and contraction rate.
","['patients with high obesity with lumbar instability', 'obese patients with lumbar instability', 'highly obese patients with low back pain', '46 highly obese patients (body mass index [BMI]\u200a≥\u200a30\u200akg/m2) with lumbar instability']","['progressive neuromuscular stabilization exercise', 'Intensive neuromuscular stabilization exercise', 'intensive progressive exercise', 'Progressive neuromuscular stabilization exercise program']","['pain, motor function, psychosocial factors, balance, and abdominal contraction', 'pain level, increase motor function, balance, and transverse abdominis muscle thickness in contraction and contraction rate', 'QVAS, K-ODI, balance ability, transverse abdominis muscle thickness in contraction, and contraction rate', 'BMI, QVAS, K-ODI, FABQ, and balance ability', 'transverse abdominis muscle thickness in contraction and contraction rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",46.0,0.130633,"Compared to the control group, the experimental group showed significant difference (P < .05) in the amount of changes for QVAS, K-ODI, balance ability, transverse abdominis muscle thickness in contraction, and contraction rate.
","[{'ForeName': 'Sam-Ho', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School.'}, {'ForeName': 'Myung-Mo', 'Initials': 'MM', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Daejeon University, Dong-gu, Daejeon city, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000023285']
1066,33496795,Clinical Efficacy of Enzalutamide vs Bicalutamide Combined With Androgen Deprivation Therapy in Men With Metastatic Hormone-Sensitive Prostate Cancer: A Randomized Clinical Trial.,"Importance


Black patients have been underrepresented in prospective clinical trials of advanced prostate cancer. This study evaluated the efficacy of enzalutamide compared with bicalutamide, with planned subset analysis of Black patients with metastatic hormone-sensitive prostate cancer (mHSPC), which is a disease state responsive to androgen deprivation therapy (ADT).
Objective


To compare the efficacy of enzalutamide vs bicalutamide in combination with ADT in men with mHSPC, with a subset analysis of Black patients.
Design, Setting, and Participants


In this randomized clinical trial, a phase 2 screening design enabled a nondefinitive comparison of the primary outcome by treatment. Patients were stratified by race (Black or other) and bone pain (present or absent). Accrual of at least 30% Black patients was required. This multicenter trial was conducted at 4 centers in the US. Men with mHSPC with no history of seizures and adequate marrow, renal, and liver function were eligible. Data analysis was performed from February 2019 to March 2020.
Interventions


Participants were randomized 1:1 to receive oral enzalutamide (160 mg daily) or bicalutamide (50 mg daily) in addition to ADT.
Main Outcomes and Measures


The primary end point was the 7-month prostate-specific antigen (PSA) response (SMPR) rate, a previously accepted surrogate for overall survival (OS) outcome. Secondary end points included adverse reactions, time to PSA progression, and OS.
Results


A total of 71 men (median [range] age, 65 [51-86] years) were enrolled; 29 (41%) were Black, 41 (58%) were White, and 1 (1%) was Asian. Thirty-six patients were randomized to receive enzalutamide, and 35 were randomized to receive bicalutamide. Twenty-six patients (37%) had bone pain and 37 patients (52%) had extensive disease. SMPR was achieved in 30 of 32 patients (94%; 95% CI, 80%-98%) taking enzalutamide and 17 of 26 patients (65%; 95% CI, 46%-81%) taking bicalutamide (P = .008) (difference, 29%; 95% CI, 5%-50%). Among Black patients, the SMPR was 93% (95% CI, 69%-99%) among those taking enzalutamide and 42% (95% CI, 19%-68%) among those taking bicalutamide (P = .009); among non-Black patients, the SMPR was 94% (95% CI, 74%-99%) among those taking enzalutamide and 86% (95% CI, 60%-96%) among those taking bicalutamide. The 12-month PSA response rates were 84% with enzalutamide and 34% with bicalutamide.
Conclusions and Relevance


The findings of this randomized clinical trial comparing enzalutamide with bicalutamide suggest that enzalutamide is associated with improved outcomes compared with bicalutamide, in terms of the rate and duration of PSA response, in Black patients with mHSPC.
Trial Registration


ClinicalTrials.gov Identifier: NCT02058706.",2021,"SMPR was achieved in 30 of 32 patients (94%; 95% CI, 80%-98%) taking enzalutamide and 17 of 26 patients (65%; 95% CI, 46%-81%) taking bicalutamide (P = .008)","['Men', 'Patients were stratified by race (Black or other) and bone pain (present or absent', 'With Metastatic Hormone-Sensitive Prostate Cancer', '4 centers in the US', 'A total of 71 men (median [range] age, 65 [51-86] years) were enrolled; 29 (41%) were Black, 41 (58%) were White, and 1 (1%) was Asian', 'men with mHSPC, with a subset analysis of Black patients', 'Thirty-six patients', 'Black patients with mHSPC', 'Black patients with metastatic hormone-sensitive prostate cancer (mHSPC', 'Importance\n\n\nBlack patients', 'Men with mHSPC with no history of seizures and adequate marrow, renal, and liver function were eligible']","['bicalutamide', 'enzalutamide', 'oral enzalutamide', 'Enzalutamide vs Bicalutamide', 'Androgen Deprivation Therapy', 'enzalutamide vs bicalutamide']","['SMPR', '12-month PSA response rates', 'bone pain', '7-month prostate-specific antigen (PSA) response (SMPR) rate, a previously accepted surrogate for overall survival (OS) outcome', 'adverse reactions, time to PSA progression, and OS', 'rate and duration of PSA response', 'extensive disease']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0151825', 'cui_str': 'Bone pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]","[{'cui': 'C0285590', 'cui_str': 'bicalutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0151825', 'cui_str': 'Bone pain'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0849867', 'cui_str': 'Generalized illness'}]",36.0,0.362188,"SMPR was achieved in 30 of 32 patients (94%; 95% CI, 80%-98%) taking enzalutamide and 17 of 26 patients (65%; 95% CI, 46%-81%) taking bicalutamide (P = .008)","[{'ForeName': 'Ulka N', 'Initials': 'UN', 'LastName': 'Vaishampayan', 'Affiliation': 'Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Lance K', 'Initials': 'LK', 'LastName': 'Heilbrun', 'Affiliation': 'Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monk', 'Affiliation': 'Department of Internal Medicine, The Ohio State University, Columbus.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Tejwani', 'Affiliation': 'Department of Internal Medicine, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Guru', 'Initials': 'G', 'LastName': 'Sonpavde', 'Affiliation': 'Department of Internal Medicine, Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Daryn', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Jasti', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Kimberlee', 'Initials': 'K', 'LastName': 'Dobson', 'Affiliation': 'Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Dickow', 'Affiliation': 'Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Elisabeth I', 'Initials': 'EI', 'LastName': 'Heath', 'Affiliation': 'Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Louie', 'Initials': 'L', 'LastName': 'Semaan', 'Affiliation': 'Department of Urology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Cher', 'Affiliation': 'Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Fontana', 'Affiliation': 'Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Sreenivasa', 'Initials': 'S', 'LastName': 'Chinni', 'Affiliation': 'Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.34633']
1067,33503527,Periodized versus classic exercise therapy in Multiple Sclerosis: a randomized controlled trial.,"BACKGROUND


Periodizing exercise interventions in Multiple Sclerosis (MS) shows good high intensity exercise training adherence. Whether this approach induces comparable training adaptations with respect to exercise capacity, body composition and muscle strength compared to conventional, linear progressive training programs however is not known.
METHODS


Thirty-one persons with MS (all phenotypes, mean EDSS 2.3±1.3) were randomized into a twelve-week periodized (MS PER , n=17) or a classic endurance (MS CLA , n=14) training program. At baseline (PRE), exercise capacity (maximal exercise test, VO 2max ), body composition (DEXA) and muscle strength (Biodex®) were assessed. Classic, moderate intensity endurance training (60-80% HR max , 5 training sessions/2w, 60min/session) was performed on a stationary bicycle. Periodized exercise included 4 recurrent 3-week cycles of alternated endurance training (week 1: endurance training as described above), high intense exercise (week 2: 3 sessions/w, 3 × 20s all-out sprints, 10min/session) and recovery weeks (week 3: one sprint session as described above). POST measurements were performed similar to baseline. Total exercise volume of both programs was expressed as total peak-effort training minutes.
RESULTS


For MS CLA , total exercise volume included 1728 total peak-effort training minutes, whereas MS PER  included only 736. Despite this substantially reduced training volume, twelve weeks of periodized training significantly (p<0.05) improved VO 2max  (+14%, p=0.001), workload (+20%) and time until exhaustion (+25%). Classic training significantly (p<0.05) improved workload (+10%) and time until exhaustion (+17%), but not VO 2max  (+5%, p=0.131). Pre-post improvements for VO 2max  were significantly higher in MS PER  compared to MS CLA  (p=0.046).
CONCLUSION


These data show that despite substantially lower training time (57% less peak-effort training minutes), 12 weeks of periodized exercise training in persons with MS seems to induce larger improvements in parameters of exercise capacity compared to classic endurance training. We therefore recommend to further investigate the effect of training periodization on various functional rehabilitation measures in MS.",2021,"Classic training significantly (p<0.05) improved workload (+10%) and time until exhaustion (+17%), but not VO 2max  (+5%, p=0.131)","['Multiple Sclerosis', 'Thirty-one persons with MS (all phenotypes, mean EDSS 2.3±1.3', 'Multiple Sclerosis (MS']","['Classic, moderate intensity endurance training', 'classic endurance (MS CLA , n=14) training program', 'Periodized versus classic exercise therapy', 'training periodization', 'MS CLA', 'alternated endurance training (week 1: endurance training as described above), high intense exercise', 'Classic training', 'Periodizing exercise interventions', 'Periodized exercise', 'periodized exercise training']","['time until exhaustion', 'Total exercise volume', 'workload', 'At baseline (PRE), exercise capacity (maximal exercise test, VO 2max ), body composition (DEXA) and muscle strength (Biodex®', 'VO 2max']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}]","[{'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",31.0,0.0124644,"Classic training significantly (p<0.05) improved workload (+10%) and time until exhaustion (+17%), but not VO 2max  (+5%, p=0.131)","[{'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Keytsman', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium; BIOMED Biomedical Research Institute, Hasselt University, Agoralaan Building A, B-3590, Diepenbeek, Belgium. Electronic address: charly.keytsman@uhasselt.be.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Van Noten', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium; BIOMED Biomedical Research Institute, Hasselt University, Agoralaan Building A, B-3590, Diepenbeek, Belgium.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Verboven', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium; BIOMED Biomedical Research Institute, Hasselt University, Agoralaan Building A, B-3590, Diepenbeek, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Asch', 'Affiliation': 'Move to Sport Foundation, Mechelsesteenweg, Kontich, Belgium.'}, {'ForeName': 'Bert O', 'Initials': 'BO', 'LastName': 'Eijnde', 'Affiliation': 'BIOMED Biomedical Research Institute, Hasselt University, Agoralaan Building A, B-3590, Diepenbeek, Belgium; Faculty of Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102782']
1068,33517104,"The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: A randomized controlled trial.","OBJECTIVES


To evaluate the effects of two manual treatment methods on pain, disability, and pressure pain threshold (PPT) in tension-type headache (TTH) patients with and neck pain.
METHODS


Forty-five patients with TTH were randomly assigned to one of three groups and received eight sessions treatment: manipulation plus exercise (manipulation), suboccipital inhibition plus exercise (myofascial release), and exercise only (control). Headache frequency, pain severity (VAS-headache, VAS-neck pain) and headache and neck disability (HIT-6 and NDI, respectively) were measured at baseline, posttreatment, and at the third month follow-up. PPT was also evaluated on the temporalis muscle.
RESULTS


Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores. Also, manipulation group showed statistically significant improvements in all outcome criteria when compared control group.
CONCLUSIONS


Manipulation and exercise, in addition to pharmacologic treatment in TTH patients with cervical dysfunction appear to be a promising approach.",2021,"RESULTS


Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores.","['Forty-five patients with TTH', 'tension-type headache (TTH) patients with and neck pain', 'TTH patients with cervical dysfunction', 'tension-type headache patients with neck pain']","['spinal manipulation, myofascial release and exercise', 'eight sessions treatment: manipulation plus exercise (manipulation), suboccipital inhibition plus exercise (myofascial release), and exercise only (control']","['Headache frequency, pain severity (VAS-headache, VAS-neck pain) and headache and neck disability (HIT-6 and NDI, respectively', 'pain, disability, and pressure pain threshold (PPT', 'headache frequency, headache severity, and PPT scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",45.0,0.0458596,"RESULTS


Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores.","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Corum', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: mustafacorum@gmail.com.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Aydin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: drtugbaaydin@gmail.com.'}, {'ForeName': 'Cansın', 'Initials': 'C', 'LastName': 'Medin Ceylan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: cansinmedin@hotmail.com.'}, {'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Kesiktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: nur.kesiktas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101319']
1069,33517103,Green tea extract for mild-to-moderate diabetic peripheral neuropathy A randomized controlled trial.,"BACKGROUND AND AIM


This randomized study aimed to evaluate the effect of green tea extract (GTE) intake on clinical and neurophysiological parameters in patients with mild-to-moderate diabetic peripheral neuropathy (DPN).
PATIENTS AND METHODS


The present study included 194 patients with DPN. Patients were randomized into two treatment arms: GTE (n = 96) and placebo (n = 98) arms who received allocated treatment for 16 weeks. Symptoms of DPN were assessed using Toronto Clinical Scoring System (TCSS). Sensorineural pain was assessed using visual analog scale (VAS). Neural dysfunction was evaluated using the vibration perception thresholds (VPT). Assessments were made at baseline and after 4, 8, and 16 weeks of starting treatment.
RESULTS


At baseline and after 4 weeks of treatment, VAS, TCSS and VPT were comparable in the studied groups. However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT. As treatment continued, the differences between groups regarding the outcome parameters became more evident at 16 weeks.
CONCLUSIONS


GTE intake may have a beneficial value in treatment of DPN.",2021,"However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT.","['194 patients with DPN', 'mild-to-moderate diabetic peripheral neuropathy', 'patients with mild-to-moderate diabetic peripheral neuropathy (DPN']","['GTE', 'placebo', 'green tea extract (GTE) intake', 'Green tea extract']","['Sensorineural pain', 'VAS, TCSS and VPT', 'vibration perception thresholds (VPT', 'Symptoms of DPN', 'Neural dysfunction', 'VAS scores', 'visual analog scale (VAS', 'TCSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",194.0,0.185216,"However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Essmat', 'Affiliation': 'Department of Neurology, Al-Azhar University, Faculty of Medicine, Cairo, Egypt. Electronic address: ahmadesmat81@yahoo.com.'}, {'ForeName': 'Mohammed Salah', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Internal Medicine Department, Al-Azhar University, Faculty of Medicine, Cairo, Egypt.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101317']
1070,33517038,Exercise effects on backward walking speed in people with dementia: A randomized controlled trial.,"BACKGROUND


Multidirectional walking, including backward walking, is integral to daily activities, and seems particularly challenging in older age, and in people with pathology affecting postural control such as dementia.
RESEARCH QUESTION


Does exercise influence backward walking speed in people with dementia, when tested using habitual walking aids and without, and do effects differ according to walking aid use?
METHODS


This study included 141 women and 45 men (mean age 85 years) with dementia from the Umeå Dementia and Exercise (UMDEX), a cluster-randomized controlled trial study set in 16 nursing homes in Umeå, Sweden. Participants were randomized to a High-Intensity Functional Exercise (HIFE) program targeting lower limb strength-, balance and mobility exercise or to a seated attention control activity. Blinded assessors measured 2.4-meter usual backward walking speed, at baseline, 4 - (intervention completion) and 7-month follow-up; tested 1) with habitual walking aids allowed, and 2) without walking aids.
RESULTS


Linear mixed models showed no between-group effect in either backward walking speed test at 4 or 7 months; test 1) 0.005 m/s, P = .788 and -0.006 m/s, P = .754 and test 2) 0.030 m/s, P = .231 and 0.015 m/s, P = .569, respectively. In interaction analyses, exercise effects differed significantly between participants who habitually walked unaided compared with those that used a walking aid at 7 months (0.094 m/s, P = .027).
SIGNIFICANCE


In this study of older people with dementia living in nursing homes, the effects of exercise had no overall effects on backwards walking speed. Nevertheless, some benefit was indicated in participants who habitually walked unaided, which is promising and merits further investigation in future studies.",2021,"RESULTS


Linear mixed models showed no between-group effect in either backward walking speed test at 4 or 7 months; test 1) 0.005 m/s, P","['141 women and 45 men (mean age 85 years) with dementia from the Umeå Dementia and Exercise (UMDEX), a cluster-randomized controlled trial study set in 16 nursing homes in Umeå, Sweden', 'older people with dementia living in nursing homes', 'people with dementia']","['High-Intensity Functional Exercise (HIFE) program targeting lower limb strength-, balance and mobility exercise or to a seated attention control activity', 'habitual walking aids allowed, and 2) without walking aids']","['backward walking speed', 'exercise effects', 'backward walking speed test']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0557834', 'cui_str': 'Walking aid'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",141.0,0.208358,"RESULTS


Linear mixed models showed no between-group effect in either backward walking speed test at 4 or 7 months; test 1) 0.005 m/s, P","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Toots', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå University, 901 87, Umeå, Sweden. Electronic address: annika.toots@umu.se.'}, {'ForeName': 'Lillemor', 'Initials': 'L', 'LastName': 'Lundin-Olsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå University, 901 87, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, 901 87, Sweden.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Gustafson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, 901 87, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå University, 901 87, Umeå, Sweden.'}]",Gait & posture,['10.1016/j.gaitpost.2020.12.028']
1071,33539664,A novel prognostic nomogram for colorectal cancer liver metastasis patients with recurrence after hepatectomy.,"PURPOSE


We aimed to construct a nomogram to predict personalized post-recurrence survival (PRS) among colorectal cancer liver metastasis (CRLM) patients with post-hepatectomy recurrence.
METHODS


Colorectal cancer liver metastasis patients who received initial hepatectomy and had subsequent recurrence between 2001 and 2019 in Sun Yat-sen University Cancer Center from China were included in the study. Patients were randomly assigned to a training cohort and a validation cohort on a ratio of 2:1. Univariable analysis was first employed to select potential predictive factors for PRS. Then, the multivariable Cox regression model was applied to recognize independent prognostic factors. According to the model, a nomogram to predict PRS was established. The nomogram's predictive capacity was further assessed utilizing concordance index (C-index) values, calibration plots, and Kaplan-Meier curves.
RESULTS


About 376 patients were finally enrolled, with a 3-year PRS rate of 37.3% and a 5-year PRS rate of 24.6%. The following five independent predictors for PRS were determined to construct the nomogram: the largest size of liver metastases at initial hepatectomy, relapse-free survival, CEA level at recurrence, recurrent sites, and treatment for recurrence. The nomogram displayed fairly good discrimination and calibration. The C-index value was 0.742 for the training cohort and 0.773 for the validation cohort. Patients were grouped into three risk groups very well by the nomogram, with 5-year PRS rates of 45.2%, 23.3%, and 9.0%, respectively (p < 0.001) in the training cohort and 36.0%, 9.2%, and 4.6%, respectively (p < 0.001) in the validation cohort.
CONCLUSION


A novel nomogram was built and validated to enable the prediction of personal PRS in CRLM patients with post-hepatectomy recurrence. The nomogram may help physicians in decision making.",2021,"Patients were grouped into three risk groups very well by the nomogram, with 5-year PRS rates of 45.2%, 23.3%, and 9.0%, respectively (p < 0.001) in the training cohort and 36.0%, 9.2%, and 4.6%, respectively (p < 0.001) in the validation cohort.
","['colorectal cancer liver metastasis (CRLM) patients with post-hepatectomy recurrence', 'Colorectal cancer liver metastasis patients who received initial hepatectomy and had subsequent recurrence between 2001 and 2019 in Sun Yat-sen University Cancer Center from China were included in the study', '376 patients', 'CRLM patients with post-hepatectomy recurrence', 'colorectal cancer liver metastasis patients with recurrence after hepatectomy']",[],"['3-year PRS rate', '5-year PRS rates', '5-year PRS rate', 'concordance index (C-index) values, calibration plots, and Kaplan-Meier curves', 'largest size of liver metastases at initial hepatectomy, relapse-free survival, CEA level at recurrence, recurrent sites, and treatment for recurrence']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0426688', 'cui_str': 'Liver size'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",376.0,0.0305345,"Patients were grouped into three risk groups very well by the nomogram, with 5-year PRS rates of 45.2%, 23.3%, and 9.0%, respectively (p < 0.001) in the training cohort and 36.0%, 9.2%, and 4.6%, respectively (p < 0.001) in the validation cohort.
","[{'ForeName': 'Jie-Ying', 'Initials': 'JY', 'LastName': 'Liang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hao-Cheng', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Zhongshan School of Medicine, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'De-Shen', 'Initials': 'DS', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Yuan', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Bin-Kui', 'Initials': 'BK', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Wu', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Feng-Hua', 'Initials': 'FH', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhi-Zhong', 'Initials': 'ZZ', 'LastName': 'Pan', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'De-Sen', 'Initials': 'DS', 'LastName': 'Wan', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Xu', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}]",Cancer medicine,['10.1002/cam4.3697']
1072,33530190,Open reduction and plate fixation versus sling in treatment of mid-shaft fractures of clavicle: A prospective randomized study protocol.,"BACKGROUND


For this prospective randomized clinical trial, it is implemented for the comparison of the outcomes of open reduction and internal fixation versus the sling treatment for mid-shaft clavicle fractures.
METHODS


We will evaluate the eligible patients diagnosed with the mid-shaft clavicle fractures in our hospital from December 2020 to December 2021. The outcomes acquired were reported in accordance with the guidelines of Consolidated Standards of Reporting Trials (CONSORT). Approval for this prospective randomized clinical trial was obtained from the institution alethics review committee of Wuzhong People's Hospital. The criteria for inclusion included: one third of clavicle fracture with at least 1 axial width displacement (Robinson type 2B2 or 2B1); agreed to take part in our research; over 18 years of age; patients with isolated clavicle fracture. While the criteria for exclusion contained: the medial or lateral segment clavicle fracture; open fracture; injuries related to neurovascular; over 21 days of changes from accident. The primary outcome was described as the evidence of nonunion at 1 year, which was defined as the intact bone bridge without X-ray fracture after more than 6 months. The secondary outcomes included the function of arm, overall health, adverse events, the satisfaction related to appearance, and pain.
CONCLUSIONS


It was hypothesized that in the case of clavicular comminuted mid-shaft fracture, for the open reduction and internal fixation, its nonunion rate was lower and satisfaction rate was higher, although there were a variety of complications.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry6295).",2021,"The secondary outcomes included the function of arm, overall health, adverse events, the satisfaction related to appearance, and pain.
","['mid-shaft fractures of clavicle', 'eligible patients diagnosed with the mid-shaft clavicle fractures in our hospital from December 2020 to December 2021', 'The criteria for inclusion included: one third of clavicle fracture with at least 1 axial width displacement (Robinson type 2B2 or 2B1); agreed to take part in our research; over 18 years of age; patients with isolated clavicle fracture']",['plate fixation versus sling'],"['function of arm, overall health, adverse events, the satisfaction related to appearance, and pain', 'satisfaction rate', 'evidence of nonunion at 1 year, which was defined as the intact bone bridge without X-ray fracture', 'nonunion rate']","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0337141', 'cui_str': 'Shaft'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1282382', 'cui_str': 'Third of clavicle'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0406737', 'cui_str': 'Robinson nail dystrophy-deafness syndrome'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0183346', 'cui_str': 'Sling'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",,0.0693838,"The secondary outcomes included the function of arm, overall health, adverse events, the satisfaction related to appearance, and pain.
","[{'ForeName': 'Guanggao', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Yanbian University Hospital, Jilin, 133000.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Radiology, Huizhou Central Municipal Hospital, Guangdong, 516001.'}, {'ForeName': 'Wencai', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': ""Department of Orthopedics, Wuzhong People's Hospital, Ningxia, 751100, China.""}]",Medicine,['10.1097/MD.0000000000023910']
1073,33530186,"A randomized, controlled, multicenter clinical study of the ""improved sitting Wuqinxi"" intervention for mechanically ventilated patients in the intensive care unit.","INTRODUCTION


Mechanical ventilation is a powerful tool for the treatment of various critical emergencies. However, surviving critically ill patients often have poor psychological and physiological outcomes. Prevention of various complications and adverse outcomes of mechanical ventilation is a priority and a challenge in the intensive care unit (ICU). Early intervention is the key to reducing complications and improving outcomes of mechanical ventilation in the ICU. As an auxiliary rehabilitation treatment, the improved sitting Wuqinxi intervention has recognized unique advantages. It has achieved beneficial therapeutic effects during early intervention in clinical practice. It can reduce the incidence of delirium, shorten the duration of mechanical ventilation, and prevent complications and secondary damages related to mechanical ventilation in the ICU. Therefore, the purpose of this study will be to explore the effect of improved sitting Wuqinxi on the clinical outcomes of mechanically ventilated ICU patients.
METHODS


This prospective, multicenter, randomized, single-blinded, parallel controlled clinical study will involve 160 patients who met the inclusion criteria. The patients will be randomly divided into the experimental and control groups. Both groups will be given standardized comprehensive western medicine treatment (including mechanical ventilation) and routine care in the ICU. Management of the experimental group will also include ""improved sitting Wuqinxi,"" with the treatment objective to observe the effect of the improved sitting Wuqinxi intervention on the clinical outcomes in mechanically ventilated ICU patients. The outcome measures will include the incidence of complications, duration of mechanical ventilation, length of ICU stay, and cost of hospitalization. In addition, the effect of the improved sitting Wuqinxi intervention on the safety indexes of mechanically ventilated ICU patients will be assessed and the clinical effects of the improved sitting Wuqinxi intervention will be comprehensively evaluated.
DISCUSSION


The purpose of this study will be to evaluate the effect of the improved sitting Wuqinxi intervention on the incidence of complications, duration of mechanical ventilation, length of ICU stay, cost of hospitalization, and safety indicators. If successful, it will provide a reliable, simple, and feasible auxiliary rehabilitation treatment scheme for mechanically ventilated ICU patients.",2021,"It can reduce the incidence of delirium, shorten the duration of mechanical ventilation, and prevent complications and secondary damages related to mechanical ventilation in the ICU.","['mechanically ventilated ICU patients', '160 patients who met the inclusion criteria', 'mechanically ventilated patients in the intensive care unit']","['improved sitting Wuqinxi"" intervention', 'Mechanical ventilation', 'sitting Wuqinxi intervention', 'sitting Wuqinxi', 'mechanical ventilation']","['incidence of complications, duration of mechanical ventilation, length of ICU stay, and cost of hospitalization', 'incidence of complications, duration of mechanical ventilation, length of ICU stay, cost of hospitalization, and safety indicators']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",160.0,0.0390187,"It can reduce the incidence of delirium, shorten the duration of mechanical ventilation, and prevent complications and secondary damages related to mechanical ventilation in the ICU.","[{'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': 'The outpatient department.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Nursing Department.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yue', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xiangwen', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Zilin', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Wendong', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Kunlan', 'Initials': 'K', 'LastName': 'Long', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}]",Medicine,['10.1097/MD.0000000000023898']
1074,33530182,Clinical control study of traditional Chinese medicine hot compress combined with traction in the treatment of cervical spondylotic radiculopathy: Study protocol.,"ABSTRACT


Cervical spondylotic radiculopathy (CSR) is the most common type of cervical spondylosis, accounting for about 60% of the incidence of cervical spondylosis. Both cervical traction and traditional Chinese medicine hot compress are common and effective treatment for CSR. This study will be performed to investigate the effect of a combination of cervical traction and traditional Chinese medicine hot compress on CSR. In this non-blinded, randomized controlled trial, 100 eligible patients will be randomly divided into a treatment group (intermittent cervical traction combines with traditional Chinese medicine hot compress) and a control group (intermittent cervical traction combined with hot compresses). Before and after the intervention, the Visual Analog Scale score, Neck Disability Index score, and 20-score scale of symptoms will be evaluated at baseline and at 7, 14, 21, and 28 days. During the treatment period, any signs of acute adverse events, such as paralysis of aggravated pain, nausea, dizzy, and even syncope, will be recorded at each visit. Although intermittent cervical traction and traditional Chinese medicine hot compress have been used in the treatment of CSR in China for many years, there is no consensus on its effectiveness of combination therapy. This experiment will provide convincing evidence of the efficacy of intermittent cervical traction combined with traditional Chinese medicine hot compress in the treatment of CSR.",2021,"Before and after the intervention, the Visual Analog Scale score, Neck Disability Index score, and 20-score scale of symptoms will be evaluated at baseline and at 7, 14, 21, and 28 days.",['100 eligible patients'],"['treatment group (intermittent cervical traction combines with traditional Chinese medicine hot compress) and a control group (intermittent cervical traction combined with hot compresses', 'cervical traction and traditional Chinese medicine', 'traditional Chinese medicine hot compress combined with traction']","['signs of acute adverse events, such as paralysis of aggravated pain, nausea, dizzy, and even syncope', 'Visual Analog Scale score, Neck Disability Index score, and 20-score scale of symptoms']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0556664', 'cui_str': 'Cervical traction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0332260', 'cui_str': 'Compressing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.0455118,"Before and after the intervention, the Visual Analog Scale score, Neck Disability Index score, and 20-score scale of symptoms will be evaluated at baseline and at 7, 14, 21, and 28 days.","[{'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopaedics, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725, Wanping South Road, Fenglin Street, Xuhui District, Shanghai, China.'}, {'ForeName': 'Jinze', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Qixing', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Jinhai', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Mo', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023880']
1075,33550193,"The effect of rosemary essential oil inhalation on sleepiness and alertness of shift-working nurses: A randomized, controlled field trial.","BACKGROUND


Sleepiness during the night shift is a common complaint of shift workers, including the nurses. This study investigated the effects of inhaled rosemary oil on sleepiness and alertness of shift-working nurses.
METHODS


Eighty shift-working nurses were selected and assigned randomly into control (n = 40) and intervention (n = 40) groups. Both groups completed the Karolinska Sleep Questionnaire and Epworth Sleepiness Survey before the intervention. The intervention group received one drop of rosemary essential oil using a mask. The control group received a drop of distilled water instead, after which the questionnaires were completed for a second time.
RESULTS


The sleepiness mean score in the intervention group reduced from 12.15 to 8.3, while it increased from 11.41 to 13.76 in the control group (P < 0.001). The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001).
CONCLUSION


Rosemary aroma decreased sleepiness and increased alertness in shift-working nurses.",2021,"The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001).
","['sleepiness and alertness of shift-working nurses', 'Eighty shift-working nurses', 'n\xa0=\xa040) and intervention (n\xa0=\xa040']","['Rosemary aroma', 'rosemary essential oil using a mask', 'rosemary essential oil inhalation', 'inhaled rosemary oil']","['sleepiness mean score', 'Karolinska Sleep Questionnaire and Epworth Sleepiness Survey', 'alertness mean scores', 'sleepiness and increased alertness']","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0939869', 'cui_str': 'rosemary extract'}, {'cui': 'C2987717', 'cui_str': 'Scents'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0304114', 'cui_str': 'rosemary oil'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",80.0,0.0394962,"The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001).
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nasiri', 'Affiliation': 'Medical Toxicology and Drug Abuse Research Center (MTDRC), Birjand University of Medical Sciences, Birjand, Iran. Electronic address: nasiri2006@bums.ac.ir.'}, {'ForeName': ""Masoomeh Mo'tamed"", 'Initials': 'MM', 'LastName': 'Boroomand', 'Affiliation': 'MScN, Department of Nursing, Nursing and Midwifery Faculty, Birjand University of Medical Sciences, Birjand, Iran. Electronic address: motamed@bums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101326']
1076,33550146,Effects of mechanical thrombectomy for post-stroke patients with upper limb hemiparesis: Use of Propensity Score Matching.,"BACKGROUND


Mechanical Thrombectomy (MT) is a recommended approach for post-cerebral ischemia in acute settings. Although a large amount of evidence suggests the use of MT, existing evidence has primarily focused on assessing lower limb performance or gait performance as an outcome measure.
METHODS


This study was to investigate whether MT would be an effective approach for improving upper limb performance in post-stroke patients.This case control was divided into two groups: 154 patients as a control group only given conventional rehabilitation; and 25 patients as an intervention group given MT and conventional rehabilitation. Outcome variables were measured by calculating the change of Fugl-Meyer Assessment score at the last intervention compared with the beginning of the intervention.
RESULT


By comparing the FMA scores after, the propensity matching compared between before receiving therapy intervention and after, the intervention group showed as follows: 30.4 ± 26.4-44.3 ± 25.4, p = 0.0019, r = 0.59. The control group showed as follows: 39.9 ± 24.1-49.1 ± 21.3, p = 0.002, r = 0.69. Lastly, a comparison of the intervention group with the control group about their FMA score change indicates as follows: intervention group: 13.9 ± 19.4, control group 9.2 ± 10.0, p = 0.2967, r = 0.15.
CONCLUSION


This study indicated that there was no significant difference between MT and a conventional approach for improving UE function. However, this is the first study to investigate the course of recovery of UE function in the acute phase after MT, and this finding supports the need for further research.",2021,"intervention group: 13.9 ± 19.4, control group 9.2 ± 10.0, p = 0.2967, r = 0.15.
","['post-stroke patients with upper limb hemiparesis', 'post-stroke patients']","['Mechanical Thrombectomy (MT', 'mechanical thrombectomy', 'MT', 'intervention group given MT and conventional rehabilitation', 'control group only given conventional rehabilitation']","['change of Fugl-Meyer Assessment score', 'FMA score change', 'UE function', 'upper limb performance', 'FMA scores']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]",,0.0525222,"intervention group: 13.9 ± 19.4, control group 9.2 ± 10.0, p = 0.2967, r = 0.15.
","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Tokuda', 'Affiliation': 'Department of Rehabilitation, Hanwa Memorial Hospital, Osaka, Japan. Electronic address: tkdka3377@gmail.com.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Takebayashi', 'Affiliation': 'School of Comprehensive Rehabilitation, College of Health and Human Science, Osaka Prefecture University, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Koyama', 'Affiliation': 'Department of Cranial Nerve Surgery, Hanwa Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Cranial Nerve Surgery, Hanwa Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hanada', 'Affiliation': 'Department of Rehabilitation, Suisyokai Murata Hospital, Osaka, Japan.'}, {'ForeName': 'Yuho', 'Initials': 'Y', 'LastName': 'Okita', 'Affiliation': 'Soaring Health Sports, Wellness & Community Centre, Melbourne, Australia.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106520']
1077,33549862,Influence of Thermal and Gustatory Stimulus in the Initiation of the Pharyngeal Swallow and Bolus Location Instroke.,"INTRODUCTION/OBJECTIVE


The aim of this study is to analyze the influence of sour taste and cold temperature in the initiation of the pharyngeal swallow (IPS) and bolus location at pharyngeal swallow onset in individuals after stroke.
METHODS


Cross-sectional prospective study. The study included 52 individuals with unilateral ischemic stroke. Each individual was assessed by videofluoroscopic swallowing study with 5ml of paste bolus offering four different stimuli (natural, cold, sour, and sour-cold). The individuals were divided into two groups according to the offer sequence. Group 1 (G1) - received a randomized sequence of stimuli (24 individuals), and Group 2 (G2) -the stimuli were offered in the following order: natural, cold, sour, and sour-cold(28 individuals). The IPS time and bolus location at pharyngeal swallow onset were analyzed. The bolus location at pharyngeal swallow onset was defined using six different levels.
RESULTS


Individuals in G1 did not show a significant difference in IPS time between stimuli. However, individuals in G2 presented a significantly shorter IPS time with the sour and sour-cold stimuli than with natural or cold stimuli. The bolus location at pharyngeal swallow onset did not show significant difference between stimuli in both groups. On the other hand, in the G2 it was observed higher frequency of swallowing with sour-cold stimulus at level 1 (the bolus head was located in any region between the fauces pillar and the point where the tongue crosses the inferior border of the mandible).
CONCLUSION


The sour and sour-cold stimuli influenced the IPS time when they were offered in a sequential order. Moreover, both the IPS time and bolus location at pharyngeal swallow onset were not influenced by the sour and sour cold-bolus when offered in a random sequence.",2021,The bolus location at pharyngeal swallow onset did not show significant difference between stimuli in both groups.,"['individuals after stroke', '52 individuals with unilateral ischemic stroke']",[],"['IPS time', 'IPS time and bolus location at pharyngeal swallow onset']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",[],"[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",52.0,0.0197181,The bolus location at pharyngeal swallow onset did not show significant difference between stimuli in both groups.,"[{'ForeName': 'Ana Rita', 'Initials': 'AR', 'LastName': 'Gatto', 'Affiliation': 'Department of Neurology and Psiquiatry, Sao Paulo State University-UNESP, Botucatu SP, Brazil. Electronic address: rg.silva@unesp.br.'}, {'ForeName': 'Paula Cristina', 'Initials': 'PC', 'LastName': 'Cola', 'Affiliation': 'Department of Medicine, Marilia University - UNIMAR, Marilia SP, Brazil.'}, {'ForeName': 'Roberta Gonçalves', 'Initials': 'RG', 'LastName': 'da Silva', 'Affiliation': 'Department of Speech and Language Therapy, Sao Paulo State University - UNESP, Marília SP,Brazil.'}, {'ForeName': 'Priscila Watson', 'Initials': 'PW', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Neurology and Psiquiatry, Sao Paulo State University-UNESP,Botucatu SP, Brazil.'}, {'ForeName': 'André Augusto', 'Initials': 'AA', 'LastName': 'Spadotto', 'Affiliation': 'Department of Neurology and Psiquiatry, Sao Paulo State University-UNESP,Botucatu SP, Brazil.'}, {'ForeName': 'Maria Aparecida de Arruda Coelho', 'Initials': 'MAAC', 'LastName': 'Henry', 'Affiliation': 'Department of Surgery, Sao Paulo State University - UNESP, Botucatu SP, Brazil.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105349']
1078,33549836,"Preschoolers will drink their GREENS! Children accept, like, and drink novel smoothies containing dark green vegetables (DGVs).","Dark green vegetables (DGVs; e.g., spinach) are a nutrient rich source of essential vitamins and minerals; yet, children's intakes of DGVs fall well below dietary recommendations and creative solutions are needed. This study describes preschoolers (3-5 y) willingness to taste, liking, and intake of fruit-based smoothies containing DGVs (i.e., spinach, collards, kale), commonly referred to as ""green smoothies,"" and explores individual differences in children's eating responses. Using a between-subjects design, preschoolers were randomized to either a FRUIT ONLY smoothie condition (n = 36) or FRUIT+DGV smoothie condition (n = 32). Children's acceptance and intake were collected in one tasting session and one ad libitum snack session, respectively. Parents reported on child food pickiness, food responsiveness, and approach, and children's intake of fruits and DGVs. Children self-reported on previous experience with the study fruits and DGVs. The initial tasting session revealed that the majority of children (84.3%) in the FRUIT+DGV condition willingly tasted all five green smoothies and rated the green smoothies as moderately liked (2.3 ± 0.1). Children in the FRUIT+DGV condition consumed 225.7 ± 31.4 g (9.0 ± 1.3 oz; 1.1 ± 0.2 cups; 91.9 ± 12.9 kcals) of their most preferred green smoothie, providing 18.3 ± 3.7 g (or 0.7 ± 0.1 cups) of DGVs. Children's willingness to try, liking, and intake did not differ by smoothie condition. Individual differences in children's intake are reported. In conclusion, children were willing to try fruit smoothies supplemented with DGVs. Children rated the green smoothies as moderately-liked and children's intake during snack met 31% of their weekly USDA recommendations for DGVs. Adding DGVs to fruit-based smoothies may compliment other effective feeding strategies for increasing children's vegetable consumption.",2021,"Children's willingness to try, liking, and intake did not differ by smoothie condition.","[""children's eating responses""]",['FRUIT ONLY smoothie condition (n = 36) or FRUIT+DGV smoothie condition'],"[""child food pickiness, food responsiveness, and approach, and children's intake of fruits and DGVs""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",,0.019016,"Children's willingness to try, liking, and intake did not differ by smoothie condition.","[{'ForeName': 'Brandi Y', 'Initials': 'BY', 'LastName': 'Rollins', 'Affiliation': 'Biobehavioral Health, The Pennsylvania State University, 219 Biobehavioral Health Building, University Park, PA, 16802, USA. Electronic address: byr104@psu.edu.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stein', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, 110 Chandlee Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, 110 Chandlee Laboratory, University Park, PA, 16802, USA; Department of Food Science, The Pennsylvania State University, 202 Rodney A. Erickson Food Science Building, University Park, PA, 16802, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, 110 Chandlee Laboratory, University Park, PA, 16802, USA; Center for Childhood Obesity Research, The Pennsylvania State University, 129 Noll Laboratory, University Park, PA, 16802, USA.'}]",Appetite,['10.1016/j.appet.2021.105148']
1079,33549820,Effects of progressive elastic band resistance exercise for aged osteosarcopenic adiposity women.,"PURPOSE


Osteosarcopenic adiposity (OSA), which is described as the concurrent occurrence of osteopenia, sarcopenia, and adiposity, can lead to frailty and increase the risk of physical disability in elderly women. Progressive elastic band resistance exercise training (peRET) is considered a safe and feasible exercise intervention for elderly women with sarcopenic obesity. This study investigated the effects of elastic band resistance exercise on the physical capacity and body composition of elderly women with osteosarcopenic adiposity.
METHOD


A total of 15 and 12 women were randomly assigned to the experimental (12 weeks of resistance exercise) and control groups (no exercise intervention), respectively. Lean mass (measured using a dual-energy X-ray absorptiometer) and physical capacity assessments (such as timed up and go test and single leg stance tests) were conducted at baseline, 12 weeks (end of intervention), and 6 months after the intervention. Outcome differences within the study and control groups were analyzed using repeated-measures analysis of variance with a post-hoc test. The Mann-Whitney U test was used to examine differences between groups at different time points.
RESULTS


After the intervention, no body composition changes in muscle mass and fat were observed between the study and control groups. Moreover, muscle mass and fat body composition did not significantly differ at different time points. The bone density was higher in the study group, with a higher T-score than their baseline values, but did not significantly differ compared with the control group. The study group exhibited more improved physical function than the control group, but the effect did not last after 6 months of follow-up.
CONCLUSIONS


A 12-week progressive elastic band resistance training program effectively increased the physical capacity and improved the bone density; however, without persistent training, the positive effect diminished at 6-month follow-up.",2021,"The bone density was higher in the study group, with a higher T-score than their baseline values, but did not significantly differ compared with the control group.","['elderly women with osteosarcopenic adiposity', 'aged osteosarcopenic adiposity women', 'A total of 15 and 12 women', 'elderly women', 'elderly women with sarcopenic obesity']","['elastic band resistance exercise', 'resistance exercise) and control groups (no exercise intervention', 'progressive elastic band resistance exercise', 'Progressive elastic band resistance exercise training (peRET']","['muscle mass and fat body composition', 'Lean mass', 'bone density', 'physical capacity', 'physical function']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0015665', 'cui_str': 'Fat Body'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0299405,"The bone density was higher in the study group, with a higher T-score than their baseline values, but did not significantly differ compared with the control group.","[{'ForeName': 'Yu-Hao', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Pi-Hsia', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei 10675, Taiwan.'}, {'ForeName': 'Li-Fong', 'Initials': 'LF', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Institute of Gerontology and Health Management, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chun-De', 'Initials': 'CD', 'LastName': 'Liao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Tsan-Hon', 'Initials': 'TH', 'LastName': 'Liou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University, Taiwan.'}, {'ForeName': 'Shih-Wei', 'Initials': 'SW', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan, Taiwan. Electronic address: 13001@s.tmu.edu.tw.'}]",Experimental gerontology,['10.1016/j.exger.2021.111272']
1080,33503656,"Bedside Allogeneic Erythrocyte Washing with a Cell Saver to Remove Cytokines, Chemokines, and Cell-derived Microvesicles.","BACKGROUND


Removal of cytokines, chemokines, and microvesicles from the supernatant of allogeneic erythrocytes may help mitigate adverse transfusion reactions. Blood bank-based washing procedures present logistical difficulties; therefore, we tested the hypothesis that on-demand bedside washing of allogeneic erythrocyte units is capable of removing soluble factors and is feasible in a clinical setting.
METHODS


There were in vitro and prospective, observation cohort components to this a priori planned substudy evaluating bedside allogeneic erythrocyte washing, with a cell saver, during cardiac surgery. Laboratory data were collected from the first 75 washed units given to a subset of patients nested in the intervention arm of a parent clinical trial. Paired pre- and postwash samples from the blood unit bags were centrifuged. The supernatant was aspirated and frozen at -70°C, then batch-tested for cell-derived microvesicles, soluble CD40 ligand, chemokine ligand 5, and neutral lipids (all previously associated with transfusion reactions) and cell-free hemoglobin (possibly increased by washing). From the entire cohort randomized to the intervention arm of the trial, bedside washing was defined as feasible if at least 75% of prescribed units were washed per protocol.
RESULTS


Paired data were available for 74 units. Washing reduced soluble CD40 ligand (median [interquartile range]; from 143 [1 to 338] ng/ml to zero), chemokine ligand 5 (from 1,314 [715 to 2,551] to 305 [179 to 488] ng/ml), and microvesicle numbers (from 6.90 [4.10 to 20.0] to 0.83 [0.33 to 2.80] × 106), while cell-free hemoglobin concentration increased from 72.6 (53.6 to 171.6) mg/dl to 210.5 (126.6 to 479.6) mg/dl (P < 0.0001 for each). There was no effect on neutral lipids. Bedside washing was determined as feasible for 80 of 81 patients (99%); overall, 293 of 314 (93%) units were washed per protocol.
CONCLUSIONS


Bedside erythrocyte washing was clinically feasible and greatly reduced concentrations of soluble factors thought to be associated with transfusion-related adverse reactions, increasing concentrations of cell-free hemoglobin while maintaining acceptable (less than 0.8%) hemolysis.
EDITOR’S PERSPECTIVE


",2021,"CONCLUSIONS


Bedside erythrocyte washing was clinically feasible and greatly reduced concentrations of soluble factors thought to be associated with transfusion-related adverse reactions, increasing concentrations of cell-free hemoglobin while maintaining acceptable (less than 0.8%) hemolysis.
",[],[],"['cell-free hemoglobin concentration', 'neutral lipids', 'microvesicle numbers', 'soluble CD40 ligand']",[],[],"[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0369320', 'cui_str': 'Hemoglobin, free measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0167627', 'cui_str': 'Lymphocyte antigen CD154'}]",,0.104986,"CONCLUSIONS


Bedside erythrocyte washing was clinically feasible and greatly reduced concentrations of soluble factors thought to be associated with transfusion-related adverse reactions, increasing concentrations of cell-free hemoglobin while maintaining acceptable (less than 0.8%) hemolysis.
","[{'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Welsby', 'Affiliation': ''}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Norris', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Mauermann', 'Affiliation': ''}, {'ForeName': 'Mihai V', 'Initials': 'MV', 'LastName': 'Podgoreanu', 'Affiliation': ''}, {'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Conn', 'Affiliation': ''}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Meade', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Cannon', 'Affiliation': ''}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Keating', 'Affiliation': ''}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Silliman', 'Affiliation': ''}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Kehler', 'Affiliation': ''}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Schulte', 'Affiliation': ''}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'Kor', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003689']
1081,33509703,Target attainment in insulin-naive patients at high risk for hypoglycemia: Results from ACHIEVE Control.,"AIMS


To better understand outcomes in people with type 2 diabetes at high risk of hypoglycemia, we conducted post hoc analyses in subgroups of participants from the real-world ACHIEVE Control study (NCT02451137) with ≥1 hypoglycemia risk factor.
METHODS


Insulin-naive adults with type 2 diabetes and A1c ≥8% were randomized 1:1 to insulin glargine 300 U/mL (Gla-300) or standard-of-care basal insulin (SOC-BI). Participants had documented history of ≥1 risk factors for hypoglycemia: chronic kidney disease, cardiovascular disease, dementia or blindness, age ≥65 years, or history of hypoglycemia. Outcomes included individualized A1c target attainment without documented symptomatic hypoglycemia (blood glucose [BG] ≤3.9 mmol/L or <3.0 mmol/L) or severe hypoglycemia, A1c target attainment, and absence of documented symptomatic or severe hypoglycemia at 6 and 12 months.
RESULTS


Within subgroups, odds ratios generally showed trends favoring Gla-300 versus SOC-BI, particularly for hypoglycemia avoidance in participants ≥65 years of age (BG ≤3.9 mmol/L; odds ratio, 1.52; 95% confidence interval, 1.14-2.03) and those with chronic kidney disease (BG ≤3.9 mmol/L; odds ratio, 2.28; 95% confidence interval, 1.26-4.12). Results were consistent with the overall population.
CONCLUSIONS


These data suggest potential benefit of Gla-300 versus SOC-BI for avoiding hypoglycemia in participants with ≥1 hypoglycemia risk factor.",2021,"Within subgroups, odds ratios generally showed trends favoring Gla-300 versus SOC-BI, particularly for hypoglycemia avoidance in participants ≥65 years of age (BG ≤3.9 mmol/L; odds ratio, 1.52; 95% confidence interval, 1.14-2.03) and those with chronic kidney disease (BG ≤3.9 mmol/L; odds ratio, 2.28; 95% confidence interval, 1.26-4.12).","['insulin-naive patients at high risk for hypoglycemia', 'participants with ≥1 hypoglycemia risk factor', 'Participants had documented history of ≥1 risk factors for hypoglycemia: chronic kidney disease, cardiovascular disease, dementia or blindness, age ≥65\u202fyears, or history of hypoglycemia', 'Insulin-naive adults with type 2 diabetes and A1c ≥8', 'people with type 2 diabetes at high risk of hypoglycemia']","['Gla-300 versus SOC-BI', 'insulin glargine 300\u202fU/mL (Gla-300) or standard-of-care basal insulin (SOC-BI']","['chronic kidney disease', 'individualized A1c target attainment without documented symptomatic hypoglycemia (blood glucose [BG] ≤3.9\u202fmmol/L or <3.0\u202fmmol/L) or severe hypoglycemia, A1c target attainment, and absence of documented symptomatic or severe hypoglycemia', 'hypoglycemia avoidance']","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]",,0.074384,"Within subgroups, odds ratios generally showed trends favoring Gla-300 versus SOC-BI, particularly for hypoglycemia avoidance in participants ≥65 years of age (BG ≤3.9 mmol/L; odds ratio, 1.52; 95% confidence interval, 1.14-2.03) and those with chronic kidney disease (BG ≤3.9 mmol/L; odds ratio, 2.28; 95% confidence interval, 1.26-4.12).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'The Frist Clinic, 2400 Patterson Street, Suite 400, Nashville, TN, USA. Electronic address: jeamd89@gmail.com.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Meneghini', 'Affiliation': 'University of Texas Southwestern Medical Center and Parkland Health & Hospital System, 5323 Harry Hines Boulevard, Dallas, TX, USA. Electronic address: Luigi.Meneghini@sanofi.com.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hinnen', 'Affiliation': 'Memorial Hospital Diabetes Center, University of Colorado Health, 175 S Union Boulevard, Suite 305, Colorado Springs, CO, USA. Electronic address: dh@sugar3rn.com.'}, {'ForeName': 'Jasvinder', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'Sanofi, 55 Corporate Drive, Bridgewater, NJ, USA. Electronic address: jasvinder.gill@sanofi.com.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Coudert', 'Affiliation': 'Sanofi, 1 Avenue Pierre Brossolette, Chilly-Mazarin, France. Electronic address: Mathieu.Coudert@sanofi.com.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Evenou', 'Affiliation': 'Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, UK. Electronic address: Pierre.Evenou@sanofi.com.'}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Munshi', 'Affiliation': 'Joslin Diabetes Center, 1 Joslin Place, Boston, MA, USA. Electronic address: mmunshi@bidmc.harvard.edu.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107831']
1082,33515781,Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients.,"BACKGROUND


Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy ('TAKE IT') that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence.
METHODS


The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined.
CONCLUSION


The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.",2021,"BACKGROUND


Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence.","['kidney transplant recipients (KTRs', 'transplant recipients', 'kidney recipients', 'diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n\u202f=\u202f225 per site) within 2\u202fyears of transplantation and 2\u202fyears of follow-up']",['online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators'],"['cost-effectiveness', 'medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0376387', 'cui_str': 'Recipient, Transplant'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.106032,"BACKGROUND


Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Serper', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States of America; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: marinas2@pennmedicine.upenn.edu.'}, {'ForeName': 'Daniela P', 'Initials': 'DP', 'LastName': 'Ladner', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Department of Surgery, Northwestern Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Curtis', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Sumi S', 'Initials': 'SS', 'LastName': 'Nair', 'Affiliation': 'Mayo Clinic Arizona Transplant Center, Mayo Clinic, Phoenix, AZ, United States of America.'}, {'ForeName': 'Scott I', 'Initials': 'SI', 'LastName': 'Hur', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Ho', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Division of Nephrology/Hypertension Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Friedewald', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Division of Nephrology/Hypertension Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States of America; Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Renal-Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States of America.'}, {'ForeName': 'Michael M I', 'Initials': 'MMI', 'LastName': 'Abecassis', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106294']
1083,33528862,Nitrous oxide versus lidocaine versus no analgesic for in-office hysteroscopy: a randomised clinical trial.,"OBJECTIVE


To compare the effect of inhaled nitrous oxide (INO) on pain control during in-office hysteroscopy with 1% lidocaine paracervical infiltration and no analgesic.
DESIGN


Single-blind stratified randomised clinical trial with masked assessment by a third party.
SETTING


Department of Obstetrics and Gynaecology in a Spanish hospital.
POPULATION


Women who underwent hysteroscopy.
METHODS


Patients were stratified into three groups according to the purpose of the hysteroscopy (biopsy, polypectomy or tubal sterilisation) and then assigned to different treatment groups through a permuted-blocks randomisation within strata. Pain scale was provided by a gynaecologist totally blinded to procedures and treatments. Effects were assessed using a one-way analysis of variance following an intention-to-treat approach.
MAIN OUTCOME MEASURES


Visual analogue scale (VAS) from 0 to 100 mm.
RESULTS


A total of 314 women were included: 105 to INO, 104 to 1% lidocaine and 105 to no analgesic. Baseline characteristics were comparable. Mean VAS score after the procedure was 34.7 ± 25.8 mm, 36.1 ± 22.9 mm (P = 1.0) and 47.3 ± 28.2 mm (P = 0.001) for INO, 1% lidocaine and no analgesic, respectively. No adverse events were reported in 91 (86.7%) patients in the INO group compared with 79 (76%) in the 1%-lidocaine group (P = 0.04) and 85 (81%) in the no-analgesic group (P = 0.26).
CONCLUSION


INO was as effective as 1% lidocaine in pain control for in-office hysteroscopy and was better tolerated. The no-analgesic group presented the poorer results, so was the least recommended clinical option.",2021,"No adverse events were reported in ninety-one (86.7%) patients in the INO group compared to 79 (76%) in the lidocaine-1% group (p=0.04) and 85 (81%) in the no-analgesic group (p=0.26).
","['Patients', 'Department of Obstetrics and Gynaecology from a Spanish hospital', 'office Hysteroscopy', 'A total of 314 women were included: 105 to INO, 104 to lidocaine-1% and 105 to no-analgesic', 'Women who underwent hysteroscopy']","['hysteroscopy (biopsy, polypectomy or tubal sterilisation', 'inhaled nitrous oxide (INO', 'Nitrous Oxide vs Lidocaine']","['pain control', 'Visual analog scale (VAS', 'Pain scale', 'adverse events', 'tolerated', 'Mean VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0038289', 'cui_str': 'Sterilization, Tubal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",314.0,0.196541,"No adverse events were reported in ninety-one (86.7%) patients in the INO group compared to 79 (76%) in the lidocaine-1% group (p=0.04) and 85 (81%) in the no-analgesic group (p=0.26).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Solano Calvo', 'Affiliation': ""Department of Obstetrics and Gynaecology, University Hospital 'Príncipe de Asturias', Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Del Valle Rubido', 'Affiliation': ""Department of Obstetrics and Gynaecology, University Hospital 'Ramón y Cajal', Madrid, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rodríguez-Miguel', 'Affiliation': ""Clinical Pharmacology Unit, University Hospital 'Príncipe de Asturias', Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'de Abajo', 'Affiliation': ""Clinical Pharmacology Unit, University Hospital 'Príncipe de Asturias', Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Delgado Espeja', 'Affiliation': ""Department of Obstetrics and Gynaecology, University Hospital 'Príncipe de Asturias', Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'González Hinojosa', 'Affiliation': ""Department of Obstetrics and Gynaecology, University Hospital 'Príncipe de Asturias', Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fernández Muñoz', 'Affiliation': ""Department of Obstetrics and Gynaecology, University Hospital 'Príncipe de Asturias', Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'Á', 'Initials': 'Á', 'LastName': 'Zapico Goñi', 'Affiliation': ""Department of Obstetrics and Gynaecology, University Hospital 'Príncipe de Asturias', Alcalá de Henares, Madrid, Spain.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16657']
1084,33534613,Bridge-Enhanced Anterior Cruciate Ligament Repair Leads to Greater Limb Asymmetry and Less Cartilage Damage Than Untreated ACL Transection or ACL Reconstruction in the Porcine Model.,"BACKGROUND


The extent of posttraumatic osteoarthritis (PTOA) in the porcine anterior cruciate ligament (ACL) transection model is dependent on the surgical treatment selected. In a previous study, animals treated with bridge-enhanced ACL repair using a tissue-engineered implant developed less PTOA than those treated with ACL reconstruction (ACLR). Alterations in gait, including asymmetric weightbearing and shorter stance times, have been noted in clinical studies of subjects with osteoarthritis.
HYPOTHESIS


Animals receiving a surgical treatment that results in less PTOA (ie, bridge-enhanced ACL repair) would exhibit fewer longitudinal postoperative gait asymmetries over a 1-year period when compared with treatments that result in greater PTOA (ie, ACLR and ACL transection).
STUDY DESIGN


Controlled laboratory study.
METHODS


Thirty-six Yucatan minipigs underwent ACL transection and were randomized to receive (1) no further treatment, (2) ACLR, or (3) bridge-enhanced ACL repair. Gait analyses were performed preoperatively, and at 4, 12, 26, and 52 weeks postoperatively. Macroscopic cartilage assessments were performed at 52 weeks.
RESULTS


Knees treated with bridge-enhanced ACL repair had less macroscopic damage in the medial tibial plateau than those treated with ACLR or ACL transection (adjusted  P  = .03 for both comparisons). The knees treated with bridge-enhanced ACL repair had greater asymmetry in hindlimb maximum force and impulse loading at 52 weeks than the knees treated with ACL transection (adjusted  P  < .05 for both comparisons). Although not significant, there was a trend that knees treated with bridge-enhanced ACL repair had greater asymmetry in hindlimb maximum force and impulse loading (adjusted  P  < .10 for both comparisons) compared with ACLR.
CONCLUSION


Contrary to our hypothesis, the surgical treatment resulting in less macroscopic cartilage damage (ie, bridge-enhanced ACL repair) exhibited greater asymmetry in load-related gait parameters than the other surgical groups. This finding suggests that increased offloading of the surgical knee may be associated with a slower rate of PTOA development.
CLINICAL RELEVANCE


Less cartilage damage at 52 weeks was found in the surgical group that continued to protect the limb from full body weight during gait. This finding suggests that protection of the knee from maximum stresses may be important in minimizing the development of PTOA in the ACL-injured knee within 1 year.",2021,"CLINICAL RELEVANCE


Less cartilage damage at 52 weeks was found in the surgical group that continued to protect the limb from full body weight during gait.","['Thirty-six Yucatan minipigs', 'porcine anterior cruciate ligament (ACL) transection model', 'subjects with osteoarthritis']","['bridge-enhanced ACL repair', 'ACL reconstruction (ACLR', 'Untreated ACL Transection or ACL Reconstruction', 'ACL transection', 'receive (1) no further treatment, (2) ACLR, or (3) bridge-enhanced ACL repair', 'Bridge-Enhanced Anterior Cruciate Ligament Repair']","['medial tibial plateau', 'macroscopic damage', 'Macroscopic cartilage assessments', 'hindlimb maximum force and impulse loading', 'longitudinal postoperative gait asymmetries', 'macroscopic cartilage damage']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C1269265', 'cui_str': 'Yucatan Miniature pig'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0152060', 'cui_str': 'Transection'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0152060', 'cui_str': 'Transection'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0549421', 'cui_str': 'Cartilage damage'}]",,0.0238024,"CLINICAL RELEVANCE


Less cartilage damage at 52 weeks was found in the surgical group that continued to protect the limb from full body weight during gait.","[{'ForeName': 'Naga Padmini', 'Initials': 'NP', 'LastName': 'Karamchedu', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Martha M', 'Initials': 'MM', 'LastName': 'Murray', 'Affiliation': ""Division of Sports Medicine, Department of Orthopedic Surgery, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jakob T', 'Initials': 'JT', 'LastName': 'Sieker', 'Affiliation': ""Division of Sports Medicine, Department of Orthopedic Surgery, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Benedikt L', 'Initials': 'BL', 'LastName': 'Proffen', 'Affiliation': ""Division of Sports Medicine, Department of Orthopedic Surgery, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Portilla', 'Affiliation': ""Division of Sports Medicine, Department of Orthopedic Surgery, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Meggin Q', 'Initials': 'MQ', 'LastName': 'Costa', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Molino', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Braden C', 'Initials': 'BC', 'LastName': 'Fleming', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island, USA.'}]",The American journal of sports medicine,['10.1177/0363546521989265']
1085,33539993,The shifting perspectives study protocol: Cognitive remediation therapy as an adjunctive treatment to family based treatment for adolescents with anorexia nervosa.,"BACKGROUND


Adolescents with anorexia nervosa have set-shifting inefficiencies that can be exacerbated by starvation and that may interfere with outcomes of treatment interventions. Cognitive Remediation Therapy (CRT), an adjunctive treatment focused on improving set-shifting, can target inefficiencies and may augment treatment effectiveness. The best way to add CRT to the standard of care (Family Based Treatment, FBT) for adolescents with anorexia remains understudied.
METHODS/DESIGN


This is a randomized controlled trial designed to determine if CRT is effective in increasing flexibility in adolescents with anorexia and/or their parents. Participants are adolescents 12-18 years old with anorexia and their parents. 54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study.
DISCUSSION


This is the first study of its kind to apply CRT to parents. All forms of CRT in the context of anorexia have targeted the individual with anorexia's thinking style. We propose that it may be impactful to target the parent of the adolescent with anorexia as parents carry the burden of treatment and re-nourishment of their child during FBT and may have similar thinking styles.
CONCLUSION


This study takes an experimental therapeutics approach to further our understanding of the mechanisms of treatment for adolescents with anorexia. It focuses on increasing cognitive flexibility in patients or their parents and determining the appropriate dose of CRT needed to achieve positive change.
TRIAL REGISTRATION


ClinicalTrails.gov Identifier NCT03928028.",2021,"54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT.","['adolescents with anorexia and/or their parents', 'Adolescents with anorexia nervosa', 'Participants are adolescents 12-18\u202fyears old with anorexia and their parents', 'adolescents with anorexia remains understudied', 'adolescents with anorexia', 'adolescents with anorexia nervosa']","['CRT', 'Cognitive remediation therapy', 'Cognitive Remediation Therapy (CRT', 'FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT']","['Psychosocial, neurocognitive, and behavioral measures', 'cognitive flexibility']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",,0.0465957,"54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT.","[{'ForeName': 'C Alix', 'Initials': 'CA', 'LastName': 'Timko', 'Affiliation': ""Eating Disorder Assessment and Treatment Program, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: timkoc@email.chop.edu.""}, {'ForeName': 'Anushua', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': ""Eating Disorder Assessment and Treatment Program, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Kathleen Kara', 'Initials': 'KK', 'LastName': 'Fitzpatrick', 'Affiliation': 'Private Practice, Palo Alto, CA, United States of America.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Howe', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'School of Nursing and Health Sciences and Public Health, La Salle University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Mears', 'Affiliation': ""Eating Disorder Assessment and Treatment Program, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Heckert', 'Affiliation': ""Deptartment of Clinical Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ubel', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, NC, United States of America; Sanford School of Policy, Duke University, Durham, NC, United States of America; School of Medicine, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Ehrenreich-May', 'Affiliation': 'Psychology Department, University of Miami, Miami, FL, United States of America.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Peebles', 'Affiliation': ""Craig Dalsimer Division of Adolescent Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, United States of America; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106313']
1086,33539991,The active workplace study: Protocol for a randomized controlled trial with sedentary workers.,"OBJECTIVES


Sedentary behavior is pervasive in the workplace and is harmful to health. Research on the effectiveness of comprehensive workplace interventions to reduce sedentary behavior and improve worker health and safety is crucial as sedentary jobs become more common.
METHODS


We developed a Total Worker Health intervention targeting sedentary behavior in call centers, and are evaluating intervention effectiveness in a randomized controlled trial. Four worksites will be randomly assigned to an intervention or control condition. The intervention condition includes the provision of active workstations along with programs and procedures at environmental, organizational, and individual levels. Control worksites will receive active workstations with no additional support, following common organizational practices.
RESULTS


Outcomes include objectively measured physical activity, biological markers of health, and self-report survey data at baseline, after the 6-month intervention or control period, and at a 12-month follow-up.
CONCLUSIONS


The aims of the study are to determine whether a Total Worker Health intervention has stronger impacts on workplace sedentary behavior, uninterrupted bouts of sitting, and worker health and safety compared to a usual practice control condition. The study will inform future workplace sedentary behavior intervention and dissemination research, along with organizational best practices for reducing sedentary behavior in the workplace.",2021,"The intervention condition includes the provision of active workstations along with programs and procedures at environmental, organizational, and individual levels.",['sedentary workers'],"['Total Worker Health intervention', 'comprehensive workplace interventions', 'Total Worker Health intervention targeting sedentary behavior']","['physical activity, biological markers of health, and self-report survey data', 'workplace sedentary behavior, uninterrupted bouts of sitting, and worker health and safety', 'worker health and safety']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4.0,0.104672,"The intervention condition includes the provision of active workstations along with programs and procedures at environmental, organizational, and individual levels.","[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wipfli', 'Affiliation': 'OHSU-PSU School of Public Health, Portland State University, PO Box 751, SCH, Portland, OR 97207-0751, United States of America; Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: bwipfli@pdx.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wild', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: wilsa@ohsu.edu.'}, {'ForeName': 'Ginger C', 'Initials': 'GC', 'LastName': 'Hanson', 'Affiliation': 'School of Nursing, Johns Hopkins University, 525 N. Wolfe Street, Baltimore, MD 21205, United States of America. Electronic address: ghanson4@jhu.edu.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Shea', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: sheast@ohsu.edu.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Winters-Stone', 'Affiliation': ""OHSU School of Nursing, Oregon Health & Science University, 3455 SW US Veteran's Hospital Rd, Portland, OR 97239, United States of America. Electronic address: wintersk@ohsu.edu.""}, {'ForeName': 'Saurabh S', 'Initials': 'SS', 'LastName': 'Thosar', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: thosar@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106311']
1087,33548749,Effects of deep tissue massage on pain and comfort after cesarean: A randomized controlled trial.,"PURPOSE


In this study, it was aimed to determine the effect of deep tissue massage (DTM) applied by midwife on pain and comfort after cesarean section.
MATERIAL AND METHODS


This study was designed as a randomized controlled trial conducted with experimental and control groups. The data were collected using a personal information form, visual analogue scale (VAS), the Postpartum Comfort Questionnaire (PPCQ). DTM was applied to participants in the experimental group twice (at the 10th and 22nd h) after cesarean. No applications were performed in the control group.
RESULTS


According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001).
CONCLUSIONS


It was indicated that DTM application decreased the levels of pain and increased the comfort levels of the women who had cesarean sections.",2021,"According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001).
",['after cesarean'],"['DTM', 'deep tissue massage (DTM', 'deep tissue massage']","['pain and comfort', 'visual analogue scale (VAS), the Postpartum Comfort Questionnaire (PPCQ', 'levels of pain', 'PPCQ total and sub-dimension mean scores', 'mean VAS score']",[],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0341934,"According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001).
","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Güney', 'Affiliation': 'Inonu University, Department of Midwifery, 44280 Malatya, Turkey. Electronic address: esra.guney@inonu.edu.tr.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Uçar', 'Affiliation': 'Inonu University, Department of Midwifery, 44280 Malatya, Turkey. Electronic address: tuba.ucar@inonu.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101320']
1088,33548748,Clinical and phytochemical studies of Plantago major in pressure ulcer treatment: A randomized controlled trial.,"BACKGROUND


Plantago major L. is used by local people to improve various wounds and lesions such as pressure ulcer. In this study, the therapeutic effects of P. major topical formulation on the stage 1 pressure ulcer in patients have been investigated.
MATERIALS AND METHODS


This randomized triple blind clinical trial study was performed on 130 patients. During the 14 days of study, each of the test and control groups was checked according to check list. Also the topical formulation was standardized by HPLC based on the amount of quercetin.
RESULTS


The findings of this study indicated a significant difference in resolution of the damage between the test and control groups. Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found.
CONCLUSION


The results confirmed the traditional use of P. major in resolution of the damage. CLINICAL TRIAL ID: (IRCT201609209014N117).",2021,"Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found.
",['130 patients'],[],[],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],130.0,0.0438995,"Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found.
","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ghiasian', 'Affiliation': 'Department of Neurology, School of Medicine, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Niroomandi', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Dastan', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Poorolajal', 'Affiliation': 'Department of Epidemiology, School of Public Health, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Zare', 'Affiliation': 'Department of Neurology, School of Medicine, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ataei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: s.ataei@umsha.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101325']
1089,33548747,"Effect of therapeutic touch on daytime sleepiness, stress and fatigue among students of nursing and midwifery: A randomized sham-controlled trial.","OBJECTIVES


This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among students of nursing and midwifery.
METHODS


96 students were randomized into three groups: the therapeutic touch (TT) group, the sham therapeutic touch (STT) group, and the control group. In this randomized sham-controlled study, the TT group was subjected to therapeutic touch twice a week for four weeks with each session lasting 20 min.
RESULTS


When the TT group was compared to the STT and control groups following the intervention, the decrease in the levels of stress (p < 0.001), fatigue (p < 0.001) and daytime sleepiness (p < 0.001), and the increase in the sleep quality (p < 0.001) were found to be significant.
CONCLUSION


It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.",2021,"It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.","['students of nursing and midwifery', '96 students']","['STT', 'therapeutic touch', 'therapeutic touch (TT) group, the sham therapeutic touch (STT']","['stress, daytime sleepiness, sleep quality and fatigue', 'daytime sleepiness', 'levels of stress, fatigue and daytime sleepiness', 'sleep quality', 'fatigue', 'daytime sleepiness, stress and fatigue', 'levels of stress']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",96.0,0.0270069,"It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.","[{'ForeName': 'Birgül', 'Initials': 'B', 'LastName': 'Vural Doğru', 'Affiliation': 'Mersin University, Faculty of Nursing, Internal Nursing Department, Mersin, Turkey. Electronic address: bvuraldogru@gmail.com.'}, {'ForeName': 'Hediye', 'Initials': 'H', 'LastName': 'Utli', 'Affiliation': 'Mardin Artuklu University, Elderly Care Department, Mardin, Turkey. Electronic address: hediyeutli@gmail.com.'}, {'ForeName': 'Fisun', 'Initials': 'F', 'LastName': 'Şenuzun Aykar', 'Affiliation': 'Izmir Tinaztepe University, Faculty of Health Sciences, Nursing Department, Izmir, Turkey. Electronic address: fisunsenuzun@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101322']
1090,33540351,The role of psychological variables in improving resilience: Comparison of an online intervention with a face-to-face intervention. A randomised controlled clinical trial in students of health sciences.,"BACKGROUND


Most studies on improving resilience lack representative samples and pre- and post-intervention assessments. Results regarding the effectiveness of online interventions versus face-to-face interventions are mixed.
OBJECTIVES


To evaluate the effectiveness of online and face-to-face programmes for the improvement of coping strategies to develop resilience to stressful situations, and to assess their relationship with personality traits, mood, and academic stressors.
DESIGN


Randomised controlled clinical trial. Three-armed parallel design.
PARTICIPANTS


245 students of the Nursing and Physical Therapy Degree.
METHODS


Students were randomly assigned to the control group (CG), intervention group 1 (IG-1, face-to-face) or intervention group 2 (IG-2, online). They were assessed after the intervention with the following instruments: the Positive and Negative Affect Schedule (PANAS), the Academic Stressors Scale, the Coping Orientation to Problems Experienced (COPE), the Connor-Davidson Resilience Scale, and the NEO-FFI scale.
RESULTS


Negative affect was higher in IG-1 (p = 0.12). The greatest stressors were methodological deficiencies of the teaching staff, academic overload, and beliefs about academic performance. The most widely used coping strategies were ""Active Problem-Focused Coping"" and ""Seeking Social Support"". There were differences between IG-1 and IG-2 only regarding ""Focus on and Venting of Emotions"" (p = 0.086). On the Resilience scale, ""Persistence, Tenacity, and Self-Efficacy"" was higher in the CG, and there were differences with IG-1 (p = 0.06). With respect to the traits measured by the NEO-FFI questionnaire, higher levels of emotional instability (neuroticism) were observed in IG-1 than in the CG (p = 0.06).
CONCLUSIONS


The results of both interventions are similar, with increased self-awareness of negative personality traits, which is useful for those ignoring their areas for improvement. In addition, these factors are further increased in individuals with high levels of neuroticism and low levels of extraversion. The online intervention was as effective as the face-to-face intervention.",2021,"There were differences between IG-1 and IG-2 only regarding ""Focus on and Venting of Emotions"" (p = 0.086).","['Students', 'students of health sciences', '245 students of the Nursing and Physical Therapy Degree']","['control group (CG), intervention group 1 (IG-1, face-to-face) or intervention group 2 (IG-2, online', 'online intervention with a face-to-face intervention']","['methodological deficiencies of the teaching staff, academic overload, and beliefs about academic performance', 'Resilience scale, ""Persistence, Tenacity, and Self-Efficacy', 'NEO-FFI questionnaire, higher levels of emotional instability (neuroticism', 'IG-1 and IG-2 only regarding ""Focus on and Venting of Emotions', 'Positive and Negative Affect Schedule (PANAS), the Academic Stressors Scale, the Coping Orientation to Problems Experienced (COPE), the Connor-Davidson Resilience Scale, and the NEO-FFI scale']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0206042', 'cui_str': 'Fatal familial insomnia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C1842981', 'cui_str': 'Neuroticism Traits'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",245.0,0.0251234,"There were differences between IG-1 and IG-2 only regarding ""Focus on and Venting of Emotions"" (p = 0.086).","[{'ForeName': 'Luis Iván', 'Initials': 'LI', 'LastName': 'Mayor-Silva', 'Affiliation': 'Faculty of Nursing, Physical Therapy, and Podiatry, Complutense University of Madrid, Faculty of Medicine Building, 3.ª Planta, Plaza de Ramón y Cajal, 3, CP: 28040 Madrid, Spain. Electronic address: limayors@ucm.es.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Romero-Saldaña', 'Affiliation': 'Grupo Asociado de Investigación Estilos de vida, innovación y salud. Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC). Faculty of Nursing, University of Cordoba. Avda. Menéndez Pidal, s/n 14071, Córdoba, Spain. Electronic address: z92rosam@uco.es.'}, {'ForeName': 'Antonio Gabriel', 'Initials': 'AG', 'LastName': 'Moreno-Pimentel', 'Affiliation': 'Faculty of Nursing, Physical Therapy, and Podiatry, Complutense University of Madrid, Faculty of Medicine Building, 3.ª Planta, Plaza de Ramón y Cajal, 3, CP: 28040 Madrid, Spain. Electronic address: antomo05@ucm.es.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Álvarez-Melcón', 'Affiliation': 'Faculty of Nursing, Physical Therapy, and Podiatry, Complutense University of Madrid, Faculty of Medicine Building, 3.ª Planta, Plaza de Ramón y Cajal, 3, CP: 28040 Madrid, Spain. Electronic address: angela.alvarez@ucm.es.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Molina-Luque', 'Affiliation': 'Grupo Asociado de Investigación Estilos de vida, innovación y salud. Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC). Faculty of Nursing, University of Cordoba. Avda. Menéndez Pidal, s/n 14071, Córdoba, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Meneses-Monroy', 'Affiliation': 'Faculty of Nursing, Physical Therapy, and Podiatry, Complutense University of Madrid, Faculty of Medicine Building, 3.ª Planta, Plaza de Ramón y Cajal, 3, CP: 28040 Madrid, Spain. Electronic address: ameneses@ucm.es.'}]",Nurse education today,['10.1016/j.nedt.2021.104778']
1091,33540180,"Role of active cycle of breathing technique for patients with chronic obstructive pulmonary disease: A pragmatic, randomized clinical trial.","BACKGROUND


While active cycle of breathing technique for chronic obstructive pulmonary disease patients with more sputum can improve clinic outcomes, less is known about sputum viscosity and sputum production of the intervention.
OBJECTIVE


The purpose of our study was to explore the effect of active cycle of breathing technique on sputum viscosity and production among patients with chronic obstructive pulmonary disease.
DESIGN


This was a two-arms, parallel, randomized clinical trial.
SETTING


Study enrollment, randomization and implementation were conducted in the department of respiratory medicine inpatient at the Medical Center in Changchun, China.
PARTICIPANTS


Hospitalized patients due to chronic obstructive pulmonary disease who met additional eligibility criteria were randomized to active cycle of breathing technique (n = 50) or usual care group (n = 50).
METHODS


Patients in the intervention group received a week-long intervention from an experienced physical therapist. Patients in the usual care group received usual care as well as information and advice in the light of their health plan from respiratory medicine. The primary outcome was the changes on sputum viscosity and production.
RESULTS


Among one hundred patients who were randomized (mean [SD] age, 54.89 [12.06] years; females, 58%), ninety-six participants completed the study. No significant differences were found between two groups on the changes of sputum viscosity (t = 0.277, P = 0.782). And there were insignificant differences between groups in the average amount of sputum among 1 h (Z=-1.848, P = 0.065) and significant differences in the average amount of sputum among 24 h (Z=-2.236, P = 0.025). From admission to one week recovery, the changes in ratio of forced expiratory volume in 1 s to forced vital capacity (Z=-4.511, P<0.0001) and arterial oxygen saturation (Z=-2.997, P = 0.003) were better in active cycle breathing technique group. Total Chronic Obstructive Pulmonary Disease Assessment Test scale were similar among two groups (Z=-1.818, P = 0.069). No adverse events occurred during the study.
CONCLUSION


For patients with chronic obstructive pulmonary disease, active cycle of breathing technique can significantly result in sputum production and respiratory function, especially those of Global Initiative for Chronic Obstructive Lung Disease classification level 3, but did not result in the short-term improvement of sputum viscosity, quality of life and cost effectiveness. Registration number: ChiCTR2000033068.",2021,"Total Chronic Obstructive Pulmonary Disease Assessment Test scale were similar among two groups (Z=-1.818, P = 0.069).","['chronic obstructive pulmonary disease patients with more sputum', 'one hundred patients who were randomized (mean [SD] age, 54.89 [12.06] years; females, 58%), ninety-six participants completed the study', 'Hospitalized patients due to chronic obstructive pulmonary disease who met additional eligibility criteria', 'Patients in the intervention group received a', 'Study enrollment, randomization and implementation were conducted in the department of respiratory medicine inpatient at the Medical Center in Changchun, China', 'patients with chronic obstructive pulmonary disease']","['usual care as well as information and advice in the light of their health plan from respiratory medicine', 'breathing technique', 'week-long intervention from an experienced physical therapist', 'active cycle of breathing technique (n\xa0=\xa050) or usual care group (n\xa0=\xa050']","['average amount of sputum', 'arterial oxygen saturation', 'changes in ratio of forced expiratory volume in 1\xa0s to forced vital capacity', 'sputum viscosity and production', 'adverse events', 'Total Chronic Obstructive Pulmonary Disease Assessment Test scale', 'changes of sputum viscosity', 'sputum viscosity, quality of life and cost effectiveness']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034060', 'cui_str': 'Pulmonary medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0018727', 'cui_str': 'Health Planning'}, {'cui': 'C0034060', 'cui_str': 'Pulmonary medicine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0454503', 'cui_str': 'Active cycle of breathing technique'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4758039', 'cui_str': 'Chronic Obstructive Pulmonary Disease Assessment Test scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",100.0,0.175681,"Total Chronic Obstructive Pulmonary Disease Assessment Test scale were similar among two groups (Z=-1.818, P = 0.069).","[{'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Shen', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: shenmy18@jlu.edu.cn.'}, {'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: yuewei@jlu.edu.cn.'}, {'ForeName': 'L Q', 'Initials': 'LQ', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: xulq18@jlu.edu.cn.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Shi', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: shihy18@jlu.edu.cn.'}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Ni', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: niyy18@jlu.edu.cn.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Lin', 'Affiliation': 'The First Hospital of Jilin University, No 71, Xinmin Street, 130000 Changchun, Jilin Province, China. Electronic address: 2571807028@qq.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: fli@jlu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2021.103880']
1092,33550719,Nutrition intervention is beneficial to the quality of life of patients with gastrointestinal cancer undergoing chemotherapy in Vietnam.,"INTRODUCTION


The best treatment therapy for gastrointestinal cancer patients is assessed by the improvement of health status and quality of life (QoL) after treatments. Malnutrition is related to loss of muscle strengths which leads to lower physical performance and emotional status. Thus, this study aimed to estimate the effects of nutritional interventions on the improvement of QoL among gastrointestinal patients undergoing chemotherapy in Vietnam.
METHODS


A quasi-experiment with intervention and control groups for pre- and post-intervention assessment was carried out at the Department of Oncology and Palliative Care-Hanoi Medical University Hospital from 2016 to 2019. Sixty gastrointestinal cancer patients were recruited in each group. The intervention regimen consisted of nutritional counseling, a specific menu with a recommended amount of energy, protein, and formula milk used within 2 months. Nutritional status and QoL of patients were evaluated using The Scored Patient-Generated Subjective Global Assessment (PG-SGA) and The European Organization for Research and Treatment of Cancer (EORTC). The difference in differences (DiD) method was utilized to estimate the outcome between control and intervention groups.
RESULTS


After the intervention, patients of the intervention group had better changes in scores of global health status (Coef =16.68; 95% CI =7.90; 25.46), physical (Coef =14.51; 95% CI =5.34; 23.70), and role functioning (Coef =14.67; 95% CI =1.63; 27.70) compared to the control group. Regarding symptom scales, the level of fatigue, pain, and insomnia symptoms significantly reduced between pre- and post-intervention in the intervention group. In addition, living in urban areas, defined as malnourished and having low prealbumin levels, were positively associated with the lower global health status/QoL score.
CONCLUSION


Nutritional therapy with high protein was beneficial to the improvement in QoL, physical function and the reduction of negative symptoms among gastrointestinal cancer patients. Early individualized nutritional support in consultation with professional dietitians during chemotherapy plays an integral part in enhancing the QoL and better treatment prognosis.
CLINICAL TRIAL REGISTRATION NUMBER


NCT04517708.",2021,"Regarding symptom scales, the level of fatigue, pain, and insomnia symptoms significantly reduced between pre- and post-intervention in the intervention group.","['patients with gastrointestinal cancer undergoing chemotherapy in Vietnam', 'gastrointestinal cancer patients', 'Sixty gastrointestinal cancer patients', 'gastrointestinal patients undergoing chemotherapy in Vietnam']","['Nutrition intervention', 'nutritional counseling, a specific menu with a recommended amount of energy, protein, and formula milk used within 2\xa0months', 'nutritional interventions']","['health status and quality of life (QoL', 'level of fatigue, pain, and insomnia symptoms', 'global health status/QoL score', 'QoL, physical function', 'scores of global health status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",60.0,0.0249722,"Regarding symptom scales, the level of fatigue, pain, and insomnia symptoms significantly reduced between pre- and post-intervention in the intervention group.","[{'ForeName': 'Linh Thuy', 'Initials': 'LT', 'LastName': 'Nguyen', 'Affiliation': 'Institute for Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Anh Kim', 'Initials': 'AK', 'LastName': 'Dang', 'Affiliation': 'Institute for Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Phuong Thi', 'Initials': 'PT', 'LastName': 'Duong', 'Affiliation': 'Department of Nutrition and Dietetic, Hanoi Medical University Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Hanh Bich Thi', 'Initials': 'HBT', 'LastName': 'Phan', 'Affiliation': 'Institute for Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Chinh Tuyet Thi', 'Initials': 'CTT', 'LastName': 'Pham', 'Affiliation': 'Department of Nutrition and Dietetic, Hanoi Medical University Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Anh Tuan Le', 'Initials': 'ATL', 'LastName': 'Nguyen', 'Affiliation': 'Institute for Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Huong Thi', 'Initials': 'HT', 'LastName': 'Le', 'Affiliation': 'Institute for Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam.'}]",Cancer medicine,['10.1002/cam4.3766']
1093,33516047,Effectiveness of a nurse-led temporal self-regulation theory-based program on heart failure self-care: A randomized controlled trial.,"BACKGROUND


Heart failure self-care is crucial for sustainable heart failure management but its adherence remains poor worldwide. Despite having an intention to change, individuals often face difficulties in modifying existing lifestyle habits and sustaining change motivations.
OBJECTIVES


To examine the effectiveness of a novel theory-driven nurse-led self-regulation program on improving heart failure self-care behaviours, future-thinking and behavioural automaticity.
DESIGN


A two-arm randomized controlled trial.
SETTINGS & PARTICIPANTS


144 patients with heart failure were recruited from September 2018 to July 2019 at a tertiary hospital in Singapore.
METHODS


Participants were randomly assigned to a self-regulation intervention (n = 72) or usual care group (n = 72). The three-month intervention was developed based on the temporal self-regulation theory and consisted of one face-to-face session, a print booklet and three reinforcement telephone follow-ups at week 3, 6 and 9. Outcomes were measured at baseline (T0), immediate after a three-month intervention (T1) and a further three-month follow-up (T2). heart failure self-care was measured using the Self-Care of Heart Failure Index (SCHFI) maintenance subscale, future-thinking was measured using the Consideration of Future Consequences Scale (CFCS) and behaviour automaticity was measured using the Self-Reported Behavioural Automaticity Index (SRBAI). The outcomes were compared between groups by using generalized estimating equations (GEE) based on intention-to-treat principle.
RESULTS


No significant differences were found between the groups at baseline except for age. Participants were on average 61 years old, men (79.2%), had mild heart failure symptoms (50.7%) and had three comorbidities (66.0% dyslipidaemia; 65.3% hypertension; 61.8% history of myocardial infarction). Baseline scores indicated poor heart failure self-care (52.9±17.2, cut off ≥70). GEE results showed significantly higher heart failure self-care improvements in intervention group than control group at both T1 (regression coefficient, B = 13.9, 95% CI: 8.02 to 19.9, p < 0.001) and T2 (B = 8.34, 95% CI: 1.68 to 15.0, p = 0.014) after adjusting for gender, living alone, education level, comorbidity and age. Results also showed significantly higher increase in future-thinking (B[95% CI]=0.694[.123, 1.26], p = 0.017) and behaviour automaticity (B[95% CI]=0.656[.085, 1.23], p = 0.024) at T1 and only increase in behaviour automaticity (B[95% CI]=0.674[.099, 1.25], p = 0.022) at T2. However, only the differences in self-care scores at T1 remained significant after Bonferroni correction. No significant differences were found for intention, quality of life and clinical biomarkers.
CONCLUSIONS


The program was effective in improving heart failure self-care and has potential for clinical implementation and generalisation to other chronic illnesses. Longer follow-up study is needed to uncover its long-term benefits on clinical outcomes.",2021,"GEE results showed significantly higher heart failure self-care improvements in intervention group than control group at both T1 (regression coefficient, B = 13.9, 95% CI: 8.02 to 19.9, p < 0.001) and T2 (B = 8.34, 95% CI: 1.68 to 15.0, p = 0.014) after adjusting for gender, living alone, education level, comorbidity and age.","['Participants were on average 61 years old, men (79.2%), had mild heart failure symptoms (50.7%) and had three comorbidities (66.0% dyslipidaemia; 65.3% hypertension; 61.8% history of myocardial infarction', '144 patients with heart failure were recruited from September 2018 to July 2019 at a tertiary hospital in Singapore', 'heart failure self-care', 'Participants']","['nurse-led temporal self-regulation theory-based program', 'self-regulation intervention (n\xa0=\xa072) or usual care group', 'novel theory-driven nurse-led self-regulation program']","['heart failure self-care improvements', 'Behavioural Automaticity Index (SRBAI', 'Self-Care of Heart Failure Index (SCHFI) maintenance subscale, future-thinking', 'heart failure self-care', 'intention, quality of life and clinical biomarkers', 'future-thinking', 'Future Consequences Scale (CFCS) and behaviour automaticity', 'self-care scores', 'behaviour automaticity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1275835', 'cui_str': 'History of myocardial infarction'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",144.0,0.0805317,"GEE results showed significantly higher heart failure self-care improvements in intervention group than control group at both T1 (regression coefficient, B = 13.9, 95% CI: 8.02 to 19.9, p < 0.001) and T2 (B = 8.34, 95% CI: 1.68 to 15.0, p = 0.014) after adjusting for gender, living alone, education level, comorbidity and age.","[{'ForeName': 'Han Shi Jocelyn', 'Initials': 'HSJ', 'LastName': 'Chew', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin, School of Medicine, National University of Singapore. Electronic address: jocelyn.chew.hs@nus.edu.sg.'}, {'ForeName': 'Kheng Leng David', 'Initials': 'KLD', 'LastName': 'Sim', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin, School of Medicine, National University of Singapore; National Heart Centre Singapore, 5 Hospital Drive, 169609, Singapore. Electronic address: david.sim@singhealth.com.sg.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin, School of Medicine, National University of Singapore. Electronic address: kchoi@cuhk.edu.hk.'}, {'ForeName': 'Sek Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin, School of Medicine, National University of Singapore. Electronic address: sychair@cuhk.edu.hk.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2021.103872']
1094,33529810,"Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study.","INTRODUCTION


Dapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce.
AIM


The aim of this study was to evaluate the safety and effectiveness of dapoxetine 30 mg and 60 mg on demand in Chinese men with PE.
METHODS


Phase IV real-world study on 1,252 patients with PE. If men reported no response to dapoxetine 30 mg after 4 weeks treatment, dapoxetine has been uptitrated at 60 mg for 4 weeks more.
MAIN OUTCOME MEASURE


Self-reported data were collected for demographics, general and sexual health characteristics, PE severity, and treatment safety and effectiveness, as measured by the PE profile questionnaire.
RESULTS


Adverse events (AEs), such as nausea, thirst, headache, and dizziness, similarly to previous literature, were detected. The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively). No new safety concerns were observed. The overall effectiveness rates were 88.2% in subjects using 30 mg of dapoxetine, whereas a rescue from the previous failure was in 55.7% in the patients who received 60 mg after the initial 30 mg. Overall, 83.2% responded to dapoxetine at dosages equal to or lower than 60 mg.
CONCLUSION


The results in this study demonstrated in a large Chinese population that on-demand dapoxetine is a safe and effective symptomatic treatment in patients with PE. J Peng, L Yang, L Liu, et al. Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study. Sex Med 2020;XX:XXX-XXX.",2021,"The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively).","['patients with PE', 'Chinese men with PE', '1,252 patients with PE', 'Chinese Men With Premature Ejaculation', 'premature ejaculation (PE) management in China']","['dapoxetine', 'Dapoxetine']","['safety and effectiveness', 'Adverse events (AEs), such as nausea, thirst, headache, and dizziness', 'overall effectiveness rates', 'treatment-emergent AEs rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",1252.0,0.0218966,"The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, North Theater General Hospital, Shenyang, China.'}, {'ForeName': 'Renyuan', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Shanghai Jingan District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ningchen', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Urology, General Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yongguang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, Beijing Anzhen Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuqiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Urology, Second Hospital of Shandong University, Ji'nan, China.""}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Beijing Chaoyang Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': ""Department of Urology, Shanghai Fifth People's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Medical Department, A Menarini Asia Pacific, Singapore.'}, {'ForeName': 'Emmanuele A', 'Initials': 'EA', 'LastName': 'Jannini', 'Affiliation': 'Chair of Endocrinology and Medical Sexology (ENDOSEX), Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China. Electronic address: zhangzhichao@bjmu.edu.cn.'}]",Sexual medicine,['10.1016/j.esxm.2020.100296']
1095,33524659,Clinical efficacy of adductor canal block in medial open wedge high tibial osteotomy.,"BACKGROUND


To evaluate the effect of adductor canal block (ACB) on short-term postoperative outcomes in patients who underwent medial open-wedge high tibial osteotomy (MOWHTO) compared to that of a placebo.
METHODS


35 patients who underwent unilateral MOWHTO between 2017 and 2019 were prospectively reviewed and randomly divided into two groups: 19 patients who received a single-shot ACB and 16 patients who received a saline injection (a placebo group). Primary outcomes were (1) pain measured using the visual analog scale and range of motion, (2) patient satisfaction, (3) postoperative need for additional opioids, (3) quadriceps strength (the time to straight leg raising [SLR]), (4) clinical outcomes, and (5) complications.
RESULTS


The pain score was lower in the ACB group than in the placebo group in the first 12 h (p = 0.04). ACB did not exhibit significantly less quadriceps strength weakness postoperatively. There was no statistical difference in the time to SLR (23.5 ± 17.7 h in ACB vs. 27.6 ± 11.4 in placebo, p = 0.520). The opioid consumption rate within postoperative 12 h was significantly decreased after ACB (16.7% in ACB, 70% in placebo, p = 0.017). The proportion of patients with more than 5 opioid injections within 72 h postoperatively was lower in the ACB group (8.3% in ACB, 50% in placebo, p = 0.043). Both groups did not show any localized and systemic complications.
CONCLUSION


ACB following MOWHTO exhibited better outcomes than a placebo with respect to opioid consumption with no changes in the quadriceps strength and complications.
LEVEL OF EVIDENCE


II, Prospectively comparative study.",2021,"ACB following MOWHTO exhibited better outcomes than a placebo with respect to opioid consumption with no changes in the quadriceps strength and complications.
","['35 patients who underwent unilateral MOWHTO between 2017 and 2019 were prospectively reviewed and randomly divided into two groups: 19 patients who received a', 'patients who underwent medial open-wedge high tibial osteotomy (MOWHTO', 'medial open wedge high tibial osteotomy']","['ACB', 'placebo', 'saline injection (a placebo', 'adductor canal block (ACB', 'single-shot ACB', 'adductor canal block']","['pain score', 'opioid consumption rate', '1) pain measured using the visual analog scale and range of motion, (2) patient satisfaction, (3) postoperative need for additional opioids, (3) quadriceps strength (the time to straight leg raising [SLR]), (4) clinical outcomes, and (5) complications', 'time to SLR', 'quadriceps strength and complications', 'quadriceps strength weakness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0445153', 'cui_str': 'Opening wedge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]",35.0,0.218775,"ACB following MOWHTO exhibited better outcomes than a placebo with respect to opioid consumption with no changes in the quadriceps strength and complications.
","[{'ForeName': 'Jae Ang', 'Initials': 'JA', 'LastName': 'Sim', 'Affiliation': 'Department of Orthopaedics Surgery, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: sim_ja@gilhospital.com.'}, {'ForeName': 'Mi Geum', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: mikeum2@gilhospital.com.'}, {'ForeName': 'Wol Seon', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: cherish@gilhospital.com.'}, {'ForeName': 'Beom Koo', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedics Surgery, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: knee@gilhospital.com.'}, {'ForeName': 'Byung Hoon', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedics Surgery, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: oselite@naver.com.'}]",The Knee,['10.1016/j.knee.2020.12.017']
1096,33466128,CO2 artificial pneumothorax on coagulation and fibrinolysis during thoracoscopic esophagectomy.,"BACKGROUND


CO2 artificial pneumothorax creates a sufficient operative field for thoracoscopic esophagectomy. However, it has potential complications and continuous CO2 insufflation may impede coagulation and fibrinolysis. We sought to compare the effects of CO2 artificial pneumothorax on perioperative coagulation and fibrinolysis during thoracoscopic esophagectomy.
METHODS


We investigated patients who underwent thoracoscopic esophagectomy with (group P, n = 24) or without CO2 artificial pneumothorax (group N, n = 24). The following parameters of coagulation-fibrinolysis function: intraoperative bleeding volume; serum levels of tissue plasminogen activator (t-PA), plasminogen activator inhibitor (PAI-1), thromboelastogram (TEG), D-Dimer; and arterial blood gas levels were compared with two groups.
RESULTS


Group P showed higher levels of PaCO2, reaction time (R) value and kinetics (K) value, but significantly lower pH value, alpha (α) angle and Maximum Amplitude (MA) value at 60 minutes after the initiation of CO2 artificial pneumothorax than group N ((P < .05, all). The t-PA level after CO2 insufflation for 60 minutes was significantly higher in group P than in group N (P < .05), but preoperative levels were gradually restored on cessation of CO2 insufflation for 30 min (P > .05). There was no significant difference in D-dimer.
CONCLUSION


CO2 artificial pneumothorax during thoracoscopic esophagectomy had a substantial impact on coagulation and fibrinolysis, inducing significant derangements in pH and PaCO2.
TRIAL REGISTRATION


The study was registered at the Chinese clinical trial registry (ChiCTR1800019004).",2021,"The t-PA level after CO2 insufflation for 60 minutes was significantly higher in group P than in group N (P < .05), but preoperative levels were gradually restored on cessation of CO2 insufflation for 30 min (P > .05).",['thoracoscopic esophagectomy'],"['thoracoscopic esophagectomy with (group P, n\u200a=\u200a24) or without CO2 artificial pneumothorax', 'CO2 artificial pneumothorax']","['pH value, alpha (α) angle and Maximum Amplitude (MA) value', 'perioperative coagulation and fibrinolysis', 'tissue plasminogen activator (t-PA), plasminogen activator inhibitor (PAI-1), thromboelastogram (TEG), D-Dimer; and arterial blood gas levels', 'levels of PaCO2, reaction time (R) value and kinetics (K) value', 't-PA level after CO2 insufflation', 'coagulation and fibrinolysis', 'D-dimer']","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0032328', 'cui_str': 'Therapeutic pneumothorax'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032145', 'cui_str': 'Plasminogen activator inhibitor'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]",,0.0361945,"The t-PA level after CO2 insufflation for 60 minutes was significantly higher in group P than in group N (P < .05), but preoperative levels were gradually restored on cessation of CO2 insufflation for 30 min (P > .05).","[{'ForeName': 'Yunqin', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Department of Anesthesiology, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Hengjiang', 'Initials': 'H', 'LastName': 'Ge', 'Affiliation': ''}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ''}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023784']
1097,33535141,Culture moderates the relationship between self-control ability and free will beliefs in childhood.,"We investigate individual, developmental, and cultural differences in self-control in relation to children's changing belief in ""free will"" - the possibility of acting against and inhibiting strong desires. In three studies, 4- to 8-year-olds in the U.S., China, Singapore, and Peru (N = 441) answered questions to gauge their belief in free will and completed a series of self-control and inhibitory control tasks. Children across all four cultures showed predictable age-related improvements in self-control, as well as changes in their free will beliefs. Cultural context played a role in the timing of these emerging free will beliefs: Singaporean and Peruvian children's beliefs changed at later ages than Chinese and U.S. children. Critically, culture moderated the link between self-control abilities and free will beliefs: Individual differences in self-control behaviors were linked to individual differences in free will beliefs in U.S. children, but not in children from China, Singapore or Peru. There was also evidence of a causal influence of self-control performance on free will beliefs in our U.S. sample. In Study 2, a randomly assigned group of U.S. 4- and 5-year-olds who failed at two self-control tasks showed reduced belief in free will, but a group of children who completed free will questions first did not show changes to self-control. Together these results suggest that culturally-acquired causal-explanatory frameworks for action, along with observations of one's own abilities, might influence children's emerging understanding of free will.",2021,"Critically, culture moderated the link between self-control abilities and free will beliefs: Individual differences in self-control behaviors were linked to individual differences in free will beliefs in U.S. children, but not in children from China, Singapore or Peru.",['childhood'],['U.S. 4- and 5-year-olds who failed at two self-control tasks'],[],"[{'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",[],,0.0150515,"Critically, culture moderated the link between self-control abilities and free will beliefs: Individual differences in self-control behaviors were linked to individual differences in free will beliefs in U.S. children, but not in children from China, Singapore or Peru.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'East China Normal University, China.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Wente', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'María Fernández', 'Initials': 'MF', 'LastName': 'Flecha', 'Affiliation': 'Pontificia Universidad Católica del Perú, Peru.'}, {'ForeName': 'Denise Segovia', 'Initials': 'DS', 'LastName': 'Galvan', 'Affiliation': 'Pontificia Universidad Católica del Perú, Peru.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Gopnik', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Kushnir', 'Affiliation': 'Cornell University, USA. Electronic address: tk397@cornell.edu.'}]",Cognition,['10.1016/j.cognition.2021.104609']
1098,33539729,"4 Gy versus 24 Gy radiotherapy for follicular and marginal zone lymphoma (FoRT): long-term follow-up of a multicentre, randomised, phase 3, non-inferiority trial.","BACKGROUND


The optimal radiotherapy dose for indolent non-Hodgkin lymphoma is uncertain. We aimed to compare 24 Gy in 12 fractions (representing the standard of care) with 4 Gy in two fractions (low-dose radiation).
METHODS


FoRT (Follicular Radiotherapy Trial) is a randomised, multicentre, phase 3, non-inferiority trial at 43 study centres in the UK. We enrolled patients (aged >18 years) with indolent non-Hodgkin lymphoma who had histological confirmation of follicular lymphoma or marginal zone lymphoma requiring radical or palliative radiotherapy. No limit on performance status was stipulated, and previous chemotherapy or radiotherapy to another site was permitted. Radiotherapy target sites were randomly allocated (1:1) either 24 Gy in 12 fractions or 4 Gy in two fractions using minimisation and stratified by histology, treatment intent, and study centre. Randomisation was centralised through the Cancer Research UK and University College London Cancer Trials Centre. Patients, treating clinicians, and investigators were not masked to random assignments. The primary endpoint was time to local progression in the irradiated volume based on clinical and radiological evaluation and analysed on an intention-to-treat basis. The non-inferiority threshold aimed to exclude the chance that 4 Gy was more than 10% inferior to 24 Gy in terms of local control at 2 years (HR 1·37). Safety (in terms of adverse events) was analysed in patients who received any radiotherapy and who returned an adverse event form. FoRT is registered with ClinicalTrials.gov, NCT00310167, and the ISRCTN Registry, ISRCTN65687530, and this report represents the long-term follow-up.
FINDINGS


Between April 7, 2006, and June 8, 2011, 614 target sites in 548 patients were randomly assigned either 24 Gy in 12 fractions (n=299) or 4 Gy in two fractions (n=315). At a median follow-up of 73·8 months (IQR 61·9-88·0), 117 local progression events were recorded, 27 in the 24 Gy group and 90 in the 4 Gy group. The 2-year local progression-free rate was 94·1% (95% CI 90·6-96·4) after 24 Gy and 79·8% (74·8-83·9) after 4 Gy; corresponding rates at 5 years were 89·9% (85·5-93·1) after 24 Gy and 70·4% (64·7-75·4) after 4 Gy (hazard ratio 3·46, 95% CI 2·25-5·33; p<0·0001). The difference at 2 years remains outside the non-inferiority margin of 10% at -13·0% (95% CI -21·7 to -6·9). The most common events at week 12 were alopecia (19 [7%] of 287 sites with 24 Gy vs six [2%] of 301 sites with 4 Gy), dry mouth (11 [4%] vs five [2%]), fatigue (seven [2%] vs five [2%]), mucositis (seven [2%] vs three [1%]), and pain (seven [2%] vs two [1%]). No treatment-related deaths were reported.
INTERPRETATION


Our findings at 5 years show that the optimal radiotherapy dose for indolent lymphoma is 24 Gy in 12 fractions when durable local control is the aim of treatment.
FUNDING


Cancer Research UK.",2021,"The 2-year local progression-free rate was 94·1% (95% CI 90·6-96·4) after 24 Gy and 79·8% (74·8-83·9) after 4 Gy; corresponding rates at 5 years were 89·9% (85·5-93·1) after 24 Gy and 70·4% (64·7-75·4) after 4 Gy (hazard ratio 3·46, 95% CI 2·25-5·33; p<0·0001).","['43 study centres in the UK', 'Between April 7, 2006, and June 8, 2011', 'enrolled patients (aged >18 years) with indolent non-Hodgkin lymphoma who had histological confirmation of follicular lymphoma or marginal zone lymphoma requiring radical or palliative radiotherapy', '614 target sites in 548 patients']","['radiotherapy', '24 Gy radiotherapy', 'Radiotherapy', '24 Gy in 12 fractions (representing the standard of care) with 4 Gy in two fractions (low-dose radiation']","['alopecia', '117 local progression events', 'fatigue', 'dry mouth', '2-year local progression-free rate', 'mucositis', 'time to local progression in the irradiated volume based on clinical and radiological evaluation and analysed on an intention-to-treat basis', 'Safety', 'pain']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0242647', 'cui_str': 'Mucosa-associated lymphoma'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0454197', 'cui_str': 'Irradiated volume'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",548.0,0.239951,"The 2-year local progression-free rate was 94·1% (95% CI 90·6-96·4) after 24 Gy and 79·8% (74·8-83·9) after 4 Gy; corresponding rates at 5 years were 89·9% (85·5-93·1) after 24 Gy and 70·4% (64·7-75·4) after 4 Gy (hazard ratio 3·46, 95% CI 2·25-5·33; p<0·0001).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoskin', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK; Division of Cancer Sciences, University of Manchester, Manchester, UK. Electronic address: peterhoskin@nhs.net.'}, {'ForeName': 'Biliana', 'Initials': 'B', 'LastName': 'Popova', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schofield', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Brammer', 'Affiliation': 'Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'A Murray', 'Initials': 'AM', 'LastName': 'Brunt', 'Affiliation': 'University Hospitals of North Midland & Keele University, Stoke-on-Trent, UK.'}, {'ForeName': 'Krishnaswamy', 'Initials': 'K', 'LastName': 'Madhavan', 'Affiliation': 'Southend University Hospital, Westcliff-on-Sea, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Illidge', 'Affiliation': 'National Institute of Health Research Biomedical Research Centre, University of Manchester, Christie Hospital, Manchester, UK.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Gallop-Evans', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clifton-Hadley', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Kirkwood', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30686-0']
1099,33545575,"The effects of yoga on dyspnea, sleep and fatigue in chronic respiratory diseases.","PURPOSE


This study was carried out to find out the effects of yoga applied to chronic respiratory disease patients on dyspnea, sleep quality and fatigue.
MATERIAL AND METHOD


The study was conducted between May and August 2020 as a randomized controlled study. 'Personal Information Form', 'Respiratory Functions Monitoring Form', 'COPD and Asthma Fatigue Scale (CAFS), ""Asthma and COPD Sleep Impact Scale (CASIS)"" and Modified Medical Research Council Dyspnea Scale (mMRC) were used in data collection.
RESULTS


When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05).
CONCLUSION


Yoga has been found to reduce the severity of dyspnea and fatigue and improve sleep quality in chronic respiratory diseases.",2021,"When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05).
",['chronic respiratory diseases'],[],"['severity of dyspnea and fatigue and improve sleep quality', 'dyspnea, sleep and fatigue', 'dyspnea, sleep quality and fatigue', 'CAFS, CASIS and mMRC mean scores', 'Personal Information Form\', \'Respiratory Functions Monitoring Form\', \'COPD and Asthma Fatigue Scale (CAFS), ""Asthma and COPD Sleep Impact Scale (CASIS)"" and Modified Medical Research Council Dyspnea Scale (mMRC']","[{'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0106463,"When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05).
","[{'ForeName': 'Zülfünaz', 'Initials': 'Z', 'LastName': 'Özer', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Istanbul Sabahattin Zaim University, Istanbul, Turkey. Electronic address: zulfinazozer@gmail.com.'}, {'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Bahçecioğlu Turan', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Firat University, Elazıg, Turkey. Electronic address: glcnbah@hotmail.com.'}, {'ForeName': 'Meyreme', 'Initials': 'M', 'LastName': 'Aksoy', 'Affiliation': 'Department of Nursing, Faculty of Health Science Siirt University, Siirt, Turkey. Electronic address: meryeme_072@hotmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101306']
1100,33545574,The effect of compound Da-Cheng-Qi Decoction on the treatment of malignant bowel obstruction with transnasal ileus tube.,"OBJECTIVE


To study the effect of compound Da-Cheng-Qi Decoction (CDCQD) on the treatment of malignant bowel obstruction (MBO) with transnasal ileus tube (TIT).
METHODS


We observed 30 cases of MBO from July 2018 to August 2019. The patients were divided into the control group (n = 15) and the CDCQD group (n = 15) according to a random number table. All patients were inserted the TIT after admission. Twenty-four hours later, the CDCQD group began to take 100 ml CDCQD twice a day for 7 days. The control group took the plain boiled water instead. Other treatment was the same in the two groups. The waistline reduction, the release time of abdominal pain and distention, recovery of exhaust and defecation time, drainage volume of TIT were observed and compared between the two groups.
RESULTS


Three days after insertion of TIT, the abdominal plain film was re-examined in the two groups. Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05). The effective rate of CDCQD group (86.7%) was significantly higher than that of control group (53.3%). The recovery time of exhaust and defecation in the CDCQD group was earlier than that in the control group (P < 0.05). The daily drainage volume of TIT in the CDCQD group was less than that in the control group, especially from the fourth day to the sixth day after insertion of TIT, with a significant difference (P < 0.05).
CONCLUSION


TIT is an effective treatment for patients with MBO. With the basis of TIT treatment, CDCQD therapy can improve the curative effect of MBO. It can promote intestinal exhaust and defecation and improves the curative effect of palliative treatment of MBO. It is an effective method to assist Tit in the treatment for MBO patients.",2021,Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05).,"['30 cases of MBO from July 2018 to August 2019', 'malignant bowel obstruction (MBO) with transnasal ileus tube (TIT', 'patients with MBO', 'malignant bowel obstruction with transnasal ileus tube', 'MBO patients']","['compound Da-Cheng-Qi Decoction', 'plain boiled water instead', 'TIT', 'compound Da-Cheng-Qi Decoction (CDCQD', 'CDCQD']","['curative effect of MBO', 'recovery time of exhaust and defecation', 'effective rate', 'release time of abdominal pain and distention, recovery of exhaust and defecation time, drainage volume of TIT', 'daily drainage volume of TIT', 'gas-liquid level']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C2935869', 'cui_str': 'Da-Cheng-Qi'}, {'cui': 'C0439892', 'cui_str': 'Boiled water'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0162882,Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05).,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Nutrition, Tianjin Nankai Hospital, 300100, Tianjin, China. Electronic address: xiangqixiangqi@163.com.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shimin', 'Affiliation': 'Department of Gastrointestinal Surgery, Tianjin Nankai Hospital, 300100, Tianjin, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, Tianjin Nankai Hospital, 300100, Tianjin, China.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101316']
1101,33547453,Measuring the impact of COVID-19 vaccine misinformation on vaccination intent in the UK and USA.,"Widespread acceptance of a vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will be the next major step in fighting the coronavirus disease 2019 (COVID-19) pandemic, but achieving high uptake will be a challenge and may be impeded by online misinformation. To inform successful vaccination campaigns, we conducted a randomized controlled trial in the UK and the USA to quantify how exposure to online misinformation around COVID-19 vaccines affects intent to vaccinate to protect oneself or others. Here we show that in both countries-as of September 2020-fewer people would 'definitely' take a vaccine than is likely required for herd immunity, and that, relative to factual information, recent misinformation induced a decline in intent of 6.2 percentage points (95th percentile interval 3.9 to 8.5) in the UK and 6.4 percentage points (95th percentile interval 4.0 to 8.8) in the USA among those who stated that they would definitely accept a vaccine. We also find that some sociodemographic groups are differentially impacted by exposure to misinformation. Finally, we show that scientific-sounding misinformation is more strongly associated with declines in vaccination intent.",2021,"Widespread acceptance of a vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will be the next major step in fighting the coronavirus disease 2019 (COVID-19) pandemic, but achieving high uptake will be a challenge and may be impeded by online misinformation.",[],['COVID-19 vaccine misinformation'],[],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0079843', 'cui_str': 'Misinformation'}]",[],,0.153916,"Widespread acceptance of a vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will be the next major step in fighting the coronavirus disease 2019 (COVID-19) pandemic, but achieving high uptake will be a challenge and may be impeded by online misinformation.","[{'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Loomba', 'Affiliation': 'Department of Mathematics, Imperial College London, London, UK.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'de Figueiredo', 'Affiliation': 'The Vaccine Confidence Project, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK. alex.defigueiredo@lshtm.ac.uk.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Piatek', 'Affiliation': 'The Vaccine Confidence Project, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'de Graaf', 'Affiliation': 'The Vaccine Confidence Project, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Larson', 'Affiliation': 'The Vaccine Confidence Project, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK. heidi.larson@lshtm.ac.uk.'}]",Nature human behaviour,['10.1038/s41562-021-01056-1']
1102,33548339,Local Control For High-Grade Nonrhabdomyosarcoma Soft Tissue Sarcoma Assigned to Radiation Therapy on ARST0332: A Report From the Childrens Oncology Group.,"PURPOSE


The ARST0332 trial for pediatric and young adults with nonrhabdomyosarcoma soft tissue sarcoma (NRSTS) used risk-based treatment including primary resection with lower-than-standard radiation doses to optimize local control (LC) while minimizing long-term toxicity in those requiring radiation therapy (RT). RT for high-grade NRSTS was based on extent of resection (R0: negative margins, R1: microscopic margins, R2/U: gross disease/unresectable); those with >5 cm tumors received chemotherapy (CT; ifosfamide/doxorubicin). This analysis evaluates LC for patients assigned to RT and prognostic factors associated with local recurrence (LR).
METHODS AND MATERIALS


Patients aged <30 years with high-grade NRSTS received RT (55.8 Gy) for R1 ≤5 cm tumor (arm B); RT (55.8 Gy)/CT for R0/R1 >5 cm tumor (arm C); or neoadjuvant RT (45 Gy)/CT plus delayed surgery, CT, and postoperative boost to 10.8 Gy R0 <5 mm margins/R1 or 19.8 Gy for R2/unresected tumors (arm D).
RESULTS


One hundred ninety-three eligible patients had 24 LRs (arm B 1/15 [6.7%], arm C 7/65 [10.8%], arm D 16/113 [14.2%]) at median time to LR of 1.1 years (range, 0.11-5.27). Of 95 eligible for delayed surgery after neoadjuvant therapy, 89 (93.7%) achieved R0/R1 margins. Overall LC after RT were as follows: R0, 106 of 109 (97%); R1, 51 of 60 (85%); and R2/unresectable, 2 of 6 (33%). LR predictors include extent of delayed resection (P <.001), imaging response before delayed surgery (P < .001), histologic subtype (P <.001), and no RT (P = .046). The 5-year event-free survival was significantly lower (P = .0003) for patients unable to undergo R0/R1 resection.
CONCLUSIONS


Risk-based treatment for young patients with high-grade NRSTS treated on ARST0332 produced very high LC, particularly after R0 resection (97%), despite lower-than-standard RT doses. Neoadjuvant CT/RT enabled delayed R0/R1 resection in most patients and is preferred over adjuvant therapy due to the lower RT dose delivered.",2021,"The 5-year event-free survival (EFS) was significantly lower (p=0.0003) for patients unable to undergo R0/R1 resection.
","['193 eligible patients had 24 LR', 'pediatric and young adults with NRSTS used risk-based treatment including primary resection with lower-than', 'Patients']","['radiation therapy (RT', 'radiation therapy', 'standard radiation doses to optimize local control (LC', 'chemotherapy (CT; ifosfamide/doxorubicin', 'Neoadjuvant CT/RT']","['R0/R1 margins', 'Overall LC', 'imaging response before delayed surgery (p<0.001), histologic subtype', 'delayed R0/R1 resection', '5-year event-free survival (EFS']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1301142', 'cui_str': 'WHO tumor classification'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",193.0,0.0257095,"The 5-year event-free survival (EFS) was significantly lower (p=0.0003) for patients unable to undergo R0/R1 resection.
","[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Million', 'Affiliation': 'Department of Radiation Oncology (LM, SSD) and Department of Pediatrics (SS), Stanford University, Stanford, California. Electronic address: lmillion@stanford.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hayes-Jordan', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'Department of Biostatistics, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Donaldson', 'Affiliation': 'Department of Radiation Oncology (LM, SSD) and Department of Pediatrics (SS), Stanford University, Stanford, California.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Wolden', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Cancer Center, New York, New York.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Morris', 'Affiliation': 'Department of Orthopedic Surgery, Johns Hopkins University, Baltimore Maryland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Terezakis', 'Affiliation': 'Department of Radiation Oncology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Laurie', 'Affiliation': 'Imaging and Radiation Oncology Core (IROC), Lincoln, Rhode Island.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Morano', 'Affiliation': 'Imaging and Radiation Oncology Core (IROC), Lincoln, Rhode Island.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Radiation Oncology, University of Massachusetts, Worcester, Massachusetts.'}, {'ForeName': 'Torunn I', 'Initials': 'TI', 'LastName': 'Yock', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston Massachusetts.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rodeberg', 'Affiliation': 'Department of Surgery, East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'MERCK Research Laboratories, North Wales, Pennsylvania.'}, {'ForeName': 'Rose Anne', 'Initials': 'RA', 'LastName': 'Speights', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Black', 'Affiliation': ""Department of Pathology, Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Coffin', 'Affiliation': 'Department of Pathology, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'McCarville', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': 'Department of Radiology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Spunt', 'Affiliation': 'Department of Radiation Oncology (LM, SSD) and Department of Pediatrics (SS), Stanford University, Stanford, California.'}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'Department of Orthopedics, University of California Davis, Sacramento, California.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.01.051']
1103,33548329,"Evaluating Combined Effect of Oral Premedication with Ibuprofen and Dexamethasone on Success of Inferior Alveolar Nerve Block in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Prospective, Double-blind, Randomized Clinical Trial.","INTRODUCTION


The success rate of inferior alveolar nerve block decreases exorbitantly in teeth with symptomatic irreversible pulpitis. The purpose of this prospective, double-blind, randomized clinical trial was to evaluate the combined effect of oral premedication with ibuprofen and dexamethasone on the success rate of inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis.
METHODS


Ninety-four adult patients actively experiencing pain and diagnosed with symptomatic irreversible pulpitis willingly participated in this study. Preoperative pain was recorded on the Heft-Parker visual analog scale. Patients were randomly allocated to 4 different groups and received placebo, 0.5 mg dexamethasone, 800 mg ibuprofen, or a combination of 0.5 mg dexamethasone and 800 mg ibuprofen. One hour after oral premedication, all patients received standard inferior alveolar nerve block containing 2% lignocaine with 1:200,000 adrenaline. Access cavity preparation was initiated 15 minutes after the administration of anesthesia. Pain scores were recorded on VAS after anesthesia, at dentin penetration to pulp chamber opening, and on file placement. Success was defined as no or mild pain (0-54 mm) throughout the procedure.
RESULTS


The chi-square test was used for qualitative data comparison. The 1-way analysis of variance test and post hoc Bonferroni test showed a statistically significant difference between the combination of 0.5 mg dexamethasone and 800 mg ibuprofen group and the other 3 groups (P < .001).
CONCLUSIONS


Preoperative administration of a combination of dexamethasone and ibuprofen improved the success rate of inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis.",2021,Preoperative administration of combination of dexamethasone and ibuprofen improved the success rate of inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis.,"['mandibular molars with symptomatic irreversible pulpitis', 'ON SUCCESS OF INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR MOLARS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS ', 'mandibular molars with symptomatic irreversible pulpits METHODS: Ninety-four adult patients actively experiencing pain and diagnosed with symptomatic irreversible pulpitis willingly participated in this study']","['standard inferior alveolar nerve block containing 2% lignocaine with 1:200000 adrenaline', 'EFFECT OF ORAL PREMEDICATION WITH IBUPROFEN AND DEXAMETHASONE', 'dexamethasone and ibuprofen', 'ibuprofen and dexamethasone', 'placebo (PLAg), 0.5 mg dexamethasone (DEXg), 800 mg ibuprofen (IBUg) and combination of 0.5mg dexamethasone and 800 mg ibuprofen (COMg']","['success rate of inferior alveolar nerve block', 'Pain scores', 'Preoperative pain', 'Heft Parker visual analog scale (VAS']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0986668', 'cui_str': 'Ibuprofen 800 MG'}]","[{'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",94.0,0.347831,Preoperative administration of combination of dexamethasone and ibuprofen improved the success rate of inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis.,"[{'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, JCD Dental College, Sirsa, Haryana, India. Electronic address: drmohit2163@gmail.com.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Singla', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, JCD Dental College, Sirsa, Haryana, India.'}, {'ForeName': 'Gurdeep Singh', 'Initials': 'GS', 'LastName': 'Gill', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, JCD Dental College, Sirsa, Haryana, India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Kalra', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, JCD Dental College, Sirsa, Haryana, India.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, JCD Dental College, Sirsa, Haryana, India.'}]",Journal of endodontics,['10.1016/j.joen.2021.01.005']
1104,33550670,Authors' reply re: Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy-a multicentre randomised controlled trial (LAVA trial).,,2021,,['uterine prolapse stage 2 or higher'],['laparoscopic sacrohysteropexy versus sacrospinous hysteropexy'],[],"[{'cui': 'C0042140', 'cui_str': 'Uterine prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C3164185', 'cui_str': 'Sacrohysteropexy'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy'}]",[],,0.389019,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Ijsselmuiden', 'Affiliation': 'Department of Obstetrics & Gynaecology, Isala, Zwolle, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van Oudheusden', 'Affiliation': 'Department of Obstetrics & Gynecology, GROW school for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Veen', 'Affiliation': 'Department of Obstetrics & Gynecology, Máxima Medical Centre, Veldhoven, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'van de Pol', 'Affiliation': 'Department of Obstetrics & Gynecology, Gelre Hospitals, Apeldoorn, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vollebregt', 'Affiliation': 'Department of Obstetrics & Gynecology, Spaarnegasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Radder', 'Affiliation': 'Department of Obstetrics & Gynecology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Housmans', 'Affiliation': 'Department of Obstetrics & Gynecology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Obstetrics & Gynecology, GROW school for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Deprest', 'Affiliation': 'Department of Obstetrics & Gynecology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics & Gynecology, GROW school for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Eijndhoven', 'Affiliation': 'Department of Obstetrics & Gynaecology, Isala, Zwolle, The Netherlands.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16640']
1105,33556391,Out of the lab and into the wild: The influence of portion size on food intake in laboratory vs. real-world settings.,"External influences on eating behaviour, such as portion size, have been reliably shown to influence food intake in the laboratory. However, little research has examined whether laboratory settings under or overestimate the effect that external influences have on food intake compared to when studied in the real-world. In Study 1, 60 participants (mean age = 32 years) were randomized to consume a large (200 g) or small (100 g) portion of popcorn under controlled laboratory conditions and during a separate session in their home. Results showed that the effect of portion size on food intake was larger at home (d = 0.97) than in the laboratory (d = 0.56). Furthermore, participants reported feeling more relaxed eating at home compared to the laboratory. In Study 2, we examined whether comparable results were observed in a semi-naturalistic laboratory designed to resemble a home setting. 59 participants (mean age = 28 years) completed the same procedure as Study 1 in a standard and a semi-naturalistic laboratory setting. Although participants reported having higher levels of private self-awareness in the standard laboratory, the effect that portion size had on food intake did not differ between the standard laboratory (d = 0.50) and the semi-naturalistic laboratory (d = 0.49). The impact that external influences on eating, such as portion size, have on food intake in the real-world may be underestimated when studied under laboratory conditions.",2021,Results showed that the effect of portion size on food intake was larger at home (d = 0.97) than in the laboratory (d = 0.56).,"['59 participants (mean age = 28 years) completed the same procedure as Study 1 in a standard and a semi-naturalistic laboratory setting', '60 participants (mean age = 32 years']",[],"['private self-awareness', 'portion size on food intake']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",[],"[{'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C3658326', 'cui_str': 'Portion Size'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",,0.0597397,Results showed that the effect of portion size on food intake was larger at home (d = 0.97) than in the laboratory (d = 0.56).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gough', 'Affiliation': 'Department of Psychology, University of Liverpool, L69 7ZA, UK. Electronic address: tomgough@liverpool.ac.uk.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'Department of Psychology, University of Liverpool, L69 7ZA, UK; Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Clarke', 'Affiliation': 'Department of Psychology, University of Liverpool, L69 7ZA, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hansell', 'Affiliation': 'Department of Psychology, University of Liverpool, L69 7ZA, UK.'}, {'ForeName': 'Mahrukh', 'Initials': 'M', 'LastName': 'Kaimkhani', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Price', 'Affiliation': 'Department of Psychology, University of Liverpool, L69 7ZA, UK.'}, {'ForeName': 'Araby', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Hardman', 'Affiliation': 'Department of Psychology, University of Liverpool, L69 7ZA, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychology, University of Liverpool, L69 7ZA, UK. Electronic address: eric.robinson@liverpool.ac.uk.'}]",Appetite,['10.1016/j.appet.2021.105160']
1106,33563495,Reply letter to the editor-post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial.,,2021,,['patients at nutritional risk after surgery for gastric cancer'],['editor-post-discharge oral nutritional supplements with dietary advice'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]",[],,0.0546417,,"[{'ForeName': 'Shanjun', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guohao', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: prowugh@163.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.01.032']
1107,33563494,"Comment on ""post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial"".",,2021,,['patients at nutritional risk after surgery for gastric cancer'],['dietary advice'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}]",[],,0.0535175,,"[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Tongde Hospital of Zhejiang Province, 234 Gucui RD, Hangzhou, 310012, China.'}, {'ForeName': 'Yuanshui', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of General Surgery, Tongde Hospital of Zhejiang Province, 234 Gucui RD, Hangzhou, 310012, China. Electronic address: 15658827827@163.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.01.034']
1108,33561085,Methodological Approach of the Iron and Muscular Damage: Female Metabolism and Menstrual Cycle during Exercise Project (IronFEMME Study).,"Background : The increase in exercise levels in the last few years among professional and recreational female athletes has led to an increased scientific interest about sports health and performance in the female athlete population. The purpose of the IronFEMME Study described in this protocol article is to determine the influence of different hormonal profiles on iron metabolism in response to endurance exercise, and the main markers of muscle damage in response to resistance exercise; both in eumenorrheic, oral contraceptive (OC) users and postmenopausal well-trained women.  Methods : This project is an observational controlled randomized counterbalanced study. One hundered and four (104) active and healthy women were selected to participate in the IronFEMME Study, 57 of which were eumenorrheic, 31 OC users and 16 postmenopausal. The project consisted of two sections carried out at the same time: iron metabolism (study I) and muscle damage (study II). For the study I, the exercise protocol consisted of an interval running test (eight bouts of 3 min at 85% of the maximal aerobic speed), whereas the study II protocol was an eccentric-based resistance exercise protocol (10 sets of 10 repetitions of plate-loaded barbell parallel back squats at 60% of their one repetition maximum (1RM) with 2 min of recovery between sets). In both studies, eumenorrheic participants were evaluated at three specific moments of the menstrual cycle: early-follicular phase, late-follicular phase and mid-luteal phase; OC users performed the trial at two moments: withdrawal phase and active pill phase. Lastly, postmenopausal women were only tested once, since their hormonal status does not fluctuate. The three-step method was used to verify the menstrual cycle phase: calendar counting, blood test confirmation, and urine-based ovulation kits. Blood samples were obtained to measure sex hormones, iron metabolism parameters, and muscle damage related markers.  Discussion : IronFEMME Study has been designed to increase the knowledge regarding the influence of sex hormones on some aspects of the exercise-related female physiology. Iron metabolism and exercise-induced muscle damage will be studied considering the different reproductive status present throughout well-trained females' lifespan.",2021,The increase in exercise levels in the last few years among professional and recreational female athletes has led to an increased scientific interest about sports health and performance in the female athlete population.,"['users and postmenopausal well-trained women', 'One hundered and four (104) active and healthy women were selected to participate in the IronFEMME Study, 57 of which were eumenorrheic, 31 OC users and 16 postmenopausal', 'Discussion ']","['eumenorrheic, oral contraceptive (OC', 'eccentric-based resistance exercise protocol', ' ']","['sex hormones, iron metabolism parameters, and muscle damage related markers', 'exercise levels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1.0,0.0334022,The increase in exercise levels in the last few years among professional and recreational female athletes has led to an increased scientific interest about sports health and performance in the female athlete population.,"[{'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Peinado', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Alfaro-Magallanes', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Romero-Parra', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Barba-Moreno', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Rael', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Maestre-Cascales', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rojo-Tirado', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Eliane A', 'Initials': 'EA', 'LastName': 'Castro', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Benito', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'Ortega-Santos', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santiago', 'Affiliation': 'Clínica Tambre, 28002 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Butragueño', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-de-Alcaraz', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Jesús J', 'Initials': 'JJ', 'LastName': 'Rojo', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Calderón', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'García-Bataller', 'Affiliation': 'Department of Sports, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Cupeiro', 'Affiliation': 'LFE Research Group, Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18020735']
1109,33570787,"Clinical, radiographic and economic evaluation of short-6-mm implants and longer implants combined with osteotome sinus floor elevation in moderately atrophic maxillae: A 3-year randomized clinical trial.","AIM


To compare the 3-year clinical, radiographic and economic outcomes of short-6-mm implants and longer implants combined with osteotome sinus floor elevation (OSFE) in the posterior maxilla.
MATERIAL AND METHODS


This study enrolled 225 patients (225 implants with diameter of 4.1 mm and 4.8 mm) with a posterior maxillary residual bone height (RBH) of 6-8 mm. Patients were randomly divided into three groups: Group 1 (6 mm implants alone), Group 2 (8 mm implants + OSFE) and Group 3 (10 mm implants + OSFE). The following outcomes were recorded at 1 and 3-year examinations: implant survival, probing pocket depth (PPD), bleeding on probing (BOP), modified plaque index (mPI), marginal bone loss (MBL), biological and technical complications, complication-free survival and treatment costs.
RESULTS


At the 3-year follow-up, 199 patients (Group 1: 67; Group 2: 62; Group 3: 70) were re-examined. Implant survival rates were 91.80%, 97.08% and 100.00% in groups 1, 2 and 3. Implant survival rate in Group 1 was significantly lower than that in Group 3 (p = 0.029). A multivariate Cox model showed that the short-6-mm implants with wide diameter had a protective effect on implant survival (hazard ratio: 0.59, p = 0.001). No significant differences in BOP%, PPD, mPI, MBL and complication-free survival rate were found among the three groups. The average costs of retreatment were 8.31%, 1.96% and 0.56% of the total costs in groups 1, 2 and 3. The cost to avoid a 1% increase in implant loss associated with 6-mm implants over a 3-year period was 369 CNY (56 USD) using a 10-mm implant with OSFE and 484 CNY (74 USD) using an 8-mm implant with OSFE.
CONCLUSION


In the moderately atrophic posterior maxillae, the three treatments showed acceptable clinical, radiographic and economic outcomes with up to 3-year follow-up. 10-mm implants combined with OSFE showed more favourable implant survival and fewer maintenance costs in comparison with short-6-mm implants, which were less expensive.",2021,"No significant differences in BOP%, PPD, mPI, MBL and complication-free survival rate were found among the three groups.","['225 patients (225 implants with diameter of 4.1mm and 4.8mm) with a posterior maxillary residual bone height （RBH） of 6-8 mm', 'moderately atrophic maxillae']","['short-6-mm implants and longer implants combined with osteotome sinus floor elevation', 'short-6-mm implants and longer implants combined with osteotome sinus floor elevation (OSFE', 'OSFE']","['favorable implant survival', 'Implant survival rate', 'implant survival', 'implant loss', 'BOP%, PPD, mPI, MBL and complication-free survival rate', '3-year examinations: implant survival, probing pocket depth (PPD), bleeding on probing (BoP), modified plaque index (mPI), marginal bone loss (MBL), biological and technical complications, complication-free survival and treatment costs', 'Implant survival rates', 'average costs of re-treatment']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0182092', 'cui_str': 'Osteotome'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",225.0,0.123459,"No significant differences in BOP%, PPD, mPI, MBL and complication-free survival rate were found among the three groups.","[{'ForeName': 'Jun-Yu', 'Initials': 'JY', 'LastName': 'Shi', 'Affiliation': ""Department of Oral and Maxillo-facial Implantology, National Clinical Research Center for Oral Diseases, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.""}, {'ForeName': 'Yi-Rao', 'Initials': 'YR', 'LastName': 'Lai', 'Affiliation': ""Department of Oral and Maxillo-facial Implantology, National Clinical Research Center for Oral Diseases, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.""}, {'ForeName': 'Shu-Jiao', 'Initials': 'SJ', 'LastName': 'Qian', 'Affiliation': ""Department of Oral and Maxillo-facial Implantology, National Clinical Research Center for Oral Diseases, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.""}, {'ForeName': 'Shi-Chong', 'Initials': 'SC', 'LastName': 'Qiao', 'Affiliation': ""Department of Oral and Maxillo-facial Implantology, National Clinical Research Center for Oral Diseases, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.""}, {'ForeName': 'Maurizio S', 'Initials': 'MS', 'LastName': 'Tonetti', 'Affiliation': ""Department of Oral and Maxillo-facial Implantology, National Clinical Research Center for Oral Diseases, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.""}, {'ForeName': 'Hong-Chang', 'Initials': 'HC', 'LastName': 'Lai', 'Affiliation': ""Department of Oral and Maxillo-facial Implantology, National Clinical Research Center for Oral Diseases, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.""}]",Journal of clinical periodontology,['10.1111/jcpe.13444']
1110,33516795,Surgical wound infection prevention using topical negative pressure therapy on closed abdominal incisions - the 'SWIPE IT' randomized clinical trial.,"BACKGROUND


Surgical site infections (SSIs) are the most common cause of healthcare-associated infections in surgical patients. It is unclear whether incisional negative pressure wound therapy (NPWT) can reduce the risk of SSIs in patients after open abdominal surgery.
METHODS


A prospective, non-blinded multi-centre randomized controlled trial (RCT) was performed to evaluate the incidence of SSI post-laparotomy using incisional NPWT compared with a standard dressing. The primary outcome was the rate of superficial SSI.
RESULTS


A total of 124 patients (61 patients in the NPWT arm and 63 patients in the control arm) were included. One hundred and nine (87.9%) patients underwent colorectal surgery; 61 patients (49.2%) had emergency surgery. There were more superficial SSIs in the control group than in the NPWT group, although not statistically significant (20.6% vs 9.8%, P=0.1). Upon multiple logistic regression analysis, control dressings were associated with increased risk of superficial SSI although again, not statistically significant (odds ratio (OR) 2.41, 95% confidence interval (CI) 0.81-7.17, P=0.11). There was no superficial non-SSI related wound dehiscence in the NPWT group compared with 9.5% in the control group (P=0.03). There was no difference in postoperative complications (P=0.15), nor in other wound complications (P=0.79).
CONCLUSION


NPWT was not associated with decreased superficial SSI in this RCT. However, there was a statistically significant reduction in superficial wound dehiscence with NWPT dressings. The results of this study should be included in meta-analyses for better evaluation of NPWT on closed abdominal incisions.",2021,"There was no difference in post-operative complications (p=0.15), nor other wound complications (p=0.79).
","['124 patients (61 patients in the NPWT arm and 63 patients in the control arm) included', 'patients underwent colorectal surgery; 61 patients (49.2%) had emergency surgery', 'patients after open abdominal surgery', 'One hundred and nine (87.9', 'surgical patients']","['Topical Negative Pressure Therapy', 'NPWT', 'incisional negative pressure wound therapy (NPWT']","['superficial SSIs', 'superficial wound dehiscence', 'superficial SSI', 'rate of superficial SSI', 'superficial non-SSI related wound dehiscence', 'risk of superficial SSI', 'wound complications', 'post-operative complications']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",124.0,0.120088,"There was no difference in post-operative complications (p=0.15), nor other wound complications (p=0.79).
","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Di Re', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia; School of Physics, University of Sydney, Sydney, NSW, Australia. Electronic address: Angelina.dire@gmail.com.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia; Department of Surgery, Blacktown-Mount Druitt Hospital, Mount Druitt, NSW, Australia.'}, {'ForeName': 'J W T', 'Initials': 'JWT', 'LastName': 'Toh', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia; School of Medicine, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'El-Khoury', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia; School of Medicine, Notre Dame University, Sydney, NSW, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pathma-Nathan', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Gosselink', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia; Dr. Horacio E. Oduber Hospital, Aruba.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Khanijaun', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Raman', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia; Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ctercteko', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia; Department of Surgery, Blacktown-Mount Druitt Hospital, Mount Druitt, NSW, Australia; School of Medicine, University of Sydney, Sydney, NSW, Australia.'}]",The Journal of hospital infection,['10.1016/j.jhin.2021.01.013']
1111,33516752,Rationale and design of the pragmatic randomized trial of icosapent ethyl for high cardiovascular risk adults (MITIGATE).,"OBJECTIVE


The MITIGATE study aims to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), compared with usual care, on laboratory-confirmed viral upper respiratory infection (URI)-related morbidity and mortality in adults with established atherosclerotic cardiovascular disease (ASCVD).
BACKGROUND


IPE is a highly purified and stable omega-3 fatty acid prescription medication that is approved for cardiovascular risk reduction in high-risk adults on statin therapy with elevated triglycerides. Preclinical data and clinical observations suggest that IPE may have pleiotropic effects including antiviral and anti-inflammatory properties that may prevent or reduce the downstream sequelae and cardiopulmonary consequences of viral URIs.
METHODS


MITIGATE is a virtual, electronic health record-based, open-label, randomized, pragmatic clinical trial enrolling ∼16,500 participants within Kaiser Permanente Northern California - a fully integrated and learning health care delivery system with 21 hospitals and >255 ambulatory clinics serving ∼4.5 million members. Adults ≥50 years with established ASCVD and no prior history of coronavirus disease 2019 (COVID-19) will be prospectively identified and pre-randomized in a 1:10 allocation ratio (∼ 1,500 IPE: ∼15,000 usual care) stratified by age and previous respiratory health status to the intervention (IPE 2 grams by mouth twice daily with meals) vs the control group (usual care) for a minimum follow-up duration of 6 months. The co-primary endpoints are moderate-to-severe laboratory-confirmed viral URI and worst clinical status due to a viral URI at any point in time.
CONCLUSION


The MITIGATE study will inform clinical practice by providing evidence on the real-world clinical effectiveness of pretreatment with IPE to prevent and/or reduce the sequelae of laboratory-confirmed viral URIs in a high-risk cohort of patients with established ASCVD.",2021,The MITIGATE study will inform clinical practice by providing evidence on the real-world clinical effectiveness of pre-treatment with IPE to prevent and/or reduce the sequelae of laboratory-confirmed viral URIs in a high-risk cohort of patients with established ASCVD.,"['High Cardiovascular Risk Adults (MITIGATE', 'Adults ≥50 years with established ASCVD and no prior history of coronavirus disease 2019 (COVID-19) will be prospectively identified and pre-randomized in a 1:10 allocation ratio (∼1,500 IPE: ∼15,000 usual care) stratified by age and previous respiratory health status to the', 'adults with established atherosclerotic cardiovascular disease (ASCVD', 'high-risk adults on statin therapy with elevated triglycerides', '∼16,500 participants within Kaiser Permanente Northern California (KPNC) - a fully integrated and learning health care delivery system with 21 hospitals and >255 ambulatory clinics serving ∼4.5 million members']","['Icosapent Ethyl', 'intervention (IPE two grams by mouth twice daily with meals) vs. the control group (usual care', 'IPE', 'pre-treatment with icosapent ethyl (IPE']",['moderate-to-severe laboratory-confirmed viral URI and worst clinical status due to a viral URI'],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0011211', 'cui_str': 'Health Care Delivery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4553624', 'cui_str': 'With meals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.137137,The MITIGATE study will inform clinical practice by providing evidence on the real-world clinical effectiveness of pre-treatment with IPE to prevent and/or reduce the sequelae of laboratory-confirmed viral URIs in a high-risk cohort of patients with established ASCVD.,"[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA; Division of Research, Kaiser Permanente Northern California, Oakland, CA. Electronic address: andrew.p.ambrosy@kp.org.'}, {'ForeName': 'Umar I', 'Initials': 'UI', 'LastName': 'Malik', 'Affiliation': 'Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Thomas', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA.'}, {'ForeName': 'Rishi V', 'Initials': 'RV', 'LastName': 'Parikh', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA.'}, {'ForeName': 'Thida C', 'Initials': 'TC', 'LastName': 'Tan', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA.'}, {'ForeName': 'Choon H', 'Initials': 'CH', 'LastName': 'Goh', 'Affiliation': 'Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.'}, {'ForeName': 'Van N', 'Initials': 'VN', 'LastName': 'Selby', 'Affiliation': 'Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Solomon', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Cardiology, Kaiser Permanente Oakland Medical Center, Oakland, CA.'}, {'ForeName': 'Harshith R', 'Initials': 'HR', 'LastName': 'Avula', 'Affiliation': 'Department of Cardiology, Kaiser Permanente Walnut Creek Medical Center, Walnut Creek, CA.'}, {'ForeName': 'Jesse K', 'Initials': 'JK', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Skarbinski', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Infectious Disease, Kaiser Permanente Oakland Medical Center, Oakland, CA.'}, {'ForeName': 'Sephy', 'Initials': 'S', 'LastName': 'Philip', 'Affiliation': 'Amarin Pharma, Inc., Bridgewater, NJ.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Granowitz', 'Affiliation': 'Amarin Pharma, Inc., Bridgewater, NJ.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Go', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA; Departments of Medicine (Nephrology), Epidemiology, and Biostatistics, University of California, San Francisco, San Francisco, CA; Department of Medicine (Nephrology), Stanford University, Palo Alto, CA.'}]",American heart journal,['10.1016/j.ahj.2021.01.018']
1112,33528904,"Reducing the need for carbohydrate counting in type 1 diabetes using closed-loop automated insulin delivery (artificial pancreas) and empagliflozin: A randomized, controlled, non-inferiority, crossover pilot trial.","AIM


To assess whether adding empagliflozin to closed-loop automated insulin delivery could reduce the need for carbohydrate counting in type 1 diabetes (T1D) without worsening glucose control.
MATERIALS AND METHODS


In an open-label, crossover, non-inferiority trial, 30 adult participants with T1D underwent outpatient automated insulin delivery interventions with three random sequences of prandial insulin strategy days: carbohydrate counting, simple meal announcement (no carbohydrate counting) and no meal announcement. During each sequence of prandial insulin strategies, participants were randomly assigned empagliflozin (25 mg/day) or not, and crossed over to the comparator. Mean glucose for carbohydrate counting without empagliflozin (control) was compared with no meal announcement with empagliflozin (in the primary non-inferiority comparison) and simple meal announcement with empagliflozin (in the conditional primary non-inferiority comparison).
RESULTS


Participants were aged 40 ± 15 years, had 27 ± 15 years diabetes duration and HbA1c of 7.6% ± 0.7% (59 ± 8 mmol/mol). The system with no meal announcement and empagliflozin was not non-inferior (and thus reasonably considered inferior) to the control arm (mean glucose 10.0 ± 1.6 vs. 8.5 ± 1.5 mmol/L; non-inferiority p = .94), while simple meal announcement and empagliflozin was non-inferior (8.5 ± 1.4 mmol/L; non-inferiority p = .003). Use of empagliflozin on the background of automated insulin delivery with carbohydrate counting was associated with lower mean glucose, corresponding to a 14% greater time in the target range. While no ketoacidosis was observed, mean fasting ketones levels were higher on empagliflozin (0.22 ± 0.18 vs. 0.13 ± 0.11 mmol/L; p < .001).
CONCLUSIONS


Empagliflozin added to automated insulin delivery has the potential to eliminate the need for carbohydrate counting and improves glycaemic control in conjunction with carbohydrate counting, but does not allow for the elimination of meal announcement.",2021,"Use of empagliflozin on the background of automated insulin delivery with carbohydrate counting was associated with lower mean glucose, corresponding to a 14% greater time in target range.","['type 1 diabetes (T1D) without worsening glucose control', 'Participants were aged 40±15\u2009years, had 27±15\u2009years diabetes duration, and HbA1c 7.6±0.7% (59±8\u2009mmol/mol', '30 adult participants with T1D underwent outpatient automated insulin delivery interventions with three random sequences of']","['empagliflozin', 'Empagliflozin', 'empagliflozin (control', 'prandial insulin strategy days: carbohydrate counting, simple meal announcement (no carbohydrate counting), and no meal announcement']","['Mean glucose', 'mean fasting ketones levels', 'ketoacidosis']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]",30.0,0.0649338,"Use of empagliflozin on the background of automated insulin delivery with carbohydrate counting was associated with lower mean glucose, corresponding to a 14% greater time in target range.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Department of Biomedical Engineering, McGill Universit, Montréal, Québec, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Yale', 'Affiliation': 'The Research Institute of McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Leif Erik', 'Initials': 'LE', 'LastName': 'Lovblom', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cardinez', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Orszag', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'C Marcelo', 'Initials': 'CM', 'LastName': 'Falappa', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Gouchie-Provencher', 'Affiliation': 'The Research Institute of McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Tsoukas', 'Affiliation': 'The Research Institute of McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'El Fathi', 'Affiliation': 'Department of Biomedical Engineering, McGill Universit, Montréal, Québec, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rene', 'Affiliation': 'Department of Biomedical Engineering, McGill Universit, Montréal, Québec, Canada.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Eldelekli', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Sebastien O', 'Initials': 'SO', 'LastName': 'Lanctôt', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Scarr', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14335']
1113,33540298,"The effect on gastrointestinal system functions, pain and anxiety of acupressure applied following laparoscopic cholecystectomy operation: A randomised, placebo-controlled study.","The aim of this randomised, placebo-controlled, 3-way blinded study was to determine the effect on GIS symptoms, pain and anxiety of acupressure applied for a total of 12 min, as 3 min at each of the ST25, CV12, TH6, and HT7 acupuncture points, at 0, 4 and 8 h after laparoscopic cholecystectomy operation. The research data were collected using a patient data collection form, the Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory. The patients were evaluated in respect of the time to first flatus and defecation, pain and the State-Trait Anxiety points at 0, 4, and 8 h postoperatively. The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05). The application of acupressure can be recommended in the nursing interventions following laparoscopic cholecystectomy to reduce acute pain and shorten the time to defecation.",2021,The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05).,[],"['laparoscopic cholecystectomy operation', 'placebo', 'acupressure']","['acute postoperative pain', 'gastrointestinal system functions, pain and anxiety of acupressure', 'Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory', 'GIS symptoms, pain and anxiety of acupressure', 'time to first flatus and defecation, pain and the State-Trait Anxiety points']",[],"[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0012240', 'cui_str': 'Structure of digestive system'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.05456,The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05).,"[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Soylu', 'Affiliation': 'Erciyes University, Institute of Health Sciences, Surgical Nursing, Kayseri, Turkey. Electronic address: dsoylu@ksu.edu.tr.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Tekinsoy Kartın', 'Affiliation': 'Erciyes University, Faculty of Health Sciences, Nursing Department, Kayseri, Turkey. Electronic address: ptekinsoy@erciyes.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101304']
1114,33544337,"Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study.","BACKGROUND


In the global FLAURA study, first-line osimertinib, a third-generation irreversible tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR), significantly improved progression-free survival (PFS) and overall survival (OS) versus comparator EGFR TKIs in patients with EGFR mutation-positive (EGFRm) advanced non-small-cell lung cancer (NSCLC).
OBJECTIVE


The FLAURA China study assessed first-line osimertinib in Chinese patients with EGFRm advanced NSCLC (NCT02296125).
METHODS


FLAURA China was a double-blind, randomized, phase III study. Adults from mainland China with previously untreated EGFRm (Exon 19 deletion or L858R) advanced NSCLC were enrolled in the global study or a China-only study under the same protocol; 136 patients were randomized to osimertinib (80 mg once daily [od]; n = 71) or comparator EGFR TKI (gefitinib or erlotinib; all sites selected gefitinib 250 mg od; n = 65). Patients were randomized and allocated to treatment groups by a central computer system. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was investigator-assessed PFS; OS was a secondary endpoint.
RESULTS


All 136 randomized patients were analyzed. Osimertinib extended median PFS by 8.0 months versus comparator EGFR TKI (17.8 vs. 9.8 months; hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.37-0.85). Median OS was 33.1 months in the osimertinib group versus 25.7 months in the comparator group (HR 0.85; 95% CI 0.56-1.29). At 3 years, 20% of patients on osimertinib and 8% on the comparator remained on randomized treatment. Grade 3 or higher adverse events (AEs) were reported in 54 and 28% of patients in the osimertinib and comparator groups, respectively, driven by increased local reporting of laboratory- and disease-related AEs. No new safety signals were identified.
CONCLUSIONS


First-line osimertinib treatment resulted in a clinically meaningful PFS and OS benefit versus comparator EGFR TKI in Chinese patients with EGFRm advanced NSCLC. Safety data were consistent with the known safety profile of osimertinib.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT02296125, registered 20 November 2014.",2021,Median OS was 33.1 months in the osimertinib group versus 25.7 months in the comparator group (HR 0.85; 95% CI 0.56-1.29).,"['patients with EGFR mutation-positive (EGFRm) advanced non-small-cell lung cancer (NSCLC', 'Chinese patients with EGFRm advanced NSCLC', 'advanced NSCLC were enrolled in the global study or a China-only study under the same protocol; 136 patients', 'EGFR-Mutated Advanced NSCLC', 'Chinese patients with EGFRm advanced NSCLC (NCT02296125', 'Adults from mainland China with previously untreated EGFRm (Exon 19 deletion or L858R']","['comparator EGFR TKI (gefitinib or erlotinib', 'Osimertinib Versus Comparator EGFR TKI', 'osimertinib']","['investigator-assessed PFS; OS', 'Grade 3 or higher adverse events (AEs', 'unacceptable toxicity, or withdrawal of consent', 'local reporting of laboratory- and disease-related AEs', 'Median OS', 'median PFS', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}]","[{'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",136.0,0.387661,Median OS was 33.1 months in the osimertinib group versus 25.7 months in the comparator group (HR 0.85; 95% CI 0.56-1.29).,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Jilin Provincial Cancer Hospital, Changchun, 130000, China. jl.cheng@163.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Respiratory Disease, Daping Hospital, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'He-Long', 'Initials': 'HL', 'LastName': 'Zhang', 'Affiliation': ""Tangdu Hospital of Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Buhai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology of Subei People's Hospital, Yangzhou University, Yangzhou, Jiangsu, China.""}, {'ForeName': 'Chunling', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Tumor Hospital, Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walding', 'Affiliation': 'Global Medicines Development, GMED Oncology, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Saggese', 'Affiliation': 'Global Medicines Development, GMED Oncology, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Xiangning', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Global Medicines Development, GMED Oncology, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Minhao', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'Global Medicines Development, AstraZeneca, Shanghai, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Global Medicines Development, AstraZeneca, Shanghai, China.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.'}]",Targeted oncology,['10.1007/s11523-021-00794-6']
1115,33530205,"Effect of education and muscle relaxation program on anxiety, depression and care burden in caregivers of acute stroke survivors: A randomized, controlled study.","ABSTRACT


This study intended to discover the effect of education and muscle relaxation (EMR) program on anxiety, depression and care burden among caregivers of acute stroke survivors.This randomized, controlled study enrolled a total of 110 caregivers of first-ever acute stroke patients, and randomly assigned to EMR (N = 55) and control (N = 55) groups. The caregivers in the EMR group received 12-month health education and progressive muscle relaxation, and those in control group were provided common rehabilitation advices. Hospital Anxiety and Depression Scale (HADS) and Zarit Caregiver Burden Scale in caregivers were evaluated at the time of patients' discharge from hospital (M0), then at month(M) 3, M6 and M12 after the discharge.HADS-anxiety score, anxiety rate and severity were similar at M0, M3, while were reduced at M6 and M12 in EMR group compared to control group. Furthermore, HADS-depression score was similar at M0 and M3 but was decreased at M6 and M12 in EMR group compared with control group, however, there was no difference of depression rate and severity between the 2 groups at each time point. Moreover, Zarit Caregiver Burden Scale score was similar at M0 and M3, but was decreased at M6 and M12; meanwhile, degree of care burden was similar at M0, M3 and M6, but was reduced at M12 in EMR group compared to control group.EMR program decreases anxiety, depression and care burden in caregivers of acute stroke survivors, suggesting its potential in improving mental health and further promoting quality of lives in these caregivers.",2021,"EMR program decreases anxiety, depression and care burden in caregivers of acute","['caregivers of acute stroke survivors', '110 caregivers of first-ever acute stroke patients', 'caregivers of acute', 'stroke survivors']","['education and muscle relaxation program', 'education and muscle relaxation (EMR) program', 'EMR', 'health education and progressive muscle relaxation, and those in control group were provided common rehabilitation advices', 'EMR program']","['Hospital Anxiety and Depression Scale (HADS) and Zarit Caregiver Burden Scale', 'anxiety, depression and care burden', 'Furthermore, HADS-depression score', 'depression rate and severity', 'degree of care burden', 'Zarit Caregiver Burden Scale score', 'HADS-anxiety score, anxiety rate and severity']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026836', 'cui_str': 'Muscle relaxation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",110.0,0.0614626,"EMR program decreases anxiety, depression and care burden in caregivers of acute","[{'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of CT.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular, The 2nd Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Man', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Zhaojun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology.'}]",Medicine,['10.1097/MD.0000000000024154']
1116,33548422,"A multicenter, prospective randomized trial of negative pressure wound therapy for infrainguinal revascularization with a groin incision.","BACKGROUND


Wound complications after open infrainguinal revascularization are a frequent cause of patient morbidity, resulting in increased healthcare costs. The purpose of the present study was to assess the effects of closed incision negative pressure therapy (ciNPT) on groin wound complications after infrainguinal bypass and femoral endarterectomy.
METHODS


A total of 242 patients who had undergone infrainguinal bypass (n = 124) or femoral endarterectomy (n = 118) at five academic medical centers in New England from April 2015 to August 2019 were randomized to ciNPT (PREVENA; 3M KCI, St Paul, Minn; n = 118) or standard gauze (n = 124). The primary outcome measure was a composite endpoint of groin wound complications, including surgical site infections (SSIs), major noninfectious wound complications, or graft infections within 30 days after surgery. The secondary outcome measures included 30-day SSIs, 30-day noninfectious wound complications, readmission for wound complications, significant adverse events, and health-related quality of life using the EuroQoL 5D-3L survey.
RESULTS


The ciNPT and control groups had similar demographics (age, 67 vs 67 years, P = .98; male gender, 71% vs 70%, P = .86; white race, 93% vs 93%, P = .97), comorbidities (previous or current smoking, 93% vs 94%, P = .46; diabetes, 41% vs 48%, P = .20; renal insufficiency, 4% vs 7%, P = .31), and operative characteristics, including procedure type, autogenous conduit, and operative time. No differences were found in the primary composite outcome at 30 days between the two groups (ciNPT vs control: 31% vs 28%; P = .55). The incidence of SSI at 30 days was similar between the two groups (ciNPT vs control: 11% vs 12%; P = .58). Infectious (13.9% vs 12.6%; P = .77) and noninfectious (20.9% vs 17.6%; P = .53) wound complications at 30 days were also similar for the ciNPT and control groups. Wound complications requiring readmission also similar between the two groups (ciNPT vs control: 9% vs 7%; P = .54). The significant adverse event rates were not different between the two groups (ciNPT vs control: 13% vs 16%; P = .53). The mean length of the initial hospitalization was the same for the ciNPT and control groups (5.2 vs 5.7 days; P = .63). The overall health-related quality of life was similar at baseline and at 14 and 30 days postoperatively for the two groups. Although not powered for stratification, we found no differences among the subgroups in gender, obesity, diabetes, smoking, claudication, chronic limb threatening ischemia, bypass, or endarterectomy. On multivariable analysis, no differences were found in wound complications at 30 days for the ciNPT vs gauze groups (odds ratio, 1.4; 95% confidence interval, 0.8-2.6; P = .234).
CONCLUSIONS


In contrast to other randomized studies, our multicenter trial of infrainguinal revascularization found no differences in the 30-day groin wound complications for patients treated with ciNPT vs standard gauze dressings. However, the SSI rate was lower in the control group than reported in other studies, suggesting other practice patterns and processes of care might have reduced the rate of groin infections. Further study might identify the subsets of high-risk patients that could benefit from ciNPT.",2021,"On multivariable analysis there was no difference in wound complications at 30 days for ciNPT vs gauze (Odds ratio 1.4, 95% CI 0.8-2.6, P= 0.234).
","['patients treated with', 'n=118) at five academic medical centers in New England from April 2015 to August 2019 were randomized to', 'Infrainguinal Revascularization with a Groin Incision', 'Patients (n=242) undergoing infrainguinal bypass (n=124) or']","['ciNPT (PREVENA™, KCI) ', 'ciNPT and standard gauze dressings', 'Negative Pressure Wound Therapy', 'femoral endarterectomy', 'closed incision negative pressure therapy (ciNPT', 'standard gauze']","['non-infectious wound complications', '30-day groin wound complications', 'rate of groin infections', 'Overall HR QoL', 'Significant adverse event rates', 'groin wound complications', 'composite endpoint of groin wound complications including surgical site infection (SSI), major non-infectious wound complications, or graft infection within 30 days of surgery', 'SSI rate', 'operative characteristics including procedure type, autogenous conduit and operative time', 'mean length of initial hospitalization', 'Infectious', '1) 30-day SSI (2) 30-day non-infectious wound complications, (3) readmission for wound complications, (4) significant adverse events, and (5) health related (HR) quality of life (QoL) by Euro QoL 5D-3L survey', 'wound complications', 'Wound complications requiring readmission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027965', 'cui_str': 'Northeastern United States'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1319109', 'cui_str': 'Arterial bypass of lower limb artery'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1998495', 'cui_str': 'Gauze dressing'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0398048', 'cui_str': 'Femoral endarterectomy'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0919796', 'cui_str': 'Groin infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0349725', 'cui_str': 'Graft infection'}, {'cui': 'C3887296', 'cui_str': 'Within thirty days of surgery'}, {'cui': 'C0455713', 'cui_str': 'Procedure type'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",242.0,0.116879,"On multivariable analysis there was no difference in wound complications at 30 days for ciNPT vs gauze (Odds ratio 1.4, 95% CI 0.8-2.6, P= 0.234).
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bertges', 'Affiliation': 'Division of Vascular Surgery, University of Vermont Medical Center, Burlington, Vt. Electronic address: daniel.bertges@uvmhealth.org.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Office of Clinical Trials Research, University of Vermont College of Medicine, Burlington, Vt.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Scully', 'Affiliation': ""Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wyers', 'Affiliation': 'Division of Vascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eldrup-Jorgensen', 'Affiliation': 'Division of Vascular Surgery, Maine Medical Center, Portland, Me.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Suckow', 'Affiliation': 'Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'C Keith', 'Initials': 'CK', 'LastName': 'Ozaki', 'Affiliation': ""Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Nguyen', 'Affiliation': ""Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery,['10.1016/j.jvs.2020.12.100']
1117,33555415,[Intraocular inflammation with brolucizumab use : Patient management-diagnosis-therapy].,"The anti-vascular endothelial growth factor (anti-VEGF) agent brolucizumab has been approved in the USA in October 2019 and in Europe in February 2020 for the treatment of neovascular age-related macular degeneration (nAMD). The approval was based on the randomized, double-blind phase III studies HAWK and HARRIER with a total of 1817 patients. Brolucizumab 6 mg (administered every 12 or 8 weeks depending on the activity of the disease) showed a non-inferior efficacy in terms of best-corrected visual acuity compared to aflibercept 2 mg (administered every 8 weeks). Initial reports on the use of brolucizumab after its approval in the USA indicated a safety signal of rare adverse events termed as retinal vasculitis and/or retinal vascular occlusion that may result in severe loss of vision. Typically, these events occurred in the presence of intraocular inflammation (IOI). A safety review committee (SRC) subsequently carried out an independent analysis of data from the pivotal studies. This article sets out the current state of knowledge and aims to provide users with orientation-from the authors' perspective-in treating brolucizumab-associated IOI. It appears mandatory to provide patients with information about possible symptoms of IOI. Even though the case reports and the SRC review of HAWK/HARRIER may not yet provide sufficient evidence for any final conclusions, it seems crucial to educate patients about signs and symptoms to ensure an early detection and diagnosis in cases of IOI. Once a patient is diagnosed with IOI, retinal vasculitis, and/or retinal vascular occlusive events, physicians should act promptly with an adequate and intensive anti-inflammatory treatment and brolucizumab treatment should be discontinued. It is important to note that these recommendations are primarily based on the authors' expert opinions and should be considered as guidance in managing these events rather than a formal protocol or guidelines.",2021,Initial reports on the use of brolucizumab after its approval in the USA indicated a safety signal of rare adverse events termed as retinal vasculitis and/or retinal vascular occlusion that may result in severe loss of vision.,"['1817\xa0patients', 'USA in October 2019 and in Europe in February 2020 for the treatment of neovascular age-related macular degeneration (nAMD']","['Brolucizumab', 'brolucizumab']",['intraocular inflammation (IOI'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}]","[{'cui': 'C4550124', 'cui_str': 'brolucizumab'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}]",,0.0857608,Initial reports on the use of brolucizumab after its approval in the USA indicated a safety signal of rare adverse events termed as retinal vasculitis and/or retinal vascular occlusion that may result in severe loss of vision.,"[{'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'Universitäts-Augenklinik Bonn, Ernst-Abbe-Str.\xa02, 53127, Bonn, Deutschland. frank.holz@ukbonn.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Heinz', 'Affiliation': 'Augenzentrum am St. Franziskus-Hospital Münster, Münster, Deutschland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Klinik für Augenheilkunde am Universitätsklinikum Ulm, Ulm, Deutschland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hoerauf', 'Affiliation': 'Augenklinik, Universitätsmedizin Göttingen, Göttingen, Deutschland.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pleyer', 'Affiliation': 'Klinik für Augenheilkunde, Charité -\xa0Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Deutschland.'}]",Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft,['10.1007/s00347-021-01321-8']
1118,33556861,Feasibility of telephone-delivered therapy for common mental health difficulties embedded in pediatric epilepsy clinics.,"BACKGROUND


Mental and physical health treatment should be delivered together for children and young people with epilepsy. Training healthcare professionals (HCPs) in epilepsy services to deliver mental health interventions is an important way to facilitate integrated care.
OBJECTIVE


To determine the feasibility of remotely delivered assessment and psychological treatment for mental health difficulties delivered by HCPs in pediatric epilepsy clinics with limited formal training in psychological interventions. We hypothesized that it would be (i) feasible to train HCPs to deliver the psychological intervention and (ii) that participants receiving the psychological therapy would report reductions in symptoms of mental health difficulties including anxiety, depression, and behavior difficulties and improve quality of life.
METHODS


Thirty-four children and young people with epilepsy who had impairing symptoms of a common mental health difficulty (anxiety, depression, disruptive behavior, and/or trauma) were allocated to receive 6 months of a modular cognitive behavioral intervention delivered by a HCP with limited formal psychological therapy experience. Thirteen HCPs were trained in delivery of the intervention. Healthcare professional competence was assessed in a two-stage process. Parent-reported measures of mental health symptoms and quality of life were completed at baseline and following the intervention. Paired t-tests were used to analyze changes in symptoms over time.
RESULTS


All thirteen HCPs who participated in the training were considered competent in therapeutic delivery by the end of the training period. Twenty-three patients completed pre- and post-intervention measures and were included in the analysis. There were statistically significant improvements in: symptoms of mental health problems (p = 0.01; Cohen's d = 0.62), total impact of mental health problems (p = 0.03; Cohen's d = 0.52), anxiety and depression symptoms (p = 0.02; Cohen's d = 0.57) and quality of life (p = 0.01; Cohen's d = 0.57).
CONCLUSION


A modular cognitive behavioral treatment delivered over the telephone by HCPs with limited experience of psychological therapy was feasible and effective in treating mental health problems in children and young people with epilepsy. Health-related Quality of Life also improved over the duration of treatment. A randomized controlled trial (RCT) is needed to demonstrate efficacy of the intervention.",2021,"There were statistically significant improvements in: symptoms of mental health problems (p = 0.01; Cohen's d = 0.62), total impact of mental health problems (p = 0.03; Cohen's d = 0.52), anxiety and depression symptoms (p = 0.02; Cohen's d = 0.57) and quality of life (p = 0.01; Cohen's d = 0.57).
CONCLUSION


A modular cognitive behavioral treatment delivered over the telephone by HCPs with limited experience of psychological therapy was feasible and effective in treating mental health problems in children and young people with epilepsy.","['children and young people with epilepsy', 'Thirty-four children and young people with epilepsy who had impairing symptoms of a common mental health difficulty (anxiety, depression, disruptive behavior, and/or trauma', 'pediatric epilepsy clinics with limited formal training in psychological interventions', 'pediatric epilepsy clinics']","['modular cognitive behavioral intervention delivered by a HCP with limited formal psychological therapy experience', 'telephone-delivered therapy', 'psychological therapy']","['mental health problems', 'anxiety, depression, and behavior difficulties and improve quality of life', ' symptoms of mental health problems', 'Health-related Quality of Life', 'Healthcare professional competence', 'anxiety and depression symptoms', 'total impact of mental health problems', 'mental health symptoms and quality of life', 'quality of life', 'therapeutic delivery']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0162531', 'cui_str': 'Hereditary coproporphyria'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1320526', 'cui_str': 'Formal psychological therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}]","[{'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",34.0,0.0761899,"There were statistically significant improvements in: symptoms of mental health problems (p = 0.01; Cohen's d = 0.62), total impact of mental health problems (p = 0.03; Cohen's d = 0.52), anxiety and depression symptoms (p = 0.02; Cohen's d = 0.57) and quality of life (p = 0.01; Cohen's d = 0.57).
CONCLUSION


A modular cognitive behavioral treatment delivered over the telephone by HCPs with limited experience of psychological therapy was feasible and effective in treating mental health problems in children and young people with epilepsy.","[{'ForeName': 'Sophie D', 'Initials': 'SD', 'LastName': 'Bennett', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK. Electronic address: sophie.bennett.10@ucl.ac.uk.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Au', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chorpita', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Coughtrey', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'J Helen', 'Initials': 'JH', 'LastName': 'Cross', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dalrymple', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Heyman', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lewins', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reilly', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107743']
1119,33561528,Patient reported outcome measures in clinical trials should be initially analyzed as continuous outcomes for statistical significance and responder analyses should be reserved as secondary analyses.,"OBJECTIVE


To evaluate the power of responder analyses in a randomized controlled trial.
STUDY DESIGN AND SETTING


Simulations were based on the Chronic Kidney Disease Antidepressant Sertraline Trial (CAST), which compared sertraline to placebo for the treatment of depression in kidney disease. Baseline disease severity, placebo response, effect size, and the proportion of responders were varied across 72 scenarios. Power was assessed using a t-test for change scores, and the chi-square test for dichotomized outcomes of the minimal important difference (MID), improvement and remission in 10,000 datasets with a fixed sample size of 193.
RESULTS


The t-test had >80% power except for scenarios with the lowest sertraline effect size. The chi-square test using the MID had <7% power in all scenarios while improvement and remission of achieved >80% power only at higher effect sizes and/or when the proportion of responders was highest at 0.5. The chi-square test for improvement had marginal power increases compared to the t-test (4/72 scenarios = 5.6%) and that for remission did not outperform the t-test in any scenario.
CONCLUSIONS


The t-test outperforms the chi-square test for dichotomized outcomes regardless of baseline disease severity, placebo response, effect size and the proportion of responders to the intervention.",2021,"The chi-square test for improvement had marginal power increases compared to the t-test (4/72 scenarios = 5.6%) and that for remission did not outperform the t-test in any scenario.
","['kidney disease', 'Simulations were based on the Chronic Kidney Disease Antidepressant Sertraline Trial (CAST), which compared', 'patients with kidney disease and depression']",['sertraline to placebo'],"['Baseline disease severity, placebo response, effect size, and the proportion of responders']","[{'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",10000.0,0.143304,"The chi-square test for improvement had marginal power increases compared to the t-test (4/72 scenarios = 5.6%) and that for remission did not outperform the t-test in any scenario.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Collister', 'Affiliation': 'Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada. Electronic address: dtcollister@gmail.com.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Bangdiwala', 'Affiliation': 'Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada. Electronic address: Shrikant.Bangdiwala@phri.ca.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada. Electronic address: lastwalsh1975@gmail.com.'}, {'ForeName': 'Rajibul', 'Initials': 'R', 'LastName': 'Mian', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada. Electronic address: Rajibul.Mian@phri.ca.'}, {'ForeName': 'Shun Fu', 'Initials': 'SF', 'LastName': 'Lee', 'Affiliation': 'Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada. Electronic address: ShunFu.Lee@phri.ca.'}, {'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Kyoto University School of Public Health, Kyoto, Japan. Electronic address: furukawa@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Guyatt', 'Affiliation': 'Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada. Electronic address: guyatt@mcmaster.ca.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2021.01.026']
1120,33587397,Effects of Oxytocin on Emotion Recognition in Schizophrenia: A Randomized Double-Blind Pilot Study.,"BACKGROUND


Schizophrenia (SCZ) is a neurodevelopmental disorder that leads to poor social function. Oxytocin (OXT), a neuropeptide involved in social cognition, is a potential therapeutic agent for alleviating social dysfunction. Therefore, we investigated the effects of intranasal oxytocin (IN-OXT) on emotional processes in experimental interactive social contexts in individuals with SCZ.
METHODS


In a male-only parallel randomized placebo-controlled double-blind trial, we investigated the effects of IN-OXT (24 IU) on visual fixation on pictures of faces and emotion recognition in an interactive ball-tossing game that probed processing of social and nonsocial stimuli.
RESULTS


Intranasal oxytocin enhanced the recognition of emotions during an emotion-based ball-tossing game. This improvement was specific to the game that included social cue processing. Intranasal oxytocin did not affect eye gaze duration or gaze dwell time on faces in these patients.
CONCLUSIONS


An acute low dose of IN-OXT had a modest effect on social cue processing and was limited to emotion recognition. Higher doses and long-term trials targeting emotional processing in SCZ may lead to improved social function.",2021,An acute low dose of IN-OXT had a modest effect on social cue processing and was limited to emotion recognition.,"['individuals with SCZ', 'Schizophrenia']","['placebo', 'Intranasal oxytocin', 'intranasal oxytocin (IN-OXT', 'Oxytocin (OXT', 'IN-OXT', 'Oxytocin']","['visual fixation on pictures of faces and emotion recognition', 'eye gaze duration or gaze dwell time', 'Emotion Recognition', 'social cue processing', 'recognition of emotions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0016183', 'cui_str': 'Ocular fixation observable'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",,0.298628,An acute low dose of IN-OXT had a modest effect on social cue processing and was limited to emotion recognition.,"[{'ForeName': 'Elissar', 'Initials': 'E', 'LastName': 'Andari', 'Affiliation': 'From the Department of Psychiatry, College of Medicine and Life Sciences, University of Toledo, Toledo, OH.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Massa', 'Affiliation': ''}, {'ForeName': 'Molly D', 'Initials': 'MD', 'LastName': 'Fargotstein', 'Affiliation': 'Atlanta Veterans Affairs Health Care System, Decatur.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Taylor', 'Affiliation': 'Atlanta Veterans Affairs Health Care System, Decatur.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Halverson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Andrew V', 'Initials': 'AV', 'LastName': 'Owens', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Currin', 'Affiliation': ''}, {'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': ''}, {'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Gitman', 'Affiliation': 'Atlanta Veterans Affairs Health Care System, Decatur.'}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Cuthbert', 'Affiliation': ''}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Erica J', 'Initials': 'EJ', 'LastName': 'Duncan', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001367']
1121,33587394,"Efficacy of Vortioxetine Monotherapy for Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial.","PURPOSE/BACKGROUND


There are few efficacious pharmacological treatments for posttraumatic stress disorder (PTSD) and many patients fail to benefit from existing treatments. Vortioxetine, a recently developed antidepressant, acts as a serotonin modulator through inhibition of the serotonin transporter and actions at multiple types of serotonin receptors. Its unique pharmacodynamic profile suggests it may have efficacy for the treatment of PTSD.
METHODS/PROCEDURES


We conducted a 12-week placebo-controlled, randomized clinical trial of vortioxetine (flexibly dosed from 10 to 20 mg/d) versus placebo in adults with PTSD. The primary outcome was change from baseline in the past-month version of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), analyzed using a mixed-model repeated-measures analysis of variance.
FINDINGS/RESULTS


Forty-one patients were randomized, and 32 (78%) completed the 12 weeks of treatment. The mean reduction in CAPS-5 scores at week 12 did not significantly differ between the 2 arms; the effect size for the difference in changes between vortioxetine and placebo on CAPS-5 total scores at week 12 was Cohen d = 0.29. However, at week 8, the drug-placebo difference was d = 0.78, which met the multivariate criteria for statistical significance, P = 0.014.
IMPLICATIONS/CONCLUSIONS


In this study of 41 patients, vortioxetine did not demonstrate superiority over placebo for adults with PTSD. Future PTSD trials may benefit from stratifying the randomization based on number of years since the index traumatic event and a history of failure to respond to treatment.",2021,The mean reduction in CAPS-5 scores at week 12 did not significantly differ between the 2 arms; the effect size for the difference in changes between vortioxetine and placebo on CAPS-5 total scores at week 12 was Cohen d = 0.29.,"['Forty-one patients', 'Posttraumatic Stress Disorder', 'adults with PTSD', '41 patients']","['placebo', 'vortioxetine and placebo', 'vortioxetine', 'Placebo', 'Vortioxetine Monotherapy', 'Vortioxetine']","['CAPS-5 total scores', 'change from baseline in the past-month version of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), analyzed using a mixed-model repeated-measures analysis of variance', 'mean reduction in CAPS-5 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",41.0,0.267323,The mean reduction in CAPS-5 scores at week 12 did not significantly differ between the 2 arms; the effect size for the difference in changes between vortioxetine and placebo on CAPS-5 total scores at week 12 was Cohen d = 0.29.,"[{'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Rakofsky', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'D Jeffrey', 'Initials': 'DJ', 'LastName': 'Newport', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Institute for Early Life Adversity Research, University of Texas at Austin Dell Medical School, Austin, TX.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Mletzko-Crowe', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Barone', 'Affiliation': 'University of Miami Miller School of Medicine.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Nemeroff', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Institute for Early Life Adversity Research, University of Texas at Austin Dell Medical School, Austin, TX.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001363']
1122,33539612,Obstetric anal sphincter injury after episiotomy in vacuum extraction: an epidemiological study using an emulated randomised trial approach.,"OBJECTIVE


To emulate a randomised controlled trial investigating whether lateral or mediolateral episiotomy compared with no episiotomy reduces the prevalence of obstetric anal sphincter injury (OASIS) in nulliparous women delivered with vacuum extraction.
DESIGN


A population-based observational study.
SETTING


Sweden.
POPULATION


63 654 nulliparous women delivered with vacuum extraction derived from the Swedish Medical Birth Register 2000-2011, with a live singleton baby with no known malformations in cephalic presentation in gestational week ≥34 +0  , and subject to lateral or mediolateral episiotomy or no episiotomy.
METHODS


The effect of episiotomy was calculated using a causal doubly robust estimation method based on propensity scores. Results are presented as the average treatment effect and numbers needed to treat (NNT).
MAIN OUTCOME MEASURES


OASIS (third- and fourth-degree perineal injury) in nulliparous women delivered with vacuum extraction.
RESULTS


Episiotomy was associated with a reduction in OASIS from 15.5% to 11.8%, average treatment effect of -3.66% (95% CI -4.31 to -3.01) and NNT 27. Third-degree perineal injuries were reduced from 14.0% to 10.9% (-3.08, 95% CI -3.71 to -2.42) with NNT 32. Fourth-degree perineal injuries were reduced from 1.6% to 1.0 % (-0.58%, 95% CI -0.79 to -0.37) with NNT 172.
CONCLUSIONS


Lateral or mediolateral episiotomy reduced the prevalence of OASIS in nulliparous women delivered with vacuum extraction, compared to women with no episiotomy.
TWEETABLE ABSTRACT


To prevent one case of OASIS in first-time mothers delivered with vacuum, 27 episiotomies had to be performed.",2021,"RESULTS


Episiotomy was associated with a reduction in OASIS from 15.5% to 11.8%, average treatment effect -3.66% (95% CI -4.31 to -3.01) and NNT 27.","['63 654 nulliparous women delivered with vacuum extraction derived from the Swedish Medical Birth Register 2000-2011, with a live singleton baby without known malformations in cephalic presentation in gestational week ≥34+0, and subject to', 'nulliparous women delivered with', 'nulliparous women delivered with vacuum extraction', 'Sweden']","['lateral or mediolateral episiotomy compared to no episiotomy', 'lateral or mediolateral episiotomy or no episiotomy', 'Lateral or mediolateral episiotomy', 'Obstetric anal sphincter injury after episiotomy in vacuum extraction', 'vacuum extraction']","['obstetric anal sphincter injury (OASIS', 'OASIS (third- and fourth-degree perineal injury', 'Fourth-degree perineal injuries', 'prevalence of OASIS', 'Third-degree perineal injuries', 'OASIS']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042225', 'cui_str': 'Delivery by vacuum extraction'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}, {'cui': 'C0042225', 'cui_str': 'Delivery by vacuum extraction'}]","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3544174', 'cui_str': 'Perineal injury'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0443323', 'cui_str': 'Third degree'}]",63654.0,0.190079,"RESULTS


Episiotomy was associated with a reduction in OASIS from 15.5% to 11.8%, average treatment effect -3.66% (95% CI -4.31 to -3.01) and NNT 27.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ankarcrona', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jacobsson', 'Affiliation': 'Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brismar Wendel', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16663']
1123,33530252,Effects of Baduanjin on patients with chronic nonspecific low back pain: A randomized controlled trial.,"BACKGROUND


Chronic low back pain (CLBP) is 1 of the common clinical diseases, and many treatment methods can only improve the symptoms of pain in the short term. Traditional Chinese sports - Baduanjin has been proven to have a positive effect on chronic low back pain. However, the quality of the research is low, the sample size is small, and safety observations are lacking. We describe the protocol of a randomized controlled trial to study the efficacy and safety of Baduanjin chronic low back pain.
METHODS


This randomized, controlled, evaluator-blind, two-arm, parallel clinical trial will include 90 outpatients with chronic low back pain recruited from the First Hospital of Nanping City, Fujian Province. The patients were randomly assigned to the intervention group (Baduanjin exercise training) and the control group (not receiving any special exercise training) at a ratio of 1:1. Patients in the intervention group will receive Baduanjin exercise training 3 times a week for 24 weeks. The 2 groups received a 4- week follow-up observation at 24 weeks. The main result from the intervention before intervention to 24 weeks later, and the follow-up of 4 changes the visual analog scale score at weeks, and by independent t are tested groups. It will also review the Pain-related disability index, The Quebec Back Pain Disability Scale, Health-related quality of life, Roland Morris (Roland Morris) Disability Questionnaire, Overall Perceived Effect (OPE) and safety Compare. Cost data for cost-benefit and cost-benefit analysis will be collected.
DISCUSSION


This will be the first study to compare the effectiveness and safety of Baduanjin for patients with chronic low back pain. The results may help healthcare professionals make clinical decisions and may reduce the cost of treatment for this disease.
TRIAL REGISTRATION


ChiCTR2000033908.",2021,This will be the first study to compare the effectiveness and safety of Baduanjin for patients with chronic low back pain.,"['90 outpatients with chronic low back pain recruited from the First Hospital of Nanping City, Fujian Province', 'Chronic low back pain (CLBP', 'patients with chronic low back pain', 'patients with chronic nonspecific low back pain']","['intervention group (Baduanjin exercise training) and the control group (not receiving any special exercise training', 'Baduanjin exercise training', 'Baduanjin']","['efficacy and safety', 'Quebec Back Pain Disability Scale, Health-related quality of life, Roland Morris (Roland Morris', 'Disability Questionnaire, Overall Perceived Effect (OPE) and safety Compare', 'visual analog scale score']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",90.0,0.125694,This will be the first study to compare the effectiveness and safety of Baduanjin for patients with chronic low back pain.,"[{'ForeName': 'Qingtang', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation, First Hospital of Nanping City.'}, {'ForeName': 'Shiliang', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation, First Hospital of Nanping City.'}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, First Hospital of Nanping City.'}, {'ForeName': 'Caiyun', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ""Department of Rehabilitation, Nanping People's Hospital, Fujian Province, Nanping.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation, First Hospital of Nanping City.'}, {'ForeName': 'Debiao', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation, Fujian Provincial Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Xiangmei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation, First Hospital of Nanping City.'}]",Medicine,['10.1097/MD.0000000000024448']
1124,33530238,The efficacy of a short one-on-one nursing intervention in people with coronary heart disease: A randomized controlled trial protocol.,,2021,,['people with coronary heart disease'],['short one-on-one nursing intervention'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0960428,,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Physical Examination Center.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Department of Cardiovascular Medicine, Wuhan No.1 Hospital, Hubei, China.'}]",Medicine,['10.1097/MD.0000000000024405']
1125,33548897,Functional evaluation of NK 1  antagonism on cue reactivity in opiate dependence; An fMRI study.,"BACKGROUND


Opiate addiction is a major health challenge with substantial societal cost. Though harm minimisation strategies have been effective, there is a growing need for new treatments for detoxification and relapse prevention. Preclinical research has found neurokinin 1 (NK 1 ) receptors have prominent effects on opiate reward and reinforcement, and human studies have found NK 1  antagonism led to reductions in craving and withdrawal. However, its effect on brain mechanisms in opiate addiction has not yet been examined.
METHODS


This study aims to assess the impact of NK 1  antagonist aprepitant on heroin cue-elicited changes in blood-oxygenation level dependent (BOLD) signal in opiate dependent individuals undergoing detoxification. Participants will attend two scanning sessions and receive a single dose of aprepitant (320 mg) and a placebo in a randomised, cross-over design. During functional magnetic resonance imaging participants will undergo two runs of a cue reactivity task, which consists of passive viewing of drug cues or neutral cues in a block design fashion. We hypothesise that NK 1  antagonism will attenuate the BOLD response to drug cues in the caudate nucleus and amygdala. Regions of interest were selected based on NK 1  receptor density and their role in cue reactivity and craving.",2021,"During functional magnetic resonance imaging participants will undergo two runs of a cue reactivity task, which consists of passive viewing of drug cues or neutral cues in a block design fashion.","['opiate dependence', 'opiate dependent individuals undergoing detoxification']",['placebo'],['blood-oxygenation level dependent (BOLD) signal'],"[{'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.0567241,"During functional magnetic resonance imaging participants will undergo two runs of a cue reactivity task, which consists of passive viewing of drug cues or neutral cues in a block design fashion.","[{'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Fonville', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom. Electronic address: l.fonville@imperial.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Paterson', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Herlinger', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hayes', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hill', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nutt', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lingford-Hughes', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108564']
1126,33574056,Deep Learning Model for Real-Time Prediction of Intradialytic Hypotension.,"BACKGROUND AND OBJECTIVES


Intradialytic hypotension has high clinical significance. However, predicting it using conventional statistical models may be difficult because several factors have interactive and complex effects on the risk. Herein, we applied a deep learning model (recurrent neural network) to predict the risk of intradialytic hypotension using a timestamp-bearing dataset.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We obtained 261,647 hemodialysis sessions with 1,600,531 independent timestamps ( i.e ., time-varying vital signs) and randomly divided them into training (70%), validation (5%), calibration (5%), and testing (20%) sets. Intradialytic hypotension was defined when nadir systolic BP was <90 mm Hg (termed intradialytic hypotension 1) or when a decrease in systolic BP ≥20 mm Hg and/or a decrease in mean arterial pressure ≥10 mm Hg on the basis of the initial BPs (termed intradialytic hypotension 2) or prediction time BPs (termed intradialytic hypotension 3) occurred within 1 hour. The area under the receiver operating characteristic curves, the area under the precision-recall curves, and F1 scores obtained using the recurrent neural network model were compared with those obtained using multilayer perceptron, Light Gradient Boosting Machine, and logistic regression models.
RESULTS


The recurrent neural network model for predicting intradialytic hypotension 1 achieved an area under the receiver operating characteristic curve of 0.94 (95% confidence intervals, 0.94 to 0.94), which was higher than those obtained using the other models ( P <0.001). The recurrent neural network model for predicting intradialytic hypotension 2 and intradialytic hypotension 3 achieved area under the receiver operating characteristic curves of 0.87 (interquartile range, 0.87-0.87) and 0.79 (interquartile range, 0.79-0.79), respectively, which were also higher than those obtained using the other models ( P ≤0.001). The area under the precision-recall curve and F1 score were higher using the recurrent neural network model than they were using the other models. The recurrent neural network models for intradialytic hypotension were highly calibrated.
CONCLUSIONS


Our deep learning model can be used to predict the real-time risk of intradialytic hypotension.",2021,The area under the precision-recall curve and F1 score were higher using the recurrent neural network model than they were using the other models.,"['261,647 hemodialysis sessions with 1,600,531 independent timestamps ( i.e ., time-varying vital signs']",[],"['area under the precision-recall curve and F1 score', 'Intradialytic hypotension', 'nadir systolic BP']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C1301890', 'cui_str': 'Timestamp'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",[],"[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0259875,The area under the precision-recall curve and F1 score were higher using the recurrent neural network model than they were using the other models.,"[{'ForeName': 'Hojun', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Intelligence and Information, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Donghwan', 'Initials': 'D', 'LastName': 'Yun', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jayeon', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': 'Department of Intelligence and Information, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Kiyoon', 'Initials': 'K', 'LastName': 'Yoo', 'Affiliation': 'Department of Intelligence and Information, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Yong Chul', 'Initials': 'YC', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong Ki', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kook-Hwan', 'Initials': 'KH', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kwon Wook', 'Initials': 'KW', 'LastName': 'Joo', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yon Su', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Nojun', 'Initials': 'N', 'LastName': 'Kwak', 'Affiliation': 'Department of Intelligence and Information, Seoul National University, Seoul, Korea hansway80@gmail.com nojunk@snu.ac.kr.'}, {'ForeName': 'Seung Seok', 'Initials': 'SS', 'LastName': 'Han', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Korea hansway80@gmail.com nojunk@snu.ac.kr.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.09280620']
1127,33581294,Dyspnea during exercise and voluntary hyperpnea in women with obesity.,"Temporal responses of ratings of perceived breathlessness (RBP) during constant-load and incremental exercise, and during voluntary hyperpnea (EVH) were examined in women with obesity. Following 6 min of constant-load (60W) cycling, 34 women rated RPB≥4 (+DOE) and 22 women rated RPB≤2 (-DOE). Both groups completed an incremental cycling test and an EVH test at 40 and 60L/min; RPB was assessed each minute of incremental cycling and at the end of each EVH trial. RPB increased with ventilation during constant-load (+DOE: R 2 =0.86; -DOE: R 2 =0.82) and incremental (+DOE: R 2 =0.91; -DOE: R 2 =0.92) exercise, but + DOE had a greater y-intercept than -DOE (60W: -0.16±1.53 vs. -0.73±0.55; incremental: -0.50±1.40 vs. -1.71±0.84). Despite matching ventilation, RPB was greater in + DOE at baseline (0.97±1.14 vs. 0.14±0.28), 40L/min (2.50±1.43 vs. 0.98±0.91), and 60L/min (3.94±2.19 vs. 2.07±1.32) during EVH. These findings show that despite linear associations between RPB and ventilation during exercise and voluntary hyperpnea, breathlessness perception at a given ventilatory demand is heightened in +DOE compared with -DOE.",2021,"RPB increased with ventilation during constant-load (+DOE: R 2  = 0.86; -DOE: R 2  = 0.82) and incremental (+DOE: R 2  = 0.91; -DOE: R 2  = 0.92) exercise, but + DOE had a greater y-intercept than -DOE","['women with obesity', 'obese women']","['constant-load and incremental exercise, and during voluntary hyperpnea (EVH', 'DOE', 'Dyspnea during exercise and voluntary hyperpnea']","['RPB', 'Temporal responses of ratings of perceived breathlessness (RBP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0220854', 'cui_str': 'Hyperpnea'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0035342', 'cui_str': 'Retinol binding protein'}]",,0.125686,"RPB increased with ventilation during constant-load (+DOE: R 2  = 0.86; -DOE: R 2  = 0.82) and incremental (+DOE: R 2  = 0.91; -DOE: R 2  = 0.92) exercise, but + DOE had a greater y-intercept than -DOE","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Spencer', 'Affiliation': 'Centre for Research in Occupational Safety and Health, Laurentian University, ON, Canada.'}, {'ForeName': 'Bryce N', 'Initials': 'BN', 'LastName': 'Balmain', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Vipa', 'Initials': 'V', 'LastName': 'Bernhardt', 'Affiliation': 'Texas A&M University Commerce, Department of Health and Human Performance, Commerce, TX, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Wilhite', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Tony G', 'Initials': 'TG', 'LastName': 'Babb', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: DrTonyBabb@TexasHealth.org.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2021.103638']
1128,33582566,Associations between fatigue impact and lifestyle factors in people with multiple sclerosis - The Danish MS hospitals rehabilitation study.,"BACKGROUND


The lack of medical treatment options to reduce fatigue in patients with multiple sclerosis (MS) emphasize the importance of identifying potential non-pharmacological modifiable factors, as this may help advance current treatment strategies. The aim of this study was to identify potential modifiable lifestyle factors as well as patient- and disease-related characteristics, that are associated with fatigue in a large sample of clinically well-characterized patients with MS.
METHODS


This study was a secondary analysis of a pragmatic randomized controlled trial of inpatient multidisciplinary rehabilitation in Denmark. MS patients aged 18 to 65 years and with a disease severity score ≤ 7.5 according to the Expanded Disability Status Scale participated. Data on patient- and disease-related characteristics, fatigue impact (Modified Fatigue Impact Scale (MFIS)), and on lifestyle factors (tobacco smoking, alcohol intake, and physical activity), were collected at baseline. A linear mixed model was used to compare MFIS total, physical, cognitive, and psychosocial scores across subgroups of selected characteristics. Regression analyses were used to examine associations between lifestyle factors and MFIS total, physical, cognitive, and psychosocial scores.
RESULTS


In the sample of 417 MS patients, median age was 51 years, 69% were female, median time since diagnosis was 8 years, with 41% having relapsing remitting MS. Higher MFIS total scores were observed in MS patients with shorter time since diagnosis, being a tobacco smoker, and not undertaking regular physical activity. Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores. In the multivariate analyses, physical activity was significantly associated with fatigue impact on total, physical and psychosocial functioning. Tobacco smoking was significantly associated with fatigue impact on psychosocial functioning. Alcohol intake was not associated with fatigue impact. None of the lifestyle factors were associated with fatigue impact on cognitive functioning. In the adjusted models time since diagnosis was significantly associated with fatigue impact on total, physical and cognitive functioning, as was disease severity with fatigue impact on physical and cognitive functioning.
CONCLUSION


Physical activity showed the most pronounced associations with fatigue impact on physical and psychosocial functioning, while the impact on cognitive functioning showed a trend. Tobacco smoking contributed significantly to impact on psychosocial functioning, while alcohol intake did not contribute to fatigue impact. Introducing or supporting maintenance of physical activity/exercise and cessation of tobacco smoking seems to be a useful approach for rehabilitation services to help patients with MS manage fatigue.",2021,"Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores.","['patients with multiple sclerosis (MS', 'MS patients aged 18 to 65 years and with a disease severity score ≤ 7.5 according to the Expanded Disability Status Scale participated', '417 MS patients, median age was 51 years, 69% were female, median time since diagnosis was 8 years, with 41% having relapsing remitting MS', 'people with multiple sclerosis - The Danish MS hospitals rehabilitation study', 'inpatient multidisciplinary rehabilitation in Denmark']",['physical activity/exercise and cessation of tobacco smoking'],"['Alcohol intake', 'fatigue impact on cognitive functioning', 'Tobacco smoking', 'MFIS total, physical, cognitive, and psychosocial scores', 'lifestyle factors and MFIS total, physical, cognitive, and psychosocial scores', 'physical and psychosocial functioning', 'Higher MFIS total scores', 'fatigue impact on total, physical and cognitive functioning', 'MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores', 'patient- and disease-related characteristics, fatigue impact (Modified Fatigue Impact Scale (MFIS)), and on lifestyle factors (tobacco smoking, alcohol intake, and physical activity', 'fatigue impact on total, physical and psychosocial functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",417.0,0.0213903,"Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores.","[{'ForeName': 'Sverker', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden; Allied Health Professionals Function, Medical Unit Occupational Therapy & Physiotherapy, Karolinska University Hospital, Stockholm, Sweden. Electronic address: sverker.johansson@ki.se.'}, {'ForeName': 'Anders G', 'Initials': 'AG', 'LastName': 'Skjerbæk', 'Affiliation': 'MS Hospitals in Denmark, Ry and Haslev, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nørgaard', 'Affiliation': 'MS Hospitals in Denmark, Ry and Haslev, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Boesen', 'Affiliation': 'MS Hospitals in Denmark, Ry and Haslev, Denmark.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Hvid', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102799']
1129,33582525,Efficacy of intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS) in Obsessive Compulsive Disorder: A Randomized Placebo Controlled Study.,"Transcranial magnetic stimulation (TMS) can non-invasively modulate specific brain regions in Obsessive-compulsive disorder (OCD). Citing orbito-frontal cortex (OFC) hyper-connectivity with striatum as the most consistent finding implicated in patho-physiologically of OCD, we aimed to study the effect of novel continuous Theta Burst Stimulation (cTBS) targeting OFC in OCD subjects on a randomized placebo control design. Thirty-three patients were randomly allocated to active cTBS (n= 18) and sham (n= 15) groups. They received 10 TBS sessions, 2 per day (total of 1200 pulses; intensive protocol) for 5 days in a week. The Yale Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression-Severity (CGI-S) scores were assessed at baseline, after last session and at 2 weeks post-rTMS. On repeated measures-ANOVA, a significant group*time effect (from pretreatment to 2 weeks post TBS) for obsessions, compulsions, HAM-A, HAM-D, and CGI scores was found. But when controlled for confounding variables, only HAM-A scores and CGI effect retained statistical significance. We conclude that intensive OFC cTBS (iOFcTBS) in OCD is well tolerated with clinically significant improvements in anxiety symptoms and global severity. This improvement in anxiety symptoms could be due to modulations of state dependent dysregulation in OCD.",2021,Transcranial magnetic stimulation (TMS) can non-invasively modulate specific brain regions in Obsessive-compulsive disorder (OCD).,"['Obsessive-compulsive disorder (OCD', 'Obsessive Compulsive Disorder', 'Thirty-three patients']","['Transcranial magnetic stimulation (TMS', 'active cTBS', 'intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS', 'Placebo', 'intensive OFC cTBS']","['obsessions, compulsions, HAM-A, HAM-D, and CGI scores', 'anxiety symptoms and global severity', 'Yale Brown Obsessive Compulsive Scale\xa0(Y-BOCS), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression-Severity (CGI-S) scores', 'anxiety symptoms']","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1861537', 'cui_str': 'Orofacial Cleft 1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}]","[{'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",33.0,0.0778492,Transcranial magnetic stimulation (TMS) can non-invasively modulate specific brain regions in Obsessive-compulsive disorder (OCD).,"[{'ForeName': 'Parth', 'Initials': 'P', 'LastName': 'Dutta', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Dhyani', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Shobit', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India. Electronic address: shobit.garg@gmail.com.'}, {'ForeName': 'Sai Krishna', 'Initials': 'SK', 'LastName': 'Tikka', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Raipur, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Khattri', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mishra', 'Affiliation': 'Clinical Psychology, Government Medical College and Hospital, Chandigarh, India.'}]",Psychiatry research,['10.1016/j.psychres.2021.113784']
1130,33582490,Effects of acute distress and tobacco cues on tobacco demand.,"INTRODUCTION


Cigarette demand, or relative value, can be assessed via analysis of performance on a hypothetical behavioral economic cigarette purchase task (CPT). Substance purchase tasks are highly amenable to manipulation, namely, external stimuli, instructional changes, or acute stressors. In this regard, the current secondary analysis evaluates the role a novel, computerized stress induction paradigm, the Contextual-Frustration Intolerance Typing Task (C-FiTT), plays in eliciting varying levels of stress and resulting demand.
METHOD


Daily smokers (n = 484) completed the C-FiTT wherein they were randomly assigned to one of five distress conditions: combination of task difficulty (low or high difficulty) with neutral or withdrawal cues, and a neutral control group. Tobacco demand was assessed immediately following the distress task using the hypothetical CPT.
RESULTS


The C-FiTT distress-induction task significantly increased key cigarette demand indices, including price at maximum expenditure (P max ) and first price where consumption was suppressed to zero (breakpoint). Moreover, demand increased with severity of C-FiTT condition, with the high-difficulty condition resulting in significantly higher breakpoint and P max , compared to other conditions. C-FiTT condition was not related to a significant increase in O max , intensity, or elasticity.
DISCUSSION


The novel C-FiTT paradigm produced comparable effects on tobacco demand relative to in vivo withdrawal induction, indicating that the C-FiTT is a viable procedure by which to influence demand. Reduction of internal and external stressors may be effective in lowering motivation for tobacco. These results highlight the importance of state distress in tobacco demand, and offer a potential avenue for intervention.",2021,"The C-FiTT distress-induction task significantly increased key cigarette demand indices, including price at maximum expenditure (P max ) and first price where consumption was suppressed to zero (breakpoint).",['Daily smokers (n = 484) completed the C-FiTT wherein they were randomly assigned to one of five distress conditions'],"['combination of task difficulty (low or high difficulty) with neutral or withdrawal cues, and a neutral control group']","['price at maximum expenditure (P max ) and first price where consumption', 'O max , intensity, or elasticity']","[{'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016770', 'cui_str': 'Feeling frustrated'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0441704', 'cui_str': 'Typings'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",484.0,0.0173953,"The C-FiTT distress-induction task significantly increased key cigarette demand indices, including price at maximum expenditure (P max ) and first price where consumption was suppressed to zero (breakpoint).","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Aston', 'Affiliation': 'Brown University School of Public Health, Center for Alcohol and Addiction Studies, Providence, RI USA. Electronic address: Elizabeth_Aston@Brown.edu.'}, {'ForeName': 'Jacqueline E', 'Initials': 'JE', 'LastName': 'Smith', 'Affiliation': 'Brown University School of Public Health, Center for Alcohol and Addiction Studies, Providence, RI USA.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Brown University School of Public Health, Center for Alcohol and Addiction Studies, Providence, RI USA; City University of New York (CUNY), Brooklyn College, Brooklyn, NY USA.'}, {'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Farris', 'Affiliation': 'Rutgers, the State University of New Jersey, Piscataway, NJ, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108522']
1131,33591291,"The Impact of Nonpharmacological Interventions on Patient Experience, Opioid Use, and Health Care Utilization in Adult Cardiac Surgery Patients: Protocol for a Mixed Methods Study.","BACKGROUND


Despite pharmacological treatments, patients undergoing cardiac surgery experience severe anxiety and pain, which adversely affect outcomes. Previous work examining pediatric and nonsurgical adult patients has documented the effectiveness of inexpensive, nonpharmacological techniques to reduce anxiety and pain as well as health care costs and length of hospitalization. However, the impact of nonpharmacological interventions administered by a dedicated comfort coach has not been evaluated in an adult surgical setting.
OBJECTIVE


This trial aims to assess whether nonpharmacological interventions administered by a trained comfort coach affect patient experience, opioid use, and health care utilization compared with usual care in adult cardiac surgery patients. This study has 3 specific aims: assess the effect of a comfort coach on patient experience, measure differences in inpatient and outpatient opioid use and postoperative health care utilization, and qualitatively evaluate the comfort coach intervention.
METHODS


To address these aims, we will perform a prospective, randomized controlled trial of 154 adult cardiac surgery patients at Michigan Medicine. Opioid-naive patients undergoing first-time, elective cardiac surgery via sternotomy will be randomized to undergo targeted interventions from a comfort coach (intervention) versus usual care (control). The individualized comfort coach interventions will be administered at 6 points: preoperative outpatient clinic, preoperative care unit on the day of surgery, extubation, chest tube removal, hospital discharge, and 30-day clinic follow-up. To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at preoperative outpatient clinic, discharge, 30-day follow-up, and 90-day follow-up. For aim 2, we will record inpatient opioid use and collect postdischarge opioid use and pain-related outcomes through an 11-item questionnaire administered at the 30-day follow-up. Hospital length of stay, readmission, number of days in an extended care facility, emergency room, urgent care, and an unplanned doctor's office visit will be recorded as the primary composite endpoint defined as total days spent at home within the first 30 days after surgery. For aim 3, we will perform semistructured interviews with patients in the intervention arm to understand the comfort coach intervention through a thematic analysis.
RESULTS


This trial, funded by Blue Cross Blue Shield of Michigan Foundation in 2019, is presently enrolling patients with anticipated manuscript submissions from our primary aims targeted for the end of 2020.
CONCLUSIONS


Data generated from this mixed methods study will highlight effective nonpharmacological techniques and support a multidisciplinary approach to perioperative care during the adult cardiac surgery patient experience. This study's findings may serve as the foundation for a subsequent multicenter trial and broader dissemination of these techniques to other types of surgery.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04051021; https://clinicaltrials.gov/ct2/show/NCT04051021.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/21350.",2021,"To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at preoperative outpatient clinic, discharge, 30-day follow-up, and 90-day follow-up.","['154 adult cardiac surgery patients at Michigan Medicine', 'patients undergoing cardiac surgery experience severe anxiety and pain', 'adult cardiac surgery patient experience', 'Adult Cardiac Surgery Patients', 'enrolling patients with anticipated manuscript submissions from our primary aims targeted for the end of 2020', 'naive patients undergoing first-time, elective cardiac surgery via sternotomy', 'adult cardiac surgery patients']","['comfort coach', 'Opioid', 'comfort coach (intervention) versus usual care (control', 'Nonpharmacological Interventions', 'nonpharmacological interventions']","['Patient Experience, Opioid Use, and Health Care Utilization', 'perioperative anxiety, self-reported pain, functional status, and patient satisfaction', ""Hospital length of stay, readmission, number of days in an extended care facility, emergency room, urgent care, and an unplanned doctor's office visit""]","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0031834', 'cui_str': ""Physician's Office""}]",154.0,0.127237,"To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at preoperative outpatient clinic, discharge, 30-day follow-up, and 90-day follow-up.","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Brescia', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Piazza', 'Affiliation': 'Office of Patient Experience, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Jenkins', 'Affiliation': ""Department of Child and Family Life, CS Mott Children's Hospital, Michigan Medicine, Ann Arbor, MI, United States.""}, {'ForeName': 'Lindsay K', 'Initials': 'LK', 'LastName': 'Heering', 'Affiliation': ""Department of Child and Family Life, CS Mott Children's Hospital, Michigan Medicine, Ann Arbor, MI, United States.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Ivacko', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Piazza', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Molly C', 'Initials': 'MC', 'LastName': 'Dwyer-White', 'Affiliation': 'Office of Patient Experience, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Stefanie L', 'Initials': 'SL', 'LastName': 'Peters', 'Affiliation': 'Frankel Cardiovascular Center, Michigan Medicine, Ann Arbor, MI, United States.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Cepero', 'Affiliation': ""Children and Women's Hospital, Michigan Medicine, Ann Arbor, MI, United States.""}, {'ForeName': 'Bailey H', 'Initials': 'BH', 'LastName': 'Brown', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Faraz N', 'Initials': 'FN', 'LastName': 'Longi', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Katelyn P', 'Initials': 'KP', 'LastName': 'Monaghan', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Bauer', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Varun G', 'Initials': 'VG', 'LastName': 'Kathawate', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Jafri', 'Affiliation': 'Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Webster', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Kasperek', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Nickole L', 'Initials': 'NL', 'LastName': 'Garvey', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schwenzer', 'Affiliation': 'Office of Patient Experience, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Kiran H', 'Initials': 'KH', 'LastName': 'Lagisetty', 'Affiliation': 'Department of Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Nicholas H', 'Initials': 'NH', 'LastName': 'Osborne', 'Affiliation': 'Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Waljee', 'Affiliation': 'Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Riba', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Likosky', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Byrnes', 'Affiliation': 'Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/21350']
1132,33588227,Bifactor model of cognition in schizophrenia: Evidence for general and specific abilities.,"BACKGROUND


Despite extensive study of cognition in schizophrenia, it remains unclear as to whether cognitive deficits and their latent structure are best characterized as reflecting a generalized deficit, specific deficits, or some combination of general and specific constructs.
METHOD


To clarify latent structure of cognitive abilities, confirmatory factor analysis was used to examine the latent structure of cognitive data collected for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) for Schizophrenia study. Baseline assessment data (n = 813) were randomly divided into calibration (n = 413) and cross-validation samples (n = 400). To examine whether generalized or specific deficit models provided better explanation of the data, we estimated first-order, hierarchical, and bifactor models.
RESULTS


A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples.
CONCLUSIONS


These findings lend support for a replicable bifactor model of cognition in schizophrenia, characterized by both a general cognitive factor and specific domains. This suggests that cognitive deficits in schizophrenia might be best understood by separate general and specific contributions.",2021,"A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples.
",['schizophrenia'],[],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",[],[],813.0,0.0242855,"A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples.
","[{'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Anthony O', 'Initials': 'AO', 'LastName': 'Ahmed', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Benning', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Barchard', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'John', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA; Department of Brain Health, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA. Electronic address: daniel.allen@unlv.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.01.051']
1133,33588150,"Afatinib plus gemcitabine versus gemcitabine alone as first-line treatment of metastatic pancreatic cancer: The randomised, open-label phase II ACCEPT study of the Arbeitsgemeinschaft Internistische Onkologie with an integrated analysis of the 'burden of therapy' method.","BACKGROUND


Targeting the epidermal growth factor receptor pathway remains controversial in pancreatic cancer. Afatinib is an oral irreversible ErbB family blocker approved in non-small-cell lung cancer. This open-label, multicenter, randomised phase II trial evaluated gemcitabine plus afatinib (Gem/afatinib) versus gemcitabine (Gem) alone as first-line treatment for metastatic pancreatic cancer.
PATIENTS AND METHODS


Patients were randomised in a 2:1 ratio to either Gem (1000 mg/m 2  weekly for three weeks followed by one week of rest, repeated every four weeks) and afatinib (40 mg orally once daily) or Gem alone. Overall survival (OS) was the primary study end-point. The novel BOTh©™ methodology was implemented to derive a quantitative estimate for the 'Burden of Therapy/Toxicity' (BOTh) for each patient on every day during the clinical study.
RESULTS


One hundred nineteen patients from 25 centres were randomised, 79 patients for Gem/afatinib and 40 for Gem. Median OS was 7.3 months in the Gem/afatinib arm versus 7.4 months in the Gem-alone arm (hazard ratio [HR]: 1.06, p = 0.80). Median progression-free survival was identical in both arms (3.9 months versus 3.9 months, HR: 0.85, p = 0.43). Adverse events were more frequent in the Gem/afatinib arm, especially diarrhoea (71% vs. 13%) and skin rash (65% vs. 5%). The BOTh©™ analysis revealed a significantly higher burden of toxicity in the combination arm (p = 0.0005).
CONCLUSION


The addition of afatinib to Gem did not improve treatment efficacy and was more toxic. The BOTh©™ methodology allowed a detailed insight into the course of treatment-related adverse events over the study period. The trial was registered at clinicaltrials.gov (NCT01728818) and Eudra-CT (2011-004063-77).",2021,"Adverse events were more frequent in the Gem/afatinib arm, especially diarrhoea (71% vs. 13%) and skin rash (65% vs. 5%).","['One hundred nineteen patients from 25 centres were randomised, 79 patients for Gem/afatinib and 40 for Gem', 'metastatic pancreatic cancer', 'Patients']","['gemcitabine alone', 'afatinib (40\xa0mg orally once daily) or Gem alone', 'Gem', 'gemcitabine plus afatinib (Gem/afatinib) versus gemcitabine (Gem) alone', 'Afatinib', 'Afatinib plus gemcitabine']","['skin rash', 'Overall survival (OS', 'Median OS', 'Adverse events', 'burden of toxicity', 'diarrhoea', 'Median progression-free survival']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",119.0,0.0472573,"Adverse events were more frequent in the Gem/afatinib arm, especially diarrhoea (71% vs. 13%) and skin rash (65% vs. 5%).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany. Electronic address: michael.haas@med.uni-muenchen.de.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Waldschmidt', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stahl', 'Affiliation': 'Department of Medical Oncology, Evang. Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reinacher-Schick', 'Affiliation': 'Department of Hematology and Oncology, St. Josef Hospital, Ruhr University Bochum, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Freiberg-Richter', 'Affiliation': 'Practice for Hematology and Oncology, Dresden, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Department of Oncology, Gesundheitszentrum St. Marien, Amberg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'VK & K Studien GbR, Landshut, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kanzler', 'Affiliation': 'Department of Internal Medicine II, Leopoldina Krankenhaus Schweinfurt, Schweinfurt, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Frickhofen', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Helios Dr. Horst-Schmidt-Kliniken, Wiesbaden, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Department of Internal Medicine I, University of Ulm, Ulm, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dechow', 'Affiliation': 'Practice for Hematology and Oncology, Ravensburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mahlberg', 'Affiliation': 'Department of Internal Medicine I, Klinikum Mutterhaus der Borromaeerinnen, Trier, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Malfertheiner', 'Affiliation': 'Otto von Guericke University Magdeburg, Clinic of Gastroenterology, Hepatology, and Infectious Diseases, Magdeburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Illerhaus', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kubicka', 'Affiliation': 'Cancer Center Reutlingen, Reutlingen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abdul-Ahad', 'Affiliation': 'BoTh Analytics GmbH, Munich, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Snijder', 'Affiliation': 'BoTh Analytics GmbH, Munich, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kruger', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Westphalen', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'von Bergwelt-Baildon', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boeck', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.12.029']
1134,33596938,"Insulin treatment improves liver histopathology and decreases expression of inflammatory and fibrogenic genes in a hyperglycemic, dyslipidemic hamster model of NAFLD.","BACKGROUND


Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are highly prevalent comorbidities in patients with Type 2 diabetes. While many of these patients eventually will need treatment with insulin, little is known about the effects of insulin treatment on histopathological parameters and hepatic gene expression in diabetic patients with co-existing NAFLD and NASH. To investigate this further, we evaluated the effects of insulin treatment in NASH diet-fed hamsters with streptozotocin (STZ) -induced hyperglycemia.
METHODS


Forty male Syrian hamsters were randomized into four groups (n = 10/group) receiving either a NASH-inducing (high fat, fructose and cholesterol) or control diet (CTRL) for four weeks, after which they were treated with STZ or sham-injected and from week five treated with either vehicle (CTRL, NASH, NASH-STZ) or human insulin (NASH-STZ-HI) for four weeks by continuous s.c. infusion via osmotic minipumps.
RESULTS


NASH-STZ hamsters displayed pronounced hyperglycemia, dyslipidemia and more severe liver pathology compared to both CTRL and NASH groups. Insulin treatment attenuated dyslipidemia in NASH-STZ-HI hamsters and liver pathology was considerably improved compared to the NASH-STZ group, with prevention/reversal of hepatic steatosis, hepatic inflammation and stellate cell activation. In addition, expression of inflammatory and fibrotic genes was decreased compared to the NASH-STZ group.
CONCLUSIONS


These results suggest that hyperglycemia is important for development of inflammation and profibrotic processes in the liver, and that insulin administration has beneficial effects on liver pathology and expression of genes related to inflammation and fibrosis in a hyperglycemic, dyslipidemic hamster model of NAFLD.",2021,"Insulin treatment attenuated dyslipidemia in NASH-STZ-HI hamsters and liver pathology was considerably improved compared to the NASH-STZ group, with prevention/reversal of hepatic steatosis, hepatic inflammation and stellate cell activation.","['diabetic patients with co-existing NAFLD and NASH', 'patients with Type 2 diabetes', 'Forty male Syrian hamsters']","['Insulin treatment', 'NASH-inducing (high fat, fructose and cholesterol) or control diet (CTRL', 'NASH-STZ', 'streptozotocin (STZ', 'STZ or sham-injected and from week five treated with either vehicle (CTRL, NASH, NASH-STZ) or human insulin (NASH-STZ-HI']","['liver histopathology and decreases expression of inflammatory and fibrogenic genes', 'expression of inflammatory and fibrotic genes', 'hyperglycemia, dyslipidemia and more severe liver pathology', 'hepatic steatosis, hepatic inflammation and stellate cell activation', 'dyslipidemia in NASH-STZ-HI hamsters and liver pathology']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018561', 'cui_str': 'Mesocricetus auratus'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0038432', 'cui_str': 'Streptozocin'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205141', 'cui_str': 'Stellate'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0038432', 'cui_str': 'Streptozocin'}, {'cui': 'C0018557', 'cui_str': 'Subfamily Cricetinae'}]",40.0,0.0224061,"Insulin treatment attenuated dyslipidemia in NASH-STZ-HI hamsters and liver pathology was considerably improved compared to the NASH-STZ group, with prevention/reversal of hepatic steatosis, hepatic inflammation and stellate cell activation.","[{'ForeName': 'Victoria Svop', 'Initials': 'VS', 'LastName': 'Jensen', 'Affiliation': 'Section of Experimental Animal Models, Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Ridebanevej 9, 1870, Frederiksberg, Denmark. victoriasvop@gmail.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fledelius', 'Affiliation': 'Diabetes Pharmacology, Novo Nordisk A/S, Novo Nordisk Park 1, 2760, Måløv, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Zachodnik', 'Affiliation': 'Diabetes Pharmacology, Novo Nordisk A/S, Novo Nordisk Park 1, 2760, Måløv, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Damgaard', 'Affiliation': 'Diabetes Pharmacology, Novo Nordisk A/S, Novo Nordisk Park 1, 2760, Måløv, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Nygaard', 'Affiliation': 'Diabetes Pharmacology, Novo Nordisk A/S, Novo Nordisk Park 1, 2760, Måløv, Denmark.'}, {'ForeName': 'Kristina Steinicke', 'Initials': 'KS', 'LastName': 'Tornqvist', 'Affiliation': 'Diabetes Pharmacology, Novo Nordisk A/S, Novo Nordisk Park 1, 2760, Måløv, Denmark.'}, {'ForeName': 'Rikke Kaae', 'Initials': 'RK', 'LastName': 'Kirk', 'Affiliation': 'Pathology & Imaging, Novo Nordisk A/S, Novo Nordisk Park 1, 2760, Måløv, Denmark.'}, {'ForeName': 'Birgitte Martine', 'Initials': 'BM', 'LastName': 'Viuff', 'Affiliation': 'Pathology & Imaging, Novo Nordisk A/S, Novo Nordisk Park 1, 2760, Måløv, Denmark.'}, {'ForeName': 'Erik Max', 'Initials': 'EM', 'LastName': 'Wulff', 'Affiliation': 'Gubra ApS, Hørsholm Kongevej 11B, 2970, Hørsholm, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lykkesfeldt', 'Affiliation': 'Section of Experimental Animal Models, Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Ridebanevej 9, 1870, Frederiksberg, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Hvid', 'Affiliation': 'Pathology & Imaging, Novo Nordisk A/S, Novo Nordisk Park 1, 2760, Måløv, Denmark.'}]",Journal of translational medicine,['10.1186/s12967-021-02729-1']
1135,33599993,Pre-oxygenation using high-flow nasal oxygen vs. tight facemask during rapid sequence induction.,"Pre-oxygenation using high-flow nasal oxygen can decrease the risk of desaturation during rapid sequence induction in patients undergoing emergency surgery. Previous studies were single-centre and often in limited settings. This randomised, international, multicentre trial compared high-flow nasal oxygen with standard facemask pre-oxygenation for rapid sequence induction in emergency surgery at all hours of the day and night. A total of 350 adult patients from six centres in Sweden and one in Switzerland undergoing emergency surgery where rapid sequence induction was required were included and randomly allocated to pre-oxygenation with 100% oxygen using high-flow nasal oxygen or a standard tight-fitting facemask. The primary outcome was the number of patients developing oxygen saturations <93% from the start of pre-oxygenation until 1 min after tracheal intubation. Data from 349 of 350 patients who entered the study were analysed (174 in the high-flow nasal oxygen group and 175 in the facemask group). No difference was detected in the number of patients desaturating <93%, five (2.9%) vs. six (3.4%) patients in the high-flow nasal oxygen and facemask group, respectively (p = 0.77). The risk of desaturation was not increased during on-call hours. No difference was seen in end-tidal carbon dioxide levels in the first breath after tracheal intubation or in the number of patients with signs of regurgitation between groups. These results confirm that high-flow nasal oxygen maintains adequate oxygen levels during pre-oxygenation for rapid sequence induction.",2021,No difference was seen in end-tidal carbon dioxide levels in the first breath after tracheal intubation or in the number of patients with signs of regurgitation between groups.,"['emergency surgery at all hours of the day and night', '350 adult patients from six centres in Sweden and one in Switzerland undergoing emergency surgery where rapid sequence induction was required were included and randomly allocated to', 'patients undergoing emergency surgery', 'Data from 349 of 350 patients who entered the study were analysed (174 in the high-flow nasal oxygen group and 175 in the facemask group']","['Pre-oxygenation using high-flow nasal oxygen vs. tight facemask', 'Pre-oxygenation using high-flow nasal oxygen', 'high-flow nasal oxygen with standard facemask pre-oxygenation', 'pre-oxygenation with 100% oxygen using high-flow nasal oxygen or a standard tight-fitting facemask']","['risk of desaturation', 'number of patients developing oxygen saturations', 'end-tidal carbon dioxide levels']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0412767', 'cui_str': 'Rapid sequence induction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",350.0,0.309832,No difference was seen in end-tidal carbon dioxide levels in the first breath after tracheal intubation or in the number of patients with signs of regurgitation between groups.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sjöblom', 'Affiliation': 'Department of Physiology and Pharmacology, Section\xa0for Anesthesiology and Intensive Care, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Broms', 'Affiliation': 'South General Hospital, Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hedberg', 'Affiliation': 'Peri-operative Medicine and Intensive Care, Karolinska University Hospital Solna, Stockholm, Sweden.'}, {'ForeName': 'Å', 'Initials': 'Å', 'LastName': 'Lodenius', 'Affiliation': 'Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Furubacke', 'Affiliation': 'Linköping University Hospital, Linköping, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Henningsson', 'Affiliation': 'Karlstad Central Hospital, Karlstad, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wiklund', 'Affiliation': 'Capio St. Göran Hospital, Stockholm, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nabecker', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Theiler', 'Affiliation': 'Anaesthesia Department, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jonsson Fagerlund', 'Affiliation': 'Peri-operative Medicine and Intensive Care, Karolinska University Hospital Solna, Solna, Sweden.'}]",Anaesthesia,['10.1111/anae.15426']
1136,33526957,Privacy concerns can explain unwillingness to download and use contact tracing apps when COVID-19 concerns are high.,"Governments around the world have increasingly relied on technology to promote public health, such as using electronic health records and portable fitness devices. During the COVID-19 pandemic, ""contact tracing apps"" for smartphones have also been promoted in many countries as a way to allow public officials to facilitate contact tracing. But uptake in virtually all countries where such apps have been promoted is slow, one reason being privacy concerns. Conducting three experiments across France ( n  = 471), Australia ( n  = 202), and the United States ( n  = 1005), we explore if salient COVID-19 concerns, which intuitively should increase concerns about personal and public health, might in fact increase privacy concerns and thereby reduce uptake of contact tracing apps. Using an experimental design where we randomly assign participants to either a disease concerns or control condition, we find that salient COVID-19 concerns decrease intentions to download contact tracing apps. Mediation results reveal that greater valuations of privacy explain the lower willingness. We therefore explain why COVID-19 contact tracing apps that are promoted when the pandemic is at its peak see low levels of uptake. Our results provide policy makers with implications concerning how to promote uptake to help ""flatten the curve"" of not just the current pandemic but potentially also future ones.",2021,"Governments around the world have increasingly relied on technology to promote public health, such as using electronic health records and portable fitness devices.",[],[],[],[],[],[],,0.0279168,"Governments around the world have increasingly relied on technology to promote public health, such as using electronic health records and portable fitness devices.","[{'ForeName': 'Eugene Y', 'Initials': 'EY', 'LastName': 'Chan', 'Affiliation': 'Division of Consumer Science, Purdue University, USA.'}, {'ForeName': 'Najam U', 'Initials': 'NU', 'LastName': 'Saqib', 'Affiliation': 'Department of Marketing and Management, Laurentian University, Canada.'}]",Computers in human behavior,['10.1016/j.chb.2021.106718']
1137,33556350,A Comparative Study of Treatment Interventions for Patellar Tendinopathy: A Randomized Controlled Trial.,"OBJECTIVES


To determine the additional effect of dry needling (DN) or percutaneous needle electrolysis (PNE) combined with eccentric exercise (EE) and determine which is the most effective for patients with patellar tendinopathy (PT).
DESIGN


Blinded, randomized controlled trial, with follow-up at 10 and 22 weeks.
SETTINGS


Recruitment was performed in sport clubs. Diagnosis and intervention were conducted at San Jorge University.
PARTICIPANTS


Patients (N=48) with PT with pain for at least 3 months between the ages of 18 and 45 years.
INTERVENTIONS


Three interventions were carried out: DN and EE, PNE and EE, and EE with sham needle as the control group.
MAIN OUTCOME MEASURES


Disability was measured using the Victorian Institute of Sports Assessment Questionnaire, patellar tendon. Visual analog scale was used to measure pain over time, the Short Form-36 was used to measure quality of life, and ultrasound was used to measure structural abnormalities.
RESULTS


A total of 48 participants (42 men, 6 women; average age, 32.46y; SD, 7.14y) were enrolled. The improvement in disability and pain in each group between baseline and post-treatment and baseline and follow-up was significant (P≤.05), without differences among groups.
CONCLUSION


DN or PNE combined with an EE program has not shown to be more effective than a program of only EE to improve disability and pain in patients with PT in the short (10wk) and medium (22wk) terms. Clinical improvements were not associated with structural changes in the tendon.",2021,"The improvement in disability and pain in each group between baseline and post-treatment and baseline and follow-up was significant (p≤0.05), without differences among groups.
","['patellar tendinopathy', '48 participants (42 men and 6 women, average age 32.46 (SD 7.14) years) were enrolled', 'Patients with PT with pain ≥3 months between 18 and 45 years', 'Recruitment was performed in sport clubs', 'patients with patellar tendinopathy (PT']","['dry needling (DN) or percutaneous needle electrolysis (PNE) combined with eccentric exercise (EE', 'PNE and EE group (PNE-G) and EE with sham needle as the control group (CG']","['pain overtime, Short Form-36 to measure quality of life and ultrasound to measure structural abnormalities', 'disability and pain', 'Visual Analogue Scale', 'Disability']","[{'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2961731', 'cui_str': 'Overtime'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",48.0,0.109548,"The improvement in disability and pain in each group between baseline and post-treatment and baseline and follow-up was significant (p≤0.05), without differences among groups.
","[{'ForeName': 'María Pilar', 'Initials': 'MP', 'LastName': 'López-Royo', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Villanueva de Gállego, Zaragoza, Spain; Universidad de Zaragoza, Faculty of Health Sciences, Zaragoza, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Ríos-Díaz', 'Affiliation': 'San Juan De Dios Foundation, Health Sciences University Centre, Antonio de Nebrija University, Madrid, Spain.'}, {'ForeName': 'Rita María', 'Initials': 'RM', 'LastName': 'Galán-Díaz', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Villanueva de Gállego, Zaragoza, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'Universidad de Zaragoza, Faculty of Health Sciences, Zaragoza, Spain. Electronic address: pherrero@unizar.es.'}, {'ForeName': 'Eva María', 'Initials': 'EM', 'LastName': 'Gómez-Trullén', 'Affiliation': 'Universidad de Zaragoza, Faculty of Health Sciences, Zaragoza, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.01.073']
1138,33561565,A Rapid Review of Interventions to Prevent First Pregnancy among Adolescents and Its Applicability to Latin America.,"STUDY OBJECTIVE


To summarize recent literature on the effectiveness of interventions to prevent adolescent pregnancy and to explore the applicability of these interventions to Latin America (LA). Design, Setting, Participants, Interventions, and Main Outcome Measures: We carried out a rapid review of the literature (2005-2019). Studies were included if: they evaluated interventions targeting adolescents and prevention of pregnancy; they used a randomized controlled design; and pregnancy was measured as an outcome. Applicability of the interventions to LA was assessed using the following information: target population; intervention design and resources; type, skills, and training of providers; system arrangements; and acceptability and social context.
RESULTS


Nine studies were included, 5 described interventions in African countries, 2 in the United Kingdom, and 2 in the United States. Interventions were rated as highly applicable to LA in the context of target population, profile of the providers, and design; however, variations arose when assessing system arrangements and social context. Incentive-based interventions showed significant effects in the prevention of adolescent pregnancy and were rated as highly applicable.
CONCLUSION


This review provides professionals, policymakers, researchers, and educators potential criteria to consider when adapting successful evidence-based interventions to prevent adolescent pregnancy in LA.",2021,"Interventions were rated as highly applicable to Latin America when considering target population, profile of the providers and design; however, variations arose when assessing system arrangements and social context.",[],[],[],[],[],[],,0.101819,"Interventions were rated as highly applicable to Latin America when considering target population, profile of the providers and design; however, variations arose when assessing system arrangements and social context.","[{'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'Estrada', 'Affiliation': 'CONACYT-Instituto Nacional de Salud Pública, Mexico City, Mexico.'}, {'ForeName': 'Erika E', 'Initials': 'EE', 'LastName': 'Atienzo', 'Affiliation': 'Independent Research Consultant, Hermosillo, Mexico. Electronic address: eatienzo@ibisreproductivehealth.org.'}, {'ForeName': 'Lizeth', 'Initials': 'L', 'LastName': 'Cruz-Jiménez', 'Affiliation': 'Reproductive Health Division, Centre for Population Health Research, National Institute of Public Health, Mexico City, Mexico.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Campero', 'Affiliation': 'Reproductive Health Division, Centre for Population Health Research, National Institute of Public Health, Morelos, Mexico.'}]",Journal of pediatric and adolescent gynecology,['10.1016/j.jpag.2021.01.022']
1139,33571839,Hysteroscopic morcellation versus bipolar resection for removal of type 0 and 1 submucous myomas: A randomized trial.,"OBJECTIVES


To compare hysteroscopic morcellation with bipolar resection for the removal of submucous type 0 and 1 myomas, in terms of procedure time (primary outcome), adverse events, tissue availability, short term effectiveness and postoperative adhesion formation (secondary outcomes).
STUDY DESIGN


The study was performed from May 2011 to May 2018 in the Catharina hospital (Eindhoven, the Netherlands) and the Ghent University hospital (Ghent, Belgium). Women with type 0 and 1 submucous myomas up to 3 cm were randomized to hysteroscopic morcellation with the TruClear TM  8.0 Tissue Removal System or to bipolar resection with a rigid 8.5-mm resectoscope. Skewed time variables were log-transformed and analyzed with the Student t-test. Multiple linear regression analysis was performed to assess the effect of myoma diameter on operating time.
RESULTS


Forty-five and 38 women were included in the hysteroscopic morcellation and resection group, respectively. The median operating time was significantly shorter for hysteroscopic morcellation compared with resection (9.2 min [interquartile range 5.6-14.4] versus 13.4 min [interquartile range 8.6-17.5], P = .04). In the morcellation group, operating time, corrected for the myoma diameter, was reduced by 26 % (95 % CI 5-43%; P = .02). The median setup time was significantly longer in the morcellation group (5.2 min [interquartile range 4.2-6.9] versus 3.8 min [interquartile range 3.3-5.3], P = .006). The median total procedure time was not significantly different between the two techniques (14.4 min [interquartile range 11.4-19.2] versus 17.3 [interquartile range 12.7-23.8], P = .18). Two procedures of the morcellation group were converted to bipolar resection because of the myoma hardness. Complete resection was found in 89 % of the morcellation group and 95 % of the resection group. Adverse events occurred in 3 patients of the morcellation group, namely a fluid deficit > 2500 mL with the need of potassium suppletion, an asystolic vasovagal response after conversion to resection and postoperative fever requiring antibiotics. Tissue was available for pathology analysis in all cases. Routine second-look hysteroscopy performed in one center showed no intrauterine adhesions.
CONCLUSION


Overall, there is no difference in total procedure time between hysteroscopic morcellation using the TruClear TM  system compared to bipolar resection for the removal of smaller type 0 and 1 submucous myomas. Although hysteroscopic morcellation is faster, its setup time is longer. Calcified myomas can be challenging and fluid deficit remains a limiting factor.",2021,"Overall, there is no difference in total procedure time between hysteroscopic morcellation using the TruClear TM  system compared to bipolar resection for the removal of smaller type 0 and 1 submucous myomas.","['Women with type 0 and 1 submucous myomas up to 3 cm', '2011 to May 2018 in the Catharina hospital (Eindhoven, the Netherlands) and the Ghent University hospital (Ghent, Belgium', 'Forty-five and 38 women were included in the hysteroscopic morcellation and resection group, respectively']","['Routine second-look hysteroscopy', 'Hysteroscopic morcellation versus bipolar resection', 'hysteroscopic morcellation with the TruClear TM  8.0 Tissue Removal System or to bipolar resection with a rigid 8.5-mm resectoscope', 'hysteroscopic morcellation', 'hysteroscopic morcellation with bipolar resection']","['median operating time', 'Complete resection', 'median setup time', 'adverse events, tissue availability, short term effectiveness and postoperative adhesion formation (secondary outcomes', 'asystolic vasovagal response', 'total procedure time', 'operating time, corrected for the myoma diameter', 'Adverse events', 'median total procedure time', 'intrauterine adhesions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0949626', 'cui_str': 'Incision and reexploration for second look'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001510', 'cui_str': 'Postoperative adhesion'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}]",,0.120602,"Overall, there is no difference in total procedure time between hysteroscopic morcellation using the TruClear TM  system compared to bipolar resection for the removal of smaller type 0 and 1 submucous myomas.","[{'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'van Wessel', 'Affiliation': ""Women's Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium. Electronic address: steffi.vanwessel@ugent.be.""}, {'ForeName': 'Hubertus A A M', 'Initials': 'HAAM', 'LastName': 'van Vliet', 'Affiliation': 'Department of Obstetrics and Gynecology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.'}, {'ForeName': 'Benedictus C', 'Initials': 'BC', 'LastName': 'Schoot', 'Affiliation': ""Women's Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium; Department of Obstetrics and Gynecology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Weyers', 'Affiliation': ""Women's Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.""}, {'ForeName': 'Tjalina W O', 'Initials': 'TWO', 'LastName': 'Hamerlynck', 'Affiliation': ""Women's Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2021.01.050']
1140,33571687,"Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov.","BACKGROUND


Choosing the right recruitment strategy has implications for the successful conduct of a trial. Our objective was to compare a novel peer recruitment strategy to four other recruitment strategies for a large randomized trial testing a digital tobacco intervention.
METHODS


We compared enrollment rates, demographic and baseline smoking characteristics, and odds of completing the 6-month study by recruitment strategy. Cost of recruitment strategies per retained participant was calculated using staff personnel time and advertisement costs.
FINDINGS


We enrolled 1487 participants between August 2017 and March 2019 from: Peer recruitment n = 273 (18.4%), Facebook Ads n = 505 (34%), Google Ads = 200 (13.4%), ResearchMatch n = 356 (23.9%) and Smokefree.govn = 153 (10.3%). Mean enrollment rate per active recruitment month: 1) Peer recruitment, n = 13.9, 2) Facebook ads, n = 25.3, 3) Google ads, n = 10.51, 4) Research Match, n = 59.3, and 5) Smokefree.gov, n = 13.9. Peer recruitment recruited the greatest number of males (n = 110, 40.3%), young adults (n = 41, 14.7%), participants with a high school degree or less (n = 24, 12.5%) and smokers within one's social network. Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%). Peer recruitment was moderate in cost per retained participant ($47.18) and substantially less costly than Facebook ($173.60).
CONCLUSIONS


Though peer recruitment had lower enrollment than other strategies, it may provide greater access to harder to reach populations and possibly others who smoke within one's social network while being moderately cost-effective. ClinicalTrials.gov: NCT03224520.",2021,"Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%).","[""Peer recruitment recruited the greatest number of males (n\u202f=\u202f110, 40.3%), young adults (n\u202f=\u202f41, 14.7%), participants with a high school degree or less (n\u202f=\u202f24, 12.5%) and smokers within one's social network"", 'We enrolled 1487 participants between August 2017 and March 2019 from: Peer recruitment n\u202f=\u202f273 (18.4']","['digital tobacco intervention', 'Facebook Ads']","['Mean enrollment rate per active recruitment month: 1) Peer recruitment, n\u202f=\u202f13.9, 2']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517562', 'cui_str': '13.9'}]",1487.0,0.147848,"Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%).","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Faro', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States. Electronic address: Jamie.faro@umassmed.edu.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Nagawa', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Orvek', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Bridget M', 'Initials': 'BM', 'LastName': 'Smith', 'Affiliation': 'Center of Innovation for Complex Chronic Healthcare (CINCCH), Spinal Cord Injury Quality Enhancement Research Initiative (QUERI), Hines VAMC, Chicago, IL, United States; Department of Pediatrics and Center for Community Health, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Blok', 'Affiliation': 'Department of Systems, Populations and Leadership, University of Michigan School of Nursing, Ann Arbor, MI, United States.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC, United States.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Kamberi', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Sharina D', 'Initials': 'SD', 'LastName': 'Person', 'Affiliation': 'Division of Biostatistics and Health Services Research, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Rajani S', 'Initials': 'RS', 'LastName': 'Sadasivam', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106314']
1141,33578226,Early vs. late enoxaparin for the prevention of venous thromboembolism in patients with ICH: A double blind placebo controlled multicenter study.,"BACKROUND


Venous thromboembolism (VTE) after primary intracerebral hemorrhage (ICH) worsens patient prognosis. Administering low-molecular weight heparins (LMWH) to prevent VTE early (24 h) may increase the risk of hematoma enlargement, whereas administering late (72 h) after onset may decrease its effect on VTE prevention. The authors investigated when it is safe and effective to start LMWH in ICH patients.
METHODS


In the setting of double blinded, placebo controlled randomization, patients >18 years of age with paretic lower extremity, and admitted to the emergency room within 12 h of the onset of ICH, were randomized into two groups. Patients in the enoxaparin group received 20 mg twice a day 24 h (early) after the onset of ICH and in the placebo group 72 h (late) after onset respectively. Both groups immediately received intermittent pneumatic compression stockings at the ER. Patients were prospectively and routinely screened for VTE and hemorrhagic complications 1 day after entering the study and again before discharge.
RESULTS


139 patients were included for randomization in this study. Only 3 patients developed VTE, 2 in the early enoxaparin group and one in the late enoxaparin group. No patients developed PE. Thromboembolic events (p = 0.901), risk of hematoma enlargement (p = 0.927) and overall outcome (P = 0.904) did not differ significantly between the groups.
CONCLUSION


Administering 40 mg/d LMWH for prevention of VTE to a spontaneous ICH patient is safe regardless of whether it is started 24 h (early) or 72 h (late) after the hemorrhage. Risk of hemorrhage enlargement is not associated with early LMWH treatment. Administering LMWH late did not increase VTEs.",2021,"Thromboembolic events (p = 0.901), risk of hematoma enlargement (p = 0.927) and overall outcome (P = 0.904) did not differ significantly between the groups.
","['139 patients were included for randomization in this study', 'patients with ICH', 'primary intracerebral hemorrhage (ICH) worsens patient prognosis', 'patients >18 years of age with paretic lower extremity, and admitted to the emergency room within 12 h of the onset of ICH']","['Administering low-molecular weight heparins (LMWH', 'intermittent pneumatic compression stockings', 'enoxaparin', 'placebo']","['risk of hematoma enlargement', 'PE', 'overall outcome', 'Thromboembolic events', 'VTEs', 'venous thromboembolism']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1287404', 'cui_str': 'Prognosis/outlook finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C2711456', 'cui_str': 'Intermittent pneumatic compression stockings'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",139.0,0.311758,"Thromboembolic events (p = 0.901), risk of hematoma enlargement (p = 0.927) and overall outcome (P = 0.904) did not differ significantly between the groups.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Department of Neurosurgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huhtakangas', 'Affiliation': 'Department of Neurology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Juvela', 'Affiliation': 'Department of Clinical Neurosciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Bode', 'Affiliation': 'Department of Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tatlisumak', 'Affiliation': 'Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland; Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Savolainen', 'Affiliation': 'Department of Clinical Neurosciences, University of Helsinki, Helsinki, Finland; Department of Neurology, South Karelian Central Hospital, Lappeenranta, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Numminen', 'Affiliation': 'Department of Neurology, Tampere University Hospital, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ollikainen', 'Affiliation': 'Department of Neurology, Tampere University Hospital, Finland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Luostarinen', 'Affiliation': 'Department of Neurology, Päijät-Häme Central Hospital, Finland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kupila', 'Affiliation': 'Department of Neurology, Päijät-Häme Central Hospital, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tetri', 'Affiliation': 'Department of Neurosurgery, Oulu University Hospital, Oulu, Finland. Electronic address: sami.tetri@ppshp.fi.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106534']
1142,33578224,The development and efficacy of a mobile phone application to improve medication adherence for persons with epilepsy in limited resource settings: A preliminary study.,"OBJECTIVE


Persons with epilepsy (PWE), especially those with limited education backgrounds from developing countries, are challenged by complicated medication regimens, debilitating seizures, and stigmatization in their daily life. Consequently, it is difficult for physicians to ensure medication adherence. This study validates a novel mobile application which was hypothesized to increase medication adherence and self-management skills in PWE. Created by medical professionals, the application included behavioral and educational components and was built to be easy-to-understand for those of socio-economically disadvantaged backgrounds.
METHODS


This was a parallel, two-armed randomized controlled trial in which a total of 96 participants were enrolled from a Neurology Outpatient Department into a control standard care group and a mobile application group that used the smartphone application (app) in addition to the standard medical treatment. The app was intuitive and easy to understand for those coming from a socio-economically disadvantaged background. Medication adherence and self-efficacy were assessed with the Morisky Green and Levine Scale (MGLS) and the Epilepsy Self Efficacy Scale (ESES). Patients were reassessed 12 weeks later. Change in seizure frequency following administration of the application was a secondary outcome.
RESULTS


In an intent-to-treat analysis, the mobile application interventional group showed over a 60% increase in the proportion of medication adherence (P < 0.0001). The mean self-efficacy score for the mobile application group was increased from 269.5 to 289.75 (P < 0.0001). The control group showed no statistically significant increases in either the proportion adherent or mean self-efficacy scores.
SIGNIFICANCE


This study demonstrated the statistically significant performance of a mobile application in improving medication adherence and self-management skills in Indian persons with epilepsy.",2021,The mean self-efficacy score for the mobile application group was increased from 269.5 to 289.75,"['Indian persons with epilepsy', 'Persons with epilepsy (PWE', 'persons with epilepsy in limited resource settings', '96 participants were enrolled from a Neurology Outpatient Department into a']","['mobile phone application', 'control standard care group and a mobile application group that used the smartphone application (app) in addition to the standard medical treatment']","['mean self-efficacy score', 'proportion adherent or mean self-efficacy scores', 'medication adherence and self-management skills', 'Medication adherence and self-efficacy', 'seizure frequency', 'medication adherence', 'Morisky Green and Levine Scale (MGLS) and the Epilepsy Self Efficacy Scale (ESES', 'proportion of medication adherence']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]",96.0,0.0382893,The mean self-efficacy score for the mobile application group was increased from 269.5 to 289.75,"[{'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Mirpuri', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'P Prarthana', 'Initials': 'PP', 'LastName': 'Chandra', 'Affiliation': 'Hamdard Institute of Medical Sciences and Research, New Delhi, India.'}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Samala', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Doddamani', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kirandeep', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Department of Neurology, All India Institute of Medical Sciences, New Delhi, India; MEG Facility, National Brain Research Centre, Manesar, Haryana, India.'}, {'ForeName': 'Bhargavi', 'Initials': 'B', 'LastName': 'Ramanujan', 'Affiliation': 'Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'P Sarat', 'Initials': 'PS', 'LastName': 'Chandra', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Manjari', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'Department of Neurology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: mantriaiims@gmail.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107794']
1143,33578191,Subgroup analysis of clinical and MRI outcomes in participants with a first clinical demyelinating event at risk of multiple sclerosis in the ORACLE-MS study.,"BACKGROUND


In the Phase 3, 96-week ORACLE-MS study, cladribine 10 mg tablets (3.5 mg/kg or 5.25 mg/kg cumulative dose over 2 years) significantly reduced the rate of conversion to clinically definite multiple sclerosis (CDMS) per the Poser criteria (henceforth referred to as CDMS), multiple sclerosis (MS) per the 2005 McDonald criteria, and the number of new or persisting T1 gadolinium-enhancing (Gd+), new or enlarging T2, and combined unique active (CUA) lesions versus placebo in participants with a first clinical demyelinating event (FCDE). Patient demographic and disease characteristics may be predictors of disease progression. The current study analyzed the effect of cladribine tablets in subgroups of participants in the ORACLE-MS study by baseline demographics and disease characteristics.
METHODS


This analysis retrospectively examined data collected from 616 participants enrolled in the ORACLE-MS study (placebo, n=206; cladribine tablets 3.5 mg/kg, n=206; cladribine tablets 5.25 mg/kg, n=204). Five subgroups were predetermined by baseline demographics, including sex, age (<30 or ≥30 years), classification of FCDE, and lesion characteristics, including absence or presence of T1 Gd+ lesions and number of T2 lesions (<9 or ≥9). Selected endpoints of the ORACLE-MS study were re-analyzed for these subgroups. The primary and main secondary endpoints were time to conversion to CDMS and MS (2005 McDonald criteria), respectively. Secondary magnetic resonance imaging (MRI) endpoints included cumulative T1 Gd+ and new or enlarging T2 lesions. Cox proportional hazards models were used to evaluate time to conversion to CDMS and MS (2005 McDonald criteria). This analysis focused primarily on the results for the cladribine tablets 3.5 mg/kg group because this dosage is approved for relapsing forms of MS.
RESULTS


In the overall intent-to-treat (ITT) population, cladribine tablets 3.5 mg/kg significantly reduced the risk of conversion to CDMS (hazard ratio [HR]=0.326; P<0.0001) and MS (2005 McDonald criteria; HR=0.485; P<0.0001) versus placebo. Similar effects of cladribine tablets on risk of conversion were observed in post hoc analyses of subgroups defined by various baseline characteristics. In both the ITT population and across subgroups, cladribine tablets 3.5 mg/kg reduced the numbers of cumulative T1 Gd+ (range of rate ratios: 0.106-0.399), new or enlarging T2 (range of rate ratios: 0.178-0.485), and CUA (range of rate ratios: 0.154-0.384) lesions versus placebo (all nominal P<0.03). Multivariate Cox proportional hazards models revealed that age (HR=0.577, nominal P<0.0001), FCDE classification (HR=0.738, nominal P=0.0043), presence of T1 Gd+ lesions (HR=0.554, nominal P<0.0001), and number of T2 lesions (HR=0.417, nominal P<0.0001) at baseline were factors associated with risk of conversion to MS (2005 McDonald criteria), whereas no baseline factors examined were associated with risk of conversion to CDMS.
CONCLUSION


In this post hoc analysis of the ORACLE-MS study, cladribine tablets reduced the risk of conversion to multiple sclerosis and lesion burden in participants with an FCDE in the overall ITT population and multiple subgroups defined by baseline demographics and lesion characteristics.",2020,"Multivariate Cox proportional hazards models revealed that age (HR=0.577, nominal P<0.0001), FCDE classification (HR=0.738, nominal P=0.0043), presence of T1 Gd+ lesions (HR=0.554, nominal P<0.0001), and number of T2 lesions (HR=0.417, nominal P<0.0001) at baseline were factors associated with risk of conversion to MS (2005 McDonald criteria), whereas no baseline factors examined were associated with risk of conversion to CDMS.
","['participants with a first clinical demyelinating event at risk of multiple sclerosis in the ORACLE-MS study', '616 participants enrolled in the ORACLE-MS study (placebo, n=206; cladribine tablets 3.5 mg/kg, n=206', 'participants with a first clinical demyelinating event (FCDE', 'Five subgroups were predetermined by baseline demographics, including sex, age (<30 or ≥30 years), classification of FCDE, and lesion characteristics, including absence or presence of T1 Gd+ lesions and number of T2 lesions (<9 or ≥9', 'subgroups of participants in the ORACLE-MS study by baseline demographics and disease characteristics']","['placebo', 'cladribine tablets', 'Secondary magnetic resonance imaging (MRI', 'cladribine']","['FCDE classification', 'number of T2 lesions', 'risk of conversion to CDMS', 'risk of conversion', 'rate of conversion', 'numbers of cumulative T1 Gd', 'risk of conversion to multiple sclerosis and lesion burden', 'presence of T1 Gd+ lesions', 'cumulative T1 Gd+ and new or enlarging T2 lesions', 'time to conversion to CDMS and MS']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",616.0,0.133533,"Multivariate Cox proportional hazards models revealed that age (HR=0.577, nominal P<0.0001), FCDE classification (HR=0.738, nominal P=0.0043), presence of T1 Gd+ lesions (HR=0.554, nominal P<0.0001), and number of T2 lesions (HR=0.417, nominal P<0.0001) at baseline were factors associated with risk of conversion to MS (2005 McDonald criteria), whereas no baseline factors examined were associated with risk of conversion to CDMS.
","[{'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'UCSF Weill Institute for Neurosciences, San Francisco, CA, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Bowen', 'Affiliation': 'Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, WA, USA.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, University Hospital of Düsseldorf, Medical Faculty, Heinrich-Heine-Universität, Düsseldorf, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'University of Lille, INSERM U1172, Lille Neurosciences and Cognition, CHU Lille, FHU Imminent, F-59000 Lille, France.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Hughes', 'Affiliation': 'MercyOne Ruan Multiple Sclerosis Center, Des Moines, IA, USA.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Damian', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Hyvert', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Dangond', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Galazka', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Grosso', 'Affiliation': 'EMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'EMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Leist', 'Affiliation': 'Comprehensive Multiple Sclerosis Center, Jefferson University, Philadelphia, PA, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102695']
1144,33577989,Author queries via email text elicited high response and took less reviewer time than data forms - a randomised study within a review.,"OBJECTIVE


To compare two strategies for requesting additional information for systematic reviews (SR) from study authors.
STUDY DESIGN AND SETTING


Randomised study within a SR of hospital volume-outcome relationships in total knee arthroplasty. We sent personalized email requests for additional information to study authors as either email text (""Email"" group) or attachment with self-developed, personalised data request forms (""Attachment"" group). The primary outcome was the response rate, the secondary outcomes were the data completeness rate and the reviewer time invested in author contact.
RESULTS


Of 57 study authors, 29 were randomised to the Email group and 28 to the Attachment group. The response rate was 93% for Email and 75% for Attachment (odds ratio 4.5, 95% confidence interval [0.9-24.0]). Complete data were provided by 55% (Email) vs. 36% (Attachment) of authors (odds ratio 2.2 [0.8-6.4]). The mean reviewer time was shorter in the Email (mean ± standard deviation of 20.2±14.4 minutes/author) than the Attachment group (31.8±14.4 minutes/author) with a mean difference of 11.6 [4.1-19.1] minutes/author.
CONCLUSION


Personalised email requests elicited high response but only moderate data completeness rates regardless of the method (email text or attachment). Email requests as text took less reviewer time than creating attachments.",2021,Personalised email requests elicited high response but only moderate data completeness rates regardless of the method (email text or attachment).,"['total knee arthroplasty', 'Of 57 study authors, 29 were randomised to the Email group and 28 to the Attachment group']",[],"['response rate', 'mean reviewer time', 'data completeness rate and the reviewer time invested in author contact']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.17283,Personalised email requests elicited high response but only moderate data completeness rates regardless of the method (email text or attachment).,"[{'ForeName': 'Käthe', 'Initials': 'K', 'LastName': 'Goossen', 'Affiliation': 'Institute for Research in Operative Medicine (IFOM), Faculty of Health, School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109 Cologne, Germany. Electronic address: kaethe.goossen@uni-wh.de.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Rombey', 'Affiliation': 'Institute for Research in Operative Medicine (IFOM), Faculty of Health, School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109 Cologne, Germany.'}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Kugler', 'Affiliation': 'Institute for Research in Operative Medicine (IFOM), Faculty of Health, School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109 Cologne, Germany.'}, {'ForeName': 'Karina K', 'Initials': 'KK', 'LastName': 'De Santis', 'Affiliation': 'Institute for Research in Operative Medicine (IFOM), Faculty of Health, School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109 Cologne, Germany; Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstr. 30, 28359 Bremen, Germany.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Pieper', 'Affiliation': 'Institute for Research in Operative Medicine (IFOM), Faculty of Health, School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109 Cologne, Germany.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2021.02.006']
1145,33583424,Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)-study protocol for a randomised controlled trial.,"INTRODUCTION


Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis.
METHODS


The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle.
DISCUSSION


We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients' relapse management.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04233970 . Registered on 18 January 2020.",2021,The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment.,"['people with multiple sclerosis', '188 people with possible or relapsing-remitting multiple sclerosis with ≥\u20091 relapse within the last year and/or ≥\u20092 relapses within the last 2\xa0years']","['placebo', 'web-based relapse management programme', 'web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum', 'oral corticosteroids', 'interactive web-based decision-making programme']","['annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness', 'proportion of relapses not treated or treated with oral corticosteroids']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",188.0,0.153948,The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment.,"[{'ForeName': 'Anne Christin', 'Initials': 'AC', 'LastName': 'Rahn', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. anne.christin.rahn@uni-oldenburg.de.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stahmann', 'Affiliation': 'MS Forschungs- und Projektentwicklungs-gGmbH, Hannover, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Scheiderbauer', 'Affiliation': 'Stiftung für Selbstbestimmung und Selbstvertretung von MS-Betroffenen, Trier, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Grentzenberg', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vomhof', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Montalbo', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical, Göttingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heesen', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute of Nursing Science, University Hospital Cologne and Faculty of Medicine, University of Cologne, Cologne, Germany.'}]",Trials,['10.1186/s13063-021-05059-1']
1146,33587782,The effect of motor and cognitive placebos on the serial reaction time task.,"Motor learning is a key component of human motor functions. Repeated practice is essential to gain proficiency over time but may induce fatigue. The aim of this study was to determine whether motor performance and motor learning (as assessed with the serial reaction time task, SRTT) and perceived fatigability (as assessed with subjective scales) are improved after two types of placebo interventions (motor and cognitive). A total of 90 healthy volunteers performed the SRTT with the right hand in three sessions (baseline, training and final). Before the training and the final session, one group underwent a motor-related placebo intervention in which inert electrical stimulation (TENS) was applied over the hand and accompanied by verbal suggestion that it improves movement execution (placebo-TENS). The other group underwent a cognitive-related placebo intervention in which sham transcranial direct current stimulation (tDCS) was delivered to the supraorbital area and accompanied by verbal suggestion that it increases attention (placebo-tDCS). A control group performed the same task without receiving treatment. Overall better performance on the SRTT (not ascribed to sequence-specific learning) was noted for the placebo-TENS group, which also reported less perceived fatigability at the physical level. The same was observed in a subgroup tested 24 hr later. The placebo-tDCS group reported less perceived fatigability, both at the mental and physical level. These findings indicate that motor- and cognitive-related placebo effects differently shape motor performance and perceived fatigability on a repeated motor task.",2021,"Overall better performance on the SRTT (not ascribed to sequence-specific learning) was noted for the placebo-TENS group, which also reported less perceived fatigability at the physical level.",['90 healthy volunteers'],"['Motor learning', 'motor-related placebo intervention in which inert electrical stimulation (TENS) was applied over the hand and accompanied by verbal suggestion that it improves movement execution (placebo-TENS', 'placebo-tDCS', 'cognitive-related placebo intervention in which sham transcranial direct current stimulation (tDCS', 'motor and cognitive placebos']","['motor performance and motor learning', 'serial reaction time task', 'serial reaction time task, SRTT) and perceived fatigability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}]",90.0,0.108468,"Overall better performance on the SRTT (not ascribed to sequence-specific learning) was noted for the placebo-TENS group, which also reported less perceived fatigability at the physical level.","[{'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Villa-Sánchez', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Emadi Andani', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cesari', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Fiorio', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}]",The European journal of neuroscience,['10.1111/ejn.15148']
1147,33589575,Development and validation of RNA binding protein-applied prediction model for gastric cancer.,"RNA-binding proteins (RBPs) have been reported to be associated with the occurrence and progression of multiple cancers, but the role in gastric adenocarcinoma remains poorly understood. The present study aims to uncover potential RBPs associated with the survival of gastric adenocarcinoma, as well as corresponding biologic properties and signaling pathways of these RBPs. RNA sequencing and clinical data of GC were obtained from The Cancer Genome Atlas (n=373) and the Gene Expression Omnibus (GSE84437, n=433) database. Tumor samples in TCGA were randomly divided into the training and internal testing group by R software. A total of 238 DERBPs were selected for univariate and multivariate Cox regression analyses. Five pivotal RBP genes (RNASE2, METTL1, ANG, YBX2 and LARP6) were screened out and were used to construct a new prognostic model. Survival relevance and prediction accuracy of model were tested via Kaplan-Meier (K-M) curves and receiver operating characteristic (ROC) curves in internal and external testing groups. Further analysis has also showed that this model could serve as an independent prognosis-related parameter. A prognostic nomogram has been eventually developed, and presents a good performance of prediction.",2021,"Five pivotal RBP genes (RNASE2, METTL1, ANG, YBX2 and LARP6) were screened out and were used to construct a new prognostic model.","['gastric cancer', 'Tumor samples in TCGA']",[],"['Survival relevance', 'Kaplan-Meier (K-M) curves and receiver operating characteristic (ROC) curves']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",238.0,0.015527,"Five pivotal RBP genes (RNASE2, METTL1, ANG, YBX2 and LARP6) were screened out and were used to construct a new prognostic model.","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Zi-Han', 'Initials': 'ZH', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Lung Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Zhi-Wu', 'Initials': 'ZW', 'LastName': 'Wang', 'Affiliation': ""Department of Chemoradiotherapy, Tangshan People's Hospital, Tangshan 063000, P.R. China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, Lung Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}]",Aging,['10.18632/aging.202483']
1148,33589569,The joint effect of energy reduction with calcium supplementation on the risk factors of type 2 diabetes in the overweight population: a two-year randomized controlled trial.,"Both excessive energy intake and low calcium intake are inversely associated with the aging-related diseases, particularly for type 2 diabetes mellitus(T2DM). This study examined whether energy reduction coupled with calcium supplementation aided in the prevention of T2DM among the overweight population. A randomized controlled trial(RCT) of 1021 overweight participants was performed, in which participants were randomly assigned to 4 groups: 1) energy-reduction group(ERG), 2) calcium supplementation group(CSG), 3) energy-reduction with calcium supplementation group(ER-CSG), 4) control group(CG). Nutritional habits, anthropometric and diabetes-related indicators were measured at baseline and each follow-up time. To analyze the separate effects of dietary energy reduction and calcium supplementation, ERG and ER-CSG were integrated into ERGs. Similarly, CSG and ER-CSG were integrated into CSGs. Compared to the non-energy-reduction groups(NERGs), ERGs had lower values of ΔBMI(-0.9kg/m 2 ), ΔFSG (-0.34mmol/L), ΔHbA1c(0.16%), and ΔHOMA-IR(-0.13), and higher value of ΔGutt index(-5.82). Compared to the non-calcium supplementation groups(NCSGs), the ΔGutt index(-5.46) in CSGs showed a significant decrease. Moreover, these risk factors for T2DM were most effectively ameliorated in ER-CSG group with the decreased values of ΔFSG(-0.42mmol/L), ΔGutt index(-0.73), and the slowest increasing rate value of Δ2h-glucose(0.37mmol/L). This RCT demonstrated that energy-reduction with calcium supplementation was a useful dietary intervention strategy for preventing the development of T2DM in the overweight population.",2021,"Compared to the non-calcium supplementation groups(NCSGs), the ΔGutt index(-5.46) in CSGs showed a significant decrease.","['type 2 diabetes in the overweight population', '1021 overweight participants', 'T2DM among the overweight population']","['calcium supplementation', 'energy-reduction group(ERG), 2) calcium supplementation group(CSG), 3) energy-reduction with calcium supplementation group(ER-CSG), 4) control group(CG', 'dietary energy reduction and calcium supplementation, ERG and ER-CSG']",[],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}]",[],1021.0,0.0235172,"Compared to the non-calcium supplementation groups(NCSGs), the ΔGutt index(-5.46) in CSGs showed a significant decrease.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Huanyu', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Haiyang', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Guili', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Qingrao', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Postgraduate, The Third Affiliated Hospital of Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Xuanyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Changhao', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}]",Aging,['10.18632/aging.202485']
1149,33588138,Evaluation and comparison of the efficacy of long-acting betamethasone and dexamethasone as injections in the treatment of idiopathic sudden hearing loss.,"INTRODUCTION & OBJECTIVE


The aim of the present study was to determine the efficacy of long-acting betamethasone, and its comparison with Dexamethasone as an intratympanic injection in the treatment of Sudden Sensorineural Hearing Loss (SSNHL).
MATERIALS AND METHODS


Thirty-one patients who do not respond to systemic steroids and poor prognosis patients were enrolled in this study. The patients divided randomly into two groups: 1- Dexamethasone and 2- Long acting betamethasone. Dexamethasone (0.4 ml/mg) or long-acting betamethasone (0.1 ml/mg) was slowly injected (0.4 to 0.6 cc) into the superior-anterior area of the tympanic membrane as 6 injections twice a week for a total of 3 weeks. Right after the treatment and one, two and six months after completion of treatment, an audiometry was performed and compared with the pre-injection values.
RESULTS


Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline. Speech Discrimination Score (SDS) also improved in both groups directly after treatment and at one-month follow-up. The hearing improvement in the Dexamethasone group was clinically better than in the Beta group, but due to the non-parametric data, it was not possible to analyze the hearing improvement process in the variable group.
CONCLUSION


According to the results obtained in this study, intratympanic corticosteroid injection in the treatment of patients with SSNHL has positive and promising results on improving hearing level.",2021,"RESULTS


Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline.","['Sudden Sensorineural Hearing Loss (SSNHL', 'idiopathic sudden hearing loss', 'Thirty-one patients who do not respond to systemic steroids and poor prognosis patients']","['betamethasone', 'Dexamethasone (0.4\xa0ml/mg) or long-acting betamethasone', 'Dexamethasone and 2- Long acting betamethasone', 'Dexamethasone', 'long-acting betamethasone and dexamethasone']","['Speech Discrimination Score (SDS', 'hearing level', 'hearing improvement process', 'hearing improvement', 'Speech Reception Threshold (SRT']","[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0011057', 'cui_str': 'Sudden hearing loss'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0429202', 'cui_str': 'Speech discrimination score'}, {'cui': 'C0175841', 'cui_str': 'Hearing level'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}]",31.0,0.0155399,"RESULTS


Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline.","[{'ForeName': 'Hakima', 'Initials': 'H', 'LastName': 'Abdullah', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Erfanian', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: r_erfanian@sina.tums.ac.ir.""}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Yazdani', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: n_yazdani@tums.ac.ir.""}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Hajbegloo', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Tajdini', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: a-tajdini@sina.tums.ac.ir.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.102955']
1150,33608793,Pulse dose steroid experience among hospitalized patients with systemic lupus erythematosus: a single-center feasibility study.,"INTRODUCTION/OBJECTIVES


Pulse intravenous (IV) methylprednisolone (MEP) is often used for severe SLE manifestations requiring hospitalization. However, the accuracy of pulse dose documentation extracted from the electronic health record (EHR) is unknown. We assessed the feasibility to study pulse steroid dosing among hospitalized patients with SLE at our institution.
METHOD


Using the Stanford Medicine Research Data Repository (STARR) extracted from the EHR, we identified patients with ≥ 1 SLE ICD code before/during hospitalization receiving steroids (1/2008-12/2017). SLE diagnosis required rheumatologist confirmation. For our feasibility study, we randomly sampled 40/747 patients meeting search criteria. Pulse IV MEP was defined as ≥ 200 mg. Pharmacy dispensation data required EHR confirmation.
RESULTS


Forty adult and pediatric subjects were identified, passing initial criteria screen; 6 pediatric patients were excluded as EHR pharmacy confirmation was unavailable. Of the 34 adults, 14 had SLE confirmed. Among 5 adult SLE patients with pulse documentation, 3 occurred while hospitalized, for the following indications: acute renal transplant rejection (2 patients, 2 hospitalizations) and lupus flare (1 patient, 2 hospitalizations). No discrepancies were observed in pharmacy dispensation documentation of pulse dosing between EHR and STARR for all 4 hospitalizations.
CONCLUSIONS


Assessment of pulse steroid dose dispensation among hospitalized patients with SLE can be reliably ascertained from the extracted portion of the EHR designed for research. Reliance on a single ICD code for SLE in the EHR may lead to high rate of false-positive diagnoses of SLE among hospitalized patients. We document the importance of supplementing one ICD code with additional clinical information when confirming SLE diagnosis. Key Points • Assessment of pulse steroid dosing dispensation among hospitalized patients with SLE can be reliably determined from the extracted portion of the EHR designed for research purposes. • Reliance on a single ICD code contributes to a high rate of false positive diagnoses of SLE among hospitalized patients. • Supplementing ICD coding with additional clinical information is vital when confirming SLE diagnosis.",2021,"No discrepancies were observed in pharmacy dispensation documentation of pulse dosing between EHR and STARR for all 4 hospitalizations.
","['hospitalized patients with SLE at our institution', 'patients with ≥ 1 SLE ICD code before/during hospitalization receiving steroids (1/2008-12/2017', 'hospitalized patients with SLE', '5 adult SLE patients with pulse documentation, 3 occurred while hospitalized, for the following indications: acute renal transplant rejection (2 patients, 2 hospitalizations) and lupus flare (1 patient, 2 hospitalizations', 'hospitalized patients', '34 adults, 14 had SLE confirmed', 'Forty adult and pediatric subjects', 'hospitalized patients with systemic lupus erythematosus', 'randomly sampled 40/747 patients meeting search criteria']",['methylprednisolone (MEP'],[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1136256', 'cui_str': 'International Classification of Disease Codes'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0238217', 'cui_str': 'Renal transplant rejection'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]",[],5.0,0.0248861,"No discrepancies were observed in pharmacy dispensation documentation of pulse dosing between EHR and STARR for all 4 hospitalizations.
","[{'ForeName': 'Yashaar', 'Initials': 'Y', 'LastName': 'Chaichian', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, USA. ychaich@stanford.edu.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Weisman', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Simard', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, USA.'}]",Clinical rheumatology,['10.1007/s10067-021-05644-4']
1151,33606901,"Hybrid closed-loop glucose control with faster insulin aspart compared with standard insulin aspart in adults with type 1 diabetes: A double-blind, multicentre, multinational, randomized, crossover study.","AIM


To evaluate the use of hybrid closed-loop glucose control with faster-acting insulin aspart (Fiasp) in adults with type 1 diabetes (T1D).
RESEARCH DESIGN AND METHODS


In a double-blind, multinational, randomized, crossover study, 25 adults with T1D using insulin pump therapy (mean ± SD, age 38 ± 9 years, HbA1c 7.4% ± 0.8% [57 ± 8 mmol/mol]) underwent two 8-week periods of unrestricted living comparing hybrid closed-loop with Fiasp and hybrid closed-loop with standard insulin aspart in random order. During both interventions the CamAPS FX closed-loop system incorporating the Cambridge model predictive control algorithm was used.
RESULTS


In an intention-to-treat analysis, the proportion of time sensor glucose was in the target range (3.9-10.0 mmol/L; primary endpoint) was not different between interventions (75% ± 8% vs. 75% ± 8% for hybrid closed-loop with Fiasp vs. hybrid closed-loop with standard insulin aspart; mean-adjusted difference -0.6% [95% CI -1.8% to 0.7%]; p < .001 for non-inferiority [non-inferiority margin 5%]). The proportion of time with sensor glucose less than 3.9 mmol/L (median [IQR] 2.4% [1.2%-3.2%] vs. 2.9% [1.7%-4.0%]; p = .01) and less than 3.0 mmol/L (median [IQR] 0.4% [0.2%-0.7%] vs. 0.7% [0.2%-0.9%]; p = .03) was reduced with Fiasp versus standard insulin aspart. There was no difference in mean glucose (8.1 ± 0.8 vs. 8.0 ± 0.8 mmol/L; p = .13) or glucose variability (SD of sensor glucose 2.9 ± 0.5 vs. 2.9 ± 0.5 mmol/L; p = .90). Total daily insulin requirements did not differ (49 ± 15 vs. 49 ± 15 units/day; p = .45). No severe hypoglycaemia or ketoacidosis occurred.
CONCLUSIONS


The use of Fiasp in the CamAPS FX closed-loop system may reduce hypoglycaemia without compromising glucose control compared with standard insulin aspart in adults with T1D.",2021,Total daily insulin requirements did not differ (49 ± 15 vs. 49 ± 15 units/day; P = 0.45).,"['adults with T1D', 'adults with type 1 diabetes (T1D', '25 adults with T1D using insulin pump therapy (mean\u2009±\u2009SD, age 38\u2009±\u20099\u2009years, HbA1c 7.4\u2009±\u20090.8% [57\u2009±\u20098\u2009mmol/mol', 'adults with type 1 diabetes']","['Fiasp in CamAPS FX closed-loop system', 'Hybrid closed-loop glucose control with faster insulin aspart (Fiasp', 'hybrid closed-loop glucose control with faster-acting insulin aspart (Fiasp', 'standard insulin aspart', 'unrestricted living comparing hybrid closed-loop with Fiasp and hybrid closed-loop with standard insulin aspart']","['severe hypoglycaemia or ketoacidosis', 'proportion of time with sensor glucose', 'glucose variability', 'hypoglycaemia', 'mean glucose', 'proportion of time sensor glucose', 'Total daily insulin requirements']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",25.0,0.167002,Total daily insulin requirements did not differ (49 ± 15 vs. 49 ± 15 units/day; P = 0.45).,"[{'ForeName': 'Charlotte K', 'Initials': 'CK', 'LastName': 'Boughton', 'Affiliation': ""Wellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hartnell', 'Affiliation': 'Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Hood', 'Initials': 'H', 'LastName': 'Thabit', 'Affiliation': 'Diabetes, Endocrinology and Metabolism Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Poettler', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': ""Wellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Ashcroft', 'Affiliation': ""Wellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Sibayan', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Mader', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ""Wellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Lalantha', 'Initials': 'L', 'LastName': 'Leelarathna', 'Affiliation': 'Diabetes, Endocrinology and Metabolism Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': ""Wellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14355']
1152,33476838,Impact of an antimicrobial stewardship and monitoring of infection control bundle in a surgical intensive care unit of a tertiary-care hospital in India.,"OBJECTIVES


Antimicrobial stewardship (AMS) in resource-limited settings lacks models that can be readily adapted to their settings. Here we discuss the impact of a combined strategy of AMS and monitoring of infection control practices in a tertiary-care centre of a developing country.
METHODS


This study was undertaken in the surgical unit of a tertiary-care hospital over an 8-month period. In the first 2 months (baseline phase), prospective audit and feedback alone was undertaken, while in the next 6 months (intervention phase) this was supplemented with strategies such as antimicrobial timeout, correction of doses and bundle approach for prevention of hospital-acquired infections.
RESULTS


A total of 337 patients were included (94 in the baseline phase and 243 in the intervention phase). There was a decrease in days of therapy per 1000 patient-days (1000PD) (1112.3 days vs. 1048.6 days), length of therapy per 1000PD (956 days vs. 936.3 days) and defined daily doses (DDD) per 1000PD for most antimicrobials. A decrease in double cover for Gram-negative infections (9.6% vs. 2.9%) but an increase in double anaerobic cover (4.2% vs. 7.4%) was observed. There was a decrease in the incidence of ventilator-associated pneumonia per 1000 ventilator-days in the intervention phase (46.4 vs. 35.4), whereas central line-associated bloodstream infections per 1000 central line-days remained the same (14.7 vs. 14.8).
CONCLUSION


This study shows that implementation of routine AMS activities with monitoring of infection control practices can help decrease overall antimicrobial use. With furtherance of measures to control infection, antimicrobial use may be further curtailed.",2021,A decrease in double cover for Gram-negative infections (9.6% vs. 2.9%) but an increase in double anaerobic cover (4.2% vs. 7.4%) was observed.,"['surgical unit of a tertiary-care hospital over an 8-month period', 'a tertiary-care centre of a developing country', 'A total of 337 patients were included (94 in the baseline phase and 243 in the intervention phase', 'surgical intensive care unit of a tertiary-care hospital in India']","['Antimicrobial stewardship (AMS', 'antimicrobial stewardship']","['double anaerobic cover', 'incidence of ventilator-associated pneumonia', 'central line-associated bloodstream infections', 'double cover for Gram-negative infections']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",337.0,0.0379005,A decrease in double cover for Gram-negative infections (9.6% vs. 2.9%) but an increase in double anaerobic cover (4.2% vs. 7.4%) was observed.,"[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Panditrao', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Shafiq', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India. Electronic address: shafiq.nusrat@pgimer.edu.in.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar-M', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India.'}, {'ForeName': 'Amritpal Kaur', 'Initials': 'AK', 'LastName': 'Sekhon', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Biswal', 'Affiliation': 'Department of Medical Microbiology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Gurpreet', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Kulbeer', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Infection Control, PGIMER, Chandigarh, India.'}, {'ForeName': 'Pallab', 'Initials': 'P', 'LastName': 'Ray', 'Affiliation': 'Department of Medical Microbiology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Malhotra', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gautam', 'Affiliation': 'Department of Medical Microbiology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Yadav', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ishita', 'Initials': 'I', 'LastName': 'Laroiya', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Hemanth', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Salvania', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2021.01.003']
1153,33559677,Prevention of Hand Eczema among Nurse Apprentice (PREVEDERM): An Interventional Study.,"BACKGROUND


Workers in the healthcare sector are at high risk of developing occupational hand eczema mainly due to frequent exposure to irritants and/or allergens. Amongst workers in healthcare, nurses are at higher risk of developing hand dermatitis.
OBJECTIVES


To evaluate the effectiveness of a short educational intervention program in preventing occupational hand eczema in nurse apprentices, using two objective tools, namely TEWL and EH, and the HECSI score.
METHODS


Data regarding professions, wet work exposure, activities performed during working hours, self-reported eczema were collected from 230 nurse students, divided in two study groups: the intervention and the control group (CG). The intervention group (IG) was given education about risks and proper skin care and was provided with cosmeceuticals to be used for skin care during hospital activity. The evaluation of skin properties was performed using questionnaires, HECSI score, measurement of transepidermal water loss (TEWL) and epidermal hydration (EH).
RESULTS


A number of 139 apprentice nurses completed the study. Of those participants who completed the study, 19.1% from CG and 19.6% from IG reported, at T1, hand eczema in the last 3 months, while at T2 (3 months later), 59.52 % of the CG and only 11.34 % from the IG stated having eczema in the last 3 months. In the IG, results showed an improvement of CM with 17% and of TEWL with 16%, with only a 0.5% improvement of CM in CG and a marked impairment of TEWL by 33%.
CONCLUSION


Hand eczema is a common occupational dermatosis affecting the medical staff, even during apprenticeship. Early preventive training programs are effective in reducing the burden of occupational contact dermatitis.",2021,"In the IG, results showed an improvement of CM with 17% and of TEWL with 16%, with only a 0.5% improvement of CM in CG and a marked impairment of TEWL by 33%.
","['139 apprentice nurses completed the study', 'Hand Eczema among Nurse Apprentice (PREVEDERM', 'Data regarding professions, wet work exposure, activities performed during working hours, self-reported eczema were collected from 230 nurse students']",['short educational intervention program'],"['burden of occupational contact dermatitis', 'questionnaires, HECSI score, measurement of transepidermal water loss (TEWL) and epidermal hydration (EH', 'improvement of CM']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0239816', 'cui_str': 'Hand eczema'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0443352', 'cui_str': 'Wet work'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2888171', 'cui_str': 'Occupational contact dermatitis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}]",,0.025234,"In the IG, results showed an improvement of CM with 17% and of TEWL with 16%, with only a 0.5% improvement of CM in CG and a marked impairment of TEWL by 33%.
","[{'ForeName': 'Horatiu Remus', 'Initials': 'HR', 'LastName': 'Moldovan', 'Affiliation': 'Occupational Medicine Department, GE Palade University of Medicine, Pharmacy, Science and Technology of Targu-Mures, Gheorghe Marinescu, Târgu Mureș, Romania.'}, {'ForeName': 'Ionela', 'Initials': 'I', 'LastName': 'Manole', 'Affiliation': 'Dermatology Research Unit, Colentina Clinical Hospital, Stefan cel Mare, Bucharest, Romania.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Suru', 'Affiliation': 'Dermatology Research Unit, Colentina Clinical Hospital, Stefan cel Mare, Bucharest, Romania.'}, {'ForeName': 'Alexandra-Irina', 'Initials': 'AI', 'LastName': 'Butacu', 'Affiliation': 'Dermatology Research Unit, Colentina Clinical Hospital, Stefan cel Mare, Bucharest, Romania.'}, {'ForeName': 'Alin Laurentiu', 'Initials': 'AL', 'LastName': 'Tatu', 'Affiliation': 'Faculty of Medicine and Pharmacy, Dunarea de Jos University, Clinical Medical Department, Galati, Romania, Alexandru Ioan Cuza, Galati, Romania.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Lupu', 'Affiliation': 'Faculty of Medicine and Pharmacy, University Dunarea de Jos, Alexandru Ioan Cuza,Galati, Romania.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Dascalu', 'Affiliation': 'Department of Computer Science, Faculty of Automated Control and Computers, University Politehnica of Bucharest, Splaiul Independentei, Bucharest, Romania.'}, {'ForeName': 'George-Sorin', 'Initials': 'GS', 'LastName': 'Tiplica', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Eroii Sanitari, Bucharest, Romania.'}, {'ForeName': 'Carmen Maria', 'Initials': 'CM', 'LastName': 'Salavastru', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Eroii Sanitari, Bucharest, Romania.'}]",Annals of work exposures and health,['10.1093/annweh/wxaa122']
1154,33555943,A Randomized Controlled Trial of Eccentric Versus Concentric Cycling for Anterior Cruciate Ligament Reconstruction Rehabilitation.,"BACKGROUND


Persistent strength and biomechanical deviations remain after anterior cruciate ligament reconstruction (ACLR). Eccentric training may reduce these and associated reinjury or osteoarthritis risks.
HYPOTHESIS


For male patients who have undergone ACLR, eccentric training is more effective than concentric training at improving knee flexion angle and other biomechanical deviations, as well as strength and patient-reported outcomes, using a matched perceived exertion dose.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


A total of 26 men, 10-16 weeks after hamstring tendon graft ACLR, were randomized to an eccentric training group or a concentric control group. Both groups trained 3 times a week for 8 weeks using the same isokinetic cycle ergometer in a matched studio environment. Exercise dose was matched in training frequency, time, progression, and intensity using a target rating of perceived exertion. Baseline and follow-up testing included questionnaires, dynamometer strength testing, and walk/run gait analysis.
RESULTS


Eccentric training increased knee (+2.1°;  P  = .022) and hip (+2.1°;  P  = .010) flexion angles more than concentric training but not more than the minimal clinically important difference of 3°. Very large asymmetries in baseline knee abduction moment (walk, -0.10 N·m/kg/m; run, -0.54 N·m/kg/m) had not changed in either group by follow-up. Knee valgus angle effects were mixed. Tibial rotation angle increased in both groups, but concentric training was more effective at promoting symmetry ( P  < .001). Both groups had similar increases in affected limb quadriceps strength and knee flexion moments during walk/run gait (by 20% to 33%). Hamstring strength increased in the eccentric group (+15.4%) but not the concentric group. Eccentric group limb forces were 33% to 70% higher than those of the concentric group, with a lower heart rate. Both groups had low pain scores throughout.
CONCLUSION


For rehabilitation after ACLR, progressive eccentric cycle training was not more clinically effective than concentric training at a matched perceived intensity dose in male patients. This can guide exercise prescription for reducing gait and strength deviations of these patients.
REGISTRATION


PACTR201602001449365 (Pan African Clinical Trials Registry), NHREC 4344 (South African).",2021,"Tibial rotation angle increased in both groups, but concentric training was more effective at promoting symmetry ( P  < .001).","['anterior cruciate ligament reconstruction (ACLR', 'male patients who have undergone ACLR, eccentric training', 'A total of 26 men, 10-16 weeks after hamstring tendon graft ACLR', 'Anterior Cruciate Ligament Reconstruction Rehabilitation', 'male patients']","['Eccentric training', 'Eccentric Versus Concentric Cycling', 'progressive eccentric cycle training', 'eccentric training group or a concentric control group']","['questionnaires, dynamometer strength testing, and walk/run gait analysis', 'Eccentric group limb forces', 'Hamstring strength', 'gait and strength deviations', 'Tibial rotation angle', 'low pain scores', 'limb quadriceps strength and knee flexion moments', 'knee']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1279739', 'cui_str': 'Tendon transplantation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",26.0,0.0569584,"Tibial rotation angle increased in both groups, but concentric training was more effective at promoting symmetry ( P  < .001).","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Milandri', 'Affiliation': 'Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sudesh', 'Initials': 'S', 'LastName': 'Sivarasu', 'Affiliation': 'Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}]",The American journal of sports medicine,['10.1177/0363546520987566']
1155,33565694,"Do alcohol product labels stating lower strength verbal description, percentage alcohol-by-volume, or their combination affect wine consumption? A bar laboratory adaptive randomised controlled trial.","BACKGROUND AND AIMS


A previous research study concluded that wine and beer labelled as lower in strength increase consumption compared with the same drinks labelled as regular strength. The label included both a verbal and numerical descriptor of strength. The present study aimed to estimate the effect of each of these label components.
DESIGN


Adaptive, parallel group randomised controlled trial, comprising an internal pilot sample (n 1   = 90) and a confirmatory sample (n 2   = 57).
SETTING


University bar laboratory in London, United Kingdom (UK).
PARTICIPANTS


A total of 147 weekly wine drinkers were sampled from a nationally representative English panel.
INTERVENTION


Participants were randomised to one of three groups to taste test wine in a bar-laboratory, varying only in the label displayed: (i) verbal descriptor only (Super Low); (ii) numerical descriptor only (4% alcohol by volume (ABV)); and (iii) verbal descriptor and numerical descriptor combined (Super Low 4%ABV) (each group n = 49).
MEASUREMENTS


The primary outcome was total volume (ml) of wine consumed.
FINDINGS


Participants randomised to the numerical descriptor label group (4%ABV: M = 155.12 ml, B = 20.30; 95% CI = 3.92, 36.69; P value = 0.016) and combined verbal and numerical descriptor label group (Super Low 4%ABV: M = 154.59 ml, B = 20.68; 95% CI = 4.32, 37.04; P value = 0.014) drank significantly greater amounts than those randomised to the verbal descriptor label group (Super Low: M = 125.65 ml).
CONCLUSIONS


This bar laboratory study estimated that a greater quantity of 'lower' strength wine was consumed when the label included a numerical strength descriptor compared with a verbal only strength descriptor.",2021,"Participants were randomised to one of three groups to taste test wine in a bar-laboratory, varying only in the label displayed: (i) verbal descriptor only (Super Low); (ii) numerical descriptor only (4%ABV); and (iii) verbal descriptor and numerical descriptor combined (Super Low 4%ABV) [each group n = 49].
","['University bar laboratory in London UK', 'One-hundred and forty-seven weekly wine drinkers were sampled from a nationally representative English panel', 'internal pilot sample (N 1  = 90) and a confirmatory sample (N 2  = 57']","['verbal descriptor label', 'taste test wine in a bar-laboratory, varying only in the label displayed: (i) verbal descriptor only (Super Low); (ii) numerical descriptor only (4%ABV); and (iii) verbal descriptor and numerical descriptor combined (Super Low 4%ABV) [each group n = 49']",['total volume (ml) of wine consumed'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0282354', 'cui_str': 'Descriptor'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456762', 'cui_str': 'Numerical descriptors'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1451765', 'cui_str': 'SNAP25 protein, human'}, {'cui': 'C0441848', 'cui_str': 'Group N'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0043188', 'cui_str': 'Wine'}]",,0.210544,"Participants were randomised to one of three groups to taste test wine in a bar-laboratory, varying only in the label displayed: (i) verbal descriptor only (Super Low); (ii) numerical descriptor only (4%ABV); and (iii) verbal descriptor and numerical descriptor combined (Super Low 4%ABV) [each group n = 49].
","[{'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Vasiljevic', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Frings', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pilling', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.15444']
1156,33567336,"Effectiveness of Dry Needling Therapy on Pain, Hip Muscle Strength, and Physical Function in Patients With Hip Osteoarthritis: A Randomized Controlled Trial.","OBJECTIVE


To investigate the short-term effects of dry needling (DN) on physical function, pain, and hip muscle strength in patients with hip osteoarthritis (OA).
DESIGN


A double-blind, placebo-control, randomized controlled trial.
SETTING


Private practice physiotherapy clinic.
PARTICIPANTS


Patients with unilateral hip OA (N=45) were randomly allocated to a DN group, sham DN group, or control group.
INTERVENTIONS


Patients in the DN and sham groups received 3 treatment sessions. Three active myofascial trigger points (MTrPs) were treated in each session with DN or a sham needle procedure. The treatment was applied in active MTrPs of the iliopsoas, rectus femoris, tensor fasciae latae, and gluteus minimus muscles.
MAIN OUTCOME MEASURES


Physical function was assessed with the Western Ontario and McMaster Universities (WOMAC) physical function subscale, the timed Up and Go test, and the 40-meter self-paced walk test. Intensity of hip pain related to physical function was evaluated using the visual analog scale and WOMAC pain subscale. The maximal isometric force of hip muscles was recorded with a handheld dynamometer.
RESULTS


Significant group by time interactions were shown for physical function, pain, and hip muscle force variables. Post hoc tests revealed a significant reduction in hip pain and significant improvements in physical function and hip muscle strength in the DN group compared with the sham and control groups. The DN group showed within- and between-groups large effect sizes (d>0.8).
CONCLUSIONS


DN therapy in active MTrPs of the hip muscles reduced pain and improved hip muscle strength and physical function in patients with hip OA. DN in active MTrPs of the hip muscles should be considered for the management of hip OA.",2021,Post hoc tests revealed a significant reduction in hip pain and significant improvements in physical function and hip muscle strength in DN group compared to sham and control groups.,"['Patients with unilateral hip OA (N=45', 'Private practice physiotherapy clinic', 'patients with hip osteoarthritis (OA', 'HIP OSTEOARTHRITIS', 'patients with hip OA']","['sham DN group or control group', 'dry needling (DN', 'placebo']","['Western Ontario and McMaster Universities (WOMAC) physical function subscale, the Timed Up & Go test and the 40-m self-paced walk test', 'hip pain', 'physical function and hip muscle strength', 'visual analogue scale and WOMAC pain subscale', 'physical function, pain and hip muscle force variables', 'maximal isometric force of hip muscles', 'pain and improved hip muscle strength and physical function', 'physical function, pain and hip muscle strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}]",45.0,0.0640028,Post hoc tests revealed a significant reduction in hip pain and significant improvements in physical function and hip muscle strength in DN group compared to sham and control groups.,"[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ceballos-Laita', 'Affiliation': 'Department of Surgery, Ophthalmology, Otorhinolaryngology and Physiotherapy. Faculty of Health Sciences, University of Valladolid, Soria. Electronic address: Luis.ceballos@uva.es.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jiménez-Del-Barrio', 'Affiliation': 'Department of Surgery, Ophthalmology, Otorhinolaryngology and Physiotherapy. Faculty of Health Sciences, University of Valladolid, Soria.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Marín-Zurdo', 'Affiliation': 'ID_ERGO Research Group, I3A, Department of Design and Manufacturing Engineering, University of Zaragoza, Zaragoza.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Moreno-Calvo', 'Affiliation': 'ID_ERGO Research Group, I3A, Department of Design and Manufacturing Engineering, University of Zaragoza, Zaragoza.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Marín-Boné', 'Affiliation': 'ID_ERGO Research Group, I3A, Department of Design and Manufacturing Engineering, University of Zaragoza, Zaragoza.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Albarova-Corral', 'Affiliation': 'Department of Physiatrist and Nursery, Faculty of Health Science, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Estébanez-de-Miguel', 'Affiliation': 'Department of Physiatrist and Nursery, Faculty of Health Science, University of Zaragoza, Zaragoza, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.01.077']
1157,33579759,Evaluation of Multiple Sclerosis Disability Outcome Measures Using Pooled Clinical Trial Data.,,2021,,[],[],[],[],[],[],,0.0609729,,[],Neurology,['10.1212/WNL.0000000000011677']
1158,33577800,"Rationale and design for the study of rivaroxaban to reduce thrombotic events, hospitalization and death in outpatients with COVID-19: The PREVENT-HD study.","BACKGROUND


COVID-19 is associated with both venous and arterial thrombotic complications. While prophylactic anticoagulation is now widely recommended for hospitalized patients with COVID-19, the effectiveness and safety of thromboprophylaxis in outpatients with COVID-19 has not been established.
STUDY DESIGN


PREVENT-HD is a double-blind, placebo-controlled, pragmatic, event-driven phase 3 trial to evaluate the efficacy and safety of rivaroxaban in symptomatic outpatients with laboratory-confirmed COVID-19 at risk for thrombotic events, hospitalization, and death. Several challenges posed by the pandemic have necessitated innovative approaches to clinical trial design, start-up, and conduct. Participants are randomized in a 1:1 ratio, stratified by time from COVID-19 confirmation, to either rivaroxaban 10 mg once daily or placebo for 35 days. The primary efficacy end point is a composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non-central nervous system systemic embolization, all-cause hospitalization, and all-cause mortality. The primary safety end point is fatal and critical site bleeding according to the International Society on Thrombosis and Haemostasis definition. Enrollment began in August 2020 and is expected to enroll approximately 4,000 participants to yield the required number of end point events.
CONCLUSIONS


PREVENT-HD is a pragmatic trial evaluating the efficacy and safety of the direct oral anticoagulant rivaroxaban in the outpatient setting to reduce major venous and arterial thrombotic events, hospitalization, and mortality associated with COVID-19.",2021,"The primary efficacy endpoint is a composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non-central nervous systemic embolization, all-cause hospitalization, and all-cause mortality.","['Outpatients with COVID-19', 'hospitalized patients with COVID-19', 'symptomatic outpatients with laboratory-confirmed COVID-19 at risk for thrombotic events, hospitalization, and death']","['rivaroxaban 10mg once daily or placebo', 'Rivaroxaban', 'rivaroxaban', 'placebo']","['Thrombotic Events, Hospitalization and Death', 'major venous and arterial thrombotic events, hospitalization, and mortality', 'efficacy and safety', 'fatal and critical site bleeding according to the International Society on Thrombosis and Haemostasis definition', 'composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non-central nervous systemic embolization, all-cause hospitalization, and all-cause mortality']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}]",,0.215879,"The primary efficacy endpoint is a composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non-central nervous systemic embolization, all-cause hospitalization, and all-cause mortality.","[{'ForeName': 'Warren H', 'Initials': 'WH', 'LastName': 'Capell', 'Affiliation': 'CPC Clinical Research, Aurora, CO; Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO. Electronic address: warren.capell@cuanschutz.edu.'}, {'ForeName': 'Elliot S', 'Initials': 'ES', 'LastName': 'Barnathan', 'Affiliation': 'Janssen Research and Development LLC, Raritan, NJ.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Spyropoulos', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Huntington, NY; Institute for Health Innovation and Outcomes Research, Feinstein Institutes for Medical Research, Manhasset, NY; Department of Medicine, Northwell Health at Lenox Hill Hospital, New York, NY.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hsia', 'Affiliation': 'CPC Clinical Research, Aurora, CO; Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Bull', 'Affiliation': 'Janssen Research and Development LLC, Raritan, NJ.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Lipardi', 'Affiliation': 'Janssen Research and Development LLC, Raritan, NJ.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Sugarmann', 'Affiliation': 'Janssen Research and Development LLC, Raritan, NJ.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Suh', 'Affiliation': 'Janssen Research and Development LLC, Raritan, NJ.'}, {'ForeName': 'Jaya Prakash', 'Initials': 'JP', 'LastName': 'Rao', 'Affiliation': 'REDCap Cloud, Encinitas, CA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'CPC Clinical Research, Aurora, CO; Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'CPC Clinical Research, Aurora, CO; Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}]",American heart journal,['10.1016/j.ahj.2021.02.001']
1159,33582295,Harnessing mobile technology to reduce mental health disorders in college populations: A randomized controlled trial study protocol.,"About a third of college students struggle with anxiety, depression, or an eating disorder, and only 20-40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach to detect mental health problems and engage college students in services. We have developed a transdiagnostic, low-cost mobile mental health targeted prevention and intervention platform that uses population-level screening to engage college students in tailored services that address common mental health problems. We will test the impact of this mobile mental health platform for service delivery in a large-scale trial across 20+ colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or an eating disorder and who are not currently engaged in mental health services (N = 7884) will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center). We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases, disorder-specific symptoms, and improved quality of life and functioning. We will also test mediators, predictors, and moderators of improved mental health outcomes, as well as stakeholder-relevant outcomes, including cost-effectiveness and academic performance. This population-level approach to service engagement has the potential to improve mental health outcomes for the millions of students enrolled in U.S. colleges and universities.",2021,"We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases and disorder-specific symptoms, and improved quality of life and functioning.","['college students struggle with anxiety, depression, or an eating disorder, and only 20-40% of college students with mental disorders receive treatment', 'students enrolled in U.S. colleges and universities', 'Students who screen positive or at high-risk for clinical anxiety, depression, or an eating disorder and who are not currently engaged in mental health services (N\u202f=\u202f7884', 'college populations']","['Harnessing mobile technology', 'intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center']","['cost-effectiveness and academic performance', 'mental health disorders']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",7884.0,0.257177,"We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases and disorder-specific symptoms, and improved quality of life and functioning.","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Fitzsimmons-Craft', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: fitzsimmonse@wustl.edu.'}, {'ForeName': 'C Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA. Electronic address: btaylor@stanford.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, Penn State University, University Park, PA, USA. Electronic address: mgn1@psu.edu.'}, {'ForeName': 'Nur Hani', 'Initials': 'NH', 'LastName': 'Zainal', 'Affiliation': 'Department of Psychology, Penn State University, University Park, PA, USA. Electronic address: nvz5057@psu.edu.'}, {'ForeName': 'Elsa E', 'Initials': 'EE', 'LastName': 'Rojas-Ashe', 'Affiliation': 'Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA. Electronic address: erojas@paloaltou.edu.'}, {'ForeName': 'Sarah Ketchen', 'Initials': 'SK', 'LastName': 'Lipson', 'Affiliation': 'Department of Health Law Policy and Management, Boston University School of Public Health, Boston, MA, USA. Electronic address: sklipson@bu.edu.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Firebaugh', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: mcallewaert@wustl.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ceglarek', 'Affiliation': 'Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, USA. Electronic address: peterceg@umich.edu.'}, {'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Topooco', 'Affiliation': 'Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA; Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden. Electronic address: naira.topooco@liu.se.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Jacobson', 'Affiliation': 'Departments of Biomedical Data Science and Psychiatry, Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Hanover, NH, USA. Electronic address: Nicholas.C.Jacobson@dartmouth.edu.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA. Electronic address: andrea.graham@northwestern.edu.'}, {'ForeName': 'Hyungjin Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA. Electronic address: myrakim@umich.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eisenberg', 'Affiliation': 'Department of Health Policy and Management, Fielding School of Public Health, University of California at Los Angeles, Los Angeles, CA, USA. Electronic address: daniel.eisenberg@ucla.edu.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: wilfleyd@wustl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106320']
1160,33587893,"Short-term outcomes of complete mesocolic excision versus D2 dissection in patients undergoing laparoscopic colectomy for right colon cancer (RELARC): a randomised, controlled, phase 3, superiority trial.","BACKGROUND


Whether extended lymphadenectomy for right colon cancer leads to increased perioperative complications or improves survival is still controversial. This trial aimed to compare the efficacy and safety of complete mesocolic excision (CME) versus D2 dissection in laparoscopic right hemicolectomy for patients with right colon cancer. This article reports the early safety results from the trial.
METHODS


This randomised, controlled, phase 3, superiority, trial was done at 17 hospitals in nine provinces of China. Eligible patients were aged 18-75 years with histologically confirmed primary adenocarcinoma located between the caecum and the right third of the transverse colon, without evidence of distant metastases. Central randomisation was done by means of the Clinical Information Management-Central Randomisation System via block randomisation (block size of four). Patients were randomly assigned (1:1) to CME or D2 dissection during laparoscopic right colectomy. Central lymph nodes were dissected in the CME but not in the D2 procedure. Neither investigators nor patients were masked to their group assignment but the quality control committee were masked to group assignment. The primary endpoint was 3-year disease-free survival, but the data for this endpoint are not yet mature; thus, only the secondary outcomes-intraoperative surgical complications and postoperative complications within 30 days of surgery, graded according to the Clavien-Dindo classification, mortality (death from any cause within 30 days of surgery), and central lymph node metastasis rate in the CME group only-are reported in this Article. This early analysis of safety was preplanned. The outcomes were analysed according to a modified intention-to-treat principle (excluding patients who no longer met inclusion criteria after surgery or who did not have surgery). This study is registered with ClinicalTrials.gov, NCT02619942. Study recruitment is complete, and follow-up is ongoing.
FINDINGS


Between Jan 11, 2016, and Dec 26, 2019, 1072 patients were enrolled and randomly assigned. After exclusion of 77 patients, 995 patients were included in the modified intention-to-treat population (495 in the CME group and 500 in the D2 dissection group). The postoperative surgical complication rate was 20% (97 of 495 patients) in the CME group versus 22% (109 of 500 patients) in the D2 group (difference, -2·2% [95% CI -7·2 to 2·8]; p=0·39); the frequency of Clavien-Dindo grade I-II complications were similar between groups (91 [18%] vs 92 [18%], difference, -0·0% [95% CI -4·8 to 4·8]; p=1·0) but Clavien-Dindo grade III-IV complications were significantly less frequent in the CME group than in the D2 group (six [1%] vs 17 [3%], -2·2% [-4·1 to -0·3]; p=0·022); no deaths occurred in either group. Of the intraoperative complications, vascular injury was significantly more common in the CME group than in the D2 group (15 [3%] vs six [1%], difference, 1·8 [95% CI 0·04 to 3·6]; p=0·045). Metastases in the central lymph nodes were detected in 13 (3%) of 394 patients who underwent central lymph node biopsy in the CME group; no patient had isolated metastases to central lymph nodes.
INTERPRETATION


Although the CME procedure might increase the risk of intraoperative vascular injury, it generally seems to be safe and feasible for experienced surgeons.
FUNDING


The Capital Characteristic Clinical Project of Beijing and the Chinese Academy of Medical Sciences.",2021,"p=0·39); the frequency of Clavien-Dindo grade I-II complications were similar between groups (91 [18%] vs 92 [18%], difference, -0·0% [95% CI -4·8 to 4·8]; p=1·0) but Clavien-Dindo grade III-IV complications were significantly less frequent in the CME group than in the D2 group (six [1%] vs 17 [3%], -2·2% [-4·1 to -0·3]; p=0·022); no deaths occurred in either group.","['17 hospitals in nine provinces of China', '77 patients, 995 patients were included in the modified intention-to-treat population (495 in the CME group and 500 in the D2 dissection group', 'Eligible patients were aged 18-75 years with histologically confirmed primary adenocarcinoma located between the caecum and the right third of the transverse colon, without evidence of distant metastases', 'Between Jan 11, 2016, and Dec 26, 2019, 1072 patients were enrolled and randomly assigned', '394 patients who underwent central lymph node biopsy in the CME group; no patient had isolated metastases to central lymph nodes', 'patients undergoing laparoscopic colectomy for right colon cancer (RELARC', 'patients who no longer met inclusion criteria after surgery or who did not have surgery', 'patients with right colon cancer']","['CME or D2 dissection during laparoscopic right colectomy', 'CME', 'complete mesocolic excision (CME) versus D2 dissection', 'complete mesocolic excision versus D2 dissection']","['central lymph node metastasis rate', 'Clavien-Dindo grade III-IV complications', 'postoperative surgical complication rate', 'intraoperative complications, vascular injury', 'deaths', 'efficacy and safety', 'frequency of Clavien-Dindo grade I-II complications', '3-year disease-free survival', 'intraoperative surgical complications and postoperative complications within 30 days of surgery, graded according to the Clavien-Dindo classification, mortality (death']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0227386', 'cui_str': 'Transverse colon structure'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0193842', 'cui_str': 'Biopsy of lymph node'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0178324', 'cui_str': 'Injury of blood vessel'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3887296', 'cui_str': 'Within thirty days of surgery'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1072.0,0.36714,"p=0·39); the frequency of Clavien-Dindo grade I-II complications were similar between groups (91 [18%] vs 92 [18%], difference, -0·0% [95% CI -4·8 to 4·8]; p=1·0) but Clavien-Dindo grade III-IV complications were significantly less frequent in the CME group than in the D2 group (six [1%] vs 17 [3%], -2·2% [-4·1 to -0·3]; p=0·022); no deaths occurred in either group.","[{'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Surgery IV, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Zirui', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Chenghai', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Surgery IV, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Junyang', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China.'}, {'ForeName': 'Guannan', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China.'}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Colorectal Surgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""Department of General Surgery, Chinese General Hospital of People's Liberation Army, Beijing, China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fujian, China.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Aiwen', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Department of Unit III & Ostomy Service, Gastrointestinal Cancer Centre, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Anlong', 'Initials': 'A', 'LastName': 'Zhu', 'Affiliation': 'Department of Colorectal Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Suo', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yingjiang', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': ""Department of Gastroenterological Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Kefeng', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Department of Colorectal Surgery and Oncology, Key Laboratory of Cancer Prevention and Intervention (Ministry of Education), The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology and Statistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China; School of Basic Medicine, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhongtao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Beijing Friendship Hospital, Capital Medical University and National Clinical Research Centre for Digestive Diseases, Beijing, China.'}, {'ForeName': 'Minhua', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China. Electronic address: xiaoy@pumch.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30685-9']
1161,33587894,Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study.,"BACKGROUND


Melanoma lacks validated blood-based biomarkers for monitoring and predicting treatment efficacy. Cell-free circulating tumour DNA (ctDNA) is a promising biomarker; however, various detection methods have been used, and, to date, no large studies have examined the association between serial changes in ctDNA and survival after BRAF, MEK, or BRAF plus MEK inhibitor therapy. We aimed to evaluate whether baseline ctDNA concentrations and kinetics could predict survival outcomes.
METHODS


In this clinical validation study, we used analytically validated droplet digital PCR assays to measure BRAF V600 -mutant ctDNA in pretreatment and on-treatment plasma samples from patients aged 18 years or older enrolled in two clinical trials. COMBI-d (NCT01584648) was a double-blind, randomised phase 3 study of dabrafenib plus trametinib versus dabrafenib plus placebo in previously untreated patients with BRAF V600  mutation-positive unresectable or metastatic melanoma. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. COMBI-MB (NCT02039947) was an open-label, non-randomised, phase 2 study evaluating dabrafenib plus trametinib in patients with BRAF V600  mutation-positive metastatic melanoma and brain metastases. Patients in cohort A of COMBI-MB had asymptomatic brain metastases, no previous local brain-directed therapy, and an ECOG performance status of 0 or 1. Biomarker analysis was a prespecified exploratory endpoint in both trials and performed in the intention-to-treat populations in COMBI-d and COMBI-MB. We investigated the association between mutant copy number (baseline or week 4 or zero conversion status) and efficacy endpoints (progression-free survival, overall survival, and best overall response). We used Cox models, Kaplan-Meier plots, and log-rank tests to explore the association of pretreatment ctDNA concentrations with progression-free survival and overall survival. The effect of additional prognostic variables such as lactate dehydrogenase was also investigated in addition to the mutant copy number.
FINDINGS


In COMBI-d, pretreatment plasma samples were available from 345 (82%) of 423 patients and on-treatment (week 4) plasma samples were available from 224 (53%) of 423 patients. In cohort A of COMBI-MB, pretreatment and on-treatment samples were available from 38 (50%) of 76 patients with intracranial and extracranial metastatic melanoma. ctDNA was detected in pretreatment samples from 320 (93%) of 345 patients (COMBI-d) and 34 (89%) of 38 patients (COMBI-MB). When assessed as a continuous variable, elevated baseline BRAF V600  mutation-positive ctDNA concentration was associated with worse overall survival outcome (hazard ratio [HR] 1·13 [95% CI 1·09-1·18], p<0·0001 by univariate analysis), independent of treatment group and baseline lactate dehydrogenase concentrations (1·08 [1·03-1·13], p=0·0020), in COMBI-d. A ctDNA cutoff point of 64 copies per mL of plasma stratified patients enrolled in COMBI-d as high risk or low risk with respect to survival outcomes (HR 1·74 [95% CI 1·37-2·21], p<0·0001 for progression-free survival; 2·23 [1·73-2·87], p<0·0001 for overall survival) and was validated in the COMBI-MB cohort (3·20 [1·39-7·34], p=0·0047 for progression-free survival; 2·94 [1·18-7·32], p=0·016 for overall survival). In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival).
INTERPRETATION


Pretreatment and on-treatment BRAF V600 -mutant ctDNA measurements could serve as independent, predictive biomarkers of clinical outcome with targeted therapy.
FUNDING


Novartis.",2021,"In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival).
","['1·13', 'previously untreated patients with BRAF V600  mutation-positive unresectable or metastatic melanoma', 'patients with advanced melanoma treated with', '76 patients with intracranial and extracranial metastatic melanoma', 'patients aged 18 years or older enrolled in two clinical trials', 'Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', 'patients with BRAF V600  mutation-positive metastatic melanoma and brain metastases']","['dabrafenib or dabrafenib plus trametinib', 'dabrafenib plus trametinib versus dabrafenib plus placebo']","['extended progression-free and overall survival', 'survival outcomes', 'elevated lactate dehydrogenase concentrations', 'efficacy endpoints (progression-free survival, overall survival, and best overall response', 'ctDNA', 'overall survival outcome (hazard ratio [HR', 'overall survival', 'baseline lactate dehydrogenase concentrations']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",423.0,0.610155,"In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival).
","[{'ForeName': 'Mahrukh M', 'Initials': 'MM', 'LastName': 'Syeda', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Wiggins', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Broderick C', 'Initials': 'BC', 'LastName': 'Corless', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Dana-Farber Cancer Institute/Harvard Medical School and Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Nathan', 'Affiliation': 'East and North NHS Trust, Northwood, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institute Gustave Roussy and Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Davies', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancer Department, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Squires', 'Affiliation': 'Novartis Institute for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Marker', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garrett', 'Affiliation': 'Novartis Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': 'NYU Langone Health, New York, NY, USA. Electronic address: david.polsky@nyulangone.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30726-9']
1162,33588087,"A Phase 2b randomized trial of lorecivivint, a novel intra-articular CLK2/DYRK1A inhibitor and Wnt pathway modulator for knee osteoarthritis.","OBJECTIVE


Lorecivivint (LOR; SM04690), an investigational Wnt pathway modulator, previously demonstrated patient-reported and radiographic outcome improvements vs placebo in clinically relevant subjects with moderate to severe knee osteoarthritis (OA). This study's objective was to identify effective LOR doses.
DESIGN


Subjects in this 24-week, Phase 2b, multicenter, randomized, double-blind, placebo (PBO)-controlled trial received an intra-articular injection of 2 mL LOR (0.03, 0.07, 0.15, or 0.23 mg), PBO, or dry-needle sham. The primary efficacy endpoints were changes in Pain NRS [0-10], WOMAC Pain [0-100], WOMAC Function [0-100], and radiographic mJSW outcomes, which were measured using baseline-adjusted analysis of covariance at Week 24. Multiple Comparison Procedure-Modeling (MCP-Mod) was performed for dose modeling.
RESULTS


In total, 695/700 subjects were treated. Pain NRS showed significant improvements vs PBO after treatment with 0.07 mg and 0.23 mg LOR at Weeks 12 (-0.96, 95% CI [-1.54, -0.37], P = 0.001; -0.78 [-1.39, -0.17], P = 0.012) and 24 (-0.70 [-1.34, -0.06], P = 0.031; -0.82 [-1.51, -0.12], P = 0.022). Additionally, 0.07 mg LOR significantly improved WOMAC Pain and Function subscores vs PBO at Week 12 (P = 0.04, P = 0.021), and 0.23 mg LOR significantly improved both WOMAC subscores at Week 24 (P = 0.031, P = 0.017). No significant differences from PBO were observed for other doses. No radiographic progression was observed in any group at Week 24. MCP-Mod identified 0.07 mg LOR as the lowest effective dose.
CONCLUSION


This 24-week Phase 2b trial demonstrated the efficacy of LOR on PROs in knee OA subjects. The optimal dose for future studies was identified as 0.07 mg LOR.",2021,"Pain NRS showed significant improvements versus PBO after treatment with 0.07 mg and 0.23 mg LOR at Weeks 12 (-0.96, 95% CI [-1.54, -0.37], P=0.001; -0.78, [-1.39,","['knee OA subjects', 'clinically relevant subjects with moderate to severe knee osteoarthritis (OA', '695/700 subjects were treated', 'Knee Osteoarthritis']","['placebo', 'intra-articular injection of 2 mL LOR', 'PBO, or dry-needle sham', 'Multiple Comparison Procedure-Modeling (MCP-Mod', 'LOR', 'MCP-Mod identified 0.07 mg LOR']","['changes in Pain NRS [0-10], WOMAC Pain [0-100], WOMAC Function [0-100], and radiographic mJSW outcomes', 'WOMAC Pain and Function subscores versus PBO', 'WOMAC subscores', 'PBO', 'radiographic progression']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C4518239', 'cui_str': '0.07'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0436033,"Pain NRS showed significant improvements versus PBO after treatment with 0.07 mg and 0.23 mg LOR at Weeks 12 (-0.96, 95% CI [-1.54, -0.37], P=0.001; -0.78, [-1.39,","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yazici', 'Affiliation': 'Samumed, LLC, San Diego, CA, USA; New York University School of Medicine, New York, NY, USA. Electronic address: yusuf@samumed.com.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'McAlindon', 'Affiliation': 'Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gibofsky', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'University of California Davis Medical School, Burlingame, CA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lattermann', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Skrepnik', 'Affiliation': 'Tucson Orthopaedic Institute, Tucson, AZ, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Swearingen', 'Affiliation': 'Samumed, LLC, San Diego, CA, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Simsek', 'Affiliation': 'Samumed, LLC, San Diego, CA, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ghandehari', 'Affiliation': 'Samumed, LLC, San Diego, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'DiFrancesco', 'Affiliation': 'Samumed, LLC, San Diego, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gibbs', 'Affiliation': 'Samumed, LLC, San Diego, CA, USA.'}, {'ForeName': 'J R S', 'Initials': 'JRS', 'LastName': 'Tambiah', 'Affiliation': 'Samumed, LLC, San Diego, CA, USA.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2021.02.004']
1163,33588078,The multi-ethnic study of atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study.,"The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D 3  supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response.",2021,"The final study visit was attended by 611 participants (92%), and median adherence was 98%.","['2210 MESA participants approached for screening, and 96% of those found to be eligible', '666 racially and ethnically diverse participants from January 2017 to April 2019']","['vitamin D 3  supplementation', 'vitamin D supplementation', 'VITamin D (INVITe', 'placebo']",['median adherence'],"[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",2210.0,0.263891,"The final study visit was attended by 611 participants (92%), and median adherence was 98%.","[{'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: deboer@uw.edu.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Prince', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Kayleen', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Norrina B', 'Initials': 'NB', 'LastName': 'Allen', 'Affiliation': 'Department of Internal Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Burke', 'Affiliation': 'Division of Public Health Sciences Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The Institute for Translational Genomics and Population Sciences, Department of Pediatrics, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Kiang J', 'Initials': 'KJ', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'McClelland', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Michos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States of America; Department of Epidemiology and the Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Psaty', 'Affiliation': 'Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology and Health Services, University of Washington, Seattle, WA, United States of America; Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, United States of America; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, United States of America.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Rice', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Jerome I', 'Initials': 'JI', 'LastName': 'Rotter', 'Affiliation': 'The Institute for Translational Genomics and Population Sciences, Department of Pediatrics, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Siscovick', 'Affiliation': 'New York Academy of Medicine, New York, NY, United States of America.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Departments of Pathology & Laboratory Medicine, and Biochemistry, University of Vermont Larner College of Medicine, Burlington, VT, United States of America.'}, {'ForeName': 'Karol E', 'Initials': 'KE', 'LastName': 'Watson', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Kestenbaum', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106318']
1164,33601293,Impact of depatuxizumab mafodotin on health-related quality of life and neurological functioning in the phase II EORTC 1410/INTELLANCE 2 trial for EGFR-amplified recurrent glioblastoma.,"BACKGROUND


In the EORTC 1410/INTELLANCE 2 randomised, phase II study (NCT02343406), with the antibody-drug conjugate depatuxizumab mafodotin (Depatux-M, ABT-414) in patients with recurrent EGFR-amplified glioblastoma, the primary end-point (overall survival) was not met, and the drug had ocular dose-limiting toxicity. This study reports results from the prespecified health-related quality of life (HRQoL) and neurological deterioration-free survival (NDFS) exploratory analysis.
PATIENTS AND METHODS


Patients (n = 260) were randomised 1:1:1 to receive either Depatux-M 1.25 mg/kg or 1.0 mg/kg intravenously every 2 weeks with oral temozolomide (TMZ) 150 mg/m 2 , Depatux-M alone, or TMZ or oral lomustine (CCNU) 110 mg/m 2  (TMZ/CCNU). HRQoL outcomes were recorded using the EORTC core Quality of Life QLQ-C30, and brain cancer-specific QLQ-BN20 questionnaires. Questionnaires were completed at baseline, weeks 8 and 16, and month 6, and changes from baseline to each time point were calculated. NDFS was defined as time to first deterioration in World Health Organisation performance status.
RESULTS


Compliance with HRQoL was 88.1% at baseline and decreased to 37.9% at month 6. Differences from baseline between Depatux-M arms and TMZ/CCNU in global health/QoL status throughout treatment did not reach clinical relevance (≥10 points). Self-reported visual disorders deteriorated to a clinically relevant extent with Depatux-M arms versus TMZ/CCNU at all timepoints (mean differences range: 24.6-35.1 points). Changes from baseline for other HRQoL scales and NDFS were generally similar between treatment arms.
CONCLUSIONS


Depatux-M had no impact on HRQoL and NDFS in patients with EGFR-amplified recurrent glioblastoma, except for more visual disorders, an expected side-effect of the study drug.
CLINICAL TRIAL REGISTRATION


NCT02343406.",2021,Self-reported visual disorders deteriorated to a clinically relevant extent with Depatux-M arms versus TMZ/CCNU at all timepoints (mean differences range: 24.6-35.1 points).,"['patients with recurrent EGFR-amplified glioblastoma, the primary end-point (overall survival) was not met, and the drug had ocular dose-limiting toxicity', '110', '260', 'Patients (n\xa0']","['mg/m 2  (TMZ/CCNU', 'CCNU', 'NDFS', 'Depatux-M alone, or TMZ or oral lomustine', 'Depatux-M 1.25\xa0mg/kg or 1.0\xa0mg/kg intravenously every 2 weeks with oral temozolomide (TMZ', 'depatuxizumab mafodotin', 'TMZ/CCNU']","['visual disorders', 'global health/QoL status', 'HRQoL and NDFS', 'health-related quality of life and neurological functioning', 'HRQoL scales and NDFS', 'EORTC core Quality of Life QLQ-C30, and brain cancer-specific QLQ-BN20 questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4517669', 'cui_str': '260'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0687700', 'cui_str': 'CCNU'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4477221', 'cui_str': 'depatuxizumab mafodotin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0042790', 'cui_str': 'Disorder of vision'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",260.0,0.161017,Self-reported visual disorders deteriorated to a clinically relevant extent with Depatux-M arms versus TMZ/CCNU at all timepoints (mean differences range: 24.6-35.1 points).,"[{'ForeName': 'Paul M J', 'Initials': 'PMJ', 'LastName': 'Clement', 'Affiliation': 'Department of Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium. Electronic address: paul.clement@uzleuven.be.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Dirven', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, the Netherlands. Electronic address: l.dirven@lumc.nl.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Eoli', 'Affiliation': 'Unit of Molecular Neuro-Oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy. Electronic address: marica.eoli@istituto-besta.it.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Sepulveda-Sanchez', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: jmsepulveda76@gmail.com.'}, {'ForeName': 'Annemiek M E', 'Initials': 'AME', 'LastName': 'Walenkamp', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: a.walenkamp@umcg.nl.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Frenel', 'Affiliation': ""Medical Oncology, Institut de Cancerologie de L'Ouest, Saint-Herblain, France. Electronic address: Jean-Sebastien.Frenel@ico.unicancer.fr.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Franceschi', 'Affiliation': 'Medical Oncology Department, AUSL / IRCCS Institute of Neurological Sciences, Bologna, Italy. Electronic address: enricofra@yahoo.it.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland. Electronic address: michael.weller@usz.ch.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Aix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, CHU Timone, Service de Neuro-Oncologie, Marseille, France. Electronic address: olivier.chinot@ap-hm.fr.'}, {'ForeName': 'Filip Y F L', 'Initials': 'FYFL', 'LastName': 'De Vos', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, University Utrecht, Utrecht, the Netherlands. Electronic address: f.devos@umcutrecht.nl.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Whenham', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Brussels, Belgium. Electronic address: nicolas.whenham@uclouvain.be.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sanghera', 'Affiliation': 'University Hospitals Birmingham, Edgbaston, Birmingham, United Kingdom. Electronic address: paul.sanghera@uhb.nhs.uk.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Looman', 'Affiliation': 'Pharmaceutical Development, AbbVie, Hoofddorp, the Netherlands. Electronic address: jim.looman@abbvie.com.'}, {'ForeName': 'Madan G', 'Initials': 'MG', 'LastName': 'Kundu', 'Affiliation': 'Statistics, AbbVie Inc, North Chicago, IL, USA. Electronic address: madan_g.kundu@yahoo.com.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Peter de Geus', 'Affiliation': 'Clinical Program Development, AbbVie, Hoofddorp, the Netherlands. Electronic address: jan.peter.de.geus@abbvie.com.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nuyens', 'Affiliation': 'EORTC, Brussels, Belgium. Electronic address: sarah.nuyens@eortc.org.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Spruyt', 'Affiliation': 'EORTC, Brussels, Belgium. Electronic address: maarten.spruyt@eortc.org.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: thierry.gorlia@eortc.org.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: corneel.coens@eortc.org.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: Vassilis.golfinopoulos@eortc.org.'}, {'ForeName': 'Jaap C', 'Initials': 'JC', 'LastName': 'Reijneveld', 'Affiliation': 'Brain Tumor Center Amsterdam, Amsterdam University Medical Centers, Amsterdam, the Netherlands; Stichting Epilepsie Instellingen Nederland (SEIN), Heemstede, the Netherlands. Electronic address: jc.reijneveld@amsterdamumc.nl.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neurology, Brain Tumor Center at Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands. Electronic address: m.vandenbent@erasmusmc.nl.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.01.010']
1165,33601285,A tailored mindfulness-based program for resident physicians: A qualitative study.,"BACKGROUND


Diminished well-being is prevalent in resident physicians. This qualitative study explored the effects of a tailored mindfulness-based program (MBP) aimed at increasing resident physicians' well-being. A second goal was to compare the MBP with an active control group.
MATERIALS AND METHODS


We conducted interviews with 35 resident physicians: 21 physicians attended an eight-week MBP (intervention group) and 14 physicians received text-based information about mindfulness for self-study (control group). The interviews were analyzed using thematic analysis.
RESULTS


Participants in the intervention group reported that the MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being, and had positive effects on their self-care and interactions with patients. In the control group, the perceived effects were minor.
CONCLUSION


A tailored mindfulness-based program can help resident physicians care for their own well-being during medical residency and can have positive effects on their interactions with patients.",2021,"RESULTS


Participants in the intervention group reported that the MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being, and had positive effects on their self-care and interactions with patients.",['We conducted interviews with 35 resident physicians: 21 physicians attended an eight-week'],"['MBP (intervention group) and 14 physicians received text-based information about mindfulness for self-study (control group', 'tailored mindfulness-based program (MBP']","['MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being']","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0147913,"RESULTS


Participants in the intervention group reported that the MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being, and had positive effects on their self-care and interactions with patients.","[{'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Aeschbach', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 8, 79104, Freiburg, Germany. Electronic address: vanessa.aeschbach@uniklinik-freiburg.de.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Fendel', 'Affiliation': 'Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Engelbergerstraße 41, 79106, Freiburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 8, 79104, Freiburg, Germany; Institute of Frontier Areas of Psychology and Mental Health, Wilhelmstr. 3a, 79098, Freiburg, Germany.'}, {'ForeName': 'Anja S', 'Initials': 'AS', 'LastName': 'Göritz', 'Affiliation': 'Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Engelbergerstraße 41, 79106, Freiburg, Germany.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101333']
1166,33601214,Feeding frozen complementary foods promotes food acceptance in infants: The randomized intervention trial Baby Gourmet.,"Infancy may represent a sensitive window for establishing food preferences that could affect the individual's long-term potential to establish healthy eating patterns. Our study was based on the hypothesis that preserving the natural flavor of the ingredients of commercially prepared complementary foods would increase the acceptance of new foods, especially vegetables. Frozen vegetable-based meals for infants were developed to preserve the natural taste of the ingredients better than sterilization of meals in jars. In a 3-month randomized, controlled intervention study, 51 infants were fed either frozen menus (intervention group) or commercial sterilized meals in jars (control group) on at least 5 days per week. Then the acceptability of a known vegetable-based puree was tested in comparison to an unknown puree, measuring the quantities consumed and also the mother's assessment of the infants' liking. In conclusion, the results of this study clearly indicated that infants fed vegetable-based frozen meals for 3 months accepted a new vegetable better than infants fed sterilized commercial meals in jars.",2021,Frozen vegetable-based meals for infants were developed to preserve the natural taste of the ingredients better than sterilization of meals in jars.,"['51 infants were fed either', 'infants']","['frozen menus (intervention group) or commercial sterilized meals', 'Frozen vegetable-based meals']",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],51.0,0.037024,Frozen vegetable-based meals for infants were developed to preserve the natural taste of the ingredients better than sterilization of meals in jars.,"[{'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Kalhoff', 'Affiliation': 'Pediatric Clinic, Klinikum Dortmund, Beurhausstrasse 40, D-44137 Dortmund, Germany; Research Department for Child Nutrition [FKE], Paediatric University Hospital, Ruhr University, Bochum, Germany; [formerly Research Institute of Child Nutrition, Dortmund]. Electronic address: hermann.kalhoff@klinikumdo.de.'}, {'ForeName': 'Inga V', 'Initials': 'IV', 'LastName': 'Schmidt', 'Affiliation': 'Research Institute of Child Nutrition, Dortmund, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Heindl', 'Affiliation': 'Institute of Health, Nutrition and Sport Sciences, Europa-Universität, Flensburg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kunert', 'Affiliation': 'Department of Statistics, Technical University of Dortmund, 44221 Dortmund, Germany.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Kersting', 'Affiliation': 'Research Department for Child Nutrition [FKE], Paediatric University Hospital, Ruhr University, Bochum, Germany; [formerly Research Institute of Child Nutrition, Dortmund].'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.12.020']
1167,33571946,MAGNIMS score predicts long-term clinical disease activity-free status and confirmed disability progression in patients treated with subcutaneous interferon beta-1a.,"BACKGROUND


Subcutaneous (sc) interferon (IFN) β-1a reduces relapse rates and delays disability progression in patients with MS. We examined the association of the year 1 Magnetic Resonance Imaging in MS (MAGNIMS) score with long-term clinical disease activity (CDA) -free status and confirmed disability progression in patients treated with sc IFN β-1a in PRISMS.
METHODS


Patients treated with sc IFN β-1a three-times-weekly (22 or 44 μg; pooled data) were classified by MAGNIMS score (0, n = 129; 1, n = 108; 2, n = 130) at year 1. Hazard ratios (HR; 95% confidence intervals [CI]) for risk of CDA and confirmed Expanded Disability Status Score (EDSS) progression were calculated by MAGNIMS score for up to 15 years of follow-up.
RESULTS


The risk of CDA was higher with a year 1 MAGNIMS score of 1 versus 0 (HR 1.82 [1.38-2.41]), 2 versus 0 (2.63 [2.01-3.45]) and 2 versus 1 (1.45 [1.11-1.89], all p < 0.0001). The same outcome was observed with the risk of confirmed EDSS progression (1 versus 0: 1.93 [1.23-3.02]; 2 versus 0: 2.95 [1.95-4.46]; 2 versus 1: 1.53 [1.05-2.23]; all p < 0.0001).
CONCLUSION


In PRISMS, MAGNIMS score at Year 1 predicted risk of CDA and confirmed disability progression in sc IFN β-1a-treated patients over up to 15 years. PRISMS-15 clinicaltrial.gov identifier: NCT01034644.",2021,"The risk of CDA was higher with a year 1 MAGNIMS score of 1 versus 0 (HR 1.82 [1.38-2.41]), 2 versus 0 (2.63 [2.01-3.45]) and 2 versus 1 (1.45 [1.11-1.89],","['Patients treated with sc IFN β-1a three-times-weekly (22 or 44\xa0μg; pooled data) were classified by MAGNIMS score (0, n\xa0=\xa0129; 1, n\xa0=\xa0108; 2, n\xa0=\xa0130) at year 1', 'patients treated with sc IFN β-1a in PRISMS', 'patients with MS']",['Subcutaneous (sc) interferon (IFN) β-1a'],"['risk of confirmed EDSS progression', 'disability progression', 'risk of CDA', 'relapse rates and delays disability progression', 'risk of CDA and confirmed Expanded Disability Status Score (EDSS) progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}]",,0.115578,"The risk of CDA was higher with a year 1 MAGNIMS score of 1 versus 0 (HR 1.82 [1.38-2.41]), 2 versus 0 (2.63 [2.01-3.45]) and 2 versus 1 (1.45 [1.11-1.89],","[{'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'Department of Health Sciences (DISSAL), University of Genoa and Ospedale Policlinico San Martino IRCCS, Via Pastore 1, 16132, Genova, Italy. Electronic address: mariapia.sormani@unige.it.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, 501 Smyth Box 511, Ottawa, ON K1H 8L6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Aldridge', 'Affiliation': 'EMD Serono Research & Development Institute Inc., 45 Middlesex Turnpike, Billerica, MA 01821-3936, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Marhardt', 'Affiliation': 'Merck GmbH, Zimbagasse 5, 1147 Vienna, Austria.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Research Center Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'De Stefano', 'Affiliation': 'Department of Medicine, Surgery and Neuroscience, University of Siena, Viale Bracci 2, 53100, Siena, Italy.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102790']
1168,33578359,Short and long versions of a 12-week netball specific neuromuscular warm-up improves landing technique in youth netballers.,"OBJECTIVE


To investigate the efficacy of two 'NetballSmart', netball specific warm-ups in improving landing technique measures in New Zealand secondary school netball players.
DESIGN


Multi-site cluster experimental trial.
PARTICIPANTS


77 youth participants, mean ± SD age = 15.8 ± 0.9 were recruited from secondary school netball teams.
SETTING


12 teams from 6 schools performed either the NetballSmart Dynamic Warm-up (NSDW) (n = 37); or Power warm-up (PWU) (n = 40), three times a week for 12 weeks. All players within a school (2 teams) were assigned the same warm-up, avoiding treatment contamination.
MAIN OUTCOME MEASURES


A series of unilateral and bilateral drop vertical jumps on to a portable force plate were completed by all participants. Measures included peak vertical ground reaction force (GRF) for single-leg and bilateral landings; frontal plane projection angle (FPPA) for right and left single-leg landings and Landing error scoring system (LESS) for bilateral landings. Paired t-tests were used to assess mean differences pre and post the warm-up. Generalised linear mixed effects models were developed to evaluate the effects between the NSDW and PWU groups.
RESULTS


Significant improvements were found in all the landing technique outcome measures for both warm-up groups (ES Range- GRF = -0.6 to -1.1; FPPA = 0.8 to 1.2; LESS = -1.6 to-3.2; p < 0.05). Results of mixed effects models revealed that there was only a significantly greater improvement in LESS for the PWU group (β = -0.30, p = 0.001).
CONCLUSION


Results show both warm-ups can improve landing technique measures in youth secondary school netball players. It is recommended that coaches should consider implementing one of the two warm-ups in their netball programmes. Their choice of warm-up will likely be dependent on their environment and time demands.",2021,"RESULTS


Significant improvements were found in all the landing technique outcome measures for both warm-up groups (ES Range- GRF = ","['12 teams from 6 schools performed either the', 'All players within a school (2 teams', 'youth secondary school netball players', '77 youth participants, mean\xa0±', 'New Zealand secondary school netball players', 'SD age\xa0', '15.8\xa0±\xa00.9 were recruited from secondary school netball teams', 'youth netballers']","[""two 'NetballSmart', netball specific warm-ups"", 'NetballSmart Dynamic Warm-up (NSDW) (n\xa0=\xa037); or Power warm-up (PWU']","['LESS', 'landing technique measures', 'peak vertical ground reaction force (GRF) for single-leg and bilateral landings; frontal plane projection angle (FPPA) for right and left single-leg landings and Landing error scoring system (LESS) for bilateral landings', 'landing technique outcome measures']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0840974', 'cui_str': 'Netball'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C0840974', 'cui_str': 'Netball'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]","[{'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",77.0,0.0207781,"RESULTS


Significant improvements were found in all the landing technique outcome measures for both warm-up groups (ES Range- GRF = ","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Belcher', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand; Netball New Zealand, Auckland, New Zealand. Electronic address: Suzanne.belcher@netballnorthern.co.nz.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Whatman', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Brughelli', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Borotkanics', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.01.016']
1169,33578328,Efficacy of a new dispatcher-assisted cardiopulmonary resuscitation protocol with audio call-to-video call transition.,"BACKGROUND


Video call based dispatcher-assisted cardiopulmonary resuscitation (V-DACPR) has been suggested to improve the quality of bystander cardiopulmonary resuscitation. In the current system, dispatchers must convert the audio calls to video calls to provide V-DACPR. We aimed to develop new audio call-to-video call transition protocols and test its efficacy and safety compared to conventional DACPR(C-DACPR).
METHODS


This was a randomized controlled simulation trial that compared the quality of bystander chest compression that was performed under three different DACPR protocols: C-DACPR, V-DACPR with rapid transition, and V-DACPR with delayed transition. Adult volunteers excluding healthcare providers were recruited for the trial. The primary outcome of the study was the mean proportion of adequate hand positioning during chest compression.
RESULTS


Simulation results of 131 volunteers were analyzed. The mean proportion of adequate hand positioning was highest in V-DACPR with rapid transition (V-DACPR with rapid transition vs. C-DACPR: 92.7% vs. 82.4%, p = 0.03). The mean chest compression depth was deeper in both V-DACPR groups than in the C-DACPR group (V-DACPR with rapid transition vs. C-DACPR: 40.7 mm vs. 35.9 mm, p = 0.01, V-DACPR with delayed transition vs. C- DACPR: 40.9 mm vs. 35.9 mm, p = 0.01). Improvement in the proportion of adequate hand positioning was observed in the V-DACPR groups (r = 0.25, p < 0.01 for rapid transition and r = 0.19, p < 0.01 for delayed transition).
CONCLUSION


Participants in the V-DACPR groups performed higher quality chest compression with higher appropriate hand positioning and deeper compression depth compared to the C-DACPR group.",2021,Participants in the V-DACPR groups performed higher quality chest compression with higher appropriate hand positioning and deeper compression depth compared to the C-DACPR group.,"['131 volunteers were analyzed', 'Adult volunteers excluding healthcare providers']","['Video call based dispatcher-assisted cardiopulmonary resuscitation (V-DACPR', 'DACPR', 'new dispatcher-assisted cardiopulmonary resuscitation protocol with audio call-to-video call transition', 'conventional DACPR(C-DACPR']","['quality chest compression', 'mean proportion of adequate hand positioning', 'compression depth', 'proportion of adequate hand positioning', 'mean chest compression depth', 'mean proportion of adequate hand positioning during chest compression']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",131.0,0.044295,Participants in the V-DACPR groups performed higher quality chest compression with higher appropriate hand positioning and deeper compression depth compared to the C-DACPR group.,"[{'ForeName': 'Stephen Gyung Won', 'Initials': 'SGW', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul, Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: leestephengyungwon@gmail.com.'}, {'ForeName': 'Tae Han', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: adoong01@snu.ac.kr.'}, {'ForeName': 'Hee Soon', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'EMS Situation Management Center, Seoul Emergency Operation Center, Seoul Metropolitan Fire & Disaster Headquarters, Republic of Korea. Electronic address: namsan1004@seoul.go.kr.'}, {'ForeName': 'Sang Do', 'Initials': 'SD', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul, Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: sdshin@snu.ac.kr.'}, {'ForeName': 'Kyoung Jun', 'Initials': 'KJ', 'LastName': 'Song', 'Affiliation': 'Department of Emergency Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: skciva@gmail.com.'}, {'ForeName': 'Ki Jeong', 'Initials': 'KJ', 'LastName': 'Hong', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul, Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: emkjhong@gmail.com.'}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul, Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: 83191@snuh.org.'}, {'ForeName': 'Yong Joo', 'Initials': 'YJ', 'LastName': 'Park', 'Affiliation': 'Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute; National EMS Control Center, National Fire Agency, Sejong, Korea. Electronic address: parkyongjoo@gmail.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.01.049']
1170,33581774,"Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial.","BACKGROUND


Despite therapeutic advances in HER2-positive metastatic breast cancer, resistance to trastuzumab inevitably develops. In the PHOEBE study, we aimed to assess the efficacy and safety of pyrotinib (an irreversible pan-HER inhibitor) plus capecitabine after previous trastuzumab.
METHODS


This is an open-label, randomised, controlled, phase 3 trial done at 29 hospitals in China. Patients with pathologically confirmed HER2-positive metastatic breast cancer, aged 18-70 years, who had an Eastern Cooperative Oncology Group performance status of 0 or 1, and had been previously treated with trastuzumab and taxanes were randomly assigned (1:1) to receive oral pyrotinib 400 mg or lapatinib 1250 mg once daily plus oral capecitabine 1000 mg/m 2  twice daily on days 1-14 of each 21-day cycle. Randomisation was done via a centralised interactive web-response system with a block size of four or six and stratified by hormone receptor status and previous lines of chemotherapy for metastatic disease. The primary endpoint was progression-free survival according to masked independent central review. Efficacy and safety were assessed in all patients who received at least one dose of the study drugs. Results presented here are from a prespecified interim analysis. This study is registered with ClinicalTrials.gov, NCT03080805.
FINDINGS


Between July 31, 2017, and Oct 30, 2018, 267 patients were enrolled and randomly assigned. 134 patients received pyrotinib plus capecitabine and 132 received lapatinib plus capecitabine. At data cutoff of the interim analysis on March 31, 2019, median progression-free survival was significantly longer with pyrotinib plus capecitabine (12·5 months [95% CI 9·7-not reached]) than with lapatinib plus capecitabine (6·8 months [5·4-8·1]; hazard ratio 0·39 [95% CI 0·27-0·56]; one-sided p<0·0001). The most common grade 3 or worse adverse events were diarrhoea (41 [31%] in the pyrotinib group vs 11 [8%] in the lapatinib group) and hand-foot syndrome (22 [16%] vs 20 [15%]). Serious adverse events were reported for 14 (10%) patients in the pyrotinib group and 11 (8%) patients in the lapatinib group. No treatment-related deaths were reported in the pyrotinib group and one sudden death in the lapatinib group was considered treatment related.
INTERPRETATION


Pyrotinib plus capecitabine significantly improved progression-free survival compared with that for lapatinib plus capecitabine, with manageable toxicity, and can be considered an alternative treatment option for patients with HER2-positive metastatic breast cancer after trastuzumab and chemotherapy.
FUNDING


Jiangsu Hengrui Medicine and National Key R&D Program of China.
TRANSLATIONS


For the Chinese translation of the abstract see Supplementary Materials section.",2021,"No treatment-related deaths were reported in the pyrotinib group and one sudden death in the lapatinib group was considered treatment related.
","['Patients with pathologically confirmed HER2-positive metastatic breast cancer, aged 18-70 years, who had an Eastern Cooperative Oncology Group performance status of 0 or 1, and had been previously treated with', '134 patients received', 'all patients who received at least one dose of the study drugs', 'patients with HER2-positive metastatic breast cancer after trastuzumab and chemotherapy', 'HER2-positive metastatic breast cancer (PHOEBE', '29 hospitals in China', 'Between July 31, 2017, and Oct 30, 2018, 267 patients were enrolled and randomly assigned']","['pyrotinib plus capecitabine', 'oral pyrotinib 400 mg or lapatinib 1250 mg once daily plus oral capecitabine', 'capecitabine', 'lapatinib plus capecitabine', 'Pyrotinib plus capecitabine versus lapatinib plus capecitabine', 'trastuzumab and taxanes']","['sudden death', 'progression-free survival', 'median progression-free survival', 'Efficacy and safety', 'deaths', 'efficacy and safety', 'Serious adverse events', 'diarrhoea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242755', 'cui_str': 'Phoebe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C4517554', 'cui_str': '1250'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",267.0,0.376178,"No treatment-related deaths were reported in the pyrotinib group and one sudden death in the lapatinib group was considered treatment related.
","[{'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: xubinghe@medmail.com.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Liaoning Cancer Hospital & Institute, Shenyang, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Bethune Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yuanting', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'The First Bethune Hospital of Jilin University, Changchun, China; The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Qianjun', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Wuhan Union Hospital, Wuhan, China.'}, {'ForeName': 'Cuizhi', 'Initials': 'C', 'LastName': 'Geng', 'Affiliation': 'The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Cancer Centre of Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sun Yat-Sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': 'Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Third Hospital of Nanchang, Nanchang, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Luo', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yudong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Shandong Tumor Hospital, Jinan, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30702-6']
1171,33591613,Metformin and carotid intima-media thickness in never-smokers with type 1 diabetes: The REMOVAL trial.,"AIM


To determine whether metformin's effects on carotid artery intima-media thickness (cIMT) in type 1 diabetes differ according to smoking status.
METHODS


Regression model effect estimates for the effect of metformin versus placebo (double-blind) on carotid IMT were calculated as a subgroup analysis of the REMOVAL trial.
RESULTS


In 428 randomized participants (227 never-smokers, 201 ever-smokers), averaged mean carotid IMT progression (per year) was reduced by metformin versus placebo in never-smokers (-0.012 mm, 95% CI -0.021 to -0.002; p = .0137) but not in ever-smokers (0.003 mm, 95% CI -0.008 to 0.014; p = .5767); and similarly in non-current smokers (-0.008 mm, 95% CI -0.015 to -0.00001; p = .0497) but not in current smokers (0.013 mm, 95% CI -0.007 to 0.032; p = .1887). Three-way interaction terms (treatment*time*smoking status) were significant for never versus ever smoking (p = .0373, prespecified) and non-current versus current smoking (p = .0496, exploratory). Averaged maximal carotid IMT progression (per year) was reduced by metformin versus placebo in never-smokers (-0.020 mm, 95% CI -0.034 to -0.006; p = .0067) but not in ever-smokers (-0.006 mm, 95% CI -0.020 to 0.008; p = .4067), although this analysis was not supported by a significant three-way interaction term.
CONCLUSIONS


This subgroup analysis of the REMOVAL trial provides additional support for a potentially wider role of adjunct metformin therapy in cardiovascular risk management in type 1 diabetes, particularly for individuals who have never smoked cigarettes.",2021,,['never smokers with type'],['Metformin'],[],"[{'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]",[],,0.0223947,,"[{'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Timmons', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Greenlaw', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Boyle', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nish', 'Initials': 'N', 'LastName': 'Chaturvedi', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Martijn C G J', 'Initials': 'MCGJ', 'LastName': 'Brouwers', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Tillin', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': ""St Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Alun D', 'Initials': 'AD', 'LastName': 'Hughes', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, UK.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Barbara E K', 'Initials': 'BEK', 'LastName': 'Klein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Klein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Teik C', 'Initials': 'TC', 'LastName': 'Ooi', 'Affiliation': 'Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen and the University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Coen D A', 'Initials': 'CDA', 'LastName': 'Stehouwer', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands; and, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Petrie', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14350']
1172,33589406,"Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.","BACKGROUND


Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
OBJECTIVE


This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION


This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m 2 , and 24-hour proteinuria level of 0.5-3.0 g, were recruited in 41 hospitals across 19 provinces in China and were randomly divided into five groups: SYKFT, losartan potassium 50 mg or 100 mg, SYKFT plus losartan potassium 50 mg or 100 mg.
MAIN OUTCOME MEASURES


The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
RESULTS


A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
CONCLUSION


SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
TRIAL REGISTRATION NUMBER


NCT02063100 on ClinicalTrials.gov.",2021,"The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group.","['primary glomerulonephritis patients', 'Primary glomerulonephritis patients, aged 18-70\xa0years, with blood pressure\xa0≤', 'primary glomerulonephritis', '735 participants were enrolled', '41 hospitals across 19 provinces in China']","['SYKFT plus losartan potassium', 'SYKFT, losartan potassium 50\xa0mg or 100\xa0mg, SYKFT plus losartan potassium 50', 'losartan', 'losartan potassium', 'SYKFT', 'SYKFT plus losartan potassium therapy', 'Shenyankangfu Tablet (SYKFT', 'Shenyankangfu Tablet, a Chinese patent medicine']","['glomerular filtration rate (eGFR', '24-hour proteinuria level', 'Efficacy and safety', 'obvious adverse reactions', 'urine protein level', 'TCM syndrome scores', 'efficacy and safety', 'TCM syndrome score', 'eGFR, serum creatinine and serum albumin', 'urine protein', 'urine protein quantification']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0017658', 'cui_str': 'Glomerulonephritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0700492', 'cui_str': 'Losartan potassium'}, {'cui': 'C2912320', 'cui_str': 'Losartan Potassium 50 MG'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}]",735.0,0.24206,"The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China.""}, {'ForeName': 'Shu-Wei', 'Initials': 'SW', 'LastName': 'Duan', 'Affiliation': ""Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China.""}, {'ForeName': 'Hong-Tao', 'Initials': 'HT', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300192, China.'}, {'ForeName': 'Yue-Yi', 'Initials': 'YY', 'LastName': 'Deng', 'Affiliation': 'Department of Nephrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Shandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan 250011, Shandong Province, China.'}, {'ForeName': 'Ya-Ni', 'Initials': 'YN', 'LastName': 'He', 'Affiliation': 'Department of Nephrology, Daping Hospital, Army Medical University, Chongqing 400042, China.'}, {'ForeName': 'Zhao-Hui', 'Initials': 'ZH', 'LastName': 'Ni', 'Affiliation': 'Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University, Shanghai 200127, China.'}, {'ForeName': 'Yong-Li', 'Initials': 'YL', 'LastName': 'Zhan', 'Affiliation': ""Department of Nephrology, Guang'anmen Hospital, China Academy of Traditional Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, Tianjin Medical University General Hospital, Tianjin 300052, China.'}, {'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Guo', 'Affiliation': 'Department of Nephrology, Changhai Hospital of Shanghai, Naval Medical University, Shanghai 200433, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Nephrology, West China Hospital, Chengdu 610083, Sichuan Province, China.'}, {'ForeName': 'Jing-Ai', 'Initials': 'JA', 'LastName': 'Fang', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital of Shanxi Medical University, Taiyuan 030001, Shanxi Province, China.'}, {'ForeName': 'Xu-Sheng', 'Initials': 'XS', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, Guangdong Province, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Shanxi Medical University Second Affiliated Hospital, Taiyuan 030001, Shanxi Province, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Shandong Provincial Hospital, Jinan 250021, Shandong Province, China.'}, {'ForeName': 'Nian-Song', 'Initials': 'NS', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology and Rheumatology, Affiliated Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai 200233, China.""}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Cheng', 'Affiliation': ""Department of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi'an 710003, Shaanxi Province, China.""}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'He', 'Affiliation': 'Department of Nephrology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Luo', 'Affiliation': 'Department of Nephrology, Jilin University Second Hospital, Changchun 130041, Jilin Province, China.'}, {'ForeName': 'Shi-Ren', 'Initials': 'SR', 'LastName': 'Sun', 'Affiliation': ""Department of Nephrology, Xijing Hospital, Air Force Military Medical University, Xi'an 710032, Shaanxi Province, China.""}, {'ForeName': 'Ji-Feng', 'Initials': 'JF', 'LastName': 'Sun', 'Affiliation': ""Department of Nephrology, Tangdu Hospital, Air Force Military Medical University, Xi'an 710038, Shaanxi Province, China.""}, {'ForeName': 'Ai-Ping', 'Initials': 'AP', 'LastName': 'Yin', 'Affiliation': ""Department of Nephrology, the First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an 710061, Shaanxi Province, China.""}, {'ForeName': 'Geng-Ru', 'Initials': 'GR', 'LastName': 'Jiang', 'Affiliation': 'Department of Nephrology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China.'}, {'ForeName': 'Hong-Yu', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou 310007, Zhejiang Province, China.'}, {'ForeName': 'Wen-Hu', 'Initials': 'WH', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.'}, {'ForeName': 'Hong-Li', 'Initials': 'HL', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, Liaoning Province, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': ""Department of Nephrology, the 174th Hospital of the People's Liberation Army, Xiamen 361003, Fujian Province, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Nephrology, 281th Hospital of Chinese People's Liberation Army, Qinhuangdao 066100, Hebei Province, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China.'}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'Song', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, Heilongjiang Province, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Nephrology, 900th Hospital of the Joint Logistics Team of the Chinese People's Liberation Army, Fuzhou 350001, Fujian Province, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Nephrology, Henan Provincial People's Hospital, Zhengzhou 450003, Henan Province, China.""}, {'ForeName': 'Chang-Ying', 'Initials': 'CY', 'LastName': 'Xing', 'Affiliation': 'Department of Nephrology, Jiangsu Province Hospital, Nanjing 210029, Jiangsu Province, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Jiangxi Provincial People's Hospital, Nanchang 330006, Jiangxi Province, China.""}, {'ForeName': 'Ji-Ning', 'Initials': 'JN', 'LastName': 'Gao', 'Affiliation': 'Department of Nephrology, Shanxi Hospital of Integrated Traditional and Western Medicine, Taiyuan 030001, Shanxi Province, China.'}, {'ForeName': 'Rong-Shan', 'Initials': 'RS', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Shanxi Provincial People's Hospital, Taiyuan 030012, Shanxi Province, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, the Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, the Third Xiangya Hospital of Central South University, Changsha 410000, Hunan Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Nephrology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, Zhejiang Province, China.'}, {'ForeName': 'Qiao-Ling', 'Initials': 'QL', 'LastName': 'Zhou', 'Affiliation': 'Department of Nephrology, Xiangya Hospital of Central South University, Changsha 410008, Hunan Province, China.'}, {'ForeName': 'Jun-Zhou', 'Initials': 'JZ', 'LastName': 'Fu', 'Affiliation': ""Department of Nephrology, Guangzhou First People's Hospital, Guangzhou 510180, Guangdong Province, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Nephrology, Zhejiang Provincial People's Hospital, Hangzhou 310014, Zhejiang Province, China.""}, {'ForeName': 'Guang-Yan', 'Initials': 'GY', 'LastName': 'Cai', 'Affiliation': ""Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China. Electronic address: caiguangyan@sina.com.""}, {'ForeName': 'Xiang-Mei', 'Initials': 'XM', 'LastName': 'Chen', 'Affiliation': ""Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China. Electronic address: xmchen301@126.com.""}]",Journal of integrative medicine,['10.1016/j.joim.2021.01.009']
1173,33592561,"First-line Chemotherapy in Advanced Biliary Tract Cancer Ten Years After the ABC-02 Trial: ""And Yet It Moves!""","Biliary tract cancers (BTCs) include a heterogeneous group of highly aggressive hepatobiliary malignancies, representing the 3% of all gastrointestinal cancers and the second most frequent type of primary liver cancer after hepatocellular carcinoma. Ten years after the publication of the phase III, randomized, ABC-02 trial, the combination of cisplatin plus gemcitabine remains the standard first-line treatment for patients with advanced BTC. In the last decade, a large number of attempts has been made to improve the efficacy of the reference doublet by using novel drugs or adding a third agent to cisplatin-gemcitabine. Unfortunately, despite the addition of different cytotoxic drugs failed to improve clinical outcomes in several studies, recently published clinical trials have provided interesting results, and other first-line chemotherapy options are currently under investigation in randomized phase III studies. Moreover, recent years have witnessed the parallel emergence of molecularly targeted therapies and immune checkpoint inhibitors, with these novel agents having the potential to revolutionize the therapeutic algorithm of advanced BTC. In this review, we will provide an overview on first-line therapeutic opportunities currently available in the management of advanced BTCs, especially focusing on recently published data and ongoing clinical trials in this setting.",2021,"Ten years after the publication of the phase III, randomized, ABC-02 trial, the combination of cisplatin plus gemcitabine remains the standard first-line treatment for patients with advanced BTC.","['patients with advanced BTC', 'Ten Years', 'Advanced Biliary Tract Cancer']","['cisplatin plus gemcitabine', 'cisplatin-gemcitabine', 'First-line Chemotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0053251', 'cui_str': 'Benzotrichloride'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0327104,"Ten years after the publication of the phase III, randomized, ABC-02 trial, the combination of cisplatin plus gemcitabine remains the standard first-line treatment for patients with advanced BTC.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy; Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, via Albertoni, 15 Bologna, Italy. Electronic address: rizzo.alessandro179@gmail.com.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy; Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, via Albertoni, 15 Bologna, Italy.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2021.100335']
1174,33592558,Effect of Δ9-Tetrahydrocannabinol on frontostriatal resting state functional connectivity and subjective euphoric response in healthy young adults.,"BACKGROUND


Few studies have examined how Δ9-Tetrahydrocannabinol (THC), the main psychoactive component of cannabis, impacts brain reward circuitry in humans. In this study, we examined if an acute dose of THC altered resting state functional connectivity between the striatum and prefrontal cortex among healthy young adults with limited cannabis use.
METHODS


Participants received THC (n = 24) or placebo (n = 22) in a double-blind, randomized, between-subject design. Participants completed self-report measures of euphoria and drug-liking throughout the visit. Approximately 120 min after drug administration, participants completed an 8-min resting state functional MRI (rs-fMRI) scan. We utilized seed-based connectivity of the striatum (bilateral putamen, caudate, and NAcc seeds) to the frontal cortex.
RESULTS


Individuals who received THC demonstrated greater rs-fMRI connectivity between the right NAcc and regions of the medial prefrontal cortex (mPFC) (p-values<0.05, corrected) and higher subjective euphoria ratings (p = .03) compared to compared to individuals who received placebo. Higher ratings of euphoria were related to greater right NAcc-dorsal mPFC (dmPFC) connectivity for the THC group (p=.03), but not for the placebo group (p=.98).
CONCLUSIONS


This is one of the first studies to examine rs-fMRI connectivity in healthy young non-users after THC administration. We found individuals receiving THC show greater rs-fMRI connectivity between the NAcc and mPFC, regions implicated in reward, compared to individuals receiving placebo. In addition, individuals receiving THC reported higher subjective euphoria ratings, which were positively associated with NAcc-dmPFC connectivity. Overall, our findings suggest THC may produce subjective and neural reward responses that contribute to the rewarding, reinforcing properties of cannabis.",2021,"RESULTS


Individuals who received THC demonstrated greater rs-fMRI connectivity between the right NAcc and regions of the medial prefrontal cortex (mPFC) (p-values<0.05, corrected) and higher subjective euphoria ratings (p = .03) compared to compared to individuals who received placebo.","['healthy young non-users after THC administration', 'healthy young adults', 'Participants received THC (n\u2009=\u200924) or', 'healthy young adults with limited cannabis use']","['Δ9-Tetrahydrocannabinol (THC', 'placebo', 'Δ9-Tetrahydrocannabinol', 'THC']","['right NAcc-dorsal mPFC (dmPFC) connectivity', 'medial prefrontal cortex (mPFC', 'rs-fMRI connectivity', 'euphoria and drug-liking', 'subjective euphoria ratings', 'Higher ratings of euphoria']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.239823,"RESULTS


Individuals who received THC demonstrated greater rs-fMRI connectivity between the right NAcc and regions of the medial prefrontal cortex (mPFC) (p-values<0.05, corrected) and higher subjective euphoria ratings (p = .03) compared to compared to individuals who received placebo.","[{'ForeName': 'Natania A', 'Initials': 'NA', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, United States. Electronic address: ncrane3@uic.edu.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, United States; Department of Psychiatry and Behavioral Health, The Ohio State University, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108565']
1175,33609066,Serum potassium and outcomes in heart failure with preserved ejection fraction: a post-hoc analysis of the PARAGON-HF trial.,"AIMS


The relationship between serum potassium concentration and outcomes in patients with heart failure and preserved ejection fraction (HFpEF) is not well-established. The aim of this study was to explore the association between serum potassium and clinical outcomes in the PARAGON-HF trial in which 4822 patients with HFpEF were randomised to treatment with sacubitril/valsartan or valsartan.
METHODS AND RESULTS


The relationship between serum potassium concentrations and the primary study composite outcome of total (first and recurrent) heart failure hospitalisations and cardiovascular death was analysed. Hypo-, normo-, and hyperkalaemia were defined as serum potassium <4 mmol/L, 4-5 mmol/L and >5 mmol/L, respectively. Both screening and time-updated potassium (categorical and continuous spline-transformed) were studied. Patient mean age was 73 years and 52% were women. Patients with higher baseline potassium more often had an ischaemic aetiology and diabetes and mineralocorticoid receptor antagonist treatment. Compared with normokalaemia, both time-updated (but not screening) hypo- and hyperkalaemia were associated with a higher risk of the primary outcome [adjusted hazard ratio (HR) for hypokalaemia 1.55, 95% confidence interval (CI) 1.30-1.85; P < 0.001, and for hyperkalaemia HR 1.21, 95% CI 1.02-1.44; P = 0.025]. Hypokalaemia had a stronger association with a higher risk of all-cause, cardiovascular and non-cardiovascular death than hyperkalaemia. The association of hypokalaemia with increased risk of all-cause and cardiovascular death was most marked in participants with impaired kidney function (interaction P < 0.05). Serum potassium did not significantly differ between sacubitril/valsartan and valsartan throughout the follow-up.
CONCLUSIONS


Both hypo- and hyperkalaemia were associated with heart failure hospitalisation but only hypokalaemia was associated with mortality, especially in the context of renal impairment. Hypokalaemia was as strongly associated with death from non-cardiovascular causes as with cardiovascular death. Collectively, these findings suggest that potassium disturbances are a more of a marker of HFpEF severity rather than a direct cause of death.",2021,"Both hypo- and hyperkalaemia were associated with heart failure hospitalisation but only hypokalaemia was associated with mortality, especially in the context of renal impairment.","['Patient mean age was 73\u2009years and 52% were women', 'patients with heart failure and preserved ejection fraction (HFpEF) is not well-established', 'participants with impaired kidney function (interactionP<0.05', 'heart failure with preserved ejection fraction', '4822 patients with HFpEF']","['sacubitril/valsartan or valsartan', 'sacubitril/valsartan and valsartan']","['Hypokalaemia', 'Hypo-, normo-, and hyperkalaemia', 'serum potassium concentrations', 'cardiovascular death', 'heart failure hospitalisation', 'total (first and recurrent) heart failure hospitalisations and cardiovascular death', 'Serum potassium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0184571', 'cui_str': 'Renal alteration'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",4822.0,0.118117,"Both hypo- and hyperkalaemia were associated with heart failure hospitalisation but only hypokalaemia was associated with mortality, especially in the context of renal impairment.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'National Institute of Health and Medical Research, Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jiankang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiovascular Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Van Veldhuisen', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kober', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Institute of Cardiology, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Victor C', 'Initials': 'VC', 'LastName': 'Shi', 'Affiliation': 'Novartis, East Hanover, NJ, USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis, East Hanover, NJ, USA.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Vardeny', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'National Institute of Health and Medical Research, Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}]",European journal of heart failure,['10.1002/ejhf.2134']
1176,33607697,Modeling the mindfulness-to-meaning theory's mindful reappraisal hypothesis: Replication with longitudinal data from a randomized controlled study.,"The Mindfulness to Meaning Theory provides a detailed process model of the mechanisms by which mindfulness may promote well-being. Central to the Mindfulness to Meaning Theory is the mindful reappraisal hypothesis (MRH), which suggests mindfulness training promotes well-being by facilitating positive reappraisal. Emerging evidence from interconnected domains of research supports the MRH. However, it remains unclear whether mindful reappraisal continues to develop after a mindfulness training course and whether this continued development encourages well-being over time. As such, this randomized controlled study compared participants receiving a mindfulness-based stress reduction (MBSR) course with participants receiving no mindfulness training on positive reappraisal use and well-being over the course of 6 years. Latent growth curve modeling revealed that mindfulness training increased well-being by significantly increasing the trajectory of positive reappraisal over time. The MRH was then unpacked by examining whether MBSR also stimulated decentering and broadened awareness, core components of the MRH. Multivariate path analysis revealed that mindfulness training increased decentering, which in turn broadened awareness, which was then associated with positive reappraisal, ultimately promoting well-being. Taken together, these findings suggest that MBSR cultivates a downstream cascade of adaptive psychological processes that continue to promote quality of life 6-years after mindfulness training.",2021,"Multivariate path analysis revealed that mindfulness training increased decentering, which in turn broadened awareness, which was then associated with positive reappraisal, ultimately promoting well-being.",['participants receiving a'],['Mindfulness-Based Stress Reduction (MBSR) course with participants receiving no mindfulness training'],[],[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0162631,"Multivariate path analysis revealed that mindfulness training increased decentering, which in turn broadened awareness, which was then associated with positive reappraisal, ultimately promoting well-being.","[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'College of Social Work, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'de Vibe', 'Affiliation': 'Norwegian Knowledge Centre for the Health Services, Oslo, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Solhaug', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Farb', 'Affiliation': 'Department of Psychology, University of Toronto Mississauga, Toronto, ON, Canada.'}, {'ForeName': 'Phillipe R', 'Initials': 'PR', 'LastName': 'Goldin', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gross', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'College of Social Work, University of Utah, Salt Lake City, Utah, USA.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.3035']
1177,33610052,Effect of peer education model on nursing students' knowledge and attitudes towards HIV/AIDS.,"OBJECTIVES


This research is an intervention study designed as a single group pre-test post-test model without control group in order to examine the effect of education provided to nursing students based on peer education model on HIV/AIDS knowledge level and attitude.
DESIGN, METHODS, SETTINGS AND PARTICIPANTS


The research was carried out at Nursing Department of Ankara Yıldırım Beyazıt University. Sample of the study consisted of second year nursing students who agreed to participate in the study and enrolled Internal Medicine Nursing course for the first time (n = 88). In the first stage of the study, nine peer mentors were selected and a total of 12 h of training were given to them by the researchers. In the second stage, peer mentors provided a total of 12 h of training to nine peer students groups. All groups were created by simple randomization on the ""research randomizer"" website. Demographics questionnaire, AIDS knowledge scale and AIDS attitude scale were used to collect the data. Data was analyzed by using descriptive statistics, Pearson Chi-square test, paired sample t-Test, Wilcoxon test and Spearman correlation test.
RESULTS


It was determined that peer education provided a statistically significant increase in AIDS knowledge scale score in peer students (pretest x¯=10.32 ± 3.59, posttest x¯=19.69 ± 1.51) (p < 0.001). In addition, peer education was found to provide a statistically significant increase in AIDS attitude scale score in peer students (pretest x¯=56.64 ± 8.36, posttest x¯=72.95 ± 7.02) (p < 0.001).
CONCLUSION


It has been determined that peer education method is an effective method in increasing HIV/AIDS knowledge and attitude towards people living with HIV/AIDS in nursing students. Therefore, it is recommended to include peer education model in nursing educations regarding HIV/AIDS.",2021,"In addition, peer education was found to provide a statistically significant increase in AIDS attitude scale score in peer students (pretest x¯=56.64 ± 8.36, posttest x¯=72.95 ± 7.02) (p < 0.001).
","['Sample of the study consisted of second year nursing students who agreed to participate in the study and enrolled Internal Medicine Nursing course for the first time (n\xa0=\xa088', ""nursing students' knowledge and attitudes towards HIV/AIDS"", 'peer students ']",['peer education model'],"['AIDS attitude scale score', 'AIDS knowledge scale score', 'Demographics questionnaire, AIDS knowledge scale and AIDS attitude scale']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0172579,"In addition, peer education was found to provide a statistically significant increase in AIDS attitude scale score in peer students (pretest x¯=56.64 ± 8.36, posttest x¯=72.95 ± 7.02) (p < 0.001).
","[{'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Ceylan', 'Affiliation': 'Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Nursing Department, Ankara, Turkey. Electronic address: erdlcyln.ec@gmail.com.'}, {'ForeName': 'Ayşegül', 'Initials': 'A', 'LastName': 'Koç', 'Affiliation': 'Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Nursing Department, Ankara, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2021.104808']
1178,33609973,Impact of high-risk features for stage II adenocarcinoma of the appendix.,"BACKGROUND


Clinico-pathological high-risk features are frequently utilized in adjuvant chemotherapy (AC) decisions in stage II colorectal cancer and their utility in stage II appendiceal adenocarcinoma (AA) is not established. The aim of this study is to determine the impact of high-risk features in clinical outcomes and whether high risk features are predictive of AC benefit in stage II AA.
METHODS


Patients with pathological stage II AA between 2010 and 2015 were identified from the National Cancer Database (NCDB) using ICD-O-3 morphology and topography codes: 8140, 8480 and C18.1. High risk stage II AA was defined as having at least one of the following clinicopathological features: T4 tumor, <12 lymph nodes examined, poorly differentiated histology, positive margins, or lymphovascular invasion. Patients with none of these features were defined as low-risk.
RESULTS


A total of 1040 patients with pathological stage II AA were identified. 51.0% males, 84.5% Caucasian; median age 61 (range, 19-90). 46.4% were determined to have high-risk stage II AA. High-risk status was associated with worse OS compared to low-risk in univariate (HR 1.55; 95% CI 1.18-2.02; p = 0.001) and multivariable analyses (HR 1.36; 95% CI 1.03-1.79; p = 0.028). High-risk stage II AA patients had significantly worse 5-year OS compared to low-risk patients (67.1% vs. 74.5%, p = 0.0013). AC was administered in 34.4% (n = 166) of high-risk patients and in 36.5% (n = 203) of low-risk patients. Among high-risk patients, AC was not associated with better OS in univariate (HR 0.86; 95% CI 0.59-1.26; p = 0.448) and multivariable analyses (HR 1.35; 95% CI 0.90-2.04; p = 0.151) compared to no AC. Similarly, among low-risk patients, AC was not associated with better OS in univariate (HR 0.92; 95% CI 0.60-1.39; p = 0.679) and multivariable analyses (HR 1.27; 95% CI 0.81-2.02; p = 0.299) compared to no AC. For high-risk patients, 5-year OS was 68.3% in patients that received AC vs. 66.5% in patients that did not (p = 0.722). For low-risk patients, 5-year OS was 74.0% in patients that received AC vs. 76.3% in patients that did not (p = 0.813).
CONCLUSION


High-risk stage II AA patients had significantly worse 5-year OS compared to low-risk patients. AC did not improve survival regardless of high-risk features in stage II AA in this retrospective study. A prospective randomized clinical trial would be required to determine the impact of high-risk features on AC in stage II AA.",2021,"For high-risk patients, 5-year OS was 68.3% in patients that received AC vs. 66.5% in patients that did not (p = 0.722).","['203) of low-risk patients', '51.0% males, 84.5% Caucasian; median age 61 (range, 19-90', '1040 patients with pathological stage II AA', 'stage II adenocarcinoma of the appendix', 'Patients with pathological stage II AA between 2010 and 2015 were identified from the National Cancer Database (NCDB) using ICD-O-3 morphology and topography codes: 8140, 8480 and C18.1']",[],"['High risk stage II AA', '5-year OS', 'High-risk stage']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0238003', 'cui_str': 'Adenocarcinoma of appendix'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0009219', 'cui_str': 'Coding'}]",[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",1040.0,0.29023,"For high-risk patients, 5-year OS was 68.3% in patients that received AC vs. 66.5% in patients that did not (p = 0.722).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Akce', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA. Electronic address: mehmet.akce@emory.edu.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Zakka', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'McKenna', 'Initials': 'M', 'LastName': 'Penley', 'Affiliation': 'Winship Research Informatics, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Renjian', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Winship Research Informatics, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Khalil', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Olatunji B', 'Initials': 'OB', 'LastName': 'Alese', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Walid L', 'Initials': 'WL', 'LastName': 'Shaib', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Behera', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA; Winship Research Informatics, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Bassel F', 'Initials': 'BF', 'LastName': 'El-Rayes', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2021.100329']
1179,33617972,"Efficacy and safety of a supplement combination on hand pain among people with symptomatic hand osteoarthritis an internet-based, randomised clinical trial the RADIANT study.","OBJECTIVE


The RADIANT study aimed to investigate the efficacy and safety of a complementary medicine supplement combination in people with hand osteoarthritis (HOA).
METHOD


This was an internet-based, double-blind, randomised, placebo-controlled trial. Participants aged over 40 years with symptomatic HOA with radiographic confirmation (Kellgren Lawrence grade ≥ 2) throughout Australia were recruited and randomly assigned (1:1) to receive either a supplement combination composed of Boswellia serrata extract 250 mg/day, pine bark extract 100 mg/day, methylsulfonylmethane 1,500 mg/day and curcumin 168 mg/day or placebo for 12 weeks. The primary outcome was change in hand pain assessed using a visual analogue scale (VAS 0-100) from baseline to week 12. A range of secondary outcomes and additional measures were recorded. Adverse events were monitored weekly.
RESULTS


One hundred and six participants were included with mean age 65.6 years and 81% were women. 45% of the participants were graded as KLG 4, 40% KLG three and 39 (37%) had erosive OA. There was no significant difference in pain VAS reduction between groups. The adjusted between group difference in means (95%CI) was 5.34 (-2.39 to 13.07). Five participants (10%) in the supplement combination group discontinued study treatment due to AE vs four participants (7%) in the placebo group.
CONCLUSION


There were no significant differences in symptomatic relief between the two groups over 12 weeks. These findings do not support the use of the supplement combination for treating hand pain in people with HOA.
REGISTRATION


Prospectively registered (Australian New Zealand Clinical Trials Registry ACTRN12619000835145, 31/05/2019).",2021,There were no significant differences in symptomatic relief between the two groups over 12 weeks.,"['people with hand osteoarthritis (HOA', 'One hundred and six participants were included with mean age 65.6 years and 81% were women', 'Participants aged over 40 years with symptomatic HOA with radiographic confirmation (Kellgren Lawrence grade ≥ 2) throughout Australia', 'People with Symptomatic Hand Osteoarthritis', 'people with HOA']","['placebo', 'supplement combination composed of Boswellia serrata extract 250 mg/day, pine bark extract 100 mg/day, methylsulfonylmethane 1500 mg/day and curcumin 168 mg/day or placebo', 'Supplement Combination', 'medicine supplement combination']","['change in hand pain assessed using a visual analogue scale', 'Hand Pain', 'pain VAS reduction', 'symptomatic relief', 'Adverse events', 'efficacy and safety', 'Efficacy and Safety', 'erosive OA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0873038', 'cui_str': 'boswellia preparation'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0872909', 'cui_str': 'pine bark extract'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1949455', 'cui_str': 'methylsulfonylmethane 1500 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0239833', 'cui_str': 'Hand pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}]",106.0,0.73013,There were no significant differences in symptomatic relief between the two groups over 12 weeks.,"[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: xliu2328@uni.sydney.edu.au.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Robbins', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: sarah.robbins@sydney.edu.au.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Eyles', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: jillian.eyles@sydney.edu.au.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fedorova', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: tatyana.fedorova@sydney.edu.au.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Virk', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: sonika.virk@sydney.edu.au.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Deveza', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia. Electronic address: leticia.alle@sydney.edu.au.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Australia. Electronic address: andrew.mclachlan@sydney.edu.au.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Australia; Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2021.01.011']
1180,33621815,Evaluation of a self-management intervention for adults with epilepsy in Taiwan: A longitudinal randomized controlled trial.,"PURPOSE


Epilepsy is a neurological disease that causes recurrent seizures and can have a significant impact on a person's quality of life (QOL). A self-management intervention (SMI) can allow adults with epilepsy to modify behaviors in order to manage their seizures and evaluate the impact of medication and treatments on their daily lives. The purpose of this study was to investigate the effects of a SMI for adults with epilepsy.
METHODS


This was a longitudinal randomized controlled trial. Adults with epilepsy between the age of 20 and 65 years were recruited from a medical center in northern Taiwan. Participants were assigned to an intervention group (IG) or control group (CG) through simple randomization. Data regarding demographic and clinical characteristics were collected at baseline (T0). In addition, participants answered nine validated self-report questionnaires, which were used as outcome measures. Following collection of baseline data, the CG received routine monthly counseling over the next 3 months. The IG received the routine monthly counseling, as well as individual face-to-face health counseling on self-management 1 h/month and remote counseling via the phone or computer network at least twice per month. After the first month (T1) and at the end of the third (T2) and sixth months (T3) participants answered the nine questionnaires again. Differences in outcomes between the IGs and CGs were analyzed by comparing scores for the nine outcome variables at T0 with scores at T1, T2, and T3 with generalized estimating equations.
RESULTS


A total of 210 adults agreed to participate in the study; however, only 155 participants completed the questionnaires for all three time points: 75 in the CG and 80 in the IG. The mean age of the 155 participants was 39.6 years (SD = 10.9). There was no significant difference between demographic or clinical variables between the two groups. The only difference in baseline scores (T0) among the nine self-report questionnaires was in epilepsy knowledge, measured with the Epilepsy Knowledge Profile questionnaire, which were significantly higher for the CG (mean = 32.28, SD = 3.92) than the IG (mean = 23.01, SD = 2.79) (p < 0.001). Generalized estimating equations (GEE) analysis showed scores decreased significantly at T3 from baseline for the CG for epilepsy knowledge and QOL (p < 0.001). Improvements in scores for sleep quality, anxiety, depression, self-efficacy, coping, and social support did not differ between groups. Classification of the IG by gender showed a significantly greater increase for males compared with females from baseline to T3 for epilepsy knowledge (p < 0.001). If we further classified the IGs by seizure frequency, participants with a seizure frequency of ≥1 per year had a more significant increase in epilepsy knowledge and increase in QOL compared with participants with a seizure frequency of <1 per year at T3 compared with T0.
CONCLUSION


The lack of improvement in health-related quality of life (HRQoL) following the SMI may indicate that additional time is required to change behaviors that impact this variable for patients with epilepsy. Additional research should focus on variables associated with medication compliance, epilepsy knowledge, medicine symptom distress, self-efficacy, anxiety, and HRQoL.",2021,"Improvements in scores for sleep quality, anxiety, depression, self-efficacy, coping, and social support did not differ between groups.","['The mean age of the 155 participants was 39.6\u202fyears (SD\u202f=\u202f10.9', '210 adults agreed to participate in the study; however, only 155 participants completed the questionnaires for all three time points: 75 in the CG and 80 in the IG', 'patients with epilepsy', 'Adults with epilepsy between the age of 20 and 65\u202fyears were recruited from a medical center in northern Taiwan', 'adults with epilepsy in Taiwan', 'adults with epilepsy']","['SMI', 'self-management intervention (SMI', 'routine monthly counseling, as well as individual face-to-face health counseling on self-management 1\u202fh/month and remote counseling via the phone or computer network at least twice per month', 'intervention group (IG) or control group (CG', 'self-management intervention']","['sleep quality, anxiety, depression, self-efficacy, coping, and social support', 'health-related quality of life (HRQoL', 'medication compliance, epilepsy knowledge, medicine symptom distress, self-efficacy, anxiety, and HRQoL', 'epilepsy knowledge and increase in QOL']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",210.0,0.0794783,"Improvements in scores for sleep quality, anxiety, depression, self-efficacy, coping, and social support did not differ between groups.","[{'ForeName': 'Hsiu-Fang', 'Initials': 'HF', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan; Department of Nursing, Chang Gung Memorial Hospital at Linkou, Taiwan.'}, {'ForeName': 'Yun-Fang', 'Initials': 'YF', 'LastName': 'Tsai', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan; School of Nursing, Chang Gung University, Tao-Yuan, Taiwan; Department of Psychiatry, Chang Gung Memorial Hospital at Keelung, Keelung, Taiwan. Electronic address: yftsai@mail.cgu.edu.tw.'}, {'ForeName': 'Jun-Yu', 'Initials': 'JY', 'LastName': 'Fan', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan; Department of Nursing, Chang Gung Memorial Hospital at Linkou, Taiwan.'}, {'ForeName': 'Min-Chi', 'Initials': 'MC', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Biomedical Sciences, Chang Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Mo-Song', 'Initials': 'MS', 'LastName': 'Hsi', 'Affiliation': 'Department of Neurology, Chang Gung Memorial Hospital at Linkou, Taiwan.'}, {'ForeName': 'Mau-Sun', 'Initials': 'MS', 'LastName': 'Hua', 'Affiliation': 'Department of Psychology, National Taiwan University, Taipei, Taiwan.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107845']
1181,33621809,Testing the effects of the GLP-1 receptor agonist exenatide on cocaine self-administration and subjective responses in humans with cocaine use disorder.,"BACKGROUND


Preclinical rodent studies have demonstrated reduced cocaine taking after administration of glucagon-like peptide 1 (GLP-1) analogues. We investigated effects of a GLP-1 analogue (exenatide) on behavioral and subjective effects of cocaine in individuals with cocaine use disorder (CUD).
METHODS


Non-treatment-seeking CUD subjects underwent two human laboratory cocaine self-administration test sessions following an acute 3 -h pre-treatment with exenatide (5 mcg; subcutaneously) or placebo. Primary outcomes consisted of infusions of cocaine and visual analog scale self-ratings of euphoria and wanting cocaine. Secondary outcomes consisted of pertinent hormone levels (GLP-1, insulin, and amylin).
RESULTS


Thirteen individuals completed the study. Acute pretreatment with exenatide versus placebo did not change cocaine infusions (8.5 ± 1.2 vs. 9.1 ± 1.2; p = 0.39), self-reported euphoria (4.4 ± 0.8 vs. 4.1 ± 0.8; p = 0.21), or wanting of cocaine (5.6 ± 0.9 vs. 5.4 ± 0.9; p = 0.46). Exenatide vs. placebo reduced levels of GLP-1 (p = 0.03) and insulin (p = 0.02). Self-administered cocaine also reduced levels of GLP-1 (p < 0.0001), insulin (p < 0.0001), and amylin (p < 0.0001).
CONCLUSIONS


We did not find evidence that low dose exenatide alters cocaine self-administration or the subjective effects of cocaine in people with CUD. Limitations such as single acute rather than chronic pre-treatment, as well as evaluation of only one dose, preclude drawing firm conclusions about the efficacy of exenatide. Exenatide and cocaine independently reduced levels of GLP-1 and insulin, while cocaine also reduced levels of amylin.",2021,Exenatide vs. placebo reduced levels of GLP-1 (p = 0.03) and insulin (p = 0.02).,"['Non-treatment-seeking CUD subjects underwent two human laboratory cocaine self-administration test sessions following an acute 3 -h pre-treatment with', 'Thirteen individuals completed the study', 'individuals with cocaine use disorder (CUD', 'humans with cocaine use disorder', 'people with CUD']","['GLP-1 receptor agonist exenatide', 'Exenatide vs. placebo', 'placebo', 'GLP-1 analogue (exenatide', 'exenatide versus placebo', 'exenatide', 'Exenatide and cocaine', 'cocaine']","['behavioral and subjective effects', 'pertinent hormone levels (GLP-1, insulin, and amylin', 'visual analog scale self-ratings of euphoria and wanting cocaine', 'levels of GLP-1 and insulin', 'levels of GLP-1']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",13.0,0.0754243,Exenatide vs. placebo reduced levels of GLP-1 (p = 0.03) and insulin (p = 0.02).,"[{'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Clinical Neuroscience Research Unit, Connecticut Mental Health Center, 34 Park Street, New Haven, CT, 06519, USA. Electronic address: gustavo.angarita@yale.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Matuskey', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Department of Radiology and Biomedical Imaging, Yale University School of Medicine, 801 Howard Ave, New Haven, CT, 06519, USA; Department of Neurology, Yale University School of Medicine, 15 York Street, New Haven, CT, 06510, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Costeines', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Clinical Neuroscience Research Unit, Connecticut Mental Health Center, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Potenza', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Child Study Center, Yale University School of Medicine, New Haven, CT, 06510, USA; Department of Neuroscience, Yale University, New Haven, CT, 06510, USA; Connecticut Mental Health Center, New Haven, CT, 06519, USA; Connecticut Council on Problem Gambling, Wethersfield, CT, 06109, USA.'}, {'ForeName': 'Ania M', 'Initials': 'AM', 'LastName': 'Jastreboff', 'Affiliation': 'Department of Internal Medicine (Endocrinology & Metabolism), Yale University School of Medicine, New Haven, CT, 06519, USA; Department of Pediatrics (Pediatric Endocrinology), Yale University School of Medicine, New Haven, CT, 06520, USA.'}, {'ForeName': 'Heath D', 'Initials': 'HD', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 125 South 31stStreet, Philadelphia, PA, 19104, USA; Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, 125 South 31stStreet, Rm 2214, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Malison', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Clinical Neuroscience Research Unit, Connecticut Mental Health Center, 34 Park Street, New Haven, CT, 06519, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108614']
1182,33587403,Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Lisdexamfetamine in Healthy Adults.,"BACKGROUND


Viloxazine extended-release is a novel nonstimulant under investigation as a potential treatment for attention-deficit/hyperactivity disorder (ADHD). Given the potential for viloxazine extended-release to be co-administered with stimulant ADHD pharmacotherapies, this trial investigated the pharmacokinetics and safety of combination viloxazine extended-release + lisdexamfetamine dimesylate (lisdexamfetamine) versus viloxazine extended-release and lisdexamfetamine alone.
METHODS


In this single-center, cross-over, open-label trial, healthy, non-ADHD adults received single oral doses of 700 mg viloxazine extended-release alone, 50 mg lisdexamfetamine alone, and a combination of viloxazine extended-release (700 mg) + lisdexamfetamine (50 mg), with blood samples collected over 4 days postadministration. The active drug in viloxazine extended-release (viloxazine) and primary metabolite of lisdexamfetamine (d-amphetamine) were measured using chromatographic tandem mass spectrometry. Safety assessments included adverse events, vital signs, echocardiograms, and clinical laboratory evaluations.
RESULTS


Thirty-six adults were enrolled, and 34 completed the trial. The least squares geometric mean ratios are reported as [combination / single drug (90% confidence intervals)]. Viloxazine extended-release: Cmax = 95.96% (91.33-100.82), area under the concentration-time curve from 0 to the last measurable time (AUC0-t) = 99.19% (96.53-101.91), and area under the concentration-time curve from 0 to infinity (AUCinf) = 99.23% (96.61-101.93). Lisdexamfetamine: Cmax = 112.78% (109.93-115.71), AUC0-t = 109.64% (105.25-114.22), and AUCinf = 109.52% (105.19-114.03). All reported adverse events, except 1 (moderate vomiting), were mild in severity.
CONCLUSIONS


Co-administration of viloxazine extended-release and lisdexamfetamine did not impact the pharmacokinetics of viloxazine or d-amphetamine relative to administration of either drug alone. After single dose administration, the combination appeared to be safe and well tolerated.",2021,"Cmax = 95.96% (91.33-100.82), area under the concentration-time curve from 0 to the last measurable time (AUC0-t) = 99.19% (96.53-101.91), and area under the concentration-time curve from 0 to infinity (AUCinf) =","['Thirty-six adults were enrolled, and 34 completed the trial', 'Healthy Adults']","['viloxazine extended-release alone, 50 mg lisdexamfetamine alone, and a combination of viloxazine extended-release (700 mg) + lisdexamfetamine', 'lisdexamfetamine (D-amphetamine', 'viloxazine', 'Lisdexamfetamine', 'Coadministered Viloxazine Extended-Release', 'Viloxazine extended-release', 'lisdexamfetamine', 'lisdexamfetamine dimesylate (lisdexamfetamine']","['adverse events, vital signs, echocardiograms, and clinical laboratory evaluations', 'area under the concentration-time curve', 'safe and well tolerated', 'adverse events, except 1 (moderate vomiting']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0042665', 'cui_str': 'Viloxazine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1873633', 'cui_str': 'Lisdexamfetamine'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0011812', 'cui_str': 'Dextroamphetamine'}, {'cui': 'C1739826', 'cui_str': 'Lisdexamfetamine dimesylate'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",36.0,0.0712771,"Cmax = 95.96% (91.33-100.82), area under the concentration-time curve from 0 to the last measurable time (AUC0-t) = 99.19% (96.53-101.91), and area under the concentration-time curve from 0 to infinity (AUCinf) =","[{'ForeName': 'Shamia L', 'Initials': 'SL', 'LastName': 'Faison', 'Affiliation': 'From the Department of Clinical Research, Supernus Pharmaceuticals, Inc., Rockville, MD.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Fry', 'Affiliation': 'From the Department of Clinical Research, Supernus Pharmaceuticals, Inc., Rockville, MD.'}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Adewole', 'Affiliation': 'From the Department of Clinical Research, Supernus Pharmaceuticals, Inc., Rockville, MD.'}, {'ForeName': 'Oyinkansola', 'Initials': 'O', 'LastName': 'Odebo', 'Affiliation': 'From the Department of Clinical Research, Supernus Pharmaceuticals, Inc., Rockville, MD.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'From the Department of Clinical Research, Supernus Pharmaceuticals, Inc., Rockville, MD.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Maletic', 'Affiliation': 'Department of Psychiatry/Behavioral Science, University of South Carolina School of Medicine, Greenville, SC.'}, {'ForeName': 'Azmi', 'Initials': 'A', 'LastName': 'Nasser', 'Affiliation': 'From the Department of Clinical Research, Supernus Pharmaceuticals, Inc., Rockville, MD.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001361']
1183,33587402,Effects of Oral Administration of Alprazolam and Lorazepam as Hypnotics on Cardiovascular Parameters in Hypertensive Patients.,"BACKGROUND


Previous studies have suggested that evening intake of benzodiazepine affects blood pressure (BP) and/or heart rate (HR) in healthy and hypertensive subjects. The aim of this study was to compare the effect of chronic oral administration of alprazolam and lorazepam as hypnotics on ambulatory BP and HR in patients with mild hypertension.
METHODS


Consecutive outpatients of both sexes with newly diagnosed, never-treated mild hypertension were randomized, after a 4-week placebo run-in period, to receive alprazolam 0.5 mg plus placebo, lorazepam 1 mg plus placebo, or placebo plus placebo for 2 weeks in 3 crossover periods, each separated by a 1-week placebo wash-out period. At the end of the initial placebo run-in and of each treatment period, 24-hour ambulatory BP and HR monitoring was performed using a noninvasive device.
RESULTS


In the 32 patients, no treatment had any effect on 24-hour and daytime systolic BP (SBP), diastolic BP (DBP), and HR, which remained unchanged. During the nighttime, SBP and DBP values were unaffected by alprazolam, as compared with placebo, whereas DBP was significantly higher after treatment with lorazepam (+3.7%, P < 0.05 vs placebo). Nocturnal HR mean values were significantly increased by lorazepam (+10.1%, P < 0.01 vs placebo), whereas they did not change after alprazolam.
CONCLUSIONS


In patients with mild hypertension, oral intake of alprazolam or lorazepam as hypnotics did not affect ambulatory BP or HR values. A slight increase in nighttime DBP was observed with lorazepam, whereas alprazolam showed no effect on nocturnal BP and HR, probably reflecting a stimulating effect of the drug on central α2-receptors.",2021,"Nocturnal HR mean values were significantly increased by lorazepam (+10.1%, P < 0.01 vs placebo), whereas they did not change after alprazolam.
","['patients with mild hypertension, oral intake of', 'Consecutive outpatients of both sexes with newly diagnosed, never-treated mild hypertension', 'healthy and hypertensive subjects', 'Hypertensive Patients', 'patients with mild hypertension']","['placebo', 'Alprazolam and Lorazepam', 'alprazolam', 'alprazolam or lorazepam', 'alprazolam 0.5 mg plus placebo, lorazepam 1 mg plus placebo, or placebo plus placebo', 'benzodiazepine', 'lorazepam', 'alprazolam and lorazepam']","['nighttime DBP', 'nighttime, SBP and DBP values', 'DBP', 'blood pressure (BP) and/or heart rate (HR', '24-hour and daytime systolic BP (SBP), diastolic BP (DBP), and HR, which remained unchanged', 'ambulatory BP or HR values', 'ambulatory BP and HR', '24-hour ambulatory BP and HR monitoring', 'Nocturnal HR mean values', 'Cardiovascular Parameters', 'nocturnal BP and HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0991957', 'cui_str': 'Alprazolam 0.5 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0987272', 'cui_str': 'Lorazepam 1 MG'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0199637', 'cui_str': 'Cardiotachometry'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.328406,"Nocturnal HR mean values were significantly increased by lorazepam (+10.1%, P < 0.01 vs placebo), whereas they did not change after alprazolam.
","[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Internal Medicine and Therapeutics, University of Pavia.'}, {'ForeName': 'Matteo Cotta', 'Initials': 'MC', 'LastName': 'Ramusino', 'Affiliation': ''}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Perini', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Bosone', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': 'Internal Medicine and Therapeutics, University of Pavia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Fogari', 'Affiliation': 'Internal Medicine and Therapeutics, University of Pavia.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001362']
1184,33586360,Anlotinib for previously treated advanced or metastatic esophageal squamous cell carcinoma: A double-blind randomized phase 2 trial.,"BACKGROUND


Currently, there are no randomized trials on the effect of antiangiogenic therapy in patients with esophageal squamous cell carcinoma (ESCC). The following study investigated the efficacy and safety of anlotinib in patients with advanced ESCC who were previously treated with chemotherapy.
METHODS


This randomized, placebo-controlled, double-blind phase 2 trial (NCT02649361) was conducted in 13 Chinese hospitals. Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC who were previously treated with chemotherapy, and were randomly assigned (2:1) to receive oral anlotinib 12 mg or placebo on days 1-14 (repeated every 21 days). The primary endpoint was progression-free survival (PFS).
RESULTS


One hundred and sixty-five patients were randomly assigned to the anlotinib (n = 110) or the placebo (n = 55) arm. Median PFS was 3.02 months (95% CI 2.63-3.65) in the anlotinib group and 1.41 months (95% CI 1.38-1.41) in the placebo group (hazard ratio 0.46 [95% CI 0.32-0.66]; p < 0.001). The most common treatment-related adverse events of grade 3 or 4 were hypertension (17 [16%] patients), decreased appetite (6 [6%] patients), and hyponatremia (4 [4%] patients) in the anlotinib group and decreased appetite (2 [4%] patients) in the placebo group. Three (3%) deaths in the anlotinib group were considered as drug related, while there were no treatment-related deaths in the placebo group.
CONCLUSIONS


The use of anlotinib in previously treated, recurrent, or metastatic ESCC patients significantly improved PFS compared with placebo. Our findings suggest that antiangiogenesis might be an important therapeutic target in advanced ESCC.
CLINICAL TRIALS REGISTRATION


Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102), NCT02649361.",2021,Median PFS was 3.02 months (95% CI 2.63-3.65) in the anlotinib group and 1.41 months (95% CI 1.38-1.41) in the placebo group (hazard ratio 0.46 [95% CI 0.32-0.66]; p < 0.001).,"['Patients With Esophageal Squamous Cell Carcinoma (ALTER1102', 'One hundred and sixty-five patients', 'Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC who were previously treated with', 'previously treated advanced or metastatic esophageal squamous cell carcinoma', 'patients with esophageal squamous cell carcinoma (ESCC', 'patients with advanced ESCC who were previously treated with chemotherapy', '13 Chinese hospitals']","['oral anlotinib 12\xa0mg or placebo', 'antiangiogenic therapy', 'placebo', 'chemotherapy']","['PFS', 'appetite', 'efficacy and safety', 'decreased appetite', 'Median PFS', 'progression-free survival (PFS', 'hyponatremia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1142025', 'cui_str': 'Oesophageal squamous cell carcinoma stage IV'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4519250', 'cui_str': 'anlotinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}]",165.0,0.728124,Median PFS was 3.02 months (95% CI 2.63-3.65) in the anlotinib group and 1.41 months (95% CI 1.38-1.41) in the placebo group (hazard ratio 0.46 [95% CI 0.32-0.66]; p < 0.001).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Juxiang', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ""Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Department of Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ba', 'Affiliation': 'Department of Medical Oncology, Tianjin Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Affiliated Tumor Hospital, Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Cancer medicine,['10.1002/cam4.3771']
1185,33596508,"Adiponectin/leptin ratio increases after a 12-week very low-carbohydrate, high-fat diet, and exercise training in healthy individuals: A non-randomized, parallel design study.","This study aimed to investigate the effect of a 12-week very low-carbohydrate, high-fat (VLCHF) diet and exercise on biomarkers of inflammation in healthy individuals. Since the anti-inflammatory effects of a ketogenic diet have been established, we hypothesized that the VLCHF diet, along with exercise, would have an additional favorable effect on biomarkers of inflammation. Twenty-four healthy individuals were allocated to the VLCHF diet (VLCHF: N = 12, age 25.3 ± 2.0 years, body mass 66.7 ± 9.8 kg, fat mass 21.5% ± 4.9%), or habitual diet (HD: N = 12, age 23.9 ± 3.8 years, body mass 72.7 ± 15.0 kg, fat mass 23.4 ± 8.4 %) group. Biomarkers of inflammation (adiponectin, leptin, and high-sensitive interleukin-6 [hs-IL-6]) and substrate metabolism (glycated hemoglobin, fasting glucose, triacylglycerides, and cholesterol) were analyzed from blood at baseline and after 12 weeks. The adiponectin-leptin ratio significantly increased in the VLCHF group after the intervention period (ES [95% CL]: -0.90 [-0.96, -0.77], P ≤ .001, BF 10  = 22.15). The adiponectin-leptin ratio changes were associated with both a significant increase in adiponectin (-0.79 [-0.91, -0.54], P ≤ .001, BF 10  = 9.43) and a significant decrease in leptin (0.58 [0.19, 0.81], P = .014, BF 10  = 2.70). There was moderate evidence of changes in total cholesterol (-1.15 [-2.01, -0.27], P = .010, BF 10  = 5.20), and LDL cholesterol (-1.12 [-2.01, -0.21], P = .016, BF 10  = 4.56) in the VLCHF group. Body weight (kg) and fat mass (%) decreased in the VLCHF group by 5.4% and 14.9%, respectively. We found that in healthy young individuals, consuming a VLCHF diet while performing regular exercise over a 12-week period produced favorable changes in body weight and fat mass along with beneficial changes in serum adiponectin and leptin concentrations. These data support the use of a VLCHF diet strategy for the primary prevention of chronic diseases associated with systemic low-grade inflammation.",2021,"Body weight (kg) and fat mass (%) decreased in the VLCHF group by 5.4% and 14.9%, respectively.","['healthy individuals', 'N = 12, age 25.3 ± 2.0 years, body mass 66.7 ± 9.8 kg, fat mass 21.5% ± 4.9%), or habitual diet (HD: N = 12, age 23.9 ± 3.8 years, body mass 72.7 ± 15.0 kg, fat mass 23.4 ± 8.4 %) group', 'Twenty-four healthy individuals', 'healthy young individuals']","['VLCHF', 'VLCHF diet strategy', 'VLCHF diet (VLCHF', 'exercise training', 'low-carbohydrate, high-fat (VLCHF) diet and exercise']","['adiponectin', 'Body weight (kg) and fat mass', 'leptin', 'total cholesterol', 'serum adiponectin and leptin concentrations', 'Adiponectin/leptin ratio', 'adiponectin-leptin ratio', 'body weight and fat mass', 'LDL cholesterol', 'Biomarkers of inflammation (adiponectin, leptin, and high-sensitive interleukin-6 [hs-IL-6]) and substrate metabolism (glycated hemoglobin, fasting glucose, triacylglycerides, and cholesterol', 'adiponectin-leptin ratio changes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",24.0,0.0149964,"Body weight (kg) and fat mass (%) decreased in the VLCHF group by 5.4% and 14.9%, respectively.","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Cipryan', 'Affiliation': 'Department of Human Movement Studies and Human Motion Diagnostic Centre, The University of Ostrava, Ostrava, Czech Republic. Electronic address: lukas.cipryan@osu.cz.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Dostal', 'Affiliation': 'Department of Human Movement Studies and Human Motion Diagnostic Centre, The University of Ostrava, Ostrava, Czech Republic. Electronic address: tomas.dostal@osu.cz.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Plews', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand. Electronic address: dan@danplews.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hofmann', 'Affiliation': 'Institute of Human Movement Science, Sport and Health; Exercise Physiology, Training and Training Therapy Research Group, University of Graz, Graz, Austria. Electronic address: peter.hofmann@uni-graz.at.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Laursen', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand. Electronic address: paul@hiitscience.com.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.12.012']
1186,33596494,Randomized placebo-controlled pilot clinical trial on the efficacy of ayurvedic treatment regime on COVID-19 positive patients.,"BACKGROUND


Specific treatment for COVID-19 is still an unmet need. Outcomes of clinical trials on repurposed drugs have not been yielding success. Therefore, it is necessary to include complementary approaches of medicine against COVID-19.
PURPOSE


This study was designed to evaluate the impact of traditional Indian Ayurvedic treatment regime on asymptomatic patients with COVID-19 infection.
STUDY DESIGN


It is a placebo controlled randomized double-blind pilot clinical trial.
METHODS


The study was registered with Clinical Trial Registry-India (vide Registration No. CTRI/2020/05/025273) and conducted at the Department of Medicine in National Institute of Medical Sciences and Research, Jaipur, India. 1 g of Giloy Ghanvati (Tinospora cordifolia) and 2 g of Swasari Ras (traditional herbo-mineral formulation) and 0.5 g each of Ashwagandha (Withania somnifera) and Tulsi Ghanvati (Ocimum sanctum) were given orally to the patients in treatment group twice per day for 7 days. Medicines were given in the form of tablets and each tablet weighed 500 mg. While, Swasari Ras was administered in powdered form, 30 min before breakfasts and dinners, rest were scheduled for 30 min post-meals. Patients in the treatment group also received 4 drops of Anu taila (traditional nasal drop) in each nostril every day 1 h before breakfast. Patients in the placebo group received identical-looking tablets and drops, post randomization and double blinded assortments. RT-qPCR test was used for the detection of viral load in the nasopharyngeal and oropharyngeal swab samples of study participants during the study. Chemiluminescent immunometric assay was used to quantify serum levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α) and high sensitivity C-reactive protein (hs-CRP) on day 1 and day 7 of the study.
RESULTS


By day 3, 71.1 % and 50.0 % patients recovered in the treatment and placebo groups, respectively. Treatment group witnessed 100 % recovery by day 7, while it was 60.0 % in the placebo group. Average fold changes in serum levels of hs-CRP, IL-6 and TNF-α in treatment group were respectively, 12.4, 2.5 and 20 times lesser than those in the placebo group at day 7. There was 40 % absolute reduction in the risk of delayed recovery from infection in the treatment group.
CONCLUSIONS


Ayurvedic treatment can expedite virological clearance, help in faster recovery and concomitantly reduce the risk of viral dissemination. Reduced inflammation markers suggested less severity of SARS-CoV-2 infection in the treatment group. Moreover, there was no adverse effect observed to be associated with this treatment.",2021,"Average fold changes in serum levels of hs-CRP, IL-6 and TNF-α in treatment group were respectively, 12.4, 2.5 and 20 times lesser than those in the placebo group at day 7.","['asymptomatic patients with COVID-19 infection', 'COVID-19 positive patients']","['Giloy Ghanvati (Tinospora cordifolia) and 2 g of Swasari Ras (traditional herbo-mineral formulation) and 0.5 g each of Ashwagandha (Withania somnifera) and Tulsi Ghanvati (Ocimum sanctum', 'placebo', 'Swasari Ras', '4 drops of Anu taila (traditional nasal drop', 'traditional Indian Ayurvedic treatment regime', 'identical-looking tablets']","['serum levels of hs-CRP, IL-6 and TNF-α', 'serum levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α) and high sensitivity C-reactive protein (hs-CRP', 'risk of viral dissemination']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C1009737', 'cui_str': 'Tinospora'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C1483721', 'cui_str': 'Ocimum tenuiflorum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}]",,0.46614,"Average fold changes in serum levels of hs-CRP, IL-6 and TNF-α in treatment group were respectively, 12.4, 2.5 and 20 times lesser than those in the placebo group at day 7.","[{'ForeName': 'Ganpat', 'Initials': 'G', 'LastName': 'Devpura', 'Affiliation': 'Department of Medicine, National Institute of Medical Sciences, Jaipur-Delhi Highway (NH-11C), Jaipur 303121, Rajasthan, India.'}, {'ForeName': 'Balvir S', 'Initials': 'BS', 'LastName': 'Tomar', 'Affiliation': 'Department of Pediatrics, National Institute of Medical Sciences, Jaipur-Delhi Highway (NH-11C) Expy, Shobha Nagar, Jaipur 303121, Rajasthan, India. Electronic address: chancellor@nimsuniversity.com.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Nathiya', 'Affiliation': 'Department of Clinical Pharmacology, National Institute of Medical Sciences, Jaipur-Delhi Highway (NH-11C), Jaipur 303121, Rajasthan, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine, National Institute of Medical Sciences, Jaipur-Delhi Highway (NH-11C), Jaipur 303121, Rajasthan, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhandari', 'Affiliation': 'Patanjali Chikitsalya, Amrapali Circle, Vaishali Nagar, Jaipur 302021, Rajasthan, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Haldar', 'Affiliation': 'Drug Discovery and Development Division, Patanjali Research Institute, Roorkee-Haridwar Road, Haridwar 249405, Uttarakhand, India.'}, {'ForeName': 'Acharya', 'Initials': 'A', 'LastName': 'Balkrishna', 'Affiliation': 'Drug Discovery and Development Division, Patanjali Research Institute, Roorkee-Haridwar Road, Haridwar 249405, Uttarakhand, India; Department of Allied and Applied Sciences, University of Patanjali, NH-58, Haridwar 249405, Uttarakhand, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Varshney', 'Affiliation': 'Drug Discovery and Development Division, Patanjali Research Institute, Roorkee-Haridwar Road, Haridwar 249405, Uttarakhand, India; Department of Allied and Applied Sciences, University of Patanjali, NH-58, Haridwar 249405, Uttarakhand, India. Electronic address: anurag@prft.co.in.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2021.153494']
1187,33602555,"Regular insulin added to total parenteral nutrition vs subcutaneous glargine in non-critically ill diabetic inpatients, a multicenter randomized clinical trial: INSUPAR trial.",,2021,,['non-critically ill diabetic inpatients'],['Regular insulin added to total parenteral nutrition vs subcutaneous glargine'],[],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]",[],,0.119969,,"[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Olveira', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Regional Universitario de Málaga - Instituto de Investigación Biomédica de Málaga (IBIMA), Spain, Universidad de Málaga, Spain, CIBERDEM (CB07/08/0019), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: gabrielm.olveira.sspa@juntadeandalucia.es.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Abuin-Fernández', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Regional Universitario de Málaga - Instituto de Investigación Biomédica de Málaga (IBIMA), Spain, Universidad de Málaga, Spain.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.01.029']
1188,33600846,"Comparison of the effect of Morphine and Fentanyl in patients with acute coronary syndrome receiving Ticagrelor - The COMET (Comparison Morphine, Fentayl and Ticagrelor) randomized controlled trial.","INTRODUCTION


Dual antiplatelet therapy (DAPT) remains the cornerstone of acute coronary syndrome (ACS) management, and ticagrelor is one of the commonly used second antiplatelet agents. There is some evidence to suggest that morphine may reduce the antiplatelet effect of ticagrelor.
METHODS AND RESULTS


In a single-center, randomized controlled trial, we compared the effect of morphine and fentanyl on platelet aggregation (PA) among patients with ACS treated with ticagrelor. Platelet aggregation was studied by automated light transmittance aggregometry (LTA) at baseline, and at 2 h after ticagrelor loading. The primary outcome was the difference in the maximal inhibition of platelet aggregation [IPA(%)] between the groups at 2 h. Pain relief, and drug-related adverse events were secondary outcomes. Of 136 patients randomized, 70 received fentanyl and 66 received morphine. At baseline, the median (IQR) platelet aggregation [61.35% (54.6 to 70) Vs. 58.8% (52.7 to 72.9)] were comparable between the groups. There was no statistically significant difference between the fentanyl and the morphine groups in IPA at 2-h [85.88%(64.65-98.16) and 81.93%(44.2-98.03), p = 0.09]. However, morphine use was independently associated with a PA of >30% at 2 h (p < 0.009). There was no difference in adverse events.
CONCLUSION


In patients with ACS, there was no significant difference between the use of fentanyl or morphine on the effect of ticagrelor on PA. (CTRI/2018/04/013423).",2021,There was no statistically significant difference between the fentanyl and the morphine groups in IPA at 2-h,"['patients with ACS treated with', 'patients with acute coronary syndrome ', '136 patients randomized, 70 received']","['morphine', 'morphine and fEntanyl', 'Dual antiplatelet therapy (DAPT', 'ticagrelor', 'fentanyl', 'morphine and fentanyl']","['Platelet aggregation', 'platelet aggregation (PA', 'maximal inhibition of platelet aggregation [IPA', 'adverse events', 'Pain relief, and drug-related adverse events', 'median (IQR) platelet aggregation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",136.0,0.103846,There was no statistically significant difference between the fentanyl and the morphine groups in IPA at 2-h,"[{'ForeName': 'Nagendra Boopathy', 'Initials': 'NB', 'LastName': 'Senguttuvan', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India; Adjunct Faculty, Department of Engineering and design, Indian Institute of Technology-Madras, Chennai, India. Electronic address: drsnboopathy@gmail.com.'}, {'ForeName': 'Febe', 'Initials': 'F', 'LastName': 'Suman', 'Affiliation': 'Department of Pathology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'TamilAnbu', 'Initials': 'T', 'LastName': 'Paneerselvam', 'Affiliation': 'Department of Emergency Medicine, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Balakrishna', 'Initials': 'B', 'LastName': 'Malepati', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Sankaran', 'Initials': 'S', 'LastName': 'Ramesh', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Mano Vikash', 'Initials': 'MV', 'LastName': 'Vallivedu', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Phalgun', 'Initials': 'P', 'LastName': 'Badimela', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Mahalakshmi', 'Initials': 'M', 'LastName': 'Ramadoss', 'Affiliation': 'Faculty of Clinical Research, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Iyer', 'Affiliation': 'Faculty of Clinical Research, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Preetam', 'Initials': 'P', 'LastName': 'Krishnamurthy', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Balakrishnan', 'Initials': 'B', 'LastName': 'Vinod Kumar', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Jayanthy Venkata', 'Initials': 'JV', 'LastName': 'Balasubramaniyan', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Shanmugasundram', 'Initials': 'S', 'LastName': 'Sadhanandham', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Rathinasamy', 'Initials': 'R', 'LastName': 'Jebaraj', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Panchanatham', 'Initials': 'P', 'LastName': 'Manokar', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Thoddi Ramamurthy', 'Initials': 'TR', 'LastName': 'Muralidharan', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Jayanthy Sathyanarayana', 'Initials': 'JS', 'LastName': 'Murthy', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Sadagopan', 'Initials': 'S', 'LastName': 'Thanikachalam', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Parasuram', 'Initials': 'P', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Division of Interventional Cardiology, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York 10029, United States of America.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'Division of Interventional cardiology, Cardiovascular Institute - Suite 2E, Oklahoma University, 825 N.E. 10th St., Oklahoma City, OK 73104, United States of America.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Karthikeyan', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India.'}]",International journal of cardiology,['10.1016/j.ijcard.2021.02.037']
1189,33600761,"Endoscopic surgery compared with intensity-modulated radiotherapy in resectable locally recurrent nasopharyngeal carcinoma: a multicentre, open-label, randomised, controlled, phase 3 trial.","BACKGROUND


The role of surgery compared with reirradiation in the primary treatment of patients with resectable, locally recurrent nasopharyngeal carcinoma (NPC) who have previously received radiotherapy is a matter of debate. In this trial, we compared the efficacy and safety outcomes of salvage endoscopic surgery versus intensity-modulated radiotherapy (IMRT) in patients with resectable locally recurrent NPC.
METHODS


This multicentre, open-label, randomised, controlled, phase 3 trial was done in three hospitals in southern China. We included patients aged 18-70 years with a Karnofsky Performance Status score of at least 70 who were histopathologically diagnosed with undifferentiated or differentiated, non-keratinising, locally recurrent NPC with tumours confined to the nasopharyngeal cavity, the post-naris or nasal septum, the superficial parapharyngeal space, or the base wall of the sphenoid sinus. Eligible patients were randomly assigned (1:1) to receive either endoscopic nasopharyngectomy (ENPG group) or IMRT (IMRT group). Randomisation was done manually using a computer-generated random number code and patients were stratified by treatment centre. Treatment group assignment was not masked. The primary endpoint was overall survival, compared between the groups at 3 years. Efficacy analyses were done by intention to treat. Safety analysis was done in patients who received treatment according to the treatment they actually received. This trial was prospectively registered at the Chinese Clinical Trial Registry, ChiCTR-TRC-11001573, and is currently in follow-up.
FINDINGS


Between Sept 30, 2011, and Jan 16, 2017, 200 eligible patients were randomly assigned to receive either ENPG (n=100) or IMRT (n=100). At a median follow-up of 56·0 months (IQR 42·0-69·0), 74 patients had died (29 [29%] of 100 patients in the ENPG group and 45 [45%] of 100 patients in the IMRT group). The 3-year overall survival was 85·8% (95% CI 78·9-92·7) in the ENPG group and 68·0% (58·6-77·4) in the IMRT group (hazard ratio 0·47, 95% CI 0·29-0·76; p=0·0015). The most common grade 3 or worse radiation-related late adverse event was pharyngeal mucositis (in five [5%] of 99 patients who underwent ENPG and 26 [26%] of 101 patients who underwent IMRT). Five [5%] of the 99 patients who underwent ENPG and 20 [20%] of the 101 patients who underwent IMRT died due to late toxic effects specific to radiotherapy; attribution to previous radiotherapy or trial radiotherapy is unclear due to the long-term nature of radiation-related toxicity.
INTERPRETATION


Endoscopic surgery significantly improved overall survival compared with IMRT in patients with resectable locally recurrent NPC. These results suggest that ENPG could be considered as the standard treatment option for this patient population, although long-term follow-up is needed to further determine the efficacy and toxicity of this strategy.
FUNDING


Sun Yat-sen University Clinical Research 5010 Program.",2021,"The 3-year overall survival was 85·8% (95% CI 78·9-92·7) in the ENPG group and 68·0% (58·6-77·4) in the IMRT group (hazard ratio 0·47, 95% CI 0·29-0·76; p=0·0015).","['resectable locally recurrent nasopharyngeal carcinoma', 'Between Sept 30, 2011, and Jan 16, 2017, 200 eligible patients', 'Eligible patients', 'patients with resectable locally recurrent NPC', 'three hospitals in southern China', 'patients aged 18-70 years with a Karnofsky Performance Status score of at least 70 who were histopathologically diagnosed with undifferentiated or differentiated, non-keratinising, locally recurrent NPC with tumours confined to the nasopharyngeal cavity, the post-naris or nasal septum, the superficial parapharyngeal space, or the base wall of the sphenoid sinus', 'patients with resectable, locally recurrent nasopharyngeal carcinoma (NPC) who have previously received']","['Endoscopic surgery', 'radiotherapy', 'endoscopic nasopharyngectomy (ENPG group) or IMRT (IMRT', 'ENPG', 'radiotherapy or trial radiotherapy', 'salvage endoscopic surgery versus intensity-modulated radiotherapy (IMRT', 'IMRT', 'intensity-modulated radiotherapy']","['efficacy and safety outcomes', 'pharyngeal mucositis', 'efficacy and toxicity', '3-year overall survival', 'overall survival']","[{'cui': 'C0278952', 'cui_str': 'Nasopharyngeal cancer recurrent'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4545792', 'cui_str': 'KPS (Karnofsky Performance Status) score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0225497', 'cui_str': 'Structure of nasopharyngeal cavity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0027432', 'cui_str': 'Nasal septum structure'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0227148', 'cui_str': 'Structure of lateral pharyngeal space'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0037885', 'cui_str': 'Sphenoid sinus structure'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}]","[{'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4076352', 'cui_str': 'Endoscopic nasopharyngectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",200.0,0.252491,"The 3-year overall survival was 85·8% (95% CI 78·9-92·7) in the ENPG group and 68·0% (58·6-77·4) in the IMRT group (hazard ratio 0·47, 95% CI 0·29-0·76; p=0·0015).","[{'ForeName': 'You-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou Key Laboratory of Otorhinolaryngology, Otorhinolaryngology Institute of Sun Yat-sen University, Guangzhou, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Yi-Hui', 'Initials': 'YH', 'LastName': 'Wen', 'Affiliation': 'Department of Otolaryngology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou Key Laboratory of Otorhinolaryngology, Otorhinolaryngology Institute of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': ""Department of Otolaryngology, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Otolaryngology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou Key Laboratory of Otorhinolaryngology, Otorhinolaryngology Institute of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'You', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Xiao-Lin', 'Initials': 'XL', 'LastName': 'Zhu', 'Affiliation': 'Department of Otolaryngology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou Key Laboratory of Otorhinolaryngology, Otorhinolaryngology Institute of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou Key Laboratory of Otorhinolaryngology, Otorhinolaryngology Institute of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou Key Laboratory of Otorhinolaryngology, Otorhinolaryngology Institute of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'Department of Medical Statistics, School of Public Health, and Center for Migrant Health Policy, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Yi-Jun', 'Initials': 'YJ', 'LastName': 'Hua', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'You-Mou', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Li-Xia', 'Initials': 'LX', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Ming-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Wei-Ping', 'Initials': 'WP', 'LastName': 'Wen', 'Affiliation': 'Department of Otolaryngology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou Key Laboratory of Otorhinolaryngology, Otorhinolaryngology Institute of Sun Yat-sen University, Guangzhou, China; Department of Otolaryngology, the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: wenwp@mail.sysu.edu.cn.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30673-2']
1190,33600729,SYmbicort given as needed in mild asthma (SYGMA study): a retrospective subanalysis of the Russian population.,"INTRODUCTION


While mild asthma is generally better controlled than more severe disease, patients with mild asthma may experience severe exacerbations. Definite differences between countries in terms of asthma severity and control were described previously. Since SYGMA was a global study, this sub-analysis was conducted in geographic region to investigate potential regional specificities.
METHODS


The SYGMA2 trial is double-blind multicenter study involving patients ≥12 years of age with mild asthma ( n  = 4176), eligible for regular treatment with inhaled corticosteroid (ICS). We conducted an open-label descriptive subanalysis of the baseline characteristics of the Russian population ( n  = 579) comparing to rest of participants of SYGMA2 trial from other 24 countries. The subanalysis is solely descriptive and will be used for hypothesis generation.
RESULTS


The Russian population of patients with mild asthma hardly differs from the population in other countries in terms of baseline demographic and anthropometric characteristics, smoking status, and duration of asthma. At the study entry few patients from Russia received maintenance therapy with ICS and had symptom control, but the majority was uncontrolled on short-acting bronchodilators, thus the uncontrolled/controlled ratio was 52%/48% vs 45%/55% in other countries. More patients with mild asthma in the Russian group had faced at least one severe exacerbation in the previous year (30.1% vs 20.7%).
CONCLUSIONS


The subanalysis revealed a delayed prescription of controller (ICS) therapy and overuse of short-acting bronchodilators in the Russian population with mild asthma. These factors can lead to insufficient symptom control and higher risk of severe exacerbation in the Russian population with mild asthma.",2021,The subanalysis revealed a delayed prescription of controller (ICS) therapy and overuse of short-acting bronchodilators in the Russian population with mild asthma.,"['patients ≥12 years of age with mild asthma (n\u2009=\u20094176), eligible for regular treatment with inhaled corticosteroid (ICS', 'Mild Asthma (SYGMA study', 'Russian population (n\u2009=\u2009579) comparing to rest of participants of SYGMA2 trial from other 24 countries', 'Russian population with mild asthma']",['controller (ICS) therapy and overuse of short-acting bronchodilators'],['severe exacerbation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035967', 'cui_str': 'Russian language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.283198,The subanalysis revealed a delayed prescription of controller (ICS) therapy and overuse of short-acting bronchodilators in the Russian population with mild asthma.,"[{'ForeName': 'Zaurbek', 'Initials': 'Z', 'LastName': 'Aisanov', 'Affiliation': 'Pulmonology Department, Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Avdeev', 'Affiliation': 'Pulmonology Department, I M Sechenov First Moscow State Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Arkhipov', 'Affiliation': 'Department of Clinical Pharmacology and Therapy, Russian Medical Academy of Continuing Professional Education, Moscow, Russian Federation.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Belevsky', 'Affiliation': 'Pulmonology Department, Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2021.1892753']
1191,33594821,Molecular response and quality of life in chronic myeloid leukemia patients treated with intermittent TKIs: First interim analysis of OPTkIMA study.,"BACKGROUND


Intermittent treatment with TKIs is an option for the great majority (70%-80%) of CML patients who do not achieve a stable deep molecular response and are not eligible for treatment discontinuation. For these patients, the only alternative is to assume TKI continuously, lifelong.
METHODS


The Italian phase III multicentric randomized OPTkIMA study started in 2015, with the aim to evaluate if a progressive de-escalation of TKIs (imatinib, nilotinib, and dasatinib) is able to maintain the molecular response (MR 3.0  ) and to improve Health Related Quality of Life (HRQoL).
RESULTS


Up to December 2018, 166/185 (90%) elderly CML patients in stable MR 3.0  /MR 4.0  completed the first year of any TKI intermittent schedule 1 month ON and 1 month OFF. The first year probability of maintaining the MR 3.0  was 81% and 23.5% of the patients who lost the molecular response regained the MR 3.0  after resuming TKI continuously. Patients' HRQoL at baseline was better than that of matched peers from healthy population. Women was the only factor independently associated with worse baseline HRQoL (p > 0.0001). Overall, global HRQoL worsened at 6 (p < 0.001) but returned to the baseline value at 12 months and it was statistically significantly worse in women (p = 0.001).
CONCLUSIONS


De-escalation of any TKI by 1 month ON/OFF schedule maintains the MR 3.0  /MR 4.0  in 81% of the patients during the first 12-24 months. No patients progressed to accelerated/blastic phase, all the patients (23.5%) losing MR 3.0  regained the MR 3.0  and none suffered from TKI withdrawn syndrome. The study firstly report on HRQoL in elderly CML patients moving from a continuous daily therapy to a de-escalated intermittent treatment.",2021,"Overall, global HRQoL worsened at 6 (p < 0.001) but returned to the baseline value at 12 months and it was statistically significantly worse in women (p = 0.001).
","['elderly CML patients moving from a continuous daily therapy to a de-escalated intermittent treatment', 'chronic myeloid leukemia patients treated with']","['TKIs (imatinib, nilotinib, and dasatinib', 'TKIs', 'intermittent TKIs']","['Health Related Quality of Life (HRQoL', 'Overall, global HRQoL', 'Molecular response and quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1269909', 'cui_str': 'MOVED FROM'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.033998,"Overall, global HRQoL worsened at 6 (p < 0.001) but returned to the baseline value at 12 months and it was statistically significantly worse in women (p = 0.001).
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Malagola', 'Affiliation': 'Unit of Blood Disease and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Iurlo', 'Affiliation': 'Hematology Division, Foundation IRCCS Ca, Granda Ospedale Maggiore Policlinico, Milan, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Abruzzese', 'Affiliation': 'Division of Hematology, S. Eugenio Hospital, ASL ROMA2, Tor Vergata University, Roma, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Bonifacio', 'Affiliation': 'Department of Medicine, Section of Hematology, University of Verona, Verona, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Stagno', 'Affiliation': 'Department of Hematology, University of Catania, Catania, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Binotto', 'Affiliation': 'Hematology and Clinical Immunology, Department of Medicine, Padua School of Medicine, Padua, Italy.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': ""D'Adda"", 'Affiliation': 'Division of Hematology, ASST-Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Lunghi', 'Affiliation': 'Division of Hematology, Department of Translation Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Crugnola', 'Affiliation': 'Hematology Unit and BMT Center Azienda Ospedaliero Universitaria Parma, Parma, Italy.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Ferrari', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Lunghi', 'Affiliation': 'Hematology and Bone Marrow Transplantation (BMT) Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Castagnetti', 'Affiliation': 'Hematology Unit, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Gianantonio', 'Initials': 'G', 'LastName': 'Rosti', 'Affiliation': 'IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ""Dino Amadori"", Meldola, Italy.'}, {'ForeName': 'Roberto M', 'Initials': 'RM', 'LastName': 'Lemoli', 'Affiliation': 'Clinic of Hematology, University of Genoa, Ospedale Policlinico S. Martino, IRCCS, Genoa, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Sancetta', 'Affiliation': ""Hematology Unit, Dell'Angelo Hospital, Venezia-Mestre, Italy.""}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Coppi', 'Affiliation': 'Haematology and BMT Unit ""Antonio Perrino"" Hospital, Brindisi, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Corsetti', 'Affiliation': 'Hematology Division, Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Rege Cambrin', 'Affiliation': 'Medicina Interna a Indirizzo Ematologico, Ospedale San Luigi, Orbassano, Italy.'}, {'ForeName': 'Atelda', 'Initials': 'A', 'LastName': 'Romano', 'Affiliation': 'IRCCS Regina Elena National Cancer Institute-Rome, Roma, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Tiribelli', 'Affiliation': 'Division of Hematology and BMT, Department of Medical and Morphological Researches, University of Udine, Udine, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Russo Rossi', 'Affiliation': 'Hematology and Transplants Unit, University of Bari, Bari, Italy.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Russo', 'Affiliation': ""Division of Hematology, Dipartimento di Patologia Umana dell'Adulto e dell'Età Evolutiva, Policlinico G Martino, University of Messina, Messina, Italy.""}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Aprile', 'Affiliation': 'Hematology Unit, Department of Medicine, Surgery and Neuroscience, Azienda Ospedaliera Universitaria Senese, University of Siena, Siena, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gandolfi', 'Affiliation': 'Unit of Blood Disease and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Farina', 'Affiliation': 'Unit of Blood Disease and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bernardi', 'Affiliation': 'Unit of Blood Disease and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Polverelli', 'Affiliation': 'Unit of Blood Disease and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Aldo M', 'Initials': 'AM', 'LastName': 'Roccaro', 'Affiliation': 'Clinical Research Development and Phase I Unit, ASST-Spedali Civili Brescia, Brescia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'De Vivo', 'Affiliation': 'Hematology Unit, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': 'University of Bologna, Bologna, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Russo', 'Affiliation': 'Unit of Blood Disease and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST-Spedali Civili, Brescia, Italy.'}]",Cancer medicine,['10.1002/cam4.3778']
1192,33594772,"Randomized, Double-Blind, Placebo-Controlled Phase II Study of Yeast-Brachyury Vaccine (GI-6301) in Combination with Standard-of-Care Radiotherapy in Locally Advanced, Unresectable Chordoma.","BACKGROUND


Brachyury is a transcription factor overexpressed in chordoma and is associated with chemotherapy resistance and epithelial-to-mesenchymal transition. GI-6301 is a recombinant, heat-killed Saccharomyces cerevisiae yeast-based vaccine targeting brachyury. A previous phase I trial of GI-6301 demonstrated a signal of clinical activity in chordomas. This trial evaluated synergistic effects of GI-6301 vaccine plus radiation.
MATERIALS AND METHODS


Adults with locally advanced, unresectable chordoma were treated on a randomized, placebo-controlled trial. Patients received three doses of GI-6301 (80 × 10 7  yeast cells) or placebo followed by radiation, followed by continued vaccine or placebo until progression. Primary endpoint was overall response rate, defined as a complete response (CR) or partial response (PR) in the irradiated tumor site at 24 months. Immune assays were conducted to evaluate immunogenicity.
RESULTS


Between May 2015 and September 2019, 24 patients enrolled on the first randomized phase II study in chordoma. There was one PR in each arm; no CRs were observed. Median progressive-free survival for vaccine and placebo arms was 20.6 months (95% confidence interval [CI], 5.7-37.5 months) and 25.9 months (95% CI, 9.2-30.8 months), respectively. Hazard ratio was 1.02 (95% CI, 0.38-2.71). Vaccine was well tolerated with no vaccine-related serious adverse events. Preexisting brachyury-specific T cells were detected in most patients in both arms. Most patients developed T-cell responses during therapy, with no difference between arms in frequency or magnitude of response.
CONCLUSION


No difference in overall response rate was observed, leading to early discontinuation of this trial due to low conditional power to detect statistical difference at the planned end of accrual.
IMPLICATIONS FOR PRACTICE


Chordoma is a rare neoplasm lacking effective systemic therapies for advanced, unresectable disease. Lack of clinically actionable somatic mutations in chordoma makes development of targeted therapy quite challenging. While the combination of yeast-brachyury vaccine (GI-6301) and standard radiation therapy did not demonstrate synergistic antitumor effects, brachyury still remains a good target for developmental therapeutics in chordoma. Patients and their oncologists should consider early referral to centers with expertise in chordoma (or sarcoma) and encourage participation in clinical trials.",2021,"No difference in overall response rate was observed, leading to early discontinuation of this trial due to low conditional power to detect statistical difference at the planned end of accrual.
","['Locally Advanced, Unresectable Chordoma', 'Adults with locally advanced, unresectable chordoma', 'Between May 2015 and September 2019, 24 patients enrolled on the first randomized phase 2 study in chordoma']","['placebo', 'GI-6301 vaccine plus radiation', 'Yeast-Brachyury Vaccine (GI-6301) in Combination with Standard-of-Care Radiotherapy', 'yeast-brachyury vaccine (GI-6301) and standard radiation therapy', 'placebo followed by radiation, followed by continued vaccine or placebo', 'Vaccine', 'Placebo', 'GI-6301']","['T-cell responses', 'overall response rate', 'Pre-existing brachyury-specific T cells', 'overall response rate, defined as a CR or PR', 'frequency or magnitude of response', 'Median PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0008487', 'cui_str': 'Chordoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0170844', 'cui_str': 'Brachyury protein'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0170844', 'cui_str': 'Brachyury protein'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",24.0,0.660893,"No difference in overall response rate was observed, leading to early discontinuation of this trial due to low conditional power to detect statistical difference at the planned end of accrual.
","[{'ForeName': 'Peter Joseph', 'Initials': 'PJ', 'LastName': 'DeMaria', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Marijo', 'Initials': 'M', 'LastName': 'Bilusic', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Deric M', 'Initials': 'DM', 'LastName': 'Park', 'Affiliation': 'Neuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Heery', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Renee N', 'Initials': 'RN', 'LastName': 'Donahue', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Ravi A', 'Initials': 'RA', 'LastName': 'Madan', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mohammad Hadi', 'Initials': 'MH', 'LastName': 'Bagheri', 'Affiliation': 'Clinical Image Processing Service, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Strauss', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shen', 'Affiliation': 'Clinical Image Processing Service, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Marté', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schlom', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Gilbert', 'Affiliation': 'Neuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}]",The oncologist,['10.1002/onco.13720']
1193,33607215,The effect of GB21 acupressure on pain intensity in the first stage of labor in primiparous women: A randomized controlled trial.,"INTRODUCTION


Labor pain is one of the most intensive pains experienced by women; it results in physical, emotional, and physiological changes in women's body. The present study aimed to examine the effect of GB21 acupressure on labor pain.
DESIGN


In this randomized clinical trial, 174 primiparous women in their first stage of labor were selected and assigned to three groups: GB21 acupressure group (n = 58), sham group (n = 58), and control group (n = 58).
INTERVENTIONS


The acupressure and sham groups received routine labor care and acupressure in three different phases of cervical dilations to 3-5 cm, 6-7 cm, and 8-10 cm. The control group received routine care in labor.
MAIN OUTCOME MEASURES


Pain severity was measured using a pain scale ruler in three cervical dilations before and after intervention. The collected data were analyzed using the ANOVA, Kruskal-Wallis, paired-t test and Mann-Whitney tests.
RESULTS


Pain reduction was significantly higher in GB21 groups compared with sham and control groups (P = 0.001). No statistically significant difference was observed between the three groups in terms of delivery outcomes.
CONCLUSIONS


In this study, GB21 acupressure was effective in pain relief during labor, hence recommended as a practical, effective, inexpensive, and accessible method for labor pain management.",2021,"RESULTS


Pain reduction was significantly higher in GB21 groups compared with sham and control groups (P = 0.001).","['primiparous women', '174 primiparous women in their first stage of labor']","['GB21 acupressure', 'routine care in labor', 'acupressure and sham groups received routine labor care and acupressure']","['pain relief', 'Pain reduction', 'pain intensity', 'delivery outcomes', 'Pain severity']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}]","[{'cui': 'C0450741', 'cui_str': 'GB21'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",174.0,0.0748518,"RESULTS


Pain reduction was significantly higher in GB21 groups compared with sham and control groups (P = 0.001).","[{'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Torkiyan', 'Affiliation': 'Student Research Committee, Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: iranifarvahar@gmail.com.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Sedigh Mobarakabadi', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Sedighehsedigh@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Heshmat', 'Affiliation': 'Iranian Scientific Acupuncture Association, Tehran, Iran. Electronic address: heshmat@tebbessozani.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khajavi', 'Affiliation': 'Department of Biostatistics, School of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: khajavi.student@gmail.com.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Ozgoli', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: gozgoli@sbmu.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102683']
1194,33626254,Muscarinic Cholinergic Receptor Agonist and Peripheral Antagonist for Schizophrenia.,"BACKGROUND


The muscarinic receptor agonist xanomeline has antipsychotic properties and is devoid of dopamine receptor-blocking activity but causes cholinergic adverse events. Trospium is a peripherally restricted muscarinic receptor antagonist that reduces peripheral cholinergic effects of xanomeline. The efficacy and safety of combined xanomeline and trospium in patients with schizophrenia are unknown.
METHODS


In this double-blind, phase 2 trial, we randomly assigned patients with schizophrenia in a 1:1 ratio to receive twice-daily xanomeline-trospium (increased to a maximum of 125 mg of xanomeline and 30 mg of trospium per dose) or placebo for 5 weeks. The primary end point was the change from baseline to week 5 in the total score on the Positive and Negative Syndrome Scale (PANSS; range, 30 to 210, with higher scores indicating more severe symptoms of schizophrenia). Secondary end points were the change in the PANSS positive symptom subscore, the score on the Clinical Global Impression-Severity (CGI-S) scale (range, 1 to 7, with higher scores indicating greater severity of illness), the change in the PANSS negative symptom subscore, the change in the PANSS Marder negative symptom subscore, and the percentage of patients with a response according to a CGI-S score of 1 or 2.
RESULTS


A total of 182 patients were enrolled, with 90 assigned to receive xanomeline-trospium and 92 to receive placebo. The PANSS total score at baseline was 97.7 in the xanomeline-trospium group and 96.6 in the placebo group. The change from baseline to week 5 was -17.4 points with xanomeline-trospium and -5.9 points with placebo (least-squares mean difference, -11.6 points; 95% confidence interval, -16.1 to -7.1; P<0.001). The results for the secondary end points were significantly better in the xanomeline-trospium group than in the placebo group, with the exception of the percentage of patients with a CGI-S response. The most common adverse events in the xanomeline-trospium group were constipation, nausea, dry mouth, dyspepsia, and vomiting. The incidences of somnolence, weight gain, restlessness, and extrapyramidal symptoms were similar in the two groups.
CONCLUSIONS


In a 5-week trial, xanomeline-trospium resulted in a greater decrease in the PANSS total score than placebo but was associated with cholinergic and anticholinergic adverse events. Larger and longer trials are required to determine the efficacy and safety of xanomeline-trospium in patients with schizophrenia. (Funded by Karuna Therapeutics and the Wellcome Trust; ClinicalTrials.gov number, NCT03697252.).",2021,"The primary end point was the change from baseline to week 5 in the total score on the Positive and Negative Syndrome Scale (PANSS; range, 30 to 210, with higher scores indicating more severe symptoms of schizophrenia).","['patients with schizophrenia are unknown', 'patients with schizophrenia', '182 patients were enrolled, with 90 assigned to receive', 'patients with schizophrenia in a 1:1 ratio to']","['combined xanomeline and trospium', 'receive twice-daily xanomeline-trospium (increased to a maximum of 125 mg of xanomeline and 30 mg of trospium per dose) or placebo', 'xanomeline-trospium and 92 to receive placebo', 'placebo']","['constipation, nausea, dry mouth, dyspepsia, and vomiting', 'total score on the Positive and Negative Syndrome Scale', 'cholinergic and anticholinergic adverse events', 'incidences of somnolence, weight gain, restlessness, and extrapyramidal symptoms', 'severe symptoms of schizophrenia', 'change in the PANSS positive symptom subscore, the score on the Clinical Global Impression-Severity (CGI-S) scale', 'efficacy and safety', 'PANSS total score', 'PANSS negative symptom subscore']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246836', 'cui_str': 'xanomeline'}, {'cui': 'C0772089', 'cui_str': 'Trospium'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0242893', 'cui_str': 'Acetylcholine Agents'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",182.0,0.212432,"The primary end point was the change from baseline to week 5 in the total score on the Positive and Negative Syndrome Scale (PANSS; range, 30 to 210, with higher scores indicating more severe symptoms of schizophrenia).","[{'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Brannan', 'Affiliation': 'From Karuna Therapeutics, Boston (S.K.B., S.S., A.C.M., S.M.P.); Columbia University Vagelos College of Physicians and Surgeons, New York (J.A.L.); and Indiana University School of Medicine, Indianapolis (A.B.).'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Sawchak', 'Affiliation': 'From Karuna Therapeutics, Boston (S.K.B., S.S., A.C.M., S.M.P.); Columbia University Vagelos College of Physicians and Surgeons, New York (J.A.L.); and Indiana University School of Medicine, Indianapolis (A.B.).'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Miller', 'Affiliation': 'From Karuna Therapeutics, Boston (S.K.B., S.S., A.C.M., S.M.P.); Columbia University Vagelos College of Physicians and Surgeons, New York (J.A.L.); and Indiana University School of Medicine, Indianapolis (A.B.).'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'From Karuna Therapeutics, Boston (S.K.B., S.S., A.C.M., S.M.P.); Columbia University Vagelos College of Physicians and Surgeons, New York (J.A.L.); and Indiana University School of Medicine, Indianapolis (A.B.).'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Paul', 'Affiliation': 'From Karuna Therapeutics, Boston (S.K.B., S.S., A.C.M., S.M.P.); Columbia University Vagelos College of Physicians and Surgeons, New York (J.A.L.); and Indiana University School of Medicine, Indianapolis (A.B.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Breier', 'Affiliation': 'From Karuna Therapeutics, Boston (S.K.B., S.S., A.C.M., S.M.P.); Columbia University Vagelos College of Physicians and Surgeons, New York (J.A.L.); and Indiana University School of Medicine, Indianapolis (A.B.).'}]",The New England journal of medicine,['10.1056/NEJMoa2017015']
1195,33588077,Rationale and protocol for a randomized waitlist controlled trial of videoconference delivered cognitive behaviour therapy for insomnia (CBT-I) to improve perceived cognitive impairment (PCI) among cancer survivors.,"Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning. Cognitive-behaviour therapy for insomnia (CBT-I) is the treatment of choice for insomnia among cancer survivors. Literature suggests that treatment with CBT-I may lead to an improvement in PCI, but this needs to be tested in a sample of patients with PCI at study entry with cognitive impairments as the primary study outcome. Here we describe the design of a clinical trial to evaluate the efficacy of videoconference-delivered CBT-I for the improvement of PCI among cancer survivors. This project is a randomized waitlist-controlled trial with a recruitment target of 124 adult cancer survivors (solid tumors and hematological malignancies) who have completed primary treatment at least 6 months prior, report PCI and meet criteria for insomnia disorder. Participants will complete assessments at baseline, 4 weeks (mid-treatment), 8 weeks (post treatment), and 3 and 6 months post-treatment. The primary outcome is the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog). Treatment of PCI in cancer patients is a priority for clinicians, researchers, and patients. This research will increase our understanding of the mechanisms of cognitive impairment associated with cancer, and potentially expand currently available treatment options.",2021,Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning.,"['124 adult cancer survivors (solid tumors and hematological malignancies) who have completed primary treatment at least 6\u202fmonths prior, report PCI and meet criteria for insomnia disorder', 'cancer survivors', 'cancer patients']","['videoconference-delivered CBT-I', 'videoconference delivered cognitive behaviour therapy', 'Cognitive-behaviour therapy', 'PCI']","['Functional Assessment of Cancer Therapy - Cognitive Function', 'Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]",124.0,0.109037,Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning.,"[{'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada; Discipline of Oncology, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada; Beatrice Hunter Cancer Research Institute, Halifax, Nova Scotia, Canada. Electronic address: sheila.garland@mun.ca.'}, {'ForeName': 'Josée', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'École de psychologie, Université Laval and CHU de Québec-Université Laval Research Center, Quebec, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dalton', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Nyissa A', 'Initials': 'NA', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada; Beatrice Hunter Cancer Research Institute, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Seal', 'Affiliation': 'Discipline of Oncology, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rash', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Sondria', 'Initials': 'S', 'LastName': 'Browne', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Urquhart', 'Affiliation': 'Department of Community Health and Epidemiology, Faculty of Medicine, Dalhousie University, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thoms', 'Affiliation': 'Discipline of Oncology, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Veeresh', 'Initials': 'V', 'LastName': 'Gadag', 'Affiliation': 'Division of Community Health and Humanities, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Laing', 'Affiliation': 'Discipline of Oncology, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106322']
1196,33588061,The effect of prophylaxis with ertapenem versus cefuroxime/metronidazole on intestinal carriage of carbapenem-resistant or third-generation-cephalosporin-resistant Enterobacterales after colorectal surgery.,"OBJECTIVES


Compared to cephalosporin-based prophylaxis, ertapenem prophylaxis lowers the risk of surgical site infection among carriers of extended-spectrum β-lactamase-producing Enterobacterales (ESBL-PEs) undergoing colorectal surgery. We aimed to determine whether ertapenem prophylaxis leads to increased postoperative colonization with carbapenem-resistant Enterobacterales (CREs) and third-generation-cephalosporin-resistant Enterobacterales (3GCR-Es).
METHODS


This study was nested within a quality improvement study of prophylaxis for ESBL-PE carriers undergoing colorectal surgery. Patients were screened 4-6 days after surgery for carriage of ESBL-PEs or other 3GCR-Es and CREs. When CREs were detected, pre- and postsurgical clones were compared using Fourier-transform infrared (FT-IR) spectroscopy.
RESULTS


The sample consisted of 56 patients who carried ESBL-PEs before surgery and received cefuroxime/metronidazole prophylaxis (Group 1), 66 who carried ESBL-PEs before surgery and received ertapenem (Group 2), and 103 ESBL-PE non-carriers who received cefuroxime/metronidazole prophylaxis (Group 3). CRE carriage was detected postoperatively in one patient (1.5%) in Group 2 versus eight patients (14.3%) in Group 1 (RD -12.8%; 95%CI -22.4% to -3.1%). For seven out of nine patients, preoperative ESBL-PE and postoperative CRE isolates were compared; in five of them, the pre- and postoperative clones were identical. Postoperative 3GCR-E carriage was detected in 37 patients (56.1%) in Group 2 versus 46 patients in Group 1 (82.1%) (aRD -20.7%, 95%CI -37.3% to -4.1%).
CONCLUSIONS


Among ESBL-PE carriers undergoing colorectal surgery, detection of short-term postsurgical colonization by CREs and 3GCR-Es was significantly lower among patients who received ertapenem prophylaxis than those who received cephalosporin-metronidazole prophylaxis. Resistance development in a colonizing bacterial clone, rather than carbapenemase acquisition, was the major mechanism of carbapenem resistance.",2021,CRE carriage was detected post-operatively in 1 patient (1.5%) in Group 2 versus 8 patients (14.3%) in Group 1 (RD:-12.8%; 95% CI:-22.4%- -3.1).,"['56 patients who carried ESBL-PE before surgery and received', 'ESBL-PE carriers undergoing colorectal surgery', 'carriers of extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-PE) undergoing colorectal surgery', 'intestinal carriage of carbapenem-resistant or third-generation cephalosporin-resistant Enterobacterales after colorectal surgery']","['ESBL-PE non-carriers who received cefuroxime/metronidazole prophylaxis', 'cefuroxime/metronidazole prophylaxis', 'carbapenem-resistant Enterobacterales (CRE) and third-generation cephalosporin-resistant Enterobacterales (3GCR-E', 'cephalosporin-based prophylaxis, ertapenem prophylaxis', 'cephalosporin-metronidazole prophylaxis', 'cefuroxime/metronidazole']","['CRE carriage', 'Post-operative 3GCR-E carriage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0304320', 'cui_str': 'Third generation cephalosporin'}]","[{'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0304320', 'cui_str': 'Third generation cephalosporin'}, {'cui': 'C3536856', 'cui_str': 'Cephalosporin antibiotic product'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1120106', 'cui_str': 'ertapenem'}]","[{'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0691421,CRE carriage was detected post-operatively in 1 patient (1.5%) in Group 2 versus 8 patients (14.3%) in Group 1 (RD:-12.8%; 95% CI:-22.4%- -3.1).,"[{'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Hoffman', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health, Tel Aviv, Israel; Infectious Disease Unit, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lellouche', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health, Tel Aviv, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nutman', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health, Tel Aviv, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Temkin', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health, Tel Aviv, Israel.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Frenk', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health, Tel Aviv, Israel.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Infection Control Program, Geneva University Hospitals and Faculty of Medicine, WHO Collaborating Center, Geneva, Switzerland.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Carevic', 'Affiliation': 'Department of Hospital Epidemiology, Clinical Center of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Shimrit', 'Initials': 'S', 'LastName': 'Cohen-Percia', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health, Tel Aviv, Israel.'}, {'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Kariv', 'Affiliation': 'Department of Surgery, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Noga', 'Initials': 'N', 'LastName': 'Fallach', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health, Tel Aviv, Israel.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Klausner', 'Affiliation': 'Department of Surgery, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Carmeli', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health, Tel Aviv, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: yehudac@tlvmc.gov.il.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2021.02.002']
1197,33592551,Effects of art-based mandala intervention on distress and anxiety in cancer patients.,"OBJECTIVE


This study was planned to determine the effect of art-based mandala intervention on the distress and anxiety experienced by cancer patients.
METHODS


This semi-experimental study with a single group pretest-posttest design was performed with 12 breast cancer survival patients. The data were collected through ""Patient Diagnostic Form"", ""Distress Thermometer"", ""Trait Anxiety Inventory"". Patients participated in the ""Art-Based Mandala Interventıon"" for eight weeks, one day a week, 2 h each. The distress and anxiety levels of the patients were measured before starting the program and at the end of the program.
RESULTS


Cancer patients experienced moderate level of anxiety (50.66 ± 6.91) and clinically significant distress (4.08 ± 2.74). Anxiety scores of cancer patients decreased significantly after the program compared to before the program (p < 0.05). The distress scores of cancer patients increased after the program compared to before the program (p > 0.05).
CONCLUSION


After the art-based mandala intervention program, anxiety scores of breast cancer survival patients decreased, and distress scores increased.",2021,Anxiety scores of cancer patients decreased significantly after the program compared to before the program (p < 0.05).,"['cancer patients', 'distress and anxiety experienced by cancer patients', '12 breast cancer survival patients']",['art-based mandala intervention'],"['anxiety scores of breast cancer survival', 'moderate level of anxiety', 'distress and anxiety', 'Anxiety scores of cancer patients', 'distress scores of cancer patients', 'distress and anxiety levels']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",12.0,0.0286735,Anxiety scores of cancer patients decreased significantly after the program compared to before the program (p < 0.05).,"[{'ForeName': 'Hatice Karabuga', 'Initials': 'HK', 'LastName': 'Yakar', 'Affiliation': 'Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey. Electronic address: hatice.karabuga@marmara.edu.tr.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Yilmaz', 'Affiliation': 'Mandala Meditation Therapy Specialist, Bachelor of Arts in Human Behavior, Newport International University, California, United States.'}, {'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Ozkol', 'Affiliation': 'License Graduated Nurse, Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Fadime', 'Initials': 'F', 'LastName': 'Gevher', 'Affiliation': 'License Graduated Nurse, Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Celik', 'Affiliation': 'License Graduated Nurse, Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101331']
1198,33600874,Statin use moderates the beneficial effects of aerobic exercise on older adults' performances on the Stroop test: A subanalysis.,"Aerobic training can lead to improved cognition in older adults and this effect can be explained by enhanced cardiorespiratory fitness. However, statins could limit the physical benefits of aerobic training by altering the mechanisms through which exercise improves cognition. Whether statins could have an effect on the cognitive benefits associated with aerobic training remains to be elucidated. The objective of this study was to determine whether the cognitive benefits of aerobic training were comparable in statin users and non-users. A total of 144 sedentary participants (>60 y.o.; 106 non-users, 38 statin users) were included. Participants were either part of an aerobic training group (n = 75) or a control group (n = 69). Cognition was assessed using the Stroop test. Analyses were performed on z-score changes from pre to post-intervention of Stroop reaction time (RT) and number of errors, using Two-factor ANCOVAs, while controlling for potential confounding factors (age, education, BMI, Charlson Comorbidity Index, sex, protocol and handgrip strength). The moderating effect of statins on the cognitive changes associated with aerobic training was determined through moderation analyses. An interaction effect on the Stroop switching condition was detected between intervention and statin intake (F [1, 140] = 5.659, P < 0.01). The intervention effect on switching RT was moderated by statin intake, where intervention improved switching RT only in non-users (Effect = 0.1678; P < 0.01). Statins could limit the cognitive benefits of aerobic training on switching capacities in some patients. Future randomized studies including a larger number of participants and looking at different types of statins should be conducted to confirm these results.",2021,"The intervention effect on switching RT was moderated by statin intake, where intervention improved switching RT only in non-users (Effect = 0.1678; P < 0.01).","['144 sedentary participants (>60 y.o.; 106 non-users, 38 statin users) were included', 'older adults', 'statin users and non-users']","['aerobic training', 'aerobic exercise', 'Aerobic training', 'statins']","['Stroop reaction time (RT) and number of errors, using Two-factor ANCOVAs, while controlling for potential confounding factors (age, education, BMI, Charlson Comorbidity Index, sex, protocol and handgrip strength', 'Stroop switching condition', 'switching RT']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",144.0,0.0337659,"The intervention effect on switching RT was moderated by statin intake, where intervention improved switching RT only in non-users (Effect = 0.1678; P < 0.01).","[{'ForeName': 'Kathia', 'Initials': 'K', 'LastName': 'Saillant', 'Affiliation': ""Departement of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada; Centre de recherche de l'Institut de Cardiologie de Montréal, Montreal, Quebec, Canada; Centre de recherche de l'Institut Universitaire de Gériatrie de Montréal, Montreal, Quebec, Canada. Electronic address: saillant.kathia@gmail.com.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Langeard', 'Affiliation': 'Normandie Univ, UNICAEN, INSERM, COMETE, 14 000 Caen, France.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kaushal', 'Affiliation': 'Department of Health Sciences, School of Health and Human Sciences, Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'Thien Tuong Minh', 'Initials': 'TTM', 'LastName': 'Vu', 'Affiliation': ""Centre de recherche de l'Institut Universitaire de Gériatrie de Montréal, Montreal, Quebec, Canada; Centre de recherche du Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Kristell', 'Initials': 'K', 'LastName': 'Pothier', 'Affiliation': 'University of Tours, EA 2114, PAVEA Laboratory, Tours, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Langlois', 'Affiliation': ""CSSS de l'Estrie Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bherer', 'Affiliation': ""Centre de recherche de l'Institut de Cardiologie de Montréal, Montreal, Quebec, Canada; Centre de recherche de l'Institut Universitaire de Gériatrie de Montréal, Montreal, Quebec, Canada; Department of Medicine, Université de Montréal, Montreal, Quebec, Canada. Electronic address: louis.bherer@umontreal.ca.""}]",Experimental gerontology,['10.1016/j.exger.2021.111277']
1199,33600868,Combined exercise training improves specific domains of cognitive functions and metabolic markers in middle-aged and older adults with type 2 diabetes mellitus.,"AIM


To investigate the effects of 8-weeks of CT on specific domains of cognitive function, metabolic and cardiovascular parameters of subjects with Type 2 Diabetes Mellitus (T2DM).
METHODS


31 sedentary T2DM adults and older divided into CT (3x/week, during 8-week, n = 16) or Control group (CONT, n = 15). Before and after the intervention, a cognitive task battery, blood samples, and functional tests were assessed.
RESULTS


CT improved inhibitory control (d = 0.89), working memory (d = 0.88), cognitive flexibility (d = 0.67) and attention/concentration (d = 0.64) in T2DM subjects. However, memory, verbal fluency, and processing speed (d < 0.1, p > 0.05 for all) were not changed. The CT-induced improvements on global cognitive z-score (r = -0.51; p < 0.001) were inversely correlated to cognitive screening scores. Moreover, CT improved functional performance (p < 0.05) and reduced insulin levels (p = 0.04). Although there was no statistical significance, there were a clinically relevant reduction of peripheral insulin sensitivity (d = 0.51, p = 0.09), resistin levels (d = 0.53, p = 0.08), diastolic (d = 0.63, p = 0.09) and mean blood pressure (d = 0.50, p = 0.09). Conversely, no changes were observed for glucose, fructosamine and blood lipids (d < 0.2 for all).
CONCLUSION


CT partially reversed the negative effects of T2DM on specific cognitive domains possibly by amelioration of metabolic regulation. Moreover, lower cognitive scores may modulate the responsivity of cognitive function to CT.",2021,The CT-induced improvements on global cognitive z-score (r= -.51; p<.001) were inversely correlated to cognitive screening scores.,"['subjects with Type 2 Diabetes Mellitus (T2DM', '31 sedentary T2DM adults and older divided into CT (3x/week, during 8-week, n=16) or Control group (CONT, n=15', 'middle-aged and older adults with type 2 diabetes mellitus']","['CT', 'Combined exercise training']","['cognitive task battery, blood samples, and functional tests', 'cognitive flexibility', 'specific domains of cognitive functions and metabolic markers', 'diastolic', 'peripheral insulin sensitivity', 'global cognitive z-score', 'CT improved functional performance (p<.05) and reduced insulin levels', 'resistin levels', 'mean blood pressure', 'glucose, fructosamine and blood lipids', 'working memory', 'cognitive screening scores', 'memory, verbal fluency, and processing speed']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]",31.0,0.0143669,The CT-induced improvements on global cognitive z-score (r= -.51; p<.001) were inversely correlated to cognitive screening scores.,"[{'ForeName': 'João Gabriel', 'Initials': 'JG', 'LastName': 'Silveira-Rodrigues', 'Affiliation': 'Exercise Physiology Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Av. Pres. Antônio Carlos, 6627 Belo Horizonte, MG 31270-901, Brazil. Electronic address: joaogabrielsrod@gmail.com.'}, {'ForeName': 'Washington', 'Initials': 'W', 'LastName': 'Pires', 'Affiliation': 'Sports Center of Federal University of Ouro Preto, St. Two, MG 35400-000, Brazil.'}, {'ForeName': 'Patrícia Ferreira', 'Initials': 'PF', 'LastName': 'Gomes', 'Affiliation': 'Exercise Physiology Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Av. Pres. Antônio Carlos, 6627 Belo Horizonte, MG 31270-901, Brazil.'}, {'ForeName': 'Pedro Henrique Madureira', 'Initials': 'PHM', 'LastName': 'Ogando', 'Affiliation': 'Exercise Physiology Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Av. Pres. Antônio Carlos, 6627 Belo Horizonte, MG 31270-901, Brazil.'}, {'ForeName': 'Bruno Pereira', 'Initials': 'BP', 'LastName': 'Melo', 'Affiliation': 'Exercise Physiology Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Av. Pres. Antônio Carlos, 6627 Belo Horizonte, MG 31270-901, Brazil.'}, {'ForeName': 'Ivana Montandon Soares', 'Initials': 'IMS', 'LastName': 'Aleixo', 'Affiliation': 'Exercise Physiology Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Av. Pres. Antônio Carlos, 6627 Belo Horizonte, MG 31270-901, Brazil.'}, {'ForeName': 'Danusa Dias', 'Initials': 'DD', 'LastName': 'Soares', 'Affiliation': 'Exercise Physiology Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Av. Pres. Antônio Carlos, 6627 Belo Horizonte, MG 31270-901, Brazil.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2021.108700']
1200,33592310,Improving racial disparities in unmet palliative care needs among intensive care unit family members with a needs-targeted app intervention: The ICUconnect randomized clinical trial.,"INTRODUCTION


The technologies used to treat the millions who receive care in intensive care unit (ICUs) each year have steadily advanced. However, the quality of ICU-based communication has remained suboptimal, particularly concerning for Black patients and their family members. Therefore we developed a mobile app intervention for ICU clinicians and family members called ICUconnect that assists with delivering need-based care.
OBJECTIVE


To describe the methods and early experiences of a clustered randomized clinical trial (RCT) being conducted to compare ICUconnect vs. usual care.
METHODS AND ANALYSIS


The goal of this two-arm, parallel group clustered RCT is to determine the clinical impact of the ICUconnect intervention in improving outcomes overall and for each racial subgroup on reducing racial disparities in core palliative care outcomes over a 3-month follow up period. ICU attending physicians are randomized to either ICUconnect or usual care, with outcomes obtained from family members of ICU patients. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 3 days post-randomization. Secondary outcomes include goal concordance of care and interpersonal processes of care at 3 days post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use hierarchical linear models to compare outcomes between the ICUconnect and usual care arms within all participants and assess for differential intervention effects in Blacks and Whites by adding a patient-race interaction term. We hypothesize that both compared to usual care as well as among Blacks compared to Whites, ICUconnect will reduce unmet palliative care needs, psychological distress and healthcare resource utilization while improving goal concordance and interpersonal processes of care. In this manuscript, we also describe steps taken to adapt the ICUconnect intervention to the COVID-19 pandemic healthcare setting.
ENROLLMENT STATUS


A total of 36 (90%) of 40 ICU physicians have been randomized and 83 (52%) of 160 patient-family dyads have been enrolled to date. Enrollment will continue until the end of 2021.",2021,The technologies used to treat the millions who receive care in intensive care unit (ICUs) each year have steadily advanced.,"['Blacks and Whites by adding a patient-race interaction term', 'ICU attending physicians', 'A total of 36 (90%) of 40 ICU physicians have been randomized and 83 (52%) of 160 patient-family dyads have been enrolled to date']","['ICUconnect intervention', 'ICUconnect vs. usual care', 'ICUconnect']","['change in unmet palliative care needs measured by the NEST instrument', 'goal concordance of care and interpersonal processes of care at 3\u202fdays post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",,0.132682,The technologies used to treat the millions who receive care in intensive care unit (ICUs) each year have steadily advanced.,"[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Isaretta L', 'Initials': 'IL', 'LastName': 'Riley', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: isaretta.riley@duke.edu.'}, {'ForeName': 'Deepshikha C', 'Initials': 'DC', 'LastName': 'Ashana', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: deepshikha.ashana@duke.edu.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Haines', 'Affiliation': 'Department of Surgery, Division of Trauma and Critical Care and Acute Care Surgery, Duke University, Durham, North Carolina, United States of America. Electronic address: krista.haines@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: jessie.gu@duke.edu.'}, {'ForeName': 'Elias H', 'Initials': 'EH', 'LastName': 'Pratt', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: elias.pratt@duke.edu.'}, {'ForeName': 'Mashael', 'Initials': 'M', 'LastName': 'Al-Hegelan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: mashael.alhegelan@duke.edu.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Harrison', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University, Durham, NC, United States of America. Electronic address: robert.w.harrison@duke.edu.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Naglee', 'Affiliation': 'Department of Anesthesia, Division of Neurology, Duke University, Durham, NC, United States of America. Electronic address: colleen.naglee@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States of America. Electronic address: honqiu.yang@duke.edu.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Division of Geriatrics, Center for the Study of Aging and Human Development, Duke University, Durham, NC, United States of America; Durham Veterans Affairs Geriatrics Research Education and Clinical Center (GRECC), United States of America. Electronic address: kimberly.s.johnson@duke.edu.'}, {'ForeName': 'Sharron L', 'Initials': 'SL', 'LastName': 'Docherty', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America. Electronic address: sharron.docherty@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106319']
1201,33610094,Modafinil reduces smoked cocaine self-administration in humans: effects vary as a function of cocaine 'priming' and cost.,"BACKGROUND


The absence of an FDA-approved medication for the treatment of cocaine use disorder (CUD) may, in part, reflect the varying conditions present when the decision to use cocaine is made, with one medication unlikely to work under all conditions. The objective of this double-blind, placebo-controlled, human laboratory study was to test the effects of modafinil, a medication with mixed efficacy for the treatment of CUD, using a novel self-administration procedure designed to model distinct clinical scenarios.
METHODS


During modafinil maintenance (0, 300 mg/day), participants chose to self-administer up to 7 doses of smoked cocaine (25 mg) under 9 conditions: immediately after exposure to: (a) cues associated with cocaine and a non-contingent cocaine administration, i.e. 'prime' (25 mg), (b) only cocaine cues, and (c) neither cues nor cocaine. Each condition was tested when self-administered cocaine cost $5, $10 and $15/dose.
RESULTS


Nontreatment-seeking cocaine smokers (3 F,13 M), spending $388 ± 218/week on cocaine and with no history of alcohol use disorder, completed the study. Relative to placebo, modafinil robustly attenuated self-administration when cocaine was expensive ($10,$15/dose) and when there was no 'prime.' Modafinil had no effect on self-administration when cocaine was inexpensive ($5/dose) or when participants received a 'prime.'
CONCLUSIONS


Modafinil's effects on cocaine-taking varied substantially as a function of recent cocaine exposure and cost, which may help explain the mixed clinical findings. Modafinil may be most effective for preventing relapse in abstinent patients, particularly under conditions in which cocaine is costly, rather than initiating abstinence for those continuing to use cocaine.",2021,"Relative to placebo, modafinil robustly attenuated self-administration when cocaine was expensive ($10,$15/dose) and when there was no 'prime.'","['smoked cocaine self-administration in humans', 'abstinent patients', 'Nontreatment-seeking cocaine smokers (3\u2009F,13\u2009M), spending $388\u2009±\u2009218/week on']","['Modafinil', 'placebo', ""smoked cocaine (25\u2009mg) under 9 conditions: immediately after exposure to: (a) cues associated with cocaine and a non-contingent cocaine administration, i.e. 'prime' (25\u2009mg), (b) only cocaine cues, and (c) neither cues nor cocaine"", 'placebo, modafinil', 'modafinil maintenance', 'modafinil', 'cocaine']",[],"[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",[],,0.0245067,"Relative to placebo, modafinil robustly attenuated self-administration when cocaine was expensive ($10,$15/dose) and when there was no 'prime.'","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Haney', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and the New York State Psychiatric Institute, USA. Electronic address: mh235@cumc.columbia.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rubin', 'Affiliation': 'Department of Psychiatry, Harlem Hospital Center, Columbia University College of Physicians and Surgeons, USA.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Denson', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and the New York State Psychiatric Institute, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Foltin', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and the New York State Psychiatric Institute, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108554']
1202,33610093,Self-efficacy as a mediator of patient navigation interventions to engage persons living with HIV and substance use.,"BACKGROUND


People living with HIV who report substance use (PLWH-SU) face many barriers to care, resulting in an increased risk for poor health outcomes and the potential for ongoing disease transmission. This study evaluates the mechanisms by which Patient Navigation (PN) and Contingency Management (CM) interventions may work to address barriers to care and improve HIV outcomes in this population.
METHODS


Mediation analysis was conducted using data from a randomized, multi-site trial testing PN interventions to improve HIV care outcomes among 801 hospitalized PLHW-SU. Direct and indirect effects of PN and PN + CM were evaluated through five potential mediators-psychosocial conditions, healthcare avoidance, financial hardship, system barriers, and self-efficacy for HIV treatment adherence-on engagement in HIV care and viral suppression.
RESULTS


The PN + CM intervention had an indirect effect on improving engagement in HIV care at 6 months by increasing self-efficacy for HIV treatment adherence (β = 0.042, 95% CI = 0.008, 0.086). PN + CM also led to increases in viral suppression at 6 months (β = 0.090, 95% CI = 0.023, 0.168) and 12 months (β = 0.069, 95% CI = 0.009, 0.129) via increases in self-efficacy, although the direct effects were not significant. No mediating effects were observed for PN alone.
CONCLUSION


PN + CM interventions for PLWH-SU can increase an individual's self-efficacy for HIV treatment adherence, which in turn improves engagement in care at 6 months and may contribute to viral suppression over 12 months. Building self-efficacy may be a key factor in the success of such interventions and should be considered as a primary goal of PN + CM in practice.",2021,The PN + CM intervention had an indirect effect on improving engagement in HIV care at 6 months by increasing self-efficacy for HIV treatment adherence (,"['People living with HIV who report substance use (PLWH-SU', '801 hospitalized PLHW-SU', 'engage persons living with HIV and substance use']","['PN\u2009+\u2009CM intervention', 'PN and PN\u2009+\u2009CM', 'Patient Navigation (PN) and Contingency Management (CM) interventions', 'patient navigation interventions']","['viral suppression', 'self-efficacy', 'Self-efficacy', 'HIV care outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0631912,The PN + CM intervention had an indirect effect on improving engagement in HIV care at 6 months by increasing self-efficacy for HIV treatment adherence (,"[{'ForeName': 'Sharleen M', 'Initials': 'SM', 'LastName': 'Traynor', 'Affiliation': 'University of Miami Miller School of Public Health, Department of Public Health Sciences, 1120 NW 14th Street, Miami, FL, 33136, USA. Electronic address: smtraynor@med.miami.edu.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Columbia University, Mailman School of Public Health, Department of Sociomedical Sciences, 2971 Broadway, 612 Lewisohn Hall, New York, NY, 10027, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Gooden', 'Affiliation': 'Columbia University, Mailman School of Public Health, Department of Sociomedical Sciences, 2971 Broadway, 612 Lewisohn Hall, New York, NY, 10027, USA.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Stitzer', 'Affiliation': 'Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences, 5510 Nathan Shock Drive, Suite 1500, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matheson', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, 25 Van Ness Avenue, Suite 500, San Francisco, CA, 94102, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tross', 'Affiliation': 'Columbia University, Department of Psychiatry, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Carrico', 'Affiliation': 'University of Miami Miller School of Public Health, Department of Public Health Sciences, 1120 NW 14th Street, Miami, FL, 33136, USA.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Internal Medicine, 5323 Harry Hines Boulevard, Dallas, TX, 75390, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Del Rio', 'Affiliation': 'Emory University School of Medicine, Division of Infectious Diseases, 100 Woodruff Circle, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'University of Miami Miller School of Public Health, Department of Public Health Sciences, 1120 NW 14th Street, Miami, FL, 33136, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108567']
1203,33610080,Tissue adhesives for peripheral intravenous catheter securement: A prospective randomized controlled pilot trial.,"BACKGROUND


In some patients securing the peripheral intravenous cannula (PIVC) with a standard adhesive dressing can be difficult because of sweat or other body fluids. The aim of our study was to evaluate the use of tissue adhesives alone as a means to secure PIVCs inserted in the emergency department.
METHODS


We performed a prospective interventional pilot study from November 2019 to May 2020 in a medical emergency department of an urban tertiary hospital. Patients were randomized to two groups: tissue adhesives (TA) or adhesive dressing (AD) group. After randomization we followed them until day 4.
RESULTS


There were no significant differences between TA and AD groups in the rate of unplanned removal of PIVCs in the first 72 h (57.1% vs. 45.8%, p = 0.29), the rate of unplanned removal of PIVCs in the ED (0% vs. 2.1%, p = 1.00), the rate of unplanned removal of PIVC in the first 24 h (42.8% vs. 35.4%, p = 0.52), as well as in the rate of phlebitis (7.1% vs. 14.6%, p = 0.34) and the rate of any blood-stream infection (0% vs. 0%, p = 1.00).
CONCLUSION


We did not observe any significant differences when PIVCs inserted in the emergency department were secured with tissue adhesives alone, compared to standard adhesive dressings. We observed a high rate of unplanned removal of PIVCs, necessitating further research to determine more reliable ways of securing PIVCs.",2021,"There were no significant differences between TA and AD groups in the rate of unplanned removal of PIVCs in the first 72 h (57.1% vs. 45.8%, p = 0.29), the rate of unplanned removal of PIVCs in the ED (0% vs. 2.1%, p = 1.00), the rate of unplanned removal of PIVC in the first 24 h (42.8% vs. 35.4%, p = 0.52), as well as in the rate of phlebitis (7.1% vs. 14.6%, p = 0.34) and the rate of any blood-stream infection (0% vs. 0%, p = 1.00).
","['November 2019 to May 2020 in a medical emergency department of an urban tertiary hospital', 'peripheral intravenous catheter securement', 'patients securing the peripheral intravenous cannula (PIVC']",['tissue adhesives (TA) or adhesive dressing (AD) group'],"['rate of unplanned removal of PIVC', 'rate of phlebitis', 'rate of unplanned removal of PIVCs', 'rate of any blood-stream infection']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}]","[{'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0677509,"There were no significant differences between TA and AD groups in the rate of unplanned removal of PIVCs in the first 72 h (57.1% vs. 45.8%, p = 0.29), the rate of unplanned removal of PIVCs in the ED (0% vs. 2.1%, p = 1.00), the rate of unplanned removal of PIVC in the first 24 h (42.8% vs. 35.4%, p = 0.52), as well as in the rate of phlebitis (7.1% vs. 14.6%, p = 0.34) and the rate of any blood-stream infection (0% vs. 0%, p = 1.00).
","[{'ForeName': 'Amadeus', 'Initials': 'A', 'LastName': 'Lešnik', 'Affiliation': 'Medical Emergency Department, University Medical Centre Maribor, Ljubljanska 5, Maribor 2000, Slovenia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gorenjak', 'Affiliation': 'Centre for Human Molecular Genetics and Pharmacogenomics, Faculty of Medicine, University of Maribor, Taborska ulica 8, Maribor 2000, Slovenia.'}, {'ForeName': 'Sandi', 'Initials': 'S', 'LastName': 'Žumer', 'Affiliation': 'Medical Emergency Department, University Medical Centre Maribor, Ljubljanska 5, Maribor 2000, Slovenia.'}, {'ForeName': 'Valerija', 'Initials': 'V', 'LastName': 'Zorčič', 'Affiliation': 'Medical Emergency Department, University Medical Centre Maribor, Ljubljanska 5, Maribor 2000, Slovenia.'}, {'ForeName': 'Žarko', 'Initials': 'Ž', 'LastName': 'Mišanović', 'Affiliation': 'Medical Emergency Department, University Medical Centre Maribor, Ljubljanska 5, Maribor 2000, Slovenia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Majhenič', 'Affiliation': 'Medical Emergency Department, University Medical Centre Maribor, Ljubljanska 5, Maribor 2000, Slovenia.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Podstenšek', 'Affiliation': 'Medical Emergency Department, University Medical Centre Maribor, Ljubljanska 5, Maribor 2000, Slovenia.'}, {'ForeName': 'Matevž', 'Initials': 'M', 'LastName': 'Toplak', 'Affiliation': 'Medical Emergency Department, University Medical Centre Maribor, Ljubljanska 5, Maribor 2000, Slovenia.'}, {'ForeName': 'Urška', 'Initials': 'U', 'LastName': 'Fekonja', 'Affiliation': 'Medical Emergency Department, University Medical Centre Maribor, Ljubljanska 5, Maribor 2000, Slovenia.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Markota', 'Affiliation': 'Medical Intensive Care Unit, University Medical Centre Maribor, Ljubljanska 5, Maribor 2000, Slovenia; Faculty of Medicine, University of Maribor, Taborska ulica 8, Maribor 2000, Slovenia. Electronic address: andrejmarkota@hotmail.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.01.088']
1204,33618195,The impact of free choice in alcohol treatment. Primary outcomes of the self-match study.,"INTRODUCTION


A paternalistic approach to treatment planning is common, but there is a growing interest in involving clients in the planning of their own treatment, both in medical care and psychotherapy. Several studies on matching patients to treatment have failed to improve outcome. Studies on Shared Decision-Making in mental health are encouraging but somewhat ambiguous in addiction treatment.
OBJECTIVE


This study investigated whether self-matching (Informed Choice) to treatment improves alcohol consumption, retention, and quality of life.
METHOD


402 consecutive clients (female 46.7 %, mean age 47.4) seeking treatment for alcohol use disorder at the outpatient clinic in Odense, Denmark were enrolled in this single-blinded randomized controlled trial. Clients randomized to the intervention group watched an 8-minute video presentation of the treatments and then chose the treatment they preferred. Clients in the treatment as usual (TAU) group were allocated to treatment by an evidence-based algorithm. Measurements on alcohol consumption, quality of life, and retention in care were completed at baseline and 6-month follow-up.
RESULTS


There was no significant difference on primary and secondary outcome measures between the Informed Choice group and TAU group at 6-month follow-up. 80 % of clients in the Informed Choice group were satisfied with being randomized to self-matching whereas 24 % in the TAU group were satisfied with being assigned by expert matching.
CONCLUSION


Our hypothesis, that outcome is improved if clients choose their own treatment, was not supported. However, an important finding is that client self-matching is just as beneficial as expert matching.",2021,There was no significant difference on primary and secondary outcome measures between the Informed Choice group and TAU group at 6-month follow-up.,"['402 consecutive clients (female 46.7 %, mean age 47.4) seeking treatment for alcohol use disorder at the outpatient clinic in Odense']",[],"['alcohol consumption, retention, and quality of life', 'alcohol consumption, quality of life, and retention in care']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}]",402.0,0.0672012,There was no significant difference on primary and secondary outcome measures between the Informed Choice group and TAU group at 6-month follow-up.,"[{'ForeName': 'Morten Ellegaard', 'Initials': 'ME', 'LastName': 'Hell', 'Affiliation': 'Unit of Clinical Alcohol Research, Clinical Institute, Faculty of Health, University of Southern Denmark, Denmark; Psychiatric Hospital, University Section, Region of Southern Denmark, Denmark; Odense Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark. Electronic address: mhell@health.sdu.dk.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Nielsen', 'Affiliation': 'Unit of Clinical Alcohol Research, Clinical Institute, Faculty of Health, University of Southern Denmark, Denmark; Odense Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mejldal', 'Affiliation': 'Unit of Clinical Alcohol Research, Clinical Institute, Faculty of Health, University of Southern Denmark, Denmark.'}, {'ForeName': 'Anette Søgaard', 'Initials': 'AS', 'LastName': 'Nielsen', 'Affiliation': 'Unit of Clinical Alcohol Research, Clinical Institute, Faculty of Health, University of Southern Denmark, Denmark; Psychiatric Hospital, University Section, Region of Southern Denmark, Denmark; Odense Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark; BRIDGE, Brain Research - Inter-Disciplinary Guided Excellence, University of Southern Denmark, Denmark.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108587']
1205,33617910,Two-year toxicity of simultaneous integrated boost in hypofractionated prone breast cancer irradiation: Comparison with sequential boost in a randomized trial.,"INTRODUCTION


A simultaneous integrated boost (SIB) leads to less acute toxicity. Less is known for late toxicity due to SIB. In this first and only randomized trial, two-years toxicity is analysed.
MATERIALS AND METHODS


Physician-assessed toxicity, using the LENT SOMA scale, and photographs, analysed with the BCCT.core software, was examined for 150 patients, randomized between SIB and sequential boost (SEB).
RESULTS


Differences in physician-assessed two-years toxicity and photographic analysis between SIB and SEB are very small and not significant.
CONCLUSION


There is no indication that a SIB leads to an excess in toxicity or worse cosmetic outcome at 2 years.",2021,"RESULTS


Differences in physician-assessed two-years toxicity and photographic analysis between SIB and SEB are very small and not signicant.
","['hypofractionated prone breast cancer irradiation', '150 patients, randomized between SIB and sequential boost (SEB']",[],['acute toxicity'],"[{'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0294634,"RESULTS


Differences in physician-assessed two-years toxicity and photographic analysis between SIB and SEB are very small and not signicant.
","[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Hulle', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Hans.VanHulle@Ugent.be.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Desaunois', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Eline.Desaunois@Ugent.be.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vakaet', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Vincent.Vakaet@Ugent.be.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Paelinck', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Leen.Paelinck@Uzgent.be.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Schoepen', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Industrial Systems Engineering and Product Design, Kortrijk, Belgium. Electronic address: Max.Schoepen@Ugent.be.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Post', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Giselle.Post@Ugent.be.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Van Greveling', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Annick.VanGreveling@Uzgent.be.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Speleers', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Bruno.Speleers@Ugent.be.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Mareel', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Marc.Mareel@Ugent.be.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Wilfried.DeNeve@Ugent.be.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Monten', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Chris.Monten@Uzgent.be.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Deseyne', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Pieter.Deseyne@Uzgent.be.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Veldeman', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Liv.Veldeman@Uzgent.be.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.02.010']
1206,33620131,Haemodynamic effects of the nitroxyl donor cimlanod (BMS-986231) in chronic heart failure: a randomized trial.,"AIMS


Nitroxyl provokes vasodilatation and inotropic and lusitropic effects in animals via post-translational modification of thiols. We aimed to compare effects of the nitroxyl donor cimlanod (BMS-986231) with those of nitroglycerin (NTG) or placebo on cardiac function in patients with chronic heart failure with reduced ejection fraction (HFrEF).
METHODS AND RESULTS


In a randomized, multicentre, double-blind, crossover trial, 45 patients with stable HFrEF were given a 5 h intravenous infusion of cimlanod, NTG, or placebo on separate days. Echocardiograms were done at the start and end of each infusion period and read in a core laboratory. The primary endpoint was stroke volume index derived from the left ventricular outflow tract at the end of each infusion period. Stroke volume index with placebo was 30 ± 7 mL/m 2  and was lower with cimlanod (29 ± 9 mL/m 2  ; P = 0.03) and NTG (28 ± 8 mL/m 2  ; P = 0.02). Transmitral E-wave Doppler velocity on cimlanod or NTG was lower than on placebo and, consequently, E/e' (P = 0.006) and E/A ratio (P = 0.003) were also lower. NTG had similar effects to cimlanod on these measurements. Blood pressure reduction was similar with cimlanod and NTG and greater than with placebo.
CONCLUSION


In patients with chronic HFrEF, the haemodynamic effects of cimlanod and NTG are similar. The effects of cimlanod may be explained by venodilatation and preload reduction without additional inotropic or lusitropic effects. Ongoing trials of cimlanod will further define its potential role in the treatment of heart failure.",2021,"Transmitral E-wave Doppler velocity on cimlanod or NTG was lower than on placebo and, consequently, E/e' (p = 0.006) and E/A ratio (p = 0.003) were also lower.","['45 patients with stable HFrEF', 'Chronic Heart Failure', 'patients with chronic heart failure with reduced ejection fraction (HFrEF']","['cimlanod, NTG, or placebo', 'NTG', 'placebo', 'nitroglycerin (NTG) or placebo', 'Nitroxyl Donor Cimlanod (BMS-986231', 'HNO donor cimlanod (BMS-986231']","['cardiac function', 'Blood pressure reduction', 'stroke volume index (SVI) derived from the left ventricular outflow tract', 'Transmitral E-wave Doppler velocity on cimlanod or NTG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0068882', 'cui_str': 'nitroxyl'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]",45.0,0.366756,"Transmitral E-wave Doppler velocity on cimlanod or NTG was lower than on placebo and, consequently, E/e' (p = 0.006) and E/A ratio (p = 0.003) were also lower.","[{'ForeName': 'Ninian N', 'Initials': 'NN', 'LastName': 'Lang', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Faheem A', 'Initials': 'FA', 'LastName': 'Ahmad', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics & Clinical Trials, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart & Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Department of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jorg', 'Initials': 'J', 'LastName': 'Taubel', 'Affiliation': 'Richmond Pharmacology Limited, London, UK.'}, {'ForeName': 'Anke R', 'Initials': 'AR', 'LastName': 'Hodes', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Anwar', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Karra', 'Affiliation': 'Department of Medicine, Duke Advanced Heart and Lung Failure Clinic, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Hospital, Suita, Osaka, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Ishihara', 'Affiliation': 'Department of Cardiology, Nippon Medical School, Kawasaki-shi, Japan.'}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': 'Department of Cardiovascular Research, Northwick Park Hospital & Department of Cardiology, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Khemka', 'Affiliation': 'Department of Cardiology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Narayana G', 'Initials': 'NG', 'LastName': 'Prasad', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'DeSouza', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Seiffert', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'June Y', 'Initials': 'JY', 'LastName': 'Ye', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Kessler', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Borentain', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, Duke Clinical Research Institute (DCRI), Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.'}]",European journal of heart failure,['10.1002/ejhf.2138']
1207,33637427,Impact of a nurse-led family support intervention on family members' satisfaction with intensive care and psychological wellbeing: A mixed-methods evaluation.,"BACKGROUND


Families of critically ill persons face uncertainty and experience distress during and after their close other's stay in an intensive care unit (ICU). Proactive nurse engagement and support is recommended to meet families' needs in the ICU, but little is known about its impact on quality of family care. We introduced a family support intervention that consisted of an interprofessional family support pathway and a new role of an advanced practice family nurse.
OBJECTIVES


The aim of the study was to examine the effect of an advanced practice nurse-led family support intervention on family members' satisfaction, wellbeing, and psychological distress.
METHODS


We conducted a quasi-experimental before-and-after study with embedded qualitative interviews in a Swiss University Hospital from March 2018 to July 2019 using a questionnaire (Family Satisfaction in the ICU-24 Survey, Hospital Anxiety and Depression Scale, and Impact of Event Scale-Revised-6) and qualitative interviews (n = 19) after patient discharge.
RESULTS


Families in the intervention group (n = 75) showed a trend for increased overall satisfaction (difference of 5.544, 95% confidence interval [CI]: -0.11 to 11.20), a statistically significant increase in satisfaction with decision-making (7.258, 95% CI: 0.89 to 13.63), and a nonsignificant increase in satisfaction with care (4.178, 95% CI: -1.53 to 9.89). Psychological distress was higher in the intervention group, with depression reaching statistical significance (difference of 1.706, 95% CI: 0.16 to 3.25), which may be explained by longer ICU stays and higher proportion of deaths in the intervention group. Families receiving the intervention reported to be feeling cared for, well informed, and better able to cope. Data integration suggests that early onset, fit to need, and quality of intervention were the most important intervention characteristics impacting family wellbeing.
CONCLUSIONS


Our study found that family members experience a nurse-led support intervention as beneficial for their wellbeing. It increased their satisfaction, but was unable to demonstrate a favourable impact on psychological distress.",2021,"Psychological distress was higher in the intervention group, with depression reaching statistical significance (difference of 1.706, 95% CI: 0.16 to 3.25), which may be explained by longer ICU stays and higher proportion of deaths in the intervention group.","['quasi-experimental before-and-after study with embedded qualitative interviews in a Swiss University Hospital from March 2018 to July 2019 using a questionnaire (Family Satisfaction in the ICU-24\xa0Survey, Hospital Anxiety and Depression Scale, and Impact of Event Scale-Revised-6) and qualitative interviews (n\xa0=\xa019) after patient discharge', ""family members' satisfaction with intensive care and psychological wellbeing""]","['advanced practice nurse-led family support intervention', 'nurse-led family support intervention']","['satisfaction with decision-making', 'Psychological distress', 'overall satisfaction', 'satisfaction with care', 'psychological distress']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C3472482', 'cui_str': 'Impact of event scale revised'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0545307,"Psychological distress was higher in the intervention group, with depression reaching statistical significance (difference of 1.706, 95% CI: 0.16 to 3.25), which may be explained by longer ICU stays and higher proportion of deaths in the intervention group.","[{'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Naef', 'Affiliation': 'Centre of Clinical Nursing Science, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland; Institute for Implementation Science in Health Care, Faculty of Medicine, University of Zurich, Universitätsstrasse 84, 8006 Zurich, Switzerland. Electronic address: rahel.naef@usz.ch.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'von Felten', 'Affiliation': 'Department of Biostatistics, Institute of Epidemiology, Biostatistics, and Prevention, Faculty of Medicine, University of Zurich, Hirschengraben 84, 8001 Zurich, Switzerland. Electronic address: stefanie.vonfelten@uzh.ch.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Petry', 'Affiliation': 'Centre of Clinical Nursing Science, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland. Electronic address: heidi.petry@usz.ch.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Ernst', 'Affiliation': 'Centre of Clinical Nursing Science, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland. Electronic address: jutta.ernst@usz.ch.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Massarotto', 'Affiliation': 'Institute of Intensive Medicine, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland. Electronic address: paola.massarotto@usz.ch.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2020.10.014']
1208,33639578,Group status rapidly shapes preschoolers' social judgments in minimal group settings.,"Previous developmental research has consistently detected the presence of an explicit and implicit ingroup preference among preschoolers. More recent research has also demonstrated that this general ingroup bias is influenced by perceived social status when ""real"" groups are involved (i.e., groups with a previous history of interactions). Indeed, ingroup bias is significantly tempered among low-status group members. The main aim of the current study was to further investigate the role of social status by assessing both implicit and explicit intergroup attitudes in the context of newly formed groups. More specifically, children were randomly assigned to one of two fictitious groups on the basis of trivial criteria, thereby forming the so-called ""minimal"" groups. To manipulate group status, participants were then informed that one specific group-either the ingroup or the outgroup-was typically better than the other group during competitions. Finally, implicit and explicit intergroup attitudes were assessed. Overall, results showed that children rapidly formed implicit and explicit intergroup attitudes toward newly formed groups. Most important, the perceived status of the groups modulated such intergroup attitudes. Indeed, on both types of measures, ingroup bias emerged when the ingroup was associated with a high status, whereas it disappeared when the ingroup was in a low-status position.",2021,"Indeed, on both types of measures, ingroup bias emerged when the ingroup was associated with a high status, whereas it disappeared when the ingroup was in a low-status position.",[],[],[],[],[],[],,0.0116031,"Indeed, on both types of measures, ingroup bias emerged when the ingroup was associated with a high status, whereas it disappeared when the ingroup was in a low-status position.","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Castelli', 'Affiliation': 'Department of Developmental and Social Psychology, University of Padova, 35131 Padova, Italy. Electronic address: castelli.luigi@unipd.it.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Carraro', 'Affiliation': 'Department of Developmental and Social Psychology, University of Padova, 35131 Padova, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Valmori', 'Affiliation': 'Department of Developmental and Social Psychology, University of Padova, 35131 Padova, Italy.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2021.105102']
1209,33607462,Effects of increased attention allocation to threat and safety stimuli on fear extinction and its recall.,"BACKGROUND AND OBJECTIVES


Attention plays an important role in the treatment of anxiety. Increased attention to threat has been shown to yield improved treatment outcomes in anxious patients following exposure-based therapy. This study examined whether increasing attention to learned stimuli during fear extinction, an experimental analogue for exposure-based treatments, could improve extinction learning and its maintenance.
METHODS


Sixty-five healthy adults were randomized into experimental or control conditions. All completed a differential fear conditioning task. During extinction, a subtle attentional manipulation was implemented in the experimental group, designed to increase participants' attention to both threat and safety cues. Three days later, an extinction recall test was conducted using the original cues and two perceptually similar morphs.
RESULTS


Fear conditioning was achieved in both behavioral and psychophysiological measures. In addition, between-group differences emerged during extinction. The experimental group exhibited increased attention to stimuli and lower fear responses in physiological measure than the control group. Similarly, during extinction recall, the experimental group exhibited lower startle responses than the control group. Last, across groups, attending to the safety cue during extinction was associated with lower self-reported risk of the two generalization morphs displayed during extinction recall.
LIMITATIONS


Skin conductance response (SCR) was not measured during extinction recall. Future research should include both SCR and additional generalization morphs so as to allow for the examination of more subtle individual differences.
CONCLUSIONS


Results indicate that the attentional manipulation increased attention allocation to stimuli during extinction; this, in turn, affected fear-related physiological response.",2021,The experimental group exhibited increased attention to stimuli and lower fear responses in physiological measure than the control group.,['Sixty-five healthy adults'],[],"['startle responses', 'fear extinction and its recall', 'attention to stimuli and lower fear responses']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0038186', 'cui_str': 'Startle Reaction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",65.0,0.0226257,The experimental group exhibited increased attention to stimuli and lower fear responses in physiological measure than the control group.,"[{'ForeName': 'Zohar', 'Initials': 'Z', 'LastName': 'Klein', 'Affiliation': 'School of Psychological Sciences and the Integrated Brain and Behavior Research Center, University of Haifa, Abba Hushi 199, Mt Carmel, Haifa, Israel.'}, {'ForeName': 'Rivkah', 'Initials': 'R', 'LastName': 'Ginat-Frolich', 'Affiliation': 'School of Psychological Sciences and the Integrated Brain and Behavior Research Center, University of Haifa, Abba Hushi 199, Mt Carmel, Haifa, Israel.'}, {'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Barry', 'Affiliation': ""Department of Psychology, The University of Hong Kong, Hong Kong. the Institute of Psychiatry, Psychology, & Neuroscience, King's College, London, UK.""}, {'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Shechner', 'Affiliation': 'School of Psychological Sciences and the Integrated Brain and Behavior Research Center, University of Haifa, Abba Hushi 199, Mt Carmel, Haifa, Israel. Electronic address: tshechner@psy.haifa.ac.il.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2021.101640']
1210,33607374,"The pneumatization of the sphenoid sinus, its variations and relations with surrounding neurovascular anatomic structures: A computerized tomography study.","INTRODUCTION AND OBJECTIVES


The wide range of variability of SS pneumatization and relation with surrounding structures can result in serious complications; seeing that, the assessment of regional anatomy is essential for both surgeons and radiologists. We mainly aim to reveal the possible correlation between the SS pneumatization types and protrusion/dehiscence of the adjacent neurovascular structures in a larger population by using computerized tomography (CT) images.
METHODS


The type of SS pneumatization (I-IV), pneumatization of anterior clinoid process (ACP), greater wing of sphenoid (GWS), and pterygoid process (PP) was evaluated. Protrusion and dehiscence of ICA, ON, MN, and VN was noted.
RESULTS


1003 patients were included into the study. ICA, ON, and MN protrusions were not seen in patients with the type I or II SS on both sides. These protrusions were most frequently seen along with the type IV SS on both sides (p < 0.05). ICA, ON, MN, and VN dehiscence was not found in any patients with the type I SS. The rate of ICA protrusion increased with presence of GWS and PP; ICA dehiscence was found to be positively correlated with ACP, GWS, and PP pneumatization.
CONCLUSIONS


Variations, either amount or the extent, of the pneumatization of the SS are related with the presence of protrusion/dehiscence of ICA, ON, MN and VN. Knowing and reporting these relations can decrease the rate of complications during skull base surgery.",2021,"ICA, ON, and MN protrusions were not seen in patients with the type I or II SS on both sides.",['1003 patients were included into the study'],[],"['rate of ICA protrusion', 'SS pneumatization (I-IV), pneumatization of anterior clinoid process (ACP), greater wing of sphenoid (GWS), and pterygoid process (PP', 'ACP, GWS, and PP pneumatization', 'ICA, ON, and MN protrusions', 'rate of complications', 'Protrusion and dehiscence of ICA, ON, MN, and VN', 'ICA, ON, MN, and VN dehiscence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0201519', 'cui_str': 'Islet cell antibody measurement'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0230053', 'cui_str': 'Structure of anterior clinoid process'}, {'cui': 'C0222728', 'cui_str': 'Structure of greater wing of sphenoid bone'}, {'cui': 'C0222730', 'cui_str': 'Structure of pterygoid process of sphenoid bone'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}]",1003.0,0.0264324,"ICA, ON, and MN protrusions were not seen in patients with the type I or II SS on both sides.","[{'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Fatihoglu', 'Affiliation': 'Department of Radiology, Erzincan University, Erzincan, Turkey.'}, {'ForeName': 'Sonay', 'Initials': 'S', 'LastName': 'Aydin', 'Affiliation': 'Department of Radiology, Erzincan University, Erzincan, Turkey. Electronic address: sonay.aydin@erzincan.edu.tr.'}, {'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Karavas', 'Affiliation': 'Department of Radiology, Erzincan University, Erzincan, Turkey.'}, {'ForeName': 'Mecit', 'Initials': 'M', 'LastName': 'Kantarci', 'Affiliation': 'Department of Radiology, Erzincan University, Erzincan, Turkey; Department of Radiology, Atatürk University, Erzurum, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.102958']
1211,33609618,The effect of a structured clinical algorithm on glycemic control in patients with combined tuberculosis and diabetes in Indonesia: A randomized trial.,"AIMS


Diabetes mellitus (DM) is associated with worse tuberculosis (TB) treatment outcomes, especially among those with poor glycemic control. We examined whether a structured clinical algorithm could improve glycemic control in TB patients with DM.
METHODS


In an open label randomized trial, TB-DM patients were randomized to scheduled counselling, glucose monitoring, and adjustment of medication using a structured clinical algorithm (intervention arm) or routine DM management (control arm), with glycated hemoglobin (HbA1c) at month 6 as the primary end point.
RESULTS


We randomized 150 pulmonary TB-DM patients (92% culture positive, 51.3% male, mean age 53 years). Baseline mean HbA1c was 11.0% in the intervention arm (n = 76) and 11.6% in the control arm (n = 74). At 6 months, HbA1c had decreased more in the intervention arm compared with the control arm (a difference of 1.82% HbA1c, 95% CI 0.82-2.83, p < 0.001). Five patients were hospitalized in the intervention arm and seven in the control arm. There was more hypoglycemia (35.0% vs 11.8%; p = 0.002) in the intervention arm. Two deaths occurred in the intervention arm, one due to cardiorespiratory failure and one because of suspected septic shock and multiorgan failure.
CONCLUSION


Regular monitoring and algorithmic adjustment of DM treatment led to improved glycemic control.",2021,There was more hypoglycemia (35.0% vs 11.8%; p=0.002) in the intervention arm.,"['patients with combined tuberculosis and diabetes in Indonesia', '150 pulmonary TB-DM patients (92% culture positive, 51.3% male, mean age 53 years', 'Five patients were hospitalized in the intervention arm and seven in the control arm', 'TB patients with DM']","['structured clinical algorithm', 'scheduled counselling, glucose monitoring, and adjustment of medication using a structured clinical algorithm (intervention arm) or routine DM management (control arm), with glycated hemoglobin (HbA1c']","['hypoglycemia', 'suspected septic shock and multiorgan failure', 'glycemic control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0159125', 'cui_str': 'Culture positive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0948092', 'cui_str': 'Diabetes mellitus management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",150.0,0.146808,There was more hypoglycemia (35.0% vs 11.8%; p=0.002) in the intervention arm.,"[{'ForeName': 'Rovina', 'Initials': 'R', 'LastName': 'Ruslami', 'Affiliation': 'Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia; Department of Biomedical Science, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Raspati C', 'Initials': 'RC', 'LastName': 'Koesoemadinata', 'Affiliation': 'Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia; Department of Internal Medicine, Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: r.c.koesoemadinata@unpad.ac.id.'}, {'ForeName': 'Nanny N M', 'Initials': 'NNM', 'LastName': 'Soetedjo', 'Affiliation': 'Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia; Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran / Hasan Sadikin General Hospital, Bandung, Indonesia.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Imaculata', 'Affiliation': 'Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Yuanita', 'Initials': 'Y', 'LastName': 'Gunawan', 'Affiliation': 'Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Hikmat', 'Initials': 'H', 'LastName': 'Permana', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran / Hasan Sadikin General Hospital, Bandung, Indonesia.'}, {'ForeName': 'Prayudi', 'Initials': 'P', 'LastName': 'Santoso', 'Affiliation': 'Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia; Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran / Hasan Sadikin General Hospital, Bandung, Indonesia.'}, {'ForeName': 'Bachti', 'Initials': 'B', 'LastName': 'Alisjahbana', 'Affiliation': 'Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia; Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran / Hasan Sadikin General Hospital, Bandung, Indonesia.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'McAllister', 'Affiliation': 'Centre for International Health, Department of Preventive and Social Medicine, University of Otago Medical School, Dunedin, New Zealand.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grint', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, England, UK.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Critchley', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, England, UK.""}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Hill', 'Affiliation': 'Centre for International Health, Department of Preventive and Social Medicine, University of Otago Medical School, Dunedin, New Zealand.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine and Radboud Centre for Infectious Disease (RCI), Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2021.108701']
1212,33610726,Effect of French maritime pine bark extract supplementation on metabolic status and serum vascular cell adhesion molecule-1 levels in patients with type 2 diabetes and microalbuminuria.,"OBJECTIVES


This study investigated the effect of French maritime pine bark extract (PBE) supplementation on metabolic parameters, vascular cell adhesion molecule 1 (VCAM-1), urinary albumin-to-creatinine ratio (UACR), and anthropometric indexes in patients with type 2 diabetes (T2DM) and microalbuminuria.
DESIGN


This randomized, double-blind, placebo-controlled clinical trial was conducted on 46 patients with T2DM and the evidence of microalbuminuria aged 30-65 years.
SETTING


Patients were recruited from the endocrinology clinic of Sina hospital (Tabriz, Iran) from March 2018 to April 2019.
INTERVENTIONS


The subjects were randomly assigned to receive two capsules/day each containing 50mg of PBE or placebo for eight weeks.
MAIN OUTCOME MEASURES


Glycemic parameters, serum VCAM-1 and lipid profile, UACR, and anthropometric indexes were measured for all patients at baseline and the end of the study.
RESULTS


PBE supplementation significantly reduced glycosylated hemoglobin, VCAM-1, total cholesterol, UACR, waist circumference, and waist-to-height ratio compared to the placebo group at the end of the study (all P < 0.05). Changes in fasting blood glucose, insulin, triglyceride, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were not significant between the two groups (all P > 0.05).
CONCLUSIONS


The study findings demonstrated some favorable effects of PBE supplementation on glycemic control, serum VCAM-1 and total cholesterol levels, and microalbuminuria, as well as abdominal obesity in patients with T2DM.",2021,"RESULTS


PBE supplementation significantly reduced glycosylated hemoglobin, VCAM-1, total cholesterol, UACR, waist circumference, and waist-to-height ratio compared to the placebo group at the end of the study (all P < 0.05).","['patients with T2DM', 'Patients were recruited from the endocrinology clinic of Sina hospital (Tabriz, Iran) from March 2018 to April 2019', 'patients with type 2 diabetes (T2DM) and microalbuminuria', 'patients with type 2 diabetes and microalbuminuria', '46 patients with T2DM and the evidence of microalbuminuria aged 30 to 65 years']","['placebo', 'PBE supplementation', 'PBE or placebo', 'French maritime pine bark extract supplementation', 'French maritime pine bark extract (PBE) supplementation']","['fasting blood glucose, insulin, triglyceride, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol', 'Glycemic parameters, serum VCAM-1 and lipid profile, UACR, and anthropometric indexes', 'metabolic status and serum vascular cell adhesion molecule-1 levels', 'glycemic control, serum VCAM-1 and total cholesterol levels, and microalbuminuria, as well as abdominal obesity', 'metabolic parameters, vascular cell adhesion molecule 1 (VCAM-1), urinary albumin-to-creatinine ratio (UACR), and anthropometric indexes', 'glycosylated hemoglobin, VCAM-1, total cholesterol, UACR, waist circumference, and waist-to-height ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3810855', 'cui_str': 'Endocrinology clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872909', 'cui_str': 'pine bark extract'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4283948', 'cui_str': 'French maritime pine bark extract'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}]",46.0,0.220432,"RESULTS


PBE supplementation significantly reduced glycosylated hemoglobin, VCAM-1, total cholesterol, UACR, waist circumference, and waist-to-height ratio compared to the placebo group at the end of the study (all P < 0.05).","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Navval-Esfahlan', 'Affiliation': ""Students' Research Committee, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Rafraf', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: rafrafm@tbzmed.ac.ir.'}, {'ForeName': 'Somayyeh', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Imani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Karimi-Avval', 'Affiliation': 'Department of Endocrine and Metabolism, Sina Medical Research and Training Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102689']
1213,33612170,Effectiveness of Minimal Contact Interventions: An RCT.,"INTRODUCTION


Around 23% of adults worldwide are insufficiently active. Wearable devices paired with virtual coaching software could increase physical activity. The effectiveness of 3 minimal contact interventions (paper-based physical activity diaries, activity trackers, and activity trackers coupled with virtual coaching) in increasing physical activity energy expenditure and cardiorespiratory fitness were compared over 12 weeks among inactive adults.
METHODS


This was an open label, parallel-group RCT. Inactive adults (aged ≥18 years, N=488) were randomized to no intervention (Control; n=121), paper-based diary (Diary; n=124), activity tracker (Activity Band; n=122), or activity tracker plus virtual coaching (Activity Band PLUS; n=121) groups. Coprimary outcomes included 12-week changes in physical activity energy expenditure and fitness (May 2012-January 2014). Analyses were conducted in 2019-2020.
RESULTS


There were no differences between groups overall (physical activity energy expenditure: p=0.114, fitness: p=0.417). However, there was a greater increase in physical activity energy expenditure (4.21 kJ/kg/day, 95% CI=0.42, 8.00) in the Activity Band PLUS group than in the Diary group. There were also greater decreases in BMI and body fat percentage in the Activity Band PLUS group than in the Control group (BMI= -0.24 kg/m 2 , 95% CI= -0.45, -0.03; body fat= -0.48%, 95% CI= -0.88, -0.08) and in theActivity Band PLUS group than in the Diary group (BMI= -0.30 kg/m 2 , 95% CI= -0.50, -0.09; body fat= -0.57%, 95% CI= -0.97, -0.17).
CONCLUSIONS


Coupling activity trackers with virtual coaching may facilitate increases in physical activity energy expenditure compared with a traditional paper‒based physical activity diary intervention and improve some secondary outcomes compared with a traditional paper‒based physical activity diary intervention or no intervention.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov ISRCTN31844443.",2021,"There were no differences between groups overall (physical activity energy expenditure: p=0.114, fitness: p=0.417).","['Inactive adults (aged ≥18 years, N=488']","['activity tracker (Activity Band; n=122), or activity tracker plus virtual coaching (Activity Band PLUS', 'Minimal Contact Interventions', '3 minimal contact interventions (paper-based physical activity diaries, activity trackers, and activity trackers coupled with virtual coaching']","['physical activity', 'BMI and body fat percentage', 'physical activity energy expenditure and cardiorespiratory fitness', 'physical activity energy expenditure and fitness (May 2012-January 2014', 'physical activity energy expenditure']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0676574,"There were no differences between groups overall (physical activity energy expenditure: p=0.114, fitness: p=0.417).","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hajna', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Andrew J M', 'Initials': 'AJM', 'LastName': 'Cooper', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Williams', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Esther M F', 'Initials': 'EMF', 'LastName': 'van Sluijs', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.10.010']
1214,33618123,Evaluation of the cognitive benefits of intrathecal baclofen pump implantation in people with intractable multiple sclerosis related spasticity.,"BACKGROUND


Spasticity is a common problematic symptom in Multiple Sclerosis with over one third of patients failing first line therapies. Intrathecal baclofen is a safe and efficacious option for treatment resistant spasticity. Anecdotally patients report improved concentration/cognitive performance when switching to intrathecal baclofen (ITB) from systemic medications.
AIM


To explore whether subjects who proceed with ITB pump implantation for spasticity management and reduce oral anti-spasticity agents will have improved cognitive function.
METHODS


Subjects were admitted for trial of ITB via lumbar puncture and subsequent pump implantation. Spasticity and cognitive measures before ITB trial and 3 months post implant were recorded. Paired t-test or Wilcoxon Signed Ranks test was used for within subject change and effect sizes (Cohen's d z ) were calculated. Subgroup analysis of those on ≥2, or ≤ 1 spasticity medications at baseline was performed.
RESULTS


27 subjects with MS completed per protocol. Mean age 46 years [26 - 56], disease duration 15 years [6 - 26], RRMS = 3, SPMS = 17 and PPMS=7. The majority were on multiple spasticity medications. Spasticity scores significantly improved post pump implant. Mean ITB dose at 3 months was 143 mcg / day and 19 discontinued all other treatments for spasticity. There was no deterioration on any cognitive or mood measure. An improvement of moderate effect size was found in Backwards Digit Span (d=0.41, p=0.059) and HADS - anxiety (d=0.37, p=0.097). Fatigue Severity Scale score decreased substantially (d=0.81, p=0.005). Small improvements in Symbol Digit Modalities Test score (d=0.24) and Sustained Attention to Response Task response time (d=0.23) were non-significant. Performance on other measures did not change. Effect sizes were larger in subgroup on ≥2 oral spasticity medications at baseline, compared to the group on ≤1 medication (SDMT, d=0.42 vs d=0.07; Backwards digit span 0.45 vs 0.28; HADS-anxiety 0.39 vs 0.32; HADS-depression d=0.32 vs 0.05 and FSS, d= 1.14 vs 0.42).
CONCLUSIONS


In a pilot study exploring the impact of ITB on cognition, spasticity scores improved universally and beneficial effects on some measures of fatigue, anxiety, auditory attention and verbal working memory were found. Improvement of speed of processing in those withdrawing higher doses of oral medication was also demonstrated suggesting that switching to ITB has added cognitive and psychological benefits for people with MS.",2021,Small improvements in Symbol Digit Modalities Test score (d=0.24) and Sustained Attention to Response Task response time (d=0.23) were non-significant.,"['27 subjects with MS completed per protocol', 'people with intractable multiple sclerosis related spasticity', 'Subjects were admitted for trial of ITB via lumbar puncture and subsequent pump implantation', 'Mean age 46 years [26 - 56], disease duration 15 years [6 - 26], RRMS\xa0=\xa03, SPMS\xa0=\xa017 and PPMS=7']","['ITB pump implantation', 'intrathecal baclofen pump implantation', 'Intrathecal baclofen']","['cognition, spasticity scores', 'fatigue, anxiety, auditory attention and verbal working memory', 'Backwards Digit Span', 'Fatigue Severity Scale score', 'HADS - anxiety', 'concentration/cognitive performance', 'Symbol Digit Modalities Test score (d=0.24) and Sustained Attention to Response Task response time', 'cognitive or mood measure', 'Spasticity scores', 'moderate effect size', 'oral spasticity medications', 'Spasticity and cognitive measures']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",27.0,0.0685907,Small improvements in Symbol Digit Modalities Test score (d=0.24) and Sustained Attention to Response Task response time (d=0.23) were non-significant.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Farrell', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London; Department of Neuroinflammation, Queen Square, Institute of Neurology, University College London; NIHR University College London Hospitals, Biomedical Research Centre. Electronic address: rachel.farrell@ucl.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Department of Clinical Neuropsychology, National Hospital for Neurology & Neurosurgery, London, United Kingdom.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Doogan', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mulhert', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Keenan', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Buchanan', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Padilla', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Stevenson', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102831']
1215,33618120,Feasibility and efficacy of a physical activity intervention for managing restless legs syndrome in multiple sclerosis: Results of a pilot randomized controlled trial.,"BACKGROUND


This pilot randomized controlled trial examined the feasibility and efficacy of a physical activity behavior change intervention for improving restless legs syndrome (RLS) severity and secondary sleep outcomes among a sample of adults with multiple sclerosis (MS).
METHODS


Participants with MS(N=15) were randomly assigned into intervention(n=8) or waitlist control(n=7) conditions. The physical activity intervention was delivered over a 16-week period and outcomes were assessed at baseline and immediately following the 16-week period in both conditions.
RESULTS


There was a significant, positive effect of the intervention on overall RLS severity (p=.01;η ρ 2 =.43), severity during the night(p=.03,η ρ 2 =.35), severity during the day while resting(p=.01,η ρ 2 =.44), and severity during the day while active(p<.01,η ρ 2 =.61), and non-significant improvements in RLS severity while falling asleep (p=.33,η ρ 2 =.09). There were significant positive effects on sleep satisfaction(p<.01,η ρ 2 =.49) and non-significant improvements in self-reported global sleep quality(p=.35,η ρ 2 =.08). There was a significant intervention effect on self-reported time in bed(p=.03,η ρ 2 =.37) and total sleep time(p=.03,η ρ 2 =.36), and non-significant improvements in self-reported sleep latency (p=.08,η ρ 2 =.25), sleep efficiency(p=.27,η ρ 2 =.11), and daytime sleepiness (p=.52,η ρ 2 =.04;p=.35,η ρ 2 =.08;p=.51,η ρ 2 =.04). There was no significant effect of the intervention on device-measured sleep quality.
CONCLUSIONS


We provide preliminary evidence for the feasibility and efficacy of a physical activity intervention for reducing RLS severity and potentially improving self-reported sleep outcomes in adults with MS. CLINICALTRIALS.
GOV IDENTIFICATION NUMBER


NCT04061681.",2021,"There were significant positive effects on sleep satisfaction(p<.01,η ρ 2 =.49) and non-significant improvements in self-reported global sleep quality(p=.35,η ρ 2 =.08).","['adults with MS', 'managing restless legs syndrome in multiple sclerosis', 'Participants with MS(N=15', 'adults with multiple sclerosis (MS']","['physical activity intervention', 'physical activity behavior change intervention']","['daytime sleepiness', 'device-measured sleep quality', 'Feasibility and efficacy', 'overall RLS severity', 'RLS severity while falling asleep', 'self-reported sleep latency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",15.0,0.0800824,"There were significant positive effects on sleep satisfaction(p<.01,η ρ 2 =.49) and non-significant improvements in self-reported global sleep quality(p=.35,η ρ 2 =.08).","[{'ForeName': 'Katie L J', 'Initials': 'KLJ', 'LastName': 'Cederberg', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Stanford University, 401 Quarry Road, Stanford, CA, USA. Electronic address: kcederb@stanford.edu.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102836']
1216,33618070,Enhancing attention and memory of individuals at clinical high risk for psychosis with mHealth technology.,"BACKGROUND


Cognitive impairment has adverse impact on the social and role functions of those at clinical high risk for psychosis and it has become an important target for intervention. Mobile health applications are user-friendly, real-time, personalized and portable in administering cognitive training and have promising application prospects in the field of mental health.
METHODS


Eighty CHR subjects were randomized into an intervention group and a control group. CHR subjects of the intervention group performed attention and memory training via a Specific Memory Attention Resource and Training (SMART) application in their smart phones for 10 min per day, five days per week for three months. Both groups were followed up for three months. At baseline and follow-up phases, cognitive function was measured using the MATRICS Consensus Cognitive Battery (MCCB). In the follow-up, the intervention group completed the Mobile Application Rating Scale (MARS) to provide feedback to improve SMART.
RESULTS


There is a significant group by time interaction effect in the Attention/Vigilance domain, which is significantly better in the intervention group than in the control group at 3- month follow-up. The improvement in Attention/Vigilance in the intervention group is significantly related to the amount of cognitive training time. Global Assessment of Function (GAF) reduction rate at baseline could predict the improvement of Attention/Vigilance. MARS results indicate that CHR subjects were receptive of SMART.
CONCLUSION


Mobile technology can be applied to improve cognitive function of CHR individuals, especially in the Attention/Vigilance domain.",2021,"CHR subjects of the intervention group performed attention and memory training via a Specific Memory Attention Resource and Training (SMART) application in their smart phones for 10 min per day, five days per week for three months.","['individuals at clinical high risk for psychosis with mHealth technology', 'Eighty CHR subjects']",['attention and memory training via a Specific Memory Attention Resource and Training (SMART) application'],"['Global Assessment of Function', 'Attention/Vigilance', 'Mobile Application Rating Scale (MARS', 'cognitive training time', 'GAF) reduction rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043459', 'cui_str': 'Zellweger syndrome'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1565805', 'cui_str': 'FGF9 protein, human'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0194268,"CHR subjects of the intervention group performed attention and memory training via a Specific Memory Attention Resource and Training (SMART) application in their smart phones for 10 min per day, five days per week for three months.","[{'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Florida A&M University, 501 Orr Drive, Psychology Department, United States. Electronic address: Huijun.li@famu.edu.'}, {'ForeName': 'Shuwen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Shanghai Mental Health Center, 600 Wanping Nan Road, Shanghai, China. Electronic address: yangshuwen95@163.com.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Chi', 'Affiliation': 'Florida A&M University, 501 Orr Drive, Psychology Department, United States. Electronic address: Hongmei.chi@famu.edu.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Shanghai Mental Health Center, 600 Wanping Nan Road, Shanghai, China. Electronic address: mas_xulihua2008@163.com.'}, {'ForeName': 'Tianghong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Mental Health Center, 600 Wanping Nan Road, Shanghai, China. Electronic address: zhang_tianhong@126.com.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Singleton', 'Affiliation': 'Florida A&M University, 501 Orr Drive, Psychology Department, United States. Electronic address: Gwendolyn.singleton@famu.edu.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Shanghai Mental Health Center, 600 Wanping Nan Road, Shanghai, China. Electronic address: yytang0522@gmail.com.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Stone', 'Affiliation': 'Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, 02115, United States. Electronic address: wstone@bidmc.harvard.edu.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, 600 Wanping Nan Road, Shanghai, China. Electronic address: jijunwang27@163.com.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2021.102587']
1217,33620016,Effect of a genetically engineered interferon-alpha versus traditional interferon-alpha in the treatment of moderate-to-severe COVID-19: a randomised clinical trial.,"BACKGROUND


There are few effective therapies for coronavirus disease 2019 (COVID-19) upon the outbreak of the pandemic. To compare the effectiveness of a novel genetically engineered recombinant super-compound interferon (rSIFN-co) with traditional interferon-alpha added to baseline antiviral agents (lopinavir-ritonavir or umifenovir) for the treatment of moderate-to-severe COVID-19.
METHOD


In this multicenter randomized (1:1) trial, patients hospitalized with moderate-to-severe COVID-19 received either rSIFN-co nebulization or interferon-alpha nebulization added to baseline antiviral agents for no more than 28 days. The primary endpoint was the time to clinical improvement. Secondary endpoints included the overall rate of clinical improvement assessed on day 28, the time to radiological improvement and virus nucleic acid negative conversion.
RESULTS


A total of 94 patients were included in the safety set (46 patients assigned to rSIFN-co group, 48 to interferon-alpha group). The time to clinical improvement was 11.5 days versus 14.0 days (95% CI 1.10 to 2.81,  p  = .019); the overall rate of clinical improvement on day 28 was 93.5% versus 77.1% (difference, 16.4%; 95% CI 3% to 30%); the time to radiological improvement was 8.0 days versus 10.0 days ( p  = .002), the time to virus nucleic acid negative conversion was 7.0 days versus 10.0 days ( p  = .018) in the rSIFN-co and interferon alpha arms, respectively. Adverse events were balanced with no deaths among groups.
CONCLUSIONS AND RELEVANCE


rSIFN-co was associated with a shorter time of clinical improvement than traditional interferon-alpha in the treatment of moderate-to-severe COVID-19 when combined with baseline antiviral agents. rSIFN-co therapy alone or combined with other antiviral therapy is worth to be further studied.Key messagesThere are few effective therapies for coronavirus disease 2019 (COVID-19) upon the outbreak of the pandemic. Interferon alphas, by inducing both innate and adaptive immune responses, have shown clinical efficacy in treating severe acute respiratory syndrome coronavirus and Middle East respiratory syndrome coronavirus.In this multicenter, head-to-head, randomized, clinical trial which included 94 participants with moderate-to-severe COVID-19, the rSIFN-co plus antiviral agents (lopinavir-ritonavir or umifenovir) was associated with a shorter time of clinical improvement than interferon-alpha plus antiviral agents.",2021,"CONCLUSIONS AND RELEVANCE


rSIFN-co was associated with a shorter time of clinical improvement than traditional interferon-alpha in the treatment of moderate-to-severe COVID-19 when combined with baseline antiviral agents.","['patients hospitalized with moderate-to-severe COVID-19 received either', 'A total of 94 patients were included in the safety set (46 patients assigned to rSIFN-co group, 48 to interferon-alpha group', '94 participants with moderate-to-severe COVID-19, the', 'moderate-to-severe COVID-19']","['interferon-alpha plus antiviral agents', 'rSIFN-co therapy alone or combined with other antiviral therapy', 'rSIFN-co plus antiviral agents (lopinavir-ritonavir or umifenovir', 'novel genetically engineered recombinant super-compound interferon (rSIFN-co) with traditional interferon-alpha added to baseline antiviral agents (lopinavir-ritonavir or umifenovir', 'rSIFN-co nebulization or interferon-alpha nebulization added to baseline antiviral agents for no more than 28\u2009days', 'genetically engineered interferon-alpha versus traditional interferon-alpha']","['time to radiological improvement', 'time to virus nucleic acid negative conversion', 'overall rate of clinical improvement assessed on day 28, the time to radiological improvement and virus nucleic acid negative conversion', 'Adverse events', 'time to clinical improvement', 'overall rate of clinical improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}]","[{'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3653892', 'cui_str': 'Other antivirals'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0017387', 'cui_str': 'Engineering, Genetic'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",94.0,0.125514,"CONCLUSIONS AND RELEVANCE


rSIFN-co was associated with a shorter time of clinical improvement than traditional interferon-alpha in the treatment of moderate-to-severe COVID-19 when combined with baseline antiviral agents.","[{'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Fengming', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Chengwu', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Xiong', 'Affiliation': 'Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Critical Care Medicine, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, First Affiliated Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine, The Public Health Clinical Center of Chengdu, Chengdu, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases, Guanggu District, the Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Department of Infectious Diseases, Guanggu District, the Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Disease, Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Disease, The Affiliated Hospital of Southwest Medical University, Luzhou, China.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ruoyang', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory Disease, Sichuan Second Hospital of T. C. M, Chengdu, China.'}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Senyi', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yuanhong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Infectious Disease, The Public Health Clinical Center of Chengdu, Chengdu, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Tuberculosis, The Public Health Clinical Center of Chengdu, Chengdu, China.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Tuberculosis, The Public Health Clinical Center of Chengdu, Chengdu, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': 'Department of Liver Disease, The Public Health Clinical Center of Chengdu, Chengdu, China.'}, {'ForeName': 'Deying', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Department of Evidence based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Bioengineering, Bourns College of Engineering, University of California, Riverside, CA, USA.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lunxu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, China.'}]",Annals of medicine,['10.1080/07853890.2021.1890329']
1218,33621479,How Does Octyl-2-Cyanoacrylate Tissue Adhesive Compare With Prolene Sutures in Cleft Lip Repair?,"PURPOSE


Comparative evidence of the usefulness of octyl-2-cyanoacrylate tissue adhesive in cleft lip epidermal skin closure especially in Africans is still lacking. This study aimed to compare the outcome of wound healing after the use of Dermabond tissue adhesive and 5/0 Prolene sutures in cleft lip repair.
METHODS


This was a prospective randomized controlled clinical study. The sampled population was patients undergoing cleft lip repair at a tertiary health facility in Lagos, Nigeria. Study patients were randomly allocated to either group A (Dermabond) or group B (suture). The predictor variable was the type of material used in skin closure; the primary outcome variable was the esthetics of the resulting scar, and secondary outcome variables were wound healing complications. Assessment of the 3-month postoperative wound scar was performed using the cosmetic visual analog scale (CVAS) and the Hollander Wound Evaluation scale (HWES). Calculated sample size was 14 participants per group. Descriptive and comparative statistics were computed, and the P value was set at <0.05.
RESULTS


Analysis of result included 38 participants. Median age was 4 months and 52.6% were women. Two cases (5.3%) of wound healing complications were recorded (1 in each group). Blinded evaluation of the 3-month postoperative photographs yielded a mean CVAS score of 86.0 (±11.2) and HWES score of 5.0 (±0.9) for group A and a mean CVAS score of 76.5 (±14.5) and HWES score of 4.5 (±1.1) for group B. There was no statistically significant difference between these 2 groups based on the CVAS (P = .052) and HWES (P = .152).
CONCLUSIONS


The results of this study suggest Dermabond offers a comparable cosmetic outcome as 5/0 Prolene suture in epidermal closure of cleft lip. There was no statistically significant difference in wound complications and wound cosmetic scores between the 2 groups.",2021,"B. There was no statistically significant difference between these 2 groups based on the CVAS (P = .052) and HWES (P = .152).
","['patients undergoing cleft lip repair at a tertiary health facility in Lagos, Nigeria']","['octyl-2-cyanoacrylate tissue adhesive', 'Dermabond tissue adhesive and 5/0 Prolene sutures', 'group A (Dermabond) or group B (suture', 'Prolene suture', 'Prolene Sutures']","['cosmetic visual analog scale (CVAS) and the Hollander Wound Evaluation scale (HWES', 'wound healing', 'esthetics of the resulting scar', 'mean CVAS score', 'HWES score', 'wound complications and wound cosmetic scores', 'wound healing complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0192070', 'cui_str': 'Repair of cleft lip'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0391770', 'cui_str': '2-octyl cyanoacrylate'}, {'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}, {'cui': 'C0491217', 'cui_str': 'Polypropylene suture'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",38.0,0.0641702,"B. There was no statistically significant difference between these 2 groups based on the CVAS (P = .052) and HWES (P = .152).
","[{'ForeName': 'Olutayo', 'Initials': 'O', 'LastName': 'James', 'Affiliation': 'Senior Lecturer, Department of Oral and Maxillofacial Surgery, College of Medicine, University of Lagos, Idi - Araba, Lagos, Nigeria.'}, {'ForeName': 'Adegbayi Adeola', 'Initials': 'AA', 'LastName': 'Adekunle', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, Lagos University Teaching Hospital, Idi - Araba, Lagos, Nigeria. Electronic address: aadeadekunle01@gmail.com.'}, {'ForeName': 'Wasiu Lanre', 'Initials': 'WL', 'LastName': 'Adeyemo', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, College of Medicine, University of Lagos, Idi - Araba, Lagos, Nigeria.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2021.01.026']
1219,33621942,The effect of laboratory and real world gait training with vibration feedback on center of pressure during gait in people with chronic ankle instability.,"BACKGROUND


External feedback has can medially shift the center of pressure (COP) location in people with chronic ankle instability(CAI) during walking. However, previous modalities are restricted to controlled environments which limits motor learning. Vibration feedback during gait may maximize motor learning by allowing for training in the laboratory and real world (RW) but has not been investigated in those with CAI.
RESEARCH QUESTION


Does vibration feedback change COP location in people with CAI following laboratory and RW training?
METHODS


Nineteen CAI participants walked for 10 min on a treadmill (lab training) and a one mile loop on a sidewalk (RW training) with vibration feedback. When pressure under the 5th metatarsal exceeded a threshold, a vibration stimulus was applied to the lateral malleolus encouraging the participant to medially shift the COP. One minute baseline, posttest, and short term retention gait assessments were taken for each environment. The stance phase of gait was divided into 10 subphases and data were averaged within each subphase. Repeated measures ANOVAs were completed for each subphase to compare COP location over time.
RESULTS


After lab based training the COP was more medial at posttest for the first 90 % of stance versus baseline (Mean differences (MD): -0.57 to -5.12 mm, p < 0.023). Relative to baseline, the COP remained more medial at retention from 20 to 90% of stance (MD: -1.69 to -4.40 mm, p < 0.049). For RW training, the COP was more medial at posttest for the first 70 % of stance versus baseline (MD: -4.24 to -8.27 mm, p < 0.017) and the first 60 % of stance at retention versus baseline (MD: -4.14 to -6.42 mm, p < 0.049).
SIGNIFICANCE


Vibration feedback during laboratory and RW gait training has the ability to immediately shift the COP location medially and retain this shift for a short period in individuals with CAI.",2021,After lab based training the COP was more medial at posttest for the first 90 % of stance versus baseline,"['people with chronic ankle instability', 'people with CAI following laboratory and RW training', 'people with chronic ankle instability(CAI', 'Nineteen CAI participants walked for 10\u2009min on a', 'individuals with CAI']","['laboratory and real world gait training with vibration feedback', 'RW gait training', 'treadmill (lab training) and a one mile loop on a sidewalk (RW training) with vibration feedback']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0331865', 'cui_str': 'miles'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0557772', 'cui_str': 'Sidewalk'}]",[],19.0,0.0183191,After lab based training the COP was more medial at posttest for the first 90 % of stance versus baseline,"[{'ForeName': 'Kimmery G', 'Initials': 'KG', 'LastName': 'Migel', 'Affiliation': 'MOTION Science Institute, University of North Carolina at Chapel Hill, 209 Fetzer Hall, CB8700, Chapel Hill, NC, 27599, United States. Electronic address: kmigel@live.unc.edu.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'MOTION Science Institute, University of North Carolina at Chapel Hill, 209 Fetzer Hall, CB8700, Chapel Hill, NC, 27599, United States. Electronic address: wikstrom@unc.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2021.02.011']
1220,33636344,The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety Trial 1 (AESOPS-1): Electronic health record nudges.,"BACKGROUND


There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. Despite clinical guidelines and education, prescribing continues at a higher rate than before the opioids crisis. The objective of trial 1 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-1) is to discourage unnecessary opioid prescribing in primary care by applying ""behavioral insights""-empirically-tested social and psychological interventions that affect choice.
METHODS


AESOPS-1 randomizes primary care clinics in Illinois and California to behavioral intervention or control. Both arms receive opioid guideline education. Clinics randomized to the behavioral intervention arm receive nudges within the electronic health record (EHR) including: 1) an ""accountable justification"" entered in the chart, 2) a precommitment to address high-risk prescriptions, and 3) a ""PainTracker"" that broadens discussions about pain. The control arm receives no EHR-based intervention. The primary outcome is the change in weekly milligram morphine equivalents (MME) prescribed. The secondary outcome is the change in the proportion of patients prescribed at least 50 daily MME. To evaluate these outcomes, we will use a difference-in-differences mixed-effects regression model on clinician MME weekly or daily dose. The analysis will be ""intent-to-treat."" The intervention period is 18-months, with a 6-month follow-up period to measure persistence of effects.
DISCUSSION


The AESOPS-1 trial will evaluate the effect of EHR-based interventions in reducing noncancer opioid prescribing in primary care. AESOPS-1 may demonstrate practical and scalable strategies to lower unnecessary population exposure to opioids.",2021,"The objective of trial 1 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-1) is to discourage unnecessary opioid prescribing in primary care by applying ""behavioral insights""-empirically-tested social and psychological interventions that affect choice.","['primary care', 'Methods AESOPS-1 randomizes primary care clinics in Illinois and California to behavioral intervention or control']","['EHR-based interventions', 'behavioral intervention arm receive nudges within the electronic health record (EHR) including: 1) an ""accountable justification"" entered in the chart, 2) a precommitment to address high-risk prescriptions, and 3) a ""PainTracker"" that broadens discussions about pain']","['change in the proportion of patients prescribed at least 50 daily MME', 'change in weekly milligram morphine equivalents (MME) prescribed']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0066662', 'cui_str': '1,2,3,4,9,9-hexachloro-1,4,4a,5,8,8a-hexahydro-6- methyl-6,7-epoxy-1,4-methanonaphthalene'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",,0.103082,"The objective of trial 1 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-1) is to discourage unnecessary opioid prescribing in primary care by applying ""behavioral insights""-empirically-tested social and psychological interventions that affect choice.","[{'ForeName': 'Marcella A', 'Initials': 'MA', 'LastName': 'Kelley', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; School of Pharmacy, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Persell', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Linder', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Friedberg', 'Affiliation': 'Blue Cross Blue Shield of Massachusetts, Boston, MA, United States of America.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Meeker', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Fox', 'Affiliation': 'Anderson School of Management, University of California at Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Goldstein', 'Affiliation': 'Anderson School of Management, University of California at Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Tara K', 'Initials': 'TK', 'LastName': 'Knight', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; Sol Price School of Public Policy, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Zein', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Rowe', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Washington, School of Medicine, Seattle, WA, United States of America.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Doctor', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; School of Pharmacy, University of Southern California, Los Angeles, CA, United States of America; Sol Price School of Public Policy, University of Southern California, Los Angeles, CA, United States of America. Electronic address: jdoctor@usc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106329']
1221,33636297,Yoga versus home exercise program in children with enthesitis related arthritis: A pilot study.,"PURPOSE


The aim was to compare the effects of yoga and home exercise program on lower extremity functional status, pain, and quality of life in children with enthesitis related arthritis (ERA).
METHODS


Twenty-one children with ERA were divided into two groups as yoga (n = 11) and home exercise (n = 10). Yoga group performed supervised yoga exercises twice a week for eight weeks. Home exercise group performed video-based exercises for the same period. Pain in rest and activity, lower extremity functional status, and quality of life were evaluated at baseline and following eight weeks.
RESULTS


The groups were similar at baseline (p > 0.05). All the parameters, except parent reported quality of life, significantly improved in yoga group (p < 0.05), where only stair climb test times significantly improved in home exercise group (p < 0.05).
CONCLUSIONS


Yoga seems promising for improving lower extremity functional status, pain, and quality of life as an exercise intervention in rehabilitation programs of children with ERA.",2021,"All the parameters, except parent reported quality of life, significantly improved in yoga group (p < 0.05), where only stair climb test times significantly improved in home exercise group (p < 0.05).
","['children with ERA', 'Twenty-one children with ERA', 'children with enthesitis related arthritis (ERA', 'Children with Enthesitis Related Arthritis']","['yoga and home exercise program', 'home exercise', 'Yoga versus Home Exercise Program', 'Home exercise group performed video-based exercises', 'supervised yoga exercises']","['quality of life', 'lower extremity functional status, pain, and quality of life', 'stair climb test times', 'Pain in rest and activity, lower extremity functional status, and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",21.0,0.02317,"All the parameters, except parent reported quality of life, significantly improved in yoga group (p < 0.05), where only stair climb test times significantly improved in home exercise group (p < 0.05).
","[{'ForeName': 'Ezgi', 'Initials': 'E', 'LastName': 'Yasar', 'Affiliation': 'Pamukkale University, Institute of Health Sciences, Department of Physical Therapy and Rehabilitation, Denizli, Turkey. Electronic address: ezgiyasar4@gmail.com.'}, {'ForeName': 'Erdogan', 'Initials': 'E', 'LastName': 'Kavlak', 'Affiliation': 'Pamukkale University, School of Physical Therapy and Rehabilitation, Denizli, Turkey. Electronic address: kavlake@hotmail.com.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Turkucar', 'Affiliation': 'Dokuz Eylul University, Faculty of Medicine, Department of Pediatrics, Division of Pediatric Rheumatology, Izmir, Turkey. Electronic address: serkan_turkucar@hotmail.com.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Bayraktar', 'Affiliation': 'Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Izmir, Turkey. Electronic address: ptdenislav@yahoo.com.'}, {'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Acari', 'Affiliation': 'Dokuz Eylul University, Faculty of Medicine, Department of Pediatrics, Division of Pediatric Rheumatology, Izmir, Turkey. Electronic address: ceyhun_acari@hotmail.com.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Dokuz Eylul University, Faculty of Medicine, Department of Pediatrics, Division of Pediatric Rheumatology, Izmir, Turkey. Electronic address: erbil.unsal@deu.edu.tr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102696']
1222,33636217,The effect of messaging on the acceptance of swaps to reduce the energy content of snacks and non-alcoholic drinks ordered in an experimental online workplace canteen: A randomised controlled trial.,"Finding effective ways to increase acceptance of lower-energy swaps offered for snacks and non-alcoholic drinks may reduce population energy intake. We examined whether incrementally increasing the tangibility of information accompanying swaps offered increased their acceptance. UK adults (n = 3481) selected a sweet snack, a savoury snack, and a drink in an experimental online canteen after being equally randomised to receive one of four messages when swaps were offered; a control message providing no specific information, a vague calorie message, an exact numeric-calories message or, a physical activity calorie equivalent (PACE). Primary outcomes were the between-group differences in (i) the odds that a sweet, savoury, or drink swap would be accepted and (ii) the energy content for each type of item ordered. Compared with control, the numeric-calories and PACE messages significantly increased the odds of accepting a sweet snack swap. All interventions significantly increased the odds of accepting savoury swaps compared with control. Only the PACE message significantly increased the odds of drink swap acceptance. The numeric-calories and PACE messages significantly reduced the energy content of sweet snacks. All interventions significantly reduced the energy content of savoury snacks. None of the intervention messages significantly reduced the energy content of drinks compared with control. Increasing the tangibility of information provided when offering swaps increased swap acceptance. PACE messaging was the most promising.",2021,All interventions significantly increased the odds of accepting savoury swaps compared with control.,"['UK adults (n=3,481) selected a sweet snack, a savoury snack, and a drink in an experimental online canteen after being equally randomised to']","['receive one of four messages when swaps were offered; a control message providing no specific information, a vague calorie message, an exact numeric-calories message or, a physical activity calorie equivalent (PACE']","['energy content of savoury snacks', 'energy content of sweet snacks', 'energy content of drinks', 'odds of accepting savoury swaps', 'odds of drink swap acceptance', 'sweet, savoury, or drink swap would be accepted and (ii) the energy content for each type of item ordered']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205408', 'cui_str': 'Vague'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]",3481.0,0.030462,All interventions significantly increased the odds of accepting savoury swaps compared with control.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Breathnach', 'Affiliation': 'Research Department Behavioural Science and Health, Faculty of Epidemiology & Public Health, University College London, London, WC1E 7HB, UK. Electronic address: sarah.breathnach.17@ucl.ac.uk.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Koutoukidis', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lally', 'Affiliation': 'Research Department Behavioural Science and Health, Faculty of Epidemiology & Public Health, University College London, London, WC1E 7HB, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Boniface', 'Affiliation': 'Research Department Behavioural Science and Health, Faculty of Epidemiology & Public Health, University College London, London, WC1E 7HB, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sutherland', 'Affiliation': 'Behavioural Insights Team, 4 Matthew Parker Street, London, SW1H 9NP, UK.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Llewellyn', 'Affiliation': 'Research Department Behavioural Science and Health, Faculty of Epidemiology & Public Health, University College London, London, WC1E 7HB, UK.'}]",Appetite,['10.1016/j.appet.2021.105171']
1223,33641430,Single dose of tranexamic acid effectively reduces blood loss and transfusion rates in elderly patients undergoing surgery for hip fracture: a randomized controlled trial.,"AIMS


The aim of this study was to investigate the hypothesis that a single dose of tranexamic acid (TXA) would reduce blood loss and transfusion rates in elderly patients undergoing surgery for a subcapital or intertrochanteric (IT) fracture of the hip.
METHODS


In this single-centre, randomized controlled trial, elderly patients undergoing surgery for a hip fracture, either hemiarthroplasty for a subcapital fracture or intramedullary nailing for an IT fracture, were screened for inclusion. Patients were randomly allocated to a study group using a sealed envelope. The TXA group consisted of 77 patients, (35 with a subcapital fracture and 42 with an IT fracture), and the control group consisted of 88 patients (29 with a subcapital fracture and 59 with an IT fracture). One dose of 15 mg/kg of intravenous (IV) TXA diluted in 100 ml normal saline (NS,) or one dose of IV placebo 100 ml NS were administered before the incision was made. The haemoglobin (Hb) concentration was measured before surgery and daily until the fourth postoperative day. The primary outcomes were the total blood loss and the rate of transfusion from the time of surgery to the fourth postoperative day.
RESULTS


Homogeneity with respect to baseline characteristics was ensured between groups. The mean total blood loss was significantly lower in patients who received TXA (902.4 ml (-279.9 to 2,156.9) vs 1,226.3 ml (-269.7 to 3,429.7); p = 0.003), while the likelihood of requiring a transfusion of at least one unit of red blood cells was reduced by 22%. Subgroup analysis showed that these differences were larger in patients who had an IT fracture compared with those who had a subcapital fracture.
CONCLUSION


Elderly patients who undergo intramedullary nailing for an IT fracture can benefit from a single dose of 15 mg/kg TXA before the onset of surgery. A similar tendency was identified in patients undergoing hemiarthroplasty for a subcapital fracture but not to a statistically significant level. Cite this article:  Bone Joint J  2021;103-B(3):442-448.",2021,"The mean total blood loss was significantly lower in patients who received TXA (902.4 ml (-279.9 to 2,156.9) vs 1,226.3 ml (-269.7 to 3,429.7);","['elderly patients undergoing surgery for a hip fracture, either hemiarthroplasty for a subcapital fracture or intramedullary nailing for an IT fracture, were screened for inclusion', 'Elderly patients who undergo', 'elderly patients undergoing surgery for a subcapital or intertrochanteric (IT) fracture of the hip', 'elderly patients undergoing surgery for hip fracture', '77 patients, (35 with a subcapital fracture and 42 with an IT fracture), and the control group consisted of 88 patients (29 with a subcapital fracture and 59 with an IT fracture']","['tranexamic acid', 'tranexamic acid (TXA', 'intramedullary nailing', 'intravenous (IV) TXA diluted in 100 ml normal saline (NS,) or one dose of IV placebo', 'TXA']","['likelihood of requiring a transfusion of at least one unit of red blood cells', 'total blood loss and the rate of transfusion from the time of surgery to the fourth postoperative day', 'haemoglobin (Hb) concentration', 'mean total blood loss', 'blood loss and transfusion rates']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric fracture'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.481517,"The mean total blood loss was significantly lower in patients who received TXA (902.4 ml (-279.9 to 2,156.9) vs 1,226.3 ml (-269.7 to 3,429.7);","[{'ForeName': 'Vasileios S', 'Initials': 'VS', 'LastName': 'Nikolaou', 'Affiliation': '2nd Academic Department of Orthopaedics, School of Medicine, Konstandopoulio General Hospital, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Masouros', 'Affiliation': 'Department of Orthopaedic, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Themistoklis', 'Initials': 'T', 'LastName': 'Floros', 'Affiliation': '2nd Academic Department of Orthopaedics, School of Medicine, Konstandopoulio General Hospital, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Chronopoulos', 'Affiliation': '2nd Academic Department of Orthopaedics, School of Medicine, Konstandopoulio General Hospital, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Skertsou', 'Affiliation': 'Department of Haematology, Konstandopoulio General Hospital, Athens, Greece.'}, {'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Babis', 'Affiliation': '2nd Academic Department of Orthopaedics, School of Medicine, Konstandopoulio General Hospital, National & Kapodistrian University of Athens, Athens, Greece.'}]",The bone & joint journal,['10.1302/0301-620X.103B3.BJJ-2020-1288.R1']
1224,33641414,Direct superior approach for total hip arthroplasty.,"AIMS


The purpose of this study was to compare the clinical, radiological, and patient-reported outcome measures (PROMs) in the first 100 consecutive patients undergoing total hip arthroplasty (THA) via a direct superior approach (DSA) with a matched group of patients undergoing THA by the same surgeon, using a posterolateral approach (PLA).
METHODS


This was a retrospective single surgeon study comparing the first 100 consecutive DSA THA patients with a matched group of patients using a standard PLA. Case notes were examined for patient demographics, length of hospital stay, operating time, intra- and postoperative complications, pain score, satisfaction score, and Oxford Hip Score (OHS). Leg length discrepancy and component positioning were measured from postoperative plain radiographs.
RESULTS


The DSA patients had a shorter length of hospital stay (mean 2.09 days (SD 1.20) DSA vs 2.74 days (SD 1.17) PLA; p < 0.001) and shorter time to discharge from the inpatient physiotherapy teams (mean 1.44 days (SD 1.17) DSA vs 1.93 days (SD 0.96) PLA; p < 0.001). There were no differences in operating time (p = 0.505), pain levels up to postoperative day 1 (p = 0.106 to p =0.242), OHS (p = 0.594 to p = 0.815), satisfaction levels (p = 0.066 to p = 0.299), stem alignment (p = 0.240), acetabular component inclination (p < 0.001) and anteversion (p < 0.001), or leg length discrepancy (p = 0.134).
CONCLUSION


While the DSA appears safe and was not associated with a significant difference in PROMs, radiological findings, or intraoperative or postoperative complications, a randomized controlled trial with functional outcomes in the postoperative phase is needed to evaluate this surgical approach formally. Cite this article:  Bone Joint J  2021;103-B(3):500-506.",2021,"There were no differences in operating time (p = 0.505), pain levels up to postoperative day 1 (p = 0.106 to p =0.242), OHS (p = 0.594 to p = 0.815), satisfaction levels (p = 0.066 to p = 0.299), stem alignment (p = 0.240), acetabular component inclination (p < 0.001) and anteversion (p < 0.001), or leg length discrepancy (p = 0.134).
","['100 consecutive patients undergoing total hip arthroplasty (THA) via a direct superior approach (DSA) with a matched group of patients undergoing THA by the same surgeon, using a posterolateral approach (PLA', '100 consecutive DSA THA patients with a matched group of patients using a standard PLA', 'total hip arthroplasty']",['DSA'],"['shorter time to discharge', 'patient demographics, length of hospital stay, operating time, intra- and postoperative complications, pain score, satisfaction score, and Oxford Hip Score (OHS', 'operating time', 'acetabular component inclination', 'leg length discrepancy', 'satisfaction levels', 'OHS', 'shorter length of hospital stay', 'Leg length discrepancy and component positioning', 'pain levels']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C0268353', 'cui_str': 'Cutis laxa, x-linked'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0023221', 'cui_str': 'Leg length inequality'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",100.0,0.0918085,"There were no differences in operating time (p = 0.505), pain levels up to postoperative day 1 (p = 0.106 to p =0.242), OHS (p = 0.594 to p = 0.815), satisfaction levels (p = 0.066 to p = 0.299), stem alignment (p = 0.240), acetabular component inclination (p < 0.001) and anteversion (p < 0.001), or leg length discrepancy (p = 0.134).
","[{'ForeName': 'Hollie J', 'Initials': 'HJ', 'LastName': 'Leonard', 'Affiliation': 'Department of Orthopaedics, Golden Jubilee National Hospital, Glasgow, UK.'}, {'ForeName': 'Nicholas E', 'Initials': 'NE', 'LastName': 'Ohly', 'Affiliation': 'Department of Orthopaedics, Golden Jubilee National Hospital, Glasgow, UK.'}]",The bone & joint journal,['10.1302/0301-620X.103B3.BJJ-2020-0916.R1']
1225,33648834,A randomized trial to examine the impact of food on pharmacokinetics of 4-phenylbutyrate and change in amino acid availability after a single oral administration of sodium 4-phenylbutyrarte in healthy volunteers.,"Urea cycle disorders (UCDs), inborn errors of hepatocyte metabolism, result in the systemic accumulation of ammonia to toxic levels. Sodium 4-phenylbutyrate (NaPB), a standard therapy for UCDs for over 20 years, generates an alternative pathway of nitrogen deposition through glutamine consumption. Administration during or immediately after a meal is the accepted use of NaPB. However, this regimen is not based on clinical evidence. Here, an open-label, single-dose, five-period crossover study was conducted in healthy adults to investigate the effect of food on the pharmacokinetics of NaPB and determine any subsequent change in amino acid availability. Twenty subjects were randomized to one of four treatment groups. Following an overnight fast, NaPB was administered orally at 4.3 g/m 2  (high dose, HD) or 1.4 g/m 2  (low dose, LD) either 30 min before or just after breakfast. At both doses, compared with post-breakfast administration, pre-breakfast administration significantly increased systemic exposure of PB and decreased plasma glutamine availability. Pre-breakfast LD administration attenuated plasma glutamine availability to the same extent as post-breakfast HD administration. Regardless of the regimen, plasma levels of branched-chain amino acids (BCAA) were decreased below baseline in a dose-dependent manner. In conclusion, preprandial oral administration of NaPB maximized systemic exposure of the drug and thereby its potency to consume plasma glutamine. This finding may improve poor medication compliance because of the issues with odor, taste, and pill burden of NaPB and reduce the risk of BCAA deficiency in NaPB therapy.",2021,"Regardless of the regimen, plasma levels of branched-chain amino acids (BCAA) were decreased below baseline in a dose-dependent manner.","['healthy volunteers', 'Twenty subjects', 'healthy adults']","['Sodium 4-phenylbutyrate (NaPB', 'sodium 4-phenylbutyrarte']","['Urea cycle disorders (UCDs), inborn errors of hepatocyte metabolism, result in the systemic accumulation of ammonia to toxic levels', 'systemic exposure of PB and decreased plasma glutamine availability', 'plasma glutamine availability', 'plasma levels of branched-chain amino acids (BCAA']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0718066', 'cui_str': 'sodium phenylbutyrate'}, {'cui': 'C1834304', 'cui_str': 'Hereditary Neuralgic Amyotrophy'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0154246', 'cui_str': 'Disorder of the urea cycle metabolism'}, {'cui': 'C0227525', 'cui_str': 'Hepatic parenchymal cell'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}]",20.0,0.0594796,"Regardless of the regimen, plasma levels of branched-chain amino acids (BCAA) were decreased below baseline in a dose-dependent manner.","[{'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Osaka', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Science, The University of Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Science, The University of Tokyo, Japan; Department of Pediatrics, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tadahaya', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Science, The University of Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Hiraoka', 'Affiliation': 'Laboratory of Proteomics and Biomolecular Science, Research Support Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Minowa', 'Affiliation': 'Department of Pediatrics, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Hirai', 'Affiliation': 'Department of Pediatrics, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Mizutani', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Science, The University of Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sabu', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Science, The University of Tokyo, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Miura', 'Affiliation': 'Laboratory of Proteomics and Biomolecular Science, Research Support Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Pediatrics, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kusuhara', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Science, The University of Tokyo, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Pediatrics, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisamitsu', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Science, The University of Tokyo, Japan. Electronic address: hayapi@mol.f.u-tokyo.ac.jp.'}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2021.02.002']
1226,33651442,The efficacy of oral vs different dilutions of intradermal tranexamic acid microinjections in melasma-A randomized clinical trial.,"Melasma is a common acquired disorder of pigmentation, remains challenging despite numerous treatment modalities. Tranexamic acid (TXA) has emerged as a potential treatment for melasma. Different forms of TXA (oral, topical, and intradermal microinjections) have shown promising results. To evaluate and compare the efficacy of oral vs different dilutions of intradermal TXA in melasma. A total of 45 female patients with melasma were randomly and equally assigned to three treatment groups. Group A (oral TXA 250 mg bid), Group B (100 mg/mL intradermal TXA) & Group C (4 mg/mL intradermal TXA) every 2 weeks, treatment period was 8 weeks. At 8 weeks, a significant reduction in the mMASIwas noted in groups A, B, and C (P value .002, .003, and .005). Melanin index (MI) was significantly reduced in groups A, B, and C (P value .016, .005, and .003). Erythema index (EI) showed significant improvement in group A (P value .028), however was statistically insignificant for groups B and C. No statistically significant difference was found between the three groups as regards changes in mMASI, MI, and EI at 8 weeks. Both oral and intradermal microinjections of TXA regardless dilution appear to be effective and safe in treatment of melasma with comparable results.",2021,"Melanin index (MI) was significantly reduced in group A, B and C (pvalue 0.016, 0.005, 0.003).",['45 female patients with melasma'],"['intradermal Tranexamic acid microinjections', 'TXA (oral, topical and intradermal microinjections', 'Group B (100mg/ml intradermal TXA) & Group C ', 'TXA', '4mg./ml intradermal TXA ', 'Tranexamic acid (TXA', 'intradermal TXA']","['Melanin index (MI', 'mMASI, MI and EI', 'Erythema index (EI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0025991', 'cui_str': 'Microinjections'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",45.0,0.035847,"Melanin index (MI) was significantly reduced in group A, B and C (pvalue 0.016, 0.005, 0.003).","[{'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'El Hadidi', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Mosaad', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nanis', 'Initials': 'N', 'LastName': 'Ragab', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Dermatologic therapy,['10.1111/dth.14924']
1227,33607104,No clinical benefit of high dose corticosteroid administration in patients with COVID-19: A preliminary report of a randomized clinical trial.,"The aim of this study was to evaluate the clinical effects of dexamethasone administration in patients with mild to moderate acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19). The study included 50 patients who were randomly assigned to the dexamethasone group or control group. Dexamethasone was administered at a dose of 20 mg/day from day 1-5 and then at 10 mg/day from day 6-10. The need for invasive mechanical ventilation, death rate, duration of clinical improvement, length of hospital stay, and radiological changes in the computed tomography scan were assessed. The results revealed that 92% and 96% of patients in the dexamethasone and control groups, respectively, required noninvasive ventilation (P = 0.500). Among them, 52% and 44% of patients in the dexamethasone and control groups, respectively, required invasive mechanical ventilation (P = 0.389). At the end of the study, 64% of patients in the dexamethasone group and 60% of patients in the control group died (P = 0.500); the remaining patients were discharged from the hospital during the 28-day follow-up period. The median length of hospital stay was 11 days in the dexamethasone group and 6 days in the control group (P = 0.036) and the median length of hospital stay was 7 days in the dexamethasone group and 3 days in the control group (P < 0.001). No significant differences were observed in the other outcomes. This study showed that corticosteroid administration had no clinical benefit in patients with COVID-19-induced mild to moderate ARDS.",2021,"The results revealed that 92% and 96% of patients in the dexamethasone and control groups, respectively, required noninvasive ventilation (P = 0.500).","['patients with COVID-19-induced mild to moderate ARDS', 'patients with COVID-19', 'patients with mild to moderate acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19', '50 patients who were randomly assigned to the']","['corticosteroid', 'dexamethasone group or control group', 'Dexamethasone', 'dexamethasone']","['invasive mechanical ventilation, death rate, duration of clinical improvement, length of hospital stay, and radiological changes in the computed tomography scan', 'invasive mechanical ventilation', 'noninvasive ventilation', 'median length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",50.0,0.091205,"The results revealed that 92% and 96% of patients in the dexamethasone and control groups, respectively, required noninvasive ventilation (P = 0.500).","[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Jamaati', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed MohammadReza', 'Initials': 'SM', 'LastName': 'Hashemian', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behrooz', 'Initials': 'B', 'LastName': 'Farzanegan', 'Affiliation': 'Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Malekmohammad', 'Affiliation': 'Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Tabarsi', 'Affiliation': 'Clinical Tuberculosis and Epidemiology Research Centre, National Research Institute for Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Marjani', 'Affiliation': 'Clinical Tuberculosis and Epidemiology Research Centre, National Research Institute for Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Moniri', 'Affiliation': 'Virology Research Center, National Research Institute for Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Abtahian', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Haseli', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Mortaz', 'Affiliation': 'Clinical Tuberculosis and Epidemiology Research Centre, National Research Institute for Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran; Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Dastan', 'Affiliation': 'Ernest and Julio Gallo Management Program, School of Engineering, University of California, Merced, United States.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Mohamadnia', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolbaset', 'Initials': 'A', 'LastName': 'Vahedi', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Monjazebi', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yassari', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Fadaeizadeh', 'Affiliation': 'Telemedicine Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Saffaei', 'Affiliation': 'Student Research Committee, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Dastan', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: fzh.dastan@gmail.com.'}]",European journal of pharmacology,['10.1016/j.ejphar.2021.173947']
1228,33611104,Impact of lung metastases on overall survival in the phase 3 SELECT study of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer.,"BACKGROUND


Lung metastases may worsen overall survival (OS) in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). We investigated (post hoc) the impact of lung metastases on survival in SELECT (a phase 3 study).
PATIENTS AND METHODS


392 patients with RR-DTC were randomised 2:1 to lenvatinib 24 mg daily (n = 261) or placebo (n = 131). Placebo-treated patients could crossover to open-label lenvatinib following progression. Patients were grouped by size of baseline lung metastases. Safety/efficacy outcomes, collated by these lung-metastases subgroups, were generated.
RESULTS


Lenvatinib-treated population distributions per baseline lung metastases subgroup were any lung metastases (target/nontarget lesions; n = 226), and by maximum size of target lung lesions ≥1.0 cm (n = 199), ≥1.5 cm (n = 150), ≥2.0 cm (n = 94) and <2.0 cm (n = 105). In patients with any lung metastases, no statistically significant difference in OS was observed between treatment arms (HR: 0.76; 95% CI: 0.57-1.01; P = 0.0549). Median OS for lung metastases of ≥1.0 cm was 44.7 months (lenvatinib) versus 33.1 months (placebo) (HR: 0.63; 95% CI: 0.47-0.85; P = 0.0025). OS was significantly prolonged with lenvatinib versus placebo among patients with lung metastases of ≥1.0 cm, ≥1.5 cm, ≥2.0 cm and <2.0 cm; median OS was shorter in the ≥2.0 cm subgroup (lenvatinib: 34.7 months) versus other subgroups (lenvatinib: 44.1-49.2 months). Multivariate analysis demonstrated lenvatinib significantly prolonged OS in patients with lung metastases of ≥1.0 cm after adjustment for baseline characteristics.
CONCLUSIONS


Lenvatinib treatment resulted in longer OS in patients with lung metastases of ≥1.0 cm versus placebo (even with the 89% crossover rate). Early initiation of lenvatinib may improve outcomes in patients with RR-DTC and lung metastases of ≥1.0 cm.
SOURCE STUDY REGISTRATION


ClinicalTrials.Gov Identifier: NCT01321554.",2021,"Multivariate analysis demonstrated lenvatinib significantly prolonged OS in patients with lung metastases of ≥1.0 cm after adjustment for baseline characteristics.
","['patients with lung metastases', '392 patients with RR-DTC', 'patients with lung metastases of ≥1.0\xa0cm versus', 'patients with RR-DTC and lung metastases of ≥1.0\xa0cm', 'patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC', 'patients with radioiodine-refractory differentiated thyroid cancer']","['placebo', 'Placebo', 'lenvatinib versus placebo', 'lenvatinib 24\xa0mg daily (n\xa0=\xa0261) or placebo']","['overall survival (OS', 'OS', 'Median OS for lung metastases', 'median OS', 'longer OS', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}, {'cui': 'C2828294', 'cui_str': 'iodide ion I-131'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",392.0,0.264504,"Multivariate analysis demonstrated lenvatinib significantly prolonged OS in patients with lung metastases of ≥1.0 cm after adjustment for baseline characteristics.
","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: matahara@east.ncc.go.jp.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Kobe University Hospital Cancer Center, Kobe, Japan.'}, {'ForeName': 'Ana O', 'Initials': 'AO', 'LastName': 'Hoff', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Corin', 'Initials': 'C', 'LastName': 'Badiu', 'Affiliation': 'National Institute of Endocrinology, C. Davila University, Bucharest, Romania.'}, {'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Eisai Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Wirth', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.12.032']
1229,33619550,Pertuzumab and trastuzumab as adjuvant treatment for HER2-positive early breast cancer: outcomes in Chinese patients in the APHINITY study.,"BACKGROUND


The addition of pertuzumab to trastuzumab plus standard chemotherapy as adjuvant therapy following surgery significantly improved invasive disease-free survival (IDFS) in patients with HER2-positive early breast cancer in the multinational randomized APHINITY trial (NCT01358877, BIG 4-11/BO25126/TOC4939G). We analyzed clinical outcomes in the subgroup of patients recruited at Chinese sites.
METHODS


Patients were randomized to standard adjuvant chemotherapy plus 1 year of trastuzumab with pertuzumab or placebo. Patients recruited in mainland China, Hong Kong and Taiwan are included in this descriptive analysis.
RESULTS


Chinese patients had similar demographic characteristics to the global population, but a higher proportion had nodal involvement. Although this subgroup analysis was not powered to detect statistical significance, a numerical improvement in IDFS was observed with the addition of pertuzumab to trastuzumab in Chinese patients (hazard ratio, 0.69; 95% confidence interval: 0.39-1.19; 3-year IDFS event-free estimates 92.5% [pertuzumab] and 91.7% [placebo]), which was consistent with the primary analysis of the global population. Further subgroup analyses showed numerical improvements in the Chinese node-positive, hormone receptor-negative and -positive subgroups, although confidence intervals were wide due to the low number of events. The incidence of diarrhea was higher in the pertuzumab arm, and no primary cardiac events occurred in Chinese patients in either arm.
CONCLUSIONS


Pertuzumab, used in combination with trastuzumab and chemotherapy in APHINITY, is effective as an adjuvant treatment regimen for Chinese patients with HER2-positive early breast cancer in a setting with curative intent. The safety profile in Chinese patients was consistent with that of the global population.",2021,"Further subgroup analyses showed numerical improvements in the Chinese node-positive, hormone receptor-negative and -positive subgroups, although confidence intervals were wide due to the low number of events.","['HER2-positive early breast cancer', 'subgroup of patients recruited at Chinese sites', 'Patients', 'Chinese patients with HER2-positive early breast cancer in a setting with curative intent', 'Chinese patients', 'patients with HER2-positive early breast cancer', 'Patients recruited in mainland China, Hong Kong and Taiwan are included in this descriptive analysis']","['standard adjuvant chemotherapy plus 1\xa0year of trastuzumab with pertuzumab or placebo', 'trastuzumab plus standard chemotherapy', 'Pertuzumab and trastuzumab', 'trastuzumab and chemotherapy']","['IDFS', 'invasive disease-free survival', 'incidence of diarrhea']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.364428,"Further subgroup analyses showed numerical improvements in the Chinese node-positive, hormone receptor-negative and -positive subgroups, although confidence intervals were wide due to the low number of events.","[{'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Fudan University, Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ling-Ming', 'Initials': 'LM', 'LastName': 'Tseng', 'Affiliation': 'Taipei-Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiun-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Pang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Youngsen', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Taichung Veterans General Hospital, Taichung, Taiwan and College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Liao', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Cuizhi', 'Initials': 'C', 'LastName': 'Geng', 'Affiliation': 'Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Donggeng', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Sun Yatsen University Cancer Hospital, Guangzhou, China.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Kwong', 'Affiliation': 'The University of Hong Kong, Hong Kong.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa216']
1230,33618193,Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder.,"BACKGROUND


Integrated interventions for comorbid posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) are effective, but many patients prematurely drop out from treatment. Little is known about within-treatment risk factors for dropout, limiting the ability during therapy to identify patients at risk for attrition.
METHODS


We examined measures assessing PTSD (PTSD Checklist for DSM-5; PCL-5), alcohol use (Substance Use Inventory; SUI), and patient satisfaction (Client Satisfaction Questionnaire; CSQ-8) as potential within-treatment markers of dropout risk, administered to 110 veterans in a randomized clinical trial of integrated exposure therapy versus integrated coping skills therapy for comorbid PTSD + AUD. Hierarchical Cox proportional hazard models with dropout status as the endpoint assessed effects of PCL-5, SUI, and CSQ-8 on dropout risk, and whether effects differed by treatment modality.
RESULTS


A significant interaction between treatment and changes in alcohol use was observed (HR = 2.86, p =  .007), where between-session alcohol use was positively associated with dropout hazard rate for those receiving integrated exposure therapy (HR = 2.34, p =  .004), but not coping skills therapy (HR = 0.73, p =  .19). Specifically, an increase of one drink consumed per day in the interval since last assessment (typically 2-3 weeks) was associated with a 5-fold increase in dropout hazard rate.
CONCLUSIONS


The findings provide preliminary evidence of detectable within-treatment markers of dropout during integrated treatment for PTSD + AUD. Study of within-treatment indicators proximal to dropout may help identify at-risk patients and inform timely strategies to boost retention.",2021,"A significant interaction between treatment and changes in alcohol use was observed (HR = 2.86, p =  .007), where between-session alcohol use was positively associated with dropout hazard rate for those receiving integrated exposure therapy (HR = 2.34, p =  .004), but not coping skills therapy (HR = 0.73, p =  .19).",['110 veterans'],['integrated exposure therapy versus integrated coping skills therapy'],"['alcohol use', 'PTSD (PTSD Checklist for DSM-5; PCL-5), alcohol use (Substance Use Inventory; SUI), and patient satisfaction (Client Satisfaction Questionnaire; CSQ-8', 'dropout hazard rate']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0144686,"A significant interaction between treatment and changes in alcohol use was observed (HR = 2.86, p =  .007), where between-session alcohol use was positively associated with dropout hazard rate for those receiving integrated exposure therapy (HR = 2.34, p =  .004), but not coping skills therapy (HR = 0.73, p =  .19).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Dr, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, USA. Electronic address: alexander.kline@va.gov.'}, {'ForeName': 'Kaitlyn E', 'Initials': 'KE', 'LastName': 'Panza', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Dr, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Katia M', 'Initials': 'KM', 'LastName': 'Harlé', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Dr, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Angkaw', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Dr, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, USA; National Center for Posttraumatic Stress Disorder, 163 Veterans Dr, White River Junction, VT, 05009, USA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Dr, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 171 Ashley Ave, Charleston, SC, 29425, USA; Ralph H. Johnson Veteran Affairs Medical Center, 109 Bee St, Charleston, SC, 29401, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, USA; National Center for Posttraumatic Stress Disorder, 163 Veterans Dr, White River Junction, VT, 05009, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108592']
1231,33617776,Rationale to continue approving placebo-controlled COVID-19 vaccine trials in LMICs.,,2021,,[],[],[],[],[],[],,0.206476,,"[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Sisa', 'Affiliation': 'College of Health Sciences, Universidad San Francisco de Quito, Quito 170901, Ecuador. Electronic address: isisa@usfq.edu.ec.'}, {'ForeName': 'Estefania', 'Initials': 'E', 'LastName': 'Noblecilla', 'Affiliation': 'Institutional Review Board, Universidad San Francisco de Quito, Quito 170901, Ecuador.'}, {'ForeName': 'Fadya', 'Initials': 'F', 'LastName': 'Orozco', 'Affiliation': 'College of Health Sciences, Universidad San Francisco de Quito, Quito 170901, Ecuador.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)00357-3']
1232,33621631,Stanford Pragmatiec Effectiveness Comparison (SPEC) protocol: Comparing long-term effectiveness of high-frequency and burst spinal cord stimulation in real-world application.,"OBJECTIVES


High-frequency and burst stimulation are newer waveforms that have demonstrated promise compared to traditional tonic spinal cord stimulation (SCS), but more studies are needed to compare their effectiveness. We report the study methods for an ongoing, single center, pragmatic randomized clinical trial to compare the effectiveness of high-frequency and burst SCS in patients with chronic back and/or leg pain.
MATERIALS AND METHODS


Participants who are candidates for spinal cord stimulation are enrolled and screened. Participants will be randomly assigned using point-of-care randomization to receive either high-frequency or burst SCS. Data collection will be through Stanford Pain Management Center's learning healthcare system: CHOIR. CHOIR surveys include National Institutes of Health Patient Reported Outcomes Measurement Information System item banks, a body map, questions about pain intensity, pain catastrophizing scale, and questions about patients' pain experience and healthcare utilization. Participants will complete online surveys at baseline and then 1, 3, 6, 12, 18, 24 and 36 months after their device implant. All participants will use our routine process of trial and implant. Reported adverse events are monitored throughout the study. Our primary outcome is change from baseline in pain intensity at 12 months.
RESULTS


We hypothesize that high-frequency SCS is more effective than burst SCS in improving pain, physical function and pain interference in participants with chronic low back and/or leg pain.
CONCLUSIONS


The pragmatic nature of our proposed trial enables us to recruit a larger participant cohort faster and to follow up these participants longer than currently published clinical trials.",2021,"We hypothesize that high-frequency SCS is more effective than burst SCS in improving pain, physical function and pain interference in participants with chronic low back and/or leg pain.
","['patients with chronic back and/or leg pain', 'Participants who are candidates for spinal cord stimulation are enrolled and screened', 'participants with chronic low back and/or leg pain']","['high-frequency and burst spinal cord stimulation', 'high-frequency and burst SCS', 'Stanford pragmatic effectiveness comparison (SPEC) protocol']","['pain intensity', ""pain intensity, pain catastrophizing scale, and questions about patients' pain experience and healthcare utilization"", 'pain, physical function and pain interference', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.212619,"We hypothesize that high-frequency SCS is more effective than burst SCS in improving pain, physical function and pain interference in participants with chronic low back and/or leg pain.
","[{'ForeName': 'Philip Anthony', 'Initials': 'PA', 'LastName': 'Petrou', 'Affiliation': 'Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Leong', 'Affiliation': 'Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, USA.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Mackey', 'Affiliation': 'Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, USA.'}, {'ForeName': 'Vafi', 'Initials': 'V', 'LastName': 'Salmasi', 'Affiliation': 'Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, USA. Electronic address: vsalmasi@stanford.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106324']
1233,33621613,Compensation and transfer effects of eating behavior change in daily life: Evidence from a randomized controlled trial.,"Pursuing specific eating goals may lead to the adoption of other healthy behaviors (transfer) or compensation with unhealthy behaviors. Previous research has mostly investigated such processes using non-experimental studies focusing on interindividual differences. To investigate transfer or compensation of eating behavior in daily life, we analyzed data from a 2 (eating goal: more fruit and vegetables [FV] vs. fewer unhealthy snacks) x 2 (intervention vs. control group) factorial randomized trial. Adopting a within-person perspective, we studied potential transfer and compensation 1) between different eating behaviors and physical activity (PA), and 2) in response to an eating behavior change intervention. Participants (N = 203) received either goals to increase FV intake or decrease unhealthy snack intake and completed a daily e-diary. Eating more unhealthy snacks predicted 0.16 less FV portions (β = -0.07; p < 0.001) and 18% less unhealthy snack intake the next day (p < 0.001). Eating more FV predicted 0.42 less FV portions the next day (β = -0.07; p < 0.001). Participants with the FV eating goal intervention decreased unhealthy snacks (p = 0.012) and PA (p = 0.019) by 8% compared to controls, respectively. Similar but non-significant patterns were observed for participants with the decreasing unhealthy snack goal intervention (p > 0.05). Results indicated both compensation and transfer processes in daily life. Relationships mostly occur within the same behavior and rather support compensatory effects. In turn, a behavior change intervention to promote FV intake potentially enhances non-assigned eating behaviors, indicating transfer, but may lower PA.",2021,"Participants with the FV eating goal intervention decreased unhealthy snacks (p = 0.012) and PA (p = 0.019) by 8% compared to controls, respectively.",[],"['fruit and vegetables [FV] vs. fewer unhealthy snacks', 'goals to increase FV intake or decrease unhealthy snack intake and completed a daily e-diary']",['unhealthy snacks'],[],"[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0453863', 'cui_str': 'Snack food'}]",,0.0915953,"Participants with the FV eating goal intervention decreased unhealthy snacks (p = 0.012) and PA (p = 0.019) by 8% compared to controls, respectively.","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Nigg', 'Affiliation': 'Karlsruhe Institute of Technology, Institute of Sports and Sports Science, Engler-Bunte-Ring 15, 76131, Karlsruhe, Germany. Electronic address: carina.nigg@partner.kit.edu.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Amrein', 'Affiliation': 'University of Zurich, Department of Psychology, Binzmühlestrasse 14 / Box 14, CH-8050, Zurich, Switzerland.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rackow', 'Affiliation': 'University of Stirling, Division of Psychology, Faculty of Natural Sciences, Stirling FK9 4LA, Scotland, UK.'}, {'ForeName': 'Urte', 'Initials': 'U', 'LastName': 'Scholz', 'Affiliation': 'University of Zurich, Department of Psychology, Binzmühlestrasse 14 / Box 14, CH-8050, Zurich, Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Inauen', 'Affiliation': 'University of Bern, Institute of Psychology, Bern, Fabrikstrasse 8, 3012, Bern, Switzerland.'}]",Appetite,['10.1016/j.appet.2021.105170']
1234,33627334,"Statin treatment and muscle symptoms: series of randomised, placebo controlled n-of-1 trials.","OBJECTIVE


To establish the effect of statins on muscle symptoms in people who had previously reported muscle symptoms when taking statins.
DESIGN


Series of randomised, placebo controlled n-of-1 trials.
SETTING


Primary care across 50 sites in the United Kingdom, December 2016 to April 2018.
PARTICIPANTS


200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms.
INTERVENTIONS


Participants were randomised to a sequence of six double blinded treatment periods (two months each) of atorvastatin 20 mg daily or placebo.
MAIN OUTCOME MEASURES


At the end of each treatment period, participants rated their muscle symptoms on a visual analogue scale (0-10). The primary analysis compared symptom scores in the statin and placebo periods.
RESULTS


151 participants provided symptoms scores for at least one statin period and one placebo period and were included in the primary analysis. Overall, no difference in muscle symptom scores was found between the statin and placebo periods (mean difference statin minus placebo -0.11, 95% confidence interval -0.36 to 0.14; P=0.40)). Withdrawals because of intolerable muscle symptoms were 18 participants (9%) during a statin period and 13 (7%) during a placebo period. Two thirds of those completing the trial reported restarting long term treatment with statins.
CONCLUSIONS


No overall effect of atorvastatin 20 mg on muscle symptoms compared with placebo was found in participants who had previously reported severe muscle symptoms when taking statins. Most people completing the trial intended to restart treatment with statins. N-of-1 trials can assess drug effects at the group level and guide individual treatment.
TRIAL REGISTRATION


ISRCTN30952488, EUDRACT 2016-000141-31, NCT02781064.",2021,No overall effect of atorvastatin 20 mg on muscle symptoms compared with placebo was found in participants who had previously reported severe muscle symptoms when taking statins.,"['200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms', 'Primary care across 50 sites in the United Kingdom, December 2016 to April 2018', 'people who had previously reported muscle symptoms when taking statins']","['placebo', 'Statin', 'atorvastatin 20 mg daily or placebo', 'atorvastatin', 'statins']","['muscle symptoms', 'severe muscle symptoms', 'intolerable muscle symptoms', 'muscle symptom scores', 'visual analogue scale', 'symptom scores', 'symptoms scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1379773', 'cui_str': 'atorvastatin 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",200.0,0.71197,No overall effect of atorvastatin 20 mg on muscle symptoms compared with placebo was found in participants who had previously reported severe muscle symptoms when taking statins.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Herrett', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Brack', 'Affiliation': 'Clinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Beaumont', 'Affiliation': 'Clinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Perkins', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thayne', 'Affiliation': 'Clinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Haleema', 'Initials': 'H', 'LastName': 'Shakur-Still', 'Affiliation': 'Clinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Clinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Prowse', 'Affiliation': 'Clinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Goldacre', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tjeerd', 'Initials': 'T', 'LastName': 'van Staa', 'Affiliation': 'Division of Informatics, Imaging and Data Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'MacDonald', 'Affiliation': 'MEMO Research, University of Dundee, Dundee, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': 'Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Wimborne', 'Affiliation': 'Bay Medical Practice, York Bridge Surgery, Morecambe, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Melrose', 'Affiliation': 'Bay Medical Practice, York Bridge Surgery, Morecambe, UK.'}, {'ForeName': 'Jayshireen', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': ""NIHR Clinical Research Network, Guy's Hospital, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brooks', 'Affiliation': 'Keats and Hampstead Group Practice, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'School of Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Patient member of the trial steering committee appointed by NIHR, London, UK.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Smeeth', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.n135']
1235,33627312,"Effect of screening by clinical breast examination on breast cancer incidence and mortality after 20 years: prospective, cluster randomised controlled trial in Mumbai.","OBJECTIVE


To test the efficacy of screening by clinical breast examination in downstaging breast cancer at diagnosis and in reducing mortality from the disease, when compared with no screening.
DESIGN


Prospective, cluster randomised controlled trial.
SETTING


20 geographically distinct clusters located in Mumbai, India, randomly allocated to 10 screening and 10 control clusters; total trial duration was 20 years (recruitment began in May 1998; database locked in March 2019 for analysis).
PARTICIPANTS


151 538 women aged 35-64 with no history of breast cancer.
INTERVENTIONS


Women in the screening arm (n=75 360) received four screening rounds of clinical breast examination (conducted by trained female primary health workers) and cancer awareness every two years, followed by five rounds of active surveillance every two years. Women in the control arm (n=76 178) received one round of cancer awareness followed by eight rounds of active surveillance every two years.
MAIN OUTCOME MEASURES


Downstaging of breast cancer at diagnosis and reduction in mortality from breast cancer.
RESULTS


Breast cancer was detected at an earlier age in the screening group than in the control group (age 55.18 (standard deviation 9.10)  v  56.50 (9.10); P=0.01), with a significant reduction in the proportion of women with stage III or IV disease (37% (n=220)  v  47% (n=271), P=0.001). A non-significant 15% reduction in breast cancer mortality was observed in the screening arm versus control arm in the overall study population (age 35-64; 20.82 deaths per 100 000 person years (95% confidence interval 18.25 to 23.97)  v  24.62 (21.71 to 28.04); rate ratio 0.85 (95% confidence interval 0.71 to 1.01); P=0.07). However, a post hoc subset analysis showed nearly 30% relative reduction in breast cancer mortality in women aged 50 and older (24.62 (20.62 to 29.76)  v  34.68 (27.54 to 44.37); 0.71 (0.54 to 0.94); P=0.02), but no significant reduction in women younger than 50 (19.53 (17.24 to 22.29)  v  21.03 (18.97 to 23.44); 0.93 (0.79 to 1.09); P=0.37). A 5% reduction in all cause mortality was seen in the screening arm versus the control arm, but it was not statistically significant (rate ratio 0.95 (95% confidence interval 0.81 to 1.10); P=0.49).
CONCLUSIONS


These results indicate that clinical breast examination conducted every two years by primary health workers significantly downstaged breast cancer at diagnosis and led to a non-significant 15% reduction in breast cancer mortality overall (but a significant reduction of nearly 30%in mortality in women aged ≥50). No significant reduction in mortality was seen in women younger than 50 years. Clinical breast examination should be considered for breast cancer screening in low and middle income countries.
TRIAL REGISTRATION


Clinical Trials Registry of India CTRI/2010/091/001205; ClinicalTrials.gov NCT00632047.",2021,A non-significant 15% reduction in breast cancer mortality was observed in the screening arm versus control arm in the overall study population (age 35-64; 20.82 deaths per 100 000 person years (95% confidence interval 18.25 to 23.97)  v  24.62 (21.71 to 28.04); rate ratio 0.85 (95% confidence interval 0.71 to 1.01); P=0.07).,"['breast cancer incidence and mortality after 20 years', 'Women in the screening arm (n=75\u2009360) received four screening rounds of clinical breast examination (conducted by trained female primary health workers) and cancer awareness every two years, followed by five rounds of active surveillance every two years', 'women younger than 50 years', '151\u2009538 women aged 35-64 with no history of breast cancer', '20 geographically distinct clusters located in Mumbai, India, randomly allocated to 10 screening and 10 control clusters; total trial duration was 20 years (recruitment began in May 1998; database locked in March 2019 for analysis', 'Women in the control arm (n=76\u2009178) received one round of cancer awareness followed by eight rounds of active surveillance every two years']",['screening by clinical breast examination'],"['mortality', 'breast cancer mortality overall', 'proportion of women with stage III or IV disease', 'Downstaging of breast cancer at diagnosis and reduction in mortality from breast cancer', 'cause mortality', 'breast cancer mortality']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0199850', 'cui_str': 'Examination of breast'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0557958', 'cui_str': 'Locked door procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0199850', 'cui_str': 'Examination of breast'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",151538.0,0.189094,A non-significant 15% reduction in breast cancer mortality was observed in the screening arm versus control arm in the overall study population (age 35-64; 20.82 deaths per 100 000 person years (95% confidence interval 18.25 to 23.97)  v  24.62 (21.71 to 28.04); rate ratio 0.85 (95% confidence interval 0.71 to 1.01); P=0.07).,"[{'ForeName': 'Indraneel', 'Initials': 'I', 'LastName': 'Mittra', 'Affiliation': 'Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Dr Ernest Borges Road, Parel, Mumbai 400 012, Maharashtra, India indraneel.mittra@gmail.com.'}, {'ForeName': 'Gauravi A', 'Initials': 'GA', 'LastName': 'Mishra', 'Affiliation': 'Centre for Cancer Epidemiology, Department of Preventive Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, India.'}, {'ForeName': 'Rajesh P', 'Initials': 'RP', 'LastName': 'Dikshit', 'Affiliation': 'Centre for Cancer Epidemiology, Tata Memorial Centre, Advanced Centre for Treatment, Research and Education in Cancer, Homi Bhabha National Institute, Kharghar, Mumbai, India.'}, {'ForeName': 'Subhadra', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Centre for Cancer Epidemiology, Department of Preventive Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, India.'}, {'ForeName': 'Vasundhara Y', 'Initials': 'VY', 'LastName': 'Kulkarni', 'Affiliation': 'Centre for Cancer Epidemiology, Department of Preventive Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, India.'}, {'ForeName': 'Heena Kauser A', 'Initials': 'HKA', 'LastName': 'Shaikh', 'Affiliation': 'Centre for Cancer Epidemiology, Department of Preventive Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, India.'}, {'ForeName': 'Surendra S', 'Initials': 'SS', 'LastName': 'Shastri', 'Affiliation': 'Centre for Cancer Epidemiology, Department of Preventive Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, India.'}, {'ForeName': 'Rohini', 'Initials': 'R', 'LastName': 'Hawaldar', 'Affiliation': 'Research Administration Council, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, India.'}, {'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, India.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Pramesh', 'Affiliation': 'Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Dr Ernest Borges Road, Parel, Mumbai 400 012, Maharashtra, India.'}, {'ForeName': 'Rajendra A', 'Initials': 'RA', 'LastName': 'Badwe', 'Affiliation': 'Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Dr Ernest Borges Road, Parel, Mumbai 400 012, Maharashtra, India.'}]",BMJ (Clinical research ed.),['10.1136/bmj.n256']
1236,33635382,Correction to: Protective effect of flumazenil infusion in severe acute benzodiazepine toxicity: a pilot randomized trial.,,2021,,['severe acute benzodiazepine toxicity'],['flumazenil infusion'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0040539', 'cui_str': 'TO'}]","[{'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",[],,0.0960357,,"[{'ForeName': 'Akram Sadat', 'Initials': 'AS', 'LastName': 'Razavizadeh', 'Affiliation': 'Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Zamani', 'Affiliation': 'Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Ziaeefar', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ebrahimi', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Hassanian-Moghaddam', 'Affiliation': 'Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. hassanian@sbmu.ac.ir.'}]",European journal of clinical pharmacology,['10.1007/s00228-021-03117-w']
1237,33639181,Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial.,"A registry-based follow-up of pregnancy data until the end of 2014 was conducted based on a community-randomized trial to assess human papillomavirus (HPV) vaccination strategies and a reference cohort from the same community with no intervention. Our objective was to determine whether prophylactic HPV vaccination (three doses of Cervarix® (AS04-HPV-16/18)-vaccine) affects preterm birth (PTB) rates. All identified 80,272 residents in 1992-95 birth cohorts in Finland were eligible for the trial and 20,513 of 39,420 (51.9%) females consented to participate. The final study population consisted of age-aligned 6226 HPV16/18 vaccinated females and 1770 HBV vaccinated (Engerix® B, hepatitis B-virus vaccine) females that did not receive HPV vaccine at the age of 18 from the 1992-93 birth cohorts, and 19,849 females from the 1990-91 non-vaccinated reference birth cohorts. We compared the rates of preterm (22 + 0-36 + 6 pregnancy weeks) and early preterm (22 + 0-31 + 6) per term (at least 37 + 0) singleton births among the HPV- and non-HPV-vaccinated women, using nationwide Medical Birth Registry data. We observed 409 singleton first pregnancies lasting at least 22 + 0 weeks among 6226 HPV-vaccinated and 1923 among 21,619 non-HPV-vaccinated women. In the first pregnancy the PTB rate was 13/409 (3.2%) among the HPV-vaccinated and 98/1923 (5.1%) among the non-HPV-vaccinated (OR 0.61, 95% CI 0.34-1.09). Early preterm birth rate was 0/409 (0%) in the HPV-vaccinated women and 20/1923 (1.0%) in the non-HPV-vaccinated women (p = 0.04). PTB rate, especially early PTB rate, was lower among the HPV-vaccinated women. Reduction of PTB incidence after prophylactic HPV vaccination would lead to public health benefits globally. Trial Registration:NCT00534638.",2021,Early preterm birth rate was 0/409,"['6226 HPV16/18 vaccinated females and 1770 HBV vaccinated (Engerix® B, hepatitis B-virus vaccine) females that did not receive HPV vaccine at the age of 18 from the 1992-93 birth cohorts, and 19,849 females from the 1990-91 non-vaccinated reference birth cohorts', 'All identified 80,272 residents in 1992-95 birth cohorts in Finland were eligible for the trial and 20,513 of 39,420 (51.9%) females consented to participate', '409 singleton first pregnancies lasting at least 22\xa0+\xa00\xa0weeks among 6226 HPV-vaccinated and 1923 among 21,619 non-HPV-vaccinated women']","['HPV- and non-HPV-vaccinated women', 'human papillomavirus (HPV) vaccination strategies', 'prophylactic HPV vaccination (three doses of Cervarix® (AS04-HPV-16/18)-vaccine']","['PTB rate, especially early PTB rate', 'preterm birth (PTB) rates', 'Early preterm birth rate', 'Preterm birth rate', 'PTB rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456592', 'cui_str': '1992'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0860096', 'cui_str': 'Primigravida'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C1721789', 'cui_str': 'Cervarix'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.226184,Early preterm birth rate was 0/409,"[{'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Kalliala', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, 00290 Helsinki, Finland; Department of Surgery & Cancer, Institute of Reproductive and Developmental Biology, Imperial College London, Hammersmith Campus, Du Cane Road, London W12 0NN, UK. Electronic address: ilkka.kalliala@hus.fi.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Fican Mid, P.O. Box 100, Tampere University, FI-33014 Tampere, Finland. Electronic address: tiina.eriksson@tuni.fi.'}, {'ForeName': 'Karoliina', 'Initials': 'K', 'LastName': 'Aro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, 00290 Helsinki, Finland. Electronic address: karoliina.aro@helsinki.fi.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hokkanen', 'Affiliation': 'Fican Mid, P.O. Box 100, Tampere University, FI-33014 Tampere, Finland. Electronic address: mari.hokkanen@tuni.fi.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Deutsches Krebsforschungszentrum, Infection & Cancer Epidemiology, Im Neuenheimer Feld 242, D-69120 Heidelberg, Germany; Karolinska Institute, Department of Lab Medicine, Alfred Nobels Allé 8, 8th Floor, 141 52 Huddinge, Sweden. Electronic address: matti.lehtinen@tuni.fi.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Gissler', 'Affiliation': 'THL Finnish Institute for Health and Welfare, Information Services Department, Mannerheimintie 166, 00300 Helsinki, Finland; Karolinska Institute, Department of Neurobiology, Care Sciences and Society, Zanderska huset, Alfred Nobels Allé 23, 141 83 Huddinge, Sweden. Electronic address: mika.gissler@thl.fi.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Nieminen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, 00290 Helsinki, Finland. Electronic address: pekka.nieminen@hus.fi.'}]",Preventive medicine,['10.1016/j.ypmed.2021.106473']
1238,33640458,"Effects of applying external cold and vibration to children during vaccination on pain, fear and anxiety.","OBJECTIVES


This study aimed to evaluate the effectiveness of the application of external cold and vibration on children experiencing pain, fear and anxiety during vaccination.
DESIGN AND SETTING


This randomized controlled, experimental study was conducted in primary schools selected within the scope of school immunization days by a community health center. The study population consisted of first grade students who were scheduled to receive a booster dose of diphtheria, tetanus, and acellular pertussis, inactivated poliovirus vaccine (DTaP-IPV) vaccine within the scope of the school immunization program of the said community health center and the study sample consisted of 90 students (experimental: 45, control:45).
MAIN OUTCOME MEASURES


In the experimental group, a device that applies external cold and vibration (Buzzy®) was placed on the injection site for 30 s before administration of the vaccine. The device was then placed above the injection site and kept there during the injection. No intervention was made during the injections in children included in the control group. The same nurse administered the injections in the experimental and control groups.
RESULTS


In the current study, it was found that there was a statistically significant difference between the experimental group and the control group in terms of the children's pain, the nurse's pain, the nurse's fear and the children's anxiety (p < 0.05), but no statistically significant difference in terms of the children's fear (p > 0.05).
CONCLUSIONS


It was concluded that applying external cold and vibration during vaccination has an effect on the level of children's pain and anxiety.",2021,"This study aimed to evaluate the effectiveness of the application of external cold and vibration on children experiencing pain, fear and anxiety during vaccination.
","['said community health center and the study sample consisted of 90 students (experimental: 45, control:45', 'primary schools selected within the scope of school immunization days by a community health center', 'children experiencing pain, fear and anxiety during vaccination']","['device that applies external cold and vibration (Buzzy®', 'diphtheria, tetanus, and acellular pertussis, inactivated poliovirus vaccine (DTaP-IPV) vaccine', 'external cold and vibration']","['pain, fear and anxiety', ""children's pain, the nurse's pain, the nurse's fear and the children's anxiety"", ""children's fear""]","[{'cui': 'C0080151', 'cui_str': 'Simian AIDS'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",90.0,0.0269343,"This study aimed to evaluate the effectiveness of the application of external cold and vibration on children experiencing pain, fear and anxiety during vaccination.
","[{'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Sapçi', 'Affiliation': 'Gaziantep 25 Aralık State Hospital, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Bilsin Kocamaz', 'Affiliation': 'Gaziantep University, Faculty of Health Sciences, Department of Nursing, Turkey. Electronic address: elifbilsin-86@hotmail.com.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Gungormus', 'Affiliation': 'Gaziantep University, Faculty of Health Sciences, Department of Nursing, Turkey.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102688']
1239,33639517,Therapeutic effects of auricular point acupressure on the recovery of patients after pterygium surgery: A pilot study.,"BACKGROUND


and purpose: Postoperative pain in the pterygium of the eye seriously affects patient recovery. This study was conducted to assess the efficacy of auricular point acupressure treatment on post-operative recovery in patients after pterygium surgery.
MATERIALS AND METHODS


This was a pilot, randomized controlled study. A total of 60 patients (60 eyes) were randomly assigned to two groups. After pterygium surgery, the auricular group was treated using ear acupressure (acupressure points with Cowherb seeds) and the control group was treated using sham auricular therapy (acupressure points without Cowherb seeds). Both groups were treated for one week. Outcome measures included pain score, corneal epithelial score, best-corrected visual acuity, and recurrence rate.
RESULTS


Fifty-three patients completed the study. The mean pain scores and corneal epithelial scores were significantly reduced over time in the auricular group compared with those in the control group (p < 0.05). The time-group interaction for both pain scores and corneal epithelial scores was significant between the two groups (p < 0.05). Simple main effect analysis showed the mean pain scores in the auricular group were significantly lower at each time point (the first 2-h, the first day, the third day and the first week, p < 0.05) than the control group. Mean corneal epithelial scores of the auricular group were significantly lower on the first day and third day respectively than the control group (p < 0.05). There was no significant difference in the best-corrected visual acuity or recurrence rate between the two groups (p > 0.05).
CONCLUSION


Auricular point acupressure accelerates corneal epithelium reconstruction and suppresses postoperative pain, making it an ideal adjunct treatment for postoperative pterygium recovery.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR2000032490 on http://www.chictr.org.cn/.",2021,Mean corneal epithelial scores of the auricular group were significantly lower on the first day and third day respectively than the control group (p < 0.05).,"['60 patients (60 eyes', 'Fifty-three patients completed the study', 'patients after pterygium surgery']","['auricular point acupressure', 'ear acupressure (acupressure points with Cowherb seeds) and the control group was treated using sham auricular therapy (acupressure points without Cowherb seeds', 'Auricular point acupressure', 'auricular point acupressure treatment']","['Mean corneal epithelial scores', 'pain scores and corneal epithelial scores', 'mean pain scores and corneal epithelial scores', 'pain score, corneal epithelial score, best-corrected visual acuity, and recurrence rate', 'mean pain scores', 'best-corrected visual acuity or recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",60.0,0.0907746,Mean corneal epithelial scores of the auricular group were significantly lower on the first day and third day respectively than the control group (p < 0.05).,"[{'ForeName': 'Lusha', 'Initials': 'L', 'LastName': 'Cen', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Youdian Rd.54th, Hangzhou, 310006, China. Electronic address: 201811010712026@zcmu.edu.cn.'}, {'ForeName': 'Cao', 'Initials': 'C', 'LastName': 'Yi', 'Affiliation': 'Department of Dermatology, The First Affiliated Hospital of Zhejiang Chinese Medical University, China. Electronic address: 19873034@zcmu.edu.cn.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101339']
1240,33639454,Effect of Kegel exercises on the prevention of urinary and fecal incontinence in patients with prostate cancer undergoing radiotherapy.,"PURPOSE


This is a nonrandomized experimental study conducted to evaluate the effect of Kegel exercises on the prevention of urinary and fecal incontinence in prostate cancer patients undergoing radiotherapy.
METHOD


The study was conducted with 30 patients in the intervention group (IG) and 30 patients in the control group (CG). Data were collected using a patient information form, CTCAE, EORTC QLQ-C30, and a follow-up form reporting weekly Kegel exercises. Before radiotherapy, the IG was provided with Kegel exercise training via visual training material; exercises were performed under the supervision of the researcher, and the exercise pamphlet was handed out. During radiotherapy, weekly follow-ups were performed by face-to-face contact or phone calls. No similar application was provided to the CG. CTCAE and EORTC QLQ-C30 were evaluated three times (baseline, 4th and 8th weeks of exercises).
RESULTS


At the end of the 4th week of exercises, 1st-grade urinary incontinence (UI) developed in the IG (10%) and in the CG (13.3%). At the end of the 8th week, 2nd-grade UI (3.3%) developed in the IG and 1st-grade (10%) and 2nd-grade UI (6.7%) developed in the CG. Fecal incontinence developed in neither group. At the end of the intervention, there was a significant improvement in Role, Social function and Global Health Status in the IG compared with the 4th week scores. In addition, less Fatigue, Diarrhea, Anorexia and Constipation scores were found compared with the baseline.
CONCLUSION


Kegel exercises can be recommended as an approach in the prevention of urinary incontinence and to improve quality of life.",2021,"At the end of the intervention, there was a significant improvement in Role, Social function and Global Health Status in the IG compared with the 4th week scores.","['patients with prostate cancer undergoing radiotherapy', 'prostate cancer patients undergoing radiotherapy', '30 patients in the intervention group (IG) and 30 patients in the control group (CG']","['Kegel exercise training via visual training material; exercises', 'Kegel exercises']","['CTCAE and EORTC QLQ-C30', 'urinary and fecal incontinence', 'Fecal incontinence', 'Role, Social function and Global Health Status', 'quality of life', 'Fatigue, Diarrhea, Anorexia and Constipation scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0200244', 'cui_str': 'Visual training'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0178002,"At the end of the intervention, there was a significant improvement in Role, Social function and Global Health Status in the IG compared with the 4th week scores.","[{'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Urvaylıoğlu', 'Affiliation': 'Yozgat Bozok University Faculty of Health Sciences, Department of Medical Nursing, Yozgat, Turkey. Electronic address: aydan.urvaylioglu@yobu.edu.tr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kutlutürkan', 'Affiliation': 'Ankara University Faculty of Nursing, Department of Medical Nursing, Ankara, Turkey.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kılıç', 'Affiliation': 'Gazi University Faculty of Medicine, Department of Radiation Oncology, Ankara, Turkey.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2021.101913']
1241,33639559,The combination of feedback and modeling in online simulation training of child sexual abuse interviews improves interview quality in clinical psychologists.,"BACKGROUND


Previous research has shown the effectiveness of simulation training using avatars paired with feedback in improving child sexual abuse interview quality. However, it has room for improvement.
OBJECTIVE


The present study aimed to determine if the combination of two interventions, feedback and modeling, would further improve interview quality compared to either intervention alone.
PARTICIPANTS


Thirty-two clinical psychologists were randomly assigned to a feedback, modeling, or the combination of feedback and modeling group.
METHODS


The participants conducted five simulated child sexual abuse interviews online while receiving the intervention(s) corresponding to their allocated group. Feedback was provided after each interview and consisted of the outcome of the alleged cases and comments on the quality of the questions asked in the interviews. Modeling was provided after the 1st interview and consisted of learning points and videos illustrating good and bad questioning methods.
RESULTS


The proportion of recommended questions improved over the five interviews when considering all groups combined. The combined intervention (vs. feedback alone) showed a higher proportion of recommended questions from the 2nd interview onward while the difference between the combined intervention and modeling alone and the difference between the modeling alone and feedback alone were mostly not significant. The number of correct details were affected in the same way. No significant differences in the number of incorrect details were found.
CONCLUSIONS


The results show that the combination of feedback and modeling achieves improvement greater than that of feedback alone.",2021,The combined intervention (vs. feedback alone) showed a higher proportion of recommended questions from the 2nd interview onward while the difference between the combined intervention and modeling alone and the difference between the modeling alone and feedback alone were mostly not significant.,"['child sexual abuse interviews improves interview quality in clinical psychologists', 'Thirty-two clinical psychologists']","['feedback, modeling, or the combination of feedback and modeling group', 'feedback and modeling in online simulation training']","['number of incorrect details', 'number of correct details', 'interview quality', 'child sexual abuse interview quality']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0237412', 'cui_str': 'Clinical psychologist'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}]",,0.0193637,The combined intervention (vs. feedback alone) showed a higher proportion of recommended questions from the 2nd interview onward while the difference between the combined intervention and modeling alone and the difference between the modeling alone and feedback alone were mostly not significant.,"[{'ForeName': 'Shumpei', 'Initials': 'S', 'LastName': 'Haginoya', 'Affiliation': 'Faculty of Arts and Sciences, NYU Shanghai, Shanghai, China; Life Skill Education Institute, Graduate School of Hosei University, Tokyo, Japan. Electronic address: shumpei.haginoya@nyu.edu.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Forensic Science Laboratory, Hokkaido Prefectural Police Headquarters, Hokkaido, Japan.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Santtila', 'Affiliation': 'Faculty of Arts and Sciences, NYU Shanghai, Shanghai, China.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105013']
1242,33647827,Integrating cognitive dissonance and social consensus to reduce weight stigma.,"Weight stigma is pervasive and has a range of deleterious effects. Among the most promising approaches for modifying this form of stigma are cognitive dissonance and social consensus. Due to their theoretical connection, this study tested the effects of an experimental manipulation of cognitive dissonance blended with social consensus for targeting weight stigma. It also added to research investigating the effects of cognitive dissonance on weight stigma by investigating a broader range of stigma measures. Participants were university students aged 18-35 years (N = 98) who were randomly allocated to one of four experimental conditions: blended cognitive dissonance, standard cognitive dissonance, blended control or standard control. Stigma measures included the perceived characteristics of, affective reactions towards, social avoidance of, and blameworthiness attributed to a higher-weight individual, and general weight stigma. Results showed that those in the cognitive dissonance conditions reported significantly lower weight stigma than those in the non-dissonance, control conditions. Moreover, those in the blended cognitive dissonance condition with higher in-group identification reported less negative affective reactions than those with lower in-group identification. The results provide consistent support for cognitive dissonance as an approach for reducing weight stigma and some additive support for an integrated cognitive dissonance and social consensus approach.",2021,"Results showed that those in the cognitive dissonance conditions reported significantly lower weight stigma than those in the non-dissonance, control conditions.",['Participants were university students aged 18-35 years (N = 98'],"['blended cognitive dissonance, standard cognitive dissonance, blended control or standard control']","['negative affective reactions', 'perceived characteristics of, affective reactions towards, social avoidance of, and blameworthiness attributed to a higher-weight individual, and general weight stigma', 'weight stigma']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",98.0,0.0235066,"Results showed that those in the cognitive dissonance conditions reported significantly lower weight stigma than those in the non-dissonance, control conditions.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Meaney', 'Affiliation': 'Research School of Psychology, Australian National University, Canberra, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rieger', 'Affiliation': 'Research School of Psychology, Australian National University, Canberra, Australia. Electronic address: Elizabeth.Rieger@anu.edu.au.'}]",Body image,['10.1016/j.bodyim.2021.02.003']
1243,33647748,Evaluation of different coatings of the tibial tray in uncemented total knee arthroplasty. A randomized controlled trial with 5 years follow-up with RSA and DEXA.,"BACKGROUND


Regenerex® is a porous titanium construct with a 3D interconnecting pore structure and biomechanical characteristics close to that of normal trabecular bone. This study aimed to compare the Regenerex (VR) to the non-interconnecting pore structure Porous Plasma Spray (VP) on tibial implants for total knee arthroplasty (TKA) at 5 years.
METHODS


We enrolled and randomized 61 patients (mean age = 63(49-71) years, Female/Male = 35/26) who were planned for an uncemented Vanguard TKA (Biomet, Warsaw, Indiana, USA) to receive either a VR or a VP coated tibial component (31/29). We performed radiostereometric analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) postoperatively, and at three, six, 12, 24 and 60 months with measurements of migration. In total 55 patients attended the 5-year follow-up.
RESULTS


One patient died and four were reoperated during the 60-months period; none due to aseptic loosening. All reoperations were in the VR-group. The mean (range) 60-months MTPM was 1.4 mm (0.5-3.7) for the VP-group and 1.8 mm (0.4-4.9) for the VR-group (p = 0.8). The 24 to 60-months mean (range) MTPM was -0.3 mm (-5 to 1.24) in the VP-group and 0.2 mm (-0.4 to 3.5) in the VR-group (p = 0.8).
CONCLUSION


We did not find any statistically significant differences between the VP- and VR-group and both groups show recognizable migration. We will continue to follow the groups for years to come.",2021,We did not find any statistically significant differences between the VP- and VR-group and both groups show recognizable migration.,"['uncemented total knee arthroplasty', 'In total 55 patients attended the 5-year follow-up', 'tibial implants for total knee arthroplasty (TKA) at 5\xa0years', 'We enrolled and randomized 61 patients (mean age\xa0', '63(49-71) years, Female/Male\xa0=\xa035/26) who were planned for an uncemented Vanguard TKA (Biomet, Warsaw, Indiana, USA) to receive either a VR or a VP coated tibial component (31/29']","['Regenerex (VR) to the non-interconnecting pore structure Porous Plasma Spray (VP', 'tibial tray', 'RSA and DEXA']",['aseptic loosening'],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0085898', 'cui_str': 'Biomet'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}]",61.0,0.0388195,We did not find any statistically significant differences between the VP- and VR-group and both groups show recognizable migration.,"[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dyreborg', 'Affiliation': 'Department of Orthopaedic Surgery, Centre of Head and Orthopaedics, Rigshospitalet, 2100 Copenhagen Ø, Denmark. Electronic address: karendyreborg@hotmail.com.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Winther', 'Affiliation': 'Department of Orthopaedic Surgery, Centre of Head and Orthopaedics, Rigshospitalet, 2100 Copenhagen Ø, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'Department of Orthopaedic Surgery, Clinic of Hip, Knee and Foot Surgery, Gentofte and Herlev Hospital, 2900 Hellerup, Denmark. Electronic address: thomas.lind@regionh.dk.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Flivik', 'Affiliation': 'Clinical Sciences, Lund University, Department of Orthopaedics, Skåne University Hospital, 221 85 Lund, Sweden. Electronic address: gunnar.flivik@med.lu.se.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mørk Petersen', 'Affiliation': 'Department of Orthopaedic Surgery, Centre of Head and Orthopaedics, Rigshospitalet, 2100 Copenhagen Ø, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. Electronic address: michael.moerk.petersen@regionh.dk.'}]",The Knee,['10.1016/j.knee.2021.02.002']
1244,33619120,"Kidney, Cardiovascular, and Safety Outcomes of Canagliflozin according to Baseline Albuminuria: A CREDENCE Secondary Analysis.","BACKGROUND AND OBJECTIVES


The kidney protective effects of renin-angiotensin system inhibitors are greater in people with higher levels of albuminuria at treatment initiation. Whether this applies to sodium-glucose cotransporter 2 (SGLT2) inhibitors is uncertain, particularly in patients with a very high urine albumin-to-creatinine ratio (UACR; ≥3000 mg/g). We examined the association between baseline UACR and the effects of the SGLT2 inhibitor, canagliflozin, on efficacy and safety outcomes in the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) randomized controlled trial.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


The study enrolled 4401 participants with type 2 diabetes, an eGFR of 30 to <90 ml/min per 1.73 m 2 , and UACR of >300 to 5000 mg/g. Using Cox proportional hazards regression, we examined the relative and absolute effects of canagliflozin on kidney, cardiovascular, and safety outcomes according to a baseline UACR of ≤1000 mg/g ( n =2348), >1000 to <3000 mg/g ( n =1547), and ≥3000 mg/g ( n =506). In addition, we examined the effects of canagliflozin on UACR itself, eGFR slope, and the intermediate outcomes of glycated hemoglobin, body weight, and systolic BP.
RESULTS


Overall, higher UACR was associated with higher rates of kidney and cardiovascular events. Canagliflozin reduced efficacy outcomes for all UACR levels, with no evidence that relative benefits varied between levels. For example, canagliflozin reduced the primary composite outcome by 24% (hazard ratio [HR], 0.76; 95% confidence interval [95% CI], 0.56 to 1.04) in the lowest UACR subgroup, 28% (HR, 0.72; 95% CI, 0.56 to 0.93) in the UACR subgroup >1000 to <3000 mg/g, and 37% (HR, 0.63; 95% CI, 0.47 to 0.84) in the highest subgroup ( P   heterogeneity =0.55). Absolute risk reductions for kidney outcomes were greater in participants with higher baseline albuminuria; the number of primary composite events prevented across ascending UACR categories were 17 (95% CI, 3 to 38), 45 (95% CI, 9 to 81), and 119 (95% CI, 35 to 202) per 1000 treated participants over 2.6 years ( P   heterogeneity =0.02). Rates of kidney-related adverse events were lower with canagliflozin, with a greater relative reduction in higher UACR categories.
CONCLUSIONS


Canagliflozin safely reduces kidney and cardiovascular events in people with type 2 diabetes and severely increased albuminuria. In this population, the relative kidney benefits were consistent over a range of albuminuria levels, with greatest absolute kidney benefit in those with an UACR ≥3000 mg/g.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


ClinicalTrials.gov: CREDENCE, NCT02065791.
PODCAST


This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2021_02_22_CJN15260920_final.mp3.",2021,"Absolute risk reductions for kidney outcomes were greater in participants with higher baseline albuminuria; the number of primary composite events prevented across ascending UACR categories were 17 (95% CI, 3 to 38), 45 (95% CI, 9 to 81), and 119 (95% CI, 35 to 202) per 1000 treated participants over 2.6 years ( P   heterogeneity =0.02).","['Diabetes with Established Nephropathy Clinical Evaluation', 'people with higher levels of albuminuria at treatment initiation', 'patients with a very high urine albumin-to-creatinine ratio (UACR; ≥3000 mg/g', 'people with type 2 diabetes', '4401 participants with type 2 diabetes, an eGFR of 30 to <90 ml/min per 1.73 m 2 , and UACR of >300 to 5000 mg']","['canagliflozin', 'sodium-glucose cotransporter 2 (SGLT2) inhibitors', 'renin-angiotensin system inhibitors', 'Canagliflozin', 'PODCAST', 'SGLT2 inhibitor, canagliflozin']","['Rates of kidney-related adverse events', 'rates of kidney and cardiovascular events', 'ascending UACR categories', 'kidney, cardiovascular, and safety outcomes', 'Kidney, Cardiovascular, and Safety Outcomes of Canagliflozin according to Baseline Albuminuria', 'kidney and cardiovascular events', 'UACR itself, eGFR slope, and the intermediate outcomes of glycated hemoglobin, body weight, and systolic BP', 'efficacy and safety outcomes', 'albuminuria']","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319610', 'cui_str': '5000'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",4401.0,0.277866,"Absolute risk reductions for kidney outcomes were greater in participants with higher baseline albuminuria; the number of primary composite events prevented across ascending UACR categories were 17 (95% CI, 3 to 38), 45 (95% CI, 9 to 81), and 119 (95% CI, 35 to 202) per 1000 treated participants over 2.6 years ( P   heterogeneity =0.02).","[{'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Hiddo J', 'Initials': 'HJ', 'LastName': 'Lambers Heerspink', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Carinna', 'Initials': 'C', 'LastName': 'Hockham', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia chockham@georgeinstitute.org.au.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Nephrology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Charytan', 'Affiliation': 'Nephrology Division, New York University School of Medicine and New York University Langone Medical Center, New York, New York.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, Department of Population Health Sciences, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jing-Wei', 'Initials': 'JW', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Oh', 'Affiliation': 'Metabolism, Janssen Research and Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute of Medical Research, Sydney Medical School, University of Sydney, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Renal Medicine, University College London Medical School, London, United Kingdom.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.15260920']
1245,33618051,Interval versus constant-load exercise training in adults with Cystic Fibrosis.,"BACKGROUND


The efficacy of interval exercise (IE) compared to constant-load exercise (CLE) training remains unsettled in adults with Cystic Fibrosis (CF).
METHODS


Twenty-four adults with CF were randomised to 30-min IE (100 % peak work capacity (WRpeak) for 30-s alternated with 40 % WRpeak for 30-s; n = 12) or 30-min CLE (70 % WRpeak; n = 12) training, 3 times weekly, for 12 weeks. Isometric quadriceps muscle strength was assessed using a strain gauge Myometer.
RESULTS


The magnitude of improvement in quadriceps muscle strength was greater (p = 0.037) in the IE (by 32 ± 13 Nm) compared to the CLE (by 23 ± 12 Nm) groups. Maximum inspiratory and expiratory mouth pressures were significantly improved only in the IE group (by 30 ± 10 cmH 2 O; p = 0.009 and 13 ± 4 cmH 2 O; p = 0.007, respectively). Arterial oxygen saturation during training was higher (p = 0.002) for IE (94 ± 1%) compared to CLE (91 ± 1%), whereas dyspnoea scores were lower (p = 0.001) for IE (3.8 ± 0.7) compared to CLE (5.9 ± 0.8) CONCLUSIONS: IE is superior to CLE in improving peripheral and respiratory muscle strength and preferable to CLE because it is associated with lower exercise-induced arterial oxygen desaturation and breathlessness.",2021,"Arterial oxygen saturation during training was higher (p = 0.002) for IE (94 ± 1%) compared to CLE (91 ± 1%), whereas dyspnoea scores were lower (p = 0.001) for IE (3.8 ± 0.7) compared to CLE (5.9 ± 0.8)","['adults with Cystic Fibrosis', 'adults with Cystic Fibrosis (CF', 'Twenty-four adults with CF']","['Interval versus constant-load exercise training', '30-min IE (100% peak work capacity (WRpeak) for 30-s alternated with 40% WRpeak for 30-s; n\u2009=\u200912) or 30-min CLE', 'CLE', 'interval exercise (IE) compared to constant-load exercise (CLE) training']","['quadriceps muscle strength', 'dyspnoea scores', 'Arterial oxygen saturation', 'Isometric quadriceps muscle strength', 'Maximum inspiratory and expiratory mouth pressures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",24.0,0.0220536,"Arterial oxygen saturation during training was higher (p = 0.002) for IE (94 ± 1%) compared to CLE (91 ± 1%), whereas dyspnoea scores were lower (p = 0.001) for IE (3.8 ± 0.7) compared to CLE (5.9 ± 0.8)","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kaltsakas', 'Affiliation': 'Lane Fox Respiratory Service, Guy\'s and St Thomas\' NHS Foundation Trust, London, UK; Centre of Human and Applied Physiological Sciences, Faculty of Life Sciences and Medicine, King\'s College London, London, UK; 1st Respiratory Medicine Department, ""Sotiria"" Hospital for Diseases of the Chest, National and Kapodistrian University of Athens Medical School, Athens, Greece. Electronic address: Georgios.Kaltsakas@gstt.nhs.uk.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Chynkiamis', 'Affiliation': '1st Respiratory Medicine Department, ""Sotiria"" Hospital for Diseases of the Chest, National and Kapodistrian University of Athens Medical School, Athens, Greece; Thorax Research Foundation, Centre of Intensive Care and Emergency Thoracic Medicine, Athens, Greece; Faculty of Health and Life Sciences, Department of Sport, Exercise and Rehabilitation, Northumbria University Newcastle, Newcastle Upon Tyne, UK. Electronic address: nikchy@thorax.org.gr.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Anastasopoulos', 'Affiliation': '1st Respiratory Medicine Department, ""Sotiria"" Hospital for Diseases of the Chest, National and Kapodistrian University of Athens Medical School, Athens, Greece. Electronic address: n.anastasopoulos1@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zeliou', 'Affiliation': 'Adult Cystic Fibrosis Unit, ""Sismanogleion"" General Hospital of Attica, Athens, Greece. Electronic address: p.zeliou@gmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Karapatoucha', 'Affiliation': 'Adult Cystic Fibrosis Unit, ""Sismanogleion"" General Hospital of Attica, Athens, Greece. Electronic address: karapvicky@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kotsifas', 'Affiliation': 'Adult Cystic Fibrosis Unit, ""Sismanogleion"" General Hospital of Attica, Athens, Greece. Electronic address: kotsifaskostas@yahoo.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Diamantea', 'Affiliation': 'Adult Cystic Fibrosis Unit, ""Sismanogleion"" General Hospital of Attica, Athens, Greece. Electronic address: fdiamantea@gmail.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Inglezos', 'Affiliation': 'Adult Cystic Fibrosis Unit, ""Sismanogleion"" General Hospital of Attica, Athens, Greece. Electronic address: ilinglezos@gmail.com.'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Koulouris', 'Affiliation': '1st Respiratory Medicine Department, ""Sotiria"" Hospital for Diseases of the Chest, National and Kapodistrian University of Athens Medical School, Athens, Greece. Electronic address: koulnik@med.uoa.gr.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vogiatzis', 'Affiliation': '1st Respiratory Medicine Department, ""Sotiria"" Hospital for Diseases of the Chest, National and Kapodistrian University of Athens Medical School, Athens, Greece; Faculty of Health and Life Sciences, Department of Sport, Exercise and Rehabilitation, Northumbria University Newcastle, Newcastle Upon Tyne, UK. Electronic address: ioannis.vogiatzis@northumbria.ac.uk.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2021.103643']
1246,33618033,Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol.,"OBJECTIVE


Juvenile-onset fibromyalgia (JFM) is a chronic debilitating pain condition that negatively impacts physical, social and academic functioning. Cognitive-behavioral therapy (CBT) is beneficial in reducing functional disability among adolescents with JFM but has only a modest impact on pain reduction and does not improve physical exercise participation. This randomized controlled trial (RCT) aims to test whether a novel intervention that combines CBT with specialized neuromuscular exercise training (the Fibromyalgia Integrative Training program for Teens ""FIT Teens"") is superior to CBT alone or a graded aerobic exercise (GAE) program.
DESIGN/METHODS


This 3-arm multi-site RCT will examine the efficacy of the FIT Teens intervention in reducing functional disability (primary outcome) and pain intensity (secondary outcome), relative to CBT or GAE. All interventions are 8-weeks (16 sessions) in duration and are delivered in small groups of 4-6 adolescents with JFM. A total of 420 participants are anticipated to be enrolled across seven sites with approximately equal allocation to each treatment arm. Functional disability and average pain intensity in the past week will be assessed at baseline, post-treatment and at 3-, 6-, 9- and 12-month follow-up. The 3-month follow-up is the primary endpoint to evaluate treatment efficacy; longitudinal assessments will determine maintenance of treatment gains. Changes in coping, fear of movement, biomechanical changes and physical fitness will also be evaluated.
CONCLUSIONS


This multi-site RCT is designed to evaluate whether the combined FIT Teens intervention will have significantly greater effects on disability and pain reduction than CBT or GAE alone for youth with JFM. Clinical trials.gov registration: NCT03268421.",2021,All interventions are 8-weeks,"['Teens ""FIT Teens', 'adolescents with JFM', '420 participants are anticipated to be enrolled across seven sites with approximately equal allocation to each treatment arm', 'adolescents with juvenile fibromyalgia - Study design and protocol', 'Juvenile-onset fibromyalgia (JFM']","['fibromyalgia integrative training (FIT teens', 'CBT with specialized neuromuscular exercise training (the Fibromyalgia Integrative Training program', 'CBT alone or a graded aerobic exercise (GAE) program', 'Cognitive-behavioral therapy (CBT']","['Functional disability and average pain intensity', 'functional disability', 'disability and pain reduction', 'Changes in coping, fear of movement, biomechanical changes and physical fitness', 'pain intensity (secondary outcome), relative to CBT or GAE']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]",420.0,0.0985581,All interventions are 8-weeks,"[{'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Kashikar-Zuck', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. Electronic address: susmita.kashikar-zuck@cchmc.org.""}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Briggs', 'Affiliation': 'Sports Medicine Research Institute, and Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bout-Tabaku', 'Affiliation': 'Department of Pediatric Medicine, Sidra Medicine, Doha, Qatar; Weill Cornell Medicine, Doha, Qatar.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Connelly', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Hospital, Kansas City, KS, USA.""}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Daffin', 'Affiliation': ""Department of Pediatrics, University of Louisville, School of Medicine, Norton Children's Hospital, Louisville, KY, USA.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Guite', 'Affiliation': 'Department of Pediatrics and Nursing, University of Connecticut, Hartford, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ittenbach', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Deirdre E', 'Initials': 'DE', 'LastName': 'Logan', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesia, Boston Children's Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Lynch-Jordan', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Myer', 'Affiliation': 'Sports Performance and Research Center, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Ounpuu', 'Affiliation': ""Center for Motion Analysis, Connecticut Children's Medical Center, Department of Orthopedic Surgery, University of Connecticut School of Medicine, Hartford, CT, USA.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peugh', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Schikler', 'Affiliation': ""Department of Pediatrics, University of Louisville, School of Medicine, Norton Children's Hospital, Louisville, KY, USA.""}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Sport Sciences, Waseda University, Tokyo, Japan; The Micheli Center for Sports Injury Prevention, Waltham, MA, USA.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Stinson', 'Affiliation': 'Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, Toronto, Canada; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Tracy V', 'Initials': 'TV', 'LastName': 'Ting', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Division of Sports Medicine, SPORT Center, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Williams', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Zempsky', 'Affiliation': ""Department of Pediatrics and Nursing, University of Connecticut, Hartford, CT, USA; Division of Pain and Palliative Medicine, Connecticut Children's Medical Center, Hartford, CT, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106321']
1247,33621782,"A preliminary study on the effects of the Peer-Led Self-Management (PLSM) program on self-efficacy, self-management, and physiological measures in older adults with diabetes: a block randomized controlled trial.","This study explored the effects and feasibility of the peer-led self-management (PLSM) program for older adults with diabetes. Twenty-eight participants from 10 communities in southern Taiwan were randomly allocated to experimental and control groups. Those in the experimental group were enrolled in a 4-week PLSM program; those in the control group received a self-management manual and continued their usual clinical care. Improvement in outcomes (self-efficacy, self-management, physiological measures) over time in both groups were evaluated. After PLSM intervention, self-efficacy and self-management had improved; body weight and body mass index measures of the experimental group at post-test 1 and post-test 2 were significantly lower than those of the control group (p < .001); HbA1c, total cholesterol, and triglycerides at post-test 2 were also significantly better (p < .001; p = .03; p = .02). We discuss preliminary benefits and feasibility of the PLSM program.",2021,This study explored the effects and feasibility of the peer-led self-management (PLSM) program for older adults with diabetes.,"['Twenty-eight participants from 10 communities in southern Taiwan', 'older adults with diabetes']","['self-management manual and continued their usual clinical care', 'Peer-Led Self-Management (PLSM) program', 'peer-led self-management (PLSM) program']","['HbA1c, total cholesterol, and triglycerides', 'outcomes (self-efficacy, self-management, physiological measures', ' body weight and body mass index measures', 'self-efficacy, self-management, and physiological measures']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",28.0,0.018694,This study explored the effects and feasibility of the peer-led self-management (PLSM) program for older adults with diabetes.,"[{'ForeName': 'Wen-Chun', 'Initials': 'WC', 'LastName': 'Chen', 'Affiliation': 'Department of Community Medicine, St. Martin De Porres Hospital, Chiayi, Taiwan; School of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Nursing, Chang Gung University of Science and Technology, Chiayi Campus, Taiwan. Electronic address: shermie@stm.org.tw.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Kuo', 'Affiliation': 'Emergency Department, Chi-Mei Medical Center, Tainan, Taiwan; Department of Nursing, Chang Jung Christian University, Tainan, Taiwan.'}, {'ForeName': 'Chiu-Chu', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Renal Care, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Medical Research, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: chiuchu@kmu.edu.tw.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, Fooyin University, Kaohsiung, Taiwan.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.01.011']
1248,33621762,Comparison of efficacy of endoscopic versus microscopic transcanal inlay butterfly cartilage myringoplasty.,"BACKGROUND AND OBJECTIVES


Butterfly cartilage myringoplasty has been widely practiced over two decades due to its simplicity and feasibility. The present study is aimed to compare the efficacy of endoscopic versus microscopic transcanal inlay butterfly cartilage myringoplasty.
SUBJECTS AND METHODS


In this randomised control trial, fifty patients with small to medium sized perforation were included. The first group underwent butterfly cartilage myringoplasty using endoscope and the second group using microscope and, outcomes were compared.
RESULTS


Graft success rates in the endoscopic group was 96% ± 4% and in the microscopic group was 92% ± 8%. The improvement in the Air-Bone Gap was 11.00 ± 7.21 dB in the endoscopic group and 10.8 ± 7.59 dB in the microscopic group. The difference was not statistically significant.
CONCLUSIONS


The overall success rates and hearing outcomes were similar in the endoscopic and microscopic group with added advantages of less pain, shorter operative time and better field of vision in the endoscopic group.",2021,"The overall success rates and hearing outcomes were similar in the endoscopic and microscopic group with added advantages of less pain, shorter operative time and better field of vision in the endoscopic group.",['fifty patients with small to medium sized perforation were included'],"['butterfly cartilage myringoplasty using endoscope', 'endoscopic versus microscopic transcanal']","['Air-Bone Gap', 'overall success rates and hearing outcomes', 'pain, shorter operative time and better field of vision', 'Graft success rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0006496', 'cui_str': 'Butterfly'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]",50.0,0.0458088,"The overall success rates and hearing outcomes were similar in the endoscopic and microscopic group with added advantages of less pain, shorter operative time and better field of vision in the endoscopic group.","[{'ForeName': 'Nimisha', 'Initials': 'N', 'LastName': 'Ravi', 'Affiliation': 'Department of ENT Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Meher', 'Affiliation': 'Department of ENT Maulana Azad Medical College, New Delhi 110002, India. Electronic address: ravimeher@gmail.com.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Rathore', 'Affiliation': 'Department of ENT Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Ishwar', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Department of ENT Maulana Azad Medical College, New Delhi 110002, India.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.102978']
1249,33621675,Dissociating the causal role of left and right dorsal premotor cortices in planning and executing bimanual movements - A neuro-navigated rTMS study.,"BACKGROUND


The dorsal premotor cortex (PMd) is a key region in bimanual coordination. However, causal evidence linking PMd functionality during motor planning and execution to movement quality is lacking.
OBJECTIVE


We investigated how left (PMd L ) and right PMd (PMd R ) are causally involved in planning and executing bimanual movements, using short-train repetitive transcranial magnetic stimulation (rTMS). Additionally, we explored to what extent the observed rTMS-induced modulation of performance could be explained by rTMS-induced modulation of PMd-M1 interhemispheric interactions (IHI).
METHODS


Twenty healthy adults (mean age ± SD = 22.85 ± 3.73 years) participated in two sessions, in which either PMd L  or PMd R  was targeted with rTMS (10 Hz) in a pseudo-randomized design. PMd functionality was transiently modulated during the planning or execution of a complex bimanual task, whereby the participant was asked to track a moving dot by controlling two dials. The effect of rTMS on several performance measures was investigated. Concurrently, rTMS-induced modulation of PMd-M1 IHI was measured using a dual-coil paradigm, and associated with the rTMS-induced performance modulation.
RESULTS


rTMS over PMd L  during planning increased bilateral hand movement speed (p = 0.03), thereby improving movement accuracy (p = 0.02). In contrast, rTMS over PMd R  during both planning and execution induced deterioration of movement stability (p = 0.04). rTMS-induced modulation of PMd-M1 IHI during planning did not predict rTMS-induced performance modulation.
CONCLUSION


The current findings support the growing evidence on PMd L  dominance during motor planning, as PMd L  was crucially involved in planning the speed of each hand, subserving bimanual coordination accuracy. Moreover, the current results suggest that PMd R  fulfills a role in continuous adjustment processes of movement.",2021,"rTMS-induced modulation of PMd-M1 IHI during planning did not predict rTMS-induced performance modulation.
",['Twenty healthy adults (mean age ± SD = 22.85±3.73 years'],"['rTMS', 'PMd L  or PMd R  was targeted with rTMS (10Hz', 'left (PMd L ) and right PMd (PMd R ']","['movement accuracy', 'PMd-M1 IHI', 'PMd functionality', 'bilateral hand movement speed', 'deterioration of movement stability']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205711', 'cui_str': 'Pelizaeus-Merzbacher disease'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205711', 'cui_str': 'Pelizaeus-Merzbacher disease'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",20.0,0.032337,"rTMS-induced modulation of PMd-M1 IHI during planning did not predict rTMS-induced performance modulation.
","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Verstraelen', 'Affiliation': 'Neuroplasticity and Movement Control Research Group, Rehabilitation Research Institute (REVAL), Hasselt University, Diepenbeek, Belgium. Electronic address: stefanie.verstraelen@uhasselt.be.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'van Dun', 'Affiliation': 'Neuroplasticity and Movement Control Research Group, Rehabilitation Research Institute (REVAL), Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Siel', 'Initials': 'S', 'LastName': 'Depestele', 'Affiliation': 'Neuroplasticity and Movement Control Research Group, Rehabilitation Research Institute (REVAL), Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Sybren', 'Initials': 'S', 'LastName': 'Van Hoornweder', 'Affiliation': 'Neuroplasticity and Movement Control Research Group, Rehabilitation Research Institute (REVAL), Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Neuroplasticity and Movement Control Research Group, Rehabilitation Research Institute (REVAL), Hasselt University, Diepenbeek, Belgium; Department of Psychology and Neurosciences, Leibniz Research Center for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Ensiyeh', 'Initials': 'E', 'LastName': 'Ghasemian-Shirvan', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Center for Working Environment and Human Factors, Dortmund, Germany; International Graduate School of Neuroscience, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Center for Working Environment and Human Factors, Dortmund, Germany; Department of Neurology, University Medical Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Shanti', 'Initials': 'S', 'LastName': 'Van Malderen', 'Affiliation': 'Movement Control and Neuroplasticity Research Group, Department of Movement Sciences, Group Biomedical Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Stephan P', 'Initials': 'SP', 'LastName': 'Swinnen', 'Affiliation': 'Movement Control and Neuroplasticity Research Group, Department of Movement Sciences, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Leuven Brain Institute (LBI), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Cuypers', 'Affiliation': 'Neuroplasticity and Movement Control Research Group, Rehabilitation Research Institute (REVAL), Hasselt University, Diepenbeek, Belgium; Movement Control and Neuroplasticity Research Group, Department of Movement Sciences, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Leuven Brain Institute (LBI), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Raf L J', 'Initials': 'RLJ', 'LastName': 'Meesen', 'Affiliation': 'Neuroplasticity and Movement Control Research Group, Rehabilitation Research Institute (REVAL), Hasselt University, Diepenbeek, Belgium; Movement Control and Neuroplasticity Research Group, Department of Movement Sciences, Group Biomedical Sciences, KU Leuven, Leuven, Belgium.'}]",Brain stimulation,['10.1016/j.brs.2021.02.006']
1250,33621632,Integration of a smartwatch within an internet-delivered intervention for depression: Protocol for a feasibility randomized controlled trial on acceptance.,"BACKGROUND


Mood tracking is commonly employed within a range of mental health interventions. Physical activity and sleep are also important for contextualizing mood data but can be difficult to track manually and rely on retrospective recall. Smartwatches could enhance self-monitoring by addressing difficulties in recall of sleep and physical activity and reducing the burden on patients in terms of remembering to track and the effort of tracking. This feasibility study will explore the acceptance of a smartwatch app for self-monitoring of mood, sleep, and physical activity, in an internet-based cognitive-behavioral therapy (iCBT) for depression offered in a routine care setting.
METHODS


Seventy participants will be randomly allocated to (i) iCBT intervention plus smartwatch app or (ii) iCBT intervention alone. Patient acceptance will be measured longitudinally using a theory-based acceptance questionnaire to understand and compare the evolution of acceptance of the technology-delivered self-report in the two groups. A post-treatment interview will explore participants subjective experience of using the smartwatch. Engagement with the intervention, including self-report, and clinical outcomes, will be measured across both groups to assess for any differences.
IMPLICATIONS


This is the first study investigating the evolution of patient acceptance of smartwatch self-report in an iCBT delivered intervention in a clinical sample. Through an engaging and convenient means of capturing ecologically valid mood data, the study has the potential to show that smartwatches are an acceptable means for patient self-monitoring within iCBT interventions for depression and support potential use-cases for smartwatches in the context of mental health interventions in general. Prospectively registered at ClinicalTrials.gov (NCT04568317).",2021,"This feasibility study will explore the acceptance of a smartwatch app for self-monitoring of mood, sleep, and physical activity, in an internet-based cognitive-behavioral therapy (iCBT) for depression offered in a routine care setting.
",['Seventy participants will be randomly allocated to'],"['iCBT intervention plus smartwatch app or (ii) iCBT intervention alone', 'internet-based cognitive-behavioral therapy (iCBT']",['Physical activity and sleep'],"[{'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",70.0,0.0743286,"This feasibility study will explore the acceptance of a smartwatch app for self-monitoring of mood, sleep, and physical activity, in an internet-based cognitive-behavioral therapy (iCBT) for depression offered in a routine care setting.
","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Nadal', 'Affiliation': 'School of Computer Science and Statistics, Trinity College Dublin, College Green, Dublin, Ireland. Electronic address: nadalc@tcd.ie.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Earley', 'Affiliation': 'E-mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland; SilverCloud Health, 1 Stephen Street Upper, Dublin, Ireland. Electronic address: caroline.earley@silvercloudhealth.com.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Enrique', 'Affiliation': 'E-mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland; SilverCloud Health, 1 Stephen Street Upper, Dublin, Ireland. Electronic address: angel.enrique@silvercloudhealth.com.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Vigano', 'Affiliation': 'SilverCloud Health, 1 Stephen Street Upper, Dublin, Ireland. Electronic address: noemi.vigano@silvercloudhealth.com.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Sas', 'Affiliation': 'Lancaster University, School of Computing and Communications, Lancaster, UK. Electronic address: c.sas@lancaster.ac.uk.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'E-mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland; SilverCloud Health, 1 Stephen Street Upper, Dublin, Ireland. Electronic address: derek.richards@tcd.ie.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Doherty', 'Affiliation': 'School of Computer Science and Statistics, Trinity College Dublin, College Green, Dublin, Ireland. Electronic address: gavin.doherty@tcd.ie.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106323']
1251,33626423,A randomised controlled feasibility trial to evaluate Lawsonia inermis (henna)'s effect on palmar-plantar erythrodysesthesia induced by capecitabine or pegylated liposomal doxorubicin.,"PURPOSE


To test the effectiveness of henna in the management of palmar-plantar erythrodysesthesia (PPE) in patients receiving treatment with capecitabine or pegylated liposomal doxorubicin (PLD).
METHOD


This was a randomized controlled feasibility study in three specialized tertiary cancer centers with 56 patients with a PPE grade 1 or above and various cancer diagnoses. The intervention included the local application of henna to the affected areas. The control group followed the same process with a henna inert. Primary outcome was PPE grade and secondary outcomes were the EORTC QLQ-C30, PPE-related QoL (HFS-14), activities of daily living (ECOG) and pain. Patients in both groups were assessed at baseline and then weekly at four follow-ups.
RESULTS


PPE grade in the intervention group (1-3.8%) was lower compared to the control group (4-13.38%) and also lower levels of pain were reported by the patients in the intervention group (2.46 ± 1.17) compared to the control (5.57 ± 2.01). ECOG status in the intervention group was improved compared to the control (p = 0.039). The intervention group, experienced higher Global Health Status (p ≤ 0.008), Physical function (p ≤ 0.001), Emotional Function (p = 0.029), Social function (p ≤ 0.001) and lower Fatigue (p ≤ 0.001) and Pain (p ≤ 0.001) compared to the Control group. A statistically significant interaction was found between Group and Time over the weekly measurements of HFS-14 scores (F = 5,009, p ≤ 0.002) indicating the significant effect of the intervention throughout the weekly assessments.
CONCLUSION


The trial provided preliminary evidence on henna's effectiveness for treating PPE during treatment with capecitabine or PLD, with lower PPE grades, better performance status and better HRQoL observed in the henna group. CLINICALTRIALS.
GOV IDENTIFIER


NCT01751893.",2021,"RESULTS


PPE grade in the intervention group (1-3.8%) was lower compared to the control group (4-13.38%) and also lower levels of pain were reported by the patients in the intervention group (2.46 ± 1.17) compared to the control (5.57 ± 2.01).","['three specialized tertiary cancer centers with 56 patients with a PPE grade 1 or above and various cancer diagnoses', 'palmar-plantar erythrodysesthesia (PPE) in patients receiving treatment with']","['capecitabine or PLD', 'capecitabine or pegylated liposomal doxorubicin', 'Lawsonia inermis (henna', 'capecitabine or pegylated liposomal doxorubicin (PLD']","['ECOG status', 'palmar-plantar erythrodysesthesia', 'Global Health Status', 'PPE grade and secondary outcomes were the EORTC QLQ-C30, PPE-related QoL (HFS-14), activities of daily living (ECOG) and pain', 'Emotional Function', 'lower Fatigue', 'performance status and better HRQoL', 'Pain', 'levels of pain', 'HFS-14 scores', 'Physical function', 'Social function']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C1068389', 'cui_str': 'Henna Plant'}, {'cui': 'C0064698', 'cui_str': 'lawsone'}]","[{'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2745948', 'cui_str': 'Juvenile hyaline fibromatosis'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",56.0,0.0614142,"RESULTS


PPE grade in the intervention group (1-3.8%) was lower compared to the control group (4-13.38%) and also lower levels of pain were reported by the patients in the intervention group (2.46 ± 1.17) compared to the control (5.57 ± 2.01).","[{'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Stavrinou', 'Affiliation': 'American Medical Centre, 215 2047, B22, Nicosia, Cyprus.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Tsitsi', 'Affiliation': 'Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Astras', 'Affiliation': 'American Medical Centre, 215 2047, B22, Nicosia, Cyprus.'}, {'ForeName': 'Lefkios', 'Initials': 'L', 'LastName': 'Paikousis', 'Affiliation': 'Improvast, Arkadias 7, Fairdeal House, Flat 206, Nicosia, 1048, Cyprus.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Charalambous', 'Affiliation': 'Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus; University of Turku, Department of Nursing, Finland. Electronic address: andreas.charalambous@cut.ac.cy.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2021.101908']
1252,33630408,Renal handling of nitrate in women and men with elevated blood pressure.,"AIM


The inorganic anions nitrate and nitrite are oxidation products of nitric oxide (NO) that have often been used as an index of NO generation. More than just being surrogate markers of NO, nitrate/nitrite can recycle to bioactive NO again. Nitrate is predominantly eliminated via the kidneys; however, there is less knowledge regarding tubular handling. The aim of this study, as part of a large randomized controlled trial, was to explore potential sex differences in renal nitrate handling during low and high dietary nitrate intake. We hypothesized that renal clearance and excretion of nitrate are higher in men compared to women.
METHODS


In prehypertensive and hypertensive individuals (n = 231), nitrate and nitrite were measured in plasma and urine at low dietary nitrate intake (baseline) and after 5 weeks supplementation with nitrate (300 mg potassium nitrate/day) or placebo (300 mg potassium chloride/day). Twenty-four hours ambulatory blood pressure recordings and urine collections were conducted.
RESULTS


At baseline, plasma nitrate and nitrite, as well as the downstream marker of NO signalling cyclic guanosine monophosphate, were similar in women and men. Approximately 80% of filtered nitrate was spared by the kidneys. Urinary nitrate concentration, amount of nitrate excreted, renal nitrate clearance (C nitrate  ) and fractional excretion of nitrate (FE nitrate  ) were lower in women compared to men. No association was observed between plasma nitrate concentrations and glomerular filtration rate (GFR), nor between FE nitrate  and GFR in either sex. After 5 weeks of nitrate supplementation plasma nitrate and nitrite increased significantly, but blood pressure remained unchanged. FE nitrate  increased significantly and the sex difference observed at baseline disappeared.
CONCLUSION


Our findings demonstrate substantial nitrate sparing capacity of the kidneys, which is higher in women compared to men. This suggests higher tubular nitrate reabsorption in women but the underlying mechanism(s) warrants further investigation.",2021,"No association was observed between plasma nitrate concentrations and glomerular filtration rate (GFR), nor between FE nitrate  and GFR in either sex.","['women and men with elevated blood pressure', 'men compared to women']","['nitrate (300 mg potassium nitrate/day) or placebo', 'renal nitrate handling during low and high dietary nitrate intake']","['plasma nitrate and nitrite as well as the downstream marker of NO signaling cyclic guanosine monophosphate', 'FE nitrate', 'nitrate supplementation plasma nitrate and nitrite', 'tubular nitrate reabsorption', 'Urinary nitrate concentration, amount of nitrate excreted, renal nitrate clearance (C nitrate  ) and fractional excretion of nitrate (FE nitrate  ', 'blood pressure', 'renal clearance and excretion of nitrate', 'plasma nitrate concentrations and glomerular filtration rate (GFR), nor between FE nitrate  and GFR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",,0.0315171,"No association was observed between plasma nitrate concentrations and glomerular filtration rate (GFR), nor between FE nitrate  and GFR in either sex.","[{'ForeName': 'Michaela L', 'Initials': 'ML', 'LastName': 'Sundqvist', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jon O', 'Initials': 'JO', 'LastName': 'Lundberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Carlström', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}]","Acta physiologica (Oxford, England)",['10.1111/apha.13637']
1253,33629506,"Sex, Food, and the Gut Microbiota: Disparate Response to Caloric Restriction Diet with Fiber Supplementation in Women and Men.","SCOPE


Dietary-based strategies are regularly explored in controlled clinical trials to provide cost-effective therapies to tackle obesity and its comorbidities. The article presents a complementary analysis based on a multivariate multi-omics approach of a caloric restriction intervention (CRD) with fiber supplementation to unveil synergic effects on body weight control, lipid metabolism, and gut microbiota.
METHODS AND RESULTS


The study explores fecal bile acids (BAs) and short-chain fatty acids (SCFAs), plasma BAs, and fecal shotgun metagenomics on 80 overweight participants of a 12-week caloric restriction clinical trial (-500 kcal day -1  ) randomly allocated into fiber (10 g day -1  inulin + 10 g day -1  resistant maltodextrin) or placebo (maltodextrin) supplementation groups. The multi-omic data integration analysis uncovered the benefits of the fiber supplementation and/or the CRD (e.g., increase of Parabacteroides distasonis and fecal propionate), showing sex-specific effects on either adiposity and fasting insulin; effects thought to be linked to changes of specific gut microbiota species, functional genes, and bacterially produced metabolites like SCFAs and secondary BAs.
CONCLUSIONS


This study identifies diet-microbe-host interactions helping to design personalised interventions. It also suggests that sex perspective should be considered routinely in future studies on dietary interventions efficacy. All in all, the study uncovers that the dietary intervention is more beneficial for women than men.",2021,"The multi-omic data integration analysis (sparse PLS-DA method) uncovered the benefits of the fibre supplementation and/or the CRD (e.g., increase of Parabacteroides distasonis and faecal propionate), showing sex-specific effects on either adiposity and fasting insulin; effects thought to be linked to changes of specific gut microbiota species, functional genes, and bacterially produced metabolites like SCFAs and secondary BAs.
","['Women and Men', '80 overweight participants of a 12-week caloric restriction clinical trial (-500\xa0kcal/day) randomly allocated into']","['Caloric Restriction Diet with Fibre Supplementation', 'fibre (10\xa0g/day inulin + 10\xa0g/day resistant maltodextrin) or placebo (maltodextrin) supplementation']","['faecal BAs and SCFAs, plasma BAs, and faecal shotgun metagenomics', 'Sex, Food, and the Gut Microbiota', 'body weight control, lipid metabolism, and gut microbiota']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}]","[{'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0037003', 'cui_str': 'Shotgun'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",80.0,0.0363558,"The multi-omic data integration analysis (sparse PLS-DA method) uncovered the benefits of the fibre supplementation and/or the CRD (e.g., increase of Parabacteroides distasonis and faecal propionate), showing sex-specific effects on either adiposity and fasting insulin; effects thought to be linked to changes of specific gut microbiota species, functional genes, and bacterially produced metabolites like SCFAs and secondary BAs.
","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Benítez-Páez', 'Affiliation': 'Microbial Ecology, Nutrition & Health Research Unit, Institute of Agrochemistry and Food Technology, Spanish National Research Council (IATA-CSIC), Valencia, 46980, Spain.'}, {'ForeName': 'Anne Lundby', 'Initials': 'AL', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg C, 1958, Denmark.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Krautbauer', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University of Regensburg, Regensburg, 93053, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Liebisch', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University of Regensburg, Regensburg, 93053, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg C, 1958, Denmark.'}, {'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg C, 1958, Denmark.'}, {'ForeName': 'Thomas Meinert', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg C, 1958, Denmark.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Sanz', 'Affiliation': 'Microbial Ecology, Nutrition & Health Research Unit, Institute of Agrochemistry and Food Technology, Spanish National Research Council (IATA-CSIC), Valencia, 46980, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Molecular nutrition & food research,['10.1002/mnfr.202000996']
1254,33629488,"Pseudofolliculitis barbae treatment: Efficacy of topical eflornithine, long-pulsed Nd-YAG laser versus their combination.","BACKGROUND


Pseudofolliculitis barbae (PFB) is a chronic inflammatory disorder occurring mostly in regions of thick hair growth after shaving. PFB is characterized clinically by multiple painful, pruritic erythematous papules and, less commonly, pustules, nodules, or abscesses.
AIM


To evaluate the efficacy of topical eflornithine cream only, long-pulsed Nd-YAG laser, versus their combination for PFB management.
PATIENTS AND METHODS


Overall, 40 male patients with PFB were allocated into 3 treatment groups; Group 1 (n = 12): Treated by topical eflornithine cream twice daily for 16 weeks, Group II (n = 13): Treated by long-pulsed Nd-YAG laser for 4 sessions 4-week interval, Group III (n = 15): Treated by this combination for 16 weeks. The patients were evaluated after 16 weeks and for a further 12 weeks through serial photographs, Folliscopic evaluation, and a quartile grading system for improvement.
RESULTS


After 16 weeks of treatments, the mean improvement percentages of the inflammatory papules, as well as hair density in the long-pulsed Nd-YAG laser +eflornithine cream, treated group were significantly higher compared with either eflornithine cream treated group or laser-only treated group. The same relationship was demonstrated after 12 weeks of follow-up but with lower improvements compared with 16 weeks of treatment outcome.
CONCLUSIONS


Topical eflornithine cream exerts an additive effect on long-pulsed Nd-YAG laser in enhancing the rate and degree of hair reduction and inflammatory papules in PFB cases with a further follow-up improvement. This combined approach should be long-established in larger sample sizes and long-term studies.",2021,"The same relationship was demonstrated after 12 weeks of follow-up but with lower improvements compared with 16 weeks of treatment outcome.
",['40 male patients with PFB'],"['topical eflornithine, long-pulsed Nd-YAG laser versus their combination', 'topical eflornithine cream', 'eflornithine cream', 'Long-pulsed Nd-YAG laser', 'Topical eflornithine cream']","['hair density', 'rate and degree of hair reduction and inflammatory papules']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549150', 'cui_str': 'Pseudofolliculitis barbae'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0002260', 'cui_str': 'Eflornithine'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332563', 'cui_str': 'Papule'}]",40.0,0.0257451,"The same relationship was demonstrated after 12 weeks of follow-up but with lower improvements compared with 16 weeks of treatment outcome.
","[{'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Shokeir', 'Affiliation': 'National Institute of Laser Enhanced Sciences, Medical Applications of Laser Department, Cairo University, Giza, Egypt.'}, {'ForeName': 'Nevien', 'Initials': 'N', 'LastName': 'Samy', 'Affiliation': 'National Institute of Laser Enhanced Sciences, Medical Applications of Laser Department, Cairo University, Giza, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Taymour', 'Affiliation': 'Private sector, Dermatology & Andrology, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14027']
1255,33629384,A pilot double-blind safety and feasibility randomized controlled trial of high-dose intravenous zinc in hospitalized COVID-19 patients.,"Zinc inhibits replication of the SARS-CoV virus. We aimed to evaluate the safety, feasibility, and biological effect of administering high-dose intravenous zinc (HDIVZn) to patients with COVID-19. We performed a Phase IIa double-blind, randomized controlled trial to compare HDIVZn to placebo in hospitalized patients with COVID-19. We administered trial treatment per day for a maximum of 7 days until either death or hospital discharge. We measured zinc concentration at baseline and during treatment and observed patients for any significant side effects. For eligible patients, we randomized and administered treatment to 33 adult participants to either HDIVZn (n = 15) or placebo (n = 18). We observed no serious adverse events throughout the study for a total of 94 HDIVZn administrations. However, three participants in the HDIVZn group reported infusion site irritation. Mean serum zinc on Day 1 in the placebo, and the HDIVZn group was 6.9 ± 1.1 and 7.7 ± 1.6 µmol/l, respectively, consistent with zinc deficiency. HDIVZn, but not placebo, increased serum zinc levels above the deficiency cutoff of 10.7 µmol/l (p < .001) on Day 6. Our study did not reach its target enrollment because stringent public health measures markedly reduced patient hospitalizations. Hospitalized COVID-19 patients demonstrated zinc deficiency. This can be corrected with HDIVZn. Such treatment appears safe, feasible, and only associated with minimal peripheral infusion site irritation. This pilot study justifies further investigation of this treatment in COVID-19 patients.",2021,increased serum zinc levels above the deficiency cut off of 10.7 µmol/l (P<0.001) by day 6.,"['hospitalised COVID-19 patients', 'COVID-19 patients', 'patients with COVID-19', 'hospitalised patients with COVID-19', '33 adult participants to either']","['high-dose intravenous zinc', 'HDIVZn', 'placebo', 'HDIVZn to placebo', 'administering high-dose intravenous zinc (HDIVZn']","['zinc deficiency', 'infusion site irritation', 'Mean serum zinc', 'zinc concentration', 'safety, feasibility and biological effect', 'serum zinc levels']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0235950', 'cui_str': 'Zinc deficiency'}, {'cui': 'C1695897', 'cui_str': 'Infusion site irritation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1318315', 'cui_str': 'Serum zinc measurement'}]",33.0,0.691175,increased serum zinc levels above the deficiency cut off of 10.7 µmol/l (P<0.001) by day 6.,"[{'ForeName': 'Oneel', 'Initials': 'O', 'LastName': 'Patel', 'Affiliation': 'Department of Surgery, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Vidyasagar', 'Initials': 'V', 'LastName': 'Chinni', 'Affiliation': 'Department of Surgery, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'El-Khoury', 'Affiliation': 'Department of Surgery, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Perera', 'Affiliation': 'Department of Surgery, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Ary S', 'Initials': 'AS', 'LastName': 'Neto', 'Affiliation': 'Australian and New Zealand Intensive Care-Research Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'See', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bolton', 'Affiliation': 'Department of Surgery, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Trubiano', 'Affiliation': 'Department of Infectious Disease, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ischia', 'Affiliation': 'Department of Surgery, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.'}]",Journal of medical virology,['10.1002/jmv.26895']
1256,33631360,Study protocol for a randomized controlled trial comparing two low-intensity weight loss maintenance interventions based on acceptance and commitment therapy or self-regulation.,"BACKGROUND


Weight regain is common following behavioral obesity treatment and attenuates many of the benefits of initial weight loss. This paper describes a randomized controlled trial that will evaluate the efficacy of two low-contact weight loss maintenance interventions based on Acceptance and Commitment Therapy (ACT) and self-regulation (SR). Potential mechanisms of action and moderators of treatment effects will also be evaluated.
METHODS


Adults (anticipated N = 480) with overweight or obesity will complete an initial 3-month online weight loss program (Phase 1). Participants who achieve ≥4 kg weight loss (anticipated N = 288) will then be randomized to an ACT or SR weight loss maintenance intervention. Both interventions will entail four 2.5 h, face-to-face, group-based workshop sessions and 6 months of email contact. Assessments will be conducted at phase 1 baseline, phase 1 completion/pre-randomization, and 6, 12, 18, 24, and 30 months post-randomization. The primary outcome will be weight change for the period from randomization to 30 months. Potential process measures including ACT-based constructs (e.g., psychological acceptance, values-consistent behavior), self-weighing frequency, and motivation will be also be assessed, as will potential moderators (e.g., initial weight loss).
CONCLUSIONS


This study will compare the efficacy of two intervention approaches (ACT and SR) delivered in a scalable workshop format for long-term weight loss maintenance. Future research could examine efficacy and cost-effectiveness of these approaches in real world settings.",2021,This study will compare the efficacy of two intervention approaches (ACT and SR) delivered in a scalable workshop format for long-term weight loss maintenance.,"['Adults (anticipated N\u202f=\u202f480) with overweight or obesity will complete an initial 3-month online weight loss program (Phase 1', 'Participants who achieve ≥4\u202fkg weight loss (anticipated N\u202f=\u202f288']","['intervention approaches (ACT and SR', 'low-contact weight loss maintenance interventions', 'ACT or SR weight loss maintenance intervention', 'low-intensity weight loss maintenance interventions']","['ACT-based constructs (e.g., psychological acceptance, values-consistent behavior), self-weighing frequency, and motivation', 'Acceptance and Commitment Therapy (ACT) and self-regulation (SR', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",480.0,0.0980461,This study will compare the efficacy of two intervention approaches (ACT and SR) delivered in a scalable workshop format for long-term weight loss maintenance.,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lillis', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA. Electronic address: jasonlillis22@gmail.com.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Schumacher', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Department of Psychology, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Unick', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'Jacqueline F', 'Initials': 'JF', 'LastName': 'Hayes', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106327']
1257,33636616,"Low vitamin D, but not tobacco use or high BMI, is associated with long-term disability progression in multiple sclerosis.","BACKGROUND


Low vitamin D levels, tobacco use and high body mass index (BMI) have been linked to adverse disease outcomes in multiple sclerosis (MS), but their influence on long-term disability progression remains unclear. Therefore, we explored whether these modifiable lifestyle factors were associated with 10-year clinical disability progression in patients with MS.
METHODS


In this prospective study, a cohort of 88 patients with relapsing-remitting MS completed a randomized controlled study on ω-3 fatty acids between 2004 and 2008. During 24 months, serum 25-hydroxyvitamin D (25(OH)D), serum cotinine (nicotine metabolite), and BMI were repeatedly measured. In 2017, a follow-up study was conducted among 80 of the participants, including disability assessment by the Expanded Disability Status Scale (EDSS). Linear regression was used to explore associations between the lifestyle factors and the EDSS change over 10 years.
RESULTS


Higher seasonally adjusted 25(OH)D levels were associated with lower 10-year EDSS progression (change in EDSS per 1 SD increase in 25(OH)D in a model adjusted for sex, age and baseline EDSS: -0.45 point, 95% CI: -0.75 to -0.16, p=0.003). Further adjustments for potential confounders related to lifestyle and disease status gave similar results. The association was mainly driven by low 25(OH)D levels during spring, as well as seasonally adjusted levels below 80 nmol/L. No clear association was found for BMI and cotinine.
CONCLUSION


Lower 25(OH)D levels, but apparently not tobacco use or higher BMI, were significantly associated with worse long-term disability progression in MS.",2021,"Lower 25(OH)D levels, but apparently not tobacco use or higher BMI, were significantly associated with worse long-term disability progression in MS.",['88 patients with relapsing-remitting MS completed a randomized controlled study on ω-3 fatty acids between 2004 and 2008'],['Low vitamin D'],"['Lower 25(OH)D levels', 'worse long-term disability progression', 'serum 25-hydroxyvitamin D (25(OH)D), serum cotinine (nicotine metabolite), and BMI', 'disability assessment by the Expanded Disability Status Scale (EDSS', '10-year EDSS progression', '10-year clinical disability progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C4285871', 'cui_str': 'Vitamin D low'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",88.0,0.0179158,"Lower 25(OH)D levels, but apparently not tobacco use or higher BMI, were significantly associated with worse long-term disability progression in MS.","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Wesnes', 'Affiliation': ""Department of Clinical Medicine, University of Bergen, Bergen, Norway; Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Neurology, St. Olav's University Hospital, Trondheim, Norway. Electronic address: kristin.wesnes@uib.no.""}, {'ForeName': 'Kjell-Morten', 'Initials': 'KM', 'LastName': 'Myhr', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway; Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Riise', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Silje Stokke', 'Initials': 'SS', 'LastName': 'Kvistad', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway; Department of Immunology and Transfusion medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Torkildsen', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway; Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Wergeland', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Norwegian Multiple Sclerosis Competence Center, Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Holmøy', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Neurology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Midgard', 'Affiliation': 'Department of Neurology, Molde Hospital, Molde, Norway.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Bru', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Edland', 'Affiliation': 'Department of Neurology, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Eikeland', 'Affiliation': 'Department of Neurology and Department of Paediatrics, Sørlandet Hospital Trust, Arendal, Norway.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Gosal', 'Affiliation': 'Department of Neurology, Østfold Hospital Kalnes, Grålum, Norway.'}, {'ForeName': 'Hanne F', 'Initials': 'HF', 'LastName': 'Harbo', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Neurology, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Kleveland', 'Affiliation': 'Department of Neurology, Innlandet Hospital Lillehammer, Lillehammer, Norway.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Sørenes', 'Affiliation': 'Department of Neurology, Haugesund Hospital, Haugesund, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Øksendal', 'Affiliation': 'Department of Neurology, Nordland hospital trust, Bodø, Norway.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Bjørnevik', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102801']
1258,33636601,Opposite effects of one session of 1 Hz rTMS on functional connectivity between pre-supplementary motor area and putamen depending on the dyskinesia state in Parkinson's disease.,"OBJECTIVE


To explore the effects of low-frequency repetitive transcranial magnetic stimulation (LF rTMS) on cortico-striatal-cerebellar resting state functional connectivity in Parkinson's disease (PD), with and without dyskinesias.
METHODS


Because there is increasing evidence of an involvement of the pre-supplementary motor area (pre-SMA) in the pathophysiology of levodopa induced dyskinesias, we targeted the right pre-SMA with LF rTMS in 17 PD patients. We explored the effects of one sham-controlled LF rTMS session on resting state functional connectivity of interconnected brain regions by using functional MRI, and how it is modified by levodopa. The clinical effect on motor function and dyskinesias was documented.
RESULTS


As expected, one LF rTMS session did not alleviate dyskinesias. However, real, and not sham LF rTMS significantly increased the functional connectivity with the right putamen in patients with dyskinesias. In patients without dyskinesias, the real LF rTMS session significantly decreased functional connectivity in the right putamen and the cerebellum. We found no effects on functional connectivity after levodopa ingestion.
CONCLUSION


One session of 1 Hz rTMS has opposing effects on pre-SMA functional connectivity depending on the PD patients' dyskinesia state.
SIGNIFICANCE


Patients dyskinesias state determines the way LF rTMS affects functional connectivity in late stage PD.",2021,"One session of 1 Hz rTMS has opposing effects on pre-SMA functional connectivity depending on the PD patients' dyskinesia state.
","[""Parkinson's disease (PD"", ""Parkinson's disease"", 'patients with dyskinesias', '17 PD patients']","['low-frequency repetitive transcranial magnetic stimulation (LF rTMS', 'real LF rTMS session', 'sham-controlled LF rTMS session', '1\xa0Hz rTMS']","['motor function and dyskinesias', 'pre-SMA functional connectivity', 'functional connectivity', 'dyskinesias']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0307833,"One session of 1 Hz rTMS has opposing effects on pre-SMA functional connectivity depending on the PD patients' dyskinesia state.
","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Flamez', 'Affiliation': 'Department of Neurology, UZ Brussel, Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090 Brussels, Belgium. Electronic address: anja.flamez@uzbrussel.be.'}, {'ForeName': 'Guo-Rong', 'Initials': 'GR', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Wietse', 'Initials': 'W', 'LastName': 'Wiels', 'Affiliation': 'Department of Neurology, UZ Brussel, Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Schuerbeek', 'Affiliation': 'Department of Radiology, UZ Brussel, Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'De Mey', 'Affiliation': 'Department of Radiology, UZ Brussel, Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'De Keyser', 'Affiliation': 'Department of Neurology, UZ Brussel, Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Psychiatry, UZ Brussel, Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090 Brussels, Belgium; Ghent University, Department of Head and Skin and GHEP Lab, C. Heymanslaan 10, 9000 Ghent, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.12.024']
1259,33636517,Predictors of Depressive Symptoms and Post Traumatic Stress Disorder Among Women Engaged in Commercial Sex Work in Southern Uganda.,"This study examined the factors associated with depressive symptoms and post traumatic depressive disorder (PTSD) among economically vulnerable women engaged in commercial sex work (WESW) in southern Uganda. Baseline data from a longitudinal cluster randomized study involving 542 self-identified WESW (18-55 years), recruited from 19 HIV hotspots were analyzed. Hierarchical linear regression modelling was utilized to estimate individual, family-level and economic-level predictors of depressive symptoms and PTSD. Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners, were associated with PTSD. Similarly, family cohesion, number of people in the household, HIV status, sex work stigma, financial distress, and household assets, were associated with depressive symptoms. Women engaged in commercial sex work are at a higher risk of HIV and poor mental health outcomes. Sex work stigma and financial distress elevate levels of depressive symptoms and PTSD, over and above an individual's HIV status. Family and economic-level factors have the potential to mitigate the risk of poor mental health outcomes. As such, integrating stigma reduction and economic strengthening components in the programming targeting WESW-a key population, may be critical to address their mental health outcomes.",2021,"Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners, were associated with PTSD.","['542 self-identified WESW (18-55 years), recruited from 19 HIV hotspots were analyzed', 'depressive symptoms and post traumatic depressive disorder (PTSD) among economically vulnerable women engaged in commercial sex work (WESW) in southern Uganda', 'Women', 'Engaged in Commercial Sex Work in Southern Uganda']",[],"['family cohesion, number of people in the household, HIV status, sex work stigma, financial distress', 'Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0557163', 'cui_str': 'Household income'}]",542.0,0.0321672,"Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners, were associated with PTSD.","[{'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: nabunyap@wustl.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: byansiw@wustl.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: damulirac@wustl.edu.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: ozge.sensoybahar@wustl.edu.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Jennings Mayo-Wilson', 'Affiliation': 'Indiana University School of Public Health, Department of Applied Health Science, 1025 E. 7(TH) Street, Bloomington, IN 47405, USA. Electronic address: ljmayowi@iu.edu.'}, {'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'New York University College of Global Public Health, 14 East 4(th) street, 3(rd) floor. New York, NY 10003, USA. Electronic address: yt23@nyu.edu.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kiyingi', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: j.kiyingi@wustl.edu.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Nabayinda', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: josepn84@gmail.com.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Braithwaite', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: rachel.brathwaite@wustl.edu.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Witte', 'Affiliation': 'Columbia University School of Social Work1255 Amsterdam Avenue, New York, NY 10027, USA. Electronic address: ssw12@columbia.edu.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: fms1@wustl.edu.'}]",Psychiatry research,['10.1016/j.psychres.2021.113817']
1260,33636453,Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial.,"OBJECTIVES


The JAVELIN Lung 200 phase 3 trial did not meet its primary endpoint of improving overall survival (OS) with avelumab vs docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report post hoc analyses assessing the effects of subsequent immune checkpoint inhibitor (ICI) treatment on OS.
MATERIAL AND METHODS


Patients with stage IIIB/IV NSCLC progressed following platinum-doublet therapy were randomized to receive avelumab or docetaxel. OS was analyzed in the PD-L1+ population (≥1% of tumor cells) and full analysis set (PD-L1+ or PD-L1-). Effects of subsequent ICI (after permanent discontinuation of study treatment) on OS were analyzed using a preplanned naive sensitivity analysis and post hoc inverse probability of censoring weighting (IPCW) analysis. Subgroups with or without subsequent ICI treatment were analyzed using descriptive statistics.
RESULTS


In the avelumab and docetaxel arms, a subsequent ICI was received by 16/396 (4.0 %) and 104/396 (26.3 %) after a median of 10.5 months (range, 3.9-20.4) and 5.7 months (range, 0.1-24.4), respectively. Some subgroups showed trends for higher subsequent ICI treatment, including patients with non-squamous NSCLC (avelumab arm, 4.3 % vs docetaxel arm, 32.1 %) or with a baseline ECOG performance status of 0 (6.3 % vs 31.3 %); those enrolled in the early recruitment wave (11.6 % vs 54.3 %), or enrolled in the US/Western Europe (2.8 % vs 45.5 %) or Asia (11.0 % vs 35.4 %); and non-white patients (10.1 % vs 35.0 %). The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively).
CONCLUSION


In the JAVELIN Lung 200 trial, avelumab showed clinical activity as second-line treatment for patients with advanced NSCLC. Post hoc analyses suggest that the primary OS analysis may have been confounded by subsequent ICI use in the docetaxel arm. ClinicalTrials.gov identifier: NCT02395172.",2021,"The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively).
","['patients with platinum-treated PD-L1+ NSCLC', 'patients with advanced NSCLC', 'Patients with stage IIIB/IV NSCLC progressed following platinum-doublet therapy', 'platinum-treated advanced NSCLC']","['avelumab and docetaxel', 'avelumab vs docetaxel', 'avelumab or docetaxel', 'subsequent immune checkpoint inhibitor (ICI', 'subsequent ICI']","['overall survival (OS', 'clinical activity', 'hazard ratio for OS', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.166791,"The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively).
","[{'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: kpark@skku.edu.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Cerrahpaşa Medical Faculty, Istanbul University Cerrahpaşa, Istanbul, Turkey. Electronic address: ozguroglu@gmail.com.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'Department of Respiratory Oncology, University Hospital KU Leuven, Leuven, Belgium. Electronic address: johan.vansteenkiste@uzleuven.be.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN, USA. Electronic address: David.Spigel@sarahcannon.com.'}, {'ForeName': 'James C-H', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan. Electronic address: chihyang@ntu.edu.tw.'}, {'ForeName': 'Marcis', 'Initials': 'M', 'LastName': 'Bajars', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. Electronic address: marcis.bajars@emdserono.com.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ruisi', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. Electronic address: mary.ruisi@emdserono.com.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Manitz', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. Electronic address: juliane.manitz@emdserono.com.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Aix Marseille University, CNRS, INSERM, CRCM, Marseille, France; Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: fabrice.barlesi@gustaveroussy.fr.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.01.026']
1261,33626615,[Evaluating the effectiveness of HIV/syphilis joint self-testing in promoting syphilis testing among men who have sex with men].,"Objective:  To evaluate the effectiveness of HIV/syphilis joint self-testing in promoting syphilis testing among men who have sex with men (MSM).  Methods:  In July 2019, the research participants were recruited through the Danlan website (https://www.danlan.org). Participants who met the selection criteria, and were randomly assigned into one of the three study groups (1∶1∶1) including HIV/syphilis joint self-testing group and lottery incentive self-testing group and control group. Self-test reagents were mailed to HIV/syphilis joint self-testing group and lottery incentive self-testing group, and the subjects in control group were encouraged to go to offline locations for testing. One month later, follow-up was conducted to evaluate the differences in the testing rates of syphilis among the three groups.  Results:  A total of 145 subjects were included in this study, including 48 in control group, 49 in HIV/syphilis joint self-testing group and 48 in lottery incentive self-testing group. During the follow-up period, the self-testing rate of syphilis was 74.4% (32/43) in HIV/syphilis joint self-testing group, 70.0% (28/40) in lottery incentive self-testing group and 36.4% (16/44) in control group. Multivariate logistic analysis revealed that the proportions of syphilis testing in HIV/syphilis joint self-testing group and lottery incentive self-testing group were 5.38 (95% CI : 2.06-14.04) times and 4.54 (95%  CI : 1.75-11.74) times higher than that in control group during the follow-up period.  Conclusions:  HIV/syphilis joint self-testing and lottery-incentives-prompted self-testing significantly increased the testing rate of syphilis in MSM, respectively. HIV/syphilis joint self-testing is feasible for promotion.",2021,"One month later, follow-up was conducted to evaluate the differences in the testing rates of syphilis among the three groups.  ","['In July 2019, the research participants were recruited through the Danlan website (https://www.danlan.org', 'men who have sex with men (MSM', 'Participants who met the selection criteria', 'A total of 145 subjects were included in this study, including 48 in control group, 49 in HIV/syphilis joint self-testing group and 48 in lottery incentive self-testing group', 'men who have sex with men']","['HIV/syphilis joint self-testing group and lottery incentive self-testing group and control group', 'HIV/syphilis joint self-testing', 'Self-test reagents were mailed to HIV/syphilis joint self-testing group and lottery incentive self-testing group, and the subjects in control group were encouraged to go to offline locations for testing']",[],"[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034760', 'cui_str': 'Reagents'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0450429', 'cui_str': 'Location'}]",[],145.0,0.0136017,"One month later, follow-up was conducted to evaluate the differences in the testing rates of syphilis among the three groups.  ","[{'ForeName': 'P Z', 'Initials': 'PZ', 'LastName': 'Zhao', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou 510095, China.'}, {'ForeName': 'W B', 'Initials': 'WB', 'LastName': 'Cheng', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou 510095, China.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou 510095, China; University of North Carolina at Chapel Hill, Project-China, Guangzhou 510095, China.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Zheng', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou 510095, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou 510095, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou 510095, China.'}]",Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi,['10.3760/cma.j.cn112338-20200624-00880']
1262,33630043,Balanced Opioid-free Anesthesia with Dexmedetomidine versus Balanced Anesthesia with Remifentanil for Major or Intermediate Noncardiac Surgery.,"BACKGROUND


It is speculated that opioid-free anesthesia may provide adequate pain control while reducing postoperative opioid consumption. However, there is currently no evidence to support the speculation. The authors hypothesized that opioid-free balanced anesthetic with dexmedetomidine reduces postoperative opioid-related adverse events compared with balanced anesthetic with remifentanil.
METHODS


Patients were randomized to receive a standard balanced anesthetic with either intraoperative remifentanil plus morphine (remifentanil group) or dexmedetomidine (opioid-free group). All patients received intraoperative propofol, desflurane, dexamethasone, lidocaine infusion, ketamine infusion, neuromuscular blockade, and postoperative lidocaine infusion, paracetamol, nefopam, and patient-controlled morphine. The primary outcome was a composite of postoperative opioid-related adverse events (hypoxemia, ileus, or cognitive dysfunction) within the first 48 h after extubation. The main secondary outcomes were episodes of postoperative pain, opioid consumption, and postoperative nausea and vomiting.
RESULTS


The study was stopped prematurely because of five cases of severe bradycardia in the dexmedetomidine group. The primary composite outcome occurred in 122 of 156 (78%) dexmedetomidine group patients compared with 105 of 156 (67%) in the remifentanil group (relative risk, 1.16; 95% CI, 1.01 to 1.33; P = 0.031). Hypoxemia occurred 110 of 152 (72%) of dexmedetomidine group and 94 of 155 (61%) of remifentanil group patients (relative risk, 1.19; 95% CI, 1.02 to 1.40; P = 0.030). There were no differences in ileus or cognitive dysfunction. Cumulative 0 to 48 h postoperative morphine consumption (11 mg [5 to 21] versus 6 mg [0 to 17]) and postoperative nausea and vomiting (58 of 157 [37%] versus 37 of 157 [24%]; relative risk, 0.64; 95% CI, 0.45 to 0.90) were both less in the dexmedetomidine group, whereas measures of analgesia were similar in both groups. Dexmedetomidine patients had more delayed extubation and prolonged postanesthesia care unit stay.
CONCLUSIONS


This trial refuted the hypothesis that balanced opioid-free anesthesia with dexmedetomidine, compared with remifentanil, would result in fewer postoperative opioid-related adverse events. Conversely, it did result in a greater incidence of serious adverse events, especially hypoxemia and bradycardia.
EDITOR’S PERSPECTIVE


",2021,There were no differences in ileus or cognitive dysfunction.,['Patients'],"['dexmedetomidine', 'Dexmedetomidine', 'standard balanced anesthetic with either intraoperative remifentanil plus morphine (remifentanil group) or dexmedetomidine (opioid-free group', 'remifentanil', 'Dexmedetomidine versus Balanced Anesthesia with Remifentanil', 'intraoperative propofol, desflurane, dexamethasone, lidocaine infusion, ketamine infusion, neuromuscular blockade, and postoperative lidocaine infusion, paracetamol, nefopam, and patient-controlled morphine']","['ileus or cognitive dysfunction', 'Cumulative 0 to 48 h postoperative morphine consumption', 'composite of postoperative opioid-related adverse events (hypoxemia, ileus, or cognitive dysfunction', 'episodes of postoperative pain, opioid consumption, and postoperative nausea and vomiting', 'severe bradycardia', 'delayed extubation and prolonged postanesthesia care unit stay', 'serious adverse events, especially hypoxemia and bradycardia', 'Hypoxemia', 'postoperative nausea and vomiting', 'analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C2936341', 'cui_str': 'Balanced Anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027556', 'cui_str': 'Nefopam'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.209579,There were no differences in ileus or cognitive dysfunction.,"[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Beloeil', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Garot', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lebuffe', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gerbaud', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Bila', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cuvillon', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dubout', 'Affiliation': ''}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Oger', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Nadaud', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Becret', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Coullier', 'Affiliation': ''}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Lecoeur', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Fayon', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Godet', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Mazerolles', 'Affiliation': ''}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Atallah', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sigaut', 'Affiliation': ''}, {'ForeName': 'Pierre-Marie', 'Initials': 'PM', 'LastName': 'Choinier', 'Affiliation': ''}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roquilly', 'Affiliation': ''}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Chanques', 'Affiliation': ''}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Esvan', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003725']
1263,33631357,"RAMIC: Design of a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of ramipril in patients with COVID-19.","BACKGROUND AND AIMS


Retrospective studies have shown that angiotensin-converting-enzyme (ACE) inhibitors are associated with a reduced risk of complications and mortality in persons with novel coronavirus disease 2019 (COVID-19). Thus, we aimed to examine the efficacy of ramipril, an ACE-inhibitor, in preventing ICU admission, mechanical ventilation and/or mortality while also minimizing the risk of transmission and use of personal protective equipment (PPE).
METHODS


RAMIC is a multicenter, randomized, double-blind, allocation-concealed, placebo-controlled trial comparing the efficacy of treatment with ramipril 2.5 mg orally daily compared to placebo for 14 days. The study population includes adult patients with COVID-19 who were admitted to a hospital or assessed in an emergency department or ambulatory clinic. Key exclusion criteria include ICU admission or need for mechanical ventilation at screening, use of an ACE inhibitor or angiotensin-receptor-II blocker within 7 days, glomerular filtration rate < 40 mL/min or a systolic blood pressure (BP) < 100 mmHg or diastolic BP < 65 mmHg. Patients are randomized 2:1 to receive ramipril (2.5 mg) or placebo daily. Informed consent and study visits occur virtually to minimize the risk of SARS-CoV-2 transmission and preserve PPE. The primary composite endpoint of ICU admission, invasive mechanical ventilation and death are adjudicated virtually.
CONCLUSIONS


RAMIC is designed to assess the efficacy of treatment with ramipril for 14 days to decrease ICU admission, mechanical ventilator use and mortality in patients with COVID-19 and leverages virtual study visits and endpoint adjudication to mitigate risk of infection and to preserve PPE (ClinicalTrials.gov, NCT04366050).",2021,Informed consent and study visits occur virtually to minimize the risk of SARS-CoV-2 transmission and preserve PPE.,"['adult patients with COVID-19 who were admitted to a hospital or assessed in an emergency department or ambulatory clinic', 'persons with novel coronavirus disease 2019 (COVID-19', 'patients with COVID-19']","['RAMIC', 'placebo', 'ACE inhibitor or angiotensin-receptor-II blocker', 'ramipril 2.5\u202fmg orally daily compared to placebo', 'ramipril', 'angiotensin-converting-enzyme (ACE) inhibitors']","['systolic blood pressure (BP', 'ICU admission, mechanical ventilator use and mortality', 'ICU admission, invasive mechanical ventilation and death are adjudicated virtually']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0003011', 'cui_str': 'Angiotensin II Receptor'}, {'cui': 'C0989605', 'cui_str': 'Ramipril 2.5 MG'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0042497', 'cui_str': 'Mechanical ventilator'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.362811,Informed consent and study visits occur virtually to minimize the risk of SARS-CoV-2 transmission and preserve PPE.,"[{'ForeName': 'Veeral', 'Initials': 'V', 'LastName': 'Ajmera', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, United States of America; NAFLD Research Center, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Wesley K', 'Initials': 'WK', 'LastName': 'Thompson', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Davey M', 'Initials': 'DM', 'LastName': 'Smith', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care & Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Ravindra L', 'Initials': 'RL', 'LastName': 'Mehta', 'Affiliation': 'Division of Nephrology-Hypertension, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Vaishal', 'Initials': 'V', 'LastName': 'Tolia', 'Affiliation': 'Department of Emergency Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Pharmacy, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Sriram', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Insel', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, California, United States of America; Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Collier', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Richards', 'Affiliation': 'NAFLD Research Center, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, United States of America; NAFLD Research Center, Department of Medicine, University of California San Diego, La Jolla, California, United States of America. Electronic address: roloomba@ucsd.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106330']
1264,33631355,Denosumab versus alendronate in long-term glucocorticoid users: A 12-month randomized controlled trial.,"OBJECTIVES


To compare the efficacy of denosumab and alendronate on raising spine bone mineral density (BMD) in long-term glucocorticoid (GC) users.
METHODS


Adult patients receiving long-term prednisolone (≥2.5 mg/day for ≥1 year) were recruited and randomized to either subcutaneous denosumab (60 mg/6 months) or oral alendronate (70 mg/week). BMD (lumbar spine, femoral neck, hip) and bone markers (serum P1NP and CTX) were measured at month 0, 6 and 12. The difference in spine BMD (primary outcome) at month 12 was compared between the two groups.
RESULTS


139 subjects were recruited (age 50.0 ± 12.7 years; 96% women): 69 assigned denosumab and 70 assigned alendronate. At entry, 73(53%) patients were osteoporotic and 82(59%) patients were naive to the bisphosphonates. Baseline clinical characteristics and BMD values were similar in the two groups. At month 12, a significant gain in mean BMD at the lumbar spine (+3.5 ± 2.5%; p<0.001), hip (+0.9 ± 2.8%; p=0.01) and femoral neck (+1.04 ± 4.1%; p=0.047); was observed in denosumab-treated patients, whereas the corresponding change was +2.5 ± 2.9% (p<0.001), +1.6 ± 2.7% (p<0.001) and + 1.5 ± 3.9% (p=0.002) in the alendronate group. The spine, but not the hip or femoral neck, BMD at month 12 was significantly higher in the denosumab than alendronate group after adjustment for baseline BMD values, age, sex, osteoporosis risk factors and the cumulative prednisolone doses received in one year. The drop in P1NP and CTX was significantly higher in the denosumab than alendronate group. Frequency of adverse events (AEs), including infections, was similar in the two treatment arms. Seven patients withdrew from the study but not related to AEs.
CONCLUSIONS


In patients receiving long-term GCs, denosumab is superior to alendronate in raising the spine BMD after 12 months. Both drugs are well-tolerated.",2021,The drop in P1NP and CTX was significantly higher in the denosumab than alendronate group.,"['≥2.5\u202fmg/day for ≥1\u202fyear', '139 subjects were recruited (age 50.0\u202f±\u202f12.7\u202fyears; 96% women): 69 assigned', 'Adult patients receiving', 'long-term glucocorticoid users']","['Denosumab versus alendronate', 'alendronate', 'subcutaneous denosumab', 'oral alendronate', 'denosumab', 'long-term prednisolone', 'denosumab and alendronate']","['mean BMD at the lumbar spine', 'Frequency of adverse events (AEs), including infections', 'BMD (lumbar spine, femoral neck, hip) and bone markers (serum P1NP and CTX', 'P1NP and CTX', 'spine BMD', 'femoral neck', 'hip or femoral neck, BMD', 'raising spine bone mineral density (BMD', 'BMD values']","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",139.0,0.109833,The drop in P1NP and CTX was significantly higher in the denosumab than alendronate group.,"[{'ForeName': 'Chi Chiu', 'Initials': 'CC', 'LastName': 'Mok', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong. Electronic address: ccmok2005@yahoo.com.'}, {'ForeName': 'Ling Yin', 'Initials': 'LY', 'LastName': 'Ho', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Stella Mei Tik', 'Initials': 'SMT', 'LastName': 'Leung', 'Affiliation': 'Department of Pathology, Queen Elizabeth Hospital, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Hoi Ning', 'Initials': 'HN', 'LastName': 'Cheung', 'Affiliation': 'Department of Pathology, Queen Elizabeth Hospital, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Sammy Pak Lam', 'Initials': 'SPL', 'LastName': 'Chen', 'Affiliation': 'Department of Pathology, Queen Elizabeth Hospital, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Kwok Man', 'Initials': 'KM', 'LastName': 'Ma', 'Affiliation': 'Department of Nuclear Medicine, Tuen Mun Hospital, Hong Kong.'}]",Bone,['10.1016/j.bone.2021.115902']
1265,33636401,Transcranial laser stimulation: Mitochondrial and cerebrovascular effects in younger and older healthy adults.,"BACKGROUND


Transcranial laser stimulation is a novel method of noninvasive brain stimulation found safe and effective for improving prefrontal cortex neurocognitive functions in healthy young adults. This method is different from electric and magnetic stimulation because it causes the photonic oxidation of cytochrome-c-oxidase, the rate-limiting enzyme for oxygen consumption and the major intracellular acceptor of photons from near-infrared light. This photobiomodulation effect promotes mitochondrial respiration, cerebrovascular oxygenation and neurocognitive function. Pilot studies suggest that transcranial photobiomodulation may also induce beneficial effects in aging individuals.
OBJECTIVES


Randomized, sham-controlled study to test photobiomodulation effects caused by laser stimulation on cytochrome-c-oxidase oxidation and hemoglobin oxygenation in the prefrontal cortex of 68 healthy younger and older adults, ages 18-85.
METHODS


Broadband near-infrared spectroscopy was used for the noninvasive quantification of bilateral cortical changes in oxidized cytochrome-c-oxidase and hemoglobin oxygenation before, during and after 1064-nm wavelength laser (IR-A laser, area: 13.6 cm 2 , power density: 250 mW/cm 2 ) or sham stimulation of the right anterior prefrontal cortex (Brodmann Area 10).
RESULTS


As compared to sham control, there was a significant laser-induced increase in oxidized cytochrome-c-oxidase during laser stimulation, followed by a significant post-stimulation increase in oxygenated hemoglobin and a decrease in deoxygenated hemoglobin. Furthermore, there was a greater laser-induced effect on cytochrome-c-oxidase with increasing age, while laser-induced effects on cerebral hemodynamics decreased with increasing age. No adverse laser effects were found.
CONCLUSION


The findings support the use of transcranial photobiomodulation for cerebral oxygenation and alleviation of age-related decline in mitochondrial respiration. They justify further research on its therapeutic potential in neurologic and psychiatric diseases.",2021,"As compared to sham control, there was a significant laser-induced increase in oxidized cytochrome-c-oxidase during laser stimulation, followed by a significant post-stimulation increase in oxygenated hemoglobin and a decrease in deoxygenated hemoglobin.","['younger and older healthy adults', 'healthy young adults', '68 healthy younger and older adults, ages 18-85']","['transcranial photobiomodulation', 'Transcranial laser stimulation', 'laser stimulation on cytochrome-c-oxidase oxidation and hemoglobin oxygenation', '1064-nm wavelength laser (IR-A laser, area: 13.6 cm 2 , power density: 250 mW/cm 2 ) or sham stimulation of the right anterior prefrontal cortex (Brodmann Area 10']","['mitochondrial respiration, cerebrovascular oxygenation and neurocognitive function', 'cerebral hemodynamics', 'adverse laser effects', 'oxygenated hemoglobin', 'deoxygenated hemoglobin', 'oxidized cytochrome-c-oxidase']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0010760', 'cui_str': 'Cytochrome c oxidase'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0599720', 'cui_str': 'Brodmann area'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0010760', 'cui_str': 'Cytochrome c oxidase'}]",,0.0291808,"As compared to sham control, there was a significant laser-induced increase in oxidized cytochrome-c-oxidase during laser stimulation, followed by a significant post-stimulation increase in oxygenated hemoglobin and a decrease in deoxygenated hemoglobin.","[{'ForeName': 'Celeste L', 'Initials': 'CL', 'LastName': 'Saucedo', 'Affiliation': 'Department of Psychology and Institute for Neuroscience, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Courtois', 'Affiliation': 'Department of Psychology and Institute for Neuroscience, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Wade', 'Affiliation': 'Department of Psychology and Institute for Neuroscience, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Kelley', 'Affiliation': 'Department of Psychology and Institute for Neuroscience, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Nusha', 'Initials': 'N', 'LastName': 'Kheradbin', 'Affiliation': 'Department of Psychology and Institute for Neuroscience, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychology and Institute for Neuroscience, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gonzalez-Lima', 'Affiliation': 'Department of Psychology and Institute for Neuroscience, University of Texas at Austin, Austin, TX, USA. Electronic address: gonzalezlima@utexas.edu.'}]",Brain stimulation,['10.1016/j.brs.2021.02.011']
1266,33639518,Effects of progressive muscle relaxation training with music therapy on sleep and anger of patients at Community Mental Health Center.,"OBJECTIVE


The objective is to examine the effects of progressive muscle relaxation training and music therapy applied to chronic psychiatric patients attending the Community Mental Health Center (CMHC) on their anger level and sleep quality.
METHODS


The sample of the study consisted of 66 chronic psychiatric patients (n = 32 in the control group; n = 34 in the intervention group). Progressive muscle relaxation training with music therapy were implemented in the intervention group as 2 sessions per week for 3 months.
RESULTS


A statistically significant difference was found between the pre-test and post-test mean scores of the intervention group (p ≤ .001). After the intervention, a statistically significant difference was found between the PSQI, anger-in, anger-out, anger-control, and trait anger scale scores of the two groups (p ≤ .001).
CONCLUSION


Relaxation training and music therapy are effective in controlling anger and increasing sleep quality in chronic psychiatric patients.
CLINICAL TRIAL NUMBER


NCT04620122.",2021,"After the intervention, a statistically significant difference was found between the PSQI, anger-in, anger-out, anger-control, and trait anger scale scores of the two groups (p ≤ .001).
","['chronic psychiatric patients attending the Community Mental Health Center (CMHC) on their anger level and sleep quality', 'chronic psychiatric patients', '66 chronic psychiatric patients (n\xa0=\xa032 in the control group; n\xa0=\xa034 in the intervention group', 'patients at Community Mental Health Center']","['progressive muscle relaxation training with music therapy', 'Relaxation training and music therapy', 'progressive muscle relaxation training and music therapy', 'Progressive muscle relaxation training with music therapy']","['sleep quality', 'PSQI, anger-in, anger-out, anger-control, and trait anger scale scores', 'sleep and anger']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",66.0,0.0280356,"After the intervention, a statistically significant difference was found between the PSQI, anger-in, anger-out, anger-control, and trait anger scale scores of the two groups (p ≤ .001).
","[{'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'İçel', 'Affiliation': 'Gaziantep Islamic Science and Technology University, Faculty of Health Sciences, Midwifery Department, Gaziantep, Turkey. Electronic address: icelsema@gmail.com.'}, {'ForeName': 'Ceyda', 'Initials': 'C', 'LastName': 'Başoğul', 'Affiliation': 'Adıyaman University, Faculty of Health Sciences, Department of Psychiatric Nursing, Adıyaman, Turkey. Electronic address: cbasogul@adiyaman.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101338']
1267,33647676,"Effect of guided imagery on anxiety, muscle pain, and vital signs in patients with COVID-19: A randomized controlled trial.","BACKGROUND


COVID-19 can lead to anxiety due to its high mortality rate. Patients with COVID-19 may suffer from muscle pain. This study aimed to determine the effect of guided imagery on anxiety, muscle pain, and vital signs in patients with COVID-19.
METHODS


110 patients with COVID-19 were recruited and randomly assigned to two control and intervention groups. Data were collected using the Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale. The intervention group received ten training sessions of guided imagery.
RESULTS


The results indicated a significant difference in the mean scores of state (t = -3.829, p < .001), trait anxiety (t = -2.946, p = .004), pain quality (t = -4.223, p < .001), pain intensity (t = -3.068, p = .003), and heart rate, systolic blood pressure, and oxygen saturation (p < .001) between the two groups after the intervention.
CONCLUSIONS


Guided imagery as a cost-effective method of complementary medicine is recommended to manage anxiety and pain in patients with COVID-19.",2021,"Data were collected using the Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale.","['110 patients with COVID-19', 'patients with COVID-19', 'Patients with COVID-19 may suffer from muscle pain']","['guided imagery', 'training sessions of guided imagery']","['trait anxiety', 'Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale', 'pain intensity', 'anxiety, muscle pain, and vital signs', 'mean scores of state', 'pain quality', 'heart rate, systolic blood pressure, and oxygen saturation']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",110.0,0.109641,"Data were collected using the Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale.","[{'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Parizad', 'Affiliation': 'Patient Safety Research Center, Clinical Research Institute, Nursing & Midwifery School, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Goli', 'Affiliation': 'Department of Medical-surgical Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: rasoulgoli94@gmail.com.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Faraji', 'Affiliation': 'Department of Medical-surgical Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mam-Qaderi', 'Affiliation': 'Department of Medical-surgical Nursing, School of Nursing and Midwifery, Islamic Azad University, Urmia Branch, Urmia, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Mirzaee', 'Affiliation': 'Department of Psychiatric Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Gharebaghi', 'Affiliation': 'Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Baghaie', 'Affiliation': 'Patient Safety Research Center, Clinical Research Institute, Nursing & Midwifery School, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Haedeh', 'Initials': 'H', 'LastName': 'Feizipour', 'Affiliation': 'Department of Medical Sicences, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mah-Monir', 'Initials': 'MM', 'LastName': 'Haghighi', 'Affiliation': 'Department of Medical Sicences, Urmia University of Medical Sciences, Urmia, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101335']
1268,33646565,Indirect Comparison of Lanadelumab and Intravenous C1-INH Using Data from the HELP and CHANGE Studies: Bayesian and Frequentist Analyses.,"BACKGROUND


Hereditary angioedema (HAE) with C1-esterase inhibitor (C1-INH) deficiency is a rare disease associated with painful, potentially fatal swelling episodes affecting subcutaneous or submucosal tissues. HAE attacks recur with unpredictable severity and frequency throughout patients' lives; long-term prophylaxis is essential for some patients. In the absence of head-to-head studies, indirect treatment comparison (ITC) of long-term prophylactic agents is a valid approach to evaluate comparative efficacy.
METHODS


We conducted an ITC using data from the placebo-controlled HELP study (assessing patients receiving lanadelumab 300 mg every 2 or 4 weeks) and the 12-week, parallel arm, crossover CHANGE study (assessing intravenous C1-INH). Outcomes of interest were attack rate ratio (ARR) and time to attack after day 0 (TTA0) and after day 70 (TTA70). Two ITC methodologies were used: a Bayesian approach using study results to update non-informative prior distributions to posterior distributions on relative treatment effects, and a frequentist approach using patient-level data from HELP and CHANGE to generate Poisson regressions (for ARR) and Cox models (for TTA0 and TT70).
RESULTS


Both Bayesian and frequentist analyses suggested that lanadelumab reduced HAE attack rate by 46-73% versus intravenous C1-INH. Relative to intravenous C1-INH, risk of first attack after day 0 was comparable between intravenous C1-INH and both lanadelumab doses; risk of first attack after day 70 was reduced by 81-83% with lanadelumab 300 mg every 2 weeks, compared with C1-INH.
CONCLUSIONS


Findings from these two ITC methodologies support the favorable efficacy of lanadelumab in reducing the HAE attack rate and extending attack-free intervals in patients with HAE.",2021,"Relative to intravenous C1-INH, risk of first attack after day 0 was comparable between intravenous C1-INH and both lanadelumab doses; risk of first attack after day 70 was reduced by 81-83% with lanadelumab 300 mg every 2 weeks, compared with C1-INH.
",['patients with HAE'],"['lanadelumab', 'Lanadelumab and Intravenous C1-INH', 'placebo']","['HAE attack rate', 'HAE attack rate and extending attack-free intervals', 'attack rate ratio (ARR) and time to attack after day 0 (TTA0) and after day 70 (TTA70']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}]","[{'cui': 'C4505508', 'cui_str': 'lanadelumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009500', 'cui_str': 'Complement Component 1 Inactivator Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0293967,"Relative to intravenous C1-INH, risk of first attack after day 0 was comparable between intravenous C1-INH and both lanadelumab doses; risk of first attack after day 70 was reduced by 81-83% with lanadelumab 300 mg every 2 weeks, compared with C1-INH.
","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Mendivil', 'Affiliation': 'Takeda Pharmaceuticals International AG, A Takeda Company, Zurich, Switzerland. joan.mendivil@takeda.com.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Malmenäs', 'Affiliation': 'ICON plc, Stockholm, Sweden.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Haeussler', 'Affiliation': 'ICON plc, Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hunger', 'Affiliation': 'ICON plc, Munich, Germany.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Jain', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Lexington, MA, USA.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Devercelli', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Lexington, MA, USA.'}]",Drugs in R&D,['10.1007/s40268-021-00337-4']
1269,33658007,Impact of goal-directed hemodynamic management on the incidence of acute kidney injury in patients undergoing partial nephrectomy: a pilot randomized controlled trial.,"BACKGROUND


The incidence of acute kidney injury (AKI) remains high after partial nephrectomy. Ischemia-reperfusion injury produced by renal hilum clamping during surgery might have contributed to the development of AKI. In this study we tested the hypothesis that goal-directed fluid and blood pressure management may reduce AKI in patients following partial nephrectomy.
METHODS


This was a pilot randomized controlled trial. Adult patients who were scheduled to undergo partial nephrectomy were randomized into two groups. In the intervention group, goal-directed hemodynamic management was performed from renal hilum clamping until end of surgery; the target was to maintain stroke volume variation < 6%, cardiac index 3.0-4.0 L/min/m 2  and mean arterial pressure > 95 mmHg with crystalloid fluids and infusion of dobutamine and/or norepinephrine. In the control group, hemodynamic management was performed according to routine practice. The primary outcome was the incidence of AKI within the first 3 postoperative days.
RESULTS


From June 2016 to January 2017, 144 patients were enrolled and randomized (intervention group, n = 72; control group, n = 72). AKI developed in 12.5% of patients in the intervention group and in 20.8% of patients in the control group; the relative reduction of AKI was 39.9% in the intervention group but the difference was not statistically significant (relative risk 0.60, 95% confidence interval [CI] 0.28-1.28; P = 0.180). No significant differences were found regarding AKI classification, change of estimated glomerular filtration rate over time, incidence of postoperative 30-day complications, postoperative length of hospital stay, as well as 30-day and 6-month mortality between the two groups.
CONCLUSION


For patients undergoing partial nephrectomy, goal-directed circulatory management during surgery reduced postoperative AKI by about 40%, although not significantly so. The trial was underpowered. Large sample size randomized trials are needed to confirm our results.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT02803372 . Date of registration: June 6, 2016.",2021,"AKI developed in 12.5% of patients in the intervention group and in 20.8% of patients in the control group; the relative reduction of AKI was 39.9% in the intervention group but the difference was not statistically significant (relative risk 0.60, 95% confidence interval [CI] 0.28-1.28; P = 0.180).","['patients undergoing partial nephrectomy', 'patients following partial nephrectomy', 'Adult patients who were scheduled to undergo partial nephrectomy', 'patients undergoing partial nephrectomy, goal-directed circulatory management during surgery', 'From June 2016 to January 2017, 144 patients were enrolled and randomized (intervention group, n\u2009=\u200972; control group, n\u2009=\u200972']","['goal-directed hemodynamic management', 'dobutamine and/or norepinephrine']","['AKI', 'relative reduction of AKI', 'incidence of AKI within the first 3 postoperative days', 'reduced postoperative AKI', 'AKI classification, change of estimated glomerular filtration rate over time, incidence of postoperative 30-day complications, postoperative length of hospital stay, as well as 30-day and 6-month mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",144.0,0.451577,"AKI developed in 12.5% of patients in the intervention group and in 20.8% of patients in the control group; the relative reduction of AKI was 39.9% in the intervention group but the difference was not statistically significant (relative risk 0.60, 95% confidence interval [CI] 0.28-1.28; P = 0.180).","[{'ForeName': 'Qiong-Fang', 'Initials': 'QF', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Kong', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhen-Zhen', 'Initials': 'ZZ', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Huai-Jin', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Dong-Liang', 'Initials': 'DL', 'LastName': 'Mu', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Dong-Xin', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China. dxwang65@bjmu.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-021-01288-8']
1270,33657998,"Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial.","BACKGROUND


Non - pharmacological management of migraine, tension-type headache (TTH), and cervicogenic headache (CGH) may include spinal manual therapy and exercise. Mulligan Manual Therapy (MMT) utilizes a protocol of headache elimination procedures to manage headache parameters and associated disability, but has only been evaluated in CGH. There is little evidence for its effectiveness in migraine and TTH. This study aims to determine the effectiveness of MMT and exercise over exercise and placebo in the management of migraine, TTH, and CGH.
METHODS


This pragmatic trial is designed as a prospective, three-armed randomised controlled trial in a clinical setting provided at a general hospital physiotherapy department. Two hundred ninety-seven participants with a diagnosis of migraine, TTH or CGH based on published headache classification guidelines will be included. An assessor blind to group allocation will measure outcomes pre-and post-intervention as well as 3 and 6 months after commencement of treatment. Participants will be allocated to one of the three groups: MMT and exercise; placebo and exercise; and exercise alone. The primary outcome measure is headache frequency. Secondary outcome measures are headache duration and intensity, medication intake, pressure pain threshold (PPT), range of motion recorded with the flexion rotation test, and headache disability recorded with Headache Activities of Daily Living Index (HADLI). The intention-to-treat principle will be followed for statistical analysis. Between groups differences for all outcome measures at baseline and at reassessment points and 95% confidence intervals will be calculated using a mixed model ANOVA. Post hoc tests will be conducted to identify any significant difference between groups and over time.
DISCUSSION


This pragmatic study will provide evidence for the effectiveness of MMT when compared with a placebo intervention and exercise on headache frequency, intensity, and disability. Limitations are that baseline evaluation of headache parameters may be affected by recall bias. External validity will be limited to the population with a minimum 1-year history of headache. The HADLI is not yet extensively evaluated for its psychometric properties and association between PPT and headache parameters is lacking. Performance bias is inevitable as a single therapist will be delivering all interventions.
TRIAL REGISTRATION


The trial was registered prospectively under the Clinical Trial Registry India (Registration number: CTRI/2019/06/019506 , dated on 03/06/2019). .",2021,"This pragmatic study will provide evidence for the effectiveness of MMT when compared with a placebo intervention and exercise on headache frequency, intensity, and disability.","['Two hundred ninety-seven participants with a diagnosis of migraine, TTH or CGH based on published headache classification guidelines will be included', 'patients with migraine, tension-type headache and cervicogenic headache - a protocol']","['MMT and exercise over exercise and placebo', 'Mulligan manual therapy over exercise', 'MMT and exercise; placebo and exercise; and exercise alone', 'Mulligan Manual Therapy (MMT', 'placebo intervention and exercise', 'MMT']","['headache frequency, intensity and disability', 'migraine, TTH, and CGH', 'headache frequency, intensity, and disability', 'headache frequency', 'headache duration and intensity, medication intake, pressure pain threshold (PPT), range of motion recorded with the flexion rotation test, and headache disability recorded with Headache Activities of Daily Living Index (HADLI']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0796358', 'cui_str': 'Comparative Genome Hybridization'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0458101', 'cui_str': 'Cervicogenic headache'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0796358', 'cui_str': 'Comparative Genome Hybridization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}, {'cui': 'C0451227', 'cui_str': 'Index of activities of daily living'}]",297.0,0.322908,"This pragmatic study will provide evidence for the effectiveness of MMT when compared with a placebo intervention and exercise on headache frequency, intensity, and disability.","[{'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Satpute', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Smt. Kashibai Navale College of Physiotherapy, Off Westerly by Pass, Narhe, Pune, Maharashatra, 411041, India. Kiran_ptist@yahoo.co.in.'}, {'ForeName': 'Nilima', 'Initials': 'N', 'LastName': 'Bedekar', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Sancheti Institute College of Physiotherapy, Thube Park, Shivaji Nagar, Pune, Maharashatra, 411001, India.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Hall', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, P.O. Box U1987, Perth, WA, 6845, Australia.'}]",BMC musculoskeletal disorders,['10.1186/s12891-021-04105-y']
1271,33656816,Pilot Study of a Brief Sleep Intervention for Suicidal Ideation in Bipolar Disorder.,"OBJECTIVE


We investigated the feasibility and acceptability of a brief sleep intervention and sleep monitoring device in bipolar disorder (BD), as well as the intervention's effectiveness in reducing suicidal ideation through improved sleep quality and duration.
METHODS


Participants (N=13) with BD received 4 sessions of cognitive-behavioral therapy for sleep disturbance and completed assessments of the intervention and sleep device acceptability, mood, suicidal ideation, and sleep at pretreatment and posttreatment.
RESULTS


Feasibility and acceptability of the intervention were high at both pretreatment and posttreatment and did not significantly change by the intervention's conclusion, although participants reported being significantly more likely to recommend the intervention to others at posttreatment. The sleep device was easy to understand, wear, and did not interfere with participants' sleep. Suicidal ideation and depressive symptoms significantly decreased from pretreatment to posttreatment (P<0.05). There were small, but not significant, improvements in the percentage of time spent in stable sleep and total average nightly sleep.
CONCLUSION


The potential of this intervention for reducing suicidal ideation and improving sleep is promising, but future research is warranted.",2021,"RESULTS


Feasibility and acceptability of the intervention were high at both pretreatment and posttreatment and did not significantly change by the intervention's conclusion, although participants reported being significantly more likely to recommend the intervention to others at posttreatment.","['Participants (N=13) with BD received', 'bipolar disorder (BD', 'Suicidal Ideation in Bipolar Disorder']","['Brief Sleep Intervention', 'brief sleep intervention and sleep monitoring device', '4 sessions of cognitive-behavioral therapy']","['feasibility and acceptability', 'sleep quality and duration', 'suicidal ideation and improving sleep', 'Suicidal ideation and depressive symptoms', 'sleep device acceptability, mood, suicidal ideation, and sleep', 'percentage of time spent in stable sleep and total average nightly sleep']","[{'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",13.0,0.0356027,"RESULTS


Feasibility and acceptability of the intervention were high at both pretreatment and posttreatment and did not significantly change by the intervention's conclusion, although participants reported being significantly more likely to recommend the intervention to others at posttreatment.","[{'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': ''}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Janos', 'Affiliation': ''}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Pegg', 'Affiliation': ''}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Montana', 'Affiliation': ''}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Bianchi', 'Affiliation': ''}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000528']
1272,33639484,Acoustic enhancement of slow wave sleep on consecutive nights improves alertness and attention in chronically short sleepers.,"INTRODUCTION


Chronic sleep restriction has been linked to occupational errors and motor vehicle crashes. Enhancing slow wave sleep may alleviate some of the cognitive deficits associated with chronic sleep restriction. However, the extent to which acoustic stimulation of slow wave activity (SWA) may improve alertness and attention is not well established, particularly with respect to consecutive nights of exposure.
METHODS


Twenty-five healthy adults (32.9 ± 8.2 years; 16 female) who self-restricted their sleep during workdays participated in a randomized, double-blind, cross-over study. Participants wore an automated acoustic stimulation device for two consecutive nights. Acoustic tones (50 ms long) were delivered on the up-phase of the slow wave first and then at constant 1-s inter-tone-intervals once N3 was identified (STIM), until an arousal or shift to another sleep stage occurred, or at inaudible decibels during equivalent stimulation periods (SHAM). Subjective alertness/fatigue (KSS, Samn-Perelli) was assessed across both days, and objective measures of alertness (MSLT) and attention (PVT) were assessed after two nights of stimulation.
RESULTS


After one night of acoustic stimulation, increased slow wave energy was observed in 68% of participants, with an average significant increase of 17.7% (p = 0.01), while Night 2 was associated with a 22.2% increase in SWA (p = 0.08). SWE was highly stable across the two nights of STIM (ICC 0.93, p < 0.001), and around half (56%) of participants were consistently classified as responders (11/25) or non-responders (3/25). Daytime testing showed that participants felt more alert and awake following each night of acoustic stimulation (p < 0.05), with improved objective attention across the day following two nights of acoustic stimulation.
DISCUSSION


Consecutive nights of acoustic stimulation enhanced SWA on both nights, and improved next day alertness and attention. Given large individual differences, we highlight the need to examine both the long-term effects of stimulation, and to identify inter-individual differences in acoustic stimulation response. Our findings suggest that the use of an acoustic device to enhance slow wave sleep may alleviate some of the deficits in alertness and attention typically associated with sleep restriction.",2021,"Daytime testing showed that participants felt more alert and awake following each night of acoustic stimulation (p < 0.05), with improved objective attention across the day following two nights of acoustic stimulation.
","['Twenty-five healthy adults (32.9\xa0±\xa08.2 years; 16 female) who self-restricted their sleep during workdays participated', 'chronically short sleepers']",['automated acoustic stimulation device'],"['Acoustic tones', 'objective attention', 'SWA', 'Daytime testing', 'Subjective alertness/fatigue (KSS, Samn-Perelli', 'SWE', 'objective measures of alertness (MSLT) and attention (PVT', 'slow wave energy']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0751509', 'cui_str': 'Short-sleeper'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",25.0,0.0783764,"Daytime testing showed that participants felt more alert and awake following each night of acoustic stimulation (p < 0.05), with improved objective attention across the day following two nights of acoustic stimulation.
","[{'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Diep', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 3800, Clayton, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, 3800, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Garcia-Molina', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA; Department of Psychiatry, University of Wisconsin-Madison, WI, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Jasko', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Manousakis', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 3800, Clayton, Australia.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Ostrowski', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 3800, Clayton, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, 3800, Australia. Electronic address: clare.anderson@monash.edu.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.044']
1273,33656064,A prospective and randomized clinical trial evaluating the effectiveness of ART restorations with high-viscosity glass-ionomer cement versus conventional restorations with resin composite in Class II cavities of permanent teeth: two-year follow-up.,"OBJECTIVE


To compare the effectiveness of ART restorations using High Viscosity Glass-ionomer cement (HVGIC) with conventional restorations using resin composite in Class II cavities of permanent teeth, in a 2-year follow-up.
METHODOLOGY


Seventy-seven restorations were made with each restorative material, Equia Fil-GC Corporation (ART restorations) and Z350-3M (conventional restoration), in 54 participants in this parallel and randomized clinical trial. Restorations were evaluated at 6 months, 1 and 2 years using the ART and the modified United States Public Health Service (USPHS) criteria. Chi-square test and Survival Analysis (p<0.05) were used for statistical analysis.
RESULTS


The success rates for ART restorations were 98.7% (6 months) and 95.8% (1 year) for both criteria. At 2 years, success rate was 92% and 90.3% when scored by the modified USPHS and ART criteria (p=0.466), respectively. The success rates for conventional restorations were 100% (6 months), 98.7% (1 year) and 91.5% (2 years) for both assessment criteria. ART restorations presented a lower survival rate by the criterion of ART (83.7%) when compared to the modified USPHS criterion of (87.8%), after 2 years (p=0.051). The survival of conventional restorations was 90.7% for both evaluation criteria.
CONCLUSION


At the 2-years follow-up evaluation, no statistically significant difference was observed between the success rate of ART restorations with HVGIC compared to conventional restorations with resin composite in Class II cavities of permanent teeth.",2021,"The success rates for conventional restorations were 100% (6 months), 98.7% (1 year) and 91.5% (2 years) for both assessment criteria.","['Seventy-seven restorations were made with each', 'Class II cavities of permanent teeth']","['ART restorations using High Viscosity Glass-ionomer cement (HVGIC', 'HVGIC', 'ART restorations with high-viscosity glass-ionomer cement', 'restorative material, Equia Fil-GC Corporation (ART restorations) and Z350-3M (conventional restoration']","['success rate of ART restorations', 'success rate', 'success rates for conventional restorations', 'survival rate', 'survival of conventional restorations', 'success rates for ART restorations']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C4085648', 'cui_str': 'Tagalog language'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",77.0,0.093848,"The success rates for conventional restorations were 100% (6 months), 98.7% (1 year) and 91.5% (2 years) for both assessment criteria.","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Menezes-Silva', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia de Bauru, Departamento de Materiais Dentários, Endodontia e Dentística, Bauru, SP, Brasil.'}, {'ForeName': 'Sofia R Maito', 'Initials': 'SRM', 'LastName': 'Velasco', 'Affiliation': 'Universidade de São Paulo, Faculdade de Saúde Pública, São Paulo, SP, Brasil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'BRESCIANi', 'Affiliation': 'Universidade Estadual Paulista (UNESP), Instituto de Ciências e Tecnologia, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Roosevelt da Silva', 'Initials': 'RDS', 'LastName': 'Bastos', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia de Bauru, Departamento de Materiais Dentários, Endodontia e Dentística, Bauru, SP, Brasil.'}, {'ForeName': 'Maria Fidela de Lima', 'Initials': 'MFL', 'LastName': 'Navarro', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia de Bauru, Departamento de Materiais Dentários, Endodontia e Dentística, Bauru, SP, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0609']
1274,33666595,"Acute Inflammatory, Cortisol, and Soreness Responses to Supramaximal Accentuated Eccentric Loading.","ABSTRACT


Merrigan, JJ and Jones, MT. Acute inflammatory, cortisol, and soreness responses to supramaximal accentuated eccentric loading. J Strength Cond Res 35(2S): S107-S113, 2021-The purpose was to determine differences in time under tension, cortisol, inflammation, and perceived soreness between accentuated eccentric (AEL) and traditional loading (TRA) resistance exercise protocols. Resistance-trained men (n = 21) completed the AEL and TRA protocols in a random order, separated by 48 hours (sets × reps at eccentric/concentric) as follows: AEL65, 3 × 5 at 120/65% 1 repetition maximum (RM); AEL80, 3 × 3 at 120/80% 1RM; TRA65, 3 × 5 at 65/65% 1RM; and TRA80, 3 × 3 at 80/80% 1RM. Four linear position transducers measured eccentric time under tension (ETUT) and total time under tension (TTUT). Ultrasonography measured vastus lateralis muscle thickness and echo intensity at baseline and immediately post-exercise. Salivary cortisol was assessed at baseline, 0-, 15-, 30-, and 60-minute post-exercise. Perceived soreness was assessed at baseline, 24-, and 48-hours post-exercise. During rep 1, AEL65 and AEL80 had longer ETUT and TTUT than TRA65 (p ≤ 0.002) and TRA80 (p ≤ 0.008), respectively. However, AEL65 had shorter ETUT (reps 3-5) and TTUT (reps 3-5) than TRA65 (p ≤ 0.043). Similarly, ETUT (reps 2-3) and TTUT (rep 3) was shorter in AEL80 than TRA80 (p ≤ 0.045). However, there was no protocol effect for ETUT and TTUT (p > 0.05). Muscle thickness changes were trivial after each protocol (AEL80, d = 0.19; TRA80, d = 0.15; AEL65, d = 0.24; TRA65, d = 0.23), but changes in echo intensity were moderate (AEL80, d = 0.61; TRA80, d = 0.61; AEL65, d = 0.61; TRA65, d = 0.76). Salivary cortisol decreased below baseline at 30- and 60-minute post-exercise (p ≤ 0.006). Perceived soreness elevated from baseline to 24 hours for AEL80 (p = 0.006). The inflammatory, cortisol, and soreness responses after AEL were either low or similar to TRA, indicating similar recovery patterns between protocols.",2021,Salivary cortisol decreased below baseline at 30- and 60-minute post-exercise (p ≤ 0.006).,['Resistance-trained men (n = 21) completed the'],"['AEL and TRA protocols', 'J Strength Cond Res 35(2S']","['Perceived soreness', 'Ultrasonography measured vastus lateralis muscle thickness and echo intensity', 'Salivary cortisol', 'inflammatory, cortisol, and soreness responses', 'time under tension, cortisol, inflammation, and perceived soreness between accentuated eccentric (AEL) and traditional loading (TRA) resistance exercise protocols', 'Acute inflammatory, cortisol, and soreness responses', 'Muscle thickness changes', 'eccentric time under tension (ETUT) and total time under tension (TTUT', 'Acute Inflammatory, Cortisol, and Soreness Responses', 'changes in echo intensity', 'Perceived soreness elevated']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0023440', 'cui_str': 'Acute myeloid leukemia, M6 type'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1997416', 'cui_str': 'Accentuated'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0486506,Salivary cortisol decreased below baseline at 30- and 60-minute post-exercise (p ≤ 0.006).,"[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Merrigan', 'Affiliation': 'School of Kinesiology, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Jones', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003764']
1275,33664528,"The Effects of Cooperative Learning on Peer Relations, Academic Support, and Engagement in Learning Among Students of Color.","Despite  Brown vs. Board of Education , prejudice still exists in the American school system. These attitudes can give rise to negative social experiences for students of color (i.e., discrimination), negatively impacting their mental and physical health and creating disparities in educational outcomes. Rather than seeking to ameliorate these negative experiences, our approach attempts to address the underlying prejudices and, in so doing, reduce these disparities. Using 4 waves of data from a cluster randomized trial ( N  = 15 middle schools, 1,890 students, 47.1% female, 75.2% White), we hypothesized that cooperative learning, which has been shown to reduce prejudice in previous research, would create positive gains in peer relatedness, perceptions of academic support, and engagement in learning, and that gains would be larger for students of color; our results confirmed these hypotheses. Our findings highlight the potential role of cooperative learning in reducing disparities and creating greater equity in education.",2020,"Using 4 waves of data from a cluster randomized trial ( N  = 15 middle schools, 1,890 students, 47.1% female, 75.2% White), we hypothesized that cooperative learning, which has been shown to reduce prejudice in previous research, would create positive gains in peer relatedness, perceptions of academic support, and engagement in learning, and that gains would be larger for students of color; our results confirmed these hypotheses.","['Students of Color', 'Using 4 waves of data from a cluster randomized trial ( N  = 15 middle schools, 1,890 students, 47.1% female, 75.2% White']",['Cooperative Learning'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",[],1890.0,0.016565,"Using 4 waves of data from a cluster randomized trial ( N  = 15 middle schools, 1,890 students, 47.1% female, 75.2% White), we hypothesized that cooperative learning, which has been shown to reduce prejudice in previous research, would create positive gains in peer relatedness, perceptions of academic support, and engagement in learning, and that gains would be larger for students of color; our results confirmed these hypotheses.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Van Ryzin', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Cary J', 'Initials': 'CJ', 'LastName': 'Roseth', 'Affiliation': 'Michigan State University, East Lansing, MI.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McClure', 'Affiliation': 'University of Oregon, Eugene, OR.'}]",The Journal of educational research,['10.1080/00220671.2020.1806016']
1276,33663059,Efficacy evaluation of acupuncture combined with Liujunzi Decoction in the treatment of functional dyspepsia: A protocol of randomized controlled trial.,"BACKGROUND


Functional dyspepsia (FD) is a common and frequently-occurring disease in internal medicine. It is known that Liujunzi decoction and acupuncture are widely used in the treatment of FD, but there are few studies on the combination of Liujunzi decoction and acupuncture in the treatment of FD, and its safety and efficacy are still controversial. Therefore, the purpose of this study is to evaluate the efficacy and safety of acupuncture combined with Liujunzi decoction in the treatment of FD.
METHODS


We designed a prospective randomized controlled trial. The study protocol was approved by the Clinical Research Ethics Committee of our hospital. Patients with FD were randomly assigned to the treatment group of acupuncture combined with Liujunzi Decoction (the experimental group) and the treatment group of Liujunzi Decoction (the control group) in a ratio of 1:1. Outcome indicators were Nepean Dyspepsia Index, the MOS item short from health survey, and adverse reactions. Finally, SPSS 18.0 software would be used for statistical analysis of the data.
DISCUSSION


This study will evaluate the efficacy and safety of acupuncture combined with Liujunzi Decoction in the treatment of FD and provide clinical basis for the use of acupuncture combined with Liujunzi Decoction in the treatment of FD.
OSF REGISTRATION NUMBER


DOI 10.17605/OSF.IO/67GKN.",2021,"This study will evaluate the efficacy and safety of acupuncture combined with Liujunzi Decoction in the treatment of FD and provide clinical basis for the use of acupuncture combined with Liujunzi Decoction in the treatment of FD.
","['functional dyspepsia', 'Patients with FD']","['acupuncture combined with Liujunzi Decoction', 'Liujunzi Decoction', 'Liujunzi decoction and acupuncture', 'acupuncture combined with Liujunzi decoction']","['Nepean Dyspepsia Index, the MOS item short from health survey, and adverse reactions', 'efficacy and safety']","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1959069', 'cui_str': 'liujunzi'}]","[{'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.11913,"This study will evaluate the efficacy and safety of acupuncture combined with Liujunzi Decoction in the treatment of FD and provide clinical basis for the use of acupuncture combined with Liujunzi Decoction in the treatment of FD.
","[{'ForeName': 'Yulan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Fifth Hospital in Wuhan.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': ""Wuhan Children's Welfare Home, Wuhan, Hubei Province, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Long', 'Affiliation': 'Fifth Hospital in Wuhan.'}, {'ForeName': 'Weichen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Fifth Hospital in Wuhan.'}, {'ForeName': 'Yuqiong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Wuhan Children's Welfare Home, Wuhan, Hubei Province, China.""}]",Medicine,['10.1097/MD.0000000000024528']
1277,33631604,Per- and polyfluoroalkyl substances and calcifications of the coronary and aortic arteries in adults with prediabetes: Results from the diabetes prevention program outcomes study.,"BACKGROUND


Per- and polyfluoroalkyl substances (PFAS) are endocrine disrupting chemicals that have been associated with cardiovascular risk factors including elevated body weight and hypercholesterolemia. Therefore, PFAS may contribute to the development of atherosclerosis and cardiovascular disease (CVD). However, no previous study has evaluated associations between PFAS exposure and arterial calcification.
METHODS AND RESULTS


This study used data from 666 prediabetic adults enrolled in the Diabetes Prevention Program trial who had six PFAS quantified in plasma at baseline and two years after randomization, as well as measurements of coronary artery calcium (CAC) and ascending (AsAC) and descending (DAC) thoracic aortic calcification 13-14 years after baseline. We performed multinomial regression to test associations between PFAS and CAC categorized according to Agatston score [low (<10), moderate (11-400) and severe (>400)]. We used logistic regression to assess associations between PFAS and presence of AsAC and DAC. We adjusted models for baseline sex, age, BMI, race/ethnicity, cigarette smoking, education, treatment assignment (placebo or lifestyle intervention), and statin use. PFAS concentrations were similar to national means; 53.9% of participants had CAC > 11, 7.7% had AsAC, and 42.6% had DAC. Each doubling of the mean sum of plasma concentrations of linear and branched isomers of perfluorooctane sulfonic acid (PFOS) was associated with 1.49-fold greater odds (95% CI: 1.01, 2.21) of severe versus low CAC. This association was driven mainly by the linear (n-PFOS) isomer [1.54 (95% CI: 1.05, 2.25) greater odds of severe versus low CAC]. Each doubling of mean plasma N-ethyl-perfluorooctane sulfonamido acetic acid concentration was associated with greater odds of CAC in a dose-dependent manner [OR = 1.26 (95% CI:1.08, 1.47) for moderate CAC and OR = 1.37 (95% CI:1.07, 1.74) for severe CAC, compared to low CAC)]. Mean plasma PFOS and n-PFOS were also associated with greater odds of AsAC [OR = 1.67 (95% CI:1.10, 2.54) and OR = 1.70 (95% CI:1.13, 2.56), respectively], but not DAC. Other PFAS were not associated with outcomes.
CONCLUSIONS


Prediabetic adults with higher plasma concentrations of select PFAS had higher risk of coronary and thoracic aorta calcification. PFAS exposure may be a risk factor for adverse cardiovascular health among high-risk populations.",2021,Mean plasma PFOS and n-PFOS were also associated with greater odds of AsAC [OR = 1.67,"['adults with prediabetes', '666 prediabetic adults enrolled in the Diabetes Prevention Program trial who had six PFAS quantified in plasma at baseline and two years after randomization, as well as measurements of coronary artery calcium (CAC) and ascending (AsAC) and descending (DAC) thoracic aortic calcification 13-14\xa0years after baseline']",[],"['Mean plasma PFOS and n-PFOS', 'plasma concentrations of linear and branched isomers of perfluorooctane sulfonic acid (PFOS', 'risk of coronary and thoracic aorta calcification', 'mean plasma N-ethyl-perfluorooctane sulfonamido acetic acid concentration', 'PFAS concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0022203', 'cui_str': 'Isomerism'}, {'cui': 'C0172926', 'cui_str': 'perfluorooctane sulfonic acid'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1522460', 'cui_str': 'Thoracic aorta structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0166273', 'cui_str': 'Perfluorooctane'}, {'cui': 'C0429922', 'cui_str': 'Acetic acid concentration'}]",666.0,0.0721227,Mean plasma PFOS and n-PFOS were also associated with greater odds of AsAC [OR = 1.67,"[{'ForeName': 'Citlalli', 'Initials': 'C', 'LastName': 'Osorio-Yáñez', 'Affiliation': 'Instituto de Investigaciones Biomédicas, Universidad Nacional Autonoma de Mexico, Ciudad de Mexico, Mexico. Electronic address: citlalli.osorio@iibiomedicas.unam.mx.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sanchez-Guerra', 'Affiliation': 'Department of Developmental Neurobiology, National Institute of Perinatology, Mexico City, Mexico. Electronic address: msanchezguerra@alumni.harvard.edu.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Pi-I D', 'Initials': 'PD', 'LastName': 'Lin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Hauser', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Ken P', 'Initials': 'KP', 'LastName': 'Kleinman', 'Affiliation': 'Department of Biostatistics, School of Public Health and Human Sciences, University of Massachusetts Amherst, Amherst, MA, USA.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Hivert', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Abby F', 'Initials': 'AF', 'LastName': 'Fleisch', 'Affiliation': 'Pediatric Endocrinology and Diabetes, Maine Medical Center, Portland, ME, USA; Center for Outcomes Research and Evaluation, Maine Medical Center Research Institute, Portland, ME, USA.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Webster', 'Affiliation': 'Department of Environmental Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}]",Environment international,['10.1016/j.envint.2021.106446']
1278,33631541,Piloting a brief intervention plus mobile boosters for drug use among emerging adults receiving emergency department care.,"PURPOSE


There are few efficacious prevention interventions for emerging adults (ages 18-25) drug use and concomitant risks (e.g., sexual risk behaviors). We developed and evaluated the feasibility and acceptability of an Emergency Department (ED)-initiated brief intervention (BI) combined with booster messaging as a clinician-extender primarily focusing on drug use, with a secondary focus on condomless sex. We examined descriptive outcomes of alcohol, drug use, and condomless sex.
PROCEDURES


We recruited N = 63 emerging adults who used drugs (primarily cannabis) from an ED (72.4 % participation rate). Their mean age was 21.7 years (SD = 2.3); 67 % were female and 52.4 % were Black/African American. Participants randomized to the intervention (N = 31) received a BI and 28 days of tailored booster messaging (based on drug use motives) daily, and the control condition received a community resource brochure. A post-test occurred at 1-month with a follow-up at 2-months.
RESULTS


The intervention was well-received (83.9 % allocated completed the BI) with 79 % overall liking the BI and 71 % finding it helpful to discuss substances. Mean ratings of booster messages were >4.0 (5-point scale); 77 % liked the daily messages and 91 % found them helpful. Descriptively, the intervention group evidenced absolute reductions over time on alcohol outcomes, cannabis use, and condomless sex.
CONCLUSIONS


This BI with booster messages was feasible and acceptable in the target population of emerging adults who use drugs (i.e., mostly cannabis). This intervention model, initiated during a healthcare visit and accompanied by a clinician-extender, should be tested in a future fully-powered trial.",2021,Mean ratings of booster messages were >4.0 (5-point scale); 77 % liked the daily messages and 91 % found them helpful.,"['adults receiving emergency department care', 'Their mean age was 21.7 years (SD = 2.3); 67 % were female and 52.4 % were Black/African American', 'We recruited N = 63 emerging adults who used drugs (primarily cannabis) from an ED (72.4 % participation rate']","['Emergency Department (ED)-initiated brief intervention (BI) combined with booster messaging', 'BI and 28 days of tailored booster messaging (based on drug use motives) daily, and the control condition received a community resource brochure']","['absolute reductions over time on alcohol outcomes, cannabis use, and condomless sex', 'Mean ratings of booster messages']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]",63.0,0.0467803,Mean ratings of booster messages were >4.0 (5-point scale); 77 % liked the daily messages and 91 % found them helpful.,"[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA; Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI, 48109, USA; Center for Sexuality and Health Disparities, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109, USA. Electronic address: erinbona@med.umich.edu.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI, 48109, USA; Department of Emergency Medicine, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI, 48109, USA; Department of Health Behavior and Health Education, School of Public Health, University of Michigan, 1415 Washington Heights, Ann Arbor, MI, 48109, USA; Emergency Medicine, Hurley Medical Center, 1 Hurley Plaza, Flint, MI, 48503, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Sweezea', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Frederic C', 'Initials': 'FC', 'LastName': 'Blow', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA; VA Center for Clinical Management Research, North Campus Research Complex, 2800 Plymouth Rd Bldg 16, Ann Arbor, MI, 48109-2800, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Drislane', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA; Department of Psychology and Philosophy, Sam Houston State University, 1901 Avenue I, Huntsville, TX, 77340, USA.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA; Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI, 48109, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108625']
1279,33636650,Effects of self-healing intervention on quality of life and mother-child interaction among female breadwinners.,"OBJECTIVES


This study aimed to investigate the effectiveness of self-healing (the healing codes) intervention on quality of life (QoL) and mother-child interaction among female breadwinners.
METHODS


The study population comprised all female breadwinners who referred to the welfare centers of Isfahan in 2020; using convenience sampling, we selected 30 women and divided them into experimental and control groups (n = 15 per group). The experimental group underwent fourteen sessions (90-min sessions per week) of self-healing training.
RESULTS


The mean ± SD of QoL and mother-child interaction for experimental and control groups in the post-test stage were 84.33 ± 3.92 and 160.86 ± 8.74 respectively. Self-healing intervention had significant effects on QoL and mother-child interaction among female breadwinners. The intervention program improved the components of QoL and mother-child interaction among female breadwinners (p < 0.01).
CONCLUSIONS


Self-healing training can be used as a novel approach to enhance QoL and mother-child interaction in this group of women.",2021,"The intervention program improved the components of QoL and mother-child interaction among female breadwinners (p < 0.01).
","['study population comprised all female breadwinners who referred to the welfare centers of Isfahan in 2020; using', 'female breadwinners']","['self-healing intervention', 'Self-healing intervention', 'self-healing (the healing codes) intervention', 'convenience sampling', 'self-healing training']","['quality of life (QoL', 'mean\xa0±\xa0SD of QoL and mother-child interaction', 'QoL and mother-child interaction', 'quality of life and mother-child interaction']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0885003', 'cui_str': 'Xiakucao'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}]",30.0,0.0108561,"The intervention program improved the components of QoL and mother-child interaction among female breadwinners (p < 0.01).
","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Zarean', 'Affiliation': 'Department of Education and Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: zareanfah@gmail.com.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101334']
1280,33639493,Monopolar electrocautery tip vs plasma ablation in tonsillotomy: A randomized case-control study comparing outcomes in pediatric population.,"BACKGROUND


The objective of this study was to compare the low-priced monopolar electrocautery to the high-priced, worldwide used, plasma ablation in tonsillotomy among children aged between three and twelve years, suffering from obstructive breathing disorders (OBD), with respect to post-operative pain, bleeding and related morbidities.
METHODS


A randomized case-control study was conducted in the Eye and Ear Hospital International- Lebanon. 103 children aged between three and twelve years suffering from OBD secondary to tonsillar hypertrophy were randomly assigned into two groups. Post-operative pain was evaluated using age-adequate validated scales: ""FLACC-R"" (Face, Legs, Activity, Cry, Consolability-Revised) for children aged less than five years, and ""Wong Baker faces"" for older children. Additional post-operative outcomes were evaluated using Pain-PROM (Patient reported Pain-Related Outcome Measures) and TAHSI (Tonsil and Adenoid Health Status Instrument) scales.
RESULTS


Significantly, higher rates of patients who underwent tonsillotomy via plasma ablation technique used analgesics and had severe pain compared to the monopolar electrocautery group. A longer operative duration was significantly associated with higher pain scores, and the plasma ablation technique yielded significantly higher operative mean durations. 10 days post-operatively, a significantly higher percentage of children reported an overall high pain severity and more than expected overall pain when using the plasma ablation technique compared to the monopolar electrocautery one. Overall bleeding rates were similar. No difference was reported one month post-operatively.
CONCLUSION


When compared to plasma ablation, monopolar electrocautery, can provide the same efficiency in relieving OBD in healthy children, with equal overall bleeding rates, but significantly lower cost, operating time, pain scores and need for analgesics.",2021,"A longer operative duration was significantly associated with higher pain scores, and the plasma ablation technique yielded significantly higher operative mean durations.","['children aged less than five years, and ""Wong Baker faces"" for older children', 'children aged between three and twelve years, suffering from obstructive breathing disorders (OBD', 'healthy children', '103 children aged between three and twelve years suffering from OBD secondary to tonsillar hypertrophy', 'pediatric population', 'Eye and Ear Hospital International- Lebanon']","['low-priced monopolar electrocautery', 'Monopolar electrocautery tip vs plasma ablation', 'plasma ablation, monopolar electrocautery', 'monopolar electrocautery']","['Overall bleeding rates', 'operative duration', 'higher pain scores', 'Pain-PROM (Patient reported Pain-Related Outcome Measures) and TAHSI (Tonsil and Adenoid Health Status Instrument) scales', 'scales: ""FLACC-R"" (Face, Legs, Activity, Cry, Consolability-Revised', 'overall pain', 'overall high pain severity', 'severe pain', 'cost, operating time, pain scores and need for analgesics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0272386', 'cui_str': 'Hypertrophy of tonsils'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0580788', 'cui_str': 'Tonsil and adenoid structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",103.0,0.037979,"A longer operative duration was significantly associated with higher pain scores, and the plasma ablation technique yielded significantly higher operative mean durations.","[{'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Bou Sanayeh', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK), Jounieh, Lebanon. Electronic address: elie.h.bousanayeh@gmail.com.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Idriss', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK), Jounieh, Lebanon; Department of Otolaryngology Head and Neck Surgery, Eye and Ear International Hospital, Naccache, Lebanon.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Farchakh', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK), Jounieh, Lebanon; Department of Otolaryngology Head and Neck Surgery, Eye and Ear International Hospital, Naccache, Lebanon.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Hanna', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK), Jounieh, Lebanon; Department of Otolaryngology Head and Neck Surgery, Eye and Ear International Hospital, Naccache, Lebanon.'}, {'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'Hallit', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK), Jounieh, Lebanon; INSPECT-LB: National Institute of Public Health, Clinical Epidemiology and Toxicology, Beirut, Lebanon. Electronic address: souheilhallit@hotmail.com.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Romanos', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK), Jounieh, Lebanon; Department of Otolaryngology Head and Neck Surgery, Eye and Ear International Hospital, Naccache, Lebanon. Electronic address: romanosbassam@gmail.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2021.110655']
1281,33639440,Threat memory devaluation by a dual-task intervention: Testing return of fear and intrusive memory over 48 hours.,"BACKGROUND AND OBJECTIVES


In dual-tasking, individuals recall a threat-related memory while performing a demanding dual-task. This is a fruitful approach to reduce the unpleasantness and vividness of aversive memories and to reduce conditioned fear responses. Crucially, it remains unclear whether dual-tasking can also reduce conditioned fear responses and intrusive memories over time. In this pre-registered two-day fear conditioning paradigm, we examined whether a dual-task intervention reduces return of fear and the frequency of intrusive memories of an aversive film over time.
METHODS


On Day 1, 76 healthy participants underwent fear acquisition with aversive film clips. They were then randomly allocated to one of three conditions: dual-tasking, memory recall without a dual-task ('recall only'), or no task. Afterwards, they underwent an extinction phase and were asked to record intrusive film memories over 48 h. On Day 3, return of fear was assessed.
RESULTS


On Day 1, fear acquisition and extinction were successful. On Day 3, spontaneous recovery and renewal were evident, but, overall, participants reported few intrusions. The dual-task and recall only groups reported reduced unpleasantness of threat memory compared to the no task group, but they did not show reduced (return of) fear responses or fewer intrusions.
LIMITATIONS


Intrusion frequency was low in all three groups, which limits the detection of intervention effects.
CONCLUSIONS


Even though dual-tasking and recall only devalued threat memory temporarily compared to no task, these interventions did not reduce (return of) fear responses and intrusions. Future studies could focus on improving the potency of imagery-based interventions.",2021,"The dual-task and recall only groups reported reduced unpleasantness of threat memory compared to the no task group, but they did not show reduced (return of) fear responses or fewer intrusions.
",['76 healthy participants underwent'],"['fear acquisition with aversive film clips', ""dual-tasking, memory recall without a dual-task ('recall only'), or no task"", 'dual-task intervention']","['return of fear and the frequency of intrusive memories of an aversive film over time', 'unpleasantness of threat memory']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0679063', 'cui_str': 'Memory recall'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",76.0,0.0182144,"The dual-task and recall only groups reported reduced unpleasantness of threat memory compared to the no task group, but they did not show reduced (return of) fear responses or fewer intrusions.
","[{'ForeName': 'Elze', 'Initials': 'E', 'LastName': 'Landkroon', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, the Netherlands. Electronic address: e.landkroon@uu.nl.'}, {'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Salemink', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2021.101639']
1282,33647548,"Gender-dependent survival benefit from first-line irinotecan in metastatic colorectal cancer. Subgroup analysis of a phase III trial (XELAVIRI-study, AIO-KRK-0110).","BACKGROUND


XELAVIRI compared sequential (Arm A) versus initial (Arm B) irinotecan in combination with fluoropyrimidine plus bevacizumab in patients with metastatic colorectal cancer, trial identification: NCT01249638. In the full analysis set of the study, non-inferiority of time to failure of strategy (TFS) was not shown. The present analysis was performed to evaluate the effect of gender on treatment outcome and tolerability.
METHODS


The study end-points overall response rate (ORR), progression-free survival (PFS), TFS and overall survival (OS) were evaluated in female versus male patients and in molecular subgroups (i.e. RAS mutational status). Interaction of treatment and gender was tested by likelihood ratio tests.
RESULTS


In total, 281 male and 140 female patients (n = 421) were evaluated. Among the male patients, the ORR was 33.6% without and 58.3% with initial irinotecan (P < 0.001). PFS (hazard ratio [HR] 0.54; 95% confidence interval [CI] 0.42-0.69; P < 0.001) and OS (HR 0.63; 95% CI 0.47-0.85; P = 0.002) were also significantly better with initial irinotecan. Among the female patients, the ORR was 42.7% in Arm A and 43.1% in Arm B, PFS was similar (HR 1.09; 95% CI 0.76-1.55; P = 0.649) without and with initial irinotecan. A strong trend for inferior outcome with regard to OS with initial irinotecan was observed (HR 1.46; 95% CI 0.95-2.24; P = 0.081) and the trend reached significance in the multivariate analysis (HR 1.78; 95% CI 1.08-2.95; P = 0.02). Formal interaction of treatment and gender was observed for ORR (P = 0.018), PFS (P = 0.002) and OS (P = 0.001). Treatment-related adverse events were not significantly different between male and female patients.
CONCLUSIONS


The present analysis suggests that gender interacts with efficacy of initial irinotecan when used in combination with fluoropyrimidines and bevacizumab. Although male patients derived a significant and clinically meaningful benefit from initial combination chemotherapy, this was not observed in female patients.",2021,PFS (hazard ratio [HR] 0.54; 95% confidence interval [CI] 0.42-0.69; P < 0.001) and OS (HR 0.63; 95% CI 0.47-0.85; P = 0.002) were also significantly better with initial irinotecan.,"['patients with metastatic colorectal cancer', 'male and female patients', 'In total, 281 male and 140 female patients (n\xa0=\xa0421', 'metastatic colorectal cancer']","['bevacizumab', 'fluoropyrimidine plus bevacizumab']","['PFS', ' progression-free survival (PFS), TFS and overall survival (OS', 'overall response rate (ORR', 'ORR', 'tolerability', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",421.0,0.268787,PFS (hazard ratio [HR] 0.54; 95% confidence interval [CI] 0.42-0.69; P < 0.001) and OS (HR 0.63; 95% CI 0.47-0.85; P = 0.002) were also significantly better with initial irinotecan.,"[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, München, Germany; German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg, Germany. Electronic address: Kathrin.Heinrich@med.uni-muenchen.de.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg, Germany; Medical Department, Division of Oncology and Hematology, Charité Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ricard', 'Affiliation': 'Comprehensive Cancer Center, University Hospital, LMU Munich, München, Germany.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Gesundheitszentrum St. Marien, Amberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Oncological Practice, Ravensburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'VK&K Studien GbR, Landshut, Germany.'}, {'ForeName': 'Ullrich', 'Initials': 'U', 'LastName': 'Graeven', 'Affiliation': 'Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus, Mönchengladbach, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Uhlig', 'Affiliation': 'Oncological Practice, Naunhof, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenk', 'Affiliation': 'Krankenhaus Barmherzige Brüder Regensburg, Regensburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Freiberg-Richter', 'Affiliation': 'Oncological Practice, Dresden, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Peuser', 'Affiliation': 'Onkologische Praxis Am Diakonissenhaus, Leipzig, Germany.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Denzlinger', 'Affiliation': 'Marienhospital, Stuttgart, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Giessen-Jung', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, München, Germany; German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Stahler', 'Affiliation': 'German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg, Germany; Medical Department, Division of Oncology and Hematology, Charité Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Michl', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, München, Germany; German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg, Germany; Institut für Pathologie, Ludwig-Maximilians-Universität, München, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kirchner', 'Affiliation': 'German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg, Germany; Institut für Pathologie, Ludwig-Maximilians-Universität, München, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg, Germany; Medical Department, Division of Oncology and Hematology, Charité Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, München, Germany; German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg, Germany; Comprehensive Cancer Center, University Hospital, LMU Munich, München, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.01.025']
1283,33647529,Comparison of blood flow restriction devices and their effect on quadriceps muscle activation.,"OBJECTIVES


Blood flow restriction training (BFRT) provides an alternative approach to traditional strength training. The purpose of this study was to determine differences in quadriceps muscle activation, subject reported pain, and perceived exertion between three exercise conditions: low-load resistance BFRT with (1) regulated and (2) standardized devices, and (3) high-load resistance exercise without BFRT.
DESIGN


Randomized cross over study.
SETTING


XX University Biomechanics laboratory.
PARTICIPANTS


Thirty-four healthy subjects (18 male/16 female) each completed three randomized sessions of knee extensions using Delfi's Personalized Tourniquet System (R) at 30% of 1 repetition maximum (1RM), the B-Strong™ device (S) at 30% 1RM, and high-load resistance exercise (HL) at 80% 1RM.
MAIN OUTCOME MEASURES


Quadriceps EMG activity, numeric pain rating scale (NPRS), and perceived exertion (OMNI-RES) were recorded.
RESULTS


Average and peak EMG were greater in HL sessions than both S and R (p < .001). NPRS was greater in the R sessions compared to both S (p < .001) and HL (p < .001). OMNI-RES was greater in the R sessions compared to S (p < .02) and HL (p < .001). No differences (p > .05) in average or peak EMG activation were found between S and R sessions.
CONCLUSIONS


Quadriceps EMG amplitude was greater during high-load resistance exercise versus low-load BFR exercise and there were no differences in EMG findings between BFRT devices.",2021,OMNI-RES was greater in the R sessions compared to S (p < .02) and HL (p < .001).,"['Thirty-four healthy subjects (18 male/16 female', 'XX University Biomechanics laboratory']","['Blood flow restriction training (BFRT', ""knee extensions using Delfi's Personalized Tourniquet System (R) at 30% of 1 repetition maximum (1RM), the B-Strong™ device (S) at 30% 1RM, and high-load resistance exercise (HL) at 80% 1RM"", 'blood flow restriction devices']","['quadriceps muscle activation', 'peak EMG', 'Quadriceps EMG amplitude', 'average or peak EMG activation', 'quadriceps muscle activation, subject reported pain, and perceived exertion', 'NPRS', 'OMNI-RES', 'Quadriceps EMG activity, numeric pain rating scale (NPRS), and perceived exertion (OMNI-RES']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",34.0,0.0736933,OMNI-RES was greater in the R sessions compared to S (p < .02) and HL (p < .001).,"[{'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Bordessa', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Mason C', 'Initials': 'MC', 'LastName': 'Hearn', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Reinfeldt', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Tyler A', 'Initials': 'TA', 'LastName': 'Smith', 'Affiliation': 'San Diego State University, San Diego, CA, USA. Electronic address: Tyler.a.smith58@gmail.com.'}, {'ForeName': 'Harsimran S', 'Initials': 'HS', 'LastName': 'Baweja', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Levy', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Rosenthal', 'Affiliation': 'San Diego State University, San Diego, CA, USA. Electronic address: mrosenthal@unmc.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.02.005']
1284,33647588,How adolescents' working memory abilities relate to their alcohol craving in real-life contexts depends on biological sex.,"AIM


We sought to elucidate whether stress, peers, and in vivo (i.e., direct) alcohol cues elicit alcohol craving in daily life among adolescents and to test whether individual variation in working memory function and biological sex alters these associations.
METHODS


We leveraged ecological momentary assessment (EMA) to examine momentary associations between stress, peers, and direct alcohol cues with craving, assessed as ""urge to drink alcohol,"" among 86 male (51.2 %) and female (48.8 %) frequent drinkers (i.e., two or more drinking days per week). Participants were ages 14-24 years (M = 20.7 years, SD = 2.1). Participants completed EMA throughout the day for about one week prior to randomization to a treatment condition for an AUD clinical trial. Pre-registered, secondary analyses focused on craving for assessments when adolescents were not drinking, and assessments occurring after drinking on drinking days were removed. Working memory performance was assessed in the laboratory via the Memory for Words subtest of the Woodcock-Johnson III Tests of Cognitive Abilities.
RESULTS


Craving was heightened at more stressful moments and when adolescents were with their peers and in the presence of direct alcohol cues. Working memory function was not related to craving but altered the relation of momentary stress, peers, and cues with craving once biological sex-related differences were considered. Females generally had lower craving than males, but working memory function served to buffer against stress-induced craving for males.
CONCLUSIONS


Higher working memory function buffered the in-the-moment relation of stress with alcohol craving for males but not females.",2021,"Females generally had lower craving than males, but working memory function served to buffer against stress-induced craving for males.
","['Participants were ages 14-24 years (M = 20.7 years, SD = 2.1', '86 male (51.2 %) and female (48.8 %) frequent drinkers (i.e., two or more drinking days per week']",[],['Working memory performance'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",[],"[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",86.0,0.0315985,"Females generally had lower craving than males, but working memory function served to buffer against stress-induced craving for males.
","[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Treloar Padovano', 'Affiliation': 'Department of Psychiatry and Human Behavior, Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University, Box G-S121-4, Providence, RI, 02912, United States. Electronic address: hayley_treloar@brown.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'Department of Psychiatry and Human Behavior, Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University, Box G-S121-4, Providence, RI, 02912, United States. Electronic address: robert_miranda_jr@brown.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108642']
1285,33666594,Agreement Between the Iron Path App and a Linear Position Transducer for Measuring Average Concentric Velocity and Range of Motion of Barbell Exercises.,"ABSTRACT


Kasovic, J, Martin, B, Carzoli, JP, Zourdos, MC, and Fahs, CA. Agreement between the Iron Path app and a linear position transducer for measuring average concentric velocity and range of motion of barbell exercises. J Strength Cond Res 35(2S): S95-S101, 2021-The purpose of this study was to compare average concentric velocity (ACV) and range of motion (ROM) values measured by the Iron Path (IP) app to the previously validated Open Barbell System (OBS) linear position transducer during the front and back squat and conventional and sumo deadlift. Twenty-seven men and women (21 ± 3 years old; 76.7 ± 14.5 kg; 1.72 ± 0.09 m) with squat and deadlift training experience completed a modified one repetition maximum protocol on 4 separate occasions in a randomized order. The IP app and OBS device recorded ACV and ROM during each protocol. The level of statistical significant was set at p ≤ 0.05. Bland-Altman plots showed fairly large limits of agreement for both ACV and ROM. Furthermore, 95% confidence intervals for the intraclass correlation coefficients indicated the agreement in ACV between the devices for each of the 4 lifts to range from 0.648-0.876 to 0.849-0.930 and for agreement in ROM between devices to range from -0.053-0.480 to 0.545-0.770. Compared with the OBS, the IP app recorded significantly (p < 0.05) lower ACV values for the front squat and back squat and greater ROM values for the sumo deadlift. We suggest the IP app should not be used in place of a validated linear position transducer for measuring ACV or ROM for barbell lifts.",2021,"Compared with the OBS, the IP app recorded significantly (p < 0.05) lower ACV values for the front squat and back squat and greater ROM values for the sumo deadlift.",['Twenty-seven men and women (21 ± 3 years old; 76.7 ± 14.5 kg; 1.72 ± 0.09 m) with squat and deadlift training experience completed a'],"['J Strength Cond Res 35(2S', 'modified one repetition maximum protocol']","['ROM values', 'ACV values', 'Average Concentric Velocity and Range of Motion of Barbell Exercises', 'average concentric velocity and range of motion of barbell exercises', 'average concentric velocity (ACV) and range of motion (ROM) values']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517513', 'cui_str': '1.72'}, {'cui': 'C4517419', 'cui_str': '0.09'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0306052,"Compared with the OBS, the IP app recorded significantly (p < 0.05) lower ACV values for the front squat and back squat and greater ROM values for the sumo deadlift.","[{'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Kasovic', 'Affiliation': 'Department of Exercise Science, Lindenwood University Belleville, Belleville Illinois.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Martin', 'Affiliation': 'Department of Exercise Science, Lindenwood University Belleville, Belleville Illinois.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Carzoli', 'Affiliation': 'Department of Integrative Physiology, University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Zourdos', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, Florida; and.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Fahs', 'Affiliation': 'College of Health Sciences, Logan University, Chesterfield, Missouri.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003574']
1286,33666562,"A Personal Health System for Self-Management of Congestive Heart Failure (HeartMan): Development, Technical Evaluation, and Proof-of-Concept Randomized Controlled Trial.","BACKGROUND


Congestive heart failure (CHF) is a disease that requires complex management involving multiple medications, exercise, and lifestyle changes. It mainly affects older patients with depression and anxiety, who commonly find management difficult. Existing mobile apps supporting the self-management of CHF have limited features and are inadequately validated.
OBJECTIVE


The HeartMan project aims to develop a personal health system that would comprehensively address CHF self-management by using sensing devices and artificial intelligence methods. This paper presents the design of the system and reports on the accuracy of its patient-monitoring methods, overall effectiveness, and patient perceptions.
METHODS


A mobile app was developed as the core of the HeartMan system, and the app was connected to a custom wristband and cloud services. The system features machine learning methods for patient monitoring: continuous blood pressure (BP) estimation, physical activity monitoring, and psychological profile recognition. These methods feed a decision support system that provides recommendations on physical health and psychological support. The system was designed using a human-centered methodology involving the patients throughout development. It was evaluated in a proof-of-concept trial with 56 patients.
RESULTS


Fairly high accuracy of the patient-monitoring methods was observed. The mean absolute error of BP estimation was 9.0 mm Hg for systolic BP and 7.0 mm Hg for diastolic BP. The accuracy of psychological profile detection was 88.6%. The F-measure for physical activity recognition was 71%. The proof-of-concept clinical trial in 56 patients showed that the HeartMan system significantly improved self-care behavior (P=.02), whereas depression and anxiety rates were significantly reduced (P<.001), as were perceived sexual problems (P=.01). According to the Unified Theory of Acceptance and Use of Technology questionnaire, a positive attitude toward HeartMan was seen among end users, resulting in increased awareness, self-monitoring, and empowerment.
CONCLUSIONS


The HeartMan project combined a range of advanced technologies with human-centered design to develop a complex system that was shown to help patients with CHF. More psychological than physical benefits were observed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03497871; https://clinicaltrials.gov/ct2/history/NCT03497871.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12872-018-0921-2.",2021,"The proof-of-concept clinical trial in 56 patients showed that the HeartMan system significantly improved self-care behavior (P=.02), whereas depression and anxiety rates were significantly reduced (P<.001), as were perceived sexual problems (P=.01).","['HeartMan', '56 patients', 'Congestive Heart Failure']",[],"['mean absolute error of BP estimation', 'accuracy of psychological profile detection', 'depression and anxiety rates', 'self-care behavior', 'blood pressure (BP) estimation, physical activity monitoring, and psychological profile recognition', 'physical activity recognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",56.0,0.0817705,"The proof-of-concept clinical trial in 56 patients showed that the HeartMan system significantly improved self-care behavior (P=.02), whereas depression and anxiety rates were significantly reduced (P<.001), as were perceived sexual problems (P=.01).","[{'ForeName': 'Mitja', 'Initials': 'M', 'LastName': 'Luštrek', 'Affiliation': 'Department of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Bohanec', 'Affiliation': 'Department of Knowledge Technologies, Jožef Stefan Institute, Ljubljana, Slovenia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cavero Barca', 'Affiliation': 'Health Unit, Atos Research and Innovation (ARI), Atos Spain S.A., Madrid, Spain.'}, {'ForeName': 'Maria Costanza', 'Initials': 'MC', 'LastName': 'Ciancarelli', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Clays', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Amos Adeyemo', 'Initials': 'AA', 'LastName': 'Dawodu', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Derboven', 'Affiliation': 'Meaningful Interactions Lab, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'De Smedt', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Dovgan', 'Affiliation': 'Department of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenia.'}, {'ForeName': 'Jure', 'Initials': 'J', 'LastName': 'Lampe', 'Affiliation': 'SenLab d.o.o., Ljubljana, Slovenia.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Marino', 'Affiliation': 'Institute for Biomedical Research and Innovation, National Research Council of Italy, Messina, Italy.'}, {'ForeName': 'Miha', 'Initials': 'M', 'LastName': 'Mlakar', 'Affiliation': 'Department of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pioggia', 'Affiliation': 'Institute for Biomedical Research and Innovation, National Research Council of Italy, Messina, Italy.'}, {'ForeName': 'Paolo Emilio', 'Initials': 'PE', 'LastName': 'Puddu', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Juan Mario', 'Initials': 'JM', 'LastName': 'Rodríguez', 'Affiliation': 'Health Unit, Atos Research and Innovation (ARI), Atos Spain S.A., Madrid, Spain.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Schiariti', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Gašper', 'Initials': 'G', 'LastName': 'Slapničar', 'Affiliation': 'Department of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Slegers', 'Affiliation': 'Department of Communication & Cognition, Tilburg School of Humanities and Digital Sciences, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Tartarisco', 'Affiliation': 'Institute for Biomedical Research and Innovation, National Research Council of Italy, Messina, Italy.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Valič', 'Affiliation': 'Department of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenia.'}, {'ForeName': 'Aljoša', 'Initials': 'A', 'LastName': 'Vodopija', 'Affiliation': 'Department of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenia.'}]",JMIR medical informatics,['10.2196/24501']
1287,33666561,Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial.,"BACKGROUND


Most smokers attempt to stop using cigarettes numerous times before successfully quitting. Cigarette cravings may undermine perceived competence to quit and thus constitute psychological threats to the individual's self-concept. Self-affirmation may promote smoking cessation by offsetting these threats.
OBJECTIVE


This study examines whether self-affirmation is associated with smoking cessation in the context of a cessation app. Two types of self-affirmation are examined: tendency to spontaneously self-affirm, and self-affirmation inductions added to a publicly available smoking cessation app (Smoke-Free Quit Smoking Now). In addition, this study explores whether optimism and emotional states (happiness, anger, anxiousness, hopefulness, sadness) predict smoking cessation.
METHODS


All users who met the inclusion criteria, provided consent to participate, and completed a baseline assessment, including all individual difference measures, were randomized to 1 of 4 conditions. Half of the participants were randomly assigned to complete a self-affirmation induction upon study entry. Orthogonally, half of the participants were randomly assigned to receive self-affirming text notifications during their quit attempt or to receive conventional notifications. The induction and the text notifications were fully automated, and all data were collected through self-assessments in the app. Self-reported smoking cessation was assessed 1 month and 3 months following study entry.
RESULTS


The study enrolled 7899 participants; 647 completed the 1-month follow-up. Using an intent-to-treat analysis at the 1-month follow-up, 7.2% (569/7899) of participants self-reported not smoking in the previous week and 6.4% (503/7899) self-reported not smoking in the previous month. Greater tendency to spontaneously self-affirm predicted a greater likelihood of cessation (P<.001) at 1 month after controlling for smoking-related variables. Neither self-affirmation induction influenced cessation. In addition, spontaneous self-affirmation did not moderate the relationship between self-affirmation inductions and cessation. Greater baseline sadness was associated with a lower likelihood of reporting successful cessation. Optimism predicted past-week cessation at the 1-month follow-up, and both happiness and anger predicted past-month cessation at the 1-month follow-up; however, none of these potential predictors moderated the relationship between self-affirmation conditions and successful cessation.
CONCLUSIONS


Spontaneous self-affirmation may be an important psychological resource for managing threats to self-concept during the smoking cessation process. Sadness may hinder quit attempts. Future research can explicate how spontaneous versus induced self-affirmation can promote smoking cessation and examine boundary conditions for the effectiveness of disseminated self-affirmation interventions.
TRIAL REGISTRATION


ISRCTN Registry 56646695; https://www.isrctn.com/ISRCTN56646695.",2021,Greater tendency to spontaneously self-affirm predicted a greater likelihood of cessation (P<.001) at 1 month after controlling for smoking-related variables.,"['The study enrolled 7899 participants; 647 completed the 1-month follow-up', '56646695']",['self-affirming text notifications during their quit attempt or to receive conventional notifications'],"['Self-reported smoking cessation', 'optimism and emotional states (happiness, anger, anxiousness, hopefulness, sadness) predict smoking cessation']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}]",7899.0,0.0171002,Greater tendency to spontaneously self-affirm predicted a greater likelihood of cessation (P<.001) at 1 month after controlling for smoking-related variables.,"[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Seaman', 'Affiliation': 'CDC Foundation, Atlanta, GA, United States.'}, {'ForeName': 'Cendrine D', 'Initials': 'CD', 'LastName': 'Robinson', 'Affiliation': 'Behavioral Research Program (BRP), Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crane', 'Affiliation': 'Smoke Free, 23 Ltd, London, United Kingdom.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Taber', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, OH, United States.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Ferrer', 'Affiliation': 'Behavioral Research Program (BRP), Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, United States.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Harris', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, Brighton, United Kingdom.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'Behavioral Research Program (BRP), Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, United States.'}]",Journal of medical Internet research,['10.2196/18433']
1288,33666554,"Participants' Engagement and Satisfaction With a Smartphone App Intended to Support Healthy Weight Gain, Diet, and Physical Activity During Pregnancy: Qualitative Study Within the HealthyMoms Trial.","BACKGROUND


Excessive gestational weight gain (GWG) is common and associated with negative health outcomes for both mother and child. Mobile health-delivered lifestyle interventions offer the potential to mitigate excessive GWG. The effectiveness of a smartphone app (HealthyMoms) was recently evaluated in a randomized controlled trial. To explore the users' experiences of using the app, a qualitative study within the HealthyMoms trial was performed.
OBJECTIVE


This qualitative study explored participants' engagement and satisfaction with the 6-month usage of the HealthyMoms app.
METHODS


A total of 19 women (mean age: 31.7, SD 4.4 years; mean BMI: 24.6, SD 3.4 kg/m 2 ; university degree attainment: 13/19, 68%; primiparous: 11/19, 58%) who received the HealthyMoms app in a randomized controlled trial completed semistructured exit interviews. The interviews were audiorecorded and fully transcribed, coded, and analyzed using thematic analysis with an inductive approach.
RESULTS


Thematic analysis revealed a main theme and 2 subthemes. The main theme, ""One could suit many: a multifunctional tool to strengthen women's health during pregnancy,"" and the 2 subthemes, ""Factors within and beyond the app influence app engagement"" and ""Trust, knowledge, and awareness: aspects that can motivate healthy habits,"" illustrated that a trustworthy and appreciated health and pregnancy app that is easy to use can inspire a healthy lifestyle during pregnancy. The first subtheme discussed how factors within the app (eg, regular updates and feedback) were perceived to motivate both healthy habits and app engagement. Additionally, factors beyond the app were described to both motivate (eg, interest, motivation, and curiosity) and limit (eg, pregnancy-related complications, lack of time) app engagement. The second subtheme reflected important aspects, such as high trustworthiness of the app, increased knowledge, and awareness from using the app, which motivated participants to improve or maintain healthy habits during pregnancy.
CONCLUSIONS


The HealthyMoms app was considered a valuable and trustworthy tool to mitigate excessive GWG, with useful features and relevant information to initiate and maintain healthy habits during pregnancy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03298555; https://clinicaltrials.gov/ct2/show/NCT03298555.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/13011.",2021,"The HealthyMoms app was considered a valuable and trustworthy tool to mitigate excessive GWG, with useful features and relevant information to initiate and maintain healthy habits during pregnancy.
","['19 women (mean age: 31.7, SD 4.4 years; mean BMI: 24.6, SD 3.4 kg/m 2 ; university degree attainment', '13/19, 68%; primiparous']","['smartphone app (HealthyMoms', 'Mobile health-delivered lifestyle interventions', 'Smartphone']","['Support Healthy Weight Gain, Diet, and Physical Activity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",19.0,0.11098,"The HealthyMoms app was considered a valuable and trustworthy tool to mitigate excessive GWG, with useful features and relevant information to initiate and maintain healthy habits during pregnancy.
","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Sandborg', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Henriksson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anna-Karin', 'Initials': 'AK', 'LastName': 'Lindqvist', 'Affiliation': 'Division of Health, Medicine and Rehabilitation, Department of Health, Education and Technology, Luleå University of Technology, Luleå, Sweden.'}, {'ForeName': 'Stina', 'Initials': 'S', 'LastName': 'Rutberg', 'Affiliation': 'Division of Health, Medicine and Rehabilitation, Department of Health, Education and Technology, Luleå University of Technology, Luleå, Sweden.'}, {'ForeName': 'Emmie', 'Initials': 'E', 'LastName': 'Söderström', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Australia.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Löf', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.'}]",JMIR mHealth and uHealth,['10.2196/26159']
1289,33663138,Tranexamic acid reduces blood cost in long-segment spinal fusion surgery: A randomized controlled study protocol: Partial Retraction.,,2021,,['long-segment spinal fusion surgery'],['Tranexamic acid'],['blood cost'],"[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0822517,,[],Medicine,['10.1097/MD.0000000000024983']
1290,33663132,The effect of web-based educational intervention on psychological status and blood glucose in newly diagnosed patients with diabetes type 2 in rural China: A protocol for randomized trial.,"BACKGROUND


No studies were located which used a web-based educational intervention to improve the knowledge about newly diagnosed type 2 diabetes mellitus (T2DM). Therefore, the primary objective of the present study was to evaluate the efficacy of web-based educational intervention on psychological outcomes and glycemic control in newly diagnosed T2DM in rural China.
METHODS


This work is a part of a comprehensive research project to assess and provide educational intervention that potentially improve psychological status and blood glucose among patients with T2DM. Eligibility criteria for the study includes newly diagnosed with T2DM, adult patients (age ≥30 years) regardless of gender; speak and understand Chinese languages; having no significant comorbidity; being not involved in any trial/study related to diabetes during last 3 months and able to attend regular visits. Eligible participants were divided into 2 groups according to completely randomized design: education group and control group. The outcomes included fasting blood glucose level, EQ-5D-3L questionnaire, Self-rating Anxiety Scale, and Self-rating Depression Scale.
RESULTS


This protocol will provide a reliable theoretical basis for the following research.
CONCLUSION


The sample came from a single health centre. Therefore, the results can not be generalized for the entire population.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry6511).",2021,"BACKGROUND


No studies were located which used a web-based educational intervention to improve the knowledge about newly diagnosed type 2 diabetes mellitus (T2DM).","['patients with T2DM', 'newly diagnosed T2DM in rural China', 'newly diagnosed patients with diabetes type 2 in rural China', 'Eligibility criteria for the study includes newly diagnosed with T2DM, adult patients (age ≥30 years) regardless of gender; speak and understand Chinese languages; having no significant comorbidity; being not involved in any trial/study related to diabetes during last 3 months and able to attend regular visits', 'Eligible participants']",['web-based educational intervention'],"['psychological status and blood glucose', 'fasting blood glucose level, EQ-5D-3L questionnaire, Self-rating Anxiety Scale, and Self-rating Depression Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0841789,"BACKGROUND


No studies were located which used a web-based educational intervention to improve the knowledge about newly diagnosed type 2 diabetes mellitus (T2DM).","[{'ForeName': 'Zhixiang', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Department of Finance.'}, {'ForeName': 'Nini', 'Initials': 'N', 'LastName': 'Jiao', 'Affiliation': 'Department of Finance.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Chengyang People's Hospital, Qingdao, China.""}, {'ForeName': 'Changjiang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Chengyang People's Hospital, Qingdao, China.""}]",Medicine,['10.1097/MD.0000000000024937']
1291,33663110,Group-based constraint-induced movement therapy in the rehabilitation of chronic poststroke patients.,"BACKGROUND


This study aimed to describe the effects of a 90-minute group-based constraint-induced movement therapy protocol (CIMT) on upper extremity (UE) rehabilitation in poststroke patients.
METHOD


The study was a case series clinical study with 6 patients with chronic stroke admitted to the institutional integrated clinic. Ten 90-minute CIMT sessions were administered, based on the principles of the original therapy. On completion of the protocol, participants underwent group care once a week, for 1 hour a day. For comparison purposes, the Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and Canadian Occupational Performance Measure (COPM) were applied on admission, shortly after completing the protocol, and 3 months after completion. In addition, the MAL and shaping tasks were applied daily.
RESULTS


There was a statistically significant difference only in the MAL Amount of Use Scale applied daily between the 2nd (3.56) and 9th (3.31) and 2nd and 10th days (4.49) (P = .004), with a moderate effect size (d' = 0.46), and in the average value of shaping repetitions between the 1st (16.10) and 2nd (6.00) and 1st and 10th tasks (7.00) (P = .014), with a moderate effect size (d' = 0.35).
CONCLUSION


The 90-minute CIMT protocol resulted in significant improvements in use of the more affected arm in activities of daily living during the 2-week protocol. Additional research with a larger sample and a control group is needed to confirm its effectiveness.",2021,The 90-minute CIMT protocol resulted in significant improvements in use of the more affected arm in activities of daily living during the 2-week protocol.,"['chronic poststroke patients', '6 patients with chronic stroke admitted to the institutional integrated clinic', 'poststroke patients']","['Group-based constraint-induced movement therapy', '90-minute group-based constraint-induced movement therapy protocol (CIMT']","['activities of daily living', 'Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and Canadian Occupational Performance Measure (COPM', 'MAL Amount of Use Scale applied daily', 'upper extremity (UE) rehabilitation']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",6.0,0.0173221,The 90-minute CIMT protocol resulted in significant improvements in use of the more affected arm in activities of daily living during the 2-week protocol.,"[{'ForeName': 'Fábio R O', 'Initials': 'FRO', 'LastName': 'Galvão', 'Affiliation': 'Occupational Therapy, MD, Federal University of Rio Grande do Norte - Faculty of Health Sciences of Trairí, Av. Rio Branco, 435 - Centro, Santa Cruz - Rio Grande do Norte, Brazil.'}, {'ForeName': 'Maria C A', 'Initials': 'MCA', 'LastName': 'Silvestre', 'Affiliation': ''}, {'ForeName': 'Camila L A', 'Initials': 'CLA', 'LastName': 'Gomes', 'Affiliation': ''}, {'ForeName': 'Nayara K F', 'Initials': 'NKF', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Viviane T B', 'Initials': 'VTB', 'LastName': 'Nóbrega', 'Affiliation': ''}, {'ForeName': 'Wellington S', 'Initials': 'WS', 'LastName': 'Lima', 'Affiliation': ''}, {'ForeName': 'Afonson L M', 'Initials': 'ALM', 'LastName': 'Gondim', 'Affiliation': ''}, {'ForeName': 'Ênio W A', 'Initials': 'ÊWA', 'LastName': 'Cacho', 'Affiliation': ''}, {'ForeName': 'Roberta O', 'Initials': 'RO', 'LastName': 'Cacho', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024864']
1292,33663100,Safety and efficacy of edaravone for patients with acute stroke: A protocol for randomized clinical trial.,"BACKGROUND


We performed a randomized clinical trial protocol to assess the effectiveness of edaravone for acute stroke. We hypothesized that edaravone is beneficial in improving neurological impairment resulting from acute stroke.
METHOD


The protocol was reviewed and approved by the Research Ethics Board of Affiliated Hospital of Chengde Medical University (0092-2394), each participant signed a written consent before participating, and SPIRIT guidelines were followed throughout. The inclusion criteria for patients were as follows: diagnosed as acute stroke (ischemic stroke or intracerebral hemorrhage) by head CT or MRI within 72 hours; age greater than 18; motor function disorder; Glasgow Coma Scale greater than 12. Patients with the following symptoms were excluded: concurrent serious complications, such as coma, drug allergy, mental disorder, and other severe organic lesions in the brain. Sixty patients were finally included in the study. The control group accepted conventional treatment, while the treatment group received edaravone treatment on top of the conventional treatment of the control group. After treatment, the differences in functional movement, living ability score, neurological score, treatment effect, and adverse reaction of these 2 groups were tested and compared.
DISCUSSION


As aging worsens, the incidence of acute stroke continues to increase. Brain damage will induce the production of oxygen radicals, which can damage the cytomembrane of brain cells and finally damage the nervous system and cause cerebral injury as well as the cerebral edema. Edaravone is an antioxidant and oxygen radical scavenger that can inhibit lipid peroxidation during the scavenging of oxygen free radicals. Besides, it can also elicit anti-inflammatory protective effects for nerve cells, increase cerebral blood flow volume, prevent the aggravation of cerebral hypoperfusion toward necrosis, reduce nerve damage, and improve neurological functions and prognosis. This is the first randomized controlled trial to assess the efficacy of edaravone for treating acute stroke. High quality, large sample size, multicenter randomized trials are still required.
TRIAL REGISTRATION


researchregistry6492.",2021,"After treatment, the differences in functional movement, living ability score, neurological score, treatment effect, and adverse reaction of these 2 groups were tested and compared.
","['The protocol was reviewed and approved by the Research Ethics Board of Affiliated Hospital of Chengde Medical University (0092-2394), each participant signed a written consent before participating, and SPIRIT guidelines were followed throughout', 'patients with acute stroke', 'Sixty patients were finally included in the study', 'Patients with the following symptoms were excluded: concurrent serious complications, such as coma, drug allergy, mental disorder, and other severe organic lesions in the brain', 'patients were as follows: diagnosed as acute stroke (ischemic stroke or intracerebral hemorrhage) by head CT or MRI within 72\u200ahours; age greater than 18; motor function disorder; Glasgow Coma Scale greater than 12']","['edaravone', 'edaravone treatment', 'Edaravone']","['Safety and efficacy', 'functional movement, living ability score, neurological score, treatment effect, and adverse reaction', 'cerebral blood flow volume']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0814851', 'cui_str': 'Research Ethics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0013182', 'cui_str': 'Allergy to drug'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0202691', 'cui_str': 'CT of head'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",60.0,0.199749,"After treatment, the differences in functional movement, living ability score, neurological score, treatment effect, and adverse reaction of these 2 groups were tested and compared.
","[{'ForeName': 'Hailei', 'Initials': 'H', 'LastName': 'Shan', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Chengde Medical University, Hebei, China.'}, {'ForeName': 'Guangmei', 'Initials': 'G', 'LastName': 'Jiao', 'Affiliation': ''}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Dou', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024811']
1293,33669436,Low-Dose Ammonium Preconditioning Enhances Endurance in Submaximal Physical Exercises.,"Preconditioning is often used in medicine to protect organs from ischemic damage and in athletes to enhance the performances. We tested whether low-dose ammonium preconditioning (AMP) could have a beneficial effect on physical exercises (PE). We used Cardiopulmonary Exercise Testing (CPET) on a treadmill to investigate the effects of low-dose AMP on the physical exercise capacity of professional track and field athletes and tested twenty-five athletes. Because of the individual differences between athletes, we performed a preliminary treadmill test (Pre-test) and, according to the results, the athletes were randomly allocated into the AMP and control (placebo, PL) group based on the similarity of the total distance covered on a treadmill. In the AMP group, the covered distance increased (11.3 ± 3.6%,  p  < 0.02) compared to Pre-test. Similarly, AMP significantly increased O 2  uptake volume-VO 2  (4.6 ± 2.3%,  p  < 0.03) and pulmonary CO 2  output-VCO 2  (8.7 ± 2.8%,  p  < 0.01). Further, the basic blood parameters (pH, pO 2 , and lactate) shift was lower despite the greater physical exercise progress in the AMP group compared to Pre-test, whereas in the placebo group there were no differences between Pre-test and Load-test. Importantly, the AMP significantly increased red blood cell count (6.8 ± 2.0%,  p  < 0.01) and hemoglobin concentration (5.3 ± 1.9%,  p  < 0.01), which might explain the beneficial effects in physical exercise progress. For the first time, we showed that low-dose AMP had clear beneficial effects on submaximal PE.",2021,"In the AMP group, the covered distance increased (11.3 ± 3.6%,  p  < 0.02) compared to Pre-test.",['professional track and field athletes and tested twenty-five athletes'],"['placebo', 'low-dose AMP', 'Cardiopulmonary Exercise Testing (CPET', 'AMP and control (placebo, PL', 'low-dose ammonium preconditioning (AMP']","['basic blood parameters (pH, pO 2 , and lactate) shift', 'red blood cell count', 'hemoglobin concentration', 'AMP significantly increased O 2  uptake volume-VO 2', 'covered distance', 'physical exercise progress']","[{'cui': 'C0040595', 'cui_str': 'Track and field'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",25.0,0.0178023,"In the AMP group, the covered distance increased (11.3 ± 3.6%,  p  < 0.02) compared to Pre-test.","[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Mindukshev', 'Affiliation': 'Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Thorez pr., 44, 194223 Saint-Petersburg, Russia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sudnitsyna', 'Affiliation': 'Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Thorez pr., 44, 194223 Saint-Petersburg, Russia.'}, {'ForeName': 'Nikolay V', 'Initials': 'NV', 'LastName': 'Goncharov', 'Affiliation': 'Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Thorez pr., 44, 194223 Saint-Petersburg, Russia.'}, {'ForeName': 'Elisaveta', 'Initials': 'E', 'LastName': 'Skverchinskaya', 'Affiliation': 'Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Thorez pr., 44, 194223 Saint-Petersburg, Russia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Dobrylko', 'Affiliation': 'Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Thorez pr., 44, 194223 Saint-Petersburg, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Nikitina', 'Affiliation': 'Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Thorez pr., 44, 194223 Saint-Petersburg, Russia.'}, {'ForeName': 'Alexandr I', 'Initials': 'AI', 'LastName': 'Krivchenko', 'Affiliation': 'Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Thorez pr., 44, 194223 Saint-Petersburg, Russia.'}, {'ForeName': 'Stepan', 'Initials': 'S', 'LastName': 'Gambaryan', 'Affiliation': 'Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Thorez pr., 44, 194223 Saint-Petersburg, Russia.'}]","Sports (Basel, Switzerland)",['10.3390/sports9020029']
1294,33669400,"Functional Food Components, Intestinal Permeability and Inflammatory Markers in Patients with Inflammatory Bowel Disease.","Inflammatory bowel diseases (IBD) are characterized by a chronic inflammatory process that affects the intestinal barrier structure. Recent evidence suggests that some food components can influence the integrity of the intestinal barrier and thus its permeability. We aimed at assessing the effect of food components on the intestinal permeability (IP) and on inflammatory markers in individuals with IBD by a single-blind randomized clinical study. Of the 53 individuals included, 47% ( n  = 25) had been diagnosed with IBD. The participants were divided into 4 groups. IBD patients were allocated to intervention group ( n  = 14) vs. no intervention group ( n  = 11), and the same happened with 28 control participants without disease ( n  = 14 in intervention group vs.  n  = 14 without intervention). Symptomatology, nutritional status, biochemical parameters (specifically serum zonulin (ZO) to measure IP) were evaluated on all individuals on an eight week period following a diet plan with/without potentially beneficial foods for the IP. At the beginning of the study, there were no significant differences in ZO values between individuals with and without IBD ( p  > 0.05). The effect of specific food components was inconclusive; however, a trend in the reduction of inflammatory parameters and on the prevalence of gastrointestinal symptomatology was observed. More controlled intervention studies with diet plans, including food components potentially beneficial for the integrity of the intestinal barrier, are of the utmost importance.",2021,"At the beginning of the study, there were no significant differences in ZO values between individuals with and without IBD ( p  > 0.05).","['53 individuals included, 47% ( n  = 25) had been diagnosed with IBD', 'Patients with Inflammatory Bowel Disease', 'individuals with IBD', 'IBD patients']","['28 control participants without disease ( n  = 14 in intervention group vs.  n  = 14 without intervention', 'food components', 'diet plan with/without potentially beneficial foods for the IP']","['ZO values', 'Functional Food Components, Intestinal Permeability and Inflammatory Markers', 'gastrointestinal symptomatology', 'Symptomatology, nutritional status, biochemical parameters (specifically serum zonulin (ZO) to measure IP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2717755', 'cui_str': 'Functional Food'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",53.0,0.0299948,"At the beginning of the study, there were no significant differences in ZO values between individuals with and without IBD ( p  > 0.05).","[{'ForeName': 'Joana Franco', 'Initials': 'JF', 'LastName': 'Lacerda', 'Affiliation': 'Nutrition Laboratory, Faculty of Medicine, University of Lisbon, 1649-045 Lisbon, Portugal.'}, {'ForeName': 'Ana Catarina', 'Initials': 'AC', 'LastName': 'Lagos', 'Affiliation': 'Hospital of Armed Forces Lisbon Pole, 1649-020 Lisbon, Portugal.'}, {'ForeName': 'Elisabete', 'Initials': 'E', 'LastName': 'Carolino', 'Affiliation': 'H&TRC-Health & Technology Research Center, Polytechnic Institute of Lisbon, School of Health Technology, 1990-096 Lisbon, Portugal.'}, {'ForeName': 'Ana Santos', 'Initials': 'AS', 'LastName': 'Silva-Herdade', 'Affiliation': 'Faculty of Medicine University of Lisbon, Institute of Molecular Medicine, University of Lisbon, 1649-045 Lisbon, Portugal.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Hospital of Armed Forces Lisbon Pole, 1649-020 Lisbon, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Sousa Guerreiro', 'Affiliation': 'Nutrition Laboratory, Faculty of Medicine, University of Lisbon, 1649-045 Lisbon, Portugal.'}]",Nutrients,['10.3390/nu13020642']
1295,33669254,The Role of Inflammatory Proteins in Anti-Glucocorticoid Therapy for Treatment-Resistant Depression.,"BACKGROUND


Optimising treatments for patients with treatment-resistant depression (TRD) is key to reducing the burden of this severe illness. The anti-glucocorticoid medication metyrapone has mixed evidence supporting a role as a possible augmentation treatment in TRD. The degree of treatment resistance in depression has been associated prospectively and retrospectively with elevated inflammation, and inflammatory activity may influence responses to antidepressant treatments.
AIMS


To investigate whether levels of pro-inflammatory cytokines are associated with clinical outcomes to metyrapone or placebo.
METHODS


A double-blind RCT randomised patients with TRD to 3 weeks of placebo or metyrapone augmentation to ongoing serotonergic antidepressants. No benefit of metyrapone was reported in the primary analysis. The current study assessed levels of pro-inflammatory proteins interleukin-6 (IL-6), tumour necrosis factor (TNFα), c-reactive protein (CRP) and interleukin-10 (IL-10) before randomisation and after treatment as potential moderators and/or mediators of clinical outcomes.
RESULTS


The three pro-inflammatory proteins (but not IL-10) were elevated in this sample of patients with TRD compared to a non-affected control group. High pre-treatment IL-6 levels predicted a poorer response in the trial overall but did not moderate response to metyrapone versus placebo. Changes in IL-6 indirectly mediated depression outcome, with metyrapone increasing IL-6 levels and IL-6 increase associated with a poorer outcome on depression. Other inflammatory proteins did not mediate or moderate treatment outcomes.
INTERPRETATION


Metyrapone is hypothesised to have a therapeutic effect in depression on the basis of inhibiting the synthesis of cortisol. In this study, metyrapone did not reduce cortisol, possibly due to glucocorticoid system overcompensation). The mediation effect of IL-6 may support this and perhaps help to indicate why the treatment was not effective.",2021,The three pro-inflammatory proteins (but not IL-10) were elevated in this sample of patients with TRD compared to a non-affected control group.,['patients with treatment-resistant depression (TRD'],"['IL-6', 'placebo']","['levels of pro-inflammatory proteins interleukin-6 (IL-6), tumour necrosis factor (TNFα), c-reactive protein (CRP) and interleukin-10 (IL-10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.282128,The three pro-inflammatory proteins (but not IL-10) were elevated in this sample of patients with TRD compared to a non-affected control group.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Strawbridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, PO74, King's College London, De Crespigny Park, London SE5 8AZ, UK.""}, {'ForeName': 'Alzbeta', 'Initials': 'A', 'LastName': 'Jamieson', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, PO74, King's College London, De Crespigny Park, London SE5 8AZ, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': 'National Institute for Health Research Maudsley Biomedical Research Centre, South London & Maudsley NHS Foundation Trust, London SE5 8AZ, UK.'}, {'ForeName': 'Ian Nicol', 'Initials': 'IN', 'LastName': 'Ferrier', 'Affiliation': 'Northern Centre for Mood Disorders, Translational and Clinical Research Institute, Newcastle University, Newcastle NE4 5PL, UK.'}, {'ForeName': 'Richard Hamish', 'Initials': 'RH', 'LastName': 'McAllister-Williams', 'Affiliation': 'Northern Centre for Mood Disorders, Translational and Clinical Research Institute, Newcastle University, Newcastle NE4 5PL, UK.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Powell', 'Affiliation': ""Social, Genetic & Developmental Psychiatry Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, PO74, King's College London, De Crespigny Park, London SE5 8AZ, UK.""}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Cleare', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, PO74, King's College London, De Crespigny Park, London SE5 8AZ, UK.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Watson', 'Affiliation': 'Northern Centre for Mood Disorders, Translational and Clinical Research Institute, Newcastle University, Newcastle NE4 5PL, UK.'}]",Journal of clinical medicine,['10.3390/jcm10040784']
1296,33669174,Healthy Lifestyle Management of Pediatric Obesity with a Hybrid System of Customized Mobile Technology: The PediaFit Pilot Project.,"Pediatric obesity management strategies suffer from a high rate of dropout and persistence of weight excess, despite the use of new tools, such as automated mobile technology (MT). We aimed to compare the efficacy of two 6-month personalized MT protocols in terms of better engagement, adherence to follow-up visits and improved anthropometric and lifestyle parameters. MT contacts consisted of three personalized/not automated What's App ®  self-monitoring or challenge messages per week. Messages, sent by a dedicated coach were inserted between three-monthly in-presence regular visits with (PediaFit 1.2) or without (PediaFit 1.1) monthly free-of charge short recall visits carried out by a specialized pediatric team. The sample included 103 children (mean age 10 years, range 6-14) recruited in the Pediatric Obesity Clinic between January 2017 and February 2019, randomized into Intervention group (IG) ( n  = 24 PediaFit 1.1;  n  = 30 PediaFit 1.2) and Control group (CG) (total  n  = 49). Controls received standard treatment only (indications for healthy nutrition and physical activity, and three months in presence regular visits). Overall, both IGs achieved significantly better results than the CGs for all considered parameters. Comparison of the two IGs at the sixth month in particular showed an IG 1.2 statistically significantly lower drop-out rate (10% vs. 62%,  p  = 0.00009), along with significantly improved BMI ( p  = 0.003), Screen Time ( p  = 0.04) and fruit and vegetables consumption ( p  = 0.02). The study suggests that the hybrid association of messaging through personalized/not automated MT plus monthly free-of charge recall visits may improve the prefixed outcomes of MT weight loss intervention programs.",2021,"Comparison of the two IGs at the sixth month in particular showed an IG 1.2 statistically significantly lower drop-out rate (10% vs. 62%,  p  = 0.00009), along with significantly improved BMI ( p  = 0.003), Screen Time ( p  = 0.04) and fruit and vegetables consumption ( p  = 0.02).","['Healthy Lifestyle Management of Pediatric Obesity with a Hybrid System of Customized Mobile Technology', '103 children (mean age 10 years, range 6-14) recruited in the Pediatric Obesity Clinic between January 2017 and February 2019, randomized into Intervention group (IG) ( n  ']","['standard treatment only (indications for healthy nutrition and physical activity', 'Messages, sent by a dedicated coach were inserted between three-monthly in-presence regular visits with (PediaFit 1.2) or without (PediaFit 1.1) monthly free-of charge short recall visits carried out by a specialized pediatric team']","['fruit and vegetables consumption', 'BMI', 'Screen Time']","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C5200690', 'cui_str': 'Healthy Nutrition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}]",103.0,0.0338921,"Comparison of the two IGs at the sixth month in particular showed an IG 1.2 statistically significantly lower drop-out rate (10% vs. 62%,  p  = 0.00009), along with significantly improved BMI ( p  = 0.003), Screen Time ( p  = 0.04) and fruit and vegetables consumption ( p  = 0.02).","[{'ForeName': 'Anna Pia', 'Initials': 'AP', 'LastName': 'Delli Bovi', 'Affiliation': 'Pediatrics Section, Department of Medicine, Surgery and Dentistry ""Scuola Medica Salernitana"", University of Salerno, 84081 Baronissi, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Manco Cesari', 'Affiliation': 'Pediatrics Section, Department of Medicine, Surgery and Dentistry ""Scuola Medica Salernitana"", University of Salerno, 84081 Baronissi, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Rocco', 'Affiliation': 'Pediatrics Section, Department of Medicine, Surgery and Dentistry ""Scuola Medica Salernitana"", University of Salerno, 84081 Baronissi, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Di Michele', 'Affiliation': 'Pediatrics Section, Department of Medicine, Surgery and Dentistry ""Scuola Medica Salernitana"", University of Salerno, 84081 Baronissi, Italy.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rimauro', 'Affiliation': 'Pediatrics Section, Department of Medicine, Surgery and Dentistry ""Scuola Medica Salernitana"", University of Salerno, 84081 Baronissi, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lugiero', 'Affiliation': 'Pediatrics Section, Department of Medicine, Surgery and Dentistry ""Scuola Medica Salernitana"", University of Salerno, 84081 Baronissi, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mottola', 'Affiliation': 'Pediatrics Section, Department of Medicine, Surgery and Dentistry ""Scuola Medica Salernitana"", University of Salerno, 84081 Baronissi, Italy.'}, {'ForeName': 'Anna Giulia Elena', 'Initials': 'AGE', 'LastName': 'De Anseris', 'Affiliation': 'Pediatrics/Clinical Pediatrics, ""San Giovanni di Dio e Ruggi d\'Aragona"" University Hospital, 84131 Salerno, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Nazzaro', 'Affiliation': 'Pediatrics/Clinical Pediatrics, ""San Giovanni di Dio e Ruggi d\'Aragona"" University Hospital, 84131 Salerno, Italy.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Massa', 'Affiliation': 'Pediatrics Section, Department of Medicine, Surgery and Dentistry ""Scuola Medica Salernitana"", University of Salerno, 84081 Baronissi, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Vajro', 'Affiliation': 'Pediatrics Section, Department of Medicine, Surgery and Dentistry ""Scuola Medica Salernitana"", University of Salerno, 84081 Baronissi, Italy.'}]",Nutrients,['10.3390/nu13020631']
1297,33668606,Eccentric Cycling Training Improves Erythrocyte Antioxidant and Oxygen Releasing Capacity Associated with Enhanced Anaerobic Glycolysis and Intracellular Acidosis.,"The antioxidant capacity of erythrocytes protects individuals against the harmful effects of oxidative stress. Despite improved hemodynamic efficiency, the effect of eccentric cycling training (ECT) on erythrocyte antioxidative capacity remains unclear. This study investigates how ECT affects erythrocyte antioxidative capacity and metabolism in sedentary males. Thirty-six sedentary healthy males were randomly assigned to either concentric cycling training (CCT,  n  = 12) or ECT ( n  = 12) at 60% of the maximal workload for 30 min/day, 5 days/week for 6 weeks or to a control group ( n  = 12) that did not receive an exercise intervention. A graded exercise test (GXT) was performed before and after the intervention. Erythrocyte metabolic characteristics and O 2  release capacity were determined by UPLC-MS and high-resolution respirometry, respectively. An acute GXT depleted Glutathione (GSH), accumulated Glutathione disulfide (GSSG), and elevated the GSSG/GSH ratio, whereas both CCT and ECT attenuated the extent of the elevated GSSG/GSH ratio caused by a GXT. Moreover, the two exercise regimens upregulated glycolysis and increased glucose consumption and lactate production, leading to intracellular acidosis and facilitation of O 2  release from erythrocytes. Both CCT and ECT enhance antioxidative capacity against severe exercise-evoked circulatory oxidative stress. Moreover, the two exercise regimens activate erythrocyte glycolysis, resulting in lowered intracellular pH and enhanced O 2  released from erythrocytes.",2021,"An acute GXT depleted Glutathione (GSH), accumulated Glutathione disulfide (GSSG), and elevated the GSSG/GSH ratio, whereas both CCT and ECT attenuated the extent of the elevated GSSG/GSH ratio caused by a GXT.","['sedentary males', 'Thirty-six sedentary healthy males']","['CCT and ECT', 'ECT', 'control group ( n  = 12) that did not receive an exercise intervention', 'concentric cycling training (CCT,  n  = 12) or ECT', 'Eccentric Cycling Training', 'eccentric cycling training (ECT', 'graded exercise test (GXT']","['erythrocyte antioxidative capacity and metabolism', 'hemodynamic efficiency', 'Erythrocyte Antioxidant and Oxygen Releasing Capacity', 'Glutathione (GSH), accumulated Glutathione disulfide (GSSG', 'glucose consumption and lactate production, leading to intracellular acidosis and facilitation of O 2  release from erythrocytes', 'Erythrocyte metabolic characteristics and O 2  release capacity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",36.0,0.0280173,"An acute GXT depleted Glutathione (GSH), accumulated Glutathione disulfide (GSSG), and elevated the GSSG/GSH ratio, whereas both CCT and ECT attenuated the extent of the elevated GSSG/GSH ratio caused by a GXT.","[{'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Therapy, College of Medical and Health Science, Asia University, Taichung 413, Taiwan.'}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Cheng', 'Affiliation': 'Metabolomics Core Laboratory, Healthy Aging Research Center, Chang Gung University, Taoyuan 333, Taiwan.'}, {'ForeName': 'Hsiang-Yu', 'Initials': 'HY', 'LastName': 'Tang', 'Affiliation': 'Metabolomics Core Laboratory, Healthy Aging Research Center, Chang Gung University, Taoyuan 333, Taiwan.'}, {'ForeName': 'Chi-Yao', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Healthy Aging Research Center, Graduate Institute of Rehabilitation Science, Medical Collage, Chang Gung University, Taoyuan 333, Taiwan.'}, {'ForeName': 'Kuan-Ming', 'Initials': 'KM', 'LastName': 'Chen', 'Affiliation': 'Healthy Aging Research Center, Graduate Institute of Rehabilitation Science, Medical Collage, Chang Gung University, Taoyuan 333, Taiwan.'}, {'ForeName': 'Jong-Shyan', 'Initials': 'JS', 'LastName': 'Wang', 'Affiliation': 'Healthy Aging Research Center, Graduate Institute of Rehabilitation Science, Medical Collage, Chang Gung University, Taoyuan 333, Taiwan.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox10020285']
1298,33668564,A Randomized Controlled Trial on the Effectiveness of Epidermal Growth Factor-Containing Ointment on the Treatment of Solar Lentigines as Adjuvant Therapy.,"Background and Objective : Little is known about the anti-pigmentation effects of whitening agents on solar lentigines. Epidermal growth factor (EGF) has been used as a booster for wound healing in the skin, and it has been suggested to have anti-pigmentation effects. This study aimed to evaluate the effect and safety of EGF-containing ointment for treating solar lentigines with a Q-switched (QS) 532 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser (Bluecore company, Seoul, Republic of Korea).  Materials and Methods : Subjects who underwent QS 532 nm Nd:YAG laser treatment of solar lentigines were randomly assigned to treatment with an EGF ointment or petrolatum. After the laser procedure, the subjects were administered the test ointment twice a day for 4 weeks. The physician's assessment of the degree of pigment clearance and patient's satisfaction were assessed after 4 and 8 weeks. Additionally, the melanin index (MI), erythema index (EI), transepidermal water loss (TEWL), and post-inflammatory hyperpigmentation (PIH) were evaluated. This trial was registered with ClinicalTrials.gov (NCT04704245).  Results : The blinded physician's assessment using 5-grade percentage improvement scale and patient's satisfaction were significantly higher in the study group than in the control group at the 4th and 8th weeks. The MI was significantly higher in the control group than in the study group at the 4th and 8th weeks. The EI and TEWL did not differ significantly between the two groups at either time point. The incidence of PIH was higher in the control group (37.5%) than in the EGF group (7.14%) at the 8th week.  Conclusions : The application of EGF-containing ointment on facial solar lentigines with a QS 532 nm Nd:YAG laser showed efficient and safe therapeutic effects, with less PIH. Thus, EGF-containing ointment could be suggested as the promising adjuvant treatment strategy with a QS laser for solar lentigines.",2021,"Additionally, the melanin index (MI), erythema index (EI), transepidermal water loss (TEWL), and post-inflammatory hyperpigmentation (PIH) were evaluated.","['facial solar lentigines with a QS 532 nm Nd', 'Materials and Methods : Subjects who underwent QS 532', 'solar lentigines']","['Epidermal Growth Factor-Containing Ointment', 'YAG laser', 'EGF', 'EGF-containing ointment', 'EGF ointment or petrolatum', 'Epidermal growth factor (EGF', 'Q-switched (QS) 532 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser']","['EI and TEWL', 'MI', 'melanin index (MI), erythema index (EI), transepidermal water loss (TEWL), and post-inflammatory hyperpigmentation (PIH', ""degree of pigment clearance and patient's satisfaction"", 'incidence of PIH', ""5-grade percentage improvement scale and patient's satisfaction""]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0036651', 'cui_str': 'Solar lentigo'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0033373', 'cui_str': 'Prolactin inhibiting factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0321402,"Additionally, the melanin index (MI), erythema index (EI), transepidermal water loss (TEWL), and post-inflammatory hyperpigmentation (PIH) were evaluated.","[{'ForeName': 'Hye One', 'Initials': 'HO', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, Korea.'}, {'ForeName': 'Hye Ran', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, Korea.'}, {'ForeName': 'Jin Cheol', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, Korea.'}, {'ForeName': 'Seok Young', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Dermatology, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, Korea.'}, {'ForeName': 'Min Je', 'Initials': 'MJ', 'LastName': 'Jung', 'Affiliation': 'Department of Dermatology, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Chang', 'Affiliation': 'Asan Medical Center, Department of Dermatology, Ulsan University College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Chun Wook', 'Initials': 'CW', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, Korea.'}, {'ForeName': 'Bo Young', 'Initials': 'BY', 'LastName': 'Chung', 'Affiliation': 'Department of Dermatology, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57020166']
1299,33668562,A Family-Based Lifestyle Intervention Focusing on Fathers and Their Children Using Co-Creation: Study Protocol of the Run Daddy Run Intervention.,"Fathers play a unique and important role in shaping their children's physical activity (PA), independent from the mother. Lifestyle interventions focusing simultaneously on PA of fathers and their children (""co-PA"") are therefore a novel and promising way to improve PA of both. A theory-based lifestyle intervention was co-created with fathers (i.e., the Run Daddy Run intervention), using the behavior change wheel as a theoretical framework. The aim of the present study is to describe the protocol of the Run Daddy Run intervention study, focusing on improving (co-)PA of fathers and children, and the prospected outcomes. The developed intervention consists of six (inter)active father-child sessions and an eHealth component, delivered over a 14-week intervention period. Baseline measurements will be conducted between November 2019-January 2020, post-test measurements in June 2020, and follow-up measurements in November 2020, with (co-)PA as the primary outcome variable. Outcomes will be measured using accelerometry and an online questionnaire. To evaluate the intervention, multilevel analyses will be conducted. This study will increase our understanding on whether a theory-based, co-created lifestyle intervention focusing exclusively on fathers and their children can improve their (co-)PA behavior and has important implications for future research and health policy, where targeting fathers might be a novel and effective approach to improve (co-)PA and associated health behaviors of both fathers and their children.",2021,"Fathers play a unique and important role in shaping their children's physical activity (PA), independent from the mother.",[],[],[],[],[],[],,0.0126838,"Fathers play a unique and important role in shaping their children's physical activity (PA), independent from the mother.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Latomme', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'PRCPAN (Priority Research Centre for Physical Activity and Nutrition), School of Education, University of Newcastle, Newcastle 2308, Australia.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'De Craemer', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Brondeel', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Maïté', 'Initials': 'M', 'LastName': 'Verloigne', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, 9000 Ghent, Belgium.'}]",International journal of environmental research and public health,['10.3390/ijerph18041830']
1300,33668362,"The Effect of Simulation Nursing Education Using the Outcome-Present State-Test Model on Clinical Reasoning, the Problem-Solving Process, Self-Efficacy, and Clinical Competency in Korean Nursing Students.","The purpose of this study was to assess the effect of a simulation nursing education program in terms of clinical reasoning, problem-solving process, self-efficacy, and clinical competency using the Outcome-Present State-Test (OPT) model in nursing students. The participants comprised 45 undergraduate nursing students recruited from two universities in Korea. The number of nursing students assigned to the experimental group and control group were 25 and 20, respectively. For a period of two weeks, the experimental group received a simulation nursing education program using the OPT model, while the control group received a traditional clinical practicum. The data were analyzed using prior homogeneity tests (Fisher's exact test and paired  t -test); ANCOVA was performed to investigate the differences in dependent variables between the two groups. There was a significant improvement in clinical reasoning (F = 10.59,  p  = 0.002), problem-solving process (F = 30.92,  p  < 0.001), and self-efficacy (F = 36.03,  p  < 0.001) in the experimental group as compared to the control group (F = 10.59,  p  = 0.002). Moreover, the experimental group showed significantly higher scores in clinical competency than the control group (F = 11.07,  p  = 0.002). This study demonstrates that the simulation nursing education program using the OPT model for undergraduate students is very effective in promoting clinical reasoning, problem-solving processes, self-efficacy, and clinical competency.",2021,"There was a significant improvement in clinical reasoning (F = 10.59,  p  = 0.002), problem-solving process (F = 30.92,  p  < 0.001), and self-efficacy (F = 36.03,  p  < 0.001) in the experimental group as compared to the control group (F = 10.59,  p  = 0.002).","['nursing students', 'Korean Nursing Students', 'undergraduate students', 'participants comprised 45 undergraduate nursing students recruited from two universities in Korea']","['Simulation Nursing Education', 'traditional clinical practicum', 'simulation nursing education program']","['clinical reasoning', 'clinical competency', 'clinical reasoning, problem-solving process, self-efficacy, and clinical competency', 'self-efficacy', 'problem-solving process']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0008956', 'cui_str': 'Competence, Clinical'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",45.0,0.020337,"There was a significant improvement in clinical reasoning (F = 10.59,  p  = 0.002), problem-solving process (F = 30.92,  p  < 0.001), and self-efficacy (F = 36.03,  p  < 0.001) in the experimental group as compared to the control group (F = 10.59,  p  = 0.002).","[{'ForeName': 'Yon Hee', 'Initials': 'YH', 'LastName': 'Seo', 'Affiliation': 'Department of Nursing, Yeoju Institute of Technology, Yeoju 12652, Gyeonggido, Korea.'}, {'ForeName': 'Mi Ran', 'Initials': 'MR', 'LastName': 'Eom', 'Affiliation': 'Department of Nursing, Mokpo National University, Muan-gun 58544, Jeollanamdo, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030243']
1301,33668355,Additional Effects of Xbox Kinect Training on Upper Limb Function in Chronic Stroke Patients: A Randomized Control Trial.,"BACKGROUND


Xbox Kinect-based virtual reality, being a novel approach, has therapeutic benefits in rehabilitation and its use is encouraged in stroke rehabilitation of upper extremities.
OBJECTIVE


Primary aim of the current study is to investigate the additional effects of Xbox Kinect training in combination with routine physiotherapy exercises based on each component of Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE). Moreover, effect of upper limb rehabilitation on cognitive functions was also assessed.
METHODS


This study was a parallel arm randomized control trial. Fifty-six participants were recruited and randomly allocated to either an Xbox Kinect training group (XKGT) or exercise training group (ETG). Measures of concern were recorded using FMA-UE, Box and Block Test (BBT), and Montreal Cognitive Assessment (MOCA). Evaluation was conducted at baseline and after completion of intervention at the sixth week.
RESULTS


There were significant differences from pre- to post-intervention scores of FMA-UE and BBT ( p  < 0.001) in both groups, whereas no difference was observed for MOCA (XKTG p value 0.417, ETG p value 0.113). At six-week follow-up there were significant differences between both groups in FMA-UE total score ( p  < 0.001), volitional movement within synergies ( p  < 0.001), wrist ( p  = 0.021), hand ( p  = 0.047), grasp ( p  = 0.006) and coordination/speed ( p  = 0.004), favoring the Xbox Kinect training group.
CONCLUSION


To conclude, results indicate repetitive use of the hemiparetic upper extremity by Xbox Kinect-based upper limb rehabilitation training in addition to conventional therapy has a promising potential to enhance upper limb motor function for stroke patients.",2021,"At six-week follow-up there were significant differences between both groups in FMA-UE total score ( p  < 0.001), volitional movement within synergies ( p  < 0.001), wrist ( p  = 0.021), hand ( p  = 0.047), grasp ( p  = 0.006) and coordination/speed ( p  = 0.004), favoring the Xbox Kinect training group.
","['stroke patients', 'Fifty-six participants', 'Chronic Stroke Patients']","['Xbox Kinect training group (XKGT) or exercise training group (ETG', 'routine physiotherapy exercises', 'Xbox Kinect-based upper limb rehabilitation training', 'Xbox Kinect Training', 'Xbox Kinect training', 'upper limb rehabilitation']","['FMA-UE, Box and Block Test (BBT), and Montreal Cognitive Assessment (MOCA', 'cognitive functions', 'FMA-UE total score', 'volitional movement within synergies', 'pre- to post-intervention scores of FMA-UE and BBT', 'Upper Limb Function']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",56.0,0.024373,"At six-week follow-up there were significant differences between both groups in FMA-UE total score ( p  < 0.001), volitional movement within synergies ( p  < 0.001), wrist ( p  = 0.021), hand ( p  = 0.047), grasp ( p  = 0.006) and coordination/speed ( p  = 0.004), favoring the Xbox Kinect training group.
","[{'ForeName': 'Qurat Ul', 'Initials': 'QU', 'LastName': 'Ain', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, Institute of Health and Rehabilitation Science, School of Life Science and Technology, Xi'an Jiaotong University, Xi'an 710049, China.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Physiotherapy Department, Mukkabir College, Gujrat 50700, Pakistan.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Ilyas', 'Affiliation': 'Department of Computer Science, Faculty of Information Technology, University of Central Punjab, Lahore 54000, Pakistan.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Yaseen', 'Affiliation': 'Riphah College of Rehabilitation & Allied Health Sciences, Faculty of Rehabilitation and Allied Health Sciences, Riphah International University, Islamabad 46000, Pakistan.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Tariq', 'Affiliation': 'Riphah College of Rehabilitation & Allied Health Sciences, Faculty of Rehabilitation and Allied Health Sciences, Riphah International University, Islamabad 46000, Pakistan.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, Institute of Health and Rehabilitation Science, School of Life Science and Technology, Xi'an Jiaotong University, Xi'an 710049, China.""}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, Institute of Health and Rehabilitation Science, School of Life Science and Technology, Xi'an Jiaotong University, Xi'an 710049, China.""}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030242']
1302,33674558,Effects of glossopharyngeal insufflation on pulmonary function in cervical cord injury patients.,"STUDY DESIGN


Quasi experimental.
OBJECTIVE


To evaluate the effect of glossopharyngeal insufflation on pulmonary function in cervical cord injury.
SETTING


Indian Spinal Injuries Centre, Vasant Kunj, Delhi, India.
METHODS


Thirty-one cervical cord injured (ISNCSCI A and B) subjects received respiratory rehabilitation for 4 weeks, with the experimental group performing glossopharyngeal insufflation along with respiratory rehabilitation. The groups were assessed at baseline and after 4 weeks for pulmonary function test, chest expansion, dyspnea, and chest tightness.
RESULTS


Significant differences were observed in IVC, IC, FVC, FEV1, MEF 75%, PEF, tidal volume, chest expansion, dyspnea, and chest tightness (p < 0.05).
CONCLUSION


Glossopharyngeal insufflation is a technique that can be used to improve the respiratory function after cervical cord injury.",2021,"RESULTS


Significant differences were observed in IVC, IC, FVC, FEV1, MEF 75%, PEF, tidal volume, chest expansion, dyspnea, and chest tightness (p < 0.05).
","['cervical cord injury patients', 'Indian Spinal Injuries Centre, Vasant Kunj, Delhi, India', 'Quasi experimental', 'Thirty-one cervical cord injured (ISNCSCI A and B) subjects received']","['respiratory rehabilitation for 4 weeks, with the experimental group performing glossopharyngeal insufflation along with respiratory rehabilitation', 'Glossopharyngeal insufflation', 'glossopharyngeal insufflation']","['pulmonary function', 'pulmonary function test, chest expansion, dyspnea, and chest tightness', 'IVC, IC, FVC, FEV1, MEF 75%, PEF, tidal volume, chest expansion, dyspnea, and chest tightness']","[{'cui': 'C0457846', 'cui_str': 'Segment of cervical spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0450355', 'cui_str': '31'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0232292', 'cui_str': 'Tight chest'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",31.0,0.0341704,"RESULTS


Significant differences were observed in IVC, IC, FVC, FEV1, MEF 75%, PEF, tidal volume, chest expansion, dyspnea, and chest tightness (p < 0.05).
","[{'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'ISIC Institute of Rehabilitation Sciences, Vasant Kunj, Delhi, India. akankshasharma1097@gmail.com.'}, {'ForeName': 'Shambhovi', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'ISIC Institute of Rehabilitation Sciences, Vasant Kunj, Delhi, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Dutta', 'Affiliation': 'Indian Spinal Injuries Centre, Vasant Kunj, Delhi, India.'}, {'ForeName': 'Jamal Ali', 'Initials': 'JA', 'LastName': 'Moiz', 'Affiliation': 'Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Delhi, India.'}]",Spinal cord series and cases,['10.1038/s41394-021-00390-w']
1303,33640715,Influence of narrow-band imaging (NBI) and enhanced operator's attention during esophagus inspection on cervical inlet patches detection.,"PURPOSE


Heterotopic gastric mucosa in the upper esophagus (cervical inlet patches - CIP) may be easily missed during esophagogastroduodenoscopy (EGD) due to low awareness of this usually, but not invariably, benign lesion. Narrow-band imaging (NBI) emphasizes contrast between normal esophageal mucosa and CIP. The purpose of this study was to investigate how NBI use and enhanced attention of operator during inspection of upper esophagus impacts cervical inlet patch detection rate (CIPDR).
MATERIALS AND METHODS


This is a prospective, randomized study in which we enrolled 1000 patients, qualified for diagnostic EGD. The trial was divided into two parts; the first, when 6 operators performed EGD with standard attention (SA), and the second, when the same operators were asked to step up with attention at CIP (enhanced attention - EA). In both parts of the study, patients were randomized to NBI and white light endoscopy (WLE) in 1:1 ratio. The study is registered in ClinicalTrials.gov (No. NCT03015571).
RESULTS


Differences in CIPDR between WLE and NBI in SA and EA were not statistically different (5.6% vs 7.6%; p ​= ​0.3, and 7.6% vs 11.6%; p ​= ​0.1, respectively). In multivariate regression analysis, the only factors improving CIPDR were NBI with EA (NBI EA , OR 3.31; 95%CI 1.57-6.98; p ​= ​0.003) and sedation (OR 1.97; 95%CI 1.27-3.05; p ​= ​0.002).
CONCLUSIONS


The use of NBI combined with EA significantly improves CIPDR.",2021,"RESULTS


Differences in CIPDR between WLE and NBI in SA and EA were not statistically different (5.6% vs 7.6%; p ​= ​0.3, and 7.6% vs 11.6%; p ​= ​0.1, respectively).","['enrolled 1000 patients, qualified for diagnostic EGD', 'Heterotopic gastric mucosa in the upper esophagus (cervical inlet patches - CIP']","['EGD with standard attention (SA), and the second, when the same operators were asked to step up with attention at CIP (enhanced attention - EA', 'narrow-band imaging (NBI', 'NBI and white light endoscopy (WLE', 'NBI combined with EA']",['CIPDR'],"[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0574894', 'cui_str': 'Heterotopic'}, {'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C3179046', 'cui_str': 'Inlets'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C1855739', 'cui_str': 'Indifference to Pain, Congenital, Autosomal Recessive'}]","[{'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C1855739', 'cui_str': 'Indifference to Pain, Congenital, Autosomal Recessive'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",[],1000.0,0.0855344,"RESULTS


Differences in CIPDR between WLE and NBI in SA and EA were not statistically different (5.6% vs 7.6%; p ​= ​0.3, and 7.6% vs 11.6%; p ​= ​0.1, respectively).","[{'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Romańczyk', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland; Department of Gastroenterology and Hepatology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland. Electronic address: mromanczyk@sum.edu.pl.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Romańczyk', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Lesińska', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland; Department of Gastroenterology and Hepatology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Romańczyk', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Hartleb', 'Affiliation': 'Department of Gastroenterology and Hepatology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Waluga', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland; Department of Gastroenterology and Hepatology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.'}]",Advances in medical sciences,['10.1016/j.advms.2021.02.002']
1304,33639543,Heart-focused breathing and perceptions of burden in Alzheimer's caregivers: An online randomized controlled pilot study.,"Informal caregivers of patients with Alzheimer's disease (AD) often experience high stress and reduced wellbeing and quality of life. HeartMath's Heart Lock-In® technique has been shown to reduce stress. In a randomized controlled pilot study among ten informal AD caregivers, we examined a two-week ten-minute daily, internet delivered heart-focused breathing protocol (n = 5) compared to waitlist control (n = 5). Participants completed pre- and post- self-assessments of perceived caregiver burden, stress, quality of life, anxiety, self-compassion and heart rate variability (HRV). Quality of life improved significantly in the control group compared to intervention, while self-compassion and HRV trended towards the expected direction. Caregiver burden and anxiety worsened in the intervention vs. waitlist control, suggesting the perception of added stress related to the required new daily task. While heart-focused breathing may hold promise for improving aspects of the caregiving experience, exploring online delivery methods and schedules that do not add extra burden is needed.",2021,"Quality of life improved significantly in the control group compared to intervention, while self-compassion and HRV trended towards the expected direction.","[""Alzheimer's caregivers"", 'ten informal AD caregivers', ""Informal caregivers of patients with Alzheimer's disease (AD""]",['internet delivered heart-focused breathing protocol (n\xa0=\xa05) compared to waitlist control'],"['Quality of life', 'Caregiver burden and anxiety', 'self-assessments of perceived caregiver burden, stress, quality of life, anxiety, self-compassion and heart rate variability (HRV']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}]",10.0,0.087476,"Quality of life improved significantly in the control group compared to intervention, while self-compassion and HRV trended towards the expected direction.","[{'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'James', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, USA. Electronic address: Taylorjamesrn@gmail.com.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'James', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Linda K', 'Initials': 'LK', 'LastName': 'Larkey', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, USA.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.02.006']
1305,33653760,"Digital health literacy intervention to support maternal, child and family health in primary healthcare settings of Pakistan during the age of coronavirus: study protocol for a randomised controlled trial.","INTRODUCTION


There is a need to continue primary healthcare services through digital communication for disadvantaged women living in underdeveloped areas of Pakistan, especially in the age of the coronavirus pandemic, social distancing and lockdown of communities. This project will be the first of its kind in aiming to implement a digital health literacy intervention, using smartphone and internet, to disadvantaged women through female community healthcare workers. Improved health literacy in women of reproductive years is known to promote maternal, child and family health overall.
METHODS AND ANALYSIS


The study will include a baseline survey, a pre- and post-test survey and a 3-month lasting intervention on (1) hygiene and prevention and (2) coronavirus awareness and prevention. Women of reproductive years will be sampled from disadvantaged areas across the four provinces of Pakistan (Baluchistan, Khyber Pakhtunkhwa, Punjab and Sindh), and the selection criteria will be poor, semiliterate or illiterate, belonging to underdeveloped neighbourhoods devoid of universal healthcare coverage and dependent on free primary health services. A target of 1000 women will comprise the sample, with 500 women each assigned randomly to the intervention and control groups. Analysis of variance and multivariate analysis will be used for analysing the intervention's effects compared with the control group.
ETHICS AND DISSEMINATION


Ethics approval for this study has been received from the Internal Review Board of the Forman Christian College University (reference number: IRB-252/06-2020). Results will be published in academic journals of repute and dissemination to the international scientific community and stakeholders will also be planned through workshops.
TRIAL REGISTRATION NUMBER


NCT04603092.",2021,"There is a need to continue primary healthcare services through digital communication for disadvantaged women living in underdeveloped areas of Pakistan, especially in the age of the coronavirus pandemic, social distancing and lockdown of communities.","['disadvantaged women living in underdeveloped areas of Pakistan', 'Forman Christian College University (reference number', 'women of reproductive years', '1000 women will comprise the sample, with 500 women', 'disadvantaged women through female community healthcare workers']",['Digital health literacy intervention'],['health literacy'],"[{'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0008532', 'cui_str': 'Christian religion'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",1000.0,0.140208,"There is a need to continue primary healthcare services through digital communication for disadvantaged women living in underdeveloped areas of Pakistan, especially in the age of the coronavirus pandemic, social distancing and lockdown of communities.","[{'ForeName': 'Sara Rizvi', 'Initials': 'SR', 'LastName': 'Jafree', 'Affiliation': 'Department of Sociology, Forman Christian College University, Lahore, Pakistan.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bukhari', 'Affiliation': 'School of Pharmacy, University College London, London, UK.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Muzamill', 'Affiliation': 'Department of Mass Communications, Forman Christian College University, Lahore, Pakistan.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Tasneem', 'Affiliation': 'Department of Business, Forman Christian College University, Lahore, Pakistan.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fischer', 'Affiliation': 'Institute of Public Health, Charité-Universitätsmedizin Berlin, Berlin, Germany florian.fischer1@charite.de.'}]",BMJ open,['10.1136/bmjopen-2020-045163']
1306,33658036,The effect of vitamin C on procalcitonin biomarker in community-acquired pneumonia.,"INTRODUCTION


Community acquired pneumonia (CAP) is a prevalent low respiratory infection. Diagnosis is based on clinical symptoms, radiologic evidence and culture. Biomarkers such as IL6, CRP and procalcitonin are helpful in diagnosis. Procalcitonin is a soluble biomarker in serum that increase in systemic inflammation and bacterial infections. People with normal procalcitonin have low risk to infect pneumonia. Patient with CAP have more oxidative stress than normal people. Studies show that receiving vitamin C can reduce incidence of pneumonia. The present study was designed to evaluate the effect of vitamin C supplement on procalcitonin biomarker in patient with CAP.
METHODS


Patients with CAP who passed inclusion and exclusion criteria after obtaining informed consent, were assigned randomly in two groups of drug and placebo. The drug group received vitamin C (1000 mg/d) daily and medications that physician prescribed for treating CAP for 10 days and placebo group received placebo and medications that physician prescribed. The serum level of procalcitonin was measured at the beginning of the study and after 10 days of intervention.
RESULTS


35 patients finished the study. Serum level of procalcitonin on the first and tenth day did not show any significant difference between drug and placebo groups.
CONCLUSIONS


To clarify the relationship between the effects of vitamin C on procalcitonin in CAP, a larger sample size is required.",2021,"Serum level of procalcitonin on the first and tenth day did not show any significant difference between drug and placebo groups.
","['Patients with CAP who passed inclusion and exclusion criteria after obtaining informed consent', '35 patients finished the study', 'community-acquired pneumonia', 'patient with CAP']","['CAP', 'vitamin C supplement', 'placebo', 'vitamin C']","['Serum level of procalcitonin', 'oxidative stress', 'serum level of procalcitonin', 'incidence of pneumonia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C3661608', 'cui_str': 'Vitamin C supplement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",,0.113413,"Serum level of procalcitonin on the first and tenth day did not show any significant difference between drug and placebo groups.
","[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Nikzad', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Department of Pharmacology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Momen-Heravi', 'Affiliation': 'Infectious Disease Research center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Haddad Kashani', 'Affiliation': 'Anatomical Sciences Research Center, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shiehmorteza', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran. maryamshiehmorteza@gmail.com.'}]",Clinical and molecular allergy : CMA,['10.1186/s12948-021-00140-1']
1307,33657306,A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis. Reply.,,2021,,['Appendicitis'],['Antibiotics with Appendectomy'],[],"[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",[],,0.0307375,,"[{'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Bizzell', 'Affiliation': 'Washington State Hospital Association, Seattle, WA.'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Kessler', 'Affiliation': 'University of Washington, Seattle, WA kesslerl@uw.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMc2035865']
1308,33657305,A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.,,2021,,['Appendicitis'],['Antibiotics with Appendectomy'],[],"[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",[],,0.0343449,,"[{'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Bertrand', 'Affiliation': 'Centre Hospitalier Universitaire de Nîmes, Nîmes, France martin.bertrand@chu-nimes.fr.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'Centre Hospitalier Universitaire de Nîmes, Nîmes, France martin.bertrand@chu-nimes.fr.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Prudhomme', 'Affiliation': 'Centre Hospitalier Universitaire de Nîmes, Nîmes, France martin.bertrand@chu-nimes.fr.'}]",The New England journal of medicine,['10.1056/NEJMc2035865']
1309,33657304,A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.,,2021,,['Appendicitis'],['Antibiotics with Appendectomy'],[],"[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",[],,0.0343449,,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pata', 'Affiliation': 'Ospedale Nicola Giannettasio, Corigliano-Rossano, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Podda', 'Affiliation': 'Cagliari University Hospital ""Duilio Casula"", Cagliari, Italy.'}, {'ForeName': 'Salomone', 'Initials': 'S', 'LastName': 'Di Saverio', 'Affiliation': 'University of Insubria, Varese, Italy salo75@inwind.it.'}]",The New England journal of medicine,['10.1056/NEJMc2035865']
1310,33657303,A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.,,2021,,['Appendicitis'],['Antibiotics with Appendectomy'],[],"[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",[],,0.0343449,,"[{'ForeName': 'Berna', 'Initials': 'B', 'LastName': 'Karaismailoglu', 'Affiliation': 'Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey bernakio@hotmail.com.'}]",The New England journal of medicine,['10.1056/NEJMc2035865']
1311,33657302,A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.,,2021,,['Appendicitis'],['Antibiotics with Appendectomy'],[],"[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",[],,0.0343449,,"[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'LoVecchio', 'Affiliation': 'Valleywise Health, Phoenix, AZ.'}]",The New England journal of medicine,['10.1056/NEJMc2035865']
1312,33657007,Associations with antibiotic prescribing for acute exacerbation of COPD in primary care: secondary analysis of a randomised controlled trial.,"BACKGROUND


C-reactive protein (CRP) point-of-care testing can reduce antibiotic use in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in primary care, without compromising patient care. Further safe reductions may be possible.
AIM


To investigate the associations between presenting features and antibiotic prescribing in patients with AECOPD in primary care.
DESIGN AND SETTING


Secondary analysis of a randomised controlled trial of participants presenting with AECOPD in primary care (the PACE trial).
METHOD


Clinicians collected participants' demographic features, comorbid illnesses, clinical signs, and symptoms. Antibiotic prescribing decisions were made after participants were randomised to receive a point-of-care CRP measurement or usual care. Multivariable regression models were fitted to explore the association between patient and clinical features and antibiotic prescribing, and extended to further explore any interactions with CRP measurement category (CRP not measured, CRP <20 mg/l, or CRP ≥20 mg/l).
RESULTS


A total of 649 participants from 86 general practices across England and Wales were included. Odds of antibiotic prescribing were higher in the presence of clinician-recorded crackles (adjusted odds ratio [AOR] = 5.22, 95% confidence interval [CI] = 3.24 to 8.41), wheeze (AOR = 1.64, 95% CI = 1.07 to 2.52), diminished vesicular breathing (AOR = 2.95, 95% CI = 1.70 to 5.10), or clinician-reported evidence of consolidation (AOR = 34.40, 95% CI = 2.84 to 417.27). Increased age was associated with lower odds of antibiotic prescribing (AOR per additional year increase = 0.98, 95% CI = 0.95 to 1.00), as was the presence of heart failure (AOR = 0.32, 95% CI = 0.12 to 0.85).
CONCLUSION


Several demographic features and clinical signs and symptoms are associated with antibiotic prescribing in AECOPD. Diagnostic and prognostic value of these features may help identify further safe reductions.",2021,"Increased age was associated with lower odds of antibiotic prescribing (AOR per-year increase =0.98,95","['patients with AECOPD in UK primary care', 'acute exacerbation of COPD in primary care', 'patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD', 'participants presenting with AECOPD in primary care', ""Clinicians collected participant's demographic features, comorbid illnesses, clinical signs, and symptoms"", '649 participants from 86 general practices across England and Wales']","['antibiotic prescribing', 'C-reactive protein point-of-care testing (CRP-POCT']","['vesicular breathing', 'heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0231857', 'cui_str': 'Vesicular breathing'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",649.0,0.151254,"Increased age was associated with lower odds of antibiotic prescribing (AOR per-year increase =0.98,95","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Hasse', 'Initials': 'H', 'LastName': 'Melbye', 'Affiliation': 'General Practice Research Unit, Department of Community Medicine, UIT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Cardiff School of Sport and Health Science, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mohammed Fasihul', 'Initials': 'MF', 'LastName': 'Alam', 'Affiliation': 'Department of Public Health, College of Health Sciences, QU-Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Jochen Wl', 'Initials': 'JW', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, School for Public Health and Primary Care, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cochrane', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Kirby', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark; University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Gurudutt', 'Initials': 'G', 'LastName': 'Naik', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Riga', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Sewell', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/BJGP.2020.0823']
1313,33639516,"The effects of reiki on heart rate, blood pressure, body temperature, and stress levels: A pilot randomized, double-blinded, and placebo-controlled study.","Reiki is a biofield energy therapy that focuses on optimizing the body's natural healing abilities by balancing the life force energy or qi/chi. Reiki has been shown to reduce stress, pain levels, help with depression/anxiety, increase relaxation, improve fatigue, and quality of life. In this pilot randomized, double-blinded, and placebo-controlled study, the effects of Reiki on heart rate, diastolic and systolic blood pressure, body temperature, and stress levels were explored in an effort to gain objective outcome measures and to understand the underlying physiological mechanisms of how Reiki may be having these therapeutic effects on subjective measures of stress, pain, relaxation, and depression/anxiety. Forty eight (n = 48) subjects were block randomized into three groups (Reiki treatment, sham treatment, and no treatment). The changes in pre- and post-treatment measurements for each outcome measure was analyzed through analysis of variance (ANOVA) post hoc multiple comparison test, which found no statistically significant difference between any of the groups. The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone. A second study with a larger sample size is warranted to investigate this finding further and perhaps with additional outcome measures to look at other possible physiological mechanisms that may underlie the therapeutic effects of Reiki.",2021,"The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone.",['Forty eight (n\xa0=\xa048) subjects'],['placebo'],"['heart rate', 'stress, pain levels, help with depression/anxiety, increase relaxation, improve fatigue, and quality of life', 'subjective measures of stress, pain, relaxation, and depression/anxiety', 'heart rate, diastolic and systolic blood pressure, body temperature, and stress levels', 'heart rate, blood pressure, body temperature, and stress levels']","[{'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",48.0,0.13131,"The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone.","[{'ForeName': 'Namuun', 'Initials': 'N', 'LastName': 'Bat', 'Affiliation': 'Ohio Wesleyan University, Delaware, OH, USA. Electronic address: namuun.bat@bastyr.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101328']
1314,33666026,[Clinical effect of lever positioning manipulation for lumbar disc herniation and its influence on Cobb angle].,"OBJECTIVE


To observe the clinical effect of lever positioning manipulation for the treatment of lumbar disc herniation and its effect on Cobb angle.
METHODS


From December 2017 to November 2018, 67 patients with lumbar disc herniation were included in the study. The patients were randomly divided into treatment group and control group by digital table method. There were 34 cases in the treatment group, including 20 males and 14 females, with an average age of (36.09±8.26) years old and a course of (13.79±15.50) months. Treatment group was treated with lever positioning manipulation. There were 33 cases in the control group, including 18 males and 15 females, with an average age of(36.48±7.81) years old and a course of (12.82±15.68) months. Control group was treated with lumbar slanting manipulation. Two groups were treated 3 times a week, once every other day, 6 times for a course of treatment, after 2 courses of treatment, the changes of Cobb angle before and after treatment were compared between two groups by imaging. The symptoms and signs were scored with reference to clinical evaluation standard;overall efficacy was evaluated with reference to ""Diagnostic Efficacy Criteria of Traditional Chinese Medicine Syndrome"" issued by the State Administration of Traditional Chinese Medicine for lumbar disc herniation.
RESULTS


One patient in each group dropped out. The symptom and sign scores of treatment group and control group before treatment were 18.56± 4.81, 18.61±3.72, while after treatment were 9.41±5.19, 13.55±3.68;treatment group was significantly lower than control group after treatment ( P <0.05). The rate of overall efficacy of treatment group and control group were 97.06% and 75.76%, respectively, and treatment group was superiorto control group( P <0.05). Post treatment Cobb angle of both groups of patients became smaller( P <0.05). The Cobb angle of treatment group and control group were(17.95±4.45)°, (18.14±3.59)° before treatment, while after treatment were (18.14±3.59)°, (15.49±1.75)°, change of Cobb angle in treatment group was better than in controlgroup( P <0.05).
CONCLUSION


Both the lever positioning manipulation and the lumbar slanting manipulation methods are effective for the treatment of lumbar disc herniation, but clinical effect of lever positioning method on lumbar disc herniation is more significant, and the effect on Cobb angle is more obvious. It is worthy of promotion.",2021,"Both the lever positioning manipulation and the lumbar slanting manipulation methods are effective for the treatment of lumbar disc herniation, but clinical effect of lever positioning method on lumbar disc herniation is more significant, and the effect on Cobb angle is more obvious.","['From December 2017 to November 2018, 67 patients with lumbar disc herniation were included in the study', '33 cases in the control group, including 18 males and 15 females, with an average age of(36.48±7.81) years old and a course of (12.82±15.68) months', '20 males and 14 females, with an average age of (36.09±8.26) years old and a course of (13.79±15.50) months']","['lumbar slanting manipulation', 'control group by digital table method', 'lever positioning manipulation']","['change of Cobb angle', 'rate of overall efficacy', 'symptom and sign scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",67.0,0.016538,"Both the lever positioning manipulation and the lumbar slanting manipulation methods are effective for the treatment of lumbar disc herniation, but clinical effect of lever positioning method on lumbar disc herniation is more significant, and the effect on Cobb angle is more obvious.","[{'ForeName': 'Li-Jiang', 'Initials': 'LJ', 'LastName': 'Lyu', 'Affiliation': 'The Third Clinical Medical College of Zhejiang University of Traditional Chinese Medicine, Hangzhou 310053, Zhejiang, China.'}, {'ForeName': 'Jing-Hu', 'Initials': 'JH', 'LastName': 'Li', 'Affiliation': 'The Third Clinical Medical College of Zhejiang University of Traditional Chinese Medicine, Hangzhou 310053, Zhejiang, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'The Third Clinical Medical College of Zhejiang University of Traditional Chinese Medicine, Hangzhou 310053, Zhejiang, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'The Third Clinical Medical College of Zhejiang University of Traditional Chinese Medicine, Hangzhou 310053, Zhejiang, China.'}, {'ForeName': 'Wei-Wa', 'Initials': 'WW', 'LastName': 'Wang', 'Affiliation': 'The Third Clinical Medical College of Zhejiang University of Traditional Chinese Medicine, Hangzhou 310053, Zhejiang, China.'}, {'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Mao', 'Affiliation': 'The Third Clinical Medical College of Zhejiang University of Traditional Chinese Medicine, Hangzhou 310053, Zhejiang, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'The Third Clinical Medical College of Zhejiang University of Traditional Chinese Medicine, Hangzhou 310053, Zhejiang, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2021.01.016']
1315,33666022,[Clinical study of hydraulic perfusion pump and traditional water flushing for percutaneous endoscopic lumbar discectomy].,"OBJECTIVE


To compare the clinical outcomes of hydraulic perfusion pump and traditional water fhushing in percutaneous endoscopic lumbar discectomy.
METHODS


From January 2016 to December 2018, 72 patients with lumbar disc herniation failed to conservative treatment were enrolled in this study. The patients were divided into hydraulic perfusion pump group and traditional water flushing group, 36 cases in each group. There were no significant differences in gender, age, prominent segment, clinical classification, preoperative visual analogue scale (VAS) and Japanese Orthopaedic Association(JOA) score between two groups ( P >0.05). All operations were performed by the same surgeon, and the operations were completed by hydraulic perfusion pumpflushing or traditional water flushing assisted surgery. The operation time, intraoperative blood loss, hospital stay were recorded;VAS and JOA scores were observed before and after operation;the incidences of postoperative complications were compared between two groups.
RESULTS


All the patients were followed up for 12 to 24 (15.7±5.1) months. Compared with the traditional water flushing group, the operation time of the hydraulic perfusion pump group was shorter [(65.5±21.3) min vs (74.8±19.9) min,  t =9.465,  P =0.003], and intraoperative blood loss was less [(21.2±12.9)ml vs (27.4± 14.1) ml,  t =8.331,  P =0.012], there was no statistical difference in hospital stay between two groups. Postoperative VAS scores at 1 day, 2 weeks and the final follow-up and postoperative JOA scores at the final follow-up of the two groups of patients improved compared with those before operation, but there was no significant difference between two groups ( P >0.05). In the traditional water flushing group, the intracranial hypertensionoccurred during operation and the operation time was forced to shorten in 5 cases, the nerve root adventitia injury in 4 cases, and the postoperative recurrence in 4 cases. No intracranial hypertension during operation was found in the hydraulic perfusion pump group, nerve root adventitia injury occurred in 1 case, postoperative recurrence in 2 cases. The incidence of complication of the hydraulic perfusion pump group was lower than that ofthe traditional water flushing group.
CONCLUSION


Both hydraulic perfusion pump and traditional water flushing assisted percutaneous endoscopic lumbar disc herniation can achieve satisfactory clinical results, but the former has shorter operation time, clearer intraoperative vision, less bleeding, and fewer intraoperative and postoperative complications.",2021,"No intracranial hypertension during operation was found in the hydraulic perfusion pump group, nerve root adventitia injury occurred in 1 case, postoperative recurrence in 2 cases.","['From January 2016 to December 2018, 72 patients with lumbar disc herniation failed to conservative treatment', 'percutaneous endoscopic lumbar discectomy']","['hydraulic perfusion pump and traditional water fhushing', 'hydraulic perfusion pumpflushing or traditional water flushing assisted surgery', 'hydraulic perfusion pump and traditional water flushing', 'hydraulic perfusion pump group and traditional water flushing']","['incidence of complication', 'gender, age, prominent segment, clinical classification, preoperative visual analogue scale (VAS) and Japanese Orthopaedic', 'operation time, intraoperative blood loss, hospital stay were recorded;VAS and JOA scores', 'intracranial hypertension', 'intraoperative blood loss', 'postoperative complications', 'Postoperative VAS scores', 'operation time', 'hospital stay', 'postoperative JOA scores', 'postoperative recurrence', 'nerve root adventitia injury', 'Association(JOA) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0021436', 'cui_str': 'Infusion pump'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0225342', 'cui_str': 'Tunica adventitia'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",72.0,0.0147361,"No intracranial hypertension during operation was found in the hydraulic perfusion pump group, nerve root adventitia injury occurred in 1 case, postoperative recurrence in 2 cases.","[{'ForeName': 'Yue-Hong', 'Initials': 'YH', 'LastName': 'Guan', 'Affiliation': ""Department of Rehabilitation, the Second People's Hospital of Changshu, Changshu 215500, Jiangsu, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Rehabilitation, the Second People's Hospital of Changshu, Changshu 215500, Jiangsu, China.""}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2021.01.012']
1316,33665997,[Clinical effects of tranexamic acid in arthroscope for femoroacetabular impingement].,"OBJECTIVE


To evaluate the clinical effects of tranexamic acid in arthroscope for femoroacetabular impingement.
METHODS


Totally 34 patients (34 hips) with femoroacetabular impingement underwent hip arthroscopy from June 2016 to December 2018, were randomly divided into two groups named as tranexamic acid group and control group, 17 patients in each group. In TXA group, there were 10 males and 7 females, aged from 20 to 49 years old with an average of (32.1±7.6) years old;15 mg/kg TXA was intravenous drops before operation incision performed at 10 min. In control group, there were 11 males and 6 females, aged from 20 to 49 years old with an average of (30.9±6.2) years old;100 ml normal saline was intravenous drops before operation incision performed at 10 min. Introopertaive and total bloodloss between two groups were compared. Visual analogue scale (VAS) at 3 and 7 days after opertaion were used to evaluate pain relief of hip joint. Modified Harris Hip Score(mHHS) of hip joint at 3, 6, 9 and 12 weeks after oeprtaion were applied to evaluate clinical effects.
RESULTS


All patients were obtained follow up over 12 weeks. Incision healed well without infection and deep vein thrombosis. There were no statistical difference in opertaion time bewteen two groups( P >0.05) . Total blood loss and introopertaive blood loss in TXA group were (0.47±0.20) L and (0.18±0.08) L, while (0.66±0.22) L and (0.24±0.01) L in control group;there were statical differences between two groups ( P <0.05). There were no dierences in VAS before opertaion and 7 days after opertaion between two groups ( P >0.05);VAS at 3 days after opertaion in TXA group was 2.35±1.12 and 3.12±0.70 in control group, and had difference ( P < 0.05). There were significance in VAS at 3 and 7 days after opertaion compared with preopertaive between two groups ( P < 0.05). Postopertaive mHHS in TXA group at 3 and 6 weeks were 87.72±1.95 and 91.92±2.32, respectively;while 84.08±1.21 and 89.77±3.30 in control group;there were difference between two groups at 3 and 6 weeks after operation ( P <0.05);there were no significant difference in mHHS between two groups at 9 and 12 weeks after operation( P >0.05).
CONCLUSION


Preoperative application of tranexamic acid could effectively reduce blood loss in arthroscopy for femoroacetabular impingement, thereby improving surgical field of vision, reducing difficulty of surgical operation, which could promote early and rapid rehabilitation of hip function.",2021,"Preoperative application of tranexamic acid could effectively reduce blood loss in arthroscopy for femoroacetabular impingement, thereby improving surgical field of vision, reducing difficulty of surgical operation, which could promote early and rapid rehabilitation of hip function.","['10 males and 7 females, aged from 20 to 49 years old with an average of (32.1±7.6) years old;15 mg/kg', 'Totally 34 patients (34 hips) with femoroacetabular impingement underwent hip arthroscopy from June 2016 to December 2018', '11 males and 6 females, aged from 20 to 49 years old with an average of (30.9±6.2) years old;100 ml normal saline was intravenous drops before operation incision performed at 10 min']","['tranexamic acid', 'TXA']","['Incision healed well without infection and deep vein thrombosis', 'Visual analogue scale (VAS', 'pain relief of hip joint', 'Introopertaive and total bloodloss', 'VAS', 'mHHS', 'Total blood loss and introopertaive blood loss', 'blood loss', 'opertaion time']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",34.0,0.0143494,"Preoperative application of tranexamic acid could effectively reduce blood loss in arthroscopy for femoroacetabular impingement, thereby improving surgical field of vision, reducing difficulty of surgical operation, which could promote early and rapid rehabilitation of hip function.","[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Sport Medicine, Shandong Wendeng Orthopaedics Hospital, Weihai 264400, Shandong, China.'}, {'ForeName': 'Li-Wu', 'Initials': 'LW', 'LastName': 'Qin', 'Affiliation': 'Department of Sport Medicine, Shandong Wendeng Orthopaedics Hospital, Weihai 264400, Shandong, China.'}, {'ForeName': 'Hong-Jiang', 'Initials': 'HJ', 'LastName': 'Jiang', 'Affiliation': 'Department of Sport Medicine, Shandong Wendeng Orthopaedics Hospital, Weihai 264400, Shandong, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2021.02.005']
1317,33665995,[Clinical observation on pulley suspension traction reduction combined with self-made splint fixation for the treatment of extended distal radius fracture].,"OBJECTIVE


To explore clinical effects of pulley suspension traction reduction combined with self-made splint fixation in treating extended distal radius fracture.
METHODS


From December 2017 to December 2019, 60 patients with extended distal radius fractures were divided into observation group and control group, 30 patients in each group. In observation group, there were 12 males and 18 females, aged from 50 to 75 years old with an average of (59.63±8.08) years old;according to AO classification, 25 patients were type A2 and 5 patients with type A3;fractures were fixed by pulley suspension traction and self-made splint. In control group, there were 11 males and 19 females, aged from 52 to 76 years old with an average of (59.77±8.03) years old;according to AO classification, 24 patients were with type A2 and 6 patients were type A3;fractures were treated by conventional manipulation with self-made splint fixation. The radius height, ulnar angle and palmar angle between two groups were compared before and after treatment, and clinical effects were evaluated by advanced Green and O'Brien wrist joint scoring after treatment.
RESULTS


All patients were followed up from 11 to 13 months with an average of (11.90± 0.80) months. The splint was removed for 42 to 60 days with an average of (50.20±4.94) days. After removal of splint, X-rays indicated that all patients obtained bone healing with smooth of joint surface. In observation group, radius height was (4.57± 1.16) mm, ulnar angle was (12.83±3.25) °, palmar angle were (-21.17±3.36) ° respectively before treatment, (10.10± 1.75) mm, (24.30±3.16) °, (9.40±2.13) ° respectively at 8 weeks after treatment;in control group, radius height, ulnar angle, palm angle were (4.50±1.43) mm, (12.83±3.10) °, (-21.50±3.38) ° respectively before treatment, and (8.90±1.24) mm, (21.20±2.91) °, (6.16±2.94) ° respectively at 8 weeks after treatment;there were no significant difference in radius height, ulnar deviation angle and palmar inclination between two groups before treatment ( P >0.05);radius height, ulnar deviation angle and palmar inclination angle of between two groups were significantly improved at 8 weeks after treatment( P <0.05), and observation group was significantly better than that of control group ( P <0.05). Green and O'Brien wrist score of observation group was 90.97±7.92 at follow-up ranged from 11 to 13 months with an average of (11.90±0.80) months, which was significantly higher than that of control group (84.77±9.14) ( t =2.807,  P <0.05);in observation group, 18 patients got excellent result, 10 good and 2 fair;in control group, 10 patients got excellent result, 15 good, 3 fair and 2 poor;there was siginifcantly difference between two groups ( Z =-2.15,  P <0.05).
CONCLUSION


Compared with conventional manual traction and reduction, pulley suspension traction reduction combined with self made splint fixation for the treatment of extended distal radius fracture has more advantages with stable and reliable traction, good reduction, and better wrist joint function. It could be selected and applied according to the actual situation of patients.",2021,"were significantly improved at 8 weeks after treatment( P <0.05), and observation group was significantly better than that of control group ( P <0.05).","['12 males and 18 females, aged from 50 to 75 years old with an average of (59.63±8.08) years old;according to AO classification, 25 patients were type A2 and 5 patients with type A3;fractures', '11 males and 19 females, aged from 52 to 76 years old with an average of (59.77±8.03) years old;according to AO classification, 24 patients were with type A2 and 6 patients were type A3;fractures were treated by', 'extended distal radius fracture', 'From December 2017 to December 2019, 60 patients with extended distal radius fractures']","['pulley suspension traction reduction combined with self-made splint fixation', 'conventional manipulation with self-made splint fixation', 'pulley suspension traction and self-made splint', 'conventional manual traction and reduction, pulley suspension traction reduction combined with self made splint fixation']","['wrist joint function', 'radius height', 'radius height, ulnar deviation angle and palmar inclination', 'radius height, ulnar angle and palmar angle', 'bone healing with smooth of joint surface', ""advanced Green and O'Brien wrist joint scoring"", 'radius height, ulnar angle, palm angle', ""Green and O'Brien wrist score""]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C1322271', 'cui_str': 'Wrist joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0449752', 'cui_str': 'Ulnar deviation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1184147', 'cui_str': 'Palmar'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0123711,"were significantly improved at 8 weeks after treatment( P <0.05), and observation group was significantly better than that of control group ( P <0.05).","[{'ForeName': 'Hai-Bin', 'Initials': 'HB', 'LastName': 'Hong', 'Affiliation': ""Tong'an District Hospital of Traditional Chinese Medicine, Xiamen 361100, Fujian, China.""}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2021.02.003']
1318,33663090,Immediate effect of non-invasive auricular acupoint stimulation on the performance and meridian activities of archery athletes: A protocol for randomized controlled trial.,"BACKGROUND


Archery has existed in human history for millenniums. Being a unique exercise and precision sport, the keys to performance are emotional control, attention, and concentration rather than explosive force, muscle power, and endurance. During the execution of archery, attention is the key to performance in elite players, especially in the initial period while drawing the bow. Auricular acupoint stimulation is one of the therapeutic methods of traditional Chinese medicine and has been reported for its use in amplifying the anesthesia effect, weight reduction, cessation of substance abuse, and autonomic nervous modulation.
METHODS


The study will recruit archery players in school teams among junior and senior high schools and colleges. The subjects will be randomly assigned to the ear and sham acupressure groups. This is a randomized controlled trial with crossover design. The outcome measures will be obtained, including the meridian activities and balance index with Ryodoraku device, the movement stability with WIMU tracking system, the continuous heart rate record, and the scores of the 2 sections as the performance. The subjects will rate their attention and fatigue levels through self-reported questionnaires.
OBJECTIVES


This study aims to investigate the immediate effect of non-invasive auricular acupoint stimulation on the performance and meridian activities of archery athletes.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04637607.",2021,"This study aims to investigate the immediate effect of non-invasive auricular acupoint stimulation on the performance and meridian activities of archery athletes.
","['archery athletes', 'elite players', 'archery players in school teams among junior and senior high schools and colleges']","['non-invasive auricular acupoint stimulation', 'Auricular acupoint stimulation']","['performance and meridian activities', 'meridian activities and balance index with Ryodoraku device, the movement stability with WIMU tracking system, the continuous heart rate record, and the scores of the 2 sections as the performance']","[{'cui': 'C0336717', 'cui_str': 'Archery'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0085282', 'cui_str': 'Jingluo'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0394662', 'cui_str': 'Ryodoraku'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1738334', 'cui_str': 'Tracking system'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.109487,"This study aims to investigate the immediate effect of non-invasive auricular acupoint stimulation on the performance and meridian activities of archery athletes.
","[{'ForeName': 'Yi-Hsun', 'Initials': 'YH', 'LastName': 'Tsai', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung.'}, {'ForeName': 'Szu-Ying', 'Initials': 'SY', 'LastName': 'Wu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung.'}, {'ForeName': 'Wen-Long', 'Initials': 'WL', 'LastName': 'Hu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung.'}, {'ForeName': 'Yun-Ru', 'Initials': 'YR', 'LastName': 'Lai', 'Affiliation': 'Department of Biological Science, National Sun Yat-Sen University.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tsao', 'Affiliation': 'Department of Leisure and Sports Management, Cheng Shiu University.'}, {'ForeName': 'Ke-Tien', 'Initials': 'KT', 'LastName': 'Yen', 'Affiliation': 'College of Management, National Kaohsiung University of Science and Technology, Kaohsiung.'}, {'ForeName': 'Cheng-Hsien', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Sports Training Science-Athletics, National Taiwan Sport University, Taoyuan, Taiwan.'}, {'ForeName': 'Chun-En Aurea', 'Initials': 'CA', 'LastName': 'Kuo', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung.'}]",Medicine,['10.1097/MD.0000000000024753']
1319,33663085,Clinical application of enhanced recovery after surgery in the treatment of choledocholithiasis by ERCP.,"ABSTRACT


This study aims to investigate the effect of applying enhanced recovery after surgery methods (ERAS) in perioperative nursing of choledocholithiasis following endoscopic retrograde cholangiopancreatography (ERCP) for treatment of biliary calculus.Clinical data from 161 patients who underwent ERCP surgery in Wuhan Union Hospital from January 2017 to December 2019 were retrospectively analyzed. A total of 78 patients received perioperative nursing using the ERAS concept (experimental group) and 83 patients received conventional perioperative nursing (control group). Group differences were compared for the time to first postoperative ambulation, exhausting time, time to first defecation and eating, intraoperative blood loss, postoperative complication incidence (pancreatitis, cholangitis, hemorrhage), white blood cell (WBC), and serum amylase (AMS) values at 24 hours, duration of nasobiliary duct indwelling, length of hospital stay, and hospitalization expenses.No significant between-group differences were noted for demographic characteristics (age, sex, BMI, ASA score, and comorbidity) (P > .05). Time to first ambulation, exhausting time, time to defecation and eating, and nasobiliary drainage time were shorter in the experimental group than the control group, and the differences were statistically significant (P < .05). There was no significant between-group difference in postoperative WBC values at 24 hours (P > .05), but the experimental group's AMS values at 24 hours postoperation were significantly lower than those of the controls (154.93 ± 190.01 vs 241.97 ± 482.64, P = .031). Postoperative complications incidence was 9.1% in the experimental group, which was significantly lower than the 20.4% in the control group, and this difference was statistically significant (P = .039). Compared with the control group, nasobiliary drainage time (26.53 ± 7.43 hours vs 37.56 ± 9.91 hours, P < .001), hospital stay (8.32 ± 1.55 days vs 4.56 ± 1.38 days, P < .001), and hospitalization expenses (36800 ± 11900 Yuan vs 28900 ± 6500 Yuan, P = .016) were significantly lower in the experimental group.ERAS is a safe and effective perioperative nursing application in ERCP for treating choledocholithiasis. It can effectively accelerate patients' recovery and reduce the incidence of complications; therefore, it is worthy of being applied and promoted in clinical nursing.",2021,"No significant between-group differences were noted for demographic characteristics (age, sex, BMI, ASA score, and comorbidity)","['161 patients who underwent ERCP surgery in Wuhan Union Hospital from January 2017 to December 2019 were retrospectively analyzed', '78 patients received perioperative nursing using the ERAS concept (experimental group) and 83 patients received']","['ERAS', 'conventional perioperative nursing (control group', 'endoscopic retrograde cholangiopancreatography (ERCP']","['hospitalization expenses', 'Time to first ambulation, exhausting time, time to defecation and eating, and nasobiliary drainage time', 'postoperative WBC values', 'AMS values', 'Postoperative complications incidence', 'hospital stay', 'demographic characteristics (age, sex, BMI, ASA score, and comorbidity', 'time to first postoperative ambulation, exhausting time, time to first defecation and eating, intraoperative blood loss, postoperative complication incidence (pancreatitis, cholangitis, hemorrhage), white blood cell (WBC), and serum amylase (AMS) values at 24\u200ahours, duration of nasobiliary duct indwelling, length of hospital stay, and hospitalization expenses', 'nasobiliary drainage time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038931', 'cui_str': 'Nursing, Perioperative'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038931', 'cui_str': 'Nursing, Perioperative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0231226', 'cui_str': 'Exhausting'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0008311', 'cui_str': 'Cholangitis'}, {'cui': 'C0201885', 'cui_str': 'Amylase measurement, serum'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",78.0,0.025184,"No significant between-group differences were noted for demographic characteristics (age, sex, BMI, ASA score, and comorbidity)","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zuhua', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024730']
1320,33663075,Efficacy and safety of Buyang Huanwu decoction in the treatment of varicose veins of the lower extremities: A protocol of randomized controlled trial.,"BACKGROUND


Varicose veins of the lower extremities are common chronic venous diseases in the clinic. Although Western medicine has various surgical methods to treat varicose veins in the lower extremities, there are still a variety of complications. Some studies have shown that Buyang Huanwu decoction treatment of varicose veins of the lower extremities has a certain effect, and can reduce the occurrence of postoperative complications, but there is no evidence of evidence-based medicine. The research carried out in this scheme is to systematically evaluate the efficacy and safety of Buyang Huanwu decoction in the treatment of varicose veins in the lower extremities, and to provide reliable evidence for guiding clinical practice.
METHODS


This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial, which studies the effectiveness and safety of Buyang Huanwu decoction in the treatment of varicose veins of the lower extremities. The patients are randomly and evenly divided into treatment group and control group, the former one is given Buyang Huanwu decoction and the latter one is given placebo. The study will last 49 days, including a 7-day washout period, 14-day intervention and 28-day follow-up, focusing on its efficacy and safety indicators. Observation indicators include: TCM syndrome score, Venous Clinical Severity Score (VCSS), Venous Disability Scote (VDS), Aberdeen Varicose Vein Questionnaire (AVVQ), Hemorheology Indicators, Adverse Reactions, etc. Data analysis is performed using SPSS 25.0 software.
DISCUSSION


This study will evaluate the effectiveness and safety of Buyang Huanwu decoction and provide clinical evidence for the treatment of varicose veins of the lower extremities.
TRIAL REGISTRATION


OSF Registration number: DOI 10.17605/OSF.IO/WGJXT.",2021,"Some studies have shown that Buyang Huanwu decoction treatment of varicose veins of the lower extremities has a certain effect, and can reduce the occurrence of postoperative complications, but there is no evidence of evidence-based medicine.",['varicose veins of the lower extremities'],"['Buyang Huanwu decoction', 'placebo']","['TCM syndrome score, Venous Clinical Severity Score (VCSS), Venous Disability Scote (VDS), Aberdeen Varicose Vein Questionnaire (AVVQ), Hemorheology Indicators, Adverse Reactions, etc', 'efficacy and safety', 'Efficacy and safety']","[{'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C1137699', 'cui_str': 'buyang huanwu'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206502', 'cui_str': 'Hemorrheology'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.211701,"Some studies have shown that Buyang Huanwu decoction treatment of varicose veins of the lower extremities has a certain effect, and can reduce the occurrence of postoperative complications, but there is no evidence of evidence-based medicine.","[{'ForeName': 'Chuanyong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Vascular Surgery, Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Suzhou, P R China.'}, {'ForeName': 'Weijian', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Zhichang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Guangfeng', 'Initials': 'G', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jianjie', 'Initials': 'J', 'LastName': 'Rong', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024663']
1321,33663073,"A simplified protocol for individualized regional citrate anticoagulation for hemodialysis: A single-center, randomized clinical study.","INTRODUCTION


The lack of individualized treatment protocols and complicated procedures are important factors limiting the use of regional citrate anticoagulation (RCA) technology in hemodialysis. This study aims to validate the safety and efficacy of a simplified individualized RCA protocol for hemodialysis.
MATERIALS AND METHODS


From June 2019 to August 2019, 45 patients with active bleeding or bleeding tendency undergoing maintenance hemodialysis in the Nephrology Department of the First Affiliated Hospital of Nanchang University were randomly divided into a modified conventional RCA protocol group with a low-flux dialyzer, a simplified individualized RCA protocol group with a high-flux dialyzer, and a simplified individualized RCA protocol group with a low-flux dialyzer.
RESULTS


A total of 45 patients were included in this study. The mean age of the patients was 57.38 ± 19.05 years, and 78% were men. Forty-three patients completed 4 hours of hemodialysis, and the median total clotting scores in the 3 groups were 11, 12, and 12. Compared with the modified conventional RCA protocol group with a low-flux dialyzer, the 2 simplified individualized RCA protocol groups had better clotting scores for the dialyzer, arterial bubble trap, and single-pool urea clearance index (spKt/VBUN) and lower costs. Moreover, these parameters did not differ between the 2 simplified individualized RCA protocol groups. No electrolyte or acid-base imbalances or citrate poisoning was observed in any of the 3 groups. Adverse events did not differ significantly among the 3 groups.
CONCLUSIONS


The simplified individualized RCA protocol is safe, effective, and easy to implement. Therefore, this protocol can be promoted for clinical practice.
TRIAL REGISTRATION


This study was registered in the Chinese Clinical Study Registry under registration number ChiCTR1900023801.",2021,"Adverse events did not differ significantly among the 3 groups.
","['hemodialysis', 'A total of 45 patients', 'From June 2019 to August 2019, 45 patients with active bleeding or bleeding tendency undergoing maintenance hemodialysis in the Nephrology Department of the First Affiliated Hospital of Nanchang University', 'The mean age of the patients was 57.38\u200a±\u200a19.05\u200ayears, and 78% were men']","['modified conventional RCA protocol group with a low-flux dialyzer, a simplified individualized RCA protocol group with a high-flux dialyzer, and a simplified individualized RCA protocol group with a low-flux dialyzer', 'individualized regional citrate anticoagulation', 'simplified individualized RCA protocol', 'modified conventional RCA protocol']","['safety and efficacy', 'electrolyte or acid-base imbalances or citrate poisoning', 'Adverse events', 'clotting scores for the dialyzer, arterial bubble trap, and single-pool urea clearance index (spKt/VBUN) and lower costs', 'median total clotting scores']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0587474', 'cui_str': 'Nephrology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0001118', 'cui_str': 'Acid-Base Imbalance'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C1318428', 'cui_str': 'Urea clearance measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}]",45.0,0.0260836,"Adverse events did not differ significantly among the 3 groups.
","[{'ForeName': 'Laimin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Nanchang University, Jiangxi, Nanchang, China.'}, {'ForeName': 'Meirong', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Qinkai', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024639']
1322,33673541,"Integration of a Virtual Dispensing Simulator ""MyDispense"" in an Experiential Education Program to Prepare Students for Community Introductory Pharmacy Practice Experience.","BACKGROUND


Technology is increasingly used to enhance pharmacy education. We sought to evaluate student learning and preparedness for community introductory pharmacy practice experiences (IPPEs) after implementation of ""MyDispense"" into experiential education.
METHODS


Both first-year pharmacy students and assigned community IPPE preceptors were eligible. Students were stratified based on previous community pharmacy experience (< or ≥ 50 h), then randomized to complete MyDispense exercises before IPPE (group A) or after 24-32 h of IPPE (group B). We evaluated preceptors' assessment of student readiness using a 6-item Likert scale survey and students' readiness and opinion of MyDispense using an anonymous 9-item survey. Descriptive statistics were used to characterize data. The Mann-Whitney U test was used to compare groups and a  p -value < 0.05 was considered statistically significant.
RESULTS


Of 177 eligible students, 155 were randomized and 56 completed study. Group A included 32 students; 56.3% had prior community practice experience. Group B included 24 students; 50% had prior community practice experience. Forty-eight preceptors were enrolled. Students who completed exercises before rotation received higher preceptor scores for patient counseling of self-care and of medications ( p  < 0.05 for both). Students self-assessed their counseling skills lower than all other skills; 30.4% and 42.9% of students felt mostly or always prepared to counsel for self-care and medications, respectively. Students found MyDispense straightforward, realistic, and appreciated the ability to practice in a safe, electronic, community pharmacy, patient-care environment.
CONCLUSION


Simulation-based software, such as MyDispense, can enhance learner understanding of the prescription fill and counseling process in a community pharmacy practice setting.",2021,Students who completed exercises before rotation received higher preceptor scores for patient counseling of self-care and of medications ( p  < 0.05 for both).,"['Group A included 32 students; 56.3% had prior community practice experience', '177 eligible students, 155 were randomized and 56 completed study', 'Group B included 24 students; 50% had prior community practice experience', 'Forty-eight preceptors were enrolled', 'Both first-year pharmacy students and assigned community IPPE preceptors were eligible', 'Students were stratified based on previous community pharmacy experience (< or ≥ 50 h', 'Students for Community Introductory Pharmacy Practice Experience']","['IPPE', 'MyDispense exercises before IPPE']",['Students self-assessed their counseling skills'],"[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",48.0,0.0254825,Students who completed exercises before rotation received higher preceptor scores for patient counseling of self-care and of medications ( p  < 0.05 for both).,"[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Johnson', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Barrack', 'Affiliation': 'St. Francis Hospital and Medical Center, Hartford, CT 06105, USA.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Fitzgerald', 'Affiliation': 'University of Connecticut School of Pharmacy, Department of Pharmacy Practice, Storrs, CT 06269, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Sobieraj', 'Affiliation': 'University of Connecticut School of Pharmacy, Department of Pharmacy Practice, Storrs, CT 06269, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Holle', 'Affiliation': 'University of Connecticut School of Pharmacy, Department of Pharmacy Practice, Storrs, CT 06269, USA.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy9010048']
1323,33673371,Oral Sucrosomial Iron Is as Effective as Intravenous Ferric Carboxy-Maltose in Treating Anemia in Patients with Ulcerative Colitis.,"Anemia is a frequent complication of ulcerative colitis, and is frequently caused by iron deficiency. Oral iron supplementation displays high rates of gastrointestinal adverse effects. However, the formulation of sucrosomial iron (SI) has shown higher tolerability. We performed a prospective study to compare the effectiveness and tolerability of oral SI and intravenous ferric carboxy-maltose (FCM) in patients with ulcerative colitis in remission and mild-to-moderate anemia. Patients were randomized 1:1 to receive 60 mg/day for 8 weeks and then 30 mg/day for 4 weeks of oral SI or intravenous 1000 mg of FCM at baseline. Hemoglobin and serum levels of iron and ferritin were assessed after 4, 8, and 12 weeks from baseline. Hemoglobin and serum iron increased in both groups after 4 weeks of therapy, and remained stable during follow up, without significant treatment or treatment-by-time interactions ( p  = 0.25 and  p  = 0.46 for hemoglobin, respectively;  p  = 0.25 and  p  = 0.26 for iron, respectively). Serum ferritin did not increase over time during SI supplementation, while it increased in patients treated with FCM (treatment effect,  p  = 0.0004; treatment-by-time interaction effect,  p  = 0.0002). Overall, this study showed that SI and FCM displayed similar effectiveness and tolerability for treatment of mild-to-moderate anemia in patients with ulcerative colitis under remission.",2021,"Hemoglobin and serum iron increased in both groups after 4 weeks of therapy, and remained stable during follow up, without significant treatment or treatment-by-time interactions ( p  = 0.25 and  p  = 0.46 for hemoglobin, respectively;  p  = 0.25 and  p  = 0.26 for iron, respectively).","['patients with ulcerative colitis under remission', 'patients with ulcerative colitis in remission and mild-to-moderate anemia', 'Patients with Ulcerative Colitis']","['FCM', 'oral SI and intravenous ferric carboxy-maltose (FCM', 'sucrosomial iron (SI', 'Intravenous Ferric Carboxy-Maltose', 'SI and FCM', 'oral SI or intravenous 1000 mg of FCM', 'Oral iron supplementation']","['Hemoglobin and serum iron', 'effectiveness and tolerability', 'gastrointestinal adverse effects', 'Serum ferritin', 'Hemoglobin and serum levels of iron and ferritin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3697010', 'cui_str': 'Ulcerative colitis in remission'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]","[{'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0024658', 'cui_str': 'Maltose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}]",,0.0401531,"Hemoglobin and serum iron increased in both groups after 4 weeks of therapy, and remained stable during follow up, without significant treatment or treatment-by-time interactions ( p  = 0.25 and  p  = 0.46 for hemoglobin, respectively;  p  = 0.25 and  p  = 0.26 for iron, respectively).","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Bertani', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Tricò', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Zanzi', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Baiano Svizzero', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Coppini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'de Bortoli', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Bellini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Antonioli', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Blandizzi', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, 56100 Pisa, Italy.'}, {'ForeName': 'Santino', 'Initials': 'S', 'LastName': 'Marchi', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56100 Pisa, Italy.'}]",Nutrients,['10.3390/nu13020608']
1324,33673280,Assessment of Novel Inhaler Technique Reminder Labels in Image Format on the Correct Demonstration of Inhaler Technique Skills in Asthma: A Single-Blinded Randomized Controlled Trial.,"BACKGROUND


Prevalence of asthma in the United Arab Emirates (UAE) is high, and training patients on correct inhaler technique is vital.
OBJECTIVES


To assess the effectiveness of inhaler technique labels incorporating the individual technique steps in image format on the retention of correct inhaler technique for patients with asthma living in the UAE and following inhaler training; secondly to investigate the effect of inhaler technique education using self-check pictorial labels on patients' overall asthma control.
METHODS


This single-blinded randomized controlled study was conducted in 2019 and followed consecutive recruitment of asthma patients visiting respiratory clinics at Rashid Hospital in Dubai. Patients were using a controller inhaler (Turbuhaler (TH), Accuhaler (ACC), or pressurized metered-dose inhaler (pMDI)). Following recruitment, patients were randomized into active group receiving educational intervention plus the inhaler label, and control group receiving educational intervention without the label. Patients were assessed at baseline and at one-month on their inhaler technique and asthma control.
RESULTS


Participants ( n  = 245; 93 = TH, 70 = ACC, 82 = pMDI) showed a significant difference between the groups at one-month for inhaler technique scores for TH (active 5.29 ± 1.86 vs. control = 24.4 ± 21.28), ACC (active = 3.99 ± 1.43 vs. control = 25.45 ± 22.57), and pMDI (active = 4.59 ± 0.10 vs. control = 120.55 ± 17.2),  p  < 0.001 for all. Asthma control for active group indicated significant improvements compared to control for TH and pMDI ( p  < 0.001 for both), but not ACC group ( p  = 0.087).
CONCLUSIONS


Retention of correct inhaler technique and improved asthma control can be enhanced by using a specialized inhaler technique label in image format.",2021,"Asthma control for active group indicated significant improvements compared to control for TH and pMDI ( p  < 0.001 for both), but not ACC group ( p  = 0.087).
","['patients with asthma living in the UAE and following inhaler training', ""patients' overall asthma control"", 'Asthma', '2019 and followed consecutive recruitment of asthma patients visiting respiratory clinics at Rashid Hospital in Dubai']","['educational intervention plus the inhaler label, and control group receiving educational intervention without the label', 'controller inhaler (Turbuhaler (TH), Accuhaler (ACC), or pressurized metered-dose inhaler (pMDI', 'inhaler technique education using self-check pictorial labels']",['TH and pMDI'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}]",[],,0.0885896,"Asthma control for active group indicated significant improvements compared to control for TH and pMDI ( p  < 0.001 for both), but not ACC group ( p  = 0.087).
","[{'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Basheti', 'Affiliation': 'Department of Clinical Pharmacy and Therapeutics, Faculty of Pharmacy, Applied Science Private University, P.O. Box 166, Amman 11931, Jordan.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Mahboub', 'Affiliation': 'Rashid Hospital, Dubai Health Authority, Dubai 4545, United Arab Emirates.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Salameh', 'Affiliation': 'Rashid Hospital, Dubai Health Authority, Dubai 4545, United Arab Emirates.'}, {'ForeName': 'Mena', 'Initials': 'M', 'LastName': 'Al-Ani', 'Affiliation': 'Sharjah Institute for Medical Research, University of Sharjah, Sharjah 27272, United Arab Emirates.'}, {'ForeName': 'Ammar Abdulrahman', 'Initials': 'AA', 'LastName': 'Jairoun', 'Affiliation': 'Health and Safety Department, Dubai Municipality, Dubai 67, United Arab Emirates.'}, {'ForeName': 'Basema', 'Initials': 'B', 'LastName': 'Saddik', 'Affiliation': 'Sharjah Institute for Medical Research, University of Sharjah, Sharjah 27272, United Arab Emirates.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Abu-Gharbieh', 'Affiliation': 'Department of Clinical Sciences, College of Medicine, University of Sharjah, Sharjah 27272, United Arab Emirates.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph14020150']
1325,33673247,Percutaneous Mitral Valve Repair: Outcome Improvement with Operator Experience and a Second-Generation Device.,"BACKGROUND AND AIM


Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system.
METHODS


This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system.
RESULTS


A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively;  p  = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group;  p  = 0.032).
CONCLUSIONS


The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.",2021,"Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively;  p  = 0.025).","['patients undergoing', 'patients with functional MR (FMR', 'patients undergoing PMVR with the Mitraclip system', '18 centers between 2012 and 2017', '545 consecutive patients were included in the study']","['Percutaneous Mitral Valve Repair', 'percutaneous mitral valve repair (PMVR', 'PMVR using a second-generation Mitraclip device (Mitraclip NT', 'generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system']","['Procedural success', 'rate of pericardial effusion', 'Major adverse events', 'death, surgery, and admission for congestive heart failure (CHF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517809', 'cui_str': '545'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0031039', 'cui_str': 'Pericardial effusion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]",545.0,0.0373141,"Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively;  p  = 0.025).","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Freixa', 'Affiliation': 'Hospital Clinic de Barcelona, Institut Clínic Cardiovascular, 08036 Barcelona, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Estévez-Loureiro', 'Affiliation': 'Hospital Universitario de León, 24071 León, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco-Chinchilla', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, 29010 Málaga, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Millán', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Amat-Santos', 'Affiliation': 'Hospital Clínico Universitario de Valladolid, 47003 Valladolid, Spain.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Regueiro', 'Affiliation': 'Hospital Clinic de Barcelona, Institut Clínic Cardiovascular, 08036 Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Nombela-Franco', 'Affiliation': 'Hospital Clínico de San Carlos, 28040 Madrid, Spain.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Pascual', 'Affiliation': 'Hospital Central de Asturias, 33011 Oviedo, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Cid', 'Affiliation': 'Complejo Hospitalario Universitario de Santiago, 15706 Santiago de Compostela, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'López-Mínguez', 'Affiliation': 'Hospital Universitario Infanta Cristina, 06080 Badajoz, Spain.'}, {'ForeName': 'Rosa Ana', 'Initials': 'RA', 'LastName': 'Hernández-Antolín', 'Affiliation': 'Hospital Ramón y Cajal, 28034 Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz-González', 'Affiliation': 'Hospital Clínico Universitario de Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Andraka', 'Affiliation': 'Hospital Civil de Basurto, 48013 Basurto, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Goicolea', 'Affiliation': 'Hospital Puerta de Hierro, 28222 Madrid, Spain.'}, {'ForeName': 'Valeriano', 'Initials': 'V', 'LastName': 'Ruíz-Quevedo', 'Affiliation': 'Complejo Hospitalario de Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Jose Luís', 'Initials': 'JL', 'LastName': 'Díez', 'Affiliation': 'Hospital La Fe de Valencia, 46026 Valencia, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Berenguer', 'Affiliation': 'Hospital General Universitario de Valencia, 46014 Valencia, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Baz', 'Affiliation': 'Complejo Hospitalario Universidad de Vigo, 36310 Vigo, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pan', 'Affiliation': 'Hospital Reina Sofía de Córdoba, 14004 Córdoba, Spain.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Benito-González', 'Affiliation': 'Hospital Universitario de León, 24071 León, Spain.'}, {'ForeName': 'Juan H Alonso', 'Initials': 'JHA', 'LastName': 'Briales', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, 29010 Málaga, Spain.'}, {'ForeName': 'Chi Hion', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sanchis', 'Affiliation': 'Hospital Clinic de Barcelona, Institut Clínic Cardiovascular, 08036 Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Serrador', 'Affiliation': 'Hospital Clínico Universitario de Valladolid, 47003 Valladolid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Jiménez-Quevedo', 'Affiliation': 'Hospital Clínico de San Carlos, 28040 Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Avanzas', 'Affiliation': 'Hospital Central de Asturias, 33011 Oviedo, Spain.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Salido', 'Affiliation': 'Hospital Ramón y Cajal, 28034 Madrid, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fernández-Vázquez', 'Affiliation': 'Hospital Universitario de León, 24071 León, Spain.'}, {'ForeName': 'José Maria', 'Initials': 'JM', 'LastName': 'Hernández-García', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, 29010 Málaga, Spain.'}, {'ForeName': 'Dabit', 'Initials': 'D', 'LastName': 'Arzamendi', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10040734']
1326,33671968,Postoperative Ileus after Stimulation with Probiotics before Ileostomy Closure.,"Loop ileostomy closure after colorectal surgery is often associated with Postoperative ileus, with an incidence between 13-20%. The aim of this study is to evaluate the efficacy and safety of preoperative stimulation of the efferent loop with probiotics prior to ileostomy closure in patients operated on for colorectal carcinoma. For this, a prospective, randomized, double-blind, controlled study is designed. All patients who underwent surgery for colorectal carcinoma with loop ileostomy were included. Randomized and divided into two groups, 34 cases and 35 controls were included in the study. Postoperative ileus, the need for nasogastric tube insertion, the time required to begin tolerating a diet, restoration of bowel function, and duration of hospital stay were evaluated. The incidence of Postoperative ileus was similar in both groups, 9/34 patients stimulated with probiotics and 10/35 in the control group (CG) with a  p  = 0.192. The comparative analysis showed a direct relationship between Postoperative ileus after oncological surgery and Postoperative ileus after reconstruction surgery, independently of stimulation. Postoperative ileus after closure ileostomy is independent of stimulation of the ileostomy with probiotics through the efferent loop. There seem to be a relationship between Postoperative ileus after reconstruction and the previous existence of Postoperative ileus after colorectal cancer surgery.",2021,"The comparative analysis showed a direct relationship between Postoperative ileus after oncological surgery and Postoperative ileus after reconstruction surgery, independently of stimulation.","['34 cases and 35 controls were included in the study', 'All patients who underwent surgery for colorectal carcinoma with loop ileostomy were included', 'patients operated on for colorectal carcinoma']",['probiotics prior to ileostomy closure'],"['Postoperative ileus', 'Postoperative ileus, the need for nasogastric tube insertion, the time required to begin tolerating a diet, restoration of bowel function, and duration of hospital stay', 'Postoperative Ileus', 'incidence of Postoperative ileus']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0023985', 'cui_str': 'Creation of continent ileostomy'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0192775', 'cui_str': 'Closure of ileostomy'}]","[{'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0302865,"The comparative analysis showed a direct relationship between Postoperative ileus after oncological surgery and Postoperative ileus after reconstruction surgery, independently of stimulation.","[{'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Rodríguez-Padilla', 'Affiliation': 'Department of General Surgery, Infanta Elena University Clinical Hospital, 21080 Huelva, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Morales-Martín', 'Affiliation': 'Department of General Surgery, Infanta Elena University Clinical Hospital, 21080 Huelva, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Pérez-Quintero', 'Affiliation': 'Department of General Surgery, Juan Ramón Jiménez University Clinical Hospital, 21005 Huelva, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gómez-Salgado', 'Affiliation': 'Department of Sociology, Social Work and Public Health, Faculty of Labour Sciences, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Balongo-García', 'Affiliation': 'Chief of Gastrointestinal Surgery, Department of General Surgery, Juan Ramón Jiménez University Clinical Hospital, 21005 Huelva, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Frutos', 'Affiliation': 'Department of Sociology, Social Work and Public Health, Faculty of Labour Sciences, University of Huelva, 21007 Huelva, Spain.'}]",Nutrients,['10.3390/nu13020626']
1327,33671931,"Clinical Efficacy and Safety of Low-Level Laser Therapy in Patients with Perennial Allergic Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Trial.","Allergic rhinitis (AR) is a common disease that interferes with the daily activities and reduces the quality of life. Conventional treatments often do not provide complete resolution of the symptoms, and many new treatment modalities have been tried. This study aimed to evaluate the efficacy and safety of low-level laser therapy (LLLT) for AR in a randomized, double-blind, placebo-controlled trial. Patients diagnosed with AR were randomly allocated to receive LLLT or sham treatment. The primary outcome was a change in the reflective total nasal symptom score (TNSS). The secondary outcome was quality of life scores assessed using the Rhinoconjunctivitis Quality of Life Questionnaire. Incidences of adverse events were also recorded. Among 67 randomized subjects, 41 subjects (22 in LLLT group and 19 in sham treatment group) were included for efficacy analysis. The LLLT group showed a significantly improved TNSS score compared to the sham treatment group for decreasing AR symptom severity ( p  = 0.011) and improving quality of life regarding nasal symptoms ( p  = 0.036) at the end of treatment. Throughout the treatment period, no severe adverse events occurred. This clinical trial showed that LLLT is an effective and safe option for the management of AR regarding symptom relief and quality of life improvement.",2021,The LLLT group showed a significantly improved TNSS score compared to the sham treatment group for decreasing AR symptom severity ( p  = 0.011) and improving quality of life regarding nasal symptoms ( p  = 0.036) at the end of treatment.,"['Patients diagnosed with AR', '67 randomized subjects, 41 subjects (22 in LLLT group and 19 in sham treatment group) were included for efficacy analysis', 'Allergic rhinitis (AR', 'Patients with Perennial Allergic Rhinitis']","['placebo', 'low-level laser therapy (LLLT', 'Low-Level Laser Therapy', 'Placebo', 'LLLT']","['severe adverse events', 'Incidences of adverse events', 'quality of life scores assessed using the Rhinoconjunctivitis Quality of Life Questionnaire', 'AR symptom severity', 'efficacy and safety', 'reflective total nasal symptom score (TNSS', 'quality of life regarding nasal symptoms', 'TNSS score', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",67.0,0.469609,The LLLT group showed a significantly improved TNSS score compared to the sham treatment group for decreasing AR symptom severity ( p  = 0.011) and improving quality of life regarding nasal symptoms ( p  = 0.036) at the end of treatment.,"[{'ForeName': 'Hahn Jin', 'Initials': 'HJ', 'LastName': 'Jung', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Chungbuk National University College of Medicine, Chungbuk National University Hospital, Cheongju 361711, Korea.'}, {'ForeName': 'Young-Jun', 'Initials': 'YJ', 'LastName': 'Chung', 'Affiliation': 'Department of Otorhinolaryngology, Dankook University College of Medicine, Cheonan 31116, Korea.'}, {'ForeName': 'Young-Seok', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Chungbuk National University College of Medicine, Chungbuk National University Hospital, Cheongju 361711, Korea.'}, {'ForeName': 'Phil Sang', 'Initials': 'PS', 'LastName': 'Chung', 'Affiliation': 'Department of Otorhinolaryngology, Dankook University College of Medicine, Cheonan 31116, Korea.'}, {'ForeName': 'Ji-Hun', 'Initials': 'JH', 'LastName': 'Mo', 'Affiliation': 'Department of Otorhinolaryngology, Dankook University College of Medicine, Cheonan 31116, Korea.'}]",Journal of clinical medicine,['10.3390/jcm10040772']
1328,33671925,Quality of Life and Bowel Function Following Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer: A Report from a Single-Center Randomized Controlled Trial.,"The aim of this study was to assess quality of life and bowel function in patients undergoing early vs. standard ileostomy closure. We retrospectively assessed patients from our previous randomized controlled trial. Patients with a temporary ileostomy who underwent rectal cancer surgery and did not have anastomotic leakage or other. Early closure (EC; 30 days after creation) and standard closure (SC; 90 days after creation) of ileostomy were compared. Thirty-six months (17-97) after stoma closure, we contacted patients by phone and filled in two questionnaires-The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and low anterior resection syndrome (LARS) score. This index trial was not powered to assess the difference in bowel function between the two groups. All the patients in the SC group had anastomosis <6 cm from the anal verge compared to 42 of 43 (97.7%) in the EC group. There were no statistically significant differences between EC (26 patients) and SC (25 patients) groups in the EORTC QLQ-C30 and LARS questionnaires. Global quality of life was 37.2 (0-91.7; ±24.9) in the EC group vs. 34.3 (0-100; ±16.2) in the SC ( p  = 0.630). Low anterior resection syndrome was present in 46% of patients in the EC and 56% in the SC group ( p  = 0.858). Major LARS was found more often in younger patients. However, no statistical significance was found ( p  = 0.364). The same was found with quality of life ( p  = 0.219). Age, gender, ileostomy closure timing, neoadjuvant treatment, complications had no effect of worse bowel function or quality of life. There was no difference in quality of life or bowel function in the late postoperative period after the early vs. late closure of ileostomy based on two questionnaires and small sample size. None of our assessed risk factors had a negative effect on bowel function o quality of life.",2021,There was no difference in quality of life or bowel function in the late postoperative period after the early vs. late closure of ileostomy based on two questionnaires and small sample size.,"['Patients with a temporary ileostomy who underwent rectal cancer surgery and did not have anastomotic leakage or other', 'patients undergoing early vs. standard ileostomy closure', 'Patients with Rectal Cancer']",['Early Closure of a Temporary Ileostomy'],"['bowel function', 'Global quality of life', 'Low anterior resection syndrome', 'bowel function or quality of life', 'bowel function o quality of life', 'Quality of Life and Bowel Function', 'Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and low anterior resection syndrome (LARS) score', 'quality of life', 'quality of life and bowel function', 'quality of life or bowel function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937270', 'cui_str': 'Temporary ileostomy'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0192775', 'cui_str': 'Closure of ileostomy'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C2937270', 'cui_str': 'Temporary ileostomy'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.112602,There was no difference in quality of life or bowel function in the late postoperative period after the early vs. late closure of ileostomy based on two questionnaires and small sample size.,"[{'ForeName': 'Audrius', 'Initials': 'A', 'LastName': 'Dulskas', 'Affiliation': 'Departament of General and Abdominal Surgery and Oncology, National Cancer Institute, LT-08406 Vilnius, Lithuania.'}, {'ForeName': 'Vidas', 'Initials': 'V', 'LastName': 'Petrauskas', 'Affiliation': 'Faculty of Medicine, Vilnius University, LT-03101 Vilnius, Lithuania.'}, {'ForeName': 'Justas', 'Initials': 'J', 'LastName': 'Kuliavas', 'Affiliation': 'Departament of General and Abdominal Surgery and Oncology, National Cancer Institute, LT-08406 Vilnius, Lithuania.'}, {'ForeName': 'Klaudija', 'Initials': 'K', 'LastName': 'Bickaite', 'Affiliation': 'Faculty of Medicine, Vilnius University, LT-03101 Vilnius, Lithuania.'}, {'ForeName': 'Mikalojus', 'Initials': 'M', 'LastName': 'Kairys', 'Affiliation': 'Faculty of Medicine, Vilnius University, LT-03101 Vilnius, Lithuania.'}, {'ForeName': 'Kastytis', 'Initials': 'K', 'LastName': 'Pauza', 'Affiliation': 'Departament of General and Abdominal Surgery and Oncology, National Cancer Institute, LT-08406 Vilnius, Lithuania.'}, {'ForeName': 'Alfredas', 'Initials': 'A', 'LastName': 'Kilius', 'Affiliation': 'Departament of General and Abdominal Surgery and Oncology, National Cancer Institute, LT-08406 Vilnius, Lithuania.'}, {'ForeName': 'Egidijus', 'Initials': 'E', 'LastName': 'Sangaila', 'Affiliation': 'Departament of General and Abdominal Surgery and Oncology, National Cancer Institute, LT-08406 Vilnius, Lithuania.'}, {'ForeName': 'Rimantas', 'Initials': 'R', 'LastName': 'Bausys', 'Affiliation': 'Departament of General and Abdominal Surgery and Oncology, National Cancer Institute, LT-08406 Vilnius, Lithuania.'}, {'ForeName': 'Eugenijus', 'Initials': 'E', 'LastName': 'Stratilatovas', 'Affiliation': 'Departament of General and Abdominal Surgery and Oncology, National Cancer Institute, LT-08406 Vilnius, Lithuania.'}]",Journal of clinical medicine,['10.3390/jcm10040768']
1329,33671846,"Erratum: Bosch-Sierra, N., et al. Effect of Fibre-Enriched Orange Juice on Postprandial Glycaemic Response and Satiety in Healthy Individuals: An Acute, Randomised, Placebo-Controlled, Double-Blind, Crossover Study.  Nutrients  2019,  11 , 3014.",The authors have requested that the following changes be made to their paper [...].,2021,The authors have requested that the following changes be made to their paper [...].,['Healthy Individuals'],"['Placebo', 'Fibre-Enriched Orange Juice']",['Postprandial Glycaemic Response and Satiety'],"[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",,0.306479,The authors have requested that the following changes be made to their paper [...].,"[{'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Bosch-Sierra', 'Affiliation': 'Service of Endocrinology, University Hospital Doctor Peset, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO), Avda Gaspar Aguilar 90, 46017 València, Valencia, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Marqués-Cardete', 'Affiliation': 'Zumos Valencianos del Mediterraneo S.A., Calle del Pollancar (Pol Industrial Parc Sagunt I) S/N, 46520 Puerto de Sagunto, Valencia, Spain.'}, {'ForeName': 'Aránzazu', 'Initials': 'A', 'LastName': 'Gurrea-Martínez', 'Affiliation': 'Zumos Valencianos del Mediterraneo S.A., Calle del Pollancar (Pol Industrial Parc Sagunt I) S/N, 46520 Puerto de Sagunto, Valencia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Grau-Del Valle', 'Affiliation': 'Service of Endocrinology, University Hospital Doctor Peset, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO), Avda Gaspar Aguilar 90, 46017 València, Valencia, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Talens', 'Affiliation': 'AZTI, Food Research, Basque Research and Technology Alliance (BRTA), Parque Tecnológico de Biz-kaia, Astondo Bidea, Edificio 609, 48160 Derio, Bizkaia, Spain.'}, {'ForeName': 'Saioa', 'Initials': 'S', 'LastName': 'Alvarez-Sabatel', 'Affiliation': 'AZTI, Food Research, Basque Research and Technology Alliance (BRTA), Parque Tecnológico de Biz-kaia, Astondo Bidea, Edificio 609, 48160 Derio, Bizkaia, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bald', 'Affiliation': 'AZTI, Food Research, Basque Research and Technology Alliance (BRTA), Parque Tecnológico de Biz-kaia, Astondo Bidea, Edificio 609, 48160 Derio, Bizkaia, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Morillas', 'Affiliation': 'Service of Endocrinology, University Hospital Doctor Peset, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO), Avda Gaspar Aguilar 90, 46017 València, Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Hernández-Mijares', 'Affiliation': 'Service of Endocrinology, University Hospital Doctor Peset, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO), Avda Gaspar Aguilar 90, 46017 València, Valencia, Spain.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Bañuls', 'Affiliation': 'Service of Endocrinology, University Hospital Doctor Peset, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO), Avda Gaspar Aguilar 90, 46017 València, Valencia, Spain.'}]",Nutrients,['10.3390/nu13020696']
1330,33671743,Impact of Service User Video Presentations on Explicit and Implicit Stigma toward Mental Illness among Medical Students in Nepal: A Randomized Controlled Trial.,"This study evaluated the impact of didactic videos and service user testimonial videos on mental illness stigma among medical students. Two randomized controlled trials were conducted in Nepal. Study 1 examined stigma reduction for depression. Study 2 examined depression and psychosis. Participants were Nepali medical students (Study 1:  n  = 94, Study 2:  n  = 213) randomized to three conditions: a didactic video based on the mental health Gap Action Programme (mhGAP), a service user video about living with mental illness, or a control condition with no videos. In Study 1, videos only addressed depression. In Study 2, videos addressed depression and psychosis. In Study 1, both didactic and service user videos reduced stigma compared to the control. In Study 2 (depression and psychosis), there were no differences among the three arms. When comparing Study 1 and 2, there was greater stigma reduction in the service user video arm with only depression versus service user videos describing depression and psychosis. In summary, didactic and service user videos were associated with decreased stigma when content addressed only depression. However, no stigma reduction was seen when including depression and psychosis. This calls for considering different strategies to address stigma based on types of mental illnesses. ClinicalTrials.gov identifier: NCT03231761.",2021,This study evaluated the impact of didactic videos and service user testimonial videos on mental illness stigma among medical students.,"['Medical Students in Nepal', 'mental illness stigma among medical students', 'Participants were Nepali medical students (Study 1:  n  = 94, Study 2:  n  = 213) randomized to three conditions: a']","['didactic videos and service user testimonial videos', 'didactic video based on the mental health Gap Action Programme (mhGAP), a service user video about living with mental illness, or a control condition with no videos', 'Service User Video Presentations']","['Explicit and Implicit Stigma toward Mental Illness', 'stigma reduction']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0027690', 'cui_str': 'Nepali language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",213.0,0.0614702,This study evaluated the impact of didactic videos and service user testimonial videos on mental illness stigma among medical students.,"[{'ForeName': 'Cori L', 'Initials': 'CL', 'LastName': 'Tergesen', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, IL 60604, USA.'}, {'ForeName': 'Dristy', 'Initials': 'D', 'LastName': 'Gurung', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'Saraswati', 'Initials': 'S', 'LastName': 'Dhungana', 'Affiliation': 'Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Risal', 'Affiliation': 'Department of Psychiatry, Kathmandu University School of Medical Sciences, Dhulikhel, Nepal.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Basel', 'Affiliation': 'Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Tamrakar', 'Affiliation': 'Department of Psychiatry, Kathmandu University School of Medical Sciences, Dhulikhel, Nepal.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Amatya', 'Affiliation': 'Save the Children, Kathmandu, Nepal.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Park', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC 27708, USA.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC 27708, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph18042143']
1331,33671310,"Grape Seed Extract Positively Modulates Blood Pressure and Perceived Stress: A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Volunteers.","It is well established that maintaining healthy blood pressure is fundamental in order to avoid disorders to the heart and blood vessels. In prevention, and alongside pharmacological therapy, the use of natural substances has been proven to be extremely helpful for pre- and mild hypertensive subjects. Our study was therefore focused on the effects, both in vitro and in humans, of a grape seed extract, Enovita (GSEe), a highly standardized extract in polyphenols of  Vitis vinifera  L. The in vitro human umbilical vein endothelial cells (HUVEC) model was chosen to explore the extract properties related to vascular inflammation/vasodilation. A significant reduction of both soluble Inter-Cellular Adhesion Molecule-1 (sICAM) and endothelin-1 secretion/release was induced by GSEe in HUVEC cells. A randomized, double-blind, placebo-controlled clinical study in healthy volunteers was further performed to investigate GSEe benefits. In healthy volunteers, both supplementations significantly modulated blood pressure, with a pronounced effect after GSEe tablets (300 mg/day for 16 weeks) in respect to placebo. In the male gender subgroup, no placebo effect was observed as it was for the female group. As an additional outcome, an overall GSEe positive modulation emerged on mood related to stress perception. Thus, GSEe resulted in a benefit of modulating endothelial functionality and blood pressure. It was noteworthy that GSEe relieved the perceived stress, promising new future perspectives on mood comfort.",2021,A significant reduction of both soluble Inter-Cellular Adhesion Molecule-1 (sICAM) and endothelin-1 secretion/release was induced by GSEe in HUVEC cells.,"['mild hypertensive subjects', 'healthy volunteers', 'Healthy Volunteers']","['Placebo', 'placebo', 'Grape Seed Extract']","['Blood Pressure and Perceived Stress', 'soluble Inter-Cellular Adhesion Molecule-1 (sICAM) and endothelin-1 secretion/release', 'blood pressure', 'endothelial functionality and blood pressure']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0772454', 'cui_str': 'Grape Seed Extract'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}]",,0.203685,A significant reduction of both soluble Inter-Cellular Adhesion Molecule-1 (sICAM) and endothelin-1 secretion/release was induced by GSEe in HUVEC cells.,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Schön', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Allegrini', 'Affiliation': 'Research and Development Department, Indena SpA, 20139 Milan, Italy.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Engelhart-Jentzsch', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Riva', 'Affiliation': 'Research and Development Department, Indena SpA, 20139 Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrangolini', 'Affiliation': 'Research and Development Department, Indena SpA, 20139 Milan, Italy.'}]",Nutrients,['10.3390/nu13020654']
1332,33671235,A Fish-Derived Protein Hydrolysate Induces Postprandial Aminoacidaemia and Skeletal Muscle Anabolism in an In Vitro Cell Model Using Ex Vivo Human Serum.,"Fish-derived proteins, particularly fish protein hydrolysates (FPH), offer potential as high-quality sources of dietary protein, whilst enhancing economic and environmental sustainability. This study investigated the impact of a blue whiting-derived protein hydrolysate (BWPH) on aminoacidaemia in vivo and skeletal muscle anabolism in vitro compared with whey protein isolate (WPI) and an isonitrogenous, non-essential amino acid (NEAA) control (0.33 g·kg -1 ·body mass -1 ) in an ex vivo, in vitro experimental design. Blood was obtained from seven healthy older adults (two males, five females; age: 72 ± 5 years, body mass index: 24.9 ± 1.6 kg·m 2 ) in three separate trials in a randomised, counterbalanced, double-blind design. C2C12 myotubes were treated with ex vivo human serum-conditioned media (20%) for 4 h. Anabolic signalling (phosphorylation of mTOR, p70S6K, and 4E-BP1) and puromycin incorporation were determined by immunoblotting. Although BWPH and WPI both induced postprandial essential aminoacidaemia in older adults above the NEAA control, peak and area under the curve (AUC) leucine and essential amino acids were more pronounced following WPI ingestion. Insulin was elevated above baseline in WPI and BWPH only, a finding reinforced by higher peak and AUC values compared with NEAA. Muscle protein synthesis, as measured by puromycin incorporation, was greater after incubation with WPI-fed serum compared with fasted serum ( P  = 0.042), and delta change was greater in WPI ( P  = 0.028) and BWPH ( P  = 0.030) compared with NEAA. Myotube hypertrophy was greater in WPI and BWPH compared with NEAA (both  P  = 0.045), but was similar between bioactive conditions ( P  = 0.853). Taken together, these preliminary findings demonstrate the anabolic potential of BWPH in vivo and ex vivo, thus providing justification for larger studies in older adults using gold-standard measures of acute and chronic MPS in vivo.",2021,"Myotube hypertrophy was greater in WPI and BWPH compared with NEAA (both  P  = 0.045), but was similar between bioactive conditions ( P  = 0.853).","['older adults', 'seven healthy older adults (two males, five females; age: 72 ± 5 years, body mass index: 24.9 ± 1.6 kg·m 2 ']","['blue whiting-derived protein hydrolysate (BWPH', 'whey protein isolate (WPI) and an isonitrogenous, non-essential amino acid (NEAA) control', 'Fish-Derived Protein Hydrolysate']","['Myotube hypertrophy', 'Muscle protein synthesis', 'Anabolic signalling (phosphorylation of mTOR, p70S6K, and 4E-BP1) and puromycin incorporation', 'WPI and BWPH', 'BWPH']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517508', 'cui_str': '1.6'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033631', 'cui_str': 'protein hydrolysates'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0311461', 'cui_str': 'Nonessential amino acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C1704336', 'cui_str': 'Skeletal muscle fiber'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C1136240', 'cui_str': 'p70 S6 Kinase'}, {'cui': 'C0254260', 'cui_str': 'EIF4EBP1 protein, human'}, {'cui': 'C0034145', 'cui_str': 'Puromycin'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033631', 'cui_str': 'protein hydrolysates'}]",,0.0468106,"Myotube hypertrophy was greater in WPI and BWPH compared with NEAA (both  P  = 0.045), but was similar between bioactive conditions ( P  = 0.853).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Lees', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Education and Health Sciences, University of Limerick, V94 T9PX Limerick, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nolan', 'Affiliation': 'School of Health and Human Performance, Dublin City University, D09 V209 Dublin, Ireland.'}, {'ForeName': 'Miryam', 'Initials': 'M', 'LastName': 'Amigo-Benavent', 'Affiliation': 'Health Research Institute, University of Limerick, V94 T9PX Limerick, Ireland.'}, {'ForeName': 'Conor J', 'Initials': 'CJ', 'LastName': 'Raleigh', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Education and Health Sciences, University of Limerick, V94 T9PX Limerick, Ireland.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Khatib', 'Affiliation': 'Department of Biological Sciences, University of Limerick, V94 T9PX Limerick, Ireland.'}, {'ForeName': 'Pádraigín', 'Initials': 'P', 'LastName': 'Harnedy-Rothwell', 'Affiliation': 'Department of Biological Sciences, University of Limerick, V94 T9PX Limerick, Ireland.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'FitzGerald', 'Affiliation': 'Department of Biological Sciences, University of Limerick, V94 T9PX Limerick, Ireland.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Egan', 'Affiliation': 'School of Health and Human Performance, Dublin City University, D09 V209 Dublin, Ireland.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Carson', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Education and Health Sciences, University of Limerick, V94 T9PX Limerick, Ireland.'}]",Nutrients,['10.3390/nu13020647']
1333,33671220,Efficacy of Docosahexaenoic Acid for the Prevention of Necrotizing Enterocolitis in Preterm Infants: A Randomized Clinical Trial.,"Necrotizing enterocolitis (NEC) is an inflammatory bowel disease and a leading cause of morbidity and mortality in preterm infants. In this study, a randomized double-blind parallel-group (1:1) trial was carried out in two neonatal intensive care units of two tertiary hospitals. Two hundred and twenty-five preterm newborns with an expected functional gastrointestinal tract were recruited and received an enteral dose of 75 mg of docosahexaenoic acid (DHA)/kg body weight or high-oleic sunflower oil daily for 14 days from the first enteral feed after birth. Confirmed NEC was evaluated with Bell's scale from stage ≥ IIa. Two hundred and fourteen randomized infants were analyzed in terms of the intent-to-treat (DHA-group:  n  = 105; control-group:  n  = 109); data for two hundred infants were analysed per protocol. Confirmed NEC was lower in infants from the DHA-group compared with the control-group (0/100 vs. 7/100;  p  = 0.007), with RR = 0.93 (95% CI 0.881 to 0.981), risk difference = -7%, (95% CI -12.00 to -1.99), and number needed-to-treat = 15 (95% CI 8.3 to 50). Intent-to-treat analysis showed a lower level of treatment failure in the DHA-group compared with the control-group (6/105 (6%) vs. 16/109 (15%);  p  = 0.03, RR = 0.905, (95% CI 0.826 to 0.991)). The results after multivariate-regression analysis remained significant. Adverse events (apart from the incidence of NEC) were not different between groups. A daily dose of DHA for 14 days starting with the first enteral feed may prevent NEC in preterm infants.",2021,Intent-to-treat analysis showed a lower level of treatment failure in the DHA-group compared with the control-group (6/105 (6%) vs. 16/109 (15%);  ,"['Two hundred and fourteen randomized infants were analyzed in terms of the intent-to-treat (DHA-group:  n  = 105; control-group:  n  = 109); data for two hundred infants were analysed per protocol', 'preterm infants', 'Two hundred and twenty-five preterm newborns with an expected functional gastrointestinal tract', 'two neonatal intensive care units of two tertiary hospitals', 'Preterm Infants']","['Docosahexaenoic Acid', 'DHA', 'docosahexaenoic acid (DHA)/kg body weight or high-oleic sunflower oil daily']","['level of treatment failure', 'Necrotizing Enterocolitis', 'Adverse events']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",225.0,0.578919,Intent-to-treat analysis showed a lower level of treatment failure in the DHA-group compared with the control-group (6/105 (6%) vs. 16/109 (15%);  ,"[{'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Bernabe-García', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, UMAE Hospital de Pediatría, CMN Siglo XXI, Instituto Mexicano del Seguro Social, México City 06720, Mexico.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton SO16 6YD, UK.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Villegas-Silva', 'Affiliation': 'Neonatología, Hospital Infantil de México Federico Gómez, México City 06720, Mexico.'}, {'ForeName': 'Maricela', 'Initials': 'M', 'LastName': 'Rodríguez-Cruz', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, UMAE Hospital de Pediatría, CMN Siglo XXI, Instituto Mexicano del Seguro Social, México City 06720, Mexico.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Chávez-Sánchez', 'Affiliation': 'Unidad de Investigación Médica en Inmunología, UMAE Hospital de Pediatría, CMN Siglo XXI, Instituto Mexicano del Seguro Social, México City 06720, Mexico.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Cruz-Reynoso', 'Affiliation': 'Unidad de Cuidados Intensivos Neonatales, UMAE Hospital de Gineco-Obstetricia No.3, CMN La Raza, Instituto Mexicano del Seguro Social, México City 02990, Mexico.'}, {'ForeName': 'Leovigildo', 'Initials': 'L', 'LastName': 'Mateos-Sánchez', 'Affiliation': 'Unidad de Cuidados Intensivos Neonatales, UMAE Hospital de Gineco-Obstetricia N° 4 ""Luis Castelazo Ayala"", Instituto Mexicano del Seguro Social, México City 01090, Mexico.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lara-Flores', 'Affiliation': 'Unidad de Cuidados Intensivos Neonatales, UMAE Hospital de Gineco-Obstetricia N° 4 ""Luis Castelazo Ayala"", Instituto Mexicano del Seguro Social, México City 01090, Mexico.'}, {'ForeName': 'Augusto R', 'Initials': 'AR', 'LastName': 'Aguilera-Joaquín', 'Affiliation': 'Unidad de Cuidados Intensivos Neonatales, UMAE Hospital de Gineco-Obstetricia No.3, CMN La Raza, Instituto Mexicano del Seguro Social, México City 02990, Mexico.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Sánchez-García', 'Affiliation': 'Unidad de Cuidados Intensivos Neonatales, UMAE Hospital de Gineco-Obstetricia No.3, CMN La Raza, Instituto Mexicano del Seguro Social, México City 02990, Mexico.'}]",Nutrients,['10.3390/nu13020648']
1334,33671082,Effects of Post-Exertional Malaise on Markers of Arterial Stiffness in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.,"Background:  Evidence is emerging that individuals with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) may suffer from chronic vascular dysfunction as a result of illness-related oxidative stress and vascular inflammation. The study aimed to examine the impact of maximal-intensity aerobic exercise on vascular function 48 and 72 h into recovery.  Methods:  ME/CFS ( n  = 11) with gender and age-matched controls ( n  = 11) were randomly assigned to either a 48 h or 72 h protocol. Each participant had measures of brachial blood pressure, augmentation index (AIx75, standardized to 75 bpm) and carotid-radial pulse wave velocity (crPWV) taken. This was followed by a maximal incremental cycle exercise test. Resting measures were repeated 48 or 72 h later (depending on group allocation).  Results:  No significant differences were found when ME/CFS were directly compared to controls at baseline. During recovery, the 48 h control group experienced a significant 7.2% reduction in AIx75 from baseline measures ( p  < 0.05), while the matched ME/CFS experienced no change in AIx75. The 72 h ME/CFS group experienced a non-significant increase of 1.4% from baseline measures. The 48 h and 72 h ME/CFS groups both experienced non-significant improvements in crPWV (0.56 ms -1  and 1.55 ms -1 , respectively).  Conclusions:  The findings suggest that those with ME/CFS may not experience exercise-induced vasodilation due to chronic vascular damage, which may be a contributor to the onset of post-exertional malaise (PEM).",2021,"The 48 h and 72 h ME/CFS groups both experienced non-significant improvements in crPWV (0.56 ms -1  and 1.55 ms -1 , respectively).  ","[' n  = 11) with gender and age-matched controls ( n  = 11', 'individuals with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS', 'Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome']","['maximal-intensity aerobic exercise', 'ME/CFS', 'Post-Exertional Malaise']","['brachial blood pressure, augmentation index (AIx75, standardized to 75 bpm) and carotid-radial pulse wave velocity (crPWV) taken', 'crPWV', 'ME/CFS']","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C2732413', 'cui_str': 'Postexertional fatigue'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0232142', 'cui_str': 'Radial pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}]",11.0,0.159741,"The 48 h and 72 h ME/CFS groups both experienced non-significant improvements in crPWV (0.56 ms -1  and 1.55 ms -1 , respectively).  ","[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bond', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Nielsen', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Hodges', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, Palmerston North 4442, New Zealand.'}]",International journal of environmental research and public health,['10.3390/ijerph18052366']
1335,33671071,Examining the Gastrointestinal and Immunomodulatory Effects of the Novel Probiotic  Bacillus subtilis  DE111.,"Probiotics make up a large and growing segment of the commercial market of dietary supplements and are touted as offering a variety of human health benefits. Some of the purported positive impacts of probiotics include, but are not limited to, stabilization of the gut microbiota, prevention of gastrointestinal disorders and modulation of the host immune system. Current research suggests that the immunomodulatory effects of probiotics are strain-specific and vary in mode of action. Here, we examined the immunomodulatory properties of  Bacillus subtilis  strain DE111 in a healthy human population. In a pilot randomized, double blind, placebo-controlled four-week intervention, we examined peripheral blood mononuclear cells (PBMCs) at basal levels pre- and post-intervention, as well as in response to stimulation with bacterial lipopolysaccharide (LPS). We observed an increase in anti-inflammatory immune cell populations in response to ex vivo LPS stimulation of PBMCs in the DE111 intervention group. Overall perceived gastrointestinal health, microbiota, and circulating and fecal markers of inflammation (Il-6, sIgA) and gut barrier function (plasma zonulin) were largely unaffected by DE111 intervention, although the study may have been underpowered to detect these differences. These pilot data provide information and justification to conduct an appropriately powered clinical study to further examine the immunomodulatory potential of  B. subtilis  DE111 in human populations.",2021,"Overall perceived gastrointestinal health, microbiota, and circulating and fecal markers of inflammation (Il-6, sIgA) and gut barrier function (plasma zonulin) were largely unaffected by DE111 intervention, although the study may have been underpowered to detect these differences.",['healthy human population'],"['bacterial lipopolysaccharide (LPS', 'placebo']","['Overall perceived gastrointestinal health, microbiota, and circulating and fecal markers of inflammation (Il-6, sIgA) and gut barrier function (plasma zonulin', 'peripheral blood mononuclear cells (PBMCs']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",,0.0520473,"Overall perceived gastrointestinal health, microbiota, and circulating and fecal markers of inflammation (Il-6, sIgA) and gut barrier function (plasma zonulin) were largely unaffected by DE111 intervention, although the study may have been underpowered to detect these differences.","[{'ForeName': 'Kimberley E', 'Initials': 'KE', 'LastName': 'Freedman', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hill', 'Affiliation': 'Adipose Tissue Biology Laboratory Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Yuren', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Allegra R', 'Initials': 'AR', 'LastName': 'Vazquez', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Grubb', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Roxanne E', 'Initials': 'RE', 'LastName': 'Trotter', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Wrigley', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Functional Foods & Human Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Michelle T', 'Initials': 'MT', 'LastName': 'Foster', 'Affiliation': 'Adipose Tissue Biology Laboratory Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Weir', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}]",International journal of molecular sciences,['10.3390/ijms22052453']
1336,33671031,Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation Targeting Perilesional Areas in Post-Stroke Aphasia: A Pilot Randomized Clinical Trial.,"Transcranial direct current stimulation (tDCS) may enhance speech and language treatment (SLT) for stroke survivors with aphasia; however, to date, there is no standard protocol for the application of tDCS in post-stroke aphasia. We explored the safety and efficacy of fMRI-guided tDCS on functional language and cortical activity when delivered to the lesioned left hemisphere concurrently with SLT across an extended, six-week treatment period. Twelve persons with chronic, nonfluent aphasia following a single left-hemisphere stroke participated in the three-arm (anodal vs. cathodal vs. sham) single-blind, parallel, pilot trial. No serious adverse events occurred during 30 treatment sessions or in the following six weeks. All groups demonstrated functional language gains following intensive treatment; however, active tDCS resulted in greater gains in standardized, probe, and caregiver-reported measures of functional language than sham. Evidence declaring one polarity as superior for inducing language recovery was mixed. However, cathodal stimulation to the lesioned left hemisphere, expected to have a down-regulating effect, resulted in increased areas of cortical activation across both hemispheres, and specifically perilesionally. Generalization of these preliminary findings is limited; however, results are nevertheless compelling that tDCS combined with SLT can be safely applied across extended durations, with the potential to enhance functional language and cortical activation for persons with aphasia.",2021,"All groups demonstrated functional language gains following intensive treatment; however, active tDCS resulted in greater gains in standardized, probe, and caregiver-reported measures of functional language than sham.","['stroke survivors with aphasia', 'Post-Stroke Aphasia', 'persons with aphasia', 'Twelve persons with chronic, nonfluent aphasia following a single left-hemisphere stroke participated in the three']","['fMRI-guided tDCS', 'SLT', 'Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation', 'Transcranial direct current stimulation (tDCS', 'arm (anodal vs. cathodal vs. sham) single-blind']","['serious adverse events', 'functional language and cortical activity', 'functional language gains', 'cortical activation', 'greater gains in standardized, probe, and caregiver-reported measures of functional language']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0003550', 'cui_str': 'Motor aphasia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0228176', 'cui_str': 'Left cerebral hemisphere structure'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",12.0,0.136253,"All groups demonstrated functional language gains following intensive treatment; however, active tDCS resulted in greater gains in standardized, probe, and caregiver-reported measures of functional language than sham.","[{'ForeName': 'Leora R', 'Initials': 'LR', 'LastName': 'Cherney', 'Affiliation': 'Think + Speak Lab, Shirley Ryan AbilityLab, Chicago, IL 60611, USA.'}, {'ForeName': 'Edna M', 'Initials': 'EM', 'LastName': 'Babbitt', 'Affiliation': 'Think + Speak Lab, Shirley Ryan AbilityLab, Chicago, IL 60611, USA.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Pitts', 'Affiliation': 'Think + Speak Lab, Shirley Ryan AbilityLab, Chicago, IL 60611, USA.'}]",Brain sciences,['10.3390/brainsci11030306']
1337,33670999,Coconut Oil Supplementation Does Not Affect Blood Pressure Variability and Oxidative Stress: A Placebo-Controlled Clinical Study in Stage-1 Hypertensive Patients.,"Exploring an alternative to improve the clinical management of hypertension, we tested the hypothesis that food supplementation with coconut oil (EVCO), alone or combined with aerobic exercise training, could exert an antihypertensive effect (primary outcome) in patients with stage 1 hypertension. Forty-five hypertensive volunteers of both genders participated in a placebo-controlled clinical trial. The volunteers were submitted to 24-hour ambulatory blood pressure monitoring, analysis of blood pressure variability (BPV), measurement of serum malondialdehyde (MDA) and nutritional assessment. Results indicate that EVCO consumption had no adverse effects. The supplementation did not increase the caloric intake compared with placebo, and the dietary constituents were similar between groups, except for the saturated fats, especially lauric acid. The analysis of blood pressure indicated absence of antihypertensive effect of EVCO alone or combined with physical training. Furthermore, no effects on blood pressure variability and oxidative stress were observed in the supplemented hypertensive patients. Thus, despite the results observed in pre-clinical studies, the current clinical study did not provide evidence to support the use of coconut oil as an adjuvant in the management of hypertension in humans.",2021,"The supplementation did not increase the caloric intake compared with placebo, and the dietary constituents were similar between groups, except for the saturated fats, especially lauric acid.","['Forty-five hypertensive volunteers of both genders participated in a', 'Stage-1 Hypertensive Patients', 'supplemented hypertensive patients', 'hypertension in humans', 'patients with stage 1 hypertension']","['Coconut Oil Supplementation', 'placebo', 'EVCO alone or combined with physical training', 'coconut oil', 'Placebo', 'coconut oil (EVCO), alone or combined with aerobic exercise training']","['24-hour ambulatory blood pressure monitoring, analysis of blood pressure variability (BPV), measurement of serum malondialdehyde (MDA) and nutritional assessment', 'blood pressure variability and oxidative stress', 'adverse effects', 'Blood Pressure Variability and Oxidative Stress', 'caloric intake']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0056060', 'cui_str': 'Coconut Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0028708', 'cui_str': 'Assessment of nutritional status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",45.0,0.101645,"The supplementation did not increase the caloric intake compared with placebo, and the dietary constituents were similar between groups, except for the saturated fats, especially lauric acid.","[{'ForeName': 'Francisco A O', 'Initials': 'FAO', 'LastName': 'Júnior', 'Affiliation': 'Health Sciences Center, Department of Physiology and Pathology, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Clara R', 'Initials': 'CR', 'LastName': 'Ruiz', 'Affiliation': 'Biotechnology Center, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Yohanna', 'Initials': 'Y', 'LastName': 'de Oliveira', 'Affiliation': 'Health Sciences Center, Department of Nutrition, Federal University of Paraiba,Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Marco A V', 'Initials': 'MAV', 'LastName': 'Barros', 'Affiliation': 'Medical Sciences Center, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Alexandre S', 'Initials': 'AS', 'LastName': 'Silva', 'Affiliation': 'Health Sciences Center, Department of Physical Education, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Maria S B', 'Initials': 'MSB', 'LastName': 'Santos', 'Affiliation': 'Health Sciences Center, Department of Physical Education, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Vinícius J B', 'Initials': 'VJB', 'LastName': 'Martins', 'Affiliation': 'Health Sciences Center, Department of Physiology and Pathology, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Camille M', 'Initials': 'CM', 'LastName': 'Balarini', 'Affiliation': 'Health Sciences Center, Department of Physiology and Pathology, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Valdir A', 'Initials': 'VA', 'LastName': 'Braga', 'Affiliation': 'Biotechnology Center, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}]",Nutrients,['10.3390/nu13030798']
1338,33670720,"A Three-Month Consumption of Eggs Enriched with ω-3, ω-5 and ω-7 Polyunsaturated Fatty Acids Significantly Decreases the Waist Circumference of Subjects at Risk of Developing Metabolic Syndrome: A Double-Blind Randomized Controlled Trial.","Alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), rumenic acid (RmA), and punicic acid (PunA) are claimed to influence several physiological functions including insulin sensitivity, lipid metabolism and inflammatory processes. In this double-blind randomized controlled trial, we investigated the combined effect of ALA, DHA, RmA and PunA on subjects at risk of developing metabolic syndrome. Twenty-four women and men were randomly assigned to two groups. Each day, they consumed two eggs enriched with oleic acid (control group) or enriched with ALA, DHA, RmA, and PunA (test group) for 3 months. The waist circumference decreased significantly (-3.17 cm;  p  < 0.001) in the test group. There were no major changes in plasma insulin and blood glucose in the two groups. The dietary treatments had no significant effect on endothelial function as measured by peripheral arterial tonometry, although erythrocyte nitrosylated hemoglobin concentrations tended to decrease. The high consumption of eggs induced significant elevations in plasma low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol ( p  < 0.001), which did not result in any change in the LDL/HDL ratio in both groups. These results indicate that consumption of eggs enriched with ALA, DHA, RmA and PunA resulted in favorable changes in abdominal obesity without affecting other factors of the metabolic syndrome.",2021,The waist circumference decreased significantly (-3.17 cm;  p  < 0.001) in the test group.,"['Twenty-four women and men', 'subjects at risk of developing metabolic syndrome', 'Subjects at Risk of Developing Metabolic Syndrome']","['ω-3, ω-5 and ω-7 Polyunsaturated Fatty Acids', 'oleic acid (control group) or enriched with ALA, DHA, RmA, and PunA', 'ALA, DHA, RmA and PunA', 'Alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), rumenic acid (RmA), and punicic acid (PunA']","['LDL/HDL ratio', 'abdominal obesity', 'Waist Circumference', 'peripheral arterial tonometry, although erythrocyte nitrosylated hemoglobin concentrations', 'endothelial function', 'waist circumference', 'plasma insulin and blood glucose', 'plasma low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0956901', 'cui_str': '9,11-linoleic acid, (E,Z)-isomer'}, {'cui': 'C1956989', 'cui_str': 'punicic acid'}]","[{'cui': 'C1171408', 'cui_str': 'High density/low density lipoprotein ratio measurement'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",24.0,0.314464,The waist circumference decreased significantly (-3.17 cm;  p  < 0.001) in the test group.,"[{'ForeName': 'Monique T', 'Initials': 'MT', 'LastName': 'Ngo Njembe', 'Affiliation': 'Louvain Institute of Biomolecular Science and Technology, UCLouvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pachikian', 'Affiliation': 'Center of Investigation in Clinical Nutrition, UCLouvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Lobysheva', 'Affiliation': 'Institute of Experimental and Clinical Research, Pole of Pharmacology and Therapeutics, UCLouvain, 1200 Woluwe-Saint-Lambert, Belgium.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Van Overstraeten', 'Affiliation': 'Institute of Experimental and Clinical Research, Pole of Pharmacology and Therapeutics, UCLouvain, 1200 Woluwe-Saint-Lambert, Belgium.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Dejonghe', 'Affiliation': 'Louvain Institute of Biomolecular Science and Technology, UCLouvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Eleonore', 'Initials': 'E', 'LastName': 'Verstraelen', 'Affiliation': 'Louvain Institute of Biomolecular Science and Technology, UCLouvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Buchet', 'Affiliation': 'Louvain Institute of Biomolecular Science and Technology, UCLouvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Rasse', 'Affiliation': 'Louvain Institute of Data Analysis and Modeling in economics and statistics, Statistical Methodology and Computing Service, UCLouvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Gardin', 'Affiliation': 'Louvain Institute of Biomolecular Science and Technology, UCLouvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Mignolet', 'Affiliation': 'Louvain Institute of Biomolecular Science and Technology, UCLouvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Balligand', 'Affiliation': 'Institute of Experimental and Clinical Research, Pole of Pharmacology and Therapeutics, UCLouvain, 1200 Woluwe-Saint-Lambert, Belgium.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Larondelle', 'Affiliation': 'Louvain Institute of Biomolecular Science and Technology, UCLouvain, 1348 Louvain-la-Neuve, Belgium.'}]",Nutrients,['10.3390/nu13020663']
1339,33670711,Ketoanalogs' Effects on Intestinal Microbiota Modulation and Uremic Toxins Serum Levels in Chronic Kidney Disease (Medika2 Study).,"Nutritional therapy (NT) is a therapeutic option in the conservative treatment of chronic kidney disease (CKD) patients to delay the start of dialysis. The aim of this study was to evaluate the specific effect of ketoanalogs (KA)-supplemented diets for gut microbiota modulation. In a previous study we observed that the Mediterranean diet (MD) and a KA-supplemented very-low-protein diet (VLPD) modulated beneficially gut microbiota, reducing indoxyl- and p-cresyl-sulfate (IS, PCS) serum levels, and ameliorating the intestinal permeability in CKD patients. In the current study, we added a third diet regimen consisting of KA-supplemented MD. Forty-three patients with CKD grades 3B-4 continuing the crossover clinical trial were assigned to six months of KA-supplemented MD (MD + KA). Compared to MD, KA-supplementation in MD + KA determined (i) a decrease of  Clostridiaceae ,  Methanobacteriaceae ,  Prevotellaceae , and  Lactobacillaceae  while  Bacteroidaceae  and  Lachnospiraceae  increased; (ii) a reduction of total and free IS and PCS compared to a free diet (FD)-more than the MD, but not as effectively as the VLPD. These results further clarify the driving role of urea levels in regulating gut integrity status and demonstrating that the reduction of azotemia produced by KA-supplemented VLPD was more effective than KA-supplemented MD in gut microbiota modulation mainly due to the effect of the drastic reduction of protein intake rather than the effect of KA.",2021,"Compared to MD, KA-supplementation in MD + KA determined (i) a decrease of  Clostridiaceae ,  Methanobacteriaceae ,  Prevotellaceae , and  Lactobacillaceae  while  Bacteroidaceae  and  Lachnospiraceae  increased; (ii) a reduction of total and free IS and PCS compared to a free diet (FD)-more than the MD, but not as effectively as the VLPD.","['CKD patients', 'Forty-three patients with CKD grades 3B-4 continuing the crossover clinical trial', 'Chronic Kidney Disease (Medika2 Study']","['ketoanalogs (KA)-supplemented diets', 'KA-supplemented MD', 'Nutritional therapy (NT', 'KA-supplemented MD (MD + KA', 'Mediterranean diet (MD) and a KA-supplemented very-low-protein diet (VLPD']",['Intestinal Microbiota Modulation and Uremic Toxins Serum Levels'],"[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0452269', 'cui_str': 'Protein diet'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",43.0,0.0121882,"Compared to MD, KA-supplementation in MD + KA determined (i) a decrease of  Clostridiaceae ,  Methanobacteriaceae ,  Prevotellaceae , and  Lactobacillaceae  while  Bacteroidaceae  and  Lachnospiraceae  increased; (ii) a reduction of total and free IS and PCS compared to a free diet (FD)-more than the MD, but not as effectively as the VLPD.","[{'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rocchetti', 'Affiliation': 'Department of Emergency and Organ Transplantation, Nephrology, Dialysis and Transplantation Unit, ""AldoMoro"" University, 70124 Bari, Italy.'}, {'ForeName': 'Biagio Raffaele', 'Initials': 'BR', 'LastName': 'Di Iorio', 'Affiliation': 'Nephrology, AORN San G. Moscati, 83100 Avellino, Italy.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Vacca', 'Affiliation': 'Department of Soil, Plant and Food Science, ""Aldo Moro"" University, Bari, Via G. Amendola 165/a, 70126 Bari, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Cosola', 'Affiliation': 'Department of Emergency and Organ Transplantation, Nephrology, Dialysis and Transplantation Unit, ""AldoMoro"" University, 70124 Bari, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Marzocco', 'Affiliation': 'Department of Pharmacy, University of Salerno, 84084 Fisciano, Italy.'}, {'ForeName': 'Ighli', 'Initials': 'I', 'LastName': 'di Bari', 'Affiliation': 'Department of Emergency and Organ Transplantation, Nephrology, Dialysis and Transplantation Unit, ""AldoMoro"" University, 70124 Bari, Italy.'}, {'ForeName': 'Francesco Maria', 'Initials': 'FM', 'LastName': 'Calabrese', 'Affiliation': 'Department of Soil, Plant and Food Science, ""Aldo Moro"" University, Bari, Via G. Amendola 165/a, 70126 Bari, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ciarcia', 'Affiliation': 'Department of Veterinary Medicine and Animal Productions, Faculty of Veterinary, University of Naples, 80138 Naples, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'De Angelis', 'Affiliation': 'Department of Soil, Plant and Food Science, ""Aldo Moro"" University, Bari, Via G. Amendola 165/a, 70126 Bari, Italy.'}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Gesualdo', 'Affiliation': 'Department of Emergency and Organ Transplantation, Nephrology, Dialysis and Transplantation Unit, ""AldoMoro"" University, 70124 Bari, Italy.'}]",Journal of clinical medicine,['10.3390/jcm10040840']
1340,33670571,Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).,"Randomised controlled trials of ovarian cancer (OC) screening have not yet demonstrated an impact on disease mortality. Meanwhile, the screening data from clinical trials represents a rich resource to understand the performance of modalities used. We report here on incidence screening in the ultrasound arm of UKCTOCS. 44,799 of the 50,639 women who were randomised to annual screening with transvaginal ultrasound attended annual incidence screening between 28 April 2002 and 31 December 2011. Transvaginal ultrasound was used both as the first and the second line test. Participants were followed up through electronic health record linkage and postal questionnaires. Out of 280,534 annual incidence screens, 960 women underwent screen-positive surgery. 113 had ovarian/tubal cancer (80 invasive epithelial). Of the screen-detected invasive epithelial cancers, 37.5% (95% CI: 26.9-49.0) were Stage I/II. An additional 52 (50 invasive epithelial) were diagnosed within one year of their last screen. Of the 50 interval epithelial cancers, 6.0% (95% CI: 1.3-16.5) were Stage I/II. For detection of all ovarian/tubal cancers diagnosed within one year of screen, the sensitivity, specificity, and positive predictive values were 68.5% (95% CI: 60.8-75.5), 99.7% (95% CI: 99.7-99.7), and 11.8% (95% CI: 9.8-14) respectively. When the analysis was restricted to invasive epithelial cancers, sensitivity, specificity and positive predictive values were 61.5% (95% CI: 52.6-69.9); 99.7% (95% CI: 99.7-99.7) and 8.3% (95% CI: 6.7-10.3), with 12 surgeries per screen positive. The low sensitivity coupled with the advanced stage of interval cancers suggests that ultrasound scanning as the first line test might not be suitable for population screening for ovarian cancer. Trial registration: ISRCTN22488978. Registered on 6 April 2000.",2021,"Of the 50 interval epithelial cancers, 6.0% (95% CI: 1.3-16.5) were Stage I/II.","['44,799 of the 50,639 women who were randomised to annual screening with transvaginal ultrasound attended annual incidence screening between 28 April 2002 and 31 December 2011', '960 women underwent screen-positive surgery', '113 had ovarian/tubal cancer (80 invasive epithelial']",['Transvaginal ultrasound'],"['sensitivity, specificity, and positive predictive values', 'invasive epithelial cancers, sensitivity, specificity and positive predictive values']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",960.0,0.608347,"Of the 50 interval epithelial cancers, 6.0% (95% CI: 1.3-16.5) were Stage I/II.","[{'ForeName': 'Jatinderpal', 'Initials': 'J', 'LastName': 'Kalsi', 'Affiliation': ""Department of Women's Cancer, Institute for Women's Health, University College London, London WC1E 6HU, UK.""}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Gentry-Maharaj', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UK.'}, {'ForeName': 'Naveena', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Pathology, Barts and the London, London E1 2ES, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burnell', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Massingham', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UK.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Apostolidou', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UK.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of Wales, Cardiff CF14 4XW, UK.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Williamson', 'Affiliation': 'Department of Gynaecological Oncology, Nottingham City Hospital, Nottingham NG5 1PB, UK.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Seif', 'Affiliation': ""Division of Gynaecology and of Cancer Services, St. Mary's Hospital and University of Manchester, Manchester M13 9WL, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Mould', 'Affiliation': 'Department of Gynaecological Oncology, University College Hospital, London NW1 2BU, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Woolas', 'Affiliation': 'Department of Gynaecological Oncology, Queen Alexandra Hospital, Portsmouth PO6 3LY, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Dobbs', 'Affiliation': 'Department of Gynaecological Oncology, Belfast City Hospital, Belfast BT9 7AB, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Leeson', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ysbyty Gwynedd, Bangor, Gwynedd LL57 2PW, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Fallowfield', 'Affiliation': 'Cancer Research UK Sussex Psychosocial Oncology Group at Brighton & Sussex Medical School, University of Sussex, Falmer BN1 9PX, UK.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Skates', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'Create Fertility Clinic, London EC2V 6ET, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': ""Department of Women's Cancer, Institute for Women's Health, University College London, London WC1E 6HU, UK.""}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'McGuire', 'Affiliation': 'London School of Economics and Political Science, London WC2A 2AE, UK.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Menon', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UK.'}]",Cancers,['10.3390/cancers13040858']
1341,33670544,"Fracture Load of Metal, Zirconia and Polyetheretherketone Posterior CAD-CAM Milled Fixed Partial Denture Frameworks.","The aim of this study was to investigate the load to fracture and fracture pattern of prosthetic frameworks for tooth-supported fixed partial dentures (FPDs) fabricated with different subtractive computer-aided design and computer-aided manufacturing (CAD-CAM) materials.
MATERIALS AND METHODS


Thirty standardized specimens with two abutments were fabricated to receive three-unit posterior FDP frameworks with an intermediate pontic. Specimens were randomly divided into three groups (n = 10 each) according to the material: group 1 (MM)-milled metal; group 2 (L)-zirconia; and group 3 (P)-Polyetheretherketone (PEEK). The specimens were thermo-cycled and subjected to a three-point bending test until fracture using a universal testing machine (cross-head speed: 1 mm/min). Axial compressive loads were applied at the central fossa of the pontics. Data analysis was made using one-way analysis of variance, Tamhane post hoc test, and Weibull statistics (α = 0.05).
RESULTS


Significant differences were observed among the groups for the fracture load ( p  < 0.0001). MM frameworks showed the highest fracture load values. The PEEK group registered higher fracture load values than zirconia samples. The Weibull statistics corroborated these results. The fracture pattern was different among the groups.
CONCLUSIONS


Milled metal provided the highest fracture load values, followed by PEEK, and zirconia. However, all tested groups demonstrated clinically acceptable fracture load values higher than 1000 N. PEEK might be considered a promising alternative for posterior FPDs.",2021,"RESULTS


Significant differences were observed among the groups for the fracture load ( p  < 0.0001).",['Thirty standardized specimens with two abutments were fabricated to receive three-unit posterior FDP frameworks with an intermediate pontic'],"['Metal, Zirconia and Polyetheretherketone Posterior CAD-CAM Milled Fixed Partial Denture Frameworks', 'material: group 1 (MM)-milled metal; group 2 (L)-zirconia; and group 3 (P)-Polyetheretherketone (PEEK', 'tooth-supported fixed partial dentures (FPDs) fabricated with different subtractive computer-aided design and computer-aided manufacturing (CAD-CAM']","['fracture load values', 'fracture load']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0060663', 'cui_str': 'formycin diphosphate'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0449934', 'cui_str': 'Tooth or teeth replaced'}]","[{'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0162516', 'cui_str': 'Computer-Assisted Manufacturing'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.022073,"RESULTS


Significant differences were observed among the groups for the fracture load ( p  < 0.0001).","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Conservative Dentristy and Bucofacial Prosthesis, Faculty of Odontology, University Complutense of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Tobar', 'Affiliation': 'Department of Conservative Dentristy and Bucofacial Prosthesis, Faculty of Odontology, University Complutense of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-Suárez', 'Affiliation': 'Department of Conservative Dentristy and Bucofacial Prosthesis, Faculty of Odontology, University Complutense of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Peláez', 'Affiliation': 'Department of Conservative Dentristy and Bucofacial Prosthesis, Faculty of Odontology, University Complutense of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Suárez', 'Affiliation': 'Department of Conservative Dentristy and Bucofacial Prosthesis, Faculty of Odontology, University Complutense of Madrid, 28040 Madrid, Spain.'}]","Materials (Basel, Switzerland)",['10.3390/ma14040959']
1342,33670489,Diagnostic Errors Induced by a Wrong a Priori Diagnosis: A Prospective Randomized Simulator-Based Trial.,"Preventive strategies against diagnostic errors require the knowledge of underlying mechanisms. We examined the effects of a wrong a priori diagnosis on diagnostic accuracy of a focussed assessment in an acute myocardial infarction scenario. One-hundred-and-fifty-six medical students (cohort 1) were randomized to three study arms differing in the a priori diagnosis revealed: no diagnosis (control group), myocardial infarction (correct diagnosis group), and pulmonary embolism (wrong diagnosis group). Forty-four physicians (cohort 2) were randomized to the control group and the wrong diagnosis group. Primary endpoint was the participants' final presumptive diagnosis. Among students, the correct diagnosis of an acute myocardial infarction was made by 48/52 (92%) in the control group, 49/52 (94%) in the correct diagnosis group, and 14/52 (27%) in the wrong diagnosis group ( p  < 0.001 vs. both other groups). Among physicians, the correct diagnosis was made by 20/21 (95%) in the control group and 15/23 (65%) in the wrong diagnosis group ( p  = 0.023). In the wrong diagnosis group, 31/52 (60%) students and 6/23 (19%) physicians indicated their initially given wrong a priori diagnosis pulmonary embolism as final diagnosis. A wrong a priori diagnosis significantly increases the likelihood of a diagnostic error during a subsequent patient encounter.",2021,"Among students, the correct diagnosis of an acute myocardial infarction was made by 48/52 (92%) in the control group, 49/52 (94%) in the correct diagnosis group, and 14/52 (27%) in the wrong diagnosis group (","['Forty-four physicians (cohort 2', 'One-hundred-and-fifty-six medical students (cohort 1']","['priori diagnosis revealed: no diagnosis (control group), myocardial infarction (correct diagnosis group), and pulmonary embolism']","[""participants' final presumptive diagnosis"", 'likelihood of a diagnostic error', 'correct diagnosis', 'correct diagnosis of an acute myocardial infarction']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011922', 'cui_str': 'Errors, Diagnostic'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]",156.0,0.02648,"Among students, the correct diagnosis of an acute myocardial infarction was made by 48/52 (92%) in the control group, 49/52 (94%) in the correct diagnosis group, and 14/52 (27%) in the wrong diagnosis group (","[{'ForeName': 'Felix M L', 'Initials': 'FML', 'LastName': 'Meyer', 'Affiliation': 'Department of Intensive Care, Kantonsspital Luzern, 6000 Luzern, Switzerland.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Filipovic', 'Affiliation': 'Institute of Anesthesiology, Kantonsspital Winterthur, 8400 Winterthur, Switzerland.'}, {'ForeName': 'Gianmarco M', 'Initials': 'GM', 'LastName': 'Balestra', 'Affiliation': 'Department of Intensive Care, University of Basel Hospital, 4031 Basel, Switzerland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Tisljar', 'Affiliation': 'Department of Intensive Care, University of Basel Hospital, 4031 Basel, Switzerland.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Sellmann', 'Affiliation': 'Department of Anaesthesiology, Witten/Herdecke University, 58455 Witten, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Marsch', 'Affiliation': 'Department of Intensive Care, University of Basel Hospital, 4031 Basel, Switzerland.'}]",Journal of clinical medicine,['10.3390/jcm10040826']
1343,33670481,Effects of Non-Sport-Specific Versus Sport-Specific Training on Physical Performance and Perceptual Response in Young Football Players.,"This study aimed to compare the effects of non-sport-specific and sport-specific training methods on physical performance and perceptual response in young football players. Seventy-nine under 11 participants were selected and assigned to non-sport-specific (NSSG), sport-specific (SSG), and control (CNTG) groups. The NSSG training protocol consisted of combined stimuli based on balance, agility, and jump rope drills. The SSG training protocol included technical exercises, defensive and offensive game-based drills, and a small-sided game. The CNTG included the participants not taking part in any sport training. All participants were tested for general motor coordination (Harre test), dynamic balance (Lower Quarter Y-balance test), and dribbling before and after 10 weeks of training (NSSG and SSG) or habitual activity (CNTG). At post-intervention, perceived enjoyment was requested by the Physical Activity Enjoyment Scale (PACES). A two-way repeated measure analysis of covariance was used to detect interactions and main effects of time and groups controlling for baseline values. Whereas, a one-way analysis of variance was used to evaluate PACES-related differences between groups. NSSG gained greater improvements ( p  < 0.05) compared with SSG in the Harre and Lower Quarter Y-balance tests, while dribbling skills improved similarly in both groups. Regarding PACES, NSSG and SSG presented a comparable perceived enjoyment. These findings suggest that a 10-week non-sport-specific training is an enjoyable practice capable to promote greater improvements in general motor coordination and dynamic balance compared with sport-specific training in youth football players. This can occur without impairment of football-specific skills.",2021,"NSSG gained greater improvements ( p  < 0.05) compared with SSG in the Harre and Lower Quarter Y-balance tests, while dribbling skills improved similarly in both groups.","['Seventy-nine under 11 participants were selected and assigned to non-sport-specific (NSSG), sport-specific (SSG), and control (CNTG) groups', 'young football players', 'Young Football Players']","['NSSG', 'non-sport-specific and sport-specific training methods', 'Non-Sport-Specific Versus Sport-Specific Training', 'training (NSSG and SSG) or habitual activity (CNTG']","['general motor coordination (Harre test), dynamic balance', 'physical performance and perceptual response', 'Physical Performance and Perceptual Response', 'Physical Activity Enjoyment Scale (PACES', 'general motor coordination and dynamic balance', 'dribbling skills']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030895', 'cui_str': 'Sodium Stibogluconate'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0214178,"NSSG gained greater improvements ( p  < 0.05) compared with SSG in the Harre and Lower Quarter Y-balance tests, while dribbling skills improved similarly in both groups.","[{'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Formenti', 'Affiliation': 'Department of Biotechnology and Life Sciences, University of Insubria, 21100 Varese, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Department of Computer Science, University of Pisa, 56126 Pisa, Italy.'}, {'ForeName': 'Tindaro', 'Initials': 'T', 'LastName': 'Bongiovanni', 'Affiliation': 'Department of Biomedical Sciences for Health, Università Degli Studi di Milano, 20129 Milano, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Campa', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, 47921 Rimini, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cavaggioni', 'Affiliation': 'Department of Biomedical Sciences for Health, Università Degli Studi di Milano, 20129 Milano, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università Degli Studi di Milano, 20129 Milano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Biomedical Sciences for Health, Università Degli Studi di Milano, 20129 Milano, Italy.'}, {'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Trecroci', 'Affiliation': 'Department of Biomedical Sciences for Health, Università Degli Studi di Milano, 20129 Milano, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph18041962']
1344,33670474,The Effects of Short-Term Visual Feedback Training on the Stability of the Roundhouse Kicking Technique in Young Karatekas.,"The aim of this study was to assess the efficacy of using real-time visual feedback (VF) during a one-week balance training intervention on postural sway parameters in young karatekas. Twenty-six young male karatekas (age = 14.0 ± 2.3 years) were randomly divided into two groups: real-time VF training (VFT;  n  = 14) and control (CTRL;  n  = 12). Their center of pressure (COP) displacement (path length, COPpl; distance from origin, COPod) was assessed pre- and post-training on a Wii Balance Board platform in two positions (Flex: knee of the supporting leg slightly bent, maximum hip and leg flexion of the other leg; Kick: knee of the supporting leg slightly bent, mawashi-geri posture for the kicking leg). Both groups trained twice a day for seven days, performing a one-legged stance on the non-dominant limb in the Kick position. During the training, VFT received real-time VF of COP displacement, while CTRL looked at a fixed point. No interaction effect was found ( p  > 0.05). VFT exhibited greater changes pre- and post-training in Flex COPpl (-25.2%,  g  = 1.5), Kick COPpl (-24.1%,  g  = 1.3), and Kick COPod (-44.1%,  g  = 1.0) compared to CTRL (-0.9--13.0%,  g -range: 0.1-0.7). It is possible that superimposing real-time VF to a week-long balance training intervention could induce a greater sport-specific balance-training effect in young karatekas.",2021,"VFT exhibited greater changes pre- and post-training in Flex COPpl (-25.2%,  g  = 1.5), Kick COPpl (-24.1%,  g  = 1.3), and Kick COPod (-44.1%,  g  = 1.0) compared to CTRL (-0.9--13.0%,  ","['young karatekas', 'Twenty-six young male karatekas (age = 14.0 ± 2.3 years', 'Young Karatekas']","['VFT', 'Short-Term Visual Feedback Training', 'pre- and post-training on a Wii Balance Board platform in two positions (Flex: knee of the supporting leg slightly bent, maximum hip and leg flexion of the other leg; Kick: knee of the supporting leg slightly bent, mawashi-geri posture', 'real-time VF training (VFT;  n  = 14) and control (CTRL', 'real-time visual feedback (VF) during a one-week balance training intervention']","['Kick COPod', 'postural sway parameters', 'pressure (COP) displacement (path length, COPpl; distance from origin, COPod', 'Kick COPpl']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2721267', 'cui_str': 'Balance board'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",26.0,0.0107766,"VFT exhibited greater changes pre- and post-training in Flex COPpl (-25.2%,  g  = 1.5), Kick COPpl (-24.1%,  g  = 1.3), and Kick COPod (-44.1%,  g  = 1.0) compared to CTRL (-0.9--13.0%,  ","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Vando', 'Affiliation': 'Fiamme Oro, Polizia di Stato, 00128 Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cavaggioni', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Maurino', 'Affiliation': 'CONI-Italian Olympic Committee, Campania, 80127 Napoli, Italy.'}, {'ForeName': 'Alin', 'Initials': 'A', 'LastName': 'Larion', 'Affiliation': 'Faculty of Physical Education and Sport, Ovidius University of Constanta, 900527 Constanta, Romania.'}, {'ForeName': 'Pietro Luigi', 'Initials': 'PL', 'LastName': 'Invernizzi', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Padulo', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), Università degli Studi di Milano, 20133 Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph18041961']
1345,33670454,Effects of the Health-Awareness-Strengthening Lifestyle Program in a Randomized Trial of Young Adults with an At-Risk Mental State.,"BACKGROUND


Increasing health awareness in health promotion is considered as one of the less stigmatized interventions for improving help-seeking behaviors and total well-being. This study aimed to explore the short-term and long-term effectiveness of the health-awareness-strengthening lifestyle (HASL) program on Taiwanese young adults with at-risk mental state.
METHODS


A pre- and post-test randomized trial was conducted on 92 young adults with at-risk mental state. The HASL program was provided to the experimental group as intervention, and it was only provided to the control group passively by request after the post-test for ethical reasons. The program was conducted once every six weeks, 60-90 min per session, for a total of three times. Mental health risk, anxiety level, health promotion lifestyles, quality of life, physiological index, and physical exercises were assessed one week before and after the program for both groups and followed up to 6 and 12 months for experimental group only.
RESULTS


Compared to the control group, those in the experimental group showed significant improvements regarding anxiety level, health promotion lifestyles, and quality of life one week after participating in the program. Furthermore, the experimental group also showed an additional long-term positive effect on mental risk, physical exercises, and physical health after the follow-ups.
CONCLUSIONS


The outcomes highlighted the interventions of the HASL program leading to more positive health effects on young adults with at-risk mental state. The implementation of similar clinical service is recommended for young adults with at-risk mental state.",2021,"Compared to the control group, those in the experimental group showed significant improvements regarding anxiety level, health promotion lifestyles, and quality of life one week after participating in the program.","['92 young adults with at-risk mental state', 'Taiwanese young adults with at-risk mental state', 'Young Adults with an At-Risk Mental State', 'young adults with at-risk mental state']","['health-awareness-strengthening lifestyle (HASL) program', 'Health-Awareness-Strengthening Lifestyle Program']","['Mental health risk, anxiety level, health promotion lifestyles, quality of life, physiological index, and physical exercises', 'positive health effects', 'anxiety level, health promotion lifestyles, and quality of life', 'mental risk, physical exercises, and physical health']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",92.0,0.0261944,"Compared to the control group, those in the experimental group showed significant improvements regarding anxiety level, health promotion lifestyles, and quality of life one week after participating in the program.","[{'ForeName': 'Ching-Lun', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': 'Department of Public Health (in Epidemiology and Preventive Medicine), China Medical University, Taichung 406040, Taiwan.'}, {'ForeName': 'Ya-Wen', 'Initials': 'YW', 'LastName': 'Lin', 'Affiliation': 'Department of Public Health (in Nursing), China Medical University, Taichung 406040, Taiwan.'}, {'ForeName': 'Hsing-Chi', 'Initials': 'HC', 'LastName': 'Hsu', 'Affiliation': 'Department of Public Health (in Nursing), China Medical University, Taichung 406040, Taiwan.'}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Lou', 'Affiliation': 'Department of Public Health (in Nursing), China Medical University, Taichung 406040, Taiwan.'}, {'ForeName': 'Hsien-Yuan', 'Initials': 'HY', 'LastName': 'Lane', 'Affiliation': 'Graduate Institute of Biomedical Sciences, China Medical University, Taichung 406040, Taiwan.'}, {'ForeName': 'Cheng-Hao', 'Initials': 'CH', 'LastName': 'Tu', 'Affiliation': 'The Brain Disease Research Center, China Medical University Hospital, Taichung 404332, Taiwan.'}, {'ForeName': 'Wei-Fen', 'Initials': 'WF', 'LastName': 'Ma', 'Affiliation': 'The Brain Disease Research Center, China Medical University Hospital, Taichung 404332, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph18041959']
1346,33289033,Erratum to: Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study.,,2021,,['Gonorrhea'],[],[],"[{'cui': 'C0018081', 'cui_str': 'Gonorrhea'}]",[],[],,0.0101838,,[],Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1379']
1347,33676302,The effectiveness of positive appearance and functionality reflective writing tasks on state body image and response to idealised media exposure among 35-60 year-old women.,"Functionality and appearance-based reflective writing tasks can improve body image in young women. There is limited research investigating these tasks in mature women. This study tested (a) the effectiveness of writing tasks on women's state body image and (b) whether these tasks buffered responses to idealised media. Women (N = 240, M age  = 44.58) were randomly allocated to write about the positive aspects of their body functionality, their appearance, or their stress management techniques. They were then exposed to images of cities, or thin-ideal models presented in either posed or active ways. Body appreciation, appearance satisfaction, and functionality satisfaction were measured at pre-reflection, post-reflection, and post-image exposure. Social comparison was measured at post-image. The functionality writing task produced immediate improvements across all state measures, while the positive appearance and stress reflection tasks produced improvements in functionality satisfaction. Image exposure then produced a decrease across all measures, except for body appreciation which remained stable in women who had completed the functionality reflections. No difference in social comparison was found between reflection conditions. The active images resulted in more functionality-based comparison than posed images. These findings contribute to the literature showing benefits of writing tasks which focus on appreciating one's body functionality.",2021,No difference in social comparison was found between reflection conditions.,"['young women', 'mature women', '35-60 year-old women', 'Women (N = 240, M age  = 44.58']","['positive appearance and functionality reflective writing tasks', 'writing tasks', 'Functionality and appearance-based reflective writing tasks']","['Body appreciation, appearance satisfaction, and functionality satisfaction', 'social comparison', 'functionality satisfaction']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0246504,No difference in social comparison was found between reflection conditions.,"[{'ForeName': 'Rachael M', 'Initials': 'RM', 'LastName': 'Weaver', 'Affiliation': 'School of Health and Behavioural Sciences, University of the Sunshine Coast, Maroochydore DC, Queensland, Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Health and Behavioural Sciences, University of the Sunshine Coast, Maroochydore DC, Queensland, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2021.02.008']
1348,33676296,Efficacy of systemic lidocaine on postoperative quality of recovery and analgesia after video-assisted thoracic surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Intraoperative systemic lidocaine has become widely accepted as an adjunct to general anesthesia, associated with opioid-sparing and enhanced recovery. We hypothesized that perioperative systemic lidocaine improves postoperative pain and enhances the quality of recovery (QoR) in patients following video-assisted thoracic surgery (VATS).
DESIGN


Prospective, single-center, double-blind, randomized placebo-controlled clinical trial.
SETTING


Single institution, tertiary university hospital.
PATIENTS


Adult patients aged 18 to 65 undergoing VATS were eligible for participation.
INTERVENTIONS


Patients enrolled in this study were randomized to receive either system lidocaine (a bolus of 1.5 mg kg -1 , followed by an infusion of 2 mg kg -1  h -1  until the end of the surgical procedure) or identical volumes and rates of 0.9% saline.
MEASUREMENTS


The primary outcome was a global QoR-15 score 24 h after surgery. Secondary outcomes included postoperative pain score, cumulative opioid consumption, emergence time, length of PACU stay, adverse events, and patient satisfaction.
MAIN RESULTS


There was no difference in the global QoR-15 scores at 24 h postoperatively between the lidocaine and saline groups (median 117, IQR 113.5-124, vs. median 116, IQR 111-120, P = 0.067), with a median difference of 3 (95% CI 0 to 6, P = 0.507). Similarly, postoperative pain scores, postoperative cumulative opioid consumption, PACU length of stay, the occurrence of PONV, and patient satisfaction were comparable between the two groups (all P > 0.05).
CONCLUSIONS


Our current findings do not support using perioperative systemic lidocaine as a potential strategy to improve postoperative pain and enhance QoR in patients undergoing VATS.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (identifier: ChiCTR1900027515).",2021,"There was no difference in the global QoR-15 scores at 24 h postoperatively between the lidocaine and saline groups (median 117, IQR 113.5-124, vs. median 116, IQR 111-120, P = 0.067), with a median difference of 3 (95% CI 0 to 6, P = 0.507).","['patients following video-assisted thoracic surgery (VATS', 'Adult patients aged 18 to 65 undergoing VATS were eligible for participation', 'Single institution, tertiary university hospital', 'after video-assisted thoracic surgery', 'patients undergoing VATS']","['system lidocaine', 'Intraoperative systemic lidocaine', 'placebo', 'perioperative systemic lidocaine', 'lidocaine', 'systemic lidocaine']","['postoperative pain', 'global QoR-15 scores', 'postoperative pain scores, postoperative cumulative opioid consumption, PACU length of stay, the occurrence of PONV, and patient satisfaction', 'global QoR-15 score 24\xa0h after surgery', 'postoperative pain score, cumulative opioid consumption, emergence time, length of PACU stay, adverse events, and patient satisfaction', 'quality of recovery (QoR', 'postoperative quality of recovery and analgesia', 'postoperative pain and enhance QoR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.792082,"There was no difference in the global QoR-15 scores at 24 h postoperatively between the lidocaine and saline groups (median 117, IQR 113.5-124, vs. median 116, IQR 111-120, P = 0.067), with a median difference of 3 (95% CI 0 to 6, P = 0.507).","[{'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Jundan', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yazhen', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China. Electronic address: fjslmzk@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110223']
1349,33676197,Eculizumab in Asian patients with anti-aquaporin-IgG-positive neuromyelitis optica spectrum disorder: A subgroup analysis from the randomized phase 3 PREVENT trial and its open-label extension.,"Background Eculizumab, a terminal complement inhibitor, significantly reduced the risk of relapse compared with placebo in patients with anti-aquaporin-4 immunoglobulin G-positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD) in the PREVENT trial. We report efficacy and safety analyses in Asian patients in PREVENT and its open-label extension (OLE). Methods PREVENT was a double-blind, randomized, phase 3 trial. Patients with AQP4+ NMOSD were randomly assigned (2:1) to receive intravenous eculizumab (maintenance dose, 1200 mg/2 weeks) or placebo. Patients who completed PREVENT could receive eculizumab in an OLE. Analyses were performed in a prespecified subgroup of Asian patients. Results Of 143 patients enrolled, 52 (36.4%) were included in the Asian subgroup (eculizumab, n = 37; placebo, n = 15); 45 Asian patients received eculizumab in the OLE. Most Asian patients (86.5%) received concomitant immunosuppressive therapy. During PREVENT, one adjudicated relapse occurred in patients receiving eculizumab and six occurred in patients receiving placebo in the Asian subgroup (hazard ratio, 0.05; 95% confidence interval: 0.01-0.35; p = 0.0002). An estimated 95.2% of Asian patients remained relapse-free after 144 weeks of eculizumab treatment. Upper respiratory tract infections, headache, and nasopharyngitis were the most common adverse events with eculizumab in the Asian subgroup. Conclusion Eculizumab reduces the risk of relapse in Asian patients with AQP4+ NMOSD, with a benefit-risk profile similar to the overall PREVENT population. The benefits of eculizumab were maintained during long-term therapy. Clinical trial registration ClinicalTrials.gov identifiers: NCT01892345 (PREVENT); NCT02003144 (open-label extension).",2021,"Upper respiratory tract infections, headache, and nasopharyngitis were the most common adverse events with eculizumab in the Asian subgroup.","['patients with anti-aquaporin-4 immunoglobulin G-positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD', 'Asian patients with AQP4+ NMOSD', 'Asian patients with anti-aquaporin-IgG-positive neuromyelitis optica spectrum disorder', 'Patients with AQP4+ NMOSD', 'Asian patients in PREVENT and its open-label extension (OLE', '143 patients enrolled, 52 (36.4%) were included in the Asian subgroup (eculizumab, n\xa0=\xa037; placebo, n\xa0=\xa015); 45 Asian patients received']","['intravenous eculizumab (maintenance dose, 1200\xa0mg/2 weeks) or placebo', 'placebo', 'concomitant immunosuppressive therapy', 'eculizumab in the OLE', 'eculizumab in an OLE', 'Eculizumab', 'eculizumab']","['relapse-free', 'risk of relapse', 'Upper respiratory tract infections, headache, and nasopharyngitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0292777', 'cui_str': 'Aquaporin-4'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0599635', 'cui_str': 'Aquaporin'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",143.0,0.496528,"Upper respiratory tract infections, headache, and nasopharyngitis were the most common adverse events with eculizumab in the Asian subgroup.","[{'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Research Institute and Hospital, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang 10408, South Korea. Electronic address: hojinkim@ncc.re.kr.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakashima', 'Affiliation': 'Department of Neurology, Tohoku University Graduate School of Medicine, 1-1 Seiryomachi, Aobaku, Sendai, Miyagi 980-8574, Japan; Division of Neurology, Tohoku Medical and Pharmaceutical University, 1-12-1 Fukumuro, Miyaginoku, Sendai, Miyagi 983-8512, Japan. Electronic address: nakashima@tohoku-mpu.ac.jp.'}, {'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurology, Kuala Lumpur Hospital, Jalan Pahang, Kuala Lumpur 50560, Malaysia.'}, {'ForeName': 'Kai-Chen', 'Initials': 'KC', 'LastName': 'Wang', 'Affiliation': 'Cheng Hsin General Hospital, 45 Zhenxing Street, Beitou District, Taipei, Taiwan 112; School of Medicine, National Yang-Ming University, 155, Section 2, Linong St, Beitou District, Taipei, Taiwan 112.'}, {'ForeName': 'Shulian', 'Initials': 'S', 'LastName': 'Shang', 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210, United States. Electronic address: shulian.shang@alexion.com.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210, United States. Electronic address: Larisa.Miller@alexion.com.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Yountz', 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210, United States. Electronic address: Marcus.Yountz@alexion.com.'}, {'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Wingerchuk', 'Affiliation': 'Mayo Clinic Arizona, 13400 East Shea Boulevard, Scottsdale, AZ 85259, United States. Electronic address: wingerchuk.dean@mayo.edu.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Pittock', 'Affiliation': 'Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States. Electronic address: Pittock.Sean@mayo.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'Department of Neurology,\xa0Johns Hopkins University, 1800 Orleans Street, Baltimore, MD 21287, United States. Electronic address: mlevy11@mgh.harvard.edu.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Berthele', 'Affiliation': 'Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Neuro-Kopf-Zentrum, Ismaninger Str. 22, 81675 Munich, Germany. Electronic address: achim.berthele@tum.de.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Totolyan', 'Affiliation': 'Department of Neurology, First Pavlov State Medical University of St. Petersburg, St. 6/8, Lva Tolstogo str., 197022 Petersburg, Russia. Electronic address: ntotolyan@mail.ru.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Palace', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, West Wing, John Radcliffe Hospital, University of Oxford, Headley Way, Oxford OX3 9DU, United Kingdom. Electronic address: jacqueline.palace@ndcn.ox.ac.uk.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Barnett', 'Affiliation': 'Brain and Mind Centre, University of Sydney, 94, Mallett Street, Camperdown, Sydney, NSW 2050, Australia; Royal Prince Alfred Hospital, University of Sydney, Sydney, NSW, Australia. Electronic address: michael@sydneyneurology.com.au.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Department of Neurology, Tohoku University Graduate School of Medicine, 1-1 Seiryomachi, Aobaku, Sendai, Miyagi 980-8574, Japan; Department of Multiple Sclerosis Therapeutics, Fukushima Medical University School of Medicine, 1 Hikariga-oka, Fukushima City, Fukushima 960-1295, Japan; Multiple Sclerosis and Neuromyelitis Optica Center, Southern TOHOKU Research Institute for Neuroscience (STRINS), Koriyama, 7-115, Yatsuyamada, Koriyama, Fukushima 963-8563, Japan. Electronic address: fujikazu@med.tohoku.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102849']
1350,33676071,Sex and female empowerment (SAFE): A randomized trial comparing sexual health interventions for women in treatment for opioid use disorder.,"BACKGROUND


Unintended pregnancies are prevalent among women with opioid use disorder (OUD). The Sex and Female Empowerment (SAFE) project developed a social-cognitive, theory-driven intervention to increase acceptance of and adherence to contraceptive practices among women receiving medication for OUD (MOUD). This study evaluated the feasibility and acceptability of two SAFE interventions (Face-to-face and Computer-adapted) compared to usual care as well as their efficacy to improve contraception utilization.
METHODS


This pilot randomized trial enrolled 90 heterosexual, non-pregnant, reproductive-age women receiving MOUD. Participants were randomized into either a: SAFE Face-to-face intervention, SAFE Computer-adapted intervention, or usual care (UC) condition (n = 30 each) and followed for 6 months. Outcome measures included intervention completion, intervention satisfaction, attendance at a contraception consultation appointment, and long-acting reversible contraceptive (LARC) method receipt. A generalized linear model was used for inferential testing and to estimate least squares means (predicted probabilities for binary outcomes) and their standard errors.
RESULTS


Compared to the UC condition, both the SAFE Face-to-face and the SAFE Computer-adapted intervention had higher intervention completion [Means (Standard Errors) = 0.97 (.03) and 0.97 (.03), respectively, vs. 0.53 (.09); ps<.001], higher intervention satisfaction [Ms (SEs) = 3.7 (.11) and 3.8 (.11), respectively, vs. 3.1 (.11); ps<0.001), higher contraception consultation visit attendance [Ms(SEs) = 0.80 (.07) and 0.73 (.08) vs. 0.33 (.09); p < .001], and greater LARC receipt [Ms(SEs) = 0.77 (.08) and 0.73 (.08) vs. 0.23 (.08); p < .001).
CONCLUSIONS


SAFE appears feasible and efficacious for supporting women in contraception decision-making. Integrating SAFE into women's comprehensive OUD treatment services holds promise to increase contraceptive decision-making and initiation of a chosen method.",2021,"Compared to the UC condition, both the SAFE Face-to-face and the SAFE Computer-adapted intervention had higher intervention completion [Means (Standard Errors) =","['women receiving medication for OUD (MOUD', '90 heterosexual, non-pregnant, reproductive-age women receiving MOUD', 'women with opioid use disorder (OUD', 'women in treatment for opioid use disorder', 'Sex and female empowerment (SAFE']","['SAFE interventions (Face-to-face and Computer-adapted', 'sexual health interventions', 'SAFE', 'SAFE Face-to-face intervention, SAFE Computer-adapted intervention, or usual care (UC) condition']","['intervention completion, intervention satisfaction, attendance at a contraception consultation appointment, and long-acting reversible contraceptive (LARC) method receipt', 'higher contraception consultation visit attendance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205250', 'cui_str': 'High'}]",90.0,0.046039,"Compared to the UC condition, both the SAFE Face-to-face and the SAFE Computer-adapted intervention had higher intervention completion [Means (Standard Errors) =","[{'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States; Departments of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology, School of Medicine, Johns Hopkins University, Baltimore, MD 21224 United States. Electronic address: Hendree_Jones@med.unc.edu.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': 'Martin', 'Affiliation': 'Department of Obstetrics and Gynecology & Institute of Drug and Alcohol Studies, Virginia Commonwealth University School of Medicine, Richmond, VA 23298, United States.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Andringa', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States.'}, {'ForeName': 'Rachel Middlesteadt', 'Initials': 'RM', 'LastName': 'Ellerson', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States.'}, {'ForeName': 'Essence', 'Initials': 'E', 'LastName': 'Hairston', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O' Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, College Park, MD 20742, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108634']
1351,33675599,Automated Time-Released Reminders Improve Patient Access to Colonoscopy.,"Unscheduled colonoscopy orders lead to missed opportunities for early diagnosis and screening. The aim of this study was to evaluate the effect of an automated time-released reminder program on conversion of colonoscopy orders to scheduled cases. In this prospective study, we compared patients ordered for a colonoscopy who were enrolled in an automated reminder program (intervention) with a historical cohort of patients ordered for a colonoscopy who did not receive scheduling reminders (control). The intervention group received automated text message and email reminders using a software platform at 1, 7, and 14 days after a colonoscopy order was placed. The percentage of colonoscopies scheduled within 14 days of order placement improved from 66.0% in the control group to 73.4% in the intervention group (p = .001). The percentage of colonoscopies scheduled within 30 days improved from 73.6% to 90.0% (p < .0001). For colonoscopies ordered by a nongastroenterologist, the percentage of cases scheduled within 30 days of order placement improved from 65.8% in the control group to 90.0% in the intervention group (p < .0001). There was a 10% decrease in phone calls with endoscopy staff for the intervention group relative to the control group. Automated reminders for colonoscopy scheduling improve efficiency in colonoscopy scheduling.",2021,The percentage of colonoscopies scheduled within 14 days of order placement improved from 66.0% in the control group to 73.4% in the intervention group (p = .001).,['patients ordered for a colonoscopy who were enrolled in an automated reminder program (intervention) with a historical cohort of patients ordered for a'],"['colonoscopy who did not receive scheduling reminders (control', 'automated text message and email reminders using a software platform', 'automated time-released reminder program']","['percentage of colonoscopies scheduled within 14 days of order placement', 'phone calls with endoscopy staff']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",,0.0221824,The percentage of colonoscopies scheduled within 14 days of order placement improved from 66.0% in the control group to 73.4% in the intervention group (p = .001).,"[{'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Wynter', 'Affiliation': ""Jamila Wynter, MD, is Medical Resident, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts. Shelley Hurwitz, MS, is Director of Biostatistics in the Center for Clinical Investigation and Associate Professor, Harvard Medical School, Boston, Massachusetts. John R. Saltzman, MD, is Director of Endoscopy, Harvard Medical School, and Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts. Jennifer Nayor, MD, is Director of Quality for Division of Gastroenterology, Harvard Medical School, and Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Hurwitz', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Saltzman', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nayor', 'Affiliation': ''}]",Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates,['10.1097/SGA.0000000000000581']
1352,33675596,Impact of Telephone Intervention on Bowel Preparation Quality for Colonoscopy in the Elderly.,"Bowel preparation is the basis of colonoscopy, and adequate bowel preparation is essential to the success of colonoscopy. Studies have been reported that telephone intervention can improve the quality of bowel preparation, while it remains unclear regarding effectiveness with the elderly. The purpose of this study was to evaluate the effect of telephone intervention on the quality of bowel preparation for colonoscopy in elderly outpatients. In total, 162 outpatients older than 65 years were enrolled and randomly divided into a control group and a study group. Patients in the study group were re-educated through telephone by a specific nurse 2 days before colonoscopy, whereas participants in the control group received education only on the day of appointment. The Ottawa score was used to evaluate the quality of bowel preparation between the two groups. In this study, no significant differences were observed in age, gender, body mass index, educational level, smoking and/or alcohol drinking, waiting time to colonoscopy, reasons for colonoscopy, and colonoscopic findings between the control group and the study group. Participants in the study group had higher adequate bowel preparation and compliance than the control group (83.1% vs. 59.5%, p = .03; 96.4% vs. 74.7%, p < .001). Univariate analysis showed that only noncompliance with start time was significantly associated with satisfactory bowel preparation in elderly patients. In conclusion, telephone intervention 2 days before colonoscopy can improve the quality of bowel preparation in the elderly.",2021,"Participants in the study group had higher adequate bowel preparation and compliance than the control group (83.1% vs. 59.5%, p = .03; 96.4% vs. 74.7%, p < .001).","['162 outpatients older than 65 years', 'elderly outpatients', 'Colonoscopy in the Elderly', 'elderly patients']","['telephone intervention', 'Telephone Intervention']","['quality of bowel preparation', 'Bowel Preparation Quality', 'adequate bowel preparation and compliance', 'age, gender, body mass index, educational level, smoking and/or alcohol drinking, waiting time to colonoscopy, reasons for colonoscopy, and colonoscopic findings']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",162.0,0.0250541,"Participants in the study group had higher adequate bowel preparation and compliance than the control group (83.1% vs. 59.5%, p = .03; 96.4% vs. 74.7%, p < .001).","[{'ForeName': 'Chun-Jiu', 'Initials': 'CJ', 'LastName': 'Hu', 'Affiliation': ""Chun-Jiu Hu, MD, is at Department of Gastroenterology, Ningbo First Hospital, Ningbo, China. Lin-Yan Jiang, BD, is Physician, Department of ICU, Ningbo Women & Children's Hospital, Ningbo, China. Lin-Yin Sun, BD, is Nurse-in-charge, Department of Gastroenterology, Ningbo First Hospital, Ningbo, China. Chun-Yan Hu, BD, is Nurse-in-charge, Department of Gastroenterology, Ningbo First Hospital, Ningbo, China. Ke-Mei Shi, BD, is Nurse-in-charge, Department of Gastroenterology, Ningbo First Hospital, Ningbo, China. Zhen-Fei Bao, BD, is Nurse-in-charge, Department of Gastroenterology, Ningbo First Hospital, Ningbo, China. Feng Zhou, BD, is Nurse-in-charge, Department of Gastroenterology, Ningbo First Hospital, Ningbo, China. Lei Xu, PhD, is Professor, Department of Gastroenterology, Ningbo First Hospital, Ningbo, China. Wei-Hong Wang, BD, is Associate Professor of Nursing, Department of Gastroenterology, Ningbo First Hospital, Ningbo, China.""}, {'ForeName': 'Lin-Yan', 'Initials': 'LY', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Lin-Yin', 'Initials': 'LY', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Ke-Mei', 'Initials': 'KM', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Zhen-Fei', 'Initials': 'ZF', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Wei-Hong', 'Initials': 'WH', 'LastName': 'Wang', 'Affiliation': ''}]",Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates,['10.1097/SGA.0000000000000573']
1353,33681273,Cognitive Behavioral Approach to Treat Obesity: A Randomized Clinical Trial.,"Our aim was to analyze and compare the effects of three different long-term treatments on anthropometric profiles, eating behaviors, anxiety and depression levels, and quality of life of groups of adults with obesity.  Methods:  The 43 participants in the study were randomly assigned to one of three groups: the education and health group (EH,  n  = 12), which received lectures on health topics; the physical exercise group (PE,  n  = 13), which underwent physical training; and the interdisciplinary therapy plus cognitive behavioral therapy (IT + CBT) ( n  = 18) group, which received physical training, nutritional advice, and physical and psychological therapy.  Results:  Total quality of life increased significantly in the EH group (△ = 2.00); in the PE group, body weight significantly decreased (△ = -1.42) and the physical domain of quality of life improved (△ = 1.05). However, the most significant changes were seen in the IT + CBT group, in which the anthropometric profile improved; there were an increase in quality of life in all domains (physical, psychological, social, and environmental), an improvement in eating behaviors [Dutch Eating Behavior Questionnaire (DEBQ), total △ = -8.39], and a reduction in depression [Beck Depression Inventory (BDI), △ = -10.13).  Conclusion:  The IT + CBT program was more effective than the PE and EH programs.  Clinical Trial Registration Number:  NCT02573688.",2021,"Total quality of life increased significantly in the EH group (△ = 2.00); in the PE group, body weight significantly decreased (△ = -1.42) and the physical domain of quality of life improved (△ = 1.05).","['Treat Obesity', '43 participants in the study', 'adults with obesity']","['Cognitive Behavioral Approach', 'education and health group (EH,  n  = 12), which received lectures on health topics; the physical exercise group (PE,  n  = 13), which underwent physical training; and the interdisciplinary therapy plus cognitive behavioral therapy (IT + CBT) ( n  = 18) group, which received physical training, nutritional advice, and physical and psychological therapy']","['quality of life in all domains (physical, psychological, social, and environmental', 'body weight', 'Total quality of life', 'depression [Beck Depression Inventory (BDI), △ = -10.13', 'physical domain of quality of life', 'eating behaviors [Dutch Eating Behavior Questionnaire (DEBQ), total △', 'anthropometric profiles, eating behaviors, anxiety and depression levels, and quality of life']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",43.0,0.0480659,"Total quality of life increased significantly in the EH group (△ = 2.00); in the PE group, body weight significantly decreased (△ = -1.42) and the physical domain of quality of life improved (△ = 1.05).","[{'ForeName': 'Amanda Dos Santos', 'Initials': 'ADS', 'LastName': 'Moraes', 'Affiliation': 'Post Graduate Program of Interdisciplinary Health Sciences, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo da Costa', 'Initials': 'RDC', 'LastName': 'Padovani', 'Affiliation': 'Post Graduate Program of Interdisciplinary Health Sciences, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cauê Vazquez', 'Initials': 'CV', 'LastName': 'La Scala Teixeira', 'Affiliation': 'Post Graduate Program of Interdisciplinary Health Sciences, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Gabriela Soria', 'Initials': 'MGS', 'LastName': 'Cuesta', 'Affiliation': 'Post Graduate Program of Interdisciplinary Health Sciences, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Silvandro Dos Santos', 'Initials': 'SDS', 'LastName': 'Gil', 'Affiliation': 'Post Graduate Program of Interdisciplinary Health Sciences, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'de Paula', 'Affiliation': 'Obesity Study Group (GEO), Post-Graduate Program of Nutrition, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gilberto Monteiro', 'Initials': 'GM', 'LastName': 'Dos Santos', 'Affiliation': 'Obesity Study Group (GEO), Post-Graduate Program of Nutrition, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo Tributino', 'Initials': 'RT', 'LastName': 'Gonçalves', 'Affiliation': 'Institute of Mathematical and Computer Sciences, University of São Paulo, São Carlos, Brazil.'}, {'ForeName': 'Ana Raimunda', 'Initials': 'AR', 'LastName': 'Dâmaso', 'Affiliation': 'Obesity Study Group (GEO), Post-Graduate Program of Nutrition, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lila Missae', 'Initials': 'LM', 'LastName': 'Oyama', 'Affiliation': 'Obesity Study Group (GEO), Post-Graduate Program of Nutrition, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo José', 'Initials': 'RJ', 'LastName': 'Gomes', 'Affiliation': 'Post Graduate Program of Interdisciplinary Health Sciences, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Danielle Arisa', 'Initials': 'DA', 'LastName': 'Caranti', 'Affiliation': 'Post Graduate Program of Interdisciplinary Health Sciences, Federal University of São Paulo, São Paulo, Brazil.'}]",Frontiers in nutrition,['10.3389/fnut.2021.611217']
1354,33681271,The Effects of Probiotic Supplementation on Anthropometric Growth and Gut Microbiota Composition in Patients With Prader-Willi Syndrome: A Randomized Double-Blinded Placebo-Controlled Trial.,"Background:  Prader-Willi Syndrome (PWS) is a rare genetic disorder associated with developmental delay, obesity, and neuropsychiatric comorbidities.  Bifidobacterium animalis  subsp.  lactis  has demonstrated anti-obesity and anti-inflammatory effects in previous studies.  Aim:  To evaluate the effects of  Bifidobacterium animalis  subsp.  lactis  probiotics supplementation on anthropometric growth, behavioral symptoms, and gut microbiome composition in patients with PWS.  Methods:  Ethical Approval was issued by the Internal Review Board (IRB) of the Second Affiliated Hospital of Kunming Medical University (Review-YJ-2016-06). We conducted a 12-week, randomized, double-blind, placebo-controlled trial in 68 patients with Prader-Willi syndrome aged 11 months-16 years (mean = 4.2 years old) who were randomly assigned to receive daily  B. lactis -11 probiotics (6 × 10 10  CFUs) or a placebo sachet. Weight, height, ASQ-3, ABC, SRS-2, and CGI-I were compared between the two groups at baseline and at 6 and 12 weeks into treatment. Gut microbiome data were analyzed with the QIIME 2 software package, and functional gene analysis was conducted with PICRUSt-2.  Results:  We found a significant increase in height (mean difference = 2.68 cm,  P  < 0.05) and improvement in CGI-I ( P  < 0.05) in the probiotics group compared to the placebo group. No significant change in weight or psychological measures were observed. Probiotic treatment altered the microbiome composition to favor weight loss and gut health and increased the abundance of antioxidant production-related genes.  Conclusions:  The findings suggest a novel therapeutic potential for  Bifidobacterium animalis  subsp.  lactis  probiotics in Prader-Willi syndrome patients, although further investigation is warranted.",2021,Probiotic treatment altered the microbiome composition to favor weight loss and gut health and increased the abundance of antioxidant production-related genes.  ,"['68 patients with Prader-Willi syndrome aged 11 months-16 years (mean = 4.2 years old', 'Prader-Willi syndrome patients', 'Patients With Prader-Willi Syndrome', 'patients with PWS']","['placebo', 'daily  B. lactis -11 probiotics', 'lactis  probiotics supplementation', 'placebo sachet', 'Placebo', 'Probiotic Supplementation']","['CGI-I', 'Anthropometric Growth and Gut Microbiota Composition', 'Weight, height, ASQ-3, ABC, SRS-2, and CGI', 'anthropometric growth, behavioral symptoms, and gut microbiome composition', 'weight or psychological measures', 'height', 'abundance of antioxidant production-related genes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",68.0,0.341883,Probiotic treatment altered the microbiome composition to favor weight loss and gut health and increased the abundance of antioxidant production-related genes.  ,"[{'ForeName': 'Xue-Jun', 'Initials': 'XJ', 'LastName': 'Kong', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Guobin', 'Initials': 'G', 'LastName': 'Wan', 'Affiliation': 'Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, China.'}, {'ForeName': 'Ruiyi', 'Initials': 'R', 'LastName': 'Tian', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Cullen', 'Initials': 'C', 'LastName': 'Clairmont', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'PWS Care & Support Center, Wenzhou, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Hangzhou Seventh Hospital, Hangzhou, China.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Sherman', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Junli', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Yale University, New Haven, CT, United States.'}, {'ForeName': 'Yelan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Bentley University, Waltham, MA, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Fong', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Bryan K', 'Initials': 'BK', 'LastName': 'Wang', 'Affiliation': 'Brandeis University, Waltham, MA, United States.'}, {'ForeName': 'Jinghan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'New York University, New York, NY, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Zhehao', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Second Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Second Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Second Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Hanyu', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Second Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Second Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Second Affiliated Hospital of Kunming Medical University, Kunming, China.'}]",Frontiers in nutrition,['10.3389/fnut.2021.587974']
1355,33681257,An Open Label Trial to Assess Safety of Losartan for Treating Worsening Respiratory Illness in COVID-19.,"Rationale:  Coronavirus disease 2019 (COVID-19) can cause disruption of the renin-angiotensin system in the lungs, possibly contributing to pulmonary capillary leakage. Thus, angiotensin receptor blockers (ARBs) may improve respiratory failure.  Objective:  Assess safety of losartan for use in respiratory failure related to COVID-19 (NCT04335123).  Methods:  Single arm, open label trial of losartan in those hospitalized with respiratory failure related to COVID-19. Oral losartan (25 mg daily for 3 days, then 50 mg) was administered from enrollment until day 14 or hospital discharge. A  post-hoc  external control group with patients who met all inclusion criteria was matched 1:1 to the treatment group using propensity scores for comparison.  Measures:  Primary outcome was cumulative incidence of any adverse events. Secondary, explorative endpoints included measures of respiratory failure, length of stay and vital status.  Results:  Of the 34 participants enrolled in the trial, 30 completed the study with a mean age SD of 53.8 ± 17.7 years and 17 males (57%). On losartan, 24/30 (80%) experienced an adverse event as opposed to 29/30 (97%) of controls, with a lower average number of adverse events on losartan relative to control (2.2 vs. 3.3). Using Poisson regression and controlling for age, sex, race, date of enrollment, disease severity at enrollment, and history of high-risk comorbidities, the incidence rate ratio of adverse events on losartan relative to control was 0.69 (95% CI: 0.49-0.97)  Conclusions:  Losartan appeared safe for COVID-19-related acute respiratory compromise. To assess true efficacy, randomized trials are needed.",2021,A  post-hoc  external control group with patients who met all inclusion criteria was matched 1:1 to the treatment group using propensity scores for comparison.  ,"['34 participants enrolled in the trial, 30 completed the study with a mean age SD of 53.8 ± 17.7 years and 17 males (57', 'those hospitalized with respiratory failure related to COVID-19']","['Losartan', 'losartan', 'angiotensin receptor blockers (ARBs', 'Oral losartan']","['adverse event', 'cumulative incidence of any adverse events', 'adverse events', 'respiratory failure, length of stay and vital status']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",34.0,0.0998815,A  post-hoc  external control group with patients who met all inclusion criteria was matched 1:1 to the treatment group using propensity scores for comparison.  ,"[{'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Bengtson', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Montgomery', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Nazir', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Satterwhite', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Nathan C', 'Initials': 'NC', 'LastName': 'Bahr', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Baumlin', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Salathe', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, KS, United States.'}]",Frontiers in medicine,['10.3389/fmed.2021.630209']
1356,33681244,Effectiveness of Improved Use of Chewing Gum During Capsule Endoscopy in Decreasing Gastric Transit Time: A Prospective Randomized Controlled Study.,"Background/Aim:  Chewing gum throughout small bowel capsule endoscopy (SBCE) increases completion rates (CRs) but decreases small bowel transit time (SBTT) and diagnostic yield (DY). We determined the effects of chewing gum early during SBCE on gastric transit time (GTT), SBTT, CR, DY, and gastroscopy intervention.  Methods:  We prospectively enrolled patients (ages 16-80 years) undergoing SBCE between January and June 2019. Patients were randomized to a chewing gum group (103 patients) and a control group (102 patients). Patients in the former group chewed one piece of gum for ~15 min every 30 min during the first hour of SBCE. Two gastroenterologists blinded to the study group examined the data.  Results:  GTT was shorter in the chewing gum group (19.0 min, interquartile range: 17.0-52.0 min) than in the control group [42.5 min (23.25-60 min);  P  = 0.01]. SBTT was similar in the two groups [318.5 min (239.5-421.3 min) vs. 287.0 min (216.0-386.0 min);  P  = 0.08]. Gastroscopy rate was lower in the chewing gum group (15.53 vs. 32.35%,  P  = 0.005). CR (95.15 vs. 89.22%,  P  = 0.114) and DY (66.02 vs. 59.80%,  P  = 0.359) did not differ between the groups. The number of abnormal-lesion types detected per patient was higher in the chewing gum group [1.0 (0.0-2.0) vs. 2.0 (0.0-2.0);  P  = 0.049].  Conclusions:  Chewing gum early during SBCE significantly reduced GTT and gastroscopy intervention, with no influence on SBTT (Trial number: NCT03815136).",2021,"Gastroscopy rate was lower in the chewing gum group (15.53 vs. 32.35%,  P  = 0.005).","['enrolled patients (ages 16-80 years) undergoing SBCE between January and June 2019', 'group (103 patients) and a control group (102 patients']","['Capsule Endoscopy', 'Chewing Gum', 'Chewing gum throughout small bowel capsule endoscopy ', 'chewing gum', 'SBCE']","['CR', 'Gastroscopy rate', 'completion rates (CRs', 'gastric transit time (GTT), SBTT, CR, DY, and gastroscopy intervention', 'number of abnormal-lesion types', 'small bowel transit time (SBTT) and diagnostic yield (DY']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C4285996', 'cui_str': 'Small bowel capsule endoscopy'}]","[{'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.0217453,"Gastroscopy rate was lower in the chewing gum group (15.53 vs. 32.35%,  P  = 0.005).","[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Hangzhou Red Cross Hospital, Hangzhou, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, China.'}]",Frontiers in medicine,['10.3389/fmed.2021.605393']
1357,33681022,Effectiveness of back massage on pain relief during first stage of labor in primi mothers admitted at a Tertiary care center.,"Background


Labor pain is one of the most severe pains a woman experiences in her life, causing an increase in the anxiety and stress levels. Massage therapy has proven beneficial for relaxation purposes.
Aim


To evaluate the effectiveness of back massage in relieving pain during the first stage of labor in primi mothers.
Methodology


The study included 40 primipara mothers belonging to the age group 22-25 years, equally divided into 2 groups: Experimental (massage therapy) and control (routine care). The socio-demographic data, labor assessment parameters (cervical dilation, status of fetal membranes, frequency and duration of uterine contractions during the latent and active phase of labor, and the total duration of the first stage of labor), and the level of labor pain (numerical rating pain scale) were recorded. Data analysis was performed by one-way ANOVA and two independent samples  t -test ( P  ≤ 0.05 as significant).
Results


During the latent and active phase of labor, majority of the mothers experienced 4-5 contractions in a span of 10 min. During the latent phase of labor, uterine contractions for 20-40 s were exhibited by 90% and 75% mothers in the experimental and control group, respectively; and during active phase, contractions of >40 s were exhibited by 85% mothers in both groups. A significant difference in the post-test pain scores was noted between the 2 groups ( P  < 0.0001).
Conclusion


Our study proved that back massage was effective in reducing pain during the first stage of labor in primipara mothers in comparison to those who were subjected to routine care.",2020,"A significant difference in the post-test pain scores was noted between the 2 groups ( P  < 0.0001).
","['primi mothers', '40 primipara mothers belonging to the age group 22-25 years, equally divided into 2 groups', 'primi mothers admitted at a Tertiary care center']","['Experimental (massage therapy) and control (routine care', 'back massage', 'Massage therapy']","['pain relief', 'pain', 'relieving pain', 'post-test pain scores', 'socio-demographic data, labor assessment parameters (cervical dilation, status of fetal membranes, frequency and duration of uterine contractions during the latent and active phase of labor, and the total duration of the first stage of labor), and the level of labor pain (numerical rating pain scale', 'uterine contractions']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015943', 'cui_str': 'Fetal membranes'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0233130', 'cui_str': 'Duration of uterine contraction'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0042130', 'cui_str': 'Uterine contraction'}]",40.0,0.038,"A significant difference in the post-test pain scores was noted between the 2 groups ( P  < 0.0001).
","[{'ForeName': 'Manasi P', 'Initials': 'MP', 'LastName': 'Pawale', 'Affiliation': 'Department of Obstetrics and Gynecological Nursing, Krishna Institute of Nursing Sciences, Deemed to be University, Karad, Satara District, Maharashtra, India.'}, {'ForeName': 'Jyoti A', 'Initials': 'JA', 'LastName': 'Salunkhe', 'Affiliation': 'Department of Obstetrics and Gynecological Nursing, Krishna Institute of Nursing Sciences, Deemed to be University, Karad, Satara District, Maharashtra, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_1189_20']
1358,33680944,Sentinel Lymph-Node Biopsy in Early-Stage Cervical Cancer: The 4-Year Follow-Up Results of the Senticol 2 Trial.,"Introduction


Senticol 2 is a randomized multicenter trial in the treatment of early-stage cervical cancer patients. The aim of the Senticol 2 study was to compare the effect of sentinel-lymph-node biopsy (SLNB) to that of SLNB + pelvic lymphadenectomy (PLND), and to determine the postoperative lymphatic morbidity in the two groups. Here, we report a secondary objective of this study: the follow up.
Material and Methods


In the Senticol 2 trial, patients underwent a laparoscopy with a sentinel-node-detection procedure and were randomized into two groups, namely: Group A, in which participants received SLNB, and Group B, in which participants received SLNB + PLND. Patients with an intra-operative macroscopically suspicious lymph node, were given a frozen-section evaluation and were randomized only if the results were negative. All of the patients received follow up with a clinical examination at 1, 3, and 6 months after surgery, and then every 3-4 months after that. The median follow up was 51 months (4 years and 3 months).
Results


Disease-free survival after 4 years for the SLNB group and the SLNB + PLND group were 89.51% and 93.1% ( p  = 0.53), respectively. The only statistical factor associated with recurrence in the univariate analysis was the adjuvant radiotherapy. No other factors, including the age of the patients, histological type, tumor size, lymph vascular space invasion (LVSI), and positive nodal status, were significant in the univariate or multivariate analyses. The overall survival rates after 4 years in the SLNB and SLNB + PLND groups were 95.2% and 96% ( p  = 0.97), with five and four deaths, respectively. The univariate and multivariate analyses did not find any prognostic factors.
Conclusions


This randomized study confirmed the results of the Senticol 1 study and supports the sentinel lymph node (SLN) technique as a safe technique for use in patients with early-stage cervical cancer treated with SLNB only. Disease-free survival after 4 years was similar in patients treated with SLN biopsy and patients who underwent a lymphadenectomy.",2020,Disease-free survival after 4 years was similar in patients treated with SLN biopsy and patients who underwent a lymphadenectomy.,"['early-stage cervical cancer patients', 'patients with early-stage cervical cancer treated with SLNB only', 'in Early-Stage Cervical Cancer', 'Patients with an intra-operative macroscopically suspicious lymph node, were given a frozen-section evaluation']","['lymphadenectomy', 'SLNB + pelvic lymphadenectomy (PLND', 'SLN biopsy', 'sentinel lymph node (SLN) technique', 'Sentinel Lymph-Node Biopsy', 'laparoscopy with a sentinel-node-detection procedure', 'SLNB', 'sentinel-lymph-node biopsy (SLNB', 'SLNB + PLND']","['overall survival rates', 'Disease-free survival', 'postoperative lymphatic morbidity', 'histological type, tumor size, lymph vascular space invasion (LVSI), and positive nodal status', 'Results\n\n\nDisease-free survival']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0016741', 'cui_str': 'Frozen Sections'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449574', 'cui_str': 'Histologic type'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.100722,Disease-free survival after 4 years was similar in patients treated with SLN biopsy and patients who underwent a lymphadenectomy.,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Favre', 'Affiliation': 'Department of Gynecology, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Guani', 'Affiliation': 'Department of Gynecology, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Balaya', 'Affiliation': 'Department of Gynecology, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Magaud', 'Affiliation': 'Clinical Research and Epidemiology Department, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Lecuru', 'Affiliation': 'Breast, Gynecology and Reconstructive Surgery Unit, Curie Institute, Paris, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Mathevet', 'Affiliation': 'Department of Gynecology, University Hospital of Lausanne, Lausanne, Switzerland.'}]",Frontiers in oncology,['10.3389/fonc.2020.621518']
1359,33680934,Multiple U-Net-Based Automatic Segmentations and Radiomics Feature Stability on Ultrasound Images for Patients With Ovarian Cancer.,"Few studies have reported the reproducibility and stability of ultrasound (US) images based radiomics features obtained from automatic segmentation in oncology. The purpose of this study is to study the accuracy of automatic segmentation algorithms based on multiple U-net models and their effects on radiomics features from US images for patients with ovarian cancer. A total of 469 US images from 127 patients were collected and randomly divided into three groups: training sets (353 images), validation sets (23 images), and test sets (93 images) for automatic segmentation models building. Manual segmentation of target volumes was delineated as ground truth. Automatic segmentations were conducted with U-net, U-net++, U-net with Resnet as the backbone (U-net with Resnet), and CE-Net. A python 3.7.0 and package Pyradiomics 2.2.0 were used to extract radiomic features from the segmented target volumes. The accuracy of automatic segmentations was evaluated by Jaccard similarity coefficient (JSC), dice similarity coefficient (DSC), and average surface distance (ASD). The reliability of radiomics features were evaluated by Pearson correlation and intraclass correlation coefficients (ICC). CE-Net and U-net with Resnet outperformed U-net and U-net++ in accuracy performance by achieving a DSC, JSC, and ASD of 0.87, 0.79, 8.54, and 0.86, 0.78, 10.00, respectively. A total of 97 features were extracted from the delineated target volumes. The average Pearson correlation was 0.86 (95% CI, 0.83-0.89), 0.87 (95% CI, 0.84-0.90), 0.88 (95% CI, 0.86-0.91), and 0.90 (95% CI, 0.88-0.92) for U-net++, U-net, U-net with Resnet, and CE-Net, respectively. The average ICC was 0.84 (95% CI, 0.81-0.87), 0.85 (95% CI, 0.82-0.88), 0.88 (95% CI, 0.85-0.90), and 0.89 (95% CI, 0.86-0.91) for U-net++, U-net, U-net with Resnet, and CE-Net, respectively. CE-Net based segmentation achieved the best radiomics reliability. In conclusion, U-net based automatic segmentation was accurate enough to delineate the target volumes on US images for patients with ovarian cancer. Radiomics features extracted from automatic segmented targets showed good reproducibility and for reliability further radiomics investigations.",2020,"The accuracy of automatic segmentations was evaluated by Jaccard similarity coefficient (JSC), dice similarity coefficient (DSC), and average surface distance (ASD).","['Patients With Ovarian Cancer', 'patients with ovarian cancer', 'A total of 469 US images from 127 patients']",['Multiple U-Net-Based Automatic Segmentations and Radiomics Feature Stability'],"['accuracy of automatic segmentations', 'Jaccard similarity coefficient (JSC), dice similarity coefficient (DSC), and average surface distance (ASD', 'average Pearson correlation', 'CE-Net and U-net', 'average ICC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",97.0,0.032526,"The accuracy of automatic segmentations was evaluated by Jaccard similarity coefficient (JSC), dice similarity coefficient (DSC), and average surface distance (ASD).","[{'ForeName': 'Juebin', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Medical Engineering, Wenzhou Medical University First Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Gynecology, Shanghai First Maternal and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jindi', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecology, Wenzhou Medical University First Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Ai', 'Affiliation': 'Department of Radiotherapy Center, Wenzhou Medical University First Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiotherapy Center, Wenzhou Medical University First Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Yinyan', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': 'Department of Ultrasound Imaging, Wenzhou Medical University First Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Radiotherapy Center, Wenzhou Medical University First Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Xiance', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Radiotherapy Center, Wenzhou Medical University First Affiliated Hospital, Wenzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.614201']
1360,33680898,"Efficacy of buccal piroxicam infiltration and inferior alveolar nerve block in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial.","Objectives


This randomized clinical trial aimed to assess the effectiveness of buccal infiltration with piroxicam on the anesthetic efficacy of inferior alveolar nerve block (IANB) with buccal infiltration in irreversible pulpitis, with pain assessed using the Heft-Parker visual analogue scale (HP-VAS).
Materials and Methods


This study included 56 patients with irreversible pulpitis in mandibular molars, randomly distributed between 2 groups ( n  = 28). After evaluating the initial pain score with the HP-VAS, each patient received IANB followed by buccal infiltration of 2% lignocaine with adrenaline (1:80,000). Five minutes later, the patients in groups 1 and 2 were given buccal infiltration with 40 mg/2 mL of piroxicam or normal saline, respectively. An access opening procedure (AOP) was performed 15 minutes post-IANB once the individual showed signs of lip numbness as well as 2 negative responses to electric pulp testing. The HP-VAS was used to grade the patient's pain during caries removal (CR), AOP, and working length measurement (WLM). Successful anesthesia was identified either by the absence of pain or slight pain through CR, AOP, and WLM, with no requirement of a further anesthetic dose. A statistical analysis was done using the Shapiro-Wilk and Mann-Whitney  U  tests.
Results


The piroxicam group presented a significantly lower ( p  < 0.05) mean pain score than the saline group during AOP.
Conclusions


Buccal infiltration with piroxicam enhanced the efficacy of anesthesia with IANB and buccal infiltration with lignocaine in patients with irreversible pulpitis.",2021,"The piroxicam group presented a significantly lower ( p  < 0.05) mean pain score than the saline group during AOP.
","['56 patients with irreversible pulpitis in mandibular molars, randomly distributed between 2 groups ( n  = 28', 'patients with irreversible pulpitis']","['lignocaine', 'buccal piroxicam infiltration and inferior alveolar nerve block', 'lignocaine with adrenaline', 'piroxicam']","['mean pain score', 'anesthetic efficacy of inferior alveolar nerve block (IANB', 'initial pain score', 'pain during caries removal (CR), AOP, and working length measurement (WLM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0158996', 'cui_str': 'Anemia of prematurity'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",56.0,0.139769,"The piroxicam group presented a significantly lower ( p  < 0.05) mean pain score than the saline group during AOP.
","[{'ForeName': 'Saurav', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Rama Dental College, Hospital and Research Centre, Kanpur, Uttar Pradesh, India.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Nandamuri', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Rama Dental College, Hospital and Research Centre, Kanpur, Uttar Pradesh, India.'}, {'ForeName': 'Aakrati', 'Initials': 'A', 'LastName': 'Raina', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Rama Dental College, Hospital and Research Centre, Kanpur, Uttar Pradesh, India.'}, {'ForeName': 'Mukta', 'Initials': 'M', 'LastName': 'Bansal', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Rama Dental College, Hospital and Research Centre, Kanpur, Uttar Pradesh, India.'}]",Restorative dentistry & endodontics,['10.5395/rde.2021.46.e9']
1361,33680842,Efficacy and safety of fermented oyster extract for height of children with short stature: a randomized placebo-controlled trial.,"Background


Some experimental studies have established the effect of oysters on the promotion of body growth. Yet, there is a lack of human clinical studies. The objective of this study was to evaluate the effect of a fermented oyster (FO) extract on the increase in the height of children with stature in the 25th percentile by age.
Methods


In total, 100 children (6-11 years old) were randomly divided into two (FO or control) groups. For 24 weeks, the subjects in the FO group took the FO extract once daily before sleeping, whereas the control group took placebo extracts, simultaneously. We evaluated the height gain, height velocity (HV), height standard deviation score (SDS), urine deoxypyridinoline (DPD), growth hormone (GH), insulin-like growth factor (IGF-1), and IGF binding protein 3 (IGFBP-3).
Results


The height gain and height SDS were significantly higher in the FO group than in the placebo group after 24 weeks (height gain:  p  < 0.001, height SDS:  p  < 0.005). The HV was also significantly higher in the FO group than in the placebo group after the 6th and 24th week ( p  = 0.001,  p  = 0.004). After 24 weeks, we observed a decrease in GH, IGF, and IGFBP-3 in both groups. However, serum IGFBP-3 level in the FO group reduced less than placebo group.
Conclusion


FO supplementation may help to increase the height of children, and the effect might be mediated via effects on the IGFBP-3 levels.",2021,"The HV was also significantly higher in the FO group than in the placebo group after the 6th and 24th week ( p  = 0.001,  p  = 0.004).","['children with stature in the 25th percentile by age', '100 children (6-11 years old', 'children with short stature']","['fermented oyster extract', 'placebo', 'fermented oyster (FO) extract', 'FO supplementation', 'FO extract']","['serum IGFBP-3 level', 'height gain and height', 'GH, IGF, and IGFBP-3', 'Efficacy and safety', 'SDS', 'height gain, height velocity (HV), height standard deviation score (SDS), urine deoxypyridinoline (DPD), growth hormone (GH), insulin-like growth factor (IGF-1), and IGF binding protein 3 (IGFBP-3']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013336', 'cui_str': 'Constitutional short stature'}]","[{'cui': 'C0030104', 'cui_str': 'Oyster'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0057455', 'cui_str': 'Deoxypyridinoline'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]",100.0,0.0720694,"The HV was also significantly higher in the FO group than in the placebo group after the 6th and 24th week ( p  = 0.001,  p  = 0.004).","[{'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Jeong', 'Affiliation': 'Department of Korean Pediatrics, School of Korean Medicine, Gachon University, Seongnam, Republic of Korea.'}, {'ForeName': 'Beom-Chan', 'Initials': 'BC', 'LastName': 'Park', 'Affiliation': 'Department of Korean Pediatrics, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.'}, {'ForeName': 'Hee-Yeon', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Korean Pediatrics, Korean Medicine Hospital, Pusan National University, Yangsan, Republic of Korea.'}, {'ForeName': 'Jun-Yong', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Korean Medicine, and Korean Medicine Hospital of Pusan National University, Yangsan, Republic of Korea.'}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Cheon', 'Affiliation': 'Department of Korean Pediatrics, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.'}, {'ForeName': 'Joung-Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Marine Bioprocess Co. Ltd., Busan, Republic of Korea.'}, {'ForeName': 'Bae-Jin', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Marine Bioprocess Co. Ltd., Busan, Republic of Korea.'}, {'ForeName': 'Kibong', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Korean Pediatrics, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.'}]",Integrative medicine research,['10.1016/j.imr.2020.100691']
1362,33680816,Tolerance and effectiveness of eccentric vs. concentric muscle strengthening in rotator cuff partial tears and moderate to severe shoulder pain. A randomized pilot study.,"Introduction


Rotator cuff tears are the main cause of shoulder pain and disability. First line of treatment is conservative; there is evidence regarding the advantage of using eccentric over concentric exercises in tendinopathies, but there are no evidence-based recommendations on starting strengthening exercise during painful phases nor on the effectiveness and advantages of eccentric vs. concentric exercise in rotator cuff tears.
Objective


To evaluate the tolerance of a resistance strengthening program and to compare eccentric vs. concentric programs.
Design


A pilot, experimental, randomized controlled study.
Setting


Outpatient Rehabilitation Center.
Patients


Twenty-six patients with a diagnosis of partial rotator cuff tear were randomly assigned to: the experimental group (eccentric,  n  = 12) and the control (concentric,  n  = 14).
Intervention


The experimental group performed muscle strengthening with eccentric technique directed to shoulder and scapular girdle muscles, while the control group performed the concentric technique.
Main outcome measures


Visual Analogue Scale (VAS), Constant Scale, Strength, Structure (Ultrasound report).
Results


The tolerance rate was 96% in both groups. Median age (experimental vs. control) was 54.5 vs. 54 years ( p  = 0.69). Results at baseline, and at months 1, 3, and 12 (median) were as follows: for VAS (mm), experimental: 55, 30, 30, and 10,  p  < 0.001 (intra-group); control: 50, 30, 30, and 5,  p  = 0.01; Constant scale (points): experimental 58.5, 88, 93, and 85,  p  < 0.001; control 50.62, 80, and 91.5,  p  = 0.038; normalized strength (Kg); experimental: 0.23, 0.29, 0.73, and 0.72,  p  = 0.001, and control: 0.24, 0.21, 0.54, and 0.66,  p  = 0.01. We found inter-group differences in the Constant scale at 1 and 3 months ( p  < 0.05), and in strength at months 1 and 3 ( p  < 0.05). We observed structural differences in tendon (healing) between groups at 3 and 12 months.
Conclusions


Eccentric and concentric strengthening were well tolerated; both show early improvement in pain, functionality and tendon structure. Eccentric training appears to be more effective than concentric in the early improvement of functionality, strength and tendon healing.",2021,"We found inter-group differences in the Constant scale at 1 and 3 months ( p  < 0.05), and in strength at months 1 and 3 ( p  < 0.05).","['Patients\n\n\nTwenty-six patients with a diagnosis of partial rotator cuff tear', 'rotator cuff partial tears and moderate to severe shoulder pain']","['eccentric vs. concentric muscle strengthening', 'experimental group (eccentric,  n \xa0=\xa012) and the control (concentric,  n \xa0=\xa014', 'eccentric vs. concentric exercise', 'Eccentric training', 'muscle strengthening with eccentric technique directed to shoulder and scapular girdle muscles, while the control group performed the concentric technique']","['tolerance rate', 'Visual Analogue Scale (VAS), Constant Scale, Strength, Structure (Ultrasound report', 'Constant scale', 'tolerated', 'functionality, strength and tendon healing', 'pain, functionality and tendon structure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0443274', 'cui_str': 'Partial tear'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0453903', 'cui_str': 'Girdle'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",26.0,0.0390193,"We found inter-group differences in the Constant scale at 1 and 3 months ( p  < 0.05), and in strength at months 1 and 3 ( p  < 0.05).","[{'ForeName': 'Salvador Israel', 'Initials': 'SI', 'LastName': 'Macías-Hernández', 'Affiliation': 'Department of Orthopedic Rehabilitation, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Jessica Rossela', 'Initials': 'JR', 'LastName': 'García-Morales', 'Affiliation': 'Postgraduate Division, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hernández-Díaz', 'Affiliation': 'Laboratory of Musculoskeletal Ultrasound, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Tapia-Ferrusco', 'Affiliation': 'Physical Therapy Division, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Oscar Benjamín', 'Initials': 'OB', 'LastName': 'Velez-Gutiérrez', 'Affiliation': 'Physical Therapy Division, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Tania Inés', 'Initials': 'TI', 'LastName': 'Nava-Bringas', 'Affiliation': 'Department of Orthopedic Rehabilitation, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2020.07.031']
1363,33680674,Treating Striae Distensae Albae in Asians: Efficacy and Safety of Combined MFU-V and CaHA.,"This study evaluated the efficacy and safety of a single treatment combining microfocused ultrasound with visualization (MFU-V) and subdermal diluted calcium hydroxylapatite with lidocaine (CaHA+) for Striae Distensae Albae (SDA).
Methods


Ten prospectively enrolled women with abdominal, back or thigh SDA were treated with MFU-V at 3 focal depths (4.5, 3.0, and 1.5 mm), followed by 3-6 mL of diluted CaHA+ (1:1 ratio) in the same session. Outcomes were assessed at 1 month, 3 months, and 5 months postprocedure using a 5-point quartile grading scale, an SDA scoring scale, a 10-point visual analog score, and a global aesthetic improvement scale.
Results


All patients exhibited improvement in SDA at 3 months, with further improvement at 6 months. Physicians' assessment with the quartile grading scale showed that 8 patients improved moderately, whereas 2 had good improvement at 6 months. The mean overall SDA score was 11.6 at baseline, 11.1 (not significant) at 1 month, 7.9 ( P  = 0.005) at 3 months, and 6.2 ( P  = 0.005) at 6 months. All patients had improved global aesthetic improvement scale at 3 and 6 months, with 4 patients being much improved, and 3 patients being very much improved at 6 months. At the end of the study, all patients were less bothered with their SDA compared with baseline with a mean reduction of 2.7 in visual analog score, and all patients were satisfied or very satisfied with the treatment. No adverse events occurred.
Conclusion


A single combination treatment of MFU-V and diluted CaHA+ improves SDA without side effects and may be considered for patients seeking to minimize SDA.",2021,"The mean overall SDA score was 11.6 at baseline, 11.1 (not significant) at 1 month, 7.9 ( P  = 0.005) at 3 months, and 6.2 ( P  = 0.005) at 6 months.","['Asians', 'patients seeking to minimize SDA', 'Methods\n\n\nTen prospectively enrolled women with abdominal, back or thigh SDA were treated with MFU-V at 3 focal depths (4.5, 3.0, and 1.5\u2009mm']","['diluted CaHA', 'MFU-V and diluted CaHA', 'single treatment combining microfocused ultrasound with visualization (MFU-V) and subdermal diluted calcium hydroxylapatite with lidocaine (CaHA', 'Combined MFU-V and CaHA']","['SDA', 'mean overall SDA score', 'efficacy and safety', 'global aesthetic improvement scale', '5-point quartile grading scale, an SDA scoring scale, a 10-point visual analog score, and a global aesthetic improvement scale', 'adverse events', 'Efficacy and Safety']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.0261377,"The mean overall SDA score was 11.6 at baseline, 11.1 (not significant) at 1 month, 7.9 ( P  = 0.005) at 3 months, and 6.2 ( P  = 0.005) at 6 months.","[{'ForeName': 'Joyce Teng Ee', 'Initials': 'JTE', 'LastName': 'Lim', 'Affiliation': 'Joyce Lim Skin and Laser Clinic, Singapore.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000003429']
1364,33680601,Dry Mopping vs. Saline Irrigation of Gallbladder Fossa After Bile Spillage During Laparoscopic Cholecystectomy: Randomized Control Trial.,"Introduction The laparoscopic approach, as compared to open cholecystectomy, is still considered the gold standard, despite a higher incidence of micro insults. The most common approach to treat spilled biliary contents and lost stones in laparoscopic cholecystectomy is the retrieval of the stone through an open approach, or laparoscopically, ending with a peritoneal wash and aspiration. Material and methods We conducted a double-blinded randomized controlled trial. In the study group, patients with bile spillage during cholecystectomy underwent suction of all spilled bile and evacuation of all visible stones followed by dry mopping of the gallbladder fossa with gauze swab through an epigastric port. In the control group, after suction of all bile and visible stones, the gallbladder fossa was washed with 250 ml of saline, and fluid was aspirated through the epigastric port. Results Sixty patients were included (30 patients in each group), 71.6% were female and the rest were male. There was a statistically significant difference in pain scores between the two groups (p=0.001). The dry mopping group had lower pain scores as compared to the other group postoperatively. The incidence of the intraabdominal collection in both groups are statistically insignificant, however, port site infection and intraabdominal collection are higher in the control group (irrigation group). Conclusion Although there is not much literature on the best approach to biliary spillage in laparoscopic cholecystectomy. We believe that dry mopping had better postoperative patient outcome as compared to the saline wash.",2021,"The incidence of the intraabdominal collection in both groups are statistically insignificant, however, port site infection and intraabdominal collection are higher in the control group (irrigation group).","['patients with bile spillage during', 'Results Sixty patients were included (30 patients in each group), 71.6% were female\xa0and the rest were male']","['cholecystectomy underwent suction of all spilled bile and evacuation of all visible stones followed by dry mopping of the gallbladder fossa with gauze swab through an epigastric port', 'Dry Mopping vs. Saline Irrigation of Gallbladder Fossa']","['incidence of the intraabdominal collection', 'lower pain scores', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333253', 'cui_str': 'Extravasation of bile'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C3813607', 'cui_str': 'Infant gastrointestinal regurgitation'}, {'cui': 'C0005388', 'cui_str': 'Bile'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0227511', 'cui_str': 'Structure of gallbladder fossa of liver'}, {'cui': 'C0461527', 'cui_str': 'Gauze swab'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0066785', 'cui_str': 'MOP protocol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0230168', 'cui_str': 'Abdominopelvic cavity structure'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",60.0,0.173264,"The incidence of the intraabdominal collection in both groups are statistically insignificant, however, port site infection and intraabdominal collection are higher in the control group (irrigation group).","[{'ForeName': 'Dujanah S', 'Initials': 'DS', 'LastName': 'Bhatti', 'Affiliation': 'Plastic and Reconstructive Surgery, Aberdeen Royal Infirmary, Aberdeen, GBR.'}, {'ForeName': 'Raheel', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'Surgery, Holy Family Hospital, Rawalpindi, PAK.'}]",Cureus,['10.7759/cureus.13059']
1365,33680590,Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New-Onset Type 2 Diabetes Mellitus.,"Objectives We intend to investigate the feasibility of using repaglinide as initial therapy in patients with newly diagnosed type 2 diabetes mellitus naive to the oral anti-hyperglycemic agents by validating the effects of repaglinide on glycemic control (HbA1c) in comparison with metformin monotherapy. Methodology This parallel-controlled, randomized study was carried at the outpatient department of a tertiary care hospital. Two-hundred patients of both genders with newly diagnosed type 2 diabetes mellitus were included. After taking relevant history and physical examination, we drew venous blood samples of each patient and sent them to the institutional laboratory for analysis of fasting blood sugar (FBS) levels, HbA1c, and lipid profile. We divided the patients into two subgroups based on the lottery method. Group A was prescribed metformin, and group B was prescribed repaglinide, while the dosages were adjusted according to the blood sugar levels. All data were analyzed using SPSS Software 25.0 (SPSS Inc., Chicago, USA). We reported the data as means along with the standard error. Results All patients completed the study. There was a decline in fasting blood glucose levels after three months of therapy, both in the metformin (135 mg/dl ± 6 mg/dl versus 115 mg/dl ± 7 mg/dl, p < 0.01) and repaglinide groups (145 ± 6 mg/dl versus 122 ± 6 mg/dl, p < 0.01). Similarly, significant reductions in HbA1c were seen in both metformin (7.12 ± 0.15% versus 6.67 ± 0.06%, p < 0.01) and repaglinide treatment groups (7.83 ± 0.67% versus 6.81 ± 0.07%, p < 0.01). After three months of treatment, body mass index (BMI) was significantly decreased in the metformin group (26.87±1.1 kg/m 2  versus 25.11 ± 0.44 kg/m 2 , p < 0.05). However, the patients in repaglinide group demonstrated a very slight decrease in BMI (27.11 ± 1.6 kg/m 2  versus 26.47 ± 0.40 kg/m 2 ). On follow-up, we found a significant decrease in triglyceride levels in both groups (p < 0.01 and p < 0.05. respectively). We also found that only the patients in metformin group showed some improvements in total cholesterol and low-density lipoprotein (LDL) levels (p < 0.05). Conclusion Our study concluded that both metformin and repaglinide have similar anti-hyperglycemic effects. Repaglinide can be prescribed as an alternative drug to metformin in patients with new-onset diabetes mellitus.",2021,"On follow-up, we found a significant decrease in triglyceride levels in both groups (p < 0.01 and p < 0.05. respectively).","['patients with newly diagnosed type 2 diabetes mellitus naive to the oral anti-hyperglycemic agents', 'Two-hundred patients of both genders with newly diagnosed type 2 diabetes mellitus were included', 'outpatient department of a tertiary care hospital', 'patients with new-onset diabetes mellitus', 'New-Onset Type 2 Diabetes Mellitus']","['repaglinide', 'Repaglinide', 'Metformin and Repaglinide Monotherapy', 'metformin monotherapy', 'metformin']","['body mass index (BMI', 'fasting blood sugar (FBS) levels, HbA1c, and lipid profile', 'HbA1c', 'fasting blood glucose levels', 'BMI', 'total cholesterol and low-density lipoprotein (LDL) levels', 'triglyceride levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C2356045', 'cui_str': 'metformin and repaglinide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",200.0,0.0180001,"On follow-up, we found a significant decrease in triglyceride levels in both groups (p < 0.01 and p < 0.05. respectively).","[{'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Younas', 'Affiliation': 'Medicine, Russells Hall Hospital, Dudley, GBR.'}, {'ForeName': 'Junaid', 'Initials': 'J', 'LastName': 'Riaz', 'Affiliation': 'Medicine, Nishtar Medical University, Multan, PAK.'}, {'ForeName': 'Tamoor', 'Initials': 'T', 'LastName': 'Chughtai', 'Affiliation': 'Medicine, Nishtar Medical University, Multan, PAK.'}, {'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Maqsood', 'Affiliation': 'Cardiology, Nishtar Medical University, Multan, PAK.'}, {'ForeName': 'Shifa', 'Initials': 'S', 'LastName': 'Younus', 'Affiliation': 'Medicine, Nishtar Medical University, Multan, PAK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Qasim', 'Affiliation': 'Medicine, Nishtar Medical University, Multan, PAK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Saim', 'Affiliation': 'Cardiology, Nishtar Medical University, Multan, PAK.'}, {'ForeName': 'Shaheryar', 'Initials': 'S', 'LastName': 'Qazi', 'Affiliation': 'Medicine, Nishtar Medical University, Multan, PAK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Khaliq', 'Affiliation': 'Medicine, Nishtar Medical University, Multan, PAK.'}, {'ForeName': 'Mahnoor', 'Initials': 'M', 'LastName': 'Fatima', 'Affiliation': 'Radiology, Nishtar Medical University, Multan, PAK.'}]",Cureus,['10.7759/cureus.13045']
1366,33680513,"Reliability of Lower Extremity Muscle Power and Functional Performance in Healthy, Older Women.","Evaluation of the long-term reliability of muscle power and functional performance tests in older, healthy adults is warranted since determining whether performance is consistent over longer durations is more relevant for intervention studies.  Objective . To assess the long-term test-retest reliability of measures of muscle power and lower body functional performance in healthy, nonexercising, older women.  Methods . Data were derived from a nonexercising control group ( n  = 18; age = 73.3 (3.4) years; height = 159.6 (7.7) cm; body mass = 69.5 (12.7) kg; BMI = 27.3 (4.8)) of a randomized controlled trial of muscle power training in older women. Participants underwent lower extremity muscle power (Biodex) and functional testing (Short Physical Performance Battery, gait speed, 30-second chair stands, stair climbing, and 400-meter walk) at week 0 (baseline), 9, and 15.  Results . For the upper leg, intraclass correlation coefficients (ICCs) were very high for knee extension power (0.90-0.97) and high to very high for knee flexion power (0.83-0.96). For lower-leg power, ICCs were high to very high for plantar flexion and dorsiflexion (0.83-0.96). ICCs for functional performance were moderate to very high (0.64-0.93). Coefficient of variation of the typical error (CV TE ) was <10.5% for knee extension/flexion power, 9.9-20.0% for plantar flexion/dorsiflexion power, and 1.9-14.9% for functional performance. Knee extension power and stair climb power demonstrated the highest reliability for muscle power and function, respectively. Mean values did not change over time, with the exception of the chair stands ( p  < 0.05); however, these changes were not considered clinically meaningful.  Conclusions . The current study provides evidence supporting the long-term reliability of performance assessments of muscle power and lower body functional capacity over a period of up to 15 weeks in healthy, older women.",2021,"Mean values did not change over time, with the exception of the chair stands ( p  < 0.05); however, these changes were not considered clinically meaningful.  ","['older, healthy adults', 'Healthy, Older Women', 'older women', 'healthy, older women', 'healthy, nonexercising, older women', 'Data were derived from a nonexercising control group ( n \u2009=\u200918; age\u2009=\u200973.3 (3.4) years; height\u2009=\u2009159.6 (7.7) cm; body mass\u2009=\u200969.5 (12.7) kg; BMI\u2009=\u200927.3 (4.8']",['muscle power training'],"['extremity muscle power (Biodex) and functional testing (Short Physical Performance Battery, gait speed', 'knee flexion power', 'Mean values', 'Coefficient of variation of the typical error (CV TE ']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517765', 'cui_str': '4.8'}]","[{'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.0417673,"Mean values did not change over time, with the exception of the chair stands ( p  < 0.05); however, these changes were not considered clinically meaningful.  ","[{'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Katsoulis', 'Affiliation': 'University of Toronto, Faculty of Kinesiology and Physical Education, 55 Harbord Street, Toronto, Ontario M5S 2W6, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'University of Toronto, Department of Physical Therapy, Toronto, Canada.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Amara', 'Affiliation': 'University of Toronto, Faculty of Kinesiology and Physical Education, 55 Harbord Street, Toronto, Ontario M5S 2W6, Canada.'}]",Journal of aging research,['10.1155/2021/8817231']
1367,33680487,"Effects on body weight, eating behavior, and quality of life of a low-energy diet combined with behavioral group treatment of persons with class II or III obesity: A 2-year pilot study.","Objective


Obesity is associated with reduced health-related quality of life (HRQoL). Outcomes of nonsurgical weight loss treatment on HRQoL are inconsistent and it is unclear how much weight reduction, or what type of treatment, is required for significant improvements. This study aimed to evaluate the effects of a lifestyle intervention program on weight, eating behaviors, and HRQoL, and to describe participants' experiences of treatment.
Methods


This 2-year intervention trial in persons with class II or III obesity comprised a 3-month liquid low-energy diet (880 kcal/d) followed by a 3-month reintroduction to regular foods, combined with behavioral group treatment.
Results


Fifty-five participants (73% women) were included, mean (SD) age 43.2 (12.4) years, and mean body mass index 42.0 (6.0) kg/m 2 . Mean weight loss at 6, 12, and 24 months was 18.9%, 13.7%, and 7.2%, respectively. Short- and long-term effects on eating behavior were favorable. Twelve of 14 HRQoL domains were improved at 6 months, compared to eight domains at 12 months. After 24 months, 2 of 14 domains, physical and psychosocial functioning, were improved. The treatment program was well accepted by the participants.
Conclusions


Substantial weight loss after 6 months was associated with extensive improvements in HRQoL, comprising the physical, psychosocial, and mental domains. Significant weight regain was observed between 6 and 24 months follow-up. Modest weight loss after 24 months was associated with moderate improvement in physical functioning and large improvement in psychosocial functioning. The effect on psychosocial functioning is most likely related to both weight loss and behavioral treatment.",2021,"Twelve of 14 HRQoL domains were improved at 6 months, compared to eight domains at 12 months.","['persons with class II or III obesity comprised a 3-month', 'persons with class II or III obesity', 'Fifty-five participants (73% women) were included, mean (SD) age 43.2 (12.4) years, and mean body mass index 42.0 (6.0) kg/m 2 ']","['lifestyle intervention program', 'liquid low-energy diet (880 kcal/d) followed by a 3-month reintroduction to regular foods, combined with behavioral group treatment']","['reduced health-related quality of life (HRQoL', 'weight, eating behaviors, and HRQoL', 'weight loss', 'body weight, eating behavior, and quality of life', 'Modest weight loss', 'eating behavior', 'Mean weight loss', 'physical and psychosocial functioning', 'physical functioning', 'psychosocial functioning', 'Significant weight regain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.0227818,"Twelve of 14 HRQoL domains were improved at 6 months, compared to eight domains at 12 months.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'University Health Care Research Center Faculty of Medicine and Health Örebro University Örebro Sweden.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Galavazi', 'Affiliation': 'School of Medical Sciences Faculty of Medicine and Health Örebro University Örebro Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Jansson', 'Affiliation': 'University Health Care Research Center Faculty of Medicine and Health Örebro University Örebro Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Jendle', 'Affiliation': 'School of Medical Sciences Faculty of Medicine and Health Örebro University Örebro Sweden.'}]",Obesity science & practice,['10.1002/osp4.464']
1368,33680404,Effect of Cow's-milk-free diet on chronic constipation in children; A randomized clinical trial.,"Background


Cow's milk intolerance can lead to chronic constipation in children. The present study seeks to determine the effect of cow's milk-free diet (CMFD) on chronic constipation in children who are not responding to laxatives.
Methods


Seventy children suffering from chronic constipation (described as the Rome III criteria) were enrolled in an open-label randomized clinical study. Each group included 35 children aged 4-14 years treated with laxatives for at least three months with no improvements. The intervention group received CMFD plus calcium supplements for four weeks and the control group did not have any restrictions in consuming cow's milk and dairy products. Also, both groups received polyethylene glycol (PEG; 1 gr/kg/day) and high-fiber foods (at least 10 gr/day) for four weeks. Responsiveness was described as a reduction in symptoms and signs according to the Rome III criteria after four weeks.
Results


After four weeks, 25 (71.4%) children in the CMFD group responded to the treatment compared to four (11.4%) children in the control group (P<0.001). Significant differences were found between the CMFD and control groups in terms of the seven Rome III criteria post-intervention; history of large stools (25% vs. 53.6%), large fecal mass in the rectum during examination (17.1% vs. 50%), history of painful defecation (18.2% vs. 55.6%), history of retentive posturing (10% vs. 46%), ≥1 episode/week of incontinence (25 % vs. 50%, P=0.001), ≤ 2 defecations/week (17.4% vs. 52.3%) and history of thick stool with toilet obstruction (22.2% vs. 52.3%).
Conclusion


This study showed that children with functional constipation with no response to laxatives could benefit from a cow's milk-free and dairy-free diet.",2021,"Significant differences were found between the CMFD and control groups in terms of the seven Rome III criteria post-intervention; history of large stools (25% vs. 53.6%), large fecal mass in the rectum during examination (17.1% vs. 50%), history of painful defecation (18.2% vs. 55.6%), history of retentive posturing (10% vs. 46%), ≥1 episode/week of incontinence (25 % vs. 50%, P=0.001), ≤ 2 defecations/week (17.4% vs. 52.3%) and history of thick stool with toilet obstruction (22.2% vs. 52.3%).
","['children', 'Seventy children suffering from chronic constipation (described as the Rome III criteria', 'chronic constipation in children', 'children with functional constipation', '35 children aged 4-14 years treated with laxatives for at least three months with no improvements', 'chronic constipation in children who are not responding to laxatives']","['polyethylene glycol (PEG', 'CMFD plus calcium supplements', ""control group did not have any restrictions in consuming cow's milk and dairy products"", ""cow's milk-free diet (CMFD"", ""Cow's-milk-free diet""]","['large stools', 'history of retentive posturing', 'large fecal mass', 'history of thick stool with toilet obstruction', 'history of painful defecation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0452380', 'cui_str': ""Cow's milk-free diet""}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}]","[{'cui': 'C0232721', 'cui_str': 'Bulky stool'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0237326', 'cui_str': 'Pain associated with defecation'}]",35.0,0.0577545,"Significant differences were found between the CMFD and control groups in terms of the seven Rome III criteria post-intervention; history of large stools (25% vs. 53.6%), large fecal mass in the rectum during examination (17.1% vs. 50%), history of painful defecation (18.2% vs. 55.6%), history of retentive posturing (10% vs. 46%), ≥1 episode/week of incontinence (25 % vs. 50%, P=0.001), ≤ 2 defecations/week (17.4% vs. 52.3%) and history of thick stool with toilet obstruction (22.2% vs. 52.3%).
","[{'ForeName': 'Atena', 'Initials': 'A', 'LastName': 'Mohammadi Bourkheili', 'Affiliation': 'Student Research Committee, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Mehrabani', 'Affiliation': 'Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Esmaeili Dooki', 'Affiliation': 'Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Haji Ahmadi', 'Affiliation': 'Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Moslemi', 'Affiliation': 'Health Reproductive Research Center, Sari Branch, Islamic Azad University, Sari, Iran.'}]",Caspian journal of internal medicine,['10.22088/cjim.12.1.91']
1369,33680395,"Analgesic effect of duloxetine compared to nortryptiline in patients with painful neuropathy: A randomized, double-blind, placebo-controlled trial.","Background


Diabetic neuropathic pain (DNP) is a common complication of diabetes and has a profound effect on patients' quality of life. Therefore. The purpose of the present study was to compare the analgesic effects of duloxetine and nortryptiline in the management of patients with diabetic neuropathy.
Methods


This was a randomized, double-blind, parallel-group, placebo-controlled trial in subjects with a proven diagnosis of DM and suffered from neuropathic pain .  Patients were recruited in this study from 20 February 2016 (first patient, first visit) to 22 June 2017 (last patient, last visit), including 5 weeks follow-up. A diagnosis of DNP was based on history, clinical examination, Nerve conduction velocity and Diabetic neuropathy symptom score (more than one point).
Results


Both drugs reduced pain when compared with placebo. A significant VAS reduction from 6.4 at baseline to 3.75 at endpoint was observed in the duloxetine group. However, there was no significant difference in the efficacy between nortriptyline and duloxetine based on patient's visual analogue scale (VAS) (p>0.05). No clinically significant changes or serious adverse events were found among treatment groups including changes in vital signs, laboratory assessments, physical examination or electrocardiograms. The decrease in the mean pain intensity was significantly greater in the duloxetine and nortriptyline group compared to the placebo group both in the primary analysis and in the by-visit analysis (p<0.003).
Conclusion


The present study demonstrates the safety and effectiveness of both duloxetine and nortriptyline in the management of DNP.",2021,"The decrease in the mean pain intensity was significantly greater in the duloxetine and nortriptyline group compared to the placebo group both in the primary analysis and in the by-visit analysis (p<0.003).
","['subjects with a proven diagnosis of DM and suffered from neuropathic pain ', 'Patients were recruited in this study from 20 February 2016 (first patient, first visit) to 22 June 2017 (last patient, last visit), including 5 weeks follow-up', 'patients with painful neuropathy', 'patients with diabetic neuropathy']","['duloxetine', 'placebo', 'duloxetine and nortriptyline', 'duloxetine and nortryptiline', 'nortriptyline']","[""patient's visual analogue scale (VAS"", 'pain', 'serious adverse events', 'safety and effectiveness', 'mean pain intensity', 'vital signs, laboratory assessments, physical examination or electrocardiograms', 'VAS reduction', 'history, clinical examination, Nerve conduction velocity and Diabetic neuropathy symptom score', 'Analgesic effect', 'analgesic effects']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1850383', 'cui_str': 'Neuropathy, Painful'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0429381', 'cui_str': 'Nerve conduction velocity'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",,0.45154,"The decrease in the mean pain intensity was significantly greater in the duloxetine and nortriptyline group compared to the placebo group both in the primary analysis and in the by-visit analysis (p<0.003).
","[{'ForeName': 'Mohammadali', 'Initials': 'M', 'LastName': 'Mohammadali Bayani', 'Affiliation': 'Department of Internal Medicine, Babol University of Medical sciences, Babol, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Moazammi', 'Affiliation': 'Babol Universtiy of Medical sciences, Babol, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Fadaee-Jouybari', 'Affiliation': 'Babol Universtiy of Medical sciences, Babol, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Babaei', 'Affiliation': 'Department of Internal Medicine, Babol University of Medical sciences, Babol, Iran.'}, {'ForeName': 'Alijan', 'Initials': 'A', 'LastName': 'Ahmadi-Ahangar', 'Affiliation': 'Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Saadat', 'Affiliation': 'Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}]",Caspian journal of internal medicine,['10.22088/cjim.12.1.29']
1370,33680383,Efficacy of sucralfate ointment in the prevention of acute proctitis in cancer patients: A randomized controlled clinical trial.,"Background


Acute radiation proctitis (ARP) is a usual adverse effect in patients undergoing pelvic radiotherapy. The symptoms include diarrhea, rectal blood or mucus discharge, fecal urgency and tenesmus with pain. Sucralfate, an aluminum-based salt of sucrose octasulfate, is a cytoprotective agent that forms a coating barrier at injured sites by adhering to mucoproteins. It has been used in topical management of a wide variety of local lesion. This study was designed to evaluate the preventive effect of rectal sucralfate on acute radiotherapy induced proctitis.
Methods


Seven percent sucralfate ointment was prepared for topical use. Drug quantification, chemical stability and microbial limit tests were performed carefully. In this randomized double blind placebo controlled trial, fifty-seven patients with pelvic malignancies undergoing radiotherapy were allocated to receive either 1 g of sucralfate or 1 g of placebo, given as a twice daily ointment, one day before and during radiotherapy for six weeks. The eligible patients were evaluated based on RTOG acute toxicity criteria and the following ARP symptoms weekly: rectal hemorrhage, diarrhea, rectal pain, and fecal urgency. The influence of symptoms on lifestyle was also recorded weekly.
Results


Acute proctitis was significantly less prevalent in patients in the sucralfate group. The incidence of rectal bleeding (P=0.003), diarrhea (P=0.002), rectal pain (P=<0.001) and fecal urgency (P=0.002) was significantly less common in the sucralfate group. No statistical significant difference was observed for radiotherapy induced cystitis in the placebo and sucralfate groups (P=0.27).
Conclusion


This study suggests that sucralfate7% ointment reduces the incidence of symptoms associated with acute radiation proctitis.",2020,"The incidence of rectal bleeding (P=0.003), diarrhea (P=0.002), rectal pain (P=<0.001) and fecal urgency (P=0.002) was significantly less common in the sucralfate group.","['patients undergoing pelvic radiotherapy', 'cancer patients', 'fifty-seven patients with pelvic malignancies undergoing']","['sucralfate', 'placebo', '\n\n\nAcute radiation proctitis (ARP', 'Sucralfate', 'radiotherapy', 'sucralfate ointment', 'sucralfate or 1 g of placebo', 'rectal sucralfate']","['symptoms include diarrhea, rectal blood or mucus discharge, fecal urgency and tenesmus with pain', 'rectal pain', 'radiotherapy induced cystitis', 'fecal urgency', 'Acute proctitis', 'incidence of rectal bleeding', 'RTOG acute toxicity criteria and the following ARP symptoms weekly: rectal hemorrhage, diarrhea, rectal pain, and fecal urgency', 'diarrhea', 'acute proctitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0038633', 'cui_str': 'Sucralfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0400828', 'cui_str': 'Acute radiation proctitis'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0333273', 'cui_str': 'Mucus discharge'}, {'cui': 'C0426636', 'cui_str': 'Urgent desire for stool'}, {'cui': 'C0232726', 'cui_str': 'Rectal tenesmus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034886', 'cui_str': 'Rectal pain'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0860175', 'cui_str': 'Acute proctitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0400828', 'cui_str': 'Acute radiation proctitis'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage'}]",57.0,0.318425,"The incidence of rectal bleeding (P=0.003), diarrhea (P=0.002), rectal pain (P=<0.001) and fecal urgency (P=0.002) was significantly less common in the sucralfate group.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Saei', 'Affiliation': 'Student Research Committee, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Sahebnasagh', 'Affiliation': 'Clinical Research Center, Department of Internal Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Emam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Akbari', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alipour', 'Affiliation': 'Department of Epidemiology, Faculty of Medicine, Community Medicine Department, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Lashkardoost', 'Affiliation': 'School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Yaghobi Joybari', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Nejad Dadgar', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ala', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Gastrointestinal Cancer Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Caspian journal of internal medicine,['10.22088/cjim.11.4.410']
1371,33680345,Psychodynamic and systemic group treatment for women with a history of childhood sexual abuse: five-year follow-up of a randomized controlled trial.,"Background : Childhood sexual abuse (CSA) is a significant trauma that may have lifelong impact. Due to the long-term negative personal and societal consequences of CSA, it is crucial to find treatments with enduring outcomes.  Objective : The aim of this study was to determine the relative long-term efficacy of psychodynamic and systemic group therapy for adult women exposed to CSA.  Method : A prospective randomized controlled trial was conducted with outcomes assessed at pre- and post-treatment, and 1 and 5 years post-treatment. All analyses were intention-to-treat. One hundred and six women with sequelae from childhood sexual abuse were treated with psychodynamic or systemic group therapy. Primary outcome was Global Severity Index (GSI) of SCL-90-R. Secondary outcomes included symptoms of PTSD and depression and psycho-social functioning.  Results : Treatment was completed by 81% of participants; 64% completed the 1-year follow-up and 60% completed the 5-year follow-up. Completion rates did not differ between treatments. Significant reduction in symptoms measured on GSI and improvement of psychosocial functioning was found for both interventions at all measurement points after treatment (ES range = 0.68-1.19). However, different trajectories were observed: while outcome at end of treatment was significantly better in the systemic group, no differences in gains were observed at the 1- and 5-year follow-ups when controlling for baseline differences.  Conclusions : The findings add to the evidence base for psychodynamic and systemic group therapy, but the result also underscores the importance of taking post-treatment trajectories into account in evidence-based research, in the continued efforts to improve treatment for this population.",2021,Significant reduction in symptoms measured on GSI and improvement of psychosocial functioning was found for both interventions at all measurement points after treatment (ES range = 0.68-1.19).,"['adult women exposed to CSA', 'women with a history of childhood sexual abuse', 'One hundred and six women with sequelae from childhood sexual abuse']","['psychodynamic or systemic group therapy', 'Psychodynamic and systemic group treatment', 'psychodynamic and systemic group therapy']","['psychosocial functioning', 'Completion rates', 'Global Severity Index (GSI) of SCL-90-R. Secondary outcomes included symptoms of PTSD and depression and psycho-social functioning']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C4280883', 'cui_str': 'History of child sexual abuse'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0243088', 'cui_str': 'sequels'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",106.0,0.148291,Significant reduction in symptoms measured on GSI and improvement of psychosocial functioning was found for both interventions at all measurement points after treatment (ES range = 0.68-1.19).,"[{'ForeName': 'Henriette K', 'Initials': 'HK', 'LastName': 'Elkjær', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Denmark.'}, {'ForeName': 'Erik L', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ellids', 'Initials': 'E', 'LastName': 'Kristensen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Poulsen', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}]",European journal of psychotraumatology,['10.1080/20008198.2020.1855887']
1372,33680312,Blindfolding Improves Communication in Inexperienced Residents Undergoing ACLS Training.,"Background


Closed-loop communication (CLC) is associated with decreased medical errors and improved time-to-task completion during resuscitations. Depriving team leaders of sight during training may accelerate the acquisition of favorable communication skills; however, its effect on the frequency of CLC is unclear, especially with trainees.
Objective


We assessed the effect of depriving interns of sight during advanced cardiovascular life support (ACLS) on verbal communication patterns and resuscitation confidence.
Methods


All interns undergoing ACLS training in June 2019 at a single center were eligible. Interns were randomized to blindfolded training (BT) or standard training (ST). BT team leaders were blindfolded during practice sessions and permitted to use sight during testing. Testing scenarios were video- and audio-recorded. Recordings were assessed for teams' performance and communication patterns. Participants were surveyed for confidence with resuscitation skills before and after ACLS training.
Results


All 87 eligible interns participated in the study (100% participation). Eighty-five of 87 (98%) interns were included for analysis; 46 were randomized to BT and 39 to ST. Interns in the BT group were significantly more likely to exhibit CLC (mean: BT 20.3, ST 16.6;  P  = .003), directed communication (mean: BT 4.3, ST 1.5;  P  < .001), and follower-initiated communication (mean: BT 12.8, ST 10.2;  P  = .028). There was no significant difference in clinical performance measures or self-reported confidence with resuscitation between BT and ST groups.
Conclusions


Blindfolding trainees results in greater instances of CLC, directed communication, and follower-initiated communication during ACLS training.",2021,"Interns in the BT group were significantly more likely to exhibit CLC (mean: BT 20.3, ST 16.6;  P  = .003), directed communication (mean:","['Participants were surveyed for confidence with resuscitation skills before and after ACLS training', 'All 87 eligible interns participated in the study (100% participation', 'Inexperienced Residents Undergoing ACLS Training', 'Eighty-five of 87 (98%) interns were included for analysis; 46 were randomized to BT and 39 to ST', 'Methods\n\n\nAll interns undergoing ACLS training in June 2019 at a single center were eligible']","['\n\n\nClosed-loop communication (CLC', 'depriving interns of sight during advanced cardiovascular life support (ACLS', 'blindfolded training (BT) or standard training (ST']",['clinical performance measures or self-reported confidence with resuscitation'],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C3661445', 'cui_str': 'Closed-Loop Communication'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3266594', 'cui_str': 'Clinical performance measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",,0.0462697,"Interns in the BT group were significantly more likely to exhibit CLC (mean: BT 20.3, ST 16.6;  P  = .003), directed communication (mean:","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Scicchitano', 'Affiliation': ''}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Stark', 'Affiliation': ''}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Koetter', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Michalak', 'Affiliation': ''}, {'ForeName': 'Adrian D', 'Initials': 'AD', 'LastName': 'Zurca', 'Affiliation': ''}]",Journal of graduate medical education,['10.4300/JGME-D-20-00620.1']
1373,33680304,Handheld Ultrasound Device Usage and Image Acquisition Ability Among Internal Medicine Trainees: A Randomized Trial.,"Background


There is insufficient knowledge about how personal access to handheld ultrasound devices (HUDs) improves trainee learning with point-of-care ultrasound (POCUS).
Objective


To assess whether HUDs, alongside a yearlong lecture series, improved trainee POCUS usage and ability to acquire images.
Methods


Internal medicine intern physicians (n = 47) at a single institution from 2017 to 2018 were randomized 1:1 to receive personal HUDs (n = 24) for patient care/self-directed learning vs no-HUDs (n = 23). All interns received a repeated lecture series on cardiac, thoracic, and abdominal POCUS. Main outcome measures included self-reported HUD usage rates and post-intervention assessment scores using the Rapid Assessment of Competency in Echocardiography (RACE) scale between HUD and no-HUD groups.
Results


HUD interns reported performing POCUS assessments on patients a mean 6.8 (SD 2.2) times per week vs 6.4 (SD 2.9) times per week in non-HUD arm ( P  = .66). There was no relationship between the number of self-reported examinations per week and a trainee's post-intervention RACE score (rho = 0.022,  P  = .95). HUD interns did not have significantly higher post-intervention RACE scores (median HUD score 17.0 vs no-HUD score 17.8;  P  = .72). Trainee confidence with cardiac POCUS did not correlate with RACE scores.
Conclusions


Personal HUDs without direct supervision did not increase the amount of POCUS usage or improve interns' acquisition abilities. Interns who reported performing more examinations per week did not have higher RACE scores. Improved HUD access and lectures without additional feedback may not improve POCUS mastery.",2021,"There was no relationship between the number of self-reported examinations per week and a trainee's post-intervention RACE score (rho = 0.022,  P  = .95).",['Methods\n\n\nInternal medicine intern physicians (n = 47) at a single institution from 2017 to 2018'],"['patient care/self-directed learning vs no-HUDs', 'personal HUDs']","[""amount of POCUS usage or improve interns' acquisition abilities"", 'self-reported HUD usage rates and post-intervention assessment scores using the Rapid Assessment of Competency in Echocardiography (RACE) scale between HUD and no-HUD groups', 'post-intervention RACE scores', 'Handheld Ultrasound Device Usage and Image Acquisition Ability', 'RACE scores', 'POCUS mastery']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",,0.0831194,"There was no relationship between the number of self-reported examinations per week and a trainee's post-intervention RACE score (rho = 0.022,  P  = .95).","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Buesing', 'Affiliation': ''}, {'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Weng', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kugler', 'Affiliation': ''}, {'ForeName': 'Libo', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Blaha', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hom', 'Affiliation': ''}, {'ForeName': 'Neera', 'Initials': 'N', 'LastName': 'Ahuja', 'Affiliation': ''}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': ''}]",Journal of graduate medical education,['10.4300/JGME-D-20-00355.1']
1374,33680260,The Association Between Frailty and Parkinson's Disease in the ReSPOnD Trial.,"Background


Frailty and Parkinson's disease (PD) are both highly prevalent in older people, but few studies have studied frailty in people with Parkinson's. Identifying frailty in this population is vital, to target new interventions to those who would most benefit.
Methods


Data were collected as part of the double-blind randomised controlled rivastigmine to stabilise gait ReSPonD trial in 130 people with Hoehn and Yahr 2-3, idiopathic PD who had fallen in the year prior to enrolment. Individuals were assessed at baseline and followed up at eight months, including determination of frailty status.
Results


120 patients attended for follow-up. At follow-up, the mean (SD) age was 70.2 years (8.0), MDS-UPDRS total score 91.5 (29.1), and MDS-UPDRS motor score (Part III) 42.7 (14.8). Median disease duration was 9.2 years (IQR 4.6 to 13.1), Geriatric Depression Score 4 (IQR 2 to 6). Using the Fried frailty criteria, 31 (26%) were frail and 70 (58%) pre-frail. In univariable analysis, being female, higher depression score, and MDS-UPDRS score were associated with greater frailty. Using ordinal regression, in the multivariable model, being female (odds ratio [OR] 3.10, 95%CI 1.53 to 6.26,  p =.002), higher total MDS-UPDRS score (OR 2.02, 95%CI 1.42 to 2.87,  p <.0001) and higher depression (OR 1.47, 95%CI 1.05 to 2.06,  p =.03) were associated with higher number of frailty markers.
Conclusion


There was a high prevalence (84%) of pre-frail and frail individuals in patients participating in this RCT. Future research should determine the optimum tool to assess frailty in this at-risk population, and delineate the association between Parkinson's, frailty, and health outcomes.",2021,"In univariable analysis, being female, higher depression score, and MDS-UPDRS score were associated with greater frailty.","['130 people with Hoehn and Yahr 2-3, idiopathic PD who had fallen in the year prior to enrolment', 'Using the Fried frailty criteria, 31 (26%) were frail and 70 (58%) pre-frail', '120 patients attended for follow-up']",[],"['MDS-UPDRS motor score', 'Geriatric Depression Score', 'Median disease duration', 'higher depression', 'higher total MDS-UPDRS score', 'depression score, and MDS-UPDRS score', 'MDS-UPDRS total score']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",130.0,0.210444,"In univariable analysis, being female, higher depression score, and MDS-UPDRS score were associated with greater frailty.","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Smith', 'Affiliation': 'Royal United Hospitals Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Daisy M', 'Initials': 'DM', 'LastName': 'Gaunt', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Whone', 'Affiliation': 'Movement Disorders Group, Bristol Brain Centre, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Ben-Shlomo', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Henderson', 'Affiliation': 'Royal United Hospitals Bath NHS Trust, Bath, UK.'}]",Canadian geriatrics journal : CGJ,['10.5770/cgj.24.437']
1375,33680227,Improving the LGBTQ2S+ cultural competency of healthcare trainees: advancing health professional education.,"Background


Lesbian, Gay, Bisexual, Trans, Queer, and Two-spirit (LGBTQ2S+) populations experience worse health outcomes compared to age-matched heterosexual and cisgender peers. Health professionals' deficient knowledge and negative attitudes can contribute to these inequities. Healthcare trainees report insufficient LGBTQS2+ cultural competence training.
Methods


In this prospective, mixed-methods pre-post design, Atlantic Canadian health students were tested on knowledge, attitudes and self-reported behaviours towards LGBTQ2S+ populations in healthcare settings. Assessment included psychometric measurements and clinical cases involving normative and non-normative fictional patients. Participants were randomised to intervention or control groups. The intervention consisted of three training sessions lead by LGBTQ2S+ experts and elders from the community. The control group continued with usual training. Full assessment was repeated after training. We also held focus group discussions with students and faculty.
Results


The intervention group significantly improved attitudes toward and knowledge of LGBTQ2S+ populations and changed relevant aspects of their performance in the simulated clinical situations. Focus groups identified key gaps in current local training.
Conclusions


Integrating specific training related to LGBTQ2S+ health within health professions programs is an important step toward improving these populations' accessibility to a competent, exhaustive and nurturing healthcare. Additional research on innovative means to expand and broaden the scope of our training is warranted.",2021,The intervention group significantly improved attitudes toward and knowledge of LGBTQ2S+ populations and changed relevant aspects of their performance in the simulated clinical situations.,['Atlantic Canadian health students'],['usual training'],['attitudes toward and knowledge of LGBTQ2S+ populations'],"[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.0154647,The intervention group significantly improved attitudes toward and knowledge of LGBTQ2S+ populations and changed relevant aspects of their performance in the simulated clinical situations.,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Gender and Health Promotion Studies Unit, School of Health and Human Performance, Dalhousie University, Nova Scotia, Canada.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Tasa-Vinyals', 'Affiliation': 'Department of Clinical and Health Psychology, Universitat Autònoma de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Gahagan', 'Affiliation': 'Gender and Health Promotion Studies Unit, School of Health and Human Performance, Dalhousie University, Nova Scotia, Canada.'}]",Canadian medical education journal,['10.36834/cmej.67870']
1376,33680207,Developing Children's Socio-Emotional Competencies Through Drama Pedagogy Training: An Experimental Study on Theory of Mind and Collaborative Behavior.,"Drama pedagogy training (DPT) is a drama-based-pedagogy focused on socio-emotional-learning (SEL) development, over academic or artistic. This study aims to see if DPT promotes theory of mind (ToM) and collaborative behavior in 126 French children aged 9-10 years old, randomly assigned to an experimental group (DPT), either a control group for 6 weeks. Post-tests showed large effects of training on ToM, F(1, 124) = 24.36, p < .001, η² =.16, and collaborative behavior, F(1, 124) = 29.8, p < .001, η² = .19. T-test showed significant differences on ToM (t = -4.94, p < .001) and collaborative behavior (t = -5.46, p < .001), higher for DPT. Effects of type of school and grade are discussed. Results confirm the hypotheses.",2020,"T-test showed significant differences on ToM (t = -4.94, p < .001) and collaborative behavior (t = -5.46, p < .001), higher for DPT.","[""Developing Children's Socio-Emotional Competencies Through Drama Pedagogy Training"", '126 French children aged 9-10 years old']","['Drama pedagogy training (DPT', 'experimental group (DPT', 'DPT']",['collaborative behavior'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0013109', 'cui_str': 'Drama'}, {'cui': 'C1510624', 'cui_str': 'Pedagogy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0013109', 'cui_str': 'Drama'}, {'cui': 'C1510624', 'cui_str': 'Pedagogy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",126.0,0.0346341,"T-test showed significant differences on ToM (t = -4.94, p < .001) and collaborative behavior (t = -5.46, p < .001), higher for DPT.","[{'ForeName': 'Macarena-Paz', 'Initials': 'MP', 'LastName': 'Celume', 'Affiliation': ""Laboratoire de Psychologie et d'Ergonomie Appliquées (LaPEA), Université de Paris, Paris, France.""}, {'ForeName': 'Thalia', 'Initials': 'T', 'LastName': 'Goldstein', 'Affiliation': 'Social Skills, Imagination and Theatre Lab, Department of Psychology, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Besançon', 'Affiliation': 'Laboratoire de Psychologie: Cognition, Comportement, Communication (LP3C), Université de Rennes 2, Rennes, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Zenasni', 'Affiliation': ""Laboratoire de Psychologie et d'Ergonomie Appliquées (LaPEA), Université de Paris, Paris, France.""}]",Europe's journal of psychology,['10.5964/ejop.v16i4.2054']
1377,33680199,Expressive Suppression Within Task-Oriented Dyads: The Moderating Role of Power.,"Although research has so far consistently revealed that using suppression to regulate emotions has adverse personal and social effects, it has been argued that suppression may be less detrimental within non-close relationships. In the present work, we examined the effects of experimentally induced suppression on expressive behavior, emotional experience, and social outcomes within task-oriented interactions between individuals randomly assigned to high/low vs. equal power positions. Eighty-eight participants were randomly paired with a partner of the same gender (forty-four dyads). After being randomly assigned to one of four experimental conditions created to manipulate suppression use and power, each dyad was asked to complete two problem-solving tasks. The results showed that the participants who were assigned to the subordinate (low-power) role and who used suppression to regulate their emotions reported more negative emotional experience than did individuals assigned to equal-power roles, as well as more inauthenticity and diminished feelings of rapport compared to subordinates who freely expressed their feelings. Moreover, we found that the use of suppression also influenced participants assigned to the manager (high-power) role, as they exhibited less positive behavior, reported less positive experience and lower feelings of rapport when interacting with a partner asked to suppress. When individuals were assigned to equal power roles, the participants instructed to use suppression reported lower levels of positive emotions than did their partners as well as higher feelings of inauthenticity compared to uninstructed participants. Overall, these findings seem to suggest that suppression may impair task-oriented interactions between high/low power individuals more than interactions between individuals sharing equal power.",2020,"When individuals were assigned to equal power roles, the participants instructed to use suppression reported lower levels of positive emotions than did their partners as well as higher feelings of inauthenticity compared to uninstructed participants.",['Eighty-eight participants were randomly paired with a partner of the same gender (forty-four dyads'],['Expressive Suppression Within Task-Oriented Dyads'],"['negative emotional experience', 'expressive behavior, emotional experience, and social outcomes']","[{'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",88.0,0.0178637,"When individuals were assigned to equal power roles, the participants instructed to use suppression reported lower levels of positive emotions than did their partners as well as higher feelings of inauthenticity compared to uninstructed participants.","[{'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Balzarotti', 'Affiliation': 'Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cesana', 'Affiliation': 'Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Biassoni', 'Affiliation': 'Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Ciceri', 'Affiliation': 'Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy.'}]",Europe's journal of psychology,['10.5964/ejop.v16i4.1947']
1378,33655943,The effects of robot-assisted left-hand training on hemispatial neglect in older patients with chronic stroke: A pilot and randomized controlled trial.,"BACKGROUND


Even though a variety of rehabilitative technique have been implemented to ameliorate neglect symptoms of patients with stoke, the effects of limb activation using a robotic device are still unknown. The purpose of this study was to investigate the effects of the robot-assisted hand training on hemispatial neglect of older patients with chronic stroke.
METHODS


The participants were randomly allocated to the experimental group (EG) receiving robot-assisted left-hand training (n = 12) or the control group (CG) receiving conventional treatments for neglect symptoms (n = 12). All participants received 20 sessions for 4-week. To examine the effects on hemispatial neglect, the line bisection test (LBT), the Albert test, and the Catherine Bergego Scale (CBS) were utilized. The outcome measures were analyzed before and after the 20 training sessions.
RESULTS


After the intervention, improvements in the LBT, the Albert test, and the CBS were found in the EG whereas there were significant improvements in the LBT and the CBS but not the Albert test in the CG. In addition, the EG showed a significantly greater gain in all outcome measures compared to the CG (p < .05).
CONCLUSIONS


These results indicate that robot-assisted hand training was beneficial to improving the hemispatial neglect of elderly person with chronic stroke compared to the conventional treatments. Robot-assisted limb activation might be useful to ameliorate hemispatial neglect of the elderly with chronic stroke.",2021,"In addition, the EG showed a significantly greater gain in all outcome measures compared to the CG (p < .05).
","['elderly with chronic stroke', 'elderly person with chronic stroke', 'older patients with chronic stroke']","['robot-assisted hand training', 'Robot-assisted limb activation', 'experimental group (EG) receiving robot-assisted left-hand training (n\u200a=\u200a12) or the control group (CG) receiving conventional treatments', 'robot-assisted left-hand training']","['LBT and the CBS', 'hemispatial neglect, the line bisection test (LBT), the Albert test, and the Catherine Bergego Scale (CBS', 'CBS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0230371', 'cui_str': 'Structure of left hand'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0184905', 'cui_str': 'Bisection'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0751421', 'cui_str': 'Hemispatial Neglect'}]",,0.0160025,"In addition, the EG showed a significantly greater gain in all outcome measures compared to the CG (p < .05).
","[{'ForeName': 'Jin-Hyuck', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Occupational Therapy, College of Medical Science, Soonchunhyang University, Room 1401, College of Medical Science, 22 Soonchunhyang-ro, Shinchang-myeon, Asan-si, Chungcheongnam-do, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000024781']
1379,33655941,Comparison of the treatment results of knee osteoarthritis using adipose tissue mesenchymal stromal cells derived through enzymatic digestion and mechanically fragmented adipose tissue.,"INTRODUCTION


Knee osteoarthritis is a common condition that affects daily functioning and decreases the quality of life. There are many ways of treatment depending on the stage of the disease. Advanced cases are qualified for arthroplasty, which is an extensive and demanding surgical procedure. Less advanced stages are treated in various ways: from rehabilitation, through oral and intra-articular pharmacotherapy, to surgical treatment (arthroscopy, osteotomy). Because surgical treatment is risky, scientists focus on less invasive therapeutic methods. The most valuable management is based on regeneration. Mesenchymal stromal cells (MSC) derived from the adipose tissue have a great regenerative and anti-inflammatory potential, therefore an attempt is being made to take advantage of them in knee osteoarthritis treatment.The study aims to compare the clinical effects of treatment of knee osteoarthritis using adipose tissue MSC obtained by an enzymatic method with the outcomes of the therapy with the mechanically fragmented adipose tissue.
METHODS


One hundred adults with primary knee osteoarthritis will undergo lipoaspiration under sterile conditions. The collected lipoaspirates will be further processed, depending on the randomly assigned group-enzymatically with the use of collagenase or mechanically using the Lipogems system. The preparations will be administered to the patients' knee joints in the operating room under ultrasound control.The results of treatment will be assessed using Knee Injury and Osteoarthritis Outcome Score, measuring the flexibility of the knee joint, evaluating joint gap in X-ray and the quality of cartilage in magnetic resonance T2-mapping during 1 year after treatment.
DISCUSSION/CONCLUSION


Identification and functional analysis of the regenerative capacity of adipose-derived MSC depending on three variables (body weight, sex, and age) will help to develop a targeted therapy for different groups of patients and will determine the effectiveness of both methods of treatment. An attempt will be made to identify groups of patients with the greatest regenerative potential of the adipose tissue, and thus indicate those with the most probable improvement of the joint condition.
TRIAL REGISTRATION


This study protocol has been approved by the Ethics Committee of Medical University of Warsaw and registered on www.clinicaltrials.gov: NCT04675359 (06 Jan 2021).",2021,"An attempt will be made to identify groups of patients with the greatest regenerative potential of the adipose tissue, and thus indicate those with the most probable improvement of the joint condition.
",['One hundred adults with primary knee osteoarthritis will undergo lipoaspiration under sterile conditions'],"['adipose tissue MSC', 'Mesenchymal stromal cells (MSC', 'adipose tissue mesenchymal stromal cells']","['quality of life', 'flexibility of the knee joint, evaluating joint gap in X-ray and the quality of cartilage in magnetic resonance T2-mapping']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}]",100.0,0.0337216,"An attempt will be made to identify groups of patients with the greatest regenerative potential of the adipose tissue, and thus indicate those with the most probable improvement of the joint condition.
","[{'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Krześniak', 'Affiliation': 'Medical University of Warsaw, Warszawski Uniwersytet Medyczny, Warsaw, Mazovia, Poland.'}, {'ForeName': 'Kuba', 'Initials': 'K', 'LastName': 'Radzimowski', 'Affiliation': ''}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Stolarczyk', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024777']
1380,33655929,Effects of attentional focus on upper extremity motor performance in post stroke patients: A randomized pilot study.,"INTRODUCTION


To facilitate the command to the learner, therapist can use verbal cues for guidance: internal focus (own body) and external focus (consequence of movement in the environment).
OBJECTIVE


To examine the effects of different attentional focus on upper limb motor performance in post-stroke.
METHODS


Randomized controlled trial with 2 groups. Study realized at Integrated Clinic of the Faculty of Health Science at Trairi (Santa Cruz, Rio Grande do Norte, Brazil). Twelve participants allocated into 2 groups. Two motor tasks were used: task 1, reach-point; task 2, reach-grasp-fit, with the paretic extremity, using verbal commands directed by a trained therapist. In the first phase, Group 1 received commands with internal focus, while Group 2 was instructed with commands with external focus. After 1 week, the command type was changed between groups. The variables collected was movement time, velocity and number of peaks velocity.
RESULTS


Both attentional focus promoted significant differences in movement time and velocity, however, only Internal Focus provided significant results in both tasks of the same variables.
DISCUSSION


The benefits of 1 attentional focus on the other are not fully confirmed. However, not receiving any kind of attention guidance compromises motor performance. The results support the hypothesis that the benefits of the External Focus are accentuated when preceded by the Internal Focus.
CLINICAL TRIAL REGISTRATION


Research Ethics Committee of the Faculty of Helth Science at Trairi (Facisa - UFRN)- Number CAAE 2.625.609, approved on April 13, 2018; Brazilian Registry of Clinical Trials - RBR-4995cr approved on July 4, 2019 retrospectively registered (http://www.ensaiosclinicos.gov.br/rg/RBR-4995cr/).",2021,"Both attentional focus promoted significant differences in movement time and velocity, however, only Internal Focus provided significant results in both tasks of the same variables.
",['post stroke patients'],"['Two motor tasks were used: task 1, reach-point; task 2, reach-grasp-fit, with the paretic extremity, using verbal commands directed by a trained therapist', 'attentional focus']","['movement time and velocity', 'movement time, velocity and number of peaks velocity', 'upper limb motor performance', 'upper extremity motor performance']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]",,0.048808,"Both attentional focus promoted significant differences in movement time and velocity, however, only Internal Focus provided significant results in both tasks of the same variables.
","[{'ForeName': 'Camila L A', 'Initials': 'CLA', 'LastName': 'Gomes', 'Affiliation': 'Physiotherapy, MsT, Federal University of Rio Grande do Norte, Faculty of Health Sciences at Trairi, Physiotherapist (PhD), Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Roberta O', 'Initials': 'RO', 'LastName': 'Cacho', 'Affiliation': ''}, {'ForeName': 'Viviane T B', 'Initials': 'VTB', 'LastName': 'Nobrega', 'Affiliation': ''}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galvão', 'Affiliation': ''}, {'ForeName': 'Denise S', 'Initials': 'DS', 'LastName': 'de Araújo', 'Affiliation': ''}, {'ForeName': 'Ana Loyse de S', 'Initials': 'ALS', 'LastName': 'Medeiros', 'Affiliation': ''}, {'ForeName': 'Emanoelle C V', 'Initials': 'ECV', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Rodrigo L', 'Initials': 'RL', 'LastName': 'Barreto', 'Affiliation': ''}, {'ForeName': 'Enio W A', 'Initials': 'EWA', 'LastName': 'Cacho', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024656']
1381,33666553,Transdiagnostic Internet Intervention for Indonesian University Students With Depression and Anxiety: Evaluation of Feasibility and Acceptability.,"BACKGROUND


University students with depression and anxiety do not easily receive or seek treatment; therefore, internet-based interventions have been suggested to be a promising way to improve treatment accessibility and availability. However, it has not been examined whether a guided, culturally adapted, transdiagnostic, internet-based intervention is effective for treating symptoms of depression, anxiety, or both among university students in Indonesia.
OBJECTIVE


This study aims to investigate the feasibility (acceptability and satisfaction, usability, and uptake) of a guided, culturally adapted, transdiagnostic, internet-based intervention among university students with symptoms of depression, anxiety, or both in Indonesia.
METHODS


Students from Universitas Gadjah Mada, Yogyakarta, Indonesia, were screened for symptoms of depression, anxiety, or both, and filled online informed consent, demographic questionnaires, and a quality of life measure at pretreatment assessment (T0). Subsequently, the participants started the intervention. Seven weeks after T0, the primary outcomes of this feasibility study were analyzed at posttreatment assessment (T1) using the 8-item Client Satisfaction Questionnaire (CSQ-8) and the System Usability Scale (SUS). Mean and SDs for the CSQ-8 and SUS were calculated to examine feasibility. Within-group secondary outcomes (depression, anxiety, and quality of life) were inspected for outliers and normal distribution. Paired-sample t tests were used to investigate differences between time points of secondary outcomes. A mixed-method approach of quantitative and qualitative analyses was adopted. Both the primary and secondary outcomes were additionally explored with an individual semistructured interview and synthesized descriptively.
RESULTS


A total of 50 participants completed the intervention. We found a moderate to high level of satisfaction and acceptability, a slightly below-average level of desirable usability (≥70), and an adherence rate of 52% which was higher than expected given the novelty of the intervention. Results for the secondary outcomes indicated a decrease in depression and anxiety. For depression, the overall mean difference between the 2 time points for depression was 3.92 (95% CI 2.75-5.1; Hedges g 1.15; P<.001). For anxiety, the overall mean difference between the 2 time points was 3.34 (95% CI 2.06-4.61; Hedges g 1.02; P<.001). Further, a moderate effect in improving quality of life was found (g=0.50). Overall, participants were positive about the online intervention and ECoaches (online guidance), and they found the intervention to be culturally appropriate.
CONCLUSIONS


A culturally adapted, transdiagnostic, internet-based intervention appears to be acceptable and feasible for reducing symptoms of depression, anxiety, or both, and increasing quality of life in university students in Indonesia. Future studies should include a randomized controlled trial to assess the effectiveness of such interventions as they may supplement existing counseling services in universities, reduce the treatment costs, and maximize treatment accessibility in low-resourced settings.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1016/j.invent.2018.11.002.",2021,"For anxiety, the overall mean difference between the 2 time points was 3.34 (95% CI 2.06-4.61; Hedges g 1.02; P<.001).","['university students with symptoms of depression, anxiety, or both in Indonesia', 'University students with depression and anxiety', 'university students in Indonesia', 'Indonesian University Students With Depression and Anxiety', '50 participants completed the intervention', 'Students from Universitas Gadjah Mada, Yogyakarta, Indonesia, were screened for symptoms of depression, anxiety, or both, and filled online informed consent, demographic questionnaires, and a quality of life measure at pretreatment assessment (T0']","['guided, culturally adapted, transdiagnostic, internet-based intervention', 'Transdiagnostic Internet Intervention']","['individual semistructured interview and synthesized descriptively', 'feasibility (acceptability and satisfaction, usability, and uptake', 'outcomes (depression, anxiety, and quality of life', '8-item Client Satisfaction Questionnaire (CSQ-8) and the System Usability Scale (SUS', 'depression and anxiety', 'quality of life', 'Mean and SDs for the CSQ-8 and SUS', 'adherence rate']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0432291', 'cui_str': 'Mandibuloacral dysostosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",50.0,0.108685,"For anxiety, the overall mean difference between the 2 time points was 3.34 (95% CI 2.06-4.61; Hedges g 1.02; P<.001).","[{'ForeName': 'Metta', 'Initials': 'M', 'LastName': 'Rahmadiana', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Karyotaki', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Schulte', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Division of Online Health Training, Innovation Incubator, Leuphana University of Lueneburg, Lueneburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Passchier', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'van Ballegooijen', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Supra', 'Initials': 'S', 'LastName': 'Wimbarti', 'Affiliation': 'Faculty of Psychology, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",JMIR mental health,['10.2196/20036']
1382,33662902,Lung protective ventilation strategy to reduce postoperative pulmonary complications (PPCs) in patients undergoing robot-assisted laparoscopic radical cystectomy for bladder cancer: A randomized double blinded clinical trial.,"STUDY OBJECTIVE


To evaluate the effects of ventilation with low tidal volume and positive end-expiratory pressure (PEEP) on postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic radical cystectomy (RARC) for bladder cancer.
DESIGN


A prospective randomized double-blinded study.
SETTING


A single center trial in a comprehensive tertiary hospital from January 2017 to January 2019.
PATIENTS


A total of 258 patients undergoing RARC for bladder cancer.
INTERVENTIONS


Patients were randomly assigned to receive either lung-protective ventilation (LPV group) [tidal volume 6 ml/ kg predicated body weight (PBW) + PEEP 7 cmH 2 O] or nonprotective ventilation (control group) (tidal volume 9 ml/ kg PBW without PEEP) during anesthesia.
MEASUREMENTS


The primary outcome was the occurrence of postoperative pulmonary complications (PPCs) during the first 90 days after surgery. The secondary outcomes were extubation time, oxygenation index (OI) after extubation and at postoperative day 1 in blood gas.
MAIN RESULTS


The incidence of PPCs at postoperative day1, 2 and 3 were lower in LPV group [26.8% vs. 47.2%, odds ratio (OR) 0.41, 95% confidence interval (CI), 0.24-0.69, P = 0.0007, 21.3% vs. 43.3%, OR 0.36, 95% CI, 0.20-0.61, P = 0.0002, 14.2% vs. 27.5%, OR0.43, 95%CI, 0.23-0.82, P = 0.0087, respectively], while no differences were observed at day 7 and 28 (3.9% vs. 9.4%, P = 0.0788, 0% vs. 1.6%, P = 0.4980, respectively). No PPCs were observed at postoperative day 90 in both groups. Furthermore, immediately after extubating and at postoperative day 1, OI was significantly higher in LPV group compared with control group [390(337-467) vs. 343(303-420), P = 0.0005, 406.7(73.0) vs. 425.5(74.7), P = 0.0440, respectively]. Patients in LPV group had a significant shorter extubation time after operation compared with control group [38(33-54) vs. 35(25-46), P = 0.0012].
CONCLUSION


LPV combining low tidal volume and PEEP during anesthesia for RARC may decrease the incidence of postoperative pulmonary complications.",2021,"The incidence of PPCs at postoperative day1, 2 and 3 were lower in LPV group [26.8% vs. 47.2%, odds ratio (OR)","['patients undergoing', 'A single center trial in a comprehensive tertiary hospital from January 2017 to January 2019', 'for bladder cancer', 'A total of 258 patients undergoing RARC for bladder cancer']","['lung-protective ventilation (LPV group) [tidal volume 6\xa0ml', 'nonprotective ventilation (control group) (tidal volume 9', 'robot-assisted laparoscopic radical cystectomy (RARC', 'Lung protective ventilation strategy', 'ventilation with low tidal volume and positive end-expiratory pressure (PEEP', 'LPV', 'robot-assisted laparoscopic radical cystectomy']","['shorter extubation time', 'postoperative pulmonary complications (PPCs', 'kg predicated body weight (PBW', 'extubation time, oxygenation index (OI) after extubation and at postoperative day 1 in blood gas', 'odds ratio (OR', 'occurrence of postoperative pulmonary complications (PPCs', 'postoperative pulmonary complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4041016', 'cui_str': 'Robot assisted laparoscopic radical cystectomy'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4041016', 'cui_str': 'Robot assisted laparoscopic radical cystectomy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",258.0,0.535541,"The incidence of PPCs at postoperative day1, 2 and 3 were lower in LPV group [26.8% vs. 47.2%, odds ratio (OR)","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China.; Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.'}, {'ForeName': 'Shujing', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China.; Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.'}, {'ForeName': 'Zhangjie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.. Electronic address: 13611906592@163.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China.. Electronic address: hongx93044@126.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110156']
1383,33662252,Evaluation of the Use of Potassium Iodide Application on Stained Demineralized Dentin Under Resin Composite Following Silver Diamine Fluoride Application.,"Purpose:  The purpose of this study was to assess the effect of potassium iodide (KI) after applying silver diamine fluoride (SDF) on the staining of demineralized dentin covered or not by a composite resin layer.  Methods:  Dentin blocks from 30 bovine incisors were demineralized and randomly allocated in three groups (N equals 10): (1) control (no treatment); (2) treated with SDF; and (3) treated with SDF and KI. Half of the specimens of each group received a composite resin restoration immediately after treatment. A colorimetric evaluation, according to the CIE L*a*b* system, was performed at baseline and after seven, 14, 30, and 60 days. The ΔE data were analyzed using the generalized linear model (Δ equals 0.05).  Results:  The use of KI immediately after applying SDF decreased the dentin staining at all assessment times. SDF treatment only stained the dentin under composite resin after 60 days. The application of KI reduced the dentin under composite resin staining as ΔE values were similar to the control group even after 60 days.  Conclusions:  The use of potassium iodide minimizes the darkening of dentin and prevents the staining of the dentin under composite resin restorations in the long-term.",2021,The application of KI reduced the dentin under composite resin staining as ΔE values were similar to the control group even after 60 days.  ,"['30 bovine incisors', 'Stained Demineralized Dentin']","['potassium iodide (KI', 'SDF and KI', 'silver diamine fluoride (SDF', 'composite resin restoration', 'control (no treatment); (2) treated with SDF', 'Silver Diamine Fluoride Application', 'Potassium Iodide Application']",['dentin staining'],"[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0032831', 'cui_str': 'Potassium Iodide'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}]",,0.0282486,The application of KI reduced the dentin under composite resin staining as ΔE values were similar to the control group even after 60 days.  ,"[{'ForeName': 'Tatiana Tambara', 'Initials': 'TT', 'LastName': 'Fröhlich', 'Affiliation': 'Dr. Fröhlich is a postgraduate student, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': ""Larissa D'Olanda"", 'Initials': 'LD', 'LastName': 'Gindri', 'Affiliation': 'Dr. Gindri is a postgraduate student, Dental Science Graduate Program, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Djessica', 'Initials': 'D', 'LastName': 'Pedrotti', 'Affiliation': 'Dr. Pedrotti is a postgraduate student, Dental Science Graduate Program, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Cleber Paradzinski', 'Initials': 'CP', 'LastName': 'Cavalheiro', 'Affiliation': 'Dr. Cavalheiro is a postgraduate student, Dental Science Graduate Program, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Fabio Zovico Maxnuck', 'Initials': 'FZM', 'LastName': 'Soares', 'Affiliation': 'Dr. Soares is an associate professor, Department of Restorative Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Rachel de Oliveira', 'Initials': 'RO', 'LastName': 'Rocha', 'Affiliation': 'Dr. Rocha is an associate professor, Department of Stomatology, Federal University of Santa Maria, Santa Maria, Brazil;, Email: rachelrocha@smail.ufsm.br.'}]",Pediatric dentistry,[]
1384,33662244,Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish in Remineralization of Early Carious Lesions in Primary Dentition: Randomized Clinical Trial.,"Purpose:  Casein phosphopeptide amorphous calcium phosphate fluoride varnish (commercially available as MI Varnish ® ) is a promising minimally invasive remineralizing agent. The purpose of this study was to compare the effectiveness of intensive application of MI and sodium fluoride (commercially available as Duraphat Varnish ® ) varnishes on white spot lesion remineralization.  Methods:  This randomized controlled clinical trial included a sample of 44 healthy three- to five-year-old children with at least four active white spot lesions on their anterior primary teeth. They were allocated into two groups: either a test group (MI Varnish ® ) or a control group (Duraphat Varnish ® ). Each group received three consecutive varnish applications two weeks apart. Selected teeth were evaluated for lesion activity and change in DIAGNOdent™ readings at follow-up periods of six, 18, and 30 weeks.  Results:  Both groups showed a significant decrease in the mean oral hygiene debris index score at different follow-up periods compared to baseline (P<0.001). MI Varnish ®  intervention had a significantly decreased number of active lesions when compared to Duraphat Varnish ® , at the 18 week time period. DIAGNOdent ™ scores were significantly reduced in the test group versus the control group at the 30 week assessment (P<0.001).  Conclusion:  MI Varnish ®  was more effective than Duraphat Varnish ®  in white spot lesions mineralization.",2021,Both groups showed a significant decrease in the mean oral hygiene debris index score at different follow-up periods compared to baseline (P<0.001).,"['Early Carious Lesions in Primary Dentition', '44 healthy three- to five-year-old children with at least four active white spot lesions on their anterior primary teeth']","['MI and sodium fluoride', 'control group (Duraphat Varnish ® ', 'Casein phosphopeptide amorphous calcium phosphate fluoride varnish', 'Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish', 'test group (MI Varnish ® ']","['mean oral hygiene debris index score', 'number of active lesions']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0058817', 'cui_str': 'Duraphat'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",44.0,0.0775781,Both groups showed a significant decrease in the mean oral hygiene debris index score at different follow-up periods compared to baseline (P<0.001).,"[{'ForeName': 'Ahmed I', 'Initials': 'AI', 'LastName': 'Mekky', 'Affiliation': 'Dr. Mekky is a masters degree student in Pediatric Dentistry, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Karin M L', 'Initials': 'KML', 'LastName': 'Dowidar', 'Affiliation': 'Dr. Dowidar is a professor of Pediatric Dentistry, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Dalia M', 'Initials': 'DM', 'LastName': 'Talaat', 'Affiliation': 'Dr. Talaat is an associate professor of Pediatric Dentistry, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt;, Email: Daliatalaat7576@hotmail.com.'}]",Pediatric dentistry,[]
1385,33662243,A Randomized Controlled Pilot Study Examining Effects of Animal Assisted Therapy in Children Undergoing Sealant Placement.,"Purpose:  The purpose of this study was to examine the effects of a companion canine on physiologic responses, discomfort level, and behavior in children undergoing sealant placement using a dental isolation system (Isodry ® ).  Methods:  Forty-seven healthy six- to 10-year-olds who needed sealants were randomly assigned to a control group (N =23) or experimental group (N =24) that utilized an emotional support canine in the child's lap. Preoperative baseline anxiety was obtained. Pulse, pulse oximetry, and behavior (measured by Frankl and Houpt scales) were recorded at various time points (beginning, at first sealant placement, switching the isolation system to the other side, second side sealant placement, and end) throughout the procedure. Participants reported a comfort level utilizing the FACES scale. Participants in the intervention group were asked, ""Did you like having the dog in your lap?"" The dentist rated the difficulty of and time required for the procedure.  Results:  Baseline anxiety was similar; no significant differences in physiologic measurements or FACES ratings were found between groups. The intervention group had significantly lower Houpt ratings for all three variables when the isolation system was repositioned (P=0.002, P=0.03, and P=0.05) and had higher Frankl scores at isolation repositioning and when completing sealants on the second side (P=0.02 and P=0.03, respectively). Both groups had similar ratings from the dentist.  Conclusions:  Animal-assisted therapy (AAT) should be studied more rigorously to substantiate its effectiveness in enhancing cooperative behavior in children for dental procedures. High levels of satisfaction were observed among pediatric users of AAT.",2021,"The intervention group had significantly lower Houpt ratings for all three variables when the isolation system was repositioned (P=0.002, P=0.03, and P=0.05) and had higher Frankl scores at isolation repositioning and when completing sealants on the second side (P=0.02 and P=0.03, respectively).","['Children Undergoing Sealant Placement', 'children undergoing sealant placement using a dental isolation system (Isodry ® ', 'Methods:  Forty-seven healthy six- to 10-year-olds who needed sealants']","['Animal Assisted Therapy', 'Did you like having the dog in your lap', ""control group (N =23) or experimental group (N =24) that utilized an emotional support canine in the child's lap"", 'Animal-assisted therapy (AAT', 'companion canine']","['Baseline anxiety', 'Pulse, pulse oximetry, and behavior (measured by Frankl and Houpt scales', 'High levels of satisfaction', 'comfort level utilizing the FACES scale', 'Preoperative baseline anxiety', 'physiologic responses, discomfort level, and behavior', 'physiologic measurements or FACES ratings', 'Frankl scores', 'Houpt ratings']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0150133', 'cui_str': 'Animal-assisted therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0052586', 'cui_str': 'ATA protocol'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0199213', 'cui_str': 'Physiologic measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0585553,"The intervention group had significantly lower Houpt ratings for all three variables when the isolation system was repositioned (P=0.002, P=0.03, and P=0.05) and had higher Frankl scores at isolation repositioning and when completing sealants on the second side (P=0.02 and P=0.03, respectively).","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Charowski', 'Affiliation': 'Dr. Charowski is a pediatric dentist in private practice Simpsonville, S. C., USA.'}, {'ForeName': 'Martha H', 'Initials': 'MH', 'LastName': 'Wells', 'Affiliation': 'Dr. Wells is a professor and director of the Graduate Pediatric Dentistry Program, College of Dentistry, University of Tennessee Health Science Center, Memphis, Tenn., USA;, Email: mwells@uthsc.edu.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Dormois', 'Affiliation': 'Dr. Dormois is an associate professor, College of Dentistry, University of Tennessee Health Science Center, Memphis, Tenn., USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Fernandez', 'Affiliation': 'Dr. Fernandez is an assistant professor, Department of Pediatric Dentistry and Community Health, College of Dentistry, College of Dentistry, University of Tennessee Health Science Center, Memphis, Tenn., USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Scarbecz', 'Affiliation': 'Dr. Scarbecz is a professor and an associate dean for Institutional Affairs (CoD), Department of Bioscience Research, College of Dentistry, University of Tennessee Health Science Center, Memphis, Tenn., USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Maclin', 'Affiliation': 'Dr. Maclin is an assistant professor of Pediatric Dentistry, Vanderbilt University, Nashville, Tenn., USA.'}]",Pediatric dentistry,[]
1386,33669564,The Efficacy of Pilates on Urinary Incontinence in Korean Women: A Metabolomics Approach.,"Pilates has been known as exercise intervention that improves the function of pelvic floor muscle (PFM) associated with impacting urinary incontinence (UI). This study investigated the effect of Pilates on UI in Korean women by determining the change in functional movement of PFM (FMP) and metabolic profiles. UI group with Pilates (UIP,  n  = 13) participated in 8-weeks Oov Pilates program, and 8 subjects were assigned to Control and UI group with no Pilates (UINP), respectively. Before and after 8 weeks, plasma samples were collected from all participants, and ultrasonography was used to measure the functional change of PFM for calculating FMP ratio. Plasma samples were analyzed by mass spectrometry to identify the change of metabolic features. After 8-weeks intervention, FMP ratio was remarkably decreased in UIP (48.1% ↓,  p  < 0.001), but not in Control and UINP ( p  > 0.05). In metabolic features, L-Glutamine ( m / z : 147.07 [M + H] + ), L-Cystathionine ( m / z : 240.09 [M + NH 4 ] + ), L-Arginine ( m / z : 197.1 [M + Na] + ), and L-1-Pyrroline-3-hydroxy-5-carboxylate ( m / z : 147.07 [M + NH 4 ] + ) were significantly elevated solely in UIP ( p  < 0.001). Our study elucidated that Pilates can ameliorate the FMP and enhance the specific metabolic characteristics, which was potentially associated with invigorated PFM contractility to effectively control the bladder base and continence.",2021,"After 8-weeks intervention, FMP ratio was remarkably decreased in UIP (48.1% ↓,  p  < 0.001), but not in Control and UINP ( p  > 0.05).","['Korean women', 'Korean Women']","['Pilates', 'UI group with Pilates (UIP,  n  = 13) participated in 8-weeks Oov Pilates program', 'Control and UI group with no Pilates (UINP']","['Urinary Incontinence', 'FMP ratio', 'UIP']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4721509', 'cui_str': 'Interstitial Pneumonitis, Usual'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1868598', 'cui_str': 'Enlarged parietal foramina'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4721509', 'cui_str': 'Interstitial Pneumonitis, Usual'}]",13.0,0.0194017,"After 8-weeks intervention, FMP ratio was remarkably decreased in UIP (48.1% ↓,  p  < 0.001), but not in Control and UINP ( p  > 0.05).","[{'ForeName': 'Gyumin', 'Initials': 'G', 'LastName': 'Kang', 'Affiliation': 'School of Bio-Medical Science, Korea University, 2511 Sejong-ro, Sejong 30019, Korea.'}, {'ForeName': 'Haelim', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Sports Medicine, College of Health Science, CHA University, 120 Haeryong-ro, Donggyo-dong, Pocheon 11160, Korea.'}, {'ForeName': 'Malsoon', 'Initials': 'M', 'LastName': 'Shin', 'Affiliation': 'School of Global Sport Studies, Korea University, 2511 Sejong-ro, Sejong 30019, Korea.'}, {'ForeName': 'Jaekwan', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'College of Pharmacy, Korea University, 2511 Sejong-ro, Sejong 30019, Korea.'}, {'ForeName': 'Sungki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Sports Medicine, College of Health Science, CHA University, 120 Haeryong-ro, Donggyo-dong, Pocheon 11160, Korea.'}, {'ForeName': 'Youngja', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'College of Pharmacy, Korea University, 2511 Sejong-ro, Sejong 30019, Korea.'}]",Metabolites,['10.3390/metabo11020118']
1387,33669552,Natural or Urban Campus Walks and Vitality in University Students: Exploratory Qualitative Findings from a Pilot Randomised Controlled Study.,"Despite extensive evidence of the restorative effects of nature, the potential vitalizing effects of connecting with nature are yet understudied, particularly in higher education settings. University students face high levels of stress and anxiety, and may benefit from nature-based interventions that enhance positive states such as vitality. Using preliminary data from a pilot randomized controlled study with qualitative interviews, we explored the psychological experiences associated with a brief walk either in nature or an urban environment in a sample of 13 university students. The qualitative thematic analysis revealed that walking in nature was a more energizing and vitalizing experience than the urban walk. The nature walk was also found to have both affective and cognitive enhancing effects on participants. Our study highlights the usefulness of exploring subjective psychological experiences of interacting with nature, as well as supporting its restorative potential. Implications for further research and interventions are discussed.",2021,The qualitative thematic analysis revealed that walking in nature was a more energizing and vitalizing experience than the urban walk.,"['psychological experiences associated with a brief walk either in nature or an urban environment in a sample of 13 university students', 'University Students', 'University students']",[],[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],,0.0219225,The qualitative thematic analysis revealed that walking in nature was a more energizing and vitalizing experience than the urban walk.,"[{'ForeName': 'Topaz', 'Initials': 'T', 'LastName': 'Shrestha', 'Affiliation': 'School of Applied Psychology, University College Cork, T23 TK30 Cork, Ireland.'}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'Di Blasi', 'Affiliation': 'School of Applied Psychology, University College Cork, T23 TK30 Cork, Ireland.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Cassarino', 'Affiliation': 'School of Applied Psychology, University College Cork, T23 TK30 Cork, Ireland.'}]",International journal of environmental research and public health,['10.3390/ijerph18042003']
1388,33669526,The Effect of Ventilation with Individualized Positive End-Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial.,"For patients undergoing robot-assisted radical prostatectomy, the pneumoperitoneum with a steep Trendelenburg position could worsen intraoperative respiratory mechanics and result in postoperative atelectasis. We investigated the effects of individualized positive end-expiratory pressure (PEEP) on postoperative atelectasis, evaluated using lung ultrasonography. Sixty patients undergoing robot-assisted radical prostatectomy were randomly allocated into two groups. Individualized groups ( n  = 30) received individualized PEEP determined by a decremental PEEP trial using 20 to 7 cm H 2 O, aiming at maximizing respiratory compliance, whereas standardized groups ( n  = 30) received a standardized PEEP of 7 cm H 2 O during the pneumoperitoneum. Ultrasound examination was performed on 12 sections of thorax, and the lung ultrasound score was measured as 0-3 by considering the number of B lines and the degree of subpleural consolidation. The primary outcome was the difference between the lung ultrasound scores measured before anesthesia induction and just after extubation in the operating room. An increase in the difference means the development of atelectasis. The optimal PEEP in the individualized group was determined as the median (interquartile range) 14 (12-18) cm H 2 O. Compared with the standardized group, the difference in the lung ultrasound scores was significantly smaller in the individualized group (-0.5 ± 2.7 vs. 6.0 ± 2.9, mean difference -6.53, 95% confidence interval (-8.00 to -5.07),  p  < 0.001), which means that individualized PEEP was effective to reduce atelectasis. The lung ultrasound score measured after surgery was significantly lower in the individualized group than the standardized group (8.1 ± 5.7 vs. 12.2 ± 4.2, mean difference -4.13, 95% confidence interval (-6.74 to -1.53),  p  = 0.002). However, the arterial partial pressure of the oxygen/fraction of inspired oxygen levels during the surgery showed no significant time-group interaction between the two groups in repeated-measures analysis of variance ( p  = 0.145). The incidence of a composite of postoperative respiratory complications was comparable between the two groups. Individualized PEEP determined by maximal respiratory compliance during the pneumoperitoneum and steep Trendelenburg position significantly reduced postoperative atelectasis, as evaluated using lung ultrasonography. However, the clinical significance of this finding should be evaluated by a larger clinical trial.",2021,"The lung ultrasound score measured after surgery was significantly lower in the individualized group than the standardized group (8.1 ± 5.7 vs. 12.2 ± 4.2, mean difference -4.13, 95% confidence interval (","['Sixty patients undergoing robot-assisted radical prostatectomy', 'Patients Undergoing Robot-Assisted Radical Prostatectomy']","['individualized positive end-expiratory pressure (PEEP', 'individualized PEEP', 'standardized PEEP of 7 cm H 2 O during the pneumoperitoneum', 'Ventilation with Individualized Positive End-Expiratory Pressure', 'robot-assisted radical prostatectomy']","['lung ultrasound scores', 'incidence of a composite of postoperative respiratory complications', 'lung ultrasound score', 'arterial partial pressure of the oxygen/fraction of inspired oxygen levels', 'maximal respiratory compliance', 'postoperative atelectasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0340074', 'cui_str': 'Postoperative atelectasis'}]",60.0,0.120531,"The lung ultrasound score measured after surgery was significantly lower in the individualized group than the standardized group (8.1 ± 5.7 vs. 12.2 ± 4.2, mean difference -4.13, 95% confidence interval (","[{'ForeName': 'Hyun-Kyu', 'Initials': 'HK', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-gu, Seoul 03080, Korea.'}, {'ForeName': 'Bo Rim', 'Initials': 'BR', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-gu, Seoul 03080, Korea.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-gu, Seoul 03080, Korea.'}, {'ForeName': 'Young Hyun', 'Initials': 'YH', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-gu, Seoul 03080, Korea.'}, {'ForeName': 'Ja Hyeon', 'Initials': 'JH', 'LastName': 'Ku', 'Affiliation': 'Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-gu, Seoul 03080, Korea.'}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-gu, Seoul 03080, Korea.'}]",Journal of clinical medicine,['10.3390/jcm10040850']
1389,33669491,Utilization of Bracing Arms as Additional Reinforcement in Pultruded Glass Fiber-Reinforced Polymer Composite Cross-Arms: Creep Experimental and Numerical Analyses.,"The application of pultruded glass fiber-reinforced polymer composites (PGFRPCs) as a replacement for conventional wooden cross-arms in transmission towers is relatively new. Although numerous studies have conducted creep tests on coupon-scale PGFRPC cross-arms, none had performed creep analyses on full-scale PGFRPC cross-arms under actual working load conditions. Thus, this work proposed to study the influence of an additional bracing system on the creep responses of PGFRPC cross-arms in a 132 kV transmission tower. The creep behaviors and responses of the main members in current and braced PGFRPC cross-arm designs were compared and evaluated in a transmission tower under actual working conditions. These PGFRPC cross-arms were subjected to actual working loads mimicking the actual weight of electrical cables and insulators for a duration of 1000 h. The cross-arms were installed on a custom test rig in an open area to simulate the actual environment of tropical climate conditions. Further creep analysis was performed by using Findley and Burger models on the basis of experimental data to link instantaneous and extended (transient and viscoelastic) creep strains. The addition of braced arms to the structure reduced the total strain of a cross-arm's main member beams and improved elastic and viscous moduli. The addition of bracing arms improved the structural integrity and stiffness of the cross-arm structure. The findings of this study suggested that the use of a bracing system in cross-arm structures could prolong the structures' service life and subsequently reduce maintenance effort and cost for long-term applications in transmission towers.",2021,The application of pultruded glass fiber-reinforced polymer composites (PGFRPCs) as a replacement for conventional wooden cross-arms in transmission towers is relatively new.,['Pultruded Glass Fiber-Reinforced Polymer Composite Cross-Arms'],['pultruded glass fiber-reinforced polymer composites (PGFRPCs'],[],"[{'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",[],,0.0224479,The application of pultruded glass fiber-reinforced polymer composites (PGFRPCs) as a replacement for conventional wooden cross-arms in transmission towers is relatively new.,"[{'ForeName': 'Muhammad Rizal Muhammad', 'Initials': 'MRM', 'LastName': 'Asyraf', 'Affiliation': 'Department of Aerospace Engineering, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia.'}, {'ForeName': 'Mohamad Ridzwan', 'Initials': 'MR', 'LastName': 'Ishak', 'Affiliation': 'Department of Aerospace Engineering, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia.'}, {'ForeName': 'Salit Mohd', 'Initials': 'SM', 'LastName': 'Sapuan', 'Affiliation': 'Laboratory of Biocomposite Technology, Institute of Tropical Forestry and Forest Products (INTROP), Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia.'}, {'ForeName': 'Noorfaizal', 'Initials': 'N', 'LastName': 'Yidris', 'Affiliation': 'Department of Aerospace Engineering, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia.'}]",Polymers,['10.3390/polym13040620']
1390,33669450,The Effect of Intensive Dietary Intervention on the Level of RANTES and CXCL4 Chemokines in Patients with Non-Obstructive Coronary Artery Disease: A Randomised Study.,"BACKGROUND


Inflammation is the key pathophysiological mechanism of the initiation and progression of atherosclerosis. The study objective was to assess the effects of a dietary intervention based on the model of the dietary approaches to stop hypertension (DASH) diet on the levels of chemokines RANTES and CXCL4 in patients with non-obstructive coronary artery disease.
METHODS


As part of Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography (DISCO-CT) study, patients were randomised to an intervention group ( n  = 40), where the DASH diet was introduced along with optimal pharmacotherapy, and to a control group ( n  = 39), with optimal pharmacotherapy alone. In the DASH group, systematic dietary counselling was provided for the follow-up period. RANTES and CXCL4 levels were determined using ELISA.
RESULTS


In the DASH group, the RANTES level insignificantly reduced from 42.70 ± 21.1 ng/mL to 38.09 ± 18.5 ng/mL ( p  = 0.134), and the CXCL4 concentration significantly reduced from 12.38 ± 4.1 ng/mL to 8.36 ± 2.3 ng/mL ( p  = 0.0001). At the same time, an increase in the level of both chemokines was observed in the control group: RANTES from 34.69 ± 22.7 to 40.94 ± 20.0 ng/mL ( p  = 0.06) and CXCL4 from 10.98 ± 3.6 to 13.0 5± 4.8 ng/mL ( p  = 0.009). The difference between the changes in both groups was significant for both RANTES ( p  = 0.03) and CXCL4 ( p  = 0.00001). The RANTES/CXCL4 ratio reduced in the control group (from 3.52 ± 2.8 to 3.35 ± 2.8;  p  = 0.006), while in the DASH group, an increase was observed (from 3.54 ± 1.7 to 4.77 ± 2.4;  p  = 0.001).
CONCLUSIONS


A 12-month-long intensive dietary intervention based on DASH diet guidelines as an addition to optimal pharmacotherapy causes changes in the levels of chemokines CXCL4 and RANTES and their mutual relationship in comparison to conventional treatment.",2021,"In the DASH group, the RANTES level insignificantly reduced from 42.70 ± 21.1 ng/mL to 38.09 ± 18.5 ng/mL ( p  = 0.134), and the CXCL4 concentration significantly reduced from 12.38 ± 4.1 ng/mL to 8.36 ± 2.3 ng/mL ( p  = 0.0001).","['Patients with Non-Obstructive Coronary Artery Disease', 'patients with non-obstructive coronary artery disease']","['Dietary Intervention', 'dietary approaches to stop hypertension (DASH) diet', 'dietary intervention', 'DASH diet was introduced along with optimal pharmacotherapy', 'Intensive Dietary Intervention', 'optimal pharmacotherapy alone', 'Computed Tomography']","['CXCL4 concentration', 'CXCL4 ratio', 'level of both chemokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0522872', 'cui_str': 'Platelet factor 4 assay'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}]",,0.033916,"In the DASH group, the RANTES level insignificantly reduced from 42.70 ± 21.1 ng/mL to 38.09 ± 18.5 ng/mL ( p  = 0.134), and the CXCL4 concentration significantly reduced from 12.38 ± 4.1 ng/mL to 8.36 ± 2.3 ng/mL ( p  = 0.0001).","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Makarewicz-Wujec', 'Affiliation': 'Department of Clinical Pharmacy and Pharmaceutical Care, Medical University of Warsaw, 02-091 Warsaw, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Henzel', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, 04-628 Warsaw, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Kruk', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, 04-628 Warsaw, Poland.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kępka', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, 04-628 Warsaw, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Wardziak', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, 04-628 Warsaw, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Trochimiuk', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, 04-628 Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Parzonko', 'Affiliation': 'Department of Pharmacognosy and Molecular Basis of Phytotherapy, Medical University of Warsaw, 02-091 Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, 04-628 Warsaw, Poland.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Dzielińska', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, 04-628 Warsaw, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Kozłowska-Wojciechowska', 'Affiliation': 'Department of Clinical Pharmacy and Pharmaceutical Care, Medical University of Warsaw, 02-091 Warsaw, Poland.'}]",Biology,['10.3390/biology10020156']
1391,33668309,Effects of Exercise Intervention on Mitochondrial Stress Biomarkers in Metabolic Syndrome Patients: A Randomized Controlled Trial.,"Metabolic syndrome (MetS) pathogenesis involves oxidative stress associated with mitochondrial dysfunction, which triggers integrated stress responses via various compensatory metabolic modulators like mitokines and hepatokines. However, the regulatory mechanisms underlying the exercise-derived benefits with respect to mitokines and hepatokines (potential MetS biomarkers) are unknown. Thus, we investigated the effects of exercise training on MetS biomarkers and their associations with clinical parameters. In this single-center trial, 30 women with MetS were randomly assigned to 12-week supervised exercise or control groups (1:1) and compared with 12 age-matched healthy volunteers. All participants completed the study except one subject in the control group. Expectedly, serum levels of the mitokines, fibroblast growth factor-21 (FGF21), growth differentiation factor-15 (GDF15), and the hepatokine, angiopoietin-like 6 (ANGPTL6), were higher in MetS patients than in healthy volunteers. Moreover, their levels were markedly attenuated in the exercise group. Further, exercise-mediated changes in serum FGF21 and GDF15 correlated with changes in the homeostasis model of assessment of insulin resistance (HOMA-IR) and appendicular lean mass (ALM), respectively. Additionally, changes in serum triglycerides and ANGPTL6 were correlated with changes in leptin. Aberrant mitokine and hepatokine levels can be rectified by relieving metabolic stress burden. Therefore, exercise training may reduce the need for the compensatory upregulation of MetS metabolic modulators by improving gluco-lipid metabolism.",2021,"Further, exercise-mediated changes in serum FGF21 and GDF15 correlated with changes in the homeostasis model of assessment of insulin resistance (HOMA-IR) and appendicular lean mass (ALM), respectively.","['Metabolic Syndrome Patients', 'groups (1:1) and compared with 12 age-matched healthy volunteers', '30 women with MetS']","['exercise training', 'supervised exercise or control', 'Exercise Intervention']","['serum levels of the mitokines, fibroblast growth', 'serum triglycerides', 'factor-21 (FGF21), growth differentiation factor-15 (GDF15), and the hepatokine, angiopoietin-like 6 (ANGPTL6', 'serum FGF21 and GDF15', 'insulin resistance (HOMA-IR) and appendicular lean mass (ALM', 'Mitochondrial Stress Biomarkers']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C1113649', 'cui_str': 'Angiopoietins'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",30.0,0.0181013,"Further, exercise-mediated changes in serum FGF21 and GDF15 correlated with changes in the homeostasis model of assessment of insulin resistance (HOMA-IR) and appendicular lean mass (ALM), respectively.","[{'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'Mitohormesis Research Center, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon-do 26426, Korea.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Namkung', 'Affiliation': 'Mitohormesis Research Center, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon-do 26426, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph18052242']
1392,33667827,An emotional regulation approach to psychosis recovery: The Living Through Psychosis group programme.,"BACKGROUND AND OBJECTIVES


Research indicates the value of targeting emotional regulation (ER) skills in psychological interventions for psychosis. These skills can be delivered in a group format, thereby increasing access to therapy. This pilot study examined the acceptability and clinical effects of teaching ER skills in The Living Through Psychosis (LTP) group programme.
METHODS


Patients with a psychotic illness were offered the LTP programme, comprising eight sessions over four weeks. Measures were completed by 55 participants. Acceptability was assessed by attendance rates and group cohesion. Measures of intervention targets, recovery and clinical outcomes were completed at baseline, pre-group, post-group, and one-month follow-up.
RESULTS


High group attendance and cohesion support the acceptability of the group. Participants reported less difficulty with ER (Coeff. = -8.29, 95% CI: -13.40 to -3.18, within participant uncontrolled effect size (ES) d = 0.29), increased mindful relating to distressing symptoms (Coeff. = 11.20, 95% CI: 7.02 to 15.38, d = 0.65), and improvements in recovery dimensions (Coeff. = 10.07, 95% CI: 5.6 to 14.54, d = 0.42) from pre-to post-intervention, and maintained at one-month follow-up. Participants' hallucinations and delusions reduced from pre-intervention to follow-up (t(18) = 4.64, p < 0.001; t(18) = 5.34, p < 0.001). There was no change in fear of relapse.
LIMITATIONS


The uncontrolled, pre-post design precluded blinded assessments, and may have inflated effect sizes. Other factors may have contributed to the improvements.
CONCLUSIONS


The LTP programme was acceptable to people with psychosis. The preliminary findings indicate the potential utility of teaching ER and mindfulness skills in a brief group programme. Findings require replication in a randomized controlled trial.",2021,"Participants' hallucinations and delusions reduced from pre-intervention to follow-up (t(18) = 4.64, p < 0.001; t(18) = ",['Patients with a psychotic illness'],"['LTP programme', 'teaching ER skills']","['recovery dimensions (Coeff', 'Acceptability', 'hallucinations and delusions', 'fear of relapse', 'recovery and clinical outcomes', 'mindful relating to distressing symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.196434,"Participants' hallucinations and delusions reduced from pre-intervention to follow-up (t(18) = 4.64, p < 0.001; t(18) = ","[{'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'School of Psychology, Trinity College Dublin, Ireland; Health Service Executive, Ireland.'}, {'ForeName': 'Edel', 'Initials': 'E', 'LastName': 'Crehan', 'Affiliation': ""Department of Psychology, St Patrick's Mental Health Services, Dublin, Ireland.""}, {'ForeName': 'Mizanur', 'Initials': 'M', 'LastName': 'Khondoker', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fell', 'Affiliation': 'School of Psychology, Trinity College Dublin, Ireland; Health Service Executive, Ireland.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Curtin', 'Affiliation': ""Department of Psychology, St Patrick's Mental Health Services, Dublin, Ireland.""}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Johns', 'Affiliation': 'Department of Psychiatry, University of Oxford, UK; Oxford Health NHS Foundation Trust, Oxford, UK. Electronic address: louise.johns@psych.ox.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2021.101651']
1393,33674089,The effect of cooperative learning on critical thinking of nursing students in clinical practicum: A quasi-experimental study.,"Critical thinking is a core element of higher nursing education that needs to be promoted during university study. However, lecturing as a teaching method is still heavily used by nurse educators, and nursing students have few opportunities to develop critical thinking skills. This study evaluated the impact of cooperative learning on critical thinking. A quasi-experimental study was conducted (n = 50). Students in the experimental group were arranged into small cooperative groups and completed the clinical practice together, whereas those in the control group practiced individually. After the intervention, total and subscale scores of critical thinking dispositions were significantly higher in the experimental rather than in the control group. The percentage for experiencing positive inclinations or strong dispositions toward critical thinking was 100% among the experimental group, whereas it was 85% among the control group. It is concluded that the cooperative learning-based clinical practicum is helpful for promoting students' critical thinking dispositions.",2021,"After the intervention, total and subscale scores of critical thinking dispositions were significantly higher in the experimental rather than in the control group.",['nursing students in clinical practicum'],['cooperative learning'],"['total and subscale scores of critical thinking dispositions', 'percentage for experiencing positive inclinations or strong dispositions toward critical thinking']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]",,0.0158428,"After the intervention, total and subscale scores of critical thinking dispositions were significantly higher in the experimental rather than in the control group.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Nursing, Wuhan University School of Health Sciences, PR China. Electronic address: junz@whu.edu.cn.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Sun yat-sen University School of Public Health, PR China.'}]",Journal of professional nursing : official journal of the American Association of Colleges of Nursing,['10.1016/j.profnurs.2020.05.008']
1394,33673870,"Spontaneous resolution of atopic dermatitis incidental to participation in benralizumab clinical trial for severe, uncontrolled asthma: a case report.","BACKGROUND


T cell-mediated eosinophilia is associated with numerous conditions-including atopic dermatitis, food allergies, and asthma-collectively known as the ""atopic march."" Benralizumab is a recombinant, humanized, afucosylated monoclonal antibody directed against the ⍺ chain of the eosinophil cell surface receptor IL-5R. Benralizumab treatment causes near-complete depletion of circulating eosinophils and was approved in 2017 for add-on, maintenance treatment of severe asthma with an eosinophilic phenotype, based on the results of the CALIMA and SIROCCO pivotal trials. Benralizumab is not currently approved for the treatment of eosinophilic conditions besides asthma; however, during the CALIMA trial, spontaneous resolution of atopic dermatitis was observed in a patient, concurrent with reduction in her asthma symptoms.
CASE PRESENTATION


In January 2015, a 14-year-old Asian girl with severe, uncontrolled asthma was enrolled in CALIMA. The patient's baseline eosinophil blood count was 1200 cells/μL, her pre-bronchodilator forced expiratory volume in 1 second (FEV 1 ) was 1.9 L and FEV 1 /forced vital capacity (FVC) ratio was 71.4%, and her post-bronchodilator FEV 1  was 3.2 L (FEV 1 /FVC of 115.9%). Her overall baseline asthma symptom score was 3.9 and her asthma exacerbation rate in the prior year was 4. She also displayed a pronounced, pruritic, chronic, inflammatory rash consistent with atopic dermatitis across her face. The investigator was blinded to the patient's treatment group during treatment; however, her asthma symptoms diminished over the course of the study (FEV 1  at 56 weeks, 3.01 L/110.5% (pre) and 3.25 L/119.3% (post); overall asthma symptom score 2.1; one influenza-associated exacerbation). Furthermore, her atopic dermatitis symptoms resolved spontaneously within the first 5 months of the study. After unblinding, the patient was confirmed to have been randomized to an active treatment arm, and her blood eosinophil count had dropped below the limit of detection after the first study dose.
CONCLUSIONS


Given the potential shared mechanisms between eosinophilic asthma and atopic dermatitis, it is plausible that benralizumab-induced eosinopenia factored into the resolution of the patient's atopic dermatitis. Further clinical studies are warranted to determine whether benralizumab or other drugs targeted against IL-5/IL-5R may be useful in managing multiple conditions associated with eosinophilia.",2021,"The investigator was blinded to the patient's treatment group during treatment; however, her asthma symptoms diminished over the course of the study (FEV 1  at 56 weeks, 3.01 L/110.5% (pre) and 3.25 L/119.3% (post); overall asthma symptom score 2.1; one influenza-associated exacerbation).","['In January 2015, a 14-year-old Asian girl with severe, uncontrolled asthma was enrolled in CALIMA']","['benralizumab', 'Benralizumab']","['Her overall baseline asthma symptom score', 'FEV 1 /forced vital capacity (FVC) ratio', 'eosinophil blood count', 'overall asthma symptom score 2.1; one influenza-associated exacerbation', 'blood eosinophil count', 'asthma exacerbation rate']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C2982078', 'cui_str': 'benralizumab'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}]",,0.147737,"The investigator was blinded to the patient's treatment group during treatment; however, her asthma symptoms diminished over the course of the study (FEV 1  at 56 weeks, 3.01 L/110.5% (pre) and 3.25 L/119.3% (post); overall asthma symptom score 2.1; one influenza-associated exacerbation).","[{'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Pham', 'Affiliation': 'Allianz Research Institute, 14120 Beach Blvd, Suite 101, Westminster, CA, USA. david.pham@allianzresearch.com.'}]",Journal of medical case reports,['10.1186/s13256-021-02663-2']
1395,33680155,Experimental Investigation Examining the Effects of Acute Exercise on Implicit Memory Function.,"Emerging work suggests that acute exercise can enhance explicit memory function. Minimal research, however, has examined whether acute exercise is associated with implicit memory, which was the purpose of this study. Three separate experimental studies were computed (N = 120; Mean age = 21). In Experiment 1, participants were randomly assigned to either a moderate-intensity bout of acute exercise (15-minute) or engaged in a seated control task (15-minute), followed by the completion of a word-fragmentation implicit memory task. Experiment 2 replicated Experiment 1, but instead employed a higher-intensity exercise protocol. For Experiment 3, participants were randomly assigned to either a moderate-intensity bout of acute exercise (15-minute) or engaged in a seated control task (15-minute), followed by the completion of a real world, 3-dimensional implicit memory task. For Experiment 1, the exercise and control groups, respectively, had an implicit memory score of 7.0 (0.5) and 7.5 (0.6) (t(38) = 0.67, p = .51). For Experiment 2, the exercise and control groups, respectively, had an implicit memory score of 6.9 (1.9) and 7.8 (2.4) (t(38) = 1.27, p = .21). These findings suggest that exercise, and the intensity of exercise, does not alter implicit memory from a word fragmentation task. For Experiment 3, the exercise and control groups, respectively, had a discrimination implicit memory index score of 0.48 (0.18) and 0.29 (0.32) (t(38) = 2.16, p = .03). In conclusion, acute exercise does not influence a commonly used laboratory-based assessment of implicit memory but may enhance real world-related implicit memory function.",2019,"For Experiment 3, the exercise and control groups, respectively, had a discrimination implicit memory index score of 0.48 (0.18) and 0.29 (0.32)",[],"['Acute Exercise', 'moderate-intensity bout of acute exercise (15-minute) or engaged in a seated control task (15-minute), followed by the completion of a word-fragmentation implicit memory task', 'moderate-intensity bout of acute exercise (15-minute) or engaged in a seated control task (15-minute), followed by the completion of a real world, 3-dimensional implicit memory task']","['discrimination implicit memory index score', 'Implicit Memory Function', 'implicit memory score']",[],"[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0561768', 'cui_str': 'Implicit memory'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}]","[{'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0561768', 'cui_str': 'Implicit memory'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",120.0,0.0387697,"For Experiment 3, the exercise and control groups, respectively, had a discrimination implicit memory index score of 0.48 (0.18) and 0.29 (0.32)","[{'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Loprinzi', 'Affiliation': 'Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, Oxford, MS, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Gilbert', 'Affiliation': 'Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, Oxford, MS, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Robinson', 'Affiliation': 'Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, Oxford, MS, USA.'}, {'ForeName': 'Briahna', 'Initials': 'B', 'LastName': 'Dickerson', 'Affiliation': 'Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, Oxford, MS, USA.'}]",Europe's journal of psychology,['10.5964/ejop.v15i4.1837']
1396,33680142,Predictive Attentional Bias Modification Induces Stimulus-Evoked Attentional Bias for Threat.,"Attentional Bias Modification (ABM) aims to modulate attentional biases, but questions remain about its efficacy and there may be new variants yet to explore. The current study tested effects of a novel version of ABM, predictive ABM (predABM), using visually neutral cues predicting the locations of future threatening and neutral stimuli that had a chance of appearing after a delay. Such effects could also help understand anticipatory attentional biases measured using cued Visual Probe Tasks. One hundred and two participants completed the experiment online. We tested whether training Towards Threat versus Away from Threat contingencies on the predABM would cause subsequent attentional biases towards versus away from threat versus neutral stimuli, respectively. Participants were randomly assigned and compared on attentional bias measured via a post-training Dot-Probe task. A significant difference was found between the attentional bias in the Towards Threat versus Away from Threat group. The training contingencies induced effects on bias in the expected direction, although the bias in each group separately did not reach significance. Stronger effects may require multiple training sessions. Nevertheless, the primary test confirmed the hypothesis, showing that the predABM is a potentially interesting variant of ABM. Theoretically, the results show that automatization may involve the process of selecting the outcome of a cognitive response, rather than a simple stimulus-response association. Training based on contingencies involving predicted stimuli affect subsequent attentional measures and could be of interest in future clinical studies.",2019,"The training contingencies induced effects on bias in the expected direction, although the bias in each group separately did not reach significance.",[],"['novel version of ABM, predictive ABM (predABM', 'Attentional Bias Modification (ABM', 'attentional bias measured via a post-training Dot-Probe task']","['Predictive Attentional Bias Modification', 'anticipatory attentional biases', 'attentional bias']",[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",102.0,0.033951,"The training contingencies induced effects on bias in the expected direction, although the bias in each group separately did not reach significance.","[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Gladwin', 'Affiliation': 'Institute of Education, Health and Social Sciences, University of Chichester, Chichester, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Möbius', 'Affiliation': 'Behavioural Science Institute, Radboud University Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Eni S', 'Initials': 'ES', 'LastName': 'Becker', 'Affiliation': 'Behavioural Science Institute, Radboud University Nijmegen, Nijmegen, The Netherlands.'}]",Europe's journal of psychology,['10.5964/ejop.v15i3.1633']
1397,33680093,Effects of Lee Silverman Voice Treatment BIG and conventional physiotherapy on non-motor and motor symptoms in Parkinson's disease: a randomized controlled study comparing three exercise models.,"Background


Parkinson's disease (PD) patients experience disabling motor dysfunctions as well as non-motor symptoms (NMSs) that can highly impact their perceived quality of life. Besides pharmacological treatment options, active intervention programs have set some attention in managing these symptoms. However, previous studies mainly assessed the effectiveness of active intervention programs on functional mobility and motor symptoms.
Objective


This study aimed to investigate the effect of Lee Silverman Voice Treatment (LSVT) BIG, an intensified and personalized physiotherapy (INTENSIVE), and a conventional physiotherapy (NORMAL) on NMSs in PD.
Method


Forty-four patients with mild to moderate PD were randomly assigned to one of the three treatment groups. LSVT BIG and INTENSIVE were delivered one-on-one in 16 1-hour sessions within 4 weeks (4×/week). Patients assigned to NORMAL received 16 individual 1-hour sessions within 8 weeks (2×/week). The primary outcome measure was the difference in change from baseline in the non-motor symptom assessment scale for Parkinson's disease (NMSS) between treatment groups to follow up at week 8. Patients were blinded for the NMSS being the primary outcome, but not the different treatment groups.
Results


ANCOVA (Analysis of Covariance) showed reduced NMSS scores for all groups, with INTENSIVE being superior to NORMAL ( p  = 0.033). For secondary outcome measures (stride length, gait velocity and chair rising test) LSVT BIG and INTENSIVE were both superior to NORMAL.
Conclusions


The study provides evidence that all three exercise programs are effective techniques to improve NMSs as well as motor function in PD.
DRKS registration number


DRKS00008732.",2021,"Results


ANCOVA (Analysis of Covariance) showed reduced NMSS scores for all groups, with INTENSIVE being superior to NORMAL ( p  = 0.033).","[""Parkinson's disease"", 'Method\n\n\nForty-four patients with mild to moderate PD']","['Lee Silverman Voice Treatment (LSVT) BIG', 'conventional physiotherapy (NORMAL', 'Lee Silverman Voice Treatment BIG and conventional physiotherapy']","['NMSS scores', 'functional mobility and motor symptoms', ""non-motor symptom assessment scale for Parkinson's disease (NMSS"", 'non-motor and motor symptoms', 'stride length, gait velocity and chair rising test']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",44.0,0.111929,"Results


ANCOVA (Analysis of Covariance) showed reduced NMSS scores for all groups, with INTENSIVE being superior to NORMAL ( p  = 0.033).","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Schaible', 'Affiliation': 'Department of Neurology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry, University Hospital of Cologne, Medical Faculty, Cologne, Germany.'}, {'ForeName': 'Timo Marcel', 'Initials': 'TM', 'LastName': 'Buchwitz', 'Affiliation': 'Department of Neurology, University Hospital of Marburg, Marburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neurology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Hoock', 'Affiliation': 'Department of Neurology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Eckhard', 'Initials': 'E', 'LastName': 'Schönau', 'Affiliation': 'Pediatric Endocrinology, University Hospital of Cologne, Cologne, Germany University of Cologne, Medical Faculty and University Hospital, Center of Prevention and Rehabilitation, UniReha, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Libuda', 'Affiliation': 'University of Cologne, Medical Faculty and University Hospital, Center of Prevention and Rehabilitation, UniReha, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hordt', 'Affiliation': 'University of Cologne, Medical Faculty and University Hospital, Center of Prevention and Rehabilitation, UniReha, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'van Eimeren', 'Affiliation': 'Department of Nuclear Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Timmermann', 'Affiliation': 'Department of Neurology, University Hospital of Marburg, Marburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Eggers', 'Affiliation': 'Department of Neurology, University Hospital Marburg, Baldingerstr. 1, Marburg 35033, Germany Marburg Center of Mind, Brain and Behavior, Marburg, Germany.'}]",Therapeutic advances in neurological disorders,['10.1177/1756286420986744']
1398,33680059,"Cognitive Improvement and Safety Assessment of a Dietary Supplement Containing Propolis Extract in Elderly Japanese: A Placebo-Controlled, Randomized, Parallel-Group, Double-Blind Human Clinical Study.","Objectives . This study aimed to evaluate the effect of propolis on cognitive function in elderly Japanese with a placebo-controlled design.  Material and Methods . This study was performed on 79 elderly Japanese. Participants orally received either a placebo or dietary supplement containing propolis extract for 24 weeks. Cognitive function assessed by Cognitrax and various blood or urine markers were measured at pre- and postadministration.  Results and Conclusion . Eligible data from 68 subjects (placebo: 33, propolis: 35) who completed the study were analyzed. Compared to the placebo group, the propolis group showed significant improvement in verbal memory in Cognitrax ( P =0.028). Total cholesterol, LDL cholesterol, urea nitrogen, creatinine, and uric acid were significantly improved in the propolis group compared to the placebo group ( P  = 0.011,  P  = 0.004,  P  = 0.048,  P  = 0.045, and  P  = 0.005, respectively). However, urea nitrogen, creatinine, and uric acid fluctuated within the normal level. Furthermore, a subgroup analysis was performed on those with higher than 100 of the standardized score of the neurocognitive index indicated by the overall Cognitrax score. Significant improvements in the propolis group compared to placebo were confirmed in verbal memory ( P  = 0.007) and processing speed as indications for information processing ability, complex attention, and concentration ( P  = 0.029). No side effects were observed in any of the groups. This study demonstrates that propolis is effective in improving cognitive functions such as memory, information processing, complex attention, and concentration in elderly Japanese.",2021,"Significant improvements in the propolis group compared to placebo were confirmed in verbal memory ( P  = 0.007) and processing speed as indications for information processing ability, complex attention, and concentration ( P  = 0.029).","['68 subjects (placebo: 33, propolis: 35) who completed the study were analyzed', 'elderly Japanese with a placebo-controlled design', 'Elderly Japanese', '79 elderly Japanese', 'elderly Japanese']","['Dietary Supplement Containing Propolis Extract', 'Placebo', 'placebo', 'placebo or dietary supplement containing propolis extract']","['urea nitrogen, creatinine, and uric acid fluctuated', 'Total cholesterol, LDL cholesterol, urea nitrogen, creatinine, and uric acid', 'side effects', 'Cognitive Improvement and Safety Assessment', 'Cognitive function assessed by Cognitrax and various blood or urine markers', 'processing speed as indications for information processing ability, complex attention, and concentration', 'cognitive function', 'verbal memory in Cognitrax', 'verbal memory']","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0231241', 'cui_str': 'Fluctuating'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0584951', 'cui_str': 'Ability to process information'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",79.0,0.289173,"Significant improvements in the propolis group compared to placebo were confirmed in verbal memory ( P  = 0.007) and processing speed as indications for information processing ability, complex attention, and concentration ( P  = 0.029).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Asama', 'Affiliation': 'Institute for Bee Products and Health Science, R&D Department, Yamada Bee Company, Inc., Okayama, Japan.'}, {'ForeName': 'Toshihito', 'Initials': 'T', 'LastName': 'Hiraoka', 'Affiliation': 'Institute for Bee Products and Health Science, R&D Department, Yamada Bee Company, Inc., Okayama, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ohkuma', 'Affiliation': 'Research Center for Immunological Analysis, Inc., Okayama, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Okumura', 'Affiliation': 'Institute for Bee Products and Health Science, R&D Department, Yamada Bee Company, Inc., Okayama, Japan.'}, {'ForeName': 'Ayanori', 'Initials': 'A', 'LastName': 'Yamaki', 'Affiliation': 'Institute for Bee Products and Health Science, R&D Department, Yamada Bee Company, Inc., Okayama, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Urakami', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, Tottori, Japan.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/6664217']
1399,33680000,Effects of cognitive bias modification for interpretation on hostile interpretation bias and self-reported aggression in juvenile delinquents.,"Background/Objective


The social information processing model holds that aggressive behavior is closely related to the hostile interpretation of ambiguous social cues, suggesting the possibility that an intervention that reduces hostile interpretations could reduce aggression. This study in Mainland China evaluated the remediating effects of cognitive bias modification for interpretation (CBM-I) on the hostile interpretation bias and self-reported aggressive behaviors of male juvenile delinquents, taking into account initial hostile interpretation bias as a possible moderator of the intervention effect.
Method


Fifty-six male juvenile delinquents aged 16-18 were recruited and randomly assigned to the CBM-I group ( n  = 28) or the Waiting-List group ( n  = 28). Interpretation bias and self-reported aggressive behavior were assessed at pre-test and post-test.
Results


The positive interpretations of participants in the CBM-I group were significantly increased compared with participants in the Waiting-List group. The intervention effect of CBM-I on self-reported physical aggression was significant only for juvenile delinquents with high pre-test hostile interpretation bias.
Conclusions


CBM-I can significantly improve the positive interpretation bias of juvenile delinquents, and reduce the self-reported physical aggression for some male juvenile delinquents. The results have implications for providing low-cost and high-efficiency intervention for juvenile delinquents' self-reported aggression behavior.",2021,The positive interpretations of participants in the CBM-I group were significantly increased compared with participants in the Waiting-List group.,"['Method\n\n\nFifty-six male juvenile delinquents aged 16-18', 'male juvenile delinquents', 'juvenile delinquents']",['CBM-I group ( n  = 28) or the Waiting-List group'],['physical aggression'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0522175', 'cui_str': 'Delinquent'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0424323', 'cui_str': 'Physical aggression'}]",56.0,0.0351356,The positive interpretations of participants in the CBM-I group were significantly increased compared with participants in the Waiting-List group.,"[{'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, China.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, China.'}, {'ForeName': 'Xianglian', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, China.'}]",International journal of clinical and health psychology : IJCHP,['10.1016/j.ijchp.2021.100226']
1400,33680007,"A Randomized, Open, Single-Centre, Crossed Study of the Effect of Food on the Pharmacokinetics of One Oral Dose of Alflutinib Mesylate Tablets (AST2818) in Healthy Male Subjects.","The aim of the study was to study the PK of AST2818 tablets after one oral dose in healthy male subjects on an empty stomach and in a postprandial state and to evaluate the effect of food on AST2818 bioavailability. Sixteen healthy Chinese male subjects were randomly divided into two groups: a fasting-postprandial group and a postprandial-fasting group. The drug was administered once per evaluation at a dose of 80 mg, with an interval of 22 days between the two treatments. The LC-MS/MS method was used to determine the concentrations of AST2818 and its metabolite AST5902. Plasma pharmacokinetic parameters were calculated by noncompartmental analysis (NCA). WinNonlin® version 7.0 was used to analyse PK parameters, and SAS version 9.4 was used for statistical analyses. After a meal, the peak concentration of alflutinib increased by approximately 53%, and the AUC increased by approximately 32%; The peak concentration of its metabolite AST5902 decreased by approximately 20%, and the AUC decreased by approximately 8%. There was no significant change in peak time. The peak AST5902 concentration and AUC 0-∞  were 27.4% and 71.4%, respectively, of that of alflutinib. None of the subjects experienced serious AEs, and both fasting and high-fat meal administration were safe. There was no statistically significant difference between groups in AEs ( P  = 0.102, RR = 1.40) or adverse reactions ( P  = 0.180, RR = 1.30). The effects of food may not need to be considered for the clinical use of alflutinib. No serious AEs occurred, and drug administration was safe and tolerable after fasting or a high-fat meal.",2020,"There was no statistically significant difference between groups in AEs ( P  = 0.102, RR = 1.40) or adverse reactions ( P  = 0.180, RR = 1.30).","['healthy male subjects', 'Sixteen healthy Chinese male subjects', 'Healthy Male Subjects']","['fasting-postprandial group and a postprandial-fasting group', 'Alflutinib Mesylate Tablets (AST2818']","['peak concentration of alflutinib', 'peak AST5902 concentration and AUC 0-∞', 'peak concentration of its metabolite AST5902', 'AUC', 'Plasma pharmacokinetic parameters', 'adverse reactions', 'peak time']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025619', 'cui_str': 'Mesilates'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",16.0,0.022718,"There was no statistically significant difference between groups in AEs ( P  = 0.102, RR = 1.40) or adverse reactions ( P  = 0.180, RR = 1.30).","[{'ForeName': 'Songlin', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Department of Early Clinical Trail Center, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}, {'ForeName': 'Jianfu', 'Initials': 'J', 'LastName': 'Heng', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Department of Early Clinical Trail Center, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Early Clinical Trail Center, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Early Clinical Trail Center, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Lung Cancer and Gastroenterology, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}, {'ForeName': 'Xiaobao', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410006, China.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2020.113112.14116']
1401,33680006,"The Effectiveness of Intranasal Oxytocin on Addiction Severity Index and Anhedonia Symptoms in an Alcoholic Case with Oropharyngeal Cancer, a Protocol for a Single-case Experimental Design Pilot Study.","One of the goals of all pharmacological interventions aimed to increase the survival rate of patients with alcohol-dependent oropharyngeal cancers is to decrease alcohol use. Oxytocin is an alternative therapy for craving and alcohol management. However, the effectiveness of oxytocin on the severity of alcohol dependence has not been evaluated. In an ABABC study with a 6-month follow-up, during February 2015 to June 2016, a 67-year-old man with oropharyngeal squamous cell carcinoma with comorbidity of alcohol dependence syndrome and anhedonia was selected by Respondent-Driven sampling (RDS). The patient was treated with intranasal oxytocin in two six-week stages (B 1  and B 2 ) and received placebo only in the other two stages (A 1  and A 2 ), and the follow-up results were evaluated at stage C. The data were analyzed by Generalized Estimation Equation (GEE) and Repeated Measures Correlation (rmcorr). Primary outcomes showed that addiction severity Index (ASI) was significantly reduced in five domains of medical status, occupational status, alcohol consumption, family status, and mental status (all  p 's < 0.05). There was no significant effect of treatment on legal status (all  p 's > 0.05). Also, social ( p  < 0.05) and physical ( p  < 0.01) anhedonia syndrome decreased in the treatment stages. However, these changes did not persist until the 6-month follow-up (all  p 's > 0.05). Secondary outcomes showed that there was a significant direct relationship between the severity of addiction and anhedonia (r mcorr  = 0.01). The findings of this study showed that the reduction of oxytocin-induced neurotoxic symptoms led to a decrease in the severity of addiction and an improvement in the anhedonia syndrome.",2020,"Also, social ( p  < 0.05) and physical ( p  < 0.01) anhedonia syndrome decreased in the treatment stages.","['67-year-old man with oropharyngeal squamous cell carcinoma with comorbidity of alcohol dependence syndrome and anhedonia was selected by Respondent-Driven sampling (RDS', 'patients with alcohol-dependent oropharyngeal cancers', 'Alcoholic Case with Oropharyngeal Cancer']","['Intranasal Oxytocin', 'placebo', 'intranasal oxytocin', 'oxytocin', 'Oxytocin']","['addiction severity Index (ASI', 'severity of addiction', 'Addiction Severity Index and Anhedonia Symptoms', 'anhedonia syndrome', 'survival rate', 'medical status, occupational status, alcohol consumption, family status, and mental status ', 'legal status', 'severity of addiction and anhedonia']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0014006', 'cui_str': 'Occupational Status'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0242365', 'cui_str': 'Legal status'}]",,0.0149183,"Also, social ( p  < 0.05) and physical ( p  < 0.01) anhedonia syndrome decreased in the treatment stages.","[{'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Pirnia', 'Affiliation': 'Department of Psychology, Faculty of Humanities, University of Science and Culture, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Hamdieh', 'Affiliation': 'Department of Psychosomatic, Taleghani Hospital, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kazemi Ashtiani', 'Affiliation': 'Department of Counselling, Faculty of Psychology, Arak Branch, Islamic Azad University, Arak, Iran.'}, {'ForeName': 'Parastoo', 'Initials': 'P', 'LastName': 'Malekanmehr', 'Affiliation': 'Department of Psychology, Faculty of Psychology, Tonekabon Branch, Islamic Azad University, Tonekabon, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Pirnia', 'Affiliation': 'Bijan Center for Substance Abuse Treatment, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zahiroddin', 'Affiliation': 'Department of Psychiatry, Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran .'}, {'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Psychology, Tehran Science and Research Branch, Islamic Azad University, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2020.14338.12314']
1402,33680003,Comparison of whole-body vibration training and quadriceps strength training on physical function and neuromuscular function of individuals with knee osteoarthritis: A randomised clinical trial.,"Background


Knee osteoarthritis (KOA) is one of the leading causes of global disability, which causes knee pain, stiffness and swelling. Impaired neuromuscular function may cause joint instability, alignment changes and knee stress, which leads to the progression of KOA. Whole-body vibration (WBV) training is considered to improve pain and functional mobility effectively. However, few studies have investigated the therapeutic effect of WBV on neuromuscular function in KOA.
Material and methods


A single-blinded, randomised, controlled trial was performed on 81 participants diagnosed with KOA. The participants were randomised into three groups: (1) WBV group, in which participants performed strength training (ST) with vibration exposure for 8 weeks; (2) ST group, in which participants performed ST without vibration for 8 weeks; and (3) health education (HE) group, in which participants received a HE for 8 weeks. The visual analogue scale for knee pain, isokinetic muscle strength test, proprioception test, Timed Up and Go test (TUG) and 6-min Walk Distance test (6MWD) were performed before and after the interventions.
Results


No significant difference was found on pain, proprioception, TUG and 6MWD. A significant interaction effect was found in isokinetic muscle strength between groups. Further analysis showed that compared with the HE group, the WBV group exhibited significantly greater improvement in isokinetic muscle strength (peak torque [PT] of extensors, p < 0.01, 95% CI = 0.11-0.33 Nm/kg; PT of flexors, p = 0.01, 95% CI = 0.02-0.19 Nm/kg; peak work [PW] of extensors, p < 0.01, 95% CI = 0.12-0.75 W/kg). In addition, compared with the ST group, the muscle strength of the WBV group (PT of extensors, p < 0.01, 95% CI = 0.10-0.32 Nm/kg; PW of extensors, p < 0.01, 95% CI = 0.09-0.71 W/kg) improved significantly.
Conclusion


Our findings suggested that adding WBV training to ST might benefit muscle strength around the knee joint in patients with KOA.",2021,"Nm/kg; PW of extensors, p < 0.01, 95% CI = 0.09-0.71 W/kg) improved significantly.
","['\n\n\nKnee osteoarthritis (KOA', '81 participants diagnosed with KOA', 'individuals with knee osteoarthritis', 'patients with KOA']","['Whole-body vibration (WBV) training', 'whole-body vibration training and quadriceps strength training', 'strength training (ST) with vibration exposure for 8 weeks; (2) ST', 'ST without vibration for 8 weeks; and (3) health education (HE']","['pain and functional mobility effectively', 'isokinetic muscle strength (peak torque [PT', 'muscle strength', 'physical function and neuromuscular function', 'visual analogue scale for knee pain, isokinetic muscle strength test, proprioception test, Timed Up and Go test (TUG) and 6-min Walk Distance test (6MWD', 'pain, proprioception, TUG and 6MWD', 'isokinetic muscle strength']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3160837', 'cui_str': 'Walking distance test'}]",81.0,0.0499278,"Nm/kg; PW of extensors, p < 0.01, 95% CI = 0.09-0.71 W/kg) improved significantly.
","[{'ForeName': 'Zhangqi', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Seullee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yiyang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, Canada.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2021.01.003']
1403,33679914,Clinical outcome of Montelukast Sodium in Children with Adenoid Hypertrophy.,"Background & Objectives


Generally, the blockage of upper respiratory tract in children is seen with the hypertrophy of adenoids and tonsils. Normally for patients with adenoid hypertrophy (AH), Adenoidectomy with or without Tonsillectomy is carried out, however it has its own complications like haemorrhage and recurrence of adenoid tissue. Consequently, therapeutic approach has increased extraordinary consideration rather than surgical procedure. The inflammatory process proposed for AH has prompted the utilization of anti-inflammatory drugs to treat this issue. The objective of this study was to assess the impacts of Montelukast sodium in children with enlarged adenoids.
Methods


A randomized controlled trail was performed from April 2018 to March 2019 in the Otorhinolaryngology clinic of Dr. Akbar Niazi Teaching Hospital, Islamabad. In this randomized, placebo treatment-controlled trial, 60 children aged 4-12 years meeting inclusion criteria were isolated into two groups. The study group was treated with Montelukast sodium 5mg consistently for three months while the control group got placebo treatment for a similar timeframe. A questionnaire was filled by parents/ guardians of every child before and after the intervention to evaluate the severity of sleep discomfort, snoring and mouth breathing.
Results


Following 3 months of treatment, significant reduction in size of the adenoids was seen in 76% of study group compared with just 3% of control group getting placebo treatment.
Conclusion


Montelukast sodium seems to be effective in the reduction of the size of adenoids and improvement in clinical manifestations. It can be viewed as a viable option in contrast to surgical treatment in children with hypertrophy of adenoids.",2021,"Following 3 months of treatment, significant reduction in size of the adenoids was seen in 76% of study group compared with just 3% of control group getting placebo treatment.
","['children with enlarged adenoids', 'patients with adenoid hypertrophy (AH), Adenoidectomy with or without Tonsillectomy', '60 children aged 4-12 years meeting inclusion criteria were isolated into two groups', 'children with hypertrophy of adenoids', 'Children with Adenoid Hypertrophy', 'April 2018 to March 2019 in the Otorhinolaryngology clinic of Dr. Akbar Niazi Teaching Hospital, Islamabad']","['placebo', 'Montelukast sodium', 'Montelukast Sodium']","['severity of sleep discomfort, snoring and mouth breathing', 'size of the adenoids']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0380447', 'cui_str': 'Montelukast sodium'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0026635', 'cui_str': 'Mouth breathing'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}]",60.0,0.035832,"Following 3 months of treatment, significant reduction in size of the adenoids was seen in 76% of study group compared with just 3% of control group getting placebo treatment.
","[{'ForeName': 'Syed Ali', 'Initials': 'SA', 'LastName': 'Naqi', 'Affiliation': 'Prof. Dr. Syed Ali Naqi, FCPS (ENT). Professor & HOD ENT, Islamabad Medical and Dental College, Islamabad Pakistan.'}, {'ForeName': 'Ahmad Hassan', 'Initials': 'AH', 'LastName': 'Ashfaq', 'Affiliation': 'Dr. Ahmad Hassan Ashfaq, FCPS (ENT). Associate Prof., Rawalpindi Medical University, Rawalpindi, Pakistan.'}, {'ForeName': 'Mumtaz Ahmad', 'Initials': 'MA', 'LastName': 'Umar', 'Affiliation': 'Dr. Mumtaz Ahmad Umar, FCPS (ENT). Assistant Professor, Islamabad Medical and Dental College, Islamabad Pakistan.'}, {'ForeName': 'Jais Kumar', 'Initials': 'JK', 'LastName': 'Karmani', 'Affiliation': 'Dr. Jais Kumar Karmani, MD (Medicine). Assistant Professor, Islamabad Medical and Dental College, Islamabad Pakistan.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Arshad', 'Affiliation': 'Dr. Naveed Arshad, M.Phil. (Rehabilitation Sciences). Assistant Professor, Islamabad Medical and Dental College, Islamabad Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.37.2.2670']
1404,33679906,An observation of the clinical efficacy of combining Riluzole with mannitol and hyperbaric oxygen in treating acute spinal cord injury.,"Objective


To examine the clinical efficacy of combining Riluzole with mannitol and hyperbaric oxygen therapy in treating thoracolumbar vertebral fracture-induced acute spinal cord injury (ASCI).
Methods


From June 2015 to May 2018, 80 patients with thoracolumbar fractures and ASCI who were treated at Baoding First Central Hospital were selected. All patients underwent posterior laminectomy and screw fixation, and they were randomly divided into two groups using a random number table method. The control group received conventional postoperative treatment, while the experimental group was treated with riluzole combined with mannitol and hyperbaric oxygen on the basis of conventional treatment. The recovery of nerve function which included motor function and sensory function, and the changes of serum IL-6, CRP, BDNF, BFGF and other factors before treatment and four weeks after treatment of the two groups of patients were observed and evaluated.
Results


After treatment, the motor function scores and sensory function scores of the two groups of patients were improved compared with those before treatment (p<0.05). Compared with the control group, the experimental group improved significantly, and the difference was statistically significant (p<0.05). The levels of IL-6, BDNF and NFGF in the experimental group were significantly lower than those in the control group (p<0.05).
Conclusions


For patients with thoracolumbar fractures and ASCI undergoing laminar decompression and fixation, the comprehensive treatment plan of riluzole combined with mannitol and hyperbaric oxygen has certain advantages. Compared with the conventional therapy, it may significantly improve the movement and sensory functions of patients, relieve the inflammatory response of spinal cord, and promote recovery from the injury.",2021,"The levels of IL-6, BDNF and NFGF in the experimental group were significantly lower than those in the control group (p<0.05).
","['80 patients with thoracolumbar fractures and ASCI who were treated at Baoding First Central Hospital were selected', 'treating acute spinal cord injury', 'patients with thoracolumbar fractures and ASCI undergoing laminar decompression and fixation', 'treating thoracolumbar vertebral fracture-induced acute spinal cord injury (ASCI']","['conventional postoperative treatment', 'riluzole combined with mannitol and hyperbaric oxygen', 'Riluzole with mannitol and hyperbaric oxygen', 'posterior laminectomy and screw fixation', 'Riluzole with mannitol and hyperbaric oxygen therapy']","['levels of IL-6, BDNF and NFGF', 'serum IL-6, CRP, BDNF, BFGF and other factors', 'motor function scores and sensory function scores', 'movement and sensory functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205274', 'cui_str': 'Laminar'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",80.0,0.0386235,"The levels of IL-6, BDNF and NFGF in the experimental group were significantly lower than those in the control group (p<0.05).
","[{'ForeName': 'Huan-Xia', 'Initials': 'HX', 'LastName': 'Li', 'Affiliation': 'Huan-xia Li, Department of Neurosurgery, West Part, Baoding First Central Hospital, Baoding, 071000, Hebei, P.R. China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'Jing Cui, Department of Neurosurgery, West Part, Baoding First Central Hospital, Baoding, 071000, Hebei, P.R. China.'}, {'ForeName': 'Jing-Shi', 'Initials': 'JS', 'LastName': 'Fan', 'Affiliation': 'Jing-shi Fan, Department of Neurosurgery, West Part, Baoding First Central Hospital, Baoding, 071000, Hebei, P.R. China.'}, {'ForeName': 'Jian-Zhou', 'Initials': 'JZ', 'LastName': 'Tong', 'Affiliation': 'Jian-zhou Tong, Department of Neurosurgery, West Part, Baoding First Central Hospital, Baoding, 071000, Hebei, P.R. China.'}]",Pakistan journal of medical sciences,['10.12669/pjms.37.2.3418']
1405,33679615,"A Comparison of the Efficacy of Immediate  Versus  Delayed Frozen-Thawed Embryo Transfer on the Ongoing Pregnancy Rate After a Failed IVF Attempt: Study Protocol for a Randomized, Non-Inferiority, Parallel-Group, Controlled Trial.","Introduction


In clinical practice, the ideal time at which to perform a Frozen-thawed Embryo Transfer (FET) after a failed  In-vitro  Fertilization-embryo Transfer (IVF-ET) is still unclear to most practicing physicians. In addition, physicians often delay the introduction of FET due to concerns on the possible residual effects of ovarian hyperstimulation, which may interfere with the regular menstrual cycle. Moreover, given that most of the published studies on the topic are retrospective with contradictory findings, it is crucial to provide evidence-based randomized control guides for clinical practice.
Methods/analysis


The study is a randomized, non-inferiority, parallel-group, controlled trial that will enroll a total of 732 women undergoing their first FET after a failed fresh embryo transfer (ET) cycle. The participants will then be randomized into two groups based on a computer-generated randomized list. The two groups include: (i) an immediate group were FET will be carried out during the first menstrual cycle after a failed fresh ET cycle and (ii) a delayed group where FET will be carried out during the second menstrual cycle after a failed fresh ET cycle. Primary outcomes will be defined as viable pregnancies with fetal heartbeats, diagnosed through pelvic ultrasonography after twelve weeks of gestation.
Ethics and dissemination


The study was approved by the Ethics Committee of the Assisted Reproductive Medicine at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine (SDTCM/E-2020.2.01). In addition, written informed consent will be obtained from all the participants before the study. The results of this trial will be disseminated in a peer-reviewed journal.
Discussion


Currently, there is no consensus with regard to the duration after which the effects of ovarian stimulation are observed after a failed fresh ET and the optimal time required to begin FET. Moreover, no randomized controlled trial exists that compares the ongoing pregnancy rates after immediate versus delayed FET following a failed fresh ET cycle. Therefore, it is important to conduct a well-designed randomized trial to determine whether it is necessary to delay FET for at least one menstrual cycle after the failure of fresh ET.
Clinical Trial Registration


ChiCTR2000033313 (http://www.chictr.org.cn/enIndex.aspx).",2021,"Primary outcomes will be defined as viable pregnancies with fetal heartbeats, diagnosed through pelvic ultrasonography after twelve weeks of gestation.
",['732 women undergoing their first FET after a failed fresh embryo transfer (ET) cycle'],"['Immediate  Versus', 'FET', 'Delayed Frozen-Thawed Embryo Transfer']","['viable pregnancies with fetal heartbeats, diagnosed through pelvic ultrasonography', 'pregnancy rates', 'Ongoing Pregnancy Rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0404843', 'cui_str': 'Viable pregnancy'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",732.0,0.0985133,"Primary outcomes will be defined as viable pregnancies with fetal heartbeats, diagnosed through pelvic ultrasonography after twelve weeks of gestation.
","[{'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Reproductive and Genetic Center of Integrated Traditional and Western Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Fengyi', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Child Rehabilitation Center, Jinan Maternity and Child Care Hospital, Jinan, China.'}, {'ForeName': 'Yunhan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Mengyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Yixuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Jingyan', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.603158']
1406,33679517,The Effects of an In-vehicle Collision Warning System on Older Drivers' On-road Head Movements at Intersections.,"With age might come a decline in crucial driving skills. The effect of a collision warning system (CWS) on older drivers' head movements behavior at intersections was examined.  Methods:  Twenty-six old-adults, between 55 and 64 years of age, and 16 Older drivers between 65 and 83 years of age, participated in the study. A CWS (Mobileye Inc.) and a front-back in-vehicle camera (IVC) were installed in each of the participants' own vehicles for 6 months. The CWS was utilized to identify unsafe events during naturalistic driving situations, and the IVC was used to capture head direction at intersections. The experimental design was conducted in three phases (baseline, intervention, and carryover), 2 months each. Unsafe events were recorded by the CWS during all phases of the study. In the second phase, the CWS feedback was activated to examine its effect on drivers' head movement' behavior at intersections.  Results:  Older drivers (65+) drove significantly more hours in total during the intervention phase ( M  = 79.1 h,  SE  = 10) than the baseline phase ( M  = 39.1 h,  SE  = 5.3) and the carryover phase ( M  = 37.7 h,  SE  = 5.4). The study revealed no significant differences between the head movements of older and old-adult drivers at intersections. For intersection on the left direction, a significant improvement in drivers' head movements' behavior was found at T-junctions, turns and four-way intersections from phase 1 to phase 3 ( p  < 0.01), however, two intersection types presented a decrease along the study phases. The head movements' behavior at roundabouts and merges was better at phase 1 compared to phase 3 ( p  < 0.01). There was no significant reduction of the mean number of CWS unsafe events across the study phases.  Conclusions:  The immediate feedback provided by the CWS was effective in terms of participants' head movements at certain intersections but was harmful in others. However, older drivers drove many more hours during the active feedback phase, implying that they trusted the system. Therefore, in the light of this complex picture, using the technological feedback with older drivers should be followed with an additional mediation or follow-up to ensure safety.",2021,"For intersection on the left direction, a significant improvement in drivers' head movements' behavior was found at T-junctions, turns and four-way intersections from phase 1 to phase 3 ( p  < 0.01), however, two intersection types presented a decrease along the study phases.","[""Older Drivers' On-road Head Movements at Intersections"", 'Twenty-six old-adults, between 55 and 64 years of age, and 16 Older drivers between 65 and 83 years of age, participated in the study']","['CWS', 'collision warning system (CWS', 'vehicle Collision Warning System']","[""drivers' head movements' behavior"", 'mean number of CWS unsafe events', 'Unsafe events']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0376591', 'cui_str': 'Head Movements'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0376591', 'cui_str': 'Head Movements'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0160311,"For intersection on the left direction, a significant improvement in drivers' head movements' behavior was found at T-junctions, turns and four-way intersections from phase 1 to phase 3 ( p  < 0.01), however, two intersection types presented a decrease along the study phases.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Shichrur', 'Affiliation': 'Occupational Therapy Department, Faculty of Health Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Navah Z', 'Initials': 'NZ', 'LastName': 'Ratzon', 'Affiliation': 'Occupational Therapy Department, School of Health Professions, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv-Yafo, Israel.'}, {'ForeName': 'Arava', 'Initials': 'A', 'LastName': 'Shoham', 'Affiliation': 'Occupational Therapy Department, School of Health Professions, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv-Yafo, Israel.'}, {'ForeName': 'Avinoam', 'Initials': 'A', 'LastName': 'Borowsky', 'Affiliation': ""The Department of Industrial Engineering and Management, Ben-Gurion University of the Negev, Be'er-Sheva, Israel.""}]",Frontiers in psychology,['10.3389/fpsyg.2021.596278']
1407,33679510,Continuous Support Promotes Obstetric Labor Progress and Vaginal Delivery in Primiparous Women - A Randomized Controlled Study.,"Background:  Obstetric labor and childbirth are mostly regarded as a physiological process, whereas social, cultural, psychological and transcendental aspects have received less attention. Labor support has been suggested to promote labor progress. The aim of this study was to investigate whether continuous labor support by a midwife promotes labor progress and vaginal delivery.  Material and Methods:  A randomized controlled study at a university hospital in Sweden in 2015-17. Primiparous women with singleton pregnancy and spontaneous labor onset were randomized to continuous support ( n  = 30) or standard care ( n  = 29) during delivery. The primary outcome was the duration of active labor. Secondary outcomes were delivery mode, women's need of labor analgesia and satisfaction with delivery, maternal cortisol levels, and neonatal morbidity.  Results:  Continuous support was followed by shorter active labor 11.0 ± 5.7 h compared to 13.7 ± 3.9 h with standard care ( p  = 0.001). Women in the continuous support group tended to have lower cortisol levels and low cortisol during the first ( p  = 0.02) and second ( p  = 0.04) stages of labor were correlated with shorter active labor. Continuous support was followed by spontaneous delivery in 73%, instrumental delivery in 24% and emergency cesarean section in 3% in contrast to standard care which was followed by spontaneous delivery in 62%, instrumental delivery in 24% and cesarean in 14% ( p  = 0.19). The continuous support group received combined analgesic methods more often ( p  = 0.04). Women's satisfaction with delivery and neonatal morbidity were comparable.  Conclusion:  Continuous labor support was followed by shorter active labor compared to standard care. Women with continuous support had a high rate of vaginal delivery and tended to have lower cortisol levels during all stages of active labor reflecting a lower stress level. Low cortisol was correlated to shorter active labor. Based on these results, we recommend continuous labor support for all primiparous women during active labor.",2021,"Continuous support was followed by spontaneous delivery in 73%, instrumental delivery in 24% and emergency cesarean section in 3% in contrast to standard care which was followed by spontaneous delivery in 62%, instrumental delivery in 24% and cesarean in 14% ( p  = 0.19).","['primiparous women during active labor', 'Primiparous Women', 'university hospital in Sweden in 2015-17', 'Primiparous women with singleton pregnancy and spontaneous labor onset']",['continuous support ( n  = 30) or standard care'],"['high rate of vaginal delivery', 'lower cortisol levels and low cortisol', ""delivery mode, women's need of labor analgesia and satisfaction with delivery, maternal cortisol levels, and neonatal morbidity"", 'Low cortisol', 'cortisol levels', 'Obstetric Labor Progress and Vaginal Delivery', 'duration of active labor', ""Women's satisfaction with delivery and neonatal morbidity""]","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0740379', 'cui_str': 'Cortisol decreased'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}]",,0.103231,"Continuous support was followed by spontaneous delivery in 73%, instrumental delivery in 24% and emergency cesarean section in 3% in contrast to standard care which was followed by spontaneous delivery in 62%, instrumental delivery in 24% and cesarean in 14% ( p  = 0.19).","[{'ForeName': 'Ylva Vladic', 'Initials': 'YV', 'LastName': 'Stjernholm', 'Affiliation': ""Department of Women's and Children's Health Obstetric Unit, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Paula da Silva', 'Initials': 'PDS', 'LastName': 'Charvalho', 'Affiliation': ""Department of Women's and Children's Health Obstetric Unit, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bergdahl', 'Affiliation': ""Department of Women's and Children's Health Obstetric Unit, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Vladic', 'Affiliation': ""Department of Women's and Children's Health, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Petersson', 'Affiliation': 'Department of Endocrinology, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.582823']
1408,33679507,Innovative Pedagogy and Design-Based Research on Flipped Learning in Higher Education.,"In order for higher education to provide students with up-to-date knowledge and relevant skillsets for their continued learning, it needs to keep pace with innovative pedagogy and cognitive sciences to ensure inclusive and equitable quality education for all. An adequate implementation of flipped learning, which can offer undergraduates education that is appropriate in a knowledge-based society, requires moving from traditional educational models to innovative pedagogy integrated with a playful learning environment (PLE) supported by information and communications technologies (ICTs). In this paper, based on the design-based research, a task-driven instructional approach in the flipped classroom (TDIAFC) was designed and implemented for two groups of participants in an undergraduate hands-on making course in a PLE. One group consisting of 81 students as the experimental group (EG) received flipped learning instruction, and another group of 79 students as the control group (CG) received lecture-centered instruction. The EG students experienced a three-round study, with results from the first round informing the customized design of the second round and the second round informing the third round. The experimental results demonstrated that students in the EG got higher scores of summative tests and final scores than those in the CG. In particular, students' learning performance in three domains (i.e., cognitive, affective, and psychomotor) differ significantly between the two groups.",2021,"An adequate implementation of flipped learning, which can offer undergraduates education that is appropriate in a knowledge-based society, requires moving from traditional educational models to innovative pedagogy integrated with a playful learning environment (PLE) supported by information and communications technologies (ICTs).",[],"['flipped learning instruction, and another group of 79 students as the control group (CG) received lecture-centered instruction']",['summative tests and final scores'],[],"[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0110578,"An adequate implementation of flipped learning, which can offer undergraduates education that is appropriate in a knowledge-based society, requires moving from traditional educational models to innovative pedagogy integrated with a playful learning environment (PLE) supported by information and communications technologies (ICTs).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Education Science, Nanjing Normal University, Nanjing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'School of Education Science, Nanjing Normal University, Nanjing, China.'}, {'ForeName': 'Yu-Sheng', 'Initials': 'YS', 'LastName': 'Su', 'Affiliation': 'Department of Computer Science and Engineering, National Taiwan Ocean University, Keelung, Taiwan.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.577002']
1409,33679482,Intermittent Theta-Burst Stimulation Over the DorsoLateral PreFrontal Cortex (DLPFC) in Healthy Subjects Produces No Cumulative Effect on Cortical Excitability.,"Background:  Intermittent Theta Burst Stimulation (iTBS) is a design of repetitive Transcranial Magnetic Stimulation (rTMS) and could be a candidate to replace rTMS in the treatment of depression, thanks to its efficacy, shorter duration, and ease of use. The antidepressant mechanism of iTBS, and whether this mechanism is mediated by a modulation of cortical excitability, remains unknown.  Methods:  Using a randomized double-blind, sham-controlled trial, 30 healthy volunteers received either iTBS or a sham treatment targeting the left DorsoLateral PreFrontal Cortex (L-DLPFC), twice a day over 5 consecutive days. Cortical excitability was measured before and after the 5 days of stimulation.  Results:  No difference in cortical excitability was observed between active or sham iTBS.  Conclusion:  Our study does not support any effect on cortical excitability of repetitive iTBS targeting the L-DLPFC.",2021,No difference in cortical excitability was observed between active or sham iTBS.  ,"['Healthy Subjects', '30 healthy volunteers']","[':  Intermittent Theta Burst Stimulation (iTBS', 'Intermittent Theta-Burst Stimulation Over the DorsoLateral PreFrontal Cortex (DLPFC', 'iTBS or a sham treatment targeting the left DorsoLateral PreFrontal Cortex (L-DLPFC', 'repetitive Transcranial Magnetic Stimulation (rTMS']","['cortical excitability', 'Cortical Excitability', 'Cortical excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",30.0,0.425308,No difference in cortical excitability was observed between active or sham iTBS.  ,"[{'ForeName': 'Noomane', 'Initials': 'N', 'LastName': 'Bouaziz', 'Affiliation': 'Unité de recherche clinique, Pôle 93G03, EPS de Ville Evrard, Neuilly sur Marne, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Laidi', 'Affiliation': 'Pôle de Psychiatrie, Assistance Publique-Hôpitaux de Paris, Faculté de Médecine de Créteil, DMU IMPACT, Hôpitaux Universitaires Mondor, Créteil, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Thomas', 'Affiliation': 'Unité de recherche clinique, Pôle 93G03, EPS de Ville Evrard, Neuilly sur Marne, France.'}, {'ForeName': 'Palmyre', 'Initials': 'P', 'LastName': 'Schenin-King Andrianisaina', 'Affiliation': 'Unité de recherche clinique, Pôle 93G03, EPS de Ville Evrard, Neuilly sur Marne, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Moulier', 'Affiliation': 'Unité de recherche clinique, Pôle 93G03, EPS de Ville Evrard, Neuilly sur Marne, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Januel', 'Affiliation': 'Unité de recherche clinique, Pôle 93G03, EPS de Ville Evrard, Neuilly sur Marne, France.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2021.626479']
1410,33679467,Effectiveness of CRSCE-Based De-escalation Training on Reducing Physical Restraint in Psychiatric Hospitals: A Cluster Randomized Controlled Trial.,"Background:  The use of physical restraint (PR) causes clinical and ethical issues; great efforts are being made to reduce the use of PR in psychiatric hospitals globally.  Aim:  This study aimed to examine the effectiveness of CRSCE-based de-escalation training on reducing PR in psychiatric hospitals.  Method:  The proposed study adopted cluster randomized controlled trial design. Twelve wards of a psychiatric hospital were randomly allocated to experimental group ( n  = 6) and control group ( n  = 6). Wards of control group were assigned to routine training regarding PR; wards of experimental group underwent the same routine training while additionally received CRSCE-based de-escalation training. Before and after CRSCE-based de-escalation training, the frequency of and the duration of PR, and the numbers and level of unexpected events caused by PR, were recorded.  Results:  After CRSCE-based de-escalation training, the frequency (inpatients and patients admitted within 24 h) of and the duration of PR of experimental group, showed a descending trend and were significantly lower than those of control group ( P  < 0.01); compared to control group, the numbers of unexpected events (level II and level III) and injury caused by PR of experimental group had been markedly reduced ( P  < 0.05).  Conclusions:  CRSCE-based de-escalation training would be useful to reduce the use of PR and the unexpected event caused by PR in psychiatric hospitals. The modules of CRSCE-based de-escalation training can be adopted for future intervention minimizing clinical use of PR.  Clinical Trial Registration:  This study was registered at Chinese Clinical Trial Registry (Registration Number: ChiCTR1900022211).",2021,Wards of control group were assigned to routine training regarding PR; wards of experimental group underwent the same routine training while additionally received CRSCE-based de-escalation training.,"['Twelve wards of a psychiatric hospital', 'Psychiatric Hospitals']","['CRSCE-Based De-escalation Training', 'physical restraint (PR', 'routine training regarding PR; wards of experimental group underwent the same routine training while additionally received CRSCE-based de-escalation training', 'CRSCE-based de-escalation training']",['numbers of unexpected events (level II and level III) and injury caused by PR'],"[{'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0441926', 'cui_str': 'Level II'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",,0.0251041,Wards of control group were assigned to routine training regarding PR; wards of experimental group underwent the same routine training while additionally received CRSCE-based de-escalation training.,"[{'ForeName': 'Junrong', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Zhichun', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Department of Adult Psychiatry, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Early Intervention, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingzhou Central Hospital, Jingzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Intensive Care Unit, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Yunlei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingzhou Central Hospital, Jingzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Sijue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Jiankui', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Aixiang', 'Initials': 'A', 'LastName': 'Xiao', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2021.576662']
1411,33679447,Effects of Power-Oriented Resistance Training With Heavy vs. Light Loads on Muscle-Tendon Function in Older Adults: A Study Protocol for a Randomized Controlled Trial.,"Background


Power-oriented resistance training (PRT) is one of the most effective exercise programs to counteract neuromuscular and physical function age-related declines. However, the optimal load that maximizes these outcomes or the load-specific adaptations induced on muscle power determinants remain to be better understood. Furthermore, to investigate whether these adaptations are potentially transferred to an untrained limb (i.e., cross-education phenomenon) could be especially relevant during limb-immobilization frequently observed in older people (e.g., after hip fracture).
Methods


At least 30 well-functioning older participants (>65 years) will participate in a within-person randomized controlled trial. After an 8-week control period, the effects of two 12-week PRT programs using light vs. heavy loads will be compared using an unilateral exercise model through three study arms (light-load PRT vs. non-exercise; heavy-load PRT vs. non-exercise; and light- vs. heavy- load PRT). Muscle-tendon function, muscle excitation and morphology and physical function will be evaluated to analyze the load-specific effects of PRT in older people. Additionally, the effects of PRT will be examined on a non-exercised contralateral limb.
Discussion


Tailored exercise programs are largely demanded given their potentially greater efficiency preventing age-related negative consequences, especially during limb-immobilization. This trial will provide evidence supporting the use of light- or heavy-load PRT on older adults depending on individual needs, improving decision making and exercise program efficacy.
Clinical Trial Registration


NCT03724461 registration data: October 30, 2018.",2021,"After an 8-week control period, the effects of two 12-week PRT programs using light vs. heavy loads will be compared using an unilateral exercise model through three study arms (light-load PRT vs. non-exercise; heavy-load PRT vs. non-exercise; and light- vs. heavy- load PRT).","['Methods\n\n\nAt least 30 well-functioning older participants (>65 years', 'Older Adults', 'older people']","['PRT', 'Power-Oriented Resistance Training With Heavy vs. Light Loads', 'light- or heavy-load PRT', '\n\n\nPower-oriented resistance training (PRT']","['Muscle-Tendon Function', 'Muscle-tendon function, muscle excitation and morphology and physical function']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0580292,"After an 8-week control period, the effects of two 12-week PRT programs using light vs. heavy loads will be compared using an unilateral exercise model through three study arms (light-load PRT vs. non-exercise; heavy-load PRT vs. non-exercise; and light- vs. heavy- load PRT).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodriguez-Lopez', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Alcazar', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Losa-Reyna', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Noelia Maria', 'Initials': 'NM', 'LastName': 'Martin-Espinosa', 'Affiliation': 'Faculty of Physiotherapy and Nursing, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Baltasar-Fernandez', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Ara', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Csapo', 'Affiliation': 'Research Unit for Orthopaedic Sports Medicine and Injury Prevention, ISAG, University for Health Sciences, Medical Informatics and Technology, Hall in Tirol, Austria.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Alegre', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}]",Frontiers in physiology,['10.3389/fphys.2021.635094']
1412,33679445,Weekly Physiological Changes in Blood Pressure During Three Weeks Daily Consumption of 10 Grams of Cocoa Powder Among Young Black Africans in Côte d'Ivoire.,"Background


In Caucasians, regular consumption of cocoa induces a drop in arterial blood pressure via an increase in nitric oxide (NO) production. However, black individuals have a different NO biodisponibility compared to Caucasians. The aim of this study was to determine, in black Africans, the physiological variations in arterial blood pressure among cocoa consumers.
Method


In total, 49 male black African volunteers, aged between 18 and 30 years old, were randomized into two groups; those consuming 10 g of cocoa powder per day (1,680 mg of flavonoids per day) for 3 weeks (consumer group), and those not consuming cocoa (control group). Systolic (SBP) and diastolic blood pressures (DBP), and heart rate (HR) were measured in the morning on an empty stomach (fasting), on day (D) 1 (without cocoa), D8, D15, and D22. Data were collected by groups and by subgroups established according to the level of SBP, DBP, or HR on D1. The means and variations of the means (between D1 and the subsequent days) of the recorded parameters were calculated and compared between groups and between subgroups.
Results


On D8, the variations in SBP in the consumer group were significantly different from the control group (-3.72 ± 6.01 versus 0.57 ± 6.66 mmHg;  p  = 0.02). Between the control and consumer subgroups according to SBP, no statistical difference in the means or variations in SBP was noted. On D8 and D22, the variations in the SBP of consumers with SBP ≥ 110 mmHg on D1 were significantly different from those of other consumers (D8: -6.55 ± 5.96 versus -1.1 ± 4.93 mmHg;  p  = 0.01; D22: -6.63 ± 7.77 versus 0.35 ± 5.58 mmHg;  p  = 0.01). In the subgroups with a DBP < 75 mmHg on D1, the mean DBP of the consumers was significantly lower than that of the controls on D8 (65 ± 5 versus 69 ± 6 mmHg;  p  = 0.03).
Conclusion


In young black African men living in Côte d'Ivoire, regular consumption of cocoa resulted in a decrease in SBP and DBP. The decrease in SBP appeared to be greater the higher the baseline SBP was.",2021,"On D8, the variations in SBP in the consumer group were significantly different from the control group (-3.72 ± 6.01 versus 0.57 ± 6.66 mmHg;  p  = 0.02).","[""Young Black Africans in Côte d'Ivoire"", '49 male black African volunteers, aged between 18 and 30 years old', ""young black African men living in Côte d'Ivoire""]","['cocoa powder per day (1,680 mg of flavonoids per day) for 3 weeks (consumer group), and those not consuming cocoa (control group', 'Cocoa Powder']","['Systolic (SBP) and diastolic blood pressures (DBP), and heart rate (HR', 'Blood Pressure', 'nitric oxide (NO) production', 'mean DBP of the consumers', 'level of SBP, DBP, or HR on D1', 'SBP and DBP', 'SBP', 'arterial blood pressure']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0009209', 'cui_str': 'Cocoa Powder'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}]",49.0,0.0155061,"On D8, the variations in SBP in the consumer group were significantly different from the control group (-3.72 ± 6.01 versus 0.57 ± 6.66 mmHg;  p  = 0.02).","[{'ForeName': 'Edwige', 'Initials': 'E', 'LastName': 'Siransy-Balayssac', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Soualiho', 'Initials': 'S', 'LastName': 'Ouattara', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Ahiboh', 'Affiliation': ""Laboratoire de Biochimie, Unité de Formation et de Recherche en Sciences Pharmaceutiques et Biologiques, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Toh Bi', 'Initials': 'TB', 'LastName': 'Youzan', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Fagnan Levy', 'Initials': 'FL', 'LastName': 'Gouh', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Koffi Bertrand', 'Initials': 'KB', 'LastName': 'Yao', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Mocket', 'Initials': 'M', 'LastName': 'Ehouman', 'Affiliation': ""Olopam Pharma and Research & Development, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Cyrille Serges', 'Initials': 'CS', 'LastName': 'Dah', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Bogui', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}]",Frontiers in physiology,['10.3389/fphys.2021.634791']
1413,33679430,Effects of Power-Oriented Resistance Training During an Altitude Camp on Strength and Technical Performance of Elite Judokas.,"This study investigated the effect of a 3-week power-oriented resistance training program performed at moderate altitude on leg power output variables in a countermovement jump, a related judo technique ( ippon-seoi-nage ) and the relationship between them. Twenty-four elite male judokas were randomly assigned to a hypobaric hypoxia or normoxia group. Mechanical outputs from an incremental loaded countermovement jump test and the kinematic variables transferred to a dummy during an  ippon-seoi-nage  test (time to execution and movement accelerations) were assessed before, after, 1 and 2 weeks after training. Results indicated an increase in explosive leg capacity both at moderate altitude (2320 m.a.s.l.) and sea level. The hypoxia group showed additional benefits when compared to normoxia group for peak velocities with different percentages of the body weight, maximal theoretical velocity and jump height after the training period, and these additional benefits in jump height were maintained 2 weeks after training. The hypoxia group achieved a higher peak performance in peak velocity and jump height than normoxia group (peak velocity: 8.8 vs. 5.6%, jump height: 8.2 vs. 1.4%, respectively) and was achieved earlier in hypoxia (after training) than in normoxia (1 week after training). However, there was a detrimental effect for the hypoxia group on the times of execution and acceleration of the  ippon-seoi-nage  compared to the normoxia group. These results suggest that altitude training may induce faster and greater improvements in explosive leg extension capacity. Specific technique-oriented training should be included at altitude to prevent technique impairment.",2021,Results indicated an increase in explosive leg capacity both at moderate altitude (2320 m.a.s.l.) and sea level.,"['Elite Judokas', 'Twenty-four elite male judokas']","['3-week power-oriented resistance training program', 'altitude training', 'hypobaric hypoxia or normoxia group', 'Specific technique-oriented training', 'Power-Oriented Resistance Training']","['explosive leg extension capacity', 'peak performance in peak velocity and jump height', 'explosive leg capacity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",,0.0194302,Results indicated an increase in explosive leg capacity both at moderate altitude (2320 m.a.s.l.) and sea level.,"[{'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Almeida', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Granada, Spain.'}, {'ForeName': 'Paulino', 'Initials': 'P', 'LastName': 'Padial', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Bonitch-Góngora', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Granada, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'de la Fuente', 'Affiliation': 'High Performance Center of Sierra Nevada, Spanish Sport Council, Granada, Spain.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, New York, NY, United States.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Morales-Artacho', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Benavente', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Granada, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Feriche', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Granada, Spain.'}]",Frontiers in physiology,['10.3389/fphys.2021.606191']
1414,33679419,"Phase I Trial to Evaluate the Tolerance, Pharmacokinetics and Efficacy of the Broad-Spectrum ErbB Family Inhibitor Larotinib Mesylate in Patients With Advanced Solid Tumors.","Background:  The presented phase I, first-in-human study evaluated the tolerance, pharmacokinetics, and preliminary efficacy of larotinib mesylate in patients with advanced solid tumors.  Methods:  Cancer patients were assigned to receive larotinib mesylate at 50-400 mg dose levels until disease progression or intolerance. Dose-limiting toxicities were assessed during Cycles 0 and 1. Pharmacokinetic evaluations were performed after the first dose and at steady-state.  Results:  Twenty-five patients with solid tumors were enrolled in the dose-escalation study. No DLTs were observed. Acne-like rash (68.0%), diarrhea (48.0%), paronychia (48.0%), and anemia (48.0%) were the most reported treatment-related adverse events. No clear linear pharmacokinetic characteristic could be drawn, and obvious accumulation was observed. Two patients with non-small cell lung cancer experienced a partial response, and 15 patients had stable disease after treatment.  Conclusion:  Continuous oral administration of larotinib mesylate at 50-400 mg daily demonstrated a favorable safety profile, and anti-tumor activity was observed in patients with advanced solid tumors.",2021,No DLTs were observed.,"['Patients', 'patients with advanced solid tumors', 'Twenty-five patients with solid tumors', 'Methods:  Cancer patients', 'Two patients with non-small cell lung cancer experienced a partial response, and 15 patients had stable disease after treatment']","['larotinib mesylate', 'Broad-Spectrum ErbB Family Inhibitor Larotinib Mesylate']","['paronychia', 'Dose-limiting toxicities', 'anemia', 'favorable safety profile, and anti-tumor activity', 'diarrhea', 'Acne-like rash']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0025619', 'cui_str': 'Mesilates'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3812393', 'cui_str': 'Receptor, Transforming-Growth Factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",25.0,0.0603213,No DLTs were observed.,"[{'ForeName': 'Jingrui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Unit, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Trial Unit, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Trial Unit, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Trial Unit, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Unit, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Trial Unit, The First Hospital of Jilin University, Jilin, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2021.636324']
1415,33679369,Dual-Task Exercise to Improve Cognition and Functional Capacity of Healthy Older Adults.,"Background


It has been suggested that physical inactivity and lack of stimulating cognitive activity are the two most significant modifiable risk factors to impair cognitive function. Although many studies that investigated the cognitive effects of physical exercise and cognitive stimuli in dual-task conditions showed improved cognitive performance, others have not confirmed these findings. The main aim of the present work is to analyze the effects of a dual-task multimodal physical exercise training, at moderate intensity, and cognitive stimulation on cognitive and physical function in healthy older adults.
Methods


This clinical trial was registered on the Brazilian Registry of Clinical Trials (RBR-9zrx3d). Here we tested the effects of a dual-task multimodal physical exercise training, at moderate intensity, on cognitive and physical function and quality of life in community dwelling older adults. The training protocol included 24 group sessions, 2/week, per 75 min. Cognition was assessed using CANTAB automated neuropsychological tests and Functional Capacity to Exercise tests. Performance was compared from baseline to post intervention and to a non-exercise control group using Mixed Linear Model for repeated measures.
Results


Control (CG) and dual-task (DTEx) groups progressed differentially over time on performance of episodic memory, sustained visual attention, functional mobility, cardiorespiratory fitness, lower limbs strength resistance, agility, quality of life and dual-task performance with significant improved DTEx performance. Control group did not show any significant changes on these tests except for showing a reduction in dual-task performance.
Conclusion


We suggest that the dual-task combination of multisensory cognitive stimulation and multimodal moderate physical exercise training, twice a week, may be adopted as an effective program to reduce progression of age-related cognitive decline and improve physical fitness and quality of life on healthy older adults.
Clinical Trial Registration


Brazilian Registry of Clinical Trials: https://ensaiosclinicos.gov.br/rg/RBR-9zrx3d -UTN code: U1111-1233-6349.",2021,"Results


Control (CG) and dual-task (DTEx) groups progressed differentially over time on performance of episodic memory, sustained visual attention, functional mobility, cardiorespiratory fitness, lower limbs strength resistance, agility, quality of life and dual-task performance with significant improved DTEx performance.","['Healthy Older Adults', 'community dwelling older adults', 'healthy older adults']","['UTN code', 'https://ensaiosclinicos.gov.br/rg/RBR-9zrx3d', 'Control (CG) and dual-task (DTEx', 'Dual-Task Exercise', 'multisensory cognitive stimulation and multimodal moderate physical exercise training', 'dual-task multimodal physical exercise training']","['cognitive and physical function', 'dual-task performance', 'cognitive performance', 'cognitive and physical function and quality of life', 'physical fitness and quality of life', 'performance of episodic memory, sustained visual attention, functional mobility, cardiorespiratory fitness, lower limbs strength resistance, agility, quality of life and dual-task performance with significant improved DTEx performance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.0173713,"Results


Control (CG) and dual-task (DTEx) groups progressed differentially over time on performance of episodic memory, sustained visual attention, functional mobility, cardiorespiratory fitness, lower limbs strength resistance, agility, quality of life and dual-task performance with significant improved DTEx performance.","[{'ForeName': 'Naina Yuki Vieira', 'Initials': 'NYV', 'LastName': 'Jardim', 'Affiliation': 'Neurodegeneration and Infection Research Laboratory, Institute of Biological Science/João de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.'}, {'ForeName': 'Natáli Valim Oliver', 'Initials': 'NVO', 'LastName': 'Bento-Torres', 'Affiliation': 'Neurodegeneration and Infection Research Laboratory, Institute of Biological Science/João de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.'}, {'ForeName': 'Victor Oliveira', 'Initials': 'VO', 'LastName': 'Costa', 'Affiliation': 'Neurodegeneration and Infection Research Laboratory, Institute of Biological Science/João de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.'}, {'ForeName': 'Josilayne Patricia Ramos', 'Initials': 'JPR', 'LastName': 'Carvalho', 'Affiliation': 'Neurodegeneration and Infection Research Laboratory, Institute of Biological Science/João de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.'}, {'ForeName': 'Helen Tatiane Santos', 'Initials': 'HTS', 'LastName': 'Pontes', 'Affiliation': 'Neurodegeneration and Infection Research Laboratory, Institute of Biological Science/João de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.'}, {'ForeName': 'Alessandra Mendonça', 'Initials': 'AM', 'LastName': 'Tomás', 'Affiliation': 'Neurodegeneration and Infection Research Laboratory, Institute of Biological Science/João de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.'}, {'ForeName': 'Marcia Consentino Kronka', 'Initials': 'MCK', 'LastName': 'Sosthenes', 'Affiliation': 'Neurodegeneration and Infection Research Laboratory, Institute of Biological Science/João de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.'}, {'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Bento-Torres', 'Affiliation': 'Neurodegeneration and Infection Research Laboratory, Institute of Biological Science/João de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.'}, {'ForeName': 'Cristovam Wanderley Picanço', 'Initials': 'CWP', 'LastName': 'Diniz', 'Affiliation': 'Neurodegeneration and Infection Research Laboratory, Institute of Biological Science/João de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2021.589299']
1416,33679355,No Impact of Stochastic Galvanic Vestibular Stimulation on Arterial Pressure and Heart Rate Variability in the Elderly Population.,"Objective


Noisy galvanic vestibular stimulation (nGVS) is often used to improve postural stability in disorders, such as neurorehabilitation montage. For the safe use of nGVS, we investigated whether arterial pressure (AP) and heart rate vary during static supine and slow whole-body tilt with random nGVS (0.4 mA, 0.1-640 Hz, gaussian distribution) in a healthy elderly population.
Methods


This study was conducted with a double-blind, sham-controlled, cross-over design. Seventeen healthy older adults were recruited. They were asked to maintain a static supine position on a bed for 10 min, and the bed was tilted up (TU) to 70 degrees within 30 s. After maintaining this position for 3 min, the bed was passively tilted down (TD) within 30 s. Real-nGVS or sham-nGVS was applied from 4 to 15 min. The time course of mean arterial pressure (MAP) and RR interval variability (RRIV) were analyzed to estimate the autonomic nervous activity.
Result


nGVS and/or time, including pre-/post-event (nGVS-start, TU, and TD), had no impact on MAP and RRIV-related parameters. Further, there was no evidence supporting the argument that nGVS induces pain, vertigo/dizziness, and uncomfortable feeling.
Conclusion


nGVS may not affect the AP and RRIV during static position and whole-body tilting or cause pain, vertigo/dizziness, and discomfort in the elderly.",2021,"Conclusion


nGVS may not affect the AP and RRIV during static position and whole-body tilting or cause pain, vertigo/dizziness, and discomfort in the elderly.","['Seventeen healthy older adults', 'Elderly Population', 'healthy elderly population']","['static supine and slow whole-body tilt with random nGVS', 'Noisy galvanic vestibular stimulation (nGVS', 'Stochastic Galvanic Vestibular Stimulation']","['Arterial Pressure and Heart Rate Variability', 'arterial pressure (AP) and heart rate', 'pain, vertigo/dizziness, and uncomfortable feeling', 'AP and RRIV during static position and whole-body tilting or cause pain, vertigo/dizziness, and discomfort', 'time course of mean arterial pressure (MAP) and RR interval variability (RRIV', 'Result\n\n\nnGVS and/or time, including pre-/post-event (nGVS-start, TU, and TD']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",17.0,0.0861532,"Conclusion


nGVS may not affect the AP and RRIV during static position and whole-body tilting or cause pain, vertigo/dizziness, and discomfort in the elderly.","[{'ForeName': 'Akiyoshi', 'Initials': 'A', 'LastName': 'Matsugi', 'Affiliation': 'Faculty of Rehabilitation, Shijonawate Gakuen University, Osaka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nagino', 'Affiliation': 'Faculty of Allied Health Sciences, Kansai University of Welfare Sciences, Osaka, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Shiozaki', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Faculty of Health Science, Kio University, Nara, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Mori', 'Affiliation': 'Department of Neuromodulation and Neurosurgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Faculty of Health Science, Kio University, Nara, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Douchi', 'Affiliation': 'Department of Rehabilitation, National Hospital Organization Wakayama Hospital, Wakayama, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Oku', 'Affiliation': 'Faculty of Rehabilitation, Kawasaki University of Medical Welfare, Okayama, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Nagano', 'Affiliation': 'Faculty of Rehabilitation, Shijonawate Gakuen University, Osaka, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Tamaru', 'Affiliation': 'Faculty of Rehabilitation, Shijonawate Gakuen University, Osaka, Japan.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2021.646127']
1417,33679306,The Effects of 0.01% Atropine on Adult Myopes' Contrast Sensitivity.,"Purpose


Atropine at a low concentration is considered a safe and effective treatment to mitigate myopia progression. However, the potential unwanted side effects of administering atropine at a low dose on visual functions other than best corrected visual acuity has not been investigated. In this study, we investigate the short-term (12,16, and 20 h) and long-term (1, 2, and 4 weeks) effects of 0.01% atropine (i.e., 0.1 mg/ml) on contrast sensitivity (CS) in patients with myopia.
Methods


Thirty adults (23.33 ± 2.93 years old) with myopia between -1.00 and -6.00 diopters (D), astigmatism of -1.50 D or less, and anisometropia of 1.00 D or less, participated in this prospective, masked, placebo-controlled, randomized study. The participants were randomly assigned to receive 0.01% atropine or polyvinyl alcohol eye drops once nightly to both eyes for four weeks. CS was measured binocularly at baseline and 12, 16, 20 h, 1, 2, and 4 weeks after the first use of the eye drops.
Results


There was no statistically significant differences of CS found between atropine and placebo-controlled groups in both short-term and long-term. There was no statistically significant interaction effect found between the time and group.
Conclusion


We demonstrated no significant deleterious effect of 0.01% atropine on adult myopes' CS.",2021,There was no statistically significant differences of CS found between atropine and placebo-controlled groups in both short-term and long-term.,"['patients with myopia', 'Methods\n\n\nThirty adults (23.33 ± 2.93 years old) with myopia between -1.00 and -6.00 diopters (D), astigmatism of -1.50 D or less, and anisometropia of 1.00 D or less']","['Atropine', 'atropine', 'atropine or polyvinyl alcohol eye drops', 'placebo']","[""Adult Myopes' Contrast Sensitivity"", 'CS', 'contrast sensitivity (CS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0032623', 'cui_str': 'Polyvinyl Alcohol'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}]",30.0,0.0678256,There was no statistically significant differences of CS found between atropine and placebo-controlled groups in both short-term and long-term.,"[{'ForeName': 'Ziyun', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'State Key Laboratory of Ophthalmology, Optometry and Vision Science, School of Ophthalmology and Optometry, Affiliated Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': 'State Key Laboratory of Ophthalmology, Optometry and Vision Science, School of Ophthalmology and Optometry, Affiliated Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Suqi', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Optometry and Vision Science, School of Ophthalmology and Optometry, Affiliated Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Optometry and Vision Science, School of Ophthalmology and Optometry, Affiliated Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Ophthalmology, Optometry and Vision Science, School of Ophthalmology and Optometry, Affiliated Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Yuwen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Optometry and Vision Science, School of Ophthalmology and Optometry, Affiliated Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2021.624472']
1418,33679225,A Prospective Randomised Controlled Study Comparing Ultrasonic Dissector with Electrocautery for Axillary Dissection in Patients of Carcinoma Breast.,"Background


Axillary dissection is one of the important components of modified radical mastectomy (MRM). The present study was conducted to compare surgical outcomes by using monopolar electrocautery and ultrasonic dissector for axillary dissection in MRM.
Methods


A parallel randomised controlled single blinded study was conducted with a sample size of 70 patients who were randomised into two groups. One group underwent MRM using ultrasonic dissector (Group A) and the other one using electrocautery (Group B). Intra- and post-operative outcomes were compared.
Results


Group A had an average operating time of 30.86 min, which was statistically less than that of Group B. The mean mop count and the daily drain output in Group A were less as compared to Group B and the differences were statistically significant. Drain was removed early in Group A as compared to Group B. However, post-operative pain scores and seroma formation were not statistically significant among the two groups.
Conclusion


Ultrasonic dissector group had significantly lesser intra-operative bleeding, operating time and post-operative drain output when compared to electrocautery group. However, the two groups had no significant difference in post-operative pain scores and seroma formation.",2021,The mean mop count and the daily drain output in Group A were less as compared to Group B and the differences were statistically significant.,"['Patients of Carcinoma Breast', 'sample size of 70 patients who were randomised into two groups']","['Ultrasonic dissector', 'Ultrasonic Dissector with Electrocautery', 'monopolar electrocautery and ultrasonic dissector', 'MRM using ultrasonic dissector']","['operative pain scores and seroma formation', 'Drain', 'post-operative pain scores and seroma formation', 'average operating time', 'mean mop count and the daily drain output', 'intra-operative bleeding, operating time and post-operative drain output']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0180479', 'cui_str': 'Dissector'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0066785', 'cui_str': 'MOP protocol'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",70.0,0.0597894,The mean mop count and the daily drain output in Group A were less as compared to Group B and the differences were statistically significant.,"[{'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Deori', 'Affiliation': 'Department of Surgery, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgery, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Arun Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgery, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Raghav', 'Initials': 'R', 'LastName': 'Yelamanchi', 'Affiliation': 'Department of Surgery, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Agrawal', 'Affiliation': 'Department of Surgery, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Durga', 'Affiliation': 'Department of Surgery, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi, India.'}]",The Malaysian journal of medical sciences : MJMS,['10.21315/mjms2021.28.1.12']
1419,33679220,Comparison of Non-Operative Mesotherapy and Surgery in the Management of Superficial Lipomas.,"Background


Lipomas are benign adipocytic tumours. Surgical excision is the gold standard for treating such lipomas, but it results in unaesthetic scarring.
Methods


A total of 126 patients were randomised into two groups. The patients in Group A underwent mesotherapy ( n  = 66) and those in Group B underwent surgery ( n  = 60). The patients in Group A group received six sessions of mesotherapy treatment at 2-week intervals. Both groups were followed up for 12 weeks, during which they were assessed for complications arising from treatment, reduction of the size of the lipoma and cosmetic outcomes.
Results


The overall mean age of the patients was 32.93 (± 10.1) years old and the mean volume of the lipomas was 2.29 (± 3.8) mL. A 55.86% ( P  = 0.0032) mean reduction in the volume of lipomas was noted in the patients who received mesotherapy, while one patient showed a gain of 16% by volume. The patients in Group A (cosmetic score ≥ 4: 63%) were happier with the treatment than those in Group B (cosmetic score ≥ 4: 21%).
Conclusion


Our findings indicate that mesotherapy modestly reduces the volume of lipomas with very few and minor complications and excellent cosmetic outcomes.",2021,"A 55.86% ( P  = 0.0032) mean reduction in the volume of lipomas was noted in the patients who received mesotherapy, while one patient showed a gain of 16% by volume.","['years old and the mean volume of the lipomas was 2.29 (± 3.8', '126 patients']","['mesotherapy', 'Surgical excision']",['volume of lipomas'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0023798', 'cui_str': 'Lipoma'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2242515', 'cui_str': 'Mesotherapy'}, {'cui': 'C0728940', 'cui_str': 'Excision'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0023798', 'cui_str': 'Lipoma'}]",126.0,0.0206567,"A 55.86% ( P  = 0.0032) mean reduction in the volume of lipomas was noted in the patients who received mesotherapy, while one patient showed a gain of 16% by volume.","[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Kataria', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Venkatesh', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Chumber', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Yashwant', 'Initials': 'Y', 'LastName': 'Rathore', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Dhar', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Ranjan', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajni', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Department of Pathology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Vyas', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Naranje', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}]",The Malaysian journal of medical sciences : MJMS,['10.21315/mjms2021.28.1.7']
1420,33679193,"Erratum: ""Comparative study of the efficacy and safety of intranasal azelastine hydrochloride and fluticasone furoate in the treatment of allergic rhinitis"".","[This corrects the article on p. 186 in vol. 27, PMID: 33354149.].",2021,"[This corrects the article on p. 186 in vol. 27, PMID: 33354149.].",['allergic rhinitis'],['intranasal azelastine hydrochloride and fluticasone furoate'],[],"[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0771004', 'cui_str': 'Azelastine hydrochloride'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}]",[],,0.0114394,"[This corrects the article on p. 186 in vol. 27, PMID: 33354149.].",[],Journal of family & community medicine,['10.4103/2230-8229.306433']
1421,33652233,Efficacy of core stability versus task oriented trainings on balance in ataxic persons with multiple sclerosis. A single blinded randomized controlled trial.,"BACKGROUND


Balance and ataxic symptoms are commonly encountered in people with multiple sclerosis (PwMS). Many intervention approaches have been proposed to address balance in PwMS. The purpose of this study was to investigate the efficacy of adding core stability versus task oriented trainings on traditional approaches on balance in ataxic PwMS.
METHODS


Forty five ataxic relapsing-remitting PwMS from both sexes were randomly assigned into three identical groups. Control group (CG) treated with conventional balance exercise program; study groups I (GI) and II (GII) received respectively additional training using core stability exercises and task oriented trainings. Outcome measures recorded pre and post study period included stability index (SI), anterior posterior stability index (APSI), and mediolateral stability index (MLSI) using Biodex stability system in addition to the Berg balance scale (BBS).
RESULTS


Post treatment, the results indicated significant improvement in (SI) and (APSI) (p<0.05), and non-significant improvement (p>0.05) in (MLSI) and BBS in CG. In GI and GII there was a significant improvement in all balance measures (p<0.05). Comparison of post treatment results between groups indicated a significant improvement of GII compared to CG in all study measures, GI showed non- significant difference in all balance measures compared to the CG(P>0.05).
CONCLUSION


In PwMS balance rehabilitation should be multimodal; core stability exercises and task-oriented training in addition to conventional balance training are effective to improve balance and should be considered as an essential part of the training program for balance rehabilitation in ataxic PwMS. Task-oriented training in addition to conventional balance rehabilitation seem to be a favorable approach.",2021,"Comparison of post treatment results between groups indicated a significant improvement of GII compared to CG in all study measures, GI showed non- significant difference in all balance measures compared to the CG(P>0.05).
","['people with multiple sclerosis (PwMS', 'Forty five ataxic relapsing-remitting PwMS from both sexes', 'ataxic persons with multiple sclerosis']","['Control group (CG) treated with conventional balance exercise program; study groups I (GI) and II (GII) received respectively additional training using core stability exercises and task oriented trainings', 'core stability versus task oriented trainings']","['SI) and (APSI) (p<0.05), and non-significant improvement (p>0.05) in (MLSI) and BBS', 'stability index (SI), anterior posterior stability index (APSI), and mediolateral stability index (MLSI) using Biodex stability system in addition to the Berg balance scale (BBS', 'GII']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0234366', 'cui_str': 'Ataxic'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332287', 'cui_str': 'With'}]",45.0,0.0271009,"Comparison of post treatment results between groups indicated a significant improvement of GII compared to CG in all study measures, GI showed non- significant difference in all balance measures compared to the CG(P>0.05).
","[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Department of Physical Therapy for Neuromuscular Disorders - Faculty of Physical therapy - Cairo University - Egypt; Department of Physical Therapy - Faculty of Health Sciences - Beirut Arab University - Lebanon. Electronic address: dr.shawky_2011@cu.edu.eg.'}, {'ForeName': 'Moshera H', 'Initials': 'MH', 'LastName': 'Darwish', 'Affiliation': 'Department of Physical Therapy for Neuromuscular Disorders - Faculty of Physical therapy - Cairo University - Egypt. Electronic address: dr.moshera11@yahoo.com.'}, {'ForeName': 'Nevin M', 'Initials': 'NM', 'LastName': 'Shalaby', 'Affiliation': 'Department of Neurology - Faculty of Medicine - Cairo University - Egypt. Electronic address: nevine.shalaby@kasralainy.edu.eg.'}, {'ForeName': 'Rami L', 'Initials': 'RL', 'LastName': 'Abbas', 'Affiliation': 'Department of Physical Therapy - Faculty of Health Sciences - Beirut Arab University - Lebanon. Electronic address: r.abbas@bau.edu.lb.'}, {'ForeName': 'Habiba Z', 'Initials': 'HZ', 'LastName': 'Soubhy', 'Affiliation': 'Department of Physical Therapy for Neuromuscular Disorders - Faculty of Physical therapy - Cairo University - Egypt. Electronic address: Habiba_future@yahoo.com.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102866']
1422,33647762,Effects of manipulating body temperature on sleep in postmenopausal women.,"STUDY OBJECTIVES


A decline in sleep quality, slow wave sleep (SWS) and slow wave activity (SWA) are common in older adults. Prior studies have shown that manipulating body temperature during sleep can increase SWS/SWA. The aim of this study was to determine the effects of manipulation of body temperatures during sleep, using a high heat capacity mattress, on SWS/SWA and heart rate in post-menopausal women.
METHODS


Twenty-four healthy postmenopausal women between 40 and 75 years of age (mean age 62.4 ± 8.2 years, mean BMI 25.4 ± 3.5 kg/m 2 ) were randomized in a single-blind, counterbalanced, cross-over manner to sleep on either a high heat capacity mattress (HHCM) or a low heat capacity mattress (LHCM) a week apart. Sleep was recorded using polysomnography during an 8-h sleep opportunity. Core and peripheral temperature were recorded using an ingestible capsule and thermochron respectively.
RESULTS


In comparison to the LHCM, sleep on HHCM exhibited a selective increase in SWS (average increase in Stage N3 of 9.6 min (2.1%), p = 0.04) and in slow oscillatory (SO) activity (0.5-1 Hz) in the first NREM/REM cycle (p = 0.04). In addition, the HHCM induced a greater reduction in core body temperature (p = 0.002). The reduction in core body temperature (first 180 min after lights out) from LHCM to HHCM was associated (r = 0.5, p = 0.012) with the increase in SO activity (SO cycle 1 and 2/cycle 3 and 4). Average heart rate was 1.6 beats/minute lower across the night on the HHCM compared to the LHCM (p = 0.001).
CONCLUSIONS


The results of this study indicate that manipulation of body temperature during sleep may be a useful approach to enhance SWS sleep in postmenopausal women.",2021,"Average heart rate was 1.6 beats/minute lower across the night on the HHCM compared to the LHCM (p = 0.001).
","['postmenopausal women', 'older adults', 'Twenty-four healthy postmenopausal women between 40 and 75 years of age (mean age 62.4\xa0±\xa08.2 years, mean BMI 25.4\xa0±\xa03.5\xa0kg/m 2 ', 'post-menopausal women']","['counterbalanced, cross-over manner to sleep on either a high heat capacity mattress (HHCM) or a low heat capacity mattress (LHCM', 'HHCM', 'manipulating body temperature']","['sleep quality, slow wave sleep (SWS) and slow wave activity (SWA', 'SWS', 'Sleep', 'core body temperature', 'Average heart rate', 'Core and peripheral temperature', 'SO activity', 'reduction in core body temperature', 'slow oscillatory (SO) activity', 'SWS/SWA and heart rate']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",24.0,0.0301902,"Average heart rate was 1.6 beats/minute lower across the night on the HHCM compared to the LHCM (p = 0.001).
","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Reid', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: k-reid@northwestern.edu.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kräuchi', 'Affiliation': 'Psychiatric University Clinics, Basel, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Grimaldi', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sbarboro', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Hrayr', 'Initials': 'H', 'LastName': 'Attarian', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Roneil', 'Initials': 'R', 'LastName': 'Malkani', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'Technogel Italia S.r.l. Pozzoleone (VI) Italy.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.064']
1423,33647734,Prognostic significance of early pyrexia in acute intracerebral haemorrhage: The INTERACT2 study.,"INTRODUCTION


Uncertainty exists over the prognostic significance of pyrexia in acute intracerebral haemorrhage (ICH). We aimed to determine the association of elevated body temperature with clinical and imaging outcomes among participants of the main Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2).
METHODS


Post-hoc analyses of INTERACT2, an international open, blinded outcome assessed, randomised trial of 2839 patients with spontaneous ICH (<6 h of onset) and elevated systolic blood pressure (SBP, 150-220 mmHg) randomly assigned to intensive (SBP target <140 mmHg) or guideline-recommended (SBP target < 180 mmHg) BP management. Multivariable logistic regression was used to determine associations of elevated baseline body temperature (<37.5 vs. ≥37.5 °C) and 90-day clinical outcome defined on the modified Rankin scale (mRS). Analysis of covariance determined relations of body temperature and haematoma and perihaematomal oedema (PHE) volumes, at baseline and 24 h post-randomisation.
RESULTS


Of 2792 participants with data available at admission, 39 (1.4%) patients had elevated body temperature ≥ 37.5 °C. Elevated body temperature was significantly associated with 90-day mortality (adjusted odds ratio 2.44; 95% confidence interval 1.02-5.82; P = .044) but not with major disability alone (mRS scores 3-5) and combination death or major disability (mRS scores 3-6). Elevated body temperature was also associated with larger PHE volume at baseline (10.89 vs. 3.14 cm 3 , P < .001;) and 24 h (12.43 vs 5.76 cm 3 , P = .018) but not with haematoma volumes at these time points.
CONCLUSION


Early pyrexia in mild to moderate ICH is associated with greater mortality and larger PHE volume, suggesting an early inflammatory-mediated reaction.
CLINICAL TRIAL REGISTRATION


www.clinicaltrials.gov (NCT00716079).",2021,Elevated body temperature was significantly associated with 90-day mortality (adjusted odds ratio 2.44; 95% confidence interval 1.02-5.82; P = .044) but not with major disability alone (mRS scores 3-5) and combination death or major disability (mRS scores 3-6).,"['acute intracerebral haemorrhage', 'participants of the main Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2', '2792 participants with data available at admission, 39 (1.4', '2839 patients with spontaneous ICH (<6\xa0h of onset) and elevated systolic blood pressure (SBP, 150-220\xa0mmHg) randomly assigned to', 'acute intracerebral haemorrhage (ICH', 'patients had elevated body temperature\xa0≥']",['intensive (SBP target <140\xa0mmHg) or guideline-recommended (SBP target\xa0<\xa0180\xa0mmHg'],"['larger PHE volume', 'body temperature and haematoma and perihaematomal oedema (PHE) volumes', '90-day mortality', 'Elevated body temperature', 'combination death or major disability', 'modified Rankin scale (mRS']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",2839.0,0.341944,Elevated body temperature was significantly associated with 90-day mortality (adjusted odds ratio 2.44; 95% confidence interval 1.02-5.82; P = .044) but not with major disability alone (mRS scores 3-5) and combination death or major disability (mRS scores 3-6).,"[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Shoujiang', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, PR China.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Discipline of Pharmacology, School of Medical Sciences, Faculty of Medicine and Health, Sydney, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, PR China; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia. Electronic address: canderson@georgeinstitute.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the neurological sciences,['10.1016/j.jns.2021.117364']
1424,33658612,Real-time breath recognition by movies from a small drone landing on victim's bodies.,"In local and global disaster scenes, rapid recognition of victims' breathing is vital. It is unclear whether the footage transmitted from small drones can enable medical providers to detect breathing. This study investigated the ability of small drones to evaluate breathing correctly after landing on victims' bodies and hovering over them. We enrolled 46 medical workers in this prospective, randomized, crossover study. The participants were provided with envelopes, from which they were asked to pull four notes sequentially and follow the written instructions (""breathing"" and ""no breathing""). After they lied on the ground in the supine position, a drone was landed on their abdomen, subsequently hovering over them. Two evaluators were asked to determine whether the participant had followed the ""breathing"" or ""no breathing"" instruction based on the real-time footage transmitted from the drone camera. The same experiment was performed while the participant was in the prone position. If both evaluators were able to determine the participant's breathing status correctly, the results were tagged as ""correct."" All experiments were successfully performed. Breathing was correctly determined in all 46 participants (100%) when the drone was landed on the abdomen and in 19 participants when the drone hovered over them while they were in the supine position (p < 0.01). In the prone position, breathing was correctly determined in 44 participants when the drone was landed on the abdomen and in 10 participants when it was kept hovering over them (p < 0.01). Notably, breathing status was misinterpreted as ""no breathing"" in 8 out of 27 (29.6%) participants lying in the supine position and 13 out of 36 (36.1%) participants lying in the prone position when the drone was kept hovering over them. The landing points seemed wider laterally when the participants were in the supine position than when they were in the prone position. Breathing status was more reliably determined when a small drone was landed on an individual's body than when it hovered over them.",2021,This study investigated the ability of small drones to evaluate breathing correctly after landing on victims' bodies and hovering over them.,['46 medical workers'],"['written instructions (""breathing"" and ""no breathing', 'breathing"" or ""no breathing"" instruction based on the real-time footage transmitted from the drone camera']","['breathing status', 'Breathing']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",46.0,0.0164521,This study investigated the ability of small drones to evaluate breathing correctly after landing on victims' bodies and hovering over them.,"[{'ForeName': 'Takeji', 'Initials': 'T', 'LastName': 'Saitoh', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu, 431-3125, Japan. tjsaitoh@hama-med.ac.jp.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu, 431-3125, Japan.'}, {'ForeName': 'Hisae', 'Initials': 'H', 'LastName': 'Minami', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu, 431-3125, Japan.'}, {'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu, 431-3125, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Aramaki', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu, 431-3125, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Mihara', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu, 431-3125, Japan.'}, {'ForeName': 'Takamasa', 'Initials': 'T', 'LastName': 'Iwakura', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu, 431-3125, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Odagiri', 'Affiliation': 'Center for Clinical Research, Hamamatsu University Hospital, Hamamatsu, 431-3125, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Maekawa', 'Affiliation': 'Department of Cardiology, Hamamatsu University School of Medicine, Hamamatsu, 431-3125, Japan.'}, {'ForeName': 'Atsuto', 'Initials': 'A', 'LastName': 'Yoshino', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu, 431-3125, Japan.'}]",Scientific reports,['10.1038/s41598-021-84575-1']
1425,33658575,Comparison of the effect of air tamponade versus no tamponade after pars plana vitrectomy for idiopathic epiretinal membrane.,"This study aimed to compare the surgical outcomes of pars plana vitrectomy (PPV) with and without air tamponade in patients with idiopathic epiretinal membrane (iERM). We prospectively enrolled 145 patients with iERM who underwent a 25-gauge transconjunctival sutureless PPV. Patients were assigned to either the air tamponade (air) group (79 eyes) or balanced salt solution (BSS; no tamponade) group (66 eyes). The central macular thickness (CMT), peripapillary retinal nerve fiber layer (pRNFL) thickness, and best-corrected visual acuity (BCVA) were compared for two years. At baseline, there were no significant differences between the two groups. CMT and BCVA were not significantly different between the groups for 2 years. However, the air group had a significantly lower thickness in the superior temporal pRNFL sector at 1 month (p = 0.01) and in the inferior temporal and superior temporal pRNFL sectors at 3 months (p = 0.02 for both). There were no significant differences between both groups in all the pRNFL sectors from 6 months to 2 years. The outcomes of PPV with air tamponade and that with no tamponade appear to be equivalent. This shows that air tamponade may not be an imperative procedure for iERM surgery and has no additional benefit.",2021,CMT and BCVA were not significantly different between the groups for 2 years.,"['145 patients with iERM who underwent a', 'patients with idiopathic epiretinal membrane (iERM', 'idiopathic epiretinal membrane']","['air tamponade (air) group (79 eyes) or balanced salt solution (BSS; no tamponade', '25-gauge transconjunctival sutureless PPV', 'pars plana vitrectomy (PPV) with and without air tamponade', 'air tamponade versus no tamponade after pars plana vitrectomy']","['inferior temporal and superior temporal pRNFL sectors', 'superior temporal pRNFL sector', 'CMT and BCVA', 'central macular thickness (CMT), peripapillary retinal nerve fiber layer (pRNFL) thickness, and best-corrected visual acuity (BCVA']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0442347', 'cui_str': 'Transconjunctival approach'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",145.0,0.0349705,CMT and BCVA were not significantly different between the groups for 2 years.,"[{'ForeName': 'Kyuhwan', 'Initials': 'K', 'LastName': 'Jang', 'Affiliation': 'Department of Ophthalmology, Hangil Eye Hospital, 35 Bupyeong-daero, Bupyeong-gu, Incheon, 21388, South Korea.'}, {'ForeName': 'Daniel Duck-Jin', 'Initials': 'DD', 'LastName': 'Hwang', 'Affiliation': 'Department of Ophthalmology, Hangil Eye Hospital, 35 Bupyeong-daero, Bupyeong-gu, Incheon, 21388, South Korea. daniel.dj.hwang@gmail.com.'}, {'ForeName': 'Jayoung', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Ophthalmology, Hangil Eye Hospital, 35 Bupyeong-daero, Bupyeong-gu, Incheon, 21388, South Korea.'}, {'ForeName': 'Gisung', 'Initials': 'G', 'LastName': 'Son', 'Affiliation': 'Department of Ophthalmology, Hangil Eye Hospital, 35 Bupyeong-daero, Bupyeong-gu, Incheon, 21388, South Korea.'}, {'ForeName': 'Ji In', 'Initials': 'JI', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Kangwon National University Hospital, Kangwon National University School of Medicine, Chuncheon, Gangwon-do, South Korea.'}, {'ForeName': 'Joonhong', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Department of Ophthalmology, Hangil Eye Hospital, 35 Bupyeong-daero, Bupyeong-gu, Incheon, 21388, South Korea.'}]",Scientific reports,['10.1038/s41598-021-84442-z']
1426,33665470,The Marine Suicide Prevention and Intervention REsearch (M-SPIRE) study: A randomized clinical trial investigating potential treatment mechanisms for reducing suicidal behaviors among military personnel.,"Suicides within the U.S. Armed Forces remain elevated. Brief cognitive behavioral therapy for suicide prevention (BCBT) has demonstrated preliminary efficacy as a psychotherapeutic intervention that reduces suicide attempts among U.S. Army Soldiers. The generalizability of BCBT's effects in other military groups and its underlying mechanisms of action remain unknown, however. The Marine Suicide Prevention and Intervention REsearch (M-SPIRE) study is designed to test the efficacy of BCBT for the prevention of suicide attempts among active duty U.S. Marines with recent suicidal ideation or attempts and to identify potential mechanisms of change contributing to BCBT's effects. In this protocol paper, we describe M-SPIRE's rationale and methods with a particular emphasis on measuring treatment fidelity and BCBT's hypothesized mechanisms of action.",2021,Brief cognitive behavioral therapy for suicide prevention (BCBT) has demonstrated preliminary efficacy as a psychotherapeutic intervention that reduces suicide attempts among U.S. Army Soldiers.,"['suicide prevention (BCBT', 'military personnel']","['BCBT', 'psychotherapeutic intervention', 'Brief cognitive behavioral therapy']",['suicidal behaviors'],"[{'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",,0.0243831,Brief cognitive behavioral therapy for suicide prevention (BCBT) has demonstrated preliminary efficacy as a psychotherapeutic intervention that reduces suicide attempts among U.S. Army Soldiers.,"[{'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Khazem', 'Affiliation': 'The Ohio State University Wexner Medical Center, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rozek', 'Affiliation': 'UCF RESTORES, University of Central Florida, USA.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Baker', 'Affiliation': 'The Ohio State University Wexner Medical Center, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'The Ohio State University Wexner Medical Center, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2021.100731']
1427,33663491,Cost of childhood acute otitis media in primary care in the Netherlands: economic analysis alongside a cluster randomised controlled trial.,"BACKGROUND


Acute otitis media (AOM) is among the most common paediatric conditions managed in primary care. Most recent estimates of the cost of AOM date from a decade ago and lack a full societal perspective. We therefore explored the societal cost of childhood AOM in the Netherlands within the setting of a trial comparing the effectiveness of an intervention aimed at educating general practitioners (GPs) about pain management in AOM compared to usual care.
METHODS


Economic analysis alongside a cluster randomised controlled trial conducted between February 2015 and May 2018 in 37 practices (94 GPs). In total, 224 children with AOM were included of which 223 (99%) completed the trial (intervention: n = 94; control: n = 129). The cost of AOM due to health care costs, patient and family costs, and productivity losses by parent caregivers were retrieved from study diaries and primary care electronic health records, during 28-day follow-up. We calculated mean cost (€ and $) per AOM episode per patient with standard deviations (SD, in €) regardless of study group assignment because there was no clinical effect of the trial intervention. In sensitivity analysis, we calculated cost in the intervention and usual care group, after exclusion of extreme outliers.
RESULTS


Mean total AOM cost per patient were €565.93 or $638.78 (SD €1071.01); nearly 90% of these costs were due to productivity losses experienced by parents. After exclusion of outliers, AOM cost was €526.70 or $594.50 (SD €987.96) and similar in the intervention and usual care groups: €516.10 or $582.53 (SD €949.69) and €534.55 or $603.36 (SD €920.55) respectively.
CONCLUSIONS


At €566 or $639 per episode, societal cost of AOM is higher than previously known and mainly driven by productivity losses by children's parents. Considering its high incidence, AOM poses a significant economic burden that extends beyond direct medical costs.
TRIAL REGISTRATION


Netherlands Trial Register no. NTR4920: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4920 .",2021,Mean total AOM cost per patient were €565.93 or $638.78 (SD €,"['childhood acute otitis media in primary care in the Netherlands', '224 children with AOM were included of which 223 (99%) completed the trial (intervention: n\xa0=\u200994; control: n\xa0=\u2009129', 'Acute otitis media (AOM', 'February 2015 and May 2018 in 37 practices (94 GPs']",[],"['cost of AOM due to health care costs, patient and family costs, and productivity losses', 'mean cost (€ and $) per AOM episode', 'AOM cost', 'Mean total AOM cost', 'societal cost of AOM']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",224.0,0.15973,Mean total AOM cost per patient were €565.93 or $638.78 (SD €,"[{'ForeName': 'Rick T', 'Initials': 'RT', 'LastName': 'van Uum', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands. R.T.vanUum-2@umcutrecht.nl.'}, {'ForeName': 'Roderick P', 'Initials': 'RP', 'LastName': 'Venekamp', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Clémence T B', 'Initials': 'CTB', 'LastName': 'Pasmans', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'G Ardine', 'Initials': 'GA', 'LastName': 'de Wit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Alies', 'Initials': 'A', 'LastName': 'Sjoukes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Alma C', 'Initials': 'AC', 'LastName': 'van der Pol', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Roger A M J', 'Initials': 'RAMJ', 'LastName': 'Damoiseaux', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Anne G M', 'Initials': 'AGM', 'LastName': 'Schilder', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}]",BMC health services research,['10.1186/s12913-021-06157-1']
1428,33663489,Nomogram to predict the risk of acute kidney injury in patients with diabetic ketoacidosis: an analysis of the MIMIC-III database.,"BACKGROUND


This study aimed to develop and validate a nomogram for predicting acute kidney injury (AKI) during the Intensive Care Unit (ICU) stay of patients with diabetic ketoacidosis (DKA).
METHODS


A total of 760 patients diagnosed with DKA from the Medical Information Mart for Intensive Care III (MIMIC-III) database were included and randomly divided into a training set (70%, n = 532) and a validation set (30%, n = 228). Clinical characteristics of the data set were utilized to establish a nomogram for the prediction of AKI during ICU stay. The least absolute shrinkage and selection operator (LASSO) regression was utilized to identified candidate predictors. Meanwhile, a multivariate logistic regression analysis was performed based on variables derived from LASSO regression, in which variables with P < 0.1 were included in the final model. Then, a nomogram was constructed applying these significant risk predictors based on a multivariate logistic regression model. The discriminatory ability of the model was determined by illustrating a receiver operating curve (ROC) and calculating the area under the curve (AUC). Moreover, the calibration plot and Hosmer-Lemeshow goodness-of-fit test (HL test) were conducted to evaluate the performance of our newly bullied nomogram. Decision curve analysis (DCA) was performed to evaluate the clinical net benefit.
RESULTS


A multivariable model that included type 2 diabetes mellitus (T2DM), microangiopathy, history of congestive heart failure (CHF), history of hypertension, diastolic blood pressure (DBP), urine output, Glasgow coma scale (GCS), and respiratory rate (RR) was represented as the nomogram. The predictive model demonstrated satisfied discrimination with an AUC of 0.747 (95% CI, 0.706-0.789) in the training dataset, and 0.712 (95% CI, 0.642-0.782) in the validation set. The nomogram showed well-calibrated according to the calibration plot and HL test (P > 0.05). DCA showed that our model was clinically useful.
CONCLUSION


The nomogram predicted model for predicting AKI in patients with DKA was constructed. This predicted model can help clinical physicians to identify the patients with high risk earlier and prevent the occurrence of AKI and intervene timely to improve prognosis.",2021,"The predictive model demonstrated satisfied discrimination with an AUC of 0.747 (95% CI, 0.706-0.789) in the training dataset, and 0.712 (95% CI, 0.642-0.782) in the validation set.","['patients with diabetic ketoacidosis', '760 patients diagnosed with DKA from the Medical Information Mart for Intensive Care III (MIMIC-III) database', 'patients with DKA', 'patients with diabetic ketoacidosis (DKA']",['DCA'],"['receiver operating curve (ROC) and calculating the area under the curve (AUC', 'type 2 diabetes mellitus (T2DM), microangiopathy, history of congestive heart failure (CHF), history of hypertension, diastolic blood pressure (DBP), urine output, Glasgow coma scale (GCS), and respiratory rate (RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0155765', 'cui_str': 'Disorder of capillaries'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",760.0,0.0187545,"The predictive model demonstrated satisfied discrimination with an AUC of 0.747 (95% CI, 0.706-0.789) in the training dataset, and 0.712 (95% CI, 0.642-0.782) in the validation set.","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Fan', 'Affiliation': 'Department of Endocrinology, Second Affiliated Hospital of Jilin University, Ziqiang Street 218, Changchun, 130041, Jilin, China.'}, {'ForeName': 'Haosheng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Second Affiliated Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Second Affiliated Hospital of Jilin University, Ziqiang Street 218, Changchun, 130041, Jilin, China.'}, {'ForeName': 'Wenrui', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Second Affiliated Hospital of Jilin University, Ziqiang Street 218, Changchun, 130041, Jilin, China.'}, {'ForeName': 'Haifei', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': 'Department of Endocrinology, Second Affiliated Hospital of Jilin University, Ziqiang Street 218, Changchun, 130041, Jilin, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Second Affiliated Hospital of Jilin University, Ziqiang Street 218, Changchun, 130041, Jilin, China. wangs93@sina.com.'}]",BMC endocrine disorders,['10.1186/s12902-021-00696-8']
1429,33669796,Promoting Mental Health and Well-Being among Adolescent Young Carers in Europe: A Randomized Controlled Trial Protocol.,"It is estimated that 4-8% of youth in Europe carry out substantial care for a family member or significant other. To prevent adverse psychosocial outcomes in young carers (YCs), primary prevention resilience building interventions have been recommended. We describe the study protocol of an international randomized controlled trial (RCT) of an innovative group intervention designed to promote the mental health and well-being of adolescent YCs (AYCs) aged 15-17. The RCT will be conducted in six European countries in the context of the Horizon 2020 European funded research and innovation project ""Psychosocial support for promoting mental health and well-being among adolescent young caregivers in Europe"" (""ME-WE""). The ME-WE intervention is based on Hayes and Ciarrochi's psychoeducational model for adolescents and will consist of seven 2-h sessions in a group format, aimed to help AYCs build psychological flexibility and live according to their values. The control group will be a waitlist. Primary and secondary outcomes and control variables will be measured at baseline (T0), post-intervention (T1) and 3 months follow-up (T2). The COVID-19 pandemic has made amendments necessary to the original study protocol methodology, which we describe in detail. This study will contribute to building an evidence-based manualized program that educators and health and social care professionals can use to support AYCs in their transition to adulthood. From a research perspective, the outcomes of this study will contribute to evidence-based practices in primary prevention of psychosocial difficulties in AYCs and will gather novel knowledge on the effectiveness of Hayes and Ciarrochi's model for use with middle adolescents with caring responsibilities. The trial has been preregistered (registration number: NCT04114864).",2021,"The RCT will be conducted in six European countries in the context of the Horizon 2020 European funded research and innovation project ""Psychosocial support for promoting mental health and well-being among adolescent young caregivers in Europe"" (""ME-WE"").","['middle adolescents with caring responsibilities', 'mental health and well-being of adolescent YCs (AYCs) aged 15-17', 'young carers (YCs', 'Adolescent Young Carers in Europe']",[],"['control variables will be measured at baseline (T0), post-intervention (T1) and 3 months follow-up (T2', 'adverse psychosocial outcomes']","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0678859,"The RCT will be conducted in six European countries in the context of the Horizon 2020 European funded research and innovation project ""Psychosocial support for promoting mental health and well-being among adolescent young caregivers in Europe"" (""ME-WE"").","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Casu', 'Affiliation': 'Department of Psychology, University of Bologna, 40127 Bologna, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Hlebec', 'Affiliation': 'Faculty of Social Sciences, University of Ljubljana, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Boccaletti', 'Affiliation': 'Anziani e Non Solo Società Cooperativa Sociale, 41012 Carpi, Italy.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Bolko', 'Affiliation': 'Faculty of Social Sciences, University of Ljubljana, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Manattini', 'Affiliation': 'Anziani e Non Solo Società Cooperativa Sociale, 41012 Carpi, Italy.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hanson', 'Affiliation': 'Department of Health and Caring Sciences, Linnaeus University, SE-39182 Kalmar, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph18042045']
1430,33669734,Improvement in Quality of Life with Pelvic Floor Muscle Training and Biofeedback in Patients with Painful Bladder Syndrome/Interstitial Cystitis.,"OBJECTIVE


To prove the benefits of pelvic floor muscle training with biofeedback (BFB) as a complementary treatment in women with bladder pain syndrome/interstitial cystitis (BPS/IC).
METHODS


Prospective, randomized study in 123 women with BPS/IC. Groups: BFB+ (n = 48): women with oral drug treatment (perphenazine and amitriptyline) plus intravesical instillations (sodium hyaluronate) plus pelvic floor muscle training with BFB; BFB-: (n = 75): women with oral drug treatment plus intravesical instillations.
VARIABLES


age, body mass index (BMI), time of follow-up, length of disease, time free of disease, diseases and health conditions concomitant, and responses to the SF-36 health-related quality of life questionnaire at the first consultation (SF-36 pre-treatment), and at the end of the study (SF-36 post-treatment). The treatment was considered successful when the SF-36 score reached values equal to or greater than 80 points or when the initial value increased by 30 or more points.
RESULTS


Mean age was 51.62 years old (23-82). BMI was higher in BFB-. The mean length of BPS/IC condition was 4.92 years (1-20), shorter in BFB+ than in BFB-. Mean SF-36 score pre-treatment was 45.92 points (40-58), lower in BFB+ than in BFB-. Post-treatment SF-36 score was higher than pre-treatment SF-36 score both in BFB+ and BFB-. SF-36 values were higher in BFB+ compared to BFB- over the follow-up.
CONCLUSIONS


BFB improves quality of life in women with BPS/IC as adjunct therapy to combined oral and intravesical treatment.",2021,"Mean SF-36 score pre-treatment was 45.92 points (40-58), lower in BFB+ than in BFB-.","['n = 48): women with oral drug treatment ', 'women with bladder pain syndrome/interstitial cystitis (BPS/IC', 'Patients with Painful Bladder Syndrome/Interstitial Cystitis', '123 women with BPS/IC', 'Mean age was 51.62 years old (23-82', 'n = 75): women with']","['perphenazine and amitriptyline) plus intravesical instillations (sodium hyaluronate) plus pelvic floor muscle training with BFB; BFB', 'Pelvic Floor Muscle Training and Biofeedback', 'oral drug treatment plus intravesical instillations', 'BFB', 'pelvic floor muscle training with biofeedback (BFB']","['SF-36 values', 'Quality of Life', 'BMI', 'mean length of BPS/IC condition', 'Mean SF-36 score', 'quality of life', 'body mass index (BMI), time of follow-up, length of disease, time free of disease, diseases and health conditions concomitant, and responses to the SF-36 health-related quality of life questionnaire', 'Post-treatment SF-36 score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0031184', 'cui_str': 'Perphenazine'}, {'cui': 'C0002600', 'cui_str': 'Amitriptyline'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",123.0,0.0391998,"Mean SF-36 score pre-treatment was 45.92 points (40-58), lower in BFB+ than in BFB-.","[{'ForeName': 'Pedro-Santiago', 'Initials': 'PS', 'LastName': 'Borrego-Jimenez', 'Affiliation': 'Physiotherapy Department of Institute of Applied Technology, Abu Dhabi 3798, United Arab Emirates.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Flores-Fraile', 'Affiliation': 'Department of Surgery, University of Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'Bárbara-Yolanda', 'Initials': 'BY', 'LastName': 'Padilla-Fernández', 'Affiliation': 'Departamento de Cirugía, Universidad de La Laguna, 38200 Tenerife, Spain.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Valverde-Martinez', 'Affiliation': 'Department of Surgery, University of Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Gómez-Prieto', 'Affiliation': 'Department of Emergency, University Hospital of Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'Magaly Teresa', 'Initials': 'MT', 'LastName': 'Márquez-Sánchez', 'Affiliation': 'Renal Urological Multidisciplinary Research Group (GRUMUR), Institute of Biomedical Research of Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'José-Antonio', 'Initials': 'JA', 'LastName': 'Mirón-Canelo', 'Affiliation': 'Renal Urological Multidisciplinary Research Group (GRUMUR), Institute of Biomedical Research of Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'María-Fernanda', 'Initials': 'MF', 'LastName': 'Lorenzo-Gómez', 'Affiliation': 'Department of Surgery, University of Salamanca, 37007 Salamanca, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10040862']
1431,33669715,Effects of a Music-Based Rhythmic Auditory Stimulation on Gait and Balance in Subacute Stroke.,"Gait and balance impairments are common after stroke. This study aimed to evaluate the effect of a music-based rhythmic auditory stimulation (RAS) in combination with conventional physiotherapy on gait parameters and walking ability in subacute stroke. This single-blind, historical controlled trial, included 55 patients who had suffered a stroke within the three weeks prior to enrolment. Patients from 2018 ( n  = 27) were assigned as the historical control group whereas 2019 patients ( n  = 28) received music-based RAS three times a week. Both groups received 11 h of conventional physiotherapy per week during hospitalization. Primary outcomes were gait and balance parameters (Tinetti test and Timed Up&Go test) and walking ability (Functional Ambulation Category scale). Secondary outcomes were trunk control, assistive devices, functional independence (Functional Independence Measure, Barthel index), and stroke severity and disability (modified Rankin scale, National Institutes of Health Stroke Scale). Results: No between-group differences were identified for gait and balance parameters nor for secondary outcomes. Significant between-group differences were observed in the Functional Ambulation Category: the intervention group (Δmean ± SD; 3.43 ± 1.17) showed greater improvement ( p  = 0.002) than the control group (Δmean ± SD; 2.48 ± 1.09). Compared with conventional physiotherapy alone, our results suggest that the walking ability of subacute stroke patients might be improved with music-based RAS combined with conventional physiotherapy, but this treatment is not more effective than conventional physiotherapy in obtaining gait and balance gains.",2021,No between-group differences were identified for gait and balance parameters nor for secondary outcomes.,"['subacute stroke patients', 'subacute stroke', 'Patients from 2018 ( n  = 27) were assigned as the historical control group whereas 2019 patients ( n  = 28) received', 'Subacute Stroke', '55 patients who had suffered a stroke within the three weeks prior to enrolment']","['conventional physiotherapy', 'music-based RAS', 'Music-Based Rhythmic Auditory Stimulation', 'music-based rhythmic auditory stimulation (RAS']","['Gait and Balance', 'Functional Ambulation Category', 'trunk control, assistive devices, functional independence (Functional Independence Measure, Barthel index), and stroke severity and disability (modified Rankin scale, National Institutes of Health Stroke Scale', 'gait and balance parameters', 'gait parameters and walking ability', 'gait and balance parameters (Tinetti test and Timed Up&Go test) and walking ability (Functional Ambulation Category scale']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",55.0,0.0756932,No between-group differences were identified for gait and balance parameters nor for secondary outcomes.,"[{'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Gonzalez-Hoelling', 'Affiliation': 'Neurorehabilitation Department, Hospital Sociosanitari Mutuam Girona, 17007 Girona, Spain.'}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Bertran-Noguer', 'Affiliation': 'Health and Health Care Research Group, University of Girona, 17003 Girona, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Reig-Garcia', 'Affiliation': 'Department of Nursing, Faculty of Nursing, University of Girona, 17003 Girona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Suñer-Soler', 'Affiliation': 'Health and Health Care Research Group, University of Girona, 17003 Girona, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18042032']
1432,33669689,In vitro-in vivo Validation of Stimulatory Effect of Oat Ingredients on Lactobacilli.,"The prebiotic activity of a commercially available oat product and a novel oat ingredient, at similar β-glucan loads, was tested using a validated in vitro gut model (M-SHIME ® ). The novel oat ingredient was tested further at lower β-glucan loads in vitro, while the commercially available oat product was assessed in a randomised, single-blind, placebo-controlled, and cross-over human study. Both approaches focused on healthy individuals with mild hypercholesterolemia. In vitro analysis revealed that both oat products strongly stimulated  Lactobacillaceae  and  Bifidobacteriaceae  in the intestinal lumen and the simulated mucus layer, and corresponded with enhanced levels of acetate and lactate with cross-feeding interactions leading to an associated increase in propionate and butyrate production. The in vitro prebiotic activity of the novel oat ingredient remained at lower β-glucan levels, indicating the prebiotic potential of the novel oat product. Finally, the stimulation of  Lactobacillus  spp. was confirmed during the in vivo trial, where lactobacilli abundance significantly increased in the overall population at the end of the intervention period with the commercially available oat product relative to the control product, indicating the power of in vitro gut models in predicting in vivo response of the microbial community to dietary modulation.",2021,"In vitro analysis revealed that both oat products strongly stimulated  Lactobacillaceae  and  Bifidobacteriaceae  in the intestinal lumen and the simulated mucus layer, and corresponded with enhanced levels of acetate and lactate with cross-feeding interactions leading to an associated increase in propionate and butyrate production.",['healthy individuals with mild hypercholesterolemia'],[],['lactobacilli abundance'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}]",[],[],,0.0242244,"In vitro analysis revealed that both oat products strongly stimulated  Lactobacillaceae  and  Bifidobacteriaceae  in the intestinal lumen and the simulated mucus layer, and corresponded with enhanced levels of acetate and lactate with cross-feeding interactions leading to an associated increase in propionate and butyrate production.","[{'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Duysburgh', 'Affiliation': 'ProDigest BV, 9052 Ghent, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Van den Abbeele', 'Affiliation': 'ProDigest BV, 9052 Ghent, Belgium.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Kamil', 'Affiliation': 'PepsiCo R&D, Barrington, IL 60010, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Fleige', 'Affiliation': 'PepsiCo R&D, Barrington, IL 60010, USA.'}, {'ForeName': 'Peter John', 'Initials': 'PJ', 'LastName': 'De Chavez', 'Affiliation': 'PepsiCo R&D, Barrington, IL 60010, USA.'}, {'ForeName': 'YiFang', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'PepsiCo R&D, Barrington, IL 60010, USA.'}, {'ForeName': 'Wiley', 'Initials': 'W', 'LastName': 'Barton', 'Affiliation': 'Teagasc Food Research Centre, Moorepark Fermoy, P61 C996 Cork, Ireland.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': ""O'Sullivan"", 'Affiliation': 'Teagasc Food Research Centre, Moorepark Fermoy, P61 C996 Cork, Ireland.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Cotter', 'Affiliation': 'Teagasc Food Research Centre, Moorepark Fermoy, P61 C996 Cork, Ireland.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Quilter', 'Affiliation': 'APC Microbiome Institute, T12 Cork, Ireland.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Joyce', 'Affiliation': 'APC Microbiome Institute, T12 Cork, Ireland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': 'Atlantia Food Clinical Trials, Heron House Offices, First Floor, Blackpool, T23 Cork, Ireland.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'DunnGalvin', 'Affiliation': 'Atlantia Food Clinical Trials, Heron House Offices, First Floor, Blackpool, T23 Cork, Ireland.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Dinan', 'Affiliation': 'APC Microbiome Institute, T12 Cork, Ireland.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Marzorati', 'Affiliation': 'ProDigest BV, 9052 Ghent, Belgium.'}]","Pathogens (Basel, Switzerland)",['10.3390/pathogens10020235']
1433,33673189,Consumer Likings of Different Miracle Fruit Products on Different Sour Foods.,"Miracle fruit has a high potential as a healthy sweetening enhancer, due to its powerful antioxidant capacity and its unique ability to transform sour taste into sweet taste. The aim of this study was to analyze the effect of different miracle fruit products on the likings of different sour foods. In total, 200 healthy adults (women 55%, 18-65 years old) evaluated five sour foods (apple, goat cheese, lemonade, yogurt, pickle) before and after miracle fruit application. Four commercial miracle fruit products (pills-Y; G; M, powder-P) were randomly assigned to each panelist. The pre- and post-test likings for overall, flavor, texture, and aftertaste were evaluated by using a nine-point scale. The ""meeting expectations"" was evaluated only in the post-tests. After miracle fruit administration, all the liking scores in yogurt, goat cheese, and apple increased; in contrast, lemonade and pickle liking scores decreased, except lemonade's texture with the P product. The Tukey post hoc test showed that the pre-to-post increments for overall, flavor, and texture likings in yogurt and in overall and flavor likings in apple using M product were significantly higher than using other products ( p  < 0.05). This study suggests that miracle fruit application can be an effective method for im-proving consumer likings for yogurt, goat cheese, and apple.",2021,"The Tukey post hoc test showed that the pre-to-post increments for overall, flavor, and texture likings in yogurt and in overall and flavor likings in apple using M product were significantly higher than using other products ( p  < 0.05).","['200 healthy adults (women 55%, 18-65 years old) evaluated five sour foods (apple, goat cheese, lemonade, yogurt, pickle) before and after miracle fruit application']",[],"['overall, flavor, texture, and aftertaste', 'overall, flavor, and texture likings in yogurt and in overall and flavor likings in apple using M product', 'liking scores in yogurt, goat cheese, and apple increased; in contrast, lemonade and pickle liking scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0018019', 'cui_str': 'Capra hircus'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0452446', 'cui_str': 'Lemon-flavored carbonated drink'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0453375', 'cui_str': 'Pickle'}, {'cui': 'C0996776', 'cui_str': 'Fruit, Miracle'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C1291736', 'cui_str': 'Aftertaste'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018019', 'cui_str': 'Capra hircus'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0452446', 'cui_str': 'Lemon-flavored carbonated drink'}, {'cui': 'C0453375', 'cui_str': 'Pickle'}]",200.0,0.0239984,"The Tukey post hoc test showed that the pre-to-post increments for overall, flavor, and texture likings in yogurt and in overall and flavor likings in apple using M product were significantly higher than using other products ( p  < 0.05).","[{'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Choi', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, The City University of New York, Flushing, NY 11367, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Garza', 'Affiliation': 'Garza Consulting, Grand Rapids, MI 49525, USA.'}]","Foods (Basel, Switzerland)",['10.3390/foods10020406']
1434,33673158,Health-Related Quality of Life in Weight Loss Interventions: Results from the OPTIWIN Trial.,"Obesity is highly prevalent and associated with several adverse outcomes including health-related quality-of-life (HRQoL), work productivity, and activity impairment. The objective of this study is to examine group differences in HRQoL and labor-related health outcomes among participants in the OPTIWIN program, which compared the effectiveness of two intensive behavioral weight loss interventions. Participants ( n  = 273) were randomized to OPTIFAST ® (OP) or food-based (FB) dietary interventions for 52 weeks. HRQoL and labor-related health outcomes were measured at baseline, week 26, and week 52, using two questionnaires. At baseline, there were no differences between groups on the Impact of Weight on Quality-of-Life Questionnaire (IWQOL-Lite). At week 26, the OP group had statistically significant differences towards better HRQoL for Physical Function, Self-Esteem, and the total score compared with the FB group. At week 52, the OP group showed better HRQoL in the total score ( p  = 0.0012) and in all but one domain. Moreover, the adjusted change-from-baseline normalized total score at week 52 was -5.9 points ( p  = 0.0001). Finally, the mean IWQOL-Lite normalized score showed that HRQoL improves by 0.4442 units ( p  < 0.0001) per kg lost, and that greater weight reduction was positively associated with better HRQoL. No statistically significant group differences were found with the Work Productivity and Activity Impairment (General Health) (WPAI-GH) Questionnaire. HRQoL improves with highly intensive, well-structured weight loss interventions. Greater weight loss lead to larger improvements. The lack of negative effect on productivity and activity suggests that these interventions may be compatible with an active work lifestyle.",2021,"At week 26, the OP group had statistically significant differences towards better HRQoL for Physical Function, Self-Esteem, and the total score compared with the FB group.",['Participants ( n  = 273'],"['intensive behavioral weight loss interventions', 'OPTIFAST ® (OP) or food-based (FB) dietary interventions']","['weight reduction', 'Greater weight loss', 'Work Productivity and Activity Impairment (General Health', 'HRQoL for Physical Function, Self-Esteem, and the total score', 'mean IWQOL-Lite normalized score', 'Health-Related Quality of Life in Weight Loss Interventions', 'health-related quality-of-life (HRQoL), work productivity, and activity impairment', 'total score', 'Impact of Weight on Quality-of-Life Questionnaire (IWQOL-Lite', 'HRQoL and labor-related health outcomes']",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",273.0,0.101633,"At week 26, the OP group had statistically significant differences towards better HRQoL for Physical Function, Self-Esteem, and the total score compared with the FB group.","[{'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Dainelli', 'Affiliation': 'Nestlé Research, Nestlé, 1000 Lausanne, Switzerland.'}, {'ForeName': 'Dan Roberto', 'Initials': 'DR', 'LastName': 'Luo', 'Affiliation': 'Nestlé Research, Nestlé, 1000 Lausanne, Switzerland.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Cohen', 'Affiliation': 'EpidStrategies, Durham, NC 27101, USA.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Marczewska', 'Affiliation': 'Nestlé Health Science, Nestlé, 1015 Lausanne, Switzerland.'}, {'ForeName': 'Jamy D', 'Initials': 'JD', 'LastName': 'Ard', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Coburn', 'Affiliation': 'Alaska Premier Health, Anchorage, AK 99503, USA.'}, {'ForeName': 'Kristina H', 'Initials': 'KH', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Loper', 'Affiliation': 'The Central Ohio Nutrition Center, Inc., Gohanna, OH 43230, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Matarese', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, Greenville, NC 27101, USA.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Pories', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, Greenville, NC 27101, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Rothberg', 'Affiliation': 'Department of Nutritional Sciences, School of Public Health and Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Harbour, MI 48109-2029, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph18041785']
1435,33673068,Cost-Effectiveness of Two Dry Needling Interventions for Plantar Heel Pain: A Secondary Analysis of an RCT.,"Plantar heel pain is a common cause of foot pain that affects patients' quality of life and represents a significant cost for the healthcare system. Dry needling and percutaneous needle electrolysis are two minimally invasive treatments that were shown to be effective for the management of plantar heel pain. The aim of our study was to compare these two treatments in terms of health and economic consequences based on the results of a published randomized controlled trial. For this, we evaluated the costs from the point of view of the hospital and we carried out a cost-effectiveness study using quality of life as the main variable according to the Eq-5D-5L questionnaire. The cost of the complete treatment with dry needling (DN) was €178.86, while the percutaneous needle electrolysis (PNE) was €200.90. The quality of life of patients improved and was translated into +0.615 quality-adjusted life years (QALYs) for DN and +0.669 for PNE. PNE presented an average incremental cost-effectiveness ratio (ICER) of €411.34/QALY against DN. These results indicate that PNE had a better cost-effectiveness ratio for the treatment of plantar heel pain than DN.",2021,PNE presented an average incremental cost-effectiveness ratio (ICER) of €411.34/QALY against DN.,['Plantar Heel Pain'],"['Two Dry Needling Interventions', 'dry needling (DN', 'PNE', 'Dry needling and percutaneous needle electrolysis']","['quality of life', 'cost-effectiveness ratio', 'average incremental cost-effectiveness ratio (ICER) of €411.34/QALY against DN', 'Cost-Effectiveness']","[{'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]",2.0,0.0401637,PNE presented an average incremental cost-effectiveness ratio (ICER) of €411.34/QALY against DN.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Faculty of Health Sciences, Universidad San Jorge, Campus Universitario, Autov. A23 km 299, Villanueva de Gállego, 50830 Zaragoza, Spain.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Al-Boloushi', 'Affiliation': 'Ministry of Health, State of Kuwait, Jamal Abdulnasser Street, Al Solaibeykhat Area 5, Safat, Kuwait City 13001, Kuwait.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Bellosta-López', 'Affiliation': 'Faculty of Health Sciences, Universidad San Jorge, Campus Universitario, Autov. A23 km 299, Villanueva de Gállego, 50830 Zaragoza, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'Physiatry and Nursing Department, Faculty of Health Sciences, Zaragoza University, C/Domingo Miral s/n, CP 50009 Zaragoza, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gómez', 'Affiliation': 'Faculty of Health Sciences, Universidad San Jorge, Campus Universitario, Autov. A23 km 299, Villanueva de Gállego, 50830 Zaragoza, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Calvo', 'Affiliation': 'Faculty of Health Sciences, Universidad San Jorge, Campus Universitario, Autov. A23 km 299, Villanueva de Gállego, 50830 Zaragoza, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18041777']
1436,33678697,The Impact of a Breastfeeding Promotion Intervention on Rapid Weight Gain among African American Infants.,"BACKGROUND/OBJECTIVE


To evaluate the impact of exclusive breastfeeding (EBF) on rapid weight gain (RWG) among infants of African American women enrolled in a breastfeeding promotion intervention.
METHODS


African American mothers in the 2nd or 3rd trimester who consented and attended four 30-minute breastfeeding promotion sessions prospectively provided breastfeeding and physical measurements at birth, four-, six-, and twelve-months.
RESULTS


Mean age of mothers was 28.74±6.0 years, range 15-42 years, 62(38.8%) primiparous, 59 (36.9%) had ≤high school diploma, and 68 (42.5%) annual income &lt;$15,000. Exclusive breastfeeding at birth, three, and six months were 104 (62.7%), 44 (34.4%), and 21 (17.9%). Rapid weight gain at four months and six months were 42 (36.2%) and 77 (74.8%). Difference in rapid weight gain at four months for babies breastfed up to three months vs. those who were not was significant, p&lt;.04. Maternal demographics did not predict RWG in multiple regression modelling. The incidence of overweight at 12 months for babies who experienced RWG at four months vs. those who did not was significantly different, p&lt;.001.
CONCLUSION


Exclusive breastfeeding for six months was associated with reduced risk of RWG in early infancy.",2021,"The incidence of overweight at 12 months for babies who experienced RWG at four months vs. those who did not was significantly different, p&lt;.001.
CONCLUSION


","['infants of African American women enrolled in a breastfeeding promotion intervention', 'Mean age of mothers was 28.74±6.0 years, range 15-42 years, 62(38.8%) primiparous, 59 (36.9%) had ≤high school diploma, and 68 (42.5%) annual income &lt;$15,000', 'African American Infants', 'African American mothers in the 2nd or 3rd trimester who consented and attended four 30-minute']","['Breastfeeding Promotion Intervention', 'exclusive breastfeeding (EBF', 'breastfeeding promotion sessions prospectively provided breastfeeding and physical measurements at birth, four-, six-, and twelve-months']","['Rapid Weight Gain', 'reduced risk of RWG', 'incidence of overweight', 'rapid weight gain', 'rapid weight gain (RWG', 'Rapid weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]",104.0,0.0331472,"The incidence of overweight at 12 months for babies who experienced RWG at four months vs. those who did not was significantly different, p&lt;.001.
CONCLUSION


","[{'ForeName': 'Flora A', 'Initials': 'FA', 'LastName': 'Ukoli', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Keefer', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cheaves', 'Affiliation': ''}, {'ForeName': 'Chelsei', 'Initials': 'C', 'LastName': 'Granderson', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Dexter', 'Initials': 'D', 'LastName': 'Samuels', 'Affiliation': ''}]",Journal of health care for the poor and underserved,['10.1353/hpu.2021.0024']
1437,33678687,Discrimination Experiences and Depressive Symptoms among African Americans with Osteoarthritis Enrolled in a Pain Coping Skills Training Randomized Controlled Trial.,"African Americans are more likely than members of other racial groups to report perceived discrimination in health care settings, and discrimination is linked to depression. Using data from a randomized controlled trial of pain coping skills training (PCST) for African Americans with osteoarthritis (N=164), we evaluated the interaction between discrimination experiences and experimental condition (PCST or control group) in linear regression models predicting depressive symptoms. There was a significant interaction between personal discrimination and experimental condition on depressive symptoms (interaction term coefficient: b=-3.2, 95% CI [- 6.4, - .02], p=.05). Discrimination was associated with depressive symptoms among those in the control group but not among those who received PCST. Participation in a PCST intervention may have reduced the association between discrimination experiences and depressive symptoms among participants in this sample. Future research should explore whether interventions aimed at teaching coping skills may be effective in ameliorating the harmful mental health effects of perceived discrimination.",2021,"There was a significant interaction between personal discrimination and experimental condition on depressive symptoms (interaction term coefficient: b=-3.2, 95% CI [- 6.4, - .02], p=.05).","['African Americans', 'African Americans with osteoarthritis (N=164', 'African Americans with Osteoarthritis Enrolled']","['PCST intervention', 'pain coping skills training (PCST', 'PCST']","['depressive symptoms', 'Discrimination Experiences and Depressive Symptoms']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0284873,"There was a significant interaction between personal discrimination and experimental condition on depressive symptoms (interaction term coefficient: b=-3.2, 95% CI [- 6.4, - .02], p=.05).","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Griesemer', 'Affiliation': ''}, {'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Hausmann', 'Affiliation': ''}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Arbeeva', 'Affiliation': ''}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Crystal W', 'Initials': 'CW', 'LastName': 'Cené', 'Affiliation': ''}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': ''}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': ''}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': ''}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': ''}, {'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': ''}]",Journal of health care for the poor and underserved,['10.1353/hpu.2021.0014']
1438,33678649,Effects of SET7 on angiotensin II-mediated proliferation and collagen synthesis of myocardial fibroblasts and its mechanisms.,"OBJECTIVES


Silence of SET domain containing lysine methyltransferase 7 (SET7) alleviates myocardial tissue injury caused by ischemia-reperfusion. But the effects of SET7 on angiotensin II (Ang II)-induced myocardial fibroblast proliferation and the collagen synthesis are not clear. The purpose of this study was to explore the effect of SET7 on the proliferation and collagen synthesis of myocardial fibroblasts and its mechanisms.
METHODS


Myocardial fibroblasts were isolated and identified by immunofluorescence. Myocardial fibroblasts were randomly divided into 4 groups: a control group (cells were normally cultured), an Ang II group (cells were treated with 100 nmol/L Ang II for 24 h), a siCtrl group (cells were transfected with siRNA control and were then treated with 100 nmol/L Ang II for 24 h), and a siSET7 group (cells were transfected with siRNA SET7 and were then treated with 100 nmol/L Ang II for 24 h). Cell counting kit-8 (CCK-8) and 5-ethynyl-2'-deoxyuridine (EdU) assay were used to evaluate cell proliferation. Real-time PCR was used to detect the mRNA levels of SET7, collagen I, collagen III, and α-smooth muscle actin (α-SMA). Western blotting was used to detect the protein expression of SET7, collagen I, collagen III, α-SMA, sonic hedgehog (Shh), ptched1 (Ptch1), and glioma-associated oncogene homolog 1 (Gli1).
RESULTS


Fluorescence microscopy showed positive vimentin staining, and myocardial fibroblasts were in good condition. As compared to the control group, the mRNA and protein levels of SET7 in the Ang II group were significantly upregulated; cell proliferation rate and EdU fluorescence intensity in the Ang II group were significantly increased; the mRNA and protein levels of collagen I, collagen III, and α-SMA were significantly upregulated (all  P <0.05). As compared to the siCtrl group, the mRNA and protein levels of SET7 in the siSET7 group were significantly downregulated; cell proliferation rate and EdU fluorescence intensity in the siSET7 group were significantly decreased; the mRNA and protein levels of collagen I, collagen III, and α-SMA in the siSET7 group were significantly downregulated (all  P <0.05).
CONCLUSIONS


Silence of SET7 gene inhibits Ang II-induced proliferation and collagen synthesis of myocardial fibroblasts. Shh signaling pathway may be involved in this process.",2021,"As compared to the control group, the mRNA and protein levels of SET7 in the Ang II group were significantly upregulated; cell proliferation rate and EdU fluorescence intensity in the Ang II group were significantly increased; the mRNA and protein levels of collagen",['Myocardial fibroblasts'],"['control group (cells were normally cultured), an Ang II group (cells were treated with 100 nmol/L Ang II for 24 h), a siCtrl group (cells were transfected with siRNA control and were then treated with 100 nmol/L Ang II for 24 h), and a siSET7 group (cells were transfected with siRNA SET7', 'SET7']","['cell proliferation rate and EdU fluorescence intensity', 'positive vimentin staining, and myocardial fibroblasts', 'I, collagen III, α-SMA, sonic hedgehog (Shh), ptched1 (Ptch1), and glioma-associated oncogene homolog 1 (Gli1', 'I, collagen III, and α-SMA', 'mRNA levels of SET7, collagen', 'mRNA and protein levels of collagen', 'mRNA and protein levels of SET7', ""Cell counting kit-8 (CCK-8) and 5-ethynyl-2'-deoxyuridine (EdU) assay"", 'protein expression of SET7, collagen']","[{'cui': 'C0016030', 'cui_str': 'Fibroblast'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C1099354', 'cui_str': 'Small Interfering RNA'}, {'cui': 'C1519134', 'cui_str': 'SET Domain'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0025831', 'cui_str': 'Methyltransferase'}]","[{'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}, {'cui': 'C0011535', 'cui_str': 'Deoxyuridine'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042666', 'cui_str': 'Vimentin'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1267092', 'cui_str': 'Smooth muscle (tissue)'}, {'cui': 'C0001271', 'cui_str': 'Actin'}, {'cui': 'C0018866', 'cui_str': 'Erinaceidae'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0029016', 'cui_str': 'Oncogene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1519134', 'cui_str': 'SET Domain'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0025831', 'cui_str': 'Methyltransferase'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0613970', 'cui_str': ""5-ethynyl-2'-deoxyuridine""}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0111975,"As compared to the control group, the mRNA and protein levels of SET7 in the Ang II group were significantly upregulated; cell proliferation rate and EdU fluorescence intensity in the Ang II group were significantly increased; the mRNA and protein levels of collagen","[{'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""Department of Cardiovascular Medicine, Xi'an NO.1 Hospital, Xi'an 710002, China. ma_huijunxa@163.com.""}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2021.190400']
1439,33678647,Clinical efficacy of laparoscopic modified Parks operation on the ultra-low rectal cancer.,"OBJECTIVES


To investigate the clinical efficacy of laparoscopic modified Parks operation on the patients with ultra-low rectal cancer.
METHODS


According to the preoperative stage and intraoperative anastomotic position, 98 patients with ultra-low rectal cancer above T2 stage underwent laparoscopic Dixon operation, modified Parks operation and Miles operation, respectively. All patients were divided into 3 groups: a Dixon operation group ( n =39), a modified Parks operation group ( n =43) and a Miles operation group ( n =16). The clinical data and postoperative follow-up results were collected, compared, and analyzed to evaluate the clinical efficacy of laparoscopic modified Parks operation.
RESULTS


The patients were more obese, the distance between tumor and anal margin was closer, and the operation time was longer in the modified Parks operation group than those in the Dixon operation group (all  P <0.05). However, the results of bleeding volume, the number of lymph nodes and the postoperative complications in the modified park operation group were similar than those in the Dixon operation group (all  P >0.05). In addition, the exhaust and defecation time and the hospitalization time were shorter, and the total cost of hospitalization was lower in the modified Parks operation group than those in the Dixon operation group (all  P <0.05). Although the anal function in the modified Parks operation group was poor in the early postoperative period, it reached the same level as that in the Dixon operation group from 6 months after the treatments with the regular anal function exercise ( P >0.05). There were no significant differences in tumor size, body shape, distance between tumor and anal margin, operation time, bleeding volume, number of lymph nodes detected, postoperative exhaust and defecation time between the Miles operation group and the modified Parks operation group, but the hospitalization time was shorter, the incidence of complications and the total cost of hospitalization were lower in the modified Parks operation group (all  P <0.05).
CONCLUSIONS


Laparoscopic modified Parks operation is a safe, economical and effective anus preservation operation, which can not only save the anus for some patients who had to perform Miles operation, but also recover better and faster after operation. Although the early anal function of patients performed with the modified operation is poor, it can gradually recover to the same level as the patients performed with the Dixon operation.",2021,"There were no significant differences in tumor size, body shape, distance between tumor and anal margin, operation time, bleeding volume, number of lymph nodes detected, postoperative exhaust and defecation time between the Miles operation group and the modified Parks operation group, but the hospitalization time was shorter, the incidence of complications and the total cost of hospitalization were lower in the modified Parks operation group (all  P <0.05).
","['98 patients with ultra-low rectal cancer above T2 stage underwent laparoscopic Dixon operation, modified Parks operation and Miles operation, respectively', 'patients with ultra-low rectal cancer']","['modified Parks operation group', 'Laparoscopic modified Parks operation', 'laparoscopic modified Parks operation', 'Dixon operation']","['tumor size, body shape, distance between tumor and anal margin, operation time, bleeding volume, number of lymph nodes detected, postoperative exhaust and defecation time', 'incidence of complications and the total cost of hospitalization', 'hospitalization time', 'exhaust and defecation time and the hospitalization time', 'ultra-low rectal cancer', 'anal function', 'bleeding volume, the number of lymph nodes and the postoperative complications', 'operation time', 'total cost of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0475373', 'cui_str': 'T2 category'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0331865', 'cui_str': 'miles'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0232722', 'cui_str': 'Anal function'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",98.0,0.00989795,"There were no significant differences in tumor size, body shape, distance between tumor and anal margin, operation time, bleeding volume, number of lymph nodes detected, postoperative exhaust and defecation time between the Miles operation group and the modified Parks operation group, but the hospitalization time was shorter, the incidence of complications and the total cost of hospitalization were lower in the modified Parks operation group (all  P <0.05).
","[{'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Department of Colorectal and Anal Surgery, Xiangya Hospital, Central South University, Changsha 410008. 2812097576@qq.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Colorectal and Anal Surgery, Xiangya Hospital, Central South University, Changsha 410008. lijian869@163.com.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Colorectal and Anal Surgery, Xiangya Hospital, Central South University, Changsha 410008.'}, {'ForeName': 'Zha', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': ""Department of General Surgery, Xiangtan First People's Hospital, Xiangtan Hunan 411101, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'Department of Colorectal and Anal Surgery, Xiangya Hospital, Central South University, Changsha 410008.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2021.190774']
1440,33678535,Female Voice-Related Sexual Attractiveness to Males: Does it Vary With Different Degrees of Conception Likelihood?,"Previous investigations have found that female voice-related attractiveness to males increases when both conception likelihood (CL) and voice fundamental frequency (f o ) are elevated. To test this hypothesis, we conducted a perceptual experiment where 78 heterosexual males rated sexual attractiveness of 9 female voice samples, recorded at menstrual, follicular and luteal phases of the menstrual cycle under two double-blinded randomly allocated conditions: a natural menstrual cycle (placebo condition) and when using an oral contraceptive pill (OCP condition). The voice samples yielded a total of 54 stimuli that were visually sorted and rated using Visor software. Concentrations of estrogens, progesterone and testosterone were analyzed, and measurements of speaking fundamental frequency (sf o ) and its standard deviation (sf o SD), f o  derivative (df o ) and f o  slope were made. A multilevel ordinal logistic regression model nested in listeners and in females, and adjusted by phase and condition, was carried out to assess the association between ratings and: (1) phases and conditions; (2) sex steroid hormonal concentrations; and (3) voice parameters. A high probability of obtaining high ratings of voice sexual attractiveness was found for: (1) menstrual phase of placebo use and follicular phase of OCP use; (2) for low estradiol to progesterone ratio and testosterone concentrations; and (3) for low df o . The latter showed a moderate statistical association with ratings of high attractiveness, as compared with the small association found for the remaining variables. It seems that the voice is a weak cue for female CL. Female sexual attraction to males may be a consequence of what females do in order to regulate their extended sexuality across the menstrual cycle rather than of estrus cues, the use of paralinguistic speech patterns being an example.",2021,A high probability of obtaining high ratings of voice sexual attractiveness was found for: (1) menstrual phase of placebo use and follicular phase of OCP use; (2) for low estradiol to progesterone ratio and testosterone concentrations; and (3) for low df o .,"['listeners and in females, and adjusted by phase and condition', '78 heterosexual males rated sexual attractiveness of 9 female voice samples, recorded at menstrual, follicular and luteal phases of the menstrual cycle under two double-blinded randomly allocated conditions: a', 'Female Voice-Related Sexual Attractiveness to Males']",['natural menstrual cycle (placebo condition) and when using an oral contraceptive pill (OCP condition'],"['Concentrations of estrogens, progesterone and testosterone', 'speaking fundamental frequency (sf o ) and its standard deviation (sf o SD), f o  derivative (df o ) and f o  slope', 'voice sexual attractiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1282359', 'cui_str': 'Ocular cicatricial pemphigoid'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",78.0,0.0292725,A high probability of obtaining high ratings of voice sexual attractiveness was found for: (1) menstrual phase of placebo use and follicular phase of OCP use; (2) for low estradiol to progesterone ratio and testosterone concentrations; and (3) for low df o .,"[{'ForeName': 'Filipa M B', 'Initials': 'FMB', 'LastName': 'Lã', 'Affiliation': 'Faculty of Education, National University of Distance Learning, Madrid, Spain; Centre of Social Studies, University of Coimbra, Coimbra, Portugal. Electronic address: filipa.la@edu.uned.es.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Polo', 'Affiliation': 'Faculty of Philology, National University of Distance Learning, Madrid, Spain.'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Granqvist', 'Affiliation': 'KTH Royal Institute of Technology, School of Engineering Sciences in Chemistry, Biotechnology and Health (CBH), Department of Biomedical engineering and Health systems, Karolinska University Hospital, KTH Royal Institute of Technology, Huddinge, Stockholm, Sweden; Karolinska Institute, Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Speech and Language Pathology, Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Tânia', 'Initials': 'T', 'LastName': 'Cova', 'Affiliation': 'Coimbra Chemistry Center, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Alberto C', 'Initials': 'AC', 'LastName': 'Pais', 'Affiliation': 'Coimbra Chemistry Center, University of Coimbra, Coimbra, Portugal.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2021.02.006']
1441,33678522,Efficacy and Safety of Atezolizumab Plus Bevacizumab Following Disease Progression on Atezolizumab or Sunitinib Monotherapy in Patients with Metastatic Renal Cell Carcinoma in IMmotion150: A Randomized Phase 2 Clinical Trial.,"BACKGROUND


The use of immune checkpoint inhibitors combined with vascular endothelial growth factor (VEGF)-targeted therapy as second-line treatment for metastatic clear cell renal cancer (mRCC) has not been evaluated prospectively.
OBJECTIVE


To evaluate the efficacy and safety of atezolizumab + bevacizumab following disease progression on atezolizumab or sunitinib monotherapy in patients with mRCC.
DESIGN, SETTING, AND PARTICIPANTS


IMmotion150 was a multicenter, randomized, open-label, phase 2 study of patients with untreated mRCC. Patients randomized to the atezolizumab or sunitinib arm who had investigator-assessed progression as per RECIST 1.1 could be treated with second-line atezolizumab + bevacizumab.
INTERVENTION


Patients received atezolizumab 1200 mg intravenously (IV) plus bevacizumab 15 mg/kg IV every 3 wk following disease progression on either atezolizumab or sunitinib monotherapy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The secondary endpoints analyzed during the second-line part of IMmotion150 included objective response rate (ORR), progression-free survival (PFS), and safety. PFS was examined using Kaplan-Meier methods.
RESULTS AND LIMITATIONS


Fifty-nine patients in the atezolizumab arm and 78 in the sunitinib arm were eligible, and 103 initiated second-line atezolizumab + bevacizumab (atezolizumab arm, n = 44; sunitinib arm, n = 59). ORR (95% confidence interval [CI]) was 27% (19-37%). The median PFS (95% CI) from the start of second line was 8.7 (5.6-13.7) mo. The median event follow-up duration was 19.4 (12.9-21.9) mo among the 25 patients without a PFS event. Eighty-six (83%) patients had treatment-related adverse events; 31 of 103 (30%) had grade 3/4 events. Limitations were the small sample size and selection for progressors.
CONCLUSIONS


The atezolizumab + bevacizumab combination had activity and was tolerable in patients with progression on atezolizumab or sunitinib. Further studies are needed to investigate sequencing strategies in mRCC.
PATIENT SUMMARY


Patients with advanced kidney cancer whose disease had worsened during treatment with atezolizumab or sunitinib began second-line treatment with atezolizumab + bevacizumab. Tumors shrank in more than one-quarter of patients treated with this combination, and side effects were manageable.",2021,The atezolizumab + bevacizumab combination had activity and was tolerable in patients with progression on atezolizumab or sunitinib.,"['patients with untreated mRCC', 'metastatic clear cell renal cancer (mRCC', 'Patients with advanced kidney cancer whose disease had worsened during treatment with atezolizumab or sunitinib began second-line treatment with', 'Patients with Metastatic Renal Cell Carcinoma in IMmotion150', 'patients with mRCC', 'arm, n\u2009=\u200944; sunitinib arm, n\u2009=\u200959', 'Fifty-nine patients in the atezolizumab arm and 78 in the sunitinib arm were eligible, and 103 initiated second-line', 'patients with progression on atezolizumab or sunitinib']","['atezolizumab\u2009+\u2009bevacizumab', 'atezolizumab 1200\u2009mg intravenously (IV) plus bevacizumab', 'atezolizumab or sunitinib', 'atezolizumab or sunitinib monotherapy', 'atezolizumab\u2009+\u2009bevacizumab (atezolizumab', 'Atezolizumab Plus Bevacizumab', 'vascular endothelial growth factor (VEGF)-targeted therapy']","['median event follow-up duration', 'ORR', 'median PFS', 'efficacy and safety', 'objective response rate (ORR), progression-free survival (PFS), and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",25.0,0.135672,The atezolizumab + bevacizumab combination had activity and was tolerable in patients with progression on atezolizumab or sunitinib.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: Thomas.Powles@bartshealth.nhs.uk.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'University of California, San Francisco, School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Joseph', 'Affiliation': 'Mayo Clinic Hospital, Jacksonville, FL, USA.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hainsworth', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN, USA.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'The University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'CHU Hopitaux de Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Azienda Ospedaliera S. Maria, Terni, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suarez', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Reeves', 'Affiliation': 'Florida Cancer Specialists & Research Institute, Fort Myers, FL, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Cohn', 'Affiliation': 'Rocky Mountain Cancer Center, Denver, CO, USA.'}, {'ForeName': 'Beiying', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Leng', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Mahrukh', 'Initials': 'M', 'LastName': 'Huseni', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schiff', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",European urology,['10.1016/j.eururo.2021.01.003']
1442,33678517,"Horizons and Group Motivational Enhancement Therapy: HIV Prevention for Alcohol-Using Young Black Women, a Randomized Experiment.","INTRODUCTION


Black women are at disproportionately greater risk for HIV and sexually transmitted infections than women of other ethnic/racial backgrounds. Alcohol use may further elevate the risk of HIV/sexually transmitted infection acquisition and transmission.
STUDY DESIGN


A random-assignment parallel-group comparative treatment efficacy trial was conducted with random assignment to 1 of 3 conditions.z SETTING/PARTICIPANTS: The sample comprised 560 Black or African American women aged 18-24 years who reported recent unprotected vaginal or anal sex and recent alcohol use. Participants were recruited from community settings in Atlanta, Georgia, from January 2012 to February 2014.
INTERVENTION


A Group Motivational Enhancement Therapy module was designed to complement a Centers for Disease Control and Prevention-designated evidenced-based intervention (Horizons) to reduce sexual risk behaviors, alcohol use, and sexually transmitted infections, with 3 comparison groups: (1) Horizons + Group Motivational Enhancement Therapy intervention, (2) Horizons + General Health Promotion intervention, and (3) enhanced standard of care.
MAIN OUTCOME MEASURES


Outcome measures included safe sex (abstinence or 100% condom use); condom nonuse; proportion of condom use during sexual episodes; incident chlamydia, gonorrhea, and trichomonas infections; and problematic alcohol use measured by Alcohol Use Disorders Identification Test score. Treatment effects were estimated using an intention-to-treat protocol‒generalized estimating equations with logistic regression for binomial outcomes and Poisson regression for count outcomes. Analyses were conducted between October 2018 and October 2019.
RESULTS


Participants assigned to Horizons + Group Motivational Enhancement Therapy had greater odds of safe sex (AOR=1.45, 95% CI=1.04, 2.02, p=0.03), greater proportion of condom use (AOR=1.68, 95% CI=1.18, 2.41, p=0.004), and lower odds of condom nonuse (AOR=0.57, 95% CI=0.38, 0.83, p=0.004). Both interventions had lower odds of problematic alcohol use (Horizons: AOR=0.57, 95% CI=0.39, 0.85, p=0.006; Horizons + Group Motivational Enhancement Therapy: AOR=0.61, 95% CI=0.41, 0.90, p=0.01).
CONCLUSIONS


Complementing an evidence-based HIV prevention intervention with Group Motivational Enhancement Therapy may increase safer sexual behaviors and concomitantly reduce alcohol use among young Black women who consume alcohol.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT01553682.",2021,"RESULTS


Participants assigned to Horizons + Group Motivational Enhancement Therapy had greater odds of safe sex (AOR=1.45, 95% CI=1.04, 2.02, p=0.03), greater proportion of condom use (AOR=1.68, 95% CI=1.18, 2.41, p=0.004), and lower odds of condom nonuse (AOR=0.57","['Participants were recruited from community settings in Atlanta, Georgia, from January 2012 to February 2014', ' The sample comprised 560 Black or African American women aged 18-24 years who reported recent unprotected vaginal or anal sex and recent alcohol use', 'Alcohol-Using Young Black Women', 'young Black women who consume alcohol']","['Horizons\u202f+\u202fGroup Motivational Enhancement Therapy intervention, (2) Horizons\u202f+\u202fGeneral Health Promotion intervention, and (3) enhanced standard of care', 'Horizons and Group Motivational Enhancement Therapy: HIV Prevention']","['proportion of condom use', 'safer sexual behaviors', 'safe sex (abstinence or 100% condom use); condom nonuse; proportion of condom use during sexual episodes; incident chlamydia, gonorrhea, and trichomonas infections; and problematic alcohol use measured by Alcohol Use Disorders Identification Test score', 'safe sex', 'problematic alcohol use (Horizons']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0040919', 'cui_str': 'Trichomonas'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}]",,0.0709269,"RESULTS


Participants assigned to Horizons + Group Motivational Enhancement Therapy had greater odds of safe sex (AOR=1.45, 95% CI=1.04, 2.02, p=0.03), greater proportion of condom use (AOR=1.68, 95% CI=1.18, 2.41, p=0.004), and lower odds of condom nonuse (AOR=0.57","[{'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'DiClemente', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York, New York.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Rosenbaum', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, SUNY Downstate Health Sciences University, Brooklyn, New York. Electronic address: janet.rosenbaum@downstate.edu.'}, {'ForeName': 'Eve S', 'Initials': 'ES', 'LastName': 'Rose', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Sales', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, Ohio; Department of Psychiatry & Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Tiffaney L', 'Initials': 'TL', 'LastName': 'Renfro', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Erin L P', 'Initials': 'ELP', 'LastName': 'Bradley', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia; Department of Public Health, Agnes Scott College, Decatur, Georgia.'}, {'ForeName': 'Teaniese L', 'Initials': 'TL', 'LastName': 'Davis', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia; Center for Research and Evaluation, Kaiser Permanente Georgia, Atlanta, Georgia.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Capasso', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York, New York.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Wingood', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York City, New York.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Psychological, Health, and Learning Sciences, University of Houston, Houston, Texas.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'West', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, Arizona.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Hardin', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychology, University of Rhode Island, Kingston, Rhode Island.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.11.014']
1443,33678513,"Disease-modifying effects of edasalonexent, an NF-κB inhibitor, in young boys with Duchenne muscular dystrophy: Results of the MoveDMD phase 2 and open label extension trial: Running title: Edasalonexent for Duchenne muscular dystrophy.","Chronic activation of NF-κB is a key driver of muscle degeneration and suppression of muscle regeneration in Duchenne muscular dystrophy. Edasalonexent (CAT-1004) is an orally-administered novel small molecule that covalently links two bioactive compounds (salicylic acid and docosahexaenoic acid) that inhibit NF-κB. This placebo-controlled, proof-of-concept phase 2 study with open-label extension in boys ≥4-<8 years old with any dystrophin mutation examined the effect of edasalonexent (67 or 100 mg/kg/day) compared to placebo or off-treatment control. Endpoints were safety/tolerability, change from baseline in MRI T 2  relaxation time of lower leg muscles and functional assessment, as well as pharmacodynamics and biomarkers. Treatment was well-tolerated and the majority of adverse events were mild, and most commonly of the gastrointestinal system (primarily diarrhea). There were no serious adverse events in the edasalonexent groups. Edasalonexent 100 mg/kg was associated with slowing of disease progression and preservation of muscle function compared to an off-treatment control period, with decrease in levels of NF-κB-regulated genes and improvements in biomarkers of muscle health and inflammation. These results support investigating edasalonexent in future trials and have informed the design of the edasalonexent phase 3 clinical trial in boys with Duchenne.",2021,"Edasalonexent 100 mg/kg was associated with slowing of disease progression and preservation of muscle function compared to an off-treatment control period, with decrease in levels of NF-κB-regulated genes and improvements in biomarkers of muscle health and inflammation.","['young boys with Duchenne muscular dystrophy', 'boys ≥4-<8 years old with any dystrophin mutation', 'boys with Duchenne']","['Edasalonexent', 'edasalonexent', 'placebo', 'Edasalonexent (CAT-1004']","['slowing of disease progression and preservation of muscle function', 'serious adverse events', 'safety/tolerability, change from baseline in MRI T 2  relaxation time of lower leg muscles and functional assessment, as well as pharmacodynamics and biomarkers', 'levels of NF-κB-regulated genes and improvements in biomarkers of muscle health and inflammation']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C4548371', 'cui_str': 'edasalonexent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4548372', 'cui_str': 'CAT-1004'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.058996,"Edasalonexent 100 mg/kg was associated with slowing of disease progression and preservation of muscle function compared to an off-treatment control period, with decrease in levels of NF-κB-regulated genes and improvements in biomarkers of muscle health and inflammation.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finkel', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN and Nemours Children's Hospital, Orlando, FL, United States. Electronic address: Richard.finkel@stjude.org.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Finanger', 'Affiliation': 'Oregon Health & Science University, Portland, OR, United States.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Vandenborne', 'Affiliation': 'University of Florida Health, Gainesville, FL, United States.'}, {'ForeName': 'H Lee', 'Initials': 'HL', 'LastName': 'Sweeney', 'Affiliation': 'University of Florida Health, Gainesville, FL, United States.'}, {'ForeName': 'Gihan', 'Initials': 'G', 'LastName': 'Tennekoon', 'Affiliation': ""The Children's Hospital of Philadelphia, and the University of Pennsylvania, Philadelphia, PA, United States.""}, {'ForeName': 'Perry B', 'Initials': 'PB', 'LastName': 'Shieh', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Willcocks', 'Affiliation': 'University of Florida Health, Gainesville, FL, United States.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Walter', 'Affiliation': 'University of Florida Health, Gainesville, FL, United States.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Rooney', 'Affiliation': 'Oregon Health & Science University, Portland, OR, United States.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'University of Florida Health, Gainesville, FL, United States.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Triplett', 'Affiliation': 'University of Florida Health, Gainesville, FL, United States.'}, {'ForeName': 'Sabrina W', 'Initials': 'SW', 'LastName': 'Yum', 'Affiliation': ""The Children's Hospital of Philadelphia, and the University of Pennsylvania, Philadelphia, PA, United States.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Catabasis Pharmaceuticals, Inc., Boston, MA, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacDougall', 'Affiliation': 'Catabasis Pharmaceuticals, Inc., Boston, MA, United States.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Fretzen', 'Affiliation': 'Catabasis Pharmaceuticals, Inc., Boston, MA, United States.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Bista', 'Affiliation': 'Catabasis Pharmaceuticals, Inc., Boston, MA, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nichols', 'Affiliation': 'Catabasis Pharmaceuticals, Inc., Boston, MA, United States.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Donovan', 'Affiliation': 'Catabasis Pharmaceuticals, Inc., Boston, MA, United States.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2021.02.001']
1444,33678106,Clinical Implications and Predictive Values of Early PASI Responses to Tildrakizumab in Patients with Moderate-to-Severe Plaque Psoriasis.,"Objective:  To evaluate whether early Psoriasis Area Severity Index (PASI) improvements can predict week 28 tildrakizumab responders and nonresponders. Methods:  Psoriasis patients pooled from two tildrakizumab phase 3 trials randomized to receive tildrakizumab 100 mg at weeks 0, 4, 16, and 28 were included. Patients were grouped by week 28 PASI responses (<50, 50-74, 75-89, and 90-100). PASI improvements from baseline at weeks 4 and 16 were analyzed for each response group. Results:  Of 575 patients included, 8.3%, 14.3%, 23.8%, and 53.6%, respectively, achieved PASI <50, 50-74, 75-89, and 90-100 at week 28. Of patients with PASI <50 at week 16, 85% did not achieve PASI ≥75 at week 28 (nonresponders). Rapid response, defined as PASI ≥50 at week 4 (after a single tildrakizumab dose), was observed in 41% of patients. Of these patients, 87% were week 28 responders (PASI ≥75); 67% were ""super responders"" (PASI 90-100). Among week 28 responders and super responders, 45% and 50% achieved PASI ≥50 at week 4, respectively. Conclusions:  Tildrakizumab week 28 nonresponders can be identified by week 16 PASI response. PASI improvements as early as week 4 can predict patients' week 28 PASI improvement status.",2021,"Among week 28 responders and super responders, 45% and 50% achieved PASI ≥50 at week 4, respectively.",['Patients with Moderate-to-Severe Plaque Psoriasis'],"['Tildrakizumab', 'tildrakizumab']",['early Psoriasis Area Severity Index (PASI'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}]",575.0,0.0342319,"Among week 28 responders and super responders, 45% and 50% achieved PASI ≥50 at week 4, respectively.","[{'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pariser', 'Affiliation': 'Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA.'}, {'ForeName': 'Jingchuan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Sun Pharmaceutical Industries, Princeton, NJ.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Sun Pharmaceutical Industries, Princeton, NJ.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Mendelsohn', 'Affiliation': 'Sun Pharmaceutical Industries, Princeton, NJ.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}]",The Journal of dermatological treatment,['10.1080/09546634.2021.1898528']
1445,33678098,"Drinking during low-risk labor: monocentric randomized clinical trial on patients' satisfaction, and maternal and neonatal outcomes.","INTRODUCTION


This study aimed to assess satisfaction of patients affected by various fluid regimes during uncomplicated labor; to identify factors possibly associated with the level of satisfaction; to compare obstetrical and neonatal outcomes between the intervention groups.
METHODS


Between October and December 2014, 40 women were included in the study set at the Poitiers University Hospital, France. Women were randomly allocated to two study arms: 20 to strict and 20 to liberal fluid regime group. Women's satisfaction was assessed using visual analog scale. Categorical obstetrical and neonatal outcomes were analyzed using Chi-squared test and Fischer's exact test. The between-group difference was assessed with Mann-Whitney  U -test.
RESULTS


Overall satisfaction was higher among women from the liberal fluid regime than from the strict fluid regime group (median score: 88, interquartile range [IQR]: 21 vs. 72, IQR: 21;  p  = 0.03). The active phase of the second stage of labor was shorter in the liberal fluid regime than in the strict fluid regime group (median 9 min, IQR: 7 vs. 17 min, IQR: 12;  p  = 0.02). The length of stay in the delivery room was significantly shorter in liberal fluid regime than in strict fluid regime group (median 190 min, IQR: 128 vs. 340 min, IQR: 195,  p  = 0.04). There were no significant differences in other obstetrical and neonatal outcomes.
CONCLUSION


Liberal fluid regime during labor was associated with significantly higher satisfaction of women. The active phase of the second stage of labor and the length of stay in the delivery room were significantly shorter in the liberal fluid regime group.",2021,"There were no significant differences in other obstetrical and neonatal outcomes.
","['40 women were included in the study set at the Poitiers University Hospital, France', 'Between October and December 2014']",[],"['Categorical obstetrical and neonatal outcomes', 'length of stay in the delivery room', 'visual analog scale', 'obstetrical and neonatal outcomes', 'Overall satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]",[],"[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",40.0,0.131201,"There were no significant differences in other obstetrical and neonatal outcomes.
","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Nadal', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Medicine, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Pierre', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Medicine, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'Women-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Boussac', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Medicine, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Thibaut', 'Initials': 'T', 'LastName': 'Loupec', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Medicine, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Desseauve', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Medicine, Poitiers University Hospital, Poitiers, France.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2021.1891219']
1446,33678097,"A randomized pharmacokinetic-pharmacodynamic evaluation of the potential biosimilar interferon beta-1a product, CinnoVex®.","Background : The objective of the trial was to evaluate the bioequivalence of the interferon beta-1a (IFN beta-1a) biosimilar product candidate CinnoVex® with the reference product Avonex® by comparing the pharmacokinetics/pharmacodynamics (PK/PD), safety and immunogenicity of the two products in healthy subjects. Methods : A total of 41 healthy subjects were randomized in a two-stage design to receive single doses of CinnoVex® and Avonex®. The primary PK endpoint was the area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last ). Additional PK parameters, safety and immunogenicity were evaluated as secondary endpoints. The main secondary PD endpoints were the areas under the concentration-time curves from time 0 to 168 hours (AUC 0-168h ) of the PD biomarkers. Results : The two products demonstrated similar PK parameters, and the 90% confidence interval (CI) of the primary PK endpoint was within the bioequivalence acceptance limit. No serious adverse events were reported, and all adverse events (AE) were mild or moderate in severity. Anti-drug antibodies were not observed in any of the study participants. Conclusion : This study demonstrated PK/PD bioequivalence between CinnoVex® and Avonex®. The safety and tolerability profiles of both products were similar. Clinical trials registration : EudraCT Number 2016-000139-41.",2021,The safety and tolerability profiles of both products were similar.,"['41 healthy subjects', 'healthy subjects']",['CinnoVex® and Avonex®'],"['serious adverse events', 'concentration-time curves', 'area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last ', 'safety and tolerability profiles', 'Additional PK parameters, safety and immunogenicity', 'pharmacokinetics/pharmacodynamics (PK/PD), safety and immunogenicity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0594372', 'cui_str': 'Avonex'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",41.0,0.0851637,The safety and tolerability profiles of both products were similar.,"[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'Medical Department, CRST Oy, Itäinen Pitkäkatu, Turku, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'Medical Department, CRST Oy, Itäinen Pitkäkatu, Turku, Finland.'}, {'ForeName': 'Inger-Helen', 'Initials': 'IH', 'LastName': 'Maadik', 'Affiliation': 'Statistical Department, StatFinn Estonia & EPID Research (IQVIA) Narva Mnt 9, Tartu, Estonia.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Suopanki-Lalowski', 'Affiliation': 'Clinical Operations/Projects Unit, Crown CRO Oy, Espoo, Finland.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Seyedagha', 'Affiliation': 'CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Azhdarzadeh', 'Affiliation': 'CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}]",Expert opinion on biological therapy,['10.1080/14712598.2021.1895745']
1447,33678038,A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial.,"BACKGROUND/AIM


In clinical trials, there is potential for bias from unblinded observers that may influence ascertainment of outcomes. This issue arose in the Strategies to Reduce Injuries and Develop Confidence in Elders trial, a cluster randomized trial to test a multicomponent intervention versus enhanced usual care (control) to prevent serious fall injuries, originally defined as a fall injury leading to medical attention. An unblinded nurse falls care manager administered the intervention, while the usual care arm did not involve contact with a falls care manager. Thus, there was an opportunity for falls care managers to refer participants reporting falls to seek medical attention. Since this type of observer bias could not occur in the usual care arm, there was potential for additional falls to be reported in the intervention arm, leading to dilution of the intervention effect and a reduction in study power. We describe the clinical basis for ascertainment bias, the statistical approach used to assess it, and its effect on study power.
METHODS


The prespecified interim monitoring plan included a decision algorithm for assessing ascertainment bias and adapting (revising) the primary outcome definition, if necessary. The original definition categorized serious fall injuries requiring medical attention into Type 1 (fracture other than thoracic/lumbar vertebral, joint dislocation, cut requiring closure) and Type 2 (head injury, sprain or strain, bruising or swelling, other). The revised definition, proposed by the monitoring plan, excluded Type 2 injuries that did not necessarily require an overnight hospitalization since these would be most subject to bias. These injuries were categorized into those with (Type 2b) and without (Type 2c) medical attention. The remaining Type 2a injuries required medical attention and an overnight hospitalization. We used the ratio of 2b/(2b + 2c) in intervention versus control as a measure of ascertainment bias; ratios > 1 indicated the likelihood of falls care manager bias. We determined the effect of ascertainment bias on study power for the revised (Types 1 and 2a) versus original definition (Types 1, 2a, and 2b).
RESULTS


The estimate of ascertainment bias was 1.14 (95% confidence interval: 0.98, 1.30), providing evidence of the likelihood of falls care manager bias. We estimated that this bias diluted the hazard ratio from the hypothesized 0.80 to 0.86 and reduced power to under 80% for the original primary outcome definition. In contrast, adapting the revised definition maintained study power at nearly 90%.
CONCLUSION


There was evidence of ascertainment bias in the Strategies to Reduce Injuries and Develop Confidence in Elders trial. The decision to adapt the primary outcome definition reduced the likelihood of this bias while preserving the intervention effect and study power.",2021,The estimate of ascertainment bias was 1.14,[],"['multicomponent intervention versus enhanced usual care (control', 'usual care arm did not involve contact with a falls care manager']",[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0687694', 'cui_str': 'Case manager'}]",[],,0.0625494,The estimate of ascertainment bias was 1.14,"[{'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Esserman', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Dziura', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Peduzzi', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520980070']
1448,33677935,Development of a Non-Invasive Liver Fibrosis Score Based on Transient Elastography for Risk Stratification in Patients with Type 2 Diabetes.,"BACKGROUND


In non-alcoholic fatty liver disease (NAFLD), transient elastography (TE) is an accurate non-invasive method to identify patients at risk of advanced fibrosis (AF). We developed a diabetes-specific, non-invasive liver fibrosis score based on TE to facilitate AF risk stratification, especially for use in diabetes clinics where TE is not readily available.
METHODS


Seven hundred sixty-six adults with type 2 diabetes and NAFLD were recruited and randomly divided into a training set (n=534) for the development of diabetes fibrosis score (DFS), and a testing set (n=232) for internal validation. DFS identified patients with AF on TE, defined as liver stiffness (LS) ≥9.6 kPa, based on a clinical model comprising significant determinants of LS with the lowest Akaike information criteria. The performance of DFS was compared with conventional liver fibrosis scores (NFS, FIB-4, and APRI), using area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive and negative predictive values (NPV).
RESULTS


DFS comprised body mass index, platelet, aspartate aminotransferase, high-density lipoprotein cholesterol, and albuminuria, five routine measurements in standard diabetes care. Derived low and high DFS cut-offs were 0.1 and 0.3, with 90% sensitivity and 90% specificity, respectively. Both cut-offs provided better NPVs of &gt;90% than conventional fibrosis scores. The AUROC of DFS for AF on TE was also higher (P&lt;0.01) than the conventional fibrosis scores, being 0.85 and 0.81 in the training and testing sets, respectively.
CONCLUSION


Compared to conventional fibrosis scores, DFS, with a high NPV, more accurately identified diabetes patients at-risk of AF, who need further evaluation by hepatologists.",2021,"The AUROC of DFS for AF on TE was also higher (P&lt;0.01) than the conventional fibrosis scores, being 0.85 and 0.81 in the training and testing sets, respectively.
","['Patients with Type 2 Diabetes', 'Seven hundred sixty-six adults with type 2 diabetes and NAFLD', 'patients at risk of advanced fibrosis (AF']",[],"['conventional liver fibrosis scores (NFS, FIB-4, and APRI), using area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive and negative predictive values (NPV', 'body mass index, platelet, aspartate aminotransferase, high-density lipoprotein cholesterol, and albuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",766.0,0.0142599,"The AUROC of DFS for AF on TE was also higher (P&lt;0.01) than the conventional fibrosis scores, being 0.85 and 0.81 in the training and testing sets, respectively.
","[{'ForeName': 'Chi-Ho', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Wai-Kay', 'Initials': 'WK', 'LastName': 'Seto', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Ieong', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'David T W', 'Initials': 'DTW', 'LastName': 'Lui', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Carol H Y', 'Initials': 'CHY', 'LastName': 'Fong', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Wan', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Wing-Sun', 'Initials': 'WS', 'LastName': 'Chow', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yu-Cho', 'Initials': 'YC', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Karen S L', 'Initials': 'KSL', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}]","Endocrinology and metabolism (Seoul, Korea)",['10.3803/EnM.2020.887']
1449,33665063,Building research in diet and cognition (BRIDGE): Baseline characteristics of older obese African American adults in a randomized controlled trial to examine the effect of the Mediterranean diet with and without weight loss on cognitive functioning.,"In the United States, >5.4 million people age 65 and older are affected by cognitive impairment and dementia, including Alzheimer's disease. African Americans are more likely than non-Hispanic whites to suffer from these disorders. Obesity is linked to accelerated age-related cognitive decline, and weight loss through caloric restriction is a potential strategy to prevent this cognitive impairment. Adherence to a healthful dietary pattern, such as the Mediterranean Diet (MedDiet), has also shown positive effects on reducing risk for dementia. African Americans are disproportionately affected by obesity and have less healthful diets than non-Hispanic whites. We present baseline characteristics from a three-arm randomized controlled trial that randomized 185 obese (BMI ≥ 30 kg/m 2  and ≤ 50 kg/m 2 ) healthy older adults (55-85 years of age) to: 1) Typical Diet Control (TDC); 2) MedDiet alone (MedDiet-A) intervention; or 3) MedDiet caloric restricted intervention to promote weight loss (MedDiet-WL). The majority of the sample was African American (91.4%) and female (85.9%). The two active interventions (MedDiet-A and MedDiet-WL) met once weekly for 8 months, and the TDC received weekly general health newsletters. Baseline data were collected between January 2017 and July 2019 in Chicago, IL. In our sample, closer adherence to a MedDiet pattern was associated with higher attention and information processing (AIP) and higher executive functioning (EF). Consistent with the literature, we saw that older participants performed more poorly on the cognitive assessments than younger participants, and women outperformed men across verbally mediated tasks, especially ones related to learning and memory.",2021,"In our sample, closer adherence to a MedDiet pattern was associated with higher attention and information processing (AIP) and higher executive functioning (EF).","['diet and cognition (BRIDGE', '185 obese (BMI\xa0≥\xa030\xa0kg/m 2  and\xa0≤\xa050\xa0kg/m 2 ) healthy older adults (55-85\xa0years of age) to: 1', 'older obese African American adults', 'African Americans', ""In the United States, >5.4 million people age 65 and older are affected by cognitive impairment and dementia, including Alzheimer's disease""]","['TDC received weekly general health newsletters', 'Typical Diet Control (TDC); 2) MedDiet alone (MedDiet-A) intervention; or 3) MedDiet caloric restricted intervention to promote weight loss (MedDiet-WL', 'Mediterranean diet with and without weight loss']","['cognitive functioning', 'higher attention and information processing (AIP) and higher executive functioning (EF']","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",185.0,0.125749,"In our sample, closer adherence to a MedDiet pattern was associated with higher attention and information processing (AIP) and higher executive functioning (EF).","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Sanchez-Flack', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lamar', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University, 1750 West Harrison Street, Chicago, IL 60612, United States.""}, {'ForeName': 'Giamilla', 'Initials': 'G', 'LastName': 'Fantuzzi', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 W. Taylor Street, Chicago, IL 60612, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Blumstein', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McLeod', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Dakers', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Desmona', 'Initials': 'D', 'LastName': 'Strahan', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Restrepo', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Nefertiti Oji Njideka', 'Initials': 'NON', 'LastName': 'Hemphill', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 W. Taylor Street, Chicago, IL 60612, United States.'}, {'ForeName': 'Leilah', 'Initials': 'L', 'LastName': 'Siegel', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Antonic', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States.'}]",Preventive medicine reports,['10.1016/j.pmedr.2020.101302']
1450,33663558,The effects of WeChat-based educational intervention in patients with ankylosing spondylitis: a randomized controlled trail.,"BACKGROUND


Ankylosing spondylitis (AS), as a common inflammatory rheumatic disease, often causes depression and impaired health-related quality of life (QoL). Although positive effects of patient education have been demonstrated, limited studies explored the benefits of education via mobile applications for AS patients. This study aimed to evaluate the effects of the WeChat-based educational intervention on depression, health-related QoL, and other clinical outcomes in AS patients.
METHODS


We conducted a single-blind randomized controlled trial from March to December 2017. Patients were recruited and randomized into the intervention group which received a 12-week WeChat-based educational intervention (consisting of four individual online educational sessions, online educational materials) or the control group receiving standard care. Data was collected at baseline and 12 weeks. Outcomes were measured by Beck Depression Inventory-II, the Medical Outcomes Study Short Form 36-item Health Survey (SF-36), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Patient Global Score (BAS-G), and visual analog scales.
RESULTS


A total of 118 patients with AS were included and analyzed. Measures at baseline were comparable between groups. After the intervention, the intervention group reported significant higher scores of all domains of SF-36 except for physical functioning and validity, compared with the control group. Additionally, patients in the intervention group had lower depressive symptoms than the control group. No significant difference in other outcomes was observed at 12 weeks.
CONCLUSIONS


This study found that the 12-week educational intervention via WeChat had positive effects on reducing depressive symptoms and improving health-related QoL in Chinese patients with AS. We suggest that this intervention can be integrated into current routine care of AS patients.
TRIAL REGISTRATION


This study has been approved by the hospital's ethics committee (ID: 20160364) in 2016 and registered at the Chinese Clinical Trail Registry (registry number: ChiCTR-IPR-16009293 ).",2021,"After the intervention, the intervention group reported significant higher scores of all domains of SF-36 except for physical functioning and validity, compared with the control group.","['AS patients', '118 patients with AS were included and analyzed', 'Chinese patients with AS', 'patients with ankylosing spondylitis']","['WeChat-based educational intervention', 'WeChat-based educational intervention (consisting of four individual online educational sessions, online educational materials) or the control group receiving standard care']","['lower depressive symptoms', 'Beck Depression Inventory-II, the Medical Outcomes Study Short Form 36-item Health Survey (SF-36), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Patient Global Score (BAS-G), and visual analog scales', 'depression, health-related QoL', 'depressive symptoms and improving health-related QoL']","[{'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",118.0,0.273969,"After the intervention, the intervention group reported significant higher scores of all domains of SF-36 except for physical functioning and validity, compared with the control group.","[{'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, No. 37, Guoxuexiang, Wuhou District, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Nursing, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology and Immunology, West China Hospital, Sichuan University, No. 37, Guoxuexiang, Wuhou District, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology and Immunology, West China Hospital, Sichuan University, No. 37, Guoxuexiang, Wuhou District, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Nursing Department, The First Affiliated Hospital of Harbin Medical University, No.23 Youzheng Street, Nangang, Harbin, 150001, Heilongjiang, China.'}, {'ForeName': 'Anliu', 'Initials': 'A', 'LastName': 'Nie', 'Affiliation': 'Emergency Department, The First Affiliated Hospital of Guangzhou Medical University, No. 151 Yanjiangxi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, No. 37, Guoxuexiang, Wuhou District, Chengdu, 610041, Sichuan, China. 1366109878@qq.com.'}]",Arthritis research & therapy,['10.1186/s13075-021-02453-7']
1451,33663549,Eye Movement Desensitization (EMD) to reduce posttraumatic stress disorder-related stress reactivity in Indonesia PTSD patients: a study protocol for a randomized controlled trial.,"BACKGROUND


Posttraumatic stress disorder (PTSD) may develop after exposure to a traumatic event. Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based psychological treatment for PTSD. It is yet unclear whether eye movements also reduce stress reactivity in PTSD patients. This study aims to test whether eye movements, as provided during Eye Movement Desensitization (EMD), are more effective in reducing stress reactivity in PTSD patients as compared to a retrieval-only control condition.
METHODS


The study includes participants who meet criteria of PTSD of the public psychological services in Jakarta and Bandung, Indonesia. One hundred and ten participants are randomly assigned to either an (1) Eye Movement Desensitization group (n = 55) or (2) retrieval-only control group (n = 55). Participants are assessed at baseline (T0), post-treatment (T1), 1 month (T2), and at 3 months follow-up (T3). Participants are exposed to a script-driven imagery procedure at T0 and T1. The primary outcome is heart rate variability (HRV) stress reactivity during script-driven imagery. Secondary outcomes include heart rate (HR), pre-ejection period (PEP), saliva cortisol levels, PTSD symptoms, neurocognitive functioning, symptoms of anxiety and depression, perceived stress level, and quality of life.
DISCUSSION


If the EMD intervention is effective in reducing stress reactivity outcomes, this would give us more insight into the underlying mechanisms of EMDR's effectiveness in PTSD symptom reduction.
TRIAL REGISTRATION


ISRCTN registry ISRCTN55239132 . Registered on 19 December 2017.",2021,"If the EMD intervention is effective in reducing stress reactivity outcomes, this would give us more insight into the underlying mechanisms of EMDR's effectiveness in PTSD symptom reduction.
","['Indonesia PTSD patients', 'participants who meet criteria of PTSD of the public psychological services in Jakarta and Bandung, Indonesia', 'One hundred and ten participants', 'PTSD patients']","['Eye Movement Desensitization and Reprocessing (EMDR', 'EMD intervention', 'Eye Movement Desensitization group (n\u2009=\u200955) or (2) retrieval-only control group', 'Eye Movement Desensitization (EMD']","['heart rate (HR), pre-ejection period (PEP), saliva cortisol levels, PTSD symptoms, neurocognitive functioning, symptoms of anxiety and depression, perceived stress level, and quality of life', 'stress reactivity', 'heart rate variability (HRV) stress reactivity during script-driven imagery', 'stress reactivity outcomes']","[{'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0959214,"If the EMD intervention is effective in reducing stress reactivity outcomes, this would give us more insight into the underlying mechanisms of EMDR's effectiveness in PTSD symptom reduction.
","[{'ForeName': 'Eka', 'Initials': 'E', 'LastName': 'Susanty', 'Affiliation': 'Faculty of Psychology, Universitas Jenderal Achmad Yani, Cimahi, Indonesia. e.s.susanty@vu.nl.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sijbrandij', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty Behaviour and Movement Sciences, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Wilis', 'Initials': 'W', 'LastName': 'Srisayekti', 'Affiliation': 'Department of General and Experimental Psychology, Faculty of Psychology, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Anja C', 'Initials': 'AC', 'LastName': 'Huizink', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty Behaviour and Movement Sciences, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}]",Trials,['10.1186/s13063-021-05100-3']
1452,33662894,"Efficacy of adjunctive cenobamate based on number of concomitant antiseizure medications, seizure frequency, and epilepsy duration at baseline: A post-hoc analysis of a randomized clinical study.","BACKGROUND


In an 18-week, double-blind, placebo-controlled study (YKP3089C017; NCT01866111), cenobamate was effective for the treatment of focal-onset seizures. This post-hoc analysis examined the effects of baseline clinical features on the efficacy of adjunctive cenobamate during the study.
METHODS


Adults with uncontrolled focal seizures despite treatment with 1-3 antiepileptic drugs/antiseizure medications (AEDs/ASMs) were randomized 1:1:1:1 to placebo or cenobamate 100, 200, or 400 mg once daily. Median percent seizure frequency reduction/28 days and ≥50% responder rates were assessed during the 12-week maintenance phase (n = 397) by number of baseline (concomitant) ASMs (1, 2, >2), median baseline seizure frequency/28 days (≤9.5 vs >9.5), and median baseline duration of epilepsy (≤23 vs >23 years).
RESULTS


For patients taking 1 concomitant ASM, median percent seizure frequency reductions ranged from 44.7% to 86.0% for cenobamate-treated patients vs 24.1% for placebo; for 2 concomitant ASMs, reductions were 41.4-57.9% with cenobamate vs 33.3% for placebo; and for >2 concomitant ASMs, reductions were 41.5-67.4% with cenobamate vs 26.4% for placebo. The highest reductions occurred in the 200- and 400-mg/day cenobamate groups. For patients with baseline seizure frequency ≤9.5, the greatest reduction in median percent seizure frequency occurred in the 200-mg/day cenobamate group (66.5%); for patients with baseline seizure frequency >9.5 the greatest reduction occurred in the 400-mg/day cenobamate group (70.7%). Similar improvements were observed when assessed by median duration of epilepsy at baseline. For cenobamate-treated patients taking 1, 2, or >2 ASMs respectively, ≥50% responder rates of up to 66.7% (400 mg), 62.2% (200 mg), and 66.0% (400 mg) were observed, vs 20.0%, 29.3%, and 23.9% for placebo, respectively; 100% seizure reductions were observed in up to 25.0% (400 mg/day), 22.2% (400 mg/day), and 19.1% (400 mg/day) of cenobamate-treated patients, vs 0%, 0%, and 2.2% for placebo, respectively. Incidence of common (≥10%) central nervous system adverse events (dizziness, somnolence, fatigue, and diplopia) were highest in the >2 ASM group, but the rates were within the range reported in the primary study.
CONCLUSIONS


Clinically relevant reductions in seizure frequency including 100% seizure reductions occurred with adjunctive cenobamate regardless of number of concomitant ASMs, baseline seizure frequency, or disease duration. The greatest reductions occurred in the 200- and 400-mg/day groups.",2021,"CONCLUSIONS


Clinically relevant reductions in seizure frequency including 100% seizure reductions occurred with adjunctive cenobamate regardless of number of concomitant ASMs, baseline seizure frequency, or disease duration.",['Adults with uncontrolled focal seizures despite treatment with 1-3 antiepileptic drugs/antiseizure medications (AEDs/ASMs'],"['placebo or cenobamate', 'adjunctive cenobamate', 'placebo']","['median baseline duration of epilepsy', 'seizure frequency reductions', 'median duration of epilepsy', 'highest reductions', 'median percent seizure frequency', 'seizure reductions', 'Incidence of common (≥10%) central nervous system adverse events (dizziness, somnolence, fatigue, and diplopia', 'number of concomitant antiseizure medications, seizure frequency, and epilepsy duration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012569', 'cui_str': 'Diplopia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.576846,"CONCLUSIONS


Clinically relevant reductions in seizure frequency including 100% seizure reductions occurred with adjunctive cenobamate regardless of number of concomitant ASMs, baseline seizure frequency, or disease duration.","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, 11134 Conway Road, 63131 St. Louis, MO, USA. Electronic address: werosenfeldmd@gmail.com.'}, {'ForeName': 'Arkady', 'Initials': 'A', 'LastName': 'Nisman', 'Affiliation': 'SK Life Science, Inc., Paramus, NJ, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Ferrari', 'Affiliation': 'SK Life Science, Inc., Paramus, NJ, USA.'}]",Epilepsy research,['10.1016/j.eplepsyres.2021.106592']
1453,33662760,The elderly's physiological and perceptual responses to cooling during simulated activities of daily living in UK summer climatic conditions.,"OBJECTIVES


The elderly are the most at-risk population for heat-related illness and mortality during the periods of hot weather. However, evidence-based elderly-specific cooling strategies to prevent heat-illness are limited. The aim of this investigation was to quantify the elderly's physiological and perceptual responses to cooling through cold water ingestion (COLD) or an L-menthol mouth rinse (MENT) during simulated activities of daily living in UK summer climatic conditions.
STUDY DESIGN


Randomised, controlled repeated measures research design.
METHODS


A total of ten participants (men n = 7, women n = 3: age; 69 ± 3 yrs, height; 168 ± 10 cm, body mass; 68.88 ± 13.72 kg) completed one preliminary and three experimental trials; control (CON), COLD and MENT. Experimental trials consisted of 40 min rest followed by 30 min of cycling exercise at 6 metabolic equivalents and a 6-min walk test (6MWT), within a 35 °C, 50% relative humidity environment. Experimental interventions (every 10 min); cold water (4 °C) ingestion (total of 1.5L) or menthol (5 ml mouth swill for 5 s, menthol concentration of 0.01%).
RESULTS


Peak rectal temperature (T re ) was significantly (P < 0.05) lower in COLD compared with CON (-0.34 ± 0.16 °C) and MENT (-0.36 ± 0.20 °C). End exercise heart rate (HR) decreased in COLD compared with CON (-7 ± 9 b min -1 ) and MENT (-6 ± 7 b min -1 ). There was no difference in end exercise thermal sensation (TS) (CON; 6.1 ± 0.4, COLD; 6.0 ± 0.4, MENT; 6.4 ± 0.6) or thermal comfort (TC) (CON; 4 ± 1, COLD; 4 ± 1, MENT; 4 ± 1) between trials. The participants walked significantly further during the COLD 6MWT compared with CON (40 m ± 40 m) and MENT (40 m ± 30 m). There was reduced physiological strain in the COLD 6MWT compared with CON (T re ; -0.21 ± 0.24 °C, HR; -7 ± 8 b min -1 ) and MENT (T re ; -0.23 ± 0.24 °C, HR; -4 ± 7 b min -1 ).
CONCLUSION


The elderly have reduced physiological strain (T re  and HR) during activities of daily living and a 6MWT in hot UK climatic conditions, when they drink cold water. Furthermore, the elderly's perception (TS and TC) of the hot environment did not differ from CON at the end of exercise with COLD or MENT interventions. Menthol provided neither perceptual benefit to exercise in the heat nor functional gain. The TS data indicate that elderly may be at increased risk of heat illness, due to not feeling hot and uncomfortable enough to implement physiological strain reducing strategies such as cold-water ingestion.",2021,"RESULTS


Peak rectal temperature (T re ) was significantly (P < 0.05) lower in COLD compared with CON (-0.34 ± 0.16 °C) and MENT (-0.36 ± 0.20 ","['A total of ten participants (men n\xa0=\xa07, women n\xa0=\xa03: age; 69\xa0±\xa03\xa0yrs, height; 168\xa0±\xa010\xa0cm, body mass; 68.88\xa0±\xa013.72\xa0kg) completed one preliminary and three experimental trials', 'daily living in UK summer climatic conditions']","['40\xa0min rest followed by 30\xa0min of cycling exercise at 6 metabolic equivalents and a 6-min walk test (6MWT', 'cooling through cold water ingestion (COLD) or an L-menthol mouth rinse (MENT', 'Experimental interventions (every 10\xa0min); cold water (4\xa0°C) ingestion (total of 1.5L) or menthol', 'Menthol', 'CON', 'control (CON), COLD and MENT', 'CON (-7\xa0±']","['Peak rectal temperature (T re ', 'end exercise thermal sensation (TS', 'End exercise heart rate (HR', 'physiological strain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0771655', 'cui_str': 'LEVOMENTHOL'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0084844', 'cui_str': 'trestolone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",10.0,0.120661,"RESULTS


Peak rectal temperature (T re ) was significantly (P < 0.05) lower in COLD compared with CON (-0.34 ± 0.16 °C) and MENT (-0.36 ± 0.20 ","[{'ForeName': 'K A M', 'Initials': 'KAM', 'LastName': 'Waldock', 'Affiliation': 'Army Health and Performance Research, Andover, United Kingdom; Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom. Electronic address: kirsty.waldock100@mod.gov.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hayes', 'Affiliation': 'Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Watt', 'Affiliation': 'Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Maxwell', 'Affiliation': 'Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom.'}]",Public health,['10.1016/j.puhe.2021.01.016']
1454,33670353,Predictors of Adherence in Three Low-Intensity Intervention Programs Applied by ICTs for Depression in Primary Care.,"Depression is one of the most common disorders in psychiatric and primary care settings, and is associated with disability, loss in quality of life, and economic costs. Internet-based psychological interventions have been shown to be effective in depression treatment but present problems with a low degree of adherence. The main aim of this study is to analyze the adherence predictors in three low-intensity interventions programs applied by Information and Communication Technologies (ICTs) for depression. A multi-center, randomized, controlled clinical trial was conducted with 164 participants with depression, who were allocated to: Healthy Lifestyle Program, Positive Affect Promotion Program or Mindfulness Program. Sociodemographic characteristics, Patient Health Questionnaire-9, Visual Analog Scale, Short Form Health Survey, Positive and Negative Affect Schedule, Five Facets Mindfulness Questionnaire, Pemberton Happiness Index and Treatment Expectancy Questionnaire were used to study adherence. Results showed that positive affect resulted in a predictor variable for Healthy Lifestyle Program and Positive Affect Promotion Program. Perceived health was also a negative adherence predictor for the Positive Affect Promotion Program. Our findings demonstrate that there are differences in clinical variables between treatment completers and non-completers and we provide adherence predictors in two intervention groups. Although new additional predictors have been examined, further research is essential in order to improve tailored interventions and increase adherence treatment.",2021,Perceived health was also a negative adherence predictor for the Positive Affect Promotion Program.,"['164 participants with depression, who were allocated to']","['Internet-based psychological interventions', 'Healthy Lifestyle Program, Positive Affect Promotion Program or Mindfulness Program']","['Sociodemographic characteristics, Patient Health Questionnaire-9, Visual Analog Scale, Short Form Health Survey, Positive and Negative Affect Schedule, Five Facets Mindfulness Questionnaire, Pemberton Happiness Index and Treatment Expectancy Questionnaire']","[{'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",164.0,0.0358604,Perceived health was also a negative adherence predictor for the Positive Affect Promotion Program.,"[{'ForeName': 'Adoración', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, University Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'López-Del-Hoyo', 'Affiliation': 'Institute of Health Research of Aragon (IIS), Hospital Miguel Servet, 50009 Zaragoza, Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Mayoral', 'Affiliation': 'Mental Health Department, Institute of Biomedicine of Malaga, University Regional Hospital of Malaga, 29010 Málaga, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Pérez-Ara', 'Affiliation': 'Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Rosa Mª', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'CIBER Physiopathology Obesity and Nutrition (CIBERobn), Carlos III Health Institute, 28029 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Institute of Health Research of Aragon (IIS), Hospital Miguel Servet, 50009 Zaragoza, Spain.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Hurtado', 'Affiliation': 'Mental Health Department, Institute of Biomedicine of Malaga, University Regional Hospital of Malaga, 29010 Málaga, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, University Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Barceló-Soler', 'Affiliation': 'Institute of Health Research of Aragon (IIS), Hospital Miguel Servet, 50009 Zaragoza, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Villena', 'Affiliation': 'Mental Health Department, Institute of Biomedicine of Malaga, University Regional Hospital of Malaga, 29010 Málaga, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': 'Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': 'Research Institute of Health Sciences (IUNICS), University of Balearic Islands, 07122 Palma de Mallorca, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18041774']
1455,33670295,Comparison of Learning Transfer Using Simulation Problem-Based Learning and Demonstration: An Application of Papanicolaou Smear Nursing Education.,"The purpose of this study was to compare the effects of simulation problem-based learning (S-PBL), a type of learning that reflects various clinical situations, and demonstration-based learning, a conventional type of learning that shows clinical skill performance, of Papanicolaou smear education on the self-confidence, learner satisfaction, and critical thinking of nursing students. A quasi-experimental control group pretest-posttest design was used. Nursing students who were classified as advanced beginners were randomly allocated to the control group ( n  = 53) or the experimental group ( n  = 52). Students in the control group participated in a conventional demonstration of a Papanicolaou smear, while students in the experimental group participated in S-PBL. The students' self-confidence, learner satisfaction, and critical thinking were measured via a self-reported questionnaire. Compared with the control group, self-confidence, learner satisfaction, and critical thinking increase significantly more ( p  < 0.001) in the experimental group. S-PBL was found to be an effective strategy for improving learning transfer, applying learned nursing knowledge to simulated nursing situations. Thus, S-PBL is recommended to improve training in nursing education.",2021,"S-PBL was found to be an effective strategy for improving learning transfer, applying learned nursing knowledge to simulated nursing situations.","['nursing students', 'Nursing students who were classified as advanced beginners']","['Learning Transfer', 'simulation problem-based learning (S-PBL', 'conventional demonstration of a Papanicolaou smear, while students in the experimental group participated in S-PBL', 'Simulation Problem-Based Learning and Demonstration']","['self-confidence, learner satisfaction, and critical thinking increase', 'self-confidence, learner satisfaction, and critical thinking']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0166778,"S-PBL was found to be an effective strategy for improving learning transfer, applying learned nursing knowledge to simulated nursing situations.","[{'ForeName': 'Jeongim', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Eulji University, Seongnam City 13135, Korea.'}, {'ForeName': 'Hae Kyoung', 'Initials': 'HK', 'LastName': 'Son', 'Affiliation': 'Department of Nursing, Eulji University, Seongnam City 13135, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph18041765']
1456,33670285,"GMO Food Labels Do Not Affect College Student Food Selection, Despite Negative Attitudes towards GMOs.","US Public Law 114-216 dictates that food producers in the United States of America will be required to label foods containing genetically modified organisms (GMOs) starting in 2022; however, there is little empirical evidence demonstrating how U.S. consumers would use food labels that indicate the presence or absence of GMOs. The aim of this two-phase study was to determine how attitudes towards GMOs relate to food choices and how labels indicating the presence or absence of GMOs differentially impact choices among college students-the age group which values transparent food labeling more than any other. Participants ( n  = 434) made yes/no choices for each of 64 foods. In both phases of the study, participants were randomly assigned to seeing GMO Free labels, contains GMOs labels, or no GMO labels. Across the two phases, 85% of participants reported believing that GMOs were at least somewhat dangerous to health (42% believed GMOs to be dangerous), yet in both studies, although eye-tracking data verified that participants attended to the GMO labels, these labels did not significantly affect food choices. Although college consumers may believe GMOs to be dangerous, their food choices do not reflect this belief.",2021,"Across the two phases, 85% of participants reported believing that GMOs were at least somewhat dangerous to health (42% believed GMOs to be dangerous), yet in both studies, although eye-tracking data verified that participants attended to the GMO labels, these labels did not significantly affect food choices.",['college students-the age group which values transparent food labeling more than any other'],"['seeing GMO Free labels, contains GMOs labels, or no GMO labels']",['believing that GMOs'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0016475', 'cui_str': 'Food Labelling'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0969756', 'cui_str': 'Genetically Modified Organism'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0969756', 'cui_str': 'Genetically Modified Organism'}]",,0.0981623,"Across the two phases, 85% of participants reported believing that GMOs were at least somewhat dangerous to health (42% believed GMOs to be dangerous), yet in both studies, although eye-tracking data verified that participants attended to the GMO labels, these labels did not significantly affect food choices.","[{'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Oselinsky', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Ashlie', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Lundeberg', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Johnson Holm', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Graham', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO 80523, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph18041761']
1457,33670235,"Comparing the Efficacy of Multidisciplinary Assessment and Treatment, or Acceptance and Commitment Therapy, with Treatment as Usual on Health Outcomes in Women on Long-Term Sick Leave-A Randomised Controlled Trial.","BACKGROUND


Chronic pain and mental disorders are common reasons for long term sick leave. The study objective was to evaluate the efficacy of a multidisciplinary assessment and treatment program including acceptance and commitment therapy (TEAM) and stand-alone acceptance and commitment therapy (ACT), compared with treatment as usual (Control) on health outcomes in women on long-term sick leave.
METHOD


Participants ( n  = 308), women of working age on long term sick leave due to musculoskeletal pain and/or common mental disorders, were randomized to TEAM ( n  = 102), ACT ( n  = 102) or Control ( n  = 104). Participants in the multidisciplinary assessment treatment program received ACT, but also medical assessment, occupational therapy and social counselling. The second intervention included ACT only. Health outcomes were assessed over 12 months using adjusted linear mixed models. The results showed significant interaction effects for both ACT and TEAM compared with Control in anxiety (ACT [ p  < 0.05]; TEAM [ p  < 0.001]), depression (ACT [ p  < 0.001]; TEAM [ p  < 0.001]) and general well-being (ACT [ p  < 0.05]; TEAM [ p  < 0.001]). For self-rated pain, there was a significant interaction effect in favour of ACT ( p  < 0.05), and for satisfaction with life in favour of TEAM ( p  < 0.001).
CONCLUSION


Both ACT alone and multidisciplinary assessment and treatment including ACT were superior to treatment as usual in clinical outcomes.",2021,"For self-rated pain, there was a significant interaction effect in favour of ACT ( p  < 0.05), and for satisfaction with life in favour of TEAM ( p  < 0.001).
","['Women on Long-Term Sick Leave', 'Participants ( n  = 308), women of working age on long term sick leave due to musculoskeletal pain and/or common mental disorders', 'women on long-term sick leave']","['multidisciplinary assessment and treatment program including acceptance and commitment therapy (TEAM) and stand-alone acceptance and commitment therapy (ACT', 'Multidisciplinary Assessment and Treatment, or Acceptance and Commitment Therapy', 'ACT, but also medical assessment, occupational therapy and social counselling', 'TEAM', 'ACT']","['anxiety', 'health outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0729737', 'cui_str': 'Multidisciplinary assessment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0474156', 'cui_str': 'Social counseling'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.232732,"For self-rated pain, there was a significant interaction effect in favour of ACT ( p  < 0.05), and for satisfaction with life in favour of TEAM ( p  < 0.001).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Finnes', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, SE-171 65 Solna, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Anderzén', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Husargatan 3, SE-751 22 Uppsala, Sweden.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Pingel', 'Affiliation': 'Department of Statistics, Uppsala University, Kyrkogårdsgatan 10, SE-751 20 Uppsala, Sweden.'}, {'ForeName': 'JoAnne', 'Initials': 'J', 'LastName': 'Dahl', 'Affiliation': 'Department of Psychology, Uppsala University, Campus Blåsenhus, von Kraemers allé 1A, SE-751 42 Uppsala, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Molin', 'Affiliation': 'Uppsala University Hospital, SE-751 85 Uppsala, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Lytsy', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Husargatan 3, SE-751 22 Uppsala, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph18041754']
1458,33669119,The Effect of Kefir Supplementation on Improving Human Endurance Exercise Performance and Antifatigue.,"Kefir is an acidic, carbonated, and fermented dairy product produced by fermenting milk with kefir grains. The  Lactobacillus  species constitutes an important part of kefir grains. In a previous animal study, kefir effectively improved exercise performance and had anti-fatigue effects. The purpose of this research was to explore the benefits of applying kefir to improve exercise performance, reduce fatigue, and improve physiological adaptability in humans. The test used a double-blind crossover design and supplementation for 28 days. Sixteen 20-30 year-old subjects were divided into two groups in a balanced order according to each individual's initial maximal oxygen uptake and were assigned to receive a placebo (equal flavor, equal calories, 20 g/day) or SYNKEFIR™ (20 g/day) every morning. After the intervention, there were 28 days of wash-out, during which time the subjects did not receive further interventions. After supplementation with SYNKEFIR™, the exercise time to exhaustion was significantly greater than that before ingestion ( p  = 0.0001) and higher than that in the Placebo group by 1.29-fold ( p  = 0.0004). In addition, compared with the Placebo group, the SYNKEFIR™ administration group had significantly lower lactate levels in the exercise and recovery ( p  < 0.05). However, no significant difference was observed in the changes in the gut microbiota. Although no significant changes in body composition were found, SYNKEFIR™ did not cause adverse reactions or harm to the participants' bodies. In summary, 28 days of supplementation with SYNKEFIR™ significantly improved exercise performance, reduced the production of lactic acid after exercise, and accelerated recovery while also not causing any adverse reactions.",2021,"Although no significant changes in body composition were found, SYNKEFIR™ did not cause adverse reactions or harm to the participants' bodies.","['Sixteen 20-30 year-old subjects', 'humans']","['Kefir Supplementation', 'placebo (equal flavor, equal calories, 20 g/day) or SYNKEFIR™', 'Placebo']","['body composition', 'gut microbiota', 'production of lactic acid', 'exercise performance', 'Human Endurance Exercise Performance and Antifatigue', 'lactate levels', 'exercise time to exhaustion']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0524649', 'cui_str': 'Kefir'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",,0.0835925,"Although no significant changes in body composition were found, SYNKEFIR™ did not cause adverse reactions or harm to the participants' bodies.","[{'ForeName': 'Mon-Chien', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Wei-Lun', 'Initials': 'WL', 'LastName': 'Jhang', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Chia-Chia', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Culture Collection & Research Institute, Synbio Tech Incorporation, Kaohsiung 821, Taiwan.'}, {'ForeName': 'Nai-Wen', 'Initials': 'NW', 'LastName': 'Kan', 'Affiliation': 'Center for General Education, Taipei Medical University, Taipei 11031, Taiwan.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Chin-Shan', 'Initials': 'CS', 'LastName': 'Ho', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Chun-Hao', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Cheng', 'Affiliation': 'Culture Collection & Research Institute, Synbio Tech Incorporation, Kaohsiung 821, Taiwan.'}, {'ForeName': 'Jin-Seng', 'Initials': 'JS', 'LastName': 'Lin', 'Affiliation': 'Culture Collection & Research Institute, Synbio Tech Incorporation, Kaohsiung 821, Taiwan.'}, {'ForeName': 'Chi-Chang', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}]",Metabolites,['10.3390/metabo11030136']
1459,33669067,"Comparison of Immunogenicity and Safety between a Single Dose and One Booster Trivalent Inactivated Influenza Vaccination in Patients with Chronic Kidney Disease: A 20-Week, Open-Label Trial.","BACKGROUND


Non-dialysis-dependent chronic kidney disease (CKD-ND) patients are recommended to receive a one-dose influenza vaccination annually. However, studies investigating vaccine efficacy in the CKD-ND population are still lacking. In this study, we aimed to evaluate vaccine efficacy between the one-dose and two-dose regimen and among patients with different stages of CKD throughout a 20-week follow-up period.
METHODS


We conducted a single-center, non-randomized, open-label, controlled trial among patients with all stages of CKD-ND. Subjects were classified as unvaccinated, one-dose, and two-dose groups (4 weeks apart) after enrollment. Serial changes in immunological parameters (0, 4, 8, and 20 weeks after enrollment), including seroprotection, geometric mean titer (GMT), GMT fold-increase, seroconversion, and seroresponse, were applied to evaluate vaccine efficacy.
RESULTS


There were 43, 84, and 71 patients in the unvaccinated, one-dose, and two-dose vaccination groups, respectively. At 4-8 weeks after vaccination, seroprotection rates in the one- and two-dose group for H1N1, H3N2, and B ranged from 82.6-95.8%, 97.4-100%, and 73.9-100%, respectively. The concomitant seroconversion and GMT fold-increases nearly met the suggested criteria for vaccine efficacy for the elderly population. Although the seroprotection rates for all of the groups were adequate, the seroconversion and GMT fold-increase at 20 weeks after vaccination did not meet the criteria for vaccine efficacy. The two-dose regimen had a higher probability of achieving seroprotection for B strains (Odds ratio: 3.5, 95% confidence interval (1.30-9.40)). No significant differences in vaccine efficacy were found between early (stage 1-3) and late (stage 4-5) stage CKD.
CONCLUSIONS


The standard one-dose vaccination can elicit sufficient protective antibodies. The two-dose regimen induced a better immune response when the baseline serum antibody titer was low. Monitoring change in antibody titers for a longer duration is warranted to further determine the current vaccine strategy in CKD-ND population.",2021,"No significant differences in vaccine efficacy were found between early (stage 1-3) and late (stage 4-5) stage CKD.
CONCLUSIONS


","['Patients with Chronic Kidney Disease', 'patients with all stages of CKD-ND', 'patients with different stages of CKD throughout a 20-week follow-up period', 'Non-dialysis-dependent chronic kidney disease (CKD-ND) patients']",['Single Dose and One Booster Trivalent Inactivated Influenza Vaccination'],"['vaccine efficacy', 'Immunogenicity and Safety', 'antibody titers', 'higher probability of achieving seroprotection', 'seroprotection rates', 'seroprotection, geometric mean titer (GMT), GMT fold-increase, seroconversion, and seroresponse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",,0.055444,"No significant differences in vaccine efficacy were found between early (stage 1-3) and late (stage 4-5) stage CKD.
CONCLUSIONS


","[{'ForeName': 'Yu-Tzu', 'Initials': 'YT', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Tsai-Chieh', 'Initials': 'TC', 'LastName': 'Ling', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Ya-Yun', 'Initials': 'YY', 'LastName': 'Cheng', 'Affiliation': 'Department of Environmental Health, T.H Chan School of Public Health, Harvard University, Boston, MA 02115, USA.'}, {'ForeName': 'Chien-Yao', 'Initials': 'CY', 'LastName': 'Sun', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Jia-Ling', 'Initials': 'JL', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Ching Hui', 'Initials': 'CH', 'LastName': 'Tai', 'Affiliation': 'Department of Medical Laboratory Science and Biotechnology, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Jen-Ren', 'Initials': 'JR', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Laboratory Science and Biotechnology, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Junne-Ming', 'Initials': 'JM', 'LastName': 'Sung', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}]",Vaccines,['10.3390/vaccines9030192']
1460,33668937,"Effects of Short-Term Plyometric Training on Agility, Jump and Repeated Sprint Performance in Female Soccer Players.","The aim of the study was to determine the effects of short-term (4 weeks, twice a week: 8 sessions) plyometric training on agility, jump, and repeated sprint performance in female soccer players. The study comprised 17 females performing this sports discipline. The players were randomly divided into two groups: with plyometric training (PLY) and the control (CON). All players followed the same training program, but the PLY group also performed plyometric exercises. Tests used to evaluate physical performance were carried out immediately before and after PLY. After implementing the short PLY training, significant improvement in jump performance (squat jump:  p  = 0.04, ES = 0.48, countermovement jump:  p  = 0.009, ES = 0.42) and agility ( p  = 0.003, ES = 0.7) was noted in the PLY group. In the CON group, no significant ( p  > 0.05) changes in physical performance were observed. In contrast, PLY did not improve repeated sprint performance ( p  > 0.05) among female soccer players. In our research, it was shown that PLY can also be effective when performed for only 4 weeks instead of the 6-12 weeks typically applied.",2021,"After implementing the short PLY training, significant improvement in jump performance (squat jump:  p  = 0.04, ES = 0.48, countermovement jump:  ","['Female Soccer Players', 'female soccer players', '17 females performing this sports discipline']","['PLY group also performed plyometric exercises', 'plyometric training', 'CON', 'Short-Term Plyometric Training', 'plyometric training (PLY) and the control (CON']","['jump performance', 'Agility, Jump and Repeated Sprint Performance', 'repeated sprint performance', 'physical performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",17.0,0.01195,"After implementing the short PLY training, significant improvement in jump performance (squat jump:  p  = 0.04, ES = 0.48, countermovement jump:  ","[{'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Maciejczyk', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, University of Physical Education, 31-571 Kraków, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Błyszczuk', 'Affiliation': 'Department of Physical Education, Faculty of Health Sciences, University of Applied Sciences, 33-100 Tarnów, Poland.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Drwal', 'Affiliation': 'Doctoral School, University of Physical Education, 31-571 Kraków, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Nowak', 'Affiliation': 'Department of Physical Education, Faculty of Health Sciences, University of Applied Sciences, 33-100 Tarnów, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Strzała', 'Affiliation': 'Department of Water Sports, Faculty of Physical Education and Sport, University of Physical Education, 31-571 Kraków, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph18052274']
1461,33668849,Prenatal Maternal Docosahexaenoic Acid (DHA) Supplementation and Newborn Anthropometry in India: Findings from DHANI.,"Long-chain omega-3 fatty acid status during pregnancy may influence newborn anthropometry and duration of gestation. Evidence from high-quality trials from low- and middle-income countries (LMICs) is limited. We conducted a double-blind, randomized, placebo-controlled trial among 957 pregnant women (singleton gestation, 14-20 weeks' gestation at enrollment) in India to test the effectiveness of 400 mg/day algal docosahexaenoic acid (DHA) compared to placebo provided from enrollment through delivery. Among 3379 women who were screened, 1171 were found eligible; 957 were enrolled and were randomized. The intervention was two microencapsulated algal DHA (200 × 2 = 400 mg/day) or two microencapsulated soy and corn oil placebo tablets to be consumed daily from enrollment (≤20 weeks) through delivery. The primary outcome was newborn anthropometry (birth weight, length, head circumference). Secondary outcomes were gestational age and 1 and 5 min Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score. The groups (DHA;  n  = 478 and placebo;  n  = 479) were well balanced at baseline. There were 902 live births. Compliance with the intervention was similar across groups (DHA: 88.5%; placebo: 87.1%). There were no significant differences between DHA and placebo groups for birth weight (2750.6 ± 421.5 vs. 2768.2 ± 436.6 g,  p  = 0.54), length (47.3 ± 2.0 vs. 47.5 ± 2.0 cm,  p  = 0.13), or head circumference (33.7 ± 1.4 vs. 33.8 ± 1.4 cm,  p  = 0.15). The mean gestational age at delivery was similar between groups (DHA: 38.8 ± 1.7 placebo: 38.8 ± 1.7 wk,  p  = 0.54) as were APGAR scores at 1 and 5 min. Supplementing mothers through pregnancy with 400 mg/day DHA did not impact the offspring's birthweight, length, or head circumference.",2021,Compliance with the intervention was similar across groups (DHA: 88.5%; placebo: 87.1%).,"[""957 pregnant women (singleton gestation, 14-20 weeks' gestation at enrollment) in India to test the effectiveness of 400 mg"", '3379 women who were screened, 1171 were found eligible; 957 were enrolled and were randomized']","['day algal docosahexaenoic acid (DHA', 'placebo', 'microencapsulated soy and corn oil placebo tablets', 'Prenatal Maternal Docosahexaenoic Acid (DHA) Supplementation', 'microencapsulated algal DHA']","['newborn anthropometry and duration of gestation', 'mean gestational age at delivery', 'birthweight, length, or head circumference', 'gestational age and 1 and 5 min Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score', 'birth weight', 'newborn anthropometry (birth weight, length, head circumference', 'APGAR scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0239779', 'cui_str': 'Grimaces'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}]",957.0,0.781465,Compliance with the intervention was similar across groups (DHA: 88.5%; placebo: 87.1%).,"[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Khandelwal', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Mallaiah Kenchaveeraiah', 'Initials': 'MK', 'LastName': 'Swamy', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Gangubai', 'Initials': 'G', 'LastName': 'Pujeri', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Swati Babu', 'Initials': 'SB', 'LastName': 'Mane', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Yashaswi', 'Initials': 'Y', 'LastName': 'Kudachi', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi 110016, India.'}]",Nutrients,['10.3390/nu13030730']
1462,33667246,The acceptance and impact of Google Classroom integrating into a clinical pathology course for nursing students: A technology acceptance model approach.,"BACKGROUND


Google Classroom (GC) is a free web-based instructional platform rarely used for nursing student education. The acceptance, intention to use, and learning outcomes of GC remain unclear in Taiwan. We sought to identify the technology acceptance level and factors affection the intention to use GC. We also explored how integrating GC into traditional teaching affects learning satisfaction and academic achievement among nursing students in Taiwan.
METHODS


In this randomized controlled study, based on a technology acceptance framework, 74 nursing students were randomly assigned in clusters to experimental (n = 39) and control (n = 35) groups during the spring semester of 2018. In Weeks 3-18, each member of the experimental group received one hour of traditional and GC teaching per week. The control group received two hours of traditional teaching per week. Both groups were asked to complete questionnaires to evaluate learning satisfaction and academic achievement during weeks 10 (mid-semester) and 18 (end-of-semester). The experimental group additionally completed technology acceptance questionnaires in both situations.
FINDINGS


In the experimental group, the overall end-of-semester technology acceptance score was high (141.8 out of 155); their perceived ease of use, intention to use, and technology acceptance scores increased significantly compared to mid-semester (p<0.05). At the end-of-semester, perceived playfulness and perceived usefulness explained 63.5% of the variance in intention to use. Regardless of whether the assessment was administered mid-semester or at the end-of-semester, the experimental group had higher learning satisfaction and academic achievement scores than the control group. However, the degree of progress on learning satisfaction and academic achievement demonstrated no significant between-group differences.
CONCLUSIONS


The experimental group demonstrated high acceptance of GC. Playfulness and usefulness positively influenced nursing students' intention to use GC. Blended learning-in combination with GC and traditional methods-resulted in similar learning satisfaction and academic achievement when compared to traditional learning. More research is needed to explore the effectiveness of blended learning through the GC platform with different courses and ethnic groups.",2021,Blended learning-in combination with GC and traditional methods-resulted in similar learning satisfaction and academic achievement when compared to traditional learning.,"['nursing students', '74 nursing students were randomly assigned in clusters to experimental (n = 39) and control (n = 35) groups during the spring semester of 2018', 'nursing students in Taiwan']",['Google Classroom (GC'],"['learning satisfaction and academic achievement scores', 'learning satisfaction and academic achievement', 'overall end-of-semester technology acceptance score', 'perceived ease of use, intention to use, and technology acceptance scores']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]",[],"[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0344558,Blended learning-in combination with GC and traditional methods-resulted in similar learning satisfaction and academic achievement when compared to traditional learning.,"[{'ForeName': 'Tzu-Hao', 'Initials': 'TH', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan, R.O.C.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan, R.O.C.'}, {'ForeName': 'Li-Chen', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, New Taipei City Municipal Tucheng Hospital, New Taipei, Taiwan, R.O.C.'}, {'ForeName': 'Ching-Ching', 'Initials': 'CC', 'LastName': 'Tsai', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan, R.O.C.'}]",PloS one,['10.1371/journal.pone.0247819']
1463,33667227,A survival of the fittest strategy for the selection of genotypes by which drug responders and non-responders can be predicted in small groups.,"Phenotype Prediction Scores (PPS) might be powerful tools to predict traits or the efficacy of treatments based on combinations of Single-Nucleotide Polymorphism (SNPs) in large samples. We developed a novel method to produce PPS models for small samples sizes. The set of SNPs is first filtered on those known to be relevant in biological pathways involved in a clinical condition, and then further filtered repeatedly in a survival strategy to select stabile positive/negative risk alleles. This method is applied on Female Sexual Interest/Arousal Disorder (FSIAD), for which two subtypes has been proposed: 1) a relatively insensitive excitatory system in the brain for sexual cues, and 2) a dysfunctional activation of brain mechanisms for sexual inhibition. A double-blind, randomized, placebo-controlled cross-over experiment was conducted on 129 women with FSIAD. The women received three different on-demand drug-combination treatments during 3 two-week periods: testosterone (0.5 mg) + sildenafil (50 mg), testosterone (0.5 mg) + buspirone (10 mg), or matching placebos. The resulted PPS were independently validated on patient-level and group-level. The AUC scores for T+S of the derivation set was 0.867 (95% CI = 0.796-0.939; p<0.001) and was 0.890 (95% CI = 0.778-1.000; p<0.001) on the validation set. For T+B the AUC of the derivation set was 0.957 (95% CI = 0.921-0.992; p<0.001) and 0.869 (95% CI = 0.746-0.992; p<0.001) for the validation set. Both formulas could reliably predict for each drug who benefit from the on-demand drugs and could therefore be useful in clinical practice.",2021,For T+B the AUC of the derivation set was 0.957 (95% CI = 0.921-0.992; p<0.001) and 0.869 (95% CI = 0.746-0.992; p<0.001) for the validation set.,['129 women with FSIAD'],"['testosterone (0.5 mg) + sildenafil', 'testosterone (0.5 mg) + buspirone (10 mg), or matching placebos', 'placebo']",[],"[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],129.0,0.213134,For T+B the AUC of the derivation set was 0.957 (95% CI = 0.921-0.992; p<0.001) and 0.869 (95% CI = 0.746-0.992; p<0.001) for the validation set.,"[{'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Höhle', 'Affiliation': 'Emotional Brain B.V., Almere, The Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'van Rooij', 'Affiliation': 'Emotional Brain B.V., Almere, The Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Bloemers', 'Affiliation': 'Emotional Brain B.V., Almere, The Netherlands.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Pfaus', 'Affiliation': 'Centro de Investigaciones Cerebrales, Xalapa, Mexico.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'Michiels', 'Affiliation': 'Chemistry and Life Sciences, V.O. Patients & Trademarks, Amsterdam, The Netherlands.'}, {'ForeName': 'Paddy', 'Initials': 'P', 'LastName': 'Janssen', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Claassen', 'Affiliation': 'Emotional Brain B.V., Almere, The Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Tuiten', 'Affiliation': 'Emotional Brain B.V., Almere, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0246828']
1464,33667178,Correction: A Self-Help App for Syrian Refugees With Posttraumatic Stress (Sanadak): Randomized Controlled Trial.,[This corrects the article DOI: 10.2196/24807.].,2021,[This corrects the article DOI: 10.2196/24807.].,[],['Correction'],[],[],[],[],,0.0439782,[This corrects the article DOI: 10.2196/24807.].,"[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Röhr', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, Medical Faculty, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Franziska U', 'Initials': 'FU', 'LastName': 'Jung', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, Medical Faculty, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Pabst', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, Medical Faculty, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Grochtdreis', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Dams', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Nagl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Renner', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Kersting', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Steffi G', 'Initials': 'SG', 'LastName': 'Riedel-Heller', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, Medical Faculty, University of Leipzig, Leipzig, Germany.'}]",JMIR mHealth and uHealth,['10.2196/28336']
1465,33677745,Stereoscopic virtual reality does not improve knowledge acquisition of congenital heart disease.,"Advances in virtual reality have made it possible for clinicians and trainees to interact with 3D renderings of hearts with congenital heart disease in 3D stereoscopic vision. No study to date has assessed whether this technology improved instruction compared to standard 2D interfaces. The purpose of this study was to assess whether stereoscopic virtual reality improves congenital heart disease anatomy education. Subjects in a prospective, blinded, randomized trial completed a pre-test assessing factual and visuospatial knowledge of common atrioventricular canal and were randomized to an intervention or control group based on their score. The intervention group used a 3D virtual reality (VR) headset to visualize a lecture with 3D heart models while the control group used a desktop (DT) computer interface with the same models. Subjects took a post-test and provided subjective feedback. 51 subjects were enrolled, 24 in the VR group & 27 in the DT group. The median score difference for VR subjects was 12 (IQR 9-13.3), compared to 10 (IQR 7.5-12) in the DT group. No difference in score improvement was found (p = 0.11). VR subjects' impression of the ease of use of their interface was higher than DT subjects (median 8 vs 7, respectively, p = 0.01). VR subjects' impression of their understanding of the subject matter was higher than desktop subjects (median 7 vs 5, respectively, p = 0.01). There was no statistically significant difference in the knowledge acquisition observed between the stereoscopic virtual reality group and the monoscopic desktop-based group. Participants in virtual reality reported a better learning experience and self-assessment suggesting virtual reality may increase learner engagement in understanding congenital heart disease.",2021,There was no statistically significant difference in the knowledge acquisition observed between the stereoscopic virtual reality group and the monoscopic desktop-based group.,"['51 subjects were enrolled, 24 in the VR group & 27 in the DT group']","['stereoscopic virtual reality', '3D virtual reality (VR) headset to visualize a lecture with 3D heart models while the control group used a desktop (DT) computer interface with the same models', 'pre-test assessing factual and visuospatial knowledge of common atrioventricular canal']","['knowledge acquisition', 'congenital heart disease anatomy education', 'median score difference', 'learner engagement', 'score improvement']","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1742641', 'cui_str': 'Desktop computer'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0221215', 'cui_str': 'Common atrioventricular canal'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",51.0,0.0255168,There was no statistically significant difference in the knowledge acquisition observed between the stereoscopic virtual reality group and the monoscopic desktop-based group.,"[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': ""Icahn School of Medicine at Mount Sinai, Children's Heart Center, Mt. Sinai Hospital, 1 Gustave L Levy Place, Box 1201, New York, NY, 10029, USA.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Costa', 'Affiliation': ""Icahn School of Medicine at Mount Sinai, Children's Heart Center, Mt. Sinai Hospital, 1 Gustave L Levy Place, Box 1201, New York, NY, 10029, USA.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Sanders', 'Affiliation': ""Cardiac Registry, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ezon', 'Affiliation': ""Icahn School of Medicine at Mount Sinai, Children's Heart Center, Mt. Sinai Hospital, 1 Gustave L Levy Place, Box 1201, New York, NY, 10029, USA. david.ezon@mssm.edu.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-021-02191-6']
1466,33677737,"Vestibular rehabilitation with mobile posturography as a ""low-cost"" alternative to vestibular rehabilitation with computerized dynamic posturography, in old people with imbalance: a randomized clinical trial.","BACKGROUND


Vestibular rehabilitation (VR), specifically, VR with dynamic computerized posturography (CDP) has proven to be useful to improve balance and reduce the risk of falling in old patients. Its major handicap is probably its cost, which has hindered its generalisation. One solution to reduce this cost is performing VR with mobile posturography systems, which allow assessment of stability at the center of body mass in daily-life conditions. Also, rehabilitation with vibrotactile neurofeedback training could be used in dynamic tasks.
OBJECTIVE


To assess whether two different protocols of vestibular rehabilitation (using CDP and the Vertiguard system) show significant differences in the improvement of balance among older persons with imbalance METHODS: A clinical trial comparing VR with CDP exercises and VR with mobile posturography (Vertiguard) exercises, was designed. The participants were people over 65 years, with imbalance. The composite (average balance) in the sensory organization test (SOT) of the CDP was the main outcome measure; it was compared before and 3 weeks after VR, and between both intervention groups.
RESULTS


40 patients were included in the study (19 in the CDP-VR group and 21 in the Vertiguard-VR group). Average balance was significantly improved in both intervention groups (51% pre-VR vs 60% post-VR, p = 0.002, CDP-VR group; 49% pre-VR vs 57% post-VR, p = 0.008, Vertiguard-VR group); no significant differences in this improvement were found comparing both groups (p = 0.580).
DISCUSSION AND CONCLUSIONS


VR using mobile posturography is useful to improve stability in old people with instability, showing similar improvement rates to those of VR using CDP.
UNIQUE IDENTIFIER


NCT03034655 www.clinicaltrials.gov Registered on 25 January 2017.",2021,"Average balance was significantly improved in both intervention groups (51% pre-VR vs 60% post-VR, p = 0.002, CDP-VR group; 49% pre-VR vs 57% post-VR, p = 0.008, Vertiguard-VR group); no significant differences in this improvement were found comparing both groups (p = 0.580).
","['old patients', 'old people with imbalance', 'participants were people over 65\xa0years, with imbalance', '40 patients were included in the study (19 in the CDP-VR group and 21 in the Vertiguard-VR group', 'older persons with imbalance METHODS']","['Vestibular rehabilitation (VR), specifically, VR with dynamic computerized posturography (CDP', 'VR with CDP exercises and VR with mobile posturography (Vertiguard) exercises', 'vibrotactile neurofeedback training', 'vestibular rehabilitation (using CDP and the Vertiguard system', 'Vestibular rehabilitation with mobile posturography as a ""low-cost"" alternative to vestibular rehabilitation with computerized dynamic posturography']",['Average balance'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",40.0,0.0213966,"Average balance was significantly improved in both intervention groups (51% pre-VR vs 60% post-VR, p = 0.002, CDP-VR group; 49% pre-VR vs 57% post-VR, p = 0.008, Vertiguard-VR group); no significant differences in this improvement were found comparing both groups (p = 0.580).
","[{'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Soto-Varela', 'Affiliation': 'Division of Neurotology, Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain. andres.soto@usc.es.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Rossi-Izquierdo', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del-Río-Valeiras', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Faraldo-García', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Vaamonde-Sánchez-Andrade', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lirola-Delgado', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Santos-Pérez', 'Affiliation': 'Division of Neurotology, Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}]",Aging clinical and experimental research,['10.1007/s40520-021-01813-2']
1467,33677724,Patient-controlled outpatient follow-up on demand for patients with rheumatoid arthritis: a 2-year randomized controlled trial.,"INTRODUCTION


Scheduled routine visits in patients with rheumatoid arthritis (RA) may be in a stable period without active disease. Consequently, there is a demand for developing outpatient control procedures which cater to the needs of the individual patient.
OBJECTIVE


This study aims to compare a patient-controlled outpatient follow-up system, Open Outpatient Clinic Programme (OOCP), with traditional scheduled routine follow-up (TSRF) regarding patient satisfaction and disease activity markers in RA patients.
METHOD


In a 2-year randomized controlled trial, RA patients were allocated to OOCP or TSRF. OOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist and had access to nurse-led consultations and a telephone helpline. Appointments for the TSRF group were scheduled according to routine procedures (clinical parameters: DAS-28, C-reactive protein, VAS pain, tender and swollen joint count, HAQ-DI and radiographs; psychological parameters: VAS patient satisfaction and EQ-5D).
RESULTS


Of 282 patients, 239 completed the study (OOCP/TSRF characteristics: age 61.4 ± 10.5/60.9 ± 12.2 years, females 77/74%, ACPA positive 66/65%). At years 1 and 2, OCCP had fewer visits (year 2: 2.6 ± 1.6 vs. 3.5 ± 2; p < 0.0005) but more phone calls (year 2: 0.7 ± 1.4 vs. 0.1 ± 0.3; p < 0.0005) compared to TSRF. OOCP was comparable to TSRF regarding clinical and psychological outcome measures, and no radiographic progression was observed.
CONCLUSIONS


OOCP was associated with significantly fewer visits but with more phone calls to the nurse and was comparable with TSGentofte University HospitalRF regarding clinical, psychological and radiographic outcomes. Thus, the organization of outpatient care according to OOCP may be applied to strengthen patient-centred care in patients with RA. ClinicalTrials.gov Identifier (July 20, 2020): NCT04476875 Key points • In a patient-controlled outpatient follow-up system, RA patients had significantly fewer visits compared to traditional follow-up. • The patient-controlled follow-up system was comparable with traditional follow-up regarding clinical, psychological and radiographic outcomes. • Organization of outpatient care according to a patient-controlled follow-up system may be applied to strengthen patient-centred care in patients with RA.",2021,"In a patient-controlled outpatient follow-up system, RA patients had significantly fewer visits compared to traditional follow-up.","['patients with rheumatoid arthritis', 'RA patients', 'patients with RA', 'Of 282 patients, 239 completed the study (OOCP/TSRF characteristics: age 61.4 ± 10.5/60.9 ± 12.2 years, females 77/74%, ACPA positive 66/65', 'patients with rheumatoid arthritis (RA']","['patient-controlled outpatient follow-up system, Open Outpatient Clinic Programme (OOCP), with traditional scheduled routine follow-up (TSRF', 'OOCP', 'OOCP or TSRF']","['OOCP', 'radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.047552,"In a patient-controlled outpatient follow-up system, RA patients had significantly fewer visits compared to traditional follow-up.","[{'ForeName': 'René Panduro', 'Initials': 'RP', 'LastName': 'Poggenborg', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Gentofte, Copenhagen, Denmark. poggenborg@dadlnet.dk.'}, {'ForeName': 'Ole Rintek', 'Initials': 'OR', 'LastName': 'Madsen', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Dreyer', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Gunhild', 'Initials': 'G', 'LastName': 'Bukh', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hansen', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Gentofte, Copenhagen, Denmark.'}]",Clinical rheumatology,['10.1007/s10067-021-05674-y']
1468,33677695,Serum melatonin concentration in critically ill patients randomized to sedation or non-sedation.,"BACKGROUND


Abolished circadian rhythm is associated with altered cognitive function, delirium, and as a result increased mortality in critically ill patients, especially in those who are mechanically ventilated. The causes are multifactorial, of which changes in circadian rhythmicity may play a role. Melatonin plays a crucial role as part of the circadian and sleep/wake cycle. Whether sedation effects circadian regulation is unknown. Hence, the objective of this study was to evaluate the melatonin concentration in critically ill patients randomized to sedation or non-sedation and to investigate the correlation with delirium.
METHODS


All patients were included and randomized at the intensive care unit at the hospital of southwest Jutland, Denmark. Seventy-nine patients completed the study (41 sedated and 38 non-sedated). S-melatonin was measured 3 times per day, (03.00, 14.00, and 22.00), for 4 consecutive days in total, starting on the second day upon randomization/intubation. The study was conducted as a sub-study to the NON-SEDA study in which one hundred consecutive patients were randomized to sedation or non-sedation with a daily wake-up call (50 in each arm).
PRIMARY OUTCOME


melatonin concentration in sedated vs. non-sedated patients (analyzed using linear regression). Secondary outcome: risk of developing delirium or non-medically induced (NMI) coma in sedated vs. non-sedated patients, assessed by CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) analyzed using logistic regression.
RESULTS


Melatonin concentration was suppressed in sedated patients compared to the non-sedated. All patients experienced an elevated peak melatonin level early on in the course of their critical illness (p = 0.01). The risk of delirium or coma (NMI) was significantly lower in the non-sedated group (OR 0.42 CI 0.27; 0.66 p < 0.0001). No significant relationship between delirium development and suppressed melatonin concentration was established in this study (OR 1.004 p = 0.29 95% CI 0.997; 1.010).
CONCLUSION


Melatonin concentration was suppressed in sedated, critically ill patients, when compared to non-sedated controls and the frequency of delirium was elevated in sedated patients. Trail registration Clinicaltrials.gov (NCT01967680) on October 23, 2013.",2021,All patients experienced an elevated peak melatonin level early on in the course of their critical illness (p = 0.01).,"['critically ill patients randomized to sedation or non-sedation', 'one hundred consecutive patients', 'All patients were included and randomized at the intensive care unit at the hospital of southwest Jutland, Denmark', 'Seventy-nine patients completed the study (41 sedated and 38 non-sedated', 'critically ill patients randomized to', 'critically ill patients']","['sedation or non-sedation', 'S-melatonin', 'Melatonin', 'sedation or non-sedation with a daily wake-up call (50 in each arm']","['Melatonin concentration', 'elevated peak melatonin level', 'risk of delirium or coma (NMI', 'CAM-ICU (Confusion Assessment Method for the Intensive Care Unit', 'delirium development and suppressed melatonin concentration', 'melatonin concentration', 'Serum melatonin concentration', 'risk of developing delirium or non-medically induced (NMI) coma', 'frequency of delirium']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",100.0,0.294684,All patients experienced an elevated peak melatonin level early on in the course of their critical illness (p = 0.01).,"[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Oxlund', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Hospital of Southwest Jutland, Finsensgade 35, 6700, Esbjerg, Denmark. Jakob.Oxlund@rsyd.dk.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Knudsen', 'Affiliation': 'Department of Internal Medicine, Hospital of Southwest Jutland, Finsensgade 35, 6700, Esbjerg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, J.B. Winsløwsvej 4, 5000, Odense, Denmark.'}, {'ForeName': 'Jørgen T', 'Initials': 'JT', 'LastName': 'Lauridsen', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.'}, {'ForeName': 'Poul J', 'Initials': 'PJ', 'LastName': 'Jennum', 'Affiliation': 'Department of Neurophysiology, Danish Center of Sleep Medicine. Rigshospitalet, Valdemar Hansens vej 1 - 23, 2600, Glostrup, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, J.B. Winsløwsvej 4, 5000, Odense, Denmark.'}]",Annals of intensive care,['10.1186/s13613-021-00829-1']
1469,33677520,A Cultural Dance Program Improves Hypertension Control and Cardiovascular Disease Risk in Native Hawaiians: A Randomized Controlled Trial.,"BACKGROUND


Native Hawaiians have higher hypertension (HTN) and cardiovascular disease (CVD) rates than non-Hispanic whites, calling for culturally responsive interventions to close this gap.
PURPOSE


We tested the effects of a 6-month behavioral intervention, a cultural dance program based on hula (the customary dance of Hawai'i), for improving blood pressure (BP) and CVD risk among Native Hawaiians with uncontrolled HTN.
METHODS


In a randomized controlled trial, we tested the effects of the hula-based intervention among 263 Native Hawaiians with uncontrolled HTN (systolic ≥ 140 or ≥ 130 mmHg if diabetes) and no CVD at enrollment. All participants received a brief culturally tailored heart health education before random assignment to the hula-based intervention (n = 131) or the education-only waitlist control (n = 132). Intervention received hula lessons and group-based activities for 6 months. Control received only 1-week education through 6 months.
RESULTS


Intervention yielded greater reductions in systolic (-15.3 mmHg) and diastolic (-6.4 mmHg) BP than control (-11.8 and -2.6 mmHg, respectively) from baseline to 6 months (p < .05). At 6 months, 43% of intervention participants compared to 21% of controls achieved a HTN stage <130/80 mmHg (p < .001). The 10-year CVD risk reduction was two times greater for the intervention group than the control group based on the Framingham Risk Score calculator. All improvements for intervention participants were maintained at 12 months.
CONCLUSIONS


This trial represents one of the few rigorously conducted examinations of an Indigenous practice leveraged for health promotion, with implications for other ethnic populations.",2021,The 10-year CVD risk reduction was two times greater for the intervention group than the control group based on the Framingham Risk Score calculator.,"['140 or ≥ 130 mmHg if diabetes) and no CVD at enrollment', '263 Native Hawaiians with uncontrolled HTN (systolic ≥', 'Native Hawaiians']","[""behavioral intervention, a cultural dance program based on hula (the customary dance of Hawai'i"", 'Cultural Dance Program', 'hula lessons and group-based activities for 6 months', 'hula-based intervention', 'brief culturally tailored heart health education before random assignment to the hula-based intervention (n = 131) or the education-only waitlist control']","['blood pressure (BP) and CVD risk', 'Hypertension Control and Cardiovascular Disease Risk', 'systolic (-15.3 mmHg) and diastolic', '10-year CVD risk reduction', 'hypertension (HTN) and cardiovascular disease (CVD) rates']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0337920', 'cui_str': 'Hawaiians'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018619', 'cui_str': 'Hawaii state'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.054794,The 10-year CVD risk reduction was two times greater for the intervention group than the control group based on the Framingham Risk Score calculator.,"[{'ForeName': ""Joseph Keawe'aimoku"", 'Initials': 'JK', 'LastName': 'Kaholokula', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Mele', 'Initials': 'M', 'LastName': 'Look', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Mabellos', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Hyeong Jun', 'Initials': 'HJ', 'LastName': 'Ahn', 'Affiliation': ""Department of Quantitative Health Sciences, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'So Yung', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': ""Department of Quantitative Health Sciences, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': ""Ka'imi A"", 'Initials': 'KA', 'LastName': 'Sinclair', 'Affiliation': 'Institute for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wills', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Todd B', 'Initials': 'TB', 'LastName': 'Seto', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i at Mānoa, Honolulu, HI.""}, {'ForeName': 'Māpuana', 'Initials': 'M', 'LastName': 'de Silva', 'Affiliation': ""Hālau Mōhala 'Ilima, Ka'ōhao, HI.""}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa127']
1470,33677476,Cycle more with virtual reality: a proof of concept study in an institutionalised able-bodied geriatric population.,"BACKGROUND/OBJECTIVES


Physical activity (PA) has significant benefits for older adults. However, the recommended PA is rarely achieved in nursing homes. In this proof of concept study, we assessed whether virtual reality (VR) could help to increase spontaneous PA during a stationary cycling session.
DESIGN


Prospective crossover proof of concept study.
SETTING


Nursinghome.
PARTICIPANTS


Twelve participants (10 men) aged 63-88, able-bodied but with moderate cognitive impairment.
INTERVENTION


TWO stationary cycling sessions with and withoutVR.
MEASUREMENTS


Cycling distance, pedalling duration, average speed, mean pedalling cadence and the modified Borg rating of perceived exertion scale.
RESULTS


Cycling distance and duration were significantly higher in the VR condition. Most participants would rather repeat cycling sessions with VR than without.
CONCLUSION


The use of VR seems feasible to help achieve PA recommendations for able-bodied people living in nursing homes, even with moderate cognitive impairments.",2021,"The use of VR seems feasible to help achieve PA recommendations for able-bodied people living in nursing homes, even with moderate cognitive impairments.","['Nursinghome', 'older adults', 'Twelve participants (10 men) aged 63-88, able-bodied but with moderate cognitive impairment']","['virtual reality', 'virtual reality (VR']","['Cycling distance, pedalling duration, average speed, mean pedalling cadence and the modified Borg rating of perceived exertion scale']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3839816', 'cui_str': 'Moderate cognitive impairment'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",12.0,0.0158875,"The use of VR seems feasible to help achieve PA recommendations for able-bodied people living in nursing homes, even with moderate cognitive impairments.","[{'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Loggia', 'Affiliation': 'Normandie Univ, UNICAEN, CHU de Caen Normandie, Service de Gériatrie, 14000 Caen, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Gauthier', 'Affiliation': 'Normandie Univ, UNICAEN, Inserm U1075, COMETE, GIP Cyceron, 14000 Caen, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Lemiere', 'Affiliation': 'Normandie Univ, UNICAEN, Inserm U1075, COMETE, GIP Cyceron, 14000 Caen, France.'}, {'ForeName': 'Joffrey', 'Initials': 'J', 'LastName': 'Drigny', 'Affiliation': 'Normandie Univ, UNICAEN, CHU de Caen Normandie, Service de Médecine Physique et de Réadaptation, Inserm U1075, COMETE, GIP Cyceron, 14000 Caen, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Desvergee', 'Affiliation': 'Normandie Univ, UNICAEN, CHU de Caen Normandie, Service de Médecine Physique et de Réadaptation, 14000 Caen, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Leconte', 'Affiliation': 'Normandie Univ, UNICAEN, Inserm U1075, COMETE, GIP Cyceron, 14000 Caen, France.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Normandie Univ, UNICAEN, CHU de Caen Normandie, Service de Médecine Physique et de Réadaptation, INSERM U1018 UPS UVSQ, INSERM EPHE U1077, 14000 Caen, France.'}]",Age and ageing,['10.1093/ageing/afab040']
1471,33677463,"Resistance Training, Fatigue, Quality of Life, Anxiety in Breast Cancer Survivors.","ABSTRACT


Moraes, RF, Ferreira-Júnior, JB, Marques, VA, Vieira, A, Lira, CAB, Campos, MH, Freitas-Junior, R, Rahal, RMS, Gentil, P, and Vieira, CA. Resistance training, fatigue, quality of life, anxiety in breast cancer survivors. J Strength Cond Res XX(X): 000-000, 2020-Resistance training (RT) has shown to be effective in improving fatigue, quality of life (QOL), and anxiety levels among breast cancer survivors (BCS), but there is no consensus as to how this practice should be prescribed for optimal performance. This study analyses the effects of once weekly RT on fatigue, QOL, and anxiety levels among BCS. Randomized controlled trial. Twenty-five BCS (aged 54.6 ± 5.5 years) were randomized into RT or control groups. The RT group performed 8 weeks of RT (once per week). Fatigue was assessed using the Piper Fatigue scale, QOL was assessed using the SF-36, and anxiety was assessed using the STAI State-Trait Anxiety Inventory. Resistance training significantly improved the following subscales of SF-36: aspects of physical functioning (+27%, p = 0.027); physical role functioning (+54%, p = 0.008); emotional role functioning (+42%, p = 0.027); and mental health (+16%, p = 0.032). Furthermore, RT improved fatigue levels (-55%, p = 0.001 for general fatigue) and anxiety (anxiety state, -19%, p = 0.012; anxiety trait, -23%, p = 0.001). Resistance training seemed to be a positive nonpharmacological tool for the reduction of fatigue, anxiety, and for improvement of several aspects of QOL in BCS.",2021,"Furthermore, RT improved fatigue levels (-55%, p = 0.001 for general fatigue) and anxiety (anxiety state, -19%, p = 0.012; anxiety trait, -23%, p = 0.001).","['Twenty-five BCS (aged 54.6 ± 5.5 years', 'Breast Cancer Survivors', 'breast cancer survivors (BCS', 'breast cancer survivors']","['Resistance training', '2020-Resistance training (RT', 'J Strength Cond Res XX(X']","['STAI State-Trait Anxiety Inventory', 'Piper Fatigue scale, QOL', 'Furthermore, RT improved fatigue levels', 'fatigue, quality of life (QOL), and anxiety levels', 'fatigue, QOL, and anxiety levels', 'mental health', 'Resistance training, fatigue, quality of life, anxiety', 'physical functioning', 'general fatigue) and anxiety (anxiety state', 'Fatigue', 'Resistance Training, Fatigue, Quality of Life, Anxiety', 'physical role functioning', 'emotional role functioning']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",25.0,0.0354681,"Furthermore, RT improved fatigue levels (-55%, p = 0.001 for general fatigue) and anxiety (anxiety state, -19%, p = 0.012; anxiety trait, -23%, p = 0.001).","[{'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Moraes', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goias, Goiania, GO, Brazil; College of Physical Education, Pontifical Catholic University of Goias, Goiania, GO, Brazil; Department of Education, Federal Institute of Sudeste of Minas Gerais, Campus Rio Pomba, MG, Brazil; and College of Physical Education, University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'João B', 'Initials': 'JB', 'LastName': 'Ferreira-Júnior', 'Affiliation': ''}, {'ForeName': 'Vitor A', 'Initials': 'VA', 'LastName': 'Marques', 'Affiliation': ''}, {'ForeName': 'Amilton', 'Initials': 'A', 'LastName': 'Vieira', 'Affiliation': ''}, {'ForeName': 'Claudio A B', 'Initials': 'CAB', 'LastName': 'Lira', 'Affiliation': ''}, {'ForeName': 'Mário H', 'Initials': 'MH', 'LastName': 'Campos', 'Affiliation': ''}, {'ForeName': 'Ruffo', 'Initials': 'R', 'LastName': 'Freitas-Junior', 'Affiliation': ''}, {'ForeName': 'Rosemar M S', 'Initials': 'RMS', 'LastName': 'Rahal', 'Affiliation': ''}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': ''}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Vieira', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003817']
1472,33677450,Stronger Effect of Azilsartan on Reduction of Proteinuria Compared to Candesartan in Patients with CKD: A Randomized Crossover Trial.,"INTRODUCTION


Angiotensin receptor blockers (ARBs) are preferably used in hypertensive patients with CKD. Azilsartan is a strong antihypertensive ARB, but its antiproteinuric effects are not well understood. We compared the antiproteinuric effect of azilsartan and candesartan in CKD patients in an open-label, randomized, crossover trial.
METHODS


A total of 111 patients were treated with 20 mg of azilsartan daily for 2 months as a run-in period. After the run-in period, patients were randomized into 2 arms and received either 20 mg of azilsartan or 8 mg of candesartan daily for 3 months in a crossover trial. The primary outcome was the percent change in urinary protein-to-Cr ratio (UPCR).
RESULTS


Ninety-five patients completed the trial. The mean age was 64.3 years. The estimated glomerular filtration rate (eGFR) and UPCR were 41.5 mL/min/1.73 m2 and 1.8 g/gCr, respectively. The baseline systolic and diastolic blood pressures were 131.4 and 71.0 mm Hg, respectively. The mean percent change in the UPCR was -3.8% in the azilsartan group and 30.8% in the candesartan group at the 1st endpoint (p = 0.0004), and 6.1% in the azilsartan group and 25.8% in the candesartan group at the 2nd (final) endpoint (p = 0.029). The incidence of adverse events, including eGFR levels and serum potassium levels, was not significantly different between the groups.
CONCLUSION


A 20 mg azilsartan dose had potent antiproteinuric effects compared with an 8 mg candesartan dose, without an increase in adverse events. Azilsartan may provide renal protection in addition to antihypertensive effects in CKD patients.",2021,"The incidence of adverse events, including eGFR levels and serum potassium levels, was not significantly different between the groups.
","['111 patients', 'Ninety-five patients completed the trial', 'CKD patients', 'Patients with CKD', 'hypertensive patients with CKD']","['Angiotensin receptor blockers (ARBs', 'azilsartan', 'candesartan', 'azilsartan and candesartan', 'Candesartan', 'Azilsartan', '20 mg of azilsartan or 8 mg of candesartan']","['baseline systolic and diastolic blood pressures', 'percent change in urinary protein-to-Cr ratio (UPCR', 'antiproteinuric effects', 'adverse events', 'incidence of adverse events, including eGFR levels and serum potassium levels', 'Reduction of Proteinuria', 'glomerular filtration rate (eGFR) and UPCR', 'UPCR']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C1958569', 'cui_str': 'azilsartan'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",111.0,0.0751128,"The incidence of adverse events, including eGFR levels and serum potassium levels, was not significantly different between the groups.
","[{'ForeName': 'Takaichi', 'Initials': 'T', 'LastName': 'Suehiro', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Tsuruya', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan, tsuruya@naramed-u.ac.jp.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tsujikawa', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Tsuchimoto', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Eriguchi', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kiichiro', 'Initials': 'K', 'LastName': 'Fujisaki', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Torisu', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}]",Kidney & blood pressure research,['10.1159/000512365']
1473,33677449,Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence: Results of an Early-Phase Randomized Controlled Trial and Neuroimaging Correlates.,"INTRODUCTION


Alcohol dependence is one of the most common substance use disorders, and novel treatment options are urgently needed. Neurofeedback training (NFT) based on real-time functional magnetic resonance imaging (rtf-MRI) has emerged as an attractive candidate for add-on treatments in psychiatry, but its use in alcohol dependence has not been formally investigated in a clinical trial. We investigated the use of rtfMRI-based NFT to prevent relapse in alcohol dependence.
METHODS


Fifty-two alcohol-dependent patients from the UK who had completed a detoxification program were randomly assigned to a treatment group (receiving rtfMRI NFT in addition to standard care) or the control group (receiving standard care only). At baseline, alcohol consumption was assessed as the primary outcome measure and a variety of psychological, behavioral, and neural parameters as secondary outcome measures to determine feasibility and secondary training effects. Participants in the treatment group underwent 6 NFT sessions over 4 months and were trained to downregulate their brain activation in the salience network in the presence of alcohol stimuli and to upregulate frontal activation in response to pictures related to positive goals. Four, 8, and 12 months after baseline assessment, both groups were followed up with a battery of clinical and psychometric tests.
RESULTS


Primary outcome measures showed very low relapse rates for both groups. Analysis of neural secondary outcome measures indicated that the majority of patients modulated the salience system in the desired directions, by decreasing activity in response to alcohol stimuli and increasing activation in response to positive goals. The intervention had a good safety and acceptability profile.
CONCLUSION


We demonstrated that rtfMRI-neurofeedback targeting hyperactivity of the salience network in response to alcohol cues is feasible in currently abstinent patients with alcohol dependence.",2021,"RESULTS


Primary outcome measures showed very low relapse rates for both groups.","['abstinent patients with alcohol dependence', 'Fifty-two alcohol-dependent patients from the UK who had completed a detoxification program']","['rtfMRI-based NFT', 'NFT sessions', 'Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence', 'Neurofeedback training (NFT) based on real-time functional magnetic resonance imaging (rtf-MRI', 'rtfMRI NFT in addition to standard care) or the control group (receiving standard care only']","['low relapse rates', 'good safety and acceptability profile', 'alcohol consumption', 'variety of psychological, behavioral, and neural parameters']","[{'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",52.0,0.0520849,"RESULTS


Primary outcome measures showed very low relapse rates for both groups.","[{'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Subramanian', 'Affiliation': 'MRC Centre for Neuropsychiatric Genetics and Genomics and Cardiff University Brain Research Imaging Centre, Schools of Medicine and Psychology, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Skottnik', 'Affiliation': 'School for Mental Health and Neuroscience, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands, l.skottnik@maastrichtuniversity.nl.'}, {'ForeName': 'W Miles', 'Initials': 'WM', 'LastName': 'Cox', 'Affiliation': 'School of Psychology, Bangor University, Bangor, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lührs', 'Affiliation': 'Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'McNamara', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Watson', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Whittaker', 'Affiliation': 'School of Physics and Astronomy, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Angharad N', 'Initials': 'AN', 'LastName': 'Williams', 'Affiliation': 'Adaptive Memory Research Group, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Sakhuja', 'Affiliation': 'Addiction Services, Cwm Taf Morgannwg University Health Board, Mountain Ash, United Kingdom.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Ihssen', 'Affiliation': 'Department of Psychology, Durham University, Durham, United Kingdom.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Goebel', 'Affiliation': 'Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'David E J', 'Initials': 'DEJ', 'LastName': 'Linden', 'Affiliation': 'MRC Centre for Neuropsychiatric Genetics and Genomics and Cardiff University Brain Research Imaging Centre, Schools of Medicine and Psychology, Cardiff University, Cardiff, United Kingdom.'}]",European addiction research,['10.1159/000513448']
1474,33677430,The effect of peer support approach on communication skills of nursing students in pediatric clinical setting.,"Peer support is a valuable teaching-learning approach to enhance deep learning in the clinical environment. The purpose of the present study was to investigate the effect of peer support on the communication skills of undergraduate nursing students when interacting with hospitalized children and their parents. This was a pre-and post-test quasi-experimental study with two groups. Through the cluster random sampling method, six practical groups of students who undertook a 3-week pediatric practicum were selected. Three groups were allocated to the experimental (n = 51) and control groups (n = 52). Two volunteer post-graduate students in pediatric nursing formed the peer group. First, the peers participated in three 45-min sessions using different scenarios about communication skills. They then tutored the intervention group to improve their communication skills. The communication skills with 5 children and 5 parents were observed for each undergraduate student via the checklist. The experimental group demonstrated significantly higher mean scores of the communication skills than the control groups in post-test (P < 0.001). Moreover, the mean scores of communication skills was significantly higher in post-test than pre-test in both the experimental and control groups (p < 0.001). Peer support approach promoted the communication skills of undergraduate nursing students in pediatric clinical setting.",2021,The experimental group demonstrated significantly higher mean scores of the communication skills than the control groups in post-test (P < 0.001).,"['undergraduate nursing students when interacting with hospitalized children and their parents', 'Two volunteer post-graduate students in pediatric nursing formed the peer group', 'nursing students in pediatric clinical setting', 'undergraduate nursing students in pediatric clinical setting']","['peer support approach', 'peer support']","['mean scores of communication skills', 'mean scores of the communication skills']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",5.0,0.0185718,The experimental group demonstrated significantly higher mean scores of the communication skills than the control groups in post-test (P < 0.001).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Cheraghi', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: f_cheraghi@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Hooshangian', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Doosti-Irani', 'Affiliation': 'Department of Epidemiology, School of Public Health and Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Khalili', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: arash5920@yahoo.com.'}]",Nurse education in practice,['10.1016/j.nepr.2021.102984']
1475,33677425,Comparison of the TetraGraph and TOFscan for monitoring recovery from neuromuscular blockade in the Post Anesthesia Care Unit.,"STUDY OBJECTIVE


Comparison of the TetraGraph (TG) and TOFscan (TS) for monitoring recovery from neuromuscular blockade in the Post Anesthesia Care Unit (PACU).
DESIGN


Randomized, multicenter trial.
SETTING


PACU in three tertiary care hospitals.
PATIENTS


120 patients (40 per site) receiving neuromuscular blockade during elective surgery.
INTERVENTIONS


Patients were enrolled preoperatively and intraoperative neuromuscular blockade management was at the discretion of the anesthesiologist. Upon arrival to the PACU, patients were randomized to have either TG or TS placed on their dominant hand. The alternate device (TS or TG) was placed on the non-dominant hand. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
MEASUREMENTS


Train-of-four ratios (TOFRs) were obtained upon arrival to the PACU (t = 0), after 5 min (t = + 5) and after +10 min (t = + 10).
MAIN RESULTS


There was there was no significant difference in the mean TOFRs obtained with the TG and TS at t = 0 (0.97 ± 0.18 vs 0.94 ± 0.13, P = 0.06, respectively) and t = + 5 (0.96 ± 0.20 vs 0.95 ± 0.12, P = 0.29, respectively). At (t = + 10), there was a statistically significant difference in mean TOFRs obtained with the TG and TS, (0.99 ± 0.14 vs 0.94 ± 0.12, P < 0.001, respectively). The bias between devices at t = 0 was estimated to be 0.03 (95% CI, -0.29 to 0.35, P = 0.26); at t = + 5 min, it was estimated to be 0.02 (95% CI, -0.36 to 0.40, P = 0.54); and at t = +10 min, it was estimated to be 0.05 (95% CI, -0.25 to 0.36, P = 0.77).
CONCLUSIONS


TS and TG provide interchangeable quantitative measurements once the TOF ratio has returned to a value of 0.90 or greater in the PACU.",2021,There was there was no significant difference in the mean TOFRs obtained with the TG and TS at t = 0,"['120 patients (40 per site) receiving neuromuscular blockade during elective surgery', 'PACU in three tertiary care hospitals']","['TetraGraph (TG) and TOFscan (TS', 'alternate device (TS or TG', 'TetraGraph and TOFscan']","['Train-of-four ratios (TOFRs', 'mean TOFRs', 'TOF ratio']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0428698', 'cui_str': 'Train of four ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",120.0,0.319183,There was there was no significant difference in the mean TOFRs obtained with the TG and TS at t = 0,"[{'ForeName': 'J Ross', 'Initials': 'JR', 'LastName': 'Renew', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, FL, USA. Electronic address: renew.j@mayo.edu.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Hernandez-Torres', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Logvinov', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Reka', 'Initials': 'R', 'LastName': 'Nemes', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Nagy', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Liah', 'Initials': 'L', 'LastName': 'Watt', 'Affiliation': 'Department of Anesthesiology, NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Murphy', 'Affiliation': 'Department of Anesthesiology, NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110234']
1476,33677411,A randomized pilot trial of oral prednisone taper vs placebo following iv methylprednisolone for multiple sclerosis relapses: Effects on adrenal function and clinical efficacy.,"We performed a pilot trial investigating the effect of a steroid taper on adrenal function and safety measures after acute MS relapses. Twenty-five patients were randomized to either prednisone taper (n=12) or placebo (n=13) after 3 days of intravenous methylprednisolone. No patient showed signs of adrenal insufficiency at any time by cortisol response to ACTH. This significantly increased between baseline and 6 months in both groups. Patients remained clinically and radiologically stable, but those under prednisone taper experienced more frequently mood disorders, hyperglycaemia and weight increase. If confirmed by sufficiently powered studies, these results would question the need of a steroid taper following short-term intravenous methylprednisolone.",2021,"Patients remained clinically and radiologically stable, but those under prednisone taper experienced more frequently mood disorders, hyperglycaemia and weight increase.","['multiple sclerosis relapses', 'Twenty-five patients']","['steroid taper', 'prednisone taper', 'placebo', 'oral prednisone taper vs placebo', 'methylprednisolone']","['mood disorders, hyperglycaemia and weight increase', 'signs of adrenal insufficiency', 'adrenal function and safety measures', 'adrenal function and clinical efficacy']","[{'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",25.0,0.0465453,"Patients remained clinically and radiologically stable, but those under prednisone taper experienced more frequently mood disorders, hyperglycaemia and weight increase.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Zecca', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland; Faculty of biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Disanto', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland.'}, {'ForeName': 'Gianna C', 'Initials': 'GC', 'LastName': 'Riccitelli', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Candrian', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland.'}, {'ForeName': 'Maurilio', 'Initials': 'M', 'LastName': 'Deandrea', 'Affiliation': 'Endocrinology, Diabetes and Metabolism Unit, A.O. Ordine Mauriziano, Torino, Italy.'}, {'ForeName': 'Paolo Piero', 'Initials': 'PP', 'LastName': 'Limone', 'Affiliation': 'Endocrinology, Diabetes and Metabolism Unit, A.O. Ordine Mauriziano, Torino, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Sacco', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gobbi', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland; Faculty of biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland. Electronic address: claudio.gobbi@eoc.ch.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102867']
1477,33677172,A randomised controlled trial of laser acupuncture improves early outcomes of osteoarthritis patients' physical functional ability after total knee replacement.,"BACKGROUND AND PURPOSE


Total knee replacement is the most effective intervention for late-stage osteoarthritis; however, a major concern is postoperative recovery of physical function. This randomised controlled trial evaluated the effects of acupuncture with low-level laser therapy (ALLLT) on early outcomes of physical function after total knee replacement.
MATERIALS AND METHODS


Eighty-two osteoarthritis patients were recruited and randomly assigned to the experimental group receiving ALLLT or the control group receiving sham ALLLT without laser beam output. Physical function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee replacement.
RESULTS


Generalised estimating equations revealed a significant difference between the two groups in joint flexion. The experimental group displayed better joint flexion and less stiffness on days 2 and 3 than did the control group.
CONCLUSION


ALLLT can facilitate the recovery of physical function, as evidenced by knee joint flexion and stiffness, in patients receiving total knee replacement.",2021,"Physical function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee replacement.
","['late-stage osteoarthritis', 'patients receiving total knee replacement', ""osteoarthritis patients' physical functional ability after total knee replacement"", 'Eighty-two osteoarthritis patients']","['laser acupuncture', 'acupuncture with low-level laser therapy (ALLLT', 'ALLLT or the control group receiving sham ALLLT without laser beam output']","['joint flexion', 'Physical function']","[{'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0458142', 'cui_str': 'Laser light'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",82.0,0.0676184,"Physical function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee replacement.
","[{'ForeName': 'Chiung-Hui', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Integration of Traditional Chinese Medicine with Western Nursing, National Taipei University of Nursing and Health Sciences, Nurse, Department of Nursing, Taipei Veterans General Hospital, 201, Sec. 2, Shipai Rd., Taipei City, 11217, Taiwan. Electronic address: chhuang10@vghtpe.gov.tw.'}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing and Health Sciences, 365, Minte Rd., Taipei City, 11219, Taiwan. Electronic address: meiling@ntunhs.edu.tw.'}, {'ForeName': 'Fang-Pey', 'Initials': 'FP', 'LastName': 'Chen', 'Affiliation': 'Center for Traditional Medicine, Taipei Veterans General Hospital and Adjunct Professor, National Taipei University of Nursing and Health Sciences, 201, Sec. 2, Shipai Rd., Taipei City, 11217, Taiwan. Electronic address: fpchen@vghtpe.gov.tw.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kuo', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing and Health Sciences, Student, Taipei American School, 800, Sec. 6, Zhongshan N. Rd., Taipei City, 11152, Taiwan. Electronic address: 22matthewk@students.tas.tw.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101340']
1478,33677157,The influence of high-frequency Repetitive Transcranial Magnetic Stimulation on endogenous estrogen in patients with disorders of consciousness.,"BACKGROUND


Repetitive transcranial magnetic stimulation (rTMS) has been proposed as a promising therapeutic intervention for neurological disorders. However, the precise mechanisms of rTMS in neural excitability remains poorly understood. Estradiol is known to have strong influence on cortical excitability. This study aimed to determine whether high-frequency (HF) rTMS influences endogenous estradiol in male patients with disorders of consciousness (DOC).
METHODS


A randomized controlled trial was conducted with a total of 57 male patients with DOC. Eventually, 50 patients completed the study. Twenty-five patients underwent real rTMS, and 25 patients underwent sham rTMS, which were delivered over the dorsolateral prefrontal cortex. The primary outcome measure was the change in serum estradiol from baseline to after 10 sessions of HF-rTMS. The improvement in the total score of the JFK Coma Recovery Scale-Revised (CRS-R) was also assessed.
RESULTS


Changes in estradiol levels and CRS-R scores from pre-to post-treatment were significantly different between the active rTMS and sham stimulation conditions. A significant enhancement of CRS-R scores in the patients receiving rTMS stimulation was observed compared to the sham group. Serum estradiol levels in patients following HF-rTMS were significantly higher than their baseline levels, whereas no significant changes were found in the sham group from pre-to post-stimulation. The rise in estradiol levels was greater in responders than in non-responders. The changes in estradiol levels were significantly positively correlated with the improvement in CRS-R scores.
CONCLUSION


These preliminary findings indicate that serum estradiol levels are affected by HF-rTMS and positively related to clinical responses in male patients with DOC. The elevation of estradiol levels may lay a physiological foundation for successful rTMS treatment for DOC patients by increasing cortical excitability.",2021,"RESULTS


Changes in estradiol levels and CRS-R scores from pre-to post-treatment were significantly different between the active rTMS and sham stimulation conditions.","['50 patients completed the study', 'male patients with DOC', '57 male patients with DOC', 'patients with disorders of consciousness', 'male patients with disorders of consciousness (DOC']","['Estradiol', 'real rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'high-frequency (HF) rTMS', 'sham rTMS', 'high-frequency Repetitive Transcranial Magnetic Stimulation']","['estradiol levels and CRS-R scores', 'rise in estradiol levels', 'serum estradiol levels', 'elevation of estradiol levels', 'total score of the JFK Coma Recovery Scale-Revised (CRS-R', 'estradiol levels', 'change in serum estradiol', 'CRS-R scores', 'Serum estradiol levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",57.0,0.133686,"RESULTS


Changes in estradiol levels and CRS-R scores from pre-to post-treatment were significantly different between the active rTMS and sham stimulation conditions.","[{'ForeName': 'Ren Hong', 'Initials': 'RH', 'LastName': 'He', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University.'}, {'ForeName': 'Hui Juan', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University.'}, {'ForeName': 'Jian Zhong', 'Initials': 'JZ', 'LastName': 'Fan', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University.'}, {'ForeName': 'Sheng Quan', 'Initials': 'SQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University.'}, {'ForeName': 'Yu Hua', 'Initials': 'YH', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University. Electronic address: zhongbinyue@163.com.'}]",Brain stimulation,['10.1016/j.brs.2021.02.014']
1479,33663047,"The effects of transcranial direct current stimulation on attention and inhibitory control of children and adolescents with attention-deficit/hyperactivity disorder (ADHD): Study protocol for a randomized, sham-controlled, triple-blind, cross-over trial.","ABSTRACT


Attention-deficit/hyperactivity disorder (ADHD) is characterized by a persistent pattern of inattention and hyperactivity/impulsivity. Despite the proven efficacy of pharmacological treatment, many individuals continue to suffer socially and academically and some experience significant side effects that negate the use psychotropic drugs. Transcranial direct current stimulation (tDCS) is a cortical neuromodulation feature that has shown positive results in the treatment of various neuropsychiatric conditions.
OBJECTIVES


To investigate the effect of tDCS on the performance of children and adolescents with ADHD in the neuropsychological tests of visual attention, verbal, and inhibitory control.
METHODOLOGY


Triple blind, randomized, sham-controlled, cross-over trial involving tDCS in children and adolescents with ADHD. Initial screening will be performed using Swanson, Nolan, and Pelham - IVand Wechsler intelligence scale for children fourth edition vocabulary and cube subtests. Individuals will be evaluated pre-tDCS and post-tDCS with the Wechsler intelligence scale for children fourth edition Digitus subtest, neuropsychological assessment battery second edition inhibiting responses subtest, Corsi cubes, and visual attention test-4.",2021,"Individuals will be evaluated pre-tDCS and post-tDCS with the Wechsler intelligence scale for children fourth edition Digitus subtest, neuropsychological assessment battery second edition inhibiting responses subtest, Corsi cubes, and visual attention test-4.","['children and adolescents with attention-deficit/hyperactivity disorder (ADHD', 'children and adolescents with ADHD', 'children and adolescents with ADHD in the neuropsychological tests of visual attention, verbal, and inhibitory control']","['Transcranial direct current stimulation (tDCS', 'tDCS', 'transcranial direct current stimulation']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],,0.171145,"Individuals will be evaluated pre-tDCS and post-tDCS with the Wechsler intelligence scale for children fourth edition Digitus subtest, neuropsychological assessment battery second edition inhibiting responses subtest, Corsi cubes, and visual attention test-4.","[{'ForeName': 'Rachel Silvany Quadros', 'Initials': 'RSQ', 'LastName': 'Guimarães', 'Affiliation': 'Postgraduate Program in Medicine and Health, Medical School of Bahia.'}, {'ForeName': 'Igor D', 'Initials': 'ID', 'LastName': 'Bandeira', 'Affiliation': 'Postgraduate Program in Medicine and Health, Medical School of Bahia.'}, {'ForeName': 'Bianca Lima', 'Initials': 'BL', 'LastName': 'Barretto', 'Affiliation': 'Medical School of Bahia.'}, {'ForeName': 'Thiago Lima', 'Initials': 'TL', 'LastName': 'Barretto', 'Affiliation': 'Medical School of Bahia.'}, {'ForeName': 'Thamires', 'Initials': 'T', 'LastName': 'Wanke', 'Affiliation': 'Institute of Psychology, Federal University of Bahia, Salvador.'}, {'ForeName': 'Clara Oliveira Carvalho', 'Initials': 'COC', 'LastName': 'Alves', 'Affiliation': 'Institute of Psychology, Federal University of Bahia, Salvador.'}, {'ForeName': 'Chrissie Ferreira', 'Initials': 'CF', 'LastName': 'de Carvalho', 'Affiliation': 'Department of Psychology, Federal University of Santa Catarina, Florianópolis.'}, {'ForeName': 'Pedro H', 'Initials': 'PH', 'LastName': 'Lucena', 'Affiliation': 'Bahiana School of Medicine and Public Health.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Rodrigues-Silva', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Lucena', 'Affiliation': 'Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.'}]",Medicine,['10.1097/MD.0000000000024283']
1480,33662285,"High-dose versus standard-dose twice-daily thoracic radiotherapy for patients with limited stage small-cell lung cancer: an open-label, randomised, phase 2 trial.","BACKGROUND


Concurrent chemoradiotherapy is standard treatment for limited stage small-cell lung cancer (SCLC). Twice-daily thoracic radiotherapy of 45 Gy in 30 fractions is considered to be the most effective schedule. The aim of this study was to investigate whether high-dose, twice-daily thoracic radiotherapy of 60 Gy in 40 fractions improves survival.
METHODS


This open-label, randomised, phase 2 trial was done at 22 public hospitals in Norway, Denmark, and Sweden. Patients aged 18 years and older with treatment-naive confirmed limited stage SCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1 were eligible. All participants received four courses of intravenous cisplatin 75 mg/m 2  or carboplatin (area under the curve 5-6 mg/mL × min, Calvert's formula) on day 1 and intravenous etoposide 100 mg/m 2  on days 1-3 every 3 weeks. Participants were randomly assigned (1:1) in permuted blocks (sized between 4 and 10) stratifying for ECOG performance status, disease stage, and presence of pleural effusion to receive thoracic radiotherapy of 45 Gy in 30 fractions or 60 Gy in 40 fractions to the primary lung tumour and PET-CT positive lymph node metastases starting 20-28 days after the first chemotherapy course. Patients in both groups received two fractions per day, ten fractions per week. Responders were offered prophylactic cranial irradiation of 25-30 Gy. The primary endpoint, 2-year overall survival, was assessed after all patients had been followed up for a minimum of 2 years. All randomly assigned patients were included in the efficacy analyses, patients commencing thoracic radiotherapy were included in the safety analyses. Follow-up is ongoing. This trial is registered at ClinicalTrials.gov, NCT02041845.
FINDINGS


Between July 8, 2014, and June 6, 2018, 176 patients were enrolled, 170 of whom were randomly assigned to 60 Gy (n=89) or 45 Gy (n=81). Median follow-up for the primary analysis was 49 months (IQR 38-56). At 2 years, 66 (74·2% [95% CI 63·8-82·9]) patients in the 60 Gy group were alive, compared with 39 (48·1% [36·9-59·5]) patients in the 45 Gy group (odds ratio 3·09 [95% CI 1·62-5·89]; p=0·0005). The most common grade 3-4 adverse events were neutropenia (72 [81%] of 89 patients in the 60 Gy group vs 62 [81%] of 77 patients in the 45 Gy group), neutropenic infections (24 [27%] vs 30 [39%]), thrombocytopenia (21 [24%] vs 19 [25%]), anaemia (14 [16%] vs 15 [20%]), and oesophagitis (19 [21%] vs 14 [18%]). There were 55 serious adverse events in 38 patients in the 60 Gy group and 56 serious adverse events in 44 patients in the 45 Gy group. There were three treatment-related deaths in each group (one neutropenic fever, one aortic dissection, and one pneumonitis in the 60 Gy group; one thrombocytic bleeding, one cerebral infarction, and one myocardial infarction in the 45 Gy group).
INTERPRETATION


The higher radiotherapy dose of 60 Gy resulted in a substantial survival improvement compared with 45 Gy, without increased toxicity, suggesting that twice-daily thoracic radiotherapy of 60 Gy is an alternative to existing schedules.
FUNDING


The Norwegian Cancer Society, The Liaison Committee for Education, Research and Innovation in Central Norway, the Nordic Cancer Union, and the Norwegian University of Science and Technology.",2021,"The higher radiotherapy dose of 60 Gy resulted in a substantial survival improvement compared with 45 Gy, without increased toxicity, suggesting that twice-daily thoracic radiotherapy of 60 Gy is an alternative to existing schedules.
","['limited stage small-cell lung cancer (SCLC', 'Patients aged 18 years and older with treatment-naive confirmed limited stage SCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and measurable disease according to the Response Evaluation Criteria in Solid Tumors', 'patients with limited stage small-cell lung cancer', '22 public hospitals in Norway, Denmark, and Sweden', 'Between July 8, 2014, and June 6, 2018, 176 patients were enrolled, 170 of whom were randomly assigned to 60 Gy (n=89) or 45 Gy (n=81']","['chemoradiotherapy', ""intravenous cisplatin 75 mg/m 2  or carboplatin (area under the curve 5-6 mg/mL\u2008×\u2008min, Calvert's formula) on day 1 and intravenous etoposide"", 'thoracic radiotherapy', 'thoracic radiotherapy of 45 Gy in 30 fractions or 60 Gy in 40 fractions to the primary lung tumour and PET-CT positive lymph node metastases', 'High-dose versus standard-dose twice-daily thoracic radiotherapy']","['oesophagitis', 'survival', 'serious adverse events', 'thrombocytic bleeding, one cerebral infarction, and one myocardial infarction', 'thrombocytopenia', 'anaemia', '2-year overall survival', 'toxicity', 'substantial survival improvement', 'neutropenia', 'neutropenic infections']","[{'cui': 'C0278725', 'cui_str': 'Small cell lung cancer limited stage'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024121', 'cui_str': 'Neoplasm of lung'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1167779', 'cui_str': 'Neutropenic infection'}]",176.0,0.328557,"The higher radiotherapy dose of 60 Gy resulted in a substantial survival improvement compared with 45 Gy, without increased toxicity, suggesting that twice-daily thoracic radiotherapy of 60 Gy is an alternative to existing schedules.
","[{'ForeName': 'Bjørn Henning', 'Initials': 'BH', 'LastName': 'Grønberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. Electronic address: bjorn.h.gronberg@ntnu.no.'}, {'ForeName': 'Kristin Toftaker', 'Initials': 'KT', 'LastName': 'Killingberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Fløtten', 'Affiliation': 'Department of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Odd Terje', 'Initials': 'OT', 'LastName': 'Brustugun', 'Affiliation': 'Section of Oncology, Drammen Hospital, Vestre Viken Health Trust, Drammen, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Hornslien', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tesfaye', 'Initials': 'T', 'LastName': 'Madebo', 'Affiliation': 'Department of Pulmonary Medicine, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Seppo Wang', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Schytte', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Nyman', 'Affiliation': 'Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Risum', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsakonas', 'Affiliation': 'Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Engleson', 'Affiliation': 'Department of Oncology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Tarje Onsøien', 'Initials': 'TO', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30742-7']
1481,33669979,Effects of Dry Needling on Neuromuscular Control of Ankle Stabilizer Muscles and Center of Pressure Displacement in Basketball Players with Chronic Ankle Instability: A Single-Blinded Randomized Controlled Trial.,"This study aimed to compare the effects of dry needling (DN) versus placebo DN applied to the peroneus longus (PL) and tibialis anterior (TA) on neuromuscular control and static postural control in basketball players with chronic ankle instability (CAI). A single-blinded randomized controlled trial was conducted. Thirty-two male and female basketball players with CAI were randomly assigned to receive either DN ( n  = 16) or placebo DN ( n  = 16). Pre-activation amplitudes of PL and TA were assessed with surface electromyography (EMG) during a dynamic landing test. Center of pressure (CoP) displacement and sway variability in anterior-posterior (AP) and medio-lateral (ML) directions were measured with a force platform during a single leg balance test (SLBT). Measures were obtained prior to a single DN intervention, immediately after, at 48 h, and 1 month after. The DN group displayed a significant increase in PL and TA pre-activation values, which were maintained 1 month later. Significant reductions in the ML and AP displacements and sway variability of CoP were found for the DN group. These results showed improvements in feedback/feed-forward strategies following DN, including enhanced neuromuscular control and static postural control, with the potential to become a convenient and accessible preventive treatment in CAI subjects.",2021,"These results showed improvements in feedback/feed-forward strategies following DN, including enhanced neuromuscular control and static postural control, with the potential to become a convenient and accessible preventive treatment in CAI subjects.","['Thirty-two male and female basketball players with CAI', 'basketball players with chronic ankle instability (CAI', 'Basketball Players with Chronic Ankle Instability', 'CAI subjects']","['placebo DN', 'DN', 'Dry Needling', 'dry needling (DN) versus placebo DN']","['Pre-activation amplitudes of PL and TA', 'ML and AP displacements and sway variability of CoP', 'PL and TA pre-activation values', 'Center of pressure (CoP) displacement and sway variability in anterior-posterior (AP) and medio-lateral (ML) directions', 'Neuromuscular Control of Ankle Stabilizer Muscles and Center of Pressure Displacement']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0224469', 'cui_str': 'Peroneus longus muscle structure'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",32.0,0.071819,"These results showed improvements in feedback/feed-forward strategies following DN, including enhanced neuromuscular control and static postural control, with the potential to become a convenient and accessible preventive treatment in CAI subjects.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'López-González', 'Affiliation': 'Department of Physical Therapy, University of Alcalá, 28805 Alcalá de Henares, Spain.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Falla', 'Affiliation': 'Centre of Precision Rehabilitation for Spinal Pain, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lázaro-Navas', 'Affiliation': 'Department of Physical Therapy, University of Alcalá, 28805 Alcalá de Henares, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lorenzo-Sánchez-Aguilera', 'Affiliation': 'Department of Physical Therapy, University of Alcalá, 28805 Alcalá de Henares, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Rodríguez-Costa', 'Affiliation': 'Department of Physical Therapy, University of Alcalá, 28805 Alcalá de Henares, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pecos-Martín', 'Affiliation': 'Department of Physical Therapy, University of Alcalá, 28805 Alcalá de Henares, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Gallego-Izquierdo', 'Affiliation': 'Department of Physical Therapy, University of Alcalá, 28805 Alcalá de Henares, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18042092']
1482,33669946,Visual Cortex Transcranial Direct Current Stimulation for Proliferative Diabetic Retinopathy Patients: A Double-Blinded Randomized Exploratory Trial.,"Proliferative diabetic retinopathy (PDR) is a severe complication of diabetes. PDR-related retinal hemorrhages often lead to severe vision loss. The main goals of management are to prevent visual impairment progression and improve residual vision. We explored the potential of transcranial direct current stimulation (tDCS) to enhance residual vision. tDCS applied to the primary visual cortex (V1) may improve visual input processing from PDR patients' retinas. Eleven PDR patients received cathodal tDCS stimulation of V1 (1 mA for 10 min), and another eleven patients received sham stimulation (1 mA for 30 s). Visual acuity (logarithm of the minimum angle of resolution (LogMAR) scores) and number acuity (reaction times (RTs) and accuracy rates (ARs)) were measured before and immediately after stimulation. The LogMAR scores and the RTs of patients who received cathodal tDCS decreased significantly after stimulation. Cathodal tDCS has no significant effect on ARs. There were no significant changes in the LogMAR scores, RTs, and ARs of PDR patients who received sham stimulation. The results are compatible with our proposal that neuronal noise aggravates impaired visual function in PDR. The therapeutic effect indicates the potential of tDCS as a safe and effective vision rehabilitation tool for PDR patients.",2021,"There were no significant changes in the LogMAR scores, RTs, and ARs of PDR patients who received sham stimulation.","['Eleven PDR patients', 'Proliferative Diabetic Retinopathy Patients', 'PDR patients']","['tDCS', 'Visual Cortex Transcranial Direct Current Stimulation', 'transcranial direct current stimulation (tDCS', 'sham stimulation', 'Cathodal tDCS']","['visual input processing', 'LogMAR scores, RTs, and ARs', 'LogMAR scores', 'visual function', 'visual impairment progression and improve residual vision', 'Visual acuity (logarithm of the minimum angle of resolution (LogMAR) scores) and number acuity (reaction times (RTs) and accuracy rates (ARs', 'cathodal tDCS', 'cathodal tDCS stimulation', 'Proliferative diabetic retinopathy (PDR']","[{'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}]",11.0,0.0689021,"There were no significant changes in the LogMAR scores, RTs, and ARs of PDR patients who received sham stimulation.","[{'ForeName': 'Angelito Braulio F', 'Initials': 'ABF', 'LastName': 'de Venecia', 'Affiliation': 'Eye Center, Region 1 Medical Center, Dagupan 2400, Pangasinan, Philippines.'}, {'ForeName': 'Shane M', 'Initials': 'SM', 'LastName': 'Fresnoza', 'Affiliation': 'Institute of Psychology, University of Graz, 8010 Graz, Austria.'}]",Brain sciences,['10.3390/brainsci11020270']
1483,33669930,Efficacy of Artificial-Intelligence-Driven Differential-Diagnosis List on the Diagnostic Accuracy of Physicians: An Open-Label Randomized Controlled Study.,"BACKGROUND


The efficacy of artificial intelligence (AI)-driven automated medical-history-taking systems with AI-driven differential-diagnosis lists on physicians' diagnostic accuracy was shown. However, considering the negative effects of AI-driven differential-diagnosis lists such as omission (physicians reject a correct diagnosis suggested by AI) and commission (physicians accept an incorrect diagnosis suggested by AI) errors, the efficacy of AI-driven automated medical-history-taking systems without AI-driven differential-diagnosis lists on physicians' diagnostic accuracy should be evaluated.
OBJECTIVE


The present study was conducted to evaluate the efficacy of AI-driven automated medical-history-taking systems with or without AI-driven differential-diagnosis lists on physicians' diagnostic accuracy.
METHODS


This randomized controlled study was conducted in January 2021 and included 22 physicians working at a university hospital. Participants were required to read 16 clinical vignettes in which the AI-driven medical history of real patients generated up to three differential diagnoses per case. Participants were divided into two groups: with and without an AI-driven differential-diagnosis list.
RESULTS


There was no significant difference in diagnostic accuracy between the two groups (57.4% vs. 56.3%, respectively;  p  = 0.91). Vignettes that included a correct diagnosis in the AI-generated list showed the greatest positive effect on physicians' diagnostic accuracy (adjusted odds ratio 7.68; 95% CI 4.68-12.58;  p  < 0.001). In the group with AI-driven differential-diagnosis lists, 15.9% of diagnoses were omission errors and 14.8% were commission errors.
CONCLUSIONS


Physicians' diagnostic accuracy using AI-driven automated medical history did not differ between the groups with and without AI-driven differential-diagnosis lists.",2021,"There was no significant difference in diagnostic accuracy between the two groups (57.4% vs. 56.3%, respectively;  p  = 0.91).","['January 2021 and included 22 physicians working at a university hospital', 'Physicians']","['artificial intelligence (AI)-driven automated medical-history-taking systems with AI-driven differential-diagnosis lists', 'AI-driven automated medical-history-taking systems with or without AI-driven differential-diagnosis lists', 'Artificial-Intelligence-Driven Differential-Diagnosis List']","[""physicians' diagnostic accuracy"", 'diagnostic accuracy']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0025084', 'cui_str': 'History Taking, Medical'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011906', 'cui_str': 'Differential diagnosis'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0291222,"There was no significant difference in diagnostic accuracy between the two groups (57.4% vs. 56.3%, respectively;  p  = 0.91).","[{'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Harada', 'Affiliation': 'Department of General Internal Medicine, Nagano Chuo Hospital, Nagano 380-0814, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Katsukura', 'Affiliation': 'Department of Diagnostic and Generalist Medicine, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Kawamura', 'Affiliation': 'Department of Diagnostic and Generalist Medicine, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Diagnostic and Generalist Medicine, Dokkyo Medical University, Tochigi 321-0293, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph18042086']
1484,33668789,Effectiveness of Smartwatch Guidance for High-Quality Infant Cardiopulmonary Resuscitation: A Simulation Study.,"Background and objectives:  As in adults, the survival rates and neurological outcomes after infant Cardiopulmonary resuscitation (CPR) are closely related to the quality of resuscitation. This study aimed to demonstrate that using a smartwatch as a haptic feedback device increases the quality of infant CPR performed by medical professionals.  Materials and methods:  We designed a prospective, randomized, case-crossover simulation study. The participants (n = 36) were randomly allocated to two groups: control first group and smartwatch first group. Each CPR session consisted of 2 min of chest compressions (CCs) using the two-finger technique (TFT), 2 min of rest, and 2 min of CCs using the two-thumb encircling hands technique (TTHT).  Results:  The primary outcome was the variation in the ""proportion of optimal chest compression duration"" and ""compression rate"" between the smartwatch-assisted and non-smartwatch-assisted groups. The secondary outcome was the variation in the ""compression depth"" between two groups. The proportion of optimal CC duration was significantly higher in the smartwatch-assisted group than in the non-smartwatch-assisted group. The absolute difference from 220 was much smaller in the smartwatch-assisted group (218.02) than in the non-smartwatch-assisted group (226.59) ( p -Value = 0.018).  Conclusion:  This study demonstrated the haptic feedback system using a smartwatch improves the quality of infant CPR by maintaining proper speed and depth regardless of the compression method used.",2021,The proportion of optimal CC duration was significantly higher in the smartwatch-assisted group than in the non-smartwatch-assisted group.,"['High-Quality Infant Cardiopulmonary Resuscitation', 'participants (n = 36']","['Smartwatch Guidance', 'chest compressions (CCs) using the two-finger technique (TFT), 2 min of rest, and 2 min of CCs using the two-thumb encircling hands technique (TTHT', 'control first group and smartwatch first group', 'haptic feedback device']","['proportion of optimal CC duration', 'compression depth', 'survival rates and neurological outcomes', 'quality of infant CPR', 'variation in the ""proportion of optimal chest compression duration"" and ""compression rate"" between the smartwatch-assisted and non-smartwatch-assisted groups']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0456980', 'cui_str': 'Hand endodontic technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",36.0,0.0267201,The proportion of optimal CC duration was significantly higher in the smartwatch-assisted group than in the non-smartwatch-assisted group.,"[{'ForeName': 'Seong A', 'Initials': 'SA', 'LastName': 'Jeon', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Hansol', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Department of Digital Health, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul 06355, Korea.'}, {'ForeName': 'Nayeong', 'Initials': 'N', 'LastName': 'Hwang', 'Affiliation': 'Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Seoul 06351, Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Seoul 06351, Korea.'}, {'ForeName': 'Hee', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Sung Yeon', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Tae Gun', 'Initials': 'TG', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Won Chul', 'Initials': 'WC', 'LastName': 'Cha', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Taerim', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57030193']
1485,33668740,Higher Impulse Electromyostimulation Contributes to Psychological Satisfaction and Physical Development in Healthy Men.,"Background and Objectives : This study investigated the various impulse effects of whole-body electromyostimulation (WB-EMS) on psychophysiological responses and adaptations.  Materials and Methods : The participants included fifty-four men between 20 and 27 years of age who practiced isometric exercises for 20 min, three days a week, for 12 weeks while wearing WB-EMS suits, which enabled the simultaneous activation of eight muscle groups with three types of impulse intensities. Participants were allocated to one of four groups: control group (CON), low-impulse-intensity group (LIG), mid-impulse-intensity group (MIG), and high-impulse-intensity group (HIG). Psychophysiological conditions were measured at week 0, week 4, week 8, and week 12.  Results : Compared with the CON, (1) three psychological conditions in LIG, MIG, and HIG showed positive tendencies every four weeks, and the analysis of covariance (ANCOVA) test revealed that body image ( p  = 0.004), body shape ( p  = 0.007), and self-esteem ( p  = 0.001) were significantly different among the groups. (2) Body weight, fat mass, body mass index, and percent fat in the CON showed decreasing tendencies, whereas those in LIG, MIG, and HIG showed a noticeable decrease, which revealed that there were significant differences among the groups. Specifically, a higher impulse intensity resulted in a greater increase in muscle mass. (3) Although there was no interaction effect in the abdominal visceral fat area, there were significant interactions in the abdominal subcutaneous fat (ASF) and total fat (ATF) areas. Both the ASF and ATF in the CON showed decreasing tendencies, whereas those in other groups showed a noticeable decrease. The ANCOVA revealed that the ASF ( p  = 0.002) and ATF ( p  = 0.001) were significantly different among the groups. In particular, the higher the impulse intensity, the greater the decrease in abdominal fat.  Conclusions : This study confirmed that high-impulse-intensity EMS can improve psychophysiological conditions. In other words, healthy young adults felt that the extent to which their body image, body shape, and self-esteem improved depended on how intense their EMS impulse intensities were. The results also showed that higher levels of impulse intensity led to improved physical conditions.",2021,The ANCOVA revealed that the ASF ( p  = 0.002) and ATF ( p  = 0.001) were significantly different among the groups.,"['healthy young adults', 'Healthy Men', 'participants included fifty-four men between 20 and 27 years of age who']","['whole-body electromyostimulation (WB-EMS', 'practiced isometric exercises', 'control group (CON), low-impulse-intensity group (LIG), mid-impulse-intensity group (MIG), and high-impulse-intensity group (HIG', 'Materials and Methods ']","['2) Body weight, fat mass, body mass index', 'abdominal fat', 'Psychophysiological conditions', 'muscle mass', 'self-esteem', 'psychophysiological responses and adaptations', 'abdominal subcutaneous fat (ASF) and total fat (ATF) areas', 'ATF', 'body shape']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C1563741', 'cui_str': 'Fat, Abdominal Subcutaneous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1148798', 'cui_str': 'ATF Transcription Factors'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]",54.0,0.016972,The ANCOVA revealed that the ASF ( p  = 0.002) and ATF ( p  = 0.001) were significantly different among the groups.,"[{'ForeName': 'Kangho', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Denny', 'Initials': 'D', 'LastName': 'Eun', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Yong-Seok', 'Initials': 'YS', 'LastName': 'Jee', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57030191']
1486,33668699,"Effects of Red and White Ginseng Preparations on Electrical Activity of the Brain in Elderly Subjects: A Randomized, Double-Blind, Placebo-Controlled, Three-Armed Cross-Over Study.","BACKGROUND


Recently, the superior efficacy of hydroponically cultivated red ginseng preparation HRG80 ®  compared to wild growing white ginseng (WG) in preventing stress-induced symptoms related to the daily work situation of healthy subjects was reported. The aim of this study was to compare the effects of HRG80 ® , WG, and placebo on the electrical activity in the brain of elderly human subjects during relaxation and mental challenges.
METHODS


Changes in the electroencephalogram (EEG) frequency ranges of 17 different brain regions were measured after single and repeated administration of HRG80 ® , WG, and placebo across a four-week randomized, double-blind, placebo-controlled three-armed cross-over trial.
RESULTS


Both red and white ginseng preparations had a strong impact on brain activity, with different effects on various brain regions depending on the mental load during relaxation and cognitive tasks associated with memory, attention, and mental performance. Both ginseng preparations exhibited significant effects on spectral powers compared to placebo, reflecting an activating action. The spectral changes in the quantitative EEG induced by HRG80 ®  indicated an improvement in mood as well as calming effects, evidenced by the modulation of β2 waves, representing changes in GABA-ergic neurotransmission. HRG80 ®  attenuated δ/θ powers during relaxation, suggesting the potential improvement of pathologically enhanced spectral power in aging.
CONCLUSION


The results of this study suggest that both hydroponically cultivated red and wild growing white ginseng have similar beneficial effects on the cognitive functions of elderly subjects, as reflected by electric brain activity, but their modes of action on the brain are different.",2021,"The spectral changes in the quantitative EEG induced by HRG80 ®  indicated an improvement in mood as well as calming effects, evidenced by the modulation of β2 waves, representing changes in GABA-ergic neurotransmission.","['Changes in the electroencephalogram (EEG) frequency ranges of 17 different brain regions', 'elderly human subjects during relaxation and mental challenges', 'elderly subjects', 'Elderly Subjects']","['placebo-controlled three-armed cross-over trial', 'placebo', 'Red and White Ginseng Preparations', 'HRG80 ® , WG, and placebo', 'Placebo']","['spectral powers', 'Electrical Activity', 'memory, attention, and mental performance', 'brain activity']","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1119918', 'cui_str': 'Ginseng Preparation'}]","[{'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",,0.2119,"The spectral changes in the quantitative EEG induced by HRG80 ®  indicated an improvement in mood as well as calming effects, evidenced by the modulation of β2 waves, representing changes in GABA-ergic neurotransmission.","[{'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Dimpfel', 'Affiliation': 'Departmrent of Pharmacology, Justus-Liebig-University Giessen, Germany c/o A 4164 Schwarzenberg am Böhmerwald, Panoramaweg 21, Schwarzenberg am Böhmerwald, Övre-Österrike, 4164 Österrike, Austria.'}, {'ForeName': 'Pierre-Antoine', 'Initials': 'PA', 'LastName': 'Mariage', 'Affiliation': 'Botalys SA, 8 Quai des Usines, 7800 Ath, Belgium.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Panossian', 'Affiliation': 'Department of Research & Development, Phytomed AB, Bofinkvagen 1, 31275 Vaxtorp, Sweden.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph14030182']
1487,33668674,Acute Effects of Cheddar Cheese Consumption on Circulating Amino Acids and Human Skeletal Muscle.,"Cheddar cheese is a protein-dense whole food and high in leucine content. However, no information is known about the acute blood amino acid kinetics and protein anabolic effects in skeletal muscle in healthy adults. Therefore, we conducted a crossover study in which men and women ( n  = 24; ~27 years, ~23 kg/m 2 ) consumed cheese (20 g protein) or an isonitrogenous amount of milk. Blood and skeletal muscle biopsies were taken before and during the post absorptive period following ingestion. We evaluated circulating essential and non-essential amino acids, insulin, and free fatty acids and examined skeletal muscle anabolism by mTORC1 cellular localization, intracellular signaling, and ribosomal profiling. We found that cheese ingestion had a slower yet more sustained branched-chain amino acid circulation appearance over the postprandial period peaking at ~120 min. Cheese also modestly stimulated mTORC1 signaling and increased membrane localization. Using ribosomal profiling we found that, though both milk and cheese stimulated a muscle anabolic program associated with mTORC1 signaling that was more evident with milk, mTORC1 signaling persisted with cheese while also inducing a lower insulinogenic response. We conclude that Cheddar cheese induced a sustained blood amino acid and moderate muscle mTORC1 response yet had a lower glycemic profile compared to milk.",2021,We found that cheese ingestion had a slower yet more sustained branched-chain amino acid circulation appearance over the postprandial period peaking at ~120 min.,"['men and women ( n  = 24; ~27 years, ~23 kg/m 2 ) consumed cheese (20 g protein) or an isonitrogenous amount of milk', 'healthy adults']",['Cheddar Cheese Consumption'],"['Circulating Amino Acids and Human Skeletal Muscle', 'sustained blood amino acid and moderate muscle mTORC1 response', 'membrane localization', 'Blood and skeletal muscle biopsies', 'insulinogenic response']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0452767', 'cui_str': 'Cheddar cheese'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3888046', 'cui_str': 'Target of Rapamycin Complex 1'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C2315740', 'cui_str': 'Biopsy of skeletal muscle'}]",,0.0202556,We found that cheese ingestion had a slower yet more sustained branched-chain amino acid circulation appearance over the postprandial period peaking at ~120 min.,"[{'ForeName': 'Naomi M M P', 'Initials': 'NMMP', 'LastName': 'de Hart', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, 250 S 1850 E, Salt Lake City, UT 84112, USA.'}, {'ForeName': 'Ziad S', 'Initials': 'ZS', 'LastName': 'Mahmassani', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84108, USA.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Reidy', 'Affiliation': 'Department of Kinesiology, Nutrition and Health, Miami University, 420 S Oak St., Oxford, OH 45056, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Kelley', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84108, USA.'}, {'ForeName': 'Alec I', 'Initials': 'AI', 'LastName': 'McKenzie', 'Affiliation': 'Geoge E. Wahlen Department of Veterans Affairs Medical Center, Geriatric Research, Education, and Clinical Center, 500 Foothill Dr., Salt Lake City, UT 84148, USA.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Petrocelli', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84108, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bridge', 'Affiliation': 'Cell Imaging Facility, University of Utah, 30 N 2030 E, Salt Lake City, UT 84112, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Baird', 'Affiliation': 'Department of Human Genetics, 15 N 2030 E, Salt Lake City, UT 84112, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Bastian', 'Affiliation': 'Dairy West Innovation Partnerships, 195 River Vista Place #306, Twin Falls, ID 83301, USA.'}, {'ForeName': 'Loren S', 'Initials': 'LS', 'LastName': 'Ward', 'Affiliation': 'Glanbia Nutritionals Research, 450 Falls Avenue #255, Twin Falls, ID 83301, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Howard', 'Affiliation': 'Department of Human Genetics, 15 N 2030 E, Salt Lake City, UT 84112, USA.'}, {'ForeName': 'Micah J', 'Initials': 'MJ', 'LastName': 'Drummond', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, 250 S 1850 E, Salt Lake City, UT 84112, USA.'}]",Nutrients,['10.3390/nu13020614']
1488,33667319,Prevention of depression in adults with long-term physical conditions.,"BACKGROUND


Major depression is one of the world's leading causes of disability in adults with long-term physical conditions compared to those without physical illness. This co-morbidity is associated with a negative prognosis in terms of increased morbidity and mortality rates, increased healthcare costs, decreased adherence to treatment regimens, and a substantial decline in quality of life. Therefore, preventing the onset of depressive episodes in adults with long-term physical conditions should be a global healthcare aim. In this review, primary or tertiary (in cases of preventing recurrences in those with a history of depression) prevention are the focus. While primary prevention aims at preventing the onset of depression, tertiary prevention comprises both preventing recurrences and prohibiting relapses. Tertiary prevention aims to address a depressive episode that might still be present, is about to subside, or has recently resolved. We included tertiary prevention in the case where the focus was preventing the onset of depression in those with a history of depression (preventing recurrences) but excluded it if it specifically focused on maintaining an condition or implementing rehabilitation services (relapse prevention). Secondary prevention of depression seeks to prevent the progression of depressive symptoms by early detection and treatment and may therefore be considered a 'treatment,' rather than prevention. We therefore exclude the whole spectrum of secondary prevention.
OBJECTIVES


To assess the effectiveness, acceptability and tolerability of psychological or pharmacological interventions, in comparison to control conditions, in preventing depression in adults with long-term physical conditions; either before first ever onset of depressive symptoms (i.e. primary prevention) or before first onset of depressive symptoms in patients with a history of depression (i.e. tertiary prevention).
SEARCH METHODS


We searched the Cochrane Common Mental Disorders Controlled Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO and two trials registries, up to 6 February 2020.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) of preventive psychological or pharmacological interventions, specifically targeting incidence of depression in comparison to treatment as usual (TAU), waiting list, attention/psychological placebo, or placebo. Participants had to be age 18 years or older, with at least one long-term physical condition, and no diagnosis of major depression at baseline (primary prevention). In addition, we included studies comprising mixed samples of patients with and without a history of depression, which explored tertiary prevention of recurrent depression. We excluded other tertiary prevention studies. We also excluded secondary preventive interventions. Primary outcomes included incidence of depression, tolerability, and acceptability. Secondary outcomes included severity of depression, cost-effectiveness and cost-utility.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane.
MAIN RESULTS


We included 11 RCTs, with one trial on psychological interventions, and 10 trials on pharmacological interventions. Data analyses on the psychological intervention (problem-solving therapy compared to TAU) included 194 participants with age-related macular degeneration. Data analyses on pharmacological interventions included 837 participants comparing citalopram (one trial), escitalopram (three trials), a mixed sample of fluoxetine/nortriptyline (one trial), melatonin (one trial), milnacipran (one trial), and sertraline (three trials), each to placebo. Included types of long-term physical conditions were acute coronary syndrome (one trial), breast cancer (one trial), head and neck cancer (two trials), stroke (five trials), and traumatic brain injury (one trial). Psychological interventions Very low-certainty evidence of one study suggests that problem solving therapy may be slightly more effective than TAU in preventing the incidence of depression, immediately post-intervention (odds ratio (OR) 0.43, 95% confidence interval (CI) 0.20 to 0.95; 194 participants). However, there may be little to no difference between groups at six months follow-up (OR 0.71, 95% CI 0.36 to 1.38; 190 participants; one study; very low-certainty evidence). No data were available regarding incidence of depression after six months. Regarding acceptability (drop-outs due to any cause), slightly fewer drop-outs occurred in the TAU group immediately post-intervention (OR 5.21, 95% CI 1.11 to 24.40; 206 participants; low-certainty evidence). After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence). This study did not measure tolerability. Pharmacological interventions Post-intervention, compared to placebo, antidepressants may be beneficial in preventing depression in adults with different types of long-term physical conditions, but the evidence is very uncertain (OR 0.31, 95% CI 0.20 to 0.49; 814 participants; nine studies; I 2  =0%; very low-certainty evidence). There may be little to no difference between groups both immediately and at six months follow-up (OR 0.44, 95% CI 0.08 to 2.46; 23 participants; one study; very low-certainty evidence) as well as at six to 12 months follow-up (OR 0.81, 95% CI 0.23 to 2.82; 233 participants; three studies; I 2  = 49%; very low-certainty evidence). There was very low-certainty evidence from five studies regarding the tolerability of the pharmacological intervention. A total of 669 adverse events were observed in 316 participants from the pharmacological intervention group, and 610 adverse events from 311 participants in the placebo group. There was very low-certainty evidence that drop-outs due to adverse events may be less frequent in the placebo group (OR 2.05, 95% CI 1.07 to 3.89; 561 participants; five studies; I 2  = 0%). There was also very low-certainty evidence that drop-outs due to any cause may not differ between groups either post-intervention (OR 1.13, 95% CI 0.73 to 1.73; 962 participants; nine studies; I 2  = 28%), or at six to 12 months (OR 1.13, 95% CI 0.69 to 1.86; 327 participants; three studies; I 2  = 0%).
AUTHORS' CONCLUSIONS


Based on evidence of very low certainty, our results may indicate the benefit of pharmacological interventions, during or directly after preventive treatment. Few trials examined short-term outcomes up to six months, nor the follow-up effects at six to 12 months, with studies suffering from great numbers of drop-outs and inconclusive results. Generalisation of results is limited as study populations and treatment regimes were very heterogeneous. Based on the results of this review, we conclude that for adults with long-term physical conditions, there is only very uncertain evidence regarding the implementation of any primary preventive interventions (psychological/pharmacological) for depression.",2021,"After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence).","['patients with a history of depression (i.e. tertiary prevention', 'Participants had to be age 18 years or older, with at least one long-term physical condition, and no diagnosis of major depression at baseline (primary prevention', '316 participants from the pharmacological intervention group, and 610 adverse events from 311 participants in the placebo group', '194 participants with age-related macular degeneration', '837 participants comparing citalopram (one trial), escitalopram (three trials), a mixed sample of', 'adults with long-term physical conditions', 'Included types of long-term physical conditions were acute coronary syndrome (one trial), breast cancer (one trial), head and neck cancer (two trials), stroke (five trials), and traumatic brain injury (one trial', 'patients with and without a history of depression, which explored tertiary prevention of recurrent depression']","['placebo', 'psychological intervention (problem-solving therapy compared to TAU', 'melatonin', 'preventive psychological or pharmacological interventions', 'fluoxetine/nortriptyline', 'sertraline', 'usual (TAU), waiting list, attention/psychological placebo, or placebo']","['severity of depression, cost-effectiveness and cost-utility', 'morbidity and mortality rates, increased healthcare costs', 'effectiveness, acceptability and tolerability', 'tolerability', 'incidence of depression, tolerability, and acceptability', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0679700', 'cui_str': 'Tertiary Prevention'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",194.0,0.340148,"After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence).","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Kampling', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Clinic of Giessen and Marburg, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Bengel', 'Affiliation': 'Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Mittag', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research, Center for Medical Biometry and Statistics, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011246.pub2']
1489,33674675,A randomized controlled trial on the effects induced by robot-assisted and usual-care rehabilitation on upper limb muscle synergies in post-stroke subjects.,"Muscle synergies are hypothesized to reflect connections among motoneurons in the spinal cord activated by central commands and sensory feedback. Robotic rehabilitation of upper limb in post-stroke subjects has shown promising results in terms of improvement of arm function and motor control achieved by reassembling muscle synergies into a set more similar to that of healthy people. However, in stroke survivors the potentially neurophysiological changes induced by robot-mediated learning versus usual care have not yet been investigated. We quantified upper limb motor deficits and the changes induced by rehabilitation in 32 post-stroke subjects through the movement analysis of two virtual untrained tasks of object placing and pronation. The sample analyzed in this study is part of a larger bi-center study and included all subjects who underwent kinematic analysis and were randomized into robot and usual care groups. Post-stroke subjects who followed robotic rehabilitation showed larger improvements in axial-to-proximal muscle synergies with respect to those who underwent usual care. This was associated to a significant improvement of the proximal kinematics. Both treatments had negative effects in muscle synergies controlling the distal district. This study supports the definition of new rehabilitative treatments for improving the neurophysiological recovery after stroke.",2021,Robotic rehabilitation of upper limb in post-stroke subjects has shown promising results in terms of improvement of arm function and motor control achieved by reassembling muscle synergies into a set more similar to that of healthy people.,"['post-stroke subjects', '32 post-stroke subjects']","['robot-assisted and usual-care rehabilitation', 'robotic rehabilitation', 'Robotic rehabilitation']","['axial-to-proximal muscle synergies', 'proximal kinematics']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",2.0,0.0325528,Robotic rehabilitation of upper limb in post-stroke subjects has shown promising results in terms of improvement of arm function and motor control achieved by reassembling muscle synergies into a set more similar to that of healthy people.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lencioni', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy. tlencioni@dongnocchi.it.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fornia', 'Affiliation': 'Department of Medical Biotechnologies and Translational Medicine, Università Degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bowman', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marzegan', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caronni', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Turolla', 'Affiliation': 'Movement Neuroscience Research Group, IRCCS San Camillo Hospital, Venezia, Lido, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jonsdottir', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Carpinella', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferrarin', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.'}]",Scientific reports,['10.1038/s41598-021-84536-8']
1490,33673867,Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial.,"BACKGROUND


Depression and anxiety impact up to 1 in 5 pregnant and postpartum women worldwide. Yet, as few as 20% of these women are treated with frontline interventions such as evidence-based psychological treatments. Major barriers to uptake are the limited number of specialized mental health treatment providers in most settings, and problems with accessing in-person care, such as childcare or transportation. Task sharing of treatment to non-specialist providers with delivery on telemedicine platforms could address such barriers. However, the equivalence of these strategies to specialist and in-person models remains unproven.
METHODS


This study protocol outlines the Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) randomized trial. SUMMIT is a pragmatic, non-inferiority test of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a brief, behavioral activation (BA) treatment for perinatal depressive and anxiety symptoms. Specialists (psychologists, psychiatrists, and social workers with ≥ 5 years of therapy experience) and non-specialists (nurses and midwives with no formal training in mental health care) were trained in the BA protocol, with the latter supervised by a BA expert during treatment delivery. Consenting pregnant and postpartum women with Edinburgh Postnatal Depression Scale (EPDS) score of ≥ 10 (N = 1368) will be randomized to one of four arms (telemedicine specialist, telemedicine non-specialist, in-person specialist, in-person non-specialist), stratified by pregnancy status (antenatal/postnatal) and study site. The primary outcome is participant-reported depressive symptoms (EPDS) at 3 months post-randomization. Secondary outcomes are maternal symptoms of anxiety and trauma symptoms, perceived social support, activation levels and quality of life at 3-, 6-, and 12-month post-randomization, and depressive symptoms at 6- and 12-month post-randomization. Primary analyses are per-protocol and intent-to-treat. The study has successfully continued despite the COVID-19 pandemic, with needed adaptations, including temporary suspension of the in-person arms and ongoing randomization to telemedicine arms.
DISCUSSION


The SUMMIT trial is expected to generate evidence on the non-inferiority of BA delivered by a non-specialist provider compared to specialist and telemedicine compared to in-person. If confirmed, results could pave the way to a dramatic increase in access to treatment for perinatal depression and anxiety.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04153864 . Registered on November 6, 2019.",2021,The SUMMIT trial is expected to generate evidence on the non-inferiority of BA delivered by a non-specialist provider compared to specialist and telemedicine compared to in-person.,"['5 pregnant and postpartum women worldwide', 'Consenting pregnant and postpartum women with Edinburgh Postnatal Depression Scale (EPDS) score of ≥ 10 (N\u2009=\u20091368', 'Specialists (psychologists, psychiatrists, and social workers with ≥ 5\u2009years of therapy experience) and non-specialists (nurses and midwives with no formal training in mental health care']","['telemedicine specialist, telemedicine non-specialist, in-person specialist, in-person non-specialist', 'behavioral activation (BA) treatment', 'telemedicine']","['participant-reported depressive symptoms (EPDS', 'maternal symptoms of anxiety and trauma symptoms, perceived social support, activation levels and quality of life at 3-, 6-, and 12-month post-randomization, and depressive symptoms']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.336136,The SUMMIT trial is expected to generate evidence on the non-inferiority of BA delivered by a non-specialist provider compared to specialist and telemedicine compared to in-person.,"[{'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Singla', 'Affiliation': 'Department of Psychiatry, Sinai Health and Lunenfeld Tanenbaum Research Institute, Toronto, Canada. daisy.singla@utoronto.ca.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics & Gynecology, NorthShore University HealthSystem, Chicago, IL, USA.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Vigod', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics & Gynecology, NorthShore University HealthSystem, Chicago, IL, USA.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'La Porte', 'Affiliation': 'Department of Obstetrics & Gynecology, NorthShore University HealthSystem, Chicago, IL, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ravitz', 'Affiliation': 'Department of Psychiatry, Sinai Health and Lunenfeld Tanenbaum Research Institute, Toronto, Canada.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Schiller', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schoueri-Mychasiw', 'Affiliation': 'Department of Psychiatry, Sinai Health and Lunenfeld Tanenbaum Research Institute, Toronto, Canada.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': 'Department of Psychology, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Dalfen', 'Affiliation': 'Department of Psychiatry, Sinai Health and Lunenfeld Tanenbaum Research Institute, Toronto, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dimidjian', 'Affiliation': 'Renee Crown Wellness Institute and Department of Psychology and Neuroscience, University of Colorado, Boulder, CO, USA.'}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Gaynes', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Katz', 'Affiliation': 'Department of Psychiatry, Sinai Health and Lunenfeld Tanenbaum Research Institute, Toronto, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lawson', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Chicago Pritzker School of Medicine, Chicago, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leszcz', 'Affiliation': 'Department of Psychiatry, Sinai Health and Lunenfeld Tanenbaum Research Institute, Toronto, Canada.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Maunder', 'Affiliation': 'Department of Psychiatry, Sinai Health and Lunenfeld Tanenbaum Research Institute, Toronto, Canada.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Obstetrics and Gynecology, Sinai Health and University of Toronto, Toronto, Canada.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Naslund', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Reyes-Rodríguez', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Stuebe', 'Affiliation': 'Department of Obstetrics & Gynecology, School of Medicine, University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'C-L', 'Initials': 'CL', 'LastName': 'Dennis', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Obstetrics & Gynecology, School of Medicine, University of North Carolina, Chapel Hill, USA.'}]",Trials,['10.1186/s13063-021-05075-1']
1491,33673831,"Correction to: Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2-azithromycin trial.",,2021,,[],[],[],[],[],[],,0.0280237,,"[{'ForeName': 'Iwein', 'Initials': 'I', 'LastName': 'Gyselinck', 'Affiliation': 'Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium. iwein.gyselinck@kuleuven.be.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Liesenborghs', 'Affiliation': 'Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Ewout', 'Initials': 'E', 'LastName': 'Landeloos', 'Affiliation': 'Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Leuven, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Verbeke', 'Affiliation': 'Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Janssens', 'Affiliation': 'Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-021-05153-4']
1492,33673813,The perceived deservingness of COVID-19 healthcare in the Netherlands: a conjoint experiment on priority access to intensive care and vaccination.,"BACKGROUND


Amidst the COVID-19 pandemic, governments, health experts, and ethicists have proposed guidelines about ICU triage and priority access to a vaccine. To increase political legitimacy and accountability, public support is important. This study examines what criteria beyond medical need are deemed important to be perceived of priority COVID-19 healthcare access.
METHOD


Two conjoint experiments about priority over ICU treatment and early COVID-19 vaccination were implemented in a probability-based sample of 1461 respondents representative of the Netherlands. Respondents were asked who should receive treatment out of two fictitious healthcare claimants that differed in in age, weight, complying with corona policy measures, and occupation, all randomly assigned. Average marginal coefficient effects are estimated to assess the relative importance of the attributes; attributes were interacted with relevant respondent characteristics to find whether consensus exists in this relative ranking.
RESULTS


The Dutch penalize those not complying with coronavirus policy measures, and the obese, but prioritize those employed in 'crucial' sectors. For these conditions, there is consensus among the population. For age, young people are prioritized for ICU treatment, while the middle-aged are given priority over a vaccine, with younger respondents favoring healthcare for elderly claimants, while older respondents favor support for young cohorts.
CONCLUSION


People who have no control over their social risk and are able to reciprocate to society are considered as more deserving of priority of COVID-19 healthcare. Our findings provide fair support for the implemented ethical guidelines about ICU-treatment and COVID-19 vaccines.",2021,"Respondents were asked who should receive treatment out of two fictitious healthcare claimants that differed in in age, weight, complying with corona policy measures, and occupation, all randomly assigned.","['People who have no control over their social risk', '1461 respondents representative of the Netherlands']",['ICU treatment and early COVID-19 vaccination'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],1461.0,0.0505192,"Respondents were asked who should receive treatment out of two fictitious healthcare claimants that differed in in age, weight, complying with corona policy measures, and occupation, all randomly assigned.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Reeskens', 'Affiliation': 'School of Social and Behavioral Sciences, Tilburg University, PO Box 90153, 5000 LE, Tilburg, The Netherlands. t.reeskens@tilburguniversity.edu.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Roosma', 'Affiliation': 'School of Social and Behavioral Sciences, Tilburg University, PO Box 90153, 5000 LE, Tilburg, The Netherlands.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Wanders', 'Affiliation': 'School of Social and Behavioral Sciences, Tilburg University, PO Box 90153, 5000 LE, Tilburg, The Netherlands.'}]",BMC public health,['10.1186/s12889-021-10488-3']
1493,33672963,Acacia Gum Is Well Tolerated While Increasing Satiety and Lowering Peak Blood Glucose Response in Healthy Human Subjects.,"Acacia gum (AG) is a non-viscous soluble fiber that is easily incorporated into beverages and foods. To determine its physiological effects in healthy human subjects, we fed 0, 20, and 40 g of acacia gum in orange juice along with a bagel and cream cheese after a 12 h fast and compared satiety, glycemic response, gastrointestinal tolerance, and food intake among treatments. Subjects ( n  = 48) reported less hunger and greater fullness at 15 min ( p  = 0.019 and 0.003, respectively) and 240 min ( p  = 0.036 and 0.05, respectively) after breakfast with the 40 g fiber treatment. They also reported being more satisfied at 15 min ( p  = 0.011) and less hungry with the 40 g fiber treatment at 30 min ( p  = 0.012). Subjects reported more bloating, flatulence, and GI rumbling on the 40 g fiber treatment compared to control, although values for GI tolerance were all low with AG treatment. No significant differences were found in area under the curve (AUC) or change from baseline for blood glucose response, although actual blood glucose with 20 g fiber at 30 min was significantly less than control. Individuals varied greatly in their postprandial glucose response to all treatments. AG improves satiety response and may lower peak glucose response at certain timepoints, and it is well tolerated in healthy human subjects. AG can be added to beverages and foods in doses that can help meet fiber recommendations.",2021,"Subjects ( n  = 48) reported less hunger and greater fullness at 15 min ( p  = 0.019 and 0.003, respectively) and 240 min ( p  = 0.036 and 0.05, respectively) after breakfast with the 40 g fiber treatment.","['Healthy Human Subjects', 'healthy human subjects']","['acacia gum in orange juice along with a bagel and cream cheese', 'Acacia gum (AG', 'Acacia Gum']","['Satiety and Lowering Peak Blood Glucose Response', 'GI tolerance', 'actual blood glucose', 'hunger and greater fullness', 'bloating, flatulence, and GI rumbling', 'satiety, glycemic response, gastrointestinal tolerance, and food intake', 'postprandial glucose response', 'satiety response', 'area under the curve (AUC) or change from baseline for blood glucose response', 'Tolerated']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0018389', 'cui_str': 'Gum arabic'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0452795', 'cui_str': 'Cream cheese'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0036240', 'cui_str': 'Satiety Response'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.017841,"Subjects ( n  = 48) reported less hunger and greater fullness at 15 min ( p  = 0.019 and 0.003, respectively) and 240 min ( p  = 0.036 and 0.05, respectively) after breakfast with the 40 g fiber treatment.","[{'ForeName': 'Riley', 'Initials': 'R', 'LastName': 'Larson', 'Affiliation': 'Food Science and Nutrition Department, University of Minnesota, 1334 Eckles Ave, Falcon Heights, MN 55108, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': 'Food Science and Nutrition Department, University of Minnesota, 1334 Eckles Ave, Falcon Heights, MN 55108, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korczak', 'Affiliation': 'Food Science and Nutrition Department, University of Minnesota, 1334 Eckles Ave, Falcon Heights, MN 55108, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Willis', 'Affiliation': 'Food Science and Nutrition Department, University of Minnesota, 1334 Eckles Ave, Falcon Heights, MN 55108, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Erickson', 'Affiliation': 'Food Science and Nutrition Department, University of Minnesota, 1334 Eckles Ave, Falcon Heights, MN 55108, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Clinical and Translational Science Institute, University of Minnesota, 717 Delaware Street SE, Minneapolis, MN 55414, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Slavin', 'Affiliation': 'Food Science and Nutrition Department, University of Minnesota, 1334 Eckles Ave, Falcon Heights, MN 55108, USA.'}]",Nutrients,['10.3390/nu13020618']
1494,33672908,Backstroke to Breaststroke Turning Performance in Age-Group Swimmers: Hydrodynamic Characteristics and Pull-Out Strategy.,"We compared the hydrodynamic characteristics and pull-out strategies of four backstroke-to-breaststroke turning techniques in young swimmers. Eighteen 11 and 12-year-old swimmers participated in a 4 week intervention program including 16 contextual interference sessions. The hydrodynamic variables were assessed through inverse dynamics, and the pull-out strategy kinematics were assessed with tracking markers followed by 12 land cameras and 11 underwater cameras. Swimmers randomly completed sixteen 30 m maximal backstroke-to breaststroke-open, somersault, bucket and crossover turns (four in each technique) with a 3 min rest. The data showed higher drag force, cross-sectional area and drag coefficient values for the first (compared with the second) gliding position. The crossover turn revealed the highest push-off velocity (2.17 ± 0.05 m·s -1 ), and the somersault turn demonstrated the lowest foot plant index (0.68 ± 0.03; 68%), which could have affected the first gliding, transition and second gliding depths (0.73 ± 0.13, 0.86 ± 0.17 and 0.76 ± 0.17 m). The data revealed the consistency of the time spent (4.86 ± 0.98 s) and breakout distance (6.04 ± 0.94 m) among the four turning techniques, and no differences were observed between them regarding time and average velocity up to 7.5 m. The hydrodynamic characteristics and pull-out strategy of the backstroke-to-breaststroke turns performed by the age group swimmers were independent of the selected technique.",2021,"The data showed higher drag force, cross-sectional area and drag coefficient values for the first (compared with the second) gliding position.","['young swimmers', 'Eighteen 11 and 12-year-old swimmers participated in a 4 week']",['intervention program including 16 contextual interference sessions'],"['highest push-off velocity', 'higher drag force, cross-sectional area and drag coefficient values', 'lowest foot plant index', 'breakout distance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1562415', 'cui_str': 'Skin drag'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.0147425,"The data showed higher drag force, cross-sectional area and drag coefficient values for the first (compared with the second) gliding position.","[{'ForeName': 'Phornpot', 'Initials': 'P', 'LastName': 'Chainok', 'Affiliation': 'Faculty of Sport Science, Burapha University, Chonburi 20131, Thailand.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Machado', 'Affiliation': 'Centre of Research, Education, Innovation and Intervention in Sport (CIFI2D) and Porto Biomechanics Laboratory (LABIOMEP-UP), Faculty of Sport, University of Porto, 4099-002 Porto, Portugal.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'de Jesus', 'Affiliation': 'Centre of Research, Education, Innovation and Intervention in Sport (CIFI2D) and Porto Biomechanics Laboratory (LABIOMEP-UP), Faculty of Sport, University of Porto, 4099-002 Porto, Portugal.'}, {'ForeName': 'J Arturo', 'Initials': 'JA', 'LastName': 'Abraldes', 'Affiliation': 'Faculty of Sport Science, University of Murcia, 30720 San Javier, Spain.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Borgonovo-Santos', 'Affiliation': 'Centre of Research, Education, Innovation and Intervention in Sport (CIFI2D) and Porto Biomechanics Laboratory (LABIOMEP-UP), Faculty of Sport, University of Porto, 4099-002 Porto, Portugal.'}, {'ForeName': 'Ricardo J', 'Initials': 'RJ', 'LastName': 'Fernandes', 'Affiliation': 'Centre of Research, Education, Innovation and Intervention in Sport (CIFI2D) and Porto Biomechanics Laboratory (LABIOMEP-UP), Faculty of Sport, University of Porto, 4099-002 Porto, Portugal.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Vilas-Boas', 'Affiliation': 'Centre of Research, Education, Innovation and Intervention in Sport (CIFI2D) and Porto Biomechanics Laboratory (LABIOMEP-UP), Faculty of Sport, University of Porto, 4099-002 Porto, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph18041858']
1495,33672691,Immediate Effects of a Telerehabilitation Program Based on Aerobic Exercise in Women with Fibromyalgia.,"BACKGROUND


We analyzed the immediate effects of a Telerehabilitation Program (TP) based on aerobic exercise in women with fibromyalgia (FM) syndrome during the lockdown declared in Spain due to the COVID-19 pandemic.
METHODS


A single-blind randomized controlled trial was designed. Thirty-four women with FM were randomized into two groups: TP group and Control group. The intervention lasted 15 weeks, with 2 sessions per week. The TP based on aerobic exercise was guided by video and the intensity of each session was monitored using the Borg scale. Pain intensity (Visual Analogue Scale), mechanical pain sensitivity (algometer), number of tender points, FM impact (Revised Fibromyalgia Impact Questionnaire), pain catastrophizing (Pain Catastrophizing Scale), physiological distress (Hospital Anxiety and Depression Scale), upper (Arm Curl Test) and lower-limb physical function (6-min Walk Test) were measured at baseline and after the intervention.
RESULTS


The TP group improved pain intensity ( p  = 0.022), mechanical pain sensitivity ( p  < 0.05), and psychological distress ( p  = 0.005), compared to the Control group. The Control group showed no statistically significant changes in any variable ( p  > 0.05).
CONCLUSIONS


A TP based on aerobic exercise achieved improvements on pain intensity, mechanical pain sensitivity, and psychological distress compared to a Control group during the lockdown declared in Spain due to COVID-19 pandemic.",2021,"A TP based on aerobic exercise achieved improvements on pain intensity, mechanical pain sensitivity, and psychological distress compared to a Control group during the lockdown declared in Spain due to COVID-19 pandemic.","['women with fibromyalgia (FM) syndrome during the lockdown declared in Spain due to the COVID-19 pandemic', 'Women with Fibromyalgia', 'Thirty-four women with FM']","['Telerehabilitation Program (TP) based on aerobic exercise', 'Telerehabilitation Program Based on Aerobic Exercise', 'aerobic exercise', 'TP group and Control group']","['mechanical pain sensitivity', 'pain intensity', 'Pain intensity (Visual Analogue Scale), mechanical pain sensitivity (algometer), number of tender points, FM impact (Revised Fibromyalgia Impact Questionnaire), pain catastrophizing (Pain Catastrophizing Scale), physiological distress (Hospital Anxiety and Depression Scale), upper (Arm Curl Test) and lower-limb physical function (6-min Walk Test', 'pain intensity, mechanical pain sensitivity, and psychological distress', 'psychological distress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",34.0,0.0872216,"A TP based on aerobic exercise achieved improvements on pain intensity, mechanical pain sensitivity, and psychological distress compared to a Control group during the lockdown declared in Spain due to COVID-19 pandemic.","[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Hernando-Garijo', 'Affiliation': 'Department of Surgery, Ophthalmology and Physiotherapy, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ceballos-Laita', 'Affiliation': 'Department of Surgery, Ophthalmology and Physiotherapy, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Mingo-Gómez', 'Affiliation': 'Department of Surgery, Ophthalmology and Physiotherapy, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Medrano-de-la-Fuente', 'Affiliation': 'Department of Surgery, Ophthalmology and Physiotherapy, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Estébanez-de-Miguel', 'Affiliation': 'Department of Physiatrist and Nursery, Faculty of Health Science, University of Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'María Natividad', 'Initials': 'MN', 'LastName': 'Martínez-Pérez', 'Affiliation': 'Physical and Rehabilitation Department, Santa Barbara Clinical Hospital, 42004 Soria, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jiménez-Del-Barrio', 'Affiliation': 'Department of Surgery, Ophthalmology and Physiotherapy, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18042075']
1496,33672550,A School-Based Randomized Controlled Trial to Promote Cycling to School in Adolescents: The PACO Study.,"This manuscript describes the rationale and protocol of a school-based randomized controlled trial called ""Cycling and Walk to School"" (PACO, by its Spanish acronym) that aims to promote cycling to and from school and physical activity (PA) in adolescents. This study will examine the effects of this intervention in cycling and active commuting to and from school (ACS), PA and several ACS-related factors based on self-determination theory (SDT) and a social-ecological model (SEM). A total of 360 adolescents attending six high schools (three experimental and three control) from three Spanish cities will participate in this randomized controlled trial. The intervention (four cycling sessions; 1-2 h per session, one session per week) will be conducted by the research staff; the control group will continue their usual activities. PA levels will be measured by accelerometers, whereas ACS and the other study variables will be self-reported using questionnaires at baseline and post-intervention. The primary outcomes will be: rates of cycling to school, ACS and PA levels. In addition, SDT-related variables and individual, interpersonal, community, and environment variables relevant to ACS will be based on SEM. The findings will provide a comprehensive understanding of the short-term effects of this school-based intervention on cycling to school behaviour, ACS and PA levels in Spanish adolescents.",2021,"The findings will provide a comprehensive understanding of the short-term effects of this school-based intervention on cycling to school behaviour, ACS and PA levels in Spanish adolescents.","['Spanish adolescents', 'Adolescents', 'adolescents', '360 adolescents attending six high schools (three experimental and three control) from three Spanish cities']",[],"['rates of cycling to school, ACS and PA levels', 'PA levels']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",360.0,0.0407529,"The findings will provide a comprehensive understanding of the short-term effects of this school-based intervention on cycling to school behaviour, ACS and PA levels in Spanish adolescents.","[{'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Chillón', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gálvez-Fernández', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Huertas-Delgado', 'Affiliation': '""La Inmaculada"" Teacher Training Centre, University of Granada, 18013 Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Herrador-Colmenero', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Education and Sport Sciences, University of Granada, 52005 Melilla, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Education and Sport Sciences, University of Granada, 52005 Melilla, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Aranda-Balboa', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Romina Gisele', 'Initials': 'RG', 'LastName': 'Saucedo-Araujo', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Campos-Garzón', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Molina-Soberanes', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Segura-Díaz', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodríguez-Rodríguez', 'Affiliation': 'IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, 2374631 Valparaíso, Chile.'}, {'ForeName': 'Amador Jesús', 'Initials': 'AJ', 'LastName': 'Lara-Sánchez', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Queralt', 'Affiliation': 'AFIPS Research Group, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Molina-García', 'Affiliation': 'AFIPS Research Group, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Enrique García', 'Initials': 'EG', 'LastName': 'Bengoechea', 'Affiliation': 'Physical Activity for Health, Health Research Institute, Department of Physical Education & Sport Sciences, University of Limerick, V94 T9PX Limerick, Ireland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Mandic', 'Affiliation': 'School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, Private Bag 92006, 1142 Auckland, New Zealand.'}]",International journal of environmental research and public health,['10.3390/ijerph18042066']
1497,33672531,Determining the Optimal Workrate for Cycle Ergometer Verification Phase Testing in Males with Obesity.,"The aim of the present study was to assess the validity of verification phase (VP) testing and a 3 min all-out test to determine critical power (CP) in males with obesity. Nine young adult males with a body mass index (BMI) ≥ 30 kg·m -2  completed a cycle ergometer ramp-style VO 2max  test, four randomized VP tests at 80, 90, 100, and 105% of maximum wattage attained during the ramp test, and a 3 min all-out test. There was a significant main effect for VO 2max  across all five tests ( p  = 0.049). Individually, 8 of 9 participants attained a higher VO 2max  (L/min) during a VP test compared to the ramp test. A trend ( p  = 0.06) was observed for VO 2max  during the 90% VP test (3.61 ± 0.54 L/min) when compared to the ramp test (3.37 ± 0.39 L/min). A significantly higher VO 2max  ( p  = 0.016) was found in the VP tests that occurred below 130% of CP wattage (N = 15, VO 2max  = 3.76 ± 0.52 L/min) compared to those that were above (N = 21, VO 2max  = 3.36 ± 0.41 L/min). Our findings suggest submaximal VP tests at 90% may elicit the highest VO 2max  in males with obesity and there may be merit in using % of CP wattage to determine optimal VP intensity.",2021,"A significantly higher VO 2max  ( p  = 0.016) was found in the VP tests that occurred below 130% of CP wattage (N = 15, VO 2max  = 3.76 ± 0.52 L/min) compared to those that were above (N = 21, VO 2max  = 3.36 ± 0.41 L/min).","['30 kg·m -2', 'Nine young adult males with a body mass index ', 'males with obesity', 'Males with Obesity']",[],['VO 2max'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],[],9.0,0.0249671,"A significantly higher VO 2max  ( p  = 0.016) was found in the VP tests that occurred below 130% of CP wattage (N = 15, VO 2max  = 3.76 ± 0.52 L/min) compared to those that were above (N = 21, VO 2max  = 3.36 ± 0.41 L/min).","[{'ForeName': 'Jenny M', 'Initials': 'JM', 'LastName': 'Mahoney', 'Affiliation': 'Departments of Biology, Point Loma Nazarene University, San Diego, CA 92106, USA.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Baughman', 'Affiliation': 'Department of Kinesiology, Point Loma Nazarene University, San Diego, CA 92106, USA.'}, {'ForeName': 'Ailish C', 'Initials': 'AC', 'LastName': 'Sheard', 'Affiliation': 'School of Kinesiology, Nutrition and Food Sciences, California State University Los Angeles, Los Angeles, CA 90032, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Sawyer', 'Affiliation': 'Departments of Biology, Point Loma Nazarene University, San Diego, CA 92106, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports9020030']
1498,33676886,"Efficacy of a Centralized, Blended Electronic and Human Intervention to Improve Direct Oral Anticoagulant Adherence: Smartphones to improve rivaroxaban ADHEREnce in Atrial Fibrillation (SmartADHERE) A Randomized Clinical Trial: SmartADHERE rivaroxaban adherence trial.","BACKGROUND


Improving adherence to direct oral anticoagulants (DOAC) is challenging, and simple text messaging reminders have not been effective.
METHODS


SmartADHERE was a randomized trial that tested a personalized digital and human direct oral anticoagulant adherence intervention compared to usual care. Eligibility required age ≥ 18, newly-prescribed (≤ 90 days) rivaroxaban for atrial fibrillation (AF), 1 of 4 at-risk criteria for nonadherence, and a smartphone. The intervention consisted of combination of a medication management smartphone app, daily app-based reminders, adaptive text messaging, and phone-based counseling for severe nonadherence. The primary outcome was the proportion of days covered by rivaroxaban (PDC) at 6 months. There were 25 U.S. sites, all cardiology and electrophysiology outpatient practices, activated for a target sample size of 378, but the study was terminated by the sponsor prior to reaching target enrollment.
RESULTS


There were 139 participants (age 65±9.6 years, 30% female, median CHA 2 DS 2 -VASc score 3 with IQR 2-4, mean total medication burden 7.7±4.4). DOAC adherence was high in both arms with no difference in the primary outcome (PDC 0.86±0.25 intervention vs 0.88±0.25 control, p=0.62) or in secondary outcomes including PDC ≥ 0.80 and medication persistence. Per protocol analyses had similar results. Because of the high overall PDC, the likelihood to answer the primary hypothesis was only 51% even if target enrollment were achieved. There were no study-related adverse events.
CONCLUSIONS


The use of a centralized digital and human adherence intervention was feasible across multiple sites. Overall adherence was much higher than expected despite pre-screening for at-risk individuals. SmartADHERE illustrates the challenges of trials of behavioral and technology interventions, where enrollment itself may lead to selection bias or treatment effects. Pragmatic study designs, such as cluster randomization or stepped-wedge implementation, should be considered to improve enrollment and generalizability.",2021,"DOAC adherence was high in both arms with no difference in the primary outcome (PDC 0.86±0.25 intervention vs 0.88±0.25 control, p=0.62) or in secondary outcomes including PDC ≥ 0.80 and medication persistence.","['Atrial Fibrillation (SmartADHERE', '139 participants (age 65±9.6 years, 30% female, median CHA 2 DS 2 -VASc score 3 with IQR 2-4, mean total medication burden 7.7±4.4', 'for atrial fibrillation (AF), 1 of 4 at-risk criteria for nonadherence, and a smartphone']","['Centralized, Blended Electronic and Human Intervention', 'centralized digital and human adherence intervention', 'rivaroxaban', 'medication management smartphone app, daily app-based reminders, adaptive text messaging, and phone-based counseling', 'personalized digital and human direct oral anticoagulant adherence intervention']","['Direct Oral Anticoagulant Adherence', 'proportion of days covered by rivaroxaban (PDC', 'DOAC adherence', 'Overall adherence']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.162486,"DOAC adherence was high in both arms with no difference in the primary outcome (PDC 0.86±0.25 intervention vs 0.88±0.25 control, p=0.62) or in secondary outcomes including PDC ≥ 0.80 and medication persistence.","[{'ForeName': 'Mintu', 'Initials': 'M', 'LastName': 'Turakhia', 'Affiliation': 'Center for Digital Health, Stanford University School of Medicine, Stanford CA;; VA Palo Alto Health Care System, Palo Alto, CA;. Electronic address: mintu@stanford.edu.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sundaram', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford CA.'}, {'ForeName': 'Shea N', 'Initials': 'SN', 'LastName': 'Smith', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford CA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ding', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford CA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Michael Ho', 'Affiliation': 'VA Eastern Colorado Health Care System, Denver, CO.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Kowey', 'Affiliation': 'Lankenau Heart Institute and the Jefferson Medical College, Philadelphia, PA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Duke University, Durham, CA.'}, {'ForeName': 'JoAnne', 'Initials': 'J', 'LastName': 'Foody', 'Affiliation': 'Janssen Inc, Raritan, NJ.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Birmingham', 'Affiliation': 'Janssen Inc, Raritan, NJ.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Ianus', 'Affiliation': 'Janssen Inc, Raritan, NJ.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Rajmane', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford CA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2021.02.023']
1499,33676882,Effect of oral steroids on olfactory function in chronic rhinosinusitis with nasal polyps.,"AIMS


The present study aimed to investigate the effects of oral steroids on olfactory disturbances in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
MATERIAL AND METHODS


This is a prospective randomized non-blinded study. Selected CRSwNP patients (n=140), with hyposmia, were devided into two groups; group A received a 7-day course of oral steroids with a 12-weeks course of nasal steroids and douching; group B received a 12-weeks course of nasal steroids and douching. Assessment included Sniffin' Sticks scores, visual analogue scale score for olfaction and discomfort (VASsmell, VASdis), the Sinonasal Outcome Test-22, Greek-version (SNOT22-Gr) and the endoscopic appearance (EAS).
OBJECTIVES


The main objective was to compare the olfactory effect of the different therapy in group A and group B, at 2, 12 and 24 weeks. Accessory objectives included the comparison of EAS, VASdis and SNOT22-Gr between groups, the evaluation of the therapeutic outcome duration, and, the investigation of potential correlation between the evaluated parameters.
RESULTS


The 2-weeks evaluation showed a significant statistical difference (P<0.001) for all parameters except VASdis. Olfactory outcomes (Sniffin' Sticks and VASsmell scale scores) were found significantly better in group A at the 24-weeks evaluation (P<0.001). Within groups, the therapeutic result remained stable between the 12-weeks and 24-weeks evaluation (P>0.05). Sniffin' Sticks score was strongly correlated at 12-weeks evaluation with EAS (rho=0.58, P<0.001).
CONCLUSION


Our results suggest that a combination treatment of oral and nasal steroids in well-selected patients with CRSwNP may result in early olfaction restoration with a possible long-term effect.",2021,Olfactory outcomes (Sniffin' Sticks and VASsmell scale scores) were found significantly better in group A at the 24-weeks evaluation (P<0.001).,"['chronic rhinosinusitis with nasal polyps', 'patients with chronic rhinosinusitis with nasal polyps (CRSwNP', 'Selected CRSwNP patients (n=140), with hyposmia']","['oral steroids', 'oral steroids with a 12-weeks course of nasal steroids and douching; group B received a 12-weeks course of nasal steroids and douching']","['olfactory effect', 'olfactory function', ""Sniffin' Sticks scores, visual analogue scale score for olfaction and discomfort (VASsmell, VASdis), the Sinonasal Outcome Test-22, Greek-version (SNOT22-Gr) and the endoscopic appearance (EAS"", ""Sniffin' Sticks score"", 'olfactory disturbances', ""Olfactory outcomes (Sniffin' Sticks and VASsmell scale scores""]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C2936784', 'cui_str': 'Douching'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0260585,Olfactory outcomes (Sniffin' Sticks and VASsmell scale scores) were found significantly better in group A at the 24-weeks evaluation (P<0.001).,"[{'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Papadakis', 'Affiliation': 'ENT Department, Chania General Hospital, Chania, Crete, Greece.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Chimona', 'Affiliation': 'ENT Department, Chania General Hospital, Chania, Crete, Greece.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chaidas', 'Affiliation': 'ENT Department, John-Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ladias', 'Affiliation': 'ENT Department, Chania General Hospital, Chania, Crete, Greece.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zisoglou', 'Affiliation': 'ENT Department, Chania General Hospital, Chania, Crete, Greece.'}, {'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Proimos', 'Affiliation': 'ENT Department, Chania General Hospital, Chania, Crete, Greece. Electronic address: efklidispr@hotmail.com.'}]","European annals of otorhinolaryngology, head and neck diseases",['10.1016/j.anorl.2020.06.028']
1500,33676866,Good health-related quality-of-life and high patient-reported satisfaction after delayed breast reconstruction with pedicled flaps from the back.,"BACKGROUND


This paper presents the results of a randomized controlled trial (RCT) that focus on health-related quality-of-life (QoL) and patient-reported satisfaction following breast reconstruction with pedicled flaps from the back.
MATERIALS & METHODS


We included women for unilateral delayed breast reconstruction. Patients were randomized to reconstruction by either a latissimus dorsi (LD) flap or a thoracodorsal artery perforator (TAP) flap. Assessment of QoL and patient satisfaction was made using two different patient-reported outcome measures (PROMs): The EORTC QLQ-30 and the Breast-Q questionnaire for post-mastectomy breast reconstruction.
RESULTS


A total of 50 women were enrolled over a two-year period and allocated to reconstruction. Forty patients completed both surgery and follow-up and were included in the analysis - 18 in the LD group and 22 in the TAP group. The EORTC QLQ-30 was administered at the baseline and at one-year follow-up. There was no significant effect of introducing the TAP flap on either the summary score, the global QoL-score or the financial impact-score when compared to the LD flap. The Breast-Q questionnaire was administered only at one-year follow-up. There was no significant difference between the two groups for the scores for satisfaction with the reconstructed breast, the overall outcome and QoL related to psycho-social, sexual and physical well-being.
CONCLUSION


Women from both groups report high satisfaction and QoL following the reconstruction. The quality of the dataset and the study design are, however, insufficient to rule out any existing difference. A larger cohort, longer follow-up and different design are warranted to assess the true clinical significance these reconstructions might have on satisfaction and QoL.",2020,"There was no significant difference between the two groups for the scores for satisfaction with the reconstructed breast, the overall outcome and QoL related to psycho-social, sexual and physical well-being.
","['Forty patients completed both surgery and follow-up and were included in the analysis - 18 in the LD group and 22 in the TAP group', 'We included women for unilateral delayed breast reconstruction', 'A total of 50 women were enrolled over a two-year period and allocated to reconstruction']",['latissimus dorsi (LD) flap or a thoracodorsal artery perforator (TAP) flap'],"['Assessment of QoL and patient satisfaction', 'global QoL-score or the financial impact-score', 'Good health-related quality-of-life', 'scores for satisfaction with the reconstructed breast, the overall outcome and QoL related to psycho-social, sexual and physical well-being']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0224362', 'cui_str': 'Structure of latissimus dorsi muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0182209', 'cui_str': 'Perforator'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0224362', 'cui_str': 'Structure of latissimus dorsi muscle'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0182209', 'cui_str': 'Perforator'}]","[{'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",50.0,0.0444776,"There was no significant difference between the two groups for the scores for satisfaction with the reconstructed breast, the overall outcome and QoL related to psycho-social, sexual and physical well-being.
","[{'ForeName': 'Mikkel Børsen', 'Initials': 'MB', 'LastName': 'Rindom', 'Affiliation': 'Department of Plastic Surgery, Lillebaelt Hospital, Vejle, Denmark; OPEN, Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark. Electronic address: mikkoc@rm.dk.'}, {'ForeName': 'Gudjon L', 'Initials': 'GL', 'LastName': 'Gunnarsson', 'Affiliation': 'Department of Plastic Surgery, Telemark Hospital, Skien, Norway.'}, {'ForeName': 'Marianne D', 'Initials': 'MD', 'LastName': 'Lautrup', 'Affiliation': 'Department of Breast Surgery, Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Tos', 'Affiliation': 'Department of Plastic Surgery, Herlev & Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Professor Lisbet R', 'Initials': 'PLR', 'LastName': 'Hölmich', 'Affiliation': 'Department of Plastic Surgery, Herlev & Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Professor Jens A', 'Initials': 'PJA', 'LastName': 'Sørensen', 'Affiliation': 'Department of Plastic Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jørn B', 'Initials': 'JB', 'LastName': 'Thomsen', 'Affiliation': 'Department of Plastic Surgery, Lillebaelt Hospital, Vejle, Denmark; Department of Plastic Surgery, Odense University Hospital, Odense, Denmark.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2020.12.019']
1501,33676840,Ocular microbiota and lens contamination following Mel4 peptide-coated antimicrobial contact lens (MACL) extended wear.,"PURPOSE


The purpose of this study was to investigate the effect of Mel4 antimicrobial peptide-coated contact lenses (MACL) on the microbiota of the conjunctiva and lenses during three months of extended wear.
METHODS


One hundred and seventy-six participants were recruited into a randomised, contralateral, double masked, biweekly extended wear MACL and uncoated control lens trial. At the one month and 3-month visit, the conjunctival microbiota was sampled using sterile cotton swabs and contact lenses were collected aseptically. Standard microbiological procedures were employed for culture of the swabs and contact lenses and identification of the isolated microorganisms.
RESULTS


Gram-positive bacteria (predominantly coagulase-negative staphylococci) were the most frequently isolated microbes from both contact lenses and conjunctiva. There was no difference in the frequency of isolation of most bacteria or fungi from the conjunctival swabs of eyes wearing either MACL or control lenses. The only exception was a higher frequency of eyes harbouring Staphylococcus arlettae when wearing control lenses (5%) versus MACL (<1%) (p = 0.002). There was no significant difference in the frequency of microbes isolated from MACL or control contact lenses. There were also no differences between lens types in the frequency of isolation of >1 microbial type per sampling occasion for either conjunctiva swabs or contact lenses.
CONCLUSION


MACL wear did not change the conjunctival microbiota during extended wear, and the types of microbes isolated from MACL were similar to those isolated from control lenses.",2021,There was no difference in the frequency of isolation of most bacteria or fungi from the conjunctival swabs of eyes wearing either MACL or control lenses.,['One hundred and seventy-six participants'],"['Mel4 antimicrobial peptide-coated contact lenses (MACL', 'MACL', 'Mel4 peptide-coated antimicrobial contact lens (MACL']","['higher frequency of eyes harbouring Staphylococcus arlettae', 'conjunctival microbiota', 'Ocular microbiota and lens contamination', 'frequency of isolation of most bacteria']","[{'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0318133', 'cui_str': 'Staphylococcus arlettae'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",176.0,0.0365831,There was no difference in the frequency of isolation of most bacteria or fungi from the conjunctival swabs of eyes wearing either MACL or control lenses.,"[{'ForeName': 'Parthasarathi', 'Initials': 'P', 'LastName': 'Kalaiselvan', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Australia. Electronic address: p.kalaiselvan@unsw.edu.au.'}, {'ForeName': 'Debarun', 'Initials': 'D', 'LastName': 'Dutta', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Australia; Optometry and Vision Science Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Bhombal', 'Affiliation': 'Bausch & Lomb Contact Lens Centre, L V Prasad Eye Institute, Hyderabad, India.'}, {'ForeName': 'Nagaraju', 'Initials': 'N', 'LastName': 'Konda', 'Affiliation': 'School of Medical Sciences, University of Hyderabad, Hyderabad, India.'}, {'ForeName': 'Pravin Krishna', 'Initials': 'PK', 'LastName': 'Vaddavalli', 'Affiliation': 'Bausch & Lomb Contact Lens Centre, L V Prasad Eye Institute, Hyderabad, India; The Cornea Institute, L V Prasad Eye Institute, Hyderabad, India.'}, {'ForeName': 'Savitri', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Jhaveri Microbiology Centre, L V Prasad Eye Institute, Hyderabad, India.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stapleton', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Australia.'}, {'ForeName': 'Mark D P', 'Initials': 'MDP', 'LastName': 'Willcox', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Australia.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2021.02.017']
1502,33676601,"Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial.","BACKGROUND


Pembrolizumab showed durable antitumour activity and manageable safety in metastatic triple-negative breast cancer in the single-arm KEYNOTE-012 and KEYNOTE-086 trials. In this study, we compared pembrolizumab with chemotherapy for second-line or third-line treatment of patients with metastatic triple-negative breast cancer.
METHODS


KEYNOTE-119 was a randomised, open-label, phase 3 trial done at 150 medical centres (academic medical centres, community cancer centres, and community hospitals) in 31 countries. Patients aged 18 years or older, with centrally confirmed metastatic triple-negative breast cancer, Eastern Cooperative Oncology Group performance status of 0 or 1, who had received one or two previous systemic treatments for metastatic disease, had progression on their most recent therapy, and had previous treatment with an anthracycline or taxane were eligible. Patients were randomly assigned (1:1) using a block method (block size of four) and an interactive voice-response system with integrated web-response to receive intravenous pembrolizumab 200 mg once every 3 weeks for 35 cycles (pembrolizumab group), or to single-drug chemotherapy per investigator's choice of capecitabine, eribulin, gemcitabine, or vinorelbine (60% enrolment cap for each; chemotherapy group). Randomisation was stratified by PD-L1 tumour status (positive [combined positive score (CPS) ≥1] vs negative [CPS <1]) and history of previous neoadjuvant or adjuvant treatment versus de-novo metastatic disease at initial diagnosis. Primary endpoints were overall survival in participants with a PD-L1 combined positive score (CPS) of 10 or more, those with a CPS of 1 or more, and all participants; superiority of pembrolizumab versus chemotherapy was tested in all participants only if shown in those with a CPS of one or more. The primary endpoint was analysed in the intention-to-treat population; safety was analysed in the all-subjects-as-treated population. This Article describes the final analysis of the trial, which is now completed. This trial is registered with ClinicalTrials.gov, number NCT02555657.
FINDINGS


From Nov 25, 2015, to April 11, 2017, 1098 participants were assessed for eligibility and 622 (57%) were randomly assigned to receive either pembrolizumab (312 [50%]) or chemotherapy (310 [50%]). Median study follow-up was 31·4 months (IQR 27·8-34·4) for the pembrolizumab group and 31·5 months (27·8-34·6) for the chemotherapy group. Median overall survival in patients with a PD-L1 CPS of 10 or more was 12·7 months (95% CI 9·9-16·3) for the pembrolizumab group and 11·6 months (8·3-13·7) for the chemotherapy group (hazard ratio [HR] 0·78 [95% CI 0·57-1·06]; log-rank p=0·057). In participants with a CPS of 1 or more, median overall survival was 10·7 months (9·3-12·5) for the pembrolizumab group and 10·2 months (7·9-12·6) for the chemotherapy group (HR 0·86 [95% CI 0·69-1·06]; log-rank p=0·073). In the overall population, median overall survival was 9·9 months (95% CI 8·3-11·4) for the pembrolizumab group and 10·8 months (9·1-12·6) for the chemotherapy group (HR 0·97 [95% CI 0·82-1·15]). The most common grade 3-4 treatment-related adverse events were anaemia (three [1%] patients in the pembrolizumab group vs ten [3%] in the chemotherapy group), decreased white blood cells (one [<1%] vs 14 [5%]), decreased neutrophil count (one [<1%] vs 29 [10%]), and neutropenia (0 vs 39 [13%]). 61 (20%) patients in the pembrolizumab group and 58 (20%) patients in the chemotherapy group had serious adverse events. Three (<1%) of 601 participants had treatment-related adverse events that led to death (one [<1%] in the pembrolizumab group due to circulatory collapse; two [1%] in the chemotherapy group, one [<1%] due to pancytopenia and sepsis and one [<1%] haemothorax).
INTERPRETATION


Pembrolizumab did not significantly improve overall survival in patients with previously treated metastatic triple-negative breast cancer versus chemotherapy. These findings might inform future research of pembrolizumab monotherapy for selected subpopulations of patients, specifically those with PD-L1-enriched tumours, and inform a combinatorial approach for the treatment of patients with metastatic triple-negative breast cancer.
FUNDING


Merck Sharp & Dohme.",2021,"INTERPRETATION


Pembrolizumab did not significantly improve overall survival in patients with previously treated metastatic triple-negative breast cancer versus chemotherapy.","['metastatic triple-negative breast cancer (KEYNOTE-119', 'HR 0·97', '150 medical centres (academic medical centres, community cancer centres, and community hospitals) in 31 countries', 'Patients aged 18 years or older, with centrally confirmed metastatic triple-negative breast cancer, Eastern Cooperative Oncology Group performance status of 0 or 1, who had received one or two previous systemic treatments for metastatic disease, had progression on their most recent therapy, and had previous treatment with an', 'From Nov 25, 2015, to April 11, 2017, 1098 participants were assessed for eligibility and 622 (57', 'patients with metastatic triple-negative breast cancer', 'patients with previously treated metastatic triple-negative breast cancer versus']","['anthracycline or taxane', 'pembrolizumab monotherapy', 'Pembrolizumab versus investigator-choice chemotherapy', 'pembrolizumab with chemotherapy', 'pembrolizumab', 'chemotherapy', 'pembrolizumab versus chemotherapy', ""block method (block size of four) and an interactive voice-response system with integrated web-response to receive intravenous pembrolizumab 200 mg once every 3 weeks for 35 cycles (pembrolizumab group), or to single-drug chemotherapy per investigator's choice of capecitabine, eribulin, gemcitabine, or vinorelbine""]","['PD-L1 combined positive score (CPS', 'serious adverse events', 'Median overall survival', 'circulatory collapse', 'white blood cells', 'durable antitumour activity and manageable safety', 'median overall survival', 'neutrophil count', 'intention-to-treat population; safety', 'neutropenia', 'death', 'overall survival']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1098.0,0.382782,"INTERPRETATION


Pembrolizumab did not significantly improve overall survival in patients with previously treated metastatic triple-negative breast cancer versus chemotherapy.","[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Division of Breast Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: eric_winer@dfci.harvard.edu.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Lipatov', 'Affiliation': 'Medical Oncology, Republican Clinical Oncology Dispensary, Ufa, Republic of Bashkortostan, Russia.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Internal Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Goncalves', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Centre de Recherche en Cancérologie de Marseille, Aix-Marseille University, Centre National de la Recherche Scientifique, French National Institute of Health and Medical Research, Marseille, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muñoz-Couselo', 'Affiliation': ""International Breast Cancer Center, Quiron Group, Madrid and Barcelona, Spain; Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University London, London, UK.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Testa', 'Affiliation': 'Breast Medical Oncology, Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina da Universidade do Estado do São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Witzel', 'Affiliation': 'Department of Gynaecology, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Ohtani', 'Affiliation': 'Surgical Oncology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Breast Unit, Royal Marsden National Health Service Foundation Trust, London, UK.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Zambelli', 'Affiliation': 'Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Ludwig-Maximilians-University, University Hospital, Munich, Germany.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Andre', 'Affiliation': 'Faculté de Medicine Paris-Sud XI, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dent', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Division of Medical Oncology, Merck, Kenilworth, NJ, USA.'}, {'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Karantza', 'Affiliation': 'Division of Medical Oncology, Merck, Kenilworth, NJ, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Mejia', 'Affiliation': 'Division of Medical Oncology, Merck, Kenilworth, NJ, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""International Breast Cancer Center, Quiron Group, Madrid and Barcelona, Spain; Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30754-3']
1503,33676597,"Azithromycin for community treatment of suspected COVID-19 in people at increased risk of an adverse clinical course in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial.","BACKGROUND


Azithromycin, an antibiotic with potential antiviral and anti-inflammatory properties, has been used to treat COVID-19, but evidence from community randomised trials is lacking. We aimed to assess the effectiveness of azithromycin to treat suspected COVID-19 among people in the community who had an increased risk of complications.
METHODS


In this UK-based, primary care, open-label, multi-arm, adaptive platform randomised trial of interventions against COVID-19 in people at increased risk of an adverse clinical course (PRINCIPLE), we randomly assigned people aged 65 years and older, or 50 years and older with at least one comorbidity, who had been unwell for 14 days or less with suspected COVID-19, to usual care plus azithromycin 500 mg daily for three days, usual care plus other interventions, or usual care alone. The trial had two coprimary endpoints measured within 28 days from randomisation: time to first self-reported recovery, analysed using a Bayesian piecewise exponential, and hospital admission or death related to COVID-19, analysed using a Bayesian logistic regression model. Eligible participants with outcome data were included in the primary analysis, and those who received the allocated treatment were included in the safety analysis. The trial is registered with ISRCTN, ISRCTN86534580.
FINDINGS


The first participant was recruited to PRINCIPLE on April 2, 2020. The azithromycin group enrolled participants between May 22 and Nov 30, 2020, by which time 2265 participants had been randomly assigned, 540 to azithromycin plus usual care, 875 to usual care alone, and 850 to other interventions. 2120 (94%) of 2265 participants provided follow-up data and were included in the Bayesian primary analysis, 500 participants in the azithromycin plus usual care group, 823 in the usual care alone group, and 797 in other intervention groups. 402 (80%) of 500 participants in the azithromycin plus usual care group and 631 (77%) of 823 participants in the usual care alone group reported feeling recovered within 28 days. We found little evidence of a meaningful benefit in the azithromycin plus usual care group in time to first reported recovery versus usual care alone (hazard ratio 1·08, 95% Bayesian credibility interval [BCI] 0·95 to 1·23), equating to an estimated benefit in median time to first recovery of 0·94 days (95% BCI -0·56 to 2·43). The probability that there was a clinically meaningful benefit of at least 1·5 days in time to recovery was 0·23. 16 (3%) of 500 participants in the azithromycin plus usual care group and 28 (3%) of 823 participants in the usual care alone group were hospitalised (absolute benefit in percentage 0·3%, 95% BCI -1·7 to 2·2). There were no deaths in either study group. Safety outcomes were similar in both groups. Two (1%) of 455 participants in the azothromycin plus usual care group and four (1%) of 668 participants in the usual care alone group reported admission to hospital during the trial, not related to COVID-19.
INTERPRETATION


Our findings do not justify the routine use of azithromycin for reducing time to recovery or risk of hospitalisation for people with suspected COVID-19 in the community. These findings have important antibiotic stewardship implications during this pandemic, as inappropriate use of antibiotics leads to increased antimicrobial resistance, and there is evidence that azithromycin use increased during the pandemic in the UK.
FUNDING


UK Research and Innovation and UK Department of Health and Social Care.",2021,"We found little evidence of a meaningful benefit in the azithromycin plus usual care group in time to first reported recovery versus usual care alone (hazard ratio 1·08, 95% Bayesian credibility interval [BCI] 0·95 to 1·23), equating to an estimated benefit in median time to first recovery of 0·94 days (95% BCI -0·56 to 2·43).","['people at increased risk of an adverse clinical course (PRINCIPLE), we randomly assigned people aged 65 years and older, or 50 years and older with at least one comorbidity, who had been unwell for 14 days or less with suspected COVID-19, to usual care plus', '402 (80%) of 500 participants in the azithromycin plus usual care group and 631 (77%) of 823 participants in the usual care', 'people in the community who had an increased risk of complications', 'group enrolled participants between May 22 and Nov 30, 2020, by which time 2265 participants had been randomly assigned, 540 to', 'Eligible participants with outcome data were included in the primary analysis, and those who received the allocated treatment were included in the safety analysis', '16', '2120 (94%) of 2265 participants provided follow-up data and were included in the Bayesian primary analysis, 500 participants in the azithromycin plus usual care group, 823 in the usual care alone group, and 797 in other intervention groups', '455 participants in the azothromycin plus usual care group and four (1%) of 668 participants in the']","['Azithromycin', 'azithromycin plus usual care, 875 to usual care alone, and 850 to other interventions', 'azithromycin', 'usual care alone', 'azithromycin 500 mg daily for three days, usual care plus other interventions, or usual care alone']","['time to recovery or risk of hospitalisation', 'Safety outcomes', 'admission to hospital', 'randomisation: time to first self-reported recovery, analysed using a Bayesian piecewise exponential, and hospital admission or death related to COVID-19, analysed using a Bayesian logistic regression model']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517897', 'cui_str': '875'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1126333', 'cui_str': 'Azithromycin 500 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",2265.0,0.171889,"We found little evidence of a meaningful benefit in the azithromycin plus usual care group in time to first reported recovery versus usual care alone (hazard ratio 1·08, 95% Bayesian credibility interval [BCI] 0·95 to 1·23), equating to an estimated benefit in median time to first recovery of 0·94 days (95% BCI -0·56 to 2·43).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)00461-X']
1504,33676596,"Antibacterial mouthwash to prevent sexually transmitted infections in men who have sex with men taking HIV pre-exposure prophylaxis (PReGo): a randomised, placebo-controlled, crossover trial.","BACKGROUND


Bacterial sexually transmitted infections (STIs) are highly prevalent among men who have sex with men who use HIV pre-exposure prophylaxis (PrEP), which leads to antimicrobial consumption linked to the emergence of antimicrobial resistance. We aimed to assess use of an antiseptic mouthwash as an antibiotic sparing approach to prevent STIs.
METHODS


We invited people using PrEP who had an STI in the past 24 months to participate in this single-centre, randomised, double-blind, placebo-controlled, AB/BA crossover superiority trial at the Institute of Tropical Medicine in Antwerp, Belgium. Using block randomisation (block size eight), participants were assigned (1:1) to first receive Listerine Cool Mint or a placebo mouthwash. They were required to use the study mouthwashes daily and before and after sex for 3 months each and to ask their sexual partners to use the mouthwash before and after sex. Participants were screened every 3 months for syphilis, chlamydia, and gonorrhoea at the oropharynx, anorectum, and urethra. The primary outcome was combined incidence of these STIs during each 3-month period, assessed in the intention-to-treat population, which included all participants who completed at least the first 3-month period. Safety was assessed as a secondary outcome. This trial is registered with Clinicaltrials.gov, NCT03881007.
FINDINGS


Between April 2, 2019, and March 13, 2020, 343 participants were enrolled: 172 in the Listerine followed by placebo (Listerine-placebo) group and 171 in the placebo followed by Listerine (placebo-Listerine) group. The trial was terminated prematurely because of the COVID-19 pandemic. 151 participants completed the entire study, and 89 completed only the first 3-month period. 31 participants withdrew consent, ten were lost to follow-up, and one acquired HIV. In the Listerine-placebo group, the STI incidence rate was 140·4 per 100 person-years during the Listerine period, and 102·6 per 100 person-years during the placebo period. In the placebo-Listerine arm, the STI incidence rate was 133·9 per 100 person-years during the placebo period, and 147·5 per 100 person-years during the Listerine period. We did not find that Listerine significantly reduced STI incidence (IRR 1·17, 95% CI 0·84-1·64). Numbers of adverse events were not significantly higher than at baseline and were similar while using Listerine and placebo. Four serious adverse events (one HIV-infection, one severe depression, one Ludwig's angina, and one testicular carcinoma) were not considered to be related to use of mouthwash.
INTERPRETATION


Our findings do not support the use of Listerine Cool Mint as a way to prevent STI acquisition among high-risk populations.
FUNDING


Belgian Research Foundation - Flanders (FWO 121·00).",2021,"We did not find that Listerine significantly reduced STI incidence (IRR 1·17, 95% CI 0·84-1·64).","['Between April 2, 2019, and March 13, 2020', '31 participants withdrew consent, ten were lost to follow-up, and one acquired HIV', 'men who have sex with men taking HIV pre-exposure prophylaxis (PReGo', '151 participants completed the entire study, and 89 completed only the first 3-month period', 'group and 171 in the', 'men who have sex with men who use HIV pre-exposure prophylaxis (PrEP', '343 participants were enrolled: 172 in the Listerine followed by', 'Participants were screened every 3 months for syphilis, chlamydia, and gonorrhoea at the oropharynx, anorectum, and urethra', 'invited people using PrEP who had an STI in the past 24 months to participate in this single-centre']","['placebo (Listerine-placebo', 'Listerine Cool Mint', 'placebo', 'placebo followed by Listerine (placebo-Listerine', 'Listerine Cool Mint or a placebo mouthwash', 'placebo-Listerine', 'Listerine and placebo', 'Listerine-placebo', 'antiseptic mouthwash', 'Antibacterial mouthwash']","['STI incidence rate', 'combined incidence of these STIs', 'Numbers of adverse events', 'STI incidence', 'Safety', ""Four serious adverse events (one HIV-infection, one severe depression, one Ludwig's angina, and one testicular carcinoma""]","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0065081', 'cui_str': 'Listerine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065081', 'cui_str': 'Listerine'}, {'cui': 'C0452249', 'cui_str': 'Mint'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}]","[{'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0024081', 'cui_str': ""Ludwig's angina""}, {'cui': 'C0677483', 'cui_str': 'Carcinoma testis'}]",343.0,0.639846,"We did not find that Listerine significantly reduced STI incidence (IRR 1·17, 95% CI 0·84-1·64).","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Van Dijck', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Department of Medical Microbiology, University of Antwerp, Belgium.'}, {'ForeName': 'Achilleas', 'Initials': 'A', 'LastName': 'Tsoumanis', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Department of Medical Sciences, University of Antwerp, Belgium.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Rotsaert', 'Affiliation': 'Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Vuylsteke', 'Affiliation': 'Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Van den Bossche', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Paeleman', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Irith', 'Initials': 'I', 'LastName': 'De Baetselier', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Brosius', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Jolein', 'Initials': 'J', 'LastName': 'Laumen', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Buyze', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Wouters', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Lutgarde', 'Initials': 'L', 'LastName': 'Lynen', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Van Esbroeck', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Herssens', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Abdellati', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Declercq', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Reyniers', 'Affiliation': 'Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Yven', 'Initials': 'Y', 'LastName': 'Van Herrewege', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Florence', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Kenyon', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Division of Infectious Diseases and HIV Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: ckenyon@itg.be.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30778-7']
1505,33676595,"Antiseptic mouthwash for gonorrhoea prevention (OMEGA): a randomised, double-blind, parallel-group, multicentre trial.","BACKGROUND


To address the increasing incidence of gonorrhoea and antimicrobial resistance, we compared the efficacy of Listerine and Biotène mouthwashes for preventing gonorrhoea among men who have sex with men (MSM).
METHODS


The OMEGA trial was a multicentre, parallel-group, double-blind randomised controlled trial among MSM, done at three urban sexual health clinics and one general practice clinic in Australia. Men were eligible if they were diagnosed with oropharyngeal gonorrhoea by nucleic acid amplification test (NAAT) in the previous 30 days or were aged 16-24 years. They were randomly assigned to receive Listerine (intervention) or Biotène (control) via a computer-generated sequence (1:1 ratio, block size of four). Participants, clinicians, data collectors, data analysts, and outcome adjudicators were masked to the interventions after assignment. Participants were instructed to rinse and gargle with 20 mL of mouthwash for 60 s at least once daily for 12 weeks. Oropharyngeal swabs were collected by research nurses every 6 weeks, and participants provided saliva samples every 3 weeks, to be tested for Neisseria gonorrhoeae with NAAT and quantitative PCR. The primary outcome was proportion of MSM diagnosed with oropharyngeal N gonorrhoeae infection at any point over the 12-week period, defined as a positive result for either oropharyngeal swabs or saliva samples by NAAT, and the cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit. A modified intention-to-treat analysis for the primary outcome was done that included men who provided at least one follow-up specimen over the 12-week study period. The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12616000247471).
FINDINGS


Between March 30, 2016, and Oct 26, 2018, 786 MSM were screened and 256 were excluded. 264 MSM were randomly assigned to the Biotène group and 266 to the Listerine group. The analysis population included 227 (86%) men in the Biotène group and 219 (82%) in the Listerine group. Oropharyngeal gonorrhoea was detected in ten (4%) of 227 of MSM in the Biotène group and in 15 (7%) of 219 in the Listerine group (adjusted risk difference 2·5%, 95% CI -1·8 to 6·8). The cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit did not differ between the two mouthwash groups (adjusted risk difference 3·1%, 95% CI -1·4 to 7·7).
INTERPRETATION


Listerine did not reduce the incidence of oropharyngeal gonorrhoea compared with Biotène. However, previous research suggests that mouthwash might reduce the infectivity of oropharyngeal gonorrhoea; therefore, further studies of mouthwash examining its inhibitory effect on N gonorrhoeae are warranted to determine if it has a potential role for the prevention of transmission.
FUNDING


Australian National Health and Medical Research Council.",2021,"The cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit did not differ between the two mouthwash groups (adjusted risk difference 3·1%, 95% CI -1·4 to 7·7).
","['Between March 30, 2016, and Oct 26, 2018, 786 MSM were screened and 256 were excluded', 'Men were eligible if they were diagnosed with oropharyngeal gonorrhoea by nucleic acid amplification test (NAAT) in the previous 30 days or were aged 16-24 years', 'included men who provided at least one follow-up specimen over the 12-week study period', 'urban sexual health clinics and one general practice clinic in Australia', 'The analysis population included 227 (86%) men in the Biotène group and 219 (82%) in the Listerine group', '264 MSM', 'men who have sex with men (MSM']","['Listerine (intervention) or Biotène (control) via a computer-generated sequence', 'Antiseptic mouthwash', 'rinse and gargle with 20 mL of mouthwash', 'Listerine and Biotène mouthwashes']","['cumulative incidence of oropharyngeal gonorrhoea', 'Oropharyngeal gonorrhoea', 'proportion of MSM diagnosed with oropharyngeal N gonorrhoeae infection']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0065081', 'cui_str': 'Listerine'}]","[{'cui': 'C0065081', 'cui_str': 'Listerine'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027573', 'cui_str': 'Neisseria gonorrhoeae'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",264.0,0.57534,"The cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit did not differ between the two mouthwash groups (adjusted risk difference 3·1%, 95% CI -1·4 to 7·7).
","[{'ForeName': 'Eric P F', 'Initials': 'EPF', 'LastName': 'Chow', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, VIC, Australia. Electronic address: eric.chow@monash.edu.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Hocking', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, VIC, Australia.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Law', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maddaford', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Catriona S', 'Initials': 'CS', 'LastName': 'Bradshaw', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McNulty', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales Sydney, Sydney, NSW, Australia; Sydney Sexual Health Centre, South Eastern Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Templeton', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia; Department of Sexual Health Medicine, Sydney Local Health District, Sydney, NSW, Australia; Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Moore', 'Affiliation': 'Northside Clinic, Melbourne, VIC, Australia.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Murray', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, VIC, Australia; Centre for Women's Infectious Disease Research, The Royal Women's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Danielewski', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, VIC, Australia; Centre for Women's Infectious Disease Research, The Royal Women's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wigan', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Marcus Y', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Guy', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia; China-Australia Joint Research Centre for Infectious Diseases, School of Public Health, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Donovan', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia; Sydney Sexual Health Centre, South Eastern Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Grulich', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kaldor', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Whiley', 'Affiliation': 'Pathology Queensland, Brisbane, QLD, Australia; Centre for Clinical Research, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Cornelisse', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, VIC, Australia; The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia; Kirketon Road Centre, South Eastern Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lewis', 'Affiliation': 'Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Western Sydney Sexual Health Centre, Western Sydney Local Health District, Sydney, NSW, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Tim R H', 'Initials': 'TRH', 'LastName': 'Read', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': ""Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia; China-Australia Joint Research Centre for Infectious Diseases, School of Public Health, Xi'an Jiaotong University, Xi'an, China.""}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30704-0']
1506,33676590,"Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Elevated proinflammatory cytokines are associated with greater COVID-19 severity. We aimed to assess safety and efficacy of sarilumab, an interleukin-6 receptor inhibitor, in patients with severe (requiring supplemental oxygen by nasal cannula or face mask) or critical (requiring greater supplemental oxygen, mechanical ventilation, or extracorporeal support) COVID-19.
METHODS


We did a 60-day, randomised, double-blind, placebo-controlled, multinational phase 3 trial at 45 hospitals in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain. We included adults (≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and pneumonia, who required oxygen supplementation or intensive care. Patients were randomly assigned (2:2:1 with permuted blocks of five) to receive intravenous sarilumab 400 mg, sarilumab 200 mg, or placebo. Patients, care providers, outcome assessors, and investigators remained masked to assigned intervention throughout the course of the study. The primary endpoint was time to clinical improvement of two or more points (seven point scale ranging from 1 [death] to 7 [discharged from hospital]) in the modified intention-to-treat population. The key secondary endpoint was proportion of patients alive at day 29. Safety outcomes included adverse events and laboratory assessments. This study is registered with ClinicalTrials.gov, NCT04327388; EudraCT, 2020-001162-12; and WHO, U1111-1249-6021.
FINDINGS


Between March 28 and July 3, 2020, of 431 patients who were screened, 420 patients were randomly assigned and 416 received placebo (n=84 [20%]), sarilumab 200 mg (n=159 [38%]), or sarilumab 400 mg (n=173 [42%]). At day 29, no significant differences were seen in median time to an improvement of two or more points between placebo (12·0 days [95% CI 9·0 to 15·0]) and sarilumab 200 mg (10·0 days [9·0 to 12·0]; hazard ratio [HR] 1·03 [95% CI 0·75 to 1·40]; log-rank p=0·96) or sarilumab 400 mg (10·0 days [9·0 to 13·0]; HR 1·14 [95% CI 0·84 to 1·54]; log-rank p=0·34), or in proportions of patients alive (77 [92%] of 84 patients in the placebo group; 143 [90%] of 159 patients in the sarilumab 200 mg group; difference -1·7 [-9·3 to 5·8]; p=0·63 vs placebo; and 159 [92%] of 173 patients in the sarilumab 400 mg group; difference 0·2 [-6·9 to 7·4]; p=0·85 vs placebo). At day 29, there were numerical, non-significant survival differences between sarilumab 400 mg (88%) and placebo (79%; difference +8·9% [95% CI -7·7 to 25·5]; p=0·25) for patients who had critical disease. No unexpected safety signals were seen. The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group.
INTERPRETATION


This trial did not show efficacy of sarilumab in patients admitted to hospital with COVID-19 and receiving supplemental oxygen. Adequately powered trials of targeted immunomodulatory therapies assessing survival as a primary endpoint are suggested in patients with critical COVID-19.
FUNDING


Sanofi and Regeneron Pharmaceuticals.",2021,"The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group.
","['adults (≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and pneumonia, who required oxygen supplementation or intensive care', '2020-001162-12; and WHO, U1111-1249-6021.\nFINDINGS\n\n\nBetween March 28 and July 3, 2020, of 431 patients who were screened, 420 patients were randomly assigned and 416 received', 'patients admitted to hospital with COVID-19 and receiving supplemental oxygen', '45 hospitals in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain', 'patients with critical COVID-19', 'patients with severe (requiring supplemental oxygen by nasal cannula or face mask) or critical (requiring greater supplemental oxygen, mechanical ventilation, or extracorporeal support) COVID-19', '1·03', 'patients admitted to hospital with severe or critical COVID-19']","['sarilumab 400 mg', 'sarilumab', 'sarilumab 200 mg', 'intravenous sarilumab 400 mg, sarilumab 200 mg, or placebo', 'placebo']","['proportion of patients alive', 'median time', 'rates of treatment-emergent adverse events', 'hazard ratio [HR', 'time to clinical improvement of two or more points (seven point scale ranging from 1 [death] to 7 [discharged from hospital', 'adverse events and laboratory assessments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0008107', 'cui_str': 'Chile'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",420.0,0.793895,"The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group.
","[{'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Lescure', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Infectious and Tropical Diseases Department, Bichat-Claude Bernard Hospital, INSERM, IAME, UMR 1137, University of Paris, Paris, France. Electronic address: xavier.lescure@aphp.fr.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Honda', 'Affiliation': 'Division of Infectious Diseases, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Jennifer Sloane', 'Initials': 'JS', 'LastName': 'Lazar', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Genming', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wung', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hagino', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00099-0']
1507,33676589,"Tocilizumab plus standard care versus standard care in patients in India with moderate to severe COVID-19-associated cytokine release syndrome (COVINTOC): an open-label, multicentre, randomised, controlled, phase 3 trial.","BACKGROUND


Global randomised controlled trials of the anti-IL-6 receptor antibody tocilizumab in patients admitted to hospital with COVID-19 have shown conflicting results but potential decreases in time to discharge and burden on intensive care. Tocilizumab reduced progression to mechanical ventilation and death in a trial population enriched for racial and ethnic minorities. We aimed to investigate whether tocilizumab treatment could prevent COVID-19 progression in the first multicentre randomised controlled trial of tocilizumab done entirely in a lower-middle-income country.
METHODS


COVINTOC is an open-label, multicentre, randomised, controlled, phase 3 trial done at 12 public and private hospitals across India. Adults (aged ≥18 years) admitted to hospital with moderate to severe COVID-19 (Indian Ministry of Health grading) confirmed by positive SARS-CoV-2 PCR result were randomly assigned (1:1 block randomisation) to receive tocilizumab 6 mg/kg plus standard care (the tocilizumab group) or standard care alone (the standard care group). The primary endpoint was progression of COVID-19 (from moderate to severe or from severe to death) up to day 14 in the modified intention-to-treat population of all participants who had at least one post-baseline assessment for the primary endpoint. Safety was assessed in all randomly assigned patients. The trial is completed and registered with the Clinical Trials Registry India (CTRI/2020/05/025369).
FINDINGS


180 patients were recruited between May 30, 2020, and Aug 31, 2020, and randomly assigned to the tocilizumab group (n=90) or the standard care group (n=90). One patient randomly assigned to the standard care group inadvertently received tocilizumab at baseline and was included in the tocilizumab group for all analyses. One patient randomly assigned to the standard care group withdrew consent after the baseline visit and did not receive any study medication and was not included in the modified intention-to-treat population but was still included in safety analyses. 75 (82%) of 91 in the tocilizumab group and 68 (76%) of 89 in the standard care group completed 28 days of follow-up. Progression of COVID-19 up to day 14 occurred in eight (9%) of 91 patients in the tocilizumab group and 11 (13%) of 88 in the standard care group (difference -3·71 [95% CI -18·23 to 11·19]; p=0·42). 33 (36%) of 91 patients in the tocilizumab group and 22 (25%) of 89 patients in the standard care group had adverse events; 18 (20%) and 15 (17%) had serious adverse events. The most common adverse event was acute respiratory distress syndrome, reported in seven (8%) patients in each group. Grade 3 adverse events were reported in two (2%) patients in the tocilizumab group and five (6%) patients in the standard care group. There were no grade 4 adverse events. Serious adverse events were reported in 18 (20%) patients in the tocilizumab group and 15 (17%) in the standard care group; 13 (14%) and 15 (17%) patients died during the study.
INTERPRETATION


Routine use of tocilizumab in patients admitted to hospital with moderate to severe COVID-19 is not supported. However, post-hoc evidence from this study suggests tocilizumab might still be effective in patients with severe COVID-19 and so should be investigated further in future studies.
FUNDING


Medanta Institute of Education and Research, Roche India, Cipla India, and Action COVID-19 India.",2021,Progression of COVID-19 up to day 14 occurred in eight (9%) of 91 patients in the tocilizumab group and 11 (13%) of 88 in the standard care group (difference -3·71,"['180 patients were recruited between May 30, 2020, and Aug 31, 2020', 'Adults (aged ≥18 years) admitted to hospital with moderate to severe COVID-19 (Indian Ministry of Health grading) confirmed by positive SARS-CoV-2 PCR result', 'patients in India with moderate to severe COVID-19-associated cytokine release syndrome (COVINTOC', 'patients admitted to hospital with moderate to severe COVID-19', 'patients admitted to hospital with COVID-19', 'group (n=90) or the standard care group (n=90', '12 public and private hospitals across India']","['tocilizumab 6 mg/kg plus standard care (the tocilizumab group) or standard care alone', 'Tocilizumab', 'Tocilizumab plus standard care versus standard care', 'tocilizumab', 'anti-IL-6 receptor antibody tocilizumab', 'standard care group withdrew consent after the baseline visit and did not receive any study medication']","['COVID-19 progression', 'serious adverse events', 'mechanical ventilation and death', 'Progression of COVID-19', 'progression of COVID-19 (from moderate to severe or from severe to death', 'Safety', 'Serious adverse events', 'adverse events', 'grade 4 adverse events', 'Grade 3 adverse events']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",180.0,0.146702,Progression of COVID-19 up to day 14 occurred in eight (9%) of 91 patients in the tocilizumab group and 11 (13%) of 88 in the standard care group (difference -3·71,"[{'ForeName': 'Arvinder S', 'Initials': 'AS', 'LastName': 'Soin', 'Affiliation': 'Medanta Institute of Education and Research, Medanta-The Medicity Hospital, Gurugram, Haryana, India. Electronic address: avisoin1@gmail.com.'}, {'ForeName': 'Kuldeep', 'Initials': 'K', 'LastName': 'Kumar', 'Affiliation': 'Medanta Institute of Education and Research, Medanta-The Medicity Hospital, Gurugram, Haryana, India.'}, {'ForeName': 'Narendra S', 'Initials': 'NS', 'LastName': 'Choudhary', 'Affiliation': 'Medanta Institute of Education and Research, Medanta-The Medicity Hospital, Gurugram, Haryana, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Medanta Institute of Education and Research, Medanta-The Medicity Hospital, Gurugram, Haryana, India.'}, {'ForeName': 'Yatin', 'Initials': 'Y', 'LastName': 'Mehta', 'Affiliation': 'Medanta-The Medicity Hospital, Gurugram, Haryana, India.'}, {'ForeName': 'Sushila', 'Initials': 'S', 'LastName': 'Kataria', 'Affiliation': 'Medanta-The Medicity Hospital, Gurugram, Haryana, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Govil', 'Affiliation': 'Medanta-The Medicity Hospital, Gurugram, Haryana, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Deswal', 'Affiliation': 'Medanta-The Medicity Hospital, Gurugram, Haryana, India.'}, {'ForeName': 'Dhruva', 'Initials': 'D', 'LastName': 'Chaudhry', 'Affiliation': 'Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Pawan Kumar', 'Initials': 'PK', 'LastName': 'Singh', 'Affiliation': 'Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Medeor Hospital, Manesar, Haryana, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Agarwal', 'Affiliation': 'Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Apollo Hospitals Chennai, Tamil Nadu, India.'}, {'ForeName': 'Shashikala A', 'Initials': 'SA', 'LastName': 'Sangle', 'Affiliation': 'BJ Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Chawla', 'Affiliation': 'Indraprastha Apollo Hospital, New Delhi, India.'}, {'ForeName': 'Suneetha', 'Initials': 'S', 'LastName': 'Narreddy', 'Affiliation': 'Apollo Hospital Hyderabad, Telangana, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Pandit', 'Affiliation': 'Fortis Mulund, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Mishra', 'Affiliation': 'Nayati Hospitals, Agra, Uttar Pradesh, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Goel', 'Affiliation': 'Fortis Memorial Research Institute, Gurugram, Haryana, India.'}, {'ForeName': 'Athimalaipet V', 'Initials': 'AV', 'LastName': 'Ramanan', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust and Translational Health Sciences, Bristol Medical School, Bristol, UK.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00081-3']
1508,33676580,A 16-week aerobic exercise and mindfulness-based intervention on chronic psychosocial stress: a pilot and feasibility study.,"OBJECTIVES


Researchers have begun delivering mindfulness and aerobic exercise training concurrently on the premise that a combination intervention will yield salutary outcomes over and above each intervention alone. An estimate of the effect of combination training on chronic psychosocial stress in a nonclinical population has not been established. The objective of this study was to establish protocol feasibility in preparation of a definitive RCT targeting healthy individuals, and to explore the preliminary effect of combination training on reducing chronic psychosocial stress in this population.
METHODS


Twenty-four participants were allocated to a single-arm pre-post study and subjected to 16 weeks of concurrent mindfulness psychoeducation and aerobic exercise training. Feasibility criteria were collected and evaluated. Within-group changes in chronic psychosocial stress, mindfulness, emotion regulation, and cardiorespiratory fitness were also assessed. Primary analyses were based on 17 participants.
RESULTS


Retention rate, response rate, recruitment rate, and sample size analyses indicate a definitive trial is feasible for detecting most effects with precision. There was also a decline in our primary dependent measure of chronic psychosocial stress (d pretest  = -0.56, 95% CI [ -1.14,-0.06]). With regard to secondary measures, there was an increase in the use of cognitive reappraisal, and a reduction in use of maladaptive emotion regulation strategies. We are insufficiently confident to comment on changes in mindfulness and aerobic capacity [Formula: see text]. However, there were subgroup improvements in aerobic economy at submaximal exercise intensities.
CONCLUSIONS


We recommend a definitive trial is feasible and should proceed.
TRIAL REGISTRATION


ANZCTR (ID: ACTRN12619001726145 ). Retrospectively registered December 9, 2019.",2021,"With regard to secondary measures, there was an increase in the use of cognitive reappraisal, and a reduction in use of maladaptive emotion regulation strategies.","['healthy individuals', 'Twenty-four participants']","['combination training', 'concurrent mindfulness psychoeducation and aerobic exercise training', 'aerobic exercise training', 'ID', 'aerobic exercise and mindfulness-based intervention']","['chronic psychosocial stress', 'Retention rate, response rate, recruitment rate', 'maladaptive emotion regulation strategies', 'aerobic economy at submaximal exercise intensities', 'chronic psychosocial stress, mindfulness, emotion regulation, and cardiorespiratory fitness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",24.0,0.042144,"With regard to secondary measures, there was an increase in the use of cognitive reappraisal, and a reduction in use of maladaptive emotion regulation strategies.","[{'ForeName': 'Guy A', 'Initials': 'GA', 'LastName': 'Prochilo', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Australia. guy.prochilo@gmail.com.'}, {'ForeName': 'Ricardo J S', 'Initials': 'RJS', 'LastName': 'Costa', 'Affiliation': 'Department of Nutrition Dietetics & Food, Monash University, Melbourne, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hassed', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'Mindfulness Programs, Monash University, Melbourne, Australia.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Molenberghs', 'Affiliation': 'ISN Psychology, Institute for Social Neuroscience, Melbourne, Australia.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00751-6']
1509,33676572,"27-Hydroxycholesterol, cognition, and brain imaging markers in the FINGER randomized controlled trial.","BACKGROUND


27-Hydroxycholesterol (27-OH), the main circulating oxysterol in humans and the potential missing link between peripheral hypercholesterolemia and Alzheimer's disease (AD), has not been investigated previously in relation to cognition and neuroimaging markers in the context of preventive interventions.
METHODS


The 2-year Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) included older individuals (60-77 years) at increased risk for dementia but without dementia or substantial cognitive impairment from the general population. Participants were randomized to a multidomain intervention (diet, exercise, cognitive training, and vascular risk management) or control group (general health advice) in a 1:1 ratio. Outcome assessors were masked to group allocation. This FINGER exploratory sub-study included 47 participants with measures of 27-OH, cognition, brain MRI, brain FDG-PET, and PiB-PET. Linear regression models were used to assess the cross-sectional and longitudinal associations between 27-OH, cognition, and neuroimaging markers, considering several potential confounders/intervention effect modifiers.
RESULTS


27-OH reduction during the intervention was associated with improvement in cognition (especially memory). This was not observed in the control group. The intervention reduced 27-OH particularly in individuals with the highest 27-OH levels and younger age. No associations were found between changes in 27-OH levels and neuroimaging markers. However, at baseline, a higher 27-OH was associated with lower total gray matter and hippocampal volume, and lower cognitive scores. These associations were unaffected by total cholesterol levels. While sex seemed to influence associations at baseline, it did not affect longitudinal associations.
CONCLUSION


27-OH appears to be a marker not only for dementia/AD risk, but also for monitoring the effects of preventive interventions on cholesterol metabolism.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT01041989 . Registered on 4 January 2010.",2021,"Participants were randomized to a multidomain intervention (diet, exercise, cognitive training, and vascular risk management) or control group (general health advice) in a 1:1 ratio.","['individuals with the highest 27-OH levels and younger age', 'Cognitive Impairment and Disability (FINGER) included older individuals (60-77\u2009years) at increased risk for dementia but without dementia or substantial cognitive impairment from the general population', '47 participants with measures of 27-OH, cognition, brain MRI, brain FDG-PET, and PiB-PET']","['27-Hydroxycholesterol (27-OH', 'multidomain intervention (diet, exercise, cognitive training, and vascular risk management) or control group (general health advice']","['cognition (especially memory', 'total gray matter and hippocampal volume, and lower cognitive scores', 'total cholesterol levels', '27-OH levels and neuroimaging markers', '27-Hydroxycholesterol, cognition, and brain imaging markers']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0172934', 'cui_str': '27-hydroxycholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0172934', 'cui_str': '27-hydroxycholesterol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035649', 'cui_str': 'Risk management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0172934', 'cui_str': '27-hydroxycholesterol'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}]",47.0,0.0361747,"Participants were randomized to a multidomain intervention (diet, exercise, cognitive training, and vascular risk management) or control group (general health advice) in a 1:1 ratio.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sandebring-Matton', 'Affiliation': 'Division of Neurogeriatrics, Center for Alzheimer Research, NVS, Karolinska Institutet, Stockholm, Sweden. anna.matton@ki.se.'}, {'ForeName': 'Julen', 'Initials': 'J', 'LastName': 'Goikolea', 'Affiliation': 'Division of Neurogeriatrics, Center for Alzheimer Research, NVS, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ingemar', 'Initials': 'I', 'LastName': 'Björkhem', 'Affiliation': 'Division of Clinical Chemistry, Department of Laboratory Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Paternain', 'Affiliation': 'Division of Neurogeriatrics, Center for Alzheimer Research, NVS, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kemppainen', 'Affiliation': 'Division of Clinical Neurosciences, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Ngandu', 'Affiliation': 'Division of Clinical Geriatrics, Center for Alzheimer Research, NVS, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Rinne', 'Affiliation': 'Turku PET Centre, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cedazo-Minguez', 'Affiliation': 'Division of Neurogeriatrics, Center for Alzheimer Research, NVS, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Division of Clinical Geriatrics, Center for Alzheimer Research, NVS, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Division of Clinical Geriatrics, Center for Alzheimer Research, NVS, Karolinska Institutet, Stockholm, Sweden.'}]",Alzheimer's research & therapy,['10.1186/s13195-021-00790-y']
1510,33676560,A Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) for first-time families: study protocol of a three-arm randomised controlled trial.,"BACKGROUND


Enhanced parenting self-efficacy (PSE) contributes to positive parenting and future parental-child health. First-time parents, in particular, are in need of support since the pregnancy until post-delivery to strengthen their early PSE. However, there is a lack of effective and sustainable relevant programmes in the community. The Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) aims to develop a self-learning eco-community throughout the pregnancy and early childhood to promote PSE among first-time parents. We apply choice architecture strategy using behavioural nudges and midwife-led continuity care during the first 1000 days, and test their effects on PSE and mother-child health for first-time families in Singapore.
METHODS


This three-arm randomised controlled trial will recruit up to 750 pregnant women from the KK Women's and Children's Hospital, Singapore. Participants will be randomly assigned to receive: (1) standard routine care; (2) behavioural nudges (text messages) along with the use of a social media platform; or (3) midwife-led continuity care involving individualised teleconferencing sessions, during pregnancy and post-delivery. Using web-based questionnaires, participants will be assessed for baseline socio-demography and health status in the first visit, with follow-up assessments in the third trimester, at birth, 6-week (primary end-point), 6-, 12-, 18- and 24-month post-delivery. The primary outcome is PSE. Secondary outcomes include health and birth experience, mental wellness, feeding practice, maternal and child nutritional status. Intention-to-treat and per-protocol analyses will be performed using general linear models to test the effects of interventions across three arms. Recruitment has begun in June 2020 and is estimated to complete in September 2022.
DISCUSSION


This study may identify a sustainable effective strategy in the community by helping first-time parents to have a positive experience during the pregnancy, childbirth and parenthood, leading to an enhanced PSE and health outcomes for both mother and child. Findings from this study will provide insight into the implementation of early parenting and mother-child care programmes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04275765 . Registered on 19 February 2020.",2021,The Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) aims to develop a self-learning eco-community throughout the pregnancy and early childhood to promote PSE among first-time parents.,"[""750 pregnant women from the KK Women's and Children's Hospital, Singapore""]",['standard routine care; (2) behavioural nudges (text messages) along with the use of a social media platform; or (3) midwife-led continuity care involving individualised teleconferencing sessions'],"['health and birth experience, mental wellness, feeding practice, maternal and child nutritional status']","[{'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0567465', 'cui_str': 'Feeding practice'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",750.0,0.155302,The Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) aims to develop a self-learning eco-community throughout the pregnancy and early childhood to promote PSE among first-time parents.,"[{'ForeName': 'See Ling', 'Initials': 'SL', 'LastName': 'Loy', 'Affiliation': ""Department of Reproductive Medicine, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore. loy.see.ling@kkh.com.sg.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Thilagamangai', 'Affiliation': ""Division of Nursing, KK Women's and Children's Hospital, Singapore, 100 Bukit Timah Road, Singapore, 229899, Singapore.""}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Teo', 'Affiliation': ""Medical Board, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore.""}, {'ForeName': 'Sze Wern', 'Initials': 'SW', 'LastName': 'Chan', 'Affiliation': ""Division of Nursing, KK Women's and Children's Hospital, Singapore, 100 Bukit Timah Road, Singapore, 229899, Singapore.""}, {'ForeName': 'Nurul Khairani Abdul', 'Initials': 'NKA', 'LastName': 'Razak', 'Affiliation': ""Division of Nursing, KK Women's and Children's Hospital, Singapore, 100 Bukit Timah Road, Singapore, 229899, Singapore.""}, {'ForeName': 'Oh Moh', 'Initials': 'OM', 'LastName': 'Chay', 'Affiliation': 'Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Kee Chong', 'Initials': 'KC', 'LastName': 'Ng', 'Affiliation': 'Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}]",Trials,['10.1186/s13063-021-05144-5']
1511,33676538,A novel approach to increasing community capacity for weight management a volunteer-delivered programme (ActWELL) initiated within breast screening clinics: a randomised controlled trial.,"BACKGROUND


It is estimated that around 30% of breast cancers in post-menopausal women are related to lifestyle. The breast cancer-pooling project demonstrated that sustained weight loss of 2 to 4.5 kg is associated with an 18% lower risk of breast cancer, highlighting the importance of small changes in body weight. Our study aimed to assess the effectiveness a volunteer-delivered, community based, weight management programme (ActWELL) for women with a BMI > 25 kg/m 2  attending NHS Scotland Breast Screening clinics.
METHODS


A multicentre, 1:1 parallel group, randomised controlled trial was undertaken in 560 women aged 50 to 70 years with BMI > 25 kg/m 2 . On completion of baseline measures, all participants received a breast cancer prevention leaflet. Intervention group participants received the ActWELL intervention which focussed on personalised diet advice and pedometer walking plans. The programme was delivered in leisure centres by (the charity) Breast Cancer Now volunteer coaches. Primary outcomes were changes between groups at 12 months in body weight (kg) and physical activity (accelerometer measured step count).
RESULTS


Two hundred seventy-nine women were allocated to the intervention group and 281 to the comparison group. Twelve-month data were available from 240 (81%) intervention and 227 (85%) comparison group participants. Coaches delivered 523 coaching sessions and 1915 support calls to 279 intervention participants. Mean weight change was - 2.5 kg (95% CI - 3.1 to - 1.9) in the intervention group and - 1.2 kg (- 1.8 to 0.6) in the comparison group. The adjusted mean difference was - 1.3 kg (95% CI - 2.2 to - 0.4, P = 0.003). The odds ratio for losing 5% weight was 2.20 (95% CI 1.4 to 3.4, p = 0.0005) in favour of the intervention. The adjusted mean difference in step counts between groups was 483 steps/day (95% CI - 635 to 1602) (NS).
CONCLUSIONS


A community weight management intervention initiated at breast screening clinics and delivered by volunteer coaches doubled the likelihood of clinically significant weight loss at 12 months (compared with usual care) offering significant potential to decrease breast cancer risk.
TRIAL REGISTRATION


Database of registration: ISCRTN. Registration number: 11057518 . Date trial registered:21.07.2017. Date of enrolment of first participant: 01.09.2017.",2021,Mean weight change was - 2.5 kg (95% CI - 3.1 to - 1.9) in the intervention group and - 1.2 kg (- 1.8 to 0.6) in the comparison group.,"['Breast Cancer', '560 women aged 50 to 70\u2009years with BMI >\u200925\u2009kg/m 2 ', 'women with a BMI >\u200925\u2009kg/m 2  attending NHS Scotland Breast Screening clinics', 'Two hundred seventy-nine women']","['ActWELL intervention which focussed on personalised diet advice and pedometer walking plans', 'breast cancer prevention leaflet']","['Mean weight change', 'sustained weight loss', 'body weight (kg) and physical activity (accelerometer measured step count', 'weight loss']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",560.0,0.130471,Mean weight change was - 2.5 kg (95% CI - 3.1 to - 1.9) in the intervention group and - 1.2 kg (- 1.8 to 0.6) in the comparison group.,"[{'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK. a.s.anderson@dundee.ac.uk.'}, {'ForeName': 'Huey Yi', 'Initials': 'HY', 'LastName': 'Chong', 'Affiliation': 'Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Craigie', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Division of Population Health and Genomics, University of Dundee, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gallant', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Breast Cancer Now, 222 Leith Walk, Edinburgh, EH6 5EQ, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'McAdam', 'Affiliation': ""Physical Activity for Health Research Centre, University of Edinburgh, Saint Leonard's Land, Holyrood Rd, Edinburgh, EH8 8AQ, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McKell', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McNamee', 'Affiliation': 'Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'E Jane', 'Initials': 'EJ', 'LastName': 'Macaskill', 'Affiliation': 'Department of Breast Surgery, Level 6, Ninewells Hospital and Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': ""Physical Activity for Health Research Centre, University of Edinburgh, Saint Leonard's Land, Holyrood Rd, Edinburgh, EH8 8AQ, UK.""}, {'ForeName': 'Ronan E', 'Initials': 'RE', 'LastName': ""O'Carroll"", 'Affiliation': 'University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rauchhaus', 'Affiliation': 'Tayside Clinical Trials Unit, Tayside Medical Science Centre, Ninewells Hospital and Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'University of Glasgow, Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, 126 University Place, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Stead', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, , Room 306, 3rd Floor, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-021-01099-7']
1512,33676537,Online art therapy in elementary schools during COVID-19: results from a randomized cluster pilot and feasibility study and impact on mental health.,"BACKGROUND


Emerging literature on the current COVID-19 crisis suggests that children may experience increased anxiety and depression as a result of the pandemic. To prevent such school and mental health-related problems, there is a timely need to develop preventive strategies and interventions to address potential negative impacts of COVID-19 on children's mental health, especially in school settings. Results from previous child clinical research indicate that art-based therapies, including mindfulness-based art therapy, have shown promise to increase children's well-being and reduce psychological distress.
OBJECTIVE


The goal of the present pilot and feasibility study was to compare the impact of an emotion-based directed drawing intervention and a mandala drawing intervention, on mental health in elementary school children (N = 22), in the context of the COVID-19 pandemic. Both interventions were group-based and delivered online and remotely. A pilot study using a randomized cluster design was implemented to evaluate and compare both interventions in relation to child anxiety, depression, inattention and hyperactivity symptoms.
RESULTS


Analyses of covariance revealed a significant effect of the type of drawing intervention on levels of inattention, after controlling for baseline levels. Participants in the emotion-based directed drawing group showed lower inattention scores at post-test, when compared to participants in the mandala group. Post-hoc sensitivity analyses showed significant decreases in pre-to-post scores for levels of hyperactivity for the complete sample.
CONCLUSION


Overall, results from this pilot and feasibility study showed that both an emotion-based directed drawing intervention and a mandala drawing intervention may be beneficial to improve mental health in elementary school children, in the context of the current COVID-19 pandemic. From a feasibility standpoint, results indicate that the implementation of both interventions online and remotely, through a videoconference platform, is feasible and adequate in school-based settings. Further work incorporating larger sample sizes, longitudinal data and ensuring sufficient statistical power is warranted to evaluate the long-term impact of both interventions on children's mental health.",2021,"Post-hoc sensitivity analyses showed significant decreases in pre-to-post scores for levels of hyperactivity for the complete sample.
","['elementary schools during COVID-19', ""children's mental health"", 'elementary school children', 'elementary school children (N\u2009=\u200922']",['emotion-based directed drawing intervention and a mandala drawing intervention'],"['lower inattention scores', 'levels of inattention', 'mental health', 'child anxiety, depression, inattention and hyperactivity symptoms']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0666031,"Post-hoc sensitivity analyses showed significant decreases in pre-to-post scores for levels of hyperactivity for the complete sample.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Malboeuf-Hurtubise', 'Affiliation': ""Department of Psychology, Bishop's University, 2600 College St., Sherbrooke, QC, J1M 1Z7, Canada. catherine.malboeuf-hurtubise@ubishops.ca.""}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Léger-Goodes', 'Affiliation': 'Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Canada.'}, {'ForeName': 'Geneviève A', 'Initials': 'GA', 'LastName': 'Mageau', 'Affiliation': 'Department of Psychology, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': 'Department of Education and Pedagogy, Université du Québec à Montréal, Montreal, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Herba', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Canada.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Chadi', 'Affiliation': 'Department of Paediatrics, Sainte-Justine University Hospital Centre, Montreal, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lefrançois', 'Affiliation': 'Department of Educational Sciences, Université du Québec en Outaouais, Gatineau, Canada.'}]",Child and adolescent psychiatry and mental health,['10.1186/s13034-021-00367-5']
1513,33676526,Implant design affects walking and stair navigation after total knee arthroplasty: a double-blinded randomised controlled trial.,"BACKGROUND


Dissimilar total knee arthroplasty implant designs offer different functional characteristics. This is the first work in the literature to fully assess the Columbus ultra-congruent mobile (UCR) system with a rotating platform.
METHODS


This is a double-blinded randomised controlled trial, comparing the functional performance of the low congruent fixed (CR DD), ultra-congruent fixed (UC) and UCR Columbus Total Knee Systems. The pre-operative and post-operative functional performance of twenty-four osteoarthritic patients was evaluated against nine control participants when carrying out everyday tasks. Spatiotemporal, kinematic and kinetic gait parameters in walking and stair navigation were extracted by means of motion capture.
RESULTS


The UC implant provided better post-operative function, closely followed by the UCR design. However, both the UC and UCR groups exhibited restricted post-operative sagittal RoM (walking, 52.1 ± 4.4° and 53.2 ± 6.6°, respectively), whilst patients receiving a UCR implant did not show an improvement in their tibiofemoral axial rotation despite the bearing's mobile design (walking, CR DD 13.2 ± 4.6°, UC 15.3 ± 6.7°, UCR 13.5 ± 5.4°). Patients with a CR DD fixed bearing showed a statistically significant post-operative improvement in their sagittal RoM when walking (56.8 ± 4.6°).
CONCLUSION


It was concluded that both ultra-congruent designs in this study, the UC and UCR bearings, showed comparable functional performance and improvement after TKA surgery. The CR DD group showed the most prominent improvement in the sagittal RoM during walking.
TRIAL REGISTRATION


The study is registered under the clinical trial registration number: NCT02422251 . Registered on April 21, 2015.",2021,"Patients with a CR DD fixed bearing showed a statistically significant post-operative improvement in their sagittal RoM when walking (56.8 ± 4.6°).
",['total knee arthroplasty'],"['low congruent fixed (CR DD), ultra-congruent fixed (UC) and UCR Columbus Total Knee Systems']","['tibiofemoral axial rotation', 'walking and stair navigation', 'sagittal RoM']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}]",24.0,0.353599,"Patients with a CR DD fixed bearing showed a statistically significant post-operative improvement in their sagittal RoM when walking (56.8 ± 4.6°).
","[{'ForeName': 'Dimitrios-Sokratis', 'Initials': 'DS', 'LastName': 'Komaris', 'Affiliation': 'Tyndall National Institute, University College Cork, Lee Maltings Complex Dyke Parade, Cork, T12 R5CP, Ireland. sokratis.komaris@tyndall.ie.'}, {'ForeName': 'Cheral', 'Initials': 'C', 'LastName': 'Govind', 'Affiliation': 'Department of Biomedical Engineering, University of Strathclyde, Glasgow, Scotland.'}, {'ForeName': 'Andrew James', 'Initials': 'AJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Biomedical Engineering, University of Strathclyde, Glasgow, Scotland.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'Orthopaedic Department, Golden Jubilee National Hospital, Clydebank, Scotland.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Ewen', 'Affiliation': 'Orthopaedic Department, Golden Jubilee National Hospital, Clydebank, Scotland.'}, {'ForeName': 'Hollie', 'Initials': 'H', 'LastName': 'Leonard', 'Affiliation': 'Orthopaedic Department, Golden Jubilee National Hospital, Clydebank, Scotland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Riches', 'Affiliation': 'Department of Biomedical Engineering, University of Strathclyde, Glasgow, Scotland.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-021-02311-x']
1514,33676481,Needle Adjustment Free (NAF) running suture technique (PAN suture) in laparoscopic partial nephrectomy.,"BACKGROUND


It is proposed a new running suture technique called Needle Adjustment Free (NAF) technique, or PAN suture. The efficiency and the safety were evaluated in laparoscopic partial nephrectomy.
METHODS


This new running suture technique avoids the Needle Adjustment method used in traditional techniques. The new continuous suture technique (11 patients) was compared with the traditional continuous suture method (33 patients) used in both transperitoneal and retroperitoneal laparoscopic partial nephrectomy (LPN) in terms of suture time (ST), warm ischemia time (WIT), blood loss (BL), open conversion rate and post-op discharge time, post-op bleeding, post-op DVT, ΔGFR (affected side, 3 months post-op). Differences were considered significant when P < 0.05.
RESULTS


ST in the PAN suture group was 30.37 ± 16.39 min, which was significant shorter (P = 0.0011) than in the traditional technique group which was 13.68 ± 3.33 min. WIT in the traditional technique group was 28.73 ± 7.89 min, while in the PAN suture group was 20.64 ± 5.04 min, P = 0.0028. The BL in entirety in the traditional technique group was 141.56 ± 155.23 mL, and in the PAN suture group was 43.18 ± 31.17 mL (P = 0.0017). BL in patients without massive bleeding in the traditional technique group was significantly greater than in the PAN suture group at 101.03 ± 68.73 mL versus 43.18 ± 31.17 mL (P = 0.0008). The open conversion rate was 0 % in both groups. There was no significant difference between the two groups in postoperative discharge time, post-op bleeding, post-op DVT, ΔGFR (affected side, 3 months post-op).
CONCLUSIONS


The NAF running suture technique, or PAN suture, leading to less ST, WIT and BL, which was shown to be more effective and safer than the traditional technique used for LPN. A further expanded research with larger sample size is needed.",2021,"There was no significant difference between the two groups in postoperative discharge time, post-op bleeding, post-op DVT, ΔGFR (affected side, 3 months post-op).
",[],"['Needle Adjustment Free (NAF) running suture technique (PAN suture', 'running suture technique called Needle Adjustment Free (NAF) technique, or PAN suture', 'laparoscopic partial nephrectomy', 'traditional continuous suture method (33 patients) used in both transperitoneal and retroperitoneal laparoscopic partial nephrectomy (LPN']","['postoperative discharge time, post-op bleeding, post-op DVT, ΔGFR', 'suture time (ST), warm ischemia time (WIT), blood loss (BL), open conversion rate and post-op discharge time, post-op bleeding, post-op DVT, ΔGFR', 'efficiency and the safety', 'open conversion rate', 'massive bleeding']",[],"[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}]","[{'cui': 'C0948693', 'cui_str': 'Post procedural discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1563923', 'cui_str': 'Warm Ischemic Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0333279', 'cui_str': 'Massive hemorrhage'}]",33.0,0.0163995,"There was no significant difference between the two groups in postoperative discharge time, post-op bleeding, post-op DVT, ΔGFR (affected side, 3 months post-op).
","[{'ForeName': 'Jun-Wei', 'Initials': 'JW', 'LastName': 'Pan', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China.'}, {'ForeName': 'Xing-Wei', 'Initials': 'XW', 'LastName': 'Jin', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei-Chao', 'Initials': 'WC', 'LastName': 'Tu', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China.'}, {'ForeName': 'Xian-Jin', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China.'}, {'ForeName': 'Bao-Xing', 'Initials': 'BX', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China.'}, {'ForeName': 'Guo-Liang', 'Initials': 'GL', 'LastName': 'Lu', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China.'}, {'ForeName': 'Da-Wei', 'Initials': 'DW', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China.'}, {'ForeName': 'Xiang-Hui', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China. wxh@medmail.com.cn.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Department of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 999, Xi Wang Road, Shanghai, 201801, China. shaoyuan15@126.com.'}]",BMC surgery,['10.1186/s12893-021-01112-7']
1515,33676429,BLEND-A: blending internet treatment into conventional face-to-face treatment for alcohol use disorder - a study protocol.,"BACKGROUND


A major challenge to psychological treatment for alcohol use disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase patient compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD.
AIMS


The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only.
METHODS


The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n = 1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on sociodemographics, treatment (e.g. intensity, duration), type of treatment conclusion (compliance vs. dropout), alcohol consumption, addiction severity, consequences of drinking, and quality of life, will be collected at treatment entry, at treatment conclusion, and 6 months after treatment conclusion. The primary outcome is compliance at treatment conclusion, and the secondary outcomes include alcohol consumption and quality of life at six-months follow-up. Data will be analyzed with an Intention-to-treat approach by means of generalized linear mixed models with a random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted.
DISCUSSION


Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and when successful, blended treatment has the potential to become an alternative offer in many outpatient clinics nationwide and internationally.
TRIAL REGISTRATION


Clinicaltrials.gov .: NCT04535258 , retrospectively registered 01.09.20.",2021,"A promising new treatment approach that is hypothesized to increase patient compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the internet within the same protocol.",['The included outpatient institutions (planned number of patients: n\u2009=\u20091800'],"['blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU', 'motivational interviewing and cognitive behavioral therapy']","['sociodemographics, treatment (e.g. intensity, duration), type of treatment conclusion (compliance vs. dropout), alcohol consumption, addiction severity, consequences of drinking, and quality of life', 'alcohol consumption and quality of life at six-months follow-up']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1800.0,0.0390433,"A promising new treatment approach that is hypothesized to increase patient compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the internet within the same protocol.","[{'ForeName': 'Angelina Isabella', 'Initials': 'AI', 'LastName': 'Mellentin', 'Affiliation': 'Department of Clinical Research, Unit of Clinical Alcohol Research, University of Southern Denmark, Odense, Denmark. amellentin@health.sdu.dk.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Behrendt', 'Affiliation': 'Department of Clinical Research, Unit of Clinical Alcohol Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Bilberg', 'Affiliation': 'Department of Clinical Research, Unit of Clinical Alcohol Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Marie Paldam', 'Initials': 'MP', 'LastName': 'Folker', 'Affiliation': 'Research Unit for Telepsychiatry and E-mental Health, Centre for Telepsychiatry in the Mental Health Services in the Region of Southern Denmark and Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Tarp', 'Affiliation': 'Research Unit for Telepsychiatry and E-mental Health, Centre for Telepsychiatry in the Mental Health Services in the Region of Southern Denmark and Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Uffelmann', 'Affiliation': 'Sundhed.dk, Copenhagen, Denmark.'}, {'ForeName': 'Anette Søgaard', 'Initials': 'AS', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Research, Unit of Clinical Alcohol Research, University of Southern Denmark, Odense, Denmark.'}]",BMC psychiatry,['10.1186/s12888-021-03122-4']
1516,33676417,"Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome.","BACKGROUND


The results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well.
OBJECTIVE


To determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS).
METHODS


We used data from the FIMPACT trial, a randomised controlled trial of treatment for SAPS that included 193 patients. The outcomes were shoulder pain at rest and on arm activity, both measured with the 0-100 mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST). The transition question was a five-point global rating of change. We used three anchor-based methods to determine the MID for improvement: the receiver operating characteristic (ROC) curve, the mean difference of change and the mean change methods. For the PASS, we used the ROC and 75th percentile methods and calculated estimates using two different anchor question thresholds.
RESULTS


Different MID methods yielded different estimates. The ROC method yielded the smallest estimates for MID: 20 mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94). We could not establish a reliable MID for pain at rest. The PASS estimates were consistent between methods. The ROC method PASS thresholds using a conservative anchor question threshold were 2 mm for pain at rest, 9 mm for pain on activity, 80 points for CS and 11 points for SST, with AUCs from 0.74 to 0.83.
CONCLUSION


We recommend the smallest estimate from different methods as the MID, because it is very unlikely that changes smaller than the smallest MID estimate are important to patients: 20 mm for pain VAS on arm activity, 10 points for CS and 1.5 points for SST. We recommend PASS estimates of 9 mm for pain on arm activity, 80 points for CS, and 11 points for SST.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00428870 (first registered January 29, 2007).",2021,"The ROC method yielded the smallest estimates for MID: 20 mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94).","['patients with subacromial pain syndrome', 'patients with subacromial pain syndrome (SAPS', 'SAPS that included 193 patients']",[],"['Patient acceptable symptom state (PASS', 'shoulder pain at rest and on arm activity, both measured with the 0-100\u2009mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.230023,"The ROC method yielded the smallest estimates for MID: 20 mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94).","[{'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kanto', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, Tampere University Hospital, TAYS Hatanpää, Hatanpäänkatu 24, 33900, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Lähdeoja', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, HUS, 00029, Helsinki, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, HUS, 00029, Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Aronen', 'Affiliation': 'Biostatistics Unit, Faculty of Medicine at University of Helsinki and Helsinki University Hospital, Tukholmankatu 8B, 00290, Helsinki, Finland.'}, {'ForeName': 'Teppo L N', 'Initials': 'TLN', 'LastName': 'Järvinen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, HUS, 00029, Helsinki, Finland.'}, {'ForeName': 'Jarkko', 'Initials': 'J', 'LastName': 'Jokihaara', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Hand and Microsurgery, Tampere University Hospital, Elämänaukio 2, 33520, Tampere, Finland.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Ardern', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Division of Physiotherapy, Karolinska Institute, H1 Fysioterapi, 17177, Stockholm, Sweden.'}, {'ForeName': 'Teemu V', 'Initials': 'TV', 'LastName': 'Karjalainen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Central Finland Central Hospital, Jyväskylä, Keskussairaalantie 19, 40620, Jyväskylä, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, HUS, 00029, Helsinki, Finland. simo.taimela@helsinki.fi.'}]",BMC medical research methodology,['10.1186/s12874-021-01241-w']
1517,33676384,Can changes in skin impedance be used to monitor sedation after midazolam and during recovery from anesthesia?,"It has been suggested that sympathetic activity, measured as changes in electrical skin impedance (SI), can be used to assess the adequacy of general anesthesia. Our prospective study investigated if measurements of skin impedance can determine levels of sedation induced by midazolam. Twenty-seven patients scheduled for arthroscopy requiring general anesthesia were served as their own control. These were blinded to the order of injections by telling them that they will be randomly administered a placebo (saline) or sedative agent. A DM 3900 multimeter was used for SI measurements. The degree of sedation was measured using the modified Observer's Assessment of Alertness and Sedation (mOAAS) scale. Resting SI values were noted, and all participants were then administered the placebo followed 5 minutes later by midazolam 2 mg i.v. Five minutes after that, patients were administered standard general anesthesia with propofol, oxygen, nitrous oxide 60%, and isoflurane 1 MAC via a laryngeal mask, and sufentanil 5 - 10 µg. SI significantly increased after administration of midazolam an induction of anesthesia. There were no significant differences between pre-administration (baseline) and placebo and end of surgery and end of anesthesia with closed eyes. There were highly significant differences (p<0.001) between pre-administration vs. midazolam, placebo vs. midazolam, pre-administration vs. induction of anesthesia. We found no correlation between mOAAS and SI. There were no significant changes between the end of surgery and the end of anesthesia with closed eyes, but SI significantly decreased (p<0.01) after eyes opened.",2021,"There were highly significant differences (p<0.001) between pre-administration vs. midazolam, placebo vs. midazolam, pre-administration vs. induction of anesthesia.",['Twenty-seven patients scheduled for arthroscopy requiring general anesthesia'],"['midazolam, placebo vs. midazolam', 'placebo', 'midazolam', 'propofol, oxygen, nitrous oxide 60%, and isoflurane 1 MAC via a laryngeal mask, and sufentanil', 'placebo (saline) or sedative agent']","['SI', ""modified Observer's Assessment of Alertness and Sedation (mOAAS) scale"", 'degree of sedation', 'Resting SI values']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0036557', 'cui_str': 'Sedative'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",27.0,0.100062,"There were highly significant differences (p<0.001) between pre-administration vs. midazolam, placebo vs. midazolam, pre-administration vs. induction of anesthesia.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kurzová', 'Affiliation': 'Dpt. of Pharmacology, Charles University, Prague, Czech Republic. Jiri.Sliva@lf3.cuni.cz.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hess', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Slíva', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Málek', 'Affiliation': ''}]",Physiological research,[]
1518,33683799,"Comparison of reliability, construct validity and responsiveness of the IPAQ-SF and PASE in adults with osteoarthritis.","BACKGROUND


This study assessed the measurement properties of two commonly used self-report physical activity (PA) measures: the International Physical Activity Questionnaire-Short Form (IPAQ-SF) and the Physical Activity Scale for the elderly (PASE) in adults with osteoarthritis.
METHODS


Secondary analysis of the MOSAICS cluster randomised controlled trial baseline and 3-month follow-up questionnaires, total scores and subdomains of the IPAQ-SF and PASE were compared. Intra-class correlations (ICC) were used to assess test-retest reliability, measurement error was assessed using standard error of measurement (SEM), smallest detectable change (SDC) and 95% limits of agreement (LoA). Responsiveness was assessed using effect size (ES), standard responsive measurement (SRM) and response ratio (RR).
RESULTS


There was moderate correlation (r = 0.56) between the total IPAQ-SF scores (score ranges 0-16,398) and the total PASE scores (score ranges 0-400). Subdomain correlations were also moderate (ranges 0.39-0.57). The PASE showed greater reliability compared to the IPAQ-SF (ICC = 0.68; 0.61-0.74 95% CI and ICC = 0.64; 0.55-0.72, respectively). Measurement errors in both measures were large: PASE SEM = 46.7, SDC = 129.6 and 95% LoA ranges = -117 to 136, the IPAQ-SF SEM = 3532.2 METS -1 min-1 week  , SDC = 9790.8 and 95% LoA ranges = -5222 to 5597. Responsiveness was poor: ES -0.14 and -0.16, SRM -0.21 and -0.21, and RR 0.12 and 0.09 for the IPAQ-SF and PASE, respectively.
DISCUSSION


The IPAQ-SF and PASE appear limited in reliability, measurement error and responsiveness. Researchers and clinicians should be aware of these limitations, particularly when comparing different levels of PA and monitoring PA levels changes over time in those with osteoarthritis.",2021,"The PASE showed greater reliability compared to the IPAQ-SF (ICC = 0.68; 0.61-0.74 95% CI and ICC = 0.64; 0.55-0.72, respectively).",['adults with osteoarthritis'],"['International Physical Activity Questionnaire-Short Form (IPAQ-SF', 'IPAQ-SF and PASE', 'self-report physical activity (PA) measures']","['effect size (ES), standard responsive measurement (SRM) and response ratio (RR', 'reliability', 'total scores and subdomains of the IPAQ-SF and PASE', 'total IPAQ-SF scores', 'total PASE scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",,0.0483846,"The PASE showed greater reliability compared to the IPAQ-SF (ICC = 0.68; 0.61-0.74 95% CI and ICC = 0.64; 0.55-0.72, respectively).","[{'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Smith', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'McHugh', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Quicke', 'Affiliation': 'School of Medicine, Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Dziedzic', 'Affiliation': 'School of Medicine, Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Healey', 'Affiliation': 'School of Medicine, Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}]",Musculoskeletal care,['10.1002/msc.1540']
1519,33683782,Comparison of 2% Deoxyarbutin and 4% Hydroquinone as A Depigmenting Agent in Healthy Individuals: A Double-blind Randomized Controlled Clinical Trial.,"BACKGROUND


Hydroquinone, which is considered the gold standard skin depigmenting agent, has been associated with multiple side effects. Lately, deoxyarbutin has been suggested to be an alternative of hydroquinone with better safety profile.
OBJECTIVE


to compare the depigmenting effect of 2% deoxyarbutin and 4% hydroquinone sera METHODS: this double-blind randomized controlled study was done on the right and left arms of healthy participants. Subjects were instructed to apply either 2% deoxyarbutin or 4% hydroquinone serum on each arm, which were randomly labelled as group A and B, every day for 12 weeks. Chromameter and mexameter analysis were done every 2 weeks to assess the color change. Paired and independent T-tests were used to assess the color change within and between both groups, respectively.
RESULTS


a total of 59 females participated in this study. Both groups showed significant improvement in skin depigmentation as shown by the chromameter (increase in L* value) and mexameter (decrease in melanin index) analysis at the end of the study (p<0.05). No significant difference in both parameters were observed between both groups (p>0.05). No side effects were reported in either groups.
CONCLUSION


2% deoxyarbutin and 4% hydroquinone sera showed comparable depigmenting efficacy.",2021,Both groups showed significant improvement in skin depigmentation as shown by the chromameter (increase in L* value) and mexameter (decrease in melanin index) analysis at the end of the study (p<0.05).,"['59 females participated in this study', 'Healthy Individuals', 'healthy participants']","['deoxyarbutin and 4% hydroquinone', 'deoxyarbutin or 4% hydroquinone serum', 'Deoxyarbutin and 4% Hydroquinone']","['skin depigmentation', 'side effects', 'depigmenting efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1613356', 'cui_str': 'deoxyarbutin'}, {'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C0262977', 'cui_str': 'Achromia of skin'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",59.0,0.143873,Both groups showed significant improvement in skin depigmentation as shown by the chromameter (increase in L* value) and mexameter (decrease in melanin index) analysis at the end of the study (p<0.05).,"[{'ForeName': 'Anis Irawan', 'Initials': 'AI', 'LastName': 'Anwar', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Asmarani', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Asnawi', 'Initials': 'A', 'LastName': 'Madjid', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Ilham Jaya', 'Initials': 'IJ', 'LastName': 'Patellongi', 'Affiliation': 'Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Adriani', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Suryani', 'Initials': 'S', 'LastName': ""As'ad"", 'Affiliation': 'Department of Clinical Nutrition, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Kurniadi', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14050']
1520,33683736,Nerve recognition in percutaneous transforaminal endoscopic discectomy using convolutional neural network.,"PURPOSE


Percutaneous transforaminal endoscopic discectomy (PTED) is one of the most common minimally invasive surgery methods used in clinic in recent years. In this study, we developed a computer-aided detection system (CADS) based on convolutional neural network (CNN) to automatically recognize nerve and dura mater images under PTED surgery.
METHODS


We collected surgical videos from 65 patients with lumbar disc herniation who underwent PTED; we then converted the videos into images, and randomly divided some images into a training dataset, a validation dataset, test dataset. The training dataset and validation dataset were composed of 10,454 images containing nerve and dura mater from 50 randomly selected patients; test dataset contained 12,000 images from the remaining 15 patients.
RESULTS


The results showed that sensitivity, specificity, and accuracy reached 90.90%, 93.68%, and 92.29%, respectively. CADS could recognize the nerve and dura mater with no significant difference (p>0.05) between each patient in test dataset. In comparison with clinicians of different levels, the performance of CADS was lower than that of a spinal endoscopist, but significantly higher than that of general surgeons. With the assistance of CADS, the performance of the general surgeons approached that of the spinal endoscopist.
CONCLUSIONS


CNN can recognize well nerve and dura mater images in PTED surgery, and can help general surgeons to improve their ability to recognize tissues during the operation.",2021,CADS could recognize the nerve and dura mater with no significant difference (p>0.05) between each patient in test dataset.,['65 patients with lumbar disc herniation who underwent PTED'],"['Percutaneous transforaminal endoscopic discectomy (PTED', 'computer-aided detection system (CADS) based on convolutional neural network (CNN) to automatically recognize nerve and dura mater images under PTED surgery']","['performance of CADS', 'sensitivity, specificity, and accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0013313', 'cui_str': 'Dura mater structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",50.0,0.0221854,CADS could recognize the nerve and dura mater with no significant difference (p>0.05) between each patient in test dataset.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Cui', 'Affiliation': 'Biomedical Information Engineering Lab, The University of Aizu, Aizu-Wakamatsu City, Fukushima, 965-8580, Japan.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Shu', 'Affiliation': 'Department of Spine Surgery, Pinghu Hospital, Health Science Center, Shenzhen University, Shenzhen, 518116, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Department of Orthopedics, Zhongnan Hospital, Wuhan University, Wuhan, Hubei, 430071, China.'}, {'ForeName': 'Wenxi', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Biomedical Information Engineering Lab, The University of Aizu, Aizu-Wakamatsu City, Fukushima, 965-8580, Japan.'}]",Medical physics,['10.1002/mp.14822']
1521,33683725,Prediction of spontaneous preterm birth by cervical length in the first trimester of pregnancy: comparison of two measurement methods.,"INTRODUCTION


Our objectives were to compare the single-line and two-line methods of cervical length measurement in the first trimester of pregnancy and to evaluate the potential value of the first trimester cervical length measured by the two methods in predicting spontaneous preterm birth.
MATERIAL AND METHODS


This was a prospective study in singleton pregnancies at 11 +0  -13 +6  weeks of gestation. Cervical length was measured by two methods: (i) a linear distance between the two ends of the glandular area around the endocervical canal (single-line method) and (ii) a sum of a linear distance from the internal os to the greatest cervical curvature and a linear distance from this point of the cervix to the external os (two-line method). The screening performance of the first trimester cervical length measured by the two different methods for the prediction of spontaneous preterm delivery was assessed by receiver-operating characteristics (ROC) curve analysis. The areas under the ROCs (AUROC) were compared by De Long test.
RESULTS


A total of 1484 consecutive singleton pregnancies were included in this study. Spontaneous preterm delivery at <37 weeks and <32 weeks occurred in 75 cases (5.1%) and 12 cases (0.8%), respectively. The median cervical length measured by the single-line method was significantly shorter than that by the two-line method (33.5 mm vs 36.5 mm, P<0.001). Compared to the term delivery group, the median cervical length measured by the two-line method was shorter in women with spontaneous delivery at <32 weeks of gestation (36.5 mm vs 33.6 mm, P<0.01). No significant difference in the median cervical length measured by the single-line method was detected between the spontaneous preterm delivery and term delivery groups. Receiver-operating-characteristic curves demonstrated that cervical length measured by the two-line method achieved better performance in predicting spontaneous delivery at <32 weeks than the single-line method (AUROC: 0.72 vs 0.61, P<0.01).
CONCLUSIONS


We have demonstrated that the first trimester cervical length, measured by the two-line approach, holds promise as a potential screening tool for early spontaneous preterm delivery.",2021,No significant difference in the median cervical length measured by the single-line method was detected between the spontaneous preterm delivery and term delivery groups.,"['singleton pregnancies at 11 +0  -13 +6  weeks of gestation', '1484 consecutive singleton pregnancies']",[],"['spontaneous preterm birth by cervical length', 'cervical length', 'median cervical length', 'Cervical length', 'Spontaneous preterm delivery']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}]",[],"[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",1484.0,0.0701068,No significant difference in the median cervical length measured by the single-line method was detected between the spontaneous preterm delivery and term delivery groups.,"[{'ForeName': 'Qiaoli', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Honglei', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Ju', 'Affiliation': 'Department of Obstetrics and Gynecology, Suzhou Municipal Hospital, Suzhou, China.'}, {'ForeName': 'Kubi', 'Initials': 'K', 'LastName': 'Appiah', 'Affiliation': 'Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Ka Man', 'Initials': 'KM', 'LastName': 'Yip', 'Affiliation': 'Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Yiyun', 'Initials': 'Y', 'LastName': 'Tai', 'Affiliation': 'Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Obstetrics, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Piya', 'Initials': 'P', 'LastName': 'Chaemsaithong', 'Affiliation': 'Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Liona C', 'Initials': 'LC', 'LastName': 'Poon', 'Affiliation': 'Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong SAR.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14138']
1522,33683710,Midazolam versus dexamethasone-ondansetron in preventing postoperative nausea-vomiting in patients undergoing laparoscopic surgeries.,"BACKGROUND


Midazolam reduces postoperative nausea and vomiting (PONV) when compared to a placebo or when used as an adjuvant to other antiemetics. The present study was designed to compare midazolam with a combination of dexamethasone-ondansetron in preventing PONV.
METHODS


One hundred and twenty patients undergoing laparoscopic surgeries having 2 or more risk factors for PONV (simplified Apfel score) were randomised into two groups of 60 each. Patients in group D received 8mg dexamethasone and 4 mg ondansetron for PONV prophylaxis while those in group M received 2 mg midazolam towards the end of surgery. The proportion of patients (frequency) who had PONV, postoperative nausea (PON), postoperative vomiting (POV) was noted over 24 hours over the following intervals: 0-2 hours, 2-24 hours and 0-24 hours RESULTS: The frequency of PONV at 24 hours in group D and group M was 30% and 33.3% respectively and was not significantly different (P=0.70). There was no difference the time to achieve post anaesthesia discharge score of ≥9 between the two groups {5 minutes (5, 5) in group D; 5 minutes (1.25, 5) in group M, P=0.48}. Ten patients in group D and 11 in group M required a rescue antiemetic over 24 hours (P=0.81). The frequency of PON, POV and PONV as well as the median PONV score was similar at all time periods.
CONCLUSION


Midazolam does not result in significantly different frequency of PONV than a combination of dexamethasone-ondansetron.",2021,Midazolam does not result in significantly different frequency of PONV than a combination of dexamethasone-ondansetron.,"['patients undergoing laparoscopic surgeries', 'One hundred and twenty patients undergoing laparoscopic surgeries having 2 or more risk factors for PONV (simplified Apfel score']","['dexamethasone-ondansetron', 'placebo', 'midazolam', 'ondansetron', 'Midazolam', 'dexamethasone']","['time to achieve post anaesthesia discharge score', 'frequency of PON, POV and PONV', 'proportion of patients (frequency) who had PONV, postoperative nausea (PON), postoperative vomiting (POV', 'frequency of PONV', 'median PONV score', 'postoperative nausea-vomiting', 'postoperative nausea and vomiting (PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0520905', 'cui_str': 'Postoperative vomiting'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",120.0,0.191362,Midazolam does not result in significantly different frequency of PONV than a combination of dexamethasone-ondansetron.,"[{'ForeName': 'Kelika', 'Initials': 'K', 'LastName': 'Prakash', 'Affiliation': 'Department of anaesthesiology and critical care, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Meshram', 'Affiliation': 'Department of anaesthesiology and critical care, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of epidemiology, Institute of Liver and Biliary Sciences, New Delhi, India.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13813']
1523,33683700,"Kinetics of Intestinal Presence of Spores Following Oral Administration of Bacillus clausii Formulations: Three Single-Centre, Crossover, Randomised, Open-Label Studies.","BACKGROUND AND OBJECTIVE: Probiotics are live microorganisms that may provide benefits including the prevention of gastrointestinal disorders and other diseases. Enterogermina is a probiotic mix of spores from four strains of Bacillus clausii (O/C, T, N/R and SIN), available in several oral formulations. The objective of this analysis was to evaluate and compare the kinetic profiles of different formulations of Enterogermina-vial [E4 once daily (OD) and E2 twice daily (BID)], capsule [EC2 three times daily (TID)], oral powder for suspension (ES6 OD) and oral powder not requiring suspension (E6 OD) from two studies from 2012 (EUDRACT 2010-024497-19 and 2010-023187-41) and one study from 2016 (EUDRACT 2015-003330-27).
METHODS


B. clausii spores were counted in homogenised faecal samples (results expressed as counts per gram) or after culture at 37 °C for 24-36 h (results expressed as colony-forming units). Kinetics were assessed by area under the concentration-time curve (AUC), maximum concentration (C max ), time to maximum concentration (T max ) and spore presence/persistence.
RESULTS


In total, 22 subjects in each of the 2012 studies and 30 subjects in the 2016 study were randomised (mean age 25.0-33.8 years across studies). The mean (±SD) absolute faecal spore counts (in millions) expressed as AUC per hour were 270.7 ± 147.7 (E2 BID) and 213.8 ± 60.2 (E4 OD) in 2012 EGKINETIC4, 312.7 ± 218.0 (EC2 TID) and 319.0 ± 221.1 (ES6 OD) in 2012 EGKINETIC6, and 212.6 ± 118.0 (E6 OD) and 293.2 ± 247.2 (ES6 OD) in 2016 EGKINETIC6OP. The kinetic profiles of the different formulations of Enterogermina were similar, with superimposable AUC and daily curve profiles in each study up to the 8th day post dose. B. clausii spore presence/persistence in the intestine of healthy volunteers did not differ between the two formulations within each of the three studies. Enterogermina was well tolerated across all formulations and studies.
CONCLUSION


These results show different formulations of Enterogermina had similar kinetic profiles within each study; however, they also showed that probiotics could be associated with high variability. The European Medicines Agency guidelines are the current bioequivalence reference, although only the T max  parameter is used for high variability drugs. Due to the specific kinetics of probiotics, new parameters of bioequivalence could be necessary, considering, for example, variability via a parameter such as AUC.
TRIAL REGISTRATION


EUDRACT 2010-024497-19, 2010-023187-41 and 2015-003330-27.",2021,B. clausii spore presence/persistence in the intestine of healthy volunteers did not differ between the two formulations within each of the three studies.,"['2010-024497-19, 2010-023187-41 and 2015-003330-27', 'healthy volunteers', 'two studies from 2012 (EUDRACT 2010-024497-19 and 2010-023187-41) and one study from 2016 (EUDRACT 2015-003330-27', '22 subjects in each of the 2012 studies and 30 subjects in the 2016 study were randomised (mean age 25.0-33.8 years across studies']","['Enterogermina-vial [E4 once daily (OD) and E2 twice daily (BID)], capsule ', 'Bacillus clausii Formulations', 'oral powder for suspension (ES6 OD) and oral powder not requiring suspension (E6 OD']","['mean (±SD) absolute faecal spore counts', 'concentration-time curve (AUC), maximum concentration (C max ), time to maximum concentration (T max ) and spore presence/persistence']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1706398', 'cui_str': 'Vial - unit of product usage'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1034048', 'cui_str': 'Bacillus clausii'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C1160731', 'cui_str': 'Oral powder'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0038026', 'cui_str': 'Spore Count'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0038027', 'cui_str': 'Spores'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}]",22.0,0.117092,B. clausii spore presence/persistence in the intestine of healthy volunteers did not differ between the two formulations within each of the three studies.,"[{'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Navarra', 'Affiliation': 'Section of Pharmacology, Department of Healthcare surveillance and Bioethics, Catholic University Medical School, Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Milleri', 'Affiliation': 'Centro Ricerche Cliniche di Verona srl, Verona, Italy.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Perez Iii', 'Affiliation': 'Global Medical, Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Uboldi', 'Affiliation': 'CHC Medical Department, Sanofi, Italy. MariaChiara.Uboldi@sanofi.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pellegrino', 'Affiliation': 'CHC Medical Department, Sanofi, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Bois De Fer', 'Affiliation': 'Sanofi Consumer Health Care Analytical and Scientific Platforms, Sanofi Clinical Sciences and Operations, Paris, France.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Morelli', 'Affiliation': 'DiSTAS, Università Cattolica del Sacro Cuore, Piacenza, CR, Italy.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-021-00676-2']
1524,33683643,Randomized controlled trial of energy healing effects on pain and anxiety in AIS posterior surgery: a pilot study.,"OBJECTIVES


Energy healing (EH) is a part of the diverse group of Complementary and Alternative Medicines (CAM). The purpose of this study was to evaluate the effects of EH therapy prior to and following posterior surgical correction for adolescent idiopathic scoliosis (AIS) compared to controls.
METHODS


Patients were prospectively randomized to one of two groups: standard operative care for surgery (controls) vs. standard care with the addition of three EH sessions. The outcomes included visual analog scales (VAS) for pain and anxiety (0-10), days until conversion to oral pain medication, and length of hospital stay. For the experimental group, VAS was assessed pre- and post-EH session.
RESULTS


Fifty patients were enrolled-28 controls and 22 EH patients. The controls had a median of 12 levels fused vs. 11 in the EH group (p = 0.04). Pre-operative thoracic and lumbar curve magnitudes were similar (p > 0.05). Overall VAS pain scores increased from pre- to post-operative (p < 0.001), whereas the VAS anxiety scores decreased immediately post-operative (p < 0.001). The control and pre-EH assessments were statistically similar. Significant decreases in VAS pain and anxiety scores from pre to post-EH assessment were noted for the EH group. Both groups transitioned to oral pain medication a median of 2 days post-operative (p = 0.11). The median days to discharge was four in the controls and three in the EH group (p = 0.07).
CONCLUSION


In this pilot study, EH therapy resulted in a decrease in patient's pre-operative anxiety. Offering this CAM modality may enhance the wellbeing of the patient and their overall recovery when undergoing posterior surgical correction for AIS.
LEVEL OF EVIDENCE


Therapeutic Level II.",2021,Both groups transitioned to oral pain medication a median of 2 days post-operative (p = 0.11).,"['Fifty patients were enrolled-28 controls and 22 EH patients', 'AIS posterior surgery', 'Patients', 'adolescent idiopathic scoliosis (AIS']","['posterior surgical correction', 'standard operative care for surgery (controls) vs. standard care with the addition of three EH sessions', 'EH therapy', 'energy healing']","['Overall VAS pain scores', 'VAS anxiety scores', 'Pre-operative thoracic and lumbar curve magnitudes', 'visual analog scales (VAS) for pain and anxiety (0-10), days until conversion to oral pain medication, and length of hospital stay', 'VAS pain and anxiety scores', 'median days to discharge', 'pain and anxiety', ""patient's pre-operative anxiety""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",50.0,0.0668645,Both groups transitioned to oral pain medication a median of 2 days post-operative (p = 0.11).,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'McNeil', 'Affiliation': ""Rady Children's Hospital, 3020 Children's Way, MC 5063, San Diego, CA, 92123, USA. nmcneil@rchsd.org.""}, {'ForeName': 'Tracey P', 'Initials': 'TP', 'LastName': 'Bastrom', 'Affiliation': ""Rady Children's Hospital, 3020 Children's Way, MC 5063, San Diego, CA, 92123, USA.""}, {'ForeName': 'Carrie E', 'Initials': 'CE', 'LastName': 'Bartley', 'Affiliation': ""Rady Children's Hospital, 3020 Children's Way, MC 5063, San Diego, CA, 92123, USA.""}, {'ForeName': 'Burt', 'Initials': 'B', 'LastName': 'Yaszay', 'Affiliation': ""Rady Children's Hospital, 3020 Children's Way, MC 5063, San Diego, CA, 92123, USA.""}, {'ForeName': 'Vidyadhar V', 'Initials': 'VV', 'LastName': 'Upasani', 'Affiliation': ""Rady Children's Hospital, 3020 Children's Way, MC 5063, San Diego, CA, 92123, USA.""}, {'ForeName': 'Peter O', 'Initials': 'PO', 'LastName': 'Newton', 'Affiliation': ""Rady Children's Hospital, 3020 Children's Way, MC 5063, San Diego, CA, 92123, USA.""}]",Spine deformity,['10.1007/s43390-021-00317-3']
1525,33674366,MIS-TLIF versus O-TLIF for single-level degenerative stenosis: study protocol for randomised controlled trial.,"INTRODUCTION


Patients with symptomatic single-level combination of degenerative stenosis and low-grade spondylolisthesis are often treated by nerve root decompression and spinal fusion. The gold standard is traditional open decompression and fusion, but minimally invasive method is more and more prevailing. However, there is lack of high-quality studies comparing these two techniques in order to obtain the advantages and certain indications to use one of these methods. The current study includes clinical, safety and radiological endpoints to determine the effectiveness of minimally invasive decompression and fusion (MIS-TLIF) over the traditional open one (O-TLIF).
METHODS AND ANALYSIS


All patients aged 40-75 years with neurogenic claudication or bilateral radiculopathy caused by single-level combination of degenerative stenosis and low-grade spondylolisthesis, confirmed by MRI with these symptoms persisting for at least 3 months prior to surgery, are eligible. Patients will be randomised into MIS-TLIF or traditional O-TLIF. The primary outcome measure is Oswestry Disability Index at 3-month follow-up term. The secondary outcomes are patient-reported outcome measures by the number of clinical scales, radiological parameters including sagittal balance parameters, safety endpoints and cost-effectiveness of each method. All patients will be analysed preoperatively, as well as on the 14th day of hospital stay (or on the day of hospital discharge), 3 months, 6 months, 12 months and 24 months postoperatively. The study has the design of a parallel group to demonstrate the non-inferior clinical results of MIS-TLIF compared with the traditional O-TLIF.
ETHICS AND DISSEMINATION


The study will be performed according to Helsinki Declaration. The study protocol was approved by the Local Ethical Committee of Priorov National Medical Research Center of Traumatology and Orthopedics in August 2020. Preliminary and final results will be presented in peer-reviewed journals, especially orthopaedic and spine surgery journals, at national and international congresses.
TRIAL REGISTRATION NUMBER


NCT04594980.",2021,"All patients aged 40-75 years with neurogenic claudication or bilateral radiculopathy caused by single-level combination of degenerative stenosis and low-grade spondylolisthesis, confirmed by MRI with these symptoms persisting for at least 3 months prior to surgery, are eligible.","['All patients aged 40-75 years with neurogenic claudication or bilateral radiculopathy caused by single-level combination of degenerative stenosis and low-grade spondylolisthesis, confirmed by MRI with these symptoms persisting for at least 3\u2009months prior to surgery, are eligible', 'Patients with symptomatic single-level combination of degenerative stenosis and low-grade spondylolisthesis']","['MIS-TLIF versus O-TLIF', 'minimally invasive decompression and fusion (MIS-TLIF', 'MIS-TLIF or traditional O-TLIF']","['Oswestry Disability Index', 'number of clinical scales, radiological parameters including sagittal balance parameters, safety endpoints and cost-effectiveness of each method']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580173', 'cui_str': 'Neurogenic claudication'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0038016', 'cui_str': 'Spondylolisthesis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0619494,"All patients aged 40-75 years with neurogenic claudication or bilateral radiculopathy caused by single-level combination of degenerative stenosis and low-grade spondylolisthesis, confirmed by MRI with these symptoms persisting for at least 3 months prior to surgery, are eligible.","[{'ForeName': 'Olga N', 'Initials': 'ON', 'LastName': 'Leonova', 'Affiliation': 'Neurosurgery Department, Novosibirsk Research Institute of Traumatology and Orthopaedics, Novosibirsk, Russian Federation onleonova@gmail.com.'}, {'ForeName': 'Evgeny A', 'Initials': 'EA', 'LastName': 'Cherepanov', 'Affiliation': 'Project Management, Biorasi, Aventura, Florida, USA.'}, {'ForeName': 'Aleksandr V', 'Initials': 'AV', 'LastName': 'Krutko', 'Affiliation': 'Neurosurgery Department, Priorov National Medical Research Center of Traumatology and Orthopedics, Mosсow, Russian Federation.'}]",BMJ open,['10.1136/bmjopen-2020-041134']
1526,33673587,Prospective Randomized Controlled Trial on the Effects of Almonds on Facial Wrinkles and Pigmentation.,"BACKGROUND


Almonds have long been studied as a rich source of fatty acids, phytochemical polyphenols and antioxidants such as vitamin E. A recent study compared almond supplementations to a calorie-matched intervention for 16 weeks, yielding statistically significant improvement in wrinkle severity in postmenopausal women with Fitzpatrick skin types I and II that received almonds. This study furthers that assessment with a larger population and duration of 24 weeks to assess the influence of almond consumption on wrinkle severity, skin pigmentation and other skin biophysical profiles.
OBJECTIVE


To investigate the effects of almond consumption on photoaging such as wrinkles and pigment intensity as well as facial biophysical parameters such as sebum production, skin hydration and water loss.
DESIGN AND INTERVENTIONS


A prospective, randomized controlled study assessed postmenopausal women with Fitzpatrick skin types I or II who consumed 20% of their daily energy consumption in either almonds or a calorie-matched snack for 24 weeks. A facial photograph and image analysis system was used to obtain standardized high-resolution photographs and information on wrinkle width and severity at 0, 8, 16 and 24 weeks. Measurements of transepidermal water loss (TEWL), skin pigmentation, skin hydration and sebum production were also completed at each visit.
RESULTS


The average wrinkle severity was significantly decreased in the almond intervention group at week 16 and week 24 compared to baseline by 15% and 16%, respectively. Facial pigment intensity was decreased 20% in the almond group at week 16 and this was maintained by week 24. There were no significant differences in skin hydration or TEWL in the almond group compared to the control, although sebum excretion was increased in the control group.
CONCLUSION


The daily consumption of almonds may improve several aspects of photoaging such as facial wrinkles and pigment intensity in postmenopausal women. In conclusion, the daily consumption of almonds may contribute to the improvement of facial wrinkles and reduction of skin pigmentation among postmenopausal women with Fitzpatrick skin types I and II.",2021,"There were no significant differences in skin hydration or TEWL in the almond group compared to the control, although sebum excretion was increased in the control group.
","['postmenopausal women', 'postmenopausal women with Fitzpatrick skin types I or II who consumed 20% of their daily energy consumption in either almonds or a calorie-matched snack for 24 weeks', 'postmenopausal women with Fitzpatrick skin types I and II', 'postmenopausal women with Fitzpatrick skin types']",['almond consumption'],"['Facial pigment intensity', 'skin pigmentation', 'wrinkle severity, skin pigmentation and other skin biophysical profiles', 'average wrinkle severity', 'sebum production, skin hydration and water loss', 'wrinkle severity', 'sebum excretion', 'transepidermal water loss (TEWL), skin pigmentation, skin hydration and sebum production', 'skin hydration or TEWL']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.0353015,"There were no significant differences in skin hydration or TEWL in the almond group compared to the control, although sebum excretion was increased in the control group.
","[{'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Rybak', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Carrington', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Dermatology, Southern Illinois University, Springfield, IL 62901, USA.'}, {'ForeName': 'Hera', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'College of Medicine, California Northstate University, Sacramento, CA 95757, USA.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Burney', 'Affiliation': 'Department of Biological Sciences, California State University, Sacramento, CA 90802, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Maloh', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Raja K', 'Initials': 'RK', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}]",Nutrients,['10.3390/nu13030785']
1527,33673568,Exploratory Efficacy of Calcium-Vitamin D Milk Fortification and Periodontal Therapy on Maternal Oral Health and Metabolic and Inflammatory Profile.,"In this 2 × 2 factorial, outcome-assessor blinded, feasibility randomised trial we explored the effect of a non-pharmaceutical multi-component intervention on periodontal health and metabolic and inflammatory profiles among pregnant women with periodontitis receiving prenatal care in a Brazilian public health centre. 69 pregnant women (gestational age ≤20 weeks, T0) were randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus periodontal therapy during pregnancy (early PT) ( n  = 17); (2) placebo sachet and powdered milk plus early PT ( n  = 15); (3) fortified sachet and powdered milk plus late PT (after delivery) ( n  = 19); (4) placebo sachet and powdered milk plus late PT ( n  = 18). Third trimester (T1) and 6-8 weeks postpartum (T2) exploratory outcomes included periodontal health (% sites with bleeding on probing (BOP)), glucose, insulin, C-Reactive Protein, serum calcium and vitamin D. The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups. No significant effect of fortification on BOP was observed. Changes in glucose levels and variation on birthweight did not differ among groups This feasibility trial provides preliminary evidence for estimating the minimum clinically important differences for selected maternal outcomes. A large-scale trial to evaluate the interventions' clinical benefits and cost-effectiveness is warranted.",2021,"The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups.","['69 pregnant women (gestational age ≤20 weeks, T0', 'pregnant women with periodontitis receiving prenatal care in a Brazilian public health centre']","['placebo sachet and powdered milk plus late PT', 'Calcium-Vitamin D Milk Fortification and Periodontal Therapy', 'non-pharmaceutical multi-component intervention', 'placebo sachet and powdered milk plus early PT ( n  = 15); (3) fortified sachet and powdered milk plus late PT', 'fortified sachet (vitamin D and calcium) and powdered milk plus periodontal therapy during pregnancy (early PT']","['periodontal health and metabolic and inflammatory profiles', 'mean BOP', 'periodontal health (% sites with bleeding on probing (BOP)), glucose, insulin, C-Reactive Protein, serum calcium and vitamin D', 'BOP', 'Maternal Oral Health and Metabolic and Inflammatory Profile']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0719107', 'cui_str': 'Calcium and vitamin D product'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",69.0,0.0645621,"The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rodrigues Amorim Adegboye', 'Affiliation': 'Faculty of Health and Life Sciences, School of Nursing, Midwifery and Health, Coventry University, Priory Street, Coventry CV1 5FB, UK.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Dias Santana', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Pedro Paulo', 'Initials': 'PP', 'LastName': 'Teixeira Dos Santos', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Guedes Cocate', 'Affiliation': 'Department of Bioscience and Physical Activity, School of Physical Education and Sports, Federal University of Rio de Janeiro, Rio de Janeiro 21941-599, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Benaim', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Maria Beatriz', 'Initials': 'MB', 'LastName': 'Trindade de Castro', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maia Schlüssel', 'Affiliation': 'The EQUATOR Network-UK Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Old Road, Oxford OX3 7LD, UK.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Kac', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Lilienthal Heitmann', 'Affiliation': 'Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, 2000 Frederiksberg, Denmark.'}]",Nutrients,['10.3390/nu13030783']
1528,33673567,Placebo Effect of Caffeine on Substrate Oxidation during Exercise.,"By using deceptive experiments in which participants are informed that they received caffeine when, in fact, they received an inert substance (i.e., placebo), several investigations have demonstrated that exercise performance can be enhanced to a similar degree as a known caffeine dose. This 'placebo effect' phenomenon may be part of the mechanisms explaining caffeine's ergogenicity in exercise. However, there is no study that has established whether the placebo effect of caffeine is also present for other benefits obtained with acute caffeine intake, such as enhanced fat oxidation during exercise. Therefore, the aim of this investigation was to investigate the placebo effect of caffeine on fat oxidation during exercise. Twelve young men participated in a deceptive double-blind cross-over experiment. Each participant completed three identical trials consisting of a step incremental exercise test from 30 to 80% of V.O 2max . In the two first trials, participants ingested either 3 mg/kg of cellulose (placebo) or 3 mg/kg of caffeine (received caffeine) in a randomized order. In the third trial, participants were informed that they had received 3 mg/kg of caffeine, but a placebo was provided (informed caffeine). Fat oxidation rates were derived from stoichiometric equations. In received caffeine, participants increased their rate of fat oxidation over the values obtained with the placebo at 30%, 40%, 50%, and 60% of V.O 2max  (all  p  < 0.050). In informed caffeine, participants increased their rate of fat oxidation at 30%, 40%, 50% 60%, and 70% of V.O 2max  (all  p  < 0.050) over the placebo, while there were no differences between received versus informed caffeine. In comparison to placebo (0.32 ± 0.15 g/min), the rate of maximal fat oxidation was higher in received caffeine (0.44 ± 0.22 g/min,  p  = 0.045) and in informed caffeine (0.41 ± 0.20 g/min,  p  = 0.026) with no differences between received versus informed caffeine. However, the intensity at which maximal fat oxidation rate was obtained (i.e., Fat max ) was similar in placebo, received caffeine, and informed caffeine trials (42.5 ± 4.5, 44.2 ± 9.0, and 41.7 ± 10.5% of V.O 2max , respectively,  p  = 0.539). In conclusion, the expectancy of having received caffeine produced similar effects on fat oxidation rate during exercise than actually receiving caffeine. Therefore, the placebo effect of caffeine is also present for the benefits of acute caffeine intake on substrate oxidation during exercise and it may be used to enhance fat oxidation during exercise in participants while reducing any risks to health that this substance may have.",2021,"In comparison to placebo (0.32 ± 0.15 g/min), the rate of maximal fat oxidation was higher in received caffeine (0.44 ± 0.22 g/min,  p  = 0.045) and in informed caffeine (0.41 ± 0.20 g/min,  p  = 0.026) with no differences between received versus informed caffeine.",['Twelve young men participated in a deceptive double-blind cross-over experiment'],"['caffeine', 'cellulose (placebo', 'placebo', 'caffeine (received caffeine', 'Caffeine', 'Placebo']","['rate of fat oxidation', 'Fat oxidation rates', 'Substrate Oxidation', 'fat oxidation rate', 'rate of maximal fat oxidation', 'intensity at which maximal fat oxidation rate']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",12.0,0.358221,"In comparison to placebo (0.32 ± 0.15 g/min), the rate of maximal fat oxidation was higher in received caffeine (0.44 ± 0.22 g/min,  p  = 0.045) and in informed caffeine (0.41 ± 0.20 g/min,  p  = 0.026) with no differences between received versus informed caffeine.","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Exercise and Sport Science, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Pozuelo, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, 28692 Villanueva de la Cañada, Spain.'}, {'ForeName': 'Millán', 'Initials': 'M', 'LastName': 'Aguilar-Navarro', 'Affiliation': 'Exercise and Sport Science, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Pozuelo, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Muñoz', 'Affiliation': 'Exercise and Sport Science, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Pozuelo, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Varillas-Delgado', 'Affiliation': 'Faculty of Medicine, Universidad Francisco de Vitoria, 28223 Pozuelo, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'Department of Medical Physiology, Faculty of Medicine, University of Granada, 18 Granada, Spain.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Roberts', 'Affiliation': 'Cambridge Centre for Sport and Exercise Sciences, School of Psychology and Sport Science, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, 28943 Fuenlabrada, Spain.'}]",Nutrients,['10.3390/nu13030782']
1529,33672449,A Training Proposal to Improve Multidirectional Running Technique in Male and Female Handball Players: A Pilot Study.,"Multidirectional running has been described as an important factor in team sports performance. The aim of the present study was to determine changes in T-test, 505 time, 10 m sprint, squat jump (SJ), countermovement jump (CMJ), countermovement jump right leg (CMJRL), and countermovement jump left leg (CMJLL) following exposure to 12 sessions over 4 weeks of a multidirectional running sprint training intervention in male and female handball players. A total of 31 handball players (15 male and 16 female) were recruited for this study and then randomly assigned to an experimental group (EG) or control group (CG). Male EG players showed improvements in 505 Preferred Side (PS) ( p  ≤ 0.05), 505 Non-Preferred Side (NPS) ( p  ≤ 0.05), and 10 m sprint ( p  ≤ 0.05), while female EG players presented statistically significant improvements between pre- and post-test for the T-test ( p  ≤ 0.05), 505 PS ( p  ≤ 0.05), 505 NPS ( p  ≤ 0.05), and 10 m sprint ( p  ≤ 0.05). No statistically significant pre- and post-test differences were observed in CG (all  p  ≥ 0.05) or between male and female players. We found an improvement in handball players' agility and speed of movement following the intervention protocol, suggesting the need to introduce this program into our training sessions. It may also be necessary to select and develop more specific tests in order to evaluate multidirectional work in handball players.",2021,"Male EG players showed improvements in 505 Preferred Side (PS) ( p  ≤ 0.05), 505 Non-Preferred Side (NPS) ( p  ≤ 0.05), and 10 m sprint ( p  ≤ 0.05), while female EG players presented statistically significant improvements between pre- and post-test for the T-test ( p  ≤ 0.05), 505 PS ( p  ≤ 0.05), 505 NPS ( p  ≤ 0.05), and 10 m sprint ( p  ≤ 0.05).","['Male and Female Handball Players', 'male and female handball players', '31 handball players (15 male and 16 female']","['experimental group (EG) or control group (CG', 'multidirectional running sprint training intervention', 'Multidirectional Running Technique', 'Multidirectional running']","['T-test, 505 time, 10 m sprint, squat jump (SJ), countermovement jump (CMJ), countermovement jump right leg (CMJRL), and countermovement jump left leg (CMJLL', ""handball players' agility and speed of movement""]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336936', 'cui_str': 'Handball'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0230415', 'cui_str': 'Structure of right lower limb'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",505.0,0.0228306,"Male EG players showed improvements in 505 Preferred Side (PS) ( p  ≤ 0.05), 505 Non-Preferred Side (NPS) ( p  ≤ 0.05), and 10 m sprint ( p  ≤ 0.05), while female EG players presented statistically significant improvements between pre- and post-test for the T-test ( p  ≤ 0.05), 505 PS ( p  ≤ 0.05), 505 NPS ( p  ≤ 0.05), and 10 m sprint ( p  ≤ 0.05).","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ferragut', 'Affiliation': 'Faculty of Medicine and Health Science, University of Alcalá, Research Group GRIGEDE, 28871 Alcalá de Henares, Spain.'}, {'ForeName': 'Román', 'Initials': 'R', 'LastName': 'Pedreira', 'Affiliation': 'Faculty of Education, University of Vigo, 36905 Pontevedra, Spain.'}, {'ForeName': 'José Julio', 'Initials': 'JJ', 'LastName': 'Espina', 'Affiliation': 'Faculty of Education, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Vila', 'Affiliation': 'Faculty of Education, University of Vigo, Research Group HealthyFit, 36905 Pontevedra, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18042056']
1530,33672229,Feasibility of a Digital Intervention to Promote Healthy Weight Management among Postpartum African American/Black Women.,"The study aim was to implement and evaluate the feasibility of a culturally informed (""BeFAB"") app for African American/Black women to address postpartum weight. Women ( n  = 136; mean age = 27.8 ± 5.4; mean BMI = 32.5 ± 4.3) were recruited from postpartum units, and randomly assigned to receive BeFAB ( n  = 65) or usual care ( n  = 71) for 12 weeks. App content included didactic lessons delivered via a virtual coach, app-based messages, goal setting and tracking, and edutainment videos. Feasibility outcomes included recruitment, retention and engagement, and self-reported acceptability. Behavioral (i.e., diet, physical activity), psychosocial (i.e., stress, coping, support, self-efficacy) and weight outcomes were also examined. Recruitment goals were met, but attrition was high, with 56% retention at 12 weeks. Approximately half of participants accessed the app and set a goal ≥one time, but <10% reported achieving a nutrition or activity goal. Among study completers, ≥60% found the app content at least somewhat helpful. Within-group changes for BeFAB among completers were found for increased moderate-to-vigorous physical activity and decreased fruit/vegetable intake and weight. Findings indicate initial feasibility of recruiting postpartum women to participate in a digital healthy body weight program but limited use, reflecting low acceptability and challenges in engagement and retention. Future research is needed on strategies to engage and retain participants in postpartum interventions.",2021,Within-group changes for BeFAB among completers were found for increased moderate-to-vigorous physical activity and decreased fruit/vegetable intake and weight.,"['Postpartum African American/Black Women', 'African American/Black women to address postpartum weight', 'Women ( n  = 136; mean age = 27.8 ± 5.4; mean BMI = 32.5 ± 4.3) were recruited from postpartum units']","['culturally informed (""BeFAB', 'didactic lessons delivered via a virtual coach, app-based messages, goal setting and tracking, and edutainment videos', 'BeFAB', 'Digital Intervention to Promote Healthy Weight Management', 'usual care']","['recruitment, retention and engagement, and self-reported acceptability', 'Behavioral (i.e., diet, physical activity), psychosocial (i.e., stress, coping, support, self-efficacy) and weight outcomes', 'moderate-to-vigorous physical activity and decreased fruit/vegetable intake and weight', 'nutrition or activity goal']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0355973,Within-group changes for BeFAB among completers were found for increased moderate-to-vigorous physical activity and decreased fruit/vegetable intake and weight.,"[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Napolitano', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Cherise B', 'Initials': 'CB', 'LastName': 'Harrington', 'Affiliation': 'Department of Public Health Education, North Carolina Central University, Durham, NC 27707, USA.'}, {'ForeName': 'Loral', 'Initials': 'L', 'LastName': 'Patchen', 'Affiliation': ""Women's and Infants' Services, Medstar Washington Hospital Center, Washington, DC 20010, USA.""}, {'ForeName': 'Lindsey P', 'Initials': 'LP', 'LastName': 'Ellis', 'Affiliation': ""Women's and Infants' Services, Medstar Washington Hospital Center, Washington, DC 20010, USA.""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Benten Technologies, Manassas, VA 20110, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Chang', 'Affiliation': 'Benten Technologies, Manassas, VA 20110, USA.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Gaminian', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Caitlin P', 'Initials': 'CP', 'LastName': 'Bailey', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'W Douglas', 'Initials': 'WD', 'LastName': 'Evans', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC 20052, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph18042178']
1531,33672151,Assessing Differences in the Implementation of Smoke-Free Contracts-A Cross-Sectional Analysis from the School Randomized Controlled Trial X:IT.,"OBJECTIVE


The X:IT study is a school-based smoking preventive intervention that has previously been evaluated in a large randomized controlled trial (RCT) with good effects. However, the actual effect for participating students depends on the individual implementation. The aim of this study was to examine the implementation of smoke-free contract, which is one of the three main intervention components. Specifically, we examined whether it was implemented equally across family occupational social class (OSC), separately for boys and girls, the joint effect of OSC and gender, and the participants' own reasons for not signing a contract.
RESULTS


Overall, the smoke-free contract was well implemented; 81.8% of pupils (total N = 2.015) signed a contract (girls 85.1, boys 78.6%). We found a social gradient among girls; more than 90% were in OSC group I vs. 75% in group VI. Among boys, however, we found no difference across OSC. Boys in all the OSC groups had about half the odds (i.e., medium OSC boys: OR = 0.48 (95% CI: 0.32-0.72) of having a smoke-free contract compared to girls from a high OSC.
CONCLUSION


future interventions should include initiatives to involve families from all OSC groups and allow for different preferences among boys and girls.",2021,"Specifically, we examined whether it was implemented equally across family occupational social class (OSC), separately for boys and girls, the joint effect of OSC and gender, and the participants' own reasons for not signing a contract.
",[],[],[],[],[],[],,0.0296713,"Specifically, we examined whether it was implemented equally across family occupational social class (OSC), separately for boys and girls, the joint effect of OSC and gender, and the participants' own reasons for not signing a contract.
","[{'ForeName': 'Lotus Sofie', 'Initials': 'LS', 'LastName': 'Bast', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestraede 6a, 1455 Copenhagen, Denmark.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Andersen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestraede 6a, 1455 Copenhagen, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Glenstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestraede 6a, 1455 Copenhagen, Denmark.'}, {'ForeName': 'Mogens Trab', 'Initials': 'MT', 'LastName': 'Damsgaard', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestraede 6a, 1455 Copenhagen, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Andersen', 'Affiliation': 'Steno Diabetes Center, Hedeager 3, 8200 Aarhus, Denmark.'}]",International journal of environmental research and public health,['10.3390/ijerph18042163']
1532,33672073,Energy Expenditure Improved Risk Factors Associated with Renal Function Loss in NAFLD and MetS Patients.,"To assess the efficacy of three lifestyle interventions on the reduction of liver fat content and metabolic syndrome (MetS), and whether such reductions would influence renal outcomes, we conducted a randomized controlled trial on 128 participants with MetS and non-alcoholic fatty liver disease (NAFLD), as well as available data on estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatine ratio (UACR). Patients were randomized in 1:1:1 ratio to either Conventional Diet, Mediterranean diet (MD)-high meal frequency, and MD-physical activity groups. Each intervention aimed at reducing caloric intake by 25%-30% of baseline intake and increase energy expenditure by 400 kcal/70 kg. Patients attended regular visits and were followed-up for 6 months. Increased albuminuria was present in 13.3% of patients, while 32.8% showed hyperfiltration. UACR reduction was associated with higher levels of UACR at baseline but not with changes in liver fat. eGFR decreased in patients presenting hyperfiltration at baseline and was associated with reduction in liver fat and insulin resistance, as well as with increase in energy expenditure (R 2  = 0.248,  p  = 0.006). No significant differences were observed between the three treatment groups. In patients with NAFLD and MetS, energy expenditure significantly reduced hepatic fat accumulation and insulin resistance, which reduced glomerular hyperfiltration. Increased albuminuria was reduced, but it was not associated with reduced liver fat.",2021,"eGFR decreased in patients presenting hyperfiltration at baseline and was associated with reduction in liver fat and insulin resistance, as well as with increase in energy expenditure (R 2  = 0.248,  p  = 0.006).",['128 participants with MetS and non-alcoholic fatty liver disease (NAFLD'],"['lifestyle interventions', 'Conventional Diet, Mediterranean diet (MD)-high meal frequency, and MD-physical activity groups']","['energy expenditure', 'glomerular filtration rate (eGFR) and urinary albumin-to-creatine ratio (UACR', 'UACR reduction', 'UACR', 'liver fat and insulin resistance', 'hepatic fat accumulation and insulin resistance', 'eGFR', 'liver fat content and metabolic syndrome (MetS', 'reduced liver fat', 'Increased albuminuria']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",128.0,0.0421536,"eGFR decreased in patients presenting hyperfiltration at baseline and was associated with reduction in liver fat and insulin resistance, as well as with increase in energy expenditure (R 2  = 0.248,  p  = 0.006).","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Abbate', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, University Research Institute of Health Sciences (IUNICS), University of the Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Catalina M', 'Initials': 'CM', 'LastName': 'Mascaró', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, University Research Institute of Health Sciences (IUNICS), University of the Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Montemayor', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, University Research Institute of Health Sciences (IUNICS), University of the Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Barbería-Latasa', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Casares', 'Affiliation': 'Radiodiagnosis Service, Red Asistencial Juaneda, 07011 Palma de Mallorca, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gómez', 'Affiliation': 'Clinical Analysis Service, University Hospital Son Espases, 07120 Palma de Mallorca, Spain.'}, {'ForeName': 'Escarlata', 'Initials': 'E', 'LastName': 'Angullo-Martinez', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, University Research Institute of Health Sciences (IUNICS), University of the Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Tejada', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, University Research Institute of Health Sciences (IUNICS), University of the Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Abete', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Angeles', 'Initials': 'MA', 'LastName': 'Zulet', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Sureda', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, University Research Institute of Health Sciences (IUNICS), University of the Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, University Research Institute of Health Sciences (IUNICS), University of the Balearic Islands, 07122 Palma de Mallorca, Spain.'}]",Nutrients,['10.3390/nu13020629']
1533,33671714,Medial Prefrontal Transcranial Direct Current Stimulation Aimed to Improve Affective and Attentional Modulation of Pain in Chronic Low Back Pain Patients.,"Chronic low back pain (CLBP) is often without clear underlying pathology. Affective disturbance and dysfunctional pain mechanisms, commonly observed in populations with CLBP, have, therefore, been suggested as potential contributors to CLBP development and maintenance. However, little consensus exists on how these features interact and if they can be targeted using non-invasive brain stimulation. In this pilot trial, 12 participants completed two phases (Active or Sham) of high-definition transcranial direct current stimulation (HD-tDCS) to the medial prefrontal cortex, applied for 20 min on three consecutive days. Clinical pain ratings, questionnaires, and sensitivity to painful cuff pressure were completed at baseline, then 4 trials of conditioned pain modulation (CPM; alone, with distraction using a Flanker task, with positive affect induction, and with negative affect induction using an image slideshow) were performed prior to HD-tDCS on Day 1 and Day 4 (24 h post-HD-tDCS). At baseline, attentional and affective manipulations were effective in inducing the desired state ( p  < 0.001) but did not significantly change the magnitude of CPM-effect. Active HD-tDCS was unable to significantly alter the magnitude of the shift in valence and arousal due to affective manipulations, nor did it alter the magnitude of CPM under any basal, attentional, or affective manipulation trial significantly on Day 4 compared to sham. The CPM-effect was greater across all manipulations on Day 1 than Day 4 ( p  < 0.02) but also showed poor reliability across days. Future work is needed to expand upon these findings and better understand how and if HD-tDCS can be used to enhance attentional and affective effects on pain modulation.",2021,"Active HD-tDCS was unable to significantly alter the magnitude of the shift in valence and arousal due to affective manipulations, nor did it alter the magnitude of CPM under any basal, attentional, or affective manipulation trial significantly on Day 4 compared to sham.","['Chronic Low Back Pain Patients', 'Chronic low back pain (CLBP', '12 participants completed two phases (Active or Sham) of']","['Medial Prefrontal Transcranial Direct Current Stimulation', 'high-definition transcranial direct current stimulation (HD-tDCS']","['Affective disturbance and dysfunctional pain mechanisms', 'Clinical pain ratings, questionnaires, and sensitivity to painful cuff pressure', 'CPM-effect']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",12.0,0.0435114,"Active HD-tDCS was unable to significantly alter the magnitude of the shift in valence and arousal due to affective manipulations, nor did it alter the magnitude of CPM under any basal, attentional, or affective manipulation trial significantly on Day 4 compared to sham.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'McPhee', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Department of Health Science and Technology, Aalborg University, 9220 Aalborg East, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Department of Health Science and Technology, Aalborg University, 9220 Aalborg East, Denmark.'}]",Journal of clinical medicine,['10.3390/jcm10040889']
1534,33671691,Antioxidant Effect of a Probiotic Product on a Model of Oxidative Stress Induced by High-Intensity and Duration Physical Exercise.,"This randomized double-blind and controlled single-center clinical trial was designed to evaluate the effect of a 6-week intake of a probiotic product (1 capsule/day) vs. a placebo on an oxidative stress model of physical exercise (high intensity and duration) in male cyclists (probiotic group,  n  = 22; placebo,  n  = 21). This probiotic included three lyophilized strains ( Bifidobacterium longum  CECT 7347,  Lactobacillus casei  CECT 9104, and  Lactobacillus rhamnosus  CECT 8361). Study variables were urinary isoprostane, serum malondialdehyde (MDA), serum oxidized low-density lipoprotein (Ox-LDL), urinary 8-hydroxy-2'-deoxiguanosine (8-OHdG), serum protein carbonyl, serum glutathione peroxidase (GPx), and serum superoxide dismutase (SOD). At 6 weeks, as compared with baseline, significant differences in 8-OHdG (Δ mean difference -10.9 (95% CI -14.5 to -7.3);  p  < 0.001), MDA (Δ mean difference -207.6 (95% CI -349.1 to -66.1;  p  < 0.05), and Ox-LDL (Δ mean difference -122.5 (95% CI -240 to -4.5);  p  < 0.05) were found in the probiotic group only. Serum GPx did not increase in the probiotic group, whereas the mean difference was significant in the placebo group (477.8 (95% CI 112.5 to 843.2);  p  < 0.05). These findings suggest an antioxidant effect of this probiotic on underlying interacting oxidative stress mechanisms and their modulation in healthy subjects. The study was registered in ClinicalTrials.gov (NCT03798821).",2021,"Serum GPx did not increase in the probiotic group, whereas the mean difference was significant in the placebo group (477.8 (95% CI 112.5 to 843.2);  ","['male cyclists (probiotic group,  n  = 22; placebo,  n  = 21', 'healthy subjects']","['probiotic product (1 capsule/day) vs. a placebo', 'Probiotic Product', 'placebo']","['Ox-LDL', '8-OHdG', ""urinary isoprostane, serum malondialdehyde (MDA), serum oxidized low-density lipoprotein (Ox-LDL), urinary 8-hydroxy-2'-deoxiguanosine (8-OHdG), serum protein carbonyl, serum glutathione peroxidase (GPx), and serum superoxide dismutase (SOD"", 'Serum GPx', 'MDA']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0949860', 'cui_str': 'Isoprostane'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0036825', 'cui_str': 'Serum protein'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]",,0.331462,"Serum GPx did not increase in the probiotic group, whereas the mean difference was significant in the placebo group (477.8 (95% CI 112.5 to 843.2);  ","[{'ForeName': 'Maravillas', 'Initials': 'M', 'LastName': 'Sánchez Macarro', 'Affiliation': 'Department of Exercise Physiology, San Antonio Catholic University of Murcia (UCAM), 30107 Murcia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Ávila-Gandía', 'Affiliation': 'Department of Exercise Physiology, San Antonio Catholic University of Murcia (UCAM), 30107 Murcia, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pérez-Piñero', 'Affiliation': 'Department of Exercise Physiology, San Antonio Catholic University of Murcia (UCAM), 30107 Murcia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cánovas', 'Affiliation': 'Department of Exercise Physiology, San Antonio Catholic University of Murcia (UCAM), 30107 Murcia, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'García-Muñoz', 'Affiliation': 'Department of Exercise Physiology, San Antonio Catholic University of Murcia (UCAM), 30107 Murcia, Spain.'}, {'ForeName': 'María Salud', 'Initials': 'MS', 'LastName': 'Abellán-Ruiz', 'Affiliation': 'Department of Exercise Physiology, San Antonio Catholic University of Murcia (UCAM), 30107 Murcia, Spain.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Victoria-Montesinos', 'Affiliation': 'Department of Exercise Physiology, San Antonio Catholic University of Murcia (UCAM), 30107 Murcia, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Luque-Rubia', 'Affiliation': 'Department of Exercise Physiology, San Antonio Catholic University of Murcia (UCAM), 30107 Murcia, Spain.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Climent', 'Affiliation': 'Research and Development Department, ADM-Biopolis, ADM, Parc Cientific Universitat de Valencia, Paterna, 46980 Valencia, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Genovés', 'Affiliation': 'Research and Development Department, ADM-Biopolis, ADM, Parc Cientific Universitat de Valencia, Paterna, 46980 Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ramon', 'Affiliation': 'Research and Development Department, ADM-Biopolis, ADM, Parc Cientific Universitat de Valencia, Paterna, 46980 Valencia, Spain.'}, {'ForeName': 'Empar', 'Initials': 'E', 'LastName': 'Chenoll', 'Affiliation': 'Research and Development Department, ADM-Biopolis, ADM, Parc Cientific Universitat de Valencia, Paterna, 46980 Valencia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'López-Román', 'Affiliation': 'Department of Exercise Physiology, San Antonio Catholic University of Murcia (UCAM), 30107 Murcia, Spain.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox10020323']
1535,33671493,Neurodevelopmental Outcomes and Gut Bifidobacteria in Term Infants Fed an Infant Formula Containing High sn-2 Palmitate: A Cluster Randomized Clinical Trial.,"A few studies suggested high stereo-specifically numbered (sn)-2 palmitate in a formula might favor the gut Bifidobacteria of infants. The initial colonization and subsequent development of gut microbiota in early life might be associated with development and later life functions of the central nervous system via the microbiota-gut-brain axis, such as children with autism. This study aims to assess the hypothesized effect of increasing the amount of palmitic acid esterified in the sn-2 position in infant formula on neurodevelopment in healthy full-term infants and to explore the association of this effect with the altered gut Bifidobacteria. One hundred and ninety-nine infants were enrolled in this cluster randomized clinical trial: 66 breast-fed (BF group) and 133 formula-fed infants who were clustered and randomly assigned to receive formula containing high sn-2 palmitate (sn-2 group,  n  = 66) or low sn-2 palmitate (control group,  n  = 67), where 46.3% and 10.3% of the palmitic acid (PA) was sn-2-palmitate, respectively. Infants' neurodevelopmental outcomes were measured by the Ages and Stages Questionnaire, third edition (ASQ-3). Stool samples were collected for the analysis of Bifidobacteria (Trial registration number: ChiCTR1800014479). At week 16, the risk of scoring close to the threshold for fine motor skills (reference: scoring above the typical development threshold) was significantly lower in the sn-2 group than the control group after adjustment for the maternal education level ( p  = 0.036) but did not differ significantly versus the BF group ( p  = 0.513). At week 16 and week 24, the sn-2 group (week 16: 15.7% and week 24: 15.6%) had a significantly higher relative abundance of fecal Bifidobacteria than the control group (week 16: 6.6%,  p  = 0.001 and week 24:11.2%,  p  = 0.028) and did not differ from the BF group (week 16: 14.4%,  p  = 0.674 and week 24: 14.9%,  p  = 0.749). At week 16, a higher relative abundance of Bifidobacteria was associated with the decreased odds of only one domain scoring close to the threshold in the formula-fed infants group (odds ratio (OR), 95% confidence interval (CI): 0.947 (0.901-0.996)). Elevating the sn-2 palmitate level in the formula improved infants' development of fine motor skills, and the beneficial effects of high sn-2 palmitate on infant neurodevelopment was associated with the increased gut Bifidobacteria level.",2021,"p  = 0.028) and did not differ from the BF group (week 16: 14.4%,  p  ","['children with autism', 'healthy full-term infants', 'One hundred and ninety-nine infants']","['66 breast-fed (BF group) and 133 formula-fed infants who were clustered and randomly assigned to receive formula containing high sn-2 palmitate (sn-2 group,  n  = 66) or low sn-2 palmitate (control', 'palmitic acid (PA', 'Infant Formula Containing High sn-2 Palmitate', 'sn)-2 palmitate', 'palmitic acid esterified']","['relative abundance of fecal Bifidobacteria', 'Neurodevelopmental Outcomes and Gut Bifidobacteria', 'gut Bifidobacteria level', 'relative abundance of Bifidobacteria', 'sn-2 palmitate level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}]",199.0,0.0662259,"p  = 0.028) and did not differ from the BF group (week 16: 14.4%,  p  ","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Zhao', 'Affiliation': 'Venke School of Public Health, Tsinghua University, Beijing 100091, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Milk Powder BU, Inner Mongolia Yili Industrial Group Co., Ltd., Hohhot 010000, China.'}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Ye', 'Affiliation': 'Milk Powder BU, Inner Mongolia Yili Industrial Group Co., Ltd., Hohhot 010000, China.'}, {'ForeName': 'Hong-Wen', 'Initials': 'HW', 'LastName': 'Su', 'Affiliation': 'Milk Powder BU, Inner Mongolia Yili Industrial Group Co., Ltd., Hohhot 010000, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Milk Powder BU, Inner Mongolia Yili Industrial Group Co., Ltd., Hohhot 010000, China.'}, {'ForeName': 'Yu-Mei', 'Initials': 'YM', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}]",Nutrients,['10.3390/nu13020693']
1536,33671385,Analysis of Effectiveness of Individual and Group Trauma-Focused Interventions for Female Victims of Intimate Partner Violence.,"Group psychological programs for intimate partner violence (IPV) survivors would seem particularly useful since they contribute to interrupting women's isolation and have cost-effectiveness advantage. This study aims to analyze whether the effectiveness of group interventions for female survivors of IPV is equivalent to that of the individual format. A cognitive-behavioral trauma-focused intervention program was applied in eight weekly sessions in Madrid (Spain) to IPV female survivors with significant posttraumatic symptoms that were randomly assigned to the individual ( n  = 25) or group ( n  = 28) intervention format. Measures of posttraumatic stress (Severity of Posttraumatic Stress Disorder Symptoms Scale), depression (Beck Depression Inventory), anxiety (Beck Anxiety Inventory), self-esteem (Rosenberg's Scale) and social support were analyzed at pre-treatment, post-treatment, and 1-, 3-, 6- and 12-months follow-ups. A total of 28.3% of women dropped out, without significant format differences. Intervention (both formats) had significant improvements with large effect sizes in posttraumatic stress (η 2 p  = 0.56), depression (η 2 p  = 0.45), anxiety (η 2 p  = 0.41) and self-esteem (η 2 p  = 0.26) that maintained in follow-ups ( p  < 0.001), without significant differences between formats. Both intervention formats had different evolutions for depression and anxiety ( p  < 0.05), with better effects in the individual format at the first post-test measurements, but the differences tended to disappear over time. Intervention was effective in improving social support, with no significant differences between formats. All in all, both formats showed similar effectiveness. The group format could be an alternative when applying psychological interventions for female IPV survivors, since it would maintain good cost-effectiveness balance, mainly in the long-term.",2021,"Both intervention formats had different evolutions for depression and anxiety ( p  < 0.05), with better effects in the individual format at the first post-test measurements, but the differences tended to disappear over time.","['IPV female survivors with significant posttraumatic symptoms', 'female survivors of IPV', 'Female Victims of Intimate Partner Violence', 'intimate partner violence (IPV) survivors']","['cognitive-behavioral trauma-focused intervention program', 'Individual and Group Trauma-Focused Interventions']","[""posttraumatic stress (Severity of Posttraumatic Stress Disorder Symptoms Scale), depression (Beck Depression Inventory), anxiety (Beck Anxiety Inventory), self-esteem (Rosenberg's Scale) and social support"", 'anxiety', 'depression and anxiety', 'depression', 'self-esteem', 'posttraumatic stress']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3873628', 'cui_str': 'Victim of intimate partner abuse'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",,0.0195272,"Both intervention formats had different evolutions for depression and anxiety ( p  < 0.05), with better effects in the individual format at the first post-test measurements, but the differences tended to disappear over time.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': 'Department Personality, Assessment and Clinical Psychology, Universidad Complutense de Madrid, 28223 Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Arinero', 'Affiliation': 'Department Personality, Assessment and Clinical Psychology, Universidad Complutense de Madrid, 28223 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Soberón', 'Affiliation': 'Department Personality, Assessment and Clinical Psychology, Universidad Complutense de Madrid, 28223 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18041952']
1537,33671217,The Influence of Friction on Design of the Type of Bracket and Its Relation to OHRQoL in Patients Who Use Multi-Bracket Appliances: A Randomized Clinical Trial.,"Background and objectives:  The aim of this study was to evaluate the influence of friction on design of the type of bracket, patients' perception of pain and the impact on their oral health-related quality of life.  Materials and Methods:  A randomized clinical trial was carried out with 90 patients (62.2% women and 37.8% men) with three kinds of fixed multi-bracket appliances: Conventional (GC), fixed multi-bracket low friction (GS) and self-ligating (GA). The VAS (Visual Analogue Scale) was used to determine pain during the first seven days of treatment at different points in time. The patients were also given the OHIP-14 (Oral Health Impact Profile) questionnaire to analyse their oral health-related quality of life (OHRQoL) after the first 30 days of treatment. The ANOVA test was used for the analysis of the variables and the post hoc Bonferroni test for the comparison between groups.  Results:  Maximum pain was observed between one and two days after the start of treatment. The GC group showed the greatest degree of pain, with maximum values (4.5 ± 2.0) at 24 h. The self-ligation brackets show lower impact on patients' oral health-related quality of life (0.8 ± 2.2,  p  < 0.01).  Conclusions:  Friction in the type of bracket influences pain and the Oral Health-Related Quality of Life of patients who use multi-bracket fixed orthodontics.",2021,"The self-ligation brackets show lower impact on patients' oral health-related quality of life (0.8 ± 2.2,  p  < 0.01).  ","['patients who use multi-bracket fixed orthodontics', '90 patients (62.2% women and 37.8% men) with three kinds of fixed multi-bracket appliances: Conventional (GC), fixed multi-bracket low friction (GS) and self-ligating (GA', 'Patients']",[],"['VAS (Visual Analogue Scale', 'Maximum pain', ""patients' oral health-related quality of life"", 'greatest degree of pain', 'OHIP-14 (Oral Health Impact Profile) questionnaire to analyse their oral health-related quality of life (OHRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162691', 'cui_str': 'Friction'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",[],"[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",90.0,0.086421,"The self-ligation brackets show lower impact on patients' oral health-related quality of life (0.8 ± 2.2,  p  < 0.01).  ","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'González-Sáez', 'Affiliation': 'Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n, 37007 Salamanca, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Antonio-Zancajo', 'Affiliation': 'Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n, 37007 Salamanca, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Montero', 'Affiliation': 'Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n, 37007 Salamanca, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Albaladejo', 'Affiliation': 'Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n, 37007 Salamanca, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Melo', 'Affiliation': 'Conservative Dentistry and Endodontics, Department of Stomatology, University of Valencia, Gascó Oliag 1, 46010 Valencia, Spain.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Garcovich', 'Affiliation': 'Department of Dentistry, European University of Valencia, Passeig de lÁlbereda, 7, 46010 Valencia, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Alvarado-Lorenzo', 'Affiliation': 'Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n, 37007 Salamanca, Spain.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57020171']
1538,33671191,Internal and External Load Variations in Young Students: Comparisons between Small-Sided Games and Small-Sided Games Combined with Strength Training during Physical Education Classes.,"The purpose of this study was to compare the effects of internal and external load in soccer small-sided games (SSGs) and a strength program based on CrossFit combined with SSGs for 7 weeks. Fifty-five students participated in this research (age: 9.04 ± 0.19 years) and were randomly assigned to SSGs ( n  = 27) or strength combined with SSGs ( n  = 29) group. Two sessions/week were implemented. The results revealed that internal load on SSGs promoted higher levels ( p  ≤ 0.001; d = 0.35) of light physical activity (PA) (12.24 cpm) compared with strength combined with SSGs (11.46) and % heart rate (%HR) max ( p  = 0.002; d = 0.48) between SSGs (96.21) regarding strength combined with SSGs (92.09). On external load, significant differences appear in total distance ( p  ≤ 0.001; d = 0.80) on SSGs (1326 m) compared with strength combined with SSGs (1004 m) and mean velocity ( p  ≤ 0.001; d = 0.63) in both groups; 2.71 km/h on SSGs and 2.26 km/h on strength combined with SSGs. The SSGs seem to be more appropriate at the beginning of sessions, but as the weeks advance, strength combined with SSGs results in improved internal load compared with SSGs.",2021,"On external load, significant differences appear in total distance ( p  ≤ 0.001; d = 0.80) on SSGs (1326 m) compared with strength combined with SSGs (1004 m) and mean velocity ( p  ≤ 0.001; d = 0.63) in both groups; 2.71 km/h on SSGs and 2.26 km/h on strength combined with SSGs.","['soccer small-sided games (SSGs', 'Young Students', 'Fifty-five students participated in this research (age: 9.04 ± 0.19 years']","['Small-Sided Games and Small-Sided Games Combined with Strength Training', 'strength combined with SSGs']","['mean velocity', 'total distance', 'heart rate', 'light physical activity (PA']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517435', 'cui_str': '0.19'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",55.0,0.0283929,"On external load, significant differences appear in total distance ( p  ≤ 0.001; d = 0.80) on SSGs (1326 m) compared with strength combined with SSGs (1004 m) and mean velocity ( p  ≤ 0.001; d = 0.63) in both groups; 2.71 km/h on SSGs and 2.26 km/h on strength combined with SSGs.","[{'ForeName': 'Juan Vicente', 'Initials': 'JV', 'LastName': 'Sierra-Ríos', 'Affiliation': 'Department of Physical Education, Arts Education, and Music, Faculty of Education, University of Castilla-La Mancha, 16001 Cuenca, Spain.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Teoldo', 'Affiliation': 'Centre of Research and Studies in Soccer, Universidade Federal de Viçosa, 36570-000 Viçosa, Brazil.'}, {'ForeName': 'Sixto', 'Initials': 'S', 'LastName': 'González-Víllora', 'Affiliation': 'Department of Physical Education, Arts Education, and Music, Faculty of Education, University of Castilla-La Mancha, 16001 Cuenca, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18041926']
1539,33671166,"Effect of Unripe Banana Flour on Gut-Derived Uremic Toxins in Individuals Undergoing Peritoneal Dialysis: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial.","In chronic kidney disease (CKD), the accumulation of gut-derived metabolites, such as indoxyl sulfate (IS), p-cresyl sulfate (pCS), and indole 3-acetic acid (IAA), has been associated with the burden of the disease. In this context, prebiotics emerge as a strategy to mitigate the accumulation of such compounds, by modulating the gut microbiota and production of their metabolites. The aim of this study was to evaluate the effect of unripe banana flour (UBF-48% resistant starch, a prebiotic) on serum concentrations of IS, pCS, and IAA in individuals undergoing peritoneal dialysis (PD). A randomized, double-blind, placebo-controlled, crossover trial was conducted. Forty-three individuals on PD were randomized to sequential treatment with UBF (21 g/day) and placebo (waxy corn starch-12 g/day) for 4 weeks, or vice versa (4-week washout). The primary outcomes were total and free serum levels of IS, pCS, and IAA. Secondary outcomes were 24 h urine excretion and dialysis removal of IS, pCS, and IAA, serum inflammatory markers [high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-α (TNF-α)], serum lipopolysaccharide LPS, and dietary intake. Of the 43 individuals randomized, 26 completed the follow-up (age = 55 ± 12 years; 53.8% men). UBF did not promote changes in serum levels of IS ( p  = 0.70), pCS ( p  = 0.70), and IAA ( p  = 0.74). Total serum IS reduction was observed in a subgroup of participants ( n  = 11; placebo: median 79.5 μmol/L (31-142) versus UBF: 62.5 μmol/L (31-133),  p  = 0.009) who had a daily UBF intake closer to that proposed in the study. No changes were observed in other secondary outcomes. UBF did not promote changes in serum levels of IS or pCS and IAA; a decrease in IS was only found in the subgroup of participants who were able to take 21g/day of the UBF.",2021,"UBF did not promote changes in serum levels of IS ( p  = 0.70), pCS ( p  = 0.70), and IAA ( p  = 0.74).","['Individuals Undergoing Peritoneal Dialysis', 'individuals undergoing peritoneal dialysis (PD', '43 individuals randomized, 26 completed the follow-up (age = 55 ± 12 years; 53.8% men', 'Forty-three individuals on PD']","['placebo', 'unripe banana flour (UBF-48% resistant starch, a prebiotic', 'UBF', 'Placebo', 'Unripe Banana Flour']","['serum levels of IS', 'serum levels of IS or pCS and IAA', 'serum concentrations of IS, pCS, and IAA', 'total and free serum levels of IS, pCS, and IAA', '24 h urine excretion and dialysis removal of IS, pCS, and IAA, serum inflammatory markers [high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-α (TNF-α)], serum lipopolysaccharide LPS, and dietary intake', 'Total serum IS reduction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021210', 'cui_str': 'Indican'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0936060', 'cui_str': 'Indoleacetic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.357392,"UBF did not promote changes in serum levels of IS ( p  = 0.70), pCS ( p  = 0.70), and IAA ( p  = 0.74).","[{'ForeName': 'Laila Santos', 'Initials': 'LS', 'LastName': 'de Andrade', 'Affiliation': 'Nutrition Program, Universidade Federal de São Paulo-UNIFESP, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Fabiana Andréa Hoffmann', 'Initials': 'FAH', 'LastName': 'Sardá', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Natalia Barros Ferreira', 'Initials': 'NBF', 'LastName': 'Pereira', 'Affiliation': 'Nutrition Program, Universidade Federal de São Paulo-UNIFESP, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Renata Rodrigues', 'Initials': 'RR', 'LastName': 'Teixeira', 'Affiliation': 'Nutrition Program, Universidade Federal de São Paulo-UNIFESP, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Silvia Daniéle', 'Initials': 'SD', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Basic Pathology, Universidade Federal do Paraná-UFPR, Curitiba 81531-980, Brazil.'}, {'ForeName': 'Jordana Dinorá', 'Initials': 'JD', 'LastName': 'de Lima', 'Affiliation': 'Department of Cell Biology, Universidade Federal do Paraná-UFPR, Curitiba 81531-980, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'Dalboni', 'Affiliation': 'Post-Graduate Program in Medicine, Universidade Nove de Julho-UNINOVE, São Paulo 01504-001, Brazil.'}, {'ForeName': 'Danilo Takashi', 'Initials': 'DT', 'LastName': 'Aoike', 'Affiliation': 'Division of Nephrology, Universidade Federal de São Paulo-UNIFESP, Rua Botucatu, 720/740, São Paulo 04023-062, Brazil.'}, {'ForeName': 'Lia Sumie', 'Initials': 'LS', 'LastName': 'Nakao', 'Affiliation': 'Department of Basic Pathology, Universidade Federal do Paraná-UFPR, Curitiba 81531-980, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Cuppari', 'Affiliation': 'Nutrition Program, Universidade Federal de São Paulo-UNIFESP, São Paulo 05508-000, Brazil.'}]",Nutrients,['10.3390/nu13020646']
1540,33671147,Resistant Starch Type 2 from Wheat Reduces Postprandial Glycemic Response with Concurrent Alterations in Gut Microbiota Composition.,"The majority of research on the physiological effects of dietary resistant starch type 2 (RS2) has focused on sources derived from high-amylose maize. In this study, we conduct a double-blind, randomized, placebo-controlled, crossover trial investigating the effects of RS2 from wheat on glycemic response, an important indicator of metabolic health, and the gut microbiota. Overall, consumption of RS2-enriched wheat rolls for one week resulted in reduced postprandial glucose and insulin responses relative to conventional wheat when participants were provided with a standard breakfast meal containing the respective treatment rolls (RS2-enriched or conventional wheat). This was accompanied by an increase in the proportions of bacterial taxa  Ruminococcus  and  Gemmiger  in the fecal contents, reflecting the composition in the distal intestine. Additionally, fasting breath hydrogen and methane were increased during RS2-enriched wheat consumption. However, although changes in fecal short-chain fatty acid (SCFA) concentrations were not significant between control and RS-enriched wheat roll consumption, butyrate and total SCFAs were positively correlated with relative abundance of  Faecalibacterium ,  Ruminoccocus ,  Roseburia , and  Barnesiellaceae . These effects show that RS2-enriched wheat consumption results in a reduction in postprandial glycemia, altered gut microbial composition, and increased fermentation activity relative to wild-type wheat.",2021,"This was accompanied by an increase in the proportions of bacterial taxa  Ruminococcus  and  Gemmiger  in the fecal contents, reflecting the composition in the distal intestine.",[],"['dietary resistant starch type 2 (RS2', 'placebo']","['fecal short-chain fatty acid (SCFA) concentrations', 'postprandial glucose and insulin responses', 'relative abundance of  Faecalibacterium ,  Ruminoccocus ,  Roseburia , and  Barnesiellaceae ', 'roll consumption, butyrate and total SCFAs', 'postprandial glycemia, altered gut microbial composition, and increased fermentation activity', 'fasting breath hydrogen and methane', 'Postprandial Glycemic Response']",[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0025617', 'cui_str': 'Methane'}]",,0.163272,"This was accompanied by an increase in the proportions of bacterial taxa  Ruminococcus  and  Gemmiger  in the fecal contents, reflecting the composition in the distal intestine.","[{'ForeName': 'Riley L', 'Initials': 'RL', 'LastName': 'Hughes', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Horn', 'Affiliation': 'Obesity and Metabolism, Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA 95616, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Finnegan', 'Affiliation': 'Department of Food Science & Technology, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newman', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Marco', 'Affiliation': 'Department of Food Science & Technology, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keim', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Kable', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA 95616, USA.'}]",Nutrients,['10.3390/nu13020645']
1541,33671093,Low Energy Availability with and without a High-Protein Diet Suppresses Bone Formation and Increases Bone Resorption in Men: A Randomized Controlled Pilot Study.,"Suppression of insulin-like growth factor 1 (IGF-1) and leptin secondary to low energy availability (LEA) may contribute to adverse effects on bone health. Whether a high-protein diet attenuates these effects has not been tested. Seven men completed three five-day conditions operationally defined as LEA (15 kcal kg fat-free mass (FFM) -1  day -1 ) with low protein (LEA-LP; 0.8 g protein·kg body weight (BW) -1 ), LEA with high protein (LEA-HP; 1.7 g protein·kg BW -1 ) and control (CON; 40 kcal·kg FFM -1 ·day -1 , 1.7 g protein·kg BW -1 ). In all conditions, participants expended 15 kcal·kg FFM -1 ·day -1  during supervised cycling sessions. Serum samples were analyzed for markers of bone turnover, IGF-1 and leptin. The decrease in leptin during LEA-LP (-65.6 ± 4.3%) and LEA-HP (-54.3 ± 16.7%) was greater than during CON (-25.4 ± 11.4%;  p  = 0.02). Decreases in P1NP ( p  = 0.04) and increases in CTX-I ( p  = 0.04) were greater in LEA than in CON, suggesting that LEA shifted bone turnover in favour of bone resorption. No differences were found between LEA-LP and LEA-HP. Thus, five days of LEA disrupted bone turnover, but these changes were not attenuated by a high-protein diet.",2021,"Decreases in P1NP ( p  = 0.04) and increases in CTX-I ( p  = 0.04) were greater in LEA than in CON, suggesting that LEA shifted bone turnover in favour of bone resorption.",['Men'],"['LEA', 'Low Energy Availability with and without a High-Protein Diet']","['LEA-HP', 'CTX-I', 'Bone Resorption', 'bone turnover', 'P1NP', 'leptin during LEA-LP']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0299583', 'cui_str': 'leptin'}]",,0.0206593,"Decreases in P1NP ( p  = 0.04) and increases in CTX-I ( p  = 0.04) were greater in LEA than in CON, suggesting that LEA shifted bone turnover in favour of bone resorption.","[{'ForeName': 'Chaise', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE 68503, USA.'}, {'ForeName': 'Laura D D', 'Initials': 'LDD', 'LastName': 'Bilek', 'Affiliation': 'College of Allied Health Professionals, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE 68503, USA.'}]",Nutrients,['10.3390/nu13030802']
1542,33683482,"nab-Paclitaxel and cisplatin followed by cisplatin and radiation (Arm 1) and nab-paclitaxel followed by cetuximab and radiation (Arm 2) for locally advanced head and neck squamous-cell carcinoma: a multicenter, non-randomized phase 2 trial.","In locally advanced head and neck squamous-cell carcinoma (LA-HNSCC), clinical complete response (cCR) at the primary site, assessed by clinical examination, after induction chemotherapy predicts for a low relapse risk after subsequent chemoradiotherapy. Prior studies showed a cCR rate of 77% with induction nanoparticle albumin-bound (nab)-paclitaxel given with cisplatin and 5-fluorouracil (APF). The primary aims of this non-randomized phase 2 trial were to determine the cCR rate after induction nab-paclitaxel and cisplatin (Arm 1) and after nab-paclitaxel monotherapy (Arm 2). Eligibility required LA-HNSCC, T2-T4 stage classification, and suitable (Arm 1) or unsuitable (Arm 2) candidates for cisplatin. Arm 1 patients received nab-paclitaxel and cisplatin, then cisplatin with radiation. Arm 2 patients received nab-paclitaxel, then cetuximab with radiation. The primary endpoint was cCR after two cycles of induction chemotherapy. Each arm enrolled forty patients. cCR at the primary site occurred in 28 patients (70%) after nab-paclitaxel and cisplatin and in 8 patients (20%) after nab-paclitaxel monotherapy. The overall clinical response rate was 98% after nab-paclitaxel and cisplatin and 90% after nab-paclitaxel monotherapy. In subset analyses, cCR rates by T stage classifications (T2, T3, T4) were 54, 86, and 69% after nab-paclitaxel and cisplatin, and 14, 11, and 26% after nab-paclitaxel. cCR rates by human papillomavirus status (p16 positive oropharynx vs other) were 72 and 64% after nab-paclitaxel and cisplatin and 35 and 9% after nab-paclitaxel. The cCR rate after nab-paclitaxel and cisplatin was similar to APF; however, the cCR rate after nab-paclitaxel monotherapy was lower. The trial was registered at ClinicalTrials.gov NCT02573493 on October 9, 2015.",2021,rates by human papillomavirus status (p16 positive oropharynx vs other) were 72 and 64% after nab-paclitaxel and cisplatin and 35 and 9% after nab-paclitaxel.,['locally advanced head and neck squamous-cell carcinoma'],"['nab-paclitaxel and cisplatin, then cisplatin with radiation', 'paclitaxel and cisplatin', 'induction nanoparticle albumin-bound (nab)-paclitaxel given with cisplatin and 5-fluorouracil (APF', 'nab-paclitaxel, then cetuximab with radiation', 'cisplatin', 'nab-Paclitaxel and cisplatin followed by cisplatin and radiation (Arm 1) and nab-paclitaxel followed by cetuximab and radiation (Arm 2', 'cCR', 'induction nab-paclitaxel and cisplatin (Arm 1) and after nab-paclitaxel monotherapy']","['cCR rate', 'overall clinical response rate', 'cCR rates', 'cCR']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3491832', 'cui_str': '(125I)APF'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0905458,rates by human papillomavirus status (p16 positive oropharynx vs other) were 72 and 64% after nab-paclitaxel and cisplatin and 35 and 9% after nab-paclitaxel.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oppelt', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ley', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, 660 South Euclid, Campus, Box 8056, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Daly', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Rich', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Randal', 'Initials': 'R', 'LastName': 'Paniello', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Jackson', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Pipkorn', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Hiram', 'Initials': 'H', 'LastName': 'Gay', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Palka', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Neupane', 'Affiliation': 'Division of Oncology, University of Kansas School of Medicine, Kansas, MO, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Powell', 'Affiliation': 'Sanford Cancer Center, Sanford Health, Sioux Falls, SD, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Spanos', 'Affiliation': 'Sanford Cancer Center, Sanford Health, Sioux Falls, SD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gitau', 'Affiliation': 'Sanford Cancer Center, Sanford Health, Fargo, ND, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Zevallos', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Wade', 'Initials': 'W', 'LastName': 'Thorstad', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA. dadkins@wustl.edu.'}]","Medical oncology (Northwood, London, England)",['10.1007/s12032-021-01479-w']
1543,33683435,"One-stage laparoscopic parenchymal sparing liver resection for bilobar colorectal liver metastases: safety, recurrence patterns and oncologic outcomes.","BACKGROUND AND PURPOSE


Laparoscopic liver resections (LLR) of bilobar colorectal liver metastases (CRLM) are challenging and the safety and long-term outcomes are unclear. In this study, the short- and long-term outcomes and recurrence patterns of one-stage LLR for bilobar CRLM were compared to single laparoscopic resection for CRLM.
METHODS


This single-center study consisted of all patients who underwent a parenchymal sparing LLR for CRLM between October 2011 and December 2018. Demographics, perioperative outcomes, short-term outcomes, oncologic outcomes and recurrence patterns were compared. Data were retrieved from a prospectively maintained database.
RESULTS


Thirty six patients underwent a LLR for bilobar CRLM and ninety patients underwent a single LLR. Demographics were similar among groups. More patients received neoadjuvant chemotherapy in the bilobar group (55.6% vs 34.4%, P = 0.03). There was no difference in conversion rate, R0 resection and transfusion rate. Blood loss and operative time were higher in the bilobar group (250 ml (IQR 150-450) vs 100 ml (IQR 50-250), P < 0.001 and 200 min (IQR 170-230) vs 130 min (IQR 100-165), P < 0.001) and hospital stay was longer (5 days (IQR 4-7) vs 4 days (IQR 3-6), P = 0.015). The bilobar group had more technically major resections (88.9% vs 56.7%, P < 0.001). Mortality was nil in both groups and major morbidity was similar (2.8% vs 3.3%, P = 1.0). There was no difference in recurrence pattern. Overall survival (OS) was similar (1 yr: 96% in both groups and 5 yr 76% vs 66%, P = 0.49), as was recurrence-free survival (RFS) (1 yr: 64% vs 73%, 3 yr: 38 vs 42%, 5 yr: 38% vs 28%, P = 0.62).
CONCLUSION


In experienced hands, LLR for bilobar CRLM can be performed safely with similar oncologic outcomes as patients who underwent a single LLR for CRLM.",2021,"The bilobar group had more technically major resections (88.9% vs 56.7%, P < 0.001).","['patients who underwent a parenchymal sparing LLR for CRLM between October 2011 and December 2018', 'Laparoscopic liver resections (LLR) of bilobar colorectal liver metastases (CRLM', 'bilobar colorectal liver metastases', 'Thirty']","['LLR', 'neoadjuvant chemotherapy', 'laparoscopic parenchymal sparing liver resection', 'single LLR']","['Overall survival (OS', 'recurrence-free survival (RFS', 'recurrence pattern', 'Mortality', 'Demographics, perioperative outcomes, short-term outcomes, oncologic outcomes and recurrence patterns', 'Blood loss and operative time', 'technically major resections', 'hospital stay', 'conversion rate, R0 resection and transfusion rate', 'major morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0444465', 'cui_str': 'Bilobar'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",36.0,0.170167,"The bilobar group had more technically major resections (88.9% vs 56.7%, P < 0.001).","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': ""D'Hondt"", 'Affiliation': 'Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium. Mathieudhondt2000@yahoo.com.'}, {'ForeName': 'Zoë', 'Initials': 'Z', 'LastName': 'Pironet', 'Affiliation': 'Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Parmentier', 'Affiliation': 'Department of Oncology and Statistics, Groeninge Hospital Kortrijk, Kortrijk, Belgium.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'De Meyere', 'Affiliation': 'Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Center Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Pottel', 'Affiliation': 'Interdisciplinary Research Center, Catholic University Leuven, Campus Kortrijk, Kortrijk, Belgium.'}, {'ForeName': 'Franky', 'Initials': 'F', 'LastName': 'Vansteenkiste', 'Affiliation': 'Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Verslype', 'Affiliation': 'Department of Gastroenterology and Hepatology, KU Leuven, Leuven, Belgium.'}]",Surgical endoscopy,['10.1007/s00464-021-08366-5']
1544,33683433,Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.,"BACKGROUND


More than 60% of patients who undergo surgery for colorectal cancer experience anxiety at some point during the perioperative period. In addition to the obvious impact on the experience of the therapeutic process, the presence of anxiety has also been associated with the appearance of complications. Virtual reality could reduce it by simulating the controlled exposure of the patient to the conscious part of the surgical process.
METHODS


Single-center randomized clinical trial (NCT04058600) in which patients who were to undergo surgery for colorectal cancer and who had not previously undergone surgery as adults were exposed, prior to hospital admission, to virtual reality software in which all perioperative phases in which the patient is awake, from admission to discharge, were recreated. The main objective was to determine the presence of pre- and post-exposure anxiety using the validated State-Trait Anxiety Inventory Scale (STAI-S) and Hospital Anxiety and Depression Scale (HADS).
RESULTS


A total of 126 patients were recruited (58 exposed, 68 unexposed). There were no differences between the groups in terms of age, gender, anesthetic risk, type of surgery. or levels of preoperative anxiety or depression. After exposure, all anxiety/depression rating scales decreased significantly.
CONCLUSIONS


The use of simulation using virtual reality can reduce perioperative anxiety in patients undergoing surgery for colorectal cancer.",2021,"There were no differences between the groups in terms of age, gender, anesthetic risk, type of surgery.","['patients undergoing surgery for colorectal cancer', 'patients who were to undergo surgery for colorectal cancer and who had not previously undergone surgery as adults', 'A total of 126 patients were recruited (58 exposed, 68 unexposed', 'patients undergoing colorectal cancer surgery']",[],"['perioperative anxiety', 'anxiety/depression rating scales', 'peri-operative anxiety', 'presence of pre- and post-exposure anxiety using the validated State-Trait Anxiety Inventory Scale (STAI-S) and Hospital Anxiety and Depression Scale (HADS', 'or levels of preoperative anxiety or depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",126.0,0.0549818,"There were no differences between the groups in terms of age, gender, anesthetic risk, type of surgery.","[{'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Turrado', 'Affiliation': 'Department of Gastrointestinal Surgery, Hospital Clínic de Barcelona, Carrer Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Yoelimar', 'Initials': 'Y', 'LastName': 'Guzmán', 'Affiliation': 'Department of Gastrointestinal Surgery, Hospital Clínic de Barcelona, Carrer Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Jiménez-Lillo', 'Affiliation': 'AIS Channel S.L., Barcelona, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Villegas', 'Affiliation': 'AIS Channel S.L., Barcelona, Spain.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'de Lacy', 'Affiliation': 'Department of Gastrointestinal Surgery, Hospital Clínic de Barcelona, Carrer Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Blanch', 'Affiliation': 'Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Balibrea', 'Affiliation': 'Department of Gastrointestinal Surgery, Hospital Clínic de Barcelona, Carrer Villarroel 170, 08036, Barcelona, Spain. balibrea@gmail.com.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lacy', 'Affiliation': 'Department of Gastrointestinal Surgery, Hospital Clínic de Barcelona, Carrer Villarroel 170, 08036, Barcelona, Spain.'}]",Surgical endoscopy,['10.1007/s00464-021-08407-z']
1545,33683419,The effect of oral melatonin supplementation on MT-ATP6 gene expression and IVF outcomes in Iranian infertile couples: a nonrandomized controlled trial.,"This study aims to evaluate the effect of melatonin supplementation on the outcomes of in vitro fertilization (IVF) and mitochondrial adenosine triphosphate production (MT-ATP6) gene expression in Iranian infertile couples. A single-blind nonrandomized controlled trial was conducted, recruiting 90 infertile couples who underwent IVF at an infertility center in Tehran, Iran. Patients who were assigned to the intervention group received melatonin as a supplementation to the standard controlled ovarian stimulation (COS). The control group received a COS protocol only. Primary outcome was the mRNA level of the MT-ATP6 gene in cumulus cells of ovarian follicles. Secondary outcomes were the mean number of mature oocytes retrieved, the embryo quality, and biochemical and clinical pregnancy rates. The mRNA level of the MT-ATP6 gene in cumulus cells between intervention and control groups was not statistically different (0.931 vs.1; P ˃ 0.05). The mean number of poor-quality embryos was significantly lower in the intervention group than that in the control group (0.27 vs. 0.80; P = 0.028). The biochemical and clinical pregnancy rates were higher in the intervention group (24% vs. 14%, P = 0.089, and 14% vs. 7%, P = 0.302, respectively); however, the difference was not significant. Melatonin supplementation did not increase the odds of clinical pregnancy and the number of mature oocytes retrieved, but significantly reduced the number of low-quality embryos. More extensive studies focusing on the level of MT-ATP6 gene expression in the oocyte or blastomere cells may further elucidate the effect of supplementation with melatonin in infertile couples who have poor clinical outcomes. Trial registration: Current Controlled Trials: IRCT2015042912307N4.",2021,The mRNA level of the MT-ATP6 gene in cumulus cells between intervention and control groups was not statistically different,"['infertile couples who have poor clinical outcomes', 'Iranian infertile couples', '90 infertile couples who underwent IVF at an infertility center in Tehran, Iran']","['melatonin', 'oral melatonin supplementation', 'melatonin as a supplementation to the standard controlled ovarian stimulation (COS', 'melatonin supplementation', 'Melatonin supplementation', 'COS protocol only']","['number of low-quality embryos', 'mRNA level of the MT-ATP6 gene in cumulus cells of ovarian follicles', 'mRNA level of the MT-ATP6 gene in cumulus cells', 'MT-ATP6 gene expression and IVF outcomes', 'odds of clinical pregnancy and the number of mature oocytes', 'biochemical and clinical pregnancy rates', 'mean number of poor-quality embryos', 'mean number of mature oocytes retrieved, the embryo quality, and biochemical and clinical pregnancy rates']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",90.0,0.215687,The mRNA level of the MT-ATP6 gene in cumulus cells between intervention and control groups was not statistically different,"[{'ForeName': 'Fatemeh Sadat', 'Initials': 'FS', 'LastName': 'Hosseini', 'Affiliation': 'School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran. Dr.fshosseini@goums.ac.ir.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Shamsipour', 'Affiliation': 'Department of Research Methodology and Data Analysis Institute for Environmental Research, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Yazdekhasti', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Akbari-Asbagh', 'Affiliation': 'Infertility center of Tehran Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Shahraki', 'Affiliation': 'Zabol University of Medical Sciences, Zabol, Iran.'}, {'ForeName': 'Seyed Hamid', 'Initials': 'SH', 'LastName': 'Aghaee-Bakhtiari', 'Affiliation': 'Bioinformatics Research Group, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Naunyn-Schmiedeberg's archives of pharmacology,['10.1007/s00210-021-02071-9']
1546,33683325,Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial.,"Importance


Community-acquired pneumonia (CAP) is a common occurrence in childhood; consequently, evidence-based recommendations for its treatment are required.
Objective


To determine whether 5 days of high-dose amoxicillin for CAP was associated with noninferior rates of clinical cure compared with 10 days of high-dose amoxicillin.
Design, Setting, and Participants


The SAFER (Short-Course Antimicrobial Therapy for Pediatric Respiratory Infections) study was a 2-center, parallel-group, noninferiority randomized clinical trial consisting of a single-center pilot study from December 1, 2012, to March 31, 2014, and the follow-up main study from August 1, 2016, to December 31, 2019 at the emergency departments of McMaster Children's Hospital and the Children's Hospital of Eastern Ontario. Research staff, participants, and outcome assessors were blinded to treatment allocation. Eligible children were aged 6 months to 10 years and had fever within 48 hours, respiratory symptoms, chest radiography findings consistent with pneumonia as per the emergency department physician, and a primary diagnosis of pneumonia. Children were excluded if they required hospitalization, had comorbidities that would predispose them to severe disease and/or pneumonia of unusual origin, or had previous β-lactam antibiotic therapy. Data were analyzed from March 1 to July 8, 2020.
Interventions


Five days of high-dose amoxicillin therapy followed by 5 days of placebo (intervention group) vs 5 days of high-dose amoxicillin followed by a different formulation of 5 days of high-dose amoxicillin (control group).
Main Outcomes and Measures


Clinical cure at 14 to 21 days.
Results


Among the 281 participants, the median age was 2.6 (interquartile range, 1.6-4.9) years (160 boys [57.7%] of 279 with sex listed). Clinical cure was observed in 101 of 114 children (88.6%) in the intervention group and in 99 of 109 (90.8%) in the control group in per-protocol analysis (risk difference, -0.016; 97.5% confidence limit, -0.087). Clinical cure at 14 to 21 days was observed in 108 of 126 (85.7%) in the intervention group and in 106 of 126 (84.1%) in the control group in the intention-to-treat analysis (risk difference, 0.023; 97.5% confidence limit, -0.061).
Conclusions and Relevance


Short-course antibiotic therapy appeared to be comparable to standard care for the treatment of previously healthy children with CAP not requiring hospitalization. Clinical practice guidelines should consider recommending 5 days of amoxicillin for pediatric pneumonia management in accordance with antimicrobial stewardship principles.
Trial Registration


ClinicalTrials.gov Identifier: NCT02380352.",2021,"Clinical cure at 14 to 21 days was observed in 108 of 126 (85.7%) in the intervention group and in 106 of 126 (84.1%) in the control group in the intention-to-treat analysis (risk difference, 0.023; 97.5% confidence limit, -0.061).
","['281 participants, the median age was 2.6 (interquartile range, 1.6-4.9) years (160 boys [57.7%] of 279 with sex listed', 'Acquired Pneumonia', 'Pediatric Community', ""single-center pilot study from December 1, 2012, to March 31, 2014, and the follow-up main study from August 1, 2016, to December 31, 2019 at the emergency departments of McMaster Children's Hospital and the Children's Hospital of Eastern Ontario"", 'Eligible children were aged 6 months to 10 years and had fever within 48 hours, respiratory symptoms, chest radiography findings consistent with pneumonia as per the emergency department physician, and a primary diagnosis of pneumonia', 'previously healthy children with CAP not requiring hospitalization', 'Children were excluded if they required hospitalization, had comorbidities that would predispose them to severe disease and/or pneumonia of unusual origin, or had previous β-lactam antibiotic therapy']","['placebo', 'SAFER (Short-Course Antimicrobial Therapy', 'amoxicillin']",['Clinical cure'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0586803', 'cui_str': 'Emergency department physician'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.376992,"Clinical cure at 14 to 21 days was observed in 108 of 126 (85.7%) in the intervention group and in 106 of 126 (84.1%) in the control group in the intention-to-treat analysis (risk difference, 0.023; 97.5% confidence limit, -0.061).
","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Pernica', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harman', 'Affiliation': 'Pediatric Emergency Research Canada, Calgary, Alberta, Canada.'}, {'ForeName': 'April J', 'Initials': 'AJ', 'LastName': 'Kam', 'Affiliation': 'Pediatric Emergency Research Canada, Calgary, Alberta, Canada.'}, {'ForeName': 'Redjana', 'Initials': 'R', 'LastName': 'Carciumaru', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Thuva', 'Initials': 'T', 'LastName': 'Vanniyasingam', 'Affiliation': ""Biostiatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.""}, {'ForeName': 'Tyrus', 'Initials': 'T', 'LastName': 'Crawford', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Dalgleish', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Slinger', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Fulford', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Main', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Smieja', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loeb', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.6735']
1547,33683300,Efficacy of a Combination of Conservative Therapies vs an Education Comparator on Clinical Outcomes in Thumb Base Osteoarthritis: A Randomized Clinical Trial.,"Importance


A combination of conservative treatments is commonly used in clinical practice for thumb base osteoarthritis despite limited evidence for this approach.
Objective


To determine the efficacy of a 6-week combination of conservative treatments compared with an education comparator.
Design, Setting, and Participants


Randomized, parallel trial with 1:1 allocation ratio among people aged 40 years and older with symptomatic and radiographic thumb base osteoarthritis in a community setting in Australia.
Interventions


The intervention group (n = 102) received education on self-management and ergonomic principles, a base-of-thumb splint, hand exercises, and diclofenac sodium, 1%, gel. The comparator group (n = 102) received education on self-management and ergonomic principles alone. Intervention use was at participants' discretion from 6 to 12 weeks.
Main Outcomes and Measures


Hand function (Functional Index for Hand Osteoarthritis; 0-30) and pain (visual analog scale; 0-100 mm) were measured at week 6 (primary time point) and week 12. An α of .027 was used at week 6 to account for co-primary outcomes.
Results


Of the 204 participants randomized, 195 (96%) and 194 (95%) completed follow-ups at 6 and 12 weeks, respectively; the mean (SD) age of the population was 65.6 (8.1) years, and 155 (76.0%) were female. At week 6, hand function improved significantly more in the intervention group than the comparator (between-group difference, -1.7 units; 97.3% CI, -2.9 to -0.5; P = .002). This trend was sustained at 12 weeks (-2.4 units; 95% CI, -3.5 to -1.3; P < .001). Pain scores improved similarly at week 6 (between-group difference, -4.2 mm; 97.3% CI, -11.3 to 3.0; P = .19). At week 12, pain reduction was significantly greater in the intervention group (-8.6 mm; 95% CI, -15.2 to -2.0; P = .01). There were 34 nonserious adverse events, all in the intervention group-mostly skin reactions and exercise-related pain exacerbations.
Conclusions and Relevance


In this randomized clinical trial of people with thumb base osteoarthritis, combined treatments provided small to medium and potentially clinically beneficial effects on hand function but not pain.
Trial Registration


Australian New Zealand Clinical Trials Registry Identifier: ACTRN12616000353493.",2021,"There were 34 nonserious adverse events, all in the intervention group-mostly skin reactions and exercise-related pain exacerbations.
","['people aged 40 years and older with symptomatic and radiographic thumb base osteoarthritis in a community setting in Australia', 'Thumb Base Osteoarthritis', 'people with thumb base osteoarthritis', '204 participants randomized, 195 (96%) and 194 (95%) completed follow-ups at 6 and 12 weeks, respectively; the mean (SD) age of the population was 65.6 (8.1) years, and 155 (76.0%) were female']","['education on self-management and ergonomic principles, a base-of-thumb splint, hand exercises, and diclofenac sodium, 1%, gel', 'Conservative Therapies vs an Education Comparator', 'education on self-management and ergonomic principles alone']","['mostly skin reactions and exercise-related pain exacerbations', 'Pain scores', 'pain reduction', 'Measures\n\n\nHand function (Functional Index for Hand Osteoarthritis; 0-30) and pain (visual analog scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C1143779', 'cui_str': '2-amino-7-deazaadenine'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0454330', 'cui_str': 'Hand exercises'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",204.0,0.210641,"There were 34 nonserious adverse events, all in the intervention group-mostly skin reactions and exercise-related pain exacerbations.
","[{'ForeName': 'Leticia A', 'Initials': 'LA', 'LastName': 'Deveza', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Robbins', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Duong', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne School of Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'The University of Queensland School of Health and Rehabilitation Sciences, Brisbane, Australia.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Hodges', 'Affiliation': 'The University of Queensland School of Health and Rehabilitation Sciences, Brisbane, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wajon', 'Affiliation': 'Macquarie University Clinic, Macquarie Hand Therapy, Macquarie University, New South Wales, Australia.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Jongs', 'Affiliation': 'Physiotherapy Department, Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Riordan', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Fu', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Win Min', 'Initials': 'WM', 'LastName': 'Oo', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': ""O'Connell"", 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jillian P', 'Initials': 'JP', 'LastName': 'Eyles', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.7101']
1548,33683177,"Designing dress (Sarbebe) for kangaroo care, the effect of kangaroo care provided with this dress on mother and newborn's comfort † .","The aims of the researchers were to design the clothes to be worn by the mothers in kangaroo care (KC) and to determine the effect of the KC provided with these clothes on the comfort of the mother and infant. This study was experimentally carried out as a methodological, randomized controlled trial for the designing of clothes for KC. Data were collected using the ""Parent and Newborn Information Form"", ""KC Comfort Scale"" and ""Newborn Comfort Behavior Scale (Comfort-Neo)"". The body temperature, heart rate, oxygen saturation, respiration rate parameters of the newborns were evaluated. The data were transferred to the IBM SPSS Statistics 23 program and evaluated. Our results showed that the KC Comfort Scale total score was 71.1 ± 14.8 in the control group and 84.0 ± 1.5 in the intervention group and ""Newborn Comfort Behavior Scale"" total scores were found to be 12.47 ± 6.90 in the control group and 8.67 ± 3.46 in the intervention group. It was determined that the KC Comfort Scale ( z : -4.785 p: 0.000) in the intervention group were significantly higher compared to the control group ( p  < 0.05). Pain ( z : -4.439 p: 0.000) and distress ( z : -4.601 p: 0.000) levels of the control group were found to be significantly higher compared to the intervention group. Sarbebe is recommended to be used in KC practices since it was concluded that maternal comfort and satisfaction was high and the pain and distress scores of the newborn were low after KC provided with Sarbebe.",2021,: -4.601 p: 0.000) levels of the control group were found to be significantly higher compared to the intervention group.,[],[],"['KC Comfort Scale total score', 'body temperature, heart rate, oxygen saturation, respiration rate parameters', 'pain and distress scores', 'Pain', 'Parent and Newborn Information Form"", ""KC Comfort Scale"" and ""Newborn Comfort Behavior Scale', 'KC Comfort Scale', 'Newborn Comfort Behavior Scale"" total scores', 'distress ( z']",[],[],"[{'cui': 'C0262705', 'cui_str': 'Kangaroo care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",23.0,0.0152392,: -4.601 p: 0.000) levels of the control group were found to be significantly higher compared to the intervention group.,"[{'ForeName': 'Hamide', 'Initials': 'H', 'LastName': 'Zengin', 'Affiliation': 'Faculty of Health Science, Department of Pediatric Nursing, Bilecik Seyh Edebali University, Bilecik, Turkey.'}, {'ForeName': 'Nursan', 'Initials': 'N', 'LastName': 'Cinar', 'Affiliation': 'Faculty of Health Science, Department of Pediatric Nursing, Sakarya University, Turkey.'}]",Health care for women international,['10.1080/07399332.2021.1893733']
1549,33683168,The Cardiovascular Health Integrated Lifestyle Diet (CHILD) Lowers LDL-Cholesterol Levels in Brazilian Dyslipidemic Pediatric Patients.,"OBJECTIVE


To analyze the impact of the CHILD-2 diet on the lipid profile of Brazilian children and adolescents with dyslipidemia.
METHODS


This is a quasi-experimental study, where 149 participants (5-17 years) with mild-to-moderate hypercholesterolemia were divided into two groups (GI: low or normal weight; n = 58 and GII: overweight; n = 91). Both groups underwent the CHILD-2 diet, characterized by 25-30% total fat and less than 7% of low-saturated fat (SF) for 6 months. Changes from baseline in the lipid profile, including Total cholesterol (TC), LDL-C, triacylglycerols and glucose concentrations, dietary and anthropometric data were examined at 3 and 6 months. Longitudinal analyses were performed using linear mixed-effects models in SAS.
RESULTS


Serum LDL-C concentrations reduced over time compared with baseline (Δ = -5.1 mg/dL; p < 0.01), with no difference between groups (p = 0.35). TC concentrations decreased by -2.0 mg/dL (p < 0.01); but no difference was observed between groups. We found no significant changes in body mass index/age Z scores after a dietary intervention compared with baseline in both groups (p = 0.94).
CONCLUSION


Despite the modest reduction, our findings confirm that children with dyslipidemia can benefit from the CHILD-2 diet combined with a healthy lifestyle.",2021,"We found no significant changes in body mass index/age Z scores after a dietary intervention compared with baseline in both groups (p = 0.94).
","['Brazilian children and adolescents with dyslipidemia', '149 participants (5-17\u2009years) with mild-to-moderate hypercholesterolemia', 'children with dyslipidemia', 'Brazilian Dyslipidemic Pediatric Patients']","['CHILD-2 diet', 'Cardiovascular Health Integrated Lifestyle Diet (CHILD']","['Serum LDL-C concentrations', 'Total cholesterol (TC), LDL-C, triacylglycerols and glucose concentrations, dietary and anthropometric data', 'TC concentrations', 'LDL-Cholesterol Levels', 'body mass index/age Z scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",149.0,0.0125081,"We found no significant changes in body mass index/age Z scores after a dietary intervention compared with baseline in both groups (p = 0.94).
","[{'ForeName': 'Simone Augusta', 'Initials': 'SA', 'LastName': 'Ribas', 'Affiliation': 'Department of Nutrition in Public Health, School of Nutrition, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Vitor Barreto', 'Initials': 'VB', 'LastName': 'Paravidino', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Joana Maia', 'Initials': 'JM', 'LastName': 'Brandão', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'Santana da Silva', 'Affiliation': 'Laboratory of Inborn Errors of Metabolism, Institute of Biological Sciences, Federal University of Pará, Pará, Brazil.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2021.1887006']
1550,33683019,"Improvement of respiratory symptoms and health-related quality of life with peramivir in influenza patients with chronic respiratory disease: Additional outcomes of a randomized, open-label study.","BACKGROUND


To compare peramivir 300 mg single-dose, peramivir 600 mg repeat-dose, and oseltamivir effects on health-related quality of life, including respiratory symptoms and general conditions, time to symptom alleviation, time to fever resolution, incidence of exacerbations, and virus titer, in influenza patients with chronic respiratory disease.
METHODS


We report additional outcomes from a 2-week, multicenter, randomized, open-label study in Japan (UMIN000030118). Influenza patients with chronic respiratory disease received intravenous peramivir (300 mg single-dose [n = 66], 600 mg repeat-dose [600 mg/d of 2 consecutive days; n = 70]) or oral oseltamivir (75 mg twice daily, 5 days; n = 72). The principal endpoint of this analysis was change from baseline to Day 14 at each time point in Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores.
RESULTS


Both peramivir regimens reduced total CAT score at Day 3 more than oseltamivir (peramivir 600 mg vs oseltamivir, P = .0032; peramivir 300 mg vs oseltamivir, P = .0203). Cough/phlegm CAT scores were most improved with peramivir 600 mg. Median time to alleviation of three respiratory symptoms was longer with peramivir 600 mg (68.9 hours) than with peramivir 300 mg (50.6 hours, hazard ratio [HR] 1.57; P = .0191) and shorter with peramivir 300 mg than oseltamivir (78.8 hours, HR 0.62; P = .0141). Alleviation of seven influenza symptoms and fever resolution was shortest with peramivir 300 mg.
CONCLUSIONS


Rapid improvement in CAT score, including cough, and shorter time to alleviation of respiratory symptoms associated with peramivir is of potential benefit to patients with chronic respiratory disease.",2021,"Median time to alleviation of three respiratory symptoms was longer with peramivir 600 mg (68.9 hours) than with peramivir 300 mg (50.6 hours, hazard ratio [HR] 1.57; P = .0191) and shorter with peramivir 300 mg than oseltamivir (78.8 hours, HR 0.62;","['patients with chronic respiratory disease', 'influenza patients with chronic respiratory disease', 'Influenza patients with chronic respiratory disease']","['oral oseltamivir', 'intravenous peramivir (300\xa0mg single-dose [n\xa0=\xa066], 600\xa0mg repeat-dose', 'peramivir 300\xa0mg single-dose, peramivir 600\xa0mg repeat-dose, and oseltamivir']","['Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores', 'Median time to alleviation of three respiratory symptoms', 'Alleviation of seven influenza symptoms and fever resolution', 'CAT score, including cough', 'total CAT score', 'Cough/phlegm CAT scores', 'respiratory symptoms and health-related quality of life with peramivir', 'health-related quality of life, including respiratory symptoms and general conditions, time to symptom alleviation, time to fever resolution, incidence of exacerbations, and virus titer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1675326', 'cui_str': 'peramivir'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C2960692', 'cui_str': 'Chronic obstructive pulmonary disease assessment test score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1675326', 'cui_str': 'peramivir'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C2713348', 'cui_str': 'Virus Titer'}]",,0.0732574,"Median time to alleviation of three respiratory symptoms was longer with peramivir 600 mg (68.9 hours) than with peramivir 300 mg (50.6 hours, hazard ratio [HR] 1.57; P = .0191) and shorter with peramivir 300 mg than oseltamivir (78.8 hours, HR 0.62;","[{'ForeName': 'Motokazu', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Chest Disease Clinical and Research Institute, Kishiwada City Hospital, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Saisho', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'NPO Sapporo Cough Asthma and Allergy Center, Sapporo, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Bando', 'Affiliation': 'Bando Internal Medicine Clinic, Hakusan, Japan.'}]",Influenza and other respiratory viruses,['10.1111/irv.12835']
1551,33683016,Unblinding in Randomized Controlled Trials: A Research Ethics Case.,"A pregnant woman was enrolled in a double-blind randomized controlled trial (RCT) in which participants were randomized to a placebo or a drug being tested to prevent a hypertensive complication. After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy. This case highlights an element of RCT procedure that has received minimal attention-whether to unblind study participants at the end of their participation. Given that unblinding is not standard practice for nonserious adverse events, what actions are justifiable for the investigators to take? To synthesize the information about this case, we used the CASES model, created by the National Center for Ethics in Health Care to analyze ethics cases. Ethical principles that guide research emphasize communication with participants and the importance of reducing harm within the constraints of the scientific goals. Participants may value knowing which drug they received for future health care decision-making. We review information about the benefits and harms of unblinding.",2021,"After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy.",['A pregnant woman'],['placebo'],['hypertensive complication'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3266050', 'cui_str': 'Hypertensive complication'}]",,0.239717,"After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy.","[{'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Research study coordinator in the Department of Psychiatry and Behavioral Sciences at Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Appelbaum', 'Affiliation': 'Dollard Professor of Psychiatry, Medicine, & Law, the director of the Division of Law, Ethics, and Psychiatry, and the director of the Center for Research on Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral Genetics at Columbia University College of Physicians & Surgeons.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Wisner', 'Affiliation': 'Norman and Helen Asher Professor of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology, and the director of the Asher Center for the Study and Treatment of Depressive Disorders at Northwestern University Feinberg School of Medicine.'}]",Ethics & human research,['10.1002/eahr.500084']
1552,33682997,The Effect of Partly Replacing Vegetable Fat with Bovine Milk Fat in Infant Formula on Postprandial Lipid and Energy Metabolism: A Proof-of-principle Study in Healthy Young Male Adults.,"SCOPE


Infant formula (IF) uses besides vegetable fats also bovine milk fat, which differs in triacylglycerol (TAG) structure. Furthermore, it differs in fatty acid (FA) composition. Whether changing fat source in IF affects postprandial energy metabolism, lipemic response and blood lipid profile is unknown.
METHODS AND RESULTS


A proof-of-principle study, with a randomized controlled double-blind cross-over design, was conducted. Twenty healthy male adults consumed drinks with either 100% vegetable fat (VEG) or 67% bovine milk fat and 33% vegetable fat (BOV), on two separate days. For a detailed insight in the postprandial responses, indirect calorimetry was performed continuously, and venous blood samples were taken every 30 minutes, until 5 hours postprandially. No differences in postprandial energy metabolism, serum lipids, lipoprotein, or chylomicron concentrations were observed between drinks. After consumption of VEG-drink C18:2n-6 in serum increased. Observed differences in chylomicron FA profile reflected differences in initial FA profile of test drinks. Serum ketone bodies concentrations increased following consumption of BOV-drink.
CONCLUSIONS


The use of bovine milk fat in IF does neither affect postprandial energy metabolism nor lipemic response in healthy adults, but alters postprandial FA profiles and ketone metabolism. Whether the exact same effects occur in infants requires experimental verification. This article is protected by copyright. All rights reserved.",2021,"No differences in postprandial energy metabolism, serum lipids, lipoprotein, or chylomicron concentrations were observed between drinks.","['Healthy Young Male Adults', 'Twenty healthy male adults', 'healthy adults']","['Partly Replacing Vegetable Fat with Bovine Milk Fat', 'consumed drinks with either 100% vegetable fat (VEG) or 67% bovine milk fat and 33% vegetable fat (BOV']","['postprandial energy metabolism, serum lipids, lipoprotein, or chylomicron concentrations', 'Serum ketone bodies concentrations', 'postprandial FA profiles and ketone metabolism', 'Postprandial Lipid and Energy Metabolism']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",20.0,0.0727774,"No differences in postprandial energy metabolism, serum lipids, lipoprotein, or chylomicron concentrations were observed between drinks.","[{'ForeName': 'Jeske Hj', 'Initials': 'JH', 'LastName': 'Hageman', 'Affiliation': 'Human and Animal Physiology, Wageningen University, de Elst 1, Wageningen, 6708, the Netherlands.'}, {'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Erdõs', 'Affiliation': 'Maastricht Centre for Systems Biology (MaCSBio), Maastricht University, Maastricht, 6200, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Keijer', 'Affiliation': 'Human and Animal Physiology, Wageningen University, de Elst 1, Wageningen, 6708, the Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Adriaens', 'Affiliation': 'Maastricht Centre for Systems Biology (MaCSBio), Maastricht University, Maastricht, 6200, the Netherlands.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'de Wit', 'Affiliation': 'Human and Animal Physiology, Wageningen University, de Elst 1, Wageningen, 6708, the Netherlands.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Stañková', 'Affiliation': '4th Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tvrzická', 'Affiliation': '4th Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Ilja Cw', 'Initials': 'IC', 'LastName': 'Arts', 'Affiliation': 'Maastricht Centre for Systems Biology (MaCSBio), Maastricht University, Maastricht, 6200, the Netherlands.'}, {'ForeName': 'Arie G', 'Initials': 'AG', 'LastName': 'Nieuwenhuizen', 'Affiliation': 'Human and Animal Physiology, Wageningen University, de Elst 1, Wageningen, 6708, the Netherlands.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000848']
1553,33682983,Evaluating the effect of ursodeoxycholic acid on total bilirubin of neonates with glucose-6-phosphate dehydrogenase deficiency complicated by indirect hyperbilirubinaemia.,"AIM


This study aimed to investigate the effect of adding ursodeoxycholic acid (UDCA) to phototherapy in neonates with glucose-6-phosphate dehydrogenase (G6PD) deficiency and hyperbilirubinaemia. G6PD deficiency is a common cause of severe hyperbilirubinaemia in neonates.
METHODS


This study was a triple blind, clinical trial study of 40 neonates with G6PD deficiency and hyperbilirubinaemia who admitted for phototherapy in hospitals affiliated to the University of Medical Sciences. The treatment group (n = 20) received UDCA 10 mg/kg (2 cc/kg) daily divided into 2 doses every 12 h. The control group (n = 20) received the same volume of placebo syrup. The drug and placebo treatments were continued until the bilirubin level dropped below 171 μmol/L. Both the control and treatment group received continuous phototherapy. Independent sample t-test, survival analysis and logrank test were used to statistically analyse the results.
RESULTS


The mean total bilirubin level was 231.9 ± 18.8 μmol/L and 184.3 ± 18.6 μmol/L in the control and intervention group respectively, 24 h after drug administration and 209.7 ± 19.3 μmol/L and 157.4 ± 16.4 μmol/L, respectively, 48 h after intervention (P < 0.05). The median length of hospitalisation in the treatment group was approximately 1 day lower than the control group (logrank test P value: <0.001).
CONCLUSION


The study showed that the addition of UDCA to phototherapy accelerates the reduction of total bilirubin level in neonates with G6PD deficiency and can reduce the duration of hospitalisation.",2021,"The median length of hospitalisation in the treatment group was approximately 1 day lower than the control group (logrank test P value: <0.001).
","['40 neonates with G6PD deficiency and hyperbilirubinaemia who admitted for phototherapy in hospitals affiliated to the University of Medical Sciences', 'neonates with glucose-6-phosphate dehydrogenase deficiency complicated by indirect hyperbilirubinaemia', 'neonates with glucose-6-phosphate dehydrogenase (G6PD) deficiency and hyperbilirubinaemia', 'neonates with G6PD deficiency']","['ursodeoxycholic acid', 'ursodeoxycholic acid (UDCA', 'UDCA', 'continuous phototherapy', 'placebo syrup']","['total bilirubin', 'duration of hospitalisation', 'median length of hospitalisation', 'bilirubin level', 'total bilirubin level', 'mean total bilirubin level']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C2939465', 'cui_str': 'Deficiency of glucose-6-phosphate dehydrogenase'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0268306', 'cui_str': 'Unconjugated hyperbilirubinemia'}, {'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}]","[{'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0536467,"The median length of hospitalisation in the treatment group was approximately 1 day lower than the control group (logrank test P value: <0.001).
","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Rezaie', 'Affiliation': 'Department of Family Medicine and Department of Pediatric Medicine and Neonatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Gholami', 'Affiliation': 'Department of Family medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Jafari', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hourvash', 'Initials': 'H', 'LastName': 'Haghighinejad', 'Affiliation': 'Department of Family medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of paediatrics and child health,['10.1111/jpc.15411']
1554,33682970,Effects of air purification of indoor PM 2.5  on the cardiorespiratory biomarkers in young healthy adults.,"Ambient fine particulate matter (PM 2.5  ), as one of the predominant air pollutants, has achieved effective control in recent years in China. Whether the use of indoor air purifiers is still necessary needs further exploration. A randomized crossover trial was conducted in 54 healthy students in Beijing, China. Participants were randomized assigned to the use of real or sham high-efficiency particulate air filter (HEPA) for a week and changed the status after a washout period. Health measurements of cardiorespiratory biomarkers were performed at the end of each period. Linear mixed-effects models were used to evaluate the association between PM 2.5  exposure and cardiorespiratory biomarkers. Compared with sham air purification, average diastolic blood pressure (DBP), fractional exhaled nitric oxide (FeNO), and 8-isoprostane (8-isoPGF2α) levels decreased significantly in the real purification. The effects of indoor air purification on lung function indicators including forced expiratory volume in one second (FEV 1  ), peak expiratory flow (PEF), and forced expiratory flow between the 25th and 75th percentile of forced vital capacity (FEF 25%-75%  ) were also significant. Our findings showed a protective effect of indoor HEPA air purifiers on cardiorespiratory health of young healthy adults reflected by the decreased blood pressure, respiratory inflammation, and systematic oxidative stress and improved lung function.",2021,"Compared with sham air purification, average diastolic blood pressure (DBP), fractional exhaled nitric oxide (FeNO), and 8-isoprostane (8-isoPGF2α) levels decreased significantly in the real purification.","['young healthy adults', '54 healthy students in Beijing, China']","['indoor air purification', 'air purification of indoor PM 2.5', 'indoor HEPA air purifiers', 'real or sham high-efficiency particulate air filter (HEPA']","['average diastolic blood pressure (DBP), fractional exhaled nitric oxide (FeNO), and 8-isoprostane (8-isoPGF2α) levels', 'blood pressure, respiratory inflammation, and systematic oxidative stress and improved lung function', 'lung function indicators including forced expiratory volume in one second (FEV 1  ), peak expiratory flow (PEF), and forced expiratory flow between the 25th and 75th percentile of forced vital capacity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0243114', 'cui_str': 'purification'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0262774', 'cui_str': 'Air Purifier'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0180861', 'cui_str': 'Air filter'}]","[{'cui': 'C1282163', 'cui_str': 'Average diastolic blood pressure'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",54.0,0.0144764,"Compared with sham air purification, average diastolic blood pressure (DBP), fractional exhaled nitric oxide (FeNO), and 8-isoprostane (8-isoPGF2α) levels decreased significantly in the real purification.","[{'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Occupational and Environmental Health Science, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational and Environmental Health Science, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Occupational and Environmental Health Science, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""Department of Occupational and Environmental Health School of Public Health, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Occupational and Environmental Health Science, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Guoxing', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Occupational and Environmental Health Science, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health Science, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Science, Peking University School of Public Health, Beijing, China.'}]",Indoor air,['10.1111/ina.12815']
1555,33682694,Comparison of the effects of extracorporeal shockwave treatment with kinesiological taping treatments added to exercise treatment in myofascial pain syndrome.,"BACKGROUND


Although studies examined kinesiological taping (KT) and extracorporeal shock wave therapy (ESWT) in myofascial pain syndrome (MPS), no study has yet compared these two treatments.
OBJECTIVE


This study aimed to compare the efficacy of KT and ESWT on pain, pain threshold, functional level and neck movements in the treatment of MPS, which is an important cause of disability and constitutes 50-80% of chronic painful diseases.
METHODS


Two hundred and sixty-two patients diagnosed with MPS in the upper part of the unilateral trapeze muscle were included in the study. The patients were divided into three groups according to the treatment they received: Group 1 (n= 75): ESWT + exercise, Group 2 (n= 82): KT + exercise, Group 3 (n= 105) and the latter receiving only exercise therapy (control group). Visual analog scale (VAS), pain threshold with algometer, Neck Disability Index (NDI), and neck contralateral lateral flexion angle were assessed before and three months after treatment.
RESULTS


VAS, pain threshold, NDI and contralateral flexion angle values after treatment improved significantly in the ESWT and KT groups (p< 0.05) compared to the control group. The level of improvement in the ESWT group was higher (p< 0.05) than in the KT group in terms of VAS, pain threshold and NDI scores.
CONCLUSION


Exercise, KT and ESWT applications in MPS were effective in all of the parameters examined. However, the ESWT + exercise therapy was more effective in terms of pain, pain threshold and disability.",2021,"RESULTS


VAS, pain threshold, NDI and contralateral flexion angle values after treatment improved significantly in the ESWT and KT groups (p< 0.05) compared to the control group.","['Two hundred and sixty-two patients diagnosed with MPS in the upper part of the unilateral trapeze muscle were included in the study', 'myofascial pain syndrome (MPS', 'myofascial pain syndrome']","['extracorporeal shockwave', 'kinesiological taping (KT) and extracorporeal shock wave therapy (ESWT', 'KT and ESWT', 'KT + exercise, Group 3 (n= 105) and the latter receiving only exercise therapy (control group', 'Exercise, KT and ESWT', 'exercise treatment', 'ESWT + exercise', 'ESWT + exercise therapy', 'kinesiological taping treatments']","['pain, pain threshold, functional level and neck movements', 'VAS, pain threshold and NDI scores', 'pain, pain threshold and disability', 'VAS, pain threshold, NDI and contralateral flexion angle values', 'Visual analog scale (VAS), pain threshold with algometer, Neck Disability Index (NDI), and neck contralateral lateral flexion angle']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1286126', 'cui_str': 'Movement of neck'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}]",262.0,0.0221989,"RESULTS


VAS, pain threshold, NDI and contralateral flexion angle values after treatment improved significantly in the ESWT and KT groups (p< 0.05) compared to the control group.","[{'ForeName': 'Ümit', 'Initials': 'Ü', 'LastName': 'Yalçın', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200234']
1556,33682693,The influence of Kinesio Taping on muscle fatigue in individuals with low back pain: A randomised controlled trial.,"OBJECTIVE


To evaluate the effect of different taping techniques on back muscle fatigue in people with low back pain.
METHODS


Sixty women with chronic non-specific low back pain were randomly assigned to four groups of 15 participants each: control (CG), Kinesio Taping (KT) with tension (KTT), KT no tension (KTNT) and Micropore® (MP), which were applied over the erector spinae muscles. The median frequency (MF) fatigue slopes of the longissimus muscle and sustained contraction time during a trunk fatigue test (Ito test), and pain using the numerical pain rating scale (NPRS) were collected at three time points: pre-treatment, three and ten days after intervention at a university laboratory.
RESULTS


Significant differences were seen in the MF slopes between groups (p= 0.01, η2= 0.20), with the KTT showing a mean difference (MD = 0.31, p= 0.04) and KTNT (MD = 0.28, p= 0.04) compared with CG. Significant reductions in NPRS were seen between time points (p< 0.001, η2= 0.28), with a reduction between pre and 3 days (MD = 1.87, p< 0.001), and pre and 10 days (MD = 1.38, p< 0.001), with KTT and KTNT both showing clinically important changes.
CONCLUSION


KT, with or without tension, has a tendency to reduce back muscle fatigue and reduce pain in individuals with chronic non-specific low back pain.",2021,"Significant reductions in NPRS were seen between time points (p< 0.001, η2= 0.28), with a reduction between pre and 3 days (MD = 1.87, p< 0.001), and pre and 10 days (MD = 1.38, p< 0.001), with KTT and KTNT both showing clinically important changes.
","['people with low back pain', 'individuals with chronic non-specific low back pain', 'Sixty women with chronic non-specific low back pain', 'individuals with low back pain']","['control (CG), Kinesio Taping (KT) with tension (KTT), KT no tension (KTNT) and Micropore® (MP', 'taping techniques', 'Kinesio Taping']","['median frequency (MF) fatigue slopes of the longissimus muscle and sustained contraction time during a trunk fatigue test (Ito test), and pain using the numerical pain rating scale (NPRS', 'MF slopes', 'back muscle fatigue', 'NPRS', 'muscle fatigue']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022283', 'cui_str': 'Incontinentia pigmenti achromians syndrome'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]",60.0,0.103562,"Significant reductions in NPRS were seen between time points (p< 0.001, η2= 0.28), with a reduction between pre and 3 days (MD = 1.87, p< 0.001), and pre and 10 days (MD = 1.38, p< 0.001), with KTT and KTNT both showing clinically important changes.
","[{'ForeName': 'Liane Brito', 'Initials': 'LB', 'LastName': 'Macedo', 'Affiliation': 'Faculty of Health Sciences of Trairí, Federal University of Rio Grande do Norte, Santa Cruz, Brazil.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Richards', 'Affiliation': 'Allied Health Research unit, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Daniel Tezoni', 'Initials': 'DT', 'LastName': 'Borges', 'Affiliation': 'Physiotherapy Department, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Samara Alencar', 'Initials': 'SA', 'LastName': 'Melo', 'Affiliation': 'Physiotherapy Department, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Daniela Dantas', 'Initials': 'DD', 'LastName': 'Reis', 'Affiliation': 'Technology Center, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Jamilson Simões', 'Initials': 'JS', 'LastName': 'Brasileiro', 'Affiliation': 'Physiotherapy Department, Federal University of Rio Grande do Norte, Natal, Brazil.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200207']
1557,33682678,An open label trial of anakinra to prevent respiratory failure in COVID-19.,"Background  It was studied if early suPAR-guided anakinra treatment can prevent severe respiratory failure (SRF) of COVID-19.
Methods  130 patients with suPAR ≥6 ng/ml were assigned to subcutaneous anakinra 100mg once daily for 10 days. Primary outcome was SRF incidence by day 14 defined as any respiratory ratio below 150 mmHg necessitating mechanical or non-invasive ventilation. Main secondary outcomes were 30-day mortality and inflammatory mediators; 28-day WHO-CPS was explored. Propensity-matched standard-of care comparators were studied.
Results  22.3% with anakinra treatment and 59.2% comparators (hazard ratio, 0.30; 95%CI, 0.20-0.46) progressed into SRF; 30-day mortality was 11.5% and 22.3% respectively (hazard ratio 0.49; 95% CI 0.25-0.97). Anakinra was associated with decrease in circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio on day 7 was inversely associated with SOFA score; patients were allocated to less severe WHO-CPS strata.
Conclusions  Early suPAR-guided anakinra decreased SRF and restored the pro-/anti-inflammatory balance.
Trial Registration:  ClinicalTrials.gov, NCT04357366.",2021,"Anakinra was associated with decrease in circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio on day 7 was inversely associated with SOFA score; patients were allocated to less severe WHO-CPS strata.
",['130 patients with suPAR ≥6 ng/ml'],['subcutaneous anakinra'],"['circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio', '30-day mortality and inflammatory mediators; 28-day WHO-CPS', 'SRF; 30-day mortality', 'SRF incidence by day 14 defined as any respiratory ratio below 150 mmHg necessitating mechanical or non-invasive ventilation']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0429743', 'cui_str': 'Respiratory ratio'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]",130.0,0.399825,"Anakinra was associated with decrease in circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio on day 7 was inversely associated with SOFA score; patients were allocated to less severe WHO-CPS strata.
","[{'ForeName': 'Evdoxia', 'Initials': 'E', 'LastName': 'Kyriazopoulou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Panagopoulos', 'Affiliation': '2nd Department of Internal Medicine, Democritus University of Thrace, Medical School, Alexandroupolis, Greece.'}, {'ForeName': 'Symeon', 'Initials': 'S', 'LastName': 'Metallidis', 'Affiliation': '1st Department of Internal Medicine, Aristotle University of Thessaloniki, Medical School, Thessaloniki, Greece.'}, {'ForeName': 'George N', 'Initials': 'GN', 'LastName': 'Dalekos', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Garyphallia', 'Initials': 'G', 'LastName': 'Poulakou', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Gatselis', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Karakike', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saridaki', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Loli', 'Affiliation': '1st Department of Internal Medicine, Aristotle University of Thessaloniki, Medical School, Thessaloniki, Greece.'}, {'ForeName': 'Aggelos', 'Initials': 'A', 'LastName': 'Stefos', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Danai', 'Initials': 'D', 'LastName': 'Prasianaki', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Georgiadou', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Tsachouridou', 'Affiliation': '1st Department of Internal Medicine, Aristotle University of Thessaloniki, Medical School, Thessaloniki, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Petrakis', 'Affiliation': '2nd Department of Internal Medicine, Democritus University of Thrace, Medical School, Alexandroupolis, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsiakos', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kosmidou', 'Affiliation': '1st Department of Internal Medicine, Univeristy of Ioannina School of Medicine, Ioannina, Greece.'}, {'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Lygoura', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dareioti', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Haralampos', 'Initials': 'H', 'LastName': 'Milionis', 'Affiliation': '1st Department of Internal Medicine, University of Ioannina, School of Health Sciences, Faculty of Medicine, Ioannina, Greece.'}, {'ForeName': 'Ilias C', 'Initials': 'IC', 'LastName': 'Papanikolaou', 'Affiliation': 'Department of Pulmonary Medicine, General Hospital of Kerkyra, Corfou, Greece.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Akinosoglou', 'Affiliation': 'University of Patras, Rion, Greece.'}, {'ForeName': 'Dimitra-Melia', 'Initials': 'DM', 'LastName': 'Myrodia', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Areti', 'Initials': 'A', 'LastName': 'Gravvani', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Aliki', 'Initials': 'A', 'LastName': 'Stamou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Gkavogianni', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Katrini', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Marantos', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Ioannis P', 'Initials': 'IP', 'LastName': 'Trontzas', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Syrigos', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Loukas', 'Initials': 'L', 'LastName': 'Chatzis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Stamatios', 'Initials': 'S', 'LastName': 'Chatzis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Vechlidis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Avgoustou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Stamatios', 'Initials': 'S', 'LastName': 'Chalvatzis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Miltiades', 'Initials': 'M', 'LastName': 'Kyprianou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Jos Wm', 'Initials': 'JW', 'LastName': 'van der Meer', 'Affiliation': 'Internal Medicine, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Eugen-Olsen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Internal Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}]",eLife,['10.7554/eLife.66125']
1558,33682648,"An individualized treatment rule to optimize probability of remission by continuation, switching, or combining antidepressant medications after failing a first-line antidepressant in a two-stage randomized trial.","BACKGROUND


There is growing interest in using composite individualized treatment rules (ITRs) to guide depression treatment selection, but best approaches for doing this are not widely known. We develop an ITR for depression remission based on secondary analysis of a recently published trial for second-line antidepression medication selection using a cutting-edge ensemble machine learning method.
METHODS


Data come from the SUN(^_^)D trial, an open-label, assessor blinded pragmatic trial of previously-untreated patients with major depressive disorder from 48 clinics in Japan. Initial clinic-level randomization assigned patients to 50 or 100 mg/day sertraline. We focus on the 1549 patients who failed to remit within 3 weeks and were then rerandomized at the individual-level to continuation with sertraline, switching to mirtazapine, or combining mirtazapine with sertraline. The outcome was remission 9 weeks post-baseline. Predictors included socio-demographics, clinical characteristics, baseline symptoms, changes in symptoms between baseline and week 3, and week 3 side effects.
RESULTS


Optimized treatment was associated with significantly increased cross-validated week 9 remission rates in both samples [5.3% (2.4%), p = 0.016 50 mg/day sample; 5.1% (2.7%), p = 0.031 100 mg/day sample] compared to randomization (30.1-30.8%). Optimization was also associated with significantly increased remission in both samples compared to continuation [24.7% in both: 11.2% (3.8%), p = 0.002 50 mg/day sample; 11.7% (3.9%), p = 0.001 100 mg/day sample]. Non-significant gains were found for optimization compared to switching or combining.
CONCLUSIONS


An ITR can be developed to improve second-line antidepressant selection, but replication in a larger study with more comprehensive baseline predictors might produce stronger and more stable results.",2021,"RESULTS


Optimized treatment was associated with significantly increased cross-validated week 9 remission rates in both samples [5.3% (2.4%), p = 0.016 50 mg/day sample; 5.1% (2.7%), p = 0.031 100 mg/day sample] compared to randomization (30.1-30.8%).","['previously-untreated patients with major depressive disorder from 48 clinics in Japan', '1549 patients who failed to remit within 3 weeks and were then rerandomized at the individual-level to continuation with']","['sertraline, switching to mirtazapine, or combining mirtazapine with sertraline', 'sertraline']","['cross-validated week 9 remission rates', 'socio-demographics, clinical characteristics, baseline symptoms, changes in symptoms', 'remission']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",1549.0,0.155851,"RESULTS


Optimized treatment was associated with significantly increased cross-validated week 9 remission rates in both samples [5.3% (2.4%), p = 0.016 50 mg/day sample; 5.1% (2.7%), p = 0.031 100 mg/day sample] compared to randomization (30.1-30.8%).","[{'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Kessler', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Aratama Kokorono Clinic, Nagoya, Japan.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Luedtke', 'Affiliation': 'Department of Statistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Petukhova', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Sadikova', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Sampson', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.'}]",Psychological medicine,['10.1017/S0033291721000027']
1559,33682640,"Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection.","Objective : Given the urgent need for strategies to minimize the damage caused by this pandemic, this study performed a randomized, double-blind phase 2 study to assess the safety of the effectiveness of chloroquine (CQ), hydroxychloroquine (HCQ) or ivermectin in severe forms of COVID-19, in addition to identifying predictors of mortality in this group of patients. Methods : Phase 2, double-blind, randomized study to assess the safety and efficacy of enteral CQ, HCQ or ivermectin in patients hospitalized for SARS-CoV-2 infection, admitted to a Reference Hospital in Roraima (Brazil) in may 2020. Patients were randomized in a 1:1:1 ratio. The endpoints were need of supplemental O 2 , invasive ventilation, admission in ICU and death. The study was approved by an independent IRB. Results : 168 patients were randomized. The mean age was 53.4 years (±15.6), most participants were male ( n  = 95; 58.2%). Therapy with corticosteroid, anticoagulant or antibiotics was a decision of the attending physicians, and there was no difference between the groups. The mortality was similar in three groups (22.2%; 21.3% and 23.0%) suggesting ineffectiveness of the drugs. No difference in the incidence of serious adverse events were observed. To be older than 60 years of age, obesity, diabetes, extensive pulmonary involvement and low SaO 2  at hospital admission due to independent risk factors for mortality. Conclusion : Although CQ, HCQ or ivermectin revealed a favorable safety profile, the tested drugs do not reduce the need for supplemental oxygen, ICU admission, invasive ventilation or death, in patients hospitalized with a severe form of COVID-19.",2021,The mortality was similar in three groups (22.2%; 21.3% and 23.0%) suggesting ineffectiveness of the drugs.,"['older than 60\xa0years of age, obesity, diabetes, extensive pulmonary involvement and low\xa0SaO 2 \xa0at hospital admission due to independent risk factors for mortality', 'patients hospitalized with a\xa0severe form of COVID-19', 'hospitalized patients with severe manifestations of SARS-CoV-2 infection', 'The mean age was 53.4\xa0years (±15.6), most participants were male ( n \xa0=\xa095; 58.2', 'patients hospitalized for SARS-CoV-2 infection, admitted to a\xa0Reference Hospital in Roraima (Brazil) in may 2020', '168 patients were randomized']","['chloroquine, hydroxychloroquine or ivermectin', 'chloroquine (CQ), hydroxychloroquine (HCQ) or ivermectin', 'enteral CQ, HCQ or ivermectin', 'CQ, HCQ or ivermectin', 'corticosteroid, anticoagulant or antibiotics']","['supplemental oxygen, ICU admission, invasive ventilation or death', 'mortality', 'safety and efficacy', 'incidence of serious adverse events', 'need of supplemental\xa0O 2 ,\xa0invasive ventilation, admission in ICU and death']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",168.0,0.31795,The mortality was similar in three groups (22.2%; 21.3% and 23.0%) suggesting ineffectiveness of the drugs.,"[{'ForeName': 'Luis Enrique Bermejo', 'Initials': 'LEB', 'LastName': 'Galan', 'Affiliation': 'Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.'}, {'ForeName': 'Nayara Melo Dos', 'Initials': 'NMD', 'LastName': 'Santos', 'Affiliation': 'Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.'}, {'ForeName': 'Mauro Shosuka', 'Initials': 'MS', 'LastName': 'Asato', 'Affiliation': 'Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.'}, {'ForeName': 'Jucineide Vieira', 'Initials': 'JV', 'LastName': 'Araújo', 'Affiliation': 'Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'de Lima Moreira', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Aléxia Mahara Marques', 'Initials': 'AMM', 'LastName': 'Araújo', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Artur Diogenes Pinheiro', 'Initials': 'ADP', 'LastName': 'Paiva', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Diego Guilherme Santos', 'Initials': 'DGS', 'LastName': 'Portella', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Frank Silas Saldanha', 'Initials': 'FSS', 'LastName': 'Marques', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Gabriel Melo Alexandre', 'Initials': 'GMA', 'LastName': 'Silva', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'de Sousa Resende', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Marycassiely Rodrigues', 'Initials': 'MR', 'LastName': 'Tizolim', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Poliana Lucenados', 'Initials': 'PL', 'LastName': 'Santos', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Steffi Ferreira', 'Initials': 'SF', 'LastName': 'Buttenbender', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Stephanye Batista', 'Initials': 'SB', 'LastName': 'de Andrade', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Roberto Carlos Cruz', 'Initials': 'RCC', 'LastName': 'Carbonell', 'Affiliation': 'Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.'}, {'ForeName': 'Juliana Gomes', 'Initials': 'JG', 'LastName': 'Da Rocha', 'Affiliation': 'Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.'}, {'ForeName': 'Ruy Guilherme Silveira', 'Initials': 'RGS', 'LastName': 'de Souza', 'Affiliation': 'Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.'}, {'ForeName': 'Allex Jardim', 'Initials': 'AJ', 'LastName': 'da Fonseca', 'Affiliation': 'Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.'}]",Pathogens and global health,['10.1080/20477724.2021.1890887']
1560,33682627,Behavioural effects of light intervention in people with Korsakoff Syndrome: A pilot study.,"Korsakoff Syndrome (KS) is commonly associated with behavioural symptoms such as agitation, apathy, and disinhibition. People with KS often reside in long-term care facilities, which reduces their exposure to natural light. Little is known regarding positive effects of light intervention in KS. Our objective was to evaluate the influence of a dawn simulation therapy on behavioural symptoms in KS. 38 patients residing in a 24-hour care facility were exposed for 6 weeks to a dawn simulation system in their bedrooms, which gradually increased from 0 lux to 290 lux. Behavioural symptoms were measured over 9 weeks. Weeks 1-3 consisted of the baseline phase and weeks 3-9 consisted of the light intervention phase. Our study showed that total severity of neuropsychiatric symptoms was less prominent during light intervention. More specifically, a decrease on the apathy, disinhibition, behaviour at night and appetite and eating behaviour subscales was found during the light intervention phase compared to the baseline phase. Additionally, a significant effect was found on decreasing emotional distress for caregivers. Results suggest that light intervention therapy has a positive effect on reducing behavioural symptoms in KS as well as the levels of stress experienced by the patients' caregivers.",2021,"More specifically, a decrease on the apathy, disinhibition, behaviour at night and appetite and eating behaviour subscales was found during the light intervention phase compared to the baseline phase.","['people with Korsakoff Syndrome', '38 patients residing in a 24-hour care facility']","['dawn simulation therapy', 'light intervention therapy', 'light intervention']","['apathy, disinhibition, behaviour at night and appetite and eating behaviour subscales', 'Behavioural symptoms', 'emotional distress', 'total severity of neuropsychiatric symptoms', 'behavioural symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0349464', 'cui_str': ""Korsakoff's psychosis""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}]",,0.0585221,"More specifically, a decrease on the apathy, disinhibition, behaviour at night and appetite and eating behaviour subscales was found during the light intervention phase compared to the baseline phase.","[{'ForeName': 'Misha J', 'Initials': 'MJ', 'LastName': 'Oey', 'Affiliation': 'Lelie Care Group, Slingedael Korsakoff Center, Rotterdam, Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Postma', 'Affiliation': 'Lelie Care Group, Slingedael Korsakoff Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hoes', 'Affiliation': 'Experimental Psychology, Helmholtz Institute, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Oudman', 'Affiliation': 'Lelie Care Group, Slingedael Korsakoff Center, Rotterdam, Netherlands.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2021.1890623']
1561,33682614,Impact of Reduction in Drinking vs. complete Cessation on the Severity and Type of Alcohol-Related Problems in Women Living with HIV.,"BACKGROUND


Women living with HIV (WLWH) often report heavy alcohol use and may experience substantial alcohol-related problems, but it is unclear whether it is necessary to completely quit drinking to reduce such problems.
OBJECTIVES


To assess whether complete reduction of alcohol use produced significantly greater improvement in alcohol-related problems than a partial reduction of alcohol use (reducing alcohol use to ≤7 or ≤14 drinks per week).
METHODS


We used data from a randomized clinical trial examining the effectiveness of Naltrexone in WLWH who reported heavy drinking (>7 drinks/week) at baseline. The primary outcome (alcohol-related problems) was measured using the Short Inventory of Problems. The primary predictor (drinking status: quit drinking, reduced drinking, continue heavy drinking) was measured using a 30-day timeline followback.
RESULTS


The sample consisted of 163 WLWH (50% 50 years or older, 85% Black). WLWH who reported past violence had significantly greater mean SIP scores at baseline (19.9 vs. 10.5,  p <.0001). Forty-eight percent of women quit drinking by 7 months and 28% reduced drinking to ≤7 drinks/week; these women had significant reduction in alcohol-related problems compared to those who continued heavy drinking (-8.2 and -4.8 vs. -0.8,  p  = 0.0003). Quitting and reducing drinking were also associated with statistically significant decreases among the physical, interpersonal, intrapersonal, and social subscales of the SIP ( p <.05), although a similar pattern, while not statistically significant, exists for the impulse control subscale.
CONCLUSIONS


While completely quitting drinking produced the greatest improvement, reducing drinking to ≤14 drinks per week can significantly reduce alcohol-related problems in WLWH.",2021,"To assess whether complete reduction of alcohol use produced significantly greater improvement in alcohol-related problems than a partial reduction of alcohol use (reducing alcohol use to ≤7 or ≤14 drinks per week).
","['Women living with HIV (WLWH', 'Women Living with HIV']",['Naltrexone'],"['Quitting and reducing drinking', 'physical, interpersonal, intrapersonal, and social subscales of the SIP', 'women quit drinking', 'primary outcome (alcohol-related problems', 'primary predictor (drinking status: quit drinking, reduced drinking, continue heavy drinking', 'mean SIP scores', 'alcohol-related problems']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",163.0,0.0415211,"To assess whether complete reduction of alcohol use produced significantly greater improvement in alcohol-related problems than a partial reduction of alcohol use (reducing alcohol use to ≤7 or ≤14 drinks per week).
","[{'ForeName': 'Veronica L', 'Initials': 'VL', 'LastName': 'Richards', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Vaddiparti', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Brumback', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Cook', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}]",Substance use & misuse,['10.1080/10826084.2021.1892138']
1562,33682592,Heartfulness meditation improves loneliness and sleep in physicians and advance practice providers during COVID-19 pandemic.,"ObjectiveUnprecedented work pressures and social isolation during the COVID-19 pandemic may worsen loneliness and sleep problems in health care professionals. Heartfulness meditation has been shown to improve burnout and sleep. In the current study, the effects of remote Heartfulness meditation in improving loneliness and sleep quality were measured.MethodsPhysicians and advance practice providers were randomly assigned to receive either daily Heartfulness Meditation program or no intervention (control group) in a prospective four-week randomized control study design. UCLA loneliness and PSQI scores were collected at baseline and after the program duration of 4 weeks. The study was retrospectively registered with trial Number, ISRCTN85787008 (Jan 8, 2021).ResultsOf the 155 subjects enrolled in the study, 50% were lonely and 97% had sleep problems. Attrition rate was 36%. Among those who completed the study, the mean UCLA loneliness scores decreased from 42.1 to 39.4 in the Heartfulness group (N=40, p=0.009) and 42.2 to 41.15 in the control group (N=57, p=0.254)). The mean PSQI scores decreased from 10.75 to 9.14 in the Heartfulness group (N=41, p=0.001) and 9.41 to 8.87 in the control group (N=58, p=0.122). Younger participants aged 30 and under had higher loneliness and sleep problems.ConclusionsThe current study is one of the first attempts to assess loneliness and sleep problems among physicians and advance practice providers during COVID-19 pandemic in the US. A significant burden of loneliness and sleep problems was identified. An improvement of sleep and loneliness was noted with the practice of Heartfulness meditation. This remote intervention might be a useful tool to be explored in larger studies.",2021,"The mean PSQI scores decreased from 10.75 to 9.14 in the Heartfulness group (N=41, p=0.001) and 9.41 to 8.87 in the control group (N=58, p=0.122).","['155 subjects enrolled in the study, 50% were lonely and 97% had sleep problems', 'MethodsPhysicians and advance practice providers', 'physicians and advance practice providers during COVID-19 pandemic', 'Younger participants aged 30 and under had higher loneliness and sleep problems']","['remote Heartfulness meditation', 'daily Heartfulness Meditation program or no intervention (control group', 'Heartfulness meditation']","['sleep and loneliness', 'UCLA loneliness and PSQI scores', 'loneliness and sleep problems', 'Attrition rate', 'loneliness and sleep', 'mean UCLA loneliness scores', 'loneliness and sleep quality', 'mean PSQI scores']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",50.0,0.0465316,"The mean PSQI scores decreased from 10.75 to 9.14 in the Heartfulness group (N=41, p=0.001) and 9.41 to 8.87 in the control group (N=58, p=0.122).","[{'ForeName': 'Jayaram', 'Initials': 'J', 'LastName': 'Thimmapuram', 'Affiliation': 'WellSpan York Hospital, 1001 S George St. York, PA 17403.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pargament', 'Affiliation': 'WellSpan York Hospital, 1001 S George St. York, PA 17403.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Bell', 'Affiliation': 'WellSpan York Hospital, 1001 S George St. York, PA 17403.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Schurk', 'Affiliation': 'WellSpan York Hospital, 1001 S George St. York, PA 17403.'}, {'ForeName': 'Divya K', 'Initials': 'DK', 'LastName': 'Madhusudhan', 'Affiliation': 'Harvard Medical School Post Graduate Medical Education, Boston, MA.'}]",Hospital practice (1995),['10.1080/21548331.2021.1896858']
1563,33682553,A Pilot Study to Promote Active Living among Physically Inactive Korean American Women.,"A 4-week lifestyle program called Women's Active Living for Koreans (WALK) was designed for Korean American women to promote physical activity (PA). In a pilot-controlled trial, 40 women were randomized to WALK-regular or WALK-plus. WALK-plus involved joining an online community via a social media app. WALK-plus performed significantly higher numbers of days of muscle-strengthening activities than WALK-regular at the post-intervention visit. Both groups increased vigorous activities and walking and decreased sedentary behaviors on weekdays. WALK program showed great potential in improving PA and decreasing sedentary behaviors. Online social networking may have an additional effect on PA among this population.",2021,WALK-plus performed significantly higher numbers of days of muscle-strengthening activities than WALK-regular at the post-intervention visit.,"['Physically Inactive Korean American Women', 'Korean American women to promote physical activity (PA', '40 women']","['WALK-regular or WALK-plus', ""lifestyle program called Women's Active Living for Koreans (WALK"", 'WALK-plus involved joining an online community via a social media app']","['sedentary behaviors', 'vigorous activities and walking and decreased sedentary behaviors on weekdays', 'numbers of days of muscle-strengthening activities']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",40.0,0.0667033,WALK-plus performed significantly higher numbers of days of muscle-strengthening activities than WALK-regular at the post-intervention visit.,"[{'ForeName': 'JiWon', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Institute for Health & Aging/Department of Social and Behavioral Sciences, School of Nursing, University of California, San Francisco, California, USA.'}, {'ForeName': 'Nah-Mee', 'Initials': 'NM', 'LastName': 'Shin', 'Affiliation': 'College of Nursing, Korea University, Seoul, Korea.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Cooper', 'Affiliation': 'School of Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Jih', 'Affiliation': 'School of Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Tsoh', 'Initials': 'T', 'LastName': 'Janice', 'Affiliation': 'Department of Psychiatry, School of Medicine, UCSF, San Francisco, California, USA.'}]",Journal of community health nursing,['10.1080/07370016.2021.1869420']
1564,33682556,"Safety, tolerability, and pharmacokinetics of the novel pan-phosphodiesterase inhibitor ZSP1601 in healthy subjects: a double-blinded, placebo-controlled first-in-human single-dose and multiple-dose escalation and food effect study.","Background : The pharmacokinetics (PK), safety, and tolerability profiles of ZSP1601, a first-in-class pan-phosphodiesterase (PDE) inhibitor, were evaluated in healthy Chinese volunteers. Research design and methods : This Phase 1a study consisted of a double-blinded, randomized, placebo-controlled single ascending dose (SAD) (25 to 350 mg), multiple ascending doses (MAD) (50 or 100 mg QD), and a two-period crossover food effect study (100 mg). Results : ZSP1601 was quickly absorbed, with maximum plasma concentrations (C max ) reached at 1.25 to 2.50 h (median T max ). The exposures exhibited dose-proportional increases, while the mean half-life (t1/2) ranged from 6.34-8.64 h. Steady-state was reached within seven days in the MAD study. The mean steady trough concentrations were 423 and 588 ng/mL, respectively. ZSP1601 accumulation was low, with ratios ≤ 1.5. The bioavailability of ZSP1601 was equivalent under fasted and fed states. All adverse events (AEs) were assessed as mild or moderate, with headaches as the most common. The highest single doses (275 and 350 mg) yielded more AEs, yet the rates were similar with the placebo cohorts in the MAD study. Conclusions : The safety and PK profiles of ZSP1601 support further efficacy evaluation in nonalcoholic steatohepatitis patients. Trial registration : The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT03392779).",2021,"ZSP1601 was quickly absorbed, with maximum plasma concentrations (C max ) reached at 1.25 to 2.50 h (median T max ).","['healthy Chinese volunteers', 'healthy subjects', 'nonalcoholic steatohepatitis patients']","['placebo', 'placebo-controlled single ascending dose (SAD', 'ZSP1601', ' ', 'novel pan-phosphodiesterase inhibitor ZSP1601']","['Safety, tolerability, and pharmacokinetics', 'ZSP1601 accumulation', 'bioavailability of ZSP1601', 'maximum plasma concentrations (C max ', 'pharmacokinetics (PK), safety, and tolerability profiles of ZSP1601, a first-in-class pan-phosphodiesterase (PDE) inhibitor', 'mean steady trough concentrations', 'Steady-state']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0031638', 'cui_str': 'Phosphodiesterase inhibitor'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0031638', 'cui_str': 'Phosphodiesterase inhibitor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.382695,"ZSP1601 was quickly absorbed, with maximum plasma concentrations (C max ) reached at 1.25 to 2.50 h (median T max ).","[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Jilin Medical Products Administration, Changchun, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Guangdong Raynovent Biotech Co., Ltd, Shenzhen, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Guangdong Raynovent Biotech Co., Ltd, Shenzhen, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Guangdong Zhongsheng Pharmaceutical Co., Ltd, Dongguan, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2021.1900822']
1565,33682549,Efficacy of Community-based Pelvic Floor Muscle Training to Improve Pelvic Floor Dysfunction in Chinese Perimenopausal Women: A Randomized Controlled Trial.,"To evaluate the effectiveness of pelvic floor muscle training (PFMT) on perimenopausal women with pelvic floor dysfunction (PFD). A two-group longitudinal experimental design with multiple comparisons. The intervention group (n = 37) received a 3-month intervention combining Kegel and yoga exercise. The control group (n = 37) received Kegel exercise. The combined training alleviated PFD symptoms, improved life quality and increased pelvic floor muscle strength of perimenopausal women. Women with PDF symptoms can integrate PFMT and yoga exercise to promote rehabilitation and improved outcomes. Combined exercise should be taught and practiced under supervision by qualified health professionals.",2021,"The combined training alleviated PFD symptoms, improved life quality and increased pelvic floor muscle strength of perimenopausal women.","['Women with PDF symptoms', 'Chinese Perimenopausal Women', 'perimenopausal women with pelvic floor dysfunction (PFD']","['Community-based Pelvic Floor Muscle Training', 'Combined exercise', 'PFMT and yoga exercise', 'pelvic floor muscle training (PFMT', '3-month intervention combining Kegel and yoga exercise', 'Kegel exercise']","['PFD symptoms, improved life quality and increased pelvic floor muscle strength of perimenopausal women', 'Pelvic Floor Dysfunction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}]","[{'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",,0.0366169,"The combined training alleviated PFD symptoms, improved life quality and increased pelvic floor muscle strength of perimenopausal women.","[{'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Nie', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Rong', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Shu-Wen', 'Initials': 'SW', 'LastName': 'Yue', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Sharon R', 'Initials': 'SR', 'LastName': 'Redding', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Yan-Qiong', 'Initials': 'YQ', 'LastName': 'Ouyang', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China.'}]",Journal of community health nursing,['10.1080/07370016.2020.1869416']
1566,33682527,Pilot study of tolerability and safety of opioid receptor antagonists as novel therapies for chronic pain among persons living with HIV with past year heavy drinking: a randomized controlled trial.,"CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03278886.",2021,"CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03278886.",['persons living with HIV with past year heavy drinking'],['opioid receptor antagonists'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}]",[],,0.294154,"CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03278886.","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Bendiks', 'Affiliation': 'Department of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston, MA, USA.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': 'Lab of Clinical Pharmacology of Addictions, First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Vetrova', 'Affiliation': 'Lab of Clinical Pharmacology of Addictions, First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verbitskaya', 'Affiliation': 'Lab of Clinical Pharmacology of Addictions, First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gnatienko', 'Affiliation': 'Department of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston, MA, USA.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Bryant', 'Affiliation': 'HIV/AIDS Research, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'Lab of Clinical Pharmacology of Addictions, First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Department of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston, MA, USA.'}, {'ForeName': 'Judith I', 'Initials': 'JI', 'LastName': 'Tsui', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, University of Washington/Harborview Medical Center, Seattle, WA, USA.'}]",AIDS care,['10.1080/09540121.2021.1896663']
1567,33682457,"Higher protein intake during resistance training does not potentiate strength, but modulates gut microbiota, in middle-aged adults: a randomized control trial.","Protein intake above the Recommended Dietary Allowance (RDA) and resistance training are known anabolic stimuli to support healthy aging. Specifically, protein supplementation after resistance exercise and nightly are strategies to maximize utilization of protein intake above the RDA in healthy adults. As such, the primary objective was to examine the efficacy of protein supplementation and nutritional counseling resulting in either moderate (MOD: ~1.0 g·kg -1 ·d -1 ) or higher (HIGH: ~1.6 g·kg -1 ·d -1 ) protein intake during resistance training on strength (one-repetition maximum, 1-RM; isokinetic and isometric peak torque) in healthy middle-aged adults. Exploratory analyses include diet-exercise effects on lean body mass (LBM), clinical biomarkers, gut microbiota, and diet composition. 50 middle-aged adults (age: 50 ± 8 y, BMI: 27.2 ± 4.1 kg·m -2 ) were randomized to either MOD or HIGH protein intake during a 10-week resistance training program (3 × week). Participants received dietary counseling and consumed either 15 g (MOD) or 30 g (HIGH) of protein from lean beef in the immediate post-exercise period and each evening. Maximal strength (1-RM) for all upper and lower body exercises significantly increased with no effect of protein intake (P<0.050). There was a main effect of time for LBM (P<0.005). Cardiovascular, renal, or glycemic biomarkers were not affected by the intervention. Gut microbiota were associated with several health outcomes (P<0.050). In conclusion, higher protein intake above moderate amounts does not potentiate resistance training adaptations in previously untrained middle-aged adults. This trial was registered at clinicaltrials.gov as NCT03029975.",2021,Maximal strength (1-RM) for all upper and lower body exercises significantly increased with no effect of protein intake (P<0.050).,"['healthy middle-aged adults', '50 middle-aged adults (age: 50 ± 8 y, BMI: 27.2 ± 4.1 kg·m -2 ', 'previously untrained middle-aged adults', 'middle-aged adults', 'healthy adults']","['resistance training', 'dietary counseling and consumed either 15 g (MOD) or 30 g (HIGH) of protein from lean beef in the immediate post-exercise period and each evening', 'Dietary Allowance (RDA) and resistance training', 'MOD or HIGH protein intake during a 10-week resistance training program', 'protein supplementation and nutritional counseling']","['Cardiovascular, renal, or glycemic biomarkers', 'Maximal strength (1-RM', 'strength (one-repetition maximum, 1-RM; isokinetic and isometric peak torque', 'lean body mass (LBM), clinical biomarkers, gut microbiota, and diet composition']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191357', 'cui_str': '27.2'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0524787', 'cui_str': 'Recommended Dietary Allowance'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.0261741,Maximal strength (1-RM) for all upper and lower body exercises significantly increased with no effect of protein intake (P<0.050).,"[{'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'McKenna', 'Affiliation': 'Division of Nutritional, University of Illinois at Urbana Champaign, United States.'}, {'ForeName': 'Amadeo F', 'Initials': 'AF', 'LastName': 'Salvador', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana Champaign, United States.'}, {'ForeName': 'Riley L', 'Initials': 'RL', 'LastName': 'Hughes', 'Affiliation': 'Food Science and Human Nutrition, University of Illinois at Urbana Champaign, United States.'}, {'ForeName': 'Susannah E', 'Initials': 'SE', 'LastName': 'Scaroni', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana Champaign, United States.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Alamilla', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana Champaign, United States.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Askow', 'Affiliation': 'Kinesiology and Community Health, University of Illinois at Urbana Champaign, United States.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Paluska', 'Affiliation': 'Department of Family Medicine, University of Illinois at Urbana Champaign, United States.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Dilger', 'Affiliation': 'University of Illinois at Urbana Champaign, United States.'}, {'ForeName': 'Hannah D', 'Initials': 'HD', 'LastName': 'Holscher', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'De Lisio', 'Affiliation': 'School of Human Kinetics and Department of Cellular & Molecular Medicine, University of Ottawa, Canada.'}, {'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'Kinesiology and Community Health, University of Illinois at Urbana Champaign, United States.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana Champaign, United States.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00574.2020']
1568,33682455,Prediction of residual tumor and overall survival after first-line surgery in patients with pancreatic ductal adenocarcinoma using preoperative magnetic resonance imaging findings.,"BACKGROUND


Complete resection is the only potentially curative treatment in patients with pancreatic ductal adenocarcinoma (PDA) and is associated with a longer overall survival (OS) than incomplete resection of tumor. Hence, prediction of the resection status after surgery would help predict the prognosis of patients with PDA.
PURPOSE


To predict residual tumor (R) classification and OS in patients who underwent first-line surgery for PDA using preoperative magnetic resonance imaging (MRI).
MATERIAL AND METHODS


In this study, 210 patients with PDA who underwent MRI and first-line surgery were randomly categorized into a test group (n=150) and a validation group (n=60). The R classification was divided into R0 (no residual tumor) and R1/R2 (microscopic/macroscopic residual tumor). Preoperative MRI findings associated with R classification and OS were assessed by using logistic regression and Cox proportional hazard models. In addition, the prediction models for the R classification and OS were validated using calibration plots and C statistics.
RESULTS


On preoperative MRI, portal vein encasement (odds ratio 4.755) was an independent predictor for R1/R2 resection ( P =0.040). Tumor size measured on MRI (hazard ratio [HR] per centimeter 1.539) was a predictor of OS, along with pathologic N1 and N2 stage (HR 1.944 and 3.243, respectively), R1/R2 resection (HR 3.273), and adjuvant chemoradiation therapy (HR 0.250) ( P <0.050). Calibration plots demonstrated satisfactory predictive performance.
CONCLUSION


Preoperative MRI was valuable for predicting R1/R2 resection using portal vein encasement. Tumor size measured on MRI was useful for the prediction of OS after first-line surgery for PDA.",2021,"On preoperative MRI, portal vein encasement (odds ratio 4.755) was an independent predictor for R1/R2 resection ( P =0.040).","['patients with pancreatic ductal adenocarcinoma', '210 patients with PDA who underwent MRI and first-line surgery', 'patients with pancreatic ductal adenocarcinoma (PDA']",[],"['residual tumor and overall survival', 'overall survival (OS', 'preoperative MRI, portal vein encasement', 'Tumor size measured on MRI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",210.0,0.0200048,"On preoperative MRI, portal vein encasement (odds ratio 4.755) was an independent predictor for R1/R2 resection ( P =0.040).","[{'ForeName': 'Jae Seok', 'Initials': 'JS', 'LastName': 'Bae', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo-Jin', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Joon Koo', 'Initials': 'JK', 'LastName': 'Han', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Republic of Korea.'}]","Acta radiologica (Stockholm, Sweden : 1987)",['10.1177/0284185121999998']
1569,33682431,Prognosis of Claims- Versus Trial-Based Ischemic and Bleeding Events Beyond 1 Year After Coronary Stenting.,"Background It is unknown whether clinical events identified with administrative claims have similar prognosis compared with trial-adjudicated events in cardiovascular clinical trials. We compared the prognostic significance of claims-based end points in context of trial-adjudicated end points in the DAPT (Dual Antiplatelet Therapy) study. Methods and Results We matched 1336 patients aged ≥65 years who received percutaneous coronary intervention in the DAPT study with the CathPCI registry linked to Medicare claims. We compared death at 21 months post-randomization using Cox proportional hazards models among patients with ischemic events (myocardial infarction or stroke) and bleeding events identified by: (1) both trial adjudication and claims; (2) trial adjudication only; and (3) claims only. A total of 47 patients (3.5%) had ischemic events identified by both trial adjudication and claims, 24 (1.8%) in trial adjudication only, 15 (1.1%) in claims only, and 1250 (93.6%) had no ischemic events, with annualized unadjusted mortality rates of 12.8, 5.5, 14.9, and 1.26 per 100 person-years, respectively. A total of 44 patients (3.3%) had bleeding events identified with both trial adjudication and claims, 13 (1.0%) in trial adjudication only, 65 (4.9%) in claims only, and 1214 (90.9%) had no bleeding events, with annualized unadjusted mortality rates of 11.0, 16.8, 10.7, and 0.95 per 100 person-years, respectively. Among patients with no trial-adjudicated events, patients with events in claims only had a high subsequent adjusted mortality risk (hazard ratio (HR) ischemic events: 31.5; 95% CI, 8.9‒111.9; HR bleeding events 23.9; 95% CI, 10.7‒53.2). Conclusions In addition to trial-adjudicated events, claims identified additional clinically meaningful ischemic and bleeding events that were prognostically significant for death.",2021,"A total of 44 patients (3.3%) had bleeding events identified with both trial adjudication and claims, 13 (1.0%) in trial adjudication only, 65 (4.9%) in claims only, and 1214 (90.9%) had no bleeding events, with annualized unadjusted mortality rates of 11.0, 16.8, 10.7, and 0.95 per 100 person-years, respectively.","['1336 patients aged ≥65\xa0years who received', 'in the DAPT study with the CathPCI registry linked to Medicare claims']","['percutaneous coronary intervention', 'Claims']","['bleeding events', 'no ischemic events', 'annualized unadjusted mortality rates', 'ischemic events', 'no bleeding events', 'Ischemic and Bleeding Events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1336.0,0.100759,"A total of 44 patients (3.3%) had bleeding events identified with both trial adjudication and claims, 13 (1.0%) in trial adjudication only, 65 (4.9%) in claims only, and 1214 (90.9%) had no bleeding events, with annualized unadjusted mortality rates of 11.0, 16.8, 10.7, and 0.95 per 100 person-years, respectively.","[{'ForeName': 'Neel M', 'Initials': 'NM', 'LastName': 'Butala', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Division of Cardiovascular Medicine Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Kamil F', 'Initials': 'KF', 'LastName': 'Faridi', 'Affiliation': 'Section of Cardiovascular Medicine Department of Medicine Yale School of Medicine New Haven CT.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Secemsky', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Division of Cardiovascular Medicine Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Baim Institute for Clinical Research Boston MA.'}, {'ForeName': 'Jeptha', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': 'Section of Cardiovascular Medicine Department of Medicine Yale School of Medicine New Haven CT.'}, {'ForeName': 'Charles Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Baim Institute for Clinical Research Boston MA.'}, {'ForeName': 'Dhruv', 'Initials': 'D', 'LastName': 'Kazi', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Division of Cardiovascular Medicine Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Division of Cardiovascular Medicine Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Yeh', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Division of Cardiovascular Medicine Beth Israel Deaconess Medical Center Boston MA.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.018744']
1570,33682430,Protocol forDigital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia.,"Background:  Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings and is challenging for people with insomnia to access because of uneven geographical distribution of behavioral sleep medicine providers. Prescription digital therapeutics can overcome these barriers. This study evaluates the effectiveness of a specific digital CBT-I therapeutic.  Materials & methods:   D igital  R eal-world  E vidence trial for  A dults with insomnia treated via  M obile (DREAM) is a 9-week, open-label, decentralized clinical trial to collect real-world evidence for a digital therapeutic (Somryst™) delivering CBT-I to patients with chronic insomnia. The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350).  Conclusion:  This pragmatic study seeks to assess the potential benefits of treating insomnia with an asynchronous, mobile, tailored prescription digital therapeutic.  Clinical trial registration:  NCT04325464 (ClinicalTrials.gov).",2021,The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350).  ,"['Adults with insomnia treated via Mobile (DREAM', 'patients with chronic insomnia']","['insomnia treated via  M obile\xa0(DREAM', 'Cognitive behavioral therapy', 'specific digital CBT-I therapeutic']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]",[],,0.0840211,The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350).  ,"[{'ForeName': 'Frances P', 'Initials': 'FP', 'LastName': 'Thorndike', 'Affiliation': 'Pear Therapeutics, Inc., Boston, MA\xa002109, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'University of Florida Health Sleep Disorders Center, FL 32606, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gerwien', 'Affiliation': 'Pear Therapeutics, Inc., Boston, MA\xa002109, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Braun', 'Affiliation': 'Pear Therapeutics, Inc., Boston, MA\xa002109, USA.'}, {'ForeName': 'Yuri A', 'Initials': 'YA', 'LastName': 'Maricich', 'Affiliation': 'Pear Therapeutics, Inc., Boston, MA\xa002109, USA.'}]",Journal of comparative effectiveness research,['10.2217/cer-2021-0004']
1571,33682378,"Withdrawing Ixekizumab in Patients with Psoriatic Arthritis who Achieved Minimal Disease Activity: Results from a Randomized, Double-Blind Withdrawal Study.","OBJECTIVE


To evaluate the effect of withdrawing ixekizumab in patients with psoriatic arthritis (PsA) who had achieved minimal disease activity (MDA) after open-label ixekizumab treatment.
METHODS


SPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study that enrolled biologic-naive adult patients with PsA to open-label ixekizumab (160 mg at week 0, 80 mg every two weeks [IXE Q2W]) for 36 weeks. Patients sustaining MDA for >3 consecutive months were randomized (between weeks 36-64) 1:1 to blinded IXE Q2W withdrawal (placebo) or continued IXE Q2W treatment up to week 104. The primary efficacy endpoint was time to relapse (loss of MDA) for randomized patients. Patients who relapsed were retreated with IXE Q2W until week 104.
RESULTS


A total of 394 patients were enrolled and received open-label IXE Q2W. Of those, 158 (40%) patients achieved sustained MDA and were randomized to IXE Q2W withdrawal (placebo; N=79) or continued IXE Q2W treatment (N=79). Patients relapsed more rapidly with treatment withdrawal (median 22.3 weeks [95% CI 16.1-28.3]) vs continued IXE Q2W treatment (median not estimable, p<0.0001); 67 (85%) patients vs 30 (38%) patients relapsed, respectively. Median time to re-achieving MDA on retreatment was 4.1 weeks (95% CI 4.1-4.3); 64 (96%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment. Safety was consistent with the known safety profile for ixekizumab.
CONCLUSION


Continued ixekizumab therapy is superior to ixekizumab withdrawal in maintaining low disease activity in biologic-naive patients with PsA. Retreatment with ixekizumab following relapse may restore disease control in case of treatment interruption.",2021,"Patients relapsed more rapidly with treatment withdrawal (median 22.3 weeks [95% CI 16.1-28.3]) vs continued IXE Q2W treatment (median not estimable, p<0.0001); 67 (85%) patients vs 30 (38%) patients relapsed, respectively.","['patients with psoriatic arthritis (PsA) who had achieved minimal disease activity (MDA) after open-label ixekizumab treatment', '394 patients were enrolled and received', 'Of those, 158 (40%) patients achieved sustained MDA', 'enrolled biologic-naive adult patients with PsA to', 'Patients with Psoriatic Arthritis who Achieved Minimal Disease Activity', 'Patients sustaining MDA for >3 consecutive months']","['blinded IXE Q2W withdrawal (placebo) or continued IXE Q2W', 'ixekizumab therapy', 'open-label IXE Q2W', 'IXE Q2W withdrawal (placebo', 'open-label ixekizumab', 'ixekizumab', 'withdrawing ixekizumab', 'IXE Q2W', 'Withdrawing Ixekizumab']","['Median time to re-achieving MDA', 'time to relapse (loss of MDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",394.0,0.395153,"Patients relapsed more rapidly with treatment withdrawal (median 22.3 weeks [95% CI 16.1-28.3]) vs continued IXE Q2W treatment (median not estimable, p<0.0001); 67 (85%) patients vs 30 (38%) patients relapsed, respectively.","[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford and NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Sreekumar G', 'Initials': 'SG', 'LastName': 'Pillai', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Tahir', 'Affiliation': 'Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Valter', 'Affiliation': 'Center for Clinical and Basic Research, Tallinn, Estonia.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Chandran', 'Affiliation': ""University of Toronto, Toronto, Canada, Krembil Research Institute, University Health Network, Toronto, Canada, and Memorial University, St. John's, Canada.""}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Toho University, Tokyo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': ""St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kerr', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Alves', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Adams', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Hufford', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Hojnik', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St, Joseph Health and University of Washington, Seattle, Washington.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego, San Diego, California, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41716']
1572,33682367,Impact of green tea on the deleterious cardiometabolic effects of 7-days unhealthy lifestyle in young healthy males.,"PURPOSE


The aim of this study was to examine if catechin-rich green tea abrogates the negative effects of 7-days of physical inactivity and excessive calorie-intake on insulin homeostasis and peripheral vascular function.
METHODS


Using a randomized, double-blind, crossover design, twelve healthy men (29 ± 6 yrs) underwent 7-days unhealthy lifestyle (UL), including physical inactivity (-50% steps/day) and overfeeding (+50% kcal/day). This was combined with green tea consumption (UL-tea; 3 doses/day) or placebo (UL-placebo). Before and after each intervention, we examined postprandial blood glucose and insulin (3-h after a 1,202 kcal meal) and upper and lower limb vascular function (flow-mediated dilation (FMD%)) and carotid artery reactivity (CAR%).
RESULTS


UL-placebo increased postprandial glucose and insulin, while UL-tea decreased postprandial glucose and insulin (Time*Intervention interaction effects: both p < 0.05). UL-placebo decreased CAR% and femoral FMD%, while UL-tea prevented these effects (Time*Intervention interaction effects of p < 0.04 and p < 0.001, respectively). There was no main effect of Time or Time*Intervention interaction (both p > 0.05) for brachial FMD%.
CONCLUSION


Seven days of physical inactivity and overfeeding impair insulin homeostasis and vascular function. These effects were mitigated by a daily intake of catechin-rich green tea.",2021,"There was no main effect of Time or Time*Intervention interaction (both p > 0.05) for brachial FMD%.
","['twelve healthy men (29\xa0±\xa06\xa0yrs) underwent', 'young healthy males']","['UL-placebo', '7-days unhealthy lifestyle (UL', 'green tea consumption (UL-tea; 3 doses/day) or placebo (UL-placebo', 'green tea', 'catechin-rich green tea']","['limb vascular function (flow-mediated dilation (FMD%)) and carotid artery reactivity (CAR', 'postprandial blood glucose and insulin', 'postprandial glucose and insulin, while UL-tea decreased postprandial glucose and insulin (Time*Intervention interaction effects', 'CAR% and femoral FMD', 'Time or Time*Intervention interaction']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",12.0,0.357562,"There was no main effect of Time or Time*Intervention interaction (both p > 0.05) for brachial FMD%.
","[{'ForeName': 'Kirsty A', 'Initials': 'KA', 'LastName': 'Roberts', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Draijer', 'Affiliation': 'Unilever Foods Innovation Centre, Wageningen, The Netherlands.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Hopkins', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'de Graaf', 'Affiliation': 'Unilever Foods Innovation Centre, Wageningen, The Netherlands.'}, {'ForeName': 'Sophie M', 'Initials': 'SM', 'LastName': 'Holder', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Carter', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Dick H J', 'Initials': 'DHJ', 'LastName': 'Thijssen', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Low', 'Affiliation': 'Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.'}]",Physiological reports,['10.14814/phy2.14720']
1573,33682358,"Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double-blind, parallel-controlled, phase 1 study.","The primary objective of this randomized, double-blind, parallel-controlled study (from December 2016 to October 2018) was to evaluate pharmacokinetic (PK) equivalence of adalimumab biosimilar HLX03 and reference adalimumab in healthy volunteers, and to assess safety, and immunogenicity of HLX03. The primary PK endpoints were maximum observed plasma concentration (C max  ) and area under the concentration curve from time zero to the last quantifiable concentration (AUC 0-t  ). Equivalence was determined if the 90% confidence interval (CI) of geometric least square mean ratio between the two treatment groups were within the predefined range of 80%-125%. Safety and immunogenicity were monitored during the study. Healthy Chinese males (N = 220) were randomized 1:1 to receive a single subcutaneous 40 mg dose of HLX03 or China (CN)-sourced adalimumab. The ratios of the geometric mean of C max  and AUC 0-t  were 102.2% and 105.7%, respectively, with corresponding 90% CIs falling in the predefined margins, which demonstrated PK equivalence between HLX03 and CN-adalimumab. The incidence of treatment-emergent adverse events (TEAEs) was similar in the two groups (73.8% and 66.0% in the HLX03 and CN-adalimumab groups, respectively). Grade 3-4 TEAEs were reported in 7.5% and 5.7% of participants, respectively. The incidences of participants with antidrug antibodies (HLX03: 96.2%; CN-adalimumab: 93.4%) or neutralizing antibodies (HLX03: 40.6%, CN-adalimumab: 41.4%) were comparable between groups. This study demonstrated PK bioequivalence between HLX03 and CN-adalimumab, with similar safety and immunogenicity profiles. These data support further clinical development of HLX03 as an adalimumab biosimilar.",2021,"The incidence of treatment-emergent adverse events (TEAEs) was similar in the two groups (73.8% and 66.0% in the HLX03 and CN-adalimumab groups, respectively).","['Healthy Chinese males (N\xa0=\xa0220', 'healthy Chinese male volunteers', 'healthy volunteers', 'December 2016 to October 2018']","['adalimumab biosimilar HLX03 and reference adalimumab', 'HLX03 and CN-adalimumab', 'single subcutaneous 40\xa0mg dose of HLX03 or China (CN)-sourced adalimumab']","['confidence interval (CI) of geometric least square mean ratio', 'safety, and immunogenicity of HLX03', 'Safety and immunogenicity', 'ratios of the geometric mean of C max  and AUC 0-t', 'maximum observed plasma concentration (C max  ) and area under the concentration curve from time zero to the last quantifiable concentration (AUC 0-t  ', 'Pharmacokinetics, safety, and immunogenicity of HLX03', 'pharmacokinetic (PK) equivalence', 'incidence of treatment-emergent adverse events (TEAEs']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",4.0,0.268403,"The incidence of treatment-emergent adverse events (TEAEs) was similar in the two groups (73.8% and 66.0% in the HLX03 and CN-adalimumab groups, respectively).","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jixuan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xiaodi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Chai', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}]",Pharmacology research & perspectives,['10.1002/prp2.733']
1574,33682320,UpFrontPSMA: A Randomised Phase 2 Study of Sequential  177  Lu-PSMA617 and Docetaxel versus Docetaxel in Metastatic Hormone-Naïve Prostate Cancer.,"OBJECTIVE


To assess the activity and safety of sequential  177  Lu-PSMA-617 and docetaxel versus docetaxel on a background of androgen deprivation therapy (ADT) in men with de novo metastatic hormone-naïve prostate cancer (mHNPC).  177  Lu-PSMA-617 is a novel targeted radioligand therapy directed against prostate specific membrane antigen (PSMA). We hypothesise that  177  Lu-PSMA-617 will be effective and safe when given sequentially with docetaxel in mHNPC.
PATIENTS AND METHODS


UpFrontPSMA (NCT04343885) is an open-label, randomised, multicentre, phase two trial recruiting 140 patients at 12 Australian centres. Key eligibility criteria include: prostate cancer with a histological diagnosis within 12 weeks of screening commencement; PSA >10ng/mL at diagnosis; ≤ 4 weeks on ADT; evidence of metastatic disease on CT and/or bone scan; high-volume PSMA-avid disease with the maximum standardised uptake value (SUVmax) greater than 15; and absence of extensive discordant FDG-positive, PSMA-negative disease.  68  Ga-PSMA-11 and  18  F-FDG PET/CT undergo central review to determine eligibility. Patients are randomised 1:1 to experimental treatment, Arm A, ( 177  Lu-PSMA-617 7.5GBq q6w x 2 cycles followed by docetaxel 75 mg/m 2  q3w x 6 cycles) or standard-of-care treatment, Arm B, (docetaxel 75 mg/m 2  q3w x 6 cycles). All patients receive continuous ADT. Patients are stratified based on disease volume on conventional imaging and duration of ADT at time of registration. The primary endpoint is the proportion of patients with undetectable PSA (≤ 0.2ng/L) at 12 months after study treatment commencement. Secondary endpoints include safety, time to castration resistance, overall survival, PSA and radiographic progression-free survival (PFS), objective tumour response rate, early PSMA PET response, health-related quality of life, and frequency and severity of adverse events. Enrolment commenced in April 2020.
RESULTS AND CONCLUSIONS


The results of this trial will generate data on the activity and safety of  177  Lu-PSMA-617 in men with de novo mHNPC in a randomised phase 2 design.",2021,The primary endpoint is the proportion of patients with undetectable PSA (≤ 0.2ng/L) at 12 months after study treatment commencement.,"['140 patients at 12 Australian centres', 'Sequential  177', 'Key eligibility criteria include: prostate cancer with a histological diagnosis within 12 weeks of screening commencement; PSA >10ng/mL at diagnosis; ≤ 4 weeks on ADT; evidence of metastatic disease on CT and/or bone scan; high-volume PSMA-avid disease with the maximum standardised uptake value (SUVmax) greater than 15; and absence of extensive discordant FDG-positive, PSMA-negative disease', 'q6w', 'men with de novo metastatic hormone-naïve prostate cancer (mHNPC', '177  Lu-PSMA-617 in men with de novo mHNPC', 'Metastatic Hormone-Naïve Prostate Cancer', '68']","['continuous ADT', 'UpFrontPSMA', 'androgen deprivation therapy (ADT', 'Lu-PSMA617 and Docetaxel versus Docetaxel', 'sequential  177  Lu-PSMA-617 and docetaxel versus docetaxel', 'docetaxel 75 mg/m 2  q3w x 6 cycles) or standard-of-care treatment, Arm B, (docetaxel', 'PSMA-617 7.5GBq']","['activity and safety of', 'activity and safety', 'proportion of patients with undetectable PSA', 'safety, time to castration resistance, overall survival, PSA and radiographic progression-free survival (PFS), objective tumour response rate, early PSMA PET response, health-related quality of life, and frequency and severity of adverse events']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C4078835', 'cui_str': 'PSMA-617'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C4078835', 'cui_str': 'PSMA-617'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",140.0,0.101459,The primary endpoint is the proportion of patients with undetectable PSA (≤ 0.2ng/L) at 12 months after study treatment commencement.,"[{'ForeName': 'Nattakorn', 'Initials': 'N', 'LastName': 'Dhiantravan', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Emmett', 'Affiliation': ""Department of Theranostics, St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': 'Garvan Institute of Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Pattison', 'Affiliation': ""Department of Nuclear Medicine & Specialised PET Services, Royal Brisbane & Women's Hospital, Butterfield Street, Brisbane, QLD, Australia.""}, {'ForeName': 'Roslyn J', 'Initials': 'RJ', 'LastName': 'Francis', 'Affiliation': 'Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Vela', 'Affiliation': 'Department of Urology, Princess Alexandra Hospital, Woolloongabba, GLQ, Australia.'}, {'ForeName': 'Nitika', 'Initials': 'N', 'LastName': 'Neha', 'Affiliation': 'Centre for Biostatistics and Clinical Trials (BaCT), Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Bressel', 'Affiliation': 'Centre for Biostatistics and Clinical Trials (BaCT), Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hofman', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Arun A', 'Initials': 'AA', 'LastName': 'Azad', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}]",BJU international,['10.1111/bju.15384']
1575,21113820,Exploring the divergence between self-assessment and self-monitoring.,"Many models of professional self-regulation call upon individual practitioners to take responsibility both for identifying the limits of their own skills and for redressing their identified limits through continuing professional development activities. Despite these expectations, a considerable literature in the domain of self-assessment has questioned the ability of the self-regulating professional to enact this process effectively. In response, authors have recently suggested that the construction of self-assessment as represented in the self-regulation literature is, itself, problematic. In this paper we report a pair of studies that examine the relationship between self-assessment (a global judgment of one's ability in a particular domain) and self-monitoring (a moment-by-moment awareness of the likelihood that one maintains the skill/knowledge to act in a particular situation). These studies reveal that, despite poor correlations between performance and self-assessments (consistent with what is typically seen in the self-assessment literature), participant performance was strongly related to several measures of self-monitoring including: the decision to answer or defer responding to a question, the amount of time required to make that decision to answer or defer, and the confidence expressed in an answer when provided. This apparent divergence between poor overall self-assessment and effective self-monitoring is considered in terms of how the findings might inform our understanding of the cognitive mechanisms yielding both self-monitoring judgments and self-assessments and how that understanding might be used to better direct education and learning efforts.",2011,Many models of professional self-regulation call upon individual practitioners to take responsibility both for identifying the limits of their own skills and for redressing their identified limits through continuing professional development activities.,[],[],[],[],[],[],1.0,0.0114167,Many models of professional self-regulation call upon individual practitioners to take responsibility both for identifying the limits of their own skills and for redressing their identified limits through continuing professional development activities.,"[{'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Eva', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada. kevin.eva@ubc.ca'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Regehr', 'Affiliation': ''}]",Advances in health sciences education : theory and practice,['10.1007/s10459-010-9263-2']
1576,33682284,A study on nursing effect of integrated traditional Chinese and Western medicine management mode on COVID-19.,"AIM


This study aims to explore the effect of integrated traditional Chinese and Western medicine management mode on nursing care of patients with coronavirus disease 2019 (COVID-19).
METHODS


The study included 142 COVID-19 patients hospitalized in Huoshenshan Hospital from February to March 2020. Nursing measures in the treatment (n = 111) and control (n = 31) groups included integrated management care and usual care. The integrated management model had eight components: WeChat group management, early Traditional Chinese Medicine (TCM) treatment, emotional nursing, music therapy, observation of tongue coating and pulse, vital Qi strengthening, preventing recurrence after recovery, and an individualized follow-up scheme. The endpoints included clinical outcome, recovery time of clinical symptoms and signs, days of hospital stay, and survival without intensive care unit (ICU) admission.
RESULTS


Recovery time from clinical symptoms such as fever, cough, shortness of breath, muscle aches, and fatigue in the treatment group was shorter than that in the control group. Less time was required to show negative chest computed tomography findings in the treatment group than in the control group (13.0 ± 2.8 vs. 16.7 ± 3.9, p < .025). The lengths of hospital stay in the two groups were 16.4 ± 7.3 days (treatment group) and 24.4 ± 4.8 days (control group) (p < .001). Kaplan-Meier curves for survival without ICU transfer showed statistical difference between the two groups (χ 2  = 5.427, p = .020).
CONCLUSIONS


Our study shows that the integrated management mode can relieve the symptoms of patients faster, shorten hospital stay and disease course, and reduce the rate of ICU transfers.",2021,"Kaplan-Meier curves for survival without ICU transfer showed statistical difference between the two groups (χ 2  = 5.427, p = .020).
","['142 COVID-19 patients hospitalized in Huoshenshan Hospital from February to March 2020', 'patients with coronavirus disease 2019 (COVID-19']","['integrated management care and usual care', 'Traditional Chinese Medicine (TCM) treatment, emotional nursing, music therapy, observation of tongue coating and pulse, vital Qi strengthening', 'integrated traditional Chinese and Western medicine management', 'integrated traditional Chinese and Western medicine management mode']","['hospital stay and disease course', 'lengths of hospital stay', 'rate of ICU transfers', 'fever, cough, shortness of breath, muscle aches, and fatigue', 'clinical outcome, recovery time of clinical symptoms and signs, days of hospital stay, and survival without intensive care unit (ICU) admission']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009144', 'cui_str': 'Furred tongue'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",142.0,0.0221545,"Kaplan-Meier curves for survival without ICU transfer showed statistical difference between the two groups (χ 2  = 5.427, p = .020).
","[{'ForeName': 'Lanfang', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, General Hospital of Eastern Theater Command, PLA, Nanjing, China.'}, {'ForeName': 'Yongwen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Nanjing Integrated Traditional Chinese and Western Medicine Hospital Affiliated with Nanjing University of Chinese Medicine, Nanjing, China.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12411']
1577,33682268,Comparison of irrigant activation devices and conventional needle irrigation on smear layer and debris removal in curved canals. (Smear layer removal from irrigant activation using SEM).,"AIM


To compare the effectiveness of smear layer and debris removal in the final rinse of curved canals of permanent molars using different commercially available irrigant activation devices.
METHODS


The mesial roots of 74 extracted maxillary and mandibular molars were instrumented using the Mtwo nickel-titanium rotary system (VDW GmbH, Munich, Germany). They were then randomly assigned to one of three groups, varying in their final rinse protocol. Group 1 (n = 15) - conventional needle irrigation with 4% NaOCl; Group 2 (n = 19) - EndoActivator® (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA) with 4% NaOCl; Group 3 (n = 17) - XP-endo® Finisher (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland) with 4% NaOCl. After the final rinse, all canals were flushed with 1 mL 15% EDTA for 60 s and then flushed with saline. The roots were split longitudinally and prepared for scanning electron microscope imaging. ImageJ for Windows was utilised to assess the images for smear layer removal, while two blinded investigators assessed debris presence in the middle and apical thirds using a 5-point scale.
RESULTS


There was no significant difference in smear layer and debris removal between treatment and control groups in the same canal zones. A significant difference was noted across different canal zones both within and across the groups.
CONCLUSION


There is no statistically significant difference in effectiveness between activated irrigation techniques and manual activation. Further investigations are required to evaluate all methods available and determine the most efficient technique to irrigate successfully.",2021,There was no significant difference in smear layer and debris removal between treatment and control groups in the same canal zones.,"['74 extracted maxillary and mandibular molars', 'curved canals']","['conventional needle irrigation with 4% NaOCl', 'EndoActivator® (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA) with 4% NaOCl; Group 3 (n\xa0=\xa017) - XP-endo® Finisher (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland) with 4% NaOCl', 'irrigant activation devices and conventional needle irrigation']",['smear layer and debris removal'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}, {'cui': 'C0037777', 'cui_str': 'Dental Specialty'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",74.0,0.0576456,There was no significant difference in smear layer and debris removal between treatment and control groups in the same canal zones.,"[{'ForeName': 'Yasmina', 'Initials': 'Y', 'LastName': 'Andreani', 'Affiliation': 'School of Dentistry - Faculty of Medicine and Health, The University of Sydney, Surry Hills, NSW, Australia.'}, {'ForeName': 'Benjamin Thomas', 'Initials': 'BT', 'LastName': 'Gad', 'Affiliation': 'School of Dentistry - Faculty of Medicine and Health, The University of Sydney, Surry Hills, NSW, Australia.'}, {'ForeName': 'Thomas Charles', 'Initials': 'TC', 'LastName': 'Cocks', 'Affiliation': 'School of Dentistry - Faculty of Medicine and Health, The University of Sydney, Surry Hills, NSW, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Harrison', 'Affiliation': 'School of Dentistry - Faculty of Medicine and Health, The University of Sydney, Surry Hills, NSW, Australia.'}, {'ForeName': 'Mark Edward', 'Initials': 'ME', 'LastName': 'Keresztes', 'Affiliation': 'School of Dentistry - Faculty of Medicine and Health, The University of Sydney, Surry Hills, NSW, Australia.'}, {'ForeName': 'James Kennan', 'Initials': 'JK', 'LastName': 'Pomfret', 'Affiliation': 'School of Dentistry - Faculty of Medicine and Health, The University of Sydney, Surry Hills, NSW, Australia.'}, {'ForeName': 'Evan Benjamin', 'Initials': 'EB', 'LastName': 'Rees', 'Affiliation': 'School of Dentistry - Faculty of Medicine and Health, The University of Sydney, Surry Hills, NSW, Australia.'}, {'ForeName': 'Duoduo', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'School of Dentistry - Faculty of Medicine and Health, The University of Sydney, Surry Hills, NSW, Australia.'}, {'ForeName': 'Brett Lindsay', 'Initials': 'BL', 'LastName': 'Baloun', 'Affiliation': 'School of Dentistry - Faculty of Medicine and Health, The University of Sydney, Surry Hills, NSW, Australia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'School of Dentistry and Health Sciences - Faculty of Science, Charles Sturt University, Orange, NSW, Australia.'}]",Australian endodontic journal : the journal of the Australian Society of Endodontology Inc,['10.1111/aej.12482']
1578,33682262,Effectiveness of a resistance exercise program for lower limbs in chronic renal patients on hemodialysis: A randomized controlled trial.,"INTRODUCTION


Physical inactivity in hemodialysis patients is associated with increased mortality. The objective of this study was evaluated the effect of an intradialytic resistance exercise program on chronic kidney disease (CKD) patients on hemodialysis.
METHODS


One hundred seven patients were included in the study. They were aged 18-60 years, of both sexes, had undergone hemodialysis treatment for at least 1 year, sedentary. Patients were randomly divided into two groups: stretching (STG) and resistance exercise (REG). Intervention programs were performed for 8 weeks, three times a week. The evaluations were performed before and after the training programs. The primary outcome was functional capacity using the 6-minute walk test (6MWT). Secondary outcomes were peripheral muscle strength, respiratory muscle strength, spirometric respiratory function, and laboratory data.
FINDINGS


Comparisons between groups revealed the following clinically relevant results in favor of REG: lower limb muscle strength (mean difference [MD] = -1.99, 95% confidence interval [CI] = -2.77 to -1.21; d = -0.53), distance walked in the 6MWT (MD = -26.27, 95% CI = -45.40 to -7.14; d = -0.46), creatinine (MD = -1.52, 95% CI = -2.49 to -0.54; d = -0.66), and calcium (MD = -0.44, 95% CI = -0.78 to -0.10; d = -0.49).
DISCUSSION


CKD patients on hemodialysis have reduced functional capacity compared to healthy sedentary individuals. In turn, this reduction appears to be associated with a lower survival rate and affects the performance of their daily living activities. Thus, resistance exercise performed in the intradialytic phase is an effective therapeutic strategy for CKD patients, mainly because it increases functional capacity and lower limb muscle strength.",2021,"In turn, this reduction appears to be associated with a lower survival rate and affects the performance of their daily living activities.","['chronic kidney disease (CKD) patients on hemodialysis', 'hemodialysis patients', 'chronic renal patients on hemodialysis', 'One hundred seven patients were included in the study', 'They were aged 18-60\u2009years, of both sexes, had undergone hemodialysis treatment for at least 1\u2009year, sedentary']","['intradialytic resistance exercise program', 'resistance exercise program', 'stretching (STG) and resistance exercise (REG', 'CKD', '6MWT']","['functional capacity using the 6-minute walk test (6MWT', 'limb muscle strength', 'survival rate', 'peripheral muscle strength, respiratory muscle strength, spirometric respiratory function, and laboratory data', 'functional capacity']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",107.0,0.0652633,"In turn, this reduction appears to be associated with a lower survival rate and affects the performance of their daily living activities.","[{'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Exel', 'Affiliation': 'Department of Physical Therapy, Tiradentes University Center, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Paulo Soares', 'Initials': 'PS', 'LastName': 'Lima', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Christiano Bertoldo', 'Initials': 'CB', 'LastName': 'Urtado', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Almir Vieira', 'Initials': 'AV', 'LastName': 'Dibai-Filho', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Claudia Lucio', 'Initials': 'CL', 'LastName': 'Vilanova', 'Affiliation': 'Department of Physical Therapy, Tiradentes University Center, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Elaine Fávaro Pípi', 'Initials': 'EFP', 'LastName': 'Sabino', 'Affiliation': 'Postgraduate Program in Health Sciences, Federal University of Uberlândia, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Thúlio Marquez', 'Initials': 'TM', 'LastName': 'Cunha', 'Affiliation': 'School of Medicine, Federal University of Uberlândia, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Flávio Teles', 'Initials': 'FT', 'LastName': 'de Farias-Filho', 'Affiliation': 'School of Medicine, Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Claudio Torres', 'Initials': 'CT', 'LastName': 'de Miranda', 'Affiliation': 'School of Medicine, Federal University of Alagoas, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Robinson Sabino', 'Initials': 'RS', 'LastName': 'da Silva', 'Affiliation': 'Department of Physiological Sciences, Federal University of Uberlândia, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bassi-Dibai', 'Affiliation': 'Postgraduate Program in Programs Management and Health Services, Ceuma University, São Luís, Maranhão, Brazil.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12918']
1579,33682223,Platelet-rich plasma with low dose oral minoxidil (1.25mg versus 2.5mg) along with trichoscopic pre and post treatment evaluation.,"BACKGROUND


Low dose (<5mg) oral minoxidil (OM) seems a promising option for male androgenetic alopecia (MAGA).
AIM


To evaluate the role of oral minoxidil 1.25mg versus oral minoxidil 2.5mg along with platelet rich plasma in AGA METHODS: Group A consisted of fourty seven patients which included patients on OM 1.25mg daily and Platelet rich plasma therapy and Group B consisted of patients on OM 2.5 mg daily and Platelet rich plasma therapy. Photographs were taken before and after treatment along with trichoscopic evaluation. Selection of the dermoscopic variables was based on the published literature.
RESULTS


At 24 weeks, marked improvement on GCP were seen in 19 (19/47;40.4%) in Group A and 28 (28/48;58.3%) patients in Group B with P value of 0.058. The total increase in total hair/cm2 was around 24 and 36 in group A and B respectively with P>0.05. The percentage increase in mean total hair count/cm 2  after 6 month of treatment was 15.41% in group A and 22.15% in group B, but they were not statistically significant. The patient satisfaction score on a likert scale between both group were statistically significant.
CONCLUSION


This is a pilot study where OM along with PRP at different dosage has been compared, this can be used in patients who are a bit apprehensive on taking finasteride or dutasteride and are less responsive to topical minoxidil.",2021,"The percentage increase in mean total hair count/cm 2  after 6 month of treatment was 15.41% in group A and 22.15% in group B, but they were not statistically significant.","['patients who are a bit apprehensive on taking', ' Group A consisted of fourty seven patients which included patients on', 'male androgenetic alopecia (MAGA']","['OM 1.25mg daily and Platelet rich plasma therapy and Group B consisted of patients on OM 2.5 mg daily and Platelet rich plasma therapy', 'finasteride or dutasteride', 'minoxidil', 'minoxidil (OM', 'Platelet-rich plasma with low dose oral minoxidil']","['mean total hair count/cm 2', 'patient satisfaction score on a likert scale', 'GCP', 'total increase in total hair/cm2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0045724', 'cui_str': '2-(4-ethoxybenzyl)-1-diethylaminoethyl-5-isothiocyanatobenzimidazole'}, {'cui': 'C0233485', 'cui_str': 'Apprehension'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4727879', 'cui_str': 'Platelet rich plasma therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0992616', 'cui_str': 'Minoxidil 2.5 MG'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C1175868', 'cui_str': 'GCP (supplement)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}]",,0.0191441,"The percentage increase in mean total hair count/cm 2  after 6 month of treatment was 15.41% in group A and 22.15% in group B, but they were not statistically significant.","[{'ForeName': 'Abhijeet Kumar', 'Initials': 'AK', 'LastName': 'Jha', 'Affiliation': 'Department of Skin& VD, Patna Medical College & Hospital, Patna, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Zeeshan', 'Affiliation': 'Department of Skin& VD, Patna Medical College & Hospital, Patna, India.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Skin& VD, Patna Medical College & Hospital, Patna, India.'}, {'ForeName': 'Prasoon Kumar', 'Initials': 'PK', 'LastName': 'Roy', 'Affiliation': 'Department of Skin& VD, Nalanda Medical College & Hospital, Patna, India.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14049']
1580,33680184,"""What Was His Name, Again?"": A New Method for Reducing Memory-Based Errors in an Adult False-Belief Task.","Despite considerable interest in the development of Theory of Mind (ToM) during early childhood, until recently, there has been little consideration about whether and how ToM skills continue to change into adulthood. Furthermore, the false-belief task, which is believed to capture the underlying mechanisms of ToM, is rarely used in studies of ToM with adults; those tasks that do assess false-belief understanding may be confounded by incidental task demands, such as complex narratives and excessive memory requirements, making it difficult to isolate adults' true ToM skills, much less to compare them with the skills of children. Here, we adapted a task developed by Valle, Massaro, Castelli, and Marchetti (2015, https://doi.org/10.5964/ejop.v11i1.829) to assess false-belief understanding in adults. Participants were randomly assigned to one of three conditions. In the reading condition, participants read a story about the unexpected transfer of a ball between three brothers. In the video condition, participants watched a video version of the same story. Finally, in the training condition, participants were first trained on the names of the characters, before watching the video. Although condition did not affect participants' ability to correctly answer a standard false belief question (""Where does X think Y thinks the ball is?""), participants in the training condition used more mental state language to justify their responses (""Why does X think Y thinks the ball is here?""), and this improved performance was mediated by improved memory for the story details. We conclude that at least some ""failures"" of ToM use may be due to an inability to understand, recall, or communicate complex information in a ToM task, raising important questions about how best to measure ToM in adults (and children) in the future.",2020,"Although condition did not affect participants' ability to correctly answer a standard false belief question (""Where does X think Y thinks the ball is?""), participants in the training condition used more mental state language to justify their responses (""Why does X think Y thinks the ball is here?""), and this improved performance was mediated by improved memory for the story details.",['adults'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0246055,"Although condition did not affect participants' ability to correctly answer a standard false belief question (""Where does X think Y thinks the ball is?""), participants in the training condition used more mental state language to justify their responses (""Why does X think Y thinks the ball is here?""), and this improved performance was mediated by improved memory for the story details.","[{'ForeName': 'Marea S', 'Initials': 'MS', 'LastName': 'Colombo', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bremer', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Gross', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jamin', 'Initials': 'J', 'LastName': 'Halberstadt', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Harlene', 'Initials': 'H', 'LastName': 'Hayne', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}]",Europe's journal of psychology,['10.5964/ejop.v16i2.1998']
1581,33680182,Randomised Controlled Trial of an Online Version of Compassion Mind Training in a Nonclinical Sample.,"Compassion Mind Training (CMT) is a therapeutic approach to guide highly self-critical individuals to generate compassion. The goal was to probe the efficacy of a short-term, online version of the CMT on self-compassion and self-criticism in a non-clinical population. We conducted a randomized controlled trial with pre-, post-measurements and two-month follow-up. Out of 144 randomly allocated participants 26 and 20 of those allocated to the intervention and control groups, respectively, completed the follow-up measures. The intervention group was instructed through email to practice a different CMT exercise every day for 13 consecutive days. There was a significant effect of the intervention on self-criticism, especially Hated-self and the Self-uncompassionate responding. The CMT group reported a reduction in negative thoughts and feelings with effects present at the two-month follow-up. There was no significant effect of the intervention on self-reassurance and self-compassion. Self-criticism is amenable to change following a short-term online intervention of CMT delivered to a non-clinical population with effects lasting at least two months. These findings are promising and suggest that interventions designed to reduce self-criticism can be provided to broader populations without direct involvement of mental health professionals.",2020,The CMT group reported a reduction in negative thoughts and feelings with effects present at the two-month follow-up.,[],"['Online Version of Compassion Mind Training', 'Compassion Mind Training (CMT', 'CMT exercise']","['negative thoughts and feelings', 'self-criticism, especially Hated-self and the Self-uncompassionate responding', 'self-reassurance and self-compassion']",[],"[{'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0062773', 'cui_str': 'Histone acetyltransferase'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",144.0,0.0268941,The CMT group reported a reduction in negative thoughts and feelings with effects present at the two-month follow-up.,"[{'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Halamová', 'Affiliation': 'Institute of Applied Psychology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kanovský', 'Affiliation': 'Institute of Social Anthropology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Pačutová', 'Affiliation': 'Institute of Applied Psychology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Nuriye', 'Initials': 'N', 'LastName': 'Kupeli', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, United Kingdom.'}]",Europe's journal of psychology,['10.5964/ejop.v16i2.1683']
1582,33680160,The Illusion of Knowing in College: A Field Study of Students with a Teacher-Centered Educational Past.,"In the present study, the tendency to overestimate performance (illusion of knowing) was examined in college students whose educational past experiences had emphasized verbatim learning. Female students enrolled in core curriculum classes were sampled. Classes taught by the same instructor were randomly assigned to a self-assessment practice condition, where students predicted their test and class performance and were asked to reflect on discrepancies between predictions and actual performance, or to a control condition. At the end of the semester, irrespective of condition, as performance declined on the final test, predictions of final test grades became more inflated, but less confident, indicating that students were aware of their own deficiencies. Overall, students in the practice condition displayed not only greater prediction accuracy, but also greater final test performance than students in the control condition. Practice, however, benefited the most self-assessment accuracy of students whose final test grades were just above the passing grade. Although the responses to self-assessment practice of students with a teacher-centered educational past were largely similar to the responses of students from Western countries reported in the extant literature, differences in impact and meaning could be inferred.",2019,"Overall, students in the practice condition displayed not only greater prediction accuracy, but also greater final test performance than students in the control condition.","['Students with a Teacher-Centered Educational Past', 'Female students enrolled in core curriculum classes were sampled', 'college students whose educational past experiences had emphasized verbatim learning']",[],"['final test performance', 'prediction accuracy']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0173438,"Overall, students in the practice condition displayed not only greater prediction accuracy, but also greater final test performance than students in the control condition.","[{'ForeName': 'Maura A E', 'Initials': 'MAE', 'LastName': 'Pilotti', 'Affiliation': 'College of Science and Human Studies, Prince Mohammad Bin Fahd University, Al Khobar, Kingdom of Saudi Arabia.'}, {'ForeName': 'Khadija', 'Initials': 'K', 'LastName': 'El Alaoui', 'Affiliation': 'College of Science and Human Studies, Prince Mohammad Bin Fahd University, Al Khobar, Kingdom of Saudi Arabia.'}, {'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Mulhem', 'Affiliation': 'College of Science and Human Studies, Prince Mohammad Bin Fahd University, Al Khobar, Kingdom of Saudi Arabia.'}, {'ForeName': 'Halah A', 'Initials': 'HA', 'LastName': 'Al Kuhayli', 'Affiliation': 'College of Science and Human Studies, Prince Mohammad Bin Fahd University, Al Khobar, Kingdom of Saudi Arabia.'}]",Europe's journal of psychology,['10.5964/ejop.v15i4.1921']
1583,33680156,Is Shame Managed Through Mind-Wandering?,"Shame is a notoriously unpleasant emotion, and although claims about the mechanisms through which we might manage it are none too scarce, relatively little empirical evidence is available concerning how people tend to cope with it. As such, the present study sought to investigate the effects of shame on mind-wandering. To do this, 120 participants were recruited and systematically assigned to one of the three groups, namely shame, pride, or control condition, and traits shame and self-compassion were measured for each participant. In order to assess the frequency of the incidents of mind-wandering, the participants were asked to recall a personal experience of shame or pride and then a reading task of few pages of geography followed. The duration participants spent on the reading task, their scores on a reading comprehension test, their self-reported frequency of mind-wandering, and their reported number of unrelated thoughts during the recall were used as a measure of mind-wandering. The results demonstrated that participants in the shame condition did not differ from those in the pride and control conditions in terms of mind-wandering. In spite of that, participants who had initially scored higher on trait shame (i.e., suffered from chronic shame) reported a significantly higher frequency of mind-wandering. This being the result, the underlying reasons for, and implications of, the findings were discussed.",2019,The results demonstrated that participants in the shame condition did not differ from those in the pride and control conditions in terms of mind-wandering.,['120 participants'],[],"['duration participants spent on the reading task, their scores on a reading comprehension test, their self-reported frequency of mind-wandering, and their reported number of unrelated thoughts', 'trait shame']","[{'cui': 'C4319550', 'cui_str': '120'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0036938', 'cui_str': 'Shame'}]",120.0,0.0175273,The results demonstrated that participants in the shame condition did not differ from those in the pride and control conditions in terms of mind-wandering.,"[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Sedighimornani', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK.'}]",Europe's journal of psychology,['10.5964/ejop.v15i4.1787']
1584,33680044,Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Anthracycline-cyclophosphamide Chemotherapy Regimen in Patients with Breast Cancer.,"We evaluated and compared the efficacy and safety of mirtazapine (MTZ) with olanzapine (OLP) for preventing chemotherapy-induced nausea and vomiting (CINV) following anthracycline plus cyclophosphamide (AC) regimen. Eligible participants were chemotherapy-naive early-stage breast cancer patients who were scheduled to undergo adjuvant AC. The patients were randomized to take oral MTZ or OLP in combination with aprepitant (A), dexamethasone (D), and granisetron (G), (ADG). The endpoints included rates of complete response (CR), complete control (CC), total control (TC), and adverse events during the acute, delayed, and overall phases in the two cycles of chemotherapy. The influence of CINV on the quality of life (QoL) was evaluated on day 6 of chemotherapy. Of 82 patients, 60 were randomized. In the first cycle, CR rates in cycle 1 were 83.3% and 76.6% during the acute period, 80% and 86.6% during the delayed period, and 66.6% and 63.3% during the overall period, for the ADG-M and ADG-O, respectively. High efficacy of both groups was maintained over 2 cycles. More patients in the ADG-M group noted minimal or no impact of CINV on daily life in cycle 2 (89.7%  vs.  67.9%;  p =  0.044). Incidence of somnolence and fatigue was more frequent with the olanzapine group. In this study, there was no substantial difference between mirtazapine and olanzapine in preventing CINV. Further large randomized trials are essential to demonstrate the anti-emetic effect of mirtazapine in chemotherapy.",2020,More patients in the ADG-M group noted minimal or no impact of CINV on daily life in cycle 2 (89.7%  vs.  67.9%;  p =  0.044).,"['82 patients, 60 were randomized', 'Patients with Breast Cancer', 'Eligible participants were chemotherapy-naive early-stage breast cancer patients who were scheduled to undergo adjuvant AC']","['mirtazapine (MTZ) with olanzapine (OLP', 'Anthracycline-cyclophosphamide Chemotherapy Regimen', 'oral MTZ or OLP in combination with aprepitant (A), dexamethasone (D), and granisetron (G), (ADG', 'Mirtazapine and Olanzapine', 'mirtazapine and olanzapine', 'mirtazapine', 'CINV', 'olanzapine', 'anthracycline plus cyclophosphamide (AC']","['CR rates', 'CINV on daily life', 'Nausea and Vomiting', 'nausea and vomiting (CINV', 'rates of complete response (CR), complete control (CC), total control (TC), and adverse events during the acute, delayed, and overall phases in the two cycles of chemotherapy', 'Incidence of somnolence and fatigue', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",82.0,0.0291376,More patients in the ADG-M group noted minimal or no impact of CINV on daily life in cycle 2 (89.7%  vs.  67.9%;  p =  0.044).,"[{'ForeName': 'Alimohammad', 'Initials': 'A', 'LastName': 'Maleki', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Ghadiyani', 'Affiliation': 'Department of Medical Oncology, Hematology and Bone Marrow Transplantation, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Salamzadeh', 'Affiliation': 'Food Safety Research Center, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Salari', 'Affiliation': 'Department of Medical Oncology, Hematology and Bone Marrow Transplantation, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedshahab', 'Initials': 'S', 'LastName': 'Banihashem', 'Affiliation': 'Department of Psychiatry, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tavakoli-Ardakani', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2020.113955.14584']
1585,33680042,"The Effect of Erythropoietin Administration on the Serum Level of YKL-40, pro-BNP and IL-6 in Coronary Surgery Patients.","Cardiopulmonary bypass and aortic clamping evokes the obligatory global myocardial ischemia and dysfunction with a significant inflammatory response. The discrepancy about cardioprotective effects of erythropoietin still exist. The aim of this study was to assess the clinical immunomodulatory effects of Erythropoietin (EPO) on serum inflammatory biomarkers (YKL-40, IL-6) and cardiac biomarkers, (pro-BNP, CK-MB and troponin). In this randomized double blind clinical trial, 132 patients admitted for elective coronary surgery with Cardiopulmonary Bypass (CPB) were randomly assigned in one of three groups: 1-group EPO-A (n = 35) infusion of 300 IU/Kg EPO after anesthesia induction and before undergoing CPB; 2- group EPO-CPB (n = 31) the same intervention during CPB; 3- placebo group (n = 66) saline infusion in the same volume. Cardiac enzymes and serum biomarkers were measured at intervals. There was a sharp increase in serum YKL-40 with a 24 h delay after CPB in all groups without significant difference. The increase in serum IL-6 was significant in EPO-CPB group compared with both other groups ( p  = 0.001 and  p  = 0.001, respectively). Serum pro-BNP reached maximum level 24 h after operation in all groups; in group A significantly less than others ( p  = 0.008). CK-MB increased significantly in all groups ( p  < 0.001), less prominently in CPB-A group ( p  = 0.03). EPO administration before induced ischemia may be cardioprotective in terms of cardiac biomarkers in patients undergoing CABG with CPB.",2020,"CK-MB increased significantly in all groups ( p  < 0.001), less prominently in CPB-A group ( p  = 0.03).","['132 patients admitted for elective coronary surgery with Cardiopulmonary Bypass (CPB', 'patients undergoing CABG with CPB', 'Coronary Surgery Patients']","['placebo', 'Erythropoietin', 'EPO', 'Erythropoietin (EPO', '1-group EPO-A (n = 35) infusion of 300 IU/Kg EPO after anesthesia induction and before undergoing CPB; 2- group EPO-CPB', 'Cardiopulmonary bypass and aortic clamping evokes', 'saline infusion']","['serum IL-6', 'Serum Level of YKL-40, pro-BNP and IL-6', 'serum inflammatory biomarkers (YKL-40, IL-6) and cardiac biomarkers, (pro-BNP, CK-MB and troponin', 'serum YKL-40', 'CK-MB', 'Serum pro-BNP reached maximum level', 'Cardiac enzymes and serum biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439463', 'cui_str': 'IU/kg'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0528649', 'cui_str': 'CHI3L1 protein, human'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0201934', 'cui_str': 'Cardiac enzymes/isoenzymes measurement'}]",132.0,0.125494,"CK-MB increased significantly in all groups ( p  < 0.001), less prominently in CPB-A group ( p  = 0.03).","[{'ForeName': 'Mahnoosh', 'Initials': 'M', 'LastName': 'Foroughi', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Mohammadi', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Majidi Tehrani', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Bakhtiari', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Haji Molahoseini', 'Affiliation': 'Department of Immunology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2020.112867.13993']
1586,33680026,Effects of Fish Oil Supplementation on Pregnancy Outcomes in Pregnant Women Referred to Kosar Hospital.,"The hypothesis of a protective effect of fish oil supplementation in preventing some consequences of pregnancy such as gestational hypertension is put forward which has attracted increasing attention. The aim of the present study was to evaluate the effect of fish oil supplementation on outcomes of pregnancy. This study was a clinical trial performed on 339 women with singleton pregnancy aged 18-35 and gestational age of 20 weeks who visited prenatal clinic at Kosar Hospital in Qazvin during 2015-2016. Patients were randomly divided into two groups marked as intervention group which received soft gelatin capsules (each containing 1000 mg fish oil including 120 mg DHA and 180 mg EPA) on a daily basis from the 20 th  week to the end of pregnancy, and the women in the control group with no fish oil intake. The outcomes of pregnancy including preeclampsia, eclampsia, preterm labor, gestational diabetes, weight, height, head circumference at birth and the gestational age at delivery were evaluated in both groups. Data were analyzed using statistical tests including Mann-Whitney U test and  t -test. There was significant difference in gestational age between the two study groups ( P  < 0.05). There was no significant difference in the percentage of preterm birth, preeclampsia, eclampsia, IUGR, and GDM between the two groups ( P  > 0.05). The results of this study showed that consumption of fish oil supplements from 20 th  week of gestation by 18-35 year-old pregnant women increased pregnancy age but failed to decrease the percentage of preterm birth, preeclampsia, eclampsia, IUGR, and GDM.",2020,"There was no significant difference in the percentage of preterm birth, preeclampsia, eclampsia, IUGR, and GDM between the two groups ( P  > 0.05).","['339 women with singleton pregnancy aged 18-35 and gestational age of 20 weeks who visited prenatal clinic at Kosar Hospital in Qazvin during 2015-2016', 'Pregnant Women Referred to Kosar Hospital']","['soft gelatin capsules (each containing 1000 mg fish oil including 120 mg DHA and 180 mg EPA', 'control group with no fish oil intake', 'fish oil supplementation', 'Fish Oil Supplementation']","['pregnancy including preeclampsia, eclampsia, preterm labor, gestational diabetes, weight, height, head circumference at birth and the gestational age at delivery', 'Pregnancy Outcomes', 'outcomes of pregnancy', 'percentage of preterm birth, preeclampsia, eclampsia, IUGR, and GDM', 'gestational age']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0419406', 'cui_str': 'Birth head circumference'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}]",339.0,0.0943584,"There was no significant difference in the percentage of preterm birth, preeclampsia, eclampsia, IUGR, and GDM between the two groups ( P  > 0.05).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Gholami', 'Affiliation': 'Department of Obstetrics and Gynecology, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Shokoh', 'Initials': 'S', 'LastName': 'Abotorabi', 'Affiliation': 'Department of Obstetrics and Gynecology, Clinical Research Development Unit, Kosar Hospital, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Lalooha', 'Affiliation': 'Department of Obstetrics and Gynecology, Clinical Research Development Unit, Kosar Hospital, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Oveisi', 'Affiliation': 'Department of Maternity and Child Health, Metabolic Disease Research Center, Qazvin University of Medical Sciences. Qazvin, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.13976.12041']
1587,33680001,Reducing stress and promoting well-being in healthcare workers using mindfulness-based cognitive therapy for life.,"Healthcare workers play a critical role in the health of a nation, yet rates of healthcare worker stress are disproportionately high. We evaluated whether mindfulness-based cognitive therapy for life (MBCT-L), could reduce stress in healthcare workers and target a range of secondary outcomes.  Method : This is the first parallel randomised controlled trial of MBCT-L. Participants were NHS workers, who were randomly assigned (1:1) to receive either MBCT-L or wait-list. The primary outcome was self-reported stress at post-intervention. Secondary variables were well-being, depression, anxiety, and work-related outcomes. Mixed regressions were used. Mindfulness and self/other-compassion were explored as potential mechanisms of effects on stress and wellbeing.  Results : We assigned 234 participants to MBCT-L ( n  = 115) or to wait-list ( n  = 119). 168 (72%) participants completed the primary outcome and of those who started the MBCT-L 73.40% ( n  = 69) attended the majority of the sessions. MBCT-L ameliorated stress compared with controls ( B  = 2.60, 95% CI = 1.63‒3.56;  d  = -0.72;  p  < .0001). Effects were also found for well-being, depression and anxiety, but not for work-related outcomes. Mindfulness and self-compassion mediated effects on stress and wellbeing.  Conclusions : MBCT-L could be an effective and acceptable part of a wider healthcare workers well-being and mental health strategy.",2021,"MBCT-L ameliorated stress compared with controls ( B  = 2.60, 95% CI = 1.63‒3.56;  d  ","['234 participants to MBCT-L ( n  = 115) or to wait-list ( n  = 119', 'L. Participants were NHS workers']","['MBCT-L or wait-list', 'mindfulness-based cognitive therapy for life (MBCT-L', 'MBCT', 'mindfulness-based cognitive therapy']","['well-being, depression and anxiety', 'self-reported stress', 'MBCT-L ameliorated stress', 'well-being, depression, anxiety, and work-related outcomes', 'stress and wellbeing']","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",234.0,0.12184,"MBCT-L ameliorated stress compared with controls ( B  = 2.60, 95% CI = 1.63‒3.56;  d  ","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Strauss', 'Affiliation': 'School of Psychology, University of Sussex, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Research Department, Sussex Partnership NHS Foundation Trust, Sussex Education Centre, Mill View Hospital, United Kingdom.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Whittington', 'Affiliation': 'Health Education England, Kent, Surrey and Sussex, United Kingdom.'}, {'ForeName': 'Cavita', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'Health Education England, Kent, Surrey and Sussex, United Kingdom.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, United Kingdom.'}]",International journal of clinical and health psychology : IJCHP,['10.1016/j.ijchp.2021.100227']
1588,33679948,Effect of Pressure biofeedback training on deep cervical flexors endurance in patients with mechanical neck pain: A randomized controlled trial.,"Objective


To compare the effects of Cranio cervical flexion training with and without pressure biofeedback on deep cervical muscular endurance in patients with mechanical chronic neck pain.
Methods


A randomized control trial was conducted at Railway General Hospital Rawalpindi, from May to December 2019. It consisted of thirty participants with the age ranging from 25 to 40 years, and having chronic mechanical neck pain. The participants were randomly allocated into two groups Group-A received Craniocervical flexion training with pressure biofeedback and Group-B received Craniocervical flexion training without pressure biofeedback. The intervention was applied for four weeks (3 sessions per week). Assessments were taken at Pre, Post intervention and after six weeks of follow up. Data analysis was done using SPSS-21 version.
Results


The mean age of Group-A and Group-B was 29.40±3.08 and 31.33±4.95 respectively. Between-group analyses has shown statistically and clinically significant improvement in Group-A regarding deep neck muscles endurance (p<0.05). Whereas within group analysis of both groups A & B showed a statistical and clinically significant difference (p=0.00) for deep neck muscles endurance.
Conclusions


Cranio-cervical flexion training with Pressure Biofeedback has proven to be more effective in improving endurance of deep cervical flexors in patients with mechanical neck pain.",2021,Between-group analyses has shown statistically and clinically significant improvement in Group-A regarding deep neck muscles endurance (p<0.05).,"['thirty participants with the age ranging from 25 to 40 years, and having chronic mechanical neck pain', 'patients with mechanical neck pain', 'patients with mechanical chronic neck pain']","['Pressure Biofeedback', 'Pressure biofeedback training', 'Craniocervical flexion training with pressure biofeedback and Group-B received Craniocervical flexion training without pressure biofeedback', 'Cranio cervical flexion training with and without pressure biofeedback']","['deep neck muscles endurance', 'deep cervical muscular endurance', 'deep cervical flexors endurance']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",30.0,0.0865767,Between-group analyses has shown statistically and clinically significant improvement in Group-A regarding deep neck muscles endurance (p<0.05).,"[{'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Ashfaq', 'Affiliation': 'Dr. Rabia Ashfaq, DPT, MS (OMPT). Physical Therapist, Department of Rehabilitation sciences, Riphah International University, Rawalpindi, Pakistan.'}, {'ForeName': 'Huma', 'Initials': 'H', 'LastName': 'Riaz', 'Affiliation': 'Huma Riaz, PHD(Rehab Sciences), PP-DPT, PGD (PE&TM), Bs.PT Associate Professor/ Head of Department DPT, Riphah College of Rehabilitation & Allied Health Sciences, Islamabad, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.37.2.2343']
1589,33679943,Effect of Dexmedetomidine Hydrochloride on perioperative inflammation and postoperative lung infection in patients with spinal tuberculosis.,"Objective


To explore the effect of dexmedetomidine hydrochloride on perioperative inflammation and postoperative lung infection in patients with spinal tuberculosis.
Method


A double-blind control observation was conducted in spinal tuberculosis patients with the use of general anesthesia during the operation. A total of 171 spinal tuberculosis patients who received endotracheal intubation for general anesthesia in Henan University of Chinese Medicine from January 2017 to April 2019 were included. The concentration changes in serum TNF-α and IL-6 were recorded at one hour, six hour and one day after the operation. The incidence of postoperative pulmonary complications of patients were also evaluated.
Results


The results showed that in the experimental group compared with the control group, serum TNF-α and IL-6 concentrations one hour, six hour and one day after the operation were significantly lower (P<0.05). The rate of postoperative pulmonary complications was lower in the experimental group than that in the control group (P<0.05).
Conclusion


Dexmedetomidine hydrochloride has obvious anti-inflammatory effects and can reduce the incidence of pulmonary complications after surgery.",2021,"The results showed that in the experimental group compared with the control group, serum TNF-α and IL-6 concentrations one hour, six hour and one day after the operation were significantly lower (P<0.05).","['for general anesthesia in Henan University of Chinese Medicine from January 2017 to April 2019 were included', '171 spinal tuberculosis patients who received', 'spinal tuberculosis patients with the use of general anesthesia during the operation', 'patients with spinal tuberculosis']","['Dexmedetomidine hydrochloride', 'endotracheal intubation', 'Dexmedetomidine Hydrochloride', 'dexmedetomidine hydrochloride']","['serum TNF-α and IL-6 concentrations', 'serum TNF-α and IL-6', 'rate of postoperative pulmonary complications', 'perioperative inflammation and postoperative lung infection', 'postoperative pulmonary complications']","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0041330', 'cui_str': 'Tuberculosis of vertebral column'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0752310', 'cui_str': 'Dexmedetomidine hydrochloride'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}]",171.0,0.0860763,"The results showed that in the experimental group compared with the control group, serum TNF-α and IL-6 concentrations one hour, six hour and one day after the operation were significantly lower (P<0.05).","[{'ForeName': 'Yong-Hui', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': 'Yong-hui Liu, Department of Orthopedics, Henan University of Chinese Medicine, Zhengzhou, Henan 450000, P.R. China, Department of Orthopedics, Orthopedic Hospital of Henan Province, Luoyang, Henan 471000, P.R. China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Ye Zhao, Department of Orthopedics, Henan University of Chinese Medicine, Zhengzhou, Henan 450000, P.R. China, Department of Orthopedics, Orthopedic Hospital of Henan Province, Luoyang, Henan 471000, P.R. China.'}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': 'Xiang-yang Wang, Department of Orthopedics, Henan University of Chinese Medicine, Zhengzhou, Henan 450000, P.R. China, Department of Orthopedics, Orthopedic Hospital of Henan Province, Luoyang, Henan 471000, P.R. China.'}, {'ForeName': 'Hong-Xun', 'Initials': 'HX', 'LastName': 'Cui', 'Affiliation': 'Hong-xun Cui, Department of Orthopedics, Orthopedic Hospital of Henan Province, Luoyang, Henan 471000, P.R. China.'}]",Pakistan journal of medical sciences,['10.12669/pjms.37.2.2383']
1590,33679924,Comparison of mean operative time in patients undergoing Ho: YAG laser lithotripsy and pneumatic lithotripsy in ureterorenoscopy for ureteric calculus.,"Objective


To compare the mean operative time (MOT) in patients undergoing Ho: YAG laser lithotripsy (LL) and pneumatic lithotripsy (PL) for ureteric stones.
Methods


This randomized study was conducted at Armed Forces Institute of Urology (AFIU) Rawalpindi, Pakistan from July 2016 to November 2018. Non probability consecutive sampling technique utilized to enroll 60 patients of both gender aged 18-60 years, having ureteric calculus ≤1.5cm. Randomization was done into group I (LL) and II (PL) via computer generated number tables. Six Consultant Urologists performed surgeries under spinal anesthesia utilizing Swiss Lithoclast ®  Master (EMS +  S.A. Switzerland) in group II and holmium laser fiber (365μm, 8-10Hz, 9.6-16W, 2100nm wavelength) in group I respectively. MOT was noted from insertion of cystoscope till removal out of meatus. Data obtained was analyzed through IBM SPSS 24.0.
Results


Analysis involved 60 patients (30 each group) having similar baseline characteristics (age, gender, laterality, location). There was statistically significant different MOT between LL & PL (25.48±6.99 vs 34.83± 7.47 minutes, p < 0.001). Data stratification with respect to age, gender, laterality and stone location revealed similar trend. Lithotripsy technique significantly affected MOT (p < 0.001) on Multiple Linear Regression Analysis.
Conclusions


Ho: YAG LL is an efficient technique when compared with PL in terms of MOT for ureteric stones.",2021,"Lithotripsy technique significantly affected MOT (p < 0.001) on Multiple Linear Regression Analysis.
","['Six Consultant Urologists performed surgeries under spinal anesthesia utilizing Swiss', 'Armed Forces Institute of Urology (AFIU) Rawalpindi, Pakistan from July 2016 to November 2018', '60 patients of both gender aged 18-60 years, having ureteric calculus ≤1.5cm', 'patients undergoing Ho', 'Conclusions\n\n\nHo', '60 patients (30 each group) having similar baseline characteristics (age, gender, laterality, location']","['holmium laser fiber (365μm', 'Lithotripsy technique', 'YAG laser lithotripsy (LL) and pneumatic lithotripsy (PL', 'YAG laser lithotripsy and pneumatic lithotripsy', 'Lithoclast ®  Master (EMS +  S.A. Switzerland']","['mean operative time (MOT', 'MOT']","[{'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0260314', 'cui_str': 'Urologist'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023114', 'cui_str': 'Handedness'}, {'cui': 'C0450429', 'cui_str': 'Location'}]","[{'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0441577', 'cui_str': 'Ballistic fragmentation'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",60.0,0.115286,"Lithotripsy technique significantly affected MOT (p < 0.001) on Multiple Linear Regression Analysis.
","[{'ForeName': 'Muhammad Tanveer', 'Initials': 'MT', 'LastName': 'Sajid', 'Affiliation': 'Muhammad Tanveer Sajid, Armed Forces Institute of Urology (AFIU), Rawalpindi, Pakistan.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ameen', 'Affiliation': 'Mohammad Ameen, Armed Forces Institute of Urology (AFIU), Rawalpindi, Pakistan.'}, {'ForeName': 'Badar', 'Initials': 'B', 'LastName': 'Murtaza', 'Affiliation': 'Badar Murtaza, Armed Forces Institute of Urology (AFIU), Rawalpindi, Pakistan.'}, {'ForeName': 'Muhammad Sarwar', 'Initials': 'MS', 'LastName': 'Alvi', 'Affiliation': 'Muhammad Sarwar Alvi, Armed Forces Institute of Urology (AFIU), Rawalpindi, Pakistan.'}, {'ForeName': 'Zakir', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Zakir Khan, Armed Forces Institute of Urology (AFIU), Rawalpindi, Pakistan.'}, {'ForeName': 'Faran', 'Initials': 'F', 'LastName': 'Kiani', 'Affiliation': 'Faran Kiani, Armed Forces Institute of Urology (AFIU), Rawalpindi, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.37.2.3049']
1591,33679919,Effect of balance training with Biodex Balance System to improve balance in patients with diabetic neuropathy: A quasi experimental study.,"Objective


To determine the effect of balance training with Biodex Balance System in improving balance function in patients with diabetic neuropathy.
Methods


A quasi experimental study was conducted at physiotherapy department of Rehman Medical Institute Peshawar from January to June 2018. Thirty-eight Diabetes Mellitus Type-II patients with diagnosis of diabetic neuropathy participated in the study. Those patients were included who were able to stand independently and who scored moderate or severe neuropathy on Toronto Scale. Participants received 12 sessions (two sessions per week) of balance training on Biodex stability system in six weeks. Berg Balance Scale and Time Up and Go test were used to collect pre and post treatment data. Paired sample T-test was used to compare pre and post treatment data because data was normally distributed.
Results


The mean age of the participants was 63.08 ± 3.3 years. Pretreatment Berg Balance Scale score was 42.68 ± 3.7 which improved to 48.89 ±3.7 after the treatment (P<0.001). Similarly, pretreatment Time Up and Go test score was 17.47 ± 2.0 while post treatment score was 13.57 ±1.5 (P<0.001).
Conclusion


Balance training with Biodex Balance System can significantly improve balance function in Diabetes Mellitus Type-II patients with diabetic neuropathy.",2021,Pretreatment Berg Balance Scale score was 42.68 ± 3.7 which improved to 48.89 ±3.7 after the treatment (P<0.001).,"['Thirty-eight Diabetes', 'Mellitus Type-II patients with diagnosis of diabetic neuropathy participated in the study', 'The mean age of the participants was 63.08 ± 3.3 years', 'Methods\n\n\nA quasi experimental study was conducted at physiotherapy department of Rehman Medical Institute Peshawar from January to June 2018', 'Diabetes Mellitus Type-II patients with diabetic neuropathy', 'patients with diabetic neuropathy', 'Those patients were included who were able to stand independently and who scored moderate or severe neuropathy on Toronto Scale']","['balance training', 'Biodex Balance System', 'balance training with Biodex Balance System']","['Pretreatment Berg Balance Scale score', 'pretreatment Time Up and Go test score', 'Berg Balance Scale and Time Up and Go test', 'balance function']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0560884', 'cui_str': 'Able to stand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0147859,Pretreatment Berg Balance Scale score was 42.68 ± 3.7 which improved to 48.89 ±3.7 after the treatment (P<0.001).,"[{'ForeName': 'Syeda Afsheen Hasnain', 'Initials': 'SAH', 'LastName': 'Daud', 'Affiliation': 'Syeda Afsheen Hasnain Daud, DPT, MSPT. Institute of Physical Medicine and Rehabilitation, Khyber Medical University, Peshawar, Pakistan.'}, {'ForeName': 'Mujeeb Ur', 'Initials': 'MU', 'LastName': 'Rahman', 'Affiliation': 'Mujeeb Ur Rahman, BSPT, MSPT. Institute of Physical Medicine and Rehabilitation, Khyber Medical University, Peshawar, Pakistan.'}, {'ForeName': 'Aatik', 'Initials': 'A', 'LastName': 'Arsh', 'Affiliation': 'Aatik Arsh, DPT, MSPT. Institute of Physical Medicine and Rehabilitation, Khyber Medical University, Peshawar, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Junaid', 'Affiliation': 'Muhammad Junaid, DPT. Institute of Physical Medicine and Rehabilitation, Khyber Medical University, Peshawar, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.37.2.2336']
1592,33679572,"Repetitive Transcranial Magnetic Stimulation With H-Coil in Alzheimer's Disease: A Double-Blind, Placebo-Controlled Pilot Study.","Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve cognition in Alzheimer's disease (AD) with conflicting results. We applied rTMS in AD in a pilot placebo-controlled study using the H2-coil. H-coils are suitable for targeting wider neuronal structures compared with standard focal coils, in particular the H2-coil stimulates simultaneously the frontal-parietal-temporal lobes bilaterally. Thirty patients (mean age 70.9 year, SD 8.1; mean MMSE score 16.9, SD 5.5) were randomized to sham or real 10 Hz rTMS stimulation with the H2-coil. Each patient underwent 3 sessions/week for 4 weeks, followed by 4 weeks with maintenance treatment (1 session/week). Primary outcome was improvement of ADAS-cog at 4 and 8 weeks compared with baseline. A trend toward an improved ADAS-cog score over time was observed for patients undergoing real rTMS, with actively treated patients experiencing a mean decrease of -1.01 points at the ADAS-Cog scale score per time point (95% CIs -0.02 to -3.13,  p  < 0.04). This trend was no longer evident 2 months after the end of treatment. Real rTMS showed no significant effect on MMSE and BDI changes over time. These preliminary findings suggest that rTMS with H-coil is feasible and safe in patients with probable AD and might provide beneficial, even though transient, effects on cognition. This study prompts larger studies in the early stages of AD, combining rTMS and cognitive rehabilitation.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT04562506.",2020,"H-coils are suitable for targeting wider neuronal structures compared with standard focal coils, in particular the H2-coil stimulates simultaneously the frontal-parietal-temporal lobes bilaterally.","[""Alzheimer's Disease"", 'patients with probable AD', 'Thirty patients (mean age 70.9 year, SD 8.1; mean MMSE score 16.9, SD 5.5']","['rTMS with H-coil', 'Focal repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'Repetitive Transcranial Magnetic Stimulation With H-Coil', 'Placebo']","['ADAS-cog', 'MMSE and BDI changes', 'ADAS-cog score over time']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844008', 'cui_str': '5.5'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.347669,"H-coils are suitable for targeting wider neuronal structures compared with standard focal coils, in particular the H2-coil stimulates simultaneously the frontal-parietal-temporal lobes bilaterally.","[{'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Leocani', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Dalla Costa', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Coppi', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Santangelo', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pisa', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ferrari', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Maria Paola', 'Initials': 'MP', 'LastName': 'Bernasconi', 'Affiliation': 'Neuropsychology and Clinical Psychology Service, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Falautano', 'Affiliation': 'Neuropsychology and Clinical Psychology Service, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': ""Neuroscience Laboratory, Ben-Gurion University of the Negev, Be'er Sheva, Israel.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Magnani', 'Affiliation': 'Memory Disorders Unit, Institute of Experimental Neurology-INSPE, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'University Vita-Salute San Raffaele, Milan, Italy.'}]",Frontiers in neurology,['10.3389/fneur.2020.614351']
1593,33679570,"Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study.","Background:  Pilot open-label application of high-frequency repetitive transcranial magnetic stimulation (rTMS) with H-coil in Parkinson's Disease (PD) have shown promising results.  Objective:  To evaluate safety and efficacy of high-frequency rTMS with H-coil in PD in a double-blind, placebo-controlled, randomized study.  Methods:  Sixty patients with PD were randomized into 3 groups: M1-PFC (real stimulation on primary motor-M1 and pre-frontal cortices-PFC), M1 (real rTMS on M1, sham on PFC), Sham (apparent stimulation). Primary outcome was baseline-normalized percent improvement in UPDRS part III OFF-therapy at the end of treatment (12 rTMS sessions, 4 weeks). Secondary outcomes were improvement in UPDRS part III sub-scores, timed tests, and neuropsychological tests. Statistical analysis compared improvement following real and sham stimulation at the end of the protocol using either a  t -test or a Mann-Whitney test.  Results:  All patients tolerated the treatment and concluded the study. One patient from M1-PFC group was excluded from the analysis due to newly discovered uncontrolled diabetes mellitus. No serious adverse effect was recorded. At the end of treatment, patients receiving real rTMS (M1-PFC and M1 combined) showed significantly greater improvement compared to sham in UPDRS part III total score ( p  = 0.007), tremor subscore ( p  = 0.011), and lateralized sub-scores ( p  = 0.042 for the more affected side;  p  = 0.012 for the less affected side). No significant differences have been oserved in safety and efficacy outcomes between the two real rTMS groups. Notably, mild, not-distressing and transient dyskinesias occurred in 3 patients after real rTMS in OFF state.  Conclusions:  The present findings suggest that high-frequency rTMS with H-coil is a safe and potentially effective procedure and prompt larger studies for validation as add-on treatment in PD.",2020,No significant differences have been oserved in safety and efficacy outcomes between the two real rTMS groups.,"[""Parkinson's Disease (PD"", 'Sixty patients with PD', ""Parkinson's Disease""]","['placebo', 'Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil', 'high-frequency rTMS with H-coil in PD', 'M1-PFC (real stimulation on primary motor-M1 and pre-frontal cortices-PFC), M1 (real rTMS on M1, sham on PFC), Sham (apparent stimulation', 'high-frequency repetitive transcranial magnetic stimulation (rTMS) with H-coil']","['UPDRS part III sub-scores, timed tests, and neuropsychological tests', 'lateralized sub-scores', 'serious adverse effect', 'baseline-normalized percent improvement in UPDRS part III OFF-therapy', 'mild, not-distressing and transient dyskinesias', 'safety and efficacy outcomes', 'UPDRS part III total score', 'tremor subscore']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]",60.0,0.116775,No significant differences have been oserved in safety and efficacy outcomes between the two real rTMS groups.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Spagnolo', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Scientific Institute Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Fichera', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Scientific Institute Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Chieffo', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Scientific Institute Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Dalla Costa', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Scientific Institute Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pisa', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Scientific Institute Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': 'Volonté', 'Affiliation': 'Neurological Department, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Falautano', 'Affiliation': 'Neuropsychology and Clinical Psychology Service, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Neuroscience Laboratory, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Scientific Institute Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Leocani', 'Affiliation': 'Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Scientific Institute Hospital San Raffaele, Milan, Italy.'}]",Frontiers in neurology,['10.3389/fneur.2020.584713']
1594,33679529,Efforts on Changing Lifestyle Behaviors May Not Be Enough to Improve Health-Related Quality of Life Among Adolescents: A Cluster-Randomized Controlled Trial.,"Schools have been the main context for physical activity (PA) and sedentary behavior (SB) interventions among adolescents, but there is inconsistent evidence on whether they also improve dimensions of the health-related quality of life (HRQoL). The aim of this study was to evaluate the effects of a school-based active lifestyle intervention on dimensions of HRQoL. A secondary aim was to verify whether sex, age, and HRQoL at baseline were moderators of the intervention effect. A cluster-randomized controlled trial was conducted at three control and three intervention schools in Florianopolis, Brazil. All students from 7th to 9th grade were invited to participate. A school year intervention, designed primarily to increase PA and reduce SB, included strategies focused on (i) teacher training on PA, SB, and nutrition, and availability of teaching materials related to these contents; (ii) environmental improvements (i.e., creation and revitalization of spaces for the practice of PA in school); and (iii) education strategies, with the availability of folders and posters regarding PA, SB, and nutrition. Participants and the research staffs were not blinded to group assignment, but a standardized evaluation protocol was applied at baseline and after the intervention (March and November 2017) using the KIDSCREEN-27 to assess HRQoL across five dimensions. Mixed linear models were performed to evaluate the effect of the  Movimente  intervention on the five HRQoL dimensions. Of the 921 students who answered the questionnaire at baseline, 300 and 434 completed the study in control and intervention groups, respectively (dropouts: 20%). The results revealed no significant effects of the intervention on any HRQoL dimensions. A reduction of the school environment dimension was observed in both the control (-2.44; 95% CI: -3.41 to -1.48) and intervention groups (-2.09; 95% CI: -2.89 to -1.30). Sensitivity analyses showed that students in the highest baseline tertiles of HRQoL in any dimension had a reduction in their respective scores from pre- to post-intervention in both school groups. In conclusion, our results demonstrated no intervention effect on HRQoL dimensions and those students with the highest levels of HRQoL at baseline on all dimensions reduced from pre to post-intervention.
Clinical Trial Registration


The trial is registered at the Clinical Trial Registry (Trial ID: NCT02944318; date of registration: October 18, 2016).",2021,A reduction of the school environment dimension was observed in both the control (-2.44; 95% CI: -3.41 to -1.48) and intervention groups (-2.09; 95% CI: -2.89 to -1.30).,"['921 students who answered the questionnaire at baseline, 300 and 434 completed the study in control and intervention groups, respectively (dropouts: 20', 'Adolescents', 'All students from 7th to 9th grade were invited to participate']",['school-based active lifestyle intervention'],"['HRQoL dimensions', 'PA, SB, and nutrition, and availability of teaching materials related to these contents; (ii) environmental improvements (i.e., creation and revitalization of spaces for the practice of PA in school); and (iii) education strategies', 'school environment dimension']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0039402', 'cui_str': 'Teaching Materials'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0665983,A reduction of the school environment dimension was observed in both the control (-2.44; 95% CI: -3.41 to -1.48) and intervention groups (-2.09; 95% CI: -2.89 to -1.30).,"[{'ForeName': 'Alexsandra da Silva', 'Initials': 'ADS', 'LastName': 'Bandeira', 'Affiliation': 'Research Group in Physical Activity and Health, Federal University of Santa Catarina, Department of Physical Education, Florianopolis, Brazil.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Beets', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Pablo Magno', 'Initials': 'PM', 'LastName': 'da Silveira', 'Affiliation': 'Research Group in Physical Activity and Health, Federal University of Santa Catarina, Department of Physical Education, Florianopolis, Brazil.'}, {'ForeName': 'Marcus Vinicius Veber', 'Initials': 'MVV', 'LastName': 'Lopes', 'Affiliation': 'Research Group in Physical Activity and Health, Federal University of Santa Catarina, Department of Physical Education, Florianopolis, Brazil.'}, {'ForeName': 'Valter Cordeiro', 'Initials': 'VC', 'LastName': 'Barbosa Filho', 'Affiliation': 'Federal Institute of Education, Science and Technology of Ceara, Aracati Campus, Aracati, Brazil.'}, {'ForeName': 'Bruno G G', 'Initials': 'BGG', 'LastName': 'da Costa', 'Affiliation': 'Research Group in Physical Activity and Health, Federal University of Santa Catarina, Department of Physical Education, Florianopolis, Brazil.'}, {'ForeName': 'Kelly Samara', 'Initials': 'KS', 'LastName': 'Silva', 'Affiliation': 'Research Group in Physical Activity and Health, Federal University of Santa Catarina, Department of Physical Education, Florianopolis, Brazil.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.614628']
1595,33679523,A Comparative Psycholinguistic Study on the Subjective Feelings of Well-Being Outcomes of Foreign Language Learning in Older Adults From the Czech Republic and Poland.,"Positive psychology has recently seen unprecedented rise and has reached vast achievements in the area of quality of life (QoL) improvement. The purpose of this study is to show that there are different aspects of well-being that make healthy older people motivated to learn a foreign language at a later age. The research was conducted in the Czech Republic and Poland in two groups of learners aged 55 years and more. The experimental group consisted of 105 Czech respondents who were targeted with an online questionnaire with the aim to determine the level of FLL outcomes connected to QoL in healthy older adults in their L2 acquisition. The second experimental group ( n  = 100) was established of Polish seniors who attended similar language courses. The findings of the research clearly show that FLL has an irreplaceable role as one of several non-pharmacological strategies utilized to improve the aging process and reduce drawbacks of aging. The results indicate that seniors' overall satisfaction and subjective feelings of well-being are enormously high when attending foreign language classes at older age. FLL, therefore, creates an environment that can enhance QoL of older adults that can be supplemented by other means such as well-balanced diet, other social activities, sport and physical activity, music, or computer games. All these intervention methods can significantly improve QoL of older adults and the parties engaged and/or responsible for taking care of older generation should take it into serious consideration.",2021,The results indicate that seniors' overall satisfaction and subjective feelings of well-being are enormously high when attending foreign language classes at older age.,"['healthy older people motivated to learn a foreign language at a later age', 'Czech Republic and Poland in two groups of learners aged 55 years and more', 'healthy older adults in their L2 acquisition', 'Older Adults From the Czech Republic and Poland']","['Foreign Language Learning', '105 Czech respondents who were targeted with an online questionnaire', 'FLL']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0376327', 'cui_str': 'Multinational Aspects'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0376327', 'cui_str': 'Multinational Aspects'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0010871', 'cui_str': 'Czech language'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],105.0,0.0166198,The results indicate that seniors' overall satisfaction and subjective feelings of well-being are enormously high when attending foreign language classes at older age.,"[{'ForeName': 'Blanka', 'Initials': 'B', 'LastName': 'Klimova', 'Affiliation': 'Department of Applied Linguistics, Faculty of Informatics and Management, University of Hradec Kralove, Hradec Kralove, Czechia.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Pikhart', 'Affiliation': 'Department of Applied Linguistics, Faculty of Informatics and Management, University of Hradec Kralove, Hradec Kralove, Czechia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cierniak-Emerych', 'Affiliation': 'Faculty of Business and Management, Wroclaw University of Economics and Business, Wrocław, Poland.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Dziuba', 'Affiliation': 'Faculty of Business and Management, Wroclaw University of Economics and Business, Wrocław, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Firlej', 'Affiliation': 'Department of Organization Development, Cracow University of Economics, Kraków, Poland.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.606083']
1596,33682145,"Effects of Acetate on Cerebral Blood Flow, Systemic Inflammation, and Behavior in Alcohol Use Disorder.","BACKGROUND


Alcohol use disorders (AUDs) alter the regulation of physiological processes in the brain. Acetate, a metabolite of ethanol, has been implicated in several processes that are disrupted in AUDs including transcriptional regulation, metabolism, inflammation and neurotransmission. To further understand the effects of acetate on brain function in AUDs we investigated the effects of acetate on cerebral blood flow, systemic inflammatory cytokines, and behavior in AUD.
METHODS


Sixteen participants with AUD were recruited from a non-medical, clinically-managed detoxification center. Each participant received acetate and placebo in a randomly assigned order of infusion and underwent 3T MR scanning using quantitative pseudo-continuous arterial spin labeling. Participants and the study team were blinded to the infusion. Cerebral blood flow (CBF) values (ml/100 g/min) extracted from thalamus were compared between placebo and acetate using a mixed effect linear regression model accounting for infusion order. Voxel-wise CBF comparisons were set at threshold at p<0.05 cluster-corrected for multiple comparisons, voxel-level p<0.0001. Plasma cytokine levels and behavior were also assessed between infusions.
RESULTS


Fifteen men and one woman were enrolled with Alcohol Use Disorders Identification Test (AUDIT) scores between 13 and 38 with a mean of 28.3 ± 9.1. Compared to placebo, acetate administration increased CBF in the thalamus bilaterally (Left: 51.2 vs. 68.8, p<0.001; Right: 53.7 vs. 69.6, p=0.001), as well as the cerebellum, brainstem, and cortex. Older age and higher AUDIT scores were associated with increases in acetate-induced thalamic blood flow. Cytokine levels and behavioral measures did not differ between placebo and acetate infusions.
CONCLUSIONS


This pilot study in AUD suggests that during the first week of abstinence from alcohol, the brain's response to acetate differs by brain region and this response may be associated with severity of alcohol dependence.",2021,"Compared to placebo, acetate administration increased CBF in the thalamus bilaterally (Left: 51.2 vs. 68.8, p<0.001; Right: 53.7 vs. 69.6, p=0.001), as well as the cerebellum, brainstem, and cortex.","['Sixteen participants with AUD were recruited from a non-medical, clinically-managed detoxification center', 'Fifteen men and one woman were enrolled with Alcohol Use Disorders Identification Test (AUDIT) scores between 13 and 38 with a mean of 28.3 ± 9.1']","['Acetate', 'placebo, acetate', 'placebo', '3T MR scanning using quantitative pseudo-continuous arterial spin labeling', 'acetate and placebo']","['acetate-induced thalamic blood flow', 'CBF', 'Cytokine levels and behavioral measures', 'Plasma cytokine levels and behavior', 'Cerebral blood flow (CBF) values', 'Cerebral Blood Flow, Systemic Inflammation, and Behavior in Alcohol Use Disorder', 'cerebral blood flow, systemic inflammatory cytokines, and behavior in AUD']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]",16.0,0.103136,"Compared to placebo, acetate administration increased CBF in the thalamus bilaterally (Left: 51.2 vs. 68.8, p<0.001; Right: 53.7 vs. 69.6, p=0.001), as well as the cerebellum, brainstem, and cortex.","[{'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Tanabe', 'Affiliation': 'Departments of Radiology, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Neff', 'Affiliation': 'Departments of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States.'}, {'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Sutton', 'Affiliation': 'Departments of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Patten', 'Affiliation': 'Department of Biostatistics and Informatics, School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Brown', 'Affiliation': 'Departments of Radiology, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States.'}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Hoffman', 'Affiliation': 'Departments of Pharmacology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Tabakoff', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States.'}, {'ForeName': 'Ellen L', 'Initials': 'EL', 'LastName': 'Burnham', 'Affiliation': 'Departments of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14588']
1597,33682085,"Evaluation of biophysical skin parameters and hair changes in patients with acne vulgaris treated with isotretinoin, and the effect of biotin use on these parameters.","AIM


Impairment of biotin metabolism with the use of isotretinoin and the mucocutaneous side effects observed in patients using isotretinoin suggests that they are a result of decreased enzyme activity. We aimed to determine the pattern of skin and hair changes in patients with acne receiving isotretinoin and how these changes were affected by biotin added to the treatment.
MATERIALS AND METHODS


Sixty patients were divided into two groups. Each group contained 30 patients. Groups A and B received 0.5 mg/kg/day isotretinoin, and 10 mg/day biotin supplement was added to Group B. Both groups were evaluated using a digital dermoscope for hair changes and with a DermaLab ®  Combo device for transepidermal water loss (TEWL), skin retraction, skin hydration, and skin sebum levels at the beginning and end of the fourth month.
RESULTS


In group B, the anagen hair ratio increased (P = 0.034) and the telogen hair ratio decreased significantly (P = 0.003). Skin sebum and the skin retraction values decreased in both groups. Skin hydration decreased significantly in group A (P = 0.001), but there was no significant decrease in group B (P = 0.43).
CONCLUSION


Biotin (10 mg/day) given in addition to isotretinoin treatment decreased telogen and increased anagen hair rates and helped to maintain skin hydration. The use of 10 mg/day biotin can prevent the mucocutaneous adverse effects of isotretinoin treatment.",2021,"In group B, the anagen hair ratio increased (P = 0.034) and the telogen hair ratio decreased significantly (P = 0.003).","['Sixty patients', 'patients with acne receiving', 'patients with acne vulgaris treated with']","['Biotin', 'isotretinoin']","['anagen hair rates and helped to maintain skin hydration', 'transepidermal water loss (TEWL), skin retraction, skin hydration, and skin sebum levels', 'Skin sebum and the skin retraction values', 'telogen hair ratio', 'pattern of skin and hair changes', 'anagen hair ratio', 'Skin hydration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}]","[{'cui': 'C0221976', 'cui_str': 'Anagen hair'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0221978', 'cui_str': 'Telogen hair'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",60.0,0.0297625,"In group B, the anagen hair ratio increased (P = 0.034) and the telogen hair ratio decreased significantly (P = 0.003).","[{'ForeName': 'Sema E', 'Initials': 'SE', 'LastName': 'Aksac', 'Affiliation': 'Department of Dermatology, Mersin City Hospital, Mersin, Turkey.'}, {'ForeName': 'Serap G', 'Initials': 'SG', 'LastName': 'Bilgili', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Van Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Goknur O', 'Initials': 'GO', 'LastName': 'Yavuz', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Van Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Ibrahim H', 'Initials': 'IH', 'LastName': 'Yavuz', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Van Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Aksac', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Faculty of Medicine, Mersin University, Mersin, Turkey.'}, {'ForeName': 'Ayse S', 'Initials': 'AS', 'LastName': 'Karadag', 'Affiliation': 'Department of Dermatology, Istanbul Medeniyet University Medical Faculty, Istanbul, Turkey.'}]",International journal of dermatology,['10.1111/ijd.15485']
1598,33682064,Can theory of mind of healthy older adults living in a nursing home be improved? A randomized controlled trial.,"BACKGROUND


Research in nursing homes mainly focused on interventions for residents affected by cognitive decline. Few studies have considered healthy older adults living in nursing homes, and this research targeted cognitive functioning.
AIMS


To evaluate whether socio-cognitive abilities can be improved by means of a theory of mind (ToM) training conducted by nursing home's operators.
METHODS


RESULTS: Results revealed that older adults benefitted from the ToM intervention in both practiced and non-practiced tasks, while the control group showed no change from pre- to post-test evaluation. Analyses on errors scores indicated that the ToM intervention led to a reduction of both excessive mentalizing and absence of mental states inference.
DISCUSSION


The conversation-based ToM intervention proved to be effective in improving socio-cognitive skills in cognitively healthy nursing home residents. Notably, older adults were able to transfer the skills acquired during the training to new material.
CONCLUSIONS


Promoting healthy resident's ToM ability could positively impact on their social cognition, consequently increasing their quality of life. Our findings showed that the intervention can be feasibly managed by health care assistants within the residential context.",2021,The conversation-based ToM intervention proved to be effective in improving socio-cognitive skills in cognitively healthy nursing home residents.,"['older adults', 'healthy older adults living in nursing homes', 'cognitively healthy nursing home residents', 'healthy older adults living']","['ToM intervention', 'conversation-based ToM intervention']","['excessive mentalizing and absence of mental states inference', 'socio-cognitive skills', 'quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0279667,The conversation-based ToM intervention proved to be effective in improving socio-cognitive skills in cognitively healthy nursing home residents.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cavallini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pizza Botta 6, 27100, Pavia, Italy. ecava@unipv.it.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ceccato', 'Affiliation': 'Department of Neuroscience, Imaging and Clinical Sciences, University ""G. D\' Annunzio"" of Chieti-Pescara, Via dei Vestini 31, 66100, Chieti, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Bertoglio', 'Affiliation': 'Nuova Assistenza, Via Rudinì 3, 20142, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Francescani', 'Affiliation': 'Fornaroli Hospital, Via al Donatore di Sangue 50, 20013, Magenta, MI, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Vigato', 'Affiliation': 'Korian, Viale Cassala 16, 20143, Milan, Italy.'}, {'ForeName': 'Aladar Bruno', 'Initials': 'AB', 'LastName': 'Ianes', 'Affiliation': 'Korian, Viale Cassala 16, 20143, Milan, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Lecce', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pizza Botta 6, 27100, Pavia, Italy.'}]",Aging clinical and experimental research,['10.1007/s40520-021-01811-4']
1599,33682060,Exercise in the heat blunts improvements in aerobic power.,"INTRODUCTION


PGC-1a has been termed the master regulator of mitochondrial biogenesis. The exercise-induced rise in PGC-1a transcription is blunted when acute exercise takes place in the heat. However, it is unknown if this alteration has functional implications after heat acclimation and exercise training.
PURPOSE


To determine the impact of 3 weeks of aerobic exercise training in the heat (33 °C) compared to training in room temperature (20 °C) on thermoregulation, PGC-1a mRNA response, and aerobic power.
METHODS


Twenty-one untrained college aged males (age, 24 ± 4 years; height, 178 ± 6 cm) were randomly assigned to 3 weeks of aerobic exercise training in either 33 °C (n = 12) or 20 °C (n = 11) environmental temperatures.
RESULTS


The 20 °C training group increased 20 °C [Formula: see text]̇O 2peak  from 3.21 ± 0.77 to 3.66 ± 0.78 L·min -1  (p < 0.001) while the 33 °C training group did not improve (pre, 3.16 ± 0.48 L·min -1 ; post, 3.28 ± 0.63 L·min -1 ; p = 0.283). PGC-1a increased in response to acute aerobic exercise more in 20 °C (6.6 ± 0.7 fold) than 33 °C (4.6 ± 0.7 fold, p = 0.031) before training, but was no different after training in 20 °C (2.4 ± 0.3 fold) or 33 °C (2.4 ± 0.5 fold, p = 0.999). No quantitative alterations in mitochondrial DNA were detected with training or between temperatures (p > 0.05).
CONCLUSIONS


This research indicates that exercise in the heat may limit the effectiveness of aerobic exercise at increasing aerobic power. Furthermore, this study demonstrates that heat induced blunting of the normal exercise induced PGC-1a response is eliminated after 3 weeks of heat acclimation.",2021,"No quantitative alterations in mitochondrial DNA were detected with training or between temperatures (p > 0.05).
","['Twenty-one untrained college aged males (age, 24\u2009±\u20094 years; height, 178\u2009±\u20096\xa0cm']","['PGC-1a', 'aerobic exercise training']","['mitochondrial DNA', 'response to acute aerobic exercise', 'thermoregulation, PGC-1a mRNA response, and aerobic power', 'PGC-1a response']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0005905', 'cui_str': 'Thermoregulation, function'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]",21.0,0.0203244,"No quantitative alterations in mitochondrial DNA were detected with training or between temperatures (p > 0.05).
","[{'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Slivka', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, 6001 Dodge St., Omaha, NE, 68114, USA. dslivka@unomaha.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shute', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, 6001 Dodge St., Omaha, NE, 68114, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Hailes', 'Affiliation': 'School of Integrative Physiology and Athletic Training, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Marshall', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, 6001 Dodge St., Omaha, NE, 68114, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Opichka', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, 6001 Dodge St., Omaha, NE, 68114, USA.'}, {'ForeName': 'Halee', 'Initials': 'H', 'LastName': 'Schnitzler', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, 6001 Dodge St., Omaha, NE, 68114, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Ruby', 'Affiliation': 'School of Integrative Physiology and Athletic Training, University of Montana, Missoula, MT, USA.'}]",European journal of applied physiology,['10.1007/s00421-021-04653-0']
1600,33682043,The two-point discrimination threshold depends both on the stimulation noxiousness and modality.,"The two-point discrimination threshold (2PDT) has been used to investigate the integration of sensory information, especially in relation to spatial acuity. The 2PDT has been investigated for both innocuous mechanical stimuli and noxious thermal stimuli; however, previous studies used different stimulation modalities to compare innocuous and noxious stimuli. This study investigated the 2PDT in 19 healthy participants, using both thermal (laser) and mechanical stimulation modalities. Within each modality, both innocuous and noxious intensities were applied. Concurrent point stimuli were applied to the right volar forearm, with separation distances of 0-120 mm, in steps of 10 mm. 0 mm corresponds to a single point. Following each stimulus, the participants indicated the number of perceived points (1 or 2) and the perceived intensity (NRS: 0: no perception, 3: pain threshold, 10: maximum pain). The order of stimulation modality, intensity and distance was randomized. The 2PDT for innocuous and noxious mechanical stimuli was 34.7 mm and 47.1 mm, respectively. For thermal stimuli, the 2PDT was 80.5 mm for innocuous stimuli and 66.9 mm for noxious stimuli. The average NRS for thermal stimuli was 1.6 for innocuous intensities and 4.0 for noxious intensities, while for mechanical stimuli, the average NRS was 0.9 for innocuous intensities and 3.6 for noxious intensities. This study showed that the 2PDT highly depends on both stimulation modality and intensity. Within each modality, noxious intensities modulates the 2PDT differently, i.e., noxious intensities lowers the 2PDT for thermal stimuli, but increases the 2PDT for mechanical stimuli.",2021,"The average NRS for thermal stimuli was 1.6 for innocuous intensities and 4.0 for noxious intensities, while for mechanical stimuli, the average NRS was 0.9 for innocuous intensities and 3.6 for noxious intensities.","['19 healthy participants, using both thermal (laser) and mechanical stimulation modalities']",[],"['number of perceived points (1 or 2) and the perceived intensity (NRS: 0: no perception, 3: pain threshold, 10: maximum pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1285354', 'cui_str': 'Mechanical stimulation'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",19.0,0.0319795,"The average NRS for thermal stimuli was 1.6 for innocuous intensities and 4.0 for noxious intensities, while for mechanical stimuli, the average NRS was 0.9 for innocuous intensities and 3.6 for noxious intensities.","[{'ForeName': 'Ken Steffen', 'Initials': 'KS', 'LastName': 'Frahm', 'Affiliation': 'Department of Health Science and Technology, Integrative Neuroscience group, CNAP-Center for Neuroplasticity and Pain, SMI®, Aalborg University, Fredrik Bajersvej 7D3, 9220, Aalborg, Denmark. ksf@hst.aau.dk.'}, {'ForeName': 'Sabata', 'Initials': 'S', 'LastName': 'Gervasio', 'Affiliation': 'Neural Engineering and Neurophysiology Group, SMI®, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}]",Experimental brain research,['10.1007/s00221-021-06068-x']
1601,33681860,Risk factors for severity of depression in participants with chronic medical conditions in rural primary health care settings in India.,"Background


Depression and chronic medical disorders are strongly linked. There are limited studies addressing the correlates of the severity of depression in patients with co-morbid disorders in primary care settings. This study aimed to identify the socio-demographic and disease-specific risk factors associated with the severity of depression at baseline among patients participating in a randomized controlled trial (HOPE study).
Methods


Participants were part of a randomized controlled trial in 49 primary care health centers in rural India. We included adults (≥ 30 years) with at least mild Depression or Anxiety Disorder and at least one Cardiovascular disorder or Type 2 Diabetes mellitus. They were assessed for the severity of depression using the PHQ-9, severity of anxiety, social support, number of co-morbid chronic medical illnesses, anthropometric measurements, HbA1c, and lipid profile.
Results


Proportionately there were more women in the moderate category of depression than men. Ordinal logistic regression showed co-morbid anxiety and a lower level of education significantly increased the odds of more severe depression, while more social support was significantly negatively associated with depression severity in women. In men, anxiety was positively associated with greater depression severity; while reporting more social support was negatively associated with depression.
Limitations


This is a cross-sectional study and thus, no causal conclusions are possible.
Conclusions


Anxiety and poor social support in both genders and lower educational levels in women were associated with increased severity of depression. Early identification of risk factors and appropriate treatment at a primary care setting may help in reducing the morbidity and mortality associated with depression.",2021,"Ordinal logistic regression showed co-morbid anxiety and a lower level of education significantly increased the odds of more severe depression, while more social support was significantly negatively associated with depression severity in women.","['patients with co-morbid disorders in primary care settings', 'patients participating in a randomized controlled trial (HOPE study', 'participants with chronic medical conditions in rural primary health care settings in India', 'We included adults (≥ 30 years) with at least mild Depression or Anxiety Disorder and at least one Cardiovascular disorder or Type 2 Diabetes mellitus', '49 primary care health centers in rural India']",[],"['severity of depression using the PHQ-9, severity of anxiety, social support, number of co-morbid chronic medical illnesses, anthropometric measurements, HbA1c, and lipid profile', 'depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0588006', 'cui_str': 'Mild depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",49.0,0.0436947,"Ordinal logistic regression showed co-morbid anxiety and a lower level of education significantly increased the odds of more severe depression, while more social support was significantly negatively associated with depression severity in women.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Johnson Pradeep', 'Affiliation': ""Department of Psychiatry, St John's Medical College, Sarjapur Road, Bangalore, Karnataka 560034, India.""}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, St John's Medical College, Sarjapur Road, Bangalore, Karnataka 560034, India.""}, {'ForeName': 'Sumithra', 'Initials': 'S', 'LastName': 'Selvam', 'Affiliation': ""Division of Epidemiology & Population Health, St John's Research Institute, St John's Medical College, Sarjapur Road, Bangalore, Karnataka 560034, India.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Heylen', 'Affiliation': 'Division of Prevention Sciences, University of California, San Francisco, United States.'}, {'ForeName': 'Prem K', 'Initials': 'PK', 'LastName': 'Mony', 'Affiliation': ""Division of Epidemiology & Population Health, St John's Research Institute, St John's Medical College, Sarjapur Road, Bangalore, Karnataka 560034, India.""}, {'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Department of Psychiatry, St John's Medical College, Sarjapur Road, Bangalore, Karnataka 560034, India.""}]",Journal of affective disorders reports,['10.1016/j.jadr.2020.100071']
1602,33681844,Healing rates after rotator cuff repair for patients taking either celecoxib or placebo: a double-blind randomized controlled trial.,"Background


Use of anti-inflammatory medications (NSAIDs) is an important component of multimodal pain control after orthopedic procedures to avoid opioid overutilization and abuse. However, the deleterious effects of NSAIDs on tendon healing are of particular concern in rotator cuff repair (RCR). The purpose of this study was to evaluate the effect of celecoxib or placebo on healing rates after RCR when administered in the perioperative and immediate postoperative period using MRI evaluation at one year postoperatively. A secondary aim was to determine whether clinical differences existed between patients with intact or non-intact repairs.
Methods


Patients aged ≤65 years with partial- or full-thickness rotator cuff tear (<25x25 mm) were randomized to receive celecoxib 400 mg or placebo 1 hour before the procedure and 200mg bid for 3 weeks postoperatively. All patients were treated as clinically indicated at the time of surgery and followed standard postoperative protocol. Repair integrity was evaluated with MRI using the Sugaya classification for repair integrity. Data were analyzed using multivariable logistic regression by intent to treat.
Results


Seventy-nine patients were enrolled; 21 were lost to follow-up, 6 did not have cuff repair, 5 were revised, and 2 declined follow-up, leaving 45 patients with one-year follow-up. Five of these patients did not complete MRI, leaving 40 patients for review. Eighteen of 20 patients (90%) who received celecoxib completed all doses of study medication as did 15 of 20 patients (75%) who received placebo. The patient groups were similar for demographics, clinical results, and healing rate. After adjusting for tear size, no statistically significant difference in healing rate was found between groups, with 10 of 20 celecoxib patients (50%) having intact repair at 1 year compared with 14 of 20 placebo patients (70%) (OR = 0.53, 95% CI: 0.14, 2.08,  P  = 0.35).
Conclusion


Half of the patients who received celecoxib had an intact repair compared with 70% intact repair for patients receiving placebo. Although not statistically significant in this small study, larger studies are needed to clarify this important clinical concern. The authors do not recommend use of celecoxib for postoperative pain control after RCR.",2021,"After adjusting for tear size, no statistically significant difference in healing rate was found between groups, with 10 of 20 celecoxib patients (50%) having intact repair at 1 year compared with 14 of 20 placebo patients (70%) (OR = 0.53, 95% CI: 0.14, 2.08,  P  = 0.35).
","['Patients aged ≤65 years with partial- or full-thickness rotator cuff tear (<25x25 mm', 'patients with intact or non-intact repairs', 'Results\n\n\nSeventy-nine patients were enrolled; 21 were lost to follow-up, 6 did not have cuff repair, 5 were revised, and 2 declined follow-up, leaving 45 patients with one-year follow-up']","['celecoxib or placebo', 'placebo', 'anti-inflammatory medications (NSAIDs', 'NSAIDs', 'celecoxib']","['Healing rates', 'healing rate', 'healing rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0410017', 'cui_str': 'Full thickness rotator cuff tear'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",79.0,0.62337,"After adjusting for tear size, no statistically significant difference in healing rate was found between groups, with 10 of 20 celecoxib patients (50%) having intact repair at 1 year compared with 14 of 20 placebo patients (70%) (OR = 0.53, 95% CI: 0.14, 2.08,  P  = 0.35).
","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Burns', 'Affiliation': 'SSM Health Orthopedics, SSM Health DePaul Hospital, St. Louis, MO, USA.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Robbins', 'Affiliation': 'SSM Health Orthopedics, SSM Health DePaul Hospital, St. Louis, MO, USA.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'LeMarr', 'Affiliation': 'SSM Health Orthopedics, SSM Health DePaul Hospital, St. Louis, MO, USA.'}, {'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Childress', 'Affiliation': 'SSM Health Orthopedics, SSM Health DePaul Hospital, St. Louis, MO, USA.'}, {'ForeName': 'Diane J', 'Initials': 'DJ', 'LastName': 'Morton', 'Affiliation': 'SSM Health Orthopedics, SSM Health DePaul Hospital, St. Louis, MO, USA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Wilson', 'Affiliation': 'University of Southern California, Keck School of Medicine, Department of Preventive Medicine, Los Angeles, CA, USA.'}]",JSES international,['10.1016/j.jseint.2020.10.011']
1603,33681838,Interobserver and intraobserver agreement of three-dimensionally printed models for the classification of proximal humeral fractures.,"Hypothesis


This study aimed to examine whether three-dimensionally printed models (3D models) could improve interobserver and intraobserver agreement when classifying proximal humeral fractures (PHFs) using the Neer system. We hypothesized that 3D models would improve interobserver and intraobserver agreement compared with x-ray, two-dimensional (2D) and three-dimensional (3D) computed tomography (CT) and that agreement using 3D models would be higher for registrars than for consultants.
Methods


Thirty consecutive PHF images were selected from a state-wide database and classified by fourteen observers. Each imaging modality (x-ray, 2D CT, 3D CT, 3D models) was grouped and presented in a randomly allocated sequence on two separate occasions. Interobserver and intraobserver agreements were quantified with kappa values (κ), percentage agreement, and 95% confidence intervals (CIs).
Results


Seven orthopedic registrars and seven orthopedic consultants classified 30 fractures on one occasion (interobserver). Four registrars and three consultants additionally completed classification on a second occasion (intraobserver). Interobserver agreement was greater with 3D models than with x-ray (κ = 0.47, CI: 0.44-0.50, 66.5%, CI: 64.6-68.4% and κ = 0.29, CI: 0.26-0.31, 57.2%, CI: 55.1-59.3%, respectively), 2D CT (κ = 0.30, CI: 0.27-0.33, 57.8%, CI: 55.5-60.2%), and 3D CT (κ = 0.35, CI: 0.33-0.38, 58.8%, CI: 56.7-60.9%). Intraobserver agreement appeared higher for 3D models than for other modalities; however, results were not significant. There were no differences in interobserver or intraobserver agreement between registrars and consultants.
Conclusion


Three-dimensionally printed models improved interobserver agreement in the classification of PHFs using the Neer system. This has potential implications for using 3D models for surgical planning and teaching.",2021,"Interobserver agreement was greater with 3D models than with x-ray (κ = 0.47, CI: 0.44-0.50, 66.5%, CI: 64.6-68.4% and κ = 0.29, CI: 0.26-0.31, 57.2%, CI: 55.1-59.3%, respectively), 2D CT",['orthopedic registrars and seven orthopedic consultants classified 30 fractures on one occasion (interobserver'],[],"['3D CT', '2D CT']","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0557514', 'cui_str': 'Registrar'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",[],"[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",,0.035463,"Interobserver agreement was greater with 3D models than with x-ray (κ = 0.47, CI: 0.44-0.50, 66.5%, CI: 64.6-68.4% and κ = 0.29, CI: 0.26-0.31, 57.2%, CI: 55.1-59.3%, respectively), 2D CT","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Bougher', 'Affiliation': 'James Cook University, Mackay Clinical School, Mackay, QLD, Australia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Buttner', 'Affiliation': 'James Cook University, Smithfield, QLD, Australia.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Mackay Base Hospital, Mackay, QLD, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Banks', 'Affiliation': 'James Cook University, Mackay Clinical School, Mackay, QLD, Australia.'}, {'ForeName': 'Hyun Su', 'Initials': 'HS', 'LastName': 'Na', 'Affiliation': 'Mackay Base Hospital, Mackay, QLD, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Forrestal', 'Affiliation': 'Queensland University of Technology, Brisbane City, QLD, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Heal', 'Affiliation': 'James Cook University, Mackay Clinical School, Mackay, QLD, Australia.'}]",JSES international,['10.1016/j.jseint.2020.10.019']
1604,33681832,Bristow versus Latarjet in high-demand athletes with anterior shoulder instability: a prospective randomized comparison.,"Background


Traumatic anterior shoulder instability is a common disease, especially in young athletes. The Latarjet and Bristow techniques are nonanatomical surgeries that involve the transfer of the coracoid process to the anterior border of the glenoid and are indicated in cases at a high risk for recurrence and in the presence of associated bone lesions. Studies have evaluated the recurrence and complications associated with these techniques, but they have important differences, and should not be considered synonymous. The objective of this study was to prospectively compare the Bristow and Latarjet techniques in high-demand athletes. Hypothesis: Bristow and Latarjet techniques lead to similar results.
Patients and methods


Thirty-seven athletes (41 shoulders; three athletes underwent bilateral surgery) with anterior recurrent dislocation of the shoulder that was surgically treated using the Bristow or Latarjet technique were prospectively analyzed. The follow-up time was 5 years. The mean age was 26.4 years (range: 16-46 years). In 17 cases (41.5%), the dominant side was not affected.
Results


Elevation and external rotation (passive and active) decreased in the early postoperative period and achieved values in the final follow-up similar to those found in the preoperative period. The mean postoperative scores at 5 years were as follows: ASES, 79.1 (range: 66-95); ASORS, 77.8 (range: 60-100); WOSI, 52.6 (range: 18-77); and VAS, 1.88 (range: 0-6). All of the results presented statistical significance. There was a complication rate of 9.75% in the follow-up period. There were no new dislocations after the surgery. Most (75%) of the athletes returned to the sport after the surgery, and there was no correlation between poor results and any of the variables studied. There was a statistically significant difference in passive external rotation in favor of the Latarjet technique four weeks after surgery ( P  = .01). We also found a statistically significant difference in passive elevation in favor of the Latarjet technique eight weeks after the surgery ( P  = .04). When we compared the Bristow and Latarjet techniques regarding the ASES, ASORS, and WOSI scores, we found no statistically significant difference. In the comparison regarding whether the athletes returned to sports, we found no statistically significant difference.
Conclusion


The Bristow and Latarjet techniques lead to good results in athletes with no new dislocation episodes and are suitable for treating patients with anterior recurrent dislocation of the shoulder. The Latarjet technique showed better results in some of the variables studied.",2021,We also found a statistically significant difference in passive elevation in favor of the Latarjet technique eight weeks after the surgery ( P  = .04).,"['Patients and methods\n\n\nThirty-seven athletes (41 shoulders; three athletes underwent bilateral surgery) with anterior recurrent dislocation of the shoulder that was surgically treated using the Bristow or Latarjet technique were prospectively analyzed', 'patients with anterior recurrent dislocation of the shoulder', 'The mean age was 26.4 years (range: 16-46 years', 'high-demand athletes with anterior shoulder instability', 'young athletes', 'high-demand athletes']",['Bristow versus Latarjet'],"['passive external rotation', 'mean postoperative scores', 'complication rate', 'Elevation and external rotation (passive and active', 'passive elevation', 'ASES, ASORS, and WOSI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0158100', 'cui_str': 'Recurrent dislocation of joint'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",37.0,0.0294076,We also found a statistically significant difference in passive elevation in favor of the Latarjet technique eight weeks after the surgery ( P  = .04).,"[{'ForeName': 'Paulo Santoro', 'Initials': 'PS', 'LastName': 'Belangero', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Ortopedia e Traumatologia, Centro de Traumatologia do esporte (CETE), São Paulo, SP, Brazil.'}, {'ForeName': 'Paulo Henrique Schmidt', 'Initials': 'PHS', 'LastName': 'Lara', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Ortopedia e Traumatologia, Centro de Traumatologia do esporte (CETE), São Paulo, SP, Brazil.'}, {'ForeName': 'Eduardo Antônio', 'Initials': 'EA', 'LastName': 'Figueiredo', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Ortopedia e Traumatologia, Centro de Traumatologia do esporte (CETE), São Paulo, SP, Brazil.'}, {'ForeName': 'Carlos Vicente', 'Initials': 'CV', 'LastName': 'Andreoli', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Ortopedia e Traumatologia, Centro de Traumatologia do esporte (CETE), São Paulo, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de Castro Pochini', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Ortopedia e Traumatologia, Centro de Traumatologia do esporte (CETE), São Paulo, SP, Brazil.'}, {'ForeName': 'Benno', 'Initials': 'B', 'LastName': 'Ejnisman', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Ortopedia e Traumatologia, Centro de Traumatologia do esporte (CETE), São Paulo, SP, Brazil.'}, {'ForeName': 'Ricardo Luiz', 'Initials': 'RL', 'LastName': 'Smith', 'Affiliation': 'Departamento de Morfologia e Genética da Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",JSES international,['10.1016/j.jseint.2020.11.004']
1605,33681744,"Intramuscular midazolam, olanzapine, or haloperidol for the management of acute agitation: A multi-centre, double-blind, randomised clinical trial.","Background


The safety and effectiveness of intramuscular olanzapine or haloperidol compared to midazolam as the initial pharmacological treatment for acute agitation in emergency departments (EDs) has not been evaluated.
Methods


A pragmatic, randomised, double-blind, active-controlled trial was conducted from December 2014 to September 2019, in six Hong Kong EDs. Patients (aged 18-75 years) with undifferentiated acute agitation requiring parenteral sedation were randomised to 5 mg intramuscular midazolam ( n  = 56), olanzapine ( n  = 54), or haloperidol ( n  = 57). Primary outcomes were time to adequate sedation and proportion of patients who achieved adequate sedation at each follow-up interval. Sedation levels were measured on a 6-level validated scale (ClinicalTrials.gov Identifier: NCT02380118).
Findings


Of 206 patients randomised, 167 (mean age, 42 years; 98 [58·7%] male) were analysed. Median time to sedation for IM midazolam, olanzapine, and haloperidol was 8·5 (IQR 8·0), 11·5 (IQR 30·0), and 23·0 (IQR 21·0) min, respectively. At 60 min, similar proportions of patients were adequately sedated (98%, 87%, and 97%). There were statistically significant differences for time to sedation with midazolam compared to olanzapine ( p  = 0·03) and haloperidol ( p  = 0·002). Adverse event rates were similar across the three arms. Dystonia ( n  = 1) and cardiac arrest ( n  = 1) were reported in the haloperidol group.
Interpretation


Midazolam resulted in faster sedation in patients with undifferentiated agitation in the emergency setting compared to olanzapine and haloperidol. Midazolam and olanzapine are preferred over haloperidol's slower time to sedation and potential for cardiovascular and extrapyramidal side effects.
Funding


Research Grants Council, Hong Kong.",2021,There were statistically significant differences for time to sedation with midazolam compared to olanzapine ( p  = 0·03) and haloperidol ( p  = 0·002).,"['December 2014 to September 2019, in six Hong Kong EDs', 'patients with undifferentiated agitation in the emergency setting', 'Patients (aged 18-75 years) with undifferentiated acute agitation requiring parenteral sedation', '206 patients randomised, 167 (mean age, 42 years; 98 [58·7%] male', 'acute agitation in emergency departments (EDs', 'acute agitation']","['olanzapine and haloperidol', 'haloperidol', 'Intramuscular midazolam, olanzapine, or haloperidol', 'midazolam', 'Midazolam and olanzapine', 'olanzapine or haloperidol', 'Midazolam', 'IM midazolam, olanzapine, and haloperidol', 'olanzapine', '5\xa0mg intramuscular midazolam']","['Median time to sedation', 'Sedation levels', 'safety and effectiveness', 'time to sedation', 'Adverse event rates', 'Dystonia', 'IQR 30·0), and 23·0 (IQR 21·0', 'time to adequate sedation and proportion of patients who achieved adequate sedation', 'cardiac arrest']","[{'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013421', 'cui_str': 'Dystonia'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]",1.0,0.273339,There were statistically significant differences for time to sedation with midazolam compared to olanzapine ( p  = 0·03) and haloperidol ( p  = 0·002).,"[{'ForeName': 'Esther W', 'Initials': 'EW', 'LastName': 'Chan', 'Affiliation': 'Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, The University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Kim S J', 'Initials': 'KSJ', 'LastName': 'Lao', 'Affiliation': 'Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, The University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Lam', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, The University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Sik-Hon', 'Initials': 'SH', 'LastName': 'Tsui', 'Affiliation': 'Accident and Emergency Department, Queen Mary Hospital, Pok Fu Lam, Hong Kong SAR.'}, {'ForeName': 'Chun-Tat', 'Initials': 'CT', 'LastName': 'Lui', 'Affiliation': 'Accident and Emergency Department, Tuen Mun Hospital, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Chi-Pang', 'Initials': 'CP', 'LastName': 'Wong', 'Affiliation': 'Accident and Emergency Department, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong SAR.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Graham', 'Affiliation': 'Accident and Emergency Medicine Academic Unit, Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Cheng', 'Affiliation': 'Accident and Emergency Medicine Academic Unit, Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR.'}, {'ForeName': 'Tong-Shun', 'Initials': 'TS', 'LastName': 'Chung', 'Affiliation': 'Accident and Emergency Department, Ruttonjee Hospital, Wan Chai, Hong Kong SAR.'}, {'ForeName': 'Hiu-Fung', 'Initials': 'HF', 'LastName': 'Lam', 'Affiliation': 'Accident and Emergency Department, United Christian Hospital, Kwun Tong, Hong Kong SAR.'}, {'ForeName': 'Soo-Moi', 'Initials': 'SM', 'LastName': 'Ting', 'Affiliation': 'Accident and Emergency Department, United Christian Hospital, Kwun Tong, Hong Kong SAR.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Knott', 'Affiliation': 'Department of Critical Care, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Taylor', 'Affiliation': 'Emergency Department, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'David C M', 'Initials': 'DCM', 'LastName': 'Kong', 'Affiliation': 'Pharmacy Department, Ballarat Health Services, Ballarat, Victoria, Australia.'}, {'ForeName': 'Ling-Pong', 'Initials': 'LP', 'LastName': 'Leung', 'Affiliation': 'Emergency Medicine Unit, The University of Hong Kong, Pok Fu Lam, Hong Kong SAR.'}, {'ForeName': 'Ian C K', 'Initials': 'ICK', 'LastName': 'Wong', 'Affiliation': 'Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, The University of Hong Kong, Hong Kong SAR.'}]",EClinicalMedicine,['10.1016/j.eclinm.2021.100751']
1606,33681741,Safety and efficacy of long-term mild hypothermia for severe traumatic brain injury with refractory intracranial hypertension (LTH-1): A multicenter randomized controlled trial.,"Background


Therapeutic hypothermia may need prolonged duration for the patients with severe traumatic brain injury (sTBI).
Methods


The Long-Term Hypothermia trial was a prospective, multicenter, randomized, controlled clinical trial to examine the safety and efficacy in adults with sTBI. Eligible patients were 18-65, Glasgow Coma Scale score at 4 to 8, and initial intracranial pressure (ICP) ≥ 25 mm Hg, randomly assigned to the long-term mild hypothermia group (34-35 °C for 5 days) or normothermia group at 37 °C. The primary outcome was the Glasgow outcome scale (GOS) at 6 months. Secondary outcomes included ICP control, complications and laboratory findings, the length of ICU and hospital stay, and GOS at 6 months in patients with initial ICP ≥ 30 mm Hg. This trial is registered with ClinicalTrials.gov, NCT01886222.
Findings


302 patients were enrolled from June 25, 2013, to December 31, 2018, with 6 months follow-up in 14 hospitals, 156 in hypothermia group and 146 in normothermia group. There was no difference in favorable outcome (OR 1·55, 95%CI 0·91-2·64;  P  = 0·105) and in mortality ( P  = 0·111) between groups. In patients with an initial ICP ≥ 30 mm Hg, hypothermic treatment significantly increased favorable outcome over normothermia group (60·82%, 42·71%, respectively; OR 1·861, 95%CI 1·031-3·361;  P  = 0·039). Long-term mild hypothermia did not increase the incidences of complications.
Interpretation


Long-term mild hypothermia did not improve the neurological outcomes. However, it may be a potential option in sTBI patients with initial ICP ≥ 30 mm Hg.
Funding


: Shanghai municipal government and Shanghai Jiao Tong University/School of Medicine.",2021,"There was no difference in favorable outcome (OR 1·55, 95%CI 0·91-2·64;  P  = 0·105) and in mortality ( P  = 0·111) between groups.","['severe traumatic brain injury with refractory intracranial hypertension (LTH-1', 'patients with severe traumatic brain injury (sTBI', 'Findings\n\n\n302 patients were enrolled from June 25, 2013, to December 31, 2018, with 6 months follow-up in 14 hospitals, 156 in hypothermia group and 146 in normothermia group', 'sTBI patients with initial ICP ≥', 'patients with an initial ICP ≥', 'Eligible patients were 18-65, Glasgow Coma Scale score at 4 to 8, and initial intracranial pressure (ICP) ≥', 'adults with sTBI']","['long-term mild hypothermia group (34-35\xa0°C for 5 days) or normothermia group at 37', 'long-term mild hypothermia']","['Glasgow outcome scale (GOS', 'mortality', 'safety and efficacy', 'incidences of complications', 'neurological outcomes', 'ICP control, complications and laboratory findings, the length of ICU and hospital stay, and GOS', 'Safety and efficacy']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0445043', 'cui_str': 'Mild hypothermia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}]","[{'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",302.0,0.251624,"There was no difference in favorable outcome (OR 1·55, 95%CI 0·91-2·64;  P  = 0·105) and in mortality ( P  = 0·111) between groups.","[{'ForeName': 'Jiyuan', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Head Trauma Center, Department of Neurosurgery, Renji Hospital, Shanghai Jiao Tong University/School of Medicine, Shanghai Institute of Head Trauma, Shanghai, China.'}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Head Trauma Center, Department of Neurosurgery, Renji Hospital, Shanghai Jiao Tong University/School of Medicine, Shanghai Institute of Head Trauma, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Neurological Intensive Care Unit, Beijing Chaoyang Integrative Medicine Emergency Medical Center, Beijing, China.'}, {'ForeName': 'Weituo', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Clinical Research Institute, Shanghai Jiao Tong University/School of Medicine, Shanghai, China.'}, {'ForeName': 'Chunlong', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Department of Neurosurgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuhai', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Taihu Hospital, Wuxi, China.'}, {'ForeName': 'Liansheng', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': 'Department of Neurosurgery, South Taihu Hospital, Huzhou, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, The Affiliated Hospital of Southwest Medical University, Luzhou, China.'}, {'ForeName': 'Jinfang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chaohui', 'Initials': 'C', 'LastName': 'Mou', 'Affiliation': ""Department of Neurosurgery, Taizhou First People's Hospital, Zhejiang, China.""}, {'ForeName': 'Binghui', 'Initials': 'B', 'LastName': 'Qiu', 'Affiliation': 'Department of Neurosurgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xianjian', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Neurosurgery, Shenzhen Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Qibing', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Neurosurgery, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Nu', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Emergency and Trauma Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Chaohua', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Xi'an, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Head Trauma Center, Department of Neurosurgery, Renji Hospital, Shanghai Jiao Tong University/School of Medicine, Shanghai Institute of Head Trauma, Shanghai, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Head Trauma Center, Department of Neurosurgery, Renji Hospital, Shanghai Jiao Tong University/School of Medicine, Shanghai Institute of Head Trauma, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Head Trauma Center, Department of Neurosurgery, Renji Hospital, Shanghai Jiao Tong University/School of Medicine, Shanghai Institute of Head Trauma, Shanghai, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurosurgery, The Affiliated Hospital of Southwest Medical University, Luzhou, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, The Affiliated Hospital of Southwest Medical University, Luzhou, China.'}, {'ForeName': 'Guoyi', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Department of Neurosurgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiyao', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Head Trauma Center, Department of Neurosurgery, Renji Hospital, Shanghai Jiao Tong University/School of Medicine, Shanghai Institute of Head Trauma, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EClinicalMedicine,['10.1016/j.eclinm.2021.100732']
1607,33681738,Mifepristone followed by misoprostol compared with placebo followed by misoprostol as medical treatment for early pregnancy loss (the Triple M trial): A double-blind placebo-controlled randomised trial.,"Background


Worldwide, millions of women seek treatment for early pregnancy loss (EPL) annually. Medical management with misoprostol is widely used, but only effective 60% of the time. Pre-treatment with mifepristone prior to misoprostol might improve the success rate of medical management.
Methods


This was a multi-centre, double-blind, placebo-controlled randomised trial in 17 Dutch hospitals. Women with a non-viable pregnancy between 6 and 14 weeks of gestation were eligible for inclusion after at least one week of expectant management. Participants were randomised (1:1) between oral mifepristone 600 mg or an oral placebo tablet. Participants took 400 μg misoprostol orally, repeated after four hours on day two and, if necessary, day three. Primary outcome was expulsion of gestational sac and endometrial thickness <15 mm after 6-8 weeks. Analyses were done according to intention-to-treat principles. This trial is registered with ClinicalTrials.gov, NCT03212352.
Findings


Between June 28th 2018 and January 8th 2020, 175 women were randomised to mifepristone and 176 to placebo, including 344 in the intention-to-treat analysis. In the mifepristone group 136 (79•1%) of 172 participants reached complete evacuation compared to 101 (58•7%) of 172 participants in the placebo group ( p <0•0001, RR 1•35, 95% CI 1•16-1•56). Incidence of serious adverse events was significantly lower in the mifepristone group with 24 (14%) patients affected versus 55 (32%) in the placebo group ( p  = 0•0005) (Table 3).
Interpretation


Pre-treatment with mifepristone prior to misoprostol was more effective than misoprostol alone in managing EPL.
Funding


Healthcare Insurers Innovation Foundation, Radboud University Medical Centre, Canisius Wilhelmina Hospital.",2021,"In the mifepristone group 136 (79•1%) of 172 participants reached complete evacuation compared to 101 (58•7%) of 172 participants in the placebo group ( p <0•0001, RR 1•35, 95% CI 1•16-1•56).","['early pregnancy loss (the Triple M trial', 'Women with a non-viable pregnancy between 6 and 14 weeks of gestation were eligible for inclusion after at least one week of expectant management', 'Findings\n\n\nBetween June 28th 2018 and January 8th 2020, 175 women', '17 Dutch hospitals']","['placebo', 'oral mifepristone 600\xa0mg or an oral placebo tablet', 'misoprostol', 'Mifepristone', 'mifepristone']","['complete evacuation', 'success rate of medical management', 'expulsion of gestational sac and endometrial thickness', 'Incidence of serious adverse events']","[{'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404844', 'cui_str': 'Non-viable pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",175.0,0.810343,"In the mifepristone group 136 (79•1%) of 172 participants reached complete evacuation compared to 101 (58•7%) of 172 participants in the placebo group ( p <0•0001, RR 1•35, 95% CI 1•16-1•56).","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hamel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Sjors', 'Initials': 'S', 'LastName': 'Coppus', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, the Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'van den Berg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hink', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud university medical centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Jacoba', 'Initials': 'J', 'LastName': 'van Seeters', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Kesteren', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, the Netherlands.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Merién', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rijnstate, Arnhem, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Torrenga', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, the Netherlands.'}, {'ForeName': 'Rafli', 'Initials': 'R', 'LastName': 'van de Laar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vie Curi Medical Centre, the Netherlands.'}, {'ForeName': 'Josien', 'Initials': 'J', 'LastName': 'Terwisscha van Scheltinga', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Gaugler-Senden', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Peppino', 'Initials': 'P', 'LastName': 'Graziosi', 'Affiliation': 'Department of Obstetrics and Gynaecology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Minouche', 'Initials': 'M', 'LastName': 'van Rumste', 'Affiliation': 'Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Ewka', 'Initials': 'E', 'LastName': 'Nelissen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Laurentius Hospital, Roermond, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vandenbussche', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud university medical centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Snijders', 'Affiliation': 'Department of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100716']
1608,33681737,The metformin in tuberous sclerosis (MiTS) study: A randomised double-blind placebo-controlled trial.,"Background


Tuberous Sclerosis Complex (TSC) is a genetic disorder characterised by the development of benign tumours secondary to loss of inhibitory regulation of the mTOR (mechanistic Target of Rapamycin) intracellular growth pathway. Metformin inhibits the mTOR pathway. We investigated whether metformin would reduce growth of hamartomas associated with tuberous sclerosis complex.
Methods


In this multicentre randomized, double-blind, placebo-controlled trial, patients with a clinical diagnosis of tuberous sclerosis, aged over 10 years and with at least one renal angiomyolipoma of greater than 1 cm in diameter were enrolled. Participants were randomly allocated (1:1) by a secure website to receive metformin or placebo for 12 months. The primary outcome was percentage volume change of renal angiomyolipomas (AML) at 12 months compared to baseline. Secondary outcomes were percentage change at 12 months from baseline in volume of cerebral Subependymal Giant Cell Astrocytomas (SEGA); appearance of facial and ungual hamartomas; frequency of epileptic seizures; and adaptive behaviour. The trial is registered with The International Standard Randomised Controlled Trial Number (ISRCTN), number 92545532, and the European Union Drug Regulating Authorities Clinical Trials (EUDRACT), number 2011-001319-30.
Findings


Between 1 November 2012 and 30 September 2015 72 patients were screened and 55 were randomly assigned to metformin (28) or placebo (27). Four participants withdrew between randomisation and starting treatment. All 51 patients who started therapy completed the trial and were assessed for outcome at 12 months. The median percentage change in angiomyolipoma (AML) volume was +7.6% (IQR -1.8% to +42.6%) for the placebo group and +8.9% (IQR 1.3% to 19.5%) for the metformin group ( p  = 0.28). Twenty-seven patients had SEGAs: 13 received placebo and 14 metformin. The median percentage change in SEGA volume was +3.0% (IQR -22.8% to +27.7%) for the placebo group and - 20.8% (IQR - 47.1% to - 5.0%) for the metformin group ( p  = 0.03). Twenty-one patients were assessed for seizure frequency: 9 received placebo and 12 received metformin. In the metformin group, a mean reduction of 43.7% from baseline in seizures was observed and in the placebo group a 3.1% mean reduction was observed, with a difference in response of 40.6% (95% CI -3.1% to +84.2%,  p  = 0.03). There were no significant differences between metformin and placebo groups for the other secondary outcomes. There were no deaths. Three serious adverse events (SAEs) occurred during the trial (all patients on metformin).
Interpretation


Metformin did not reduce AML volume. Metformin did reduce SEGA volume and seizure frequency compared with placebo. There may be a role for metformin in slowing or reversing growth of some life-threatening hamartomas in TSC and for reducing seizure frequency. Further study is justified.
Funding


This study was funded by the National Institute for Health and Research (NIHR) through the The Research for Patient Benefit Programme (RfPB).",2021,"In the metformin group, a mean reduction of 43.7% from baseline in seizures was observed and in the placebo group a 3.1% mean reduction was observed, with a difference in response of 40.6% (95% CI -3.1% to +84.2%,  p  = 0.03).","['number 2011-001319-30.\nFindings\n\n\nBetween 1 November 2012 and 30 September 2015 72 patients were screened and 55', 'Twenty-seven patients had SEGAs: 13 received', 'patients with a clinical diagnosis of tuberous sclerosis, aged over 10 years and with at least one renal angiomyolipoma of greater than 1\xa0cm in diameter were enrolled']","['placebo', 'metformin or placebo', 'Metformin', 'metformin', 'placebo and 14 metformin']","['percentage volume change of renal angiomyolipomas (AML', 'SEGA volume and seizure frequency', 'median percentage change in angiomyolipoma (AML) volume', 'median percentage change in SEGA volume', 'serious adverse events (SAEs', 'percentage change at 12 months from baseline in volume of cerebral Subependymal Giant Cell Astrocytomas (SEGA); appearance of facial and ungual hamartomas; frequency of epileptic seizures; and adaptive behaviour', 'AML volume', 'seizures']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241961', 'cui_str': 'Angiomyolipoma of kidney'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0241961', 'cui_str': 'Angiomyolipoma of kidney'}, {'cui': 'C0206633', 'cui_str': 'Angiomyolipoma'}, {'cui': 'C0017526', 'cui_str': 'Polykaryocyte'}, {'cui': 'C0004114', 'cui_str': 'Astrocytoma'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205768', 'cui_str': 'Subependymal giant cell astrocytoma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018552', 'cui_str': 'Hamartoma'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0085880', 'cui_str': 'Adaptation behavior'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}]",21.0,0.663151,"In the metformin group, a mean reduction of 43.7% from baseline in seizures was observed and in the placebo group a 3.1% mean reduction was observed, with a difference in response of 40.6% (95% CI -3.1% to +84.2%,  p  = 0.03).","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Clinical Neurosciences Section, Room 41, 4th Floor PUW South, UCL Great Ormond Street Institute of Child Health, University College London, London WC1N 1EH, United Kingdom.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Mallick', 'Affiliation': 'Department of Paediatric Neurology, Bristol Royal Hospital for Children, Upper Maudlin Street, Bristol BS3 8AE, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Edwards', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, United Kingdom.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortina-Borja', 'Affiliation': 'Population, Policy and Practice Teaching and Research Department, Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Laugharne', 'Affiliation': 'Radiology Department, Royal United Hospitals Bath NHS Foundation Trust, Combe Park, Bath BA1 3NG, United Kingdom.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Likeman', 'Affiliation': 'Department of Paediatric Radiology, Bristol Royal Hospital for Children, Upper Maudlin Street, Bristol BS3 8AE, United Kingdom.'}, {'ForeName': 'Finbar J K', 'Initials': 'FJK', 'LastName': ""O'Callaghan"", 'Affiliation': 'Clinical Neurosciences Section, Room 41, 4th Floor PUW South, UCL Great Ormond Street Institute of Child Health, University College London, London WC1N 1EH, United Kingdom.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100715']
1609,33681527,Usefulness of bicarbonate Ringer's solution as perfusate during transurethral resection of the prostate.,"Transurethral resection of the prostate (TURP) is the most common standard surgical procedure used for benign prostatic hyperplasia. Transurethral resection in saline (TURis) is a bipolar electrosurgery system used to prevent TURP (or TUR) syndrome. The bicarbonate Ringer's solution is not generally used as perfusate for TURP. Hence, we compared the efficacy of the bicarbonate Ringer's solution with that of physiological saline as perfusate during TURP. This prospective, multicenter, cooperative study was conducted on 40 adult patients admitted to a medical college hospital. After obtaining informed consent from all the patients, they were divided into two groups (20 patients per group). For patients of one group, bicarbonate Ringer's solution, and for other group, physiological saline was used as perfusate. Compared to the physiological saline, the electrolyte composition of the bicarbonate Ringer's solution was closer to that of plasma. Hence, the group using bicarbonate Ringer's solution as perfusate was exhibited less variation in plasma electrolytes and blood gas data. The primary endpoints were adverse events of grade 1 or higher according to the JCOG postoperative complication criteria ver. 2.0, unintended diseases, or related signs in patients who underwent the protocol therapy. The secondary endpoints were changes in blood pH, bicarbonate ion level, anion gap (AG), base excess (BE), and chloride (C1), which occurred during and after the surgeries. Therefore, bicarbonate Ringer's solution has superior with that of physiological saline as perfusate during TURP which is directly administered into the blood vessels as an infusion solution.Bicarbonate Ringer's solution is directly administered into the blood vessels as an infusion solution.",2021,"Compared to the physiological saline, the electrolyte composition of the bicarbonate Ringer's solution was closer to that of plasma.","['40 adult patients admitted to a medical college hospital', 'transurethral resection of the prostate']","[""bicarbonate Ringer's solution with that of physiological saline"", ""Bicarbonate Ringer's solution"", 'Transurethral resection in saline (TURis', 'Transurethral resection of the prostate (TURP', ""bicarbonate Ringer's solution""]","['blood pH, bicarbonate ion level, anion gap (AG), base excess (BE), and chloride (C1), which occurred during and after the surgeries', 'plasma electrolytes and blood gas data', 'adverse events of grade 1 or higher according to the JCOG postoperative complication criteria ver']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0053548', 'cui_str': 'Bicarbonate Ions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003074', 'cui_str': 'Anion gap'}, {'cui': 'C0201985', 'cui_str': 'Delta base, blood'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0858120', 'cui_str': 'Plasma electrolytes NOS'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042553', 'cui_str': 'Versed'}]",40.0,0.0336447,"Compared to the physiological saline, the electrolyte composition of the bicarbonate Ringer's solution was closer to that of plasma.","[{'ForeName': 'Fumiya', 'Initials': 'F', 'LastName': 'Hongo', 'Affiliation': 'Department of Urology, Kyoto Prefectural University of Medicine, 465 Kajii-cho Kawaramachi-Hirokoji Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Narukawa', 'Affiliation': 'Department of Urology, Kyoto Prefectural University of Medicine, 465 Kajii-cho Kawaramachi-Hirokoji Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Fujihara', 'Affiliation': 'Department of Urology, Kyoto Prefectural University of Medicine, 465 Kajii-cho Kawaramachi-Hirokoji Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Fumimasa', 'Initials': 'F', 'LastName': 'Amaya', 'Affiliation': 'Department of Pain Management and Palliative Care Medicine, Kyoto Prefectural University of Medicine, 465 Kajii-cho Kawaramachi-Hirokoji Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Teiji', 'Initials': 'T', 'LastName': 'Sawa', 'Affiliation': 'Department of Anesthesiology, Kyoto Prefectural University of Medicine, 465 Kajii-cho Kawaramachi-Hirokoji Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ukimura', 'Affiliation': 'Department of Urology, Kyoto Prefectural University of Medicine, 465 Kajii-cho Kawaramachi-Hirokoji Kamigyo-ku, Kyoto, 602-8566, Japan.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2021.100744']
1610,33681483,Voluntary versus ABC breath-hold in the context of VMAT for breast and locoregional lymph node radiotherapy including the internal mammary chain.,"Background


Deep-inspiration breath-hold (DIBH) reduces radiation dose to the heart in patients undergoing locoregional breast radiotherapy. In the context of tangential irradiation of the breast/ chest wall, a voluntary breath hold (vDIBH) technique has been shown to be as reproducible as a machine-assisted breath hold technique using the active breathing co-ordinator (ABC™, Elekta, Crawley, UK, ABC_DIBH). This study compares set-up reproducibility for vDIBH versus ABC_DIBH in patients undergoing volumetric-modulated arc radiotherapy (VMAT) for breast cancer, both with and without wax bolus.
Method


Patients with breast cancer requiring pan regional lymph node VMAT +/- wax bolus in breath-hold were CT scanned in vDIBH and ABC_DIBH. Patients were randomised to receive one technique for fractions 1-7 and the other for fractions 8-15. Daily cone beam computed tomography (CBCT) was performed and registered to planning-CT using bony anatomy. Within-patient comparisons of mean daily chest wall position were made using a paired  t -test. Population, systematic (∑) and random errors (α) were estimated. Intrafraction reproducibility was assessed by comparing chest wall position and diaphragm movement between consecutive breath holds on CBCT.
Results


16 patients were recruited. All completed treatment with both techniques (9 patients with wax bolus, 7 patients without). CBCT derived ∑ were 2.1-6.4 mm (ABC_DIBH) and 2.1-4.9 mm (vDIBH), α were 1.7-2.6 mm (ABC_DIBH) and 2.2-2.7 mm (vDIBH) and mean daily chest wall displacements (MD) were 0.0-1.5 mm (ABC_DIBH) and  - 0.1-1.6 vDIBH (all  p  non-significant). Chest wall and diaphragm position was equivalent between consecutive breath holds in ABC and vDIBH (median difference 1.0 mm and 0.8 mm respectively, non  p  significant) demonstrating equivalent intrafraction reproducibility.
Conclusion


This study demonstrates that a simple voluntary breath hold technique is feasible in combination with VMAT (+/- bolus) and is as reproducible as ABC_DIBH with VMAT for the irradiation of the breast and axillary and IMC lymph nodes in breast cancer patients.",2021,Chest wall and diaphragm position was equivalent between consecutive breath holds in ABC and vDIBH (median difference 1.0 mm and 0.8 mm respectively,"['breast cancer patients', '16 patients were recruited', 'patients undergoing', 'patients undergoing locoregional breast radiotherapy', 'Patients with breast cancer requiring pan regional lymph node VMAT ']","['volumetric-modulated arc radiotherapy (VMAT', '\n\n\nDeep-inspiration breath-hold (DIBH', 'VMAT ', 'Daily cone beam computed tomography (CBCT', 'VMAT']","['Chest wall and diaphragm position', 'Intrafraction reproducibility', 'mean daily chest wall displacements (MD', 'Population, systematic (∑) and random errors (α']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",16.0,0.0422318,Chest wall and diaphragm position was equivalent between consecutive breath holds in ABC and vDIBH (median difference 1.0 mm and 0.8 mm respectively,"[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Ranger', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Grimwood', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Durie', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Donovan', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Havilland', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Harris', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McNair', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kirby', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}]",Clinical and translational radiation oncology,['10.1016/j.ctro.2021.02.003']
1611,33681424,Comparison of Antifungal Efficacy of Zataria Multiflora and Nystatin for Treatment of Denture Stomatitis: A Randomized Clinical Trial.,"Statement of the Problem


Zataria multiflora (ZM) is a thyme-like plant that belongs to the Lamiaceae family. It is native to the center and south of Iran, Pakistan, and Afghanistan. Evidence shows that ZM contains thymol and carvacrol and is therefore, effective for the treatment of many conditions especially fungal infections. Oral candidiasis is the most common opportunistic infection of the oral mucosa that plays a role in the development of denture stomatitis.
Purpose


This study aimed to compare the antifungal efficacy of ZM and nystatin suspension for the treatment of denture stomatitis.
Materials and Method


This single-blind clinical trial evaluated 28 patients (> 18 years old) suffering from type II or III denture stomatitis. Patients were divided into two groups. The control group used nystatin suspension while the case group used ZM drop. The number of  Candida albicans  ( C. albicans ) colony-forming units (CFUs) and erythema of the palate were evaluated at baseline and at 14 days after treatment. Data were analyzed using SPSS version 11 via Student's t test and repeated measure ANOVA.
Results


The results showed similar efficacy of nystatin and ZM in the reduction of  C.albicans  CFUs compared to the baseline value ( p = 0.593). Both medications significantly decreased the colony count ( p < 0.001). Nystatin and ZM had similar efficacy for the reduction of erythema as well ( p = 0.256) and both caused a significant reduction in erythema of the palate ( p <0.001).
Conclusion


ZM drop was as effective as the nystatin drop in the resolution of erythema of the palate and reduction of  C. albicans  colony count.",2021,"Nystatin and ZM had similar efficacy for the reduction of erythema as well ( p = 0.256) and both caused a significant reduction in erythema of the palate ( p <0.001).
","['28 patients (> 18 years old) suffering from type II or III denture stomatitis', 'denture stomatitis', 'Denture Stomatitis']","['Zataria Multiflora and Nystatin', 'nystatin', 'Nystatin and ZM', 'nystatin and ZM', 'nystatin suspension', 'ZM and nystatin suspension', 'ZM']","['erythema of the palate', 'colony count', 'number of  Candida albicans  ( C. albicans ) colony-forming units (CFUs) and erythema of the palate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0038364', 'cui_str': 'Denture stomatitis'}]","[{'cui': 'C0028741', 'cui_str': 'Nystatin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0006837', 'cui_str': 'Candida albicans'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",28.0,0.0231374,"Nystatin and ZM had similar efficacy for the reduction of erythema as well ( p = 0.256) and both caused a significant reduction in erythema of the palate ( p <0.001).
","[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Gonoudi', 'Affiliation': 'Dept. of Oral Medicine, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rezai', 'Affiliation': 'Dept. of Oral Medicine, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Taraneh', 'Initials': 'T', 'LastName': 'Farrokhnia', 'Affiliation': 'Dept. of Oral Medicine, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Goudarzi', 'Affiliation': 'Dept. of Microbiology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran,\xa0Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]","Journal of dentistry (Shiraz, Iran)",['10.30476/DENTJODS.2020.84181.1069']
1612,33681423,Evaluation of the Effect of Ultra-Soft Toothbrushes with Different Commercial Brands on Plaque and Bleeding Indices.,"Statement of the Problem


Ultra-soft bristles are recommended for individuals with gingival recession, dentinal hypersensitivity, and patients who have undergone periodontal surgeries. However, comparative effectiveness of ultra-soft toothbrushes on dental plaque and bleeding indices has not extensively been studied, and a consensus has yet to be reached on their efficacy.
Purpose


The aim of this study was to investigate the effect of ultra-soft toothbrushes with different commercial brands on plaque and bleeding indices.
Materials and Method


In this crossover randomized clinical trial, 30 participants were selected using convenience sampling method. The subjects were randomly divided into three groups (n=10). In the first session, the bleeding index was recorded. Then each subject was given a toothbrush (Oral B, GUM, or Fuchs), asked to brush at least twice a day using the Bass technique, then avoid brushing for 24 hours after a week and refer for recording the indices. During the second session, bleeding on probing was recorded before brushing, and plaque indices were recorded before and after brushing. Plaque indices before brushing were considered the baseline plaque indices. After one week of washout, each subject used the next toothbrush in terms of the group involved. Turesky plaque index, O'Leary plaque index, and bleeding index were evaluated. The distribution of data was normal. Therefore, ANOVA, t-test, and post hoc tests were used for the analysis of data.
Results


The bleeding and plaque indices decreased significantly compared to the baseline with the use of all the three ultra-soft toothbrushes evaluated ( p < 0.05), with no significant differences between the three brands ( p > 0.05) except for the superiority of Fuchs toothbrush in decreasing the Turesky plaque index.
Conclusion


Ultra-soft toothbrushes can reduce plaque index compared to the baseline, but they do not decrease the plaque index up to the optimal level, which might affect their prescription.",2021,"The bleeding and plaque indices decreased significantly compared to the baseline with the use of all the three ultra-soft toothbrushes evaluated ( p < 0.05), with no significant differences between the three brands ( p > 0.05) except for the superiority of Fuchs toothbrush in decreasing the Turesky plaque index.
","['30 participants were selected using convenience sampling method', 'individuals with gingival recession, dentinal hypersensitivity, and patients who have undergone periodontal surgeries']","['Ultra-Soft Toothbrushes', 'ultra-soft toothbrushes']","['plaque index', ""Turesky plaque index, O'Leary plaque index, and bleeding index"", 'bleeding on probing', 'Turesky plaque index', 'bleeding and plaque indices', 'Plaque and Bleeding Indices', 'bleeding index', 'plaque and bleeding indices']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0398950', 'cui_str': 'Periodontal operation'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",30.0,0.0118514,"The bleeding and plaque indices decreased significantly compared to the baseline with the use of all the three ultra-soft toothbrushes evaluated ( p < 0.05), with no significant differences between the three brands ( p > 0.05) except for the superiority of Fuchs toothbrush in decreasing the Turesky plaque index.
","[{'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Saffarzadeh', 'Affiliation': 'Dept. of Endodontics, Faculty of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Khodarahmi', 'Affiliation': 'Periodontist, Kerman, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Dept. of Periodontics, Faculty of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}]","Journal of dentistry (Shiraz, Iran)",['10.30476/DENTJODS.2020.83259.1044']
1613,33681411,Functional Dyskinesias following Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease: A Report of Three Cases.,"Background


Functional (psychogenic) dyskinesias in patients with Parkinson's disease (PD) are exceedingly rare.
Cases


Herein we report three patients with PD who presented with functional dyskinesias in the first 3 months after subthalamic nucleus deep brain stimulation (DBS). All patients presented with chorea mimicking levodopa or stimulation-induced dyskinesias in the first 24 hours following stimulation adjustment. Two patients had generalized chorea and one, hemichorea. In all patients the abnormal movements could be induced or resolved with placebo/nocebo changes to the stimulation parameters. Following the diagnosis of a functional movement disorder (FMD), all patients improved with appropriate management.
Conclusions


Functional chorea following DBS might mimic organic dyskinesias in PD but can be accurately diagnosed using suggestibility and placebo responses to sham stimulation adjustments. Recognizing the presence of FMD following DBS is important for proper management of these patients.",2021,In all patients the abnormal movements could be induced or resolved with placebo/nocebo changes to the stimulation parameters.,"['Two patients had generalized chorea and one, hemichorea', ""patients with Parkinson's disease (PD"", ""Parkinson's Disease"", 'patients with PD who presented with functional dyskinesias in the first 3\u2009months after subthalamic nucleus deep brain stimulation (DBS']",['Subthalamic Nucleus Deep Brain Stimulation'],['chorea mimicking levodopa or stimulation-induced dyskinesias'],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008489', 'cui_str': 'Chorea'}, {'cui': 'C0270739', 'cui_str': 'Hemichorea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0008489', 'cui_str': 'Chorea'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]",3.0,0.107967,In all patients the abnormal movements could be induced or resolved with placebo/nocebo changes to the stimulation parameters.,"[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Maciel', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Centre Toronto Western Hospital, UHN Toronto Ontario Canada.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zúñiga-Ramírez', 'Affiliation': 'Movement Disorders and Neurodegenerative Diseases Unit Hospital Civil de Guadalajara ""Fray Antonio Alcalde"" Guadalajara Mexico.'}, {'ForeName': 'Renato P', 'Initials': 'RP', 'LastName': 'Munhoz', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Centre Toronto Western Hospital, UHN Toronto Ontario Canada.""}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Zurowski', 'Affiliation': 'Centre for Mental Health Toronto Western Hospital, UHN Toronto Ontario Canada.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Centre Toronto Western Hospital, UHN Toronto Ontario Canada.""}]",Movement disorders clinical practice,['10.1002/mdc3.13111']
1614,33681371,Optimal Values of Body Composition for the Lowest Risk of Failure in Tabata Training's Effects in Adolescents: A Pilot Study.,"Background


The optimal body mass index (BMI) and fat mass index (FMI) values for a positive change or the lowest risk of no positive change after high-intensity interval training (HIIT) using the Tabata protocol remain unclear. This study is aimed at establishing these optimal BMI and FMI values for the lowest risk of failure of aerobic performance in adolescents.
Methods


A 10-week HIIT programme was introduced into the physical education of 73 students. BMI was calculated using height and weight. Bioelectrical impedance analysis measured body fat, and the InBody apparatus generated the FMI. Based on BMI and FMI, the participants were divided into four groups. Pre- and post-HIIT intervention analyses were carried out using the Harvard step test, which was used to determine the physical efficiency index (PEI).
Results


The Youden index confirmed that the risk of no positive effects in PEI was the lowest for the second BMI interval (19.01-22.00 kg/m 2 ) and FMI  Q   2-3  (7.96-8.91 kg/m 2 ). The optimal BMI value for the lowest risk of no change in PEI was 20.60 kg/m 2 , and the optimal FMI value was 8.84 kg/m 2 .
Conclusion


A comparison of the two indices shows that FMI had stronger effects on PEI than BMI. In addition, the model obtained for FMI had higher accuracy. Identifying at-risk individuals, those in need of improving health-related fitness (H-RF), and those with a low risk of poor H-RF allows for efficient planning of individual intervention services and training programmes.",2021,The Youden index confirmed that the risk of no positive effects in PEI was the lowest for the second BMI interval (19.01-22.00 kg/m 2 ) and FMI  Q   2-3  (7.96-8.91 kg/m 2 ).,"['73 students', 'Adolescents', 'adolescents']",['FMI'],"['BMI', 'optimal body mass index (BMI) and fat mass index (FMI) values', 'physical efficiency index (PEI']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0260636,The Youden index confirmed that the risk of no positive effects in PEI was the lowest for the second BMI interval (19.01-22.00 kg/m 2 ) and FMI  Q   2-3  (7.96-8.91 kg/m 2 ).,"[{'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Domaradzki', 'Affiliation': 'Department of Biostructure, University School of Physical Education in Wroclaw, Al. I.J. Paderewskiego 35, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Rokita', 'Affiliation': 'Department of Team Sports Games, University School of Physical Education in Wroclaw, Al. I.J. Paderewskiego 35, 51-612 Wrocław, Poland.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Koźlenia', 'Affiliation': 'Department of Biostructure, University School of Physical Education in Wroclaw, Al. I.J. Paderewskiego 35, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Popowczak', 'Affiliation': 'Department of Team Sports Games, University School of Physical Education in Wroclaw, Al. I.J. Paderewskiego 35, 51-612 Wrocław, Poland.'}]",BioMed research international,['10.1155/2021/6675416']
1615,33681357,3D Printed Guides and Preoperative Planning for Uncemented Stem Anteversion Reconstruction during Hip Arthroplasty: A Pilot Study.,"Objective


To investigate if 3D printed guides and preoperative planning can accurately control femoral stem anteversion.
Methods


A prospective comparative study was carried out from 2018 to 2020, including 53 patients who underwent hip arthroplasty for femoral neck fracture. The target rotation center of the femoral head is determined by three-dimensional planning. In group A, planning was made by 2D templates. In group B, preoperative 3D planning and 3D printed osteotomy/positioning guides were performed. After the operation, 3D model registration was performed to calculate the accuracy of anteversion restoration.
Results


We screened 60 patients and randomized a total of 53 to 2 parallel study arms: 30 patients to the group A (traditional operation) and 23 patients to the group B (3D preoperative planning and 3D printed guide). There were no significant differences in demographic or perioperative data between study groups. The restoration accuracy of group A was 5.42° ± 3.65° and of group B was 2.32° ± 1.89°. The number and rate of abnormal cases was 15 (50%) and 2 (8.7%), respectively. Significant statistical differences were found in angle change, restoration accuracy, and number of abnormal cases.
Conclusion


Three-dimensional preoperative planning and 3D printed guides can improve the accuracy of the restoration of femoral anteversion during hip arthroplasty.",2021,"Significant statistical differences were found in angle change, restoration accuracy, and number of abnormal cases.
","['Hip Arthroplasty', '2018 to 2020, including 53 patients who underwent hip arthroplasty for femoral neck fracture', '60 patients and randomized a total of 53 to 2 parallel study arms: 30 patients to the group A (traditional operation) and 23 patients to the group B (3D preoperative planning and 3D printed guide']","['3D Printed Guides and Preoperative Planning for Uncemented Stem Anteversion Reconstruction', '3D printed guides and preoperative planning']","['number and rate of abnormal cases', 'angle change, restoration accuracy, and number of abnormal cases']","[{'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",60.0,0.0160668,"Significant statistical differences were found in angle change, restoration accuracy, and number of abnormal cases.
","[{'ForeName': 'Yingqi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China.'}, {'ForeName': 'Zhitao', 'Initials': 'Z', 'LastName': 'Rao', 'Affiliation': 'Department of Orthopedic Surgery, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China.'}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China.'}, {'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Yangpu Hospital, Tongji University School of Medicine, Shanghai 200090, China.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Department of Orthopedic Surgery, Yangpu Hospital, Tongji University School of Medicine, Shanghai 200090, China.'}, {'ForeName': 'Yeqing', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopedic Surgery, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China.'}]",BioMed research international,['10.1155/2021/6621882']
1616,33547717,Stronger therapeutic alliance is associated with better quality of life among patients with advanced cancer.,"OBJECTIVE


Patient-oncologist therapeutic alliance is a foundation of quality cancer care, although there is limited research demonstrating its relationship with patient outcomes. We investigated the relationship between therapeutic alliance and patient quality of life with a secondary goal of determining whether the association varied by patients' baseline level of psychological distress.
METHODS


Cross-sectional analysis of baseline data from a randomized clinical trial of 672 patients with advanced cancer participating in a primary palliative care intervention trial. Patients completed baseline self-reported measures of therapeutic alliance (The Human Connection Scale, range: 16-64), overall quality of life (Functional Assessment of Cancer Therapy-Palliative Care, range: 0-184), and psychological distress (Hospital Anxiety and Depression Scale, range: 0-42). First, we determined the relationship between therapeutic alliance and quality of life using multivariable regression adjusting for confounders. We then examined if psychological distress was an effect modifier in this relationship by adding interaction effects of depression and anxiety symptoms on therapeutic alliance into the regression model.
RESULTS


Patients reported high levels of therapeutic alliance (56.4 ± 7.4) and moderate quality of life (130.3 ± 25.5). Stronger therapeutic alliance was associated with better quality of life after adjusting for other confounding factors (β = 3.7, 95% confidence interval = 2.1, 5.3, p < 0.01). The relationship between therapeutic alliance and quality of life was generally consistent regardless of psychological distress.
CONCLUSIONS


Collaborative, trusting relationships between patients with advanced cancer and their oncologists are associated with better patient quality of life. Future research should investigate the causal, longitudinal nature of these relationships.",2021,"Stronger therapeutic alliance was associated with better quality of life after adjusting for other confounding factors (β = 3.7, 95% confidence interval = 2.1, 5.3, p < 0.01).","['672 patients with advanced cancer participating in a primary palliative care intervention trial', 'patients with advanced cancer', 'patients with advanced cancer and their oncologists']",[],"['moderate quality of life', 'patient quality of life', 'high levels of therapeutic alliance', 'overall quality of life (Functional Assessment of Cancer Therapy-Palliative Care, range: 0-184), and psychological distress (Hospital Anxiety and Depression Scale, range: 0-42', 'therapeutic alliance and quality of life', 'therapeutic alliance', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}]",672.0,0.0803562,"Stronger therapeutic alliance was associated with better quality of life after adjusting for other confounding factors (β = 3.7, 95% confidence interval = 2.1, 5.3, p < 0.01).","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Althouse', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Sigler', 'Affiliation': 'Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Arnold', 'Affiliation': 'Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Albert Einstein Cancer Center, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rosenzweig', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine Section of General Internal Medicine, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",Psycho-oncology,['10.1002/pon.5648']
1617,31944491,Clinical study of argatroban for preventing vascular thrombosis in the early period after pediatric living-related donor liver transplantation.,"OBJECTIVE


To evaluate the effect of heparin and argatroban on coagulation function and vascular thrombosis in the early period after pediatric LRDLT.
METHOD


Eighty-four congenital biliary atresia pediatric patients who had undergone LRDLT were studied. Patients were divided into two groups according to the method of anticoagulation (heparin or argatroban). AT-Ⅲ activity, APTT, and INR of the two groups were measured in the first 5 days after LRDLT. Vascular thrombosis was investigated by Doppler ultrasound daily.
RESULTS


There were no significant differences in gender, age, weight, graft-recipient weight ratio, and Kasai procedure between the two groups. The AT-Ⅲ activity of the two groups was low and increased gradually after surgery, with no significant difference between the two groups. There was no significant difference of APTT between the two groups immediately after and in the first day after surgery. After anticoagulation treatment, a significant difference in APTT between the two groups was observed. The incidences of vascular thrombosis were 4.76% (3/63) and 0% (0/21) in the heparin and argatroban groups, respectively, with no significant difference between the two groups. During the treatment, no serious complications such as active hemorrhage or drug allergy were observed in the two groups.
CONCLUSION


Argatroban is a direct anticoagulant, which is independent of AT-Ⅲ activity. Argatroban might be an alternative to heparin in uncomplicated LRDLT with recovered hepatic and coagulation function.",2020,"The incidences of vascular thrombosis were 4.76% (3/63) and 0% (0/21) in the heparin and argatroban groups, respectively, with no significant difference between the two groups.","['Eighty-four congenital biliary atresia pediatric patients who had undergone LRDLT were studied', 'early period after pediatric living-related donor liver transplantation']","['anticoagulation (heparin or argatroban', 'Argatroban', 'heparin and argatroban', 'argatroban']","['coagulation function and vascular thrombosis', 'AT-Ⅲ activity', 'Vascular thrombosis', 'AT-Ⅲ activity, APTT, and INR', 'gender, age, weight, graft-recipient weight ratio, and Kasai procedure', 'incidences of vascular thrombosis', 'active hemorrhage or drug allergy', 'vascular thrombosis']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0005411', 'cui_str': 'Congenital biliary atresia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}]","[{'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2586211', 'cui_str': 'Thrombosis of blood vessel'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032722', 'cui_str': 'Hepatic portoenterostomy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0013182', 'cui_str': 'Allergy to drug'}]",84.0,0.0203038,"The incidences of vascular thrombosis were 4.76% (3/63) and 0% (0/21) in the heparin and argatroban groups, respectively, with no significant difference between the two groups.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Na', 'Affiliation': 'ICU for Transplantation, Tianjin First Center Hospital, Tianjin, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Jindong', 'Affiliation': 'Tianjin Medical University Eye Hospital, Tianjin, China.'}]",Pediatric transplantation,['10.1111/petr.13654']
1618,32544082,Combined impact of body mass index and glycemic control on the efficacy of clopidogrel-aspirin therapy in patients with minor stroke or transient ischemic attack.,"BACKGROUND


A single index of body mass index (BMI) may not fully address its impact on anti-platelet therapy. We aimed to elucidate the combined impact of BMI and dysglycemia expressed by glycated albumin (GA) on efficacy of clopidogrel-aspirin therapy among minor stroke (MS) or transient ischemic attack (TIA) patients.
RESULTS


Patients with overweight/obesity and low GA levels still benefited from clopidogrel-aspirin therapy for stroke recurrence (Hazard ratio [HR]: 0.48, 95 % confidence interval [CI]: 0.28-0.82), so did those with high GA levels but low/normal weight (HR: 0.67, 95 % CI: 0.45-0.99). However, patients with both overweight/obesity and high GA levels did not benefit from clopidogrel-aspirin therapy (HR: 0.89, 95 % CI: 0.59-1.33).
CONCLUSIONS


Compared with aspirin alone, efficacy of clopidogrel-aspirin therapy for stroke still exists in overweight/obesity patients with normal glycemic control.
METHODS


In Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events trial, 3044 patients with available baseline GA were recruited. Low/normal weight and overweight/obesity were defined as BMI < 25 kg/m 2  and ≥ 25 kg/m 2 , respectively. Elevated and low GA levels were defined as GA levels > 15.5 % and ≤ 15.5 %, respectively. The primary outcome was stroke recurrence during the 90-day follow-up.",2020,"Compared with aspirin alone, efficacy of clopidogrel-aspirin therapy for stroke still exists in overweight/obesity patients with normal glycemic control.
","['overweight/obesity patients with normal glycemic control', 'High-Risk Patients with Acute Nondisabling Cerebrovascular Events trial, 3044 patients with available baseline GA were recruited', 'patients with minor stroke or transient ischemic attack', 'minor stroke (MS) or transient ischemic attack (TIA) patients']","['Clopidogrel', 'clopidogrel-aspirin', 'BMI and dysglycemia expressed by glycated albumin (GA', 'clopidogrel-aspirin therapy', 'aspirin']","['Elevated and low GA levels', 'stroke recurrence', 'Low/normal weight and overweight/obesity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",3044.0,0.125197,"Compared with aspirin alone, efficacy of clopidogrel-aspirin therapy for stroke still exists in overweight/obesity patients with normal glycemic control.
","[{'ForeName': 'Zimo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jinglin', 'Initials': 'J', 'LastName': 'Mo', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Anxin', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Haiqiang', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huaguang', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]",Aging,['10.18632/aging.103394']
1619,31351887,Optimizing presentation of expected treatment outcomes.,,2020,,[],[],[],[],[],[],,0.0122309,,"[{'ForeName': 'Jeremy K', 'Initials': 'JK', 'LastName': 'Bray', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Johnson', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Masicampo', 'Affiliation': 'Department of Psychology, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina; Department of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina; Department of Pathology, Wake Forest School of Medicine, Winston-Salem, North Carolina. Electronic address: sfeldman@wakehealth.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.064']
1620,32310273,Differential Plasma Protein Regulation and Statin Effects in Human Immunodeficiency Virus (HIV)-Infected and Non-HIV-Infected Patients Utilizing a Proteomics Approach.,"BACKGROUND


People with human immunodeficiency virus (PWH) demonstrate increased atherosclerotic cardiovascular disease (ASCVD). Statins are being studied to prevent ASCVD in human immunodeficiency virus (HIV), but little is known regarding the effects of statins on a broad range of inflammatory and cardiovascular proteins in this population.
METHODS


We used a highly specific discovery proteomic approach (Protein Extension Assay), to determine statin effects on over 350 plasma proteins in relevant ASCVD pathways among HIV and non-HIV groups. Responses to pitavastatin calcium were assessed in 89 PWH in the INTREPID trial and 46 non-HIV participants with features of central adiposity and insulin resistance. History of cardiovascular disease was exclusionary for both studies.
RESULTS


Among participants with HIV, PCOLCE (enzymatic cleavage of type I procollagen) significantly increased after pitavastatin therapy and PLA2G7 (systemic marker of arterial inflammation) decreased. Among participants without HIV, integrin subunit alpha M (integrin adhesive function) and defensin alpha-1 (neutrophil function) increased after pitavastatin therapy and PLA2G7 decreased. At baseline, comparing participants with and without HIV, differentially expressed proteins included proteins involved in platelet and endothelial function and immune activation.
CONCLUSIONS


Pitavastatin affected proteins important to platelet and endothelial function and immune activation, and effects differed to a degree within PWH and participants without HIV.",2020,"Among participants with HIV, PCOLCE (enzymatic cleavage of type I procollagen) significantly increased after pitavastatin therapy and PLA2G7 (systemic marker of arterial inflammation) decreased.","['People with human immunodeficiency virus (PWH', '350 plasma proteins in relevant ASCVD pathways among HIV and non-HIV groups', '89 PWH in the INTREPID trial and 46 non-HIV participants with features of central adiposity and insulin resistance', 'Human Immunodeficiency Virus ']","['pitavastatin calcium', 'Pitavastatin']","['platelet and endothelial function and immune activation', 'atherosclerotic cardiovascular disease (ASCVD', 'integrin subunit alpha M (integrin adhesive function) and defensin alpha-1 (neutrophil function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4551560', 'cui_str': 'Central obesity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]","[{'cui': 'C2720023', 'cui_str': 'Pitavastatin calcium'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0057256', 'cui_str': 'Defensins'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}]",,0.118189,"Among participants with HIV, PCOLCE (enzymatic cleavage of type I procollagen) significantly increased after pitavastatin therapy and PLA2G7 (systemic marker of arterial inflammation) decreased.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'deFilippi', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia, USA.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Toribio', 'Affiliation': 'Massachusetts General Hospital, Metabolism Unit and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Lai Ping', 'Initials': 'LP', 'LastName': 'Wong', 'Affiliation': 'Massachusetts General Hospital, Department of Molecular Biology and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Sadreyev', 'Affiliation': 'Massachusetts General Hospital, Department of Molecular Biology and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Grundberg', 'Affiliation': 'Olink Proteomics, Watertown, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Massachusetts General Hospital, Metabolism Unit and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Massachusetts General Hospital, Metabolism Unit and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Massachusetts General Hospital, Metabolism Unit and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'KOWA Pharmaceuticals America, Inc., Montgomery, Alabama, USA.'}, {'ForeName': 'Emmett', 'Initials': 'E', 'LastName': 'Sprecher', 'Affiliation': 'Olink Proteomics, Watertown, Massachusetts, USA.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Rashidi', 'Affiliation': 'Olink Proteomics, Watertown, Massachusetts, USA.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, Georgia, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Cagliero', 'Affiliation': 'Massachusetts General Hospital, Metabolism Unit and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Mount Sinai Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Laurie R', 'Initials': 'LR', 'LastName': 'Braun', 'Affiliation': 'Massachusetts General Hospital, Metabolism Unit and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Massachusetts General Hospital, Metabolism Unit and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Massachusetts General Hospital, Biostatistics Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Massachusetts General Hospital, Metabolism Unit and Harvard Medical School, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa196']
1621,31776447,Germline genetic variation in prostate susceptibility does not predict outcomes in the chemoprevention trials PCPT and SELECT.,"BACKGROUND


The development of prostate cancer can be influenced by genetic and environmental factors. Numerous germline SNPs influence prostate cancer susceptibility. The functional pathways in which these SNPs increase prostate cancer susceptibility are unknown. Finasteride is currently not being used routinely as a chemoprevention agent but the long term outcomes of the PCPT trial are awaited. The outcomes of the SELECT trial have not recommended the use of chemoprevention in preventing prostate cancer. This study investigated whether germline risk SNPs could be used to predict outcomes in the PCPT and SELECT trial.
METHODS


Genotyping was performed in European men entered into the PCPT trial (n = 2434) and SELECT (n = 4885). Next generation genotyping was performed using Affymetrix® Eureka™ Genotyping protocols. Logistic regression models were used to test the association of risk scores and the outcomes in the PCPT and SELECT trials.
RESULTS


Of the 100 SNPs, 98 designed successfully and genotyping was validated for samples genotyped on other platforms. A number of SNPs predicted for aggressive disease in both trials. Men with a higher polygenic score are more likely to develop prostate cancer in both trials, but the score did not predict for other outcomes in the trial.
CONCLUSION


Men with a higher polygenic risk score are more likely to develop prostate cancer. There were no interactions of these germline risk SNPs and the chemoprevention agents in the SELECT and PCPT trials.",2020,"Men with a higher polygenic score are more likely to develop prostate cancer in both trials, but the score did not predict for other outcomes in the trial.
",['Genotyping was performed in European men entered into the PCPT trial (n\u2009=\u20092434) and SELECT (n\u2009=\u20094885'],['Finasteride'],[],"[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0060389', 'cui_str': 'Finasteride'}]",[],,0.0708834,"Men with a higher polygenic score are more likely to develop prostate cancer in both trials, but the score did not predict for other outcomes in the trial.
","[{'ForeName': 'Mahbubl', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'The Institute of Cancer Research, Royal Marsden Hospital, NHS Foundation Trust, 123 Old Brompton Road, London, SW7 3RP, UK. Mahbubl.ahmed@icr.ac.uk.'}, {'ForeName': 'Chee', 'Initials': 'C', 'LastName': 'Goh', 'Affiliation': 'The Institute of Cancer Research, Royal Marsden Hospital, NHS Foundation Trust, 123 Old Brompton Road, London, SW7 3RP, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Saunders', 'Affiliation': 'The Institute of Cancer Research, Royal Marsden Hospital, NHS Foundation Trust, 123 Old Brompton Road, London, SW7 3RP, UK.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Cieza-Borrella', 'Affiliation': 'The Institute of Cancer Research, Royal Marsden Hospital, NHS Foundation Trust, 123 Old Brompton Road, London, SW7 3RP, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Zsofia', 'Initials': 'Z', 'LastName': 'Kote-Jarai', 'Affiliation': 'The Institute of Cancer Research, Royal Marsden Hospital, NHS Foundation Trust, 123 Old Brompton Road, London, SW7 3RP, UK.'}, {'ForeName': 'Fredrick R', 'Initials': 'FR', 'LastName': 'Schumacher', 'Affiliation': 'Department of Epidemiology and Biostatistics, Case Western Reserve University; Seidman Cancer Center, University Hospitals, Cleveland, OH, USA.'}, {'ForeName': 'Ros', 'Initials': 'R', 'LastName': 'Eeles', 'Affiliation': 'The Institute of Cancer Research, Royal Marsden Hospital, NHS Foundation Trust, 123 Old Brompton Road, London, SW7 3RP, UK.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0181-y']
1622,33463883,Factors associated with purchasing pesticide from shops for intentional self-poisoning in Sri Lanka.,"OBJECTIVE


In South Asia, up to one in five individuals who ingest pesticides for self-poisoning and survive purchased them from a shop immediately prior to the event. Thus far, no research has taken place to determine whether interventions implemented through the pesticide sellers might be acceptable or effective, despite the hundreds of thousands of such risk purchases each year. We aimed to investigate factors associated with purchasing pesticides for self-poisoning in Sri Lanka.
METHODS


We used a case-control study. Cases (n = 50) were individuals who ingested pesticides after purchasing them for the act, and controls (n = 200) were customers who bought pesticides but did not use them for self-harm. Logistic regression analysis was used to assess socio-demographic and purchase-specific risk factors.
RESULTS


Alcohol intoxication (adjusted odds ratios [AOR] 36.5, 95% confidence intervals [CI] 1.7-783.4) and being a non-farmer AOR 13.3, 95% CI 1.8-99.6 were the main distinguishing factors when purchasing pesticides for self-poisoning. The positive predictive values were 93.3% (95% CI 68.0-99.8%) and 88.2% (95% CI 72.5-96.7%), respectively. One and/or other of these factors characterised 72.0% of cases but only 2.5% controls.
CONCLUSION


While results need to be interpreted cautiously, sales restrictions to prevent alcohol-intoxicated persons and non-farmers purchasing pesticides for self-poisoning may be effective.",2020,"The positive predictive values were 93.3% (95% CI 68.0-99.8%) and 88.2% (95% CI 72.5-96.7%), respectively.","['five individuals who ingest pesticides for self-poisoning and survive purchased them from a shop immediately prior to the event', '50) were individuals who ingested pesticides after purchasing them for the act, and controls (n\xa0=\xa0200) were customers who bought pesticides but did not use them for self-harm', 'Cases (n\xa0']",[],"['Alcohol intoxication (adjusted odds ratios [AOR', 'positive predictive values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0031253', 'cui_str': 'Pesticide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",[],"[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",200.0,0.0439897,"The positive predictive values were 93.3% (95% CI 68.0-99.8%) and 88.2% (95% CI 72.5-96.7%), respectively.","[{'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Weerasinghe', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Anuradhapura, Sri Lanka.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Konradsen', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eddleston', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pearson', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Shaluka', 'Initials': 'S', 'LastName': 'Jayamanne', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Duleeka', 'Initials': 'D', 'LastName': 'Knipe', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Hawton', 'Affiliation': 'Centre for Suicide Research, Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gunnell', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Suneth', 'Initials': 'S', 'LastName': 'Agampodi', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Anuradhapura, Sri Lanka.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13469']
1623,33679176,Oral medications administration through enteral feeding tube: Clinical pharmacist-led educational intervention to improve knowledge of Intensive care units' nurses at Jordan University Hospital.,"Introduction


Medication administration through enteral feeding tubes is a practice that is commonly encountered in hospital settings, particularly in critically ill patients. This study aims to evaluate the knowledge of intensive care unit nurses regarding enteral medication administration and evaluate the effect of an educational intervention led by a clinical pharmacist that would improve nurses' knowledge regarding the subject.
Methods


A pre/post interventional study was conducted. Improvement in nurses' knowledge regarding medication administration through an enteral feeding tube was assessed using a validated questionnaire.
Results


Data were coded, entered, and analyzed using the Statistical Package for Social Sciences (IBM SPSS statistics 22). Independent samples  t -test and paired  t -test were used to detect any statistically significant differences in the mean total knowledge scores both between and within each group respectively. A P-value of <0.05 was considered statistically significant. The mean total knowledge score for nurses in the intervention and control group at the pre-interventional phase of the study was inadequate. There was a statistically significant improvement in the mean total knowledge score for the interventional group at the post-interventional phase of the study, while that of the control group remained inadequate (Intervention group total mean knowledge score at baseline 12.11 ± 3.75, post-intervention 21.50 ± 2.36, p-value <0.001; Control group total mean knowledge score at baseline 12.05 ± 3.12, post-intervention 12.60 ± 3.76, p-value 0.96).
Conclusion


Incorrect drug preparation and administration for patients with feeding tubes can affect patients. The knowledge of nurses regarding the subject can be improved significantly via an educational intervention. The activation of clinical pharmacists' role and collaboration between pharmacists, physicians, and nurses is highly recommended in this clinical setting.",2021,"There was a statistically significant improvement in the mean total knowledge score for the interventional group at the post-interventional phase of the study, while that of the control group remained inadequate (Intervention group total mean knowledge score at baseline 12.11 ± 3.75, post-intervention 21.50 ± 2.36, p-value <0.001; Control group total mean knowledge score at baseline 12.05 ± 3.12, post-intervention 12.60 ± 3.76, p-value 0.96).
","[""Intensive care units' nurses at Jordan University Hospital"", 'critically ill patients', 'patients with feeding tubes can affect patients']",['educational intervention'],"['mean total knowledge score', 'mean total knowledge scores']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0267039,"There was a statistically significant improvement in the mean total knowledge score for the interventional group at the post-interventional phase of the study, while that of the control group remained inadequate (Intervention group total mean knowledge score at baseline 12.11 ± 3.75, post-intervention 21.50 ± 2.36, p-value <0.001; Control group total mean knowledge score at baseline 12.05 ± 3.12, post-intervention 12.60 ± 3.76, p-value 0.96).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Abu Hdaib', 'Affiliation': 'Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, The University of Jordan, Jordan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albsoul-Younes', 'Affiliation': 'Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, The University of Jordan, Jordan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wazaify', 'Affiliation': 'Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, The University of Jordan, Jordan.'}]",Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society,['10.1016/j.jsps.2020.12.015']
1624,33679027,Is continuous locking suture with braided suture sufficient for arthrotomy repair in the conventional TKR? A randomized controlled trial study.,"Introduction


Medial-parapatellar-arthrotomy is the standard approach for total knee replacement(TKR). No studies have clarified the outcomes as quadriceps-strength-recovery (QS) and safety of Continuous-locking-suture-technique(CLS) for the arthrotomy-repair.
Methods


Patients were randomly assigned into a CLS(n = 40) and an interrupted-horizontal-mattress(IHM, n = 40). QS, visual-analog-scale(VAS), modified-timed-up-and-go(TUGT) test, Western-Ontario-and McMasters-Universities-Osteoarthritis-Index[WOMAC] and Knee-Society-Score[KSS] were followed for 6 months'.
Results


A significantly-shorter capsular-closure-time in CLS(233 ± 40 VS 388 ± 47 sec)(p < 0.0001). There were insignificant difference in QS, VAS, TUGT, WOMAC and KSS during the 6-month follow-up period(p > 0.05 all). No wound complications were found.
Conclusion


CLS with braided-suture is safe and effective as demonstrated a recovery of the QS and knee function outcome comparable to IHM.
Trial registration


This study was registered in Thai Clinical Trials Registry on December 2015 (https://www.clinicaltrials.in.th). The registration number was TCTR20151208003.",2021,"There were insignificant difference in QS, VAS, TUGT, WOMAC and KSS during the 6-month follow-up period(p > 0.05 all).","['Thai Clinical Trials Registry on December 2015 (https://www.clinicaltrials.in.th', '47']","['continuous locking suture with braided suture sufficient for arthrotomy repair', 'Introduction\n\n\nMedial-parapatellar-arthrotomy', 'QS, visual-analog-scale(VAS), modified-timed-up-and-go(TUGT) test, Western-Ontario-and McMasters-Universities-Osteoarthritis-Index[WOMAC']","['wound complications', 'QS, VAS, TUGT, WOMAC and KSS']","[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0185160', 'cui_str': 'Arthrotomy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}]",,0.098661,"There were insignificant difference in QS, VAS, TUGT, WOMAC and KSS during the 6-month follow-up period(p > 0.05 all).","[{'ForeName': 'Siwadol', 'Initials': 'S', 'LastName': 'Wongsak', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270, Rama VI Road, Thung Phaya Thai, Ratchathewi District, Bangkok, 10400, Thailand.'}, {'ForeName': 'Kulapat', 'Initials': 'K', 'LastName': 'Chulsomlee', 'Affiliation': 'Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 111 Suwannabhumi Canal Road, Bang Pla, Bang Phli District, Samut Prakan, 10540, Thailand.'}, {'ForeName': 'Chavarat', 'Initials': 'C', 'LastName': 'Jarungvittayakon', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270, Rama VI Road, Thung Phaya Thai, Ratchathewi District, Bangkok, 10400, Thailand.'}, {'ForeName': 'Suphaneewan', 'Initials': 'S', 'LastName': 'Jaovisidha', 'Affiliation': 'Department of Radiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270, Rama VI Road, Thung Phaya Thai, Ratchathewi District, Bangkok, 10400, Thailand.'}, {'ForeName': 'Paphon', 'Initials': 'P', 'LastName': 'Sa-Ngasoongsong', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270, Rama VI Road, Thung Phaya Thai, Ratchathewi District, Bangkok, 10400, Thailand.'}]",Journal of orthopaedics,['10.1016/j.jor.2021.02.011']
1625,33678916,Erratum: AD ERRATUM.,"[This corrects the article on p. 130 in vol. 89, PMID: 33093708.].",2021,"[This corrects the article on p. 130 in vol. 89, PMID: 33093708.].",[],[],[],[],[],[],,0.0215079,"[This corrects the article on p. 130 in vol. 89, PMID: 33093708.].",[],The Ulster medical journal,[]
1626,33678909,A Comprehensive Examination of Factors Impacting Collegiate Athletes' Utilization of Psychological Assessment and Intervention Services.,"Although collegiate athletes underutilize mental health programming, investigators have rarely examined factors that may influence their participation in such programs. The current study examined how structured interviews and demographic factors influence collegiate athletes to use psychological programming. Two-hundred and eighty-nine collegiate athletes were referred to the study. They were screened for mental health and randomly assigned to one of two semi-structured interviews based on experimental phase. Participants in Phase I received standard engagement (SE; N = 35) or SE+discussion of mental health (DMH; N = 44). Phase II participants received SE+DMH (N = 82) or SE+DMH + discussion of personal ambitions (DPA; N = 66). Phase III participants received SE+DMH+discussion about their culture of choice (DCC) (N = 25) or SE+DMH+discussion of sport culture (DSC) (N = 37). After receiving the respective interview participants were offered psychological assessment and intervention. Chi squared analyses revealed class standing, mental health symptom severity, referral type, and type of engagement interview influenced program commitment/utilization. Logistic regression analyses indicated SE+DMH+DPA and SE+DMH+DSC uniquely improved assessment attendance whereas referrals from the athletic department and coaches/teammates, participation in sport performance workshops, and senior status uniquely improved assessment and intervention attendance.",2021,"Logistic regression analyses indicated SE+DMH+DPA and SE+DMH+DSC uniquely improved assessment attendance whereas referrals from the athletic department and coaches/teammates, participation in sport performance workshops, and senior status uniquely improved assessment and intervention attendance.","['Participants in Phase', 'Two-hundred and eighty-nine collegiate athletes']","['SE+DMH+DPA and SE+DMH+DSC', 'SE+DMH+discussion about their culture of choice (DCC) (N = 25) or SE+DMH+discussion of sport culture (DSC', 'standard engagement (SE; N = 35) or SE+discussion of mental health', 'SE+DMH (N = 82) or SE+DMH + discussion of personal ambitions']","['class standing, mental health symptom severity, referral type, and type of engagement interview influenced program commitment/utilization']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",289.0,0.0136786,"Logistic regression analyses indicated SE+DMH+DPA and SE+DMH+DSC uniquely improved assessment attendance whereas referrals from the athletic department and coaches/teammates, participation in sport performance workshops, and senior status uniquely improved assessment and intervention attendance.","[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Donohue', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gavrilova', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Danlag', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Orthopedic Service Line, Novant Health, Charlotte, NC USA.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Kuhn', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Benning', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}]",Psychology in the schools,['10.1002/pits.22458']
1627,33678833,"The difference in sleep, depression, anxiety, and Internet addiction between Korean adolescents with different circadian preference.","Objectives


Compared to adults, adolescents tend to prefer evening times developmentally. The orientation toward evening times is associated with behavioral and emotional problems. Thus, this study examined the association of circadian preference with sleep-related variables, depression, anxiety, and Internet addiction in Korean adolescents.
Materials and Methods


Participants completed the questionnaires measuring sleep pattern, sleep problem, depression, anxiety, and Internet addiction.
Results


Among 765 students (age range: 13-17 years), 211 students ( N   male = 134) were allocated into morning types (MT) and 258 adolescents ( N   male = 147) were allocated into evening types (ET) based on scores of the Morningness-Eveningness Scale. Adolescents without circadian preference ( N  = 296) were defined as neither type (NT). ET, compared to MT and NT, woke up later in the weekend, showed delays in bedtimes, and spent shorter time sleeping. They also reported a higher level of daytime sleepiness, insomnia, and depression than NT. However, the group difference in wake time on school days was not significant, and adolescents showed mild insomnia regardless of their circadian preference. Although smartphone using time in the weekend was significantly different between groups, group difference in Internet addiction was significant only when gender was adjusted.
Conclusion


Circadian preference was associated with sleep patterns and sleep problems in Korean adolescents. ET showed significantly different sleep patterns compared to MT and NT. ET not only reported a higher level of daytime sleepiness and insomnia but also more depressive symptoms compared to NT. These findings suggest that the uniqueness of adolescence and environmental factors seemed to influence the association of circadian preference with mental problem.",2020,"Although smartphone using time in the weekend was significantly different between groups, group difference in Internet addiction was significant only when gender was adjusted.
","['765 students (age range: 13-17 years), 211 students ( N   male = 134) were allocated into morning types (MT) and 258 adolescents ( N   male = 147', 'Korean adolescents with different circadian preference', 'Korean adolescents', 'Adolescents without circadian preference ( N  = 296) were defined as neither type (NT']",[],"['depressive symptoms', 'delays in bedtimes, and spent shorter time sleeping', 'level of daytime sleepiness, insomnia, and depression than NT', 'sleep patterns and sleep problems', 'mild insomnia regardless of their circadian preference', 'questionnaires measuring sleep pattern, sleep problem, depression, anxiety, and Internet addiction', 'Internet addiction', 'daytime sleepiness and insomnia', 'wake time on school days', 'sleep, depression, anxiety, and Internet addiction']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",765.0,0.0482673,"Although smartphone using time in the weekend was significantly different between groups, group difference in Internet addiction was significant only when gender was adjusted.
","[{'ForeName': 'Jun-Soo', 'Initials': 'JS', 'LastName': 'Chung', 'Affiliation': ""Department of Psychiatry, The Catholic University of Korea St. Vincent's Hospital, Gyeonggi-do, Republic of Korea.""}, {'ForeName': 'Eunhye', 'Initials': 'E', 'LastName': 'Choi', 'Affiliation': ""Department of Psychiatry, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Ah Reum', 'Initials': 'AR', 'LastName': 'Lee', 'Affiliation': ""Department of Psychiatry, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Shin-Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': ""Department of Psychiatry, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Kina', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': ""Department of Psychiatry, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Bung-Nyun', 'Initials': 'BN', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Subin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Research Planning, National Center for Mental Health, Seoul, Republic of Korea.'}, {'ForeName': 'Kyu-In', 'Initials': 'KI', 'LastName': 'Jung', 'Affiliation': ""Department of Psychiatry, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Seung-Yup', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': ""Department of Psychiatry, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Min-Hyeon', 'Initials': 'MH', 'LastName': 'Park', 'Affiliation': ""Department of Psychiatry, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea.""}]",Indian journal of psychiatry,['10.4103/psychiatry.IndianJPsychiatry_254_19']
1628,33678782,"Improved Sleep Quality and Work Performance Among Shift Workers Consuming a ""Foods with Function Claims"" Containing Asparagus Extract.","The purpose of this study was to examine whether Foods with Function Claims (FFC) containing asparagus extract effectively improved sleep quality and work performance in shift workers. An intervention study with a before-and-after intervention design was conducted on nurses engaged in two-shift work at a hospital, ingesting a FFC containing asparagus extract. The evaluation period lasted at least two weeks, including three nights shifts during the period. Before and after ingestion, Pittsburgh Sleep Questionnaire Index (PSQI), Utrecht Work Engagement Scale (UWES), Sleep quality (VAS-rated), impaired work functioning, and psychiatric symptoms were evaluated. A diary record, wearing of an activity meter, and a Psychomotor vigilance test were also performed at baseline and after intervention. Data were analyzed by the paired t-test or the Wilcoxon rank sum test. Among 34 participants, 33 completed the study. The results of the primary outcome measures showed significant improvements in PSQI and Sleep Quality in the night of the day after a night shift (PSQI total score: base line 7.41/ post intervention 6.03: P < 0.001; sleep quality: base line 4.48/post intervention 6.00: P < 0.001). The results of the secondary outcome measures showed significant improvements in UWES and feeling of fatigue. There was also trend of improvement in sleep efficiency and the reaction time. There was no significant improvement in impaired work functioning. This study showed that regular consumption of an FFC containing asparagus extract could improve sleep quality, feeling of fatigue, and work engagement among shift workers. Some caution, however, is needed when interpreting the results because of the before-and-after intervention design without a control group.",2021,The results of the primary outcome measures showed significant improvements in PSQI and Sleep Quality in the night of the day after a night shift (PSQI total score: base line 7.41/ post intervention 6.03: P < 0.001; sleep quality: base line 4.48/post intervention 6.00: P < 0.001).,"['shift workers', '34 participants, 33 completed the study']","['FFC containing asparagus extract', 'Foods with Function Claims (FFC) containing asparagus extract']","['sleep efficiency and the reaction time', 'PSQI and Sleep Quality', 'A diary record, wearing of an activity meter, and a Psychomotor vigilance test', 'sleep quality', 'sleep quality, feeling of fatigue, and work engagement', 'Pittsburgh Sleep Questionnaire Index (PSQI), Utrecht Work Engagement Scale (UWES), Sleep quality (VAS-rated), impaired work functioning, and psychiatric symptoms', 'UWES and feeling of fatigue', 'Sleep Quality and Work Performance', 'impaired work functioning', 'night shift (PSQI total score', 'sleep quality and work performance']","[{'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0453110', 'cui_str': 'Asparagus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4505268', 'cui_str': 'Employee Engagement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.0405409,The results of the primary outcome measures showed significant improvements in PSQI and Sleep Quality in the night of the day after a night shift (PSQI total score: base line 7.41/ post intervention 6.03: P < 0.001; sleep quality: base line 4.48/post intervention 6.00: P < 0.001).,"[{'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Sakai', 'Affiliation': 'Department of Occupational Health Practice and Management, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Nagata', 'Affiliation': 'Department of Occupational Health Practice and Management, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Nagata', 'Affiliation': 'Department of Occupational Health Practice and Management, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Mori', 'Affiliation': 'Department of Occupational Health Practice and Management, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan.'}]",Journal of UOEH,['10.7888/juoeh.43.15']
1629,33678764,[Effect of an exercise program targeting knee pain on medical costs of elderly community-dwelling adults].,"Objectives　The aim of this study was to examine the effect of an exercise program targeting knee pain on longitudinal medical costs (MC) of elderly community-dwelling adults.Methods　A community-based health program using specific exercises for improving knee pain was held from January to February, 2015. Twenty-eight individuals participated in the program (intervention group) and seventy individuals were selected from the respondents of a health and lifestyle survey by matching age, sex, and baseline value of severity of knee pain as a control group. Twenty individuals from the intervention group and twenty-nine from the control group were included in the final analysis. The changes in MC from 2014 to 2018 were compared between the two groups using a linear mixed-effects model.Results　The effect of the program on MC, estimated as a change from the baseline in 2014, showed a reduction of -5.6×10 3  yen/person (95% CI: -39.2-28.0) for the entire four-year period after the intervention. However, this difference was not significant. The changes in MC each year after the intervention were 9.3×10 3  yen/person (95% CI: -39.6-58.3) in 2015, -2.0×10 3  yen/person (95% CI: -44.4-40.5) in 2016, -10.3×10 3  yen/person (95% CI: -42.5-21.9) in 2017, and 8.2×10 3  yen/person (95% CI: -39.1-55.4) in 2018.Conclusion　The exercise program did not show a clear benefit in reducing the MC of elderly community-dwellers during the four years after the intervention. Further research with longer study durations and larger sample populations would be necessary to determine the effect of such intervention programs on MC.",2021,"The changes in MC each year after the intervention were 9.3×10 3  yen/person (95% CI: -39.6-58.3) in 2015, -2.0×10 3  yen/person (95% CI: -44.4-40.5) in 2016, -10.3×10 3  yen/person (95% CI: -42.5-21.9) in 2017, and 8.2×10 3  yen/person (95% CI: -39.1-55.4) in 2018.Conclusion　The exercise program did not show a clear benefit in reducing the MC of elderly community-dwellers during the four years after the intervention.","['Twenty individuals from the intervention group and twenty-nine from the control group were included in the final analysis', 'elderly community-dwelling adults', 'Twenty-eight individuals participated in the program (intervention group) and seventy individuals were selected from the respondents of a health and lifestyle survey by matching age, sex, and baseline value of severity of knee pain as a control group']","['exercise program', 'specific exercises', 'exercise program targeting knee pain']","['medical costs', 'longitudinal medical costs (MC', 'knee pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]",28.0,0.0370395,"The changes in MC each year after the intervention were 9.3×10 3  yen/person (95% CI: -39.6-58.3) in 2015, -2.0×10 3  yen/person (95% CI: -44.4-40.5) in 2016, -10.3×10 3  yen/person (95% CI: -42.5-21.9) in 2017, and 8.2×10 3  yen/person (95% CI: -39.1-55.4) in 2018.Conclusion　The exercise program did not show a clear benefit in reducing the MC of elderly community-dwellers during the four years after the intervention.","[{'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Teikyo University Graduate School of Public Health.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Fukuda', 'Affiliation': 'Teikyo University Graduate School of Public Health.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Faculty of Health Sciences, University of Human Arts and Sciences.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Maruo', 'Affiliation': 'University of Tsukuba.'}, {'ForeName': 'Mutsumi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Faculty of Makuhari Human Care, Tohto University.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Nemoto', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Takeda', 'Affiliation': 'Kogakuin University.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Sawada', 'Affiliation': 'Faculty of Sport Sciences, Waseda University.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kitabatake', 'Affiliation': 'Department of Health Sciences, Saitama Prefectural University.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Arao', 'Affiliation': 'Physical Fitness Research Institute, Meiji Yasuda Life Foundation of Health and Welfare.'}]",[Nihon koshu eisei zasshi] Japanese journal of public health,['10.11236/jph.20-087']
1630,33678639,Comparison of septoplasty with three high - tension line resection and two high - tension line resection.,"OBJECTIVES


To compare the operation time, subjective and objective outcomes of septoplasty with three high-tension line resection and two high-tension line resection.
METHODS


A prospective randomized controlled study was conducted to identify patients with septal deviation and symptomatic nasal obstruction. The patients were classified into a three high-tension line resection and senior physician group (Group A), a two high-tension line resection and senior physician group (Group B), a three high-tension line resection and junior physician group (Group C), a two high-tension line resection and junior physician group (Group D). In addition, according to whether there were the anterior deviation, some of patients were also divided into a three high-tension line resection and anterior deviation group (Group E) and a two high-tension line resection and anterior deviation group (Group F). The operation time was recorded. The patients completed the Nasal Obstruction Symptom Evaluation (NOSE) Scale (subjective symptom), nasal endoscopy (bodily sign) and rhinomanometry (objective examination) before and 6 months after septoplasty. The operation time and the efficacy were compared between three high-tension line resection operation and two high-tension line resection operation.
RESULTS


There was no significant difference in the operation time between the Group A and the Group B ( t =0.724,  P =0.799), but the operation time in the Group D was significant shorter than that in the Group C ( t =4.200,  P =0.017). There were no significant difference in the NOSE scale between the Group A and the Group B, the Group C and the Group D, the Group E and the Group F ( t =0.481, -0.147, 1.369, all  P >0.05). There was no significant difference in the nasal endoscopy scale between the Group A and Group B, the Group C and Group D, the Group E and the Group F ( t =0.806, -0.111, -0.536, all  P >0.05). There was no significant difference in rhinomanometry between the Group A and the Group B, the Group C and the Group D, the Group E and the Group F ( t =0.472, 1.180, -0.225, all  P >0.05)．.
CONCLUSIONS


The effect of septoplasty with two high-tension line resection is as good as septoplasty with three high-tension line resection. The septoplasty with two high-tension line resection is more suitable to junior physician because it is easier and the operation time is shorter.",2021,"There was no significant difference in the operation time between the Group A and the Group B ( t =0.724,  P =0.799), but the operation time in the Group D was significant shorter than that in the Group C ( t =4.200,  P =0.017).",['patients with septal deviation and symptomatic nasal obstruction'],"['septoplasty with two high-tension line resection', 'septoplasty with three high - tension line resection and two high - tension line resection', 'tension line resection and anterior deviation group (Group E) and a two high-tension line resection and anterior deviation group', 'two high-tension line resection and senior physician group (Group B), a three high-tension line resection and junior physician group (Group C), a two high-tension line resection and junior physician group', 'septoplasty with three high-tension line resection and two high-tension line resection']","['rhinomanometry', 'Scale (subjective symptom), nasal endoscopy (bodily sign) and rhinomanometry (objective examination', 'operation time and the efficacy', 'operation time, subjective and objective outcomes', 'NOSE scale', 'operation time', 'nasal endoscopy scale', 'Nasal Obstruction Symptom Evaluation (NOSE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}]","[{'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0337035', 'cui_str': 'High tension line'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0524635', 'cui_str': 'Physicians, Junior'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0430615', 'cui_str': 'Rhinomanometry'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}]",,0.0111255,"There was no significant difference in the operation time between the Group A and the Group B ( t =0.724,  P =0.799), but the operation time in the Group D was significant shorter than that in the Group C ( t =4.200,  P =0.017).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, First Affiliated Hospital of Xiamen University; Xiamen Key Laboratory of Otolaryngology Head and Neck Surgery, Xiamen Fujian 361003, China. 147021642@qq.com.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, First Affiliated Hospital of Xiamen University; Xiamen Key Laboratory of Otolaryngology Head and Neck Surgery, Xiamen Fujian 361003, China. GJDZB@126.com.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2021.200237']
1631,33678624,Effect of micro-osteoperforations on external apical root resorption: A randomized controlled trial.,"Objective


This study aimed to investigate the effect of micro-osteoperforations (MOPs) on external apical root resorption (EARR) during the initial orthodontic alignment phase of maxillary anterior crowding.
Methods


Thirty patients (25 females, 5 males; mean age, 22.66 ± 3.27 years) who presented with moderate crowding of the upper labial segment and underwent extraction-based fixed appliance treatment were recruited. They were randomly allocated to receive adjunctive therapy with MOPs (n = 15) or treatment with fixed appliances only (control group; n = 15). EARR was measured from long-cone periapical radiographs taken at the start and the sixth month of treatment. A correction factor for the enlargement difference was used to calculate EARR. Data were analyzed with descriptive statistics and repeated-measures analysis of variance.
Results


The mean root lengths of 168 teeth were measured and showed no statistically significant difference ( p  > 0.05) after six months of fixed appliance treatment in the MOP (mean difference [MD] = 0.13 mm; 95% confidence interval [CI] = -0.10-0.35) and control group (MD = 0.14 mm; 95% CI = -0.10-0.37). Most of the roots in the MOP and control groups (42.86% and 52.38%, respectively) showed only mild resorption. Less than 8% of the roots in both groups (7.14% in the MOP group and 4.76% in the control group) showed moderate resorption.
Conclusions


Acceleration of orthodontic tooth movement with adjunctive MOPs therapy during the alignment phase does not exacerbate EARR in patients with moderate crowding of the upper labial segment in comparison with controls.",2021,The mean root lengths of 168 teeth were measured and showed no statistically significant difference ( p  > 0.05) after six months of fixed appliance treatment in the MOP (mean difference [MD] = 0.13 mm; 95% confidence interval [CI] =,"['patients with moderate crowding of the upper labial segment in comparison with controls', 'Methods\n\n\nThirty patients (25 females, 5 males; mean age, 22.66 ± 3.27 years) who presented with moderate crowding of the upper labial segment and underwent extraction-based fixed appliance treatment were recruited']","['micro-osteoperforations (MOPs', 'micro-osteoperforations', 'adjunctive MOPs therapy', 'adjunctive therapy with MOPs']","['EARR', 'moderate resorption', 'mild resorption', 'external apical root resorption', 'mean root lengths of 168 teeth', 'external apical root resorption (EARR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1290638', 'cui_str': 'Resorption of apex of tooth root'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]",168.0,0.0882455,The mean root lengths of 168 teeth were measured and showed no statistically significant difference ( p  > 0.05) after six months of fixed appliance treatment in the MOP (mean difference [MD] = 0.13 mm; 95% confidence interval [CI] =,"[{'ForeName': 'Azaitun Akma', 'Initials': 'AA', 'LastName': 'Shahrin', 'Affiliation': 'Centre of Paediatric Dentistry and Orthodontic Studies, Faculty of Dentistry, Universiti Teknologi MARA, Jalan Hospital, Sungai Buloh, Malaysia.'}, {'ForeName': 'Sarah Haniza Abdul', 'Initials': 'SHA', 'LastName': 'Ghani', 'Affiliation': 'Centre of Paediatric Dentistry and Orthodontic Studies, Faculty of Dentistry, Universiti Teknologi MARA, Jalan Hospital, Sungai Buloh, Malaysia.'}, {'ForeName': 'Noraina Hafizan', 'Initials': 'NH', 'LastName': 'Norman', 'Affiliation': 'Centre of Paediatric Dentistry and Orthodontic Studies, Faculty of Dentistry, Universiti Teknologi MARA, Jalan Hospital, Sungai Buloh, Malaysia.'}]",Korean journal of orthodontics,['10.4041/kjod.2021.51.2.86']
1632,33678596,"Acceptability of a patient decision aid for women aged 70 and older with stage I, estrogen receptor-positive, HER2-negative breast cancer.","OBJECTIVES


A comprehensive decision aid (DA) for women ≥70 years with Stage I ER+/HER2-negative breast cancer was developed to support locoregional and systemic treatment decision-making. We aimed to test the acceptability of this novel DA in women newly-diagnosed with breast cancer.
MATERIALS AND METHODS


Women ≥70 diagnosed with Stage I, ER+/HER2- breast cancer were recruited from three Boston-area hospitals. They underwent baseline interviews after initial surgical consultation, reviewed the DA, and were surveyed <2 weeks later to determine DA acceptability (e.g., was it helpful?), changes in decisional conflict, stage of decision-making, and knowledge. Participants could optionally complete a three-month follow-up. Paired t-tests and McNemar's tests were used for statistical comparisons, and thematic analyses were conducted to identify themes in participants' open-ended comments.
RESULTS


Thirty-three of 56 eligible patients approached completed the baseline and acceptability surveys, and 25 completed the three-month follow-up. Participants' mean age was 74.7 years (±3.8). Nearly all participants (n = 31, 94%) strongly agreed that the DA was helpful and felt that the DA prepared them for treatment decision-making, with a mean decision preparation score of 4.1 (out of 5.0); 6% (n = 2) found it very anxiety provoking. Knowledge improved with a mean of 9.0 out of 14 questions correct at baseline to 10.6 correct on the acceptability survey (p < 0.0001).
CONCLUSIONS


A DA tailored to women ≥70 with Stage I, ER+, HER2- breast cancer increased knowledge and was perceived to be helpful by older women. A randomized controlled trial is needed to evaluate its efficacy.",2021,"Knowledge improved with a mean of 9.0 out of 14 questions correct at baseline to 10.6 correct on the acceptability survey (p < 0.0001).
","['women ≥70\xa0years with Stage I ER+/HER2-negative breast cancer', 'Women ≥70 diagnosed with Stage I, ER+/HER2- breast cancer were recruited from three Boston-area hospitals', ""Participants' mean age was 74.7\xa0years (±3.8"", 'women aged 70 and older with stage I, estrogen receptor-positive, HER2-negative breast cancer', 'women newly-diagnosed with breast cancer', 'women ≥70 with Stage I', 'Thirty-three of 56 eligible patients']","['comprehensive decision aid (DA', 'novel DA']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0205314', 'cui_str': 'New'}]",[],,0.0756877,"Knowledge improved with a mean of 9.0 out of 14 questions correct at baseline to 10.6 correct on the acceptability survey (p < 0.0001).
","[{'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Minami', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karamourtopoulos', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Adlin', 'Initials': 'A', 'LastName': 'Pinheiro', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gilliam', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Gianna', 'Initials': 'G', 'LastName': 'Aliberti', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Pories', 'Affiliation': 'Mount Auburn Hospital, 300 Mount Auburn Street, Cambridge, MA, United States of America.'}, {'ForeName': 'Abram', 'Initials': 'A', 'LastName': 'Recht', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Lotz', 'Affiliation': 'Mount Auburn Hospital, 300 Mount Auburn Street, Cambridge, MA, United States of America.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Dominici', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Mara A', 'Initials': 'MA', 'LastName': 'Schonberg', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States of America. Electronic address: mschonbe@bidmc.harvard.edu.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2021.02.028']
1633,33678496,Animation or leaflet: Does it make a difference when educating young people about genome sequencing?,"OBJECTIVE


To compare the effectiveness of an animation against two leaflets with and without images, in educating young people about genome sequencing (GS).
METHODS


An experimental survey with three assessment points (pre- intervention [T1], post - intervention [T2], 6-week follow-up [T3]). Participants (N = 606) were randomly assigned to receive one of three educational interventions; animation (n = 212); leaflet with images (n = 197); or leaflet with text only (n = 197). Measures of objective and subjective knowledge were completed at T1 (N = 606), T2 (N = 606) and T3 (N = 459). Measures of attitudes, intentions and beliefs towards GS and satisfaction with intervention were completed at T2 only.
RESULTS


The type of educational intervention young people received had no significant impact on their objective or subjective knowledge at both T2 and T3 (all p > .05), nor did the educational intervention type affect their attitudes, intentions and beliefs towards GS at T2 (p > .05). However, participant satisfaction was significantly higher in the animation group than the leaflet groups (p < .001).
CONCLUSION


Animations and leaflets are both effective ways to deliver genomic education to young people, but the animations lead to higher satisfaction.
PRACTICE IMPLICATIONS


Different individuals may find different modes of educational resources more accessible than others. Therefore a range of resources should ideally be made available to patients.",2021,"However, participant satisfaction was significantly higher in the animation group than the leaflet groups (p < .001).
",['Participants (N = 606'],"['educational interventions; animation', 'Animation or leaflet']","['objective or subjective knowledge', 'participant satisfaction', 'attitudes, intentions and beliefs towards GS and satisfaction', 'educational intervention type affect their attitudes, intentions and beliefs towards GS', 'objective and subjective knowledge']",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376650', 'cui_str': 'Animation'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3875150', 'cui_str': 'Towards'}]",606.0,0.0621036,"However, participant satisfaction was significantly higher in the animation group than the leaflet groups (p < .001).
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hammond', 'Affiliation': 'North Thames Genomic Laboratory Hub, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK; Genetics and Genomic Medicine, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Garner', 'Affiliation': 'Aston Research Centre for Healthy Ageing, Aston University, Birmingham, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'North Thames Genomic Laboratory Hub, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK; Genetics and Genomic Medicine, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Patch', 'Affiliation': 'Genomics England, Queen Mary University of London, Dawson Hall, London, UK; Counselling, Society and Ethics Research, Wellcome Genome Campus, Hinxton, Cambridge, UK; Faculty of Health and Wellbeing, Sheffield Hallam University, Howard Street, Sheffield, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': 'Genetic Alliance UK, London, UK.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Searle', 'Affiliation': 'Unique - The Rare Chromosome Disorder Support Group, Oxted, UK.'}, {'ForeName': 'Saskia C', 'Initials': 'SC', 'LastName': 'Sanderson', 'Affiliation': 'Early Disease Detection Research Project UK (EDDRP UK), London, UK; Department of Behavioural Science and Health, University College London, London, UK; PHG Foundation, Cambridge, UK.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'North Thames Genomic Laboratory Hub, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK; Population, Policy and Practice, UCL Great Ormond Street Institute of Child Health, London, UK. Electronic address: celine.lewis@ucl.ac.uk.'}]",Patient education and counseling,['10.1016/j.pec.2021.02.048']
1634,33678469,"Aripiprazole vs Risperidone for the acute-phase treatment of first-episode psychosis: A 6-week randomized, flexible-dose, open-label clinical trial.","Selecting the first antipsychotic agent for the acute phase of a first episode of psychosis (FEP) is a critical task that may impact on the long-term outcome. Despite that, there is a lack of research comparing head-to-head different second-generation antipsychotics at this stage. The aim of this study was to compare the effectiveness of aripiprazole and risperidone in the treatment of the acute phase after a FEP. For that purpose, from February 2011 to October 2018, a prospective, randomized, open-label study was undertaken. Two hundred-sixty-six first-episode, drug-naïve patients were randomly assigned to aripiprazole (n = 136), or risperidone (n = 130) and followed-up for 6-weeks. The primary effectiveness measure was all-cause treatment discontinuation. In addition, an analysis based on intention-to-treat principle was conducted to assess clinical efficacy. The overall dropout rate at 6-week reached 19.5%. Effectiveness measures were similar between both treatment groups as treatment discontinuation rates (χ2 = 1.863; p = 0.172) and mean time until all-cause discontinuation (log rank = 1.421; p = 0.233) showed no statistically significant differences. In terms of clinical efficacy, risperidone proved a statistically significant better performance according to BPRS mean change between baseline and 6-week total score (t = 3.187; p = 0.002). Patients under risperidone treatment were significantly more likely to suffer sex-related adverse events. In conclusion, no differences regarding effectiveness were found between aripiprazole and risperidone for the acute-phase treatment of FEP. Despite the importance of efficacy during this phase of treatment, selecting the most effective treatment for the long-term outcome, requires addressing safety and patient´s preferences.",2021,Effectiveness measures were similar between both treatment groups as treatment discontinuation rates (χ2 = ,"['first-episode psychosis', 'Two hundred-sixty-six first-episode, drug-naïve patients']","['Aripiprazole vs Risperidone', 'risperidone', 'aripiprazole', 'aripiprazole and risperidone']","['suffer sex-related adverse events', 'overall dropout rate', 'Effectiveness measures', 'treatment discontinuation rates', 'mean time until all-cause discontinuation']","[{'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0439304,Effectiveness measures were similar between both treatment groups as treatment discontinuation rates (χ2 = ,"[{'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Gómez-Revuelta', 'Affiliation': 'University Hospital Marqués de Valdecilla-IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Avda. Valdecilla n 25, 39008, SANTANDER, Cantabria, Santander, Spain. Electronic address: marcos.gomezr@scsalud.es.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Pelayo-Terán', 'Affiliation': 'University Hospital Marqués de Valdecilla-IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Avda. Valdecilla n 25, 39008, SANTANDER, Cantabria, Santander, Spain; CIBERSAM, Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain; Servicio de Psiquiatría y Salud Mental, Hospital El Bierzo, GASBI, Servicio de Salud de Castilla y León (SACYL), Ponferrada (León), Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Vázquez-Bourgon', 'Affiliation': 'University Hospital Marqués de Valdecilla-IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Avda. Valdecilla n 25, 39008, SANTANDER, Cantabria, Santander, Spain; CIBERSAM, Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Ortiz-García de la Foz', 'Affiliation': 'University Hospital Marqués de Valdecilla-IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Avda. Valdecilla n 25, 39008, SANTANDER, Cantabria, Santander, Spain; CIBERSAM, Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain.'}, {'ForeName': 'Jacqueline Mayoral', 'Initials': 'JM', 'LastName': '-van Son', 'Affiliation': 'University Hospital Marqués de Valdecilla-IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Avda. Valdecilla n 25, 39008, SANTANDER, Cantabria, Santander, Spain; CIBERSAM, Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain; Hospital Universitario Virgen del Rocío, Department of Psychiatry, Universidad de Sevilla, Sevilla, Spain. Instituto de Investigacion Sanitaria de Sevilla, IBiS Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Ayesa-Arriola', 'Affiliation': 'University Hospital Marqués de Valdecilla-IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Avda. Valdecilla n 25, 39008, SANTANDER, Cantabria, Santander, Spain; CIBERSAM, Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain.'}, {'ForeName': 'Benedicto', 'Initials': 'B', 'LastName': 'Crespo-Facorro', 'Affiliation': 'University Hospital Marqués de Valdecilla-IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Avda. Valdecilla n 25, 39008, SANTANDER, Cantabria, Santander, Spain; CIBERSAM, Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain; Hospital Universitario Virgen del Rocío, Department of Psychiatry, Universidad de Sevilla, Sevilla, Spain. Instituto de Investigacion Sanitaria de Sevilla, IBiS Spain.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2021.02.009']
1635,33678437,Effect of short-term increase in occlusal vertical dimension on masticatory muscle electrical activities and pressure-to-pain threshold: A crossover clinical study.,"STATEMENT OF PROBLEM


Increasing the occlusal vertical dimension (OVD) is a common procedure in clinical practice. However, few studies have assessed the short-term influence of an increased OVD on the masticatory muscles.
PURPOSE


The purpose of this crossover clinical study was to investigate the effect of increased OVD on the electrical activity of masticatory muscles and the pressure-to-pain threshold (PPT) in asymptomatic participants.
MATERIAL AND METHODS


Twenty asymptomatic participants (22.7 ±2.39 years of age; 10 men, 10 women) were submitted to an increase in OVD by using interocclusal devices of different thicknesses (3- and 6-mm) for 24 hours. Masticatory muscle activity was assessed with electromyography (EMG), expressed in microvolts (μV), while the participants masticated 2 pieces of latex of different consistency (latex S and H) with and without the device. The PPT was measured with a digital algometer before and after the mastication. The results were assessed by using analysis of variance (ANOVA) and the Tukey honestly significant difference (HSD) test (α=.05).
RESULTS


The change of OVD did not significantly affect the electrical activity of the muscles. The latex of hard consistency (latex H) showed higher electrical activity values than the soft texture (latex S). For the working side anterior temporal muscle, a change in the PPT was detected on the day the 6-mm-device was inserted, but for the other muscles, device thickness and latex mastication did not change the PPT.
CONCLUSIONS


For a short time, an increase in occlusal vertical dimension did not affect the electrical activity in the masticatory muscles or pressure-to-pain threshold in asymptomatic participants.",2021,"For a short time, an increase in occlusal vertical dimension did not affect the electrical activity in the masticatory muscles or pressure-to-pain threshold in asymptomatic participants.","['asymptomatic participants', 'Twenty asymptomatic participants (22.7 ±2.39 years of age; 10 men, 10 women']",[],"['electrical activity', 'occlusal vertical dimension', 'electrical activity values', 'electromyography (EMG), expressed in microvolts (μV', 'Masticatory muscle activity', 'change of OVD']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0376394', 'cui_str': 'Occlusal vertical dimension'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1961129', 'cui_str': 'Microvolt'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.0604511,"For a short time, an increase in occlusal vertical dimension did not affect the electrical activity in the masticatory muscles or pressure-to-pain threshold in asymptomatic participants.","[{'ForeName': 'Adriana Barbosa', 'Initials': 'AB', 'LastName': 'Ribeiro', 'Affiliation': 'Collaborator Professor, Department of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, Brazil. Electronic address: driribeiro@usp.br.'}, {'ForeName': 'Murillo Sucena', 'Initials': 'MS', 'LastName': 'Pita', 'Affiliation': 'Post-doctoral Research Fellow, Department of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Aline Barbosa', 'Initials': 'AB', 'LastName': 'Ribeiro', 'Affiliation': 'Post-doctoral Research Fellow, Department of Physiology, Ribeirão Preto Medical School, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Alício Rosalino', 'Initials': 'AR', 'LastName': 'Garcia', 'Affiliation': 'Associate Professor, Department of Dental Materials and Prosthodontics, School of Dentistry of Araçatuba, São Paulo State University - UNESP, Araçatuba, SP, Brazil.'}, {'ForeName': 'Paulo Renato', 'Initials': 'PR', 'LastName': 'Junqueira Zuim', 'Affiliation': 'Associate Professor, Department of Dental Materials and Prosthodontics, School of Dentistry of Araçatuba, São Paulo State University - UNESP, Araçatuba, SP, Brazil.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2021.01.023']
1636,33678400,Impact of the Brush Day & Night Programme on Oral Health Knowledge and Behaviour in Children.,"OBJECTIVES


School-based interventions can establish positive behaviours that reduce the likelihood of oral diseases later in life. The Brush Day & Night (BDN) programme is a 21-day school-based educational programme to promote good oral health behaviours. This study aims to evaluate the effect of the BDN programme on oral health knowledge and behaviour outcomes in children after the intervention as compared to a control group over 24 weeks.
METHODS


This was a superiority cluster randomised trial of children aged 6-12 years from Indonesia (N = 2021) and Nigeria (N = 750). All children were provided with toothpaste and a toothbrush, and the intervention groups (N = 1107 and 439, respectively) received the 21-day BDN programme. Children were followed up at Weeks 3, 8, and 24 after the programme start date and completed a questionnaire addressing the objectives at all timepoints. Improvement in oral health knowledge and behaviour was calculated based on the percentage of positive change in answers and analysed based on a conditional logistic approach for each evaluation timepoint, compared with control, with a 95% CI.
RESULTS


After 24 weeks, Indonesian children following the BDN programme presented with a 30% and 60% additional probability, respectively, of adequate timing of toothbrushing and of being aware of the importance of adequate toothbrushing frequency compared with control. In Nigeria, after 24 weeks, children following the BDN programme had a 92% and 73% higher probability of adequate toothbrushing frequency and of using fluoride toothpaste, respectively, compared with control.
CONCLUSIONS


The BDN programme is effective at improving children's knowledge and behaviour compared with a control population.",2021,"In Nigeria, after 24 weeks, children following the BDN programme had a 92% and 73% higher probability of adequate toothbrushing frequency and of using fluoride toothpaste, respectively, compared with control.
","['children after the intervention as compared to a control group over 24 weeks', 'children aged 6-12 years from Indonesia (N\u202f=\u202f2021) and Nigeria (N\u202f=\u202f750', 'Children']","['Brush Day & Night Programme', 'BDN programme', '21-day BDN programme']","['Oral Health Knowledge and Behaviour', 'probability of adequate toothbrushing frequency', 'oral health knowledge and behaviour', 'oral health knowledge and behaviour outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C4517868', 'cui_str': '750'}]","[{'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0711146,"In Nigeria, after 24 weeks, children following the BDN programme had a 92% and 73% higher probability of adequate toothbrushing frequency and of using fluoride toothpaste, respectively, compared with control.
","[{'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Melo', 'Affiliation': 'Faculty of Dentistry, Institute of Public Health, EpiUnit, University of Porto, Porto, Portugal. Electronic address: paulomelopt@gmail.com.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Fine', 'Affiliation': 'FDI World Dental Federation, Geneva, Switzerland.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Unilever Oral Care, Bebington, Wirral, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'FDI World Dental Federation, Geneva, Switzerland.'}]",International dental journal,['10.1016/j.identj.2021.01.014']
1637,33678399,"Impact of the Brush Day & Night Programme on Well-Being, Plaque, and Dental Caries in Children.","OBJECTIVES


Poor oral hygiene can have an adverse effect on quality of life. School-based interventions can establish positive behaviours that reduce the likelihood of dental caries later in life. The Brush Day & Night programme aims to encourage good oral health behaviour and improve oral health and quality-of-life outcomes. In this article, we report the effect of the programme on well-being and oral hygiene measured by plaque levels at 3, 8, and 24 weeks and dental caries at 24 weeks after programme start date.
METHODS


This was a superiority cluster randomised trial of children 6-12 years of age from Indonesia (N = 2021) and Nigeria (N = 2104). All children were provided with toothpaste and a toothbrush. Children in the intervention group received the 21-day Brush Day & Night programme, whereas those in the control group did not. Children completed a questionnaire addressing the objectives at all time points. Their oral hygiene was assessed using the Oral Hygiene Index-Simplified (OHI-S). Additionally, at baseline and 24 weeks their caries status was recorded using the decayed, missing, and filled teeth (DMFT) index.
RESULTS


In Indonesia, after participation in the programme children demonstrated a 45% increased probability of no worsening in the occurrence of decayed, missing, or filled teeth. In Nigeria, children had a 71% higher probability of having confidence in their smile and the proportion of children with good oral hygiene doubled from 40% to 80% at 24 weeks.
CONCLUSIONS


The Brush Day & Night programme was successful in improving well-being and oral hygiene in children in Nigeria and reduced the likelihood of worsening in the occurrence of decayed, missing, or filled teeth in children in Indonesia.",2021,"In Indonesia, after participation in the programme children demonstrated a 45% increased probability of no worsening in the occurrence of decayed, missing, or filled teeth.","['children 6-12 years of age from Indonesia (N\u202f=\u202f2021) and Nigeria (N\u202f=\u202f2104', 'Children']",['toothpaste and a toothbrush'],"['probability of no worsening in the occurrence of decayed, missing, or filled teeth', 'oral health and quality-of-life outcomes', 'good oral hygiene', 'Well-Being, Plaque, and Dental Caries', 'quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0399066', 'cui_str': 'Insertion of malleable restoration into tooth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0457639', 'cui_str': 'Good oral hygiene'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",,0.0523013,"In Indonesia, after participation in the programme children demonstrated a 45% increased probability of no worsening in the occurrence of decayed, missing, or filled teeth.","[{'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Melo', 'Affiliation': 'Faculty of Dentistry, Institute of Public Health, EpiUnit, University of Porto, Porto, Portugal.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Fine', 'Affiliation': 'FDI World Dental Federation, Geneva, Switzerland.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Unilever Oral Care, Bebington, Wirral, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'FDI World Dental Federation, Geneva, Switzerland.'}]",International dental journal,['10.1016/j.identj.2021.01.018']
1638,33678253,Association of frequent moisturizer use in early infancy with the development of food allergy.,"BACKGROUND


Food allergy is thought to develop through transcutaneous sensitization, especially in the presence of skin barrier impairment and inflammation. Regular moisturizer application to infant skin could potentially promote transcutaneous sensitization and the development of food allergy.
OBJECTIVES


We tested this hypothesis in the Enquiring About Tolerance (EAT) study population.
METHODS


The EAT study was a population-based randomized clinical trial conducted from January 15, 2008, to August 31, 2015, and recruited 1303 exclusively breastfed 3-month-old infants and their families from England and Wales. At enrollment at 3 months, families completed a questionnaire that included questions about frequency and type of moisturizer applied, use of corticosteroid creams, and parental report of dry skin or eczema. Infants were examined for visible eczema at the enrollment visit.
RESULTS


A statistically significant dose-response relationship was observed between parent-reported moisturization frequency at 3 months of age and the subsequent development of food allergy. Each additional moisturization per week was associated with an adjusted odds ratio of 1.20 (95% CI, 1.13-1.27; P < .0005) for developing food allergy. For infants with no visible eczema at the enrollment visit, the corresponding adjusted odds ratio was 1.18 (95% CI, 1.07-1.30; P = .001) and for those with eczema at the enrollment visit, 1.20 (95% CI, 1.11-1.31; P < .0005). Moisturizer frequency showed similar dose-response relationships with the development of both food and aeroallergen sensitization at 36 months.
CONCLUSIONS


These findings support the notion that regular application of moisturizers to the skin of young infants may promote the development of food allergy through transcutaneous sensitization.",2021,"Moisturizer frequency showed similar dose-response relationships with the development of both food and aeroallergen sensitization at 36 months.
","['The EAT study was a population-based randomized clinical trial conducted from January 15, 2008, to August 31, 2015, and recruited 1303 exclusively breastfed 3-month-old infants and their families from England and Wales']",[],"['visible eczema', 'moisturization frequency']","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]",[],"[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.0512239,"Moisturizer frequency showed similar dose-response relationships with the development of both food and aeroallergen sensitization at 36 months.
","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom. Electronic address: m.perkin@sgul.ac.uk.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Logan', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Radulovic', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Craven', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Boyle', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, United Kingdom.'}, {'ForeName': 'Hywel C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, United Kingdom.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Versteeg', 'Affiliation': 'Department of Experimental Immunology, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Ree', 'Affiliation': 'Department of Experimental Immunology, Academic Medical Center, Amsterdam, The Netherlands; Department of Otorhinolaryngology, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Lack', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, School of Basic and Medical Biosciences, Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.10.044']
1639,33678218,Do nutritional warnings work on food ordering websites? An exploratory experimental study.,"OBJECTIVE


To evaluate if the inclusion of nutritional warnings in food ordering websites can discourage consumers from purchasing foods with excessive content of nutrients associated with non-communicable diseases (NCDs).
DESIGN


Participants were randomly assigned to one of the two experimental conditions: control (n=225), or nutritional warnings (n=222). Nutritional warnings corresponded to separate black octagonal signs containing the word ""Excess"" followed by the corresponding nutrient: total fat, saturated fat, sugars and sodium. Participants were asked to purchase a lunch for themselves using a simulated food ordering website.
SETTING


Online study in Uruguay.
PARTICIPANTS


Convenience sample of 447 Uruguayan participants, recruited using social media.
RESULTS


In the control condition, 76% of the participants selected a dish or a beverage with excessive content of at least one nutrient in the simulated food ordering website. When nutritional warnings were included, this percentage significantly decreased to 62% (p=0.002). In addition, nutritional warnings caused a significant reduction in the percentage of participants who selected dishes with excessive content of total fat: 50% vs. 62% (p=0.012).
CONCLUSIONS


Results from the present work provide preliminary evidence that the inclusion of nutritional warnings in food ordering websites could discourage consumers from selecting dishes and beverages with excessive content of nutrients associated with NCDs.",2021,"When nutritional warnings were included, this percentage significantly decreased to 62% (p=0.002).","['Convenience sample of 447 Uruguayan participants, recruited using social media', 'Participants were randomly assigned to one of the two experimental conditions: control (n=225), or nutritional warnings (n=222', 'Online study in Uruguay']",[],[],"[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042113', 'cui_str': 'Uruguay'}]",[],[],447.0,0.0195102,"When nutritional warnings were included, this percentage significantly decreased to 62% (p=0.002).","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Gugliucci', 'Affiliation': 'Espacio Interdisciplinario, Universidad de la República. José Enrique Rodó 1843. CP 11200. Montevideo, Uruguay.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Machín', 'Affiliation': 'Centro de Investigación Básica en Psicología, Facultad de Psicología, Universidad de la República. Tristán Narvaja 1674. C.P. 11200. Montevideo, Uruguay.'}, {'ForeName': 'María Rosa', 'Initials': 'MR', 'LastName': 'Curutchet', 'Affiliation': 'Instituto Nacional de Alimentacion, Piedras 165, C.P. 11000Montevideo, Uruguay.'}, {'ForeName': 'Gastón', 'Initials': 'G', 'LastName': 'Ares', 'Affiliation': 'Centro de Investigación Básica en Psicología, Facultad de Psicología, Universidad de la República. Tristán Narvaja 1674. C.P. 11200. Montevideo, Uruguay.'}]",Public health nutrition,['10.1017/S1368980021001026']
1640,33678201,Oral nutritional supplement use is weakly associated with increased subjective health-related quality of life in malnourished older adults: a multicentre randomised controlled trial.,"Malnutrition is common among older adults in health-care settings and is associated with decreased quality of life (QoL). This study aimed to investigate the effect on health-related QoL (HRQoL) among older adults after 6 months of treatment with individual dietary advice (DA) and/or oral nutritional supplements (ONS), utilizing 409 patients included in a multicentre randomised controlled trial of patients ≥65 years old, stratified according to nutrition status (malnourished/at risk of malnutrition), admitted to hospital in Sweden 2010-2014. Patients were randomised into four arms: DA, ONS, DA + ONS, or routine care (control). The intervention started at discharge from hospital, with HRQoL measured using EQ-5D-3L and EQ-VAS at baseline and at 6-month, 1-year, and 3-year follow-ups. Data were analysed using the Kruskal-Wallis test and multiple linear regression. Overall, HRQoL increased from baseline to follow-ups, although the magnitude of change in EQ-5D-3L did not differ significantly between the four arms in any of the nutrition groups. However, a significant difference was observed for change in EQ-VAS from baseline to 6-month follow-up in the malnourished group, with mean changes of 22·4 and -3·4 points for the ONS and control groups, respectively (P = 0·009). In the multiple linear regression analyses, participants in the ONS arm had 27·5, 34·4, and 38·8 points larger increases in EQ-VAS from baseline to the 6-month (P = 0·011), 1-year (P = 0·007), and 3-year (P = 0·032), respectively, follow-ups than the control group. The use of ONS improved subjectively assessed HRQoL in these malnourished older adults.",2021,"Overall, HRQoL increased from baseline to follow-ups, although the magnitude of change in EQ-5D-3L did not differ significantly between the four arms in any of the nutrition groups.","['patients ≥65 years old, stratified according to nutrition status (malnourished/at risk of malnutrition), admitted to hospital in Sweden 2010-2014', 'older adults after 6 months of treatment with', 'older adults in health-care settings', 'malnourished older adults']","['DA, ONS, DA + ONS, or routine care (control', 'health-related QoL (HRQoL', 'ONS', 'individual dietary advice (DA) and/or oral nutritional supplements (ONS']","['change in EQ-VAS', 'Overall, HRQoL', 'EQ-VAS', 'subjective health-related quality of life', 'magnitude of change in EQ-5D-3L', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0449286', 'cui_str': 'Degree'}]",409.0,0.0826157,"Overall, HRQoL increased from baseline to follow-ups, although the magnitude of change in EQ-5D-3L did not differ significantly between the four arms in any of the nutrition groups.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Söderström', 'Affiliation': 'Centre for Clinical Research Västerås, Region Västmanland, Uppsala University, Västerås, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bergkvist', 'Affiliation': 'Centre for Clinical Research Västerås, Region Västmanland, Uppsala University, Västerås, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenblad', 'Affiliation': 'Department of Medical Sciences, Division of Clinical Diabetology and Metabolism, Uppsala University, Uppsala, Sweden.'}]",The British journal of nutrition,['10.1017/S0007114521000805']
1641,33678179,No difference in effects of 'PACE steps to success' palliative care program for nursing home residents with and without dementia: a pre-planned subgroup analysis of the seven-country PACE trial.,"BACKGROUND


'PACE Steps to Success' is a multicomponent training program aiming to integrate generalist and non-disease-specific palliative care in nursing homes. This program did not improve residents' comfort in the last week of life, but it appeared to improve quality of care and dying in their last month of life. Because this program included only three dementia-specific elements, its effects might differ depending on the presence or stage of dementia. We aimed to investigate whether the program effects differ between residents with advanced, non-advanced, and no dementia.
METHODS


Pre-planned subgroup analysis of the PACE cluster-randomized controlled trial in 78 nursing homes in seven European countries. Participants included residents who died in the previous 4 months. The nursing home staff or general practitioner assessed the presence of dementia; severity was determined using two highly-discriminatory staff-reported instruments. Using after-death questionnaires, staff assessed comfort in the last week of life (Comfort Assessment in Dying-End-of-Life in Dementia-scale; primary outcome) and quality of care and dying in the last month of life (Quality of Dying in Long-Term Care scale; secondary outcome).
RESULTS


At baseline, we included 177 residents with advanced dementia, 126 with non-advanced dementia and 156 without dementia. Post-intervention, respectively in the control and the intervention group, we included 136 and 104 residents with advanced dementia, 167 and 110 with non-advanced dementia and 157 and 137 without dementia. We found no subgroup differences on comfort in the last week of life, comparing advanced versus without dementia (baseline-adjusted mean sub-group difference 2.1; p-value = 0.177), non-advanced versus without dementia (2.7; p = 0.092), and advanced versus non-advanced dementia (- 0.6; p = 0.698); or on quality of care and dying in the last month of life, comparing advanced and without dementia (- 0.6; p = 0.741), non-advanced and without dementia (- 1.5; p = 0.428), and advanced and non-advanced dementia (0.9; p = 0.632).
CONCLUSIONS


The lack of subgroup difference suggests that while the program did not improve comfort in dying residents with or without dementia, it appeared to equally improve quality of care and dying in the last month of life for residents with dementia (regardless of the stage) and those without dementia. A generalist and non-disease-specific palliative care program, such as PACE Steps to Success, is a useful starting point for future palliative care improvement in nursing homes, but to effectively improve residents' comfort, this program needs further development.
TRIAL REGISTRATION


ISRCTN, ISRCTN14741671 . Registered 8 July 2015 - Retrospectively registered.",2021,"This program did not improve residents' comfort in the last week of life, but it appeared to improve quality of care and dying in their last month of life.","['Participants included residents who died in the previous 4 months', 'nursing home residents with and without dementia', '\u20090.6; p\xa0=\u20090.741), non-advanced and without dementia (-\u20091.5; p\xa0=\u20090.428), and advanced and non-advanced dementia (0.9; p\xa0=\u20090.632', '136 and 104 residents with advanced dementia, 167 and 110 with non-advanced dementia and 157 and 137 without dementia', '177 residents with advanced dementia, 126 with non-advanced dementia and 156 without dementia', 'residents with advanced, non-advanced', '78 nursing homes in seven European countries']",[],"['quality of care and dying in the last month of life (Quality of Dying in Long-Term Care scale; secondary outcome', 'quality of care and dying in the last month of life, comparing advanced and without dementia', 'quality of care and dying']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454713', 'cui_str': 'European country'}]",[],"[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]",177.0,0.07727,"This program did not improve residents' comfort in the last week of life, but it appeared to improve quality of care and dying in their last month of life.","[{'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'Vrije Universiteit Brussel & Ghent University, End-of-Life Care Research Group, Laarbeeklaan 103, 1090, Brussels, Belgium. rose.miranda@vub.be.'}, {'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Smets', 'Affiliation': 'Vrije Universiteit Brussel & Ghent University, End-of-Life Care Research Group, Laarbeeklaan 103, 1090, Brussels, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Van Den Noortgate', 'Affiliation': 'Department of Geriatric Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jenny T', 'Initials': 'JT', 'LastName': 'van der Steen', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'Vrije Universiteit Brussel & Ghent University, End-of-Life Care Research Group, Laarbeeklaan 103, 1090, Brussels, Belgium.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Payne', 'Affiliation': 'International Observatory on End-of-Life Care, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Szczerbińska', 'Affiliation': 'Laboratory for Research on Aging Society, Department of Sociology of Medicine, Epidemiology and Preventive Medicine Chair, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pautex', 'Affiliation': 'Hôpitaux Universitaires de Genève, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Van Humbeeck', 'Affiliation': 'Department of Geriatric Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambassi', 'Affiliation': 'Department of Internal Medicine, Istituto di Medicina Interna e Geriatria, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kylänen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Van den Block', 'Affiliation': 'Vrije Universiteit Brussel & Ghent University, End-of-Life Care Research Group, Laarbeeklaan 103, 1090, Brussels, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC palliative care,['10.1186/s12904-021-00734-1']
1642,33678132,Evaluating telehealth delivery of a compensatory memory rehabilitation programme following stroke: A single-case experimental design.,"Rehabilitation of memory remains an unmet need for many stroke survivors. Telehealth methods may provide a solution, however evidence supporting the efficacy of remotely-delivered therapy is needed. A non-concurrent multiple baseline design was used with randomized onset of intervention across five individuals with chronic stroke-related memory complaints. A six-week compensatory memory skills programme was delivered individually via internet videoconferencing. Target behaviours of frequencies of self-reported lapses of everyday and prospective memory were measured weekly across baseline, intervention, and follow-up phases. A secondary outcome of functional goal attainment was measured once per phase, with participants setting two personal rehabilitation goals. Data were analysed visually and statistically. Improvements in memory functioning were statistically significant on at least one measure of target behaviour for four out of five participants at intervention or follow-up. Visual evidence of level change indicated at least modest improvements for all participants by follow-up. All participants attained at least one functional goal by follow-up. High rates of treatment adherence and participant satisfaction were observed. Technological issues were minimal and did not impact content delivery or engagement. These results provide preliminary support for the efficacy of a telehealth-delivered rehabilitation programme in improving memory function and achieving memory-related goals for stroke survivors.",2021,Improvements in memory functioning were statistically significant on at least one measure of target behaviour for four out of five participants at intervention or follow-up.,"['stroke', 'five individuals with chronic stroke-related memory complaints']",['compensatory memory rehabilitation programme'],"['memory functioning', 'functional goal attainment', 'High rates of treatment adherence and participant satisfaction']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",5.0,0.0990222,Improvements in memory functioning were statistically significant on at least one measure of target behaviour for four out of five participants at intervention or follow-up.,"[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Lawson', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Renerus J', 'Initials': 'RJ', 'LastName': 'Stolwyk', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Jennie L', 'Initials': 'JL', 'LastName': 'Ponsford', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2020.1843500']
1643,33686973,Effect of proning in patients with COVID-19 acute hypoxemic respiratory failure receiving noninvasive oxygen therapy.,"Background


Novel coronavirus (SARS-CoV-2) infection is associated with hypoxemic respiratory failure. Mechanical ventilation (MV) is reported to have high mortality in SARS-CoV-2 acute respiratory distress syndrome. We aimed to investigate whether awake prone positioning (PP) can improve oxygenation and prevent intubation when employed early.
Methods


This prospective interventional study included proven coronavirus disease 2019 (COVID-19) patients with room air saturation 93% or less. The primary outcome was the rate of intubation between the two groups. The secondary outcomes included ROX index (SpO 2 /FiO 2 %/respiratory rate, breaths/min) at 30 min following the intervention, ROX index at 12 h, time to recovery of hypoxemia, and mortality.
Results


A total of 45 subjects were included (30 cases and 15 controls) with a mean (standard deviation [SD]) age of 53.1 (11.0) years. The age, comorbidities, and baseline ROX index were similar between the two groups. The median duration of PP achieved was 7.5 h on the 1 st  day. The need for MV was higher in the control group (5/15; 33.3%) versus prone group (2/30; 6.7%). At 30 min, there was a statistically significant improvement in the mean (SD) ROX index of cases compared with that of the controls (10.7 [3.8] vs. 6.7 [2.6], P < 0.001). No significant adverse effects related to intervention were noted.
Conclusion


Awake PP is associated with significant improvement in oxygenation and may reduce the need for MV in subjects with COVID-19.",2021,The need for MV was higher in the control group (5/15; 33.3%) versus prone group (2/30; 6.7%).,"['subjects with COVID-19', 'A total of 45 subjects were included (30 cases and 15 controls) with a mean (standard deviation [SD]) age of 53.1 (11.0) years', 'patients with COVID-19 acute hypoxemic respiratory failure receiving noninvasive oxygen therapy', 'proven coronavirus disease 2019 (COVID-19) patients with room air saturation 93% or less']","['awake prone positioning (PP', 'Mechanical ventilation (MV']","['age, comorbidities, and baseline ROX index', 'ROX index at 12 h, time to recovery of hypoxemia, and mortality', 'ROX index (SpO 2 /FiO 2 %/respiratory rate, breaths/min', 'median duration of PP', 'need for MV', 'mean (SD) ROX index', 'rate of intubation']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}]","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",45.0,0.192515,The need for MV was higher in the control group (5/15; 33.3%) versus prone group (2/30; 6.7%).,"[{'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Sryma', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Madan', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Tiwari', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Trikha', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Dosi', 'Affiliation': 'Department of Pulmonary Medicine, Motherhood Hospital, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Bhopale', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Renjith', 'Initials': 'R', 'LastName': 'Viswanath', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Hadda', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Bhvya', 'Initials': 'B', 'LastName': 'Baldwa', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.'}]",Lung India : official organ of Indian Chest Society,['10.4103/lungindia.lungindia_794_20']
1644,33686922,Mitigating the negative effects of retrieval stress on memory: an arousal reappraisal intervention.,"In a preregistered experiment, we examined the efficacy of arousal reappraisal as an intervention for reducing the negative effects of stress at retrieval on memory. Participants ( N  = 177) were semi-randomly assigned to one of three conditions: a Stress-intervention condition, a Stress-placebo condition, and a No-stress-placebo control condition. Participants viewed four images of complex, mildly negatively valenced scenes. One day later, they received an arousal reappraisal intervention or placebo before exposure to a laboratory stressor (or a control version for the No-stress condition). Participants were then tested on their memory of the images using a free recall instruction and multiple-choice recognition questions. As expected, negative affect and blood pressure increased for the stress conditions but not the control condition. Contrary to our hypotheses, memory performance did not statistically significant differ between the Stress-placebo condition and the No-stress-placebo control condition, indicating a lack of negative effects of acute retrieval stress on memory. Furthermore, we also found no statistically significant differences between the Stress-intervention condition and Stress-placebo condition in terms of memory performance, suggesting that the intervention did not assist with enhancing memory. We integrate interpretations of the findings from this study with a discussion of avenues for future research in this area.",2021,"Contrary to our hypotheses, memory performance did not statistically significant differ between the Stress-placebo condition and the No-stress-placebo control condition, indicating a lack of negative effects of acute retrieval stress on memory.",['Participants ( N \u2009=\u2009177'],"['Stress-intervention condition, a Stress-placebo condition, and a No-stress-placebo control condition', 'arousal reappraisal intervention or placebo']",['blood pressure'],[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",177.0,0.0531176,"Contrary to our hypotheses, memory performance did not statistically significant differ between the Stress-placebo condition and the No-stress-placebo control condition, indicating a lack of negative effects of acute retrieval stress on memory.","[{'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Marr', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Sauerland', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Otgaar', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Conny W E M', 'Initials': 'CWEM', 'LastName': 'Quaedflieg', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Hope', 'Affiliation': 'Department of Psychology, University of Portsmouth, Portsmouth, UK.'}]","Memory (Hove, England)",['10.1080/09658211.2021.1893750']
1645,33686901,"Associations of Age, Gender, and Family Income with Quality of Life in Children With Advanced Cancer.","Background : Children with cancer often experience decreased quality of life (QOL) throughout the illness trajectory. The purpose of this study was to explore the associations of demographic characteristics with QOL in children with advanced cancer.  Methods:  This secondary analysis was part of a larger randomized clinical trial that evaluated the efficacy of a legacy intervention for children (7-17 years) with relapsed/refractory cancer and their primary parent caregivers. Assessments included child self-reports on the Pediatric Quality of Life Inventory (PedsQL) Cancer Module. Researchers used descriptive and linear regression statistical methods.  Results:  Children ( n  = 128) averaged 10.9 years (SD = 3.0). The majority were female ( n  = 68, 53%), white ( n  = 107, 84%), had a hematologic malignancy ( n  = 67, 52%), with family incomes of $50,000 or less ( n  = 81, 63.3%). Statistically significant positive associations of both age and income level with PedsQL scores were observed ( p  < .05) but not gender ( p  > .05). The strongest correlations for age were with the procedural anxiety ( beta  = 0.42), treatment anxiety ( beta  = 0.26), and total ( beta  = 0.28) scores (all  p  < .01). In general, there was a positive correlation between family income levels and PedsQL scores ( p  < .05). The strongest correlations for income were with nausea ( R  = 0.49), appearance ( R  = 0.44), pain, and treatment anxiety (both  R  = 0.42) (all  p  < .01). Associations adjusted for age remained essentially the same (all  p  < .01).  Discussion:  Children with advanced cancer with lower family income and younger age are at high risk for poorer QOL. Oncology nurses should seek to identify families who may benefit from additional resources to promote QOL.",2021,"In general, there was a positive correlation between family income levels and PedsQL scores ( p  < .05).","['The majority were female ( n \u2009=\u200968, 53%), white ( n \u2009=\u2009107, 84%), had a hematologic malignancy ( n \u2009=\u200967, 52%), with family incomes of $50,000 or less ( n \u2009=\u200981, 63.3', 'children (7-17 years) with relapsed/refractory cancer and their primary parent caregivers', 'Results:  Children ( n \u2009=\u2009128', 'children with advanced cancer', 'Children with cancer', 'Children with advanced cancer with lower family income and younger age', 'Children With Advanced Cancer']","['legacy intervention', ' ']","['pain, and treatment anxiety', 'procedural anxiety', 'nausea', 'child self-reports on the Pediatric Quality of Life Inventory (PedsQL) Cancer Module', 'PedsQL scores', 'quality of life (QOL', 'treatment anxiety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0242538', 'cui_str': 'Inheritance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0534424,"In general, there was a positive correlation between family income levels and PedsQL scores ( p  < .05).","[{'ForeName': 'Piera C', 'Initials': 'PC', 'LastName': 'Robson', 'Affiliation': '16194Vanderbilt University School of Nursing, Nashville, TN, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': '16194Vanderbilt University School of Nursing, Nashville, TN, USA.'}, {'ForeName': 'Terrah Foster', 'Initials': 'TF', 'LastName': 'Akard', 'Affiliation': '16194Vanderbilt University School of Nursing, Nashville, TN, USA.'}]",Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses,['10.1177/1043454221992321']
1646,33686887,Comparative Study Between Silver Nanoparticles Dressing (SilvrSTAT Gel) and Conventional Dressing in Diabetic Foot Ulcer Healing: A Prospective Randomized Study.,"BACKGROUND


We are trying to evaluate silver nanoparticles' effectiveness (SilvrSTAT Gel) in accelerating healing rate of nonischemic diabetic foot ulcers (DFUs).
METHODS


This prospective, double-blind, randomized, controlled study includes 80 patients with nonischemic DFUs classified into 2 groups. Group A was subjected to SilvrSTAT Gel dressing, and group B was subjected to conventional dressing (wet-to-moist dressing with or without povidone-iodine). All cases had minimal debridement before treatment. In both groups, all cases were nonischemic after successful revascularization either by bypass surgery or endovascular therapy.
RESULTS


The healing rate of the SilvrSTAT group was significantly higher than that of the conventional group. The healing rate per week of the SilvrSTAT group was considerably higher than that of the conventional group ( P  < .0001). The rate of complete healing for ulcers in group A was achieved in 22 patients (55%) by the 6th week, while 29 (72.5%), 34 (85%), and 36 (90%) patients were healed entirely by the 8th, 10th, and 12th weeks, respectively. In group B: 20 (50%), 27 (67.5%), and 30 (75%) patients were completeley healed by the 8th, 10th, and 12th weeks, respectively.
CONCLUSIONS


SilvrSTATGel is effective in the treatment of DFU.",2021,The healing rate per week of the SilvrSTAT group was considerably higher than that of the conventional group ( P  < .0001).,"['nonischemic diabetic foot ulcers (DFUs', '80 patients with nonischemic DFUs classified into 2 groups', 'Diabetic Foot Ulcer Healing']","['conventional dressing (wet-to-moist dressing with or without povidone-iodine', 'Silver Nanoparticles Dressing (SilvrSTAT Gel) and Conventional Dressing', 'SilvrSTAT Gel dressing', 'bypass surgery or endovascular therapy', 'SilvrSTAT Gel']","['rate of complete healing for ulcers', 'healing rate']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",80.0,0.0230779,The healing rate per week of the SilvrSTAT group was considerably higher than that of the conventional group ( P  < .0001).,"[{'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Essa', 'Affiliation': 'Benha University Hospital, Benha University, Benha, Egypt.'}, {'ForeName': 'Khaled S', 'Initials': 'KS', 'LastName': 'Ahmad', 'Affiliation': 'Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Zayed', 'Affiliation': 'Benha University Hospital, Benha University, Benha, Egypt.'}, {'ForeName': 'Samia G', 'Initials': 'SG', 'LastName': 'Ibrahim', 'Affiliation': 'Benha University Hospital, Benha University, Benha, Egypt.'}]",The international journal of lower extremity wounds,['10.1177/1534734620988217']
1647,33686708,"Comparison of three biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal patients (HYGREB-1): A multicenter, single-blind randomized clinical trial.","OBJECTIVE


To compare three types of biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal women.
METHODS


Postmenopausal women undergoing operative hysteroscopy with endometrial biopsy for abnormal uterine bleeding or endometrial thickness (≥5 mm) were included. Operative hysteroscopy with endometrial biopsy was performed by hysteroscopic forceps. Women were randomized (1:1:1 ratio) in three groups and allocated to undergo endometrial biopsy by hysteroscopy using spoon, alligator, or snake forceps.
RESULTS


Seventy-five women were included in the study, 25 in each group. The duration of the biopsy was comparable between the three groups (P = 0.334) with a median of 180 seconds (range 20-480 seconds). No differences were observed about the number of attempts (P = 0.602), the use of another instrument (P = 0.276), and the biopsy appropriateness (P = 0.592). The spoon forceps group reported higher levels of pain compared to the alligator and snake forceps groups (P <0.001). The spoon forceps received significantly lower scores by the operator compared to the alligator and snake forceps (P <0.001). The alligator and snake forceps reported wider biopsy than the spoon forceps (P <0.001).
CONCLUSION


Snake and alligator hysteroscopic forceps may be considered the first choice to perform an endometrial biopsy in postmenopausal women.",2021,"No differences were observed about the number of attempts (P = 0.602), the use of another instrument (P = 0.276), and the biopsy appropriateness (P = 0.592).","['postmenopausal women', 'postmenopausal patients (HYGREB-1', 'Postmenopausal women undergoing operative hysteroscopy with endometrial biopsy for abnormal uterine bleeding or endometrial thickness (≥5 mm) were included', 'Seventy-five women were included in the study, 25 in each group']","['hysteroscopic endometrial biopsy', 'biopsy forceps', 'Snake and alligator hysteroscopic forceps', 'endometrial biopsy by hysteroscopy using spoon, alligator, or snake forceps', 'Operative hysteroscopy with endometrial biopsy']","['duration of the biopsy', 'biopsy appropriateness', 'levels of pain']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C0180936', 'cui_str': 'Biopsy forceps'}, {'cui': 'C0037382', 'cui_str': 'Suborder Serpentes'}, {'cui': 'C0002123', 'cui_str': 'Genus Alligator'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0585591', 'cui_str': 'Hysteroscopy and endometrial biopsy'}, {'cui': 'C0581226', 'cui_str': 'Spoon'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",75.0,0.0605426,"No differences were observed about the number of attempts (P = 0.602), the use of another instrument (P = 0.276), and the biopsy appropriateness (P = 0.592).","[{'ForeName': 'Salvatore Giovanni', 'Initials': 'SG', 'LastName': 'Vitale', 'Affiliation': 'Obstetrics and Gynecology Unit, Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.'}, {'ForeName': 'Antonio Simone', 'Initials': 'AS', 'LastName': 'Laganà', 'Affiliation': 'Department of Obstetrics and Gynecology, Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Obstetrics and Gynecology Unit, Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Garzon', 'Affiliation': 'Department of Obstetrics and Gynecology, Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy.'}, {'ForeName': 'Giada Maria', 'Initials': 'GM', 'LastName': 'Vecchio', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia,"" Anatomic Pathology, School of Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Valentina Lucia', 'Initials': 'VL', 'LastName': 'La Rosa', 'Affiliation': 'Unit of Psychodiagnostics and Clinical Psychology, University of Catania, Catania, Italy.'}, {'ForeName': 'Jvan', 'Initials': 'J', 'LastName': 'Casarin', 'Affiliation': 'Department of Obstetrics and Gynecology, Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Department of Obstetrics and Gynecology, Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13669']
1648,33686683,"Comparison of Normal Saline, Ringer's and Ringer's lactate as Z-BUF fluids in management of perioperative serum Sodium and Potassium levels.","BACKGROUND


Zero-balance ultrafiltration (Z-BUF) is considered a significant method during cardiopulmonary bypass (CPB), and has always received support regarding its key role in monitoring electrolyte abnormalities including potassium and sodium derangements and managing them which occur commonly during CPB. With Z-BUF procedure's impact on controlling electrolyte abnormalities, we conducted a study in order to find out the most efficient solution regarding managing potassium and sodium levels to be selected as replacement fluid in Z-BUF out of the three commonly used normal saline, ringer's and ringer's lactate.
METHOD


a randomized clinical trial study was conducted and 90 patients were divided into three groups. Each group was given a certain solution out of the three normal saline (Z-BUF-NS), ringer's (Z-BUF-R), and ringer's lactate (Z-BUF-RL) with allocation concealment strategy then potassium and sodium levels were measured at 5 points of the whole procedure: prior to CPB and after anesthesia induction, cardioplegic solution's delivery, pre-Z-BUF, post-Z-BUFF, and at the end of CPB.
RESULTS


Comparing pre-Z-BUF and post-CPB patients' serum potassium demonstrated a change from 4.7 0.9 mEq/L to 5.2 0.7 mEq/L in Z-BUF-RL, 4.4 0.6 mEq/L to 4.7 0.5mEq/L in Z-BUF-R, and 5.1 0.5 mEq/L to 5.1 0.5 mEq/L in Z-BUF-NS. No significant difference was observed between groups regarding managing K+ abnormalities. Changes in Na+ from pre-Z-BUF to post-CPB were as following: from 134 mEq/L to 133 mEq/L in Z-BUF-RL, 137 mEq/L to 137 mEq/L in Z-BUF-R, and 135.2 4 mEq/L to 136.5 4 mEq/L in Z-BUF-NS. Ringer's lactate managed sodium abnormalities more efficiently.
CONCLUSION


Ringer's lactate is more efficient than Ringer's and normal saline regarding managing sodium and potassium abnormalities.",2021,No significant difference was observed between groups regarding managing K+ abnormalities.,['90 patients'],"[""Ringer's lactate"", ""Normal Saline, Ringer's and Ringer's lactate"", 'Zero-balance ultrafiltration (Z-BUF']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}]",[],,0.0579895,No significant difference was observed between groups regarding managing K+ abnormalities.,"[{'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Hamidi', 'Affiliation': 'Clinical Research Development Unit of Rouhani Hospital, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Azarfarin', 'Affiliation': 'Full professor of cardiac anesthesia echocardiyrephy research center rajaei Cardiovascular, Medical and research Center, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Alizadeh-Ghavidel', 'Affiliation': 'Full professor of cardiovascular surgery, cardiac value disease research center rajaei Cardiovascular, Medical and research Center, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh Abkenar', 'Affiliation': 'Associated professor of epidemiology heart research center rajaei Cardiovascular, Medical and research Center, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Pabarjay', 'Affiliation': 'Cardiovascular, Medical and research Center, perfusion, Tehran, Iran.'}]",Artificial organs,['10.1111/aor.13950']
1649,33686630,Intranasal Fentanyl for Intervention-Associated Breakthrough Pain After Cardiac Surgery.,"BACKGROUND


Cardiac bypass surgery patients have early postoperative interventions that elicit breakthrough pain. We evaluated the use of intranasal fentanyl for breakthrough pain management in these patients.
METHODS


Multimodal analgesia (paracetamol 1 g three times a day, oxycodone 2-3 mg boluses with a patient-controlled intravenous pump) was used in 16 patients (age 49-70 years, weight 59-129 kg) after cardiac bypass surgery. Intranasal fentanyl 100 µg or 200 µg was used to manage breakthrough pain on the first and third postoperative mornings in a randomised order. Blood samples were collected for up to 3 h after fentanyl administration, pain was assessed with a numeric rating scale of 0-10. Plasma fentanyl concentration was assayed using liquid chromatography-mass spectrometry. Body composition was measured with a bioelectrical impedance device.
RESULTS


Bioavailability of intranasal fentanyl was high (77%), absorption half-time short (< 2 min) and an analgesic plasma concentration ≥ 0.5 ng/mL was achieved in 31 of 32 administrations. Fentanyl exposure correlated inversely with skeletal muscle mass and total body water. Fentanyl analgesia was effective both on the first postoperative morning with chest pleural tube removal and during physiotherapy on the third postoperative morning. The median time of subsequent oxycodone administration was 1.1 h after intranasal fentanyl 100 µg and 2.1 h after intranasal fentanyl 200 µg, despite similar oxycodone concentrations (median 13.8, range 5.2-35 ng/mL) in both fentanyl dose groups.
CONCLUSIONS


Intranasal fentanyl 100 µg provided rapid-onset analgesia within 10 min and is an appropriate starting dose for incidental breakthrough pain in the first 3 postoperative days after cardiac bypass surgery.
CLINICAL TRIAL REGISTRATION


EudraCT Number: 2018-001280-22.",2021,"Bioavailability of intranasal fentanyl was high (77%), absorption half-time short (< 2 min) and an analgesic plasma concentration ≥","['16 patients (age 49-70 years, weight 59-129 kg) after cardiac bypass surgery']","['oxycodone 2-3 mg boluses with a patient-controlled intravenous pump', 'Fentanyl analgesia', 'Intranasal Fentanyl', 'Multimodal analgesia (paracetamol', 'Intranasal fentanyl', 'intranasal fentanyl', 'Fentanyl']","['breakthrough pain', 'Bioavailability', 'median time of subsequent oxycodone administration', 'skeletal muscle mass and total body water', 'Plasma fentanyl concentration', 'analgesic plasma concentration ≥', 'Body composition', 'Breakthrough Pain', 'pain', 'Blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.154395,"Bioavailability of intranasal fentanyl was high (77%), absorption half-time short (< 2 min) and an analgesic plasma concentration ≥","[{'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Valtola', 'Affiliation': 'Heart Centre, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Maisa', 'Initials': 'M', 'LastName': 'Laakso', 'Affiliation': 'Heart Centre, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Henriikka', 'Initials': 'H', 'LastName': 'Hakomäki', 'Affiliation': 'School of Pharmacy, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Anaesthesiology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kokki', 'Affiliation': 'School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Veli-Pekka', 'Initials': 'VP', 'LastName': 'Ranta', 'Affiliation': 'School of Pharmacy, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Valtteri', 'Initials': 'V', 'LastName': 'Rinne', 'Affiliation': 'Admescope Ltd, Oulu, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Kokki', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kuopio University Hospital, KYS, PO Box 100, 70029, Kuopio, Finland. merja.kokki@kuh.fi.'}]",Clinical pharmacokinetics,['10.1007/s40262-021-01002-4']
1650,33686610,"Evaluation of tramadol human pharmacokinetics and safety after co-administration of magnesium ions in randomized, single- and multiple-dose studies.","BACKGROUND


Magnesium ions (Mg 2+ ) increase and prolong opioid analgesia in chronic and acute pain. The nature of this synergistic analgesic interaction has not yet been explained. Our aim was to investigate whether Mg 2+  alter tramadol pharmacokinetics. Our secondary goal was to assess the safety of the combination.
METHODS


Tramadol was administered to healthy Caucasian subjects with and without Mg 2+  as (1) single 100-mg and (2) multiple 50-mg oral doses. Mg 2+  was administered orally at doses of 150 mg and 75 mg per tramadol dosing in a single- and multiple-dose study, respectively. Both studies were randomized, open label, laboratory-blinded, two-period, two-treatment, crossover trials. The plasma concentrations of tramadol and its active metabolite, O-desmethyltramadol, were measured.
RESULTS


A total of 25 and 26 subjects completed the single- and multiple-dose study, respectively. Both primary and secondary pharmacokinetic parameters were similar. The 90% confidence intervals for C max  and AUC 0-t  geometric mean ratios for tramadol were 91.95-102.40% and 93.22-102.76%. The 90% confidence intervals for C max,ss  and AUC 0-τ  geometric mean ratios for tramadol were 93.85-103.31% and 99.04-105.27%. The 90% confidence intervals for primary pharmacokinetic parameters were within the acceptance range. ANOVA did not show any statistically significant contribution of the formulation factor (p > 0.05) in either study. Adverse events and clinical safety were similar in the presence and absence of Mg 2+ .
CONCLUSIONS


The absence of Mg 2+  interaction with tramadol pharmacokinetics and safety suggests that this combination may be used in the clinical practice for the pharmacotherapy of pain.",2021,ANOVA did not show any statistically significant contribution of the formulation factor (p > 0.05) in either study.,"['chronic and acute pain', 'A total of 25 and 26 subjects', 'healthy Caucasian subjects with and without Mg 2+  as (1) single 100-mg and (2) multiple 50-mg oral doses']","['Tramadol', 'tramadol']","['plasma concentrations of tramadol and its active metabolite, O-desmethyltramadol', 'C max  and AUC 0-t  geometric mean ratios for tramadol', 'C max,ss  and AUC 0-τ  geometric mean ratios for tramadol', 'Adverse events and clinical safety']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0215051', 'cui_str': 'O-desmethyltramadol'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0947021,ANOVA did not show any statistically significant contribution of the formulation factor (p > 0.05) in either study.,"[{'ForeName': 'Piotr J', 'Initials': 'PJ', 'LastName': 'Rudzki', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Jarus-Dziedzic', 'Affiliation': 'BioVirtus Research Site Sp, ul. Borowa 14/18, 05-400, Otwock, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Filist', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Gilant', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Buś-Kwaśnik', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Leś', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Sasinowska-Motyl', 'Affiliation': 'Department of Pharmacodynamics, Centre for Preclinical Research and Technology, Medical University of Warsaw, ul. Banacha 1b, 01-793, Warsaw, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Nagraba', 'Affiliation': 'Orthopedic and Rehabilitation Department, Medical University of Warsaw, ul. Kondratowicza 8, 03-242, Warsaw, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Bujalska-Zadrożny', 'Affiliation': 'Department of Pharmacodynamics, Centre for Preclinical Research and Technology, Medical University of Warsaw, ul. Banacha 1b, 01-793, Warsaw, Poland. magdalena.bujalska@wum.edu.pl.'}]",Pharmacological reports : PR,['10.1007/s43440-021-00239-x']
1651,33686573,"Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial.","INTRODUCTION


We report the 48-week results of an ongoing study to assess the efficacy and safety of switching older people with HIV to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).
METHODS


This was a 96-week, phase 3b, open-label, single-arm study (GS-US-380-4449; NCT03405935). Virologically suppressed individuals aged ≥ 65 years receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or a tenofovir disoproxil fumarate-based regimen were switched to B/F/TAF. Primary endpoint was the percentage of participants with HIV-1 RNA < 50 copies/ml at week 24.
RESULTS


Eighty-six participants (median age 69 [range 65-80] years; 87% male; 95% white) were enrolled and treated in five European countries. Rates of virologic suppression were 97.7% at week 24 and 90.7% at week 48; none had HIV-1 RNA ≥ 50 copies/ml, and 100% had virologic suppression by missing = excluded analysis at both time points. No treatment-emergent resistance was observed. There were no grade 3-4 study drug-related adverse events (AEs) or study drug-related serious AEs or deaths. Three AEs led to premature discontinuation; one (moderate abdominal discomfort) was attributed to the study drug by the investigator. At week 48, median changes from baseline in weight and estimated glomerular filtration rate were + 0.1 kg (interquartile range [IQR] - 1.0, 2.3) and - 6.0 ml/min (IQR - 10.2, 0.0), respectively. There were no clinically relevant changes from baseline to week 48 in fasting lipid parameters. Treatment satisfaction improved, and health-related quality of life was maintained from baseline through week 48. Median adherence to the study drug was 98.6% (IQR 96.0, 100).
CONCLUSIONS


Switching to B/F/TAF was effective and well tolerated through 48 weeks in virologically suppressed adults aged ≥ 65 years.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03405935.",2021,There were no grade 3-4 study drug-related adverse events (AEs) or study drug-related serious AEs or deaths.,"['Virologically Suppressed People with HIV Aged\u2009≥', 'Virologically suppressed individuals aged\u2009≥', 'Eighty-six participants (median age 69 [range 65-80] years; 87% male; 95% white) were enrolled and treated in five European countries', 'switching older people with HIV to']","['Bictegravir/Emtricitabine/Tenofovir Alafenamide', 'elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or a tenofovir disoproxil fumarate-based regimen', 'bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF']","['virologic suppression', 'percentage of participants with HIV-1 RNA', 'Rates of virologic suppression', 'efficacy and safety', 'Median adherence', 'Treatment satisfaction improved, and health-related quality of life', 'weight and estimated glomerular filtration rate']","[{'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4542162', 'cui_str': 'emtricitabine, tenofovir alafenamide and bictegravir'}, {'cui': 'C4058848', 'cui_str': 'emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",,0.259308,There were no grade 3-4 study drug-related adverse events (AEs) or study drug-related serious AEs or deaths.,"[{'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'Division of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Rizzardini', 'Affiliation': 'Division of Infectious Diseases, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Department of Infectious Diseases, Saint Louis Hospital, University Paris Diderot, Paris, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Pulido', 'Affiliation': 'Unidad VIH, Hospital Universitario 12 de Octubre, imas12, UCM, Madrid, Spain.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'De Wit', 'Affiliation': 'St Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vandekerckhove', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Berenguer', 'Affiliation': 'Infectious Diseases, Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Spain.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""D'Antoni"", 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Chuck', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Piontkowsky', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haubrich', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'McNicholl', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Gallant', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA. joel.gallant@gilead.com.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00419-5']
1652,33686520,"Feasibility, engagement, and acceptability of a behavioral pain management intervention for colorectal cancer survivors with pain and psychological distress: data from a pilot randomized controlled trial.","PURPOSE


Colorectal cancer survivors report pain and psychological distress to be burdensome long-term cancer consequences. Quality cancer survivorship care includes interventions for managing these symptoms. Yet, no studies have tested the efficacy of an accessible behavioral intervention for colorectal cancer survivors with pain and comorbid psychological distress. This paper reports on the feasibility (i.e., accrual, attrition, and adherence to study procedures), engagement, acceptability, and descriptive outcomes of a telephone-based coping skills training (CST) intervention.
METHODS


This randomized pilot trial assigned colorectal cancer patients (N=31) to 5 sessions of CST or standard care. CST sessions focused on cognitive-behavioral theory-based coping skills tailored to colorectal cancer symptoms of pain and psychological distress. Participants completed assessments of pain severity, self-efficacy for pain management, health-related quality of life, and psychological distress at baseline, post-treatment, and 3-month follow-up.
RESULTS


Data indicated strong feasibility, evidenced by high completion rates for intervention sessions and assessments (93% completed all sessions; M=48.7 days; baseline=100%; post-treatment=97%; 3-month follow-up=94%). Participants demonstrated robust engagement with CST (M days per week with reported skills use=3.8) and reported high protocol satisfaction (M=3.6/4.0). Descriptive statistics showed self-efficacy for pain management and health-related quality of life improved for all participants.
CONCLUSION


Findings suggest that a telephone-based CST intervention has strong feasibility, evidenced by accrual, low attrition, and adherence to intervention sessions and assessments. Likewise, participant engagement and acceptability with CST were high. These data provide a foundation for larger randomized efficacy trials of the telephone-based CST intervention.",2021,"Descriptive statistics showed self-efficacy for pain management and health-related quality of life improved for all participants.
","['to colorectal cancer symptoms of pain and psychological distress', 'colorectal cancer survivors with pain and comorbid psychological distress', 'colorectal cancer survivors with pain and psychological distress', 'colorectal cancer patients (N=31) to 5 sessions of CST or standard care']","['telephone-based coping skills training (CST) intervention', 'CST sessions', 'telephone-based CST intervention', 'cognitive-behavioral theory-based coping skills tailored', 'behavioral pain management intervention', 'behavioral intervention']","['high protocol satisfaction', 'self-efficacy for pain management and health-related quality of life', 'pain and psychological distress', 'pain severity, self-efficacy for pain management, health-related quality of life, and psychological distress', 'Feasibility, engagement, and acceptability']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3714357', 'cui_str': 'Cognitive behavioral theory'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.090998,"Descriptive statistics showed self-efficacy for pain management and health-related quality of life improved for all participants.
","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Kelleher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA. sarah.kelleher@duke.edu.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Winger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Hope E', 'Initials': 'HE', 'LastName': 'Uronis', 'Affiliation': 'Department of Internal Medicine, Duke University Medical Center, Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'Arianna N', 'Initials': 'AN', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-021-06126-8']
1653,33686482,Early sedation with dexmedetomidine in ventilated critically ill patients and heterogeneity of treatment effect in the SPICE III randomised controlled trial.,"PURPOSE


To quantify potential heterogeneity of treatment effect (HTE), of early sedation with dexmedetomidine (DEX) compared with usual care, and identify patients who have a high probability of lower or higher 90-day mortality according to age, and other identified clusters.
METHODS


Bayesian analysis of 3904 critically ill adult patients expected to receive invasive ventilation > 24 h and enrolled in a multinational randomized controlled trial comparing early DEX with usual care sedation.
RESULTS


HTE was assessed according to age and clusters (based on 12 baseline characteristics) using a Bayesian hierarchical models. DEX was associated with lower 90-day mortality compared to usual care in patients > 65 years (odds ratio [OR], 0.83 [95% credible interval [CrI] 0.68-1.00], with 97.7% probability of reduced mortality across broad categories of illness severity. Conversely, the probability of increased mortality in patients ≤ 65 years was 98.5% (OR 1.26 [95% CrI 1.02-1.56]. Two clusters were identified: cluster 1 (976 patients) mostly operative, and cluster 2 (2346 patients), predominantly non-operative. There was a greater probability of benefit with DEX in cluster 1 (OR 0.86 [95% CrI 0.65-1.14]) across broad categories of age, with 86.4% probability that DEX is more beneficial in cluster 1 than cluster 2.
CONCLUSION


In critically ill mechanically ventilated patients, early sedation with dexmedetomidine exhibited a high probability of reduced 90-day mortality in older patients regardless of operative or non-operative cluster status. Conversely, a high probability of increased 90-day mortality was observed in younger patients of non-operative status. Further studies are needed to confirm these findings.",2021,DEX was associated with lower 90-day mortality compared to usual care in patients > ,"['Two clusters were identified: cluster 1 (976 patients) mostly operative, and cluster 2 (2346 patients), predominantly non-operative', 'ventilated critically ill patients', 'patients who have a high probability of lower or higher 90-day mortality according to age, and other identified clusters', '3904 critically ill adult patients expected to receive invasive ventilation\u2009']","['dexmedetomidine (DEX', 'dexmedetomidine', 'DEX with usual care sedation', 'DEX']","['probability of increased mortality', '90-day mortality']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",3904.0,0.202491,DEX was associated with lower 90-day mortality compared to usual care in patients > ,"[{'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Monash Health School of Clinical Sciences, Monash University, Clayton, VIC, 3186, Australia. Yahya.shehabi@monashhealth.org.'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Belinda D', 'Initials': 'BD', 'LastName': 'Howe', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Frances E', 'Initials': 'FE', 'LastName': 'Bass', 'Affiliation': 'Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Suhaini Bin', 'Initials': 'SB', 'LastName': 'Kadiman', 'Affiliation': 'Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Reade', 'Affiliation': ""Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Seppelt', 'Affiliation': 'Sydney Medical School-Nepean, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Takala', 'Affiliation': 'Department of Intensive Care, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Matt P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Steve A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-021-06356-8']
1654,33686446,Hypertrophic Scar Outcomes in Fractional Laser Monotherapy Versus Fractional Laser-Assisted Topical Corticosteroid Delivery: A Randomized Clinical Trial.,"Topical corticosteroid delivery following fractional laser treatment is an effective means of treating hypertrophic scars. However, the relative efficacy of adjuvant corticosteroid treatment vs fractional laser mono-therapy alone is unclear. The aim of this study was to compare the efficacy and safety of fractional laser-assisted topical corticosteroid delivery with fractional laser monotherapy in the treatment of hyper-trophic scars. In this randomized, comparative, split-scar trial of 19 subjects, a borderline significant reduction in scar thickness was observed at 3-month follow-up in the laser+steroid group compared with laser+petrolatum (p = 0.049). However, no significant long-term difference in scar flattening was observed between the 2 groups. Patient and Observer Scar Assessment Scale scores showed significant improvement in scar appearance from baseline without significant differences between treatment groups. In conclusion, fractional laser monotherapy is an effective treatment for hypertrophic scars, and the application of topical corticosteroids provides no long-term synergistic effect to fractional laser monotherapy.",2021,Patient and Observer Scar Assessment Scale scores showed significant improvement in scar appearance from baseline without significant differences between treatment groups.,"['hyper-trophic scars', '19 subjects']","['Fractional Laser-Assisted Topical Corticosteroid Delivery', 'Fractional Laser Monotherapy', 'laser+petrolatum', 'fractional laser treatment', 'fractional laser monotherapy', 'fractional laser-assisted topical corticosteroid delivery with fractional laser monotherapy']","['scar thickness', 'efficacy and safety', 'Hypertrophic Scar Outcomes', 'scar appearance', 'Patient and Observer Scar Assessment Scale scores', 'scar flattening']","[{'cui': 'C0008767', 'cui_str': 'Scarring'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",19.0,0.0302761,Patient and Observer Scar Assessment Scale scores showed significant improvement in scar appearance from baseline without significant differences between treatment groups.,"[{'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, 10700 Bangkok, Thailand. E-mail: Woraphong.man@mahidol.edu.'}, {'ForeName': 'Arisa', 'Initials': 'A', 'LastName': 'Kaewkes', 'Affiliation': ''}, {'ForeName': 'Chadakan', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Janice Natasha', 'Initials': 'JN', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'Joshua Zev', 'Initials': 'JZ', 'LastName': 'Glahn', 'Affiliation': ''}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3781']
1655,33686407,Do we trust scientific evidence? A multicentre retrospective analysis of first IVF/ICSI cycles before and after the OPTIMIST trial.,"STUDY QUESTION


Has the practice of individualizing the recombinant-FSH starting dose been superseded after the largest randomized controlled trial (RCT) in assisted reproduction technology (ART), the OPTIMIST trial?
SUMMARY ANSWER


The OPTIMIST trial has influenced our ART daily practice to a limited degree, but adherence is still generally poor.
WHAT IS KNOWN ALREADY


Although the 'one size fits all' approach has been discouraged for decades by most authors, the OPTIMIST study group demonstrated in a large prospective RCT that, in general, dosage individualization does not improve the prospects for live birth, although it may decrease ovarian hyperstimulation syndrome (OHSS) risk in expected high responders.
STUDY DESIGN, SIZE, DURATION


Retrospective analysis of all first in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles from 1st January 2017 to 31st December 2018, before and after the OPTIMIST publication on November 2017.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Two thousand six hundred and seventy-seven patients, between 18 and 42 years old, undergoing their first IVF-ICSI cycle in seven Italian fertility centres, were included. Patients were allocated to three groups according to their ovarian reserve markers: predicted poor ovarian responders (POR), predicted normo-responders (NR) and expected hyper-responders (HRs).
MAIN RESULTS AND THE ROLE OF CHANCE


Between 2017 and 2018, there was an overall increase in prescription of the standard 150 IU dose proposed by the OPTIMIST trial and a reduction in the use of a starting dose >300 IU. After subgroup analysis, the decrease in doses >300 IU remained significant in the POR and NR sub-groups.
LIMITATIONS, REASONS FOR CAUTION


The retrospective nature of the study. Physicians need time to adapt to new scientific evidence and a comparison between 2017 and 2019 may have found a greater impact of the Optimist trial, although other changes over the longer time span might have increased confounding. We cannot be sure that the observed changes can be attributed to knowledge of the OPTIMIST trial.
WIDER IMPLICATIONS OF THE FINDINGS


Clinicians may be slow to adopt recommendations based on RCTs; more attention should be given to how these are disseminated and promoted.
STUDY FUNDING/COMPETING INTEREST(S)


No external funding was used for this study. E.P. reports grants and personal fees from MSD, grants from Ferring, from IBSA, grants and personal fees from Merck, grants from TEVA, grants from Gedeon Richter, outside the submitted work. E.S. reports grants from Ferring, grants and personal fees from Merck-Serono, grants and personal fees from Theramex, outside the submitted work. All other authors do not have conflicts of interest to declare.
TRIAL REGISTRATION NUMBER


Not applicable.",2021,"After subgroup analysis, the decrease in doses >300 IU remained significant in the POR and NR sub-groups.
","['Two thousand six hundred and seventy-seven patients, between 18 and 42\u2009years old, undergoing their first IVF-ICSI cycle in seven Italian fertility centres, were included', 'from 1st January 2017 to 31st December 2018, before and after the OPTIMIST publication on November 2017']",['vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles'],"['ovarian hyperstimulation syndrome (OHSS) risk', 'poor ovarian responders (POR), predicted normo-responders (NR) and expected hyper-responders (HRs']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",2677.0,0.0901718,"After subgroup analysis, the decrease in doses >300 IU remained significant in the POR and NR sub-groups.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Papaleo', 'Affiliation': 'Gynecology/Obstetrics Unit, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Revelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Turin, Turin 10126, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': 'Reproductive Medicine Department, International Evangelic Hospital, Genoa 16122, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bertoli', 'Affiliation': 'Reproduction and IVF Unit, C. Poma Hospital, Mantua 46100, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zaffagnini', 'Affiliation': 'ART and Fertility Preservation Unit, Maternal Pediatric Department, AOUI Verona, Verona 37126, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Tomei', 'Affiliation': 'IVF Unit, Azienda Sanitaria Friuli Occidentale, Sacile 33077, PN, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Manno', 'Affiliation': 'IVF Unit, Azienda Sanitaria Friuli Occidentale, Sacile 33077, PN, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rebecchi', 'Affiliation': 'Gynecology/Obstetrics Unit, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Villanacci', 'Affiliation': 'Gynecology/Obstetrics Unit, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Vanni', 'Affiliation': 'Gynecology/Obstetrics Unit, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cantatore', 'Affiliation': 'Gynecology/Obstetrics Unit, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruffa', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Turin, Turin 10126, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Colia', 'Affiliation': 'Reproductive Medicine Department, International Evangelic Hospital, Genoa 16122, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sironi', 'Affiliation': 'Reproduction and IVF Unit, C. Poma Hospital, Mantua 46100, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tessari', 'Affiliation': 'Reproduction and IVF Unit, C. Poma Hospital, Mantua 46100, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Parissone', 'Affiliation': 'ART and Fertility Preservation Unit, Maternal Pediatric Department, AOUI Verona, Verona 37126, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Romanello', 'Affiliation': 'IVF Unit, Azienda Sanitaria Friuli Occidentale, Sacile 33077, PN, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reschini', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan 20122, Italy.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dallagiovanna', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan 20122, Italy.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Somigliana', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan 20122, Italy.""}]","Human reproduction (Oxford, England)",['10.1093/humrep/deab047']
1656,33686160,Association between medication adherence and intrapatient variability in tacrolimus concentration among stable kidney transplant recipients.,"This study analyzed the association between medication adherence and the intrapatient variability (IPV) of tacrolimus concentrations among kidney transplant recipients through a post hoc analysis of the dataset from a recently conducted randomized controlled trial. Among 138 patients enrolled in the original trial, 92 patients with ≥ 5 months of medication event monitoring system (MEMS) use and ≥ 4 tacrolimus trough values were included in this post hoc analysis. The variability of tacrolimus trough levels was calculated using coefficient variation (CV) and mean absolute deviation. Adherence was assessed using MEMS and self-report via the Basal Assessment of Adherence to Immunosuppressive Medication Scale. There were no statistically significant differences in the CV [median 16.5% [interquartile range 11.6-25.5%] and 16.0% [11.5-23.5%], respectively, P = .602] between the nonadherent (n = 59) and adherent groups (n = 33). There was also no significant correlation between the CV and adherence detected by MEMS (taking adherence, ρ = - 0.067, P = .527; dosing adherence, ρ = - 0.098, P = .352; timing adherence, ρ = - 0.113, P = .284). Similarly, adherence measured by self-report did not significantly affect the IPV (P = .452). In this post hoc analysis, nonadherent behavior, measured through electronic monitoring or self-report, did not affect the IPV.",2021,"There were no statistically significant differences in the CV [median 16.5% [interquartile range 11.6-25.5%] and 16.0% [11.5-23.5%], respectively, P = .602] between the nonadherent (n = 59) and adherent groups (n = 33).","['kidney transplant recipients', 'stable kidney transplant recipients', '138 patients enrolled in the original trial, 92 patients with\u2009≥\u20095\xa0months of medication event monitoring system (MEMS) use and\u2009≥\u20094 tacrolimus trough values']",[],"['CV', 'CV and adherence detected by MEMS (taking adherence', 'variability of tacrolimus trough levels']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",[],"[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",92.0,0.0748471,"There were no statistically significant differences in the CV [median 16.5% [interquartile range 11.6-25.5%] and 16.0% [11.5-23.5%], respectively, P = .602] between the nonadherent (n = 59) and adherent groups (n = 33).","[{'ForeName': 'Hyunmin', 'Initials': 'H', 'LastName': 'Ko', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyo Kee', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ahram', 'Initials': 'A', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung-Kee', 'Initials': 'SK', 'LastName': 'Min', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jongwon', 'Initials': 'J', 'LastName': 'Ha', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sangil', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, Korea. surgeonmsi@gmail.com.'}]",Scientific reports,['10.1038/s41598-021-84868-5']
1657,33686119,Patent ductus arteriosus shunt elimination results in a reduction in adverse outcomes: a post hoc analysis of the PDA RCT cohort.,"OBJECTIVE


A post hoc appraisal of the PDA RCT to assess the relationship between early patent ductus arteriosus (PDA) shunt elimination and chronic lung disease or death (CLD/Death).
STUDY DESIGN


Infants <29 weeks were divided into four groups: intervention arm in whom PDA closure was achieved (n = 17); intervention arm in whom PDA closure was not achieved (n = 13); placebo arm (n = 30); low risk infants (n = 13). The main outcome measure was CLD/Death.
RESULTS


The rates of CLD/Death were lower in the Intervention Success Group (29%) when compared to the Intervention Failure Group (85%) or the Placebo Group (60%, all p < 0.05). There was no difference in CLD/Death between the Intervention Success and Low Risk Groups (8%, p > 0.05). A persistent PDA beyond Day 8 was associated with CLD/Death (aOR 6.5 [1.7-25.5]).
CONCLUSIONS


Early shunt elimination in preterm infants with a PDA may reduce respiratory morbidity when compared to infants with prolonged shunt exposure.",2021,"The rates of CLD/Death were lower in the Intervention Success Group (29%) when compared to the Intervention Failure Group (85%) or the Placebo Group (60%, all p < 0.05).","['Infants <29 weeks', 'preterm infants with a PDA']","['PDA RCT', 'Placebo', 'placebo']","['rates of CLD/Death', 'adverse outcomes', 'respiratory morbidity', 'CLD/Death']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}]",,0.136275,"The rates of CLD/Death were lower in the Intervention Success Group (29%) when compared to the Intervention Failure Group (85%) or the Placebo Group (60%, all p < 0.05).","[{'ForeName': 'Neidín', 'Initials': 'N', 'LastName': 'Bussmann', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Colm R', 'Initials': 'CR', 'LastName': 'Breatnach', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'McCallion', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cleary', 'Affiliation': 'Department of Pharmacy, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Franklin', 'Affiliation': ""Department of Paediatric Cardiology, Our Lady's Children's Hospital Crumlin, Dublin, Ireland.""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McNamara', 'Affiliation': ""Division of Neonatology, Stead Family Children's Hospital, Iowa City, IA, USA.""}, {'ForeName': 'Afif', 'Initials': 'A', 'LastName': 'El-Khuffash', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland. afifelkhuffash@rcsi.com.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-021-01002-z']
1658,33686102,Transcranial static magnetic stimulation over the motor cortex can facilitate the contralateral cortical excitability in human.,"Transcranial static magnetic stimulation (tSMS) has been focused as a new non-invasive brain stimulation, which can suppress the human cortical excitability just below the magnet. However, the non-regional effects of tSMS via brain network have been rarely studied so far. We investigated whether tSMS over the left primary motor cortex (M1) can facilitate the right M1 in healthy subjects, based on the hypothesis that the functional suppression of M1 can cause the paradoxical functional facilitation of the contralateral M1 via the reduction of interhemispheric inhibition (IHI) between the bilateral M1. This study was double-blind crossover trial. We measured the corticospinal excitability in both M1 and IHI from the left to right M1 by recording motor evoked potentials from first dorsal interosseous muscles using single-pulse and paired-pulse transcranial magnetic stimulation before and after the tSMS intervention for 30 min. We found that the corticospinal excitability of the left M1 decreased, while that of the right M1 increased after tSMS. Moreover, the evaluation of IHI revealed the reduced inhibition from the left to the right M1. Our findings provide new insights on the mechanistic understanding of neuromodulatory effects of tSMS in human.",2021,"We found that the corticospinal excitability of the left M1 decreased, while that of the right M1 increased after tSMS.","['healthy subjects', 'human']","['Transcranial static magnetic stimulation (tSMS', 'tSMS', 'Transcranial static magnetic stimulation']","['corticospinal excitability of the left M1', 'corticospinal excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}]",,0.0467653,"We found that the corticospinal excitability of the left M1 decreased, while that of the right M1 increased after tSMS.","[{'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Department of Rehabilitation Science, Faculty of Health Sciences, Hokkaido University, Sapporo, 060-0812, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Koganemaru', 'Affiliation': 'Department of Physiology, Dokkyo Medical University, Shimotsugagun, 321-0293, Japan.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Kinugasa Research Organization, Ritsumeikan University, Kyoto, 603-8577, Japan.'}, {'ForeName': 'Sumiya', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Kinugasa Research Organization, Ritsumeikan University, Kyoto, 603-8577, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yukawa', 'Affiliation': 'Department of Rehabilitation, Murata Hospital, Osaka, 544-0011, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Minakuchi', 'Affiliation': 'Department of Rehabilitation, Murata Hospital, Osaka, 544-0011, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Shimomura', 'Affiliation': 'Department of Rehabilitation, Murata Hospital, Osaka, 544-0011, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Mima', 'Affiliation': 'Graduate School of Core Ethics and Frontier Sciences, Ritsumeikan University, Kyoto, 603-8577, Japan. t-mima@fc.ritsumei.ac.jp.'}]",Scientific reports,['10.1038/s41598-021-84823-4']
1659,33686040,"Comparative Evaluation of Gingival Depigmentation by Scalpel, Electrosurgery, and Laser: A 14 Months' Follow-up Study.","AIM AND OBJECTIVE


The aim of the study was to compare three different techniques using scalpel, electrosurgery, and laser for gingival depigmentation in terms of pain, discomfort, duration of procedure, wound healing, and repigmentation.
MATERIALS AND METHODS


Thirty patients in the age range of 24-38 years were briefed about the surgical procedure and an informed consent was obtained and they were randomly allocated into three groups of 10 individuals (5 males and 5 females) each: those undergoing depigmentation with scalpel (group I), electrosurgery (group II), and diode lasers (Biolase) (group III). Individuals of all three groups were asked to describe the level of pain and discomfort by using the visual analog scale (VAS) 2 hours, 24 hours, and 1 week postoperatively. Further, the groups were compared based on duration of procedure, wound healing, and repigmentation at the end of 14 months.
RESULTS


All the groups showed a decrease in the pain levels, which was statistically highly significant 1 week postoperatively when compared 24 hours postoperatively. There was a statistically significant difference in the pain levels between the scalpel, electrosurgery, and lasers groups after 24 hours ( p  < 0.001), with the lasers group demonstrating significantly less pain and discomfort. There was significant difference between the groups with respect to the duration of procedure, with less mean time for completion of the procedure observed for group III. Furthermore, less time for wound healing was observed in group III as compared to other groups. Total 8 out 10 patients in group I, 7 out of 10 patients in group II, and 2 out of 10 patients in group III showed repigmentation at the end of 14 months.
CONCLUSION


The rising concern for esthetic demand of an individual requires the removal of hyperpigmented gingival areas to create a confident and pleasing smile, which could be easily attained by using laser.
CLINICAL SIGNIFICANCE


Laser is an effective and fast tool that causes less pain, discomfort, faster healing, and delayed repigmentation compared with scalpel or electrosurgery for gingival depigmentation.",2020,"All the groups showed a decrease in the pain levels, which was statistically highly significant 1 week postoperatively when compared 24 hours postoperatively.",['Thirty patients in the age range of 24-38 years were briefed about the surgical procedure and an informed consent was obtained and they were randomly allocated into three groups of 10 individuals (5 males and 5 females) each: those undergoing'],"['depigmentation with scalpel (group I), electrosurgery (group II), and diode lasers (Biolase', 'scalpel, electrosurgery, and laser for gingival depigmentation', 'Gingival Depigmentation by Scalpel, Electrosurgery, and Laser', 'scalpel or electrosurgery']","['pain and discomfort', 'level of pain and discomfort', 'pain, discomfort, duration of procedure, wound healing, and repigmentation', 'time for wound healing', 'duration of procedure, wound healing, and repigmentation', 'pain levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1457900', 'cui_str': 'Each'}]","[{'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",,0.0121011,"All the groups showed a decrease in the pain levels, which was statistically highly significant 1 week postoperatively when compared 24 hours postoperatively.","[{'ForeName': 'Raghunathan', 'Initials': 'R', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Periodontics, Tagore Dental College and Hospital, Chennai, Tamil Nadu, India, Phone: +91 9884957327, e-mail: doctorraghunathan@gmail.com.'}, {'ForeName': 'Swaminathan', 'Initials': 'S', 'LastName': 'Rajendran', 'Affiliation': 'Department of Periodontics, Craniofacial Dental Clinic, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Thodur Madapusi', 'Initials': 'TM', 'LastName': 'Balaji', 'Affiliation': 'Department of Dentistry, Bharathirajaa Hospital and Research Centre, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Varadarajan', 'Affiliation': 'Department of Oral Pathology and Microbiology, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Lakshmi Priya', 'Initials': 'LP', 'LastName': 'Sridhar', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Tagore Dental College and Hospital, Chennai, Tamil Nadu, India.'}]",The journal of contemporary dental practice,[]
1660,33686031,"Staining the Ground Section of the Tooth Using an Innovative Plant Stain Found in the Pravara Region, India.","AIMS


To assess the staining efficacy of the innovative ""Pravara"" stain on ground sections of human teeth under a stereomicroscope. In this study, the ground sections were stained with the innovative stain. The stain is obtained from a leafless tree called  Terminalia chebula. Terminalia chebula , commonly known as Harad, is found in South Asia from India. Few species are found in the Pravara region of Maharashtra, India.
MATERIALS AND METHODS


A total of 40 extracted teeth were collected and ground sections of each tooth were prepared. The samples were randomly divided into two groups: group I-control (without stain), group II-study group (the samples in this group were stained with the help of innovative ""Pravara"" stain). The sections were graded from I to III according to the differentiation and contrast of tissues.
RESULTS


The ground sections in group II stained with Pravara stain demonstrated better contrast for structures within sections under a microscope in comparison with group I (control group).
CONCLUSION


The study demonstrates the efficacy of a new innovative Pravara stain, which is a simple, economical, quick, and effective staining method for the ground sections of the teeth.
CLINICAL SIGNIFICANCE


This innovative Pravara stain is cost-effective, saves time, ecofriendly, and highlights the anatomical structures more effectively and does not fade easily with time.",2020,"This innovative Pravara stain is cost-effective, saves time, ecofriendly, and highlights the anatomical structures more effectively and does not fade easily with time.",['human teeth under a stereomicroscope'],"['innovative ""Pravara"" stain']",[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0038128', 'cui_str': 'Stain'}]",[],40.0,0.0147153,"This innovative Pravara stain is cost-effective, saves time, ecofriendly, and highlights the anatomical structures more effectively and does not fade easily with time.","[{'ForeName': 'Deepak M', 'Initials': 'DM', 'LastName': 'Vikhe', 'Affiliation': 'Department of Prosthodontics, Rural Dental College and Hospital, Pravara Institute of Medical Science (DU), Pravara Medical Trust, Loni, Maharashtra, India, Phone: +91 9822811117, e-mail: drdeepak_mvikhe@yahoo.com.'}, {'ForeName': 'Sanjay G', 'Initials': 'SG', 'LastName': 'Thete', 'Affiliation': 'Department of Oral Pathology and Microbiology, Rural Dental College, Pravara Institute of Medical Science (DU), Loni, Maharashtra, India.'}, {'ForeName': 'Chaitra S', 'Initials': 'CS', 'LastName': 'Mastud', 'Affiliation': 'Department of Orthodontics, Dr DY Patil Vidyapeeth, Dr DY Patil Dental College and Hospital, Pimpri, Pune, Maharashtra, India.'}, {'ForeName': 'Tejashree', 'Initials': 'T', 'LastName': 'Mantri', 'Affiliation': 'Department of Oral Medicine and Radiology, MIDSR Dental College, Loni, Maharashtra, India.'}, {'ForeName': 'Prasad N', 'Initials': 'PN', 'LastName': 'Mhaske', 'Affiliation': 'Department of Prosthodontics, Bharati Vidyapeeth University Dental College, CBD Belapur, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Santoshkumar P', 'Initials': 'SP', 'LastName': 'Mastud', 'Affiliation': 'Department of Oral Medicine and Radiology, Dr DY Patil Vidyapeeth. Dr DY Patil Dental College and Hospital, Pimpri, Pune, Maharashtra, India.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Madanshetty', 'Affiliation': 'Department of Prosthodontics, Rural Dental College and Hospital, Pravara Institute of Medical Science (DU), Pravara Medical Trust, Loni, Maharashtra, India.'}]",The journal of contemporary dental practice,[]
1661,33677928,"Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study.","BACKGROUND


This phase 3 study evaluated the efficacy and safety of 6-month treatment with romosozumab in Korean postmenopausal women with osteoporosis.
METHODS


Sixty-seven postmenopausal women with osteoporosis (bone mineral density [BMD] T-scores ≤-2.5 at the lumbar spine, total hip, or femoral neck) were randomized (1:1) to receive monthly subcutaneous injections of romosozumab (210 mg; n=34) or placebo (n=33) for 6 months.
RESULTS


At month 6, the difference in the least square (LS) mean percent change from baseline in lumbar spine BMD (primary efficacy endpoint) between the romosozumab (9.5%) and placebo (-0.1%) groups was significant (9.6%; 95% confidence interval, 7.6 to 11.5; P&lt;0.001). The difference in the LS mean percent change from baseline was also significant for total hip and femoral neck BMD (secondary efficacy endpoints). After treatment with romosozumab, the percent change from baseline in procollagen type 1 N-terminal propeptide transiently increased at months 1 and 3, while that in C-terminal telopeptide of type 1 collagen showed a sustained decrease. No events of cancer, hypocalcemia, injection site reaction, positively adjudicated atypical femoral fracture or osteonecrosis of the jaw, or positively adjudicated serious cardiovascular adverse events were observed. At month 9, 17.6% and 2.9% of patients in the romosozumab group developed binding and neutralizing antibodies, respectively.
CONCLUSION


Treatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis (ClinicalTrials.gov identifier NCT02791516).",2021,"CONCLUSION


Treatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis (ClinicalTrials.gov identifier NCT02791516).","['Postmenopausal Korean Women with Osteoporosis', 'Sixty-seven postmenopausal women with osteoporosis (bone mineral density [BMD] T-scores ≤-2.5 at the lumbar spine, total hip, or femoral neck', 'Korean postmenopausal women with osteoporosis']","['romosozumab', 'Placebo', 'Romosozumab', 'placebo']","['lumbar spine, total hip, and femoral neck BMD', 'total hip and femoral neck BMD', 'cancer, hypocalcemia, injection site reaction, positively adjudicated atypical femoral fracture or osteonecrosis of the jaw, or positively adjudicated serious cardiovascular adverse events', 'procollagen type 1 N-terminal propeptide transiently', 'lumbar spine BMD', 'efficacy and safety', 'binding and neutralizing antibodies']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]","[{'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]",67.0,0.325782,"CONCLUSION


Treatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis (ClinicalTrials.gov identifier NCT02791516).","[{'ForeName': 'Ki-Hyun', 'Initials': 'KH', 'LastName': 'Baek', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Yoon-Sok', 'Initials': 'YS', 'LastName': 'Chung', 'Affiliation': 'Department of Endocrinology and Metabolism, Ajou University Hospital, Suwon, Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Koh', 'Affiliation': 'Division of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'In Joo', 'Initials': 'IJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.'}, {'ForeName': 'Kyoung Min', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Yong-Ki', 'Initials': 'YK', 'LastName': 'Min', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ki Deok', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Dinavahi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Maddox', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Sooa', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Amgen Korea Limited, Seoul, Korea.'}, {'ForeName': 'Sang Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Amgen Korea Limited, Seoul, Korea.'}, {'ForeName': 'Hyungjin', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Amgen Korea Limited, Seoul, Korea.'}, {'ForeName': 'Sung-Kil', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]","Endocrinology and metabolism (Seoul, Korea)",['10.3803/EnM.2020.848']
1662,33677837,Using social media comments to reduce alcohol purchase intentions: An online experiment.,"INTRODUCTION


Alcohol advertising is prevalent on social media. The current study sought to identify effective message types to pair with social media alcohol ads to minimise purchase intentions associated with exposure.
METHODS


A 6 (within) × 5 (between) randomised controlled experiment was conducted with n = 723 US participants. Participants viewed six unique social media alcohol ads and were randomised to view one of four message types (i.e. pro-drinking comments, anti-drinking comments, industry responsibility messages and health warning labels) associated with the ads or the control (i.e. no messages). Purchase intentions were measured after each ad exposure. Significant main and interactive effects were determined by two-level, random intercept hierarchical linear models.
RESULTS


Purchase intentions were significantly lower among participants who viewed anti-drinking comments relative to the control (P = 0.022) and warning labels (P = 0.016). Purchase intentions were significantly greater among participants who viewed pro-drinking comments and had a family history of alcohol use (P = 0.032) and among those who viewed warning labels and were previously exposed to alcohol depictions through family and friends' social media posts (P = 0.033).
DISCUSSION AND CONCLUSIONS


Anti-drinking messages, written by social media users, may be effective at reducing alcohol purchase intentions when posted as social media comments. Current industry responsibility messages had no effect, and caution may be needed if warning labels are applied to ads in this medium.",2021,"RESULTS


Purchase intentions were significantly lower among participants who viewed anti-drinking comments relative to the control (P = 0.022) and warning labels (P = 0.016).","['A 6 (within)\u2009×\u20095 (between) randomised controlled experiment was conducted with n = 723 US participants', 'Participants viewed six unique social media alcohol ads']",[],"['warning labels', 'alcohol purchase intentions']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517866', 'cui_str': '723'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",[],"[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",723.0,0.0115464,"RESULTS


Purchase intentions were significantly lower among participants who viewed anti-drinking comments relative to the control (P = 0.022) and warning labels (P = 0.016).","[{'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Noel', 'Affiliation': 'Department of Health Science, College of Health and Wellness, Johnson and Wales University, Providence, USA.'}]",Drug and alcohol review,['10.1111/dar.13262']
1663,33677827,Sulodexide in the treatment of patients with early stages of COVID-19: a randomized controlled trial.,"Background Sulodexide has pleiotropic properties within the vascular endothelium that can prove beneficial for the treatment of patients with COVID-19. We aimed to evaluate the effect of sulodexide when used in the early clinical stages of COVID-19. Methods In an outpatient setting, we conducted a randomized controlled trial with a parallel-group design. Including patients within three days of clinical onset, who were at a high risk of severe clinical progression due to chronic comorbidities. Participants were randomly assigned to receive an oral dose of sulodexide (500 LRU twice a day) or placebo for 21 days. Primary outcomes were need-length of hospitalization and need-length of oxygen support. Results Between June 5 and August 30, 2020, 243 patients were included in the per-protocol analysis. 124 of them received sulodexide, while 119 received placeboes. At 21 days follow-up, 17.7% patients required hospitalization in the sulodexide group compared to 29.4% in the placebo group, p=0.03. 29.8% required oxygen support in the sulodexide group vs 42% in the placebo group, p=0.05 and for fewer days [9 (7.2 SD) in the sulodexide group vs. 11.5 (9.6 SD) in the placebo group; p=0.02]. There was no between-group difference concerning the length of hospital stay. Interpretation Early intervention in COVID-19 patients with sulodexide reduced hospital admissions and oxygen support requirements. This has beneficial implications in the patient's well-being, making sulodexide a favorable medication until an effective vaccine or an antiviral becomes available. Funding Researcher independently initiated, partially funded by Alfasigma, Mexico. ISRCTN registry listed under ID ISRCTN59048638.",2021,"29.8% required oxygen support in the sulodexide group vs 42% in the placebo group, p=0.05 and for fewer days [9 (7.2 SD) in the sulodexide group vs. 11.5 (9.6 SD) in the placebo group; p=0.02].","['patients with early stages of COVID-19', 'COVID-19 patients with sulodexide reduced hospital admissions and oxygen support requirements', 'Results Between June 5 and August 30, 2020, 243 patients were included in the per-protocol analysis', 'patients with COVID-19']","['Sulodexide', 'placebo', 'sulodexide', 'sulodexide (500 LRU twice a day) or placebo', 'placeboes']","['length of hospital stay', 'need-length of hospitalization and need-length of oxygen support', 'oxygen support', 'hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0061450', 'cui_str': 'sulodexide'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0061450', 'cui_str': 'sulodexide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",243.0,0.652544,"29.8% required oxygen support in the sulodexide group vs 42% in the placebo group, p=0.05 and for fewer days [9 (7.2 SD) in the sulodexide group vs. 11.5 (9.6 SD) in the placebo group; p=0.02].","[{'ForeName': 'Alejandro Jose', 'Initials': 'AJ', 'LastName': 'Gonzalez Ochoa', 'Affiliation': 'IMSS Hospital general de zona No 12, General Surgery, San Luis rio colorado, Mexico.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Raffetto', 'Affiliation': 'VA Boston Healthcare System, Surgery, West Roxbury, United States.'}, {'ForeName': 'Ana Gabriela', 'Initials': 'AG', 'LastName': 'Hernandez Ibarra', 'Affiliation': 'CLINEDEM, Otorhinolaryngology, SAN LUIS rio colorado, Mexico.'}, {'ForeName': 'Nestor', 'Initials': 'N', 'LastName': 'Zavala', 'Affiliation': 'IMSS Hospital General de Zona No12, Director, San Luis Rio Colorado, Mexico.'}, {'ForeName': 'Obed', 'Initials': 'O', 'LastName': 'Gutierrez', 'Affiliation': 'IMSS Hospital General de Zona No12, - Emergency Department, San Luis rio colorado, Mexico.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Vargas', 'Affiliation': 'Urban out care center, Urban Outcare Center, San Luis rio colorado, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Loustaunau', 'Affiliation': 'Hospital General San Luis Rio Colorado, Emergency department, San Luis rio colorado, Mexico.'}]",Thrombosis and haemostasis,['10.1055/a-1414-5216']
1664,33677781,Examining the effect of obesity-associated gene variants on breast cancer survivors in a randomized weight loss intervention.,"PURPOSE


Our study examined whether common variants of obesity-associated genes FTO, MC4R, BDNF, and CREB1 moderated the effects of a lifestyle intervention on weight change among breast cancer survivors.
METHODS


151 breast cancer survivors with a body mass index ≥ 25 kg/m 2  were randomly assigned to a 6-month weight loss intervention or usual care group. Genotyping of FTO rs9939609, MC4R rs6567160, BDNF rs11030104, CREB1 rs17203016 was performed. Linear mixed models were used including the main effects of genotype (assuming a dominant genetic model), treatment arm on weight and percent body fat changes, and genotype by treatment interaction variable. All statistical tests were evaluated against a Bonferroni-corrected alpha of 0.0125.
RESULTS


Women in the intervention group achieved significantly greater weight loss than the usual care group (5.9% vs 0.4%, p < 0.001), regardless of genotype. Changes in weight and percent body fat did not differ significantly between carriers of the FTO rs9939609, MC4R rs6567160, BDNF rs11030104, and CREB1 rs17203016 risk alleles compared to non-carriers (p-interaction > 0.0125 for each single-nucleotide polymorphisms).
CONCLUSIONS


Women who are genetically predisposed to obesity and recently diagnosed with breast cancer may achieve significant and clinically meaningful weight loss through healthy eating and exercise.
CLINICAL TRIAL REGISTRATION


NCT02863887 (Date of Registration: August 11, 2016); NCT02110641 (Date of Registration: April 10, 2014).",2021,"Changes in weight and percent body fat did not differ significantly between carriers of the FTO rs9939609, MC4R rs6567160, BDNF rs11030104, and CREB1 rs17203016 risk alleles compared to non-carriers (p-interaction > 0.0125 for each single-nucleotide polymorphisms).
","['Women who are genetically predisposed to obesity and recently diagnosed with breast cancer', '151 breast cancer survivors with a body mass index\u2009≥\u200925\xa0kg/m 2', 'breast cancer survivors']","['lifestyle intervention', '6-month weight loss intervention or usual care group']","['weight loss', 'Genotyping of FTO rs9939609, MC4R rs6567160, BDNF rs11030104, CREB1', 'Changes in weight and percent body fat']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0527721', 'cui_str': 'MC4R protein, human'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C1447703', 'cui_str': 'CREB1 protein, human'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",151.0,0.0355977,"Changes in weight and percent body fat did not differ significantly between carriers of the FTO rs9939609, MC4R rs6567160, BDNF rs11030104, and CREB1 rs17203016 risk alleles compared to non-carriers (p-interaction > 0.0125 for each single-nucleotide polymorphisms).
","[{'ForeName': 'ThaiHien', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Yale School of Public Health, MPH, 55 Church Street, Suite 801, New Haven, CT, 06510, USA. thaihien.nguyen@yale.edu.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Yale School of Public Health, MPH, 55 Church Street, Suite 801, New Haven, CT, 06510, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Dewan', 'Affiliation': 'Yale School of Public Health, MPH, 55 Church Street, Suite 801, New Haven, CT, 06510, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale School of Public Health, MPH, 55 Church Street, Suite 801, New Haven, CT, 06510, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Yale School of Public Health, MPH, 55 Church Street, Suite 801, New Haven, CT, 06510, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ferrucci', 'Affiliation': 'Yale School of Public Health, MPH, 55 Church Street, Suite 801, New Haven, CT, 06510, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': 'Yale Cancer Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Yale School of Public Health, MPH, 55 Church Street, Suite 801, New Haven, CT, 06510, USA.'}, {'ForeName': 'Lingeng', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Yale School of Public Health, MPH, 55 Church Street, Suite 801, New Haven, CT, 06510, USA.'}, {'ForeName': 'Yasmmyn D', 'Initials': 'YD', 'LastName': 'Salinas', 'Affiliation': 'Yale School of Public Health, MPH, 55 Church Street, Suite 801, New Haven, CT, 06510, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-021-06151-5']
1665,33677771,Comparison of fibrosis regression of entecavir alone or combined with pegylated interferon alpha2a in patients with chronic hepatitis B.,"BACKGROUND AND AIMS


Antiviral treatment with necleos(t)ide analogues contributes to histological improvement and virologic response in chronic hepatitis B (CHB) patients. However, whether adding pegylated interferon alpha2a (Peg-IFN-α-2a) can help additional clinical benefit, particularly on fibrosis regression was still unknown.
METHODS


Chronic hepatitis B patients with pre-treatment biopsy-proven Ishak fibrosis score 2, 3 or 4 were randomly assigned to entecavir (ETV) alone or ETV plus Peg-IFN-α-2a (Peg-IFN-α-2a add-on) group (1:2 ratio). Post-treatment liver biopsy was performed at week 78. Fibrosis regression was defined as decrease in Ishak fibrosis score by ≥ 1 stage or predominantly regressive categorized by P-I-R score. Serum HBV DNA levels were assessed at baseline and every 26 weeks, while HBsAg and HBeAg were evaluated at baseline and every 52 weeks.
RESULTS


A total of 218 treatment-naive CHB patients were randomly assigned to ETV alone or Peg-IFN-α-2a add-on group. Totals of 155 patients (ETV alone: Peg-IFN-α-2a add-on, 47:108) were included in statistical analysis. Fibrosis regression rates were 68% (32/47) in the ETV alone and 56% (60/108) in Peg-IFN-α-2a add-on group (p = 0.144). Both groups showed a similar trend of virological suppression during the process of 104-week antiviral therapy (p = 0.132). HBeAg or HBsAg loss or seroconversion rates in the ETV alone group were lower than Peg-IFN-α-2a add-on group though without statistical significance.
CONCLUSIONS


Peg-IFN-α-2a add-on therapy did not yield additional fibrosis regression and virologic response than ETV alone therapy.",2021,"HBeAg or HBsAg loss or seroconversion rates in the ETV alone group were lower than Peg-IFN-α-2a add-on group though without statistical significance.
","['Chronic hepatitis B patients with pre-treatment biopsy-proven Ishak fibrosis score 2, 3 or 4', 'A total of 218 treatment-naive CHB patients', 'chronic hepatitis B (CHB) patients', '155 patients (ETV alone: Peg-IFN-α-2a add-on, 47:108', 'patients with chronic hepatitis B']","['ETV alone or Peg-IFN-α-2a add-on group', 'entecavir alone or combined with pegylated interferon alpha2a', 'entecavir (ETV) alone or ETV plus Peg-IFN-α-2a (Peg-IFN-α-2a', 'pegylated interferon alpha2a (Peg-IFN-α-2a']","['HBsAg and HBeAg', 'Ishak fibrosis score', 'Serum HBV DNA levels', 'virological suppression', 'HBeAg or HBsAg loss or seroconversion rates', 'Fibrosis regression rates']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}]",218.0,0.0257157,"HBeAg or HBsAg loss or seroconversion rates in the ETV alone group were lower than Peg-IFN-α-2a add-on group though without statistical significance.
","[{'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Jialing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Tongtong', 'Initials': 'T', 'LastName': 'Meng', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Bingqiong', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Pathology, Beijing You-an Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tailing', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xinyan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Ou', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Yameng', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China. sunyamenggo@163.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China. youhong30@sina.com.'}]",Hepatology international,['10.1007/s12072-021-10162-1']
1666,33677766,Connect through PLAY: a randomized-controlled trial in afterschool programs to increase adolescents' physical activity.,"The current study is a randomized controlled trial to test a novel 10-week climate-based intervention within pre-existing afterschool programs, designed to increase moderate-to-vigorous physical activity (MVPA) in underserved (low-income, minority status) middle school youth by addressing youth social developmental needs. Participants (n = 167; 56% female; 62% Black; 50% overweight/obese) enrolled in 6 middle schools were randomized to either the Connect through PLAY intervention or a wait-list control. Process evaluation measures (i.e., observations of external evaluators; staff surveys) indicated that essential elements were implemented with fidelity, and staff endorsed implementation ease/feasibility and acceptability. Regression analysis demonstrated that participation in the intervention (vs. control) was associated with an increase of 8.17 min of daily accelerometry-measured MVPA (56 min of additional weekly MVPA) at post-intervention controlling for baseline MVPA, school, gender, and weight status. The results provide support for social-motivational climate-based interventions for increasing MVPA in underserved youth that can inform future school-based health initiatives.Trial Registration: NCT03850821: https://clinicaltrials.gov/ct2/show/study/NCT03850821?term=NCT03850821&rank=1.",2021,"Regression analysis demonstrated that participation in the intervention (vs. control) was associated with an increase of 8.17 min of daily accelerometry-measured MVPA (56 min of additional weekly MVPA) at post-intervention controlling for baseline MVPA, school, gender, and weight status.","['167; 56% female; 62% Black; 50% overweight/obese) enrolled in 6 middle schools', 'underserved (low-income, minority status) middle school youth by addressing youth social developmental needs', 'Participants (n\u2009']",['Connect through PLAY intervention or a wait-list control'],"['moderate-to-vigorous physical activity (MVPA', ""adolescents' physical activity"", 'fidelity, and staff endorsed implementation ease/feasibility and acceptability']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0649417,"Regression analysis demonstrated that participation in the intervention (vs. control) was associated with an increase of 8.17 min of daily accelerometry-measured MVPA (56 min of additional weekly MVPA) at post-intervention controlling for baseline MVPA, school, gender, and weight status.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Zarrett', 'Affiliation': 'Department of Psychology, University of South Carolina, 1512 Pendleton Street, Columbia, SC, 29208, USA. zarrettn@mailbox.sc.edu.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Law', 'Affiliation': 'Department of Psychology, University of South Carolina, 1512 Pendleton Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of South Carolina, 1512 Pendleton Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Abraczinskas', 'Affiliation': 'Department of Family, Youth, and Community Sciences, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of South Carolina, 1512 Pendleton Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Brittany S', 'Initials': 'BS', 'LastName': 'Cook', 'Affiliation': 'Department of Psychology, University of South Carolina, 1512 Pendleton Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychology, University of South Carolina, 1512 Pendleton Street, Columbia, SC, 29208, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00206-0']
1667,33677694,"Muscular HSP70 content is higher in elderly compared to young, but is normalized after 12 weeks of strength training.","PURPOSE


Aging is associated with increased myocellular stress and loss of muscle mass and function. Heat shock proteins (HSPs) are upregulated during periods of stress as part of the cells protective system. Exercise can affect both acute HSP regulation and when repeated regularly counteract unhealthy age-related changes in the muscle. Few studies have investigated effects of exercise on HSP content in elderly. The aim of the study was to compare muscular HSP levels in young and elderly and to investigate how training affects HSP content in muscles from aged males and females.
METHODS


Thirty-eight elderly were randomized to 12 weeks of strength training (STG), functional strength training (FTG) or a control group (C). To compare elderly to young, 13 untrained young performed 11 weeks of strength training (Y). Muscle biopsies were collected before and after the intervention and analyzed for HSP27, αB-crystallin and HSP70.
RESULTS


Baseline HSP70 were 35% higher in elderly than in young, whereas there were no differences between young and elderly in HSP27 or αB-crystallin. After the training intervention, HSP70 were reduced in STG (- 33 ± 32%; P = 0.001) and FTG (- 28 ± 30%; P = 0.012). The decrease in HSP70 was more pronounced in the oldest. In contrast, Y increased HSP27 (134 ± 1%; P < 0.001) and αB-crystallin (84 ± 94%; P = 0.008).
CONCLUSION


Twelve weeks of STG or FTG decreased the initial high levels of HSP70 in aged muscles. Thus, regular strength training can normalize some of the increases in cellular stress associated with normal aging, and lead to a healthier cellular environment in aged muscle cells.",2021,"In contrast, Y increased HSP27 (134 ± 1%; P < 0.001) and αB-crystallin (84 ± 94%; P = 0.008).
","['young and elderly', 'elderly to young, 13 untrained young performed 11\xa0weeks of strength training (Y', 'Thirty-eight elderly', 'muscles from aged males and females', 'elderly']","['regular strength training', 'Heat shock proteins (HSPs', 'STG or FTG', 'strength training (STG), functional strength training (FTG) or a control group (C']","['HSP27', 'muscular HSP levels', 'HSP70', 'acute HSP regulation', 'Muscular HSP70 content']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018850', 'cui_str': 'Heat-Shock Protein'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018847', 'cui_str': 'Heat-Shock Protein 27'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0018850', 'cui_str': 'Heat-Shock Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243043', 'cui_str': 'Heat-Shock Proteins 70'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",38.0,0.0130242,"In contrast, Y increased HSP27 (134 ± 1%; P < 0.001) and αB-crystallin (84 ± 94%; P = 0.008).
","[{'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Cumming', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Ullevål Stadion, P.O. 4014, 0806, Oslo, Norway. kristoffer.t.cumming@hiof.no.'}, {'ForeName': 'N H', 'Initials': 'NH', 'LastName': 'Kvamme', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Ullevål Stadion, P.O. 4014, 0806, Oslo, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schaad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Ullevål Stadion, P.O. 4014, 0806, Oslo, Norway.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ugelstad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Ullevål Stadion, P.O. 4014, 0806, Oslo, Norway.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Ullevål Stadion, P.O. 4014, 0806, Oslo, Norway.'}]",European journal of applied physiology,['10.1007/s00421-021-04633-4']
1668,33677626,Gelatinisation and milling whole-wheat increases postprandial blood glucose: randomised crossover study of adults with type 2 diabetes.,"AIMS/HYPOTHESES


We examined the effects of milling and cooking whole grains in water to achieve starch gelatinisation on postprandial blood glucose using a randomised crossover open-label design. Participants were adults with type 2 diabetes whose body weight or medications had not changed in at least 3 months.
METHODS


Postprandial blood glucose (measured as incremental AUC [iAUC]) was measured following consumption of four nutrient-matched whole-wheat porridge test-meals. Test-meals included gelatinised or native starch and were made with either finely milled or intact whole-wheat.
RESULTS


Eighteen adults (63.1 ± 9.8 years, HbA 1c  57.0 ± 11.5 mmol/mol [7.4 ± 3.2%]) completed the study. iAUC was higher following cooked meals (gelatinised starch) than following uncooked meals (native starch) (mean difference [MD] 268, 95% CI 188, 348 mmol/l × min). Consuming finely milled whole-wheat produced a higher iAUC compared with intact whole-wheat (MD 173, 95% CI 80, 266 mmol/l × min). There was no evidence of an interaction effect (p = 0.841).
CONCLUSIONS


Both the nature of starch and the grain structure of whole-wheat influence the glycaemic response of adults with type 2 diabetes mellitus.
FUNDING


Baking Industry Research Trust of New Zealand and the Riddet Centre of Research Excellence.
TRIAL REGISTRATION


www.anzctr.org.au ACTRN12617000328370.",2021,iAUC was higher following cooked meals (gelatinised starch) than following uncooked meals (native starch) (mean difference [MD],"['adults with type 2 diabetes mellitus', 'Eighteen adults (63.1\xa0±\u20099.8\xa0years, HbA 1c  57.0\u2009±\u200911.5\xa0mmol/mol [7.4\u2009±\u20093.2%]) completed the study', 'adults with type 2 diabetes', 'Participants were adults with type 2 diabetes whose body weight or medications had not changed in at least 3\xa0months']","['Test-meals included gelatinised or native starch and were made with either finely milled or intact whole-wheat', 'Gelatinisation and milling whole-wheat', 'milling and cooking whole grains']","['glycaemic response', 'Postprandial blood glucose (measured as incremental AUC [iAUC', 'postprandial blood glucose', 'iAUC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",18.0,0.0632002,iAUC was higher following cooked meals (gelatinised starch) than following uncooked meals (native starch) (mean difference [MD],"[{'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Elbalshy', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Reynolds', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Mete', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Indrawati', 'Initials': 'I', 'LastName': 'Oey', 'Affiliation': 'Riddet Institute, Palmerston North, New Zealand.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Silcock', 'Affiliation': 'Riddet Institute, Palmerston North, New Zealand.'}, {'ForeName': 'Jillian J', 'Initials': 'JJ', 'LastName': 'Haszard', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Perry', 'Affiliation': 'Division of Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Te Morenga', 'Affiliation': 'Riddet Institute, Palmerston North, New Zealand. l.temorenga@massey.ac.nz.'}]",Diabetologia,['10.1007/s00125-021-05400-y']
1669,33677616,A pharmacologically-based approach to high dose methotrexate administration to investigate nephrotoxicity and acute kidney injury biomarkers in children and adolescents with newly diagnosed osteosarcoma.,"PURPOSE


High dose methotrexate (HDMTX) acute kidney injury (AKI) results in prolonged hospitalization and treatment delays. Using a pharmacologically-based approach, HDMTX was administered with standard combination therapy to patients with osteosarcoma; nephrotoxicity was assessed.
METHODS


Patients were randomized by cycle to 4 h or 12 h HDMTX (12 g/m 2 ) infusions administered with hydration, alkalization and leucovorin rescue. Urinalysis, AKI biomarkers, and estimated glomerular filtration rate using serum creatinine or cystatin C (GFR Cr  or GFR cysC ) were obtained. Serum and urine methotrexate concentrations [MTX] were measured.
RESULTS


Patients (n = 12), median (range) age 12.4 (5.7-19.2) years were enrolled; 73 MTX infusions were analyzed. Median (95% Confidence Interval) serum and urine [MTX] were 1309 (1190, 1400) µM and 16.4 (14.7, 19.4) mM at the end of 4 h infusion and 557 (493, 586) µM and 11.1 (9.9, 21.1) mM at the end of 12 h infusion. Time to serum [MTX] < 0.1 µM was 83 (80.7, 90.7) h and 87 (82.8, 92.4) h for 4 and 12 h infusions. GFR Cr  was highly variable, increased after cisplatin, and exceeded 150 ml/min/1.73 m 2 . GFR cysC  was less variable and decreased at the end of therapy. AKI biomarkers were elevated indicating acute tubular dysfunction, however, did not differ between 4 and 12 h infusions. Radiographic and histological response were similar for patients receiving 4 h or 12 h infusions; the median percent tumor necrosis was > 95%.
CONCLUSIONS


Reducing peak serum and urine MTX concentration by prolonging the infusion duration did not alter risk of acute kidney injury. GFR cysC  was decreased at the end of therapy. Proteinuria and elevations in AKI biomarkers indicate that direct tubular damage contributes to HDMTX nephrotoxicity.
CLINICAL TRIAL


NCT01848457.",2021,"Radiographic and histological response were similar for patients receiving 4 h or 12 h infusions; the median percent tumor necrosis was > 95%.
","['children and adolescents with newly diagnosed osteosarcoma', 'Patients (n\u2009=\u200912), median (range) age 12.4 (5.7-19.2) years were enrolled; 73 MTX infusions were analyzed', 'Patients']","['methotrexate (HDMTX', 'HDMTX (12\xa0g/m 2 ) infusions administered with hydration, alkalization and leucovorin rescue', 'methotrexate', 'cisplatin', 'HDMTX']","['GFR Cr', 'median percent tumor necrosis', 'serum and urine [MTX', 'Urinalysis, AKI biomarkers, and estimated glomerular filtration rate using serum creatinine or cystatin C (GFR Cr  or GFR cysC ', 'Serum and urine methotrexate concentrations [MTX', 'peak serum and urine MTX concentration', 'Radiographic and histological response', 'GFR cysC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0333516', 'cui_str': 'Tumor necrosis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}]",,0.151551,"Radiographic and histological response were similar for patients receiving 4 h or 12 h infusions; the median percent tumor necrosis was > 95%.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fox', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA. elizabeth.fox@stjude.org.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Busch', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'DeBernardo', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.""}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Segers', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gottschalk', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Womer', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Balamuth', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.""}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Bagatell', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Balis', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.""}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-021-04248-8']
1670,33677529,Using a population health management approach to enroll participants in a diabetes prevention trial: reach outcomes from the PREDICTS randomized clinical trial.,"Population health management (PHM) strategies to address diabetes prevention have the potential to engage large numbers of at-risk individuals in a short duration. We examined a PHM approach to recruit participants to a diabetes prevention clinical trial in a metropolitan health system. We examined reach and representativeness and assessed differences from active and passive respondents to recruitment outreach, and participants enrolled through two clinical screening protocols. The PHM approach included an electronic health record (EHR) query, physician review of identified patients, letter invitation, and telephone follow-up. Data describe the reach and representativeness of potential participants at multiple stages during the recruitment process. Subgroup analyses examined proportional reach, participant differences based on passive versus active recruitment response, and clinical screening method used to determine diabetes risk status. The PHM approach identified 10,177 potential participants to receive a physician letter invitation, 60% were contacted by telephone, 2,796 (46%) completed telephone screening, 1,961 were eligible from telephone screen, and 599 were enrolled in 15 months. Accrual was unaffected by shifting clinical screening protocols despite the increase in participant burden. Relative to census data, study participants were more likely to be obese, female, older, and Caucasian. Relative to the patient population, enrolled participants were less likely to be Black and were older. Active respondents were more likely to have a higher income than passive responders. PHM strategies have the potential to reach a large number of participants in a relatively short period, though concerted efforts are needed to increase participant diversity.",2021,"PHM strategies have the potential to reach a large number of participants in a relatively short period, though concerted efforts are needed to increase participant diversity.","['10,177 potential participants to receive a physician letter invitation, 60% were contacted by telephone, 2,796 (46%) completed telephone screening, 1,961 were eligible from telephone screen, and 599 were enrolled in 15 months', 'participants to a diabetes prevention clinical trial in a metropolitan health system']",[],[],"[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",[],[],,0.029366,"PHM strategies have the potential to reach a large number of participants in a relatively short period, though concerted efforts are needed to increase participant diversity.","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Wilson', 'Affiliation': 'Department of Kinesiology and Health, College of Education and Human Development, Georgia State University, Sports Arena, Atlanta, GA, USA.'}, {'ForeName': 'Tzeyu L', 'Initials': 'TL', 'LastName': 'Michaud', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Almeida', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Schwab', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Gwenndolyn C', 'Initials': 'GC', 'LastName': 'Porter', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Aquilina', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Fabiana A', 'Initials': 'FA', 'LastName': 'Brito', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Caitlin A', 'Initials': 'CA', 'LastName': 'Golden', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Emily V', 'Initials': 'EV', 'LastName': 'Dressler', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Kittel', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Lea N', 'Initials': 'LN', 'LastName': 'Harvin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Boggs', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Katula', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibab010']
1671,33677353,A randomized controlled trial of a brief behavioral intervention to reduce skin and soft tissue infections among people who inject drugs.,"BACKGROUND


People who inject drugs (PWID) are at high risk for skin and soft tissue infections (SSTIs), but few interventions have targeted their reduction. The goal of the current study was to test the effects of a brief skin and needle hygiene behavioral intervention (SKIN) in a two-group randomized controlled trial with 12-month follow-up.
METHOD


PWID (N = 252) were recruited from inpatient hospital units at a single urban medical center site and randomly assigned to an assessment-only (AO) condition or SKIN, which was a two-session intervention that included psychoeducation, behavioral skills demonstrations, and motivational interviewing. Mixed effects generalized linear models assessed the impact of the intervention on frequency of: 1) self-reported SSTIs, 2) uncleaned skin injections, and 3) injection.
RESULTS


Participants were 58.3 % male, 59.5 % White, and averaged 38 years of age. SKIN participants had 35 % fewer SSTIs compared to AO (p = .179), a difference of nearly one infection per year. The mean rate of uncleaned skin injections was about 66 % lower (IRR = 0.34, 95 % CI 0.20; 0.59, p < .001) among SKIN participants compared to AO. Almost one-third of participants reported no injection over follow-up and the mean rate of injection during follow-up was about 39 % lower (IRR = 0.61; 95 % CI 0.36; 1.02, p = .058) among persons randomized to SKIN than AO.
CONCLUSIONS


The SKIN intervention reduced uncleaned skin injections but did not reduce SSTIs significantly more than a control condition. Brief interventions can improve high-risk practices among PWID and lead to clinically meaningful outcomes.",2021,"SKIN participants had 35 % fewer SSTIs compared to AO (p = .179), a difference of nearly one infection per year.","['people who inject drugs', 'PWID (N = 252) were recruited from inpatient hospital units at a single urban medical center site and randomly assigned to an', 'People who inject drugs (PWID', 'Participants were 58.3 % male, 59.5 % White, and averaged 38 years of age']","['assessment-only (AO) condition or SKIN, which was a two-session intervention that included psychoeducation, behavioral skills demonstrations, and motivational interviewing', 'brief skin and needle hygiene behavioral intervention (SKIN', 'behavioral intervention']","['mean rate of injection', 'skin and soft tissue infections', 'uncleaned skin injections', 'frequency of: 1) self-reported SSTIs, 2) uncleaned skin injections, and 3) injection', 'mean rate of uncleaned skin injections']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0191386', 'cui_str': 'Injection of skin'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",252.0,0.0747917,"SKIN participants had 35 % fewer SSTIs compared to AO (p = .179), a difference of nearly one infection per year.","[{'ForeName': 'Kristina T', 'Initials': 'KT', 'LastName': 'Phillips', 'Affiliation': 'Center for Integrated Health Care Research, Kaiser Permanente Hawaii, Honolulu, HI, 96817, United States. Electronic address: Kristina.T.Phillips@kp.org.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Boston University School of Public Health, Boston, MA, 02118, United States.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, 02906, United States.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Liebschutz', 'Affiliation': 'Division of General Internal Medicine, Center for Research on Health Care, University of Pittsburgh, Pittsburgh, PA, 15213, United States.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Herman', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, 02906, United States; Warren Alpert Medical School of Brown University, Providence, RI, 02912, United States.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Boston University School of Public Health, Boston, MA, 02118, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108646']
1672,33677189,Effect of liraglutide 3.0mg treatment on weight reduction in obese antipsychotic-treated patients.,"BACKGROUND


Patients treated with antipsychotics experience significant weight gain and accompanying metabolic disorders. We investigated the efficacy of liraglutide 3.0 mg in reducing the weight of antipsychotic-treated obese patients.
METHOD


We retrospectively reviewed 16 obese patients with schizophrenia or bipolar disorder who were treated with 3.0 mg of liraglutide each. During the 16 weeks of treatment, changes in body weight and Clinical Global Impression-Severity scale (CGI-S) were analyzed. The participants were divided into responders (lost at least 5% of body weight) and non-responders for analysis.
RESULTS


Treatment with liraglutide 3.0 mg significantly decreased body weight (estimated marginal mean, 93.2 kg at baseline and 88.9 kg at 16 weeks; p < 0.001) as well as waist circumference, BMI and plasma glucose levels. Six of 16 patients (37.5%) complained of a modest degree of nausea. Six of the 12 subjects (50%) completing 16 weeks of treatment were responders. There were no significant differences in baseline characteristics between responders and non-responders. There was no worsening of CGI-S scores.
CONCLUSION


Liraglutide 3.0 mg significantly decreased body weight in obese patients treated with antipsychotics without altering the status of psychiatric diseases. A randomized controlled study is required to corroborate the results of this study.",2021,"During the 16 weeks of treatment, changes in body weight and Clinical Global Impression-Severity scale (CGI-S) were analyzed.","['16 obese patients with schizophrenia or bipolar disorder who were treated with 3.0 mg of liraglutide each', 'obese antipsychotic-treated patients', 'treated obese patients', 'Patients treated with antipsychotics experience significant weight gain and accompanying metabolic disorders', 'obese patients treated with']","['liraglutide', 'Liraglutide', 'antipsychotics']","['weight reduction', 'weight of antipsychotic', 'changes in body weight and Clinical Global Impression-Severity scale (CGI-S', 'body weight', 'nausea', 'CGI-S scores', 'waist circumference, BMI and plasma glucose levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",16.0,0.0244782,"During the 16 weeks of treatment, changes in body weight and Clinical Global Impression-Severity scale (CGI-S) were analyzed.","[{'ForeName': 'Seung Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.'}, {'ForeName': 'Nam Young', 'Initials': 'NY', 'LastName': 'Lee', 'Affiliation': 'Department of Neuropsychiatry, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.'}, {'ForeName': 'Se Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung-Ah', 'Initials': 'KA', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.'}, {'ForeName': 'Yong Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Nowon Eulji Hospital, Eulji University College of Medicine, Seoul, South Korea; Institute of Clinical Psychopharmacology, Dongguk University College of Medicine, Goyang, Gyeonggi-do, South Korea. Electronic address: kys@snu.ac.kr.'}]",Psychiatry research,['10.1016/j.psychres.2021.113830']
1673,33677183,Evaluation of MADRS severity thresholds in patients with bipolar depression.,"BACKGROUND


The Montgomery-Åsberg Depression Rating Scale (MADRS) is commonly used to assess depression symptom changes in clinical trials; however, the score itself can be difficult to interpret without clinical context. Categories of depression severity corresponding to MADRS total score have not been established for bipolar depression, which was the objective of this study.
METHODS


Data were pooled from 3 randomized, double-blind, placebo-controlled trials of cariprazine in patients with bipolar I depression; placebo and cariprazine arms were pooled. An anchor-based approach was used to map MADRS total score to the clinician-rated, 7-category Clinical Global Impression of Severity scale (CGI-S). Spearman's correlation coefficient was used to assess associations between MADRS total and CGI-S scores. Optimal MADRS severity thresholds for each CGI-S category was determined via Youden index using receiver operating characteristic (ROC) analyses.
RESULTS


Using data from 1523 patients with bipolar depression, mean MADRS total scores were positively correlated with mean CGI-S scores at week 6 (r = 0.87; P<.0001). Using ROC curves, MADRS severity thresholds corresponding to each CGI-S category were estimated with high sensitivity and specificity: 0-6 for ""normal, not at all ill"", 7-12 for ""borderline mentally ill"", 13-18 for ""mildly ill"", 19-23 for ""moderately ill"", 24-36 for ""markedly ill"", 37-39 for ""severely ill"", and ≥40 for ""extremely ill"".
CONCLUSIONS


Utilizing data from 3 clinical trials of patients with bipolar depression, MADRS severity thresholds were identified. These empirical findings may help clinicians contextualize MADRS results from bipolar clinical research and apply to their practice.
TRIAL REGISTRATION


clinicaltrials.gov NCT01396447, NCT02670538, NCT02670551.",2021,"Using ROC curves, MADRS severity thresholds corresponding to each CGI-S category were estimated with high sensitivity and specificity: 0-6 for ""normal, not at all ill"", 7-12 for ""borderline mentally ill"", 13-18 for ""mildly ill"", 19-23 for ""moderately ill"", 24-36 for ""markedly ill"", 37-39 for ""severely ill"", and ≥40 for ""extremely ill"".
CONCLUSIONS


Utilizing data from 3 clinical trials of patients with bipolar depression, MADRS severity thresholds were identified.","['patients with bipolar I depression', 'patients with bipolar depression', '1523 patients with bipolar depression']","['cariprazine', 'placebo and cariprazine', 'placebo']","['mean CGI-S scores', 'mean MADRS total scores', 'MADRS total and CGI-S scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C2936870', 'cui_str': 'cariprazine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",1523.0,0.297799,"Using ROC curves, MADRS severity thresholds corresponding to each CGI-S category were estimated with high sensitivity and specificity: 0-6 for ""normal, not at all ill"", 7-12 for ""borderline mentally ill"", 13-18 for ""mildly ill"", 19-23 for ""moderately ill"", 24-36 for ""markedly ill"", 37-39 for ""severely ill"", and ≥40 for ""extremely ill"".
CONCLUSIONS


Utilizing data from 3 clinical trials of patients with bipolar depression, MADRS severity thresholds were identified.","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA. Electronic address: thase@pennmedicine.upenn.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Harrington', 'Affiliation': 'AbbVie, Irvine, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Calabrese', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Mehul D', 'Initials': 'MD', 'LastName': 'Patel', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2021.02.043']
1674,33685920,Effect of the OPTIMAL programme on self-management of multimorbidity in primary care: a randomised controlled trial.,"BACKGROUND


Effective primary care interventions for multimorbidity are needed.
AIM


To evaluate the effectiveness of a group-based, 6-week, occupational therapy-led self-management support programme (OPTIMAL) for patients with multimorbidity.
DESIGN AND SETTING


A pragmatic parallel randomised controlled trial across eight primary care teams in Eastern Ireland with 149 patients with multimorbidity, from November 2015 to December 2018. Intervention was OPTIMAL with a usual care comparison.
METHOD


Primary outcomes were health-related quality of life (EQ-5D-3L) and frequency of activity participation (Frenchay Activities Index [FAI]). Secondary outcomes included independence in activities of daily living, occupational performance and satisfaction, anxiety and depression, self-efficacy, and healthcare utilisation. Complete case linear regression analyses were conducted. Age (<65/≥65 years) and the number of chronic conditions (<4/≥4) were explored further.
RESULTS


A total of 124 (83.2%) and 121 (81.2%) participants had complete data at immediate and 6-month post-intervention follow-up, respectively. Intervention participants had significant improvement in EQ-VAS (visual analogue scale) at immediate follow-up (adjusted mean difference [aMD] = 7.86; 95% confidence interval [CI] = 0.92 to 14.80) but no difference in index score (aMD = 0.04; 95% CI = -0.06 to 0.13) or FAI (aMD = 1.22; 95% CI = -0.84 to 3.29). At 6-month follow-up there were no differences in primary outcomes and mixed results for secondary outcomes. Pre-planned subgroup analyses suggested participants aged <65 years were more likely to benefit.
CONCLUSION


OPTIMAL was found to be ineffective in improving health-related quality of life or activity participation at 6-month follow-up. Existing multimorbidity interventions tend to focus on older adults; preplanned subgroup analyses results in the present study suggest that future research should target younger adults (<65 years) with multimorbidity.",2020,Intervention participants had significant improvement in EQ-VAS (visual analogue scale) at immediate follow-up (adjusted mean difference [aMD] = 7.86; 95% confidence interval [CI] = 0.92 to 14.80) but no difference in index score (aMD = 0.04; 95% CI = -0.06 to 0.13) or FAI (aMD = 1.22; 95% CI = -0.84 to 3.29).,"['eight primary care teams in Eastern Ireland with 149 patients with multimorbidity, from November 2015 to December 2018', 'older adults', 'younger adults (<65 years) with multimorbidity', 'multimorbidity in primary care', 'Age (<65/≥65 years) and the number of chronic conditions (<4/≥4) were explored further', 'patients with multimorbidity']",['occupational therapy-led self-management support programme'],"['health-related quality of life or activity participation', 'health-related quality of life (EQ-5D-3L) and frequency of activity participation (Frenchay Activities Index [FAI', 'index score', 'independence in activities of daily living, occupational performance and satisfaction, anxiety and depression, self-efficacy, and healthcare utilisation', 'EQ-VAS (visual analogue scale']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",149.0,0.154983,Intervention participants had significant improvement in EQ-VAS (visual analogue scale) at immediate follow-up (adjusted mean difference [aMD] = 7.86; 95% confidence interval [CI] = 0.92 to 14.80) but no difference in index score (aMD = 0.04; 95% CI = -0.06 to 0.13) or FAI (aMD = 1.22; 95% CI = -0.84 to 3.29).,"[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': ""O'Toole"", 'Affiliation': ""Discipline of Occupational Therapy, School of Medicine, Trinity College Dublin, St James's Hospital, Dublin.""}, {'ForeName': 'Deidre', 'Initials': 'D', 'LastName': 'Connolly', 'Affiliation': ""Discipline of Occupational Therapy, School of Medicine, Trinity College Dublin, St James's Hospital, Dublin.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Boland', 'Affiliation': 'Data Science Centre, Royal College of Surgeons in Ireland, Dublin.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X714185']
1675,33685898,"A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Biapenem in Healthy Adult Subjects.","The pharmacokinetics and safety of biapenem were studied in 36 healthy adult subjects in a randomized, placebo-controlled, double blind, sequential single and multiple-ascending dose study using doses from 250 to 1250 mg administered three times a day using 3-hour infusions. Maximum concentrations for biapenem were achieved at the end of the 3-hour infusion. Biapenem exposure (AUC) increased in a slightly greater than dose-proportional manner following single and multiple doses with no evidence of accumulation with multiple doses. Plasma AUCs increased from 18 mg*h/L at 250 mg to 150 mg*h/L at 1250 mg. Urinary recovery ranged from 14.2% at 250 mg to 42.3% at 1250 mg. Biapenem was well tolerated up to 1000 mg administered every 8 hours by 3-hour infusion for 7 days; however, a higher incidence of nausea, vomiting, and rash was reported at 1250 mg. There were no serious adverse events (SAEs) reported following either single or multiple doses of biapenem and all AEs were mild or moderate in severity.",2021,There were no serious adverse events (SAEs) reported following either single or multiple doses of biapenem and all AEs were mild or moderate in severity.,"['Healthy Adult Subjects', '36 healthy adult subjects']",['placebo'],"['Safety, Tolerability, and Pharmacokinetics of Biapenem', 'Biapenem exposure (AUC', 'Plasma AUCs', 'Maximum concentrations for biapenem', 'serious adverse events (SAEs', 'pharmacokinetics and safety of biapenem', 'nausea, vomiting, and rash', 'Urinary recovery']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0209475', 'cui_str': 'biapenem'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",36.0,0.10709,There were no serious adverse events (SAEs) reported following either single or multiple doses of biapenem and all AEs were mild or moderate in severity.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Griffith', 'Affiliation': 'Qpex Biopharma, Inc, San Diego, CA.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Morgan', 'Affiliation': 'Qpex Biopharma, Inc, San Diego, CA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Dudley', 'Affiliation': 'Qpex Biopharma, Inc, San Diego, CA.'}, {'ForeName': 'Jeffery S', 'Initials': 'JS', 'LastName': 'Loutit', 'Affiliation': 'Qpex Biopharma, Inc, San Diego, CA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02612-20']
1676,33685874,Scaling Up Patient-Centered Interdisciplinary Care for Multimorbidity: A Pragmatic Mixed-Methods Randomized Controlled Trial.,"PURPOSE


To measure the effectiveness of a 4-month interdisciplinary multifaceted intervention based on a change in care delivery for patients with multimorbidity in primary care practices.
METHODS


A pragmatic randomized controlled trial with a mixed-methods design in patients aged 18 to 80 years with 3 or more chronic conditions from 7 family medicine groups (FMGs) in Quebec, Canada. Health care professionals (nurses, nutritionists, kinesiologists) from the FMGs were trained to deliver the patient-centered intervention based on a motivational approach and self-management support. Primary outcomes: self-management (Health Education Impact Questionnaire); and self-efficacy.
SECONDARY OUTCOMES


health status, quality of life, and health behaviors. Quantitative analyses used multi-level mixed effects and generalized linear mixed models controlling for clustering within FMGs. We also conducted in-depth interviews with patients, family members, and health care professionals.
RESULTS


The trial randomized 284 patients (144 in intervention group, 140 in control group). The groups were comparable. After 4 months, the intervention showed a neutral effect for the primary outcomes. There was significant improvement in 2 health behaviors (healthy eating with odds ratios [OR] 4.36;  P  = .006, and physical activity with OR 3.43;  P  = .023). The descriptive qualitative evaluation revealed that the patients reinforced their self-efficacy and improved their self-management which was divergent from the quantitative results.
CONCLUSIONS


Quantitatively, this intervention showed a neutral effect on the primary outcomes and substantial improvement in 2 health behaviors as secondary outcomes. Qualitatively, the intervention was evaluated as positive. The combination of qualitative and quantitative designs proved to be a good design for evaluating this complex intervention.",2021,There was significant improvement in 2 health behaviors (healthy eating with odds ratios [OR] 4.36;  ,"['patients aged 18 to 80 years with 3 or more chronic conditions from 7 family medicine groups (FMGs) in Quebec, Canada', 'depth interviews with patients, family members, and health care professionals', 'patients with multimorbidity in primary care practices', '284 patients (144 in intervention group, 140 in control group']",['interdisciplinary multifaceted intervention'],"['self-management (Health Education Impact Questionnaire); and self-efficacy', 'health status, quality of life, and health behaviors', '2 health behaviors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",284.0,0.0946831,There was significant improvement in 2 health behaviors (healthy eating with odds ratios [OR] 4.36;  ,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fortin', 'Affiliation': ''}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Ngangue', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Almirall', 'Affiliation': ''}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Bélanger', 'Affiliation': ''}, {'ForeName': 'Judith Belle', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Couture', 'Affiliation': ''}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Gallagher', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Katz', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Loignon', 'Affiliation': ''}, {'ForeName': 'Bridget L', 'Initials': 'BL', 'LastName': 'Ryan', 'Affiliation': ''}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sampalli', 'Affiliation': ''}, {'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Merrick', 'Initials': 'M', 'LastName': 'Zwarenstein', 'Affiliation': ''}]",Annals of family medicine,['10.1370/afm.2650']
1677,33685873,Continuity of Cancer Care and Collaboration Between Family Physicians and Oncologists: Results of a Randomized Clinical Trial.,"PURPOSE


Collaboration between family physicians (FPs) and oncologists can be challenging. We present the results of a randomized clinical trial of an intervention designed to improve continuity of care and interprofessional collaboration, as perceived by patients with lung cancer and their FPs.
METHODS


The intervention included (1) supplying FPs with standardized summaries related to each patient, (2) recommending that patients see their FP after receiving the cancer diagnosis, (3) supplying the oncology team with patient information resulting from FP visits, and (4) providing patients with priority access to FPs as needed. A total of 206 patients with newly diagnosed lung cancer were randomly assigned to the intervention (n = 104) or control group (n = 102), and 86.4% of involved FPs participated. Perceptions of continuity of care and interprofessional collaboration were assessed every 3 months for patients and at baseline and at the end of the study for FPs. Patient distress and health service utilization were also assessed.
RESULTS


Patients and FPs in the intervention group perceived better interprofessional collaboration (patients:  P  <.0001; FPs:  P  = .0006) than those in the control group. Patients reported better informational continuity ( P  = .001) and management continuity ( P  = .05) compared to the control group, but no differences were found for FPs (information:  P  = .22; management:  P  = .13). No effect was found with regard to patient distress or health service utilization.
CONCLUSIONS


This intervention improved patient and FP perception of interprofessional collaboration, but its effectiveness on continuity of care was less clear for FPs than for patients. Additional strategies should be considered to sustainably improve continuity of care and interprofessional collaboration.",2021,"Patients reported better informational continuity ( P  = .001) and management continuity ( P  = .05) compared to the control group, but no differences were found for FPs (information:  P  = .22; management:  P  = .13).","['206 patients with newly diagnosed lung cancer', 'patients with lung cancer and their FPs']","['supplying FPs with standardized summaries related to each patient, (2) recommending that patients see their FP after receiving the cancer diagnosis, (3) supplying the oncology team with patient information resulting from FP visits, and (4) providing patients with priority access to FPs']","['Patient distress and health service utilization', 'patient distress or health service utilization', 'informational continuity', 'management continuity', 'interprofessional collaboration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",206.0,0.0407743,"Patients reported better informational continuity ( P  = .001) and management continuity ( P  = .05) compared to the control group, but no differences were found for FPs (information:  P  = .22; management:  P  = .13).","[{'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Aubin', 'Affiliation': ''}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Vézina', 'Affiliation': ''}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Verreault', 'Affiliation': ''}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Simard', 'Affiliation': ''}, {'ForeName': 'Éveline', 'Initials': 'É', 'LastName': 'Hudon', 'Affiliation': ''}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Desbiens', 'Affiliation': ''}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Fillion', 'Affiliation': ''}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Dumont', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Tourigny', 'Affiliation': ''}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Daneault', 'Affiliation': ''}]",Annals of family medicine,['10.1370/afm.2643']
1678,33685839,"Efficacy and Safety of Avanafil in Chinese Subjects With Erectile Dysfunction: A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial.","INTRODUCTION


The incidence of erectile dysfunction (ED) increases with age in mainland China and phosphodiesterase 5 inhibitors (PDE5i) are the major drugs used for its treatment.
AIM


To determine the efficacy and safety of Chinese developed avanafil as therapy for ED in China.
METHODS


This phase III trial was carried out in 7 medical centers in China. Eligible subjects suffering from ED were allocated randomly into 3 groups (ratio 1:1:1) and orally received a placebo, 100 or 200 mg avanafil for a total of 12 weeks.
MAIN OUTCOME MEASURES


The primary endpoint was changes in erectile function (EF) domain scores according to the International Index of EF (IIEF) questionnaire from baseline to week 12 of therapy. Secondary endpoints assessments were changes in the response rates of SEP, Q2 and Q3; changes in IIEF other domain scores. Safety evaluation monitored treatment-emergent adverse events (TEAEs), serious TEAEs, laboratory test results, vital signs and electrocardiographs.
RESULTS


Of 218 randomized ED subjects, 182 (83.5%) completed the study. After 12-week therapy, alterations from baseline of the mean IIEF-EF domain scores in the 100 mg and 200 mg groups were greater than for the placebo (all P < .05) group. The changes in mean SEP Q2 response rates from baseline to week 12 in the placebo, 100 mg and 200 mg groups were 5.4%, 22.3% and 22.1%, and SEP Q3 response rate were 22.7%, 42.6% and 38.1%, respectively. Avanafil treatment (regardless of dose) improved EF vs placebo for most of other secondary efficacy endpoints studied (all P < .05). No differences were detected in efficacy endpoints between the 100 and 200 mg dosage groups (all P > .05) or in the incidence of TEAEs and drug-related TEAEs among the 3 groups (all P > .05).
CONCLUSION


Avanafil (100 or 200 mg) was effective and generally well tolerated in Chinese subjects with ED.",2021,"No differences were detected in efficacy endpoints between the 100 and 200 mg dosage groups (all P > .05) or in the incidence of TEAEs and drug-related TEAEs among the 3 groups (all P > .05).
","['7 medical centers in China', 'Eligible subjects suffering from ED', 'ED in China', 'Chinese subjects with ED', 'Of 218 randomized ED subjects, 182 (83.5%) completed the study', 'Chinese Subjects With Erectile Dysfunction']","['placebo', 'EF vs placebo', 'Chinese developed avanafil', 'Placebo', 'Avanafil']","['Safety evaluation monitored treatment-emergent adverse events (TEAEs), serious TEAEs, laboratory test results, vital signs and electrocardiographs', 'SEP Q3 response rate', 'IIEF) questionnaire', 'efficacy endpoints', 'Efficacy and Safety', 'mean SEP Q2 response rates', 'efficacy and safety', 'mean IIEF-EF domain scores', 'response rates of SEP, Q2 and Q3; changes in IIEF other domain scores', 'erectile function (EF) domain scores according to the International Index of EF', 'erectile dysfunction (ED']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2698280', 'cui_str': 'avanafil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]",218.0,0.17088,"No differences were detected in efficacy endpoints between the 100 and 200 mg dosage groups (all P > .05) or in the incidence of TEAEs and drug-related TEAEs among the 3 groups (all P > .05).
","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, Peking University Third Hospital, Beijing, China; Department of Reproductive Medicine Center, Peking University Third Hospital, Beijing, China; Department of Andrology, Peking University Third Hospital, Beijing, China. Electronic address: jianghui55@163.com.'}, {'ForeName': 'Haocheng', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Peking University Third Hospital, Beijing, China; Department of Reproductive Medicine Center, Peking University Third Hospital, Beijing, China; Department of Andrology, Peking University Third Hospital, Beijing, China. Electronic address: haochenglin292@163.com.'}, {'ForeName': 'Fubiao', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Andrology, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yutian', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Andrology and Sexual Medicine, The Affiliated Drum Tower Hospital of Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Xiangsheng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Andrology, Henan Provincial People's Hospital, Henan University People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology and Andrology, The First Affiliated Hospital, Dalian Medical University, Dalian, Liaoning, China. Electronic address: Jiangt69@163.com.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': ""Department of Andrology, Guangzhou First People's Hospital, The Second Affiliated Hospital of South China University of Technology, Guangzhou, China. Electronic address: 2507297450@qq.com.""}]",Sexual medicine,['10.1016/j.esxm.2021.100337']
1679,33685836,"Reply to Alberto Briganti, Giorgio Gandaglia, Markus Graefen, Steven Joniau, R. Jeffrey Karnes, and Francesco Montorsi's Letter to the Editor re: Jean F.P. Lestingi, Giuliano B. Guglielmetti, Quoc-Dien Trinh, et al. Extended Versus Limited Pelvic Lymph Node Dissection During Radical Prostatectomy for Intermediate- and High-risk Prostate Cancer: Early Oncological Outcomes from a Randomized Phase 3 Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.11.040. Time for a Change? Clinically Meaningful Reasons Why We Will Continue Performing Extended Pelvic Lymph Node Dissection in Selected Patients with Prostate Cancer.",,2021,,"['for Intermediate- and High-risk Prostate Cancer', 'Selected Patients with Prostate Cancer']",['Pelvic Lymph Node Dissection During Radical Prostatectomy'],[],"[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]",[],,0.0274737,,"[{'ForeName': 'Jean F P', 'Initials': 'JFP', 'LastName': 'Lestingi', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. Electronic address: jeanlestingi@gmail.com.'}, {'ForeName': 'Quoc-Dien', 'Initials': 'QD', 'LastName': 'Trinh', 'Affiliation': ""DanaFarber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Coelho', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Pontes', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Diogo A', 'Initials': 'DA', 'LastName': 'Bastos', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Nahas', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}]",European urology,['10.1016/j.eururo.2021.02.038']
1680,33685834,A Correlation Analysis Between Metabolism-related Genes and Treatment Response to S-1 as First-line Chemotherapy for Metastatic Breast Cancer: The SELECT BC-EURECA Study.,"INTRODUCTION


The previous randomized phase 3 trial (SELECT BC) showed that S-1 as a first-line chemotherapy for metastatic breast cancer (MBC) is non-inferior to taxane with respect to overall survival. This study aimed to identify the usefulness of metabolism-related genes as predictive biomarkers for the response to S-1 compared with taxane using tumor tissue samples from the previous trial.   PATIENTS AND METHODS: In this SELECT BC-EURECA study, 147 patients with human epidermal growth factor 2 (HER2)-negative MBC who received either S-1 or taxane were evaluated. Formalin-fixed paraffin-embedded specimens were collected, and 14 genes involved in the pyrimidine metabolic pathway, estrogen receptor, progesterone receptor, HER2, Ki67, and beta-tubulin were measured using reverse transcription polymerase chain reaction in microdissected tumor specimens. The expression of each gene was categorized as low, intermediate, and high by tertile values.   RESULTS: Interaction tests to identify biomarkers for the response to S-1 compared with taxane, revealed the following as the top 3 biomarkers: RRM1 (P value = 0.24), GGH (P value = 0.25), and MTHFR (P value = 0.28). In the S-1 group, lower GGH and higher MTHFR expression were significantly correlated with better time to treatment failure. In the taxane group, there was no gene that was identified as a significant indicator of treatment failure.
CONCLUSION


This biomarker analysis from SELECT BC did not identify any predictive biomarkers for the response to S-1 compared with taxane. Future studies with larger sample size and information on not only mRNA, but also protein and DNA for broad functional analyses are needed.",2021,"In the S-1 group, lower GGH and higher MTHFR expression were significantly correlated with better time to treatment failure.","['Metastatic Breast Cancer', '147 patients with human epidermal growth factor 2 (HER2)-negative MBC who received either']","['S-1 or taxane', 'taxane']","['pyrimidine metabolic pathway, estrogen receptor, progesterone receptor, HER2, Ki67, and beta-tubulin', 'lower GGH and higher MTHFR expression']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0034284', 'cui_str': 'Pyrimidine'}, {'cui': 'C1291081', 'cui_str': 'Metabolic pathway'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0005290', 'cui_str': 'Beta tubulin'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0066357', 'cui_str': 'Methylenetetrahydrofolate reductase (NADPH)'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",147.0,0.0378826,"In the S-1 group, lower GGH and higher MTHFR expression were significantly correlated with better time to treatment failure.","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Fumikata', 'Initials': 'F', 'LastName': 'Hara', 'Affiliation': 'Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Iwamoto', 'Affiliation': 'Okayama University Hospital, Okayama, Japan. Electronic address: tiwamoto@cc.okayama-u.ac.jp.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Ohsumi', 'Affiliation': 'NHO Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yotsumoto', 'Affiliation': 'Sagara Hospital Miyazaki, Social Medical Corporation Miyazaki Hakuaikai, Miyazaki, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hozumi', 'Affiliation': 'University of Tsukuba Hospital, Tsukuba/Ibaraki Prefectural Central Hospital, Kasama, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'NHO Sendai Medical Center, Sendai, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Japanese Red Cross Saitama Hospital, Saitama, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Watanabe', 'Affiliation': 'NHO Hokkaido Cancer Center, Hokkaido, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Showa University, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Akabane', 'Affiliation': 'Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital, Asahikawa, Japan.'}, {'ForeName': 'Reiki', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Kumamoto Shinto General Hospital, Kumamoto, Japan.'}, {'ForeName': 'Naruto', 'Initials': 'N', 'LastName': 'Taira', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}]",Clinical breast cancer,['10.1016/j.clbc.2021.01.018']
1681,33685825,[Stress ulcer prophylaxis for critically ill children: Routine use needs to be re-examined].,"INTRODUCTION


Stress ulcer prophylaxis (SUP) is commonly used in Paediatric Intensive Care Units (PICUs). However, strong evidence for this practice is lacking and there is a dire need for paediatric randomized controlled trials (RCTs). Our aim was to assess the usefulness of SUP with omeprazole in critically ill children.
PATIENTS AND METHODS


We conducted a randomized, controlled open-label trial, including 144 children admitted into a PICU with a paediatric Sequential Organ Failure Assessment (pSOFA) score of less than 16. We randomly allocated patients to SUP with omeprazole or no SUP. The primary outcome was development of upper gastrointestinal bleeding or nosocomial infection.
RESULTS


The incidence of gastrointestinal bleeding was 27.1%, but clinically significant bleeding developed in only 5.6% of patients. We did not find a significant difference in the incidence of bleeding between the prophylaxis and control groups (27.8 vs. 26.4%; p = 0.85). We also did not find a significant difference between the group in the incidence of ventilator-associated pneumonia (VAP) (9.6 vs. 8.3%; p = 0.77). The incidence of central line-associated bloodstream infection (CLABSI) was higher in the prophylaxis group compared to the control group (30.6% vs. 12.5%; p = 0.014). None of the patients developed Clostridium difficile-associated diarrhoea. We did not find significant differences in mortality, length of PICU stay or duration of mechanical ventilation. Mechanical ventilation was an independent predictor of bleeding (OR 6.4; 95% CI, 2.73-14.9).
CONCLUSION


In PICU patients with mild to moderate organ dysfunction, omeprazole does not seem to be useful for prevention of gastrointestinal bleeding while at the same time increasing the risk of CLABSI. Thus, we recommend restricting SUP to mechanically ventilated children.",2021,"Mechanical ventilation was an independent predictor of bleeding (OR 6.4; 95% CI, 2.73-14.9).
","['144 children admitted into a PICU with a paediatric Sequential Organ Failure Assessment (pSOFA) score of less than 16', 'mechanically ventilated children', 'critically ill children']","['SUP with omeprazole or no SUP', 'Mechanical ventilation', 'SUP with omeprazole', 'Stress ulcer prophylaxis (SUP', 'omeprazole']","['incidence of ventilator-associated pneumonia (VAP', 'incidence of central line-associated bloodstream infection (CLABSI', 'Clostridium difficile-associated diarrhoea', 'mortality, length of PICU stay or duration of mechanical ventilation', 'development of upper gastrointestinal bleeding or nosocomial infection', 'incidence of bleeding', 'incidence of gastrointestinal bleeding']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0400807', 'cui_str': 'Stress ulcer of stomach'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}]",144.0,0.143321,"Mechanical ventilation was an independent predictor of bleeding (OR 6.4; 95% CI, 2.73-14.9).
","[{'ForeName': 'Sohair Sayed', 'Initials': 'SS', 'LastName': 'Abu El-Ella', 'Affiliation': 'Departamento de Pediatría, Facultad de Medicina, Universidad de Menufia, Shibin el-Kom, Egipto.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Said El-Mekkawy', 'Affiliation': 'Departamento de Pediatría, Facultad de Medicina, Universidad de Menufia, Shibin el-Kom, Egipto. Electronic address: mohamed.elmakawi@med.menofia.edu.eg.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohamed Selim', 'Affiliation': 'Departamento de Pediatría, Facultad de Medicina, Universidad de Menufia, Shibin el-Kom, Egipto.'}]","Anales de pediatria (Barcelona, Spain : 2003)",['10.1016/j.anpedi.2020.12.023']
1682,33685512,Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial-data management experience from the DESiGN Trial team.,"BACKGROUND


The use of electronic patient records for assessing outcomes in clinical trials is a methodological strategy intended to drive faster and more cost-efficient acquisition of results. The aim of this manuscript was to outline the data collection and management considerations of a maternity and perinatal clinical trial using data from electronic patient records, exemplifying the DESiGN Trial as a case study.
METHODS


The DESiGN Trial is a cluster randomised control trial assessing the effect of a complex intervention versus standard care for identifying small for gestational age foetuses. Data on maternal/perinatal characteristics and outcomes including infants admitted to neonatal care, parameters from foetal ultrasound and details of hospital activity for health-economic evaluation were collected at two time points from four types of electronic patient records held in 22 different electronic record systems at the 13 research clusters. Data were pseudonymised on site using a bespoke Microsoft Excel macro and securely transferred to the central data store. Data quality checks were undertaken. Rules for data harmonisation of the raw data were developed and a data dictionary produced, along with rules and assumptions for data linkage of the datasets. The dictionary included descriptions of the rationale and assumptions for data harmonisation and quality checks.
RESULTS


Data were collected on 182,052 babies from 178,350 pregnancies in 165,397 unique women. Data availability and completeness varied across research sites; each of eight variables which were key to calculation of the primary outcome were completely missing in median 3 (range 1-4) clusters at the time of the first data download. This improved by the second data download following clarification of instructions to the research sites (each of the eight key variables were completely missing in median 1 (range 0-1) cluster at the second time point). Common data management challenges were harmonising a single variable from multiple sources and categorising free-text data, solutions were developed for this trial.
CONCLUSIONS


Conduct of clinical trials which use electronic patient records for the assessment of outcomes can be time and cost-effective but still requires appropriate time and resources to maximise data quality. A difficulty for pregnancy and perinatal research in the UK is the wide variety of different systems used to collect patient data across maternity units. In this manuscript, we describe how we managed this and provide a detailed data dictionary covering the harmonisation of variable names and values that will be helpful for other researchers working with these data.
TRIAL REGISTRATION


Primary registry and trial identifying number: ISRCTN 67698474 . Registered on 02/11/16.",2021,The DESiGN Trial is a cluster randomised control trial assessing the effect of a complex intervention versus standard care for identifying small for gestational age foetuses.,"['182,052 babies from 178,350 pregnancies in 165,397 unique women']","['complex antenatal intervention', 'complex intervention versus standard care']",['foetal ultrasound and details of hospital activity for health-economic evaluation'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.11645,The DESiGN Trial is a cluster randomised control trial assessing the effect of a complex intervention versus standard care for identifying small for gestational age foetuses.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Relph', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK. sophie.relph@kcl.ac.uk.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Elstad', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, 4th Floor, Addison House, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'Bolaji', 'Initials': 'B', 'LastName': 'Coker', 'Affiliation': ""Division of Health and Social Care Research, King's College London, London, UK.""}, {'ForeName': 'Matias C', 'Initials': 'MC', 'LastName': 'Vieira', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Moitt', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Walter Muruet', 'Initials': 'WM', 'LastName': 'Gutierrez', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': ""Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, Blackshaw Road, London, SW17 0QT, UK.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Centre for Pragmatic Global Health Trials, Institute for Global Health, University College London, Gower Street, London, WC1E 6BT, UK.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Lawlor', 'Affiliation': 'Population Health Science, Bristol Medical School, University of Bristol, Bristol, BS8 2BL, UK.'}, {'ForeName': 'Dharmintra', 'Initials': 'D', 'LastName': 'Pasupathy', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-021-05141-8']
1683,33685505,Regular swimming exercise improves metabolic syndrome risk factors: a quasi-experimental study.,"BACKGROUND


In the past few decades, swimming became one of the most important physical activities within the health system and is considered a practical nonpharmacological approach to managing of type 2 diabetes (T2DM), hyperlipidemia, hypertension (HTN), and obesity. The current study aimed to assess the effect of long-term swimming sessions on glycemic and lipidemic parameters, hemodynamic responses, body fat percent, and body mass index for patients with metabolic risk factors from Palestine.
METHODS


Forty participants from both genders with T2DM and HTN (aged 52.4 ± 5.5 yrs) agreed to participate in this quasi-experimental study and were divided into two groups. The first group included the participants who performed long-term swimming sessions and the second group served as the control. The first group exercised for 2 h, 3 times/week in 29-33 °C swimming pool temperature for 16 weeks. Simultaneously, the control group did not participate in any exercise and advised them to keep on with their everyday lifestyle. All the obtained metabolic syndrome risk factors data were analyzed using a two-way ANOVA analysis of variance (2*2) which was applied to determine the differences according group, time, and interaction.
RESULTS


The results showed that there were statistically significant differences at p < 0.05 in the variables of Total Cholesterol (TC), High Density of Lipoprotein (HDL), Low Density of Lipoprotein (LDL), Triglycerides (TG), Blood Glucose (BG), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Body Mass Index (BMI), and body fat percent according to group, time, and interaction for the experimental group.
CONCLUSIONS


The findings of the current study suggested that the regular 16 weeks of swimming sessions could be considered nonpharmacological approaches in managing T2DM and HTN.",2021,"The results showed that there were statistically significant differences at p < 0.05 in the variables of Total Cholesterol (TC), High Density of Lipoprotein (HDL), Low Density of Lipoprotein (LDL), Triglycerides (TG), Blood Glucose (BG), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Body Mass Index (BMI), and body fat percent according to group, time, and interaction for the experimental group.
","['Forty participants from both genders with T2DM and HTN (aged 52.4\u2009±\u20095.5\u2009yrs) agreed to participate in this quasi-experimental study', 'patients with metabolic risk factors from Palestine']","['long-term swimming sessions', 'control group did not participate in any exercise and advised them to keep on with their everyday lifestyle', 'Regular swimming exercise']","['glycemic and lipidemic parameters, hemodynamic responses, body fat percent, and body mass index', 'Total Cholesterol (TC), High Density of Lipoprotein (HDL), Low Density of Lipoprotein (LDL), Triglycerides (TG), Blood Glucose (BG), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Body Mass Index (BMI), and body fat percent according to group, time, and interaction', 'metabolic syndrome risk factors']","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",40.0,0.0114748,"The results showed that there were statistically significant differences at p < 0.05 in the variables of Total Cholesterol (TC), High Density of Lipoprotein (HDL), Low Density of Lipoprotein (LDL), Triglycerides (TG), Blood Glucose (BG), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Body Mass Index (BMI), and body fat percent according to group, time, and interaction for the experimental group.
","[{'ForeName': 'Jamal Shaker', 'Initials': 'JS', 'LastName': 'Omar', 'Affiliation': 'Department of Physical Education, An-Najah National University, Nablus, 00970, Palestine.'}, {'ForeName': 'Nidal', 'Initials': 'N', 'LastName': 'Jaradat', 'Affiliation': 'Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, 00970, Palestine. nidaljaradat@najah.edu.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Qadoumi', 'Affiliation': 'Department of Physical Education, An-Najah National University, Nablus, 00970, Palestine.'}, {'ForeName': 'Abdel Naser', 'Initials': 'AN', 'LastName': 'Qadoumi', 'Affiliation': 'Department of Physical Education, An-Najah National University, Nablus, 00970, Palestine.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-021-00254-8']
1684,33685502,Early antiviral treatment in outpatients with COVID-19 (FLARE): a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The objective of this trial is to assess whether early antiviral therapy in outpatients with COVID-19 with either favipiravir plus lopinavir/ritonavir, lopinavir/ritonavir alone, or favipiravir alone, is associated with a decrease in viral load of SARS-CoV-2 compared with placebo.
TRIAL DESIGN


FLARE is a phase IIA randomised, double-blind, 2x2 factorial placebo-controlled, interventional trial.
PARTICIPANTS


This trial is being conducted in the United Kingdom, with Royal Free Hospital, London as the lead site. Participants are non-hospitalised adults with highly suspected COVID-19 within the first 5 days of symptom onset, or who have tested positive with SARS-CoV-2 causing COVID-19 within the first 7 days of symptom onset, or who are asymptomatic but tested positive for SARS-CoV-2 for the first time within the last 48 hours. Inclusion criteria are as follows: 1. Any adult with the following: Symptoms compatible with COVID-19 disease (Fever >37.8°C on at least one occasion AND either cough and/ or anosmia) within the first 5 days of symptom onset (date/time of enrolment must be within the first 5 days of symptom onset) OR ANY symptoms compatible with COVID-19 disease (may include, but are not limited to fever, cough, shortness of breath, malaise, myalgia, headache, coryza) and tested positive for SARS-CoV-2 within the first 7 days of symptom onset) (date/time of enrolment must be within the first 7 days of symptom onset) OR no symptoms but tested positive for SARS-CoV-2 within the last 48 hours (date/time of test must be within 48 hours of enrolment) 2. Male or female aged 18 years to 70 years old inclusive at screening 3. Willing and able to take daily saliva samples 4. Able to provide full informed consent and willing to comply with trial-related procedures Exclusion criteria are as follows: 1. Known hypersensitivity to any of the active ingredients or excipients in favipiravir and matched placebo, and in lopinavir/ritonavir and matched placebo (See Appendix 2) 2. Chronic liver disease at screening (known cirrhosis of any aetiology, chronic hepatitis (e.g. autoimmune, viral, steatohepatitis), cholangitis or any known elevation of liver aminotransferases with AST or ALT > 3 X ULN)* 3. Chronic kidney disease (stage 3 or beyond) at screening: eGFR < 60 ml/min/1.73m 2  * 4. HIV infection, if untreated, detectable viral load or on protease inhibitor therapy 5. Any clinical condition which the investigator considers would make the participant unsuitable for the trial 6. Concomitant medications known to interact with favipiravir and matched placebo, and with lopinavir/ritonavir and matched placebo, and carry risk of toxicity for the participant 7. Current severe illness requiring hospitalisation 8. Pregnancy and/ or breastfeeding 9. Eligible female participants of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraceptive measures during the trial and within the time point specified following last trial treatment dose. 10. Participants enrolled in any other interventional drug or vaccine trial (co-enrolment in observational studies is acceptable) 11. Participants who have received the COVID-19 vaccine *Considering the importance of early treatment of COVID-19 to impact viral load, the absence of known chronic liver/ kidney disease will be confirmed verbally by the participant during pre-screening and Screening/Baseline visit. Safety blood samples will be collected at Screening/Baseline visit (Day 1) and test results will be examined as soon as they become available and within 24 hours.
INTERVENTION AND COMPARATOR


Participants will be randomised 1:1:1:1 using a concealed online minimisation process into one of the following four arms: Arm 1: Favipiravir + Lopinavir/ritonavir Oral favipiravir at 1800mg twice daily on Day 1, followed by 400mg four (4) times daily from Day 2 to Day 7 PLUS lopinavir/ritonavir at 400mg/100mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7. Arm 2: Favipiravir + Lopinavir/ritonavir placebo Oral favipiravir at 1800mg twice daily on Day 1, followed by 400mg four (4) times daily from Day 2 to Day 7 PLUS lopinavir/ritonavir matched placebo at 400mg/100mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7. Arm 3: Favipiravir placebo + Lopinavir/ritonavir Oral favipiravir matched placebo at 1800mg twice daily on Day 1, followed by 400mg four (4) times daily from Day 2 to Day 7 PLUS lopinavir/ritonavir at 400mg/100mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7. Arm 4: Favipiravir placebo + Lopinavir/ritonavir placebo Oral favipiravir matched placebo at 1800mg twice daily on Day 1, followed by 400mg four (4) times daily from Day 2 to Day 7 PLUS lopinavir/ritonavir matched placebo at 400mg/100mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7.
MAIN OUTCOMES


The primary outcome is upper respiratory tract viral load at Day 5.
SECONDARY OUTCOMES


Percentage of participants with undetectable upper respiratory tract viral load after 5 days of therapy Proportion of participants with undetectable stool viral load after 7 days of therapy Rate of decrease in upper respiratory tract viral load during 7 days of therapy Duration of fever following commencement of trial medications Proportion of participants with hepatotoxicity after 7 days of therapy Proportion of participants with other medication-related toxicity after 7 days of therapy and 14 days post-randomisation Proportion of participants admitted to hospital with COVID-19 related illness Proportion of participants admitted to ICU with COVID-19 related illness Proportion of participants who have died with COVID-19 related illness Pharmacokinetic and pharmacodynamic analysis of favipiravir Exploratory: Proportion of participants with deleterious or resistance-conferring mutations in SARS-CoV-2 RANDOMISATION: Participants will be randomised 1:1:1:1 using a concealed online minimisation process, with the following factors: trial site, age (≤ 55 vs > 55 years old), gender, obesity (BMI <30 vs ≥30), symptomatic or asymptomatic, current smoking status (Yes = current smoker, No = ex-smoker, never smoker), ethnicity (Caucasian, other) and presence or absence of comorbidity (defined as diabetes, hypertension, ischaemic heart disease (including previous myocardial infarction), other heart disease (arrhythmia and valvular heart disease), asthma, COPD, other chronic respiratory disease).
BLINDING (MASKING)


Participants and investigators will both be blinded to treatment allocation (double-blind).
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


240 participants, 60 in each arm.
TRIAL STATUS


Protocol version 4.0 dated 7 th  January 2021. Date of first enrolment: October 2020. Recruitment is ongoing, with anticipated finish date of 31 st  March 2021.
TRIAL REGISTRATION


The FLARE trial is registered with Clinicaltrials.gov, trial identifying number NCT04499677 , date of registration 4 th  August 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2021,Chronic kidney disease (stage 3 or beyond) at screening: eGFR < 60 ml/min/1.73m 2  * 4.,"['Male or female aged 18 years to 70 years old inclusive at screening 3', 'age (≤ 55 vs > 55 years old), gender, obesity (BMI <30 vs ≥30), symptomatic or asymptomatic, current smoking status (Yes = current smoker, No = ex-smoker, never smoker), ethnicity (Caucasian, other) and presence or absence of comorbidity (defined as diabetes, hypertension, ischaemic heart disease (including previous myocardial infarction), other heart disease (arrhythmia and valvular heart disease), asthma, COPD, other chronic respiratory disease', 'Participants who have received the COVID-19 vaccine ', 'outpatients with COVID-19 (FLARE', 'participants with deleterious or resistance-conferring mutations in SARS-CoV-2 RANDOMISATION: Participants', 'Protocol version 4.0 dated 7 th  January 2021', '240 participants, 60 in each arm', 'outpatients with COVID-19 with either', 'Participants are non-hospitalised adults with highly suspected COVID-19 within the first 5 days of symptom onset, or who have tested positive with SARS-CoV-2 causing COVID-19 within the first 7 days of symptom onset, or who are asymptomatic but tested positive for SARS-CoV-2 for the first time within the last 48 hours', 'Eligible female participants of childbearing potential and male participants with a partner of childbearing potential not willing to use highly', 'Chronic kidney disease (stage 3 or beyond) at screening: eGFR < 60 ml/min/1.73m 2  * 4', 'Participants enrolled in any other interventional drug or vaccine trial (co-enrolment in observational studies is acceptable) 11']","['favipiravir plus lopinavir/ritonavir, lopinavir/ritonavir alone, or favipiravir alone', 'favipiravir and matched placebo, and with lopinavir/ritonavir and matched placebo', 'placebo', 'Favipiravir placebo + Lopinavir/ritonavir placebo Oral favipiravir matched placebo', 'PLUS lopinavir/ritonavir matched placebo', 'Favipiravir + Lopinavir/ritonavir placebo Oral favipiravir', 'lopinavir/ritonavir and matched placebo', 'PLUS lopinavir/ritonavir', 'Favipiravir + Lopinavir/ritonavir Oral favipiravir', 'Favipiravir placebo + Lopinavir/ritonavir Oral favipiravir matched placebo']","['effective contraceptive measures', 'upper respiratory tract viral load at Day 5', 'toxicity', 'Chronic liver disease']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018824', 'cui_str': 'Heart valve disorder'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]","[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0458578', 'cui_str': 'Upper respiratory tract structure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}]",,0.541821,Chronic kidney disease (stage 3 or beyond) at screening: eGFR < 60 ml/min/1.73m 2  * 4.,"[{'ForeName': 'Li-An K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'UCL Institute of Immunity and Transplantation, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK. nicholas.freemantle@ucl.ac.uk.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Breuer', 'Affiliation': 'Division of Infection and Immunity, University College London, London, UK.'}, {'ForeName': 'Hakim-Moulay', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.'}, {'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Ikeji', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Ndoutoumou', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.'}, {'ForeName': 'Krishneya', 'Initials': 'K', 'LastName': 'Santhirakumar', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Longley', 'Affiliation': 'Hospital for Tropical Diseases, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Checkley', 'Affiliation': 'Hospital for Tropical Diseases, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Standing', 'Affiliation': 'Infection, Inflammation, Immunity Section, UCL Great Ormond Street Institute of Child Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lowe', 'Affiliation': 'UCL Institute of Immunity and Transplantation, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}]",Trials,['10.1186/s13063-021-05139-2']
1685,33685500,Effects of salvianolate on microcirculatory disturbance in patients with stable coronary heart disease: study protocol for a randomized controlled trial.,"BACKGROUND


Obstruction of coronary microcirculation can lead to myocardial ischemia and poor prognosis. Salvianolate exerts cardiovascular protection at cellular levels. However, no studies have confirmed the effect of salvianolate on stable coronary heart disease (CHD) with high fractional flow reserve (FFR) and myocardial microcirculatory disturbances.
METHODS/DESIGN


This study will enroll 78 patients who have stable coronary disease with 50 to 70% stenosis in major coronary arteries and whose FFR > 0.80 and index of microcirculatory resistance (IMR) > 25. Patients will be randomly divided into the salvianolate group or the placebo group. After above evaluations, salvianolate 200 mg will be intravenously dripped immediately for the next 30 min and subsequent 7 days in the salvianolate group, and matching 0.9% normal saline will be arranged in the placebo group. IMR will be reevaluated in immediate phase after first 30 min of salvianolate or placebo treatment. The primary end point will be the IMR change in this phase, and the secondary end points will be the total ischemic burden assessed by the Seattle angina scale, quality of life scale, Holter electrocardiography, and 6-min walk test after 7 days before discharge.
DISCUSSION


This study will firstly clarify the improvement effect of salvianolate on coronary microcirculation and provide an effective treatment method for stable CHD patients with high FFR and myocardial microcirculatory disturbance.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1800018772 . Registered on 9 October 2018 and updated on 2 March 2020.",2021,"The primary end point will be the IMR change in this phase, and the secondary end points will be the total ischemic burden assessed by the Seattle angina scale, quality of life scale, Holter electrocardiography, and 6-min walk test after 7 days before discharge.
","['78 patients who have stable coronary disease with 50 to 70% stenosis in major coronary arteries and whose FFR\u2009>\u20090.80 and index of microcirculatory resistance (IMR)\u2009>\u200925', 'patients with stable coronary heart disease', 'stable CHD patients with high FFR and myocardial microcirculatory disturbance']","['salvianolate', 'Salvianolate', 'placebo', 'salvianolate or placebo', 'salvianolate group, and matching 0.9% normal saline']","['stable coronary heart disease (CHD) with high fractional flow reserve (FFR) and myocardial microcirculatory disturbances', 'total ischemic burden assessed by the Seattle angina scale, quality of life scale, Holter electrocardiography, and 6-min walk test after 7\u2009days before discharge', 'IMR change', 'IMR', 'microcirculatory disturbance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C3252125', 'cui_str': 'salvianolate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.200639,"The primary end point will be the IMR change in this phase, and the secondary end points will be the total ischemic burden assessed by the Seattle angina scale, quality of life scale, Holter electrocardiography, and 6-min walk test after 7 days before discharge.
","[{'ForeName': 'Zhanlu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luan', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China. 3313011@zju.edu.cn.""}]",Trials,['10.1186/s13063-021-05099-7']
1686,33685474,Evaluation of the effect of melatonin in patients with COVID-19-induced pneumonia admitted to the Intensive Care Unit: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


We investigate the effects of melatonin, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in severely ill patients with confirmed COVID-19 who are admitted to the Intensive Care Unit (ICU).
TRIAL DESIGN


This is a single-center, open-label, randomized, clinical trial with a parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran.
PARTICIPANTS


All patients admitted to the ICU of Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria. Inclusion criteria 1. Age >20 years 2. Definitive diagnosis of COVID-19 based on RT-PCR or/and serological testing 3. Severe pneumonia and lung involvement in imaging 4. Signing informed consent Exclusion criteria 1. Underlying diseases, including convulsive disorders, chronic hepatic and renal diseases 2. Use of mechanical ventilation 3. History of known allergy to Melatonin 4. Pregnancy and breastfeeding INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin soft gelatin capsule (Danna Pharmaceutical Company) at a dose of 5 mg twice a day for a period of seven days.
CONTROL GROUP


The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol for a period of seven days.
MAIN OUTCOMES


The primary outcomes are the recovery rate of clinical symptoms and checking arterial blood gas (ABG), C-reactive protein (C-RP), Ferritin, Lactate dehydrogenase (LDH) within seven days of randomization. The secondary outcomes are time to improvement of clinical and paraclinical features and length of stay in the ICU, need for mechanical ventilation, and mortality rate within seven days of randomization.
RANDOMIZATION


Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 6 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms.
BLINDING (MASKING)


This is an open-label trial without blinding and placebo control.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group).
TRIAL STATUS


The protocol is Version 1.0, February 16, 2021. Recruitment began February 28, 2021, and is anticipated to be completed by July 31, 2021.
TRIAL REGISTRATION


The trial protocol has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is "" IRCT20200506047323N7 "". The registration date was February 16, 2021.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2021,"CONTROL GROUP


","['60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group', 'All patients admitted to the ICU of Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria', 'patients with COVID-19-induced pneumonia admitted to the Intensive Care Unit', 'severely ill patients with confirmed COVID-19 who are admitted to the Intensive Care Unit (ICU', 'Age', 'Shahid Mohammadi Hospital, Bandar Abbas, Iran']","['placebo', 'mechanical ventilation 3', 'melatonin', ""standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin soft gelatin capsule (Danna Pharmaceutical Company"", 'GROUP']","['clinical symptoms and laboratory signs', 'time to improvement of clinical and paraclinical features and length of stay in the ICU, need for mechanical ventilation, and mortality rate', 'Severe pneumonia and lung involvement', 'recovery rate of clinical symptoms and checking arterial blood gas (ABG), C-reactive protein (C-RP), Ferritin, Lactate dehydrogenase (LDH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",60.0,0.118462,"CONTROL GROUP


","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ameri', 'Affiliation': 'Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Masoomeh Frouz', 'Initials': 'MF', 'LastName': 'Asadi', 'Affiliation': 'Anesthesiology, Critical Care, and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Manoochehr', 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'Anesthesiology, Critical Care, and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Vatankhah', 'Affiliation': 'Anesthesiology, Critical Care, and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Ziaei', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Safa', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Mahmudi', 'Affiliation': 'Anesthesiology, Critical Care, and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@yahoo.com.'}]",Trials,['10.1186/s13063-021-05162-3']
1687,33685404,CT based automatic clinical target volume delineation using a dense-fully connected convolution network for cervical Cancer radiation therapy.,"BACKGROUND


It is very important to accurately delineate the CTV on the patient's three-dimensional CT image in the radiotherapy process. Limited to the scarcity of clinical samples and the difficulty of automatic delineation, the research of automatic delineation of cervical cancer CTV based on CT images for new patients is slow. This study aimed to assess the value of Dense-Fully Connected Convolution Network (Dense V-Net) in predicting Clinical Target Volume (CTV) pre-delineation in cervical cancer patients for radiotherapy.
METHODS


In this study, we used Dense V-Net, a dense and fully connected convolutional network with suitable feature learning in small samples to automatically pre-delineate the CTV of cervical cancer patients based on computed tomography (CT) images and then we assessed the outcome. The CT data of 133 patients with stage IB and IIA postoperative cervical cancer with a comparable delineation scope was enrolled in this study. One hundred and thirteen patients were randomly designated as the training set to adjust the model parameters. Twenty cases were used as the test set to assess the network performance. The 8 most representative parameters were also used to assess the pre-sketching accuracy from 3 aspects: sketching similarity, sketching offset, and sketching volume difference.
RESULTS


The results presented that the DSC, DC/mm, HD/cm, MAD/mm, ∆V, SI, IncI and JD of CTV were 0.82 ± 0.03, 4.28 ± 2.35, 1.86 ± 0.48, 2.52 ± 0.40, 0.09 ± 0.05, 0.84 ± 0.04, 0.80 ± 0.05, and 0.30 ± 0.04, respectively, and the results were greater than those with a single network.
CONCLUSIONS


Dense V-Net can correctly predict CTV pre-delineation of cervical cancer patients and can be applied in clinical practice after completing simple modifications.",2021,"The results presented that the DSC, DC/mm, HD/cm, MAD/mm, ∆V, SI, IncI and JD of CTV were 0.82 ± 0.03, 4.28 ± 2.35, 1.86 ± 0.48, 2.52 ± 0.40, 0.09 ± 0.05, 0.84 ± 0.04, 0.80 ± 0.05, and 0.30 ± 0.04, respectively, and the results were greater than those with a single network.
","['One hundred and thirteen patients', 'cervical cancer patients based on computed tomography (CT) images', '133 patients with stage IB and IIA postoperative cervical cancer', 'cervical cancer patients', 'cervical cancer patients for radiotherapy']","['Dense-Fully Connected Convolution Network (Dense V-Net', 'CT']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",[],113.0,0.0266997,"The results presented that the DSC, DC/mm, HD/cm, MAD/mm, ∆V, SI, IncI and JD of CTV were 0.82 ± 0.03, 4.28 ± 2.35, 1.86 ± 0.48, 2.52 ± 0.40, 0.09 ± 0.05, 0.84 ± 0.04, 0.80 ± 0.05, and 0.30 ± 0.04, respectively, and the results were greater than those with a single network.
","[{'ForeName': 'Zhongjian', 'Initials': 'Z', 'LastName': 'Ju', 'Affiliation': ""Department of Radiation Oncology, The First Medical Center, People's Liberation Army General Hospital, No. 28 Fuxing Road, Haidian District, Beijing, 100853, China.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'School of Physics Science and Technology, Wuhan University, No. 299, Bayi Road, Luojiashan Street, Wuhan, 430072, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Gu', 'Affiliation': ""Department of Radiation Oncology, The First Medical Center, People's Liberation Army General Hospital, No. 28 Fuxing Road, Haidian District, Beijing, 100853, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'School of Physics Science and Technology, Wuhan University, No. 299, Bayi Road, Luojiashan Street, Wuhan, 430072, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Radiation Oncology, The First Medical Center, People's Liberation Army General Hospital, No. 28 Fuxing Road, Haidian District, Beijing, 100853, China.""}, {'ForeName': 'Xiaohu', 'Initials': 'X', 'LastName': 'Cong', 'Affiliation': ""Department of Radiation Oncology, The First Medical Center, People's Liberation Army General Hospital, No. 28 Fuxing Road, Haidian District, Beijing, 100853, China.""}, {'ForeName': 'Xiangkun', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': ""Department of Radiation Oncology, The First Medical Center, People's Liberation Army General Hospital, No. 28 Fuxing Road, Haidian District, Beijing, 100853, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Quan', 'Affiliation': 'School of Physics Science and Technology, Wuhan University, No. 299, Bayi Road, Luojiashan Street, Wuhan, 430072, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Beijing Eastraycloud Technology Inc. Chengdu R&D Center.Suite, 1405-1406,Building Guannan Shangyu,NO.1,Xingguang Road,Wuhou District, Chengdu, 610094, China.'}, {'ForeName': 'Baolin', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': ""Department of Radiation Oncology, The First Medical Center, People's Liberation Army General Hospital, No. 28 Fuxing Road, Haidian District, Beijing, 100853, China. qubl6212@sina.com.""}, {'ForeName': 'Guocai', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'College of Electrical and Information Engineering, Hunan University, Changsha, 410082, China.'}]",BMC cancer,['10.1186/s12885-020-07595-6']
1688,33685395,Use of volume controlled vs. pressure controlled volume guaranteed ventilation in elderly patients undergoing laparoscopic surgery with laryngeal mask airway.,"BACKGROUND


The peak inspiratory pressure (PIP) is crucial in mechanical ventilation with supraglottic airway device (SAD). Pressure-controlled ventilation volume-guaranteed (PCV-VG), delivering a preset tidal volume with the lowest required airway pressure, is being increasingly used during general anesthesia. In this study, we compared respiratory mechanics and circulatory parameters between volume-controlled ventilation (VCV) and PCV-VG in elderly patients undergoing laparoscopic surgery using the laryngeal mask airway supreme (LMA).
METHODS


Eighty participants scheduled for laparoscopic surgery were enrolled in this prospective, randomized clinical trial. The participants were randomly assigned to receive VCV or PCV-VG. PIP, dynamic compliance (Cdyn) and mean inspiratory pressure (Pmean) were recorded at 5 min after induction of anesthesia (T1), 5 min after pneumoperitoneum(T2), 30 and 60 min after pneumoperitoneum (T3 and T4). Data including other respiratory variables, hemodynamic variables, and arterial blood gases were also collected. The difference in PIP between VCV and PCV-VG was assessed as the primary outcome.
RESULTS


PIP was significantly lower at T2, T3, and T4 in both groups compared with T1 (all P <  0.0001), and it was significantly lower in the PCV-VG group than the VCV group at T2, T3, and T4 (all P <  0.001). Cydn was decreased at T2, T3, and T4 in two groups compared with T1 (all P <  0.0001), but it was higher in PCV-VG group than in VCV group at T2, T3, and T4 (all P <  0.0001). There were on statistically significant differences were found between the groups for other respiratory and hemodynamic variables.
CONCLUSION


In elderly patients who underwent laparoscopic surgery using an LMA, PCV-VG was superior to VCV in its ability to provide ventilation with lower peak inspiratory pressure and greater dynamic compliance.",2021,"RESULTS


PIP was significantly lower at T2, T3, and T4 in both groups compared with T1 (all P <  0.0001), and it was significantly lower in the PCV-VG group than the VCV group at T2, T3, and T4 (all P <  0.001).","['elderly patients undergoing laparoscopic surgery with laryngeal mask airway', 'elderly patients who underwent', 'elderly patients undergoing laparoscopic surgery using the laryngeal mask airway supreme (LMA', 'Eighty participants scheduled for laparoscopic surgery']","['LMA, PCV-VG', 'Pressure-controlled ventilation volume-guaranteed (PCV-VG', 'VCV', 'volume controlled vs. pressure controlled volume guaranteed ventilation', 'VCV or PCV-VG', 'volume-controlled ventilation (VCV) and PCV-VG', 'laparoscopic surgery']","['hemodynamic variables, and arterial blood gases', 'Cydn', 'PIP', 'PIP, dynamic compliance (Cdyn) and mean inspiratory pressure (Pmean', 'peak inspiratory pressure (PIP', 'PIP between VCV and PCV-VG']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0449972', 'cui_str': 'Volume control'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",80.0,0.058802,"RESULTS


PIP was significantly lower at T2, T3, and T4 in both groups compared with T1 (all P <  0.0001), and it was significantly lower in the PCV-VG group than the VCV group at T2, T3, and T4 (all P <  0.001).","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Anaesthesiology, Tongling People's Hospital, 468 Bijiashan Road, Tongling, 244000, China.""}, {'ForeName': 'Shihao', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of Anaesthesiology, Tongling People's Hospital, 468 Bijiashan Road, Tongling, 244000, China.""}, {'ForeName': 'Zongbin', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': ""Department of Anaesthesiology, Tongling People's Hospital, 468 Bijiashan Road, Tongling, 244000, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'The Second Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jinbao', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Anaesthesiology, Tongling People's Hospital, 468 Bijiashan Road, Tongling, 244000, China. tl_cjb@sina.com.""}]",BMC anesthesiology,['10.1186/s12871-021-01292-y']
1689,33685394,Effectiveness of securing central venous catheters with topical tissue adhesive in patients undergoing cardiac surgery: a randomized controlled pilot study.,"BACKGROUND


Central venous catheters (CVCs) play an important role during cardiac surgery. Topical tissue adhesives form a thin film of coating that becomes bound to keratin in the epidermis. The advantage of this ""super glue"" lies in its antimicrobial activity. This study aimed to evaluate fixation of CVCs with topical tissue adhesive in patients (prone to bleed) undergoing cardiac surgery regarding its ability to reduce the incidence of pericatheter leakage.
METHODS


This randomized controlled trial included 150 patients > 15 years of age who were (1) scheduled to undergo elective cardiac surgery, (2) required CVC insertion at the internal jugular vein, and (3) scheduled for transfer postoperatively to the cardiac intensive care unit. We randomly assigned patients to a topical tissue adhesive group (TA) or a standard control group (SC). The primary outcome was a change in dressing immediately postoperatively due to pericatheter blood oozing. Secondary outcomes were the number of dressings, total dressings per catheter day, and composite outcome of catheter failure within 3 days. Both intention-to-treat and per-protocol analyses were performed. Seven patients violated the protocol (three TA patients and four SC patients).
RESULTS


Regarding the primary outcome, the SC group exhibited a significantly increased incidence of dressing change immediately postoperatively due to pericatheter leakage compared with the TA group in both the intention-to-treat analysis (5.33% vs 18.67%, RR 0.25 [95% CI 0.08 to 0.79], P = 0.012) and the per-protocol analysis (5.56% vs 16.90%, RR 0.289 [95% CI 0.09 to 0.95], P = 0.031). No significant differences were noted in the number of dressings, total dressings per catheter day, or composite outcome of catheter failure within 3 days between the two groups. Multiple logistic regression analysis was performed to adjust baseline characteristics that were different in the per-protocol analysis. The results showed that the risk ratio of immediate postoperative dressing change in TA patients was 0.25 compared to the SC group ([95% CI 0.07 to 0.87], P = 0.029) in the per-protocol analysis.
CONCLUSION


The use of a topical tissue adhesive can reduce the incidence of immediate postoperative pericatheter blood oozing.
TRIAL REGISTRATION


TCTR20180608004 , retrospectively registered on June 06, 2018.",2021,"No significant differences were noted in the number of dressings, total dressings per catheter day, or composite outcome of catheter failure within 3 days between the two groups.","['patients undergoing cardiac surgery', 'patients (prone to bleed) undergoing cardiac surgery', '150 patients >\u200915\u2009years of age who were (1) scheduled to undergo elective cardiac surgery, (2) required CVC insertion at the internal jugular vein, and (3) scheduled for transfer postoperatively to the cardiac intensive care unit']","['topical tissue adhesive group (TA) or a standard control group (SC', 'topical tissue adhesive', 'securing central venous catheters']","['risk ratio of immediate postoperative dressing change', 'number of dressings, total dressings per catheter day, or composite outcome of catheter failure', 'change in dressing immediately postoperatively due to pericatheter blood oozing', 'incidence of dressing change immediately postoperatively due to pericatheter leakage', 'number of dressings, total dressings per catheter day, and composite outcome of catheter failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",150.0,0.177905,"No significant differences were noted in the number of dressings, total dressings per catheter day, or composite outcome of catheter failure within 3 days between the two groups.","[{'ForeName': 'Naruemol', 'Initials': 'N', 'LastName': 'Prachanpanich', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Sunthiti', 'Initials': 'S', 'LastName': 'Morakul', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand. sunthiti@hotmail.com.'}, {'ForeName': 'Napanont', 'Initials': 'N', 'LastName': 'Kiatmongkolkul', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}]",BMC anesthesiology,['10.1186/s12871-021-01282-0']
1690,33685375,"Women's perspectives on relationship dynamics with their partners and their role in HIV acquisition, HIV disclosure, hormonal contraceptive uptake, and condom use.","Background : Limited information exists about relationship dynamics and their role in HIV acquisition, HIV disclosure, hormonal contraceptive uptake, and condom use among women in Malawi. Methods : Ninety-seven women aged 18-45 years were randomly assigned to initiate the depot medroxyprogesterone acetate injectable or levonorgestrel implant from May 2014 to April 2015 in Lilongwe, Malawi. Women were recruited after randomisation to participate in semi-structured interviews about HIV and family planning using purposive sampling. Interviews were thematically analysed using within and between group comparisons. Results : We conducted individual interviews and/or focus group discussions with 41 women: 30 (73%) women living with HIV and 11 (27%) women not living with HIV. Most women living with HIV who participated in in-depth interviews disclosed their status to their partners, and most partners agreed to get HIV tested only after disclosure. Nearly all women said their partners agreed to use condoms, but few used them consistently. Nearly all women believed their current and former partners had outside partners. Most women living with HIV who participated in in-depth interviews believed their current or other serious partners were the source of their infection. Some women thought their partner's infidelity was due to their partner's disinterest in sex with them during menstrual/ breakthrough bleeding. Some women included their partners in contraceptive decision-making when the partner was supportive. Discussion : Relationship dynamics affected decision-making for contraceptive and condom use, as well as serodisclosure for the women living with HIV in the study. All women reported challenges with consistent condom use with their male partners, although contraceptive use was generally more acceptable. Women included their partners in their decision-making concerning contraceptive use when they were supportive.",2021,"Relationship dynamics affected decision-making for contraceptive and condom use, as well as serodisclosure for the women living with HIV in the study.","['women living with HIV in the study', 'Methods : Ninety-seven women aged 18-45 years', '41 women: 30 (73%) women living with HIV and 11 (27', 'Discussion ', 'women not living with HIV', 'women in Malawi']","['depot medroxyprogesterone acetate injectable or levonorgestrel implant', ' ']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",[],97.0,0.0499329,"Relationship dynamics affected decision-making for contraceptive and condom use, as well as serodisclosure for the women living with HIV in the study.","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Chapola', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Hatfield-Timajchy', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Agatha K', 'Initials': 'AK', 'LastName': 'Bula', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Hurst', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Athena P', 'Initials': 'AP', 'LastName': 'Kourtis', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}]",African journal of AIDS research : AJAR,['10.2989/16085906.2021.1872664']
1691,33685306,Greater trochanteric pain syndrome: predicting who will respond to a local glucocorticoid injection.,"Objectives:  This study aimed to explore whether certain clinical tests or a rapid improvement in lateral hip pain following periarticular injection are predictive of subsequent efficacy of local glucocorticoid (GC) injection in greater trochanteric pain syndrome (GTPS). Method:  This secondary analysis of a randomized controlled trial of an injection of GC and local anaesthetic (LA) versus placebo included 44 patients with GTPS. Two subgroups of patients were defined: (i) 30 min responders, reporting a decrease of ≥ 50% of the initial pain at 30 min post-injection; and (ii) positive triple test, presenting a combination of three positive clinical tests (30-second single-leg stance, FABER, and Lequesne). Median level of numeric rating scale for pain at 1 month was the primary outcome. Interaction analysis of treatment effect in the subgroups was performed using a linear regression adjusting for pain at baseline. Results:  Sixteen patients (36%) were 30 min responders. In this group, GC treatment was associated with a significant improvement in pain at 1 month compared to non-responders (p = 0.03). The 30 min response was not associated with the use of LA. Positive triple test (22% of patients) was associated with higher pain scores at baseline (p = 0.03). In this group, patients who received placebo had significantly more pain at 1 month than those with the cortisone injection (p = 0.04). Conclusion:  Patients with GTPS who present a rapid decrease in pain after periarticular injection, and those who display a combination of three specific clinical tests, are more likely to benefit from an injection with GC and anaesthetic.",2021,Positive triple test (22% of patients) was associated with higher pain scores at baseline (p = 0.03).,"['Two subgroups of patients were defined: (i', 'greater trochanteric pain syndrome (GTPS', '44 patients with GTPS']","['placebo', 'GC and local anaesthetic (LA', 'local glucocorticoid (GC) injection']","['higher pain scores', 'trochanteric pain syndrome', 'Median level of numeric rating scale for pain', 'initial pain', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",44.0,0.376965,Positive triple test (22% of patients) was associated with higher pain scores at baseline (p = 0.03).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jarlborg', 'Affiliation': 'Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Courvoisier', 'Affiliation': 'Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Faundez', 'Affiliation': 'Department of Orthopaedic Surgery, Geneva University Hospital, Geneva and Hospital La Tour Spine Center, Meyrin, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Brulhart', 'Affiliation': 'Department of Rheumatology, Geneva University Hospital, Geneva and Neuchâtel Hospital, La Chaux-de-Fonds, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Finckh', 'Affiliation': 'Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Nissen', 'Affiliation': 'Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Genevay', 'Affiliation': 'Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland.'}]",Scandinavian journal of rheumatology,['10.1080/03009742.2021.1871643']
1692,33685268,Acupuncture Treatment of Delirium in Older Adults Hospitalized in Internal Medicine Departments: An Open-Label Pragmatic Randomized-Controlled Trial.,"BACKGROUND


Acupuncture seems to improve cognitive function in experimental models and to reduce agitation in dementia. The addition of acupuncture to standard-of-care (SOC) may improve clinical outcomes related to delirium in hospitalized older adults.
METHODS


This pragmatic open-label randomized-controlled trial evaluated 81 older adults hospitalized in an internal medicine ward and diagnosed with delirium. Fifty were randomized to daily acupuncture combined with SOC and 31 to SOC only for up to 1 week. Delirium was diagnosed using Confusion Assessment Method (CAM) tool, and its severity was assessed by the long CAM-Severity (CAM-S) tool. The primary study outcome was delirium resolution evaluated as time-to-first delirium remission (over 7 days) and the number of days spent delirium-free.
RESULTS


Time-to-first delirium remission was shorter in the acupuncture arm as compared to the SOC only arm (p < 0.001). A multivariate Cox regression analysis showed a shorter time-to-first remission of delirium in the acupuncture arm as compared with SOC arm [Hazard Ratio 0.267 (95% CI 0.098-0.726, p = 0.010)]. In the 7 days of evaluation, a significantly higher number of delirium-free days was found in the acupuncture arm compared to the SOC arm (p < 0.001), and CAM-S sum from day 2 to day 7 of evaluation was significantly lower in the acupuncture group compared to the control group (p = 0.002). No adverse safety event was found in the acupuncture group.
CONCLUSION


Acupuncture seems to be safe and effective in the treatment of delirium in older patients hospitalized in internal medicine departments.",2021,"In the 7 days of evaluation, a significantly higher number of delirium-free days was found in the acupuncture arm compared to the SOC arm (p < 0.001), and CAM-S sum from day 2 to day 7 of evaluation was significantly lower in the acupuncture group compared to the control group (p = 0.002).","['Older Adults Hospitalized in Internal Medicine Departments', 'hospitalized older adults', 'older patients hospitalized in internal medicine departments', '81 older adults hospitalized in an internal medicine ward and diagnosed with delirium']","['acupuncture combined with SOC', 'Acupuncture', 'acupuncture to standard-of-care (SOC', 'acupuncture']","['delirium resolution evaluated as time-to-first delirium remission (over 7 days) and the number of days spent delirium-free', 'shorter time-to-first remission of delirium', 'number of delirium-free days', 'adverse safety event', 'Time-to-first delirium remission', 'CAM-S sum', 'cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",81.0,0.220058,"In the 7 days of evaluation, a significantly higher number of delirium-free days was found in the acupuncture arm compared to the SOC arm (p < 0.001), and CAM-S sum from day 2 to day 7 of evaluation was significantly lower in the acupuncture group compared to the control group (p = 0.002).","[{'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Levy', 'Affiliation': 'Internal Medicine B Department, 37772Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Sagi', 'Initials': 'S', 'LastName': 'Gavrieli', 'Affiliation': 'Complementary Medicine Department, 37772Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Hefer', 'Affiliation': 'Internal Medicine B Department, 37772Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Attias', 'Affiliation': 'Complementary Medicine Department, 37772Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Schiff', 'Affiliation': 'Faculty of Medicine, Ben-Gurion University of the Negev, Beer Sheba, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Oliven', 'Affiliation': 'Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shikma', 'Initials': 'S', 'LastName': 'Wisberg-Levi', 'Affiliation': 'Internal Medicine B Department, 37772Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hanchinsky', 'Affiliation': 'Internal Medicine C Department, 37772Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Schiff', 'Affiliation': 'Internal Medicine B Department, 37772Bnai Zion Medical Center, Haifa, Israel.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988721996804']
1693,33685241,Optimal design of cluster randomised trials with continuous recruitment and prospective baseline period.,"BACKGROUND


Cluster randomised trials, like individually randomised trials, may benefit from a baseline period of data collection. We consider trials in which clusters prospectively recruit or identify participants as a continuous process over a given calendar period, and ask whether and for how long investigators should collect baseline data as part of the trial, in order to maximise precision.
METHODS


We show how to calculate and plot the variance of the treatment effect estimator for different lengths of baseline period in a range of scenarios, and offer general advice.
RESULTS


In some circumstances it is optimal not to include a baseline, while in others there is an optimal duration for the baseline. All other things being equal, the circumstances where it is preferable not to include a baseline period are those with a smaller recruitment rate, smaller intracluster correlation, greater decay in the intracluster correlation over time, or wider transition period between recruitment under control and intervention conditions.
CONCLUSION


The variance of the treatment effect estimator can be calculated numerically, and plotted against the duration of baseline to inform design. It would be of interest to extend these investigations to cluster randomised trial designs with more than two randomised sequences of control and intervention condition, including stepped wedge designs.",2021,"We show how to calculate and plot the variance of the treatment effect estimator for different lengths of baseline period in a range of scenarios, and offer general advice.
",[],[],[],[],[],[],,0.336036,"We show how to calculate and plot the variance of the treatment effect estimator for different lengths of baseline period in a range of scenarios, and offer general advice.
","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Centre for Clinical Trials & Methodology, Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Copas', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774520976564']
1694,33685237,A Prospective Comparative Study of Pulsed High-Intensity Laser Therapy and Pulsed Electromagnetic Field on Chronic Nonspecific Low Back Pain.,"Objective:  This study explored the different effects of pulsed high-intensity laser therapy (HILT) versus pulsed electromagnetic field (EMF) in the treatment of chronic nonspecific low back pain (ChNsLBP).  Methods:  Between August and December 2019, 51 ChNsLBP participants with a mean age of 35.2 ± 8.6 years were enrolled in this prospective comparative study. At random, they were divided into three groups, 17 in each; HILT, EMF, and controls. HILT group was recruited for Nd:YAG laser using the following parameters: a wavelength of 1064 nm, fluency of 610-810 mJ, frequency of 10-40 Hz, average power of 10.5 W, and 120 μs short pulse duration in scanning mode. All groups received the treatment twice a week for 8 consecutive weeks. They were assessed for the modified Oswestry disability index (MODI), pain disability index (PDI), visual analog scale (VAS), and lumbar flexion range of motion (flex ROM) before and after 8 weeks of study program.  Results:  The results showed greater improvement in the HILT group (VAS, PDI, MODI, and lumbar flex ROM,  p  = 0.001) than the EMF group (VAS,  p  = 0.002, PDI,  p  = 0.045, MODI,  p  = 0.002, and lumbar flex ROM,  p  = 0.042), with significant difference between the two groups in favor of the HILT group ( p  ˂ 0.05).  Conclusions:  Depending on the results of the study, both HILT and EMF are useful physiotherapy modalities in the treatment of ChNsLBP with HILT exhibiting better outcomes than EMF. Clinical recommendations should be highlighted to instigate the use of HILT in the management of musculoskeletal disorders, distinctively ChNsLBP.",2021,"The results showed greater improvement in the HILT group (VAS, PDI, MODI, and lumbar flex ROM,  p  = 0.001) than the EMF group (VAS,  p  = 0.002, PDI,  p  = 0.045, MODI,  p  = 0.002, and lumbar flex ROM,  p  = 0.042), with significant difference between the two groups in favor of the HILT group ( p  ˂ 0.05).  ","['Methods:  Between August and December 2019, 51 ChNsLBP participants with a mean age of 35.2\u2009±\u20098.6 years', 'chronic nonspecific low back pain (ChNsLBP']","['EMF', 'HILT and EMF', 'Pulsed High-Intensity Laser Therapy and Pulsed Electromagnetic Field', 'pulsed high-intensity laser therapy (HILT) versus pulsed electromagnetic field (EMF']","['modified Oswestry disability index (MODI), pain disability index (PDI), visual analog scale (VAS), and lumbar flexion range of motion (flex ROM', 'Chronic Nonspecific Low Back Pain', 'HILT group (VAS, PDI, MODI, and lumbar flex ROM']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0072354', 'cui_str': 'Protein disulfide-isomerase'}, {'cui': 'C0342276', 'cui_str': 'Maturity-onset diabetes of the young'}]",,0.0159573,"The results showed greater improvement in the HILT group (VAS, PDI, MODI, and lumbar flex ROM,  p  = 0.001) than the EMF group (VAS,  p  = 0.002, PDI,  p  = 0.045, MODI,  p  = 0.002, and lumbar flex ROM,  p  = 0.042), with significant difference between the two groups in favor of the HILT group ( p  ˂ 0.05).  ","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Shereen H', 'Initials': 'SH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Gaber S', 'Initials': 'GS', 'LastName': 'Soliman', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences in Al-Qurayyat, Jouf University, Skaka, Saudi Arabia.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Alessi', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Ibrahim N', 'Initials': 'IN', 'LastName': 'Alsalem', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Saeed M', 'Initials': 'SM', 'LastName': 'Alwadai', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4975']
1695,33685234,Assessing the Clinical Requirement of 2.5% Phenylephrine for Diagnostic Pupil Examination.,"Objective:  To evaluate whether the standard dilating drop regimen consisting of phenylephrine, tropicamide, and proparacaine produces clinically significant improvement in pupil size compared to tropicamide and proparacaine during diagnostic eye examination.  Methods:  Sixty-three adult patients at Washington University School of Medicine Eye Clinic were enrolled in this prospective, randomized trial. Each patient received one of two dilating drop regimens: phenylephrine + tropicamide + proparacaine (PE+T+PP), which is considered the standard therapy, or tropicamide + proparacaine (T+PP). Main outcome measures were the proportion of pupils able to achieve successful clinical examination without need for additional dilating drops and change in predilation to postdilation pupil size. Comparisons were made using McNemar's test, repeated measures analysis of variance, and Fisher's test to determine whether PE is a necessary component of the standard eye examination.  Results:  There were no statistically significant differences between the PE+T+PP and T+PE treatment groups in predilation to postdilation changes in average resting pupil size (1.58 ± 0.66 and 2.61 ± 0.79;  P  = 0.57) or constricted pupil size (2.52 ± 0.93 and 3.56 ± 0.96;  P  = 0.15). There was no statistically significant difference between patients who obtained a successful dilated pupil examination between those receiving PE+T+PP and those receiving T+PP as determined by the examining physicians (Fisher's,  P  = 0.67).  Conclusion:  The addition of phenylephrine to tropicamide and proparacaine did not improve pupillary dilation size or ability to conduct a clinical examination. A single dilating agent using tropicamide should be considered in clinical practice.",2021,"There was no statistically significant difference between patients who obtained a successful dilated pupil examination between those receiving PE+T+PP and those receiving T+PP as determined by the examining physicians (Fisher's,  P  = 0.67).  ",['Sixty-three adult patients at Washington University School of Medicine Eye Clinic'],"['phenylephrine, tropicamide, and proparacaine', 'phenylephrine + tropicamide + proparacaine (PE+T+PP', 'PE+T+PP and T+PE', 'tropicamide + proparacaine (T+PP', 'Phenylephrine', 'tropicamide', 'PE+T+PP', 'phenylephrine', 'tropicamide and proparacaine']","['pupil size', 'average resting pupil size', 'proportion of pupils able to achieve successful clinical examination without need for additional dilating drops and change in predilation to postdilation pupil size', 'pupillary dilation size', 'successful dilated pupil examination', 'constricted pupil size']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0072510', 'cui_str': 'proparacaine'}]","[{'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}]",63.0,0.0978105,"There was no statistically significant difference between patients who obtained a successful dilated pupil examination between those receiving PE+T+PP and those receiving T+PP as determined by the examining physicians (Fisher's,  P  = 0.67).  ","[{'ForeName': 'Junsang', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'University of Missouri, School of Medicine, Columbia, Missouri, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Bruck', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Duke University, Raleigh, North Carolina, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Culican', 'Affiliation': 'Department of Ophthalmology and Visual Neurosciences, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2020.0111']
1696,33685232,Effects of a structured counselling-based intervention to improve physical activity behaviour of adolescents and young adult cancer survivors - the randomized phase II Motivate AYA - MAYA trial.,"OBJECTIVE


To explore whether a structured counselling-based intervention increases vigorous physical activity behaviour of adolescent and young adult cancer survivors.
DESIGN


Randomized controlled phase II trial.
SETTING


University Cancer Center Hamburg, Germany.
SUBJECTS


Eighty-nine participants (mean age 24.1 ± 6.3) were randomized to control ( n  = 44) or intervention group ( n  = 45).
INTERVENTIONS


The intervention group was consulted about physical activity behaviour via interview (week 0), and telephone counselling (weeks 1, 3 and 12). The control group only received general physical activity guidelines for cancer survivors (week 0).
MAIN MEASURES


The primary outcome was the rate of participants with ⩾9 metabolic equivalent (MET)-hours per week of vigorous activity post-intervention, measured with the International Physical Activity Questionnaire. Secondary outcomes included assessing physical activity behaviour (e.g. amount and type of physical activity) and quality of life. Assessments were completed in weeks 0 (baseline), 12 (post-intervention) and 52 (follow-up).
RESULTS


Sixty-nine participants completed the post-intervention- and 47 the follow-up-assessment. The rate of participants performing vigorous physical activity increased from baseline to post-intervention for both without differing significantly ( P  = 0.541). Both increased their total metabolic equivalent from baseline to post-intervention (intervention group from 55.2 ± 43.7 to 61.7 ± 29.4, control group from 75.3 ± 81.4 to 88.3 ± 80.2). At follow-up the intervention group (73.7 ± 80.2) was more active than baseline when compared to the control group (78.5 ± 50.0).
CONCLUSIONS


A structured counselling-based physical activity intervention did not significantly impact the level of vigorous physical activity behaviour in adolescent and young adult cancer survivors.",2021,A structured counselling-based physical activity intervention did not significantly impact the level of vigorous physical activity behaviour in adolescent and young adult cancer survivors.,"['Eighty-nine participants (mean age 24.1\u2009±\u20096.3', 'University Cancer Center Hamburg, Germany', 'adolescent and young adult cancer survivors', 'adolescents and young adult cancer survivors']","['structured counselling-based intervention', 'structured counselling-based physical activity intervention', 'general physical activity guidelines', 'physical activity behaviour via interview (week 0), and telephone counselling']","['physical activity behaviour (e.g. amount and type of physical activity) and quality of life', 'total metabolic equivalent', 'rate of participants with ⩾9 metabolic equivalent (MET)-hours per week of vigorous activity post-intervention, measured with the International Physical Activity Questionnaire', 'vigorous physical activity behaviour', 'rate of participants performing vigorous physical activity', 'physical activity behaviour']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0556976', 'cui_str': 'hours/week'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",89.0,0.107919,A structured counselling-based physical activity intervention did not significantly impact the level of vigorous physical activity behaviour in adolescent and young adult cancer survivors.,"[{'ForeName': 'Jannike', 'Initials': 'J', 'LastName': 'Salchow', 'Affiliation': 'Department of Oncology and Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Koch', 'Affiliation': 'Department of Oncology and Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'Department of Oncology and Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'von Grundherr', 'Affiliation': 'Department of Oncology and Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Elmers', 'Affiliation': 'Department of Oncology and Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dwinger', 'Affiliation': 'Department for Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Escherich', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Eik', 'Initials': 'E', 'LastName': 'Vettorazzi', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Reer', 'Affiliation': 'Institute of Human Movement Science, Faculty of Psychology and Human Movement, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Sinn', 'Affiliation': 'Department of Oncology and Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Freerk', 'Initials': 'F', 'LastName': 'Baumann', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Dusseldorf, University Hospital of Cologne, Cologne, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology and Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Department of Oncology and Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology and Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center - University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Clinical rehabilitation,['10.1177/0269215521997974']
1697,33685213,Prospective Multicenter Randomized All-Comers Trial to Assess the Safety and Effectiveness of the Ultra-Thin Strut Sirolimus-Eluting Coronary Stent Supraflex: Two-Year Outcomes of the TALENT Trial.,,2021,,[],['Ultra-Thin Strut Sirolimus-Eluting Coronary Stent Supraflex'],['Safety and Effectiveness'],[],"[{'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0548344,,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Xijing hospital, Xi'an, China (C.G.).""}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, the Netherlands (N.K., R.J.d.W.).'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Sharif', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway (C.G., F.S., Y.O., P.W.S.).'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Ziekenhuis, Rotterdam, the Netherlands (P.C.S.).'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Tonino', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands (P.T.).'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Hofma', 'Affiliation': 'Medical Centre Leeuwarden, the Netherlands (S.H.).'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Cardiology Department, La Paz University Hospital, Madrid, Spain (R.M.).'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Choudhury', 'Affiliation': 'Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom (A. Choudhury).'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Petrov', 'Affiliation': 'Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria (I.P.).'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'University Hospital of Bellvitge, Barcelona, Spain (A. Cequier).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Division of Interventional Cardiology, Cardio-Thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy (A. Colombo).'}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': 'Academics and Research, Batra Hospital and Medical Research Center, New Delhi, India (U.K.).'}, {'ForeName': 'Azfar', 'Initials': 'A', 'LastName': 'Zaman', 'Affiliation': 'Freeman Hospital, Newcastle University, and Newcastle upon Tyne Hospitals NHS Trust, Newcastle, United Kingdom (A.Z.).'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, the Netherlands (N.K., R.J.d.W.).'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway (C.G., F.S., Y.O., P.W.S.).'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway (C.G., F.S., Y.O., P.W.S.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.010312']
1698,33685212,Optical Coherence Tomography Versus Intravascular Ultrasound and Angiography to Guide Percutaneous Coronary Interventions: The iSIGHT Randomized Trial.,"BACKGROUND


Specific algorithms for use of optical coherence tomography (OCT) to guide percutaneous coronary intervention (PCI) are scarce. Also, the relative benefits of intravascular imaging guidance have not been tested against an optimized angiography-guided PCI strategy. In iSIGHT (Optical Coherence Tomography Versus Intravascular Ultrasound and Angiography to Guide Percutaneous Coronary Interventions), we aimed to investigate whether OCT-guided PCI achieves noninferior stent expansion compared with intravascular ultrasound (IVUS) guidance and if both imaging modalities lead to superior stent expansion compared with an optimized angiography-based strategy.
METHODS


Patients ≥18 years old undergoing PCI for ≥1 lesion in native coronaries of 2.25 to 4.00 mm in diameter were randomized 1:1:1 to OCT-, IVUS-, or angiography-guided PCI. Predetermined guidance protocols were applied in all groups. An external elastic membrane-based protocol was used for stent sizing by OCT and IVUS. The primary end point was noninferiority of stent expansion (minimum stent area ≥90% of the average reference lumen area), measured by post-PCI OCT, in OCT-guided versus IVUS-guided PCI (noninferiority margin, 6.5%).
RESULTS


One hundred fifty-one patients (156 lesions) were randomly allocated to OCT (51 lesions [32.7%]), IVUS (52 lesions [33.3%]), or angiography (53 lesions [34.0%]). Stent expansion with OCT guidance (98.01±16.14%) was noninferior to IVUS (91.69±15.75%; 1-sided lower 95% CI, 0.55 mm 2 ;  P non-inferiority <0.001) and superior to angiography (90.53±14.84%,  P =0.041). IVUS and angiography obtained similar stent expansions ( P =0.921). Stent edge dissection and periprocedural complication rates were not significantly different among the groups.
CONCLUSIONS


Stent expansion with OCT guidance using a dedicated external elastic membrane-based sizing strategy was noninferior to that achieved with IVUS and superior to an optimized angiographic strategy.
REGISTRATION


URL: plataformabrasil.saude.gov.br; Unique identifier: 69968417.8.0000.5462.",2021,Stent expansion with OCT guidance (98.01±16.14%) was noninferior to IVUS (91.69±15.75%;,"['One hundred fifty-one patients (156 lesions', 'Patients ≥18 years old undergoing PCI for ≥1 lesion in native coronaries of 2.25 to 4.00 mm in diameter']","['optical coherence tomography (OCT', 'OCT-, IVUS-, or angiography-guided PCI', 'OCT-guided PCI', 'intravascular ultrasound (IVUS) guidance', 'Optical Coherence Tomography Versus Intravascular Ultrasound and Angiography to Guide Percutaneous Coronary Interventions', 'iSIGHT (Optical Coherence Tomography Versus Intravascular Ultrasound and Angiography to Guide Percutaneous Coronary Interventions']","['Stent edge dissection and periprocedural complication rates', 'noninferiority of stent expansion']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C4068875', 'cui_str': '2.25'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}]",,0.0800815,Stent expansion with OCT guidance (98.01±16.14%) was noninferior to IVUS (91.69±15.75%;,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chamié', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}, {'ForeName': 'J Ribamar', 'Initials': 'JR', 'LastName': 'Costa', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Research Institute, Hospital do Coração, Sao Paulo, Brazil (L.P.D.).'}, {'ForeName': 'Dimytri', 'Initials': 'D', 'LastName': 'Siqueira', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Braga', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Seligman', 'Affiliation': 'International Centre for Circulatory Health, Imperial College London, United Kingdom (H.S., R.P.).'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Brito', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Barreto', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Staico', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Feres', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'International Centre for Circulatory Health, Imperial College London, United Kingdom (H.S., R.P.).'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Abizaid', 'Affiliation': 'Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil (D.C., J.R.C., D.S., S.B., R.C., F.B., G.B., R.S., F.F., A.A.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009452']
1699,33685044,[Application of different kinds of endotracheal intubation in the combined thoracoscopic and laparoscopic esophagectomy].,"Objective:  To observe the application of three different kinds of endotracheal intubation in the combined thoracoscopic and laparoscopic esophagectomy.  Methods:  one hundred and eighty patients undergoing combined thoracoscopic and laparoscopic esophagectomy under general anesthesia from the Affiliated Cancer Hospital of Zhengzhou University from February to September 2019 were randomly divided into three groups which include: double-lumen endotracheal intubation group (group S, n =60),single-lumen endotracheal intubation group (group D, n =60) and Coopdech occlusion of bronchial catheter combined with a single-lumen endotracheal intubation group (group C, n =60). The arterial blood samples were collected immediately after endotracheal intubation (T 0 ), 30 min after artificial pneumothorax (single lung ventilation) (T 1 ), 30 min after artificial pneumothorax (double lung ventilation) (T 2 ), and 30 min after extubation (T 3 ) to detect arterial blood gas. Patients' heart rate (HR), blood oxygen partial pressure (PaO 2 ), blood carbon dioxide partial pressure (PaCO 2 ) and airway pressure(Paw) were recorded at T 0 -T 3 .Completion time of endotracheal intubation, carbon dioxide intrathoracic inflation pressure, degree of lung collapse and incidence of postoperative 3-day pneumonia in three groups were recorded. The bronchoalveolar lavage fluid (BALF) of patients at T 0 , T 2  and the end of the operation (T 4 ) were collected to detect the levels of tumor necrosis factor-α(TNF-α), interleukin-6 (IL-6) and interleukin-8 (IL-8) in BALF by enzyme-linked immunosorbent assay (ELISA).  Results:  A total of 14 patients were excluded during the operation, of which 9 cases lasted longer than 6 hours, 3 cases had arrhythmia during the operation and 2 cases lasted less than 1 hour. Finally, 56 cases in group S, 54 cases in group D and 56 cases in group C completed the experiment. The satisfaction rates of lung collapse in group S, group D and group C were 85.7% (48/56), 100.0% (54/54), 89.2% (50/56), respectively, with no statistically significant difference (χ²=1.308,  P >0.05). The intrathoracic inflation pressure of carbon dioxide in group D was (10.2±2.2) mmHg (1 mmHg=0.133 kPa), which was higher than (5.1±3.4) mmHg in group S and (5.6±3.1) mmHg in group C, the difference was statistically significant ( F =-9.303,  P< 0.05). The incidence of postoperative 3-day pneumonia in group D was 14.8%, which was lower than 39.3% in group S and 17.8% in group C, the difference was statistically significant (χ²=8.300,  P< 0.05). At T 4 , the value of TNF-α in group D was (122.4±4.4) ng/L, which was lower than that in group S and group C, (257.9±6.3) and (185.8±5.6) ng/L, with statistically significant difference ( F =69.020,  P <0.05). At T 4 , the value of IL-6 in group D was (175.4±4.9) ng/L, which was lower than that of patients in group S and group C, (289.6±6.8) and (226.2±4.4) ng/L, with statistically significant difference ( F =59.750,  P <0.05). At T 4 , the value of IL-8 in group D was (303.1±7.2) ng/L, which was lower than in group S and group C, (595.4±22.1) and (436.8±10.9) ng/L, with statistically significant difference ( F =55.359,  P <0.05).  Conclusion:  All the three endotracheal intubations can produce satisfactory ventilation effect in the combined thoracoscopic and laparoscopic esophagectomy, however, single-lumen endotracheal intubation has less effect on lung injury.",2021,"At T 4 , the value of TNF-α in group D was (122.4±4.4) ng/L, which was lower than that in group S and group C, (257.9±6.3) and (185.8±5.6) ng/L, with statistically significant difference ( F =69.020,  P <0.05).","['under general anesthesia from the Affiliated Cancer Hospital of Zhengzhou University from February to September 2019', 'one hundred and eighty patients undergoing']","['double-lumen endotracheal intubation group (group S, n =60),single-lumen endotracheal intubation group (group D, n =60) and Coopdech occlusion of bronchial catheter combined with a single-lumen endotracheal intubation group', 'laparoscopic esophagectomy', 'endotracheal intubation', 'combined thoracoscopic and laparoscopic esophagectomy']","['satisfaction rates of lung collapse', 'incidence of postoperative 3-day pneumonia', 'value of IL-6', 'bronchoalveolar lavage fluid (BALF', 'arterial blood samples', 'intrathoracic inflation pressure of carbon dioxide', 'heart rate (HR), blood oxygen partial pressure (PaO 2 ), blood carbon dioxide partial pressure (PaCO 2 ) and airway pressure(Paw', 'levels of tumor necrosis factor-α(TNF-α), interleukin-6 (IL-6) and interleukin-8 (IL-8) in BALF by enzyme-linked immunosorbent assay (ELISA', 'arrhythmia', 'satisfactory ventilation effect', 'value of IL-8', '3 .Completion time of endotracheal intubation, carbon dioxide intrathoracic inflation pressure, degree of lung collapse and incidence of postoperative 3-day pneumonia']","[{'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0444253', 'cui_str': 'Arterial blood specimen'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0853167', 'cui_str': 'Blood carbon dioxide'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]",180.0,0.0414253,"At T 4 , the value of TNF-α in group D was (122.4±4.4) ng/L, which was lower than that in group S and group C, (257.9±6.3) and (185.8±5.6) ng/L, with statistically significant difference ( F =69.020,  P <0.05).","[{'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou 450008,China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Cancer Hospital, Shenzhen Hospital, Chinese Academy of Medical Sciences, Shenzhen 518000, China.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou 450008,China.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Lyu', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou 450008,China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou 450008,China.'}, {'ForeName': 'X T', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou 450008,China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou 450008,China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200628-01963']
1700,33685036,The Behavioral Effects of Combination Therapy of Memantine and Acetylcholinesterase Inhibitors Compared with Acetylcholinesterase Inhibitors Alone in Patients with Moderate Alzheimer's Dementia: A Double-Blind Randomized Placebo-Controlled Trial.,"OBJECTIVE


This study aimed to investigate treatment effects of combination therapy of memantine and acetylcholinesterase inhibitors (AchEIs) compared with AchEIs alone on behavioral and psychological symptoms of dementia (BPSD) in patients with moderate Alzheimer's dementia (AD).
METHODS


This was a 12-week, double-blind, randomized, placebo-controlled trial. A total of 148 patients with moderate AD participated in this study. Mini-Mental State Examination, Neuropsychiatric Inventory (NPI), Clinician's Interview-Based Impression of Change plus caregiver input, Gottfries-Bråne-Steen Scale, and Zarit Burden Interview were used as assessment scales.
RESULTS


There were no significant differences in age, sex, or education between AChEIs alone and combination groups. The combination group showed significantly more improvement of NPI-disinhibition score (0.76±2.15) than the AChEIs alone group (-0.14±1.71) after 12 weeks.
CONCLUSION


Our findings suggest that the combination therapy of memantine and AchEIs might be a beneficial option for reducing disinhibition symptoms of patients with moderate AD compared with AchEIs alone. We believe that clinicians need to consider additional memantine treatment when patients with moderate AD complain disinhibition symptom. A larger clinical trial is needed to further determine the efficacy and advantages of such combination therapy of memantine and AchEIs for treating BPSD of patients with moderate AD.",2021,"The combination group showed significantly more improvement of NPI-disinhibition score (0.76±2.15) than the AChEIs alone group (-0.14±1.71) after 12 weeks.
","[""patients with moderate Alzheimer's dementia (AD"", 'patients with moderate AD complain disinhibition symptom', '148 patients with moderate AD participated in this study', 'patients with moderate AD', ""Patients with Moderate Alzheimer's Dementia""]","['placebo', 'Memantine and Acetylcholinesterase Inhibitors', 'memantine and acetylcholinesterase inhibitors (AchEIs', 'Acetylcholinesterase Inhibitors Alone', 'Placebo', 'memantine']","[""Mini-Mental State Examination, Neuropsychiatric Inventory (NPI), Clinician's Interview-Based Impression of Change plus caregiver input, Gottfries-Bråne-Steen Scale, and Zarit Burden Interview"", 'disinhibition symptoms', 'NPI-disinhibition score', 'behavioral and psychological symptoms of dementia (BPSD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0001046', 'cui_str': 'Acetylcholinesterase inhibitor'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}]",148.0,0.430247,"The combination group showed significantly more improvement of NPI-disinhibition score (0.76±2.15) than the AChEIs alone group (-0.14±1.71) after 12 weeks.
","[{'ForeName': 'HyunChul', 'Initials': 'H', 'LastName': 'Youn', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Kang Joon', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Ilsanpaik Hospital, Inje University College of Medicine, Goyang, Republic of Korea.'}, {'ForeName': 'Shin-Gyeom', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Seong-Jin', 'Initials': 'SJ', 'LastName': 'Cho', 'Affiliation': 'Department of Psychiatry, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Woo Jung', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Republic of Korea.'}, {'ForeName': 'Won Joon', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Yeon', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Department of Psychiatry, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Changsu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Psychiatry, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Cheolmin', 'Initials': 'C', 'LastName': 'Shin', 'Affiliation': 'Department of Psychiatry, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Han-Yong', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}]",Psychiatry investigation,['10.30773/pi.2020.0329']
1701,33684963,Improv to improve medical student communication.,"BACKGROUND


Effective patient provider communication skills can be difficult and time-consuming to teach. Deliberate practice of communication skills through improvisational theatre exercises, with structured debriefing, can provide a solution for teaching patient-centred communication skills in time-limited settings. The objective of this study was to determine if improvisational theatre exercises improved the ratings of patient satisfaction and empathetic communication by standardised patients.
METHODS


This was a randomised controlled trial looking at the effect of improvisational theatre exercises on ratings of patient satisfaction and empathetic communication. Third-year medical students (n = 188) participated in a formative team-based standardised patient (SP) experience. Prior to the SP experience, teams of students were randomly assigned to receive a 45-minute communication-focused improvisation intervention (immediately before the SP experience) or to a control arm without intervention. All teams then participated in the SP experience; the SPs (blinded to team randomisation assignment) then assessed each team's empathetic communication and completed patient satisfaction questions focused on physician behaviours derived from Press Ganey TM  and the Hospital Consumer Assessment of Healthcare Providers and System Surveys TM  . Fifty teams of three or four students participated; 20 teams in the intervention arm and 30 teams in the control arm.
RESULTS


Student teams in the improvisation intervention group had increased measures of empathetic communication (p = 0.04) compared to the control group. The intervention group had increased patient satisfaction survey ratings of 'ability to listen carefully' (p = 0.001) and of 'physician skills' compared to control groups (p = 0.03).
DISCUSSION


Improv exercises with students increased students' empathetic communication and patient satisfaction as assessed by standardised patients.",2021,"RESULTS


Student teams in the improvisation intervention group had increased measures of empathetic communication (p = 0.04) compared to the control group.","['Fifty teams of three or four students participated; 20 teams in the intervention arm and 30 teams in the control arm', 'Third-year medical students (n\xa0=\xa0188) participated in a formative team-based standardised patient (SP) experience']","['45-minute communication-focused improvisation intervention (immediately before the SP experience) or to a control arm without intervention', 'improvisational theatre exercises']","['empathetic communication', 'physician skills', 'ratings of patient satisfaction and empathetic communication', ""students' empathetic communication and patient satisfaction"", ""patient satisfaction survey ratings of 'ability to listen carefully""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]",188.0,0.0639559,"RESULTS


Student teams in the improvisation intervention group had increased measures of empathetic communication (p = 0.04) compared to the control group.","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Grossman', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Lemay', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Byland', 'Affiliation': 'School of the Arts, Department of Theatre, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Anderson', 'Affiliation': 'School of the Arts, Department of Theatre, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Nestler', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Santen', 'Affiliation': 'Department of Emergency Medicine, Virginia Commonwealth University School of Medicine, Virginia, USA.'}]",The clinical teacher,['10.1111/tct.13336']
1702,33684960,Insomnia and falls in older adults: are they linked to executive dysfunction?,"BACKGROUND


Insomnia increases the incidence of falls and impairs executive function. Moreover, falls are associated with executive function impairment. The relationship between falls and executive function in patients with insomnia is not clear. The aim of this study was to evaluate relationship between falls and executive function in individuals with insomnia and a control group.
METHODS


This study involved 122 patients (47 insomnia, 75 controls). The Mini-Mental State Examination, Quick Mild Cognitive Impairment Screen, Trail Making Test A, clock-drawing test, and digit span test were used to measure executive function. Semantic and working memory dual task was also performed. Fall history was recorded and the Falls Efficacy Scale - International administered.
RESULTS


The median age of the patients was 71 years (range: 65-89 years), and 60.7% were women. The insomnia group scored lower on the three-word recall than the control group (P = 0.005), but there was no difference between the groups on cognitive tests. Fall history and fear of falling were more frequent in the insomnia group (P = 0.003, P < 0.001). Semantic and working memory dual tasks were correlated with clock-drawing test only in the insomnia group (r = -0.316, P = 0.031; r = -0.319, P = 0.029). Depression (odds ratio (OR) = 9.65, P = 0.001) and Trail Making Test A (OR = 1.025, P = 0.07) were independently associated with insomnia. Four-metre walking speed (OR = 2.342, P = 0.025), insomnia (OR = 3.453; P = 0.028), and the semantic memory dual task (OR = 1.589; P = 0.025) were also independently associated with falls.
CONCLUSION


Our study showed that dual tasking and executive function are related to falls in patients with insomnia. Managing insomnia and assessment of executive dysfunction may have beneficial effects on preventing falls.",2021,"The insomnia group scored lower on the three-word recall than the control group (P = 0.005), but there was no difference between the groups on cognitive tests.","['older adults', 'individuals with insomnia and a control group', '122 patients (47 insomnia, 75 controls', 'The median age of the patients was 71\u2009years (range: 65-89\u2009years), and 60.7% were women', 'patients with insomnia']",[],"['Insomnia and falls', 'Semantic and working memory dual task', 'falls and executive function', 'Falls Efficacy Scale - International administered', 'Fall history', 'Fall history and fear of falling', 'Trail Making', 'insomnia', 'semantic memory dual task', 'Depression', 'Semantic and working memory dual tasks', 'cognitive tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0542312', 'cui_str': 'Semantic memory'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",122.0,0.0199558,"The insomnia group scored lower on the three-word recall than the control group (P = 0.005), but there was no difference between the groups on cognitive tests.","[{'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Unsal', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'Sengul Aycicek', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Olgun', 'Initials': 'O', 'LastName': 'Deniz', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Mert', 'Initials': 'M', 'LastName': 'Esme', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Dikmeer', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Cafer', 'Initials': 'C', 'LastName': 'Balcı', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Koca', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Yelda', 'Initials': 'Y', 'LastName': 'Ucar', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Boga', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Suna', 'Initials': 'S', 'LastName': 'Burkuk', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Meltem Gulhan', 'Initials': 'MG', 'LastName': 'Halil', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Cankurtaran', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Burcu Balam', 'Initials': 'BB', 'LastName': 'Dogu', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12677']
1703,33684953,"Thymoquinone with Metformin Decreases Fasting, Post Prandial Glucose, and HbA1c in Type 2 Diabetic Patients.","OBJECTIVE


Antihyperglycemic activity of Thymoquinone (TQ) was evaluated in diabetic mouse model and patients.
METHODS


TQ (50 mg/kg) was orally administered daily for 21 days in combination with metformin in diabetic mice and a reduction on blood glucose level was monitored. In human, a 90-day randomized study was carried out in 60 Type 2 Diabetes mellitus patients to evaluate safety and efficacy of TQ administration with metformin in a 3-arm study. Patients in arm 1 (T1) received 1 tablet of metformin SR 1000 mg and 1 tablet of TQ 50 mg once daily. The second arm (T2) patients received 1 tablet of metformin SR 1000 mg and 2 tablets of TQ 50 mg once daily. Patients in arm 3 (R) received 1 tablet of metformin SR 1000 mg only.
RESULTS


The diabetic mice treated with combination of TQ and metformin showed significant decrease in blood sugar compared to those treated with only metformin. In patients who completed the study, the glycated hemoglobin (HbA1c) values in T1, T2 and R decreased after 3 months from 7.2, 7.2 and 7.3 to 6.7, 6.8, and 7.1, respectively. A greater reduction in Fasting Blood Glucose and Post Prandial Blood Glucose was also observed in T1 and T2 arms compared to R.
CONCLUSION


At dose levels of 50 and 100 mg of TQ combined with a daily dose of 1000 mg Metformin demonstrated a reduction in the levels of HbA1c and blood glucose compared to the standard treatment of diabetic patients with metformin alone.",2021,"A greater reduction in Fasting Blood Glucose and Post Prandial Blood Glucose was also observed in T1 and T2 arms compared to R.
CONCLUSION


At dose levels of 50 and 100 mg of TQ combined with a daily dose of 1000 mg Metformin demonstrated a reduction in the levels of HbA1c and blood glucose compared to the standard treatment of diabetic patients with metformin alone.","['diabetic patients with', 'Type 2 Diabetic Patients', 'diabetic mouse model and patients', '60 Type 2 Diabetes mellitus patients']","['TQ and metformin', 'TQ administration with metformin', 'Metformin', 'metformin SR 1000\u2009mg only', 'metformin SR 1000\u2009mg and 1 tablet of TQ 50\u2009mg once daily', 'metformin', 'Thymoquinone (TQ', 'Thymoquinone with Metformin', 'metformin SR 1000\u2009mg and 2 tablets of TQ']","['levels of HbA1c and blood glucose', 'blood glucose level', 'glycated hemoglobin (HbA1c) values in T1, T2 and R', 'Fasting Blood Glucose and Post Prandial Blood Glucose', 'blood sugar']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0076611', 'cui_str': 'thymoquinone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}]",,0.0217459,"A greater reduction in Fasting Blood Glucose and Post Prandial Blood Glucose was also observed in T1 and T2 arms compared to R.
CONCLUSION


At dose levels of 50 and 100 mg of TQ combined with a daily dose of 1000 mg Metformin demonstrated a reduction in the levels of HbA1c and blood glucose compared to the standard treatment of diabetic patients with metformin alone.","[{'ForeName': 'Shoukath M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Jina Pharmaceuticals Inc., Libertyville, IL, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Jina Pharmaceuticals Inc., Libertyville, IL, USA.'}, {'ForeName': 'Saifuddin', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Jina Pharmaceuticals Inc., Libertyville, IL, USA.'}, {'ForeName': 'Ateeq', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'Jina Pharmaceuticals Inc., Libertyville, IL, USA.'}, {'ForeName': 'Moghis', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Jina Pharmaceuticals Inc., Libertyville, IL, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Paithankar', 'Affiliation': 'Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Brijesh', 'Initials': 'B', 'LastName': 'Desai', 'Affiliation': 'Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Chaturvedi', 'Affiliation': 'Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Lambda Therapeutics Research Limited, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Dharmendra T', 'Initials': 'DT', 'LastName': 'Panchal', 'Affiliation': 'Samvedna Hospital Multispecialty, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Kuntal', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': 'Bodyline Hospitals, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Chavda', 'Affiliation': 'Rudraksha Hospital, Bareja, Gujarat, India.'}, {'ForeName': 'Banshi D', 'Initials': 'BD', 'LastName': 'Saboo', 'Affiliation': 'Bakeri Medical Research Center, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Alpesh', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Shree Nidhi Heart & Medial Hospital, Mehsana, Gujarat, India.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Jina Pharmaceuticals Inc., Libertyville, IL, USA.'}]",Drug research,['10.1055/a-1388-5415']
1704,33684925,Brentuximab Vedotin in Combination with Chemotherapy for Pediatric Patients with ALK+ALCL: Results of COG Trial ANHL12P1.,"Approximately 30% of pediatric patients with ALCL relapse. While brentuximab vendotin has demonstrated excellent activity in ALCL, it has not been used for newly diagnosed patients. Children's Oncology Group trial ANHL12P1 determined the toxicity and efficacy of brentuximab vedotin with chemotherapy in children with newly diagnosed, non-localized, ALK+/CD30+ ALCL. From 2013 to 2017, 68 children with ALK+ ALCL were enrolled and received brentuximab vedotin (Arm BV). All patients received five-day prophase followed by six cycles of chemotherapy at 21-day intervals. Brentuximab vedotin was given on day 1 of each of the six cycles. Of the 67 eligible patients for toxicity evaluation, 66 completed all six cycles of chemotherapy resulting in 399 cycles evaluable. There were no toxic deaths, no cases of progressive multifocal leukoencephalopathy syndrome, and no cases of grade 3 or 4 neuropathy. The two-year EFS is 79.1% (95% CI, 67.2% to 87.1%). The two-year OS is 97.0% (95% CI, 88.1% to 99.2%). Fourteen patients relapsed and were the only events contributing to EFS. 11 of 14 (79%) relapses occurred within ten months of initial diagnosis, with only one patient (1.5%) having relapsed during therapy. Quantitative RT-PCR for NPM-ALK at baseline (minimal disseminated disease) demonstrated prognostic value and impacted 2-year EFS (P=0.0004). Overall, the addition of brentuximab vedotin to standard chemotherapy does not add significant toxicity, nor does it alter the desired interval between cycles. The addition of brentuximab vedotin prevented relapses during therapy and the overall and event-free survival estimates compare favorably with results obtained using conventional chemotherapy.",2021,The addition of brentuximab vedotin prevented relapses during therapy and the overall and event-free survival estimates compare favorably with results obtained using conventional chemotherapy.,"['From 2013 to 2017, 68 children with ALK+ ALCL were enrolled and received', 'children with newly diagnosed, non-localized, ALK+/CD30+ ALCL', 'Pediatric Patients with ALK+ALCL', 'pediatric patients with ALCL relapse', '67 eligible patients for toxicity evaluation, 66 completed all six cycles of chemotherapy resulting in 399 cycles evaluable', 'newly diagnosed patients']","['Brentuximab vedotin', 'Brentuximab Vedotin in Combination with Chemotherapy', 'brentuximab vedotin', 'brentuximab vedotin with chemotherapy']","['progressive multifocal leukoencephalopathy syndrome', 'toxicity and efficacy', 'toxic deaths']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206180', 'cui_str': 'Large cell anaplastic lymphoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}]","[{'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0023524', 'cui_str': 'Progressive multifocal leukoencephalopathy'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",68.0,0.0979265,The addition of brentuximab vedotin prevented relapses during therapy and the overall and event-free survival estimates compare favorably with results obtained using conventional chemotherapy.,"[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lowe', 'Affiliation': ""Children's Hospital of The King's Daughters, Norfolk, Virginia, United States.""}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Reilly', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States.""}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Lim', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Saguilig', 'Affiliation': ""Children's Oncology Group, Monrovia, California, United States.""}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Barkauskas', 'Affiliation': 'Keck School of Medicine of the University of Southern California, United States.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""Children's National Health System, Washington, District of Columbia, United States.""}]",Blood,['10.1182/blood.2020009806']
1705,33684919,Metabolic Effects of Growth Hormone Treatment in Short Prepubertal Children: A Double-Blinded Randomized Clinical Trial.,"INTRODUCTION


Growth hormone (GH) is a central hormone for regulating linear growth during childhood and also highly involved in the metabolism of lipids, carbohydrates, and protein. However, few studies report on how treatment with GH during childhood influences metabolic parameters. Our aim was to investigate metabolic effects of different doses of GH in short children with GH peak levels in the low to normal range.
DESIGN


Thirty-five prepubertal short children (<-2.5 SDS), aged 7-10 years, with peak levels of GH between 7 and 14 μg/L during an arginine-insulin tolerance test, were randomized to 3 different doses (11/33/100 μg/kg/day) of GH treatment for 2 years. Auxological and metabolic investigations were performed. These included metabolites in blood and interstitial microdialysis fluid, dual-energy X-ray absorptiometry, frequently sampled intravenous glucose tolerance test (FSIVGTT), and stable isotope examinations of rates of glucose production and lipolysis.
RESULTS


At 24 months, the high-dose group (HD) had higher fasting insulin compared with the standard-dose (SD) and low-dose (LD) groups (HD: 111.7 vs. SD: 61.2 and LD: 46.0 pmol/L [p < 0.001]) and showed signs of insulin resistance (HOMA-IR, HD: 4.20 vs. SD: 2.17 and LD: 1.71 (LD) [p < 0.001]). The FSIVGTT also demonstrated higher acute insulin response (p < 0.05). Few other metabolic differences were found at 24 months, but a decreased insulin sensitivity index (Si) could already be seen at 12 months for both SD and HD compared with the LD group (p < 0.05).
CONCLUSION


Treatment with GH resulted in a dose-dependent decrease in insulin sensitivity, demonstrated by higher levels of fasting insulin and signs of insulin resistance in both HOMA indices and FSIVGTT examinations.",2021,"Treatment with GH resulted in a dose-dependent decrease in insulin sensitivity, demonstrated by higher levels of fasting insulin and signs of insulin resistance in both HOMA indices and FSIVGTT examinations.","['short children with GH peak levels in the low to normal range', 'Thirty-five prepubertal short children (<-2.5 SDS), aged 7-10 years, with peak levels of GH between 7 and 14 μg/L during an arginine-insulin tolerance test', 'Short Prepubertal Children']","['GH', 'GH treatment', 'FSIVGTT', 'Growth Hormone Treatment', 'Growth hormone (GH']","['acute insulin response', 'higher fasting insulin', 'fasting insulin and signs of insulin resistance', 'signs of insulin resistance', 'insulin sensitivity index (Si', 'insulin sensitivity']","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0063632', 'cui_str': 'insulin, Arg(B29)-'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021911', 'cui_str': 'Intravenous Glucose Tolerance'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.199038,"Treatment with GH resulted in a dose-dependent decrease in insulin sensitivity, demonstrated by higher levels of fasting insulin and signs of insulin resistance in both HOMA indices and FSIVGTT examinations.","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Tidblad', 'Affiliation': ""Department of Women's and Children's Health, Division of Pediatric Endocrinology, Karolinska Institutet, Stockholm, Sweden, anders.tidblad@ki.se.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gustafsson', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Marcus', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ritzén', 'Affiliation': ""Department of Women's and Children's Health, Division of Pediatric Endocrinology, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Klas', 'Initials': 'K', 'LastName': 'Ekström', 'Affiliation': ""Department of Women's and Children's Health, Division of Pediatric Endocrinology, Karolinska Institutet, Stockholm, Sweden.""}]",Hormone research in paediatrics,['10.1159/000513518']
1706,33684892,Pretending with realistic and fantastical stories facilitates executive function in 3-year-old children.,"Fictional stories can affect many aspects of children's behavior and cognition, yet little is known about how they might help or hinder children's executive function skills. The current study investigated the role of story content (fantasy or reality) and mode of engagement with the story (pretense or a non-pretense control) on children's inhibitory control, an important component of early executive function. A total of 60 3-year-olds were randomly assigned to hear a fantastical or realistic story and were encouraged to engage in either pretense or a non-pretense activity related to the story. They then completed the Less Is More task of inhibitory control. Story content had no impact on children's inhibitory control; children performed equally well after hearing a fantastical or realistic story. However, children who engaged in story-related pretend play showed greater inhibitory control than those who engaged in a non-pretense activity. We found no interaction between story content and play engagement type. These results held when controlling for baseline inhibitory control, receptive vocabulary, age, gender, affect, and propensity toward pretense. Therefore, mode of play engagement with a story was more important in promoting children's inhibitory control skills than the degree of realism in the story.",2021,Story content had no impact on children's inhibitory control; children performed equally well after hearing a fantastical or realistic story.,"['A total of 60 3-year-olds', '3-year-old children']","['story content (fantasy or reality) and mode of engagement with the story (pretense or a non-pretense control', 'hear a fantastical or realistic story and were encouraged to engage in either pretense or a non-pretense activity related to the story', 'Pretending with realistic and fantastical stories']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015630', 'cui_str': 'Fantasy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0521100', 'cui_str': 'Pretension for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",[],,0.0190521,Story content had no impact on children's inhibitory control; children performed equally well after hearing a fantastical or realistic story.,"[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'White', 'Affiliation': 'Hamilton College, Clinton, NY 13323, USA; University of Minnesota, Twin Cities, Minneapolis, MN 55455, USA. Electronic address: rewhite@hamilton.edu.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Carlson', 'Affiliation': 'University of Minnesota, Twin Cities, Minneapolis, MN 55455, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2021.105090']
1707,33677113,"Spa therapy for the treatment of fibromyalgia: an open, randomized multicenter trial.","Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference (MCID) at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire (FIQ) score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a MCID (p=0.013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia. PERSPECTIVE: A 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate vs. delayed (i.e. after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02265029.",2021,The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months.,"['220 patients with fibromyalgia compared an immediate vs. delayed (i.e. after 6 months) 18-day spa therapy', 'patients with fibromyalgia', 'patients with fibromyalgia comparing an', 'fibromyalgia', 'five spa therapy care facilities in France enrolled 220 patients']","['immediate vs. delayed 18-day spa therapy', 'Spa therapy']","['number of patients achieving minimal clinically important difference (MCID', 'generic quality of life (QOL), sleep or physical activity', 'baseline fibromyalgia impact questionnaire (FIQ) score', 'pain, fatigue, and symptom severity']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",220.0,0.159302,The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months.,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Maindet', 'Affiliation': 'Pain Medicine Department, CHU Grenoble Alpes, 38000 Grenoble, France; University of Grenoble Alpes, CNRS, TIMC-IMAG (UMR 5525), 38000 Grenoble, France.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Maire', 'Affiliation': 'Centre for the Study and Treatment of Pain, Hôpital Lariboisière, AP-HP, Paris, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Vermorel', 'Affiliation': 'University of Grenoble Alpes, CNRS, TIMC-IMAG (UMR 5525), 38000 Grenoble, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Cracowski', 'Affiliation': 'Pharmacology Department, INSERM CIC 1406 Grenoble, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Rolland', 'Affiliation': 'University of Grenoble Alpes, CNRS, TIMC-IMAG (UMR 5525), 38000 Grenoble, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Forestier', 'Affiliation': 'Centre for Rheumatology and Balneotherapy Research, Aix Les Bains, France.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Comte', 'Affiliation': 'University of Grenoble Alpes, CNRS, TIMC-IMAG (UMR 5525), 38000 Grenoble, France.'}, {'ForeName': 'Christian-François', 'Initials': 'CF', 'LastName': 'Roques', 'Affiliation': 'University of Toulouse, Toulouse, France (President of AFRETH Scientific Committee).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Serra', 'Affiliation': 'CHU Amiens, Laboratoire PSITEC EA/ULR 4072 Lille, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'University of Grenoble Alpes, CNRS, TIMC-IMAG (UMR 5525), 38000 Grenoble, France; Public Health Department, CHU Grenoble Alpes, 38000 Grenoble, France. Electronic address: jean-luc.bosson@univ-grenoble-alpes.fr.'}]",The journal of pain,['10.1016/j.jpain.2021.02.010']
1708,33677049,Low dose radiation therapy for severe COVID-19 pneumonia: a randomized double-blind study.,"PURPOSE


The morbidity and mortality of patients requiring mechanical ventilation for coronavirus disease 2019 (COVID-19) pneumonia is considerable. We studied the use of whole-lung low dose radiation therapy (LDRT) in this patient cohort.
METHODS AND MATERIALS


Patients admitted to the intensive care unit (ICU) and requiring mechanical ventilation for COVID-19 pneumonia were included in this randomized double-blind study. Patients were randomized to 1 Gy whole-lung LDRT or sham irradiation (sham-RT). Treatment group allocation was concealed from patients and ICU clinicians, who treated patients according to the current standard of care. Patients were followed for the primary endpoint of ventilator-free days (VFDs) at day 15 post-intervention. Secondary endpoints included overall survival, as well as changes in oxygenation and inflammatory markers.
RESULTS


Twenty-two patients were randomized to either whole-lung LDRT or sham-RT between November and December 2020. Patients were generally elderly and comorbid, with a median age of 75 years in both arms. No difference in 15-day VFDs was observed between groups (p = 1.00), with a median of 0 days (range, 0-9) in the LDRT arm, and 0 days (range, 0-13) in the sham-RT arm. Overall survival at 28 days was identical at 63.6% (95%CI, 40.7-99.5%) in both arms (p = 0.69). Apart from a more pronounced reduction in lymphocyte counts following LDRT (p < 0.01), analyses of secondary endpoints revealed no significant differences between the groups.
CONCLUSIONS


Whole-lung LDRT failed to improve clinical outcomes in critically ill patients requiring mechanical ventilation for COVID-19 pneumonia.",2021,"CONCLUSIONS


Whole-lung LDRT failed to improve clinical outcomes in critically ill patients requiring mechanical ventilation for COVID-19 pneumonia.","['patients requiring', 'critically ill patients requiring mechanical ventilation for COVID-19 pneumonia', 'severe COVID-19 pneumonia', 'Patients admitted to the intensive care unit (ICU) and requiring mechanical ventilation for COVID-19 pneumonia', 'Patients were generally elderly and comorbid, with a median age of 75 years in both arms', 'Twenty-two patients']","['Low dose radiation therapy', 'whole-lung low dose radiation therapy (LDRT', 'mechanical ventilation', 'whole-lung LDRT or sham-RT', 'Gy whole-lung LDRT or sham irradiation (sham-RT']","['ventilator-free days (VFDs', 'morbidity and mortality', 'overall survival, as well as changes in oxygenation and inflammatory markers', 'clinical outcomes', '15-day VFDs', 'Overall survival', 'lymphocyte counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}]",22.0,0.567811,"CONCLUSIONS


Whole-lung LDRT failed to improve clinical outcomes in critically ill patients requiring mechanical ventilation for COVID-19 pneumonia.","[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Papachristofilou', 'Affiliation': 'Clinic of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland. Electronic address: alexandros.papachristofilou@usb.ch.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Finazzi', 'Affiliation': 'Clinic of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Blum', 'Affiliation': 'Clinic of Intensive Care Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Zehnder', 'Affiliation': 'Clinic of Intensive Care Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Zellweger', 'Affiliation': 'Clinic of Intensive Care Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lustenberger', 'Affiliation': 'Clinic of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Bauer', 'Affiliation': 'Clinic of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dott', 'Affiliation': 'Clinic of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Avcu', 'Affiliation': 'Clinic of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Kohler', 'Affiliation': 'Clinic of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zimmermann', 'Affiliation': 'Clinic of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Pargger', 'Affiliation': 'Clinic of Intensive Care Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'Clinic of Intensive Care Medicine, University Hospital Basel, Basel, Switzerland.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.02.054']
1709,33677046,Sex-dependent complex association of TPH2 with multiple dimensions of ADHD.,"BACKGROUND


Tryptophan hydroxylase 2 (TPH2) is a key enzyme in the biosynthesis of serotonin in the brain. This study aims to investigate the role of a functional variant in TPH2 (rs17110747) in the pathophysiology of ADHD. This variant has been implicated in mood disorders in recent meta-analysis. This study uses a comprehensive approach that combines association testing and pharmaco-dynamic evaluation of behaviour, in a large sample of children with ADHD (n = 570).
METHODS


The association between various ADHD relevant traits and rs17110747 was analyzed using family-based association tests (FBAT). Children were assessed by parents, teachers and research staff under three experimental conditions (EC): baseline, placebo, and methylphenidate using a double-blind placebo-controlled crossover trial.
OUTCOMES


FBAT analysis conducted in a sample stratified based on sex of the proband, showed that there was a highly significant overtransmission of the G allele from parents to affected girls. In addition, significant association with several behavioral and cognitive dimensions of ADHD was observed only when the proband was female. Further, girls with the G/G genotype (rs17110747) had greater response to placebo when evaluated by parents.
INTERPRETATION


These results suggest that there may be a complex association of TPH2 in the etiology of ADHD, with a sex-specific effect.",2021,"Further, girls with the G/G genotype (rs17110747) had greater response to placebo when evaluated by parents.
",['children with ADHD (n\u202f=\u202f570'],"['placebo, and methylphenidate using a double-blind placebo', 'placebo']",['several behavioral and cognitive dimensions of ADHD'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]",,0.110759,"Further, girls with the G/G genotype (rs17110747) had greater response to placebo when evaluated by parents.
","[{'ForeName': 'Weam', 'Initials': 'W', 'LastName': 'Fageera', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Human Genetics, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Sarojini M', 'Initials': 'SM', 'LastName': 'Sengupta', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Ève', 'Initials': 'MÈ', 'LastName': 'Fortier', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grizenko', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Babienco', 'Affiliation': 'Department of Decision Sciences, HEC Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Labbe', 'Affiliation': 'Department of Decision Sciences, HEC Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Human Genetics, McGill University, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada. Electronic address: ridha.joober@douglas.mcgill.ca.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2021.110296']
1710,33677037,The Role of Schools in Early Adolescents' Mental Health: Findings From the MYRIAD Study.,"OBJECTIVE


Recent studies suggest deteriorating youth mental health. The current UK policy emphasises the role of schools for mental health promotion and prevention, but little data exist on what aspects of schools explain pupils' mental health. We explored school-level influences on the mental health of young people in a large school-based sample from the UK.
METHOD


We analyzed baseline data from a large cluster randomized controlled trial (ISRCTN 86619085) collected between 2016‒2018 from mainstream UK secondary schools selected to be representative in relation to their quality rating, size, deprivation, mixed or single-sex pupil population and country. Participants were pupils in their first or second year of secondary school. We assessed whether school-level factors were associated with pupil mental health.
RESULTS


26,885 pupils (response rate=90%), aged 11‒14 years, 55% of which were female, attending 85 UK schools, were included. Schools accounted for 2.4% (95% CI=2.0‒2.8; p<0.0001) of the variation in psychopathology, 1.6% (95% CI=1.2‒2.1; p<0.0001) of depression and 1.4% (95% CI=1.0‒1.7; p<0.0001) of well-being. Schools in urban locations, with a higher percentage of free school meals and of White British, were associated with poorer pupil mental health. A more positive school climate was associated with better mental health.
CONCLUSION


School-level variables, primarily related to contextual factors, characteristics of their pupil population, and school climate explain a small but significant amount of variability in young people's mental health. This might be used to identify schools that are in need of more resources to support young people's mental health.",2021,"Schools accounted for 2.4% (95% CI=2.0‒2.8; p<0.0001) of the variation in psychopathology, 1.6% (95% CI=1.2‒2.1; p<0.0001) of depression and 1.4% (95% CI=1.0‒1.7; p<0.0001) of well-being.","['86619085) collected between 2016‒2018 from mainstream UK secondary schools selected to be representative in relation to their quality rating, size, deprivation, mixed or single-sex pupil population and country', '26,885 pupils (response rate=90%), aged 11‒14 years, 55% of which were female, attending 85 UK schools, were included', 'young people in a large school-based sample from the UK', ""Early Adolescents' Mental Health"", 'Participants were pupils in their first or second year of secondary school', ""young people's mental health""]",[],['poorer pupil mental health'],"[{'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.118147,"Schools accounted for 2.4% (95% CI=2.0‒2.8; p<0.0001) of the variation in psychopathology, 1.6% (95% CI=1.2‒2.1; p<0.0001) of depression and 1.4% (95% CI=1.0‒1.7; p<0.0001) of well-being.","[{'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'University of Cambridge, United Kingdom.'}, {'ForeName': 'Michelle Degli', 'Initials': 'MD', 'LastName': 'Esposti', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Crane', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Montero-Marín', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Sarah-Jayne', 'Initials': 'SJ', 'LastName': 'Blakemore', 'Affiliation': 'University of Cambridge, United Kingdom; University College London, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bowes', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""King's College London, United Kingdom.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dalgleish', 'Affiliation': 'University of Cambridge, United Kingdom; Cambridgeshire and Peterborough NHS Foundation Trust, Cambridgeshire, United Kingdom.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Greenberg', 'Affiliation': 'Penn State University, Centre County, Pennsylvania.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nuthall', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Raja', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Obioha C', 'Initials': 'OC', 'LastName': 'Ukoumunne', 'Affiliation': 'University of Exeter, United Kingdom.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Viner', 'Affiliation': 'Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'J Mark G', 'Initials': 'JMG', 'LastName': 'Williams', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Allwood', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Aukland', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Tríona', 'Initials': 'T', 'LastName': 'Casey', 'Affiliation': 'University College Cork, Ireland.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'De Wilde', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Eleanor-Rose', 'Initials': 'ER', 'LastName': 'Farley', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kappelmann', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany, and International Max Planck Research School for Translational Psychiatry (IMPRS-TP), Munich, Germany.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Lord', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Medlicott', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Palmer', 'Affiliation': 'University of Texas South-western Medical Center, Dallas.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Petit', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Pryor-Nitsch', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Warriner', 'Affiliation': 'University of York, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sonley', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'University of Oxford, United Kingdom. Electronic address: willem.kuyken@psych.ox.ac.uk.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2021.02.016']
1711,33677032,Multipoint left ventricular pacing effects on hemodynamic parameters and functional status: HUMVEE single-arm clinical trial (NCT03189368).,"OBJECTIVES


The aim of this study was to assess the capacity of optimized multipoint pacing (MPP) over optimized cardiac resynchronization therapy (CRT), in terms of clinical, functional, and echocardiographic parameters among dyssynchronous heart failure patients.
METHODS


Eighty patients (Caucasian, 77.5% male, 68.4±10.1 years, 53.8% ischemic cardiomyopathy) sequentially received optimized CRT and optimized MPP over 6 and 12-month periods, in a single-arm clinical trial. Clinical, laboratory and echocardiographic assessment was conducted at baseline and following completion of each step.
RESULTS


Significant additive effects of optimized MPP over optimized CRT were noted regarding 6-minute walking distance (baseline/optCRT/optMPP: 293±120m vs 367±94m vs 405±129m, p<0.001), NYHA class (2.36 vs 2.19 vs 1.45, p<0.001), VTI lvot  (14.25±3.2cm vs 16.2±4cm vs 17.5±3.4cm, p<0.001), stroke volume (48±13.5ml vs 55±15ml vs 59±15ml, p<0.001), LVEF (29%±7.1% vs 33%±7.3% vs 37%±7.7%, p<0.001), maximal left atrial volume (77.2±34.2ml vs 74.2±39.5ml vs 67.7±32ml, p=0.02), pulmonary artery systolic pressure (35.9mmHg vs 33.5mmHg vs 31mmHg, p<0.001), and right ventricular strain (-8.3%±6.9% vs -8.8%±6.6% vs -11.8%±6.1%, p=0.022). Regarding VAC SW and CP as percentages of maximal, there was significant difference detected compared to baseline for both CRT and MPP. Additive effects persisted only if suitable MPP dipoles were present. Exploratory analysis revealed that ischemic cardiomyopathy continued to exhibit significant differences favoring MPP, whereas nonischemic cardiomyopathy had similar findings regarding total left atrial strain and quality of life.
CONCLUSIONS


optimized MPP showed significant improvements on hemodynamic parameters and ventricular function, in heart failure patients over optimized CRT. The beneficial effect was more prominent in men and in those with rather reduced LVEF, consistent with findings suggesting a beneficial trend in VAC and CP with the more homogenous depolarization offered by optimized MPP.",2021,"Regarding VAC SW and CP as percentages of maximal, there was significant difference detected compared to baseline for both CRT and MPP.","['Eighty patients (Caucasian, 77.5% male, 68.4±10.1 years, 53.8% ischemic cardiomyopathy) sequentially received', 'dyssynchronous heart failure patients']","['optimized CRT and optimized MPP', 'optimized multipoint pacing (MPP) over optimized cardiac resynchronization therapy (CRT']","['stroke volume', 'maximal left atrial volume', 'pulmonary artery systolic pressure', 'VTI lvot', 'hemodynamic parameters and ventricular function', 'LVEF', 'total left atrial strain and quality of life', '6-minute walking distance', 'right ventricular strain']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}]",80.0,0.0658243,"Regarding VAC SW and CP as percentages of maximal, there was significant difference detected compared to baseline for both CRT and MPP.","[{'ForeName': 'Christos-Konstantinos', 'Initials': 'CK', 'LastName': 'Antoniou', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece. Electronic address: ckantoniou@hotmail.gr.'}, {'ForeName': 'Polychronis', 'Initials': 'P', 'LastName': 'Dilaveris', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Chrysohoou', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece. Electronic address: chrysohoou@usa.net.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Konstantinou', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Magkas', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Xydis', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Manolakou', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Skiadas', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos A', 'Initials': 'KA', 'LastName': 'Gatzoulis', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece.'}, {'ForeName': 'Costas', 'Initials': 'C', 'LastName': 'Tsioufis', 'Affiliation': 'First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion General Hospital, Athens, Greece.'}]",Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese,['10.1016/j.hjc.2021.02.012']
1712,33677004,"Response to ""Efficacy of sonidegib in histologic subtypes of advanced basal cell carcinoma: Results from the final analysis of the randomized phase 2 Basal Cell Carcinoma Outcomes With LDE225 Treatment (BOLT) trial at 42 months"".",,2021,,['histologic subtypes of advanced basal cell carcinoma'],['sonidegib'],[],"[{'cui': 'C1301142', 'cui_str': 'WHO tumor classification'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}]","[{'cui': 'C3886731', 'cui_str': 'sonidegib'}]",[],,0.0397414,,"[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Villani', 'Affiliation': 'Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. Electronic address: ali.vil@hotmail.it.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Fabbrocini', 'Affiliation': 'Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Costa', 'Affiliation': 'Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Scalvenzi', 'Affiliation': 'Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.02.074']
1713,33676997,The effect of reconnection to mechanical ventilation for 1 hour after spontaneous breathing trial on reintubation among patients ventilated for more than 12 hours: A randomized clinical trial.,"BACKGROUND


The rest of the respiratory musculature after the spontaneous breathing test to prevent extubation failures in critically ill patients needs to be further studied.
RESEARCH QUESTION


Is the reconnection to mechanical ventilation (MV) for 1 hour after a successful spontaneous breathing trial (SBT) able to reduce the risk of reintubation?
STUDY DESIGN AND METHODS


Randomized clinical trial conducted in four intensive care units (ICUs) between August 2018 and July 2019. Candidates for tracheal extubation who met all screening criteria for weaning were included. Once successful in the SBT using a T-tube, the patients were randomized to the following groups: direct extubation (DE) or extubation after reconnection to MV for 1 hour (R1h). The primary outcome was reintubation within 48 hours.
RESULTS


Among the 336 patients studied (female, 41.1%; median age, 59 [45 - 70] years), 12.9% (22/171) in the R1h group required reintubation within 48 hours versus 18.2% (30/165) in the DE group (risk difference [RD] 5.3 [95% CI: -2.49-13.12; p=0.18). There were no differences in mortality, length of ICU or hospital stay, causes of reintubation, or signs of extubation failure. A prespecified exploratory analysis showed that among the 233 (69.3%) patients who were ventilated for more than 72 hours, the incidence of reintubation was 12.7% (15/118) in the R1h group compared to 22.6% (26/115) observed in the DE group (p=0.04).
INTERPRETATION


Reconnection to MV after a successful SBT, compared with DE, did not result in a statistically significant reduction in the risk of reintubation in mechanically ventilated patients. Subgroup exploratory findings suggest that the strategy may benefit patients who were ventilated for more than 72 hours, which should be confirmed in further studies.",2021,"There were no differences in mortality, length of ICU or hospital stay, causes of reintubation, or signs of extubation failure.","['336 patients studied (female, 41.1%; median age, 59 [45 - 70] years), 12.9% (22/171) in the R1h group required reintubation within 48 hours versus 18.2% (30/165) in the DE group (risk difference [RD] 5.3', 'mechanically ventilated patients', 'patients ventilated for more than 12 hours', 'four intensive care units (ICUs) between August 2018 and July 2019', 'Candidates for tracheal extubation who met all screening criteria for weaning were included', 'critically ill patients']","['reconnection to mechanical ventilation', 'direct extubation (DE) or extubation after reconnection to MV']","['mortality, length of ICU or hospital stay, causes of reintubation, or signs of extubation failure', 'reintubation within 48 hours', 'risk of reintubation', 'incidence of reintubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.372671,"There were no differences in mortality, length of ICU or hospital stay, causes of reintubation, or signs of extubation failure.","[{'ForeName': 'Michelli M', 'Initials': 'MM', 'LastName': 'Dadam', 'Affiliation': 'Universidade da Região de Joinville - UNIVILLE, Joinville, Brazil; Centro Hospitalar Unimed de Joinville, Joinville, Brazil; Hospital Municipal São José, Joinville, Brazil. Electronic address: mikidadam@gmail.com.'}, {'ForeName': 'Anderson R R', 'Initials': 'ARR', 'LastName': 'Gonçalves', 'Affiliation': 'Universidade da Região de Joinville - UNIVILLE, Joinville, Brazil; Centro Hospitalar Unimed de Joinville, Joinville, Brazil.'}, {'ForeName': 'Gilvania L', 'Initials': 'GL', 'LastName': 'Mortari', 'Affiliation': 'Centro Hospitalar Unimed de Joinville, Joinville, Brazil.'}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'Klamt', 'Affiliation': 'Hospital Municipal São José, Joinville, Brazil.'}, {'ForeName': 'Andressa', 'Initials': 'A', 'LastName': 'Hippler', 'Affiliation': 'Hospital Unimed Litoral, Balneário Camboriú, Joinville, Brazil.'}, {'ForeName': 'Juliane U', 'Initials': 'JU', 'LastName': 'Lago', 'Affiliation': 'Hospital Municipal São José, Joinville, Brazil.'}, {'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Ponikieski', 'Affiliation': 'Centro Hospitalar Unimed de Joinville, Joinville, Brazil.'}, {'ForeName': 'Bruna A', 'Initials': 'BA', 'LastName': 'Catelano', 'Affiliation': 'Hospital Municipal São José, Joinville, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Delvan', 'Affiliation': 'Hospital Municipal São José, Joinville, Brazil.'}, {'ForeName': 'Glauco A', 'Initials': 'GA', 'LastName': 'Westphal', 'Affiliation': 'Universidade da Região de Joinville - UNIVILLE, Joinville, Brazil; Centro Hospitalar Unimed de Joinville, Joinville, Brazil; Hospital Municipal São José, Joinville, Brazil; Brazilian Research in Intensive Care Network - BRICNet.'}]",Chest,['10.1016/j.chest.2021.02.064']
1714,33676969,Randomized Controlled Trial: Subcutaneous versus Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease.,"BACKGROUND & AIMS


This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) versus intravenous CT-P13 (CT-P13 IV) in inflammatory bowel disease (IBD) patients.
METHODS


This randomized, multicenter, open-label, parallel-group, phase 1 study enrolled tumor necrosis factor inhibitor-naïve patients with active ulcerative colitis (total Mayo score 6-12 points with endoscopic subscore ≥2) or Crohn's disease (Crohn's Disease Activity Index 220-450 points) at 50 centers. After CT-P13 IV induction at Week (W) 0/W2, patients were randomized (1:1) to receive CT-P13 SC every 2 weeks (q2w) from W6-W54 or CT-P13 IV every 8 weeks from W6-W22. At W30, all patients receiving CT-P13 IV switched to CT-P13 SC q2w until W54. The primary endpoint was non-inferiority of CT-P13 SC to CT-P13 IV for observed pre-dose CT-P13 concentration at W22 (C trough,W22 ), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means (gLSMs) exceeded 80%.
RESULTS


Overall, 66 and 65 patients were randomized to CT-P13 SC and CT-P13 IV, respectively. The primary endpoint of non-inferiority was met with a gLSM ratio for C trough,W22  of 1,154.17% (90% CI: 786.37-1,694.00; n=59 [CT-P13 SC]; n=57 [CT-P13 IV]). W30/W54 clinical remission rates were comparable between arms. Other efficacy, safety, and immunogenicity assessments were also broadly comparable between arms, including after switching.
CONCLUSIONS


The pharmacokinetic non-inferiority of CT-P13 SC to CT-P13 IV, and the comparable efficacy, safety, and immunogenicity profiles, support the potential suitability of CT-P13 SC treatment in IBD. ClinicalTrials.gov ID: NCT02883452.",2021,"The primary endpoint was non-inferiority of CT-P13 SC to CT-P13 IV for observed pre-dose CT-P13 concentration at W22 (C trough,W22 ), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means (gLSMs) exceeded 80%.
","[""naïve patients with active ulcerative colitis (total Mayo score 6-12 points with endoscopic subscore ≥2) or Crohn's disease (Crohn's Disease Activity Index 220-450 points) at 50 centers"", 'inflammatory bowel disease (IBD) patients']","['Subcutaneous versus Intravenous Infliximab CT-P13 Maintenance', 'infliximab biosimilar CT-P13 (CT-P13 SC', 'necrosis factor inhibitor', 'intravenous CT-P13 (CT-P13 IV', 'CT-P13 SC']","['non-inferiority of CT-P13 SC to CT-P13 IV for observed pre-dose CT-P13 concentration', 'clinical remission rates', 'efficacy, safety, and immunogenicity assessments', 'pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C3884615', 'cui_str': 'CT-P13'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C3884615', 'cui_str': 'CT-P13'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",,0.177854,"The primary endpoint was non-inferiority of CT-P13 SC to CT-P13 IV for observed pre-dose CT-P13 concentration at W22 (C trough,W22 ), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means (gLSMs) exceeded 80%.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'Director, Department for Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Shomron', 'Initials': 'S', 'LastName': 'Ben-Horin', 'Affiliation': 'Chief of Gastroenterology Department, Chaim Sheba Medical Center and Sackler School of Medicine Tel Aviv University, Tel-Hashomer, Israel.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Leszczyszyn', 'Affiliation': 'Medical Director, Department of Gastroenterology, Melita Medical, Wroclaw, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dudkowiak', 'Affiliation': 'Co-investigator, Melita Medical, and Assistant Professor, Department of Gastroenterology and Hepatology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Lahat', 'Affiliation': 'Physician, Gastroenterology Department, Chaim Sheba Medical Center and Sackler School of Medicine, Tel Aviv University, Ramat-Gan, Israel.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Gawdis-Wojnarska', 'Affiliation': 'Principal Investigator, Department of Gastroenterology, Twoja Przychodnia-Szczecińskie Centrum Medyczne, Szczecin, Poland.'}, {'ForeName': 'Aldis', 'Initials': 'A', 'LastName': 'Pukitis', 'Affiliation': 'Head of the Center of Gastroenterology, Hepatology and Nutrition, Pauls Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Horynski', 'Affiliation': 'Gastroenterology Specialist, Endoskopia sp. z o.o., Sopot, Poland.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Farkas', 'Affiliation': 'Head of Department, Department of Clinical Pharmacology, Szent Imre Egyetemi Oktatókórház, Budapest, Hungary.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Kierkus', 'Affiliation': ""Professor, Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kowalski', 'Affiliation': 'Head of Gastroenterology Department, Centrum Diagnostyczno-Lecznicze Barska sp. z o.o., Wloclawek, Poland.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Senior Executive Vice President, Head of Clinical Development Division, Celltrion, Inc., Incheon, Republic of Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Director, Head of Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea.'}, {'ForeName': 'Jee Hye', 'Initials': 'JH', 'LastName': 'Suh', 'Affiliation': 'Medical Writer, Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea.'}, {'ForeName': 'Mi Rim', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': 'Medical Writer, Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea.'}, {'ForeName': 'Seul Gi', 'Initials': 'SG', 'LastName': 'Lee', 'Affiliation': 'Biostatistician, Biometrics Department, Celltrion, Inc., Incheon, Republic of Korea.'}, {'ForeName': 'Byong Duk', 'Initials': 'BD', 'LastName': 'Ye', 'Affiliation': 'Professor at Department of Gastroenterology and Inflammatory Bowel Disease Center, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. Electronic address: bdye@amc.seoul.kr.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Professor at Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria. Electronic address: walter.reinisch@meduniwien.ac.at.'}]",Gastroenterology,['10.1053/j.gastro.2021.02.068']
1715,33676946,Reply to Comment on The Tube Versus Trabeculectomy IRIS® Registry Study: Cohort Selection and Follow-up and Comparisons to the Randomized Controlled Trial.,,2021,,[],[],[],[],[],[],,0.0503424,,"[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Vanner', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, FL. Electronic address: EAV45@med.miami.edu.'}, {'ForeName': 'Catherine Q', 'Initials': 'CQ', 'LastName': 'Sun', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, FL; University of California, San Francisco, CA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McSoley', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, FL; University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Patrice J', 'Initials': 'PJ', 'LastName': 'Persad', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, FL.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, FL.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Lum', 'Affiliation': 'American Academy of Ophthalmology, San Francisco, CA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'American Academy of Ophthalmology, San Francisco, CA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Parrish', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, FL.'}, {'ForeName': 'Ta C', 'Initials': 'TC', 'LastName': 'Chang', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, FL.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Gedde', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, FL.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.02.029']
1716,33676799,"Vessel Occlusion using Hydrogel-Coated versus Nonhydrogel Embolization Coils in Peripheral Arterial Applications: A Prospective, Multicenter, Randomized Trial.","PURPOSE


To evaluate the safety and effectiveness of hydrogel-coated coils for vessel occlusion in the body trunk.
MATERIALS AND METHODS


A total of 77 patients with various peripheral vascular lesions, treatable by embolization with coils, were randomized (hydrogel group, n = 38; nonhydrogel group, n = 39). In the hydrogel group, embolization of the target vessel was conducted using 0.018-inch hydrogel-coated coils (AZUR 18; Terumo Medical Corporation, Tokyo, Japan) with or without bare platinum coils. The nonhydrogel group received both bare platinum coils and fibered coils without the use of hydrogel-coated coils.
RESULTS


Complete target vessel occlusion was accomplished in 36 patients in the hydrogel group and 37 patients in the nonhydrogel group. No major adverse events were observed in either group. The median number of coils/vessel diameter and the median total coil length/vessel diameter were significantly larger in the nonhydrogel group than in the hydrogel group (P = .005 and P = .004, respectively). The median embolization length was significantly longer in the nonhydrogel group (31.95 mm) than in the hydrogel group (23.43 mm) (P = .002). If no expansion was assumed, the median packing density in the hydrogel group was 44.9%, which was similar to that in the nonhydrogel group (46.5%) (P = .79). With full expansion assumed, the median packing density in the hydrogel group was 125.7%.
CONCLUSIONS


Hydrogel-coated coils can be safely used for peripheral vascular coil embolization, and hydrogel-coated and conventional coils in combination allow for a shorter embolization segment and shorter coil length.",2021,"RESULTS


Complete target vessel occlusion was accomplished in 36 patients in the hydrogel group and 37 patients in the nonhydrogel group.","['77 patients with various peripheral vascular lesions, treatable by embolization with coils', '36 patients in the hydrogel group and 37 patients in the nonhydrogel group']","['bare platinum coils and fibered coils without the use of hydrogel-coated coils', 'hydrogel-coated coils', 'Vessel Occlusion using Hydrogel-Coated versus Nonhydrogel Embolization Coils']","['median packing density', 'median embolization length', 'safety and effectiveness', 'adverse events', 'median number of coils/vessel diameter and the median total coil length/vessel diameter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0522644', 'cui_str': 'Embolization coil'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",77.0,0.0427974,"RESULTS


Complete target vessel occlusion was accomplished in 36 patients in the hydrogel group and 37 patients in the nonhydrogel group.","[{'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Hongo', 'Affiliation': 'Department of Radiology, Oita University Faculty of Medicine, Oita, Japan. Electronic address: hongou@oita-u.ac.jp.'}, {'ForeName': 'Hiro', 'Initials': 'H', 'LastName': 'Kiyosue', 'Affiliation': 'Department of Radiology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Ota', 'Affiliation': 'Department of Radiology, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Norihisa', 'Initials': 'N', 'LastName': 'Nitta', 'Affiliation': 'Department of Radiology, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Masamichi', 'Initials': 'M', 'LastName': 'Koganemaru', 'Affiliation': 'Department of Radiology, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Department of Diagnostic Radiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Seishi', 'Initials': 'S', 'LastName': 'Nakatsuka', 'Affiliation': 'Department of Diagnostic Radiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Osuga', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Anai', 'Affiliation': 'Department of Radiology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Yasumoto', 'Affiliation': 'Miyakojima IGRT Clinic, Osaka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Tanoue', 'Affiliation': 'Department of Radiology, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Maruno', 'Affiliation': 'Department of Radiology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Noritaka', 'Initials': 'N', 'LastName': 'Kamei', 'Affiliation': 'Department of Radiology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Kichikawa', 'Affiliation': 'Department of Radiology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Toshi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Radiology, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Terumitsu', 'Initials': 'T', 'LastName': 'Hasebe', 'Affiliation': 'Department of Radiology/Vascular and Interventional Center, Tokai University Hachioji Hospital, Tokai University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Asayama', 'Affiliation': 'Department of Radiology, Oita University Faculty of Medicine, Oita, Japan.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.12.001']
1717,33676794,The role of cross-link augmentation on fusion rate and patient satisfaction among patients with traumatic thoracolumbar spinal fracture: A randomized clinical trial.,"INTRODUCTION AND OBJECTIVES


Most of the studies evaluating the effect of cross links on spinal stability are performed in vitro on porcine or human spine segments and there is limited data regarding clinical benefits of cross link augmentation in traumatic injuries. In this study we aimed to evaluate the effects of cross-links insertion between rods on the fusion rates and post-surgical patients' satisfaction among patients with traumatic thoracolumbar fractures who underwent posterior spinal fixation with pedicle screws.
MATERIALS AND METHODS


This study was conducted as a randomized clinical trial on 60 patients suffering from traumatic thoracolumbar vertebrae fractures. Patients were randomized into three groups: A (without any cross-link), B (One cross-link insertion) and C (two cross-links insertion). Six months after surgery outcomes were evaluated: fusion rates (plain X-ray and CT scan), Back pain (Visual Analog Scale) and patient satisfaction (fair, good, excellent).
RESULTS


In group A 13 (65%) patients had structured bone fusion, but in 7 (35%) patients bone fusion was not observed. In both groups B and C, 19 patients (95%) had bone fusion, but only in 1 patient (5%) fusion failed (p=0.009). In group A, fair satisfaction has the highest rate (8 patients (40%)) compared to the other groups. The highest reported severity of back pain was observed in group A while the lowest reported intensity of back pain was related to group B (p=0.001).
CONCLUSIONS


Adding cross link to posterior spinal fixations of patients with traumatic thoracolumbar fractures can be associated with better final fusion results and patients' satisfaction. However it is necessary to design studies with greater sample sizes to confirm this theory.
TRIAL REGISTRATION NUMBER


IRCT20120527009878N3.",2021,"In group A, fair satisfaction has the highest rate (8 patients (40%)) compared to the other groups.","['patients with traumatic thoracolumbar spinal fracture', 'patients with traumatic thoracolumbar fractures', 'patients with traumatic thoracolumbar fractures who underwent', '60 patients suffering from traumatic thoracolumbar vertebrae fractures']","['posterior spinal fixation with pedicle screws', 'cross-link augmentation']","['fusion rates (plain X-ray and CT scan), Back pain (Visual Analog Scale) and patient satisfaction (fair, good, excellent', 'structured bone fusion', 'fusion rate and patient satisfaction', 'bone fusion', 'severity of back pain', 'intensity of back pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1267077', 'cui_str': 'Thoracolumbar vertebrae'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0185364', 'cui_str': 'Osteoplasty'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",60.0,0.0764057,"In group A, fair satisfaction has the highest rate (8 patients (40%)) compared to the other groups.","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arad', 'Initials': 'A', 'LastName': 'Iranmehr', 'Affiliation': 'Department of Neurosurgery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ghaffar', 'Initials': 'G', 'LastName': 'Shokuhi', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Khadivi', 'Affiliation': 'Department of Neurosurgery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moslem', 'Initials': 'M', 'LastName': 'Shakeri', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Namvar', 'Affiliation': 'Department of Neurosurgery, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mohamad.namvar@gmail.com.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Rafiei', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Bagher', 'Initials': 'B', 'LastName': 'Matloubi', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}]","Neurocirugia (Asturias, Spain)",['10.1016/j.neucir.2021.01.002']
1718,33676757,Nontechnical skills training in cardiothoracic surgery: A pilot study.,"OBJECTIVE


The importance of nontechnical skills in surgery is widely recognized. We demonstrate the feasibility of administering and assessing the results of a formal Non-Technical Skills in Surgery (NOTSS) curriculum to cardiothoracic surgery residents.
METHODS


Eight cardiothoracic surgery residents participated in the NOTSS curriculum. They were assessed on their cognitive (situation awareness, decision-making) and social (communication and teamwork, leadership) skills based on simulated vignettes. The residents underwent pretraining NOTSS assessments followed by self-administered confidence ratings regarding the 4 skills. Subsequently, a formal NOTSS lecture was delivered and additional readings from the NOTSS textbook was assigned. A month later, the residents returned for post-training NOTSS assessments and self-administered confidence ratings. Changes across days (or within-day before vs after curriculum) were assessed using Wilcoxon signed rank test.
RESULTS


There was a significant improvement in the overall NOTSS assessment score (P = .01) as well as in the individual categories (situation awareness, P = .02; decision-making, P = .02; communication and teamwork, P = .01; leadership, P = .02). There was also an increase in resident self-perception of improvement on the post-training day (P = .01).
CONCLUSIONS


We have developed a simulation-based NOTSS curriculum in cardiothoracic surgery that can be formally integrated into the current residency education. This pilot study indicates the feasibility of reproducible assessments by course educators and self-assessments by participating residents in nontechnical skills competencies.",2021,"There was also an increase in resident self-perception of improvement on the post-training day (P = .01).
","['Surgery (NOTSS) curriculum to cardiothoracic surgery residents', 'Eight cardiothoracic surgery residents participated in the NOTSS curriculum', 'cardiothoracic surgery', 'participating residents in nontechnical skills competencies']",['Nontechnical skills training'],"['overall NOTSS assessment score', 'resident self-perception', 'cognitive (situation awareness, decision-making) and social (communication and teamwork, leadership) skills']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}]",,0.0264005,"There was also an increase in resident self-perception of improvement on the post-training day (P = .01).
","[{'ForeName': 'Juka S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, Calif.'}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Hernandez', 'Affiliation': 'Swedish Medical Center, Seattle, Wash.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Smink', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Yule', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass; Neil and Elise Wallace STRATUS Center for Medical Simulation, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Jackson', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, Calif.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shemin', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, Calif.'}, {'ForeName': 'Murray H', 'Initials': 'MH', 'LastName': 'Kwon', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, Calif. Electronic address: mkwon@mednet.ucla.edu.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2021.01.108']
1719,33676727,"Determination of equi-analgesic doses of inhaled methoxyflurane versus intravenous fentanyl using the cold pressor test in volunteers: a randomised, double-blinded, placebo-controlled crossover study.","BACKGROUND


Inhaled methoxyflurane for acute pain relief has demonstrated an analgesic effect superior to placebo. Data comparing methoxyflurane to an opioid are needed. The aim of this study was to determine the equi-analgesic doses of inhaled methoxyflurane vs i.v. fentanyl. Both drugs have an onset within minutes and an analgesic effect of 20-30 min.
METHODS


Twelve subjects were included in a randomised, double-blinded, placebo-controlled crossover study with four treatments: placebo (NaCl 0.9%), fentanyl 25 μg i.v., fentanyl 50 μg i.v., or inhaled methoxyflurane 3 ml. The subjects reported pain intensity using the verbal numeric rating scale (VNRS) from 0 to 10 during the cold pressor test (CPT). The CPT was performed before (CPT 1), 5 min (CPT 2), and 20 min (CPT 3) after drug administration.
RESULTS


Inhaled methoxyflurane and fentanyl 25 μg reduced VNRS scores significantly compared with placebo at CPT 2 (-1.14 [estimated difference in VNRS between treatment groups with 95% confidence interval {CI}: -1.50 to -0.78]; -1.15 [95% CI: -1.51 to -0.79]; both P<0.001) and CPT 3 (-0.60 [95% CI: -0.96 to -0.24]; -0.84 [95% CI: -1.20 to -0.47]; both P<0.001). There were no significant differences between the two drugs. Methoxyflurane had significantly higher VNRS scores than fentanyl 50 μg at CPT 2 (0.90 [95% CI: 0.54-1.26]; P<0.001) and CPT 3 (0.57 [95% CI: 0.21-0.94]; P<0.001).
CONCLUSIONS


Inhaled methoxyflurane 3 ml was equi-analgesic to fentanyl 25 μg i.v. at CPT 2. Both resulted in significantly less pain than placebo. Fentanyl 50 μg i.v. demonstrated analgesia superior to methoxyflurane.
CLINICAL TRIAL REGISTRATION


NCT03894800.",2021,"Methoxyflurane had significantly higher VNRS scores than fentanyl 50 μg at CPT 2 (0.90 [95% CI: 0.54-1.26]; P<0.001) and CPT 3 (0.57 [95% CI: 0.21-0.94]; P<0.001).
","['Twelve subjects', 'volunteers']","['Methoxyflurane', 'Inhaled methoxyflurane 3', 'placebo', 'inhaled methoxyflurane 3\xa0ml', 'fentanyl', 'placebo (NaCl 0.9%), fentanyl 25\xa0μg i.v', 'methoxyflurane', 'Fentanyl', 'inhaled methoxyflurane', 'Inhaled methoxyflurane and fentanyl']","['VNRS', 'pain intensity using the verbal numeric rating scale (VNRS', 'VNRS scores', 'pain']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0025688', 'cui_str': 'Methoxyflurane'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",12.0,0.706052,"Methoxyflurane had significantly higher VNRS scores than fentanyl 50 μg at CPT 2 (0.90 [95% CI: 0.54-1.26]; P<0.001) and CPT 3 (0.57 [95% CI: 0.21-0.94]; P<0.001).
","[{'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Lenz', 'Affiliation': 'Department of Anaesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway; Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway. Electronic address: harald.lenz@medisin.uio.no.'}, {'ForeName': 'Lars Ø', 'Initials': 'LØ', 'LastName': 'Høiseth', 'Affiliation': 'Department of Anaesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway; Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marlin', 'Initials': 'M', 'LastName': 'Comelon', 'Affiliation': 'Department of Anaesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Draegni', 'Affiliation': 'Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Leiv A', 'Initials': 'LA', 'LastName': 'Rosseland', 'Affiliation': 'Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.12.045']
1720,33684643,High-gamma oscillations as neurocorrelates of ADHD: A MEG crossover placebo-controlled study.,"Attention Deficit Hyperactive Disorder (ADHD) is a common neurobehavioral disorder with a significant and pervasive impact on patients' lives. Identifying neurophysiological correlates of ADHD is important for understanding its underlying mechanisms, as well as for improving clinical accuracy beyond cognitive and emotional factors. The present study focuses on finding a diagnostic stable neural correlate based on evaluating MEG resting state frequency bands. Twenty-two ADHD patients and 23 controls adults were blindly randomized to two methylphenidate/placebo evaluation days. On each evaluation day state anxiety was assessed, a 2N-back executive function task was performed, and resting state MEG brain activity was recorded at three timepoints. A frequency-based cluster analysis yielded higher high-gamma power for ADHD over posterior sensors and lower high-gamma power for ADHD over frontal-central sensors. These results were shown to be stable over three measurements, unaffected by methylphenidate treatment, and linked to cognitive accuracy and state anxiety. Furthermore, the differential high-gamma activity evidenced substantial ADHD diagnostic efficacy, comparable to the cognitive and emotional factors. These results indicate that resting state high-gamma activity is a promising, stable, valid and diagnostically-relevant neurocorrelate of ADHD. Due to the evolving understanding both in the cellular and network level of high-gamma oscillations, focusing future studies on this frequency band bears the potential for a better understanding of ADHD, thus advancing the specificity of the evaluation of the disorder and developing new tools for therapy.",2021,A frequency-based cluster analysis yielded higher high-gamma power for ADHD over posterior sensors and lower high-gamma power for ADHD over frontal-central sensors.,"['Twenty-two ADHD patients and 23 controls adults', 'ADHD']","['placebo', 'methylphenidate/placebo']","['substantial ADHD diagnostic efficacy', 'cognitive accuracy and state anxiety', 'resting state MEG brain activity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",22.0,0.0257239,A frequency-based cluster analysis yielded higher high-gamma power for ADHD over posterior sensors and lower high-gamma power for ADHD over frontal-central sensors.,"[{'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Dor-Ziderman', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel; Edmond J. Safra Brain Research Center, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Maor', 'Initials': 'M', 'LastName': 'Zeev-Wolf', 'Affiliation': 'Department of Education & Zlotowski Center for Neuroscience, Ben Gurion University of the Negev, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Hirsch Klein', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Dor', 'Initials': 'D', 'LastName': 'Bar-Oz', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Uriel', 'Initials': 'U', 'LastName': 'Nitzan', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Segev', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel; Department of Psychology, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Koubi', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Child and Adolescent Outpatient Clinic, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Mendelovic', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Child and Adolescent Outpatient Clinic, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: yuvalbloch10@gmail.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.02.050']
1721,33684639,The effects of core stabilization exercise program in obese people awaiting bariatric surgery: A randomized controlled study.,"OBJECTIVE


The aim of this study was the effects of the core stabilization exercise program (CSEP) and physical activity counseling on functional capacity, physical fitness, physical activity, fatigue and quality of life (QoL) in obese people awaiting bariatric surgery.
METHODS


Twenty-one patients were divided into two groups: an exercise group (n = 10) and a control group (n = 11). Both groups received physical activity counseling, but the exercise group also performed an 8-week CSEP. Functional capacity, physical fitness, physical activity, fatigue and QoL were assessed at baseline and after 8 weeks.
RESULTS


After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05).
CONCLUSIONS


Implementing an 8-week adding CSEP to physical activity counseling provided significant improvements in functional capacity, physical fitness, physical activity, fatigue and QoL compared to physical activity counseling in obese people awaiting bariatric surgery.",2021,"After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05).
","['obese people awaiting bariatric surgery', 'Twenty-one patients']","['core stabilization exercise program', 'exercise group', 'core stabilization exercise program (CSEP) and physical activity counseling', 'physical activity counseling, but the exercise group also performed an 8-week CSEP', 'physical activity counseling', 'CSEP to physical activity counseling']","['body composition', 'functional capacity, physical fitness, physical activity, fatigue and QoL', 'Functional capacity, physical fitness, physical activity, fatigue and QoL', 'functional capacity, physical fitness, physical activity, fatigue and quality of life (QoL']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",21.0,0.0204894,"After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05).
","[{'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Arman', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey. Electronic address: saimenilayarman@istanbul.edu.tr.'}, {'ForeName': 'Gulfidan', 'Initials': 'G', 'LastName': 'Tokgoz', 'Affiliation': ""Istanbul University-Cerrahpasa, Institute of Graduates Studies, Physiotherapy and Rehabilitation Master's Program, Istanbul, Turkey.""}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Seyit', 'Affiliation': 'University of Health Sciences, Faculty of Medicine, Bakirkoy Dr. Sadi Konuk Health Practice & Research Center, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Karabulut', 'Affiliation': 'University of Health Sciences, Faculty of Medicine, Bakirkoy Dr. Sadi Konuk Health Practice & Research Center, Department of General Surgery, Istanbul, Turkey.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101342']
1722,33684624,μ-Opioid antagonist naltrexone partially abolishes the antidepressant placebo effect and reduces OFC encoding of reinforcement.,"BACKGROUND


Like placebo analgesia, the antidepressant placebo effect appears to involve cortical and subcortical endogenous opioid signaling, yet the mechanism through which opioid release impacts mood remains unclear. The orbitofrontal cortex (OFC) - which integrates various attributes of a stimulus to predict associated outcomes - has been implicated in placebo effects and is rich in μ-opioid receptors. We hypothesized that naltrexone blockade of μ-opioid receptors would blunt OFC-dependent antidepressant placebo effects.
METHODS


Twenty psychotropic-free patients with Major Depressive Disorder (MDD) completed a randomized, double-blind, placebo-controlled, crossover study of one oral dose of 50mg of naltrexone or matching placebo immediately before completing two sessions of the Antidepressant Placebo fMRI Task. This task manipulates placebo-associated expectancies and their reinforcement while assessing expected and actual mood improvement.
RESULTS


Behaviorally, manipulations of antidepressant placebo expectancies and their reinforcement had positive, interactive effects on participants' expectancy and mood ratings. The high expectancy condition recruited the dorsolateral and ventrolateral prefrontal cortex (dl/vlPFC), as well as dorsal attention stream regions. Interestingly, increased dl/vlPFC brain responses appeared to attenuate the antidepressant placebo effect. The administration of one oral dose of naltrexone, compared to placebo, partially abolished the interaction of the expectancy and reinforcement manipulation on mood and blocked reinforcement-induced responses in the right central OFC (cOFC).
CONCLUSIONS


Our results show preliminary evidence for the role of μ-opioid cOFC modulation in antidepressant placebo effects by positively biasing the value of placebo based on reinforcement and enhancing subsequent hedonic experiences.",2021,"The administration of one oral dose of naltrexone, compared to placebo, partially abolished the interaction of the expectancy and reinforcement manipulation on mood and blocked reinforcement-induced responses in the right central OFC (cOFC).
",['Twenty psychotropic-free patients with Major Depressive Disorder (MDD'],"['placebo', 'naltrexone', 'Antidepressant Placebo fMRI Task', 'naltrexone or matching placebo', 'μ-Opioid antagonist naltrexone']","['dl/vlPFC brain responses', ""participants' expectancy and mood ratings""]","[{'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}]","[{'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.308982,"The administration of one oral dose of naltrexone, compared to placebo, partially abolished the interaction of the expectancy and reinforcement manipulation on mood and blocked reinforcement-induced responses in the right central OFC (cOFC).
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: pecinam@upmc.edu.'}, {'ForeName': 'Jiazhou', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Institute of Health, Bethesda, MD, USA; University College London, London, UK.'}, {'ForeName': 'Thandi', 'Initials': 'T', 'LastName': 'Lyew', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Alexandre Y', 'Initials': 'AY', 'LastName': 'Dombrovski', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2021.02.009']
1723,33684598,Motor Cortex Transcranial Direct Current Stimulation Effects on Knee Osteoarthritis Pain in Elderly Subjects with Dysfunctional Descending Pain Inhibitory System: A Randomized Controlled Trial.,"BACKGROUND


Although evidence has indicated a positive effect of transcranial direct current stimulation (tDCS) on reducing pain, few studies have focused on the elderly population with knee osteoarthritis (KOA).
OBJECTIVE


To evaluate whether tDCS reduces KOA pain in elderly individuals with a dysfunctional descending pain inhibitory system (DPIS).
METHODS


In a double-blind trial, individuals ≥ 60 years with KOA pain and a dysfunctional DPIS, we randomly assigned patients to receive 15 daily sessions of 2mA tDCS over the primary motor cortex (anode) and contralateral supraorbital area (cathode) (M1-SO) for 20 min or sham tDCS. Change in pain perception indexed by the Brief Pain Inventory (BPI) at the end of intervention was the primary outcome. Secondary outcomes included: disability, quantitative sensory testing, pain pressure threshold and conditioned pain modulation (CPM). Subjects were followed-up for 2 months.
RESULTS


Of the 104 enrolled subjects, with mean(SD) age of 73.9(8.01) years and 88(84.6%) female, 102 finished the trial. In the intention-to-treat analysis, the active tDCS group had a significantly greater reduction in BPI compared to the sham group (difference, 1.59; 95% CI, 0.95 to 2.23; P<0.001; Cohen's d, 0.58); and, also a significantly greater improvement in CPM-pressure in the knee (P=0.01) and CPM-pain in the hand (P=0.01). These effects were not sustained at follow-up. The intervention was well tolerated, with no severe adverse effects.
CONCLUSION


M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation. This intervention has also shown to modulate the DPIS.",2021,M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation.,"['104 enrolled subjects, with mean(SD) age of 73.9(8.01) years and 88(84.6%) female, 102 finished the trial', 'elderly patients with KOA', 'elderly individuals with a dysfunctional descending pain inhibitory system (DPIS', 'Elderly Subjects with Dysfunctional Descending Pain Inhibitory System', 'individuals ≥ 60 years with KOA pain and a dysfunctional DPIS', 'elderly population with knee osteoarthritis (KOA']","['tDCS', 'M1-SO tDCS', 'Motor Cortex Transcranial Direct Current Stimulation', '15 daily sessions of 2mA tDCS over the primary motor cortex (anode) and contralateral supraorbital area (cathode) (M1-SO) for 20 min or sham tDCS', 'transcranial direct current stimulation (tDCS']","['Knee Osteoarthritis Pain', 'pain perception indexed by the Brief Pain Inventory (BPI', 'CPM-pain', 'CPM-pressure', 'KOA pain', 'disability, quantitative sensory testing, pain pressure threshold and conditioned pain modulation (CPM', 'BPI']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0230002', 'cui_str': 'Supraorbital area structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",104.0,0.362551,M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation.,"[{'ForeName': 'Daniela Regina', 'Initials': 'DR', 'LastName': 'Brandão Tavares', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: daniela74_tavares@hotmail.com.'}, {'ForeName': 'Jane Erika', 'Initials': 'JE', 'LastName': 'Frazao Okazaki', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: erikafrazao@gmail.com.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Valéria de Andrade Santana', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: lella-andrade@hotmail.com.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Pereira Nunes Pinto', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Physical Therapy, University of Pittsburgh, Fullbright Program. Electronic address: anacarolinapnp@hotmail.com.'}, {'ForeName': 'Karina Kuraoka', 'Initials': 'KK', 'LastName': 'Tutiya', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: karina.tutiya@hotmail.com.'}, {'ForeName': 'Fernanda Martins', 'Initials': 'FM', 'LastName': 'Gazoni', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: fmgazoni@hotmail.com.'}, {'ForeName': 'Camila Bonin', 'Initials': 'CB', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: cboninpinto@gmail.com.'}, {'ForeName': 'Fania', 'Initials': 'F', 'LastName': 'Cristina Dos Santos', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: fregni.felipe@mgh.harvard.edu.'}, {'ForeName': 'Virginia Fernandes', 'Initials': 'VF', 'LastName': 'Moça Trevisani', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Rheumatology, Santo Amaro University, São Paulo, SP, Brazil. Electronic address: vmoca@uol.com.br.'}]",Brain stimulation,['10.1016/j.brs.2021.02.018']
1724,33684370,"Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND


Results from a phase 2 trial of the TPEx chemotherapy regimen (docetaxel-platinum-cetuximab) showed promising results, with a median overall survival of 14·0 months in first-line recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). We therefore aimed to compare the efficacy and safety of the TPEx regimen with the standard of care EXTREME regimen (platinum-fluorouracil-cetuximab) in this setting.
METHODS


This was a multicentre, open-label, randomised, phase 2 trial, done in 68 centres (cancer centres, university and general hospitals, and private clinics) in France, Spain, and Germany. Eligible patients were aged 18-70 years with histologically confirmed recurrent or metastatic HNSCC unsuitable for curative treatment; had at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1; and had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less. Participants were randomly assigned (1:1) using the TenAlea website by investigators or delegated clinical research associates to the TPEx regimen or the EXTREME regimen, with minimisation by ECOG performance status, type of disease evolution, previous cetuximab treatment, and country. The TPEx regimen consisted of docetaxel 75 mg/m 2  and cisplatin 75 mg/m 2 , both intravenously on day 1, and cetuximab on days 1, 8, and 15 (intravenously 400 mg/m 2  on day 1 of cycle 1 and 250 mg/m 2  weekly subsequently). Four cycles were repeated every 21 days with systematic granulocyte colony-stimulating factor (G-CSF) support at each cycle. In case of disease control after four cycles, intravenous cetuximab 500 mg/m 2  was continued every 2 weeks as maintenance therapy until progression or unacceptable toxicity. The EXTREME regimen consisted of fluorouracil 4000 mg/m 2  on day 1-4, cisplatin 100 mg/m 2  on day 1, and cetuximab on days 1, 8, and 15 (400 mg/m 2  on day 1 of cycle 1 and 250 mg/m 2  weekly subsequently) all delivered intravenously. Six cycles were delivered every 21 days followed by weekly 250 mg/m 2  cetuximab as maintenance therapy in case of disease control. G-CSF support was not mandatory per the protocol in the EXTREME regimen. The primary endpoint was overall survival in the intention-to-treat population; safety was analysed in all patients who received at least one dose of chemotherapy or cetuximab. Enrolment is closed and this is the final analysis. This study is registered at ClinicalTrials.gov, NCT02268695.
FINDINGS


Between Oct 10, 2014, and Nov 29, 2017, 541 patients were enrolled and randomly assigned to the two treatment regimens (271 to TPEx, 270 to EXTREME). Two patients in the TPEx group had major deviations in consent forms and were not included in the final analysis. Median follow-up was 34·4 months (IQR 26·6-44·8) in the TPEx group and 30·2 months (25·5-45·3) in the EXTREME group. At data cutoff, 209 patients had died in the TPEx group and 218 had died in the EXTREME group. Overall survival did not differ significantly between the groups (median 14·5 months [95% CI 12·5-15·7] in the TPEx group and 13·4 months [12·2-15·4] in the EXTREME group; hazard ratio 0·89 [95% CI 0·74-1·08]; p=0·23). 214 (81%) of 263 patients in the TPEx group versus 246 (93%) of 265 patients in the EXTREME group had grade 3 or worse adverse events during chemotherapy (p<0·0001). In the TPEx group, 118 (45%) of 263 patients had at least one serious adverse event versus 143 (54%) of 265 patients in the EXTREME group. 16 patients in the TPEx group and 21 in the EXTREME group died in association with adverse events, including seven patients in each group who had fatal infections (including febrile neutropenia). Eight deaths in the TPEx group and 11 deaths in the EXTREME group were assessed as treatment related, most frequently sepsis or septic shock (four in each treatment group).
INTERPRETATION


Although the trial did not meet its primary endpoint, with no significant improvement in overall survival with TPEx versus EXTREME, the TPEx regimen had a favourable safety profile. The TPEx regimen could provide an alternative to standard of care with the EXTREME regimen in the first-line treatment of patients with recurrent or metastatic HNSCC, especially for those who might not be good candidates for up-front pembrolizumab treatment.
FUNDING


Merck Santé and Chugai Pharma.",2021,Overall survival did not differ significantly between the groups (median 14·5 months [95% CI 12·5-15·7] in the TPEx group and 13·4 months [12·2-15·4] in the EXTREME group; hazard ratio 0·89 [95% CI 0·74-1·08]; p=0·23).,"['Between Oct 10, 2014, and Nov 29, 2017, 541 patients', 'metastatic head and neck squamous-cell carcinoma (HNSCC', '16 patients in the', '68 centres (cancer centres, university and general hospitals, and private clinics) in France, Spain, and Germany', 'patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme', 'Eligible patients were aged 18-70 years with histologically confirmed recurrent or metastatic HNSCC unsuitable for curative treatment; had at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1; and had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less', 'patients with recurrent or metastatic HNSCC, especially for those who might not be good candidates for up-front pembrolizumab treatment']","['chemotherapy or cetuximab', 'fluorouracil 4000 mg/m 2  on day 1-4, cisplatin 100 mg/m 2  on day 1, and cetuximab', 'intravenous cetuximab', 'TPEx', 'Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab', 'TPEx regimen with the standard of care EXTREME regimen (platinum-fluorouracil-cetuximab', 'TPEx chemotherapy regimen (docetaxel-platinum-cetuximab', 'docetaxel 75 mg/m 2  and cisplatin']","['overall survival', 'overall survival in the intention-to-treat population; safety', 'fatal infections (including febrile neutropenia', 'efficacy and safety', 'serious adverse event', 'Overall survival', 'major deviations', 'adverse events', 'grade 3 or worse adverse events']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",541.0,0.058274,Overall survival did not differ significantly between the groups (median 14·5 months [95% CI 12·5-15·7] in the TPEx group and 13·4 months [12·2-15·4] in the EXTREME group; hazard ratio 0·89 [95% CI 0·74-1·08]; p=0·23).,"[{'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': ""Department of Medical Oncology and Research, Centre Antoine Lacassagne, FHU Oncoage, University Côte d'Azur, Nice, France. Electronic address: joel.guigay@nice.unicancer.fr.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': 'Biostatistic and Epidemiology Unit, Gustave Roussy, Oncostat 1018 INSERM, labeled Ligue Contre le Cancer, University Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Department of Medical Oncology, University of Lyon, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada-Bouzid', 'Affiliation': ""Department of Medical Oncology, Centre Antoine Lacassagne, FHU Oncoage, University Côte d'Azur, Nice, France.""}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Department of Medical Oncology, ILC Centre Jean Bernard/Clinique Victor Hugo, Le Mans, France.'}, {'ForeName': 'Miren', 'Initials': 'M', 'LastName': 'Taberna', 'Affiliation': ""Department of Medical Oncology, Institut Català de Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Lionnel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': 'Department of Medical Oncology, Institut de Cancérologie de Lorraine, Nancy, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Department of Medical Oncology, Clinique des Ormeaux, Le Havre, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Capitain', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest Paul Papin, Angers, France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Cupissol', 'Affiliation': 'Department of Medical Oncology, Institut du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Castanie', 'Affiliation': 'Department of Medical Oncology, Hôpital Privé le Confluent, Sainte Catherine de Sienne, Nantes, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Vansteene', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest René Gauducheau, Nantes, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Medical Oncology, Universitätsklinikum Hamburg Eppendorf Hubertus Wald Tumorzentrum, Hamburg, Germany.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Department of Medical Oncology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Department of Head and Neck Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier de Bretagne Sud, Lorient, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Duplomb', 'Affiliation': 'Department of Medical Oncology, HCL, Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Evrard', 'Affiliation': 'Department of Medical Oncology, CHU, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Laguerre', 'Affiliation': 'Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Zanetta', 'Affiliation': 'Department of Medical Oncology, Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Chevassus-Clément', 'Affiliation': 'Biostatistic and Epidemiology Unit, Gustave Roussy, Oncostat 1018 INSERM, labeled Ligue Contre le Cancer, University Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Aldéric', 'Initials': 'A', 'LastName': 'Fraslin', 'Affiliation': 'Biostatistic and Epidemiology Unit, Gustave Roussy, Oncostat 1018 INSERM, labeled Ligue Contre le Cancer, University Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Louat', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sinigaglia', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Charité Comprehensive Cancer Center, Charité, Berlin, Germany.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Mesia', 'Affiliation': ""Department of Medical Oncology, Institut Català de Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30755-5']
1725,33684325,Ensuring Yoga Intervention Fidelity in a Randomized Preference Trial for the Treatment of Worry in Older Adults.,"Introduction:  Yoga for treatment of worry in older adults is an intervention that is especially likely to translate into real-world practice. Assessing treatment fidelity improves confidence that effective interventions can be consistently applied and allows researchers to explore if any null results for effectiveness are indeed the result of a lack of intervention efficacy or lack of proper intervention implementation.  Methods:  This study describes treatment fidelity of a yoga intervention in a randomized preference trial that compared cognitive-behavioral therapy (CBT) and yoga for the treatment of worry, anxiety, and sleep in worried older (≥60 years) adults. Established methods for assessing treatment fidelity of CBT guided the procedure for ensuring that the yoga intervention was delivered as intended. The yoga intervention consisted of 20, 75-min, in-person, group, gentle yoga classes held twice weekly.  Results:  Six female instructors (mean age = 64 years) taught 660 yoga classes that were videotaped. Ten percent of these classes, stratified by instructor, were randomly selected for review. The average adherence score for yoga instructors was 6.84 (range 4-8). The average competency scores were consistently high, with an average score of 7.24 (range 6-8). Teaching content not included in the protocol occurred in 26 (38.1%) sessions and decreased over time. Observed ratings of instructor adherence were significantly related to ratings of competency. Instructor adherence was also significantly associated with lower participant attendance, but not with any of the other process or outcome measures.  Conclusions:  The larger range found in adherence relative to competence scores demonstrated that teaching a yoga class according to a protocol requires different skills than competently teaching a yoga class in the community, and these skills improved with feedback. These results may foster dialog between the yoga research and practice communities. Clinical Trial Registration No.: NCT02968238.",2021,"Instructor adherence was also significantly associated with lower participant attendance, but not with any of the other process or outcome measures.  ","['older adults', 'Results:  Six female instructors (mean age\u2009=\u200964 years) taught 660 yoga classes that were videotaped', 'Older Adults', 'worried older (≥60 years) adults']","['yoga intervention', 'cognitive-behavioral therapy (CBT) and yoga']","['instructor adherence', 'average adherence score', 'Instructor adherence', 'worry, anxiety, and sleep', 'average competency scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0259579,"Instructor adherence was also significantly associated with lower participant attendance, but not with any of the other process or outcome measures.  ","[{'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Sohl', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Gretchen A', 'Initials': 'GA', 'LastName': 'Brenes', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Krucoff', 'Affiliation': 'Duke Integrative Medicine, Duke Health, Durham, NC, USA.'}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Hargis', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics and Data Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistics and Data Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Danhauer', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0476']
1726,33684310,Reducing contrast medium dose with low photon energy images in renal dual-energy spectral CT angiography and adaptive statistical iterative reconstruction (ASIR).,"OBJECTIVE


To evaluate the value of using low energy (keV) images in renal dual-energy spectral CT angiography (CTA) and adaptive statistical iterative reconstruction (ASIR) to reduce contrast medium dose.
METHODS


40 patients with renal CTA on a Discovery CT750HD were randomly divided into two groups: 20 cases (Group A) with 600 mgI kg -1  and 20 cases (Group B) with 300 mgI kg -1 . The scan protocol for both groups was: dual-energy mode with mA selection for noise index of 10HU, pitch 1.375:1, rotating speed 0.6 s/r. Images were reconstructed at 0.625 mm thickness with 40%ASIR, Group A used the conventional 70keV monochromatic images, and Group B used monochromatic images from 40keV to 70keV at 5keV interval for analysis. The CT values and standard deviation (SD) values of the renal artery and erector spine in the plain and arterial phases were measured with the erector spine SD value representing image noise. The enhancement degree of the renal artery (ΔCT = CT(arterial) -CT(plain)), signal-to-noise ratio (SNR=CT renal-artery /SD renal-artery ) and contrast-to-noise ratio (CNR=(CT renal-artery -CT erector spine )/SD erector-spine ) were calculated. The single factor analysis of variance was used to analyze the difference of ΔCT, SNR and CNR among image groups with  p  < 0.05 being statistically significant. The subjective image scores of the groups were assessed blindly by two experienced physicians using a 5-point system and the score consistency was compared by the κ test.
RESULTS


Contrast medium dose in the 300 mgI kg -1  group was reduced by 50% compared with the 600 mgI kg -1  group, while radiation dose was similar between the two groups. The subjective scores were 4.00 ± 0.65, 4.50 ± 0.60 and 3.70 ± 0.80 for images at 70keV (600 mgI kg -1  group), 40keV (300 mgI kg -1  group) and 45keV (300 mgI kg -1  group), respectively with good consistency between the two reviewers ( p  > 0.05). The 40keV images in the 300 mgI kg -1  group had similar ΔCT (469.77 ± 86.95 HU  vs  398.54 ± 73.68 HU) and CNR (15.52 ± 3.32  vs  18.78 ± 6.71) values as the 70keV images in the 600 mgI kg -1 ) group but higher SNR values (30.19 ± 4.41  vs  16.91 ± 11.12,  p  < 0,05).
CONCLUSION


Contrast dose may be reduced by 50% while maintaining image quality by using lower energy images combined with ASIR in renal dual-energy CTA.
ADVANCES IN KNOWLEDGE


Combined with ASIR and energy spectrum, can reduce the amount of contrast dose in renal CTA.",2021,"RESULTS


Contrast medium dose in the 300 mgI kg -1  group was reduced by 50% compared with the 600 mgI kg -1  group, while radiation dose was similar between the two groups.",['40 patients with renal CTA on a Discovery CT750HD'],"['SD', 'low energy (keV) images in renal dual-energy spectral CT angiography (CTA) and adaptive statistical iterative reconstruction (ASIR']","['CT values and standard deviation (SD) values of the renal artery and erector spine', 'subjective image scores', 'SNR values', 'enhancement degree of the renal artery (ΔCT = CT(arterial) -CT(plain)), signal-to-noise ratio (SNR=CT renal-artery /SD renal-artery ) and contrast-to-noise ratio (CNR=(CT renal-artery -CT erector spine ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0270912,"RESULTS


Contrast medium dose in the 300 mgI kg -1  group was reduced by 50% compared with the 600 mgI kg -1  group, while radiation dose was similar between the two groups.","[{'ForeName': 'Xirong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Zhanli', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Taiping', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}]",The British journal of radiology,['10.1259/bjr.20200974']
1727,33684207,A Pilot Randomized Controlled Trial of Text Messaging to Increase Tobacco Treatment Reach in the Emergency Department.,"BACKGROUND


Automated text messaging programs have been studied as a treatment tool, but have not been studied as an outreach tool to increase the reach of smoking cessation treatment.
METHODS


Two distinct text messaging programs were developed. One was aimed at connecting smokers to quitline phone counseling via text message (Text4Coach (T4C)) and the other was aimed at connecting smokers to a smoking cessation text messaging program (Text&Quit (T&Q)). Adult daily smokers with Medicaid insurance (N=80) were recruited from the Emergency Department at an urban hospital and randomized to T4C or T&Q. The primary outcome was program reach.
RESULTS


Outreach text messages were found to have moderately high uptake, with the majority of participants (63.8%) opting into their assigned tobacco treatment program and younger and female participants more likely to opt in (p<.01). Receipt of the treatment portion of the program differed among the programs with 67.5% of T&Q receiving the treatment program and 27.5 % of T4C receiving the program (p<.001). Most participants across both groups replied to at least 1 message (71.3%) and very few unsubscribed from the service over the 3 week trial. The majority of participants reported overall satisfaction with their program (63.8%), found it helpful for quitting smoking (60.0%) and would recommend the program to a friend (62.5%). Overall, 11 (13.8 %) participants reported being abstinent from smoking for the past 7 days at follow-up, with no differences between groups.
CONCLUSION


Outreach text messages were found to have moderately high reach among Medicaid smokers. Larger trials are needed to evaluate the impact of such programs on helping low-income smokers quit.",2021,"The majority of participants reported overall satisfaction with their program (63.8%), found it helpful for quitting smoking (60.0%) and would recommend the program to a friend (62.5%).",['Adult daily smokers with Medicaid insurance (N=80) were recruited from the Emergency Department at an urban hospital and randomized to'],"['smoking cessation text messaging program (Text&Quit (T&Q', 'T4C or T&Q', 'quitline phone counseling via text message (Text4Coach (T4C']","['helpful for quitting smoking', 'program reach', 'overall satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0475397', 'cui_str': 'Tumor stage T4c'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",80.0,0.0450189,"The majority of participants reported overall satisfaction with their program (63.8%), found it helpful for quitting smoking (60.0%) and would recommend the program to a friend (62.5%).","[{'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'George Washington University, Washington, DC, USA.'}, {'ForeName': 'Keng-Chieh', 'Initials': 'KC', 'LastName': 'Wu', 'Affiliation': 'George Washington University, Washington, DC, USA.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Krishnan', 'Affiliation': 'George Washington University, Washington, DC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Long', 'Affiliation': 'George Washington University, Washington, DC, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Belay', 'Affiliation': 'George Washington University, Washington, DC, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'New York University Langone Health, New York, New York, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': 'George Washington University, Washington, DC, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab036']
1728,33683939,Results of a Randomized Phase II Trial of Intense Androgen Deprivation Therapy Prior to Radical Prostatectomy in Men with High-Risk Localized Prostate Cancer.,"PURPOSE


This multicenter randomized phase 2 trial investigates the impact of intense androgen deprivation on radical prostatectomy (RP) pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368).
MATERIALS AND METHODS


Eligible patients had a Gleason score ≥4+3=7, PSA >20 ng/mL or T3 disease and lymph nodes <20 mm. In Part 1, patients were randomized 1:1 to apalutamide, abiraterone acetate, prednisone, and leuprolide, (AAPL) or abiraterone, prednisone, leuprolide (APL) for 6 cycles (1 cycle=28 days) followed by RP. Surgical specimens underwent central review. The primary endpoint was the rate of pathologic complete response (pCR) or minimum residual disease (MRD, tumor ≤5 mm). Secondary endpoints included PSA response, positive margin rate, and safety. MRI and tissue biomarkers of pathologic outcomes were explored.
RESULTS


The study enrolled 118 patients at four sites. Median age was 61 years and 94% of patients had high-risk disease. The combined pCR or MRD rate was 22% in the AAPL arm and 20% in the APL arm (difference: 1.5%, one-sided 95% CI: -11%, 14%, one-sided p=0.4). No new safety signals were observed. There was low concordance and correlation between post-therapy MRI-assessed and pathologically-assessed tumor volume. PTEN-loss, ERG positivity and presence of intraductal carcinoma were associated with extensive residual tumor.
CONCLUSIONS


Intense neoadjuvant hormone therapy in high-risk prostate cancer resulted in favorable pathologic responses (tumor  < 5 mm) in 21% of patients. Pathologic responses were similar between treatment arms. Part 2 of this study will investigate the impact of adjuvant hormone therapy on biochemical recurrence.",2021,Pathologic responses were similar between treatment arms.,"['Men with High-Risk Localized Prostate Cancer', '118 patients at four sites', 'Median age was 61 years and 94% of patients had high-risk disease', 'Eligible patients had a Gleason score ≥4+3=7, PSA >20 ng/mL or T3 disease and lymph nodes <20 mm']","['intense androgen deprivation', 'Intense Androgen Deprivation Therapy Prior to Radical Prostatectomy', 'apalutamide, abiraterone acetate, prednisone, and leuprolide, (AAPL) or abiraterone, prednisone, leuprolide (APL', 'adjuvant hormone therapy']","['radical prostatectomy (RP) pathologic response and radiographic and tissue biomarkers', 'PTEN-loss, ERG positivity and presence of intraductal carcinoma', 'favorable pathologic responses', 'combined pCR or MRD rate', 'rate of pathologic complete response (pCR) or minimum residual disease (MRD, tumor ≤5 mm', 'PSA response, positive margin rate, and safety', 'biochemical recurrence', 'Pathologic responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1430988', 'cui_str': 'PTEN protein, human'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",118.0,0.1364,Pathologic responses were similar between treatment arms.,"[{'ForeName': 'Rana R', 'Initials': 'RR', 'LastName': 'McKay', 'Affiliation': 'University of California San Diego, , La Jolla, California.'}, {'ForeName': 'Wanling', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Fennessy', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Rosina', 'Initials': 'R', 'LastName': 'Lis', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Calagua', 'Affiliation': 'University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Rathkopf', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Laudone', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Bubley', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Einstein', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Chang', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wagner', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'University of California San Diego, , La Jolla, California.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Preston', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Kilbridge', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Atish D', 'Initials': 'AD', 'LastName': 'Choudhury', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Pomerantz', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Quoc-Dien', 'Initials': 'QD', 'LastName': 'Trinh', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts.'}]",The Journal of urology,['10.1097/JU.0000000000001702']
1729,33683931,Food Insecurity and Weight Loss in an Underserved Primary Care Population: A Post Hoc Analysis of a Cluster Randomized Trial.,,2021,,['Underserved Primary Care Population'],[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],,0.0620761,,"[{'ForeName': 'Candice A', 'Initials': 'CA', 'LastName': 'Myers', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Arnold', 'Affiliation': 'Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'Terry C', 'Initials': 'TC', 'LastName': 'Davis', 'Affiliation': 'Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Katzmarzyk', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}]",Annals of internal medicine,['10.7326/M20-6326']
1730,33683919,Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451.,"PURPOSE


In extensive-disease small-cell lung cancer (ED-SCLC), response rates to first-line platinum-based chemotherapy are robust, but responses lack durability. CheckMate 451, a double-blind phase III trial, evaluated nivolumab plus ipilimumab and nivolumab monotherapy as maintenance therapy following first-line chemotherapy for ED-SCLC.
METHODS


Patients with ED-SCLC, Eastern Cooperative Oncology Group performance status 0-1, and no progression after ≤ 4 cycles of first-line chemotherapy were randomly assigned (1:1:1) to nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks for 12 weeks followed by nivolumab 240 mg once every 2 weeks, nivolumab 240 mg once every 2 weeks, or placebo for ≤ 2 years or until progression or unacceptable toxicity. Primary end point was overall survival (OS) with nivolumab plus ipilimumab versus placebo. Secondary end points were hierarchically tested.
RESULTS


Overall, 834 patients were randomly assigned. The minimum follow-up was 8.9 months. OS was not significantly prolonged with nivolumab plus ipilimumab versus placebo (hazard ratio [HR], 0.92; 95% CI, 0.75 to 1.12;  P  = .37; median, 9.2  v  9.6 months). The HR for OS with nivolumab versus placebo was 0.84 (95% CI, 0.69 to 1.02); the median OS for nivolumab was 10.4 months. Progression-free survival HRs versus placebo were 0.72 for nivolumab plus ipilimumab (95% CI, 0.60 to 0.87) and 0.67 for nivolumab (95% CI, 0.56 to 0.81). A trend toward OS benefit with nivolumab plus ipilimumab was observed in patients with tumor mutational burden ≥ 13 mutations per megabase. Rates of grade 3-4 treatment-related adverse events were nivolumab plus ipilimumab (52.2%), nivolumab (11.5%), and placebo (8.4%).
CONCLUSION


Maintenance therapy with nivolumab plus ipilimumab did not prolong OS for patients with ED-SCLC who did not progress on first-line chemotherapy. There were no new safety signals.",2021,"Progression-free survival HRs versus placebo were 0.72 for nivolumab plus ipilimumab (95% CI, 0.60 to 0.87) and 0.67 for nivolumab (95% CI, 0.56 to 0.81).","['Extensive-Disease Small-Cell Lung Cancer', '834 patients were randomly assigned', 'patients with tumor mutational burden ≥ 13 mutations per megabase', 'Patients with ED-SCLC, Eastern Cooperative Oncology Group performance status 0-1, and no progression after ≤ 4 cycles of first-line chemotherapy']","['nivolumab 1 mg/kg plus ipilimumab', 'placebo', 'nivolumab plus ipilimumab and nivolumab monotherapy', 'Nivolumab and Ipilimumab', 'nivolumab plus ipilimumab', 'nivolumab 240 mg once every 2 weeks, nivolumab 240 mg once every 2 weeks, or placebo']","['overall survival (OS', 'Progression-free survival HRs', 'OS', 'median OS']","[{'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1533164', 'cui_str': 'Mb'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",834.0,0.434633,"Progression-free survival HRs versus placebo were 0.72 for nivolumab plus ipilimumab (95% CI, 0.60 to 0.87) and 0.67 for nivolumab (95% CI, 0.56 to 0.81).","[{'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ramaswamy', 'Initials': 'R', 'LastName': 'Govindan', 'Affiliation': 'Alvin J Siteman Cancer Center at Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Ready', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungClinic, Grosshansdorf, Germany.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Oncology Department, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, Wichita, KS.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Navarro', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Rodríguez-Cid', 'Affiliation': 'Centro Oncológico, Médica Sur-Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'Centrul de Oncologie Sf Nectarie, Craiova, Romania.'}, {'ForeName': 'Jong-Seok', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Gutierrez', 'Affiliation': 'Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Ivor', 'Initials': 'I', 'LastName': 'Percent', 'Affiliation': 'Florida Cancer Specialists, Punta Gorda, FL.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Morgensztern', 'Affiliation': 'Alvin J Siteman Cancer Center at Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Oncology Research Center, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Aix Marseille Univ, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Baka', 'Affiliation': 'Interbalkan European Medical Center, Thessaloniki, Greece.'}, {'ForeName': 'Miten', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, FL.'}, {'ForeName': 'Wen Hong', 'Initials': 'WH', 'LastName': 'Lin', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Selvaggi', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Baudelet', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Baden', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Pandya', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Doshi', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02212']
1731,33687796,Efficacy of an Er:YAG laser in the decontamination of dental implant surfaces: an in vitro study.,"BACKGROUND


Emergence of peri-implant diseases led to the development of various methods for implant surface decontamination. This study was designed to compare the efficacy of biofilm removal from implant-like titanium surfaces by an erbium-doped yttrium-aluminum-garnet (Er:YAG) laser, titanium brush and carbon fiber curette.
METHODS


Eight study subjects were recruited. A custom mouth appliance that held 8 sandblasted and acid-etched titanium discs was fabricated for each subject. Subjects were asked to wear this appliance for 72 hours to allow for biofilm development. After retrieval, discs were removed and randomized to one of four treatment groups. The discs were stained with a two-component nucleic acid dye kit, and the residual biofilm was visualized under fluorescence microscopy. Quantification of residual biofilm was performed using an image analysis software and expressed as the percentage surface area.
RESULTS


Fifty-nine titanium discs were randomized to the 4 treatment groups. The percentage of titanium disc area covered by residual biofilm was 74.0 ± 21.6%, 32.8 ± 24.0%, 11.8 ± 10.3% and 20.1 ± 19.2% in the control, Er:YAG, titanium brush and carbon fiber curette groups, respectively (mean ± SD). The biofilm-covered area significantly decreased in each of the 3 treatment groups compared to control (P<0.008). Comparisons between treatment groups did not reveal statistical significance.
CONCLUSIONS


Er:YAG laser treatment is an effective method for reducing the bacterial biofilm on titanium discs. However, on a threadless titanium surface, Er:YAG laser does not exhibit a significantly greater efficacy in biofilm removal than commonly used titanium brushes or carbon fiber curettes. This article is protected by copyright. All rights reserved.",2021,The biofilm-covered area significantly decreased in each of the 3 treatment groups compared to control (P<0.008).,"['dental implant surfaces', 'Eight study subjects were recruited', 'Fifty-nine titanium discs']","['Er:YAG laser', 'erbium-doped yttrium-aluminum-garnet (Er:YAG) laser, titanium brush and carbon fiber curette']","['biofilm-covered area', 'percentage of titanium disc area']","[{'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0108411', 'cui_str': 'Carbon fiber'}, {'cui': 'C0180236', 'cui_str': 'Curette'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",8.0,0.0314881,The biofilm-covered area significantly decreased in each of the 3 treatment groups compared to control (P<0.008).,"[{'ForeName': 'Hani S', 'Initials': 'HS', 'LastName': 'AlMoharib', 'Affiliation': 'Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Steffensen', 'Affiliation': 'Department of Periodontology, Tufts University School of Dental Medicine, Boston, MA, 02111, USA.'}, {'ForeName': 'Driss', 'Initials': 'D', 'LastName': 'Zoukhri', 'Affiliation': 'Department of Comprehensive Care, Tufts University School of Dental Medicine, Boston, MA, 02111, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Finkelman', 'Affiliation': 'Department of Public Health and Community Service, Tufts University School of Dental Medicine, Boston, MA, 02111, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gyurko', 'Affiliation': 'Department of Periodontology, Tufts University School of Dental Medicine, Boston, MA, 02111, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0765']
1732,33687783,Improved Postprandial Glucose Control With Ultra Rapid Lispro Versus Lispro With Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes: PRONTO-Pump-2.,"AIMS


To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in persons with type 1 diabetes on continuous subcutaneous insulin infusion (CSII).
MATERIALS AND METHODS


This was a phase 3, 16-week, treat-to-target study in patients randomised to double-blind URLi (N=215) or lispro (N=217). Primary endpoint was change from baseline HbA1c (noninferiority margin 4.4 mmol/mol [0.4%]), with multiplicity-adjusted objectives for postprandial glucose (PPG) levels during a meal test, and time spent in target range 70-180 mg/dL (TIR).
RESULTS


URLi was noninferior to lispro for change in HbA1c, with least squares mean (LSM) difference of 0.3 mmol/mol (95% confidence interval [CI] -0.6, 1.2) or 0.02% (95% CI -0.06, 0.11). URLi was superior to lispro in controlling 1- and 2-hour PPG levels after the meal test: LSM difference -1.34 mmol/L (95% CI -2.00, -0.68) or -24.1 mg/dL (95% CI -36.0, -12.2) at 1-hour and -1.54 mmol/L (95% CI -2.37, -0.72) or -27.8 mg/dL(95% CI -42.6, -13.0) at 2-h; both p<0.001. TIR and time in hyperglycaemia were similar between groups but URLi resulted in significantly less time in hypoglycaemia (3.0 mmol/L [<54 mg/dL]) over the daytime, nighttime, and 24-hour period: LSM difference -0.41%, -0.97%, and -0.52% respectively, all p<0.05. The incidence of treatment-emergent adverse events was higher with URLi (60.5% vs. 44.7%), driven by infusion site reaction and infusion site pain which were mostly mild or moderate. Rates of severe hypoglycaemia and diabetic ketoacidosis were similar between groups.
CONCLUSIONS


URLi was efficacious, providing superior PPG control and less time in hypoglycaemia but with more frequent infusion site reactions compared to lispro when administered by CSII. This article is protected by copyright. All rights reserved.",2021,"TIR and time in hyperglycaemia were similar between groups but URLi resulted in significantly less time in hypoglycaemia (3.0 mmol/L [<54 mg/dL]) over the daytime, nighttime, and 24-hour period: LSM difference -0.41%, -0.97%, and -0.52% respectively, all p<0.05.","['persons with type 1 diabetes on continuous subcutaneous insulin infusion (CSII', 'N=215) or lispro (N=217', 'Type 1 Diabetes']","['Continuous Subcutaneous Insulin Infusion', 'ultra rapid lispro (URLi) versus lispro', 'double-blind URLi', 'Ultra Rapid Lispro Versus Lispro']","['Postprandial Glucose Control', 'time in hypoglycaemia', 'Rates of severe hypoglycaemia and diabetic ketoacidosis', 'hypoglycaemia', 'postprandial glucose (PPG) levels', 'TIR and time in hyperglycaemia', 'incidence of treatment-emergent adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.367681,"TIR and time in hyperglycaemia were similar between groups but URLi resulted in significantly less time in hypoglycaemia (3.0 mmol/L [<54 mg/dL]) over the daytime, nighttime, and 24-hour period: LSM difference -0.41%, -0.97%, and -0.52% respectively, all p<0.05.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Warren', 'Affiliation': 'Physicians East, PA, North Carolina, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, Georgia, USA.'}, {'ForeName': 'Jang Ik', 'Initials': 'JI', 'LastName': 'Cho', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Tobian', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hardy', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}, {'ForeName': 'Farai', 'Initials': 'F', 'LastName': 'Chigutsa', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Schneider Children's Medical Center of Israel, Petah Tikva and Sackler Faculty of Medicine, Tel-Aviv, Israel.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Horowitz', 'Affiliation': 'Metabolic Research Institute Inc. Florida, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Ignaut', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14368']
1733,33687748,Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL and insulin degludec 100 U/mL in older participants in the BRIGHT trial.,"In older populations with type 2 diabetes (T2D), individualised target HbA 1c  should be achieved with minimal hypoglycaemia, and therapies should be tested for both safety and efficacy. BRIGHT was the first head-to-head randomized trial comparing insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (IDeg-100) in insulin-naïve adults with T2D. In this sub-analysis, endpoints were studied by predefined (</≥65 years, N = 596/333) and post-hoc (</≥70 years, N = 768/161) age groups. Heterogeneity of treatment effect was observed for HbA 1c  reductions in the </≥70 years, but not </≥65 years, populations, with greater HbA 1c  reductions with Gla-300 versus IDeg-100 in the ≥70 years subgroup (least squares mean - 0.34% [95% confidence interval: -0.589 to -0.100]). There was no significant heterogeneity of treatment effect for incidence and rates of confirmed (≤3.9 mmol/L [≤70 mg/dL]) hypoglycaemia across any age subgroups over 24 weeks, but numerically lower incidence and rates were consistently observed for Gla-300 versus IDeg-100 in the ≥65 and ≥ 70 years age groups in the initial 12 weeks. Further investigation is required to determine Gla-300 glycaemic benefits in these high-risk populations without increasing hypoglycaemia risk. This article is protected by copyright. All rights reserved.",2021,Heterogeneity of treatment effect was observed for HbA 1c  reductions in the </≥70 ,"['70\u2009years age groups in the initial 12\u2009weeks', 'older populations with type 2 diabetes (T2D', 'older participants', 'insulin-naïve adults with T2D', 'years, N\xa0=\xa0596/333) and post-hoc (</≥70\u2009years, N\xa0=\xa0768/161) age groups']","['insulin glargine 300\u2009U/mL (Gla-300) and insulin degludec 100', 'insulin glargine 300\u2009U/mL and insulin degludec 100']","['hypoglycaemia', 'Glycaemic control and hypoglycaemia risk']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0682289,Heterogeneity of treatment effect was observed for HbA 1c  reductions in the </≥70 ,"[{'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Department of Medicine, Perugia University Medical School, Perugia, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Division of Endocrinology and Metabolism, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Charbonnel', 'Affiliation': 'Nantes University, Nantes, France.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Division of Endocrinology, Hypertension, and Diabetes, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Westerbacka', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Bosnyak', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Boëlle-Le-Corfec', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14372']
1734,33683617,Distraction in the Emergency department using Virtual reality for INtravenous procedures in Children to Improve comfort (DEVINCI): a pilot pragmatic randomized controlled trial.,"OBJECTIVES


Intravenous (IV) procedures cause pain and distress in the pediatric emergency department (ED). We studied the feasibility and acceptability of virtual reality distraction for patient comfort during intravenous procedures.
METHODS


Children were randomized to a control (standard care) or intervention group (standard care + virtual reality). Thresholds for feasibility and acceptability (primary outcomes) were determined through a priori established criteria. The level of procedural pain (principal clinical outcome) and distress, as well as memory of pain at 24 h were collected and reported as medians (Q1, Q3) for each group.
RESULTS


63 patients were enrolled, with a high rate of recruitment (78.8%) and game completion (90.3%). Patients, parents and, healthcare providers reported high satisfaction levels. There were no serious adverse events. Five of the 30 patients (16.7%) exposed to virtual reality reported mild side effects. Self-reported procedural pain (verbal numerical rating scale: 3 (1, 6)/10 vs 3 (1, 5.5)/10, p = 0.75) was similar between groups. Further exploratory clinical measures were reported for the intervention and control groups, respectively: self-rated distress during the procedure (Child Fear Scale: 1 (0, 2)/4 vs 2 (0, 3)/4); distress evaluated by proxy during the procedure (Procedure Behavior Check List: 8 (8, 9)/40 vs 10 (8, 15)/40); memory of pain at 24 h (VNRS: 2 (1, 3)/10 vs 4 (2, 6.5)/10).
CONCLUSION


The addition of virtual reality to standard care is feasible and acceptable for pain and distress management during IV procedures in the pediatric ED. Occasional mild, self-resolving side effects were observed in the intervention group. Self-reported pain during the procedure was similar between groups. CLINICALTRIALS.
GOV IDENTIFIER


NCT03750578.",2021,The addition of virtual reality to standard care is feasible and acceptable for pain and distress management during IV procedures in the pediatric ED.,"['Intravenous (IV) procedures cause pain and distress in the pediatric emergency department (ED', 'Children to Improve comfort (DEVINCI', 'Children', '63 patients were enrolled, with a high rate of recruitment (78.8%) and game completion (90.3']","['virtual reality distraction', 'control (standard care) or intervention group (standard care\u2009+\u2009virtual reality']","['memory of pain', 'level of procedural pain (principal clinical outcome) and distress, as well as memory of pain at 24\xa0h', 'self-rated distress', 'serious adverse events', 'Self-reported pain', 'mild side effects', 'Occasional mild, self-resolving side effects', 'procedural pain (verbal numerical rating scale']","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",63.0,0.119352,The addition of virtual reality to standard care is feasible and acceptable for pain and distress management during IV procedures in the pediatric ED.,"[{'ForeName': 'Esli', 'Initials': 'E', 'LastName': 'Osmanlliu', 'Affiliation': 'Department of Pediatric Emergency Medicine, CHU Sainte-Justine, 3175, Ch. de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada. esli.osmanlliu@mcgill.ca.'}, {'ForeName': 'Evelyne D', 'Initials': 'ED', 'LastName': 'Trottier', 'Affiliation': 'Department of Pediatric Emergency Medicine, CHU Sainte-Justine, 3175, Ch. de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Bailey', 'Affiliation': 'Department of Pediatric Emergency Medicine, CHU Sainte-Justine, 3175, Ch. de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Maryse', 'Initials': 'M', 'LastName': 'Lagacé', 'Affiliation': 'Department of Pediatric Emergency Medicine, CHU Sainte-Justine, 3175, Ch. de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Certain', 'Affiliation': 'Department of Pediatric Emergency Medicine, CHU Sainte-Justine, 3175, Ch. de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Khadra', 'Affiliation': 'CHU Sainte-Justine Research Centre, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Sanchez', 'Affiliation': 'Department of Pediatric Emergency Medicine, CHU Sainte-Justine, 3175, Ch. de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Thériault', 'Affiliation': 'Department of Pediatric Emergency Medicine, CHU Sainte-Justine, 3175, Ch. de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paquin', 'Affiliation': 'Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, Québec, Canada.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Côtes-Turpin', 'Affiliation': 'Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, Québec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Le May', 'Affiliation': 'CHU Sainte-Justine Research Centre, Université de Montréal, Montréal, Canada.'}]",CJEM,['10.1007/s43678-020-00006-6']
1735,33683616,Does utilization of an intubation safety checklist reduce omissions during simulated resuscitation scenarios: a multi-center randomized controlled trial.,"OBJECTIVES


Checklists have been used to decrease adverse events associated with medical procedures. Simulation provides a safe setting in which to evaluate a new checklist. The objective of this study was to determine if the use of a novel peri-intubation checklist would decrease practitioners' rates of omission of tasks during simulated airway management scenarios.
METHODS


Fifty-four emergency medicine (EM) practitioners from two academic centers were randomized to either their usual approach or use of our checklist, then completed three simulated airway management scenarios. A minimum of two assessors documented the number of tasks omitted and the time until definitive airway management. Discrepancies between assessors were resolved by single assessor video review. Participants also completed a post-simulation survey.
RESULTS


The average percentage of omitted tasks over three scenarios was 45.7% in the control group (n = 25) and 13.5% in the checklist group (n = 29)-an absolute difference of 32.2% (95% CI 27.8, 36.6%). Time to definitive airway management was longer in the checklist group in the first two of three scenarios (difference of 110.0 s, 95% CI 55.0 to 167.0; 83.0 s, 95% CI 35.0 to 128.0; and 36.0 s, 95% CI -18.0 to 98.0 respectively).
CONCLUSIONS


In this dual-center, randomized controlled trial, use of an airway checklist in a simulated setting significantly decreased the number of important airway tasks omitted by EM practitioners, but increased time to definitive airway management.",2021,"The average percentage of omitted tasks over three scenarios was 45.7% in the control group (n = 25) and 13.5% in the checklist group (n = 29)-an absolute difference of 32.2% (95% CI 27.8, 36.6%).","['Fifty-four emergency medicine (EM', 'practitioners from two academic centers']",['novel peri-intubation checklist'],"['time to definitive airway management', 'number of tasks omitted and the time until definitive airway management', 'number of important airway tasks', 'Time to definitive airway management']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",,0.115349,"The average percentage of omitted tasks over three scenarios was 45.7% in the control group (n = 25) and 13.5% in the checklist group (n = 29)-an absolute difference of 32.2% (95% CI 27.8, 36.6%).","[{'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Forristal', 'Affiliation': 'Division of Emergency Medicine, Department of Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Hayman', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Smith', 'Affiliation': 'London InterCommunity Health Centre, London, ON, Canada.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Mal', 'Affiliation': 'Division of Emergency Medicine, Department of Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Columbus', 'Affiliation': 'Department of Emergency Medicine, London Health Sciences Centre, E1-125 Westminster Tower, 800 Commissioners Road East, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Farooki', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Van Aarsen', 'Affiliation': 'Department of Emergency Medicine, London Health Sciences Centre, E1-125 Westminster Tower, 800 Commissioners Road East, London, ON, N6A 5W9, Canada. Kristine.VanAarsen@lhsc.on.ca.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'McLeod', 'Affiliation': 'Division of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ouellette', 'Affiliation': 'Division of Emergency Medicine, Department of Medicine, Western University, London, ON, Canada.'}]",CJEM,['10.1007/s43678-020-00010-w']
1736,33683613,The clock is ticking: using in situ simulation to improve time to blood administration for bleeding trauma patients.,"INTRODUCTION


Massive hemorrhage protocols are widely used to facilitate the administration of blood components to bleeding trauma patients. Delays in this process are associated with worse patient outcomes. We used in situ simulation as a novel and iterative quality improvement technique to reduce the mean time between massive hemorrhage protocol activation and blood administration during actual trauma resuscitations.
METHODS


We completed monthly, risk-informed unannounced in situ trauma simulations at a Canadian Level 1 trauma centre. We identified three major latent safety threats: (1) massive hemorrhage protocol activation; (2) transport of blood components; and (3) situational awareness of team members. Process improvements for each latent safety threats were tested and implemented during subsequent in situ simulation sessions. We evaluated the effect of this simulation-based intervention on the care of patients before, during and after the intervention. Demographic, clinical and massive hemorrhage protocol data were collected. The primary outcome was mean time between massive hemorrhage protocol activation and blood administration during actual trauma resuscitations as analyzed using a two-sample t test.
RESULTS


Each group was similar in demographic and injury characteristics. The time from massive hemorrhage protocol activation to blood administration decreased from 11.6 min pre-intervention to 9.1 min post-intervention. This represented a significant reduction (2.5 min, 95% confidence interval, 0.03-5.08) following the in situ simulation-based quality improvement intervention.
CONCLUSIONS


A comprehensive, in situ simulation-based quality improvement project was associated with a significant reduction in the mean time between massive hemorrhage protocol activation and blood administration among injured patients. In situ simulation represents a novel approach to the identification and mitigation of latent safety threats during massive hemorrhage protocol activation.",2021,"This represented a significant reduction (2.5 min, 95% confidence interval, 0.03-5.08) following the in situ simulation-based quality improvement intervention.
",['bleeding trauma patients'],['simulation-based intervention'],['mean time between massive hemorrhage protocol activation and blood administration during actual trauma resuscitations'],"[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0333279', 'cui_str': 'Massive hemorrhage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",,0.0700143,"This represented a significant reduction (2.5 min, 95% confidence interval, 0.03-5.08) following the in situ simulation-based quality improvement intervention.
","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Department of Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Lucas B', 'Initials': 'LB', 'LastName': 'Chartier', 'Affiliation': 'Department of Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Pavenski', 'Affiliation': ""Department of Laboratory Medicine, St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'McGowan', 'Affiliation': ""Department of Emergency Medicine, St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.""}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Lebovic', 'Affiliation': ""Applied Health Research Centre, St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Petrosoniak', 'Affiliation': 'Department of Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Canada. petro82@gmail.com.'}]",CJEM,['10.1007/s43678-020-00011-9']
1737,33683608,A randomized trial of robot-based distraction to reduce children's distress and pain during intravenous insertion in the emergency department.,"OBJECTIVES


Our objectives were to evaluate the effectiveness of humanoid robot-based distraction on reducing distress and pain in children undergoing intravenous insertion.
METHODS


A two-arm, open-label randomized controlled trial was conducted April 2017-May 2018, in a pediatric emergency department (ED). A sample of 86 children aged 6-11 years who required intravenous insertion were recruited. Exclusion criteria included hearing/visual impairments, neurocognitive delay, sensory impairment to pain, previous enrollment, and ED clinical staff discretion. Outcome measures included the Observed Scale of Behavioral Distress-Revised (OSBD-R) (distress) and the Faces Pain Scale-Revised (FPS-R) (pain).
RESULTS


Of the 86 children recruited (median age 9 years, IQR 7,10); 55% (47/86) were male, 9% (7/82) were premature, 82% (67/82) had a previous ED visit, 31% (25/82) had a previous hospitalization and 78% (64/82) had previous intravenous insertion. Ninety-six percent (78/81) received topical anesthetic prior to intravenous insertion. Total OSBD-R distress score was 1.49 ± 2.36 (standard care) versus 0.78 ± 1.32 (robot) (p < 0.05). FPS-R pain score was 4 (IQR 2,6) (standard care) versus 2 (IQR 0,4) (robot) (p = 0.13). Parental anxiety immediately after the procedure was 36.7 (11.1) (standard care) versus 31.3 (8.5) (robot) (p = 0.04). Parents were more satisfied with pain management in the robotic distraction group (95% vs 72% very satisfied) (p = 0.002).
CONCLUSIONS


Humanoid robot-based distraction therapy is associated with a modest positive impact on child distress for pediatric intravenous insertion, but not pain. It can be considered a potential tool in the ED toolkit for procedural pain-associated distress reduction.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT02997631.",2021,Total OSBD-R distress score was 1.49 ± 2.36 (standard care) versus 0.78 ± 1.32 (robot) (p < 0.05).,"['86 children aged 6-11\xa0years who required intravenous insertion were recruited', '86 children recruited (median age 9\xa0years, IQR 7,10); 55% (47/86) were male, 9% (7/82) were premature, 82% (67/82) had a previous ED visit, 31% (25/82) had a previous hospitalization and 78% (64/82) had previous intravenous insertion', 'children undergoing intravenous insertion', ""children's distress and pain during intravenous insertion in the emergency department"", 'April 2017-May 2018, in a pediatric emergency department (ED']","['humanoid robot-based distraction', 'robot-based distraction', 'topical anesthetic prior to intravenous insertion', 'Humanoid robot-based distraction therapy']","['Parental anxiety', 'FPS-R pain score', 'distress and pain', 'Observed Scale of Behavioral Distress-Revised (OSBD-R) (distress) and the Faces Pain Scale-Revised (FPS-R) (pain', 'satisfied with pain management', 'Total OSBD-R distress score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C2676780', 'cui_str': 'Progeroid Syndrome, Congenital, Petty Type'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1369038', 'cui_str': 'Distraction'}]","[{'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C2676780', 'cui_str': 'Progeroid Syndrome, Congenital, Petty Type'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",86.0,0.169397,Total OSBD-R distress score was 1.49 ± 2.36 (standard care) versus 0.78 ± 1.32 (robot) (p < 0.05).,"[{'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, 3-583 Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada. sali@ualberta.ca.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Manaloor', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Keon', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mithra', 'Initials': 'M', 'LastName': 'Sivakumar', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, 3-583 Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Beran', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Shannon D', 'Initials': 'SD', 'LastName': 'Scott', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Vandermeer', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, 3-583 Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Beirnes', 'Affiliation': ""Child Life Department, Stollery Children's Hospital, Edmonton, AB, Canada.""}, {'ForeName': 'Timothy A D', 'Initials': 'TAD', 'LastName': 'Graham', 'Affiliation': 'Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Curtis', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, 3-583 Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada.'}, {'ForeName': 'Hsing', 'Initials': 'H', 'LastName': 'Jou', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, 3-583 Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hartling', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, 3-583 Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada.'}]",CJEM,['10.1007/s43678-020-00023-5']
1738,33683573,Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass in the Elderly: 1-Year Preliminary Outcomes in a Randomized Trial (BASE Trial).,"PURPOSE


Despite the increasing prevalence of elderly obese patients, bariatric surgery remains controversial in this population. Recent publications have focused on perioperative safety, but few studies have addressed clinical outcomes.
OBJECTIVES


This study aimed to evaluate 1-year outcomes of laparoscopic sleeve gastrectomy (LSG) compared to laparoscopic Roux-en-Y gastric bypass (LRYGB) in patients 65 years or older.
METHODS


Thirty-six elderly obese patients were recruited for an open-label randomized trial from September 2017 to May 2019, comparing LSG to LRYGB. One-year outcomes were evaluated based on weight loss, functionality, and control of clinical conditions.
RESULTS


The median age (67 × 67 years; p=0.67) and initial body mass index (BMI) (46.3 × 51.3 kg/m 2 ; p=0.28) were similar between groups. Preoperative BMI (after weight loss pre-operative treatment) was higher in LRYGB group (41.9 × 47.6 kg/m 2 ; p= 0.03). After 12 months, EWL and TWL were higher in LRYGB group (60 × 68%; p=0.04; 24.9 × 31.4%; p<0.01). HbA1c reduction was higher after LRYGB (-1.1 × -0.5%; p<0.01) as well as LDL control (-27.5 × +11.5 mg/dL p= 0.02). No difference was noted between LRYGB and LSG concerning hypertension control, triglycerides, HDL, and functionality.
CONCLUSION


Weight loss, diabetes, and LDL control were better achieved with LRYGB after 12 months.",2021,HbA1c reduction was higher after LRYGB (-1.1 × -0.5%; p<0.01) as well as LDL control (-27.5 × +11.5 mg/dL p= 0.02).,"['elderly obese patients', 'Elderly', 'patients 65 years or older', 'Thirty-six elderly obese patients were recruited for an open-label randomized trial from September 2017 to May 2019, comparing LSG to LRYGB']","['laparoscopic Roux-en-Y gastric bypass (LRYGB', 'Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass', 'laparoscopic sleeve gastrectomy (LSG']","['EWL and TWL', 'HbA1c reduction', 'Preoperative BMI', 'LRYGB and LSG concerning hypertension control, triglycerides, HDL, and functionality', 'Weight loss, diabetes, and LDL control', 'initial body mass index', 'weight loss, functionality, and control of clinical conditions']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",36.0,0.0471103,HbA1c reduction was higher after LRYGB (-1.1 × -0.5%; p<0.01) as well as LDL control (-27.5 × +11.5 mg/dL p= 0.02).,"[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pajecki', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Gastroenterology, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Anna Carolina Batista', 'Initials': 'ACB', 'LastName': 'Dantas', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Gastroenterology, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Tustumi', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Gastroenterology, Universidade de São Paulo, Sao Paulo, Brazil. franciscotustumi@gmail.com.'}, {'ForeName': 'Ana Lumi', 'Initials': 'AL', 'LastName': 'Kanaji', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Gastroenterology, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marco Aurelio', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Gastroenterology, Universidade de São Paulo, Sao Paulo, Brazil.'}]",Obesity surgery,['10.1007/s11695-021-05316-x']
1739,33683572,Long-term evaluation of primary teeth molar pulpotomies with Biodentine and MTA: a CONSORT randomized clinical trial.,"BACKGROUND


Calcium silicate-based materials have become widely used in recent years due to their positive effect on pulp cells, which stimulate tertiary dentin formation.
AIM


The aim of the present study was to evaluate and compare clinically and radiographically the performance of MTA and Biodentine as pulp-dressing materials following pulpotomy in primary molars at 24-month follow-up.
DESIGN


Molars from patients aged 4-9 years scheduled for pulpotomy were treated with either MTA or Biodentine followed by a stainless-steel crown. These molars were clinically and radiographically followed up at 6, 12, 18, and 24 months. Statistical analysis was performed to detect differences between the two groups.
RESULTS


A total of 84 pulpotomies were performed obtaining a total success rate of 99.4 and 97.2% for Biodentine and MTA, respectively, at 24 months, showing no statistically significant differences between the two groups.
CONCLUSION


24-month follow-up showed that Biodentine and MTA have similar effectiveness.",2021,"A total of 84 pulpotomies were performed obtaining a total success rate of 99.4 and 97.2% for Biodentine and MTA, respectively, at 24 months, showing no statistically significant differences between the two groups.
","['primary molars at 24-month follow-up', 'Molars from patients aged 4-9\xa0years scheduled for pulpotomy were treated with either']","['MTA or Biodentine followed by a stainless-steel crown', 'MTA and Biodentine', 'Biodentine and MTA']",['total success rate'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}]",84.0,0.0764408,"A total of 84 pulpotomies were performed obtaining a total success rate of 99.4 and 97.2% for Biodentine and MTA, respectively, at 24 months, showing no statistically significant differences between the two groups.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vilella-Pastor', 'Affiliation': 'Department of Paediatric Dentistry, Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sáez', 'Affiliation': 'Department of Paediatric Dentistry, Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Veloso', 'Affiliation': 'Department of Paediatric Dentistry, Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guinot-Jimeno', 'Affiliation': 'Department of Paediatric Dentistry, Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mercadé', 'Affiliation': 'Department of Dentistry, Universitat de Barcelona, C/Feixa Llarga s/n, Hospitalet de Llobregat, 08907, , Barcelona, Spain. montsemercade@ub.edu.'}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-021-00616-3']
1740,33683403,Does sonification of action simulation training impact corticospinal excitability and audiomotor plasticity?,"Sonification is a sensory augmentation strategy whereby a sound is associated with, and modulated by, movement. Evidence suggests that sonification could be a viable strategy to maximize learning and rehabilitation. Recent studies investigated sonification of action observation, reporting beneficial effects, especially in Parkinson's disease. However, research on simulation training-a training regime based on action observation and motor imagery, in which actions are internally simulated, without physical execution-suggest that action observation alone is suboptimal, compared to the combined use of action observation and motor imagery. In this study, we explored the effects of sonified action observation and motor imagery on corticospinal excitability, as well as to evaluate the extent of practice-dependent plasticity induced by this training. Nineteen participants were recruited to complete a practice session based on combined and congruent action observation and motor imagery (AOMI) and physical imitation of the same action. Prior to the beginning, participants were randomly assigned to one of two groups, one group (nine participants) completed the practice block with sonified AOMI, while the other group (ten participants) completed the practice without extrinsic auditory information and served as control group. To investigate practice-induced plasticity, participants completed two auditory paired associative stimulation (aPAS) protocols, one completed after the practice block, and another one completed alone, without additional interventions, at least 7 days before the practice. After the practice block, both groups significantly increased their corticospinal excitability, but sonification did not exert additional benefits, compared to non-sonified conditions. In addition, aPAS significantly increased corticospinal excitability when completed alone, but when it was primed by a practice block, no modulatory effects on corticospinal excitability were found. It is possible that sonification of combined action observation and motor imagery may not be a useful strategy to improve corticospinal, but further studies are needed to explore its relationship with performance improvements. We also confirm the neuromodulatory effect of aPAS, but its interaction with audiomotor practice remain unclear.",2021,"After the practice block, both groups significantly increased their corticospinal excitability, but sonification did not exert additional benefits, compared to non-sonified conditions.",['Nineteen participants were recruited to complete a'],"['auditory paired associative stimulation (aPAS) protocols', 'practice session based on combined and congruent action observation and motor imagery (AOMI) and physical imitation of the same action', 'sonified action observation and motor imagery', 'aPAS', 'practice block with sonified AOMI, while the other group (ten participants) completed the practice without extrinsic auditory information and served as control group']",['corticospinal excitability'],"[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}]",19.0,0.0360656,"After the practice block, both groups significantly increased their corticospinal excitability, but sonification did not exert additional benefits, compared to non-sonified conditions.","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Castro', 'Affiliation': 'Research Unit of Neurophysiology and Neuroengineering of Human-Technology Interaction (NeXTlab), Università Campus Bio-Medico Di Roma, Rome, Italy. f.castro@unicampus.it.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Osman', 'Affiliation': 'Department of Life Sciences, College of Health, Medicine and Life Sciences, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Di Pino', 'Affiliation': 'Research Unit of Neurophysiology and Neuroengineering of Human-Technology Interaction (NeXTlab), Università Campus Bio-Medico Di Roma, Rome, Italy.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Vuckovic', 'Affiliation': 'School of Engineering, College of Engineering and Science, James Watt Building (South) University of Glasgow, Glasgow, G12 8QQ, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nowicky', 'Affiliation': 'Centre for Cognitive Neuroscience, Department of Clinical Sciences, College of Health, Medicine and Life Sciences, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bishop', 'Affiliation': 'Centre for Cognitive Neuroscience, Department of Life Sciences, College of Health, Medicine and Life Sciences, Brunel University London, Uxbridge, UK.'}]",Experimental brain research,['10.1007/s00221-021-06069-w']
1741,33683337,Tandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias.,"Patients with plasma cell dyscrasias (PCDs) experience an increased burden of influenza, and current practice of single-dose annual influenza vaccination yields suboptimal protective immunity in these patients. Strategies to improve immunity to influenza in these patients are clearly needed. We performed a randomized, double-blind, placebo-controlled clinical trial comparing tandem Fluzone High-Dose influenza vaccination with standard-of-care influenza vaccination. Standard-of-care vaccination was single-dose age-based vaccination (standard dose, <65 years; high dose, ≥65 years), and patients in this arm received a saline placebo injection at 30 days. A total of 122 PCD patients were enrolled; 47 received single-dose standard-of-care vaccination, and 75 received 2 doses of Fluzone High-Dose vaccine. Rates of hemagglutinin inhibition (HAI) titer seroprotection against all 3 strains (H1N1, H3N2, and influenza B) were significantly higher for patients after tandem high-dose vaccination vs control (87.3% vs 63.2%; P = .003) and led to higher seroprotection at the end of flu season (60.0% vs 31.6%; P = .04). These data demonstrate that tandem high-dose influenza vaccination separated by 30 days leads to higher serologic HAI titer responses and more durable influenza-specific immunity in PCD patients. Similar vaccine strategies may also be essential to achieve protective immunity against other emerging pathogens such as novel coronavirus in these patients. This trial was registered at www.clinicaltrials.gov as #NCT02566265.",2021,"Rates of hemagglutinin inhibition (HAI) titer seroprotection against all 3 strains (H1N1, H3N2, and influenza B) were significantly higher for patients after tandem high-dose vaccination vs control (87.3% vs 63.2%; P = .003) and led to higher seroprotection at the end of flu season (60.0% vs 31.6%; P = .04).","['Patients with plasma cell dyscrasias (PCDs) experience', 'patients with plasma cell dyscrasias', 'PCD patients', '122 PCD patients were enrolled; 47 received']","['single-dose standard-of-care vaccination, and 75 received 2 doses of Fluzone High-Dose vaccine', 'Fluzone High-Dose influenza vaccination with standard-of-care influenza vaccination', 'saline placebo injection', 'placebo']","['Rates of hemagglutinin inhibition (HAI) titer seroprotection against all 3 strains (H1N1, H3N2, and influenza B', 'serologic HAI titer responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1136084', 'cui_str': 'Plasma cell disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C2740348', 'cui_str': 'Fluzone High-Dose'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0276353', 'cui_str': 'Influenza due to Influenza B virus'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}]",122.0,0.519054,"Rates of hemagglutinin inhibition (HAI) titer seroprotection against all 3 strains (H1N1, H3N2, and influenza B) were significantly higher for patients after tandem high-dose vaccination vs control (87.3% vs 63.2%; P = .003) and led to higher seroprotection at the end of flu season (60.0% vs 31.6%; P = .04).","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Branagan', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Eamon', 'Initials': 'E', 'LastName': 'Duffy', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Geliang', 'Initials': 'G', 'LastName': 'Gan', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT; and.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT; and.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Foster', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Parker', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Seropian', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Cooper', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Brandt', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Kortmansky', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Davit', 'Initials': 'D', 'LastName': 'Witt', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Ferencz', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Kavita M', 'Initials': 'KM', 'LastName': 'Dhodapkar', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Madhav V', 'Initials': 'MV', 'LastName': 'Dhodapkar', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}]",Blood advances,['10.1182/bloodadvances.2020003880']
1742,33683334,Effect of a Compassion Cultivation Training Program for Caregivers of People With Mental Illness in Denmark: A Randomized Clinical Trial.,"Importance


Caregivers of people with mental illness are at increased risk of developing depression, anxiety, and stress.
Objective


To investigate the effect of a compassion cultivation training (CCT) program on decreasing caregiver psychological distress.
Design, Setting, and Participants


This waitlist-controlled randomized clinical trial was conducted in 2 different community settings in Denmark. Caregivers were excluded if they had a diagnosed and untreated mental illness, addiction, meditation practice, or current psychotherapeutic treatment. Enrollment occurred between May 2018 and March 2019. A repeated measurement model was used to examine the impact of the intervention. The primary analysis was based on the intention-to-treat principle. Data analysis was conducted from June 4 to July 7, 2020.
Interventions


Participants were randomized 1-to-1 to an 8-week CCT course or waitlist control. Block randomization was used with 40 participants in each block.
Main Outcomes and Measures


The main outcome was reduction in psychological distress, as measured by the Depression, Anxiety, Stress Scale (DASS). Baseline, postintervention, and 3- and 6-month follow-up measurements were collected.
Results


Among 192 participants assessed for eligibility, 161 participants were included in the study (mean [SD] age, 52.6 [12.5] years; 142 [88.2%] women), with 79 participants randomized to the CCT intervention and 82 participants in the waitlist control group. At baseline, the mean (SD) DASS scores for the intervention vs control groups were 10.89 (8.66) vs 10.80 (8.38) for depression, 6.89 (6.48) vs 6.68 (5.33) for anxiety, and 14.96 (7.90) vs 15.77 (7.40) for stress. The CCT group experienced statistically significant improvement in the primary outcome in mean change from baseline vs the control group at postintervention (adjusted mean difference: depression, -4.16 [95% CI, -6.75 to -1.58]; P = .002; anxiety, -2.24 [95% CI, -3.99 to -0.48]; P = .01; stress, -4.20 [95% CI, -6.73 to -1.67]; P = .001), the 3-month follow-up (adjusted mean difference: depression, -3.78 [95% CI, -6.40 to -1.17]; P = .005; anxiety, -2.50 [95% CI, -4.27 to -0.73]; P = .006; stress, -3.76 [95% CI, -6.32 to -1.21]; P = .004), and the 6-month follow-up (adjusted mean difference: depression: -4.24 [95% CI, -6.97 to -1.52]; P = .002; anxiety, -2.12 [95% CI, -3.96 to -0.29]; P = .02; stress: -3.79 [95% CI, -6.44 to -1.13]; P = .005).
Conclusions and Relevance


These findings suggest that CCT was superior to the waitlist control in supporting caregivers' mental health. Statistically and clinically significant reductions in psychological distress were found and sustained at the 6-month follow-up. The improvements noted in this randomized clinical trial could serve to encourage implementation of future evidence-based programs for caregivers.
Trial Registration


ClinicalTrials.gov Identifier: NCT03730155.",2021,"The CCT group experienced statistically significant improvement in the primary outcome in mean change from baseline vs the control group at postintervention (adjusted mean difference: depression, -4.16 [95% CI, -6.75 to -1.58]; P = .002; anxiety, -2.24","['Importance\n\n\nCaregivers of people with mental illness', '2 different community settings in Denmark', 'Caregivers of People With Mental Illness in Denmark', '192 participants assessed for eligibility, 161 participants were included in the study (mean [SD] age, 52.6 [12.5] years; 142 [88.2%] women), with 79 participants randomized to the', '40 participants in each block', 'Caregivers were excluded if they had a diagnosed and untreated mental illness, addiction, meditation practice, or current psychotherapeutic treatment', 'and 82 participants in the waitlist control group']","['compassion cultivation training (CCT) program', 'CCT', 'Compassion Cultivation Training Program', 'CCT course or waitlist control', 'CCT intervention']","['psychological distress, as measured by the Depression, Anxiety, Stress Scale (DASS', 'mean (SD) DASS scores', 'psychological distress']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",161.0,0.28082,"The CCT group experienced statistically significant improvement in the primary outcome in mean change from baseline vs the control group at postintervention (adjusted mean difference: depression, -4.16 [95% CI, -6.75 to -1.58]; P = .002; anxiety, -2.24","[{'ForeName': 'Nanja Holland', 'Initials': 'NH', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Juul', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Karen-Johanne', 'Initials': 'KJ', 'LastName': 'Pallesen', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lone Overby', 'Initials': 'LO', 'LastName': 'Fjorback', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.1020']
1743,33683313,Association of Intensive vs Standard Blood Pressure Control With Magnetic Resonance Imaging Biomarkers of Alzheimer Disease: Secondary Analysis of the SPRINT MIND Randomized Trial.,"Importance


Meta-analyses of randomized clinical trials have indicated that improved hypertension control reduces the risk for cognitive impairment and dementia. However, it is unclear to what extent pathways reflective of Alzheimer disease (AD) pathology are affected by hypertension control.
Objective


To evaluate the association of intensive blood pressure control on AD-related brain biomarkers.
Design, Setting, and Participants


This is a substudy of the Systolic Blood Pressure Intervention Trial (SPRINT MIND), a multicenter randomized clinical trial that compared the efficacy of 2 different blood pressure-lowering strategies. Potential participants (n = 1267) 50 years or older with hypertension and without a history of diabetes or stroke were approached for a brain magnetic resonance imaging (MRI) study. Of these, 205 participants were deemed ineligible and 269 did not agree to participate; 673 and 454 participants completed brain MRI at baseline and at 4-year follow-up, respectively; the final follow-up date was July 1, 2016. Analysis began September 2019 and ended November 2020.
Interventions


Participants were randomized to either a systolic blood pressure goal of less than 120 mm Hg (intensive treatment: n = 356) or less than 140 mm Hg (standard treatment: n = 317).
Main Outcomes and Measures


Changes in hippocampal volume, measures of AD regional atrophy, posterior cingulate cerebral blood flow, and mean fractional anisotropy in the cingulum bundle.
Results


Among 673 recruited patients who had baseline MRI (mean [SD] age, 67.3 [8.2] years; 271 women [40.3%]), 454 completed the follow-up MRI at a median (interquartile range) of 3.98 (3.7-4.1) years after randomization. In the intensive treatment group, mean hippocampal volume decreased from 7.45 cm3 to 7.39 cm3 (difference, -0.06 cm3; 95% CI, -0.08 to -0.04) vs a decrease from 7.48 cm3 to 7.46 cm3 (difference, -0.02 cm3; 95% CI, -0.05 to -0.003) in the standard treatment group (between-group difference in change, -0.033 cm3; 95% CI, -0.062 to -0.003; P = .03). There were no significant treatment group differences for measures of AD regional atrophy, cerebral blood flow, or mean fractional anisotropy.
Conclusions and Relevance


Intensive treatment was associated with a small but statistically significant greater decrease in hippocampal volume compared with standard treatment, consistent with the observation that intensive treatment is associated with greater decreases in total brain volume. However, intensive treatment was not associated with changes in any of the other MRI biomarkers of AD compared with standard treatment.
Trial Registration


ClinicalTrials.gov Identifier: NCT01206062.",2021,"Conclusions and Relevance


Intensive treatment was associated with a small but statistically significant greater decrease in hippocampal volume compared with standard treatment, consistent with the observation that intensive treatment is associated with greater decreases in total brain volume.","['205 participants were deemed ineligible and 269 did not agree to participate; 673 and 454 participants completed brain MRI at baseline and at 4-year follow-up, respectively; the final follow-up date was July 1, 2016', 'Potential participants (n\u2009=\u20091267) 50 years or older with hypertension and without a history of diabetes or stroke were approached for a brain magnetic resonance imaging (MRI) study', 'Alzheimer Disease', '673 recruited patients who had baseline MRI (mean [SD] age, 67.3 [8.2] years; 271 women [40.3']","['systolic blood pressure goal of less than 120 mm Hg (intensive treatment: n\u2009=\u2009356) or less than 140 mm Hg (standard treatment: n\u2009=\u2009317', 'Intensive vs Standard Blood Pressure Control']","['hippocampal volume', 'AD regional atrophy, cerebral blood flow, or mean fractional anisotropy', 'mean hippocampal volume', 'total brain volume', 'hippocampal volume, measures of AD regional atrophy, posterior cingulate cerebral blood flow, and mean fractional anisotropy in the cingulum bundle']","[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0228272', 'cui_str': 'Structure of cerebral cingulum'}]",673.0,0.203243,"Conclusions and Relevance


Intensive treatment was associated with a small but statistically significant greater decrease in hippocampal volume compared with standard treatment, consistent with the observation that intensive treatment is associated with greater decreases in total brain volume.","[{'ForeName': 'Ilya M', 'Initials': 'IM', 'LastName': 'Nasrallah', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Pomponio', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sudipto', 'Initials': 'S', 'LastName': 'Dolui', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Guray', 'Initials': 'G', 'LastName': 'Erus', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Clinton B', 'Initials': 'CB', 'LastName': 'Wright', 'Affiliation': 'Intramural Stroke Branch, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.'}, {'ForeName': 'Lenore J', 'Initials': 'LJ', 'LastName': 'Launer', 'Affiliation': 'Intramural Research Program, National Institute on Aging, Baltimore, Maryland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Detre', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wolk', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Davatzikos', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Section of Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'R Nick', 'Initials': 'RN', 'LastName': 'Bryan', 'Affiliation': 'Department of Diagnostic Medicine, Dell Medical School, University of Texas at Austin, Austin.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2021.0178']
1744,33683083,Once-Daily Halobetasol Propionate 0.01% Lotion for Moderate-to-Severe Plaque Psoriasis: Phase 3 Analysis of Hispanic Participants.,"BACKGROUND


Psoriasis is a chronic, inflammatory disease that may differ in prevalence and clinical presentation among patients from various racial and ethnic groups. Two phase 3 studies demonstrated efficacy and safety of halobetasol propionate (HP) 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis (NCT02514577, NCT02515097). These post hoc analyses evaluated HP 0.01% lotion in Hispanic participants.
METHODS


Participants were randomized (2:1) to receive once-daily HP or vehicle lotion for 8 weeks, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in Hispanic participants (HP, n=76; vehicle, n=43) included treatment success (&ge;2‑grade improvement in Investigator&rsquo;s Global Assessment and score of &lsquo;clear&rsquo; or &lsquo;almost clear&rsquo;), psoriasis signs, and affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated.
RESULTS


At week 8, 38.8% of participants achieved treatment success with HP versus 10.3% on vehicle (P=0.001). HP‑treated participants achieved greater improvements in psoriasis signs, compared with vehicle (P&lt;0.01 all). HP group had a greater reduction in affected BSA versus vehicle (P=0.001). Treatment-related TEAEs with HP were application site infection and dermatitis (n=1 each).
CONCLUSIONS


Once-daily HP 0.01% lotion was associated with significant reductions in disease severity in Hispanic participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks. J Drugs Dermatol. 2021;20(3):252-258. doi:10.36849/JDD.2021.5698.",2021,"HP‑treated participants achieved greater improvements in psoriasis signs, compared with vehicle (P&lt;0.01 all).","['Hispanic participants (HP, n=76; vehicle, n=43) included', 'Hispanic participants', 'Hispanic participants with moderate-to-severe psoriasis', 'Hispanic Participants', 'Participants were randomized (2:1) to']","['halobetasol propionate (HP) 0.01% lotion', 'receive once-daily HP or vehicle lotion', 'HP', 'Halobetasol Propionate 0.01% Lotion']","['efficacy and safety', 'treatment success (&ge;2‑grade improvement in Investigator&rsquo;s Global Assessment and score of &lsquo;clear&rsquo; or &lsquo;almost clear&rsquo;), psoriasis signs, and affected body surface area (BSA', 'psoriasis signs', 'disease severity']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0098735', 'cui_str': 'Halobetasol propionate'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0098735', 'cui_str': 'Halobetasol propionate'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.101051,"HP‑treated participants achieved greater improvements in psoriasis signs, compared with vehicle (P&lt;0.01 all).","[{'ForeName': 'Seemal R', 'Initials': 'SR', 'LastName': 'Desai', 'Affiliation': ''}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Glick', 'Affiliation': ''}, {'ForeName': 'James Q', 'Initials': 'JQ', 'LastName': 'Del Rosso', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2021.5698']
1745,33683076,Adding Combined Oral Contraceptives or Metformin to Laser Treatment in Polycystic Ovarian Syndrome Hirsute Patients.,"BACKGROUND


Hirsutism is estimated to affect 10% to 20% of females, provoking significant psychological damage and social embarrassment. Polycystic ovary syndrome is a major cause of hirsutism.
AIM


Assessing the impact of adding combined oral contraceptives (COCs) or metformin to laser hair removal on the quality of life of polycystic ovarian syndrome (PCOS) patients with hirsutism.
METHODOLOGY


One-hundred-fifty PCO patients diagnosed with hirsutism were included in this study. Patients were randomized into three groups: group 1 received laser hair removal alone, group 2 received metformin and laser hair removal, and group 3 received COCs and laser hair removal. A diode laser with a wavelength of 810 nm was used for hair removal in all patients according to a protocol of 6 monthly sessions followed by another two sessions after three and six months. Patients were assessed using a visual analog scale (VAS) and Dermatology Life Quality Index (DLQI) and a customized questionnaire (Hirsutism Life Quality Index; HLQI).
RESULTS


All patients showed a significant improvement in both quality indices (DLQI and HLQI) after treatment relative to pretreatment. Group 3 showed significantly better improvements when compared with group 2 and group 1. At three and six months, group 3 showed non-significantly better DLQI and HLQI as compared with at zero months. On the other hand, group 2 patients displayed significant worsening of both DLQI and HLQI scores at three months, with subsequent improvements again at six. Finally, group 1 patients showed nonsignificant worsening at three months, and significant worsening at 6 months.
CONCLUSION


Combining hormonal treatment with laser hair removal can achieve greater hair reduction, significant improvements in patients' QOL, and better maintenance as compared with when combining metformin with laser hair removal or conducting alone. J Drugs Dermatol. 2021;20(3):302-306. doi:10.36849/JDD.2021.5652.",2021,"At three and six months, group 3 showed non-significantly better DLQI and HLQI as compared with at zero months.","['Polycystic Ovarian Syndrome Hirsute Patients', 'polycystic ovarian syndrome (PCOS) patients with hirsutism', 'One-hundred-fifty PCO patients diagnosed with hirsutism']","['metformin', 'Oral Contraceptives or Metformin', 'combined oral contraceptives (COCs) or metformin to laser hair removal', 'laser hair removal alone, group 2 received metformin and laser hair removal, and group 3 received COCs and laser hair removal']","['quality indices (DLQI and HLQI', 'DLQI and HLQI scores', 'visual analog scale (VAS) and Dermatology Life Quality Index (DLQI) and a customized questionnaire (Hirsutism Life Quality Index; HLQI', 'DLQI and HLQI']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0587210', 'cui_str': 'Laser removal of hair'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",150.0,0.0305847,"At three and six months, group 3 showed non-significantly better DLQI and HLQI as compared with at zero months.","[{'ForeName': 'Nevine', 'Initials': 'N', 'LastName': 'Dorgham', 'Affiliation': ''}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Sharobim', 'Affiliation': ''}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Haggag', 'Affiliation': ''}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'El-Kalioby', 'Affiliation': ''}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Dorgham', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2021.5652']
1746,33683065,[Interferon gamma in the treatment of patients with moderate COVID-19].,"INTRODUCTION


Interferons are produced in response to the presence of pathogens in cells and are responsible for the proper formation of immune reaction. Preliminary data obtained in studies of properties of recombinant interferon gamma (IFN-γ) that involved patients with community-acquired pneumonia (including bacterial), acute respiratory viral infection (ARVI), influenza and new coronavirus infection have shown promising results.The purpose of the study was to assess the effect of subcutaneous administration of IFN-γ in patients with viral pneumonia on the changes of vital signs and the duration of hospital stay.
MATERIAL AND METHODS


An open-label, randomized, low-interventional study included patients with moderate new coronavirus infection COVID-19 over 18 years of age of both sexes. IFN-γ 500,000 IU was administered s/c, daily, once a day, during 5 days.
RESULTS


IFN-y in addition to complex therapy of the disease resulted in more favorable changes in the stabilization of vital signs, as well as in reduced length of fever and hospital stay by 2 days what allows suggesting a positive effect of this substance on the recovery processes in patients with moderate COVID-19. Special emphasis should be made to the fact that patients who received recombinant IFN- γ experienced no progression of respiratory failure and required no transfer to intensive care unit.
DISCUSSION


This study confirms earlier obtained data on the positive effect of IFN-y on the rate of clinical stabilization and recovery of patients with community-acquired pneumonia and viral infections. Presented results are limited to a small number of patients; further study of drug properties in post-marketing studies is required.
CONCLUSION


Progress in the treatment of patients with moderate COVID-19 by adding recombinant IFN-γ to the complex therapy may reasonably expand the range of existing treatment options for this infection.",2021,"RESULTS


IFN-y in addition to complex therapy of the disease resulted in more favorable changes in the stabilization of vital signs, as well as in reduced length of fever and hospital stay by 2 days what allows suggesting a positive effect of this substance on the recovery processes in patients with moderate COVID-19.","['patients with community-acquired pneumonia and viral infections', 'patients with moderate COVID-19', 'patients with moderate new coronavirus infection COVID-19 over 18 years of age of both sexes', 'patients with community-acquired pneumonia (including bacterial', 'patients with viral pneumonia on the changes of vital signs and the duration of hospital stay']","['IFN-γ', 'Interferon gamma', 'recombinant interferon gamma (IFN-γ']",['reduced length of fever and hospital stay'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032310', 'cui_str': 'Viral pneumonia'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0498504,"RESULTS


IFN-y in addition to complex therapy of the disease resulted in more favorable changes in the stabilization of vital signs, as well as in reduced length of fever and hospital stay by 2 days what allows suggesting a positive effect of this substance on the recovery processes in patients with moderate COVID-19.","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Myasnikov', 'Affiliation': 'Moscow SBIH City Clinical Hospital named after M.E. Zhadkevich of the Moscow City Health Department.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Berns', 'Affiliation': 'Moscow SBIH City Clinical Hospital named after M.E. Zhadkevich of the Moscow City Health Department.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Talyzin', 'Affiliation': 'Moscow SBIH City Clinical Hospital named after M.E. Zhadkevich of the Moscow City Health Department.'}, {'ForeName': 'F I', 'Initials': 'FI', 'LastName': 'Ershov', 'Affiliation': 'FSBI National Research Centre of Epidemiology and Microbiology named after honorary academician N.F. Gamaleya of the Ministry of Health of Russia.'}]",Voprosy virusologii,['10.36233/0507-4088-24']
1747,33682955,"Efficacy and safety of topical benzoyl peroxide for prolonged acneiform eruptions induced by cetuximab and panitumumab: A multicenter, phase II trial.","The most common adverse event of epidermal growth factor receptor inhibitors, used to treat colorectal, non-small cell lung, and head and neck cancers, is acneiform eruption, with a profound effect on treatment continuation. Prolonged acneiform eruptions treated with topical corticosteroids, a standard management, may be associated with secondary bacterial infections, thus there is a need for new treatments. We conducted a multicenter, phase II trial to evaluate the efficacy and safety of topical benzoyl peroxide for epidermal growth factor receptor inhibitor-induced prolonged acneiform eruptions. Patients with colorectal, non-small lung cell, and head and neck cancers who received epidermal growth factor receptor inhibitors for >10 weeks and had persistent acneiform eruptions were eligible. Topical benzoyl peroxide was applied to the affected area of the face once daily for 8 weeks; a clinical evaluation was performed every 2 weeks. The primary endpoint was a change in acneiform eruption severity evaluated between disease onset and end of the treatment period. The quality of life of patients was assessed using the Dermatology Life Quality Index. Of the 14 enrolled patients, 11 completed the trial. The protocol-specified grade of acneiform eruptions from baseline to week 8 improved from 2.0 to 1.0 (P < 0.01). The dermatology life quality index score from baseline to week 8 improved from 3.0 to 1.0 point (P < 0.01). No patient experienced severe adverse events. Overall, topical benzoyl peroxide may be effective for treating and managing prolonged acneiform eruptions induced by epidermal growth factor receptor inhibitors.",2021,"Overall, topical benzoyl peroxide may be effective for treating and managing prolonged acneiform eruptions induced by epidermal growth factor receptor inhibitors.","['14 enrolled patients, 11 completed the trial', 'Patients with colorectal, non-small lung cell, and head and neck cancers who received', 'for >10\xa0weeks and had persistent acneiform eruptions were eligible']","['cetuximab and panitumumab', 'Topical benzoyl peroxide', 'topical benzoyl peroxide', 'epidermal growth factor receptor inhibitors', 'topical corticosteroids']","['severe adverse events', 'dermatology life quality index score', 'Efficacy and safety', 'change in acneiform eruption severity', 'efficacy and safety', 'Dermatology Life Quality Index', 'quality of life', 'acneiform eruptions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0265783', 'cui_str': 'Congenital hypoplasia of lung'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0175167', 'cui_str': 'Acneiform eruption'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175167', 'cui_str': 'Acneiform eruption'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",14.0,0.046153,"Overall, topical benzoyl peroxide may be effective for treating and managing prolonged acneiform eruptions induced by epidermal growth factor receptor inhibitors.","[{'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Tsutsui', 'Affiliation': 'Department of Dermatological Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsuko', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Dermatology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nozawa', 'Affiliation': 'Appearance Support Center, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Takashima', 'Affiliation': 'Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Tsuchiyama', 'Affiliation': 'Department of Dermatology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Namikawa', 'Affiliation': 'Department of Dermatological Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Setsuya', 'Initials': 'S', 'LastName': 'Aiba', 'Affiliation': 'Department of Dermatology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Dermatological Oncology, National Cancer Center Hospital, Tokyo, Japan.'}]",The Journal of dermatology,['10.1111/1346-8138.15836']
1748,33682887,Medication adherence in older people with rheumatoid arthritis is lower according to electronic monitoring than according to pill count.,"OBJECTIVES


Suboptimal medication adherence is a serious problem in the treatment of chronic inflammatory diseases. To measure medication adherence, electronic monitoring is regarded as superior to pill count. GLORIA is an ongoing two-year trial on the addition of low-dose (5 mg/d) prednisolone or placebo to standard care in older people (65+ years) with rheumatoid arthritis (RA). During the entire trial adherence is measured with electronic caps, and with pill counts. The objective is to describe medication adherence patterns, and to compare the adherence results of the two methods.
METHODS


The recorded adherence patterns of patients (blinded for treatment group) were classified according to descriptive categories. The cutoff for good adherence was set at 80% of prescribed pills taken.
RESULTS


Trial inclusion has closed in 2018 at 451 patients, but trial follow-up is ongoing; the current dataset contains adherence data of 371 patients. Mean number of recorded 90-day periods per patient was 4 (range 1-8). Based on pill count over all periods, 90% of the patients had good adherence; based on cap data only 20%. Cap data classified 30% of patients as non-user (<20% of days an opening) and 40% as irregular user (different adherence patterns, in or between periods).
CONCLUSION


In our trial of older people with RA, the majority appeared to be adherent to medication according to pill count. Results from caps conflicted with those of pill counts, with patterns suggesting patients did not use the bottle for daily dispensing, despite specific advice to do so.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02585258.",2021,"Based on pill count over all periods, 90% of the patients had good adherence; based on cap data only 20%.","['older people with rheumatoid arthritis', 'older people with RA', '2018 at 451 patients, but trial follow-up is ongoing; the current dataset contains adherence data of 371 patients', 'older people (65+ years) with rheumatoid arthritis (RA']",['prednisolone or placebo'],"['Mean number', 'Medication adherence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.146762,"Based on pill count over all periods, 90% of the patients had good adherence; based on cap data only 20%.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hartman', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cutolo', 'Affiliation': 'Department of Rheumatology, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Bos', 'Affiliation': 'Department of Rheumatology, Medical Center Leeuwarden, Leeuwarden, Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Opris-Belinski', 'Affiliation': 'Department of Internal Medicine and Rheumatology, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Kok', 'Affiliation': 'Department of Rheumatology and Clinical immunology, Maasstad Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Hanneke J R M', 'Initials': 'HJRM', 'LastName': 'Griep-Wentink', 'Affiliation': 'Department of Rheumatology, Antonius Hospital, Sneek, Netherlands.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Klaasen', 'Affiliation': 'Department of Rheumatology, Meander Medical Center, Amersfoort, Netherlands.'}, {'ForeName': 'Cornelia F', 'Initials': 'CF', 'LastName': 'Allaart', 'Affiliation': 'Department of Rheumatology, Leids University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'George A W', 'Initials': 'GAW', 'LastName': 'Bruyn', 'Affiliation': 'Department of Rheumatology, Reumakliniek Flevoland, Lelystad, Netherlands.'}, {'ForeName': 'Hennie G', 'Initials': 'HG', 'LastName': 'Raterman', 'Affiliation': 'Department of Rheumatology, Northwest Clinics, Alkmaar, Netherlands.'}, {'ForeName': 'Marieke J H', 'Initials': 'MJH', 'LastName': 'Voshaar', 'Affiliation': 'Department of Pharmacy, Radboud University, Netherlands, Nijmegen.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Gomes', 'Affiliation': 'Exatronic, Aveiro, Portugal.'}, {'ForeName': 'Rui M A', 'Initials': 'RMA', 'LastName': 'Pinto', 'Affiliation': 'Bluepharma, Indústria Farmacêutica, S.A, Coimbra, Portugal.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Thomas Klausch', 'Affiliation': 'Epidemiology & Data Science, Amsterdam UMC, Vrije Universiteit, Netherlands, Amsterdam.'}, {'ForeName': 'Willem F', 'Initials': 'WF', 'LastName': 'Lems', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boers', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, location VUmc, Amsterdam, Netherlands.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keab207']
1749,33682773,Effects of core-postural stabilisation on fluoroscopy diaphragmatic measurement and dyspnea in chronic obstructive pulmonary disease: A randomized single-blinded clinical trial.,"BACKGROUND


While respiratory and core-postural stabilisation has recently gained a widespread acceptance to improve pulmonary function and dyspena, the therapeutic effects of and rationale underlying the use of respiratory and core-postural stabilisation in the management of patients with chronic obstructive pulmonary disease have not been investigated.
OBJECTIVE


This study aimed to compare the effects of abdominal breathing and respiratory and core-postural stabilisation on diaphragmatic movement and pulmonary function.
METHODS


Fourteen patients with moderate chronic obstructive pulmonary disease were randomly assigned to either the respiratory and core-postural stabilisation or abdominal breathing group. All patients underwent fluoroscopy-guided chest X-ray imaging and pulmonary function tests before and after the interventions; the modified Medical Research Council questionnaire was also administered before and after the interventions. Six sessions of either intervention were consistently provided. The obtained data were assessed using independent t-tests and Wilcoxon signed-rank test with a significance threshold of P< 0.05.
RESULTS


Respiratory and core-postural stabilisation was more effective in increasing diaphragmatic movements than abdominal breathing (P< 0.05). Pulmonary function tests revealed more significant differences in the forced vital capacity (FVC(%)predicted) only after respiratory and core-postural stabilisation (P= 0.004). The Medical Research Council questionnaire score was significantly different within the Respiratory and core-postural stabilisation group (P= 0.014).
CONCLUSIONS


Our novel results suggest that the effects of respiratory and core-postural stabilisation breathing on diaphragmatic movement and pulmonary function were superior to those of abdominal breathing in patients with chronic obstructive pulmonary disease.",2021,"RESULTS


Respiratory and core-postural stabilisation was more effective in increasing diaphragmatic movements than abdominal breathing (P< 0.05).","['chronic obstructive pulmonary disease', 'Fourteen patients with moderate chronic obstructive pulmonary disease', 'patients with chronic obstructive pulmonary disease']","['abdominal breathing and respiratory and core-postural stabilisation', 'fluoroscopy-guided chest X-ray imaging and pulmonary function tests', 'core-postural stabilisation', 'respiratory and core-postural stabilisation breathing', 'respiratory and core-postural stabilisation or abdominal breathing group']","['forced vital capacity (FVC(%)predicted) only after respiratory and core-postural stabilisation', 'diaphragmatic movements', 'Medical Research Council questionnaire score', 'fluoroscopy diaphragmatic measurement and dyspnea', 'diaphragmatic movement and pulmonary function']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730605', 'cui_str': 'Moderate chronic obstructive pulmonary disease'}]","[{'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0232079', 'cui_str': 'Diaphragmatic movement'}, {'cui': 'C0451290', 'cui_str': 'Medical Research Council questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",14.0,0.0411791,"RESULTS


Respiratory and core-postural stabilisation was more effective in increasing diaphragmatic movements than abdominal breathing (P< 0.05).","[{'ForeName': 'Gihoon', 'Initials': 'G', 'LastName': 'Jung', 'Affiliation': 'Department of Rehabilitation Medicine, WonKwang University SanBon Hospital, Gunpo, Korea.'}, {'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Sports Movement Artificial Robotics Technology (SMART) Institute, Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Jongseok', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Sports Movement Artificial Robotics Technology (SMART) Institute, Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Joshua Sung H', 'Initials': 'JSH', 'LastName': 'You', 'Affiliation': 'Sports Movement Artificial Robotics Technology (SMART) Institute, Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Chunghwi', 'Initials': 'C', 'LastName': 'Yi', 'Affiliation': 'Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Woochol Joseph', 'Initials': 'WJ', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, Yonsei University, Wonju, Korea.'}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-218034']
1750,33682752,Effects of masticatory exercise on cognitive function in community-dwelling older adults.,"BACKGROUND


Mastication improves cognitive function by activating cerebral cortical activity, and it is important to demonstrate the cognitive effects of masticatory training using a variety of different interventions.
OBJECTIVE


This study aimed to evaluate the effects of masticatory exercise on cognitive function in healthy older adults living in the community.
METHODS


For six weeks, twelve participants performed a masticatory exercise using a NOSICK exerciser device, and thirteen subjects performed daily life without masticatory exercises. Trail Making Test, Digit Span Test, and Stroop test were used to measure the cognitive function.
RESULTS


The participants in the experimental group showed significant improvements in TMT-A/B (p= 0.001 and 0.004), DST-forward (p= 0.001), and ST-word (p= 0.001). The effect sizes after the intervention were calculated as (1.2 and 0.8) for TMT-A/B, (0.8 and 0.2) for Digit Span Test forward/backward, and (0.6 and 0.2) for Stroop test color/word.
CONCLUSIONS


We suggest that the masticatory exercises improve cognitive function in healthy older adults. Therefore, masticatory exercises can be used as a therapeutic exercise during cognitive rehabilitation.",2021,"The participants in the experimental group showed significant improvements in TMT-A/B (p= 0.001 and 0.004), DST-forward (p= 0.001), and ST-word (p= 0.001).","['healthy older adults living in the community', 'healthy older adults', 'community-dwelling older adults']","['masticatory exercise using a NOSICK exerciser device, and thirteen subjects performed daily life without masticatory exercises', 'masticatory exercises', 'masticatory exercise']","['TMT-A/B', 'cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0419105', 'cui_str': 'Masticatory exercises'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",12.0,0.0335782,"The participants in the experimental group showed significant improvements in TMT-A/B (p= 0.001 and 0.004), DST-forward (p= 0.001), and ST-word (p= 0.001).","[{'ForeName': 'Tae-Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': ''}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-218013']
1751,33687555,Changes in clinical parameters following adjunctive local sodium hypochlorite gel in minimally invasive nonsurgical therapy (MINST) of periodontal pockets: a 6-month randomized controlled clinical trial.,"BACKGROUND


The mechanical disruption and removal of the subgingival biofilm represent the most important step in the treatment of periodontitis. However, in deep periodontal pockets, mechanical removal of the subgingival biofilm is difficult and frequently incomplete. Preliminary findings indicate that the use of amino acid buffered sodium hypochlorite (NaOCl) gel may chemically destroy the bacterial biofilm and facilitate its mechanical removal.
OBJECTIVES


To clinically evaluate the efficacy of minimally invasive nonsurgical therapy (MINST) of periodontal pockets with or without local application of an amino acid buffered sodium hypochlorite (NaOCl) gel.
MATERIALS AND METHODS


Forty untreated patients diagnosed with severe/advanced periodontitis (i.e. stage III/IV) with a slow/moderate rate of progression (i.e. grade A/B) were randomly allocated in two treatment groups. In the test group, the periodontal pockets were treated by means of MINST and NaOCl gel application, while in the control group, treatment consisted of MINST alone. Full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), probing depths (PD), clinical attachment levels (CAL) and gingival recessions (GR) were assessed at baseline and at 6 months following therapy. The primary outcome variable was PD reduction at sites with PD ≥ 5 mm at baseline.
RESULTS


At 6 months, statistically significant differences between the two groups were found (p = 0.001) in terms of PD and CAL change. No statistically significant differences were found in terms of GR (p = 0.81). The number of sites with PD ≥ 5 mm and BOP (+) decreased statistically significantly (p = 0.001), i.e. from 85.3 to 2.2% in the test group and from 81.6 to 7.3% in the control group, respectively. Statistically significant differences between test and control groups were recorded at 6 months (p = 0.001). MINST + NaOCl compared to MINST alone decreased statistically significantly (p = 0.001) the probability of residual PDs ≥ 5 mm with BOP- (14.5% vs 18.3%) and BOP+ (2.2% vs. 7.2%).
CONCLUSIONS


Within their limits, the present results indicate that (a) the use of MINST may represent a clinically valuable approach for nonsurgical therapy and (b) the application of NaOCl gel in conjunction with MINST may additionally improve the clinical outcomes compared to the use of MINST alone.
CLINICAL RELEVANCE


In patients with untreated periodontitis, treatment of deep pockets by means of MINST in conjunction with a NaOCl gel may represent a valuable approach to additionally improve the clinical outcomes obtained with MINST alone.",2021,"MINST + NaOCl compared to MINST alone decreased statistically significantly (p = 0.001) the probability of residual PDs ≥ 5 mm with BOP- (14.5% vs 18.3%) and BOP+ (2.2% vs. 7.2%).
","['minimally invasive nonsurgical therapy (MINST) of periodontal pockets', 'Forty untreated patients diagnosed with severe/advanced periodontitis (i.e. stage III/IV) with a slow/moderate rate of progression (i.e. grade A/B']","['adjunctive local sodium hypochlorite gel', 'MINST', 'minimally invasive nonsurgical therapy (MINST', 'MINST alone', 'MINST + NaOCl', 'amino acid buffered sodium hypochlorite (NaOCl) gel']","['probability of residual PDs ≥ 5 mm with BOP', 'number of sites with PD ≥ 5 mm and BOP ', 'BOP', 'PD reduction', 'Full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), probing depths (PD), clinical attachment levels (CAL) and gingival recessions (GR']","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0445108', 'cui_str': 'Number of sites'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]",40.0,0.070103,"MINST + NaOCl compared to MINST alone decreased statistically significantly (p = 0.001) the probability of residual PDs ≥ 5 mm with BOP- (14.5% vs 18.3%) and BOP+ (2.2% vs. 7.2%).
","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iorio-Siciliano', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Naples Federico II, Via S. Pansini 5, 80131, Naples, Italy. enzois@libero.it.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramaglia', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Naples Federico II, Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Isola', 'Affiliation': 'Department of Biomedical, Odontostomatological Sciences and of Morphological and Functional Immages, School of Dentistry, University of Messina, AOU Policlinico ""G.Martino"", Via C.Valeria 1, 98125, Messina, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Blasi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Naples Federico II, Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Salvi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}]",Clinical oral investigations,['10.1007/s00784-021-03841-8']
1752,33687525,Placebo and nocebo responses in randomized controlled trials of Janus kinase inhibitor monotherapy for rheumatoid arthritis : A meta-analysis.,"OBJECTIVE


The goal of this meta-analysis was to assess the frequency and magnitude of placebo and nocebo responses in placebo-controlled randomized controlled trials (RCTs) of Janus kinase (JAK) inhibitor monotherapy for rheumatoid arthritis (RA) METHODS: We performed a meta-analysis on the rates of placebo response, adverse effects (AEs), severe AEs (SAEs) and withdrawal due to AEs in placebo-controlled randomized clinical trials (RCTs) of JAK inhibitor therapy for RA.
RESULTS


Five RCTs contained a total of 1422 patients (746 trial participants and 676 controls). The pooled incidence of an American College of Rheumatology 20% (ACR20) response rate was 33.0% (95% CI 19.6-44.9%) in placebo-treated patients and 68.3% (95% CI 61.4-74.1%) in active drug-treated patients. A strong negative correlation was observed between drug efficacies (ACR20 response) and AE rates in the placebo arm, indicating that the stronger the placebo response, the weaker the nocebo response (r = -0.906, P = 0.034). The pooled estimate of at least one AE was 54.1% (95% CI 44.6-63.4%) in placebo-treated patients and 54.5% (95% CI 46.2-62.6%) in active drug-treated patients. The pooled SAE rate was 3.9% (95% CI 2.7-5.7%) in placebo-treated patients and 3.8% (95% CI 2.5-5.7%) in active comparator-treated patients. The pooled estimate of withdrawal owing to an AE was 4.1% (95% CI 1.4-11.3%) in placebo-treated patients and 2.1% (95% CI 0.8-5.4%) in active drug-treated patients. However, there were no differences in the pooled risk of AE, SAEs, or withdrawal owing to AEs between the active comparator and placebo groups. A strong positive correlation was observed in AE rates between the placebo and active arms, indicating that the stronger the nocebo response, the higher the AE rate in the active arm (r = 0.957, P = 0.012).
CONCLUSION


The frequency of placebo and nocebo responses was 33.0 and 54.1%, respectively, in JAK monotherapy trials for RA. The findings indicated that the strengths of placebo and nocebo responses are inversely proportional and that clinically significant differences were absent between AE, SAE, and dropout owing to AEs.",2021,"However, there were no differences in the pooled risk of AE, SAEs, or withdrawal owing to AEs between the active comparator and placebo groups.","['rheumatoid arthritis', '1422 patients (746 trial participants and 676 controls', 'rheumatoid arthritis ']","['placebo', 'Janus kinase (JAK) inhibitor monotherapy', 'Janus kinase inhibitor monotherapy', 'Placebo', 'JAK inhibitor therapy']","['pooled SAE rate', 'AE rates', 'frequency of placebo and nocebo responses', 'pooled incidence of an American College of Rheumatology 20% (ACR20) response rate', 'AE rate', 'drug efficacies (ACR20 response) and AE rates', 'rates of placebo response, adverse effects (AEs), severe AEs (SAEs) and withdrawal due to AEs', 'nocebo response', 'pooled risk of AE, SAEs, or withdrawal owing to AEs']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3854325', 'cui_str': 'Janus kinase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1422.0,0.755359,"However, there were no differences in the pooled risk of AE, SAEs, or withdrawal owing to AEs between the active comparator and placebo groups.","[{'ForeName': 'Yoon-Kyoung', 'Initials': 'YK', 'LastName': 'Sung', 'Affiliation': 'Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea (Republic of).'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, 73, Goryeodae-ro, Seongbuk-gu, 02841, Seoul, Korea (Republic of). lyhcgh@korea.ac.kr.'}]",Zeitschrift fur Rheumatologie,['10.1007/s00393-021-00969-6']
1753,33687487,"Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study.","AIMS/HYPOTHESIS


Glucagon-like peptide 1 receptor agonists (GLP-1 RA) such as exenatide are used as monotherapy and add-on therapy for maintaining glycaemic control in patients with type 2 diabetes mellitus. The current study investigated the safety and efficacy of once-weekly PB-119, a PEGylated exenatide injection, in treatment-naive patients with type 2 diabetes.
METHODS


In this Phase II, randomised, placebo-controlled, double-blind study, we randomly assigned treatment-naive Chinese patients with type 2 diabetes in a 1:1:1:1 ratio to receive subcutaneous placebo or one of three subcutaneous doses of PB-119 (75, 150, and 200 μg) for 12 weeks. The primary endpoint was the change in HbA 1c  from baseline to week 12, and other endpoints were fasting plasma glucose, 2 h postprandial glucose (PPG), and proportion of patients with HbA 1c  < 53 mmol/mol (<7.0%) and ≤48 mmol/mol (≤6.5%) at 2, 4, 8 and 12 weeks of treatment. Safety was assessed in all patients who received at least one dose of study drug.
RESULTS


We randomly assigned 251 patients to one of the four treatment groups (n = 62 in placebo and 63 each in PB-119 75 μg, 150 μg and 200 μg groups). At the end of 12 weeks, mean differences in HbA 1c  in the treatment groups were -7.76 mmol/mol (95% CI -9.23, -4.63, p < 0.001) (-0.72%, 95% CI -1.01, -0.43), -12.89 mmol/mol (95% CI -16.05, -9.72, p < 0.001) (-1.18%, 95% CI -1.47, -0.89) and -11.14 mmol/mol (95% CI -14.19, -7.97, p <0 .001) (-1.02%, 95% CI -1.30, -0.73) in the 75 μg, 150 μg and 200 μg PB-119 groups, respectively, compared with that in the placebo group after adjusting for baseline HbA 1c . Similar results were also observed for other efficacy endpoints across different time points. There was no incidence of treatment-emergent serious adverse event, severe hypoglycaemia or death.
CONCLUSIONS/INTERPRETATION


All tested PB-119 doses had superior efficacy compared with placebo and were safe and well tolerated over 12 weeks in treatment-naive Chinese patients with type 2 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03520972 FUNDING: The study was funded by National Major Scientific and Technological Special Project for Significant New Drugs Development and PegBio.",2021,"All tested PB-119 doses had superior efficacy compared with placebo and were safe and well tolerated over 12 weeks in treatment-naive Chinese patients with type 2 diabetes.
","['naive Chinese patients with type 2 diabetes in a 1:1:1:1 ratio to receive', 'patients with type 2 diabetes mellitus', 'treatment-naive type 2 diabetes mellitus patients', 'naive Chinese patients with type 2 diabetes', 'treatment-naive patients with type 2 diabetes']","['PEGylated exenatide injection', 'placebo', 'mmol/mol ', 'PB-119', 'PEGylated exenatide injection (PB-119', 'subcutaneous placebo']","['change in HbA 1c', 'safe and well tolerated', 'safety and efficacy', 'Efficacy and safety', 'fasting plasma glucose, 2\xa0h postprandial glucose (PPG), and proportion of patients with HbA 1c', 'Safety', 'incidence of treatment-emergent serious adverse event, severe hypoglycaemia or death']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C4026821', 'cui_str': 'exenatide Injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",251.0,0.611628,"All tested PB-119 doses had superior efficacy compared with placebo and were safe and well tolerated over 12 weeks in treatment-naive Chinese patients with type 2 diabetes.
","[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Peking University People's Hospital, Beijing, China. jiln@bjmu.edu.cn.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'PegBio Co., Ltd, Suzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'PegBio Co., Ltd, Suzhou, China.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'PegBio Co., Ltd, Suzhou, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Mo', 'Affiliation': 'Department of Endocrinology, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Third Endocrinology Department, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Beijing Pinggu Hospital, Beijing, China.'}, {'ForeName': 'Jingna', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Department of Endocrinology, Tianjin People's Hospital, Tianjin, China.""}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, The Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, First Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ""Department of Endocrinology and Diabetes, Chenzhou No 1 People's Hospital, Chenzhou, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Endocrinology, Zhongda Hospital Southeast University, Nanjing, China.'}, {'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Pang', 'Affiliation': 'Department of Endocrinology, Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Luoyang Central Hospital, Luoyang, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Yuncheng Central Hospital, Yuncheng, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Henan University of Science and Technology, Henan, China.'}, {'ForeName': 'Minxiu', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Department of Endocrinology, Qingdao Central Hospital, Qingdao, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Beijing Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Endocrinology, The First People's Hospital of Changzhou, Changzhou, China.""}, {'ForeName': 'Feixia', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Houfa', 'Initials': 'H', 'LastName': 'Geng', 'Affiliation': 'Department of Endocrinology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology, The First People's Hospital, Changde, China.""}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Ran', 'Affiliation': 'Department of Endocrinology, Guangzhou Red Cross Hospital, Guangzhou, China.'}, {'ForeName': 'Minxiang', 'Initials': 'M', 'LastName': 'Lei', 'Affiliation': 'Department of Endocrinology, Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Yinghong', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Endocrinology, Guangzhou Panyu Central Hospital, Guangzhou, China.'}, {'ForeName': 'Shandong', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Endocrinology, Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Qingbo', 'Initials': 'Q', 'LastName': 'Guan', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Jinan, China.'}, {'ForeName': 'Wenshan', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': 'Department of Endocrinology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, West China Hospital Sichuan University, Sichuan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, West China Hospital Sichuan University, Sichuan, China.'}, {'ForeName': 'Jinkui', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Beijing Tongren Hospital, CMU, Beijing, China.'}, {'ForeName': 'Guijun', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Zhengzhou University, Henan, China.'}, {'ForeName': 'Shiyun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital & Clinical Medical College of Chengdu University, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Suzhou Municipal Hospital, Suzhou, China.'}]",Diabetologia,['10.1007/s00125-021-05392-9']
1754,33687463,Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.,"Importance


Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results.
Objective


To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year.
Design, Setting, and Participants


Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020.
Interventions


Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion.
Main Outcomes and Measures


The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score.
Results


Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%).
Conclusions and Relevance


Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach.
Trial Registration


ClinicalTrials.gov Identifier: NCT02076113.",2021,"SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86).","['163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years', 'patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020', 'Patients', 'patients with cervical spondylotic myelopathy undergoing cervical spinal surgery']","['ventral surgery (n\u2009=\u200963) or dorsal surgery', 'Cervical Spondylotic Myelopathy', 'Ventral surgery involved anterior cervical disk removal and instrumented fusion', 'Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty', 'Ventral vs Dorsal Spinal Surgery', 'dorsal surgery (fusion or laminoplasty']","['included dysphagia', 'new neurological deficit', 'Rates of complications', '1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference\u2009=\u20095', 'dorsal surgery', 'SF-36 PCS mean improvement', 'patient-reported physical functioning', 'reoperations', '1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C1535956', 'cui_str': 'Laminaplasty'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.310609,"SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86).","[{'ForeName': 'Zoher', 'Initials': 'Z', 'LastName': 'Ghogawala', 'Affiliation': 'Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Terrin', 'Affiliation': 'Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dunbar', 'Affiliation': 'Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'Breeze', 'Affiliation': 'Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Freund', 'Affiliation': 'Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kanter', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburg, Pennsylvania.'}, {'ForeName': 'Praveen V', 'Initials': 'PV', 'LastName': 'Mummaneni', 'Affiliation': 'Department of Neurological Surgery, University of California, San Francisco.'}, {'ForeName': 'Erica F', 'Initials': 'EF', 'LastName': 'Bisson', 'Affiliation': 'Department of Neurosurgery Clinical Neurosciences Center, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Fred G', 'Initials': 'FG', 'LastName': 'Barker', 'Affiliation': 'Massachusetts General Hospital Brain Tumor Center, Boston.'}, {'ForeName': 'J Sanford', 'Initials': 'JS', 'LastName': 'Schwartz', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Harrop', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Subu N', 'Initials': 'SN', 'LastName': 'Magge', 'Affiliation': 'Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Heary', 'Affiliation': 'Department of Neurological Surgery, Hackensack Meridian School of Medicine, Nutley, New Jersey.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Fehlings', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Albert', 'Affiliation': 'Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Arnold', 'Affiliation': 'Carle Neuroscience Institute, Carle Foundation Hospital, Urbana, Illinois.'}, {'ForeName': 'K Daniel', 'Initials': 'KD', 'LastName': 'Riew', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Steinmetz', 'Affiliation': 'Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Marjorie C', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Whitmore', 'Affiliation': 'Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Heller', 'Affiliation': 'Emory Orthopaedics & Spine Center, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Benzel', 'Affiliation': 'Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio.'}]",JAMA,['10.1001/jama.2021.1233']
1755,33687312,Effects of a nursing care program based on the theory of human caring on women diagnosed with gynecologic cancer: a pilot study from Turkey.,"PURPOSE/OBJECTIVES


This pilot study aimed to determine the effects of a nursing care program based on the Theory of Human Caring (THC) on chemotherapy symptoms, hope, and meaning in life in women diagnosed with gynecologic cancer.
DESIGN/METHODS


This pilot study was conducted in a single-blinded, randomized controlled trial on 52 women diagnosed with gynecologic cancer in Turkey. In the present study, the experimental group was given a nursing care program based on the THC alongside routine nursing care for five sessions, while the control group received solely routine nursing care. Data were collected using the Chemotherapy Symptom Assessment Scale, the Herth Hope Scale, and the Life Attitude Profile.
FINDINGS


There was a statistically significant decrease in the frequency, severity, and degree of discomfort of some chemotherapy symptoms in the experimental group. In addition, the mean scores of hope and meaning in life were significantly higher in the study group compared to the control group.
CONCLUSIONS/IMPLICATIONS


This study revealed that a nursing care program based on the Theory of Human Caring might be of benefit for decreasing the frequency, intensity, and discomfort level of some chemotherapy symptoms, and also for improving the level of hope and meaning in life in women diagnosed with gynecologic cancer.",2021,"In addition, the mean scores of hope and meaning in life were significantly higher in the study group compared to the control group.
","['women diagnosed with gynecologic cancer', '52 women diagnosed with gynecologic cancer in Turkey']","['nursing care program based on the Theory of Human Caring (THC', 'nursing care program based on the THC alongside routine nursing care for five sessions, while the control group received solely routine nursing care', 'nursing care program']","['Chemotherapy Symptom Assessment Scale, the Herth Hope Scale, and the Life Attitude Profile', 'mean scores of hope and meaning in life', 'frequency, severity, and degree of discomfort of some chemotherapy symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",52.0,0.0502414,"In addition, the mean scores of hope and meaning in life were significantly higher in the study group compared to the control group.
","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Teskereci', 'Affiliation': 'Department of Maternity and Gynecological Nursing, Akdeniz University Kumluca Health Science Faculty, Antalya, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Yangın', 'Affiliation': 'Department of Maternity and Gynecological Nursing, Akdeniz University Nursing Faculty, Antalya, Turkey.'}, {'ForeName': 'Özen', 'Initials': 'Ö', 'LastName': 'Kulakaç', 'Affiliation': 'Department of Maternity and Gynecological Nursing, Ondokuz Mayis University Samsun School of Health, Samsun, Turkey.'}]",Journal of psychosocial oncology,['10.1080/07347332.2021.1878317']
1756,33687180,Comparison of two mechanical insufflation-exsufflation devices in patients with amyotrophic lateral sclerosis: a preliminary study.,"BACKGROUND


Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease affecting upper and lower motor neurons and resulting in progressive skeletal muscle weakness. Weak cough and difficulty in clearing secretions are often the cause of pulmonary infections and acute respiratory failure. Cough assistance is commonly used to provide support in coughing for patients with ALS.
METHODS


This was a preliminary parallel randomized study comparing two cough-assist devices: one utilizing mechanical insufflation/exsufflation (MI/E) and expiratory flow accelerator (EFA) technology, the other utilizing only MI/E technology. The aim was to compare the effectiveness, safety and acceptability of the two devices. Thirty patients with ALS and similar severity and functional scale were enrolled. The primary outcome was the change in respiratory function, respiratory muscle function, gas exchange, and peak cough expiratory flow as an indicator of cough efficacy. Secondary outcomes were the number of exacerbations at 1, 6 and 12 months of treatment, and the patient-perceived comfort/distress related to the interventions together with the perceived efficacy of cough.
RESULTS


30 subjects were recruited and randomized into the two groups (1:1 ratio). Primary outcomes: Respiratory function parameters decreased over time in both groups, but significantly less in the Kalos group, as did the respiratory muscle strength parameters and peak cough flows. Gas exchanges decreased over time in both groups with no clinically relevant differences between groups.
SECONDARY OUTCOMES


there were no significant differences between groups regarding the number of exacerbations over time. No adverse events were reported. All participants, in both groups, reported a similar increase in perceived cough efficacy and there was no significant difference in comfort and distress between the two treatments.
CONCLUSIONS


The cough-assist device with EFA technology performed better than a traditional MI/E device in ALS patients regarding respiratory function and cough efficacy, although number of exacerbations and acceptability of the two devices was similar. Following these promising preliminary results, further investigation is required in a larger cohort to confirm the superiority of EFA technology associated with a MI/E device.",2021,"All participants, in both groups, reported a similar increase in perceived cough efficacy and there was no significant difference in comfort and distress between the two treatments.
","['Thirty patients with ALS and similar severity and functional scale were enrolled', 'Amyotrophic lateral sclerosis (ALS', 'patients with amyotrophic lateral sclerosis', 'patients with ALS', '30 subjects']","['mechanical insufflation-exsufflation devices', 'mechanical insufflation/exsufflation (MI/E) and expiratory flow accelerator (EFA) technology']","['perceived cough efficacy', 'effectiveness, safety and acceptability', 'respiratory muscle strength parameters and peak cough flows', 'efficacy of cough', 'respiratory function and cough efficacy', 'change in respiratory function, respiratory muscle function, gas exchange, and peak cough expiratory flow as an indicator of cough efficacy', 'number of exacerbations', 'adverse events', 'comfort and distress', 'number of exacerbations over time', 'Respiratory function parameters']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C5192599', 'cui_str': 'Mechanical insufflation exsufflation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",30.0,0.121946,"All participants, in both groups, reported a similar increase in perceived cough efficacy and there was no significant difference in comfort and distress between the two treatments.
","[{'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Nicolini', 'Affiliation': 'Respiratory Diseases Unit, General Hospital, Sestri Levante, Genova, Italy - antonellonicolini#gmail.com.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Prato', 'Affiliation': 'Respiratory Diseases Unit, General Hospital, Sestri Levante, Genova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beccarelli', 'Affiliation': 'Respiratory Diseases Unit, General Hospital, Sestri Levante, Genova, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Grecchi', 'Affiliation': 'Physical Medicine and Rehabilitation, General Hospital, Sestri Levante, Genova, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Garuti', 'Affiliation': 'Department of Pulmonology, General Hospital, Mirandola, Modena, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Banfi', 'Affiliation': 'Pulmonary Rehabilitation Unit, Don Gnocchi Foundation, IRCCS, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Abrosca"", 'Affiliation': 'ARIR, Italian Association of Respiratory Physiotherapists.'}]",Panminerva medica,['10.23736/S0031-0808.21.04104-5']
1757,33687176,Exercise intensity influences plasma and sweat amino acid concentrations: a crossover trial.,"BACKGROUND


The purpose of this study was to explore the relationship between concentrations of amino acid (AA) and related metabolites in plasma and sweat obtained before and after exercise performed at different intensities and therefore different rates of sweat loss.
METHODS


Ten subjects completed a maximally ramped exercise test and three 30-min submaximal (45/60/75% VO2max) exercise bouts. Blood samples were collected before/after the exercise bouts and sweat was collected from the forearm throughout. Samples were analyzed for concentrations of AA and related molecules.
RESULTS


Sweat AA excretion rate was higher during the 60% bout compared to the 45% bout but was similar in comparison to the 75% indicating a plateau in rates of sweat AA losses as sweat rate increased. Plasma concentrations of AAs, urea, ammonia, and other non-proteinogenic AAs were not significantly different between exercise bouts performed at 45 and 60%. Exercise at 75% tended to reduce concentrations of sweat amino acids with significantly depressed concentrations of glycine, lysine, serine, threonine, histidine, arginine, tryptophan, aspartate and ornithine.
CONCLUSIONS


Overall, this research suggests that increasing exercise intensity increases AA metabolism as demonstrated by reduced plasma AA concentrations and increased excretion through sweat glands, which is mediated by a mechanism yet to be identified.",2021,"Exercise at 75% tended to reduce concentrations of sweat amino acids with significantly depressed concentrations of glycine, lysine, serine, threonine, histidine, arginine, tryptophan, aspartate and ornithine.
",['Ten subjects completed a'],['maximally ramped exercise test and three 30-min submaximal (45/60/75% VO2max) exercise bouts'],"['Exercise intensity influences plasma and sweat amino acid concentrations', 'plasma AA concentrations', 'Sweat AA excretion rate', 'Plasma concentrations of AAs, urea, ammonia, and other non-proteinogenic AAs', 'glycine, lysine, serine, threonine, histidine, arginine, tryptophan, aspartate and ornithine', 'concentrations of amino acid (AA', 'Blood samples']","[{'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0175701', 'cui_str': 'Aarskog syndrome'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C0040005', 'cui_str': 'Threonine'}, {'cui': 'C0019602', 'cui_str': 'Histidine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0029277', 'cui_str': 'Ornithine'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",10.0,0.208036,"Exercise at 75% tended to reduce concentrations of sweat amino acids with significantly depressed concentrations of glycine, lysine, serine, threonine, histidine, arginine, tryptophan, aspartate and ornithine.
","[{'ForeName': 'Michaeal', 'Initials': 'M', 'LastName': 'Stone', 'Affiliation': 'Department of Exercise and Nutritional Science, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Clayton', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Michaeal J', 'Initials': 'MJ', 'LastName': 'Buono', 'Affiliation': 'Department of Exercise and Nutritional Science, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'Department of Exercise and Nutritional Science, San Diego State University, San Diego, CA, USA - Kern@sdsu.edu.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.21.12134-6']
1758,33687163,Effect of Metformin on Premature Luteinization and Pregnancy Outcomes in Intracytoplasmic Sperm Injection-Fresh Embryo Transfer Cycles: A Randomized Double-Blind Controlled Trial.,"Background


Premature luteinization (PL) is not unusual in  in vitro  fertilization (IVF) and could not be wholly avoided by using either gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonist regimens. The study aims to evaluate metformin's efficacy in preventing PL in fresh GnRH antagonist intracytoplasmic sperm injection (ICSI) cycles with cleavage-stage embryo transfer.
Materials and Methods


This randomized, double-blind, placebo-controlled trial was conducted in a tertiary university IVF center. We recruited infertile women who were scheduled to perform their first or second ICSI trial. Eligible women were recruited and randomized in a 1:1 ratio into two groups. Metformin was administered in a dose of 1500 mg per day since the start of contraceptive pills in the cycle antecedent to stimulation cycle until the day of ovulation triggering, while women in the placebo group received a placebo for the same regimen and duration. The primary outcome was the incidence of PL, defined as serum progesterone (P) on the triggering day ≥1.5 ng/mL. Secondary outcomes comprised the live birth, ongoing pregnancy, implantation, and good-quality embryos rates.
Results


The trial involved 320 eligible participants (n=160 in each group). Both groups had comparable stimulation days, endometrial thickness, peak estradiol levels, number of oocytes retrieved, and number of mature oocytes. Metformin group experienced lower level of serum P (P<0.001) and incidence of PL (10 vs. 23.6%, P=0.001). Moreover, lower progesterone/estradiol (P/E) ratio and progesterone to mature oocyte index (PMOI) (P=0.002 and P=0.002, respectively) were demonstrated in women receiving metformin. Metformin group generated a better rate of goodquality embryos (P=0.005) and ongoing pregnancy (43.8 vs. 31.8%, P=0.026). A similar trend, though of borderline significance, was observed in the live birth rate in favor of metformin administration (38.15 vs. 27.5%, P=0.04).
Conclusion


Metformin could be used in patients with potential PL to improve fresh cycle outcomes by preventing PL (Registration number: NCT03088631).",2021,"Metformin group generated a better rate of goodquality embryos (P=0.005) and ongoing pregnancy (43.8 vs. 31.8%, P=0.026).","['tertiary university IVF center', 'infertile women who were scheduled to perform their first or second ICSI trial', '320 eligible participants (n=160 in each group', 'Intracytoplasmic Sperm Injection-Fresh Embryo Transfer Cycles', 'Eligible women']","['metformin', 'Metformin', 'placebo', '\n\n\nPremature luteinization (PL']","['rate of goodquality embryos', 'stimulation days, endometrial thickness, peak estradiol levels, number of oocytes retrieved, and number of mature oocytes', 'Premature Luteinization and Pregnancy Outcomes', 'live birth rate', 'live birth, ongoing pregnancy, implantation, and good-quality embryos rates', 'incidence of PL, defined as serum progesterone (P', 'lower progesterone/estradiol (P/E) ratio and progesterone to mature oocyte index (PMOI', 'ongoing pregnancy', 'level of serum P (P<0.001) and incidence of PL']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0334024', 'cui_str': 'Luteinization'}]","[{'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0334024', 'cui_str': 'Luteinization'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",320.0,0.650084,"Metformin group generated a better rate of goodquality embryos (P=0.005) and ongoing pregnancy (43.8 vs. 31.8%, P=0.026).","[{'ForeName': 'Reda S', 'Initials': 'RS', 'LastName': 'Hussein', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.Email: rsalah313@yahoo.com.'}, {'ForeName': 'Ihab', 'Initials': 'I', 'LastName': 'Elnashar', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed F', 'Initials': 'AF', 'LastName': 'Amin', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Yulian', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abdelmagied', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abbas', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Abdelaleem', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Farghaly', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Osama S', 'Initials': 'OS', 'LastName': 'Abdalmageed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Youssef', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Esraa', 'Initials': 'E', 'LastName': 'Badran', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hisham A', 'Initials': 'HA', 'LastName': 'Abou-Taleb', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",International journal of fertility & sterility,['10.22074/IJFS.2020.134643']
1759,33077809,Determinants favoring weight regain after weight-loss therapy among postmenopausal women.,"Little is known about the factors affecting body weight-loss maintenance among postmenopausal women. We thus performed an analysis to identify some sociodemographic, physiological, and behavioral predictors of weight regain in a targeted subpopulation of women who had lost weight 1 year earlier. We also measured how eating behaviors and habits as well as physical activity pattern differ among successful and unsuccessful weight-loss maintainers over the trial. Sixty-four postmenopausal women were followed up for a year after dieting, and the successful and unsuccessful maintainers were identified. The regainers had regained an average of 4.9 kg of their lost body weight, while the maintainers had regained only 1.5 kg. Regainers had fewer years of education and lower initial body weight loss than maintainers. They also showed poor dietary adherence during dieting, and had unhealthy patterns of eating involving the avoidance of breakfast and a lower intake of nuts, seeds, and pulses, and a higher intake of sweets, biscuits, cakes, and pastries over time (excluding the dieting period). All the significant sociodemographic, physiological and behavioral variables differentiating regainers and maintainers before and after dieting were then examined as independent variables in a logistic regression model. The model showed that less weight reduction during dieting, higher disinhibition scores after dieting, and avoidance of breakfast before dieting were significant predictors of body weight regain in postmenopausal women. From a practical point of view, early identification of postmenopausal women who are at risk of regaining lost weight can allow health professionals to create behavioral and dietary supports to help prevent this. A regular schedule of follow-ups over at least the first year should be considered for them-including psychological and dietary intervention, if necessary. Since this sample study included only postmenopausal women, our findings are not generalizable to other populations.",2020,"The model showed that less weight reduction during dieting, higher disinhibition scores after dieting, and avoidance of breakfast before dieting were significant predictors of body weight regain in postmenopausal women.","['postmenopausal women', 'postmenopausal women who are at risk of regaining lost weight', 'Sixty-four postmenopausal women', 'women who had lost weight 1 year earlier']",[],"['weight reduction', 'body weight regain', 'weight regain', 'higher intake of sweets, biscuits, cakes, and pastries over time', 'years of education and lower initial body weight loss']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0452597', 'cui_str': 'Cake'}, {'cui': 'C0452703', 'cui_str': 'Pastry'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",64.0,0.021941,"The model showed that less weight reduction during dieting, higher disinhibition scores after dieting, and avoidance of breakfast before dieting were significant predictors of body weight regain in postmenopausal women.","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Bajerska', 'Affiliation': 'Department of Human Nutrition and Dietetics, Faculty of Food Sciences and Nutrition, Poznań University of Life Sciences, Wojska Polskiego 31, 60-624, Poznan, Poland. joanna.bajerska@up.poznan.pl.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Chmurzynska', 'Affiliation': 'Department of Human Nutrition and Dietetics, Faculty of Food Sciences and Nutrition, Poznań University of Life Sciences, Wojska Polskiego 31, 60-624, Poznan, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Muzsik-Kazimierska', 'Affiliation': 'Department of Human Nutrition and Dietetics, Faculty of Food Sciences and Nutrition, Poznań University of Life Sciences, Wojska Polskiego 31, 60-624, Poznan, Poland.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Mądry', 'Affiliation': 'First Subdepartment of Pediatrics, Department of Pediatric Gastroenterology and Metabolism, Poznań University of Medical Sciences, Szpitalna 27/33, 60-572, Poznan, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Pięta', 'Affiliation': 'Department of Maternal and Child Health, Poznań University of Medical Sciences, Polna 33, 60-535, Poznan, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Sobkowski', 'Affiliation': 'Department of Maternal and Child Health, Poznań University of Medical Sciences, Polna 33, 60-535, Poznan, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': 'First Subdepartment of Pediatrics, Department of Pediatric Gastroenterology and Metabolism, Poznań University of Medical Sciences, Szpitalna 27/33, 60-572, Poznan, Poland.'}]",Scientific reports,['10.1038/s41598-020-74302-7']
1760,33243198,Exposure contrasts associated with a liquefied petroleum gas (LPG) intervention at potential field sites for the multi-country household air pollution intervention network (HAPIN) trial in India: results from pilot phase activities in rural Tamil Nadu.,"BACKGROUND


The Household Air Pollution Intervention Network (HAPIN) trial aims to assess health benefits of a liquefied petroleum gas (LPG) cookfuel and stove intervention among women and children across four low- and middle-income countries (LMICs). We measured exposure contrasts for women, achievable under alternative conditions of biomass or LPG cookfuel use, at potential HAPIN field sites in India, to aid in site selection for the main trial.
METHODS


We recruited participants from potential field sites within Villupuram and Nagapattinam districts in Tamil Nadu, India, that were identified during a feasibility assessment. We performed. (i) cross-sectional measurements on women (N = 79) using either biomass or LPG as their primary cookfuel and (ii) before-and-after measurements on pregnant women (N = 41), once at baseline while using biomass fuel and twice - at 1 and 2 months - after installation of an LPG stove and free fuel intervention. We involved participants to co-design clothing and instrument stands for personal and area sampling. We measured 24 or 48-h personal exposures and kitchen and ambient concentrations of fine particulate matter (PM2.5) using gravimetric samplers.
RESULTS


In the cross-sectional analysis, median (interquartile range, IQR) kitchen PM2.5 concentrations in biomass and LPG using homes were 134 μg/m3 [IQR:71-258] and 27 μg/m3 [IQR:20-47], while corresponding personal exposures were 75 μg/m3 [IQR:55-104] and 36 μg/m3 [IQR:26-46], respectively. In before-and-after analysis, median 48-h personal exposures for pregnant women were 72 μg/m3 [IQR:49-127] at baseline and 25 μg/m3 [IQR:18-35] after the LPG intervention, with a sustained reduction of 93% in mean kitchen PM2.5 concentrations and 78% in mean personal PM2.5 exposures over the 2 month intervention period. Median ambient concentrations were 23 μg/m3 [IQR:19-27). Participant feedback was critical in designing clothing and instrument stands that ensured high compliance.
CONCLUSIONS


An LPG stove and fuel intervention in the candidate HAPIN trial field sites in India was deemed suitable for achieving health-relevant exposure reductions. Ambient concentrations indicated limited contributions from other sources. Study results provide critical inputs for the HAPIN trial site selection in India, while also contributing new information on HAP exposures in relation to LPG interventions and among pregnant women in LMICs.
TRIAL REGISTRATION


ClinicalTrials.Gov. NCT02944682 ; Prospectively registered on October 17, 2016.",2020,Median ambient concentrations were 23 μg/m3 [IQR:19-27).,"['participants from potential field sites within Villupuram and Nagapattinam districts in Tamil Nadu, India, that were identified during a feasibility assessment', 'women and children across four low- and middle-income countries (LMICs', 'pregnant women in LMICs']","['liquefied petroleum gas (LPG) intervention', 'liquefied petroleum gas (LPG) cookfuel and stove intervention', 'biomass or LPG', 'LPG stove and fuel intervention', 'LPG stove and free fuel intervention']","['Median ambient concentrations', 'median 48-h personal exposures']","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0039285', 'cui_str': 'Tamil language'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.167979,Median ambient concentrations were 23 μg/m3 [IQR:19-27).,"[{'ForeName': 'Sankar', 'Initials': 'S', 'LastName': 'Sambandam', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Krishnendu', 'Initials': 'K', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Saritha', 'Initials': 'S', 'LastName': 'Sendhil', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Wenlu', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Pillarisetti', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Gurusamy', 'Initials': 'G', 'LastName': 'Thangavel', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Durairaj', 'Initials': 'D', 'LastName': 'Natesan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Rengaraj', 'Initials': 'R', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Amudha', 'Initials': 'A', 'LastName': 'Natarajan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Vigneswari', 'Initials': 'V', 'LastName': 'Aravindalochanan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vinayagamoorthi', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sivavadivel', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Uma Maheswari', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Lingeswari', 'Initials': 'L', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gayatri', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Nargunanathan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Sathish', 'Initials': 'S', 'LastName': 'Madhavan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Puttaswamy', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Sarada S', 'Initials': 'SS', 'LastName': 'Garg', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.'}, {'ForeName': 'Ashlinn', 'Initials': 'A', 'LastName': 'Quinn', 'Affiliation': 'Division of Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Piedhrahita', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India. kalpanasrmc@ehe.org.in.'}]",BMC public health,['10.1186/s12889-020-09865-1']
1761,32936598,Hourly 4-s Sprints Prevent Impairment of Postprandial Fat Metabolism from Inactivity.,"High postprandial plasma lipids (PPL; i.e., triglycerides) are a risk factor for cardiovascular disease. Physical inactivity, characterized by prolonged sitting and a low step count, elevates PPL and thus risk of disease.
PURPOSE


This study determined if the interruption of prolonged sitting (i.e., 8 h of inactivity) with hourly cycling sprints of only 4-s duration each (i.e., 4 s × 5 per hour × 8 h = 160 s·d SPRINTS) improves PPL. The 4-s sprints used an inertial load ergometer and were followed by 45 s of seated rest.
METHODS


Four men and four women participated in two trials. Interventions consisted of an 8-h period of sitting (SIT), or a trial with equal sitting time interrupted with five SPRINTS every hour. The morning after the interventions, PPL and fat oxidation were measured over a 6-h period. Plasma glucose, insulin, and triglyceride concentrations were measured bihourly and incremental area under the curve (AUC) was calculated.
RESULTS


No differences (P > 0.05) between interventions were found for plasma insulin or glucose AUC. However, SPRINTS displayed a 31% (408 ± 119 vs 593 ± 88 mg·dL per 6 h; P = 0.009) decrease in plasma triglyceride incremental AUC and a 43% increase in whole-body fat oxidation (P = 0.001) when compared with SIT.
CONCLUSIONS


These data indicate that hourly very short bouts (4 s) of maximal intensity cycle sprints interrupting prolonged sitting can significantly lower the next day's postprandial plasma triglyceride response and increase fat oxidation after a high-fat meal in healthy young adults. Given that these improvements were elicited from only 160 s of nonfatiguing exercise per day, it raises the question as to what is the least amount of exercise that can acutely improve fat metabolism and other aspects of health.",2020,No differences (P > 0.05) between interventions were found for plasma insulin or glucose AUC.,"['healthy young adults', 'Four men and four women participated in two trials']",['inertial load ergometer and were followed by 45 s of seated rest'],"['High postprandial plasma lipids (PPL; i.e., triglycerides', 'postprandial plasma triglyceride response and increase fat oxidation', 'PPL', 'whole-body fat oxidation', 'plasma triglyceride incremental AUC', 'Plasma glucose, insulin, and triglyceride concentrations', 'plasma insulin or glucose AUC', 'PPL and fat oxidation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",4.0,0.0365789,No differences (P > 0.05) between interventions were found for plasma insulin or glucose AUC.,"[{'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Wolfe', 'Affiliation': 'Human Performance Laboratory, Department of Kinesiology and Health Education, University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Heath M', 'Initials': 'HM', 'LastName': 'Burton', 'Affiliation': ''}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Vardarli', 'Affiliation': ''}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Coyle', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002367']
1762,33123304,Brief Acceptance and Commitment Therapy for Fibromyalgia: Feasibility and Effectiveness of a Replicated Single-Case Design.,"Objective


Overall, the literature on the effectiveness of psychological treatments in general and those for fibromyalgia in particular has been dominated by research designs that focus on large groups and explore changes on average, so the treatment impact at the individual level remains unclear. In this quasi-experimental, replicated single-case design, we will test the feasibility and effectiveness of a brief acceptance and committed therapy intervention using ecological momentary assessment supported by technology.
Methods


The sample comprised 7 patients (3 in the individual condition and 4 in the group condition) who received a brief, 5-week psychological treatment. Patient evolution was assessed one week prior to treatment onset and during the whole study with a smartphone app. Because ecological momentary assessment and the use of an app are not frequent practices in routine care, we also evaluated the feasibility of this assessment methodology (i.e., compliance with the app). Change was investigated with a nonoverlap of all pairs index. Outcomes were pain interference with sleep and social activities, fatigue, sadness, and pain intensity.
Results


Patient change was not uniform across outcomes. Four patients (two in each condition) showed relatively moderate levels of change (approximately 60% nonoverlap in several outcomes). The remaining patients showed more modest improvements which affected a reduced number of outcomes. Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format.
Conclusions


An alternative design to large-scale trials, one that focuses on the individual change, exists and it can be implemented in pain research. The use of technology (e.g., smartphones) simplifies such designs by facilitating ecological momentary assessment. Based on our findings showing that changes were not homogeneous across patients or outcomes, more single-case designs and patient-centered analyses (e.g., responder and moderation analyses) are required.",2020,"Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format.
",['Fibromyalgia'],[],"['pain interference with sleep and social activities, fatigue, sadness, and pain intensity']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0265571,"Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format.
","[{'ForeName': 'María Camino', 'Initials': 'MC', 'LastName': 'Gómez-Pérez', 'Affiliation': 'AMIMET, Tudela, Navarre, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Jaume I University, Castellón de la Plana, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition (CIBERobn),CB06/03, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Zaragozá', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition (CIBERobn),CB06/03, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Suso-Ribera', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Jaume I University, Castellón de la Plana, Spain.'}]",Pain research & management,['10.1155/2020/7897268']
1763,33462831,Pivotal Dose of Pembrolizumab: A Dose-Finding Strategy for Immuno-Oncology.,"Despite numerous publications emphasizing the value of dose finding, drug development in oncology is dominated by the mindset that higher dose provides higher efficacy. Examples of dose finding implemented by biopharmaceutical firms can change this mindset. The purpose of this article is to outline a pragmatic dose selection strategy for immuno-oncology (IO) and other targeted monoclonal antibodies (mAbs). The approach was implemented for pembrolizumab. Selecting a recommended phase II dose (RP2D) with a novel mechanism of action is often challenging due to uncertain relationships between pharmacodynamics measurements and clinical end points. Additionally, phase I efficacy and safety data are generally inadequate for RP2D selection for IO mAbs. Here, the RP2D was estimated based on phase I (clinical study KN001 A and A2) pharmacokinetics data as the dose required for target saturation, which represents a surrogate for maximal pharmacological effect for antagonist mAbs. Due to limitations associated with collecting and analyzing tumor biopsies, characterizing intratumoral target engagement (TE) is challenging. To overcome this gap, a physiologically-based pharmacokinetic model was implemented to predict intratumoral TE. As tumors are spatially heterogeneous, TE was predicted in well-vascularized and poorly vascularized tumor regions. Additionally, impact of differences in target expression, for example, due to interindividual variability and cancer type, was simulated. Simulations showed that 200 mg every 3 weeks can achieve ≥ 90% TE in clinically relevant scenarios, resulting in the recommendation of 200 mg every 3 weeks as the RP2D. Randomized dose comparison studies (KN001 B2 and D) showing similar efficacy over a fivefold dose/exposure range confirmed the RP2D as the pivotal dose.",2021,"Simulations showed that 200 mg every 3 weeks can achieve ≥ 90% TE in clinically relevant scenarios, resulting in the recommendation of 200 mg every 3 weeks as the RP2D. Randomized dose comparison studies (KN001 B2 and D) showing similar efficacy over a fivefold dose/exposure range confirmed the RP2D as the pivotal dose.",[],['Pembrolizumab'],[],[],"[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]",[],,0.0291325,"Simulations showed that 200 mg every 3 weeks can achieve ≥ 90% TE in clinically relevant scenarios, resulting in the recommendation of 200 mg every 3 weeks as the RP2D. Randomized dose comparison studies (KN001 B2 and D) showing similar efficacy over a fivefold dose/exposure range confirmed the RP2D as the pivotal dose.","[{'ForeName': 'Tommy R', 'Initials': 'TR', 'LastName': 'Li', 'Affiliation': 'Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Manash', 'Initials': 'M', 'LastName': 'Chatterjee', 'Affiliation': 'Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Lala', 'Affiliation': 'Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Anson K', 'Initials': 'AK', 'LastName': 'Abraham', 'Affiliation': 'Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Freshwater', 'Affiliation': 'Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Lokesh', 'Initials': 'L', 'LastName': 'Jain', 'Affiliation': 'Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Sinha', 'Affiliation': 'Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Dinesh P', 'Initials': 'DP', 'LastName': 'de Alwis', 'Affiliation': 'Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Mayawala', 'Affiliation': 'Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2170']
1764,31231803,The Effect of Teacher-Child Race/Ethnicity Matching and Classroom Diversity on Children's Socioemotional and Academic Skills.,"Mounting evidence suggests teacher-child race/ethnicity matching and classroom diversity benefit Black and Latinx children's academic and socioemotional development. However, less is known about whether the effects of teacher-child matching differ across levels of classroom diversity. This study examined effects of matching on teacher-reported child outcomes in a racially/ethnically diverse sample of teachers and children, and classroom diversity moderation using multilevel models. Data were drawn from a professional learning study involving 224 teachers (M age   = 41.5) and 5,200 children (M age   = 7.7) in 36 New York City elementary schools. Teacher-child race/ethnicity matching was associated with higher child engagement in learning, motivation, social skills, and fewer absences. Classroom diversity moderated matching such that teacher-child mismatch was related to lower engagement, motivation, social skills, math and reading scores in low-diversity classrooms, but not in high-diversity classrooms. Implications for practice and policy are discussed.",2020,"Classroom diversity moderated matching such that teacher-child mismatch was related to lower engagement, motivation, social skills, math and reading scores in low-diversity classrooms, but not in high-diversity classrooms.","['224 teachers (M age  \xa0=\xa041.5) and 5,200 children (M age  \xa0=\xa07.7) in 36 New York City elementary schools', 'racially/ethnically diverse sample of teachers and children, and classroom diversity moderation using multilevel models', ""Children's Socioemotional and Academic Skills""]",['Teacher-Child Race/Ethnicity Matching and Classroom Diversity'],"['lower engagement, motivation, social skills, math and reading scores', 'child engagement in learning, motivation, social skills, and fewer absences']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]",224.0,0.0239763,"Classroom diversity moderated matching such that teacher-child mismatch was related to lower engagement, motivation, social skills, math and reading scores in low-diversity classrooms, but not in high-diversity classrooms.","[{'ForeName': 'Damira S', 'Initials': 'DS', 'LastName': 'Rasheed', 'Affiliation': 'The Graduate Center at City University of New York.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Brown', 'Affiliation': 'Fordham University.'}, {'ForeName': 'Sebrina L', 'Initials': 'SL', 'LastName': 'Doyle', 'Affiliation': 'Pennsylvania State University.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Jennings', 'Affiliation': 'University of Virginia.'}]",Child development,['10.1111/cdev.13275']
1765,33682194,"A kindergarten-based, family-involved intervention to improve children's hand hygiene behavior: A cluster-randomized controlled trial.","OBJECTIVE


The present study determined the feasibility and initial efficacy of a kindergarten-based, family-involved intervention in improving children's hand hygiene (HH) behaviors.
DESIGN


A cluster-randomized controlled trial was performed, with a cluster defined as a kindergarten class.
SAMPLE


Participants were recruited from 20 classes in six kindergartens. A total of 289 children and their families were enrolled in the intervention group, and 293 children and their families were enrolled in the control group.
MEASUREMENTS


HH behavior and a related knowledge survey, as well as data on absences due to infection, were collected.
INTERVENTION


An 8-week training session on HH for children and an education program combining a seminar and WeChat groups for parents were provided to participants in the intervention group.
RESULTS


Two HH behaviors of children, namely, HH after playing outside and 7-stage HH compliance, were significantly different between the two groups after the intervention. The two HH behaviors and knowledge of infections of parents/legal guardians in the intervention group were better than those in the control group after the intervention. The number of absences due to infections in children was lower in the intervention group than in the control group.
CONCLUSIONS


Kindergarten-based, family-involved interventions effectively improved the HH behavior of kindergarten children and decreased absences due to infections.",2021,The two HH behaviors and knowledge of infections of parents/legal guardians in the intervention group were better than those in the control group after the intervention.,"[""children's hand hygiene (HH) behaviors"", 'Participants were recruited from 20 classes in six kindergartens', '289 children and their families were enrolled in the intervention group, and 293 children and their families were enrolled in the control group']","['kindergarten-based, family-involved intervention']","['HH behavior', 'HH behavior and a related knowledge survey', 'number of absences due to infections', 'HH behaviors and knowledge of infections of parents/legal guardians']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}]",289.0,0.0354442,The two HH behaviors and knowledge of infections of parents/legal guardians in the intervention group were better than those in the control group after the intervention.,"[{'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiuqun', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Pediatric Department, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jixiao', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': ""Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Yongshen', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'School of Nursing, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Abdominal and Pelvic Oncology Department, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Jielin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shiyin', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Research Management Department, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12882']
1766,33682192,Diarrhea in Tube-Fed Hospitalized Patients: Feeding Formula is Not the Most Common Cause.,"BACKGROUND


Clostridium difficile associated diarrhea (CDAD) and enteral nutrition (EN)-associated diarrhea are the most common recognized etiologies of nosocomial diarrhea. However, in clinical practice, the data regarding how each etiology contributes to the diarrheal episodes are limited. We identify the causes and factors associated with post-feeding diarrhea.
METHODS


Using the data of patients enrolled in 'Effect of Psyllium Fiber Supplementation on Diarrhea Incidence in Enteral Tube-Fed Patients: A Prospective, Randomized, and Controlled Trial' (RCT), the RCT showed no difference in diarrheal incidences between fiber-added and fiber-free formulas. Hence, we analyzed the data of all enrolled patients. The causes of diarrhea were classified according to pre-specified definitions. The factors associated with diarrhea were analyzed using logistic regression.
RESULTS


Diarrhea was found in 37.3% (n=31/83). The most common cause was medication-associated (61.3%). CDAD and EN-associated diarrhea were found in only 9.7% and 6.5%, respectively. Patients with baseline albumin <3 g/dL and underlying cerebrovascular disease were more likely to develop diarrhea (adjusted odds ratio [aOR] 5.70 [95%CI=1.79-20.51], and aOR 10.83 [95%CI=2.96-48.57], respectively). Compared with those without diarrhea, the length of hospital stay in CDAD patients was significantly longer (+23.1 days, p=0.02), a trend of longer hospital stay in patients with diarrhea from other causes was observed (+3.2 days, p=0.096).
CONCLUSIONS


Our study found that the most common cause of post-feeding diarrhea is medication-associated. Review and cessation of possible drugs should be undertaken before EN modification. CDAD accounts for <10% of diarrhea causes but it impacts the clinical outcome and should be identified and treated properly.",2021,"Compared with those without diarrhea, the length of hospital stay in CDAD patients was significantly longer (+23.1 days, p=0.02), a trend of longer hospital stay in patients with diarrhea from other causes was observed (+3.2 days, p=0.096).
","['Enteral Tube-Fed Patients', 'Tube-Fed Hospitalized Patients']","['Psyllium Fiber Supplementation', 'enteral nutrition ']","['Diarrhea', 'develop diarrhea', 'CDAD and EN-associated diarrhea', 'diarrheal incidences', 'Diarrhea Incidence', 'length of hospital stay', 'longer hospital stay', 'diarrhea']","[{'cui': 'C2945625', 'cui_str': 'Feeding tube'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033979', 'cui_str': 'Psyllium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0458672,"Compared with those without diarrhea, the length of hospital stay in CDAD patients was significantly longer (+23.1 days, p=0.02), a trend of longer hospital stay in patients with diarrhea from other causes was observed (+3.2 days, p=0.096).
","[{'ForeName': 'Pimsiri', 'Initials': 'P', 'LastName': 'Sripongpun', 'Affiliation': 'Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.'}, {'ForeName': 'Korn', 'Initials': 'K', 'LastName': 'Lertpipopmetha', 'Affiliation': 'Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.'}, {'ForeName': 'Naichaya', 'Initials': 'N', 'LastName': 'Chamroonkul', 'Affiliation': 'Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.'}, {'ForeName': 'Chanon', 'Initials': 'C', 'LastName': 'Kongkamol', 'Affiliation': 'Research Unit of Holistic Health and Safety Management in Community, Prince of Songkla University, Hat Yai, Thailand.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15484']
1767,33682156,Increasing physical activity with African-American women using Facebook™ and Pedometers.,"More than 80 percent of African American women struggle with overweight and obesity. We implemented a 5-week physical activity intervention using Facebook™ and pedometers with African American women. Twenty-seven African American women participated in a single-group pre/post design intervention to promote walking and physical activity. Participants were given access to a private Facebook™ group along with a free Omron Alvita pedometer. The five-week intervention challenged participants to increase weekly daily steps and the number of days they were physically active. At the end of the intervention, participants had significantly increased their weekly steps by 190% as compared to baseline (p = .005). Nearly, 80% of participants reported being active two or more days per week as compared to baseline (35.7%). Technologies such as social media and pedometers can assist in educating individuals and improving physical activity. These findings are relevant to public health nurses when implementing programs to increase physical activity for African American women.",2021,"At the end of the intervention, participants had significantly increased their weekly steps by 190% as compared to baseline (p = .005).","['with African American women', 'African-American women using Facebook™ and Pedometers', 'African American women', 'Twenty-seven African American women participated in a']","['private Facebook™ group along with a free Omron Alvita pedometer', 'physical activity intervention using Facebook™ and pedometers', 'single-group pre/post design intervention to promote walking and physical activity']",['physical activity'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319602', 'cui_str': '27'}]","[{'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0219975,"At the end of the intervention, participants had significantly increased their weekly steps by 190% as compared to baseline (p = .005).","[{'ForeName': 'Donna J', 'Initials': 'DJ', 'LastName': 'Biederman', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Valerie K', 'Initials': 'VK', 'LastName': 'Sabol', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Quiana', 'Initials': 'Q', 'LastName': 'Duncan', 'Affiliation': 'Albemarle Corporation, Charlotte, NC, USA.'}, {'ForeName': 'Katherine C', 'Initials': 'KC', 'LastName': 'Pereira', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12876']
1768,33682146,Efficacy of a multimodal nursing intervention strategy in the process of becoming a mother: A randomized controlled trial.,"The lack of knowledge and skills for transitioning to motherhood places first-time mothers at greater risk of depression and stress, may lower their perceived self-efficacy and satisfaction with the maternal role, and potentially affects the mother-infant bond. The purpose of this study was to test the efficacy of a multimodal nursing intervention (AMACOMPRI), based on Mercer's Becoming a Mother Theory, in supporting the process of becoming a mother in first-time mothers of term infants. This study was a parallel-group, double-blind, randomized, controlled trial with a 4-month postpartum follow-up. The outcome measures were the process of becoming a mother, functional social support, mother-infant bond, and perceived maternal self-efficacy. Sixty-six first-time mothers completed the study: 33 in the intervention group and 33 in the control group. The intervention was effective in supporting the process of becoming a mother, with a large effect size (Cohen's d = 1.50) and higher scores on the Becoming-a-Mother Scale in the intervention group compared with the control group (intergroup difference 13.04 points; 95% confidence interval: 8.72-17.34). Participants in the intervention group demonstrated higher scores in functional social support, perceived maternal self-efficacy, and mother-infant bond. This study provides evidence for the efficacy of an innovative nursing intervention that supports the process of becoming a mother. Further testing of the intervention is required in different settings and first-time mothers of low and high risk newborns.",2021,"The intervention was effective in supporting the process of becoming a mother, with a large effect size (Cohen's d = 1.50) and higher scores on the Becoming-a-Mother Scale in the intervention group compared with the control group (intergroup difference 13.04 points; 95% confidence interval: 8.72-17.34).",['Sixty-six first-time mothers completed the study: 33 in the intervention group and 33 in the control group'],"['innovative nursing intervention', 'multimodal nursing intervention strategy', 'multimodal nursing intervention (AMACOMPRI']","['process of becoming a mother, functional social support, mother-infant bond, and perceived maternal self-efficacy', 'higher scores in functional social support, perceived maternal self-efficacy, and mother-infant bond']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0532653,"The intervention was effective in supporting the process of becoming a mother, with a large effect size (Cohen's d = 1.50) and higher scores on the Becoming-a-Mother Scale in the intervention group compared with the control group (intergroup difference 13.04 points; 95% confidence interval: 8.72-17.34).","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Vargas-Porras', 'Affiliation': 'Department of Nursing, Advanced Nursing Research Group, Universitat Rovira i Virgili, Tarragona, Catalunya, Spain.'}, {'ForeName': 'Zayne M', 'Initials': 'ZM', 'LastName': 'Roa-Díaz', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hernán G', 'Initials': 'HG', 'LastName': 'Hernández-Hincapié', 'Affiliation': 'Division of Health Sciences, Universidad Santo Tomás, Bucaramanga, Santander, Colombia.'}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Ferré-Grau', 'Affiliation': 'Department of Nursing, Advanced Nursing Research Group, Universitat Rovira i Virgili, Tarragona, Catalunya, Spain.'}, {'ForeName': 'María I', 'Initials': 'MI', 'LastName': 'de Molina-Fernández', 'Affiliation': 'Department of Nursing, Advanced Nursing Research Group, Universitat Rovira i Virgili, Tarragona, Catalunya, Spain.'}]",Research in nursing & health,['10.1002/nur.22123']
1769,33681988,Matrix-free 3D culture supports human follicular development from the unilaminar to the antral stage in vitro yielding morphologically normal metaphase II oocytes.,"STUDY QUESTION


Can group culture with stage-specific anti-Müllerian hormone (AMH) modulation support human follicular development and oocyte maturation in vitro?
SUMMARY ANSWER


In the presence of FSH, AMH supplementation at the secondary-to-early antral stage followed by AMH depletion promotes the coordinated growth and function of human follicles during group culture, thereby yielding mature oocytes.
WHAT IS KNOWN ALREADY


Stage-specific AMH modulation promotes in-vitro development of nonhuman primate follicles. The group culture method supports nonhuman primate follicle growth from the primary to antral stage, producing developmentally competent oocytes.
STUDY DESIGN, SIZE, DURATION


Ovarian tissue samples were collected from 19 patients of reproductive age (22-47 years old having menstrual cycles) who underwent oophorectomy or hysterectomy for clinical purposes. Tissue pieces were cultured in a matrix-free system for 3 weeks followed by isolation of follicles for the subsequent 6-week individual or group culture.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Pieces of ovarian cortical tissue were cultured to support primordial follicle activation and early-stage follicle growth. Secondary follicles isolated from cultured tissue were then randomly assigned to two groups for individual culture: control and AMH modulation, i.e., recombinant human AMH protein supplementation during the secondary-to-early antral stage followed by the addition of neutralizing anti-human AMH antibody. Secondary follicles were also cultured in groups with the same AMH modulation. Follicle survival, growth, steroid hormone and paracrine factor production, steroidogenic protein expression, as well as oocyte maturation and morphology were assessed.
MAIN RESULTS AND THE ROLE OF CHANCE


Follicles grew to the secondary stage during 3 weeks of ovarian tissue culture. In-vitro-developed follicles expressed AMH and levels of secreted AMH increased (P < 0.05) in the culture media over time. Secondary follicles isolated from cultured ovarian tissue survived and grew to the antral stage during 6 weeks of individual follicle culture. In-vitro-developed antral follicles produced granulosa and theca cell-derived steroid hormones and paracrine factors, which were detectable in the culture media. Germinal vesicle oocytes obtained from cultured follicles exhibited a perinucleolar chromatin rim configuration. AMH modulation did not alter follicle survival or oocyte maturation relative to those of the control follicles. However, follicle diameters, as well as steroid hormone and paracrine factor production, increased (P < 0.05) in the AMH-modulation group compared with the control group. Secondary follicles isolated from cultured ovarian tissue formed aggregates and grew to the antral stage during 6 weeks of group culture. In-vitro-developed antral follicles expressed steroidogenic enzymes and secreted steroid hormones were detectable in the culture media. Oocytes obtained from cultured follicle aggregates with AMH-modulation progressed to the metaphase II stage after IVM, containing a normal-sized first polar body and meiotic spindle. Oocytes exhibited a typical ultrastructure.
LIMITATIONS, REASONS FOR CAUTION


Follicles were obtained from fresh ovarian tissue of adult patients. Oocyte maturation rates were relatively low and oocytes were assessed by morphological evaluation. Owing to the lack of a control group, the beneficial effects of AMH modulation remained undetermined for the group culture in this study.
WIDER IMPLICATIONS OF THE FINDINGS


Stage-specific AMH modulation supports human follicular development in the matrix-free group culture, which is consistent with previously reported AMH actions on growing follicles in nonhuman primates. Oocytes generated by in-vitro-developed follicles achieve meiotic maturation with a typical morphology and ultrastructure, which supports in-vitro follicle maturation as a potential approach for fertility preservation in women.
STUDY FUNDING/COMPETING INTEREST(S)


NICHD R01HD082208 and NIH Office of the Director P51OD011092. The authors have no competing interest to declare.
TRIAL REGISTRATION NUMBER


N/A.",2021,In-vitro-developed follicles expressed AMH and levels of secreted AMH increased (P < 0.05) in the culture media over time.,"['Secondary follicles isolated from cultured tissue', 'Ovarian tissue samples were collected from 19 patients of reproductive age (22-47\u2009years old having menstrual cycles) who underwent oophorectomy or hysterectomy for clinical purposes', 'Pieces of ovarian cortical tissue were cultured to support primordial follicle activation and early-stage follicle growth']","['stage-specific anti-Müllerian hormone (AMH', 'recombinant human AMH protein supplementation']","['follicles expressed AMH and levels of secreted AMH', 'follicle survival or oocyte maturation', 'steroid hormone and paracrine factor production', 'cultured ovarian tissue survived and grew to the antral stage', 'Oocyte maturation rates', 'cultured ovarian tissue formed aggregates and grew to the antral stage', 'Follicle survival, growth, steroid hormone and paracrine factor production, steroidogenic protein expression, as well as oocyte maturation and morphology']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0586787', 'cui_str': 'Tissue specimen from ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0029936', 'cui_str': 'Oophorectomy'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0682768', 'cui_str': 'Protein hormone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",,0.0414807,In-vitro-developed follicles expressed AMH and levels of secreted AMH increased (P < 0.05) in the culture media over time.,"[{'ForeName': 'Fuhua', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Maralee S', 'Initials': 'MS', 'LastName': 'Lawson', 'Affiliation': 'Division of Reproductive &\xa0Developmental Sciences, Oregon National Primate Research Center, Oregon Health &\xa0Science University, Beaverton, OR 97006, USA.'}, {'ForeName': 'Yukie', 'Initials': 'Y', 'LastName': 'Bean', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Alison Y', 'Initials': 'AY', 'LastName': 'Ting', 'Affiliation': 'Division of Reproductive &\xa0Developmental Sciences, Oregon National Primate Research Center, Oregon Health &\xa0Science University, Beaverton, OR 97006, USA.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Pejovic', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'De Geest', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Moffitt', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Shoukhrat M', 'Initials': 'SM', 'LastName': 'Mitalipov', 'Affiliation': 'Division of Reproductive &\xa0Developmental Sciences, Oregon National Primate Research Center, Oregon Health &\xa0Science University, Beaverton, OR 97006, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deab003']
1770,33681909,Comparing the effectiveness of the unified protocol in combination with an additional mindfulness treatment to the unified protocol alone as treatment for adolescents diagnosed with emotional disorders.,"OBJECTIVE


Many adolescents suffer from depressive and anxiety disorders simultaneously and current treatment methods do not put enough emphasis on comorbidity of these disorders. The unified protocol for treating emotional disorders in adolescents is a transdiagnostic therapy which targets mutual fundamental factors. Therefore, the current study aims to compare the effectiveness of the unified protocol alone with the unified protocol combined with mindfulness as an additional treatment in adolescents suffering from emotional disorders.
METHOD


A quasi-experimental study was conducted with adolescents. The participants had been diagnosed with emotional disorders and were divided into a control group (15 participants) and an experimental group (16 participants). Both groups were offered 14 sessions of therapy. They were assessed at pre-test, post-test, and two-month follow-up. Scales used in the study included the Child Behavior Checklist (CBCL), the Children's Depression Inventory (CDI), and the Youth Anxiety Measure for DSM-5 (YAM-5).
RESULTS


The results showed that both of the treatment methods effectively reduced adolescents' emotional problems, but improvements were more significant in the group administered the additional mindfulness program. Among the variables assessed, non-phobic anxiety disorders and depression improved more than specific phobia and behavioral problems. Between-subjects (Group) partial etas for non-phobic anxiety, depression, specific phobia, and behavioral problems were 0.67, 0.50, 0.23, and 0.16, respectively.
CONCLUSION


According to the findings of this study, additional treatment methods such as mindfulness could increase the effectiveness of the unified transdiagnostic protocol for adolescents (UP-A). The therapeutic implications are discussed.",2021,"The results showed that both of the treatment methods effectively reduced adolescents' emotional problems, but improvements were more significant in the group administered the additional mindfulness program.","['participants had been diagnosed with emotional disorders', 'adolescents suffering from emotional disorders', 'A quasi-experimental study was conducted with adolescents', 'adolescents diagnosed with emotional disorders']",[],"[""adolescents' emotional problems"", ""Child Behavior Checklist (CBCL), the Children's Depression Inventory (CDI), and the Youth Anxiety Measure for DSM-5"", 'specific phobia and behavioral problems', 'partial etas for non-phobic anxiety, depression, specific phobia, and behavioral problems']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0236801', 'cui_str': 'Simple phobia'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C1720127', 'cui_str': 'Eta'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}]",16.0,0.0225312,"The results showed that both of the treatment methods effectively reduced adolescents' emotional problems, but improvements were more significant in the group administered the additional mindfulness program.","[{'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': ""Department of Psychology, Faculty of Psychology and Education, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Khorramnia', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Foroughi', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Amiri', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Sasan', 'Initials': 'S', 'LastName': 'Amiri', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Trends in psychiatry and psychotherapy,['10.47626/2237-6089-2020-0046']
1771,33681908,The effects of cognitive-behavioral group therapy for reducing symptoms of internet addiction disorder and promoting quality of life and mental health.,"INTRODUCTION


Internet addiction disorder has reportedly become an important cause of health and social problems. The aim of this study was to investigate the effectiveness of cognitive-behavioral group therapy for internet addiction symptoms, quality of life, and mental health of students with internet addiction.
METHODS


This was a quasi-experimental study with pretest-posttest measures and a control group. The statistical population of the study consisted of all students at Tehran universities in the academic year of 2018-19. The target group was selected through an internet addiction test and a clinical interview using a targeted sampling method and was divided into experimental and control groups by randomization. The experimental group participated in fifteen 90-minute cognitive-behavioral group therapy sessions. Before, immediately after, and 3 months after the treatment, the internet addiction symptoms of both groups were evaluated to assess mental health with the IAT, quality of life (QOL), and SCL-90-R questionnaires. Data were analyzed with ANCOVA analysis using SPSS Statistics 20 software.
RESULTS


After treatment, cognitive-behavioral therapy groups showed reductions in internet addiction scores (p < 0.05). Results showed that the cognitive-behavioral group therapy was effective for improving quality of life (p < 0.05) and mental illnesses (p < 0.05) in students with internet addiction.
CONCLUSIONS


Cognitive-behavioral group therapy can enhance awareness and mental health of students with internet addiction. Therefore, this intervention can be used as a beneficial treatment to reduce internet addiction symptoms and improve the condition of people with behavioral addictions such as internet dependency.",2021,"Results showed that the cognitive-behavioral group therapy was effective for improving quality of life (p < 0.05) and mental illnesses (p < 0.05) in students with internet addiction.
","['all students at Tehran universities in the academic year of 2018-19', 'students with internet addiction']","['cognitive-behavioral group therapy sessions', 'cognitive-behavioral therapy', 'Cognitive-behavioral group therapy', 'cognitive-behavioral group therapy']","['quality of life', 'mental illnesses', 'internet addiction symptoms, quality of life, and mental health', 'mental health with the IAT, quality of life (QOL), and SCL-90-R questionnaires', 'internet addiction scores', 'symptoms of internet addiction disorder and promoting quality of life and mental health', 'internet addiction symptoms']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",,0.0227905,"Results showed that the cognitive-behavioral group therapy was effective for improving quality of life (p < 0.05) and mental illnesses (p < 0.05) in students with internet addiction.
","[{'ForeName': 'Seyyed Salman', 'Initials': 'SS', 'LastName': 'Alavi', 'Affiliation': 'Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghanizadeh', 'Affiliation': 'Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': 'Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Jannatifard', 'Affiliation': 'Ministry of Education, Iran.'}, {'ForeName': 'Sudeh', 'Initials': 'S', 'LastName': 'Esmaili Alamuti', 'Affiliation': ""Department of Psychology, Allame Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Farahani', 'Affiliation': 'Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Trends in psychiatry and psychotherapy,['10.47626/2237-6089-2020-0010']
1772,33681893,An open-label randomized clinical trial to evaluate the efficacy of everolimus versus tacrolimus in triple maintenance immunosuppressive therapy for kidney transplant patients.,"Tacrolimus (TAC), a calcineurin inhibitor, and everolimus (EVL), an mTOR inhibitor, have been used as immunosuppressive (ISS) drugs in post-kidney transplantation therapy. The objective of this study was to compare the efficacy of EVL vs TAC in the ISS maintenance triple therapy. Ninety-seven kidney transplant patients, who received triple maintenance therapy with TAC, mycophenolate mofetil (MMF), and methyl prednisone (PRED), were evaluated. After four months of post-kidney transplant therapy, 30 patients enrolled in a randomized controlled clinical trial, in which 16 patients received TAC+MMF+PRED (cohort 1), and 14 patients switched to EVL+MMF+PRED (cohort 2). The patients were followed-up for 36 months. Two patients from cohort 1 lost their grafts after one year due to non-adherence. Two patients from cohort 2 had intolerance to mTOR inhibitors and were switched back to TAC from EVL. One case (6.25%) in cohort 1 and three cases (21.43%) in cohort 2 of acute T-cell-mediated rejection was observed. Antibody-mediated acute rejection (ABMAR) was observed in four patients (25.0%) in cohort 1, and antibody-mediated chronic rejection (ABMCR) was observed in two patients (12.50%). One patient from cohort 2 lost the graft after 15 months due to polyomavirus infection. The graft survival rate was 87.50% in cohort 1 and 92.86% in cohort 2. This clinical trial showed that the EVL+MMF+PRED triple maintenance therapy was efficacious compared with TAC during 32 months of follow-up. However, further studies are needed to confirm the efficacy of this regimen for long-term graft survival.",2021,"Antibody-mediated acute rejection (ABMAR) was observed in four patients (25.0%) in cohort 1, and antibody-mediated chronic rejection (ABMCR) was observed in two patients (12.50%).","['Ninety-seven kidney transplant patients', 'kidney transplant patients', 'Two patients from cohort 2 had intolerance to mTOR inhibitors and were switched back to TAC from EVL']","['triple maintenance therapy with TAC, mycophenolate mofetil (MMF), and methyl prednisone (PRED', 'Tacrolimus (TAC), a calcineurin inhibitor, and everolimus (EVL', 'EVL vs TAC', 'TAC+MMF+PRED', 'everolimus versus tacrolimus', 'EVL+MMF+PRED', 'TAC', 'EVL+MMF+PRED triple maintenance therapy']","['Antibody-mediated acute rejection (ABMAR', 'chronic rejection (ABMCR', 'graft survival rate']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",97.0,0.0328661,"Antibody-mediated acute rejection (ABMAR) was observed in four patients (25.0%) in cohort 1, and antibody-mediated chronic rejection (ABMCR) was observed in two patients (12.50%).","[{'ForeName': 'B P S', 'Initials': 'BPS', 'LastName': 'Assis', 'Affiliation': 'Hospital Universitário da Faculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Lasmar', 'Affiliation': 'Hospital Universitário da Faculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Fabreti-Oliveira', 'Affiliation': 'Faculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Araujo', 'Affiliation': 'Instituto de Nefropatologia, Belo Horizonte, MG, Brasil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Faculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Wanderley', 'Affiliation': 'Instituto de Nefropatologia, Belo Horizonte, MG, Brasil.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nascimento', 'Affiliation': 'Faculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20209369']
1773,33681788,"Safety and acceptability of clozapine and risperidone in progressive multiple sclerosis: a phase I, randomised, blinded, placebo-controlled trial.","Objective


Because clozapine and risperidone have been shown to reduce neuroinflammation in humans and mice, the Clozapine and Risperidone in Progressive Multiple Sclerosis (CRISP) trial was conducted to determine whether clozapine and risperidone are suitable for progressive multiple sclerosis (pMS).
Methods


The CRISP trial (ACTRN12616000178448) was a blinded, randomised, placebo-controlled trial with three parallel arms (n=12/arm). Participants with pMS were randomised to clozapine (100-150 mg/day), risperidone (2.0-3.5 mg/day) or placebo for 6 months. The primary outcome measures were safety (adverse events (AEs)/serious adverse events (SAE)) and acceptability (Treatment Satisfaction Questionnaire for Medication-9).
Results


An interim analysis (n=9) revealed significant differences in the time-on-trial between treatment groups and placebo (p=0.030 and 0.025, clozapine and risperidone, respectively) with all participants receiving clozapine being withdrawn during the titration period (mean dose=35±15 mg/day). Participants receiving clozapine or risperidone reported a significantly higher rate of AEs than placebo (p=0.00001) but not SAEs. Specifically, low doses of clozapine appeared to cause an acute and dose-related intoxicant effect in patients with pMS who had fairly severe chronic spastic ataxic gait and worsening over all mobility, which resolved on drug cessation.
Interpretation


The CRISP trial results suggest that patients with pMS may experience increased sensitivity to clozapine and risperidone and indicate that the dose and/or titration schedule developed for schizophrenia may not be suitable for pMS. While these findings do not negate the potential of these drugs to reduce multiple sclerosis-associated neuroinflammation, they highlight the need for further research to understand the pharmacodynamic profile and effect of clozapine and risperidone in patients with pMS.
Trial registration number


ACTRN12616000178448.",2020,Participants receiving clozapine or risperidone reported a significantly higher rate of AEs than placebo (p=0.00001) but not SAEs.,"['patients with pMS who had fairly', 'progressive multiple sclerosis', 'patients with pMS', 'Participants with pMS']","['clozapine and risperidone', 'placebo', 'Clozapine and Risperidone', 'clozapine or risperidone', 'clozapine', 'risperidone']","['Safety and acceptability', 'severe chronic spastic ataxic gait and worsening over all mobility', 'rate of AEs', 'safety (adverse events (AEs)/serious adverse events (SAE)) and acceptability (Treatment Satisfaction Questionnaire for Medication-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}]","[{'cui': 'C0009079', 'cui_str': 'Clozapine'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0751837', 'cui_str': 'Ataxic gait'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.240772,Participants receiving clozapine or risperidone reported a significantly higher rate of AEs than placebo (p=0.00001) but not SAEs.,"[{'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'La Flamme', 'Affiliation': 'School of Biological Sciences, Victoria University of Wellington, Wellington, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Abernethy', 'Affiliation': 'Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Dalice', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'Biostatistical Consulting Group, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Goode', 'Affiliation': 'Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lockhart', 'Affiliation': 'Pharmaceuticol Ltd, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bourke', 'Affiliation': 'Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Milner', 'Affiliation': 'Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Toni-Marie', 'Initials': 'TM', 'LastName': 'Garrill', 'Affiliation': 'Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Purwa', 'Initials': 'P', 'LastName': 'Joshi', 'Affiliation': 'Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Eloise', 'Initials': 'E', 'LastName': 'Watson', 'Affiliation': 'Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Smyth', 'Affiliation': 'Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Lance', 'Affiliation': 'Hutt Valley District Health Board, Lower Hutt, New Zealand.'}, {'ForeName': 'Bronwen', 'Initials': 'B', 'LastName': 'Connor', 'Affiliation': 'Department of Pharmacology and Clinical Pharmacology, Centre for Brain Research, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",BMJ neurology open,['10.1136/bmjno-2020-000060']
1774,33681776,Effect of remote ischaemic preconditioning on walking in people with multiple sclerosis: double-blind randomised controlled trial.,"Background


Remote ischaemic preconditioning (RIPC) is the exposure of body parts to brief periods of circulatory occlusion and reperfusion. Recent studies have also shown that RIPC can improve exercise performance in healthy individuals.
Objective


This study aimed to assess the effect of RIPC on walking in people with multiple sclerosis (MS).
Methods


This was a double-blind randomised controlled clinical trial. We used three cycles of RIPC delivered by occluding the upper arm with a blood pressure (BP) cuff inflated to a pressure of 30 mm Hg above the systolic BP. In patients in the sham intervention group, the BP cuff was inflated only to 30 mm Hg below diastolic BP. Outcome measures included the Six-Minute Walk Test (6MWT), gait speed, the Borg rate of perceived exertion (RPE) scale, the tolerability of the RIPC using a Numerical Rating Scale for discomfort from 0 to 10, and adverse events. We identified responders meeting the minimal clinically important difference (MCID) established in the literature in each group.
Results


Seventy-five participants completed the study (RIPC: 38 and Sham: 37). The distance walked during the 6MWT improved by 1.9% in the sham group and 5.7% in the RIPC group (p=0.012). The number of responders meeting MCID criteria in the RIPC group was significantly greater compared with the sham intervention group. No serious adverse events occurred.
Conclusion


Single cycle of RIPC resulted in immediate improvement in walking distances during 6MWT in people with MS.
Trial registration numbers


NCT03153553.",2020,The distance walked during the 6MWT improved by 1.9% in the sham group and 5.7% in the RIPC group (p=0.012).,"['healthy individuals', 'Seventy-five participants completed the study (RIPC: 38 and Sham: 37', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'people with MS']","['\n\n\nRemote ischaemic preconditioning (RIPC', 'RIPC delivered by occluding the upper arm with a blood pressure (BP) cuff inflated to a pressure of 30\u2009mm Hg above the systolic BP', 'remote ischaemic preconditioning', 'RIPC']","['Six-Minute Walk Test (6MWT), gait speed, the Borg rate of perceived exertion (RPE) scale, the tolerability of the RIPC using a Numerical Rating Scale for discomfort from 0 to 10, and adverse events', 'walking distances', 'BP cuff', 'distance walked during the 6MWT', 'exercise performance', 'number of responders meeting MCID criteria']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449264', 'cui_str': 'Cuff inflated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0450396', 'cui_str': '30mm'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",75.0,0.558684,The distance walked during the 6MWT improved by 1.9% in the sham group and 5.7% in the RIPC group (p=0.012).,"[{'ForeName': 'Chayaporn', 'Initials': 'C', 'LastName': 'Chotiyarnwong', 'Affiliation': 'Rehabilitation Medicine, Mahidol University Faculty of Medicine Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Nair', 'Affiliation': 'Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Angelini', 'Affiliation': 'Department of Mechanical Engineering and INSIGNEO, The University of Sheffield, Sheffield, Sheffield, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Buckley', 'Affiliation': 'Department of Mechanical Engineering and INSIGNEO, The University of Sheffield, Sheffield, Sheffield, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': 'Department of Mechanical Engineering and INSIGNEO, The University of Sheffield, Sheffield, Sheffield, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Heyes', 'Affiliation': 'SiTRAN, The University of Sheffield, Sheffield, Sheffield, UK.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Ramiz', 'Affiliation': 'SiTRAN, The University of Sheffield, Sheffield, Sheffield, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Baster', 'Affiliation': 'Statistical Services Unit, The University of Sheffield, Sheffield, Sheffield, UK.'}, {'ForeName': 'Azza', 'Initials': 'A', 'LastName': 'Ismail', 'Affiliation': 'Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Joyutpal', 'Initials': 'J', 'LastName': 'Das', 'Affiliation': 'Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, Sheffield, UK.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lindert', 'Affiliation': 'Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Sharrack', 'Affiliation': 'Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Price', 'Affiliation': 'Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paling', 'Affiliation': 'Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}]",BMJ neurology open,['10.1136/bmjno-2019-000022']
1775,33681756,"Interchangeability, immunogenicity and safety of a combined 10-valent pneumococcal  Haemophilus influenzae  protein D conjugate vaccine (Synflorix) and 13-valent-PCV (Prevenar13) schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial.","Background


Aboriginal children living in remote communities are at high risk of early and persistent otitis media.  Streptococcus pneumoniae  and non-typeable  Haemophilus influenzae  (NTHi) are primary pathogens. Vaccines with potential to prevent early OM have not been evaluated in this population. We compared immunogenicity (ELISA and opsonophagocytic activity) of a combination of Synflorix™ (PHiD-CV10, 10 serotypes and protein D of NTHi) and Prevenar13™ (PCV13, 10 serotypes plus 3, 6A, and 19A), with recommended schedules.
Methods


This open-label superiority trial randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to PCV13 (P) at 2-4-6 months (_PPP), PHiD-CV10 (S) at 2-4-6 months (_SSS), or PHiD-CV10 at 1-2-4 plus PCV13 at -6 months (SSSP). Primary outcomes (blinded) were immunogenicity against PCV13-only serotypes 3, 6A, 19A, and PHiD-CV10-only protein D at 7 months. Secondary outcomes include immunogenicity against all serotypes at 2, 4 and 7 months.
Findings


Between 2011 and 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(1 4 1). An intention to treat approach including all available data was used. The SSSP group had superior immunogenicity against serotypes 3, 6A, and 19A compared to _SSS (OPA GMT ratios 8.1 to 59.5, p < 0.001), and against protein D compared to _PPP (GMC ratio 11.9 (95%CI 9.7 to 14.6)). Immune responses to protein D and 3, 6A, and 19A in SSSP were not significantly lower (i.e. no harm) than either _SSS or _PPP. For ten common serotypes responses at 2, 4 and 7 months were superior for SSSP (following 1-, 2-, and 4- doses) than _SSS and _PPP (following 0-, 1-, and 3- doses). At 4 months, _SSS was superior to _PPP. Reactogenicity and hospitalisations were rare and unrelated to the intervention.
Interpretation


From two months, the 1-2-4-6-month combined schedule (SSSP) was safe and significantly more immunogenic than 2-4-6-month schedules. The earlier responses may be beneficial in high-risk populations.",2021,"Immune responses to protein D and 3, 6A, and 19A in SSSP were not significantly lower (i.e. no harm) than either _SSS or _PPP.","['Findings\n\n\nBetween 2011 and 2017', '425 infants were allocated to _PPP(143), ']","['Streptococcus pneumoniae  and non-typeable  Haemophilus influenzae  (NTHi', 'Synflorix™ (PHiD-CV10, 10 serotypes and protein D of NTHi) and Prevenar13™ (PCV13, 10 serotypes plus 3, 6A, and 19A', 'combined 10-valent pneumococcal  Haemophilus influenzae  protein D conjugate vaccine (Synflorix) and 13-valent-PCV (Prevenar13', 'SSSP']","['immunogenicity (ELISA and opsonophagocytic activity', 'immunogenicity against all serotypes at 2, 4 and 7\xa0months', 'Reactogenicity and hospitalisations', 'Interchangeability, immunogenicity and safety', 'immunogenicity against PCV13-only serotypes 3, 6A, 19A, and PHiD-CV10-only protein D']","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}]","[{'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C3252923', 'cui_str': 'synflorix'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0450819', 'cui_str': 'CV10'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2756364', 'cui_str': 'Prevnar 13'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0138826', 'cui_str': 'glpQ protein, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]","[{'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0450819', 'cui_str': 'CV10'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",425.0,0.0984914,"Immune responses to protein D and 3, 6A, and 19A in SSSP were not significantly lower (i.e. no harm) than either _SSS or _PPP.","[{'ForeName': 'Amanda Jane', 'Initials': 'AJ', 'LastName': 'Leach', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.'}, {'ForeName': 'Edward Kim', 'Initials': 'EK', 'LastName': 'Mulholland', 'Affiliation': ""Murdoch Children's Research Institute, Department of Paediatrics, University of Melbourne, Australia.""}, {'ForeName': 'Mathuram', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Paul John', 'Initials': 'PJ', 'LastName': 'Torzillo', 'Affiliation': 'Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McIntyre', 'Affiliation': 'National Centre for Immunization Research and Surveillance, Sydney, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Smith-Vaughan', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Arrowsmith', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.'}, {'ForeName': 'Jemima', 'Initials': 'J', 'LastName': 'Beissbarth', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Oguoma', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Licciardi', 'Affiliation': ""Murdoch Children's Research Institute, Dept of Paediatrics, University of Melbourne, Melbourne, Australia.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Skull', 'Affiliation': ""Dept of Child Health Research, Perth Children's Hospital, University of Western Australia, Perth, Australia.""}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McDonnell', 'Affiliation': 'Consultant Statistician, 3291TR Strijen, Netherlands.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Krause', 'Affiliation': 'Centre for Disease Control, Northern Territory Department of Health, Darwin, Australia.'}, {'ForeName': 'Peter Stanley', 'Initials': 'PS', 'LastName': 'Morris', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.'}]",Vaccine: X,['10.1016/j.jvacx.2021.100086']
1776,33681747,Adjuvant melatonin for the prevention of recurrence and mortality following lung cancer resection (AMPLCaRe): A randomized placebo controlled clinical trial.,"Background


Despite curative intent resection in patients with non-small cell lung cancer (NSCLC), recurrence leading to mortality remains too common. Melatonin has shown promise for the treatment of patients with lung cancer; however, its effect following cancer resection has not been studied. We evaluated if melatonin taken after complete resection reduces lung cancer recurrence and mortality, or impacts quality of life (QOL), symptomatology or immune function.
Methods


Participants received melatonin (20 mg) or placebo nightly for one year following surgical resection of primary NSCLC. The primary outcome was two-year disease-free survival (DFS). Secondary outcomes included five-year DFS, adverse events, QOL, fatigue, sleep, depression, anxiety, pain, and biomarkers assessing for immune function/inflammation. This study is registered at https://clinicaltrials.gov NCT00668707.
Findings


709 patients across eight centres were randomized to melatonin ( n  = 356) versus placebo ( n  = 353). At two years, melatonin showed a relative risk of 1·01 (95% CI 0·83-1·22),  p  = 0·94 for DFS. At five years, melatonin showed a hazard ratio of 0·97 (95% CI 0·86-1·09),  p  = 0·84 for DFS. When stratified by cancer stage (I/II and III/IV), a hazard reduction of 25% (HR 0·75, 95% CI 0·61-0·92,  p  = 0·005) in five-year DFS was seen for participants in the treatment arm with advanced cancer (stage III/IV). No meaningful differences were seen in any other outcomes.
Interpretation


Adjuvant melatonin following resection of NSCLC does not affect DFS for patients with resected early stage NSCLC, yet may increase DFS in patients with late stage disease. Further study is needed to confirm this positive result. No beneficial effects were seen in QOL, symptoms, or immune function.
Funding


This study was funded by the Lotte and John Hecht Memorial Foundation and the Gateway for Cancer Research Foundation.",2021,"No beneficial effects were seen in QOL, symptoms, or immune function.
","['patients with late stage disease', 'patients with lung cancer', '709 patients across eight centres', 'lung cancer resection (AMPLCaRe', '0·005', 'patients with resected early stage NSCLC', 'patients with non-small cell lung cancer (NSCLC']","['placebo', 'melatonin', 'Adjuvant melatonin', 'melatonin (20\xa0mg) or placebo', '\n\n\nDespite curative intent resection', 'Melatonin']","['lung cancer recurrence and mortality, or impacts quality of life (QOL), symptomatology or immune function', 'year disease-free survival (DFS', 'five-year DFS, adverse events, QOL, fatigue, sleep, depression, anxiety, pain, and biomarkers assessing for immune function/inflammation', 'QOL, symptoms, or immune function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.663569,"No beneficial effects were seen in QOL, symptoms, or immune function.
","[{'ForeName': 'Dugald', 'Initials': 'D', 'LastName': 'Seely', 'Affiliation': 'Ottawa Integrative Cancer Centre, Otttawa, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Legacy', 'Affiliation': 'Ottawa Integrative Cancer Centre, Otttawa, Canada.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Auer', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fazekas', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Edita', 'Initials': 'E', 'LastName': 'Delic', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Anstee', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Angka', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kennedy', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Lee-Hwa', 'Initials': 'LH', 'LastName': 'Tai', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Tinghua', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Maziak', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Farid M', 'Initials': 'FM', 'LastName': 'Shamji', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'R Sudhir', 'Initials': 'RS', 'LastName': 'Sundaresan', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'P James', 'Initials': 'PJ', 'LastName': 'Villeneuve', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Ahmad S', 'Initials': 'AS', 'LastName': 'Ashrafi', 'Affiliation': 'Surrey Memorial Hospital/Fraser Health Authority, Surrey, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Inculet', 'Affiliation': 'London Health Sciences Centre, London, Canada.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yasufuku', 'Affiliation': 'University Health Network, Toronto, Canada.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Waddell', 'Affiliation': 'University Health Network, Toronto, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Finley', 'Affiliation': ""St. Joseph's Healthcare & McMaster University, Hamilton, Canada.""}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Shargall', 'Affiliation': ""St. Joseph's Healthcare & McMaster University, Hamilton, Canada.""}, {'ForeName': 'Madelaine', 'Initials': 'M', 'LastName': 'Plourde', 'Affiliation': 'QEII Health Sciences Centre/Capital Health, Halifax, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Andrew J E', 'Initials': 'AJE', 'LastName': 'Seely', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}]",EClinicalMedicine,['10.1016/j.eclinm.2021.100763']
1777,33681732,Impact and acceptability of HIV self-testing for trans men and trans women: A mixed-methods subgroup analysis of the SELPHI randomised controlled trial and process evaluation in England and Wales.,"Background


Globally, trans people are disproportionately affected by HIV, but research on strategies to increase testing are limited. SELPHI is a randomised-controlled-trial (RCT) of 10,135  cis  men, trans men, and trans women reporting lifetime anal intercourse with male partners ( cis  or trans), evaluating whether the offer of free HIV self-testing (HIVST) increases diagnosis. This subgroup analysis from the SELPHI RCT aims to describe key HIVST outcomes and HIVST acceptability for trans people.
Methods


SELPHI recruited using social networking and trans focused social media. Participants were randomised 60/40 to baseline HIVST (Biosure™) (BT) vs no baseline HIVST (nBT); and at 3-months (if completed the survey and reported recent CAI) 50/50 to 3-monthly HIVST (RT) vs no repeat HIVST (nRT). Outcomes were self-reported through online surveys. We conducted a qualitative study of semi-structured peer-led participant interviews ( n  = 20) exploring HIVST motivations and experiences. These were analysed using a framework approach.
Findings


SELPHI recruited and randomised 118 trans men and trans women (94 trans men, 24 trans women), of whom 20 (16 trans men, 4 trans women) underwent the second randomisation. Median age at baseline was 29 (IQR: 22, 37), 79% were white, 79% were UK born, 37% had degree level education, and 31% had never tested for HIV. 62% ( n  = 59) of trans men completed the 3-month survey, but survey completion by trans women in nBT was too low (1/11) for randomised comparison. In trans men HIV testing uptake by 3 months was significantly higher in BT (95% 36/38) vs nBT (29%, 6/21) (RR=3.32 (1.68, 6.55)  p <0.001). Trans people randomised to RT reported 3 times higher rate of HIV testing compared to nRT during the two-year follow-up (IRR 3.66 (1.86, 8.01)  p <0.0001). STI testing frequency (mean number of tests during each 13 week period/ 2-year follow-up) was not significantly different across interventions: RT (0.03) and nRT (0.01) (IRR=1.86 95%CI; 0.77, 5.15;  p  = 0.15). Social harms were rare. Acceptability was very high in BT: 97% (38/39) found instructions easy to understand, 97% (37/38) found the HIVST simple to use and 100% (39/39) reported good overall experience. In interviews, reported HIVST benefits included increased autonomy, privacy, convenience and avoidance of health care providers perceived to be discriminatory and services that increased dysphoria. Minor lancet and test processing issues were reported.
Interpretation


HIVST significantly increased testing uptake and frequency in trans men and trans people overall, although recruitment and retention of trans women was low. HIVST acceptability was high and indicates easy access to this novel technology may increase HIV testing access for this key population.",2021,"Trans people randomised to RT reported 3 times higher rate of HIV testing compared to nRT during the two-year follow-up (IRR 3.66 (1.86, 8.01)  p <0.0001).","['men, trans men, and trans women reporting lifetime anal intercourse with male partners ( cis  or trans', 'Median age at baseline was 29 (IQR: 22, 37), 79% were white, 79% were UK born, 37% had degree level education, and 31% had never tested for HIV', '118 trans men and trans women (94 trans men, 24 trans women), of whom 20 (16 trans men, 4 trans women', '10,135', 'trans men and trans women']","['baseline HIVST (Biosure™) (BT) vs no baseline HIVST (nBT', 'HIVST (RT) vs no repeat HIVST (nRT', 'semi-structured peer-led participant interviews ( n \xa0=\xa020) exploring HIVST motivations and experiences', 'SELPHI', 'HIV self-testing']","['autonomy, privacy, convenience and avoidance of health care providers', 'Acceptability', 'rate of HIV testing', 'dysphoria', 'HIVST acceptability']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0233477', 'cui_str': 'Dysphoric mood'}]",,0.326949,"Trans people randomised to RT reported 3 times higher rate of HIV testing compared to nRT during the two-year follow-up (IRR 3.66 (1.86, 8.01)  p <0.0001).","[{'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Witzel', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, United Kingdom.'}, {'ForeName': 'Talen', 'Initials': 'T', 'LastName': 'Wright', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, United Kingdom.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'McCabe', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, London WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Gabriel', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, London WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Aedan', 'Initials': 'A', 'LastName': 'Wolton', 'Affiliation': '56T, Chelsea and Westminster NHS Hospital Foundation Trust, 56 Dean Street, London W1D 4PR, United Kingdom.'}, {'ForeName': 'Mitzy', 'Initials': 'M', 'LastName': 'Gafos', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, London WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Lampe', 'Affiliation': 'Institute for Global Health, University College London, Royal Free Hospital, Rowland Hill Street, London NW3 2PF, United Kingdom.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, Royal Free Hospital, Rowland Hill Street, London NW3 2PF, United Kingdom.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Trevelion', 'Affiliation': 'HIV i-base, 107 The Maltings, 169 Tower Bridge Road, London SE1 3LJ, United Kingdom.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Collaco-Moraes', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, London WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Harbottle', 'Affiliation': 'SH:24, 35a Westminster Bridge Road, South Bank, London SE1 7JB, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Speakman', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, United Kingdom.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Dunn', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, London WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'McCormack', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, London WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Burns', 'Affiliation': 'Institute for Global Health, University College London, Royal Free Hospital, Rowland Hill Street, London NW3 2PF, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Weatherburn', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, United Kingdom.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, Royal Free Hospital, Rowland Hill Street, London NW3 2PF, United Kingdom.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100700']
1778,33681731,Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial.,"Background


Treatment options for outpatients with COVID-19 could reduce morbidity and prevent SARS-CoV-2 transmission.
Methods


In this randomized, double-blind, three-arm (1:1:1) placebo-equivalent controlled trial conducted remotely throughout the United States, adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited. Participants were randomly assigned to receive hydroxychloroquine (HCQ) (400 mg BID x1day, followed by 200 mg BID x9days) with or without azithromycin (AZ) (500 mg, then 250 mg daily x4days) or placebo-equivalent (ascorbic acid (HCQ) and folic acid (AZ)), stratified by risk for progression to severe COVID-19 (high-risk vs. low-risk). Self-collected nasal swabs for SARS-CoV-2 PCR, FLUPro symptom surveys, EKGs and vital signs were collected daily. Primary endpoints were: (a) 14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution (ClinicalTrials.gov: NCT04354428). Due to the low rate of clinical outcomes, the study was terminated for operational futility.
Findings


Between 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset. Among 129 high-risk participants, incident LRTI occurred in six (4.7%) participants (two control, four HCQ/AZ) and COVID-19 related hospitalization in seven (5.4%) (four control, one HCQ, two HCQ/AZ); no LRTI and two (2%) hospitalizations occurred in the 102 low-risk participants (one HCQ, one HCQ/AZ). There were no deaths. Among 152 participants with viral shedding at enrollment, median time to clearance was 5 days (95% CI=4-6) in HCQ, 6 days (95% CI=4-8) in HCQ/AZ, and 8 days (95% CI=6-10) in control. Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60,  p  = 0.047) but not HCQ/AZ (HR=1.25,  p  = 0.39) compared to control. Among 197 participants who met the COVID-19 definition at enrollment, time to symptom resolution did not differ by group (HCQ: HR=1.02, 95% CI-0.63-1.64,  p  = 0.95, HCQ/AZ: HR=0.91, 95% CI=0.57-1.45,  p  = 0.70).
Interpretation


Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection.
Funding


The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator. University of Washington Institute of Translational Health Science (ITHS) grant support (UL1 TR002319), KL2 TR002317, and TL1 TR002318 from NCATS/NIH funded REDCap. The content is solely the responsibility of the authors and does not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. PAN and MJA were supported by the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program. Trial registration  ClinicalTrials.gov number NCT04354428.",2021,"Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60,  ","['early SARS-CoV-2 infection among high-risk outpatient adults', '197 participants who met the COVID-19 definition at enrollment', 'adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited', '152 participants with viral shedding at enrollment', 'Findings\n\n\nBetween 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset']","['placebo-equivalent (ascorbic acid (HCQ) and folic acid (AZ', 'placebo', 'HCQ and HCQ/AZ', 'HCQ/AZ', 'Hydroxychloroquine with or without azithromycin', 'azithromycin (AZ', 'hydroxychloroquine (HCQ']","['14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution', 'median time to clearance', 'hospitalizations', 'incident LRTI', 'time to symptom resolution', 'Viral clearance']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439511', 'cui_str': 'times/day'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",231.0,0.474124,"Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60,  ","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Johnston', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics, University of Washington, United States.'}, {'ForeName': 'Jenell', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Helen C Stankiewicz', 'Initials': 'HCS', 'LastName': 'Karita', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Kissinger', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dwyer', 'Affiliation': 'School of Medicine, Tulane University, New Orleans, LA, United States.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.'}, {'ForeName': 'Temitope', 'Initials': 'T', 'LastName': 'Oyedele', 'Affiliation': 'John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Boston University School of Medicine, Boston, MA, United States.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Paolino', 'Affiliation': 'State University of New York Upstate Medical University, Syracuse, NY, United States.'}, {'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Heller', 'Affiliation': 'Department of Global Health, University of Washington, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Leingang', 'Affiliation': 'Department of Global Health, University of Washington, United States.'}, {'ForeName': 'Harald S', 'Initials': 'HS', 'LastName': 'Haugen', 'Affiliation': 'Department of Global Health, University of Washington, United States.'}, {'ForeName': 'Tracy Q', 'Initials': 'TQ', 'LastName': 'Dong', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bershteyn', 'Affiliation': 'New York University Grossman School of Medicine, NY, NY, United States.'}, {'ForeName': 'Arun R', 'Initials': 'AR', 'LastName': 'Sridhar', 'Affiliation': 'Division of Cardiology, University of Washington, United States.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Poole', 'Affiliation': 'Division of Cardiology, University of Washington, United States.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ackerman', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morrison', 'Affiliation': 'Department of Global Health, University of Washington, United States.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Greninger', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Washington, United States.'}, {'ForeName': 'Meei-Li', 'Initials': 'ML', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Jerome', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Washington, United States.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wener', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Washington, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Schiffer', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EClinicalMedicine,['10.1016/j.eclinm.2021.100773']
1779,33681652,Efficacy and safety of adjunctive perampanel in patients with focal seizures or generalized tonic-clonic seizures: Post hoc analysis of Phase II and Phase III double-blind and open-label extension studies in India.,"Objective


This post hoc analysis assessed the efficacy and safety of adjunctive perampanel in patients (aged ≥ 12 years) with focal seizures (FS), with/without focal to bilateral tonic-clonic seizures (FBTCS), or generalized tonic-clonic seizures (GTCS) in India.
Methods


Centers in India were identified from six double-blind, randomized, Phase II and Phase III studies of adjunctive perampanel (2-12 mg/day) and their open-label extensions (OLEx). Efficacy assessments included median percent change in seizure frequency per 28 days, 50% and 75% responder and seizure-freedom rates. Treatment-emergent adverse events (TEAEs) were monitored.
Results


Overall, 128 patients (placebo, n = 39; perampanel, n = 89) were included in the double-blind Safety Analysis Set and 126 (FS, n = 113 [placebo, n = 32; perampanel, n = 81]; FBTCS, n = 35 [placebo, n = 14; perampanel, n = 21]; GTCS, n = 13 [placebo, n = 6; perampanel, n = 7]) comprised the Full Analysis Set. Median percent reductions in seizure frequency per 28 days for placebo vs perampanel for Indian patients were as follows: 34.8% vs 49.8% (FS; not significant [NS]) and 43.1% vs 60.5% (FBTCS; NS) at 4-12 mg/day, respectively, and -22.4% vs 8.2% (GTCS; NS) at 8 mg/day, respectively. Fifty-percent responder rates were 37.5% vs 55.1% (FS; NS), 42.9% vs 60.0% (FBTCS; NS), and 16.7% vs 42.9% (GTCS; NS), respectively; seizure-freedom rates were 0.0% vs 5.8%, 7.1% vs 10.0%, and 0.0% vs 14.3%, respectively (all NS). Overall, 110 patients entered OLEx studies (FS, n = 99; GTCS, n = 11). Perampanel was efficacious for up to four years for FS and FBTCS and two years for GTCS. Across double-blind and OLEx studies, TEAEs occurred in 58.4% and 83.6% of Indian perampanel-treated patients, respectively; dizziness was most common. Efficacy and safety outcomes were generally similar overall between Indian and non-Indian patients.
Significance


These data suggest adjunctive perampanel (up to 12 mg/day) may be a suitable anti-seizure medication for patients (aged ≥ 12 years) with FS, with/without FBTCS, or GTCS in India.",2021,Perampanel was efficacious for up to four years for FS and FBTCS and two years for GTCS.,"['128 patients (placebo, n\xa0=\xa039; perampanel, n\xa0=\xa089', 'patients with focal seizures or generalized tonic-clonic seizures', 'patients (aged\xa0≥\xa012\xa0years) with FS, with/without FBTCS, or GTCS in India', 'patients (aged\xa0≥\xa012\xa0years) with focal seizures (FS), with/without focal to bilateral tonic-clonic seizures (FBTCS), or generalized tonic-clonic seizures (GTCS) in India']","['Perampanel', 'placebo, n\xa0=\xa032; perampanel, n\xa0=\xa081]; FBTCS, n\xa0=\xa035 [placebo, n\xa0=\xa014; perampanel, n\xa0=\xa021]; GTCS, n\xa0=\xa013 [placebo, n\xa0=\xa06; perampanel, n\xa0=\xa07]) comprised the Full Analysis Set', 'adjunctive perampanel', 'placebo']","['seizure-freedom rates', 'dizziness', 'responder rates', 'Efficacy and safety', 'efficacy and safety', 'Efficacy and safety outcomes', 'seizure frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}]",89.0,0.613827,Perampanel was efficacious for up to four years for FS and FBTCS and two years for GTCS.,"[{'ForeName': 'Man M', 'Initials': 'MM', 'LastName': 'Mehndiratta', 'Affiliation': 'Janakpuri Super Specialty Hospital Society Janakpuri New Delhi India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Gulhane', 'Affiliation': 'Curie Manavata Cancer Centre Nashik India.'}, {'ForeName': 'Shaik A', 'Initials': 'SA', 'LastName': 'Jabeen', 'Affiliation': 'Nizam Institute of Medical Science Hyderabad India.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd. Hatfield, Hertfordshire UK.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Dash', 'Affiliation': 'Eisai Singapore Pte., Ltd. Singapore.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc. Woodcliff Lake NJ USA.'}]",Epilepsia open,['10.1002/epi4.12448']
1780,33681596,"Fiber-Reinforced-Phospholipid Vehicle-Based Delivery of l-Ascorbic Acid: Development, Characterization, ADMET Profiling, and Efficacy by a Randomized, Single-Dose, Crossover Oral Bioavailability Study.","l-ascorbic acid (AA) or vitamin C is a crucial nutrient needed for optimal health. However, being unable to be synthesized by the body, it is thus necessary to be included in health care products. Moreover, AA is one of the antioxidants that occur naturally, which is used in pharmaceutical and food products as an antioxidant additive. However, AA is vulnerable to environmental settings and undergoes oxidative degradation to dehydroascorbic acid and further to inactive products. Therefore, new research strategies and approaches are required to augment its stability. The objective of this study is to develop and characterize a fiber-reinforced-phospholipid (FRP) matrix-based vehicle, Zeal-AA, for the delivery of AA and optimize the oral bioavailability of the obtained AA powder using an efficacy study by open-label, randomized, single-dose, two-treatment, two-sequence, two-period, two-way crossover. The structural and surface morphologies were analyzed by Fourier transform infrared spectroscopy, transmission electron microscopy, scanning electron microscopy, and differential scanning calorimetry studies. Encapsulation efficiency, mean particle size, size distribution, ζ-potential measurements, and ADMET profiling revealed the potential delivery system for AA. AUC 0- t  was found to be 55.23 (mg/dL) for Zeal-AA, whereas it was 9.38 (mg/dL) for AA, and  C   max  was found to be 6.69 (mg/dL) for Zeal-AA, whereas it was 1.23 (mg/dL) for AA, with a fold difference of bioavailability in terms of AUC found to be 5.9 fold. The results show that a single oral dose of Zeal-AA is capable of rising the AA levels in the body relative to the control up to 24 h.",2021,"Encapsulation efficiency, mean particle size, size distribution, ζ-potential measurements, and ADMET profiling revealed the potential delivery system for AA.",[],"['l-ascorbic acid (AA) or vitamin C', 'fiber-reinforced-phospholipid (FRP) matrix-based vehicle, Zeal-AA', 'Fiber-Reinforced-Phospholipid Vehicle-Based Delivery of l-Ascorbic Acid', 'AUC']","['Encapsulation efficiency, mean particle size, size distribution, ζ-potential measurements, and ADMET profiling revealed the potential delivery system for AA']",[],"[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]",,0.0269957,"Encapsulation efficiency, mean particle size, size distribution, ζ-potential measurements, and ADMET profiling revealed the potential delivery system for AA.","[{'ForeName': 'Joby', 'Initials': 'J', 'LastName': 'Jacob', 'Affiliation': 'R&D Centre, Aurea Biolabs (P) Ltd., Kolenchery, 682311 Kerala, India.'}, {'ForeName': 'Nimisha Pulikkal', 'Initials': 'NP', 'LastName': 'Sukumaran', 'Affiliation': 'R&D Centre, Aurea Biolabs (P) Ltd., Kolenchery, 682311 Kerala, India.'}, {'ForeName': 'Shintu', 'Initials': 'S', 'LastName': 'Jude', 'Affiliation': 'R&D Centre, Aurea Biolabs (P) Ltd., Kolenchery, 682311 Kerala, India.'}]",ACS omega,['10.1021/acsomega.0c05963']
1781,33427749,SARS-CoV-2-specific CD8+ T cell responses in convalescent COVID-19 individuals.,"Characterization of the T cell response in individuals who recover from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is critical to understanding its contribution to protective immunity. A multiplexed peptide-MHC tetramer approach was used to screen 408 SARS-CoV-2 candidate epitopes for CD8+ T cell recognition in a cross-sectional sample of 30 coronavirus disease 2019 convalescent individuals. T cells were evaluated using a 28-marker phenotypic panel, and findings were modelled against time from diagnosis and from humoral and inflammatory responses. There were 132 SARS-CoV-2-specific CD8+ T cell responses detected across 6 different HLAs, corresponding to 52 unique epitope reactivities. CD8+ T cell responses were detected in almost all convalescent individuals and were directed against several structural and nonstructural target epitopes from the entire SARS-CoV-2 proteome. A unique phenotype for SARS-CoV-2-specific T cells was observed that was distinct from other common virus-specific T cells detected in the same cross-sectional sample and characterized by early differentiation kinetics. Modelling demonstrated a coordinated and dynamic immune response characterized by a decrease in inflammation, increase in neutralizing antibody titer, and differentiation of a specific CD8+ T cell response. Overall, T cells exhibited distinct differentiation into stem cell and transitional memory states (subsets), which may be key to developing durable protection.",2021,"There were 132 SARS-CoV-2-specific CD8+ T cell responses detected across 6 different HLAs, corresponding to 52 unique epitope reactivities.","['convalescent COVID-19 individuals', 'individuals who recover from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection', '30 coronavirus disease 2019 convalescent individuals']",[],"['SARS-CoV-2-specific CD8+ T cell responses', '132 SARS-CoV-2-specific CD8+ T cell responses', 'neutralizing antibody titer, and differentiation of a specific CD8+ T cell response', 'CD8+ T cell responses']","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}]",,0.0443324,"There were 132 SARS-CoV-2-specific CD8+ T cell responses detected across 6 different HLAs, corresponding to 52 unique epitope reactivities.","[{'ForeName': 'Hassen', 'Initials': 'H', 'LastName': 'Kared', 'Affiliation': 'ImmunoScape, Singapore, Singapore.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Redd', 'Affiliation': 'Division of Intramural Research, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Tania S', 'Initials': 'TS', 'LastName': 'Bonny', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Hermi', 'Initials': 'H', 'LastName': 'Sumatoh', 'Affiliation': 'ImmunoScape, Singapore, Singapore.'}, {'ForeName': 'Faris', 'Initials': 'F', 'LastName': 'Kairi', 'Affiliation': 'ImmunoScape, Singapore, Singapore.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Carbajo', 'Affiliation': 'ImmunoScape, Singapore, Singapore.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Abel', 'Affiliation': 'ImmunoScape, Singapore, Singapore.'}, {'ForeName': 'Evan W', 'Initials': 'EW', 'LastName': 'Newell', 'Affiliation': 'ImmunoScape, Singapore, Singapore.'}, {'ForeName': 'Maria P', 'Initials': 'MP', 'LastName': 'Bettinotti', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Benner', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Eshan U', 'Initials': 'EU', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Littlefield', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': 'Division of Intramural Research, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Shoham', 'Affiliation': 'Department of Medicine and.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sullivan', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Casadevall', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pekosz', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Nardin', 'Affiliation': 'ImmunoScape, Singapore, Singapore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fehlings', 'Affiliation': 'ImmunoScape, Singapore, Singapore.'}, {'ForeName': 'Aaron Ar', 'Initials': 'AA', 'LastName': 'Tobian', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Quinn', 'Affiliation': 'Division of Intramural Research, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA.'}]",The Journal of clinical investigation,['10.1172/JCI145476']
1782,33154545,Infant expectations of instant or delayed gratification.,"Choices between immediate gratification and long-term (but larger) gains are prevalent in human life, which is why the decision-making processes to delay gratification have been studied extensively throughout different developmental ages. Children's delay-of-gratification behaviors have been examined in the well-known ""marshmallow test,"" in which 3- to 5-year-olds are given a marshmallow and told by an experimenter that they can eat it immediately or wait for an unspecified duration of time (which can be capped at 15 min) until the experimenter returns so that they can receive another marshmallow. Children's wait time has been viewed as a good indicator of their later development. Here we show that a group of 22-month-old infants (N = 32) already held expectations about others' choices in a violation-of-expectation looking-time task modeled after the marshmallow test. The infants expected an agent to defer gratification based on a speaker's promise of the second marshmallow available in the future, but to eat the currently attainable marshmallow when the speaker made no such promise. Our findings indicate an early-emerging understanding of others' choices of delayed or instant gratification and shed new light on the development of delay-of-gratification behaviors.",2020,"Children's delay-of-gratification behaviors have been examined in the well-known ""marshmallow test,"" in which 3- to 5-year-olds are given a marshmallow and told by an experimenter that they can eat it immediately or wait for an unspecified duration of time (which can be capped at 15 min) until the experimenter returns so that they can receive another marshmallow.",[],[],"[""Children's delay-of-gratification behaviors""]",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870398', 'cui_str': 'Deferred Gratification'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0247727,"Children's delay-of-gratification behaviors have been examined in the well-known ""marshmallow test,"" in which 3- to 5-year-olds are given a marshmallow and told by an experimenter that they can eat it immediately or wait for an unspecified duration of time (which can be capped at 15 min) until the experimenter returns so that they can receive another marshmallow.","[{'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, USA. luoy@missouri.edu.'}, {'ForeName': 'Duangporn', 'Initials': 'D', 'LastName': 'Pattanakul', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, USA.'}]",Scientific reports,['10.1038/s41598-020-76136-9']
1783,33154071,NAA is a Marker of Disability in Secondary-Progressive MS: A Proton MR Spectroscopic Imaging Study.,"BACKGROUND AND PURPOSE


The secondary progressive phase of multiple sclerosis is characterised by disability progression due to processes that lead to neurodegeneration. Surrogate markers such as those derived from MRI are beneficial in understanding the pathophysiology that drives disease progression and its relationship to clinical disability. We undertook a 1H-MRS imaging study in a large secondary progressive MS (SPMS) cohort, to examine whether metabolic markers of brain injury are associated with measures of disability, both physical and cognitive.
MATERIALS AND METHODS


A cross-sectional analysis of individuals with secondary-progressive MS was performed in 119 participants. They underwent  1 H-MR spectroscopy to obtain estimated concentrations and ratios to total Cr for total NAA, mIns, Glx, and total Cho in normal-appearing WM and GM. Clinical outcome measures chosen were the following: Paced Auditory Serial Addition Test, Symbol Digit Modalities Test, Nine-Hole Peg Test, Timed 25-foot Walk Test, and the Expanded Disability Status Scale. The relationship between these neurometabolites and clinical disability measures was initially examined using Spearman rank correlations. Significant associations were then further analyzed in multiple regression models adjusting for age, sex, disease duration, T2 lesion load, normalized brain volume, and occurrence of relapses in 2 years preceding study entry.
RESULTS


Significant associations, which were then confirmed by multiple linear regression, were found in normal-appearing WM for total NAA (tNAA)/total Cr (tCr) and the Nine-Hole Peg Test (ρ = 0.23; 95% CI, 0.06-0.40); tNAA and tNAA/tCr and the Paced Auditory Serial Addition Test (ρ = 0.21; 95% CI, 0.03-0.38) (ρ = 0.19; 95% CI, 0.01-0.36); mIns/tCr and the Paced Auditory Serial Addition Test, (ρ = -0.23; 95% CI, -0.39 to -0.05); and in GM for tCho and the Paced Auditory Serial Addition Test (ρ = -0.24; 95% CI, -0.40 to -0.06). No other GM or normal-appearing WM relationships were found with any metabolite, with associations found during initial correlation testing losing significance after multiple linear regression analysis.
CONCLUSIONS


This study suggests that metabolic markers of neuroaxonal integrity and astrogliosis in normal-appearing WM and membrane turnover in GM may act as markers of disability in secondary-progressive MS.",2020,"tNAA and tNAA/tCr and the Paced Auditory Serial Addition Test (ρ = 0.21; 95% CI, 0.03-0.38) (ρ = 0.19; 95% CI, 0.01-0.36); mIns/tCr and the Paced Auditory Serial Addition Test, (ρ = -0.23; 95% CI, -0.39 to -0.05); and in GM for tCho and the Paced Auditory Serial Addition Test (ρ = -0.24",['individuals with secondary-progressive MS was performed in 119 participants'],['NAA'],"['normal-appearing WM for total NAA (tNAA)/total Cr (tCr', 'Paced Auditory Serial Addition Test, Symbol Digit Modalities Test, Nine-Hole Peg Test, Timed 25-foot Walk Test, and the Expanded Disability Status Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}]",119.0,0.0357391,"tNAA and tNAA/tCr and the Paced Auditory Serial Addition Test (ρ = 0.21; 95% CI, 0.03-0.38) (ρ = 0.19; 95% CI, 0.01-0.36); mIns/tCr and the Paced Auditory Serial Addition Test, (ρ = -0.23; 95% CI, -0.39 to -0.05); and in GM for tCho and the Paced Auditory Serial Addition Test (ρ = -0.24","[{'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Solanky', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'John', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology nevin.john@ucl.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'DeAngelis', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stutters', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Prados', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schneider', 'Affiliation': 'Philips UK (T.S.), Guildford, Surrey, UK.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Edinburgh Clinical Trials Unit (R.A.P., C.J.W.), Usher Institute.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit (R.A.P., C.J.W.), Usher Institute.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Monteverdi', 'Affiliation': 'Department of Brain and Behavioural Sciences (A.M., C.A.M.G.W.-K.), University of Pavia, Pavia, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Plantone', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'MacManus', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Marshall', 'Affiliation': 'Centre for Clinical Brain Sciences (I.M.), University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Centre for Medical Image Computing (F.P., F.B.), Department of Medical Physics and Biomedical Engineering, University College London, London, UK.'}, {'ForeName': 'C A M', 'Initials': 'CAM', 'LastName': 'Gandini Wheeler-Kingshott', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'From the Department of Neuroinflammation (B.S.S., N.A.J., F.D., J.S., F.P., D.P., A.D., D.M., C.A.M.G.W.-K., J.C.), Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6809']
1784,33144594,Nonverbal leadership emergence in walking groups.,"The mechanisms underlying the emergence of leadership in multi-agent systems are under investigation in many areas of research where group coordination is involved. Nonverbal leadership has been mostly investigated in the case of animal groups, and only a few works address the problem in human ensembles, e.g. pedestrian walking, group dance. In this paper we study the emergence of leadership in the specific scenario of a small walking group. Our aim is to propose a rigorous mathematical methodology capable of unveiling the mechanisms of leadership emergence in a human group when leader or follower roles are not designated a priori. Two groups of participants were asked to walk together and turn or change speed at self-selected times. Data were analysed using time-dependent cross correlation to infer leader-follower interactions between each pair of group members. The results indicate that leadership emergence is due both to contextual factors, such as an individual's position in the group, and to personal factors, such as an individual's characteristic locomotor behaviour. Our approach can easily be extended to larger groups and other scenarios such as team sports and emergency evacuations.",2020,"The results indicate that leadership emergence is due both to contextual factors, such as an individual's position in the group, and to personal factors, such as an individual's characteristic locomotor behaviour.",[],['Nonverbal leadership'],['Nonverbal leadership emergence'],[],"[{'cui': 'C0023181', 'cui_str': 'Leadership'}]","[{'cui': 'C0023181', 'cui_str': 'Leadership'}]",,0.0169345,"The results indicate that leadership emergence is due both to contextual factors, such as an individual's position in the group, and to personal factors, such as an individual's characteristic locomotor behaviour.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lombardi', 'Affiliation': 'Department of Engineering Mathematics, University of Bristol, Bristol, UK.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Warren', 'Affiliation': 'Department of Cognitive,Linguistic and Psychological Sciences, Brown University, Providence, RI, 02912, USA. bill_warren@brown.edu.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'di Bernardo', 'Affiliation': 'Department of Engineering Mathematics, University of Bristol, Bristol, UK. mario.dibernardo@unina.it.'}]",Scientific reports,['10.1038/s41598-020-75551-2']
1785,33483132,Phenylephrine impairs host defence mechanisms to infection: a combined laboratory study in mice and translational human study.,"BACKGROUND


Immunosuppression after surgery is associated with postoperative complications, mediated in part by catecholamines that exert anti-inflammatory effects via the β-adrenergic receptor. Phenylephrine, generally regarded as a selective α-adrenergic agonist, is frequently used to treat perioperative hypotension. However, phenylephrine may impair host defence through β-adrenergic affinity.
METHODS


Human leukocytes were stimulated with lipopolysaccharide (LPS) in the presence or absence of phenylephrine and α- and β-adrenergic antagonists. C57BL/6J male mice received continuous infusion of phenylephrine (30-50 μg kg -1  min -1  i.v.) or saline via micro-osmotic pumps, before LPS administration (5 mg kg -1  i.v.) or caecal ligation and puncture (CLP). Twenty healthy males were randomised to a 5 h infusion of phenylephrine (0.5 μg kg -1  min -1 ) or saline before receiving LPS (2 ng kg -1  i.v.).
RESULTS


In vitro, phenylephrine enhanced LPS-induced production of the anti-inflammatory cytokine interleukin (IL)-10 (maximum augmentation of 93%) while attenuating the release of pro-inflammatory mediators. These effects were reversed by pre-incubation with β-antagonists, but not α-antagonists. Plasma IL-10 levels were higher in LPS-challenged mice infused with phenylephrine, whereas pro-inflammatory mediators were reduced. Phenylephrine infusion increased bacterial counts after CLP in peritoneal fluid (+42%, P=0.0069), spleen (+59%, P=0.04), and liver (+35%, P=0.09). In healthy volunteers, phenylephrine enhanced the LPS-induced IL-10 response (+76%, P=0.0008) while attenuating plasma concentrations of pro-inflammatory mediators including IL-8 (-15%, P=0.03).
CONCLUSIONS


Phenylephrine exerts potent anti-inflammatory effects, possibly involving the β-adrenoreceptor. Phenylephrine promotes bacterial outgrowth after surgical peritonitis. Phenylephrine may therefore compromise host defence in surgical patients and increase susceptibility towards infection.
CLINICAL TRIAL REGISTRATION


NCT02675868 (Clinicaltrials.gov).",2021,"Phenylephrine infusion increased bacterial counts after CLP in peritoneal fluid (+42%, P=0.0069), spleen (+59%, P=0.04), and liver (+35%, P=0.09).","['Human leukocytes', 'healthy volunteers', 'C57BL/6J male mice received', 'Twenty healthy males']","['continuous infusion of phenylephrine', 'saline before receiving LPS', 'Phenylephrine', 'phenylephrine', 'caecal ligation and puncture (CLP', 'lipopolysaccharide (LPS', 'phenylephrine and α- and β-adrenergic antagonists', 'saline via micro-osmotic pumps, before LPS administration']","['Plasma IL-10 levels', 'LPS-induced IL-10 response', 'plasma concentrations of pro-inflammatory mediators including IL-8', 'bacterial counts']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}]","[{'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0242889', 'cui_str': 'Substance with adrenergic receptor antagonist mechanism of action'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0029391', 'cui_str': 'Osmosis'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",20.0,0.365589,"Phenylephrine infusion increased bacterial counts after CLP in peritoneal fluid (+42%, P=0.0069), spleen (+59%, P=0.04), and liver (+35%, P=0.09).","[{'ForeName': 'Roeland F', 'Initials': 'RF', 'LastName': 'Stolk', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Intensive Care Medicine, Hospital Rijnstate, Arnhem, The Netherlands.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Naumann', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'van der Pasch', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Schouwstra', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Bressers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Antonius E', 'Initials': 'AE', 'LastName': 'van Herwaarden', 'Affiliation': 'Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Gerretsen', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Schambergen', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ruth', 'Affiliation': 'Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Henk J', 'Initials': 'HJ', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Intensive Care Medicine, Hospital Rijnstate, Arnhem, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: matthijs.kox@radboudumc.nl.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.11.040']
1786,33646265,Highly functional virus-specific cellular immune response in asymptomatic SARS-CoV-2 infection.,"The efficacy of virus-specific T cells in clearing pathogens involves a fine balance between antiviral and inflammatory features. SARS-CoV-2-specific T cells in individuals who clear SARS-CoV-2 without symptoms could reveal nonpathological yet protective characteristics. We longitudinally studied SARS-CoV-2-specific T cells in a cohort of asymptomatic (n = 85) and symptomatic (n = 75) COVID-19 patients after seroconversion. We quantified T cells reactive to structural proteins (M, NP, and Spike) using ELISpot and cytokine secretion in whole blood. Frequencies of SARS-CoV-2-specific T cells were similar between asymptomatic and symptomatic individuals, but the former showed an increased IFN-γ and IL-2 production. This was associated with a proportional secretion of IL-10 and proinflammatory cytokines (IL-6, TNF-α, and IL-1β) only in asymptomatic infection, while a disproportionate secretion of inflammatory cytokines was triggered by SARS-CoV-2-specific T cell activation in symptomatic individuals. Thus, asymptomatic SARS-CoV-2-infected individuals are not characterized by weak antiviral immunity; on the contrary, they mount a highly functional virus-specific cellular immune response.",2021,"Frequencies of SARS-CoV-2-specific T cells were similar between asymptomatic and symptomatic individuals, but the former showed an increased IFN-γ and IL-2 production.","['cohort of asymptomatic (n = 85) and symptomatic (n = 75) COVID-19 patients after seroconversion', 'asymptomatic SARS-CoV-2 infection']",[],"['T cells reactive to structural proteins (M, NP, and Spike) using ELISpot and cytokine secretion', 'IFN-γ and IL-2 production', 'Frequencies of SARS-CoV-2-specific T cells', 'proportional secretion of IL-10 and proinflammatory cytokines (IL-6, TNF-α, and IL-1β']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",[],"[{'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0582263', 'cui_str': 'Structural protein'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",85.0,0.101607,"Frequencies of SARS-CoV-2-specific T cells were similar between asymptomatic and symptomatic individuals, but the former showed an increased IFN-γ and IL-2 production.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Le Bert', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Clapham', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': 'Tan', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wan Ni', 'Initials': 'WN', 'LastName': 'Chia', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Christine Y L', 'Initials': 'CYL', 'LastName': 'Tham', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Lim', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Kamini', 'Initials': 'K', 'LastName': 'Kunasegaran', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Linda Wei Lin', 'Initials': 'LWL', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Charles-Antoine', 'Initials': 'CA', 'LastName': 'Dutertre', 'Affiliation': 'Inserm U1015, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Shankar', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Joey M E', 'Initials': 'JME', 'LastName': 'Lim', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Louisa Jin', 'Initials': 'LJ', 'LastName': 'Sun', 'Affiliation': 'Infectious Diseases, Alexandra Hospital, National University Health System, Singapore.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Zahari', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Zaw Myo', 'Initials': 'ZM', 'LastName': 'Tun', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Vishakha', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Beng Lee', 'Initials': 'BL', 'LastName': 'Lim', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Siew Hoon', 'Initials': 'SH', 'LastName': 'Lim', 'Affiliation': 'Department of Microbiology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Chia', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Yee-Joo', 'Initials': 'YJ', 'LastName': 'Tan', 'Affiliation': 'Infectious Diseases Translational Programme, Department of Microbiology and Immunology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Paul Anantharajah', 'Initials': 'PA', 'LastName': 'Tambyah', 'Affiliation': 'Infectious Disease, Department of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Kalimuddin', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lye', 'Affiliation': 'Infectious Diseases Translational Programme, Department of Microbiology and Immunology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Jenny G H', 'Initials': 'JGH', 'LastName': 'Low', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Lin-Fa', 'Initials': 'LF', 'LastName': 'Wang', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wei Yee', 'Initials': 'WY', 'LastName': 'Wan', 'Affiliation': 'Department of Microbiology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Li Yang', 'Initials': 'LY', 'LastName': 'Hsu', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bertoletti', 'Affiliation': 'Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Clarence C', 'Initials': 'CC', 'LastName': 'Tam', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}]",The Journal of experimental medicine,['10.1084/jem.20202617']
1787,33687101,Latent class mediator for multiple indicators of mediation.,"This paper demonstrates the utility of latent classes in evaluating the effect of an intervention on an outcome through multiple indicators of mediation. These indicators are observed intermediate variables that identify an underlying latent class mediator, with each class representing a different mediating pathway. The use of a latent class mediator allows us to avoid modeling the complex interactions between the multiple indicators and ensures the decomposition of the total mediating effects into additive effects from individual mediating pathways, a desirable feature for evaluating multiple indicators of mediation. This method is suitable when the goal is to estimate the total mediating effects that can be decomposed into the additive effects of distinct mediating pathways. Each indicator may be involved in multiple mediation pathways and at the same time multiple indicators may contribute to a single mediating pathway. The relative importance of each pathway may vary across subjects. We applied this method to the analysis of the first 6 months of data from a 2-year clustered randomized trial for adults in their first episode of schizophrenia. Four indicators of mediation are considered: individual resiliency training; family psychoeducation; supported education and employment; and a structural assessment for medication. The improvement in symptoms was found to be mediated by the latent class mediator derived from these four service indicators. Simulation studies were conducted to assess the performance of the proposed model and showed that the simultaneous estimation through the maximum likelihood yielded little bias when the entropy of the indicators was high.",2021,Simulation studies were conducted to assess the performance of the proposed model and showed that the simultaneous estimation through the maximum likelihood yielded little bias when the entropy of the indicators was high.,['adults in their first episode of schizophrenia'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",[],[],,0.0264249,Simulation studies were conducted to assess the performance of the proposed model and showed that the simultaneous estimation through the maximum likelihood yielded little bias when the entropy of the indicators was high.,"[{'ForeName': 'Kyaw', 'Initials': 'K', 'LastName': 'Sint', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rosenheck', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Haiqun', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'School of Nursing and School of Public Health, Rutgers Biomedical and Health Sciences, Rutgers University, the State University of New Jersey, Newark, NJ, USA.'}]",Statistics in medicine,['10.1002/sim.8929']
1788,33687052,The Addition of Tissue Stromal Vascular Fraction To Platelet-Rich Plasma Supplemented Lipofilling Does Not Improve Facial Skin Quality: A Prospective Randomized Clinical Trial.,"BACKGROUND


Lipofilling has become popular as a treatment to improve aging related skin characteristics (eg, wrinkles, pigmentation spots, pores, or rosacea). Different additives such as platelet-rich plasma (PRP) or stromal vascular fraction (SVF) have been added to lipofilling to increase the therapeutic effect of adipose derived stromal cells (ASCs).
OBJECTIVES


In this study, we hypothesized that mechanical isolated SVF augments the therapeutic effect of PRP supplemented lipofilling to improve facial skin quality.
METHODS


This prospective, double-blinded, placebo-controlled, randomized trial was conducted between 2016 and 2019. In total, 28 female subjects were enrolled with 25 completing the follow-up. All patients received PRP supplemented lipofilling with either mechanical isolated SVF or saline. SVF was isolated by means of the fractionation of adipose tissue (FAT) procedure (tissue-SVF). Results were evaluated by changes in skin elasticity and transepidermal water loss, changes in skin aging related features, ie, superficial spots, wrinkles, skin texture, pores, vascularity, and pigmentation as well as patient satisfaction (FACE-Q), recovery, and number of complications up to 1 year postoperative.
RESULTS


The addition of tSVF to PRP supplemented lipofilling did not improve skin elasticity, transepidermal water loss nor skin aging related features. No improvement in patient satisfaction with overall facial appearance nor facial skin quality was seen when tSVF was added to PRP supplemented lipofilling.
CONCLUSIONS


PRP supplemented lipofilling with tSVF compared to PRP supplemented lipofilling alone does not improve facial skin quality nor patient satisfaction in a healthy population. PRP supplemented lipofilling with tSVF can be considered a safe procedure.",2021,"The addition of tSVF to PRP supplemented lipofilling did not improve skin elasticity, transepidermal water loss nor skin aging related features.","['28 female subjects were enrolled with 25 completing the follow-up', '2016 and 2019']","['PRP supplemented lipofilling with tSVF', 'PRP supplemented lipofilling with either mechanical isolated SVF or saline', 'placebo']","['skin elasticity and transepidermal water loss, changes in skin aging related features, ie, superficial spots, wrinkles, skin texture, pores, vascularity, and pigmentation as well as patient satisfaction (FACE-Q), recovery, and number of complications', 'facial skin quality nor patient satisfaction', 'Facial Skin', 'skin elasticity, transepidermal water loss nor skin aging related features', 'Quality', 'patient satisfaction with overall facial appearance nor facial skin quality', 'facial skin quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0423761', 'cui_str': 'Skin elasticity'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037271', 'cui_str': 'Skin aging'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0282631', 'cui_str': 'Facial appearance'}]",28.0,0.0668732,"The addition of tSVF to PRP supplemented lipofilling did not improve skin elasticity, transepidermal water loss nor skin aging related features.","[{'ForeName': 'Joris A', 'Initials': 'JA', 'LastName': 'van Dongen', 'Affiliation': 'University Medical Center Utrecht, the Netherlands.'}, {'ForeName': 'Joeri V', 'Initials': 'JV', 'LastName': 'Boxtel', 'Affiliation': 'Catharina Hospital Eindhoven, the Netherlands.'}, {'ForeName': 'Joep C', 'Initials': 'JC', 'LastName': 'Willemsen', 'Affiliation': 'Albert Schweitzer Hospital Dordrecht, the Netherlands.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Pathology and Medical Biology, University of Groningen and University Medical Center of Groningen, the Netherlands.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Epidemiology, University of Groningen and University Medical Center of Groningen, the Netherlands.'}, {'ForeName': 'Aartje Jorien', 'Initials': 'AJ', 'LastName': 'Tuin', 'Affiliation': 'Department of Maxillofacial Surgery, University of Groningen and University Medical Center of Groningen, the Netherlands.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Harmsen', 'Affiliation': 'Department of Pathology and Medical Biology, University of Groningen and University Medical Center of Groningen, the Netherlands.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'van der Lei', 'Affiliation': 'Department of Plastic Surgery, University of Groningen and University Medical Center, the Netherlands.'}, {'ForeName': 'Hieronymus P', 'Initials': 'HP', 'LastName': 'Stevens', 'Affiliation': 'Plastic surgeon in private practice in Rotterdam, the Netherlands.'}]",Aesthetic surgery journal,['10.1093/asj/sjab109']
1789,33687025,Terbinafine Hydrochloride Combined With Itraconazole for Fungal Skin Diseases: A Randomized Controlled Trial.,"BACKGROUND


Terbinafine and itraconazole are the common antifungal drugs in clinic. In vitro experiments proved that terbinafine combined with itraconazole achieves better antifungal effects. However, clinical study addressing this issue was still scarce.
STUDY QUESTION


Terbinafine combined with itraconazole achieves better therapeutic effects in fungal skin diseases.
STUDY DESIGN


Approximately 178 patients with fungal skin diseases from Meizhou People's Hospital, China, between October 2016 and October 2017 were admitted to this study. Patients were randomly distributed to 3 groups by randomly selecting random numbers and were treated with terbinafine, itraconazole, monotherapy, or combined therapy. Both patients and study investigators were unaware of grouping situations during experiments. Fifteen patients were excluded due to poor compliance, and 11 patients were excluded due to incomplete data. Finally, 152 patients were analyzed for this study.
MEASURES AND OUTCOMES


The therapeutic effects were evaluated by clinic symptom scores, mycology examination, the cure rate, and the cure time. Adverse events, relapse of disease, and patient's satisfaction level were recorded during follow-up.
RESULTS


In the terbinafine + itraconazole group, at 14 days after treatment, the symptom scores were significantly decreased, compared with the terbinafine or itraconazole group (P1 < 0.05, P2 < 0.05). At 28 days after treatment, the fungal infection of 37 patients was eradicated, which were significantly more than 26 patients in the terbinafine group and 19 patients in the itraconazole group (P1 < 0.05, P2 < 0.05). The terbinafine + itraconazole group also exhibited 100% cure rate of patients with fungal skin diseases, shorter cure time, and increased number of cured patients during the same treatment period, which was better than terbinafine or itraconazole monotherapy (P1 < 0.05, P2 < 0.05). In addition, no adverse events and no relapse of fungal disease were reported in the terbinafine + itraconazole group during follow-up. Ninety-eight percent patients were satisfied with the therapeutic effects of combined treatment.
CONCLUSIONS


Compared with terbinafine or itraconazole monotherapy, terbinafine + itraconazole combined treatment achieves better therapeutic effects in fungal skin diseases.",2021,"The terbinafine + itraconazole group also exhibited 100% cure rate of patients with fungal skin diseases, shorter cure time, and increased number of cured patients during the same treatment period, which was better than terbinafine or itraconazole monotherapy (P1 < 0.05, P2 < 0.05).","['fungal skin diseases', ""Approximately 178 patients with fungal skin diseases from Meizhou People's Hospital, China, between October 2016 and October 2017 were admitted to this study"", '152 patients were analyzed for this study', 'Fungal Skin Diseases', 'Fifteen patients were excluded due to poor compliance, and 11 patients were excluded due to incomplete data']","['Terbinafine and itraconazole', 'itraconazole monotherapy', 'itraconazole', 'terbinafine + itraconazole', 'Terbinafine', 'Terbinafine Hydrochloride Combined With Itraconazole', 'itraconazole monotherapy, terbinafine + itraconazole', 'terbinafine', 'terbinafine, itraconazole, monotherapy, or combined therapy']","['antifungal effects', ""Adverse events, relapse of disease, and patient's satisfaction level"", 'symptom scores', 'clinic symptom scores, mycology examination, the cure rate, and the cure time', 'cure rate of patients with fungal skin diseases, shorter cure time', 'fungal infection', 'adverse events and no relapse of fungal disease']","[{'cui': 'C0011630', 'cui_str': 'Dermal mycosis'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}]","[{'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0771029', 'cui_str': 'Terbinafine hydrochloride'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026932', 'cui_str': 'Mycology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011630', 'cui_str': 'Dermal mycosis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}]",15.0,0.0180099,"The terbinafine + itraconazole group also exhibited 100% cure rate of patients with fungal skin diseases, shorter cure time, and increased number of cured patients during the same treatment period, which was better than terbinafine or itraconazole monotherapy (P1 < 0.05, P2 < 0.05).","[{'ForeName': 'Dongxing', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatological, Meizhou People's Hospital, Meizhou, Guangdong Province, China.""}, {'ForeName': 'Wanqing', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Department of Dermatological, Shanghai Changzheng Hospital, Huangpu District, Shanghai, China; and.'}, {'ForeName': 'Canhua', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Clinical Laboratory, Meizhou People's Hospital, MeizhouGuangdong Province, China.""}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Lai', 'Affiliation': ""Department of Dermatological, Meizhou People's Hospital, Meizhou, Guangdong Province, China.""}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Dermatological, Meizhou People's Hospital, Meizhou, Guangdong Province, China.""}]",American journal of therapeutics,['10.1097/MJT.0000000000001075']
1790,33686879,Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.,"The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm;  p sup  < 0.01). Binary restenosis occurred in 23% vs 52% of patients ( p  = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%;  p  = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%;  p  = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%;  p  = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality.  ClinicalTrials.gov Identifier: NCT02145065 .",2021,The difference in mortality was nonsignificant (7.4 vs 14.3%;  p  = 0.42).,"['occlusive femoropopliteal lesions', '66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease', 'femoropopliteal artery disease']","['Routine angiography', 'Microcrystalline paclitaxel-coated balloon', 'mcPCB', 'novel microcrystalline paclitaxel-coated balloon (mcPCB', 'POBA (plain old balloon angioplasty) (control group']","['prevalence of SAE', 'LLL', 'serious adverse events (SAE: death, amputation, repeated revascularization', 'mortality', 'Binary restenosis', 'target vessel revascularization rate', 'Late lumen loss (LLL']","[{'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}, {'cui': 'C0003838', 'cui_str': 'Arterial occlusive disease'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}]",66.0,0.071875,The difference in mortality was nonsignificant (7.4 vs 14.3%;  p  = 0.42).,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Nowakowski', 'Affiliation': 'Lesser Poland Cardiovascular Center of American Heart of Poland, Chrzanów, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Uchto', 'Affiliation': 'Lesser Poland Cardiovascular Center of American Heart of Poland, Chrzanów, Poland.'}, {'ForeName': 'Eugeniusz', 'Initials': 'E', 'LastName': 'Hrycek', 'Affiliation': 'Lesser Poland Cardiovascular Center of American Heart of Poland, Chrzanów, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Kachel', 'Affiliation': 'Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Ludyga', 'Affiliation': 'EuroMedic Cardiovascular Center, Katowice, Poland.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Polczyk', 'Affiliation': 'EuroMedic Cardiovascular Center, Katowice, Poland.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Żurakowski', 'Affiliation': 'Lesser Poland Cardiovascular Center of American Heart of Poland, Chrzanów, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Kaźmierczak', 'Affiliation': 'Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Granada', 'Affiliation': 'Skirbal Center for Innovation, Cardiovascular Research Foundation, Orangeburg, NY, USA.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Nowakowska', 'Affiliation': 'Department of Balneoclimatology and Biological Regeneration, Chair of Physiotherapy, School of Health Sciences, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Radosław S', 'Initials': 'RS', 'LastName': 'Kiesz', 'Affiliation': 'Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.'}, {'ForeName': 'Krzysztof P', 'Initials': 'KP', 'LastName': 'Milewski', 'Affiliation': 'Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.'}, {'ForeName': 'Paweł E', 'Initials': 'PE', 'LastName': 'Buszman', 'Affiliation': 'Department of Epidemiology, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Piotr P', 'Initials': 'PP', 'LastName': 'Buszman', 'Affiliation': 'Andrzej Frycz-Modrzewski, Kraków University, Kraków, Poland.'}]","Vascular medicine (London, England)",['10.1177/1358863X20988360']
1791,33686771,The effect of post-extraction socket preservation laser treatment on bone density 4 months after extraction: Randomized controlled trial.,"BACKGROUND


Post-extraction bone resorption may affect the outcome of ensuing restorations.
PURPOSE


This study aimed to evaluate a comprehensive laser post-extraction protocol by comparing resulting alveolar bone regeneration with that obtained after standard extraction procedure.
MATERIALS AND METHODS


About 53 simple extractions were randomized to either laser or control group. In the laser group, erbium (Er:YAG; 2940 nm) and neodymium (Nd:YAG; 1064 nm) lasers were used for degranulation, disinfection, de-epithelialization of the surrounding gingiva, clot stabilization, and photobiomodulation. The primary outcome measure was change in bone density in the extraction area between day 1 and 4 months after extraction. Patients were monitored for potential side effects.
RESULTS


Increase in bone density at the follow-up CBCT was significantly higher in laser than in control group (p < 0.001). No post-operative pain, bleeding, or swelling was present in the laser group. In the control group, one patient had bleeding 3-5 days after extraction, two patients had swelling and three patients reported post-operative pain rated 3-5 on a 0-10 pain scale up to 3 days after extraction.
CONCLUSIONS


The proposed laser post-extraction procedure is a safe and effective method to improve post-extraction bone healing.",2021,"RESULTS


Increase in bone density at the follow-up CBCT was significantly higher in laser than in control group (p < 0.001).",['About 53 simple extractions'],"['laser or control group', 'laser group, erbium (Er:YAG; 2940\u2009nm) and neodymium (Nd:YAG; 1064\u2009nm) lasers', 'comprehensive laser post-extraction protocol', 'post-extraction socket preservation laser treatment']","['change in bone density in the extraction area', 'operative pain, bleeding, or swelling', 'alveolar bone regeneration', 'bone density']","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}]",,0.0873276,"RESULTS


Increase in bone density at the follow-up CBCT was significantly higher in laser than in control group (p < 0.001).","[{'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Križaj Dumić', 'Affiliation': 'KRIŽAJ d.o.o, Ljubljana, Slovenia.'}, {'ForeName': 'Franja', 'Initials': 'F', 'LastName': 'Pajk', 'Affiliation': 'LA&HA - Laser and Health Academy, Ljubljana, Slovenia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Olivi', 'Affiliation': 'Università Cattolica del Sacro Cuore di Roma, Rome, Italy.'}]",Clinical implant dentistry and related research,['10.1111/cid.12991']
1792,33686753,"Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2- advanced breast cancer: MONARCH 2 & 3 trials.","This post-hoc analysis of MONARCH 2 and MONARCH 3 assesses the efficacy, safety, and pharmacokinetics (PK) of abemaciclib in combination with endocrine therapy (ET) in East Asian patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. MONARCH 2 and MONARCH 3 are global, randomized, double-blind, phase 3 studies of abemaciclib/placebo + fulvestrant and abemaciclib/placebo + nonsteroidal aromatase inhibitor (NSAI, anastrozole or letrozole), respectively. The East Asian population comprised 212 (31.7%) of the 669 intent-to-treat (ITT) population in the MONARCH 2 trial and 144 (29.2%) of the 493 ITT patients in the MONARCH 3 trial. In the East Asian population, median progression-free survival (PFS) was significantly prolonged in the abemaciclib arm compared with placebo in both MONARCH 2 (HR, 0.520; 95% CI, 0.362 to 0.747; p<0.001; median: 21.2 vs. 11.6 months) and MONARCH 3 (0.326; 95% CI, 0.200 to 0.531, p<0.001; median: not reached vs. 12.82 months). Diarrhea (MONARCH 2: 90%; MONARCH 3: 88%) and neutropenia (MONARCH 2: 68%; MONARCH 3: 58%) were the most frequent adverse events observed in the East Asian populations. Abemaciclib exposures and PK were similar in East Asians and the non-East Asian populations of both trials. Abemaciclib in combination with ET in the East Asian populations of MONARCH 2 and MONARCH 3 provided consistent results with the ITT populations, demonstrating improvements in efficacy with generally tolerable safety profiles for patients with HR+, HER2- advanced breast cancer.",2021,Abemaciclib exposures and PK were similar in East Asians and the non-East Asian populations of both trials.,"['East Asian patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer', 'The East Asian population comprised 212 (31.7%) of the 669 intent-to-treat (ITT) population in the MONARCH 2 trial and 144 (29.2%) of the 493 ITT patients in the MONARCH 3 trial', 'patients with HR+, HER2- advanced breast cancer', 'East Asian patients with HR+, HER2- advanced breast cancer']","['endocrine therapy (ET', 'placebo + fulvestrant and abemaciclib/placebo + nonsteroidal aromatase inhibitor (NSAI, anastrozole or letrozole', 'Abemaciclib in combination with endocrine therapy', 'placebo']","['Diarrhea', 'median progression-free survival (PFS', 'efficacy, safety, and pharmacokinetics (PK', 'neutropenia']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",,0.130491,Abemaciclib exposures and PK were similar in East Asians and the non-East Asian populations of both trials.,"[{'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Breast Cancer Unit, Kyoto University Hospital, Graduate School of Medicine, Kyoto University.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Division of Breast Oncology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In', 'Initials': 'I', 'LastName': 'Hae Park', 'Affiliation': 'Division of Hematology and Medical Oncology, Department of Internal Medicine, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, 03080, Korea.'}, {'ForeName': 'Shin-Cheh', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University Medical College Taoyuan, Taiwan.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Enatsu', 'Affiliation': 'Eli Lilly and Company, Tokyo, Japan.'}, {'ForeName': 'P Kellie', 'Initials': 'PK', 'LastName': 'Turner', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Valérie A M', 'Initials': 'VAM', 'LastName': 'André', 'Affiliation': 'Eli Lilly and Company, Paris, France.'}, {'ForeName': 'Molly C', 'Initials': 'MC', 'LastName': 'Hardebeck', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Sachi', 'Initials': 'S', 'LastName': 'Sakaguchi', 'Affiliation': 'Eli Lilly and Company, Tokyo, Japan.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University, Stanford, California, United States.'}]",Cancer science,['10.1111/cas.14877']
1793,33686715,Dyadic-Explanations During Preparatory Self-Study Enhance Learning: A Randomised Controlled Study.,"PURPOSE


The objective of the present study was to investigate to which extent preparatory self-study can be improved by encouraging students to engage in individual self-explanations or dyadic-explanations (that is, in pairs). Individual self-explanations refer to an act of metacognition in which students, after having processed a certain amount of information, attempt to explain their understanding to themselves of what was just learned. Dyadic-explanations refer to the same process, but instead of explaining to oneself, the student explains his/her understanding to another student.
METHOD


An experiment was conducted in which 120 medical students studied a video-recorded lecture on the role of protein synthesis inhibition on memory reconsolidation. Participants were randomly allocated to one of four conditions: (1) a control condition in which they listened to the lecture once; (2) a control condition in which they listened to the lecture twice; (3) an experimental condition in which they had to listen to the lecture and provide self-explanations individually; and (4) an experimental condition in which they had to listen to the lecture and provide dyadic-explanations. Participants' knowledge regarding the topic was measured three times; at the start and end of the experiment, and one week after the experiment to determine knowledge retention. Data were analysed by means of a 2*2 and 4*3 repeated-measures ANOVA.
RESULTS


The results suggest that participants who engaged in individual self- or dyadic-explanations significantly outperformed participants in the two control conditions in terms of learning and retention (F = 5.67, Wilks Λ = 0.94, P = 0.019, η 2  = 0.05). Moreover, the results suggest that dyadic-explanations were more effective than individual self-explanations (F = 3.70, Wilks Λ = 0.83, P = 0.002, η 2  = 0.09).
CONCLUSIONS


These outcomes suggest that encouraging students to work in pairs or in small teams to prepare for a learning event results in superior preparation and learning.",2021,"Moreover, the results suggest that dyadic-explanations were more effective than individual self-explanations (F = 3.70, Wilks Λ = 0.83, P = 0.002, η 2  = 0.09).
",['120 medical students studied a video-recorded lecture on the role of protein synthesis inhibition on memory reconsolidation'],['control condition in which they listened to the lecture once; (2) a control condition in which they listened to the lecture twice; (3) an experimental condition in which they had to listen to the lecture and provide self-explanations individually; and (4) an experimental condition in which they had to listen to the lecture and provide dyadic-explanations'],['Dyadic-Explanations'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0585347', 'cui_str': 'Single event'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",[],120.0,0.0175801,"Moreover, the results suggest that dyadic-explanations were more effective than individual self-explanations (F = 3.70, Wilks Λ = 0.83, P = 0.002, η 2  = 0.09).
","[{'ForeName': 'Jerome I', 'Initials': 'JI', 'LastName': 'Rotgans', 'Affiliation': 'Nanyang Technological University, Lee Kong Chian School of Medicine, Singapore.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': 'Nanyang Technological University, Lee Kong Chian School of Medicine, Singapore.'}]",Medical education,['10.1111/medu.14519']
1794,33686028,Sealing Ability of Calcium Silicate-based Materials in the Repair of Furcal Perforations: A Laboratory Comparative Study.,"AIM


To assess the sealing ability of two calcium silicate-based materials in the treatment of iatrogenic furcal perforations using a dye-penetration leakage model.
MATERIALS AND METHODS


Furcation perforations were performed using a size 12 round burr on the pulp chamber floor of 20 first mandibular molars. The teeth were then randomly divided into two groups, two additional molars served as negative controls. The defects were then filled with mineral trioxide aggregate (MTA) Angelus in the first group and Biodentine in the second group. Leakage at the repaired sites was then evaluated using the methylene blue dye penetration technique.
RESULTS


Significant differences in microleakage were found between the two groups at 72 hours ( p  < 0.001). MTA Angelus had greater dye penetration than Biodentine with a statistically significant difference. Subsequently, the sealing ability of Biodentine was significantly better than MTA Angelus ( p  < 0.001). However, the mean values of leakage and inadequate adhesion were significantly different from the theoretical value for both the MTA Angelus ( p  < 0.001) and Biodentine ( p  < 0.001).
CONCLUSION


The current results suggested that Biodentine possesses higher sealing quality than MTA Angelus. Yet, both materials are not ideal and still need improvement to ensure perfect adhesion in case of furcal perforation.
CLINICAL SIGNIFICANCE


This article aims to compare the sealing ability of one dental repair material over another, after iatrogenically producing a furcal perforation. Leakage resistance and sealing ability are important factors in favoring the outcome of an endodontic treatment of a tooth that could otherwise be condemned for extraction.",2020,"RESULTS


Significant differences in microleakage were found between the two groups at 72 hours ( p  < 0.001).",['Furcation perforations were performed using a size 12 round burr on the pulp chamber floor of 20 first mandibular molars'],"['Biodentine', 'calcium silicate-based materials', 'Calcium Silicate-based Materials']","['microleakage', 'sealing quality', 'sealing ability of Biodentine', 'dye penetration', 'mean values of leakage and inadequate adhesion']","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0330093', 'cui_str': 'Burr'}, {'cui': 'C0034099', 'cui_str': 'Pulp chamber of tooth'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}]",,0.0163015,"RESULTS


Significant differences in microleakage were found between the two groups at 72 hours ( p  < 0.001).","[{'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Makhlouf', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Saint Joseph University, Beirut, Lebanon, Phone: +961-1-421000 ext 2800, e-mail: michele.makhlouf@net.usj.edu.lb.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Zogheib', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Anne-Christelle', 'Initials': 'AC', 'LastName': 'Makhlouf', 'Affiliation': 'Department of Fixed Prosthesis, Faculty of Dentistry, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Marc Krikor', 'Initials': 'MK', 'LastName': 'Kaloustian', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'El Hachem', 'Affiliation': 'Department of Pediatric and Community Dentistry, Faculty of Dentistry, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Habib', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Saint Joseph University, Beirut, Lebanon.'}]",The journal of contemporary dental practice,[]
1795,33685975,Safety and Efficacy of Daratumumab in Patients with Proliferative GN with Monoclonal Immunoglobulin Deposits.,"BACKGROUND


Treatment of proliferative GN with monoclonal Ig deposits (PGNMID) is not established. A monoclonal anti-CD38 antibody (daratumumab) is effective in treating multiple myeloma. Abnormal plasma cell clones may play a role in the pathogenesis of PGNMID.
METHODS


We evaluated daratumumab's safety and efficacy in an open-label, phase 2 trial in 11 adults with PGNMID and one with C3 glomerulopathy (C3G) with monoclonal gammopathy. Patients had an eGFR >20 ml/min per 1.73 m 2  and proteinuria >1 g/d. They received daratumumab intravenously (16 mg/kg) once weekly for 8 weeks, and then every other week for eight additional doses. Primary outcome was safety, defined as major infections, grade 3 or 4 anemia, leukopenia, or thrombocytopenia. Secondary outcomes were rate of complete remission (proteinuria <500 mg/d with <15% decline in baseline eGFR) or partial remission (>50% reduction in 24-hour proteinuria with <30% decline in eGFR) and proteinuria at 6 and 12 months.
RESULTS


One patient with C3G had GN unrelated to the monoclonal gammopathy, and one with PGNMID did not complete the first infusion. Five serious adverse events occurred. During the 12 months of the trial, six of the ten patients with PGNMID who received at least one dose of daratumumab had a partial response, and four had a complete response (an overall response rate of 100%). Three patients experienced relapse, two of whom re-entered partial remission after resuming daratumumab therapy. Proteinuria declined significantly, from a median of 4346 mg/d to 1264 mg/d by 12 months.
CONCLUSIONS


Daratumumab demonstrated an acceptable safety profile and resulted in significant improvement in proteinuria while stabilizing kidney function in patients with PGNMID, suggesting the drug merits further investigation.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Daratumumab in Treatment of PGNMID and C3 GN, NCT03095118.",2021,Five serious adverse events occurred.,"['Patients with Proliferative GN with Monoclonal Immunoglobulin Deposits', '11 adults with PGNMID and one with C3 glomerulopathy (C3G) with monoclonal gammopathy', 'patients with PGNMID']","['monoclonal anti-CD38 antibody (daratumumab', 'Daratumumab']","['safety, defined as major infections, grade 3 or 4 anemia, leukopenia, or thrombocytopenia', 'Proteinuria', 'partial remission', 'Safety and Efficacy', 'rate of complete remission (proteinuria', 'baseline eGFR) or partial remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0443737', 'cui_str': 'Monoclonal immunoglobulin'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4087273', 'cui_str': 'C3 glomerulopathy'}, {'cui': 'C0026470', 'cui_str': 'Monoclonal gammopathy of undetermined significance'}]","[{'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",11.0,0.146812,Five serious adverse events occurred.,"[{'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Zand', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Leung', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'El Ters', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Fernando C', 'Initials': 'FC', 'LastName': 'Fervenza', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota fervenza.fernando@mayo.edu.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020101541']
1796,33685969,Endoscopic radiofrequency ablation or surveillance in patients with Barrett's oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial.,"OBJECTIVE


Due to an annual progression rate of Barrett's oesophagus (BO) with low-grade dysplasia (LGD) between 9% and 13% per year endoscopic ablation therapy is preferred to surveillance. Since this recommendation is based on only one randomised trial, we aimed at checking these results by another multicentre randomised trial with a similar design.
DESIGN


A prospective randomised study was performed in 14 centres comparing radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance, including patients with a confirmed diagnosis of BO with LGD. Primary outcome was the prevalence of LGD at 3 years. Secondary outcomes were the prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM) at 3 years, the rate of neoplastic progression at 3 years and the treatment-related morbidity.
RESULTS


125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group. At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p<0.001). At the same time, the prevalence LGD was 34.3% (95% CI 18.6 to 50.0) in the RFA group vs 58.1% (95% CI 40.7 to 75.4) in the surveillance group (OR=0.38 (95% CI 0.14 to 1.02), p=0.05). Neoplastic progression was found in 12.5% (RFA) vs 26.2% (surveillance; p=0.15). The complication rate was maximal after the first RFA treatment (16.9%).
CONCLUSION


RFA modestly reduced the prevalence of LGD as well as progression risk at 3 years. The risk-benefit balance of endoscopic ablation therapy should therefore be carefully weighted against surveillance in patients with BO with confirmed LGD.
TRIAL REGISTRATION NUMBER


NCT01360541.",2021,"At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p<0.001).","['patients with a confirmed diagnosis of BO with LGD', ""patients with Barrett's oesophagus with confirmed low-grade dysplasia"", 'patients with BO with confirmed LGD', '14 centres comparing', '125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group']","['RFA', 'radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance', 'Endoscopic radiofrequency ablation or surveillance', 'endoscopic ablation therapy']","['Neoplastic progression', 'complication rate', 'prevalence of LGD at 3 years', 'rate of neoplastic progression at 3 years and the treatment-related morbidity', 'CE-IM rates', 'prevalence of LGD', 'prevalence LGD', 'prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0334037', 'cui_str': 'Intestinal metaplasia'}]",125.0,0.153361,"At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p<0.001).","[{'ForeName': 'Maximilien', 'Initials': 'M', 'LastName': 'Barret', 'Affiliation': 'Gastroenterology and Digestive Oncology, Hopital Cochin, Paris, Île-de-France, France maximilien.barret@aphp.fr.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pioche', 'Affiliation': 'Gastroenterology and Endoscopy, Groupement Hospitalier Edouard Herriot, Lyon, Rhône-Alpes, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Terris', 'Affiliation': 'Pathology, Hopital Cochin, Paris, Île-de-France, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Ponchon', 'Affiliation': 'Gastroenterology, Groupement Hospitalier Edouard Herriot, Lyon, Rhône-Alpes, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Cholet', 'Affiliation': 'Digestive Endoscopy, CHRU de Brest, Brest, Bretagne, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': 'Gastroenterology, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, Aquitaine, France.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Chabrun', 'Affiliation': 'Gastroenterology, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, Aquitaine, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Le Rhun', 'Affiliation': 'Gastroenterology, Centre Hospitalier Universitaire de Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coron', 'Affiliation': 'Gastroenterology, Centre Hospitalier Universitaire de Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Giovannini', 'Affiliation': ""Gastroenterology, Institut Paoli-Calmettes, Marseille, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Caillol', 'Affiliation': ""Gastroenterology, Institut Paoli-Calmettes, Marseille, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Laugier', 'Affiliation': ""Gastroenterology, Hospital Timone, Marseille, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Jeremie', 'Initials': 'J', 'LastName': 'Jacques', 'Affiliation': 'Gastroenterology, Centre Hospitalier Universitaire de Limoges, Limoges, Limousin, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Legros', 'Affiliation': 'Gastroenterology, Centre Hospitalier Universitaire de Limoges, Limoges, Limousin, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Boustiere', 'Affiliation': ""Gastroenterology, Hopital Saint Joseph, Marseille, Provence-Alpes-Côte d'Azu, France.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rahmi', 'Affiliation': 'Gastroenterology and Digestive Endoscopy, Hopital Europeen Georges Pompidou, Paris, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Metivier-Cesbron', 'Affiliation': ""Digestive Endoscopy Unit, Centre Hospitalier Universitaire d'Angers, Angers, Pays de la Loire, France.""}, {'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Vanbiervliet', 'Affiliation': ""Gastroenterology, Centre Hospitalier Universitaire de Nice, Nice, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bauret', 'Affiliation': 'Gastroenterology, Centre Hospitalier Universitaire de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Escourrou', 'Affiliation': 'Gastroenterology, Centre Hospitalier Universitaire de Toulouse, Toulouse, Midi-Pyrénées, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branche', 'Affiliation': 'Gastroenterology, Centre Hospitalier Universitaire de Lille, Lille, Hauts-de-France, France.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Jilet', 'Affiliation': 'Clinical Research Unit, Hospital Cochin, Paris, Île-de-France, France.'}, {'ForeName': 'Hendy', 'Initials': 'H', 'LastName': 'Abdoul', 'Affiliation': 'Clinical Research Unit, Hospital Cochin, Paris, Île-de-France, France.'}, {'ForeName': 'Nadira', 'Initials': 'N', 'LastName': 'Kaddour', 'Affiliation': 'Clinical Research Unit, Hospital Cochin, Paris, Île-de-France, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Leblanc', 'Affiliation': 'Gastroenterology and Digestive Oncology, Hopital Cochin, Paris, Île-de-France, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bensoussan', 'Affiliation': 'Gastroenterology, Centre intégré de santé et de services sociaux de la Montérégie-Centre du Québec territoire Champlain-Charles-Le Moyne, Saint-Hubert, Quebec, Canada.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Prat', 'Affiliation': 'Gastroenterology and Digestive Oncology, Hopital Cochin, Paris, Île-de-France, France.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Chaussade', 'Affiliation': 'Gastroenterology and Digestive Oncology, Hopital Cochin, Paris, Île-de-France, France.'}]",Gut,['10.1136/gutjnl-2020-322082']
1797,33685928,Atorvastatin is unlikely to prevent rheumatoid arthritis in high risk individuals: results from the prematurely stopped STAtins to Prevent Rheumatoid Arthritis (STAPRA) trial.,"OBJECTIVES


Persons at high risk of rheumatoid arthritis (RA) might benefit from a low-risk pharmacological intervention aimed at primary prevention. Previous studies demonstrated disease-modifying effects of statins in patients with RA as well as an association between statin use and a decreased risk of RA development. A randomised, double-blind, placebo-controlled trial investigated whether atorvastatin could prevent arthritis development in high-risk individuals.
METHODS


Arthralgia patients with anticitrullinated protein antibody (ACPA) >3 xULN or ACPA and rheumatoid factor, without (a history of) arthritis, were randomised to receive atorvastatin 40 mg daily or placebo for 3 years. The calculated sample size was 220 participants. The primary endpoint was clinical arthritis. Cox regression analysis was used to determine the effect of atorvastatin on arthritis development.
RESULTS


Due to a low inclusion rate, mainly because of an unwillingness to participate, the trial was prematurely stopped. Data of the 62 randomised individuals were analysed. Median follow-up was 14 (inner quartiles 6-35) months. Fifteen individuals (24%) developed arthritis: 9/31 (29%) in the atorvastatin group; 6/31 (19%) in the placebo group: HR 1.40, 95% CI 0.50 to 3.95.
CONCLUSIONS


In this small set of randomised high-risk individuals, we did not demonstrate a protective effect of atorvastatin on arthritis development. The main reason for the low inclusion was unwillingness to participate; this may also impede other RA prevention trials. Further research to investigate and solve barriers for prevention trial participation is needed.",2021,"Fifteen individuals (24%) developed arthritis: 9/31 (29%) in the atorvastatin group; 6/31 (19%) in the placebo group: HR 1.40, 95% CI 0.50 to 3.95.
","['220 participants', 'patients with RA', 'Arthralgia patients with anticitrullinated protein antibody (ACPA) >3\u2009xULN or ACPA and rheumatoid factor, without (a history of) arthritis', 'high-risk individuals', 'high risk individuals', 'Persons at high risk of rheumatoid arthritis (RA']","['atorvastatin 40\u2009mg daily or placebo', 'atorvastatin', 'placebo', 'Atorvastatin']","['arthritis', 'clinical arthritis']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C1445860', 'cui_str': 'Protein antibody'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",220.0,0.609573,"Fifteen individuals (24%) developed arthritis: 9/31 (29%) in the atorvastatin group; 6/31 (19%) in the placebo group: HR 1.40, 95% CI 0.50 to 3.95.
","[{'ForeName': 'Laurette', 'Initials': 'L', 'LastName': 'van Boheemen', 'Affiliation': 'Rheumatology, Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, Noord-Holland, The Netherlands l.vanboheemen@amsterdamumc.nl.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Turk', 'Affiliation': 'Rheumatology, Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Marian van', 'Initials': 'MV', 'LastName': 'Beers-Tas', 'Affiliation': 'Rheumatology, Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Bos', 'Affiliation': 'Rheumatology, Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Marsman', 'Affiliation': 'Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'Ed N', 'Initials': 'EN', 'LastName': 'Griep', 'Affiliation': 'Rheumatology, Antonius Hospital Sneek, Sneek, The Netherlands.'}, {'ForeName': 'Mirian', 'Initials': 'M', 'LastName': 'Starmans-Kool', 'Affiliation': 'Rheumatology, Zuyderland Medisch Centrum Heerlen, Heerlen, The Netherlands.'}, {'ForeName': 'Calin D', 'Initials': 'CD', 'LastName': 'Popa', 'Affiliation': 'Rheumatology, Bernhoven Hospital Location Uden, Uden, The Netherlands.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'van Sijl', 'Affiliation': 'Rheumatology, Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Boers', 'Affiliation': 'Epidemiology and Data Science, Amsterdam Public Health, Amsterdam UMC Locatie VUmc, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Nurmohamed', 'Affiliation': 'Rheumatology, Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Dirkjan', 'Initials': 'D', 'LastName': 'van Schaardenburg', 'Affiliation': 'Rheumatology, Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, Noord-Holland, The Netherlands.'}]",RMD open,['10.1136/rmdopen-2021-001591']
1798,33685871,"App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial.","PURPOSE


Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting.
METHODS


The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis.
RESULTS


A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment.
CONCLUSIONS


App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.",2021,"The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups.","['Urinary Incontinence', '262 eligible women were randomized equally; 195 of them had follow-up through 4 months', 'women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting', 'From July 2015 to July 2018, we screened 350 women for eligibility', 'Dutch primary care including adult women with 2 episodes of UI per week']",['stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl'],"['disease-specific quality of life, patient-perceived improvement, and number of UI episodes', 'symptom severity score', 'symptom severity']","[{'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",262.0,0.131822,"The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups.","[{'ForeName': 'Anne M M', 'Initials': 'AMM', 'LastName': 'Loohuis', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands a.m.m.loohuis@umcg.nl.'}, {'ForeName': 'Nienke J', 'Initials': 'NJ', 'LastName': 'Wessels', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Janny H', 'Initials': 'JH', 'LastName': 'Dekker', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Nadine A M', 'Initials': 'NAM', 'LastName': 'van Merode', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marijke C Ph', 'Initials': 'MCP', 'LastName': 'Slieker-Ten Hove', 'Affiliation': 'Profundum Institute, Education and Research, Dordrecht, The Netherlands.'}, {'ForeName': 'Boudewijn J', 'Initials': 'BJ', 'LastName': 'Kollen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marjolein Y', 'Initials': 'MY', 'LastName': 'Berger', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van der Worp', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marco H', 'Initials': 'MH', 'LastName': 'Blanker', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}]",Annals of family medicine,['10.1370/afm.2585']
1799,33685864,Comparative Effects of Etelcalcetide and Maxacalcitol on Serum Calcification Propensity in Secondary Hyperparathyroidism: A Randomized Clinical Trial.,"BACKGROUND AND OBJECTIVES


Vitamin D receptor activators and calcimimetics (calcium-sensing receptor agonists) are two major options for medical treatment of secondary hyperparathyroidism. A higher serum calcification propensity (a shorter T 50  value) is a novel surrogate marker of calcification stress and mortality in patients with CKD. We tested a hypothesis that a calcimimetic agent etelcalcetide is more effective in increasing T 50  value than a vitamin D receptor activator maxacalcitol.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


A randomized, multicenter, open-label, blinded end point trial with active control was conducted in patients with secondary hyperparathyroidism undergoing hemodialysis in Japan. Patients were randomly assigned to receive intravenous etelcalcetide 5 mg thrice weekly (etelcalcetide group) or intravenous maxacalcitol 5 or 10  µ g thrice weekly (maxacalcitol group). The primary, secondary, and tertiary outcomes were changes in T 50  value, handgrip strength, and score of the Dementia Assessment Sheet for Community-Based Integrated Care System from baseline to 12 months, respectively.
RESULTS


In total, 425 patients from 23 dialysis centers were screened for eligibility, 326 patients were randomized (etelcalcetide,  n =167; control,  n =159), and 321 were included in the intention-to-treat analysis (median age, 66 years; 113 women [35%]). The median (interquartile range) of T 50  value was changed from 116 minutes (interquartile range, 90-151) to 131 minutes (interquartile range, 102-176) in the maxacalcitol group, whereas it was changed from 123 minutes (interquartile range, 98-174) to 166 minutes (interquartile range, 127-218) in the etelcalcetide group. The increase in T 50  value was significantly greater in the etelcalcetide group (difference in change, 20 minutes; 95% confidence interval, 7 to 34 minutes;  P =0.004). No significant between-group difference was found in the change in handgrip strength or in the Dementia Assessment Sheet for Community-Based Integrated Care System score.
CONCLUSIONS


Etelcalcetide was more effective in increasing T 50  value than maxacalcitol among patients on hemodialysis with secondary hyperparathyroidism. There was no difference in handgrip strength or cognition between the two drugs.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


VICTORY; UMIN000030636 and jRCTs051180156.",2021,"No significant between-group difference was found in the change in handgrip strength or in the Dementia Assessment Sheet for Community-Based Integrated Care System score.
","['patients on hemodialysis with secondary hyperparathyroidism', '425 patients from 23 dialysis centers were screened for eligibility, 326 patients were randomized (etelcalcetide,  n =167; control,  n =159), and 321 were included in the intention-to-treat analysis (median age, 66 years; 113 women [35', 'patients with secondary hyperparathyroidism undergoing hemodialysis in Japan', 'Secondary Hyperparathyroidism', 'patients with CKD']","['Etelcalcetide and Maxacalcitol', 'intravenous etelcalcetide 5 mg thrice weekly (etelcalcetide group) or intravenous maxacalcitol 5 or 10  µ g thrice weekly (maxacalcitol group']","['handgrip strength', 'handgrip strength or cognition', 'T 50  value', 'changes in T 50  value, handgrip strength, and score of the Dementia Assessment Sheet for Community-Based Integrated Care System']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C3713906', 'cui_str': 'etelcalcetide'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C3713906', 'cui_str': 'etelcalcetide'}, {'cui': 'C0043872', 'cui_str': 'maxacalcitol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",425.0,0.178752,"No significant between-group difference was found in the change in handgrip strength or in the Dementia Assessment Sheet for Community-Based Integrated Care System score.
","[{'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Shoji', 'Affiliation': 'Department of Vascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan t-shoji@med.osaka-cu.ac.jp.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Nakatani', 'Affiliation': 'Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Daijiro', 'Initials': 'D', 'LastName': 'Kabata', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Katsuhito', 'Initials': 'K', 'LastName': 'Mori', 'Affiliation': 'Department of Nephrology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Shintani', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kanae', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Center for Clinical Research and Innovation, Osaka City University Hospital, Osaka, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Department of Drug and Food Evaluation, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Nishi', 'Affiliation': 'Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nakatani', 'Affiliation': 'Department of Urology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Yoshiyama', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Ono Naika Clinic, Osaka, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Hamada', 'Affiliation': 'Marie Clinic, Higashi Osaka, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Imanishi', 'Affiliation': 'Ishikiri Seiki Hospital, Higashi Osaka, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Ishimura', 'Affiliation': 'Meijibashi Hospital, Matsubara, Japan.'}, {'ForeName': 'Sosuke', 'Initials': 'S', 'LastName': 'Kagitani', 'Affiliation': 'Kawamura Clinic, Osaka, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Shirasagi Minami Clinic, Osaka, Japan.'}, {'ForeName': 'Yasuro', 'Initials': 'Y', 'LastName': 'Kumeda', 'Affiliation': 'Minami Osaka Clinic, Osaka, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Maekawa', 'Affiliation': 'Fujiidera Shirasagi Clinic, Fujiidera, Japan.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Matsumura', 'Affiliation': 'Ikeda Hospital, Higashi Osaka, Japan.'}, {'ForeName': 'Harumi', 'Initials': 'H', 'LastName': 'Nagayama', 'Affiliation': 'Nagayama Clinic, Sennan-gun, Japan.'}, {'ForeName': 'Yasue', 'Initials': 'Y', 'LastName': 'Obi', 'Affiliation': 'Obi Clinic, Osaka, Japan.'}, {'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Ohno', 'Affiliation': 'Ohno Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Sai', 'Affiliation': 'Suminodo Clinic, Daito, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Sakurai', 'Affiliation': 'Jurakukai Clinic, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': 'Sasaki Medical Clinic, Osaka, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Shidara', 'Affiliation': 'Ikeda Clinic, Higashi Osaka, Japan.'}, {'ForeName': 'Shigeichi', 'Initials': 'S', 'LastName': 'Shoji', 'Affiliation': 'Shirasagi Hospital, Osaka, Japan t-shoji@med.osaka-cu.ac.jp.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Tsujimoto', 'Affiliation': 'Aijinkai Healthcare Corporation Inoue Hospital, Suita, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Yamakawa', 'Affiliation': 'Shirasagi Clinic, Osaka, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Yasuda', 'Affiliation': 'Okada Clinic, Osaka, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Yodoi', 'Affiliation': 'Yodoi Hospital, Osaka, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Inaba', 'Affiliation': 'Vascular Science Center for Translational Research, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Emoto', 'Affiliation': 'Vascular Science Center for Translational Research, Osaka City University Graduate School of Medicine, Osaka, Japan.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.16601020']
1800,33685854,"Impact of a Serious Game, ""Escape COVID-19"", on the Intention to Change COVID-19 Control Practices among Employees of Long-term Care Facilities: Web-Based, Randomized Controlled Trial.","BACKGROUND


Most residents of long-term care facilities (LTCFs) are at high risk of complication and death after SARS-CoV-2 infection. In these facilities, viral transmission can be facilitated by shortages of human and material resources, which can lead to suboptimal application of infection prevention and control (IPC) procedures. To improve the dissemination of COVID-19 IPC guidelines, we developed a serious game called ""Escape COVID-19"" using Nicholson's RECIPE for meaningful gamification, as engaging serious games have the potential to induce behavioral change.
OBJECTIVE


As the probability of executing an action is strongly linked to the intention of performing it, the objective of this study was to determine whether LTCF employees were willing to change their IPC practices after playing ""Escape COVID-19"".
METHODS


This was a web-based, triple-blind, randomized controlled trial, which took place between November 5th and December 4th, 2020. The health authorities of Geneva (Switzerland) asked the managers of all LTCFs under their jurisdiction to forward information regarding the study and the connection procedure to all their employees, regardless of their professional status. Participants were unaware that they would be randomly allocated to one of two different study paths upon registration. In the control group, participants filled in a first questionnaire designed to gather demographic data and assess baseline knowledge before accessing regular online IPC guidelines. They then answered a second questionnaire which assessed their willingness to change their IPC practices and identify the reasons underlying their decision. They were finally granted access to the serious game. Conversely, the serious game group played ""Escape COVID-19"" after answering the first questionnaire but before answering the second one. This group accessed the control material after answering the second set of questions. There was no time limit or constraint. The primary outcome was the proportion of LTCF employees willing to change their IPC practices. Secondary outcomes included the factors underlying the participants' decisions, the domains these changes would affect, the changes in the use of protective equipment items, and attrition at each stage of the study.
RESULTS


A total of 295 answer sets were analyzed. The willingness to change behavior was higher in the serious game group (82% [119/145] vs 56% [84/150], P < .001), with an odds ratio of 3.86 (95%CI 2.18 - 6.81, P < .001) after adjusting for professional category and baseline knowledge, using a mixed effects logistic regression model with LTCF as a random effect. For more than two thirds of the participants, the feeling of playing an important role against the epidemic was the most important factor explaining the willingness to change behavior. Most of the participants unwilling to change their behavior answered that they were already applying all the guidelines.
CONCLUSIONS


The serious game ""Escape COVID-19"" was more successful than standard IPC material in convincing LTCF employees to adopt COVID-19 safe IPC behavior.
CLINICALTRIAL


International Registered Report Identifier (IRRID): DERR1-10.2196/25595.
INTERNATIONAL REGISTERED REPORT


RR2-10.2196/25595.",2021,"The willingness to change behavior was higher in the serious game group (82% [119/145] vs 56% [84/150], P < .001), with an odds ratio of 3.86 (95%CI 2.18 - 6.81, P < .001) after adjusting for professional category and baseline knowledge, using a mixed effects logistic regression model with LTCF as a random effect.",['Employees of Long-term Care Facilities'],"['Serious Game, ""Escape COVID-19']","['Escape COVID-19', 'proportion of LTCF employees willing to change their IPC practices', 'changes in the use of protective equipment items, and attrition at each stage of the study', 'time limit or constraint', 'willingness to change behavior']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",,0.160925,"The willingness to change behavior was higher in the serious game group (82% [119/145] vs 56% [84/150], P < .001), with an odds ratio of 3.86 (95%CI 2.18 - 6.81, P < .001) after adjusting for professional category and baseline knowledge, using a mixed effects logistic regression model with LTCF as a random effect.","[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Suppan', 'Affiliation': 'Division of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Rue Gabrielle-Perret-Gentil 4, Geneva, CH.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abbas', 'Affiliation': 'Infection Control Programme and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, CH.'}, {'ForeName': 'Gaud', 'Initials': 'G', 'LastName': 'Catho', 'Affiliation': 'Infection Control Programme and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, CH.'}, {'ForeName': 'Loric', 'Initials': 'L', 'LastName': 'Stuby', 'Affiliation': 'Genève TEAM Ambulances, Geneva, CH.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Regard', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, CH.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Achab', 'Affiliation': 'Specialized Facility in Behavioral Addictions ReConnecte, University of Geneva Hospitals, Geneva, CH.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Infection Control Programme and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, CH.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, CH.'}]",Journal of medical Internet research,['10.2196/27443']
1801,33685850,"Does glucosamine, chondroitin sulfate, and methylsulfonylmethane supplementation improve the outcome of temporomandibular joint osteoarthritis management with arthrocentesis plus intraarticular hyaluronic acid injection. A randomized clinical trial.","The purpose of this study was to compare clinical outcomes obtained with the use of glucosamine, chondroitin sulfate, and methylsulfonylmethane (GCM) supplementation after arthrocentesis plus intraarticular hyaluronic acid (HA) injection. A randomized clinical trial was implemented with adult participants with TMJ-OA who were referred to the author's clinic between February 2014 and May 2015. The sample was entirely composed of patients with TMJ-OA who were treated randomly with a one-session arthrocentesis plus intraarticular HA injection only (control group), or an initial one-session arthrocentesis plus intraarticular HA injection followed by 3 months of GCM supplementation (study group). The predictor variable was management (treatment) technique. The outcome variables were visual analog scale evaluations (masticatory efficiency, pain complaint, joint sound) and mandibular mobility (maximal interincisal opening [MIO], and lateral and protrusive motions of the mandible). The outcome variables were recorded preoperatively and 12 months postoperatively. Thirty-one participants were enrolled in the study. Five were lost during follow-up. The final study sample consisted of 26 participants (age 28.35 ± 10.85 y): 14 in the control group (age 28.71 ± 10.94 y); and 12 in the study group (age 27.92 ± 11.20 y). Pain complaints (p < 0.001) and joint sounds (p = 0.030 for the control group; p = 0.023 for the study group) showed statistically significant decreases. Masticatory efficiency (p < 0.001 for the control group; p = 0.040 for the study group) and lateral mandibular motion (p = 0.040 for the control group; p = 0.004 for study group) showed statistically significant increases in both groups, whereas MIO and protrusive mandibular motion showed no significant changes in either group (p > 0.05). After estimating the differences between the follow-up and baseline outcomes, the mean changes in the primary outcome variables (VAS scores, MIO, and mandibular motion) showed no statistically significant differences between the two groups (p > 0.05). Progressions (reparative remodeling) of hard-tissue TMJ structures were observed on CBCT scans of some participants in both groups. These findings suggested that the use of GCM supplementation after arthrocentesis plus intraarticular HA injection produced no additional clinical benefits or improvements for patients with TMJ-OA compared with arthrocentesis plus intraarticular HA injection alone.",2021,Pain complaints (p < 0.001) and joint sounds (p = 0.030 for the control group; p = ,"[""adult participants with TMJ-OA who were referred to the author's clinic between February 2014 and May 2015"", '10.94\xa0y); and 12 in the study group (age 27.92\xa0±\xa011.20\xa0y', '26 participants (age 28.35\xa0±\xa010.85\xa0y): 14 in the control group (age 28.71\xa0±', 'Thirty-one participants were enrolled in the study', 'patients with TMJ-OA']","['one-session arthrocentesis plus intraarticular HA injection only (control group), or an initial one-session arthrocentesis plus intraarticular HA injection followed by 3 months of GCM supplementation', 'glucosamine, chondroitin sulfate, and methylsulfonylmethane supplementation', 'glucosamine, chondroitin sulfate, and methylsulfonylmethane (GCM) supplementation after arthrocentesis plus intraarticular hyaluronic acid (HA) injection', 'arthrocentesis plus intraarticular hyaluronic acid injection']","['MIO and protrusive mandibular motion', 'Masticatory efficiency', 'VAS scores, MIO, and mandibular motion', 'lateral mandibular motion', 'joint sounds', 'Pain complaints', 'visual analog scale evaluations (masticatory efficiency, pain complaint, joint sound) and mandibular mobility (maximal interincisal opening [MIO], and lateral and protrusive motions of the mandible']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",31.0,0.0540017,Pain complaints (p < 0.001) and joint sounds (p = 0.030 for the control group; p = ,"[{'ForeName': 'Songül', 'Initials': 'S', 'LastName': 'Cömert Kılıç', 'Affiliation': 'Department of Oral and Maxillofacial Surgery,Faculty of Dentistry, Atatürk University, Erzurum, 25240, Turkey. Electronic address: drsckilic@yahoo.com.tr.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2021.02.012']
1802,33685795,Effects of increased physical activity and/or weight loss diet on serum myokine and adipokine levels in overweight adults with impaired glucose metabolism.,"AIM


The purpose of this study was to investigate the changes in serum irisin, fibroblast growth factor-21 (FGF21), visfatin, follistatin like protein-1 (FSTL1), and meteorin-like protein (Metrnl) levels in response to increased physical activity and/or diet interventions in overweight subjects with impaired glucose metabolism (IGM).
METHODS


A total of 60 subjects (BMI > 25.0 kg/m 2 ) with IGM were recruited in this single-centered interventional study. Twelve subjects dropped out during the study and the study was completed with 48 patients. Patients were divided into two groups as diet only (DI, n = 24) and diet and physical activity intervention (DPA, n = 24). Patients in DI group received a diet program while DPA group received a diet combined with a physical activity intervention for 12 weeks. Additional 24 healthy subjects were recruited to compare the baseline levels of proteins. Serum protein levels, anthropometric measurements, and biochemical parameters were assessed.
RESULTS


Irisin, FGF21, visfatin, and FSTL1 levels significantly decreased in both groups after 12-week intervention (p < 0.001). However, there were no differences in protein levels between DI and DPA groups (p > 0.05). Likewise, the total change in weight was similar in both DI (-4.35 kg) and DPA (-4.85 kg) groups (p > 0.05). A 5% reduction in initial body weight with DPA therapy resulted in a stronger correlation between the changes in irisin, visfatin, and FSTL1 levels and fasting glucose and HbA1c levels.
CONCLUSIONS


These results demonstrate that serum irisin, FGF21, visfatin, and FSTL1 levels decreased in response to weight loss interventions. Weight loss induced by DI or DPA therapies had similar lowering effects on these proteins in subjects with IGM, and these myokines might be related to glucose metabolism biomarkers.",2021,"RESULTS


Irisin, FGF21, visfatin, and FSTL1 levels significantly decreased in both groups after 12-week intervention (p < 0.001).","['overweight subjects with impaired glucose metabolism (IGM', 'Twelve subjects dropped out during the study and the study was completed with 48 patients', 'overweight adults with impaired glucose metabolism', 'Additional 24 healthy subjects', '60 subjects (BMI\u202f>\u202f25.0\u202fkg/m 2 ) with IGM']","['diet and physical activity intervention', 'physical activity and/or weight loss diet', 'diet program while DPA group received a diet combined with a physical activity intervention']","['serum myokine and adipokine levels', 'Weight loss', 'protein levels', 'serum irisin, FGF21, visfatin, and FSTL1 levels', 'Irisin, FGF21, visfatin, and FSTL1 levels', 'physical activity', 'serum irisin, fibroblast growth', 'factor-21 (FGF21), visfatin, follistatin like protein-1 (FSTL1), and meteorin-like protein (Metrnl) levels', 'irisin, visfatin, and FSTL1 levels and fasting glucose and HbA1c levels', 'Serum protein levels, anthropometric measurements, and biochemical parameters', 'total change in weight', 'initial body weight']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0068707', 'cui_str': 'Nicotinamide phosphoribosyltransferase'}, {'cui': 'C1136225', 'cui_str': 'Follistatin-Related Protein 1'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0036825', 'cui_str': 'Serum protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",60.0,0.0138425,"RESULTS


Irisin, FGF21, visfatin, and FSTL1 levels significantly decreased in both groups after 12-week intervention (p < 0.001).","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Tok', 'Affiliation': 'Karadeniz Technical University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Trabzon, Turkey. Electronic address: ozlemtok@ktu.edu.tr.'}, {'ForeName': 'Savaş Volkan', 'Initials': 'SV', 'LastName': 'Kişioğlu', 'Affiliation': 'Karadeniz Technical University, Faculty of Medicine, Division of Endocrinology and Metabolism, Trabzon, Turkey.'}, {'ForeName': 'Halil Önder', 'Initials': 'HÖ', 'LastName': 'Ersöz', 'Affiliation': 'Karadeniz Technical University, Faculty of Medicine, Division of Endocrinology and Metabolism, Trabzon, Turkey.'}, {'ForeName': 'Bahittin', 'Initials': 'B', 'LastName': 'Kahveci', 'Affiliation': 'Karadeniz Technical University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Trabzon, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Göktaş', 'Affiliation': 'Hacettepe University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Ankara, Turkey. Electronic address: zeynep.goktas@hacettepe.edu.tr.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2021.107892']
1803,33685740,Effect of computer-assisted design and manufacturing cutting and drilling guides accompanied with pre-bent titanium plates on the correction of skeletal class II malocclusion: a randomized controlled trial.,"This study was performed to assess the effect of correcting skeletal class II malocclusion based on the application of computer-assisted design and manufacturing (CAD/CAM) cutting and drilling guides accompanied with pre-bent titanium plates. Fifty patients with skeletal class II malocclusion were recruited into this prospective randomized controlled clinical trial and assigned to two groups. Patients underwent bilateral sagittal split ramus osteotomy directed by CAD/CAM cutting and drilling guides accompanied with pre-bent titanium plates (group A) or CAD/CAM splints (group B). Postoperative assessments were performed. Differences between the virtually simulated and postoperative models were measured. Patients in both groups had a satisfactory occlusion and appearance. More accurate repositioning of the proximal segment was found in group A than in group B when comparing linear and angular differences to reference planes; however, no significant difference was revealed for the distal segment. In conclusion, CAD/CAM cutting and drilling guides with pre-bent titanium plates can provide considerable surgical accuracy for the positional control of the proximal segments in bilateral sagittal split ramus osteotomy for the correction of skeletal class II deformities.",2021,"More accurate repositioning of the proximal segment was found in group A than in group B when comparing linear and angular differences to reference planes; however, no significant difference was revealed for the distal segment.","['skeletal class II malocclusion', 'Fifty patients with skeletal class II malocclusion']","['computer-assisted design and manufacturing cutting and drilling guides accompanied with pre-bent titanium plates', 'computer-assisted design and manufacturing (CAD/CAM) cutting and drilling guides accompanied with pre-bent titanium plates', 'bilateral sagittal split ramus osteotomy directed by CAD/CAM cutting and drilling guides accompanied with pre-bent titanium plates (group A) or CAD/CAM splints']","['accurate repositioning of the proximal segment', 'satisfactory occlusion and appearance']","[{'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3178772', 'cui_str': 'Sagittal Split Ramus Osteotomy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0038009', 'cui_str': 'Splint'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",50.0,0.0234074,"More accurate repositioning of the proximal segment was found in group A than in group B when comparing linear and angular differences to reference planes; however, no significant difference was revealed for the distal segment.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Shanghai Stomatological Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Department of Stomatology, Sichuan Academy of Medical Science and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Stomatology, Sichuan Academy of Medical Science and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Liao', 'Affiliation': ""Department of Stomatology, Sichuan Academy of Medical Science and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fei', 'Affiliation': ""Department of Stomatology, Sichuan Academy of Medical Science and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Luo', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China. Electronic address: Luoen521125@sina.com.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2021.01.023']
1804,33685639,A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures.,,2021,,['Extra-articular Distal Tibial Fractures'],['Plating with Intramedullary Nailing'],[],"[{'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]",[],,0.11942,,"[{'ForeName': 'Rong-Xun', 'Initials': 'RX', 'LastName': 'Qian', 'Affiliation': 'Department of Joint Surgery, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu, 215300, China. Electronic address: qianrongxun2004@sina.com.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Department of Joint Surgery, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu, 215300, China. Electronic address: sgu8434@sina.com.'}]",Injury,['10.1016/j.injury.2021.02.073']
1805,33685464,Correction to: Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)-study protocol for a randomised controlled trial.,,2021,,['people with multiple sclerosis'],['interactive web-based decision-making programme'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.111325,,"[{'ForeName': 'Anne Christin', 'Initials': 'AC', 'LastName': 'Rahn', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. anne.christin.rahn@uni-oldenburg.de.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stahmann', 'Affiliation': 'MS Forschungs- und Projektentwicklungs-gGmbH, Hannover, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Scheiderbauer', 'Affiliation': 'Stiftung für Selbstbestimmung und Selbstvertretung von MS-Betroffenen, Trier, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Grentzenberg', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vomhof', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Montalbo', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical, Göttingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heesen', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute of Nursing Science, University Hospital Cologne and Faculty of Medicine, University of Cologne, Cologne, Germany.'}]",Trials,['10.1186/s13063-021-05152-5']
1806,33685434,The association between experiencing homelessness in childhood or youth and adult housing stability in Housing First.,"BACKGROUND


Researchers have pointed out the paucity of research investigating long-term consequences of experiencing homelessness in childhood or youth. Limited research has indicated that the experience of homelessness in childhood or youth is associated with adverse adjustment-related consequences in adulthood. Housing First (HF) has acknowledged effectiveness in improving housing outcomes among adults experiencing homelessness and living with serious mental illness, although some HF clients struggle with maintaining housing. The current study was conducted to examine whether the experience of homelessness in childhood or youth increases the odds of poorer housing stability following entry into high-fidelity HF among adults experiencing serious mental illness and who were formerly homeless.
METHODS


Data were drawn from the active intervention arms of a HF randomized controlled trial in Metro Vancouver, Canada. Participants (n = 297) were referred to the study from service agencies serving adults experiencing homelessness and mental illness between October 2009 and June 2011. The Residential Time-Line Follow-Back Inventory was used to measure housing stability. Least absolute shrinkage and selection operator was used to estimate the association between first experiencing homelessness in childhood or youth and later housing stability as an adult in HF.
RESULTS


Analyses indicated that homelessness in childhood or youth was negatively associated with experiencing housing stability as an adult in HF (aOR = 0.53; 95% CI = 0.31-0.90).
CONCLUSIONS


Further supports are needed within HF to increase housing stability among adult clients who have experienced homelessness in childhood or youth. Asking clients about the age they first experienced homelessness may be of clinical utility upon enrollment in HF and may help identify support needs related to developmental experiences. Results further emphasize the importance of intervening earlier in life in childhood and youth before experiencing homelessness or before it becomes chronic. Findings also contribute to a limited knowledge base regarding the adverse long-term consequences of childhood and youth homelessness.
TRIAL REGISTRATION


Current Controlled Trials: ISRCTN57595077 and ISRCTN66721740 . Registered on October 9, 2012.",2021,"Housing First (HF) has acknowledged effectiveness in improving housing outcomes among adults experiencing homelessness and living with serious mental illness, although some HF clients struggle with maintaining housing.","['Participants (n\u2009=\u2009297) were referred to the study from service agencies serving adults experiencing homelessness and mental illness between October 2009 and June 2011', 'adults experiencing serious mental illness and who were formerly homeless', 'Data were drawn from the active intervention arms of a HF randomized controlled trial in Metro Vancouver, Canada', 'adults experiencing homelessness and living with serious mental illness', 'adult clients who have experienced homelessness in childhood or youth']",['Housing First (HF'],['experiencing housing stability'],"[{'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0483409,"Housing First (HF) has acknowledged effectiveness in improving housing outcomes among adults experiencing homelessness and living with serious mental illness, although some HF clients struggle with maintaining housing.","[{'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Parpouchi', 'Affiliation': 'Somers Research Group, Faculty of Health Sciences, Simon Fraser University, Blusson Hall, Room 11300, 8888 University Drive, Burnaby, British Columbia, V5A 1S6, Canada. spa16@sfu.ca.'}, {'ForeName': 'Akm', 'Initials': 'A', 'LastName': 'Moniruzzaman', 'Affiliation': 'Somers Research Group, Faculty of Health Sciences, Simon Fraser University, Blusson Hall, Room 11300, 8888 University Drive, Burnaby, British Columbia, V5A 1S6, Canada.'}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Somers', 'Affiliation': 'Somers Research Group, Faculty of Health Sciences, Simon Fraser University, Blusson Hall, Room 11300, 8888 University Drive, Burnaby, British Columbia, V5A 1S6, Canada.'}]",BMC psychiatry,['10.1186/s12888-021-03142-0']
1807,33685421,A randomized phase II study of S-1 monotherapy versus cisplatin with vinorelbine for completely resected stage II/IIIA non-small cell lung cancer: rationale and study protocol design for the LOGIK1702 study.,"BACKGROUND


The current standard postoperative treatment for stage II-IIIA non-small cell lung cancer (NSCLC) is a regimen of platinum doublet adjuvant chemotherapy. These regimens, which are the same as for solid NSCLC tumors, often cause severe adverse reactions in the treated patients. Therefore, an effective treatment regimen with fewer side effects is needed.
METHODS/DESIGN


The purpose of this study is to evaluate the effectiveness and safety of S-1 monotherapy (80 mg/m 2  orally administrated twice daily, at day 1-14, 16 cycles) and cisplatin with vinorelbine combination therapy (cisplatin 80 mg/m 2  at day 1,vinorelbine 25 mg/m 2  at day 1, 8, 4 cycles) in patients with II/IIIA stage non-small-cell lung cancer who underwent a total resection. In addition, we will also evaluate the level of treatment side effects by assessing quality of life (QOL), work productivity and activity performance. The primary endpoint is a 2-year relapse free survival (RFS) and the second primary endpoints are 2-year overall survival (OS), rate of treatment completion, safety, work productivity and activity, and quality of adjusted life years (QALY). At the same time, we aim to obtain precise information required to perform future phase 3 randomized controlled trials. The study is designed to estimate the primary endpoint with accuracy determined as the width of its 95% confidence interval to be less than 20%. Recruitment started in May 2017 and is ongoing.
DISCUSSION


This study has been conceived to establish a superior regimen for completely resected NSCLC based on efficacy, safety and QOL.
TRIAL REGISTRATION


Registry number: UMIN000027435 . Registered May 22, 2017.",2021,"The primary endpoint is a 2-year relapse free survival (RFS) and the second primary endpoints are 2-year overall survival (OS), rate of treatment completion, safety, work productivity and activity, and quality of adjusted life years (QALY).","['completely resected stage II/IIIA non-small cell lung cancer', 'stage II-IIIA non-small cell lung cancer', 'patients with II/IIIA stage non-small-cell lung cancer who underwent a total resection']","['platinum doublet adjuvant chemotherapy', 'cisplatin with vinorelbine combination therapy (cisplatin 80\u2009mg/m 2  at day 1,vinorelbine', 'S-1 monotherapy', 'S-1 monotherapy versus cisplatin with vinorelbine']","['quality of life (QOL), work productivity and activity performance', '2-year overall survival (OS), rate of treatment completion, safety, work productivity and activity, and quality of adjusted life years (QALY', '2-year relapse free survival (RFS']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",,0.255057,"The primary endpoint is a 2-year relapse free survival (RFS) and the second primary endpoints are 2-year overall survival (OS), rate of treatment completion, safety, work productivity and activity, and quality of adjusted life years (QALY).","[{'ForeName': 'Tomoshi', 'Initials': 'T', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan. tomoshi@nagasaki-u.ac.jp.'}, {'ForeName': 'Keitaro', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan.'}, {'ForeName': 'Ryoichiro', 'Initials': 'R', 'LastName': 'Doi', 'Affiliation': 'Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Medical Information Center, Kyushu University Hospital, Kyushu, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Second department of Internal medicine, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Tomoshige', 'Affiliation': 'Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan.'}, {'ForeName': 'Hironosuke', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagayasu', 'Affiliation': 'Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.'}]",BMC cancer,['10.1186/s12885-021-07945-y']
1808,33685418,Effectiveness and cost effectiveness of a stress management training for leaders of small and medium sized enterprises - study protocol for a randomized controlled-trial.,"BACKGROUND


Leaders in small and medium-sized enterprises (SMEs) are exposed to increased stress as a result of a range of challenges. Moreover, they rarely have the opportunity to participate in stress management trainings. Therefore, KMU-GO (ger: Kleine und mittlere Unternehmen - Gesundheitsoffensive; en: small and medium-sized enterprises - health campaign) aims at conducting and evaluating such a stress management training. The focus of evaluation does not only lie on the effects on leaders participating but also on their employees.
METHODS


The study is planned as a 2 × 3 mixed design with two groups (intervention and waiting control group) as a between factor and point in time (at baseline, 6 and 12 months later) as a within factor. We aim at collecting data from N = 200 leaders. Based on the results of a preceding assessment, an already successfully implemented stress management training was adapted to SME needs and now serves as the framework of this intervention. The stress management training comprises one and a half days and is followed by two booster sessions (each 180 min) about 3 and 6 months after the training. The main focus of this intervention lies on specifying leaders stress reactivity while at the same time investigating its effects on employees' mental health. Further dependent variables are leaders´ depression and anxiety scores, effort-reward imbalance, sick days and psychophysiological measures of heart rate variability, hair cortisol, and salivary alpha-amylase. Cost-effectiveness analyses will be conducted from a societal and employers' point of view.
DISCUSSION


Stress management is a highly relevant issue for leaders in SMEs. By providing an adequate occupational stress management training, we expect to improve leaders´ and also employees` mental health, thereby preventing economic losses for SMEs and the national economy. However, collecting data from employees about the success of a stress management training of their leader is a highly sensitive topic. It requires a carefully planned proceeding ensuring for example a high degree of transparency, anonymity, and providing team incentives.
TRIAL REGISTRATION


The KMU-GO trial is registered at the German Clinical Trial Register (DRKS): DRKS00023457 (05.11.2020).",2021,"By providing an adequate occupational stress management training, we expect to improve leaders´ and also employees` mental health, thereby preventing economic losses for SMEs and the national economy.","['N\u2009=\u2009200 leaders', ""employees' mental health""]",['stress management training'],"['Effectiveness and cost effectiveness', 'leaders´ depression and anxiety scores, effort-reward imbalance, sick days and psychophysiological measures of heart rate variability, hair cortisol, and salivary alpha-amylase']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0242806', 'cui_str': 'Illness Days'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}]",,0.0280181,"By providing an adequate occupational stress management training, we expect to improve leaders´ and also employees` mental health, thereby preventing economic losses for SMEs and the national economy.","[{'ForeName': 'J A M', 'Initials': 'JAM', 'LastName': 'Lehmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Albert-Einstein-Allee 23, 89081, Ulm, Germany. janina.lehmann@uni-ulm.de.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schwarz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Rahmani Azad', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen Osianderstraße 5, 72076, Tübingen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gritzka', 'Affiliation': 'Institute of Occupational and Social Medicine, Heinrich-Heine-University Düsseldorf, Universitätsstraße 1, 40225, Düsseldorf, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Seifried-Dübon', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen Osianderstraße 5, 72076, Tübingen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diebig', 'Affiliation': 'Institute of Occupational and Social Medicine, Heinrich-Heine-University Düsseldorf, Universitätsstraße 1, 40225, Düsseldorf, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gast', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kilian', 'Affiliation': 'Department of Psychiatry II, Ulm University and Bezirkskrankenhaus Günzburg, Ludwig-Heilmeyer-Str. 2, 89312, Günzburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Nater', 'Affiliation': 'Department for Clinical and Health Psychology, Wien University, Liebiggasse 5, 1010, Wien, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jarczok', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kessemeier', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research, Faculty of Medicine, University of Freiburg, Breisacher Str. 153, 79110, Freiburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Braun', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Balint', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rothermund', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Junne', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen Osianderstraße 5, 72076, Tübingen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Angerer', 'Affiliation': 'Institute of Occupational and Social Medicine, Heinrich-Heine-University Düsseldorf, Universitätsstraße 1, 40225, Düsseldorf, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gündel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}]",BMC public health,['10.1186/s12889-021-10398-4']
1809,33685411,"Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial.","BACKGROUND


Aboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are the primary pathogens. We compared otitis media outcomes in infants randomised to either a combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A), with recommended schedules for each vaccine alone. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months.
METHODS


In an open-label superiority trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P) at 2-4-6 months (_PPP), Synflorix™ (S) at 2-4-6 months (_SSS), or Synflorix™ at 1-2-4 months plus Prevenar13™ at 6 months (SSSP). Ears were assessed using tympanometry at 1 and 2 months, combined with otoscopy at 4, 6, and 7 months. A worst ear diagnosis was made for each child visit according to a severity hierarchy of normal, otitis media with effusion (OME), acute otitis media without perforation (AOMwoP), AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM).
RESULTS


Between September 2011 and September 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). Ear assessments were successful in 96% scheduled visits. At 7 months prevalence of any OM was 91, 86, and 90% in the _PPP, _SSS, and SSSP groups, respectively. There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age. Combined group prevalence of any OM was 43, 57, 82, 87, and 89% at 1, 2, 4, 6, and 7 months of age, respectively. Of 388 infants with ear assessments at 4, 6 and 7 months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM.
CONCLUSIONS


Despite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life.
TRIAL REGISTRATION


ACTRN12610000544077 registered 06/07/2010 and ClinicalTrials.gov NCT01174849 registered 04/08/2010.",2021,There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age.,"['Between September 2011 and September 2017', 'Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6\u2009months', '388 infants with ear assessments at 4, 6 and 7\u2009months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM', 'Aboriginal children living in Australian remote communities', 'Aboriginal infants at 28 to 38\u2009days of age, to either Prevenar13™', '425 infants were allocated to _PPP(143), ']","['Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi', 'SSSP(141', 'combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A']","['AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM', 'prevalence of otitis media nor healthy ears', 'prevalence of any form of otitis media']","[{'cui': 'C0029882', 'cui_str': 'Otitis media'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0138826', 'cui_str': 'glpQ protein, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2756364', 'cui_str': 'Prevnar 13'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}]","[{'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C3252923', 'cui_str': 'synflorix'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0450819', 'cui_str': 'CV10'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2756364', 'cui_str': 'Prevnar 13'}]","[{'cui': 'C0004519', 'cui_str': 'Azoxymethane'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0029882', 'cui_str': 'Otitis media'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",425.0,0.147845,There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age.,"[{'ForeName': 'Amanda Jane', 'Initials': 'AJ', 'LastName': 'Leach', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia. amanda.leach@menzies.edu.au.'}, {'ForeName': 'Edward Kim', 'Initials': 'EK', 'LastName': 'Mulholland', 'Affiliation': ""Murdoch Children's Research Institute, Department of Paediatrics, University of Melbourne, Melbourne, Australia.""}, {'ForeName': 'Mathuram', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Paul John', 'Initials': 'PJ', 'LastName': 'Torzillo', 'Affiliation': 'Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McIntyre', 'Affiliation': 'National Centre for Immunization Research and Surveillance, Sydney, NSW, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Smith-Vaughan', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Arrowsmith', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Jemima', 'Initials': 'J', 'LastName': 'Beissbarth', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Oguoma', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Peter Stanley', 'Initials': 'PS', 'LastName': 'Morris', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Casuarina, Northern Territory, Australia.'}]",BMC pediatrics,['10.1186/s12887-021-02552-z']
1810,33684828,The effects of home visiting on mother-child interactions: Evidence from a randomized trial using dynamic micro-level data.,"BACKGROUND


Home visiting programs constitute an important policy to support vulnerable families with young children. One of their principal aims is to improve infant-parent relationships, so a key measure of their effectiveness is based on observational measures of parent-children interactions. In the present study we provide novel evidence on the effectiveness of home visiting programs in improving mother-child interactions within a randomized controlled trial (RCT) of the Pro Kind program. A major goal of the Pro Kind program is to promote child development by strengthening the intuitive parenting skills of mothers. On this basis, the following research question is addressed in this paper: What is the impact of the Pro Kind home visitation program on the quality of mother-child interaction?
METHODS


A randomly chosen subsample of the original sample was selected to participate on video recordings. This subsample of 109 mother-child dyads was videotaped during a 3-min typical play situation at the participants' homes when the child was aged 25 months. We use a novel micro-coding system which allows us to examine how the intervention affected the dynamic feedback responses of both mothers and children in three key measures of behavior: orientation, positive contingency, and negative/lack of contingency. The analysis was conducted using a set of static probit models and dynamic cross-lagged panel probit models for each measure.
RESULTS


The intervention significantly improved the interactions between girls and their mothers, by increasing the prevalence of orientation and positive contingency (and reducing that of negative/lack of contingency). This was achieved by increasing both the persistence of positive behaviors and also the probability of switching from negative to positive behaviors in the treatment group. Mixed impacts were detected for boys.
CONCLUSIONS


Overall, it can be said that the Pro Kind program has a positive impact on the quality of mother-daughter interaction. However, our findings might also influence the design and delivery of home visiting programs, to the extent that they suggest that more attention has to be devoted to the interactions between boys and their mothers. Furthermore, the results show the importance of careful dynamic modelling of interactions data from videotaped observations to have a more complete understanding of the effectiveness of home visiting programs.",2021,"The intervention significantly improved the interactions between girls and their mothers, by increasing the prevalence of orientation and positive contingency (and reducing that of negative/lack of contingency).","[""109 mother-child dyads was videotaped during a 3-min typical play situation at the participants' homes when the child was aged 25 months"", 'families with young children']","['home visiting', 'home visiting programs']",['prevalence of orientation and positive contingency'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557118', 'cui_str': 'Family with young children'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0241227,"The intervention significantly improved the interactions between girls and their mothers, by increasing the prevalence of orientation and positive contingency (and reducing that of negative/lack of contingency).","[{'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': 'Department of Economics and Social Research Institute, University College London, United Kingdom.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Poupakis', 'Affiliation': 'Institute for Global Health, University College London, United Kingdom. Electronic address: s.poupakis@ucl.ac.uk.'}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Sandner', 'Affiliation': 'Institute for Employment Research Institute, IAB, Germany.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Kliem', 'Affiliation': 'Ernst-Abbe-Hochschule Jena - University of Applied Sciences, Germany.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105021']
1811,33684737,Omega-3 fatty acids reduce cardiometabolic risk in first-episode schizophrenia patients treated with antipsychotics: Findings from the OFFER randomized controlled study.,"Metabolic syndrome (MetS) increases the risk of premature mortality observed in schizophrenia (SCZ). N-3 polyunsaturated fatty acid (PUFA) deficiency has been reported in different stages of schizophrenia. N-3 PUFA supplementation was found to be beneficial in both chronic SCZ and MetS. No intervention studies based on n-3 PUFA as add-on therapy to antipsychotics have examined the changes in MetS risk in first-episode schizophrenia.
AIM


This randomized placebo-controlled trial assesses the effect of a 26-week intervention composed of either 2.2 g/day of n-3 PUFA or olive oil placebo on the frequency of MetS and the changes in its constituents as a secondary outcome measure.
METHODS


Seventy-one adult inpatients diagnosed with first-episode schizophrenia were randomly assigned to study groups. The active intervention used a 3:2 mixture of eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids. Metabolic syndrome components were monitored throughout the study.
RESULTS


A significant reduction in the frequency of MetS was observed in the EPA + DHA group (p = 0.0408); as well as some specific MetS components: e.g., a decrease in fasting blood glucose (p = 0.045). The beneficial effects of EPA + DHA were even more pronounced in patients treated mainly with olanzapine, e.g. significant reductions of total cholesterol (p = 0.037) and blood glucose levels (p = 0.034). Significant positive correlations were found between the general psychopathology subscale of PANSS (primary outcome) and triglyceride level changes.
CONCLUSION


N-3 PUFA supplementation in early SCZ may constitute a safe and affordable intervention that can reduce the risk of MetS and its lethal complications.",2021,"e.g., a decrease in fasting blood glucose (p = 0.045).","['Seventy-one adult inpatients diagnosed with first-episode schizophrenia', 'first-episode schizophrenia patients treated with']","['Omega-3 fatty acids', 'placebo', 'n-3 PUFA or olive oil placebo', 'N-3 polyunsaturated fatty acid (PUFA', 'eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids', 'PUFA supplementation', 'N-3 PUFA supplementation', 'antipsychotics', 'olanzapine']","['frequency of MetS', 'general psychopathology subscale of PANSS (primary outcome) and triglyceride level changes', 'cardiometabolic risk', 'blood glucose levels', 'fasting blood glucose', 'total cholesterol', 'Metabolic syndrome components', 'specific MetS components']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",71.0,0.046108,"e.g., a decrease in fasting blood glucose (p = 0.045).","[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Pawełczyk', 'Affiliation': 'Department of Affective and Psychotic Disorders, Medical University of Lodz, ul. Czechoslowacka 8/10, 92-216 Lodz, Poland. Electronic address: tomasz.pawelczyk@umed.lodz.pl.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Grancow-Grabka', 'Affiliation': 'Child and Adolescent Psychiatry Unit, Central Teaching Hospital, Medical University of Lodz, ul. Pomorska 251, 92-213 Lodz, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Żurner', 'Affiliation': 'Child and Adolescent Psychiatry Unit, Central Teaching Hospital, Medical University of Lodz, ul. Pomorska 251, 92-213 Lodz, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Pawełczyk', 'Affiliation': 'Department of Neurosurgery, Spine and Peripheral Nerve Surgery, Medical University of Lodz, ul. Żeromskiego 113, 90-549 Lodz, Poland.'}]",Schizophrenia research,['10.1016/j.schres.2021.02.012']
1812,33684595,Continuous infusion versus intermittent administration of meropenem in critically ill patients (MERCY): A multicenter randomized double-blind trial. Rationale and design.,"OBJECTIVE


Meropenem is a β-lactam, carbapenem antibacterial agent with antimicrobial activity against gram-negative, gram-positive and anaerobic micro-organisms and is important in the empirical treatment of serious infections in Intensive Care Unit (ICU) patients. Multi-drug resistant gram-negative organisms, coupled with scarcity of new antibiotic classes, forced healthcare community to optimize the therapeutic potential of available antibiotics. Our aim is to investigate the effect of continuous infusion of meropenem against bolus administration, as indicated by a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens in a population of ICU patients.
DESIGN


Double blind, double dummy, multicenter randomized controlled trial (1:1 allocation ratio).
SETTING


Tertiary and University hospitals.
INTERVENTIONS


600 ICU patients with sepsis or septic shock, needing by clinical judgment antibiotic therapy with meropenem, will be randomized to receive a continuous infusion of meropenem 3 g/24 h or an equal dose divided into three daily boluses (i.e. 1g q8h).
MEASUREMENTS


The primary endpoint will be a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens. Secondary endpoints will be death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score from randomization to day 28 and the two, separate, components of the primary endpoint. We expect a primary outcome reduction from 52 to 40% in the continuous infusion group.
CONCLUSIONS


The trial will provide evidence for choosing intermittent or continuous infusion of meropenem for critically ill patients with multi-drug resistant gram-negative infections.",2021,"Secondary endpoints will be death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score from randomization to day 28 and the two, separate, components of the primary endpoint.","['critically ill patients with multi-drug resistant gram-negative infections', 'a population of ICU patients', 'Intensive Care Unit (ICU) patients', 'critically ill patients (MERCY', '600 ICU patients with sepsis or septic shock, needing by clinical judgment antibiotic therapy with', 'Tertiary and University hospitals']","['meropenem', 'Meropenem']","['composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens', 'death and emergence of extensive or pan drug-resistant pathogens', 'death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",600.0,0.746191,"Secondary endpoints will be death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score from randomization to day 28 and the two, separate, components of the primary endpoint.","[{'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Monti', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: landoni.giovanni@hsr.it.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Galbiati', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Toffoletto', 'Affiliation': 'Azienda ULSS 4 Veneto Orientale, San Donà di Piave (VE), Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Calabrò', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Colombo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ferrara', 'Affiliation': 'Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giardina', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Lembo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Marzaroli', 'Affiliation': 'Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Moizo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Mucci', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pasculli', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Plumari', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Anna Mara', 'Initials': 'AM', 'LastName': 'Scandroglio', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Tozzi', 'Affiliation': 'Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Momesso', 'Affiliation': 'Azienda ULSS 4 Veneto Orientale, San Donà di Piave (VE), Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Boffa', 'Affiliation': 'Azienda ULSS 4 Veneto Orientale, San Donà di Piave (VE), Italy.'}, {'ForeName': 'Rosetta', 'Initials': 'R', 'LastName': 'Lobreglio', 'Affiliation': 'Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Montrucchio', 'Affiliation': 'Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Guarracino', 'Affiliation': 'Azienda Ospedaliera - Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi-Zoccai', 'Affiliation': 'Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': ""D'Ascenzo"", 'Affiliation': 'Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Natascia', 'Initials': 'N', 'LastName': ""D'Andrea"", 'Affiliation': 'Università degli Studi di Udine, Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Paternoster', 'Affiliation': 'Azienda Ospedaliera Regionale ""San Carlo"", Potenza, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ananiadou', 'Affiliation': 'ASST Cremona - Presidio Ospedaliero di Cremona, Cremona, Italy.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Ballestra', 'Affiliation': 'Ente Ospedaliero Ospedali Galliera, Genova, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'De Sio', 'Affiliation': 'Pineta Grande Hospital, Castel Volturno (CE), Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pota', 'Affiliation': 'Università degli Studi della Campania Luigi Vanvitelli, Napoli, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cotoia', 'Affiliation': 'University Hospital O.O.R.R. Foggia, Foggia, Italy.'}, {'ForeName': 'Andrea Della', 'Initials': 'AD', 'LastName': 'Selva', 'Affiliation': 'Azienda Sanitaria Locale CN2 Alba - Bra, Alba (CN), Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': 'Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Iapichino', 'Affiliation': 'IRCCS Humanitas Clinical and Research Center, Rozzano (MI), Italy.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Bradić', 'Affiliation': 'University Hospital Dubrava, Zagreb, Croatia.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Corradi', 'Affiliation': 'Azienda Ospedaliera - Universitaria Pisana, Pisa, Italy; Ente Ospedaliero Ospedali Galliera, Genova, Italy; Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gemma', 'Affiliation': 'ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico, Milan, Italy.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Nogtev', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Petrova', 'Affiliation': 'Federal Research and Clinical Center of Resuscitation and Rehabilitation, Moscow, Russia.'}, {'ForeName': 'Felice Eugenio', 'Initials': 'FE', 'LastName': 'Agrò', 'Affiliation': 'Campus Bio Medico University and Teaching Hospital, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cabrini', 'Affiliation': ""ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi di Varese, Varese, Italy; Università degli Studi dell'Insubria, Varese, Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Forfori', 'Affiliation': 'Azienda Ospedaliera - Universitaria Pisana, Pisa, Italy; Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Likhvantsev', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia; Federal Research and Clinical Center of Resuscitation and Rehabilitation, Moscow, Russia.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Bove', 'Affiliation': 'Università degli Studi di Udine, Udine, Italy; Azienda Sanitaria Universitaria Friuli Centrale - Presidio Ospedaliero Universitario Santa Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Finco', 'Affiliation': 'Università degli Studi di Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zangrillo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106346']
1813,33684596,Predicting deseasonalised serum 25 hydroxy vitamin D concentrations in the D-Health Trial: An analysis using boosted regression trees.,"BACKGROUND


The D-Health Trial aims to determine whether monthly high-dose vitamin D supplementation can reduce the mortality rate and prevent cancer. We did not have adequate statistical power for subgroup analyses, so could not justify the high cost of collecting blood samples at baseline. To enable future exploratory analyses stratified by baseline vitamin D status, we developed models to predict baseline serum 25 hydroxy vitamin D [25(OH)D] concentration.
METHODS


We used data and serum 25(OH)D concentrations from participants who gave a blood sample during the trial for compliance monitoring and were randomised to placebo. Data were partitioned into training (80%) and validation (20%) datasets. Deseasonalised serum 25(OH)D concentrations were dichotomised using cut-points of 50, 60 and 75 nmol/L. We fitted boosted regression tree models, based on 13 predictors, and evaluated model performance using the validation data.
RESULTS


The training and validation datasets had 1788 (10.5% <50 nmol/L, 23.1% <60 nmol, 48.8 <75 nmol/L) and 447 (11.9% <50 nmol/L, 25.7% <60 nmol/L, and 49.2% <75 nmol/L) samples, respectively. Ambient UV radiation and total intake of vitamin D were the strongest predictors of 'low' serum 25(OH)D concentration. The area under the receiver operating characteristic curves were 0.71, 0.70, and 0.66 for cut-points of <50, <60 and <75 nmol/L respectively.
CONCLUSIONS


We exploited compliance monitoring data to develop models to predict serum 25(OH)D concentration for D-Health participants at baseline. This approach may prove useful in other trial settings where there is an obstacle to exhaustive data collection.",2021,Ambient UV radiation and total intake of vitamin D were the strongest predictors of 'low' serum 25(OH)D concentration.,['participants who gave a blood sample during the trial for compliance monitoring'],"['vitamin D supplementation', 'placebo']","['mortality rate and prevent cancer', 'Deseasonalised serum 25(OH)D concentrations', 'Ambient UV radiation and total intake of vitamin D']","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",,0.180473,Ambient UV radiation and total intake of vitamin D were the strongest predictors of 'low' serum 25(OH)D concentration.,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Waterhouse', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: mary.waterhouse@qimrberghofer.edu.au.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Baxter', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Catherine.Baxter@qimrberghofer.edu.au.'}, {'ForeName': 'Briony Duarte', 'Initials': 'BD', 'LastName': 'Romero', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Briony.DuarteRomero@qimrberghofer.edu.au.'}, {'ForeName': 'Donald S A', 'Initials': 'DSA', 'LastName': 'McLeod', 'Affiliation': ""Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; Department of Endocrinology and Diabetes, Royal Brisbane and Women's Hospital, Brisbane, Australia. Electronic address: Donald.McLeod@qimrberghofer.edu.au.""}, {'ForeName': 'Dallas R', 'Initials': 'DR', 'LastName': 'English', 'Affiliation': 'Melbourne School of Population Health, University of Melbourne, Cancer Epidemiology and Intelligence Division, Cancer Council Victoria, Melbourne, Australia. Electronic address: d.english@unimelb.edu.au.'}, {'ForeName': 'Bruce K', 'Initials': 'BK', 'LastName': 'Armstrong', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, Australia. Electronic address: bruce@brucekarmstrong.org.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Clarke', 'Affiliation': 'Metabolomics Australia, Centre for Microscopy, Characterisation and Analysis, The University of Western Australia, Perth, Australia.. Electronic address: michael.clarke@uwa.edu.au.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, Australia. Electronic address: peter.ebeling@monash.edu.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Hartel', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Gunter.Hartel@qimrberghofer.edu.au.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kimlin', 'Affiliation': 'Queensland University of Technology (QUT), School of Biomedical Sciences, Faculty of Health, Brisbane, Australia. Electronic address: m.kimlin@qut.edu.au.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': ""O'Connell"", 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia. Electronic address: rachel.oconnell@ctc.usyd.edu.au.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Pham', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Public Health, The University of Queensland, Brisbane, Australia. Electronic address: Hai.Pham@qimrberghofer.edu.au.'}, {'ForeName': 'Rachael M', 'Initials': 'RM', 'LastName': 'Rodney Harris', 'Affiliation': 'National Centre for Epidemiology and Population Health, College of Health & Medicine, The Australian National University, Canberra, Australia. Electronic address: Rachael.Rodney@anu.edu.au.'}, {'ForeName': 'Jolieke C', 'Initials': 'JC', 'LastName': 'van der Pols', 'Affiliation': 'Queensland University of Technology (QUT), School of Exercise and Nutrition Sciences, Faculty of Health, Brisbane, Australia. Electronic address: j.vanderpols@qut.edu.au.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Venn', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia. Electronic address: alison.venn@utas.edu.au.'}, {'ForeName': 'Penelope M', 'Initials': 'PM', 'LastName': 'Webb', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Penny.Webb@qimrberghofer.edu.au.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Whiteman', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: David.Whiteman@qimrberghofer.edu.au.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Neale', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Public Health, The University of Queensland, Brisbane, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106347']
1814,33684548,Tumescent Local Anesthesia Versus General Anesthesia for Subcutaneous Implantable Cardioverter-Defibrillator Implantation.,"BACKGROUND


Subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous ICD (T-ICD). General anesthesia (GA) is considered the standard sedation approach due to the pain caused by the manipulation of subcutaneous tissue with S-ICD implantation. However, GA carries several limitations, including additional risk for adverse events, prolonged in-room times, and increased costs.
OBJECTIVE


Define the effectiveness and safety of tumescent local anesthesia (TLA) in comparison to GA in patients undergoing S-ICD implantation.
METHODS


We performed a prospective non-randomized controlled multi-center study of patients referred for S-ICD implantation between 2019 and 2020. Patients were allocated to either TLA or GA based on patient's preferences and/or anesthesia service availability. TLA was prepared using lidocaine, epinephrine, sodium bicarbonate, and sodium chloride. All patients provided written informed consent, and the institutional review board at each site provided approval for the study.
RESULTS


60 patients underwent successful S-ICD implantation from July 2019 to November 2020. 30 patients (50%) received TLA and the rest GA. There were no differences between groups regarding baseline characteristics. In-room and procedural times were significantly shorter with TLA (107.6 vs. 186 min; p value <0.0001 and 53.2 vs 153.7 min; p<0.0001, respectively). Pain was reported less frequently by TLA patients. The use of opioids was significantly reduced in TLA patients (23% vs 62%, p=0.002).
CONCLUSION


TLA is an effective and safe alternative to GA in S-ICD implantation. Use of TLA is associated with shorter in-room and procedural times, less post-procedural pain, and reduced usage of opioids for analgesia.",2021,"The use of opioids was significantly reduced in TLA patients (23% vs 62%, p=0.002).
","['patients undergoing S-ICD implantation', '60 patients underwent successful S-ICD implantation from July 2019 to November 2020', 'patients referred for S-ICD implantation between 2019 and 2020']","['TLA', 'Subcutaneous implantable cardioverter-defibrillator (S-ICD', 'Subcutaneous Implantable Cardioverter-Defibrillator Implantation', 'TLA or GA', 'TLA and the rest GA', 'Tumescent Local Anesthesia Versus General Anesthesia', 'General anesthesia (GA', 'tumescent local anesthesia (TLA', 'lidocaine, epinephrine, sodium bicarbonate, and sodium chloride']",['Pain'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0460145,"The use of opioids was significantly reduced in TLA patients (23% vs 62%, p=0.002).
","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Bello', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Díaz', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US; Clinica Las Americas, Medellin, Colombia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grushko', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Velasco', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Briceno', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Gabr', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Sutopa', 'Initials': 'S', 'LastName': 'Purkayastha', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Alviz', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Dalvert', 'Initials': 'D', 'LastName': 'Polanco', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Della Rocca', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX, US.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Krumerman', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Palma', 'Affiliation': 'Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US.'}, {'ForeName': 'Dhanunjaya', 'Initials': 'D', 'LastName': 'Lakkireddy', 'Affiliation': 'Kansas City Heart Rhythm Institute, Overland Park, KS, US.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natale', 'Affiliation': ""Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US; Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX, US.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Di Biase', 'Affiliation': ""Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, US; Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX, US. Electronic address: dibbia@gmail.com.""}]",Heart rhythm,['10.1016/j.hrthm.2021.03.008']
1815,33684508,"Adverse event recording failed to reflect potential harms: A review of trial protocols of behavioural, lifestyle and psychological therapy interventions.","OBJECTIVE


To explore how potential harms are assessed in trials of behavioural, lifestyle and psychological therapy interventions.
STUDY DESIGN AND SETTING


This study was a review of protocols from the National Institute of Health Research Health Technology Assessment and Public Health Research programmes. Protocols were included if the study was a randomised controlled trial and the intervention intended to change lifestyle or behaviour to improve health or improve psychological outcomes.
RESULTS


95 of 151 protocols planned to record adverse events (AEs). Definitions of AEs were often not given and varied widely. Serious AEs were mostly defined using standards originally devised for pharmacological trials. Twenty-two protocols listed expected AEs. Few protocols described assessment of causation between AEs and intervention. Examples of useful AE recording practice were identified.
CONCLUSION


Monitoring and recording AEs in behavioural intervention trials was variable and frequently based on reporting guidelines for pharmacological trials. This may mean potential harms are being missed. Future trials should consider: 1) Potential harms posed by the intervention 2) How to define serious AEs 3) What are expected AEs. Further research to achieve consensus on AE recording is required, including identification of core adverse outcomes in clinical areas or caused by interventions.",2021,"RESULTS


95 of 151 protocols planned to record adverse events (AEs).",[],"['behavioural, lifestyle and psychological therapy interventions']",['adverse events (AEs'],[],"[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0474774,"RESULTS


95 of 151 protocols planned to record adverse events (AEs).","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Papaioannou', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom.. Electronic address: d.papaioannou@sheffield.ac.uk.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Mooney', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Glover', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coates', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2021.03.002']
1816,33684506,Fructose- and sucrose- but not glucose-sweetened beverages promote hepatic de novo lipogenesis: A randomized controlled trial.,"BACKGROUND & AIMS


Excessive fructose intake associates with increased de novo lipogenesis, blood triglycerides, and hepatic insulin resistance. Whether fructose-specific effects on lipid metabolism in healthy men exist independently from overfeeding needs clarification.
METHODS


94 subjects were studied in this double-blind, randomized trial. They were assigned to daily consumption of sugar-sweetened beverages (SSB) containing moderate amounts of fructose, sucrose (fructose-glucose disaccharide) or glucose (80g/day) in addition to their usual diet or SSB abstinence (control group) for seven weeks. De novo fatty acid (FA) and triglyceride (TAG) synthesis, lipolysis and plasma free FA (FFA) oxidation were assessed by tracer methodology.
RESULTS


Daily intake of beverages sweetened with free fructose and fructose combined with glucose (sucrose) increased basal fractional secretion rates (FSR) of newly synthesized FA by the liver 2-fold compared to control (median FSR %/day: sucrose 20.8 (p=0.0015); fructose 19.7 (p=0.013); control 9.1). Conversely, the same amounts of glucose did not change FSR (median of FSR %/day 11.0 (ns)). Fructose intake did not change basal secretion of newly synthesized VLDL-TAG. It did neither alter rates of peripheral lipolysis nor total FA and plasma FFA oxidation. Total energy intake was similar across groups with SSB intake and controls.
CONCLUSIONS


Regular consumption of both fructose and sucrose sweetened beverages in moderate doses associated with stable caloric intake increases hepatic FA synthesis even in a basal state, whereas this effect is not observed after consumption of glucose. These findings support the hypothesis of an adaptative response of the liver to regular fructose exposure, i. e. habitual SSB consumption. The study has a trial registration number of NCT01733563 (www.clinicaltrials.gov).",2021,"RESULTS


Daily intake of beverages sweetened with free fructose and fructose combined with glucose (sucrose) increased basal fractional secretion rates (FSR) of newly synthesized FA by the liver 2-fold compared to control (median FSR %/day: sucrose 20.8 (p=0.0015); fructose 19.7 (p=0.013); control 9.1).","['healthy men exist independently from overfeeding needs clarification', '94 subjects']","['daily consumption of sugar-sweetened beverages (SSB) containing moderate amounts of fructose, sucrose (fructose-glucose disaccharide) or glucose (80g/day) in addition to their usual diet or SSB abstinence (control group', 'Fructose- and sucrose- but not glucose-sweetened beverages']","['De novo fatty acid (FA) and triglyceride (TAG) synthesis, lipolysis and plasma free FA (FFA) oxidation', 'basal fractional secretion rates (FSR) of newly synthesized FA', 'lipid metabolism', 'hepatic FA synthesis', 'rates of peripheral lipolysis nor total FA and plasma FFA oxidation', 'Total energy intake']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",94.0,0.155447,"RESULTS


Daily intake of beverages sweetened with free fructose and fructose combined with glucose (sucrose) increased basal fractional secretion rates (FSR) of newly synthesized FA by the liver 2-fold compared to control (median FSR %/day: sucrose 20.8 (p=0.0015); fructose 19.7 (p=0.013); control 9.1).","[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Geidl-Flueck', 'Affiliation': 'Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Zurich (USZ) and University of Zurich (UZH), Switzerland. Electronic address: bettina.geidl@usz.ch.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Hochuli', 'Affiliation': 'Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Zurich (USZ) and University of Zurich (UZH), Switzerland; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), University Hospital Bern, Switzerland.'}, {'ForeName': 'Ágota', 'Initials': 'Á', 'LastName': 'Németh', 'Affiliation': 'Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Zurich (USZ) and University of Zurich (UZH), Switzerland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Eberl', 'Affiliation': 'Institute for Biomedicine and Health Sciences, Joanneum Research, Graz, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Derron', 'Affiliation': 'Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Zurich (USZ) and University of Zurich (UZH), Switzerland.'}, {'ForeName': 'Harald C', 'Initials': 'HC', 'LastName': 'Köfeler', 'Affiliation': 'Core Facility Mass Spectrometry, Medical University of Graz, Austria.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Tappy', 'Affiliation': 'Department of Physiology, University of Lausanne, Switzerland.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Berneis', 'Affiliation': 'Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Zurich (USZ) and University of Zurich (UZH), Switzerland.'}, {'ForeName': 'Giatgen A', 'Initials': 'GA', 'LastName': 'Spinas', 'Affiliation': 'Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Zurich (USZ) and University of Zurich (UZH), Switzerland.'}, {'ForeName': 'Philipp A', 'Initials': 'PA', 'LastName': 'Gerber', 'Affiliation': 'Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Zurich (USZ) and University of Zurich (UZH), Switzerland.'}]",Journal of hepatology,['10.1016/j.jhep.2021.02.027']
1817,33684150,Comparative study on the effect of hyperthermic massage and mechanical squeezing in the patients with mild and severe meibomian gland dysfunction: An interventional case series.,"BACKGROUND


Meibomian glands exist beneath the palpebral conjunctiva; thus, it is invisible to the naked eye without infrared imaging. This study used meibography to group patients with meibomian gland dysfunction (MGD) and assessed the effects of hyperthermic massage and mechanical squeezing in both groups.
MATERIALS AND METHODS


Patients with MGD were divided into two groups, according to the degree of meibomian gland loss: group 1, in which the sum of eyelid scores ranged from 0 to 4 (mild to moderate gland loss) and group 2, in which the sum of eyelid scores ranged from 5 to 6 (severe gland loss). Hyperthermic massage and mechanical squeezing were given to both groups once a week for 4 weeks, and only non-preservative artificial tears were allowed. Ocular surface disease index (OSDI), Schirmer's test, meibography score, tear break-up time (TBUT), ocular surface staining, expressible meibomian gland, and quality before and after treatment were compared.
RESULTS


Of the 49 patients who completed the 4 weeks of treatment and the evaluation at week 5, 29 were assigned to group 1 and 20 were assigned to group 2. Meibography scores, OSDI, TBUT, and expressibility of meibum had significant differences before and after treatments in both groups. However, there was no significant difference between the changes in clinical signs between group 1 and 2 after treatment. Without grouping, all patients showed significant decreases in meibography score, OSDI, cornea staining score, and increases in TBUT and expressibility of meibum after treatment.
CONCLUSIONS


Considering the results of the current study, hyperthermic massage and mechanical squeezing may be effective in patients with meibomian gland loss, regardless of the degree of severity.",2021,"Without grouping, all patients showed significant decreases in meibography score, OSDI, cornea staining score, and increases in TBUT and expressibility of meibum after treatment.
","['patients with meibomian gland loss', 'patients with mild and severe meibomian gland dysfunction', 'group patients with meibomian gland dysfunction (MGD', '49 patients who completed the 4 weeks of treatment and the evaluation at week 5', 'Patients with MGD']","['meibography', 'Hyperthermic massage and mechanical squeezing', 'hyperthermic massage and mechanical squeezing']","['clinical signs', 'meibography score, OSDI, cornea staining score, and increases in TBUT and expressibility of meibum', ""Ocular surface disease index (OSDI), Schirmer's test, meibography score, tear break-up time (TBUT), ocular surface staining, expressible meibomian gland, and quality"", 'Meibography scores, OSDI, TBUT, and expressibility of meibum']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0860500', 'cui_str': 'Staining cornea'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C5197842', 'cui_str': 'Meibomian Lipids'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",49.0,0.027345,"Without grouping, all patients showed significant decreases in meibography score, OSDI, cornea staining score, and increases in TBUT and expressibility of meibum after treatment.
","[{'ForeName': 'Dongkyun', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Dankook University, Cheonan, Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Dankook University, Cheonan, Republic of Korea.'}, {'ForeName': 'Sehwan', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Beckman Laser Institute Korea, Dankook University, Cheoan, Republic of Korea.'}, {'ForeName': 'Yuli', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Dankook University, Cheonan, Republic of Korea.'}, {'ForeName': 'Kyong Jin', 'Initials': 'KJ', 'LastName': 'Cho', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Dankook University, Cheonan, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0247365']
1818,33684086,Prevention of Cardiac Surgery-Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial.,"BACKGROUND


Prospective, single-center trials have shown that the implementation of the Kidney Disease: Improving Global Outcomes (KDIGO) recommendations in high-risk patients significantly reduced the development of acute kidney injury (AKI) after surgery. We sought to evaluate the feasibility of implementing a bundle of supportive measures based on the KDIGO guideline in high-risk patients undergoing cardiac surgery in a multicenter setting in preparation for a large definitive trial.
METHODS


In this multicenter, multinational, randomized controlled trial, we examined the adherence to the KDIGO bundle consisting of optimization of volume status and hemodynamics, functional hemodynamic monitoring, avoidance of nephrotoxic drugs, and prevention of hyperglycemia in high-risk patients identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 [TIMP-2] and insulin growth factor-binding protein 7 [IGFBP7] after cardiac surgery. The primary end point was the adherence to the bundle protocol and was evaluated by the percentage of compliant patients with a 95% confidence interval (CI) according to Clopper-Pearson. Secondary end points included the development and severity of AKI.
RESULTS


In total, 278 patients were included in the final analysis. In the intervention group, 65.4% of patients received the complete bundle as compared to 4.2% in the control group (absolute risk reduction [ARR] 61.2 [95% CI, 52.6-69.9]; P < .001). AKI rates were statistically not different in both groups (46.3% intervention versus 41.5% control group; ARR -4.8% [95% CI, -16.4 to 6.9]; P = .423). However, the occurrence of moderate and severe AKI was significantly lower in the intervention group as compared to the control group (14.0% vs 23.9%; ARR 10.0% [95% CI, 0.9-19.1]; P = .034). There were no significant effects on other specified secondary outcomes.
CONCLUSIONS


Implementation of a KDIGO-derived treatment bundle is feasible in a multinational setting. Furthermore, moderate to severe AKI was significantly reduced in the intervention group.",2021,"AKI rates were statistically not different in both groups (46.3% intervention versus 41.5% control group; ARR -4.8% [95% CI, -16.4 to 6.9]; P = .423).","['278 patients were included in the final analysis', 'high-risk patients undergoing cardiac surgery in a multicenter setting in preparation for a large definitive trial', 'High-Risk Patients Identified by Biomarkers']",[],"['moderate to severe AKI', 'AKI rates', 'development and severity of AKI', 'occurrence of moderate and severe AKI', 'adherence to the bundle protocol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",[],"[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",278.0,0.126598,"AKI rates were statistically not different in both groups (46.3% intervention versus 41.5% control group; ARR -4.8% [95% CI, -16.4 to 6.9]; P = .423).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Küllmar', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, Guy's & St Thomas' National Health Service Foundation Hospital, London, United Kingdom.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lucchese', 'Affiliation': ""Department of Critical Care, Guy's & St Thomas' National Health Service Foundation Hospital, London, United Kingdom.""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Baig', 'Affiliation': ""Department of Critical Care, Guy's & St Thomas' National Health Service Foundation Hospital, London, United Kingdom.""}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Cennamo', 'Affiliation': ""Department of Critical Care, Guy's & St Thomas' National Health Service Foundation Hospital, London, United Kingdom.""}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Rajani', 'Affiliation': ""Department of Critical Care, Guy's & St Thomas' National Health Service Foundation Hospital, London, United Kingdom.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McCorkell', 'Affiliation': ""Department of Critical Care, Guy's & St Thomas' National Health Service Foundation Hospital, London, United Kingdom.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Arndt', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine.'}, {'ForeName': 'Hinnerk', 'Initials': 'H', 'LastName': 'Wulf', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Irqsusi', 'Affiliation': 'Department of Cardiac Surgery, University Hospital Marburg, Marburg, Germany.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': 'Department of Anesthesia and Intensive Care, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Ambra Licia', 'Initials': 'AL', 'LastName': 'Di Prima', 'Affiliation': 'Department of Anesthesia and Intensive Care, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'García Alvarez', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Italiano', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Miralles Bagan', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Kunst', 'Affiliation': ""Department of Anesthetics, King's College Hospital, Denmark Hill, London, United Kingdom.""}, {'ForeName': 'Shrijit', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': ""Department of Anesthetics, King's College Hospital, Denmark Hill, London, United Kingdom.""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': ""L'Acqua"", 'Affiliation': 'Department of Anesthesia and Critical Care, Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hoste', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital Gent, Gent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Vandenberghe', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital Gent, Gent, Belgium.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Honore', 'Affiliation': 'Department of Intensive Care, CHU Brugmann University Hospital, Brussels, Belgium.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kellum', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Department of Intensive Care Medicine, Royal Surrey County Hospital & Faculty of Health Sciences, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grieshaber', 'Affiliation': 'Department of Cardiac Surgery, University Hospital Giessen, Giessen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Massoth', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gerss', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Wempe', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005458']
1819,33684023,"Effects of Home-Delivered Meals on Older People's Protein Intake, Physical Performance, and Health-Related Quality of Life: The Power Meals Randomized Controlled Trial.","This trial examined the effectiveness of an 8-week home meal service on protein and other nutrient intake, physical performance (PP) and health related quality of life (HRQoL) among older people living at home (≥65 years; home care clients, caregivers and care recipients). Participants were randomized into three groups; (1) protein-rich meal, snack, and bread (INT1), (2) regular meal (INT2) and (3) control group. Nutrient intake was assessed with 3-day food diaries, PP with Short Physical Performance Battery (SBBP) and HRQoL with 15 dimensional Health-related quality of life instrument. Total of 67 (59.7% women, mean age 78.2 years) participants ( n  = 22 INT1,  n  = 24 INT2,  n  = 21 CG) completed the trial. At baseline, mean protein intake was 0.92 (SD 0.32) g/kg adjusted body weight (aBW)/d. At 8 weeks, protein-rich home meal service in INT1 increased protein intake (+ 0.11 (95%CI -0.01 to 0.21) g/kg aBW/d, 9.4 (95%CI 1.0 to 17.8) g/d) compared to other groups. It also increased calcium intake (+169.9 (95%CI 26 to 314) mg/d) and improved results in Sit-to-Stand Test (-4.8 (95%CI -6.8 to -2.7) sec) in INT1 compared to CG. Both home meal services increased saturated fat intake (INT1; 4.6 (95%CI 1.0-8.2) g/d, INT2;7.8 (95%CI 1.9 to 13.7)g/d) and decreased salt intake (INT1;-2330.9 (95%CI -2998 to -1664) mg/d, INT2; -2371.9 (95%CI -3399 to -1345) mg/d) compared to CG. There was no effect on overall HRQoL.",2021,"mg/d, INT2; -2371.9 (95%CI -3399 to -1345)","['Total of 67 (59.7% women, mean age 78.2\u2009years) participants ( n \u2009=\u200922 INT1,  n \u2009=\u200924 INT2,  n \u2009=\u200921 CG) completed the trial', 'older people living at home (≥65\u2009years; home care clients, caregivers and care recipients']","['Home-Delivered Meals', 'protein-rich meal, snack, and bread (INT1), (2) regular meal (INT2) and (3) control group']","['Sit-to-Stand Test', 'calcium intake', ""Older People's Protein Intake, Physical Performance, and Health-Related Quality of Life"", 'saturated fat intake', 'salt intake', 'overall HRQoL', '3-day food diaries, PP with Short Physical Performance Battery (SBBP) and HRQoL with 15 dimensional Health-related quality of life instrument', 'mean protein intake', 'protein intake', 'protein and other nutrient intake, physical performance (PP) and health related quality of life (HRQoL']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0444661', 'cui_str': 'Protein-rich meal'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3653937', 'cui_str': 'OTHER NUTRIENTS'}]",,0.123587,"mg/d, INT2; -2371.9 (95%CI -3399 to -1345)","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Kunvik', 'Affiliation': 'Pori Social and Health Services, Pori, Finland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rautakallio-Järvinen', 'Affiliation': 'Pori Social and Health Services, Pori, Finland.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Laaksonen', 'Affiliation': 'Oy Karl Fazer Ab Research Team, Helsinki, Finland.'}, {'ForeName': 'Raisa', 'Initials': 'R', 'LastName': 'Valve', 'Affiliation': 'Department of Food and Environmental Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Maritta', 'Initials': 'M', 'LastName': 'Salonoja', 'Affiliation': 'Pori Social and Health Services, Pori, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Fogelholm', 'Affiliation': 'Compass Group FS Finland Oy, Helsinki, Finland.'}, {'ForeName': 'Merja H', 'Initials': 'MH', 'LastName': 'Suominen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Helsinki, Finland.'}]",Journal of nutrition in gerontology and geriatrics,['10.1080/21551197.2021.1892562']
1820,33684015,"Manual therapy reduces the frequency of clinical hemarthrosis and improves range of motion and perceived disability in patients with hemophilic elbow arthropathy. A randomized, single-blind, clinical trial.","PURPOSE


To evaluate the effectiveness of manual therapy in reducing the frequency of clinical hemarthrosis, increasing range of motion and improving the perception of disability in the upper limbs in patients with hemophilic elbow arthropathy.
MATERIALS AND METHODS


Sixty-nine patients were randomized into experimental ( N  = 35) and control group ( N  = 34). The outcome measures were: frequency of clinical hemarthrosis, the elbow range of motion and the perception of disability in the upper limbs (DASH questionnaire). The intervention included one 50 min weekly session, for three weeks, of upper limb fascial therapy according to our treatment protocol.
RESULTS


There were differences ( p  < 0.001) in the repeated measures analysis for frequency of elbow clinical hemarthrosis ( F  = 20.64) and range of motion in flexion ( F  = 17.37) and extension ( F  = 21.71). No differences were found in the overall perceived disability ( F  = 0.91;  p  = .37). We found group interaction with the ( p  < 0.001) in the frequency of elbow clinical hemarthrosis, range of motion and overall perceived disability.
CONCLUSIONS


Manual therapy is safe in patients with hemophilia and elbow arthropathy. Fascial therapy reduces the frequency of hemarthrosis, increases the range of motion and improves the perceived disability in the upper limbs.  Trial registration number:  id NCT03009591IMPLICATIONS FOR REHABILITATIONImpairments in the range of motion, pain and disability may occur in patients with hemophilic elbow arthropathy since early age.There is a need to validate safe and effectiveness protocols of rehabilitation to treat these patients.Prophylactic replacement is the most effective treatment for the prevention of hemarthrosis.Physiotherapists need to be trained in the specific management of patients with hemophilia.Manual therapy can be a safe and effective tool in the treatment of hemophilic arthropathy.",2021,"We found group interaction with the ( p  < 0.001) in the frequency of elbow clinical hemarthrosis, range of motion and overall perceived disability.
","['Sixty-nine patients', 'patients with hemophilia', 'patients with hemophilic elbow arthropathy', 'patients with hemophilia and elbow arthropathy', 'patients with hemophilic elbow arthropathy since early age']","['upper limb fascial therapy', 'Manual therapy', 'manual therapy', 'Prophylactic replacement', 'Fascial therapy']","['frequency of elbow clinical hemarthrosis, range of motion and overall perceived disability', 'range of motion in flexion', 'frequency of clinical hemarthrosis, the elbow range of motion and the perception of disability in the upper limbs (DASH questionnaire', 'overall perceived disability', 'frequency of elbow clinical hemarthrosis', 'frequency of clinical hemarthrosis and improves range of motion and perceived disability', 'frequency of hemarthrosis, increases the range of motion and improves the perceived disability']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C1997689', 'cui_str': 'Arthropathy of elbow'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018924', 'cui_str': 'Hemarthrosis'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0575649', 'cui_str': 'Elbow joint - range of movement'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",69.0,0.0353268,"We found group interaction with the ( p  < 0.001) in the frequency of elbow clinical hemarthrosis, range of motion and overall perceived disability.
","[{'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Cuesta-Barriuso', 'Affiliation': 'Department of Physiotherapy, Faculty of Sport Sciences, European University of Madrid, Madrid, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Pérez-Llanes', 'Affiliation': 'Department of Physiotherapy, Catholic University San Antonio-UCAM, Murcia, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'López-Pina', 'Affiliation': 'Department of Basic Phycology and Methodology, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Donoso-Úbeda', 'Affiliation': 'Department of Physiotherapy, Catholic University San Antonio-UCAM, Murcia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Meroño-Gallut', 'Affiliation': 'Tú. Bienestar 360°, Physiotherapy and Medical Center, San Javier-Murcia, Spain.'}]",Disability and rehabilitation,['10.1080/09638288.2021.1894607']
1821,33687747,A challenging task - Identifying patients with cancer of unknown primary (CUP) according to ESMO guidelines: the CUPISCO trial experience.,"BACKGROUND


CUPISCO is an ongoing randomized phase II trial (NCT03498521) comparing molecularly-guided therapy versus platinum-based chemotherapy in patients newly diagnosed with 'unfavorable' cancer of unknown primary (CUP).
PATIENTS AND METHODS


Patients with an unfavorable CUP diagnosis, as defined by the European Society of Medical Oncology (ESMO), and available cancer tissue for molecular sequencing are generally eligible. Potential CUP patients entering screening undergo a review involving reference histopathology and clinical work-up by a central Eligibility Review team (ERT). Patients with ""favorable"" CUP, a strongly suspected primary site of origin, lack of tissue, or unmet inclusion criteria are excluded.
RESULTS


As of April 30, 2020, 628 patients had entered screening and 346 (55.1%) were screen failed. Screen fails were due to technical reasons (N=89), failure to meet inclusion/exclusion criteria not directly related to CUP diagnosis (N=89) and other reasons (N=33). 124 (35.8%) patients were excluded because unfavorable adeno- or poorly differentiated CUP could not be confirmed by the ERT. These cases were classified into 3 groups ineligible due to (i) histologic subtype, such as squamous and neuroendocrine, or favorable CUP; (ii) evidence of a possible primary tumor or (iii) non-carcinoma histology.
CONCLUSIONS


Experience with CUPISCO has highlighted challenges with standardized screening in an international clinical trial and the difficulties in diagnosing unfavorable CUP. Re-confirmation of unfavorable CUP by an ERT in a clinical trial can result in many reasons for screen failures. By sharing this experience, we aim to foster understanding of diagnostic challenges and improve diagnostic pathology and clinical CUP algorithms.
IMPLICATIONS FOR PRACTICE


A high unmet need exists for improved treatment of cancer of unknown primary (CUP); however, study in a trial setting is faced with the significant challenge of definitively distinguishing CUP from other cancer types. Here we report on our experience of this challenge so far in the ongoing CUPISCO trial, which compares treatments guided by patients' unique genetic signatures versus standard chemotherapy. The data presented will aid future decision-making regarding diagnosing true CUP cases; this will have far-reaching implications in the design, execution and interpretation of not only CUPISCO, but also future clinical studies aiming to find much-needed treatment strategies.",2021,"The data presented will aid future decision-making regarding diagnosing true CUP cases; this will have far-reaching implications in the design, execution and interpretation of not only CUPISCO, but also future clinical studies aiming to find much-needed treatment strategies.","['patients with cancer of unknown primary (CUP', 'Patients with an unfavorable CUP diagnosis, as defined by the European Society of Medical Oncology (ESMO), and available cancer tissue for molecular sequencing are generally eligible', ""patients newly diagnosed with 'unfavorable' cancer of unknown primary (CUP"", 'These cases were classified into 3 groups ineligible due to (i) histologic subtype, such as squamous and neuroendocrine, or favorable CUP; (ii) evidence of a possible primary tumor or (iii) non-carcinoma histology', '628 patients had entered screening and 346 (55.1%) were screen failed', 'Potential CUP patients entering screening undergo a review involving reference histopathology and clinical work-up by a central Eligibility Review team (ERT', 'Patients with ""favorable"" CUP, a strongly suspected primary site of origin, lack of tissue, or unmet inclusion criteria are excluded']",['platinum-based chemotherapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0025098', 'cui_str': 'Medical oncology'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1301142', 'cui_str': 'WHO tumor classification'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]",[],,0.0416815,"The data presented will aid future decision-making regarding diagnosing true CUP cases; this will have far-reaching implications in the design, execution and interpretation of not only CUPISCO, but also future clinical studies aiming to find much-needed treatment strategies.","[{'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Pauli', 'Affiliation': 'Department of Pathology and Molecular Pathology, University and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tilmann', 'Initials': 'T', 'LastName': 'Bochtler', 'Affiliation': 'Clinical Cooperation Unit Molecular Haematology/Oncology, German Cancer Research Center (DKFZ) and Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Baciarello', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Losa', 'Affiliation': 'Medical Oncology Department, Hospital Sant Joan Despí - Moises Broggi, Barcelona, Spain.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Ross', 'Affiliation': 'Pathology Group, Foundation Medicine, Inc., Cambridge, MA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pentheroudakis', 'Affiliation': 'Department of Medical Oncology, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zarkavelis', 'Affiliation': 'Department of Medical Oncology, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Suayib', 'Initials': 'S', 'LastName': 'Yalcin', 'Affiliation': 'Department of Medical Oncology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Clinical Trial Unit, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Beringer', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Scarato', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Mueller-Ohldach', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Moch', 'Affiliation': 'Department of Pathology and Molecular Pathology, University and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Krämer', 'Affiliation': 'Clinical Cooperation Unit Molecular Haematology/Oncology, German Cancer Research Center (DKFZ) and Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.'}]",The oncologist,['10.1002/onco.13744']
1822,33687734,Tongue Cleaning Maintains Respiratory Function in Older Individuals: A one-year Randomized Controlled Trial.,"OBJECTIVE


The aim of this one-year longitudinal randomized controlled trial was to evaluate the effectiveness of tongue cleaning on the maintenance of respiratory function in older adults requiring care.
METHODS


The participants included 24 residents of two nursing homes in Kitakyushu, Japan. The participants were randomized to receive tongue cleaning with routine oral care (intervention group, n = 12,) or routine oral care alone (control group, n = 12). Among the participants, three in the intervention group and four in the control group had cerebrovascular disease history, four in the intervention group and four in the control group had a history of cardiac disease, and five in the intervention group and four in the control group were without medical history. Respiratory function was assessed on the basis of the peak expiratory flow rate (PEFR). Tongue pressure, swallowing function, oral health status, activities of daily living, and nutritional status were also measured at baseline and at the end of the one-year follow-up period.
RESULTS


The number of analyzed participants in each group was 12. In the control group, the PEFR (1.6 [0.4-4.2] L·s -1  vs. 1.4 [0.4-3.2] L·s -1  , p = 0.034) and tongue pressure (16.4 [1.7-35.2] kPa vs. 8.0 [1.4-38.6] kPa, p = 0.032) significantly declined after one-year. However, the PEFR (1.5 [0.8-2.9] L·s -1  vs. 1.6 [0.7-4.2] L·s -1  , p = 0.366) and tongue pressure (18.1 [4.2-37.1] kPa vs. 16.1 [5.2-41] kPa, p = 0.307) were maintained in the intervention group. The change in the PEFR was significantly greater in the intervention group compared to the control group (0.130 [-0.45-1.70] L·s -1  vs. -1.70 [-10.00-10.00] L·s -1  , p = 0.028).
CONCLUSION


Our findings suggest that tongue cleaning may help maintain tongue and respiratory function in older adults requiring care.",2021,The change in the PEFR was significantly greater in the intervention group compared to the control group (0.130,"['participants included 24 residents of two nursing homes in Kitakyushu, Japan', 'Older Individuals', 'older adults requiring care']","['tongue cleaning', 'Tongue Cleaning', 'tongue cleaning with routine oral care (intervention group, n = 12,) or routine oral care alone (control']","['Respiratory function', 'cerebrovascular disease history', 'PEFR', 'tongue pressure ', 'Tongue pressure, swallowing function, oral health status, activities of daily living, and nutritional status', 'peak expiratory flow rate (PEFR', 'tongue pressure', 'history of cardiac disease']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}]",,0.0693346,The change in the PEFR was significantly greater in the intervention group compared to the control group (0.130,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Izumi', 'Affiliation': 'School of Oral Health Sciences, Faculty of Dentistry, Kyushu Dental University, Kitakyushu, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Sonoki', 'Affiliation': 'School of Oral Health Sciences, Faculty of Dentistry, Kyushu Dental University, Kitakyushu, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Oota', 'Affiliation': 'Division of Comprehensive Internal Medicine, Faculty of Dentistry, Kyushu Dental University, Kitakyushu, Japan.'}, {'ForeName': 'Masayo', 'Initials': 'M', 'LastName': 'Fukuhara', 'Affiliation': 'Division of Comprehensive Internal Medicine, Faculty of Dentistry, Kyushu Dental University, Kitakyushu, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Nagata', 'Affiliation': 'Shin-eikai Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Sumio', 'Initials': 'S', 'LastName': 'Akifusa', 'Affiliation': 'School of Oral Health Sciences, Faculty of Dentistry, Kyushu Dental University, Kitakyushu, Japan.'}]",Journal of oral rehabilitation,['10.1111/joor.13165']
1823,33687692,A simulation-based pilot study of crisis checklists in the emergency department.,"Checklists can improve adherence to standardized procedures and minimize human error. We aimed to test if implementation of a checklist was feasible and effective in enhancing patient care in an emergency department handling internal medicine cases. We developed four critical event checklists and confronted volunteer teams with a series of four simulated emergency scenarios. In two scenarios, the teams were provided access to the crisis checklists in a randomized cross-over design. Simulated patient outcome plus statement of the underlying diagnosis defined the primary endpoint and adherence to key processes such as time to commence CPR represented the secondary endpoints. A questionnaire was used to capture participants' perception of clinical relevance and manageability of the checklists. Six teams of four volunteers completed a total of 24 crisis sequences. The primary endpoint was reached in 8 out of 12 sequences with and in 2 out of 12 sequences without a checklist (Odds ratio, 10; CI 1.11, 123.43; p = 0.03607, Fisher's exact test). Adherence to critical steps was significantly higher in all scenarios for which a checklist was available (performance score of 56.3% without checklist, 81.9% with checklist, p = 0.00284, linear regression model). All participants rated the checklist as useful and 22 of 24 participants would use the checklist in real life. Checklist use had no influence on CPR quality. The use of context-specific checklists showed a statistically significant influence on team performance and simulated patient outcome and contributed to adherence to standard clinical practices in emergency situations.",2021,"Adherence to critical steps was significantly higher in all scenarios for which a checklist was available (performance score of 56.3% without checklist, 81.9% with checklist, p = 0.00284, linear regression model).","['Six teams of four volunteers completed a total of 24 crisis sequences', 'emergency department handling internal medicine cases']",[],"['Adherence to critical steps', 'CPR quality', 'adherence to key processes such as time to commence CPR']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0018578', 'cui_str': 'Handling (Psychology)'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",[],"[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",4.0,0.0335437,"Adherence to critical steps was significantly higher in all scenarios for which a checklist was available (performance score of 56.3% without checklist, 81.9% with checklist, p = 0.00284, linear regression model).","[{'ForeName': 'Beatrice Billur', 'Initials': 'BB', 'LastName': 'Knoche', 'Affiliation': 'Department of Emergency Medicine, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Busche', 'Affiliation': 'Department of Emergency Medicine, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Grodd', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Hans-Jörg', 'Initials': 'HJ', 'LastName': 'Busch', 'Affiliation': 'Department of Emergency Medicine, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Soeren Sten', 'Initials': 'SS', 'LastName': 'Lienkamp', 'Affiliation': 'Department of Internal Medicine, Renal Division, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. soeren.lienkamp@uzh.ch.'}]",Internal and emergency medicine,['10.1007/s11739-021-02670-7']
1824,33687687,"Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar ®  Gel) for Persistently Active Systemic Lupus Erythematosus.","INTRODUCTION


We assessed patient-reported outcomes from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar ®  Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids.
METHODS


The trial enrolled adults with active SLE and moderate-to-severe rash and/or arthritis despite use of stable glucocorticoids (7.5 mg/day to 30 mg/day prednisone equivalent), antimalarials, and nonsteroidal anti-inflammatory drugs for ≥ 4 weeks and/or immunosuppressants for ≥ 8 weeks before screening. Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day through week 4, then twice weekly through week 24. Primary analyses evaluated the change from baseline to week 24 in the Lupus Quality of Life (QoL) and Work Productivity and Activity Impairment (WPAI)-Lupus questionnaires. Post hoc analyses stratified results by baseline disease activity (SLE Disease Activity Index-2000 [SLEDAI-2K] < 10 or ≥ 10; Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI]-Activity < 11 or ≥ 11; and British Isles Lupus Assessment Group [BILAG]-2004 < 20 or ≥ 20) and by BILAG-based Combined Lupus Assessment (BICLA) response at weeks 20 and 24.
RESULTS


RCI treatment resulted in greater improvement in the LupusQoL pain domain at week 16 and planning domain at week 24 compared with placebo. Post hoc analyses demonstrated greater improvements with RCI in the pain, planning, and fatigue domains than with placebo at multiple time points in patients with higher disease activity by baseline SLEDAI-2K ≥ 10, CLASI-Activity ≥ 11, and BILAG-2004 ≥ 20 and/or in BICLA responders. Compared with placebo, RCI also resulted in greater improvements in percentage work time missed at week 24 in patients with baseline CLASI-Activity < 11 and in percentage impairment while working at week 16 in BICLA responders.
CONCLUSIONS


RCI may improve QoL and work productivity in patients who have persistently active SLE despite treatment with standard SLE therapy.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT02953821.",2021,"Compared with placebo, RCI also resulted in greater improvements in percentage work time missed at week 24 in patients with baseline CLASI-Activity < 11 and in percentage impairment while working at week 16 in BICLA responders.
","['patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids', 'patients who have persistently active SLE despite treatment with standard SLE therapy', 'Persistently Active Systemic Lupus Erythematosus', 'trial enrolled adults with active SLE and moderate-to-severe rash and/or arthritis despite use of\xa0stable glucocorticoids (7.5\xa0mg/day to 30\xa0mg/day prednisone equivalent), antimalarials, and nonsteroidal anti-inflammatory drugs for\u2009≥\u20094\xa0weeks']","['placebo', 'RCI or placebo', 'Repository Corticotropin Injection (Acthar ®  Gel', 'placebo, RCI', 'repository corticotropin injection (RCI; Acthar ®  Gel', 'Placebo']","['LupusQoL pain domain', 'Lupus Quality of Life (QoL) and Work Productivity and Activity Impairment (WPAI)-Lupus questionnaires', 'percentage work time missed', 'pain, planning, and fatigue domains', 'Cutaneous Lupus Erythematosus Disease Area and Severity Index', 'QoL and work productivity', 'BILAG-based Combined Lupus Assessment (BICLA) response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0718234', 'cui_str': 'Acthar'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024137', 'cui_str': 'Cutaneous lupus erythematosus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.4567,"Compared with placebo, RCI also resulted in greater improvements in percentage work time missed at week 24 in patients with baseline CLASI-Activity < 11 and in percentage impairment while working at week 16 in BICLA responders.
","[{'ForeName': 'Anca D', 'Initials': 'AD', 'LastName': 'Askanase', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA. ada20@cumc.columbia.edu.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Wan', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Panaccio', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Enxu', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Bilyk', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}]",Rheumatology and therapy,['10.1007/s40744-021-00294-z']
1825,33687643,"Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial.","Tocilizumab has been reported to attenuate the ""cytokine storm"" in COVID-19 patients. We attempted to verify the effectiveness and safety of tocilizumab therapy in COVID-19 and identify patients most likely to benefit from this treatment. We conducted a randomized, controlled, open-label multicenter trial among COVID-19 patients. The patients were randomly assigned in a 1:1 ratio to receive either tocilizumab in addition to standard care or standard care alone. The cure rate, changes of oxygen saturation and interference, and inflammation biomarkers were observed. Thirty-three patients were randomized to the tocilizumab group, and 32 patients to the control group. The cure rate in the tocilizumab group was higher than that in the control group, but the difference was not statistically significant (94.12% vs. 87.10%, rate difference 95% CI-7.19%-21.23%, P = 0.4133). The improvement in hypoxia for the tocilizumab group was higher from day 4 onward and statistically significant from day 12 (P = 0.0359). In moderate disease patients with bilateral pulmonary lesions, the hypoxia ameliorated earlier after tocilizumab treatment, and less patients (1/12, 8.33%) needed an increase of inhaled oxygen concentration compared with the controls (4/6, 66.67%; rate difference 95% CI-99.17% to-17.50%, P = 0.0217). No severe adverse events occurred. More mild temporary adverse events were recorded in tocilizumab recipients (20/34, 58.82%) than the controls (4/31, 12.90%). Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative. For patients with bilateral pulmonary lesions and elevated IL-6 levels, tocilizumab could be recommended to improve outcome.",2021,Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative.,"['COVID-19 patients', 'patients with moderate or severe COVID-19', 'moderate disease patients with bilateral pulmonary lesions', 'Thirty-three patients']","['Tocilizumab', 'tocilizumab', 'tocilizumab in addition to standard care or standard care alone']","['severe adverse events', 'cure rate, changes of oxygen saturation and interference, and inflammation biomarkers', 'improvement in hypoxia', 'cure rate', 'inhaled oxygen concentration', 'mild temporary adverse events']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0783923,Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative.,"[{'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Binqing', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230027, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Drug Clinical Trail Institution, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, China.'}, {'ForeName': 'Dongliang', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Department of Respiratory Medicine, the Second People's Hospital of Fuyang, Fuyang, 236000, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Medicine, National Key Clinical Specialty, Branch of National Clinical Research Center for Respiratory Disease, Xiangya Hospital, Central South University, Xiangya Lung Cancer Center, Xiangya Hospital, Central South University, Hunan Provincial Clinical Research Center for Respiratory Diseases, Changsha, 410000, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Intensive Care Unit, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Tianjun', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Intensive Care Unit, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Liangye', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ""Lu'an People's Hospital Affiliated to Anhui Medical University, Lu'an, 237005, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of Bengbu Medical College, Clinical Research Center for Respiratory Disease (tumor) in Anhui Province, Bengbu, 233004, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Department of Respiratory Medicine, Anqing Hospital Affiliated to Anhui Medical University, Anqing, 246000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210000, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Rheumatology and Immunology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Xia', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Yubei', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Jumei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Hematology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Immunology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Yonggang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230027, China.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Pan', 'Affiliation': 'Intensive Care Unit, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Mei', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.'}, {'ForeName': 'Haiming', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230027, China. ustcwhm@ustc.edu.cn.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China. xxlahh8@ustc.edu.cn.'}]",Frontiers of medicine,['10.1007/s11684-020-0824-3']
1826,33687633,Process Evaluation of a Faith-Based Multicomponent Behavioral Intervention to Reduce Stroke Risk in Mexican Americans in a Catholic Church Setting: The SHARE (Stroke Health and Risk Education) Project.,"Church-based stroke prevention programs for Hispanics are underutilized. The Stroke Health and Risk Education (SHARE) project, a multicomponent cluster-randomized trial, addressed key stroke risk factors among predominantly Mexican Americans in a Catholic Church setting. Process evaluation components (implementation, mechanisms of impact, and context) are described. Partner support promoted positive health behavior change. Motivational interviewing calls were perceived as helpful, however, barriers with telephone delivery were encountered. Intervention exposure was associated with theory constructs for targeted behaviors. We conclude that health behavior interventions to prevent stroke can be successfully implemented for Mexican Americans within a Catholic Church setting, with parish priest support.",2021,"We conclude that health behavior interventions to prevent stroke can be successfully implemented for Mexican Americans within a Catholic Church setting, with parish priest support.","['Mexican Americans in a Catholic Church Setting', 'Mexican Americans within a Catholic Church setting, with parish priest support', 'predominantly Mexican Americans in a Catholic Church setting']","['health behavior interventions', 'Faith-Based Multicomponent Behavioral Intervention', 'Church-based stroke prevention programs']","['positive health behavior change', 'Stroke Risk']","[{'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0242211', 'cui_str': 'Roman Catholic, follower of religion'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0558272', 'cui_str': 'Ordained priest'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]",,0.0242519,"We conclude that health behavior interventions to prevent stroke can be successfully implemented for Mexican Americans within a Catholic Church setting, with parish priest support.","[{'ForeName': 'Mellanie V', 'Initials': 'MV', 'LastName': 'Springer', 'Affiliation': 'Stroke Program, University of Michigan Medical School, 1500 E. Medical Center Drive, SPC 5855, Ann Arbor, MI, 48109-5855, USA. mvsprin@med.umich.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Conley', 'Affiliation': 'School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti, MI, USA.'}, {'ForeName': 'Brisa N', 'Initials': 'BN', 'LastName': 'Sanchez', 'Affiliation': 'Department of Epidemiology and Biostatistics, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Cowdery', 'Affiliation': 'School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti, MI, USA.'}, {'ForeName': 'Lesli E', 'Initials': 'LE', 'LastName': 'Skolarus', 'Affiliation': 'Stroke Program, University of Michigan Medical School, 1500 E. Medical Center Drive, SPC 5855, Ann Arbor, MI, 48109-5855, USA.'}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Morgenstern', 'Affiliation': 'Stroke Program, University of Michigan Medical School, 1500 E. Medical Center Drive, SPC 5855, Ann Arbor, MI, 48109-5855, USA.'}, {'ForeName': 'Devin L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'Stroke Program, University of Michigan Medical School, 1500 E. Medical Center Drive, SPC 5855, Ann Arbor, MI, 48109-5855, USA.'}]",Journal of religion and health,['10.1007/s10943-021-01216-7']
1827,33687574,Effect of CRRT combined with low-flow ECMO on canines with ARDS and hypercapnia.,"To observe the effect of continuous renal replacement therapy (CRRT) combined with low-flow extracorporeal membrane oxygenation (ECMO) of V-V mode on anti-inflammation, improving oxygenation and reducing P a CO 2  in canines with acute respiratory distress syndrome (ARDS) and hypercapnia. A total of 30 healthy adult canines were randomly divided into sham group (n = 10), ECMO (EC) group (n = 10) and CRRT + ECMO (CR + EC) group (n = 10). Sham group was only treated with invasive mechanical ventilation. EC group was also treated with ECMO. CR + EC group was treated with CRRT combined with low-flow ECMO of V-V mode besides invasive mechanical ventilation. The results showed that hazard ratio was lower in the CR + EC group. Inflammatory factors, OI values, and PaCO 2  levels were lower in the CR + EC group. There was no significant difference in the levels of MAP, CO and T among the three groups. No significant complications or death was developed in the three groups. Compared with ECMO group at T3, T6 and T9, IL-6 [(276.13 ± 8.32, 262.04 ± 7.15, 259.33 ± 7.31)ng/L VS (352.67 ± 19.24, 360.24 ± 23.58, 362.21 ± 25.24)ng/L] and TNF-α [(50.14 ± 1.75, 50.45 ± 1.81, 48.03 ± 1.24) ng/L VS (70.25 ± 3.02, 72.45 ± 3.25, 76.69 ± 2.18)ng/L] in CR + EC group were decreased (P < 0.0001). Compared with sham group, IL-6 [(343.76 ± 21.97, 345.91 ± 19.89, 340.34 ± 22.17)ng/L]and TNF-α [(68.10 ± 2.96, 67.31 ± 3.01, 70.34 ± 3.35)ng/L] of T3, T6 and T9 in CR + EC group were lower (P < 0.0001). These findings indicated that CRRT combined with low-flow ECMO of V-V mode had a positive effect on anti-inflammation, oxygenation improvement and surplus blood CO 2  removal in canines with ARDS and hypercapnia. These results provide a promising treatment regimen for ARDS.",2021,No significant complications or death was developed in the three groups.,"['30 healthy adult canines', 'canines with ARDS and hypercapnia', 'canines with acute respiratory distress syndrome (ARDS) and hypercapnia']","['CR\u2009+\u2009EC', 'CRRT', 'ECMO (EC', 'invasive mechanical ventilation', 'continuous renal replacement therapy (CRRT) combined with low-flow extracorporeal membrane oxygenation (ECMO) of V-V mode', 'CRRT combined with low-flow ECMO', 'CRRT\u2009+\u2009ECMO (CR\u2009+\u2009EC', 'EC', 'ECMO']","['levels of MAP, CO and T', 'Inflammatory factors, OI values, and PaCO 2  levels', 'hazard ratio', 'complications or death', 'anti-inflammation, oxygenation improvement and surplus blood CO']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]","[{'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",30.0,0.055767,No significant complications or death was developed in the three groups.,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Nanjing Lishui People's Hospital, Nanjing, 211100, China. zhixinairen7812@163.com.""}, {'ForeName': 'Mengqing', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Department of Nephrology, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211100, China.'}, {'ForeName': 'Hanchao', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Department of Nephrology, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211100, China.'}, {'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211100, China.'}, {'ForeName': 'Daorong', 'Initials': 'D', 'LastName': 'Hou', 'Affiliation': 'Key Laboratory of Model Animal Research, Animal Core Facility of Nanjing Medical University, Nanjing Medical University, Nanjing, 211166, China.'}, {'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Department of ICU, the First Affiliated Hospital of Hunan University of Medicine, Huaihua, 418000, Hunan, China. 1976841746@qq.com.'}]",Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs,['10.1007/s10047-021-01253-9']
1828,33687375,[Integrated social and health care supported by home telemonitoring in patients with heart failure: the European SmartCare project in the Friuli Venezia Giulia Region].,"BACKGROUND


Home care for patients with chronic diseases and specifically with heart failure (HF) is one of the main challenges of health care for the future. Telemedicine, applied to HF, allows intensive home monitoring of the most advanced patients, improving their prognosis and quality of life. The European SmartCare project was carried out in the Friuli Venezia Giulia (FVG) region with the aim of improving integrated health and social care in patients with chronic non-communicable diseases (CNCD) through home telemonitoring (TM) and promoting self-management and patient empowerment.
METHODS


The SmartCare project in FVG was a prospective, randomized and controlled cohort study that enrolled, from November 2014 to February 2016, 201 patients in integrated home care (""usual care"" [UC] in our study) to TM (n=100) or UC (n=101). Inclusion criteria were age >50 years, at least 1 CNCD (HF, chronic obstructive pulmonary disease, or diabetes) and 1 missing BADL. There were 19 drop-outs (9%) (12 in the TM arm; 7 in the UC arm; p=NS). All patients were followed by a multiprofessional team and stratified in the short-term pathway (3-6 months; average 4 ± 1 months; n=101), enrolled at discharge from hospitalization, or in the long-term pathway (6-12 months; mean 10 ± 3 months; n=100) for frail/chronic patients already followed in home care.
RESULTS


The most frequent main diagnosis was HF (n=108, 54%), followed by diabetes (30%) and chronic obstructive pulmonary disease (16%). A Charlson score ≥3 was present in 75% of cases and over 60% were taking at least 7 drugs. Among the social characteristics of the enrolled population, 55% were living alone or with non-familial caregivers, 62% had primary education and 48% were non-self-sufficient. The days of hospitalization were significantly reduced only in the TM arm of the post-acute pathway (20 days of hospitalization avoided for 10 patient-months of follow-up, p=0.03) and the effect was mainly evident in patients with HF (p=0.02). A significant increase in the number of home accesses and telephone contacts were also documented in the TM group (12.7 and 13.7 more home interventions for 10 patient-months of follow-up; p=0.01 and p=0.002 in the post-acute and chronic pathway, respectively).
CONCLUSIONS


The SmartCare-FVG project showed in patients with chronic diseases (mainly HF), in the post-acute phase of the disease, to significantly reduce the days of hospitalization with a limited and sustainable increase in the use of nursing home care resources.",2021,"The days of hospitalization were significantly reduced only in the TM arm of the post-acute pathway (20 days of hospitalization avoided for 10 patient-months of follow-up, p=0.03) and the effect was mainly evident in patients with HF (p=0.02).","['All patients were followed by a multiprofessional team and stratified in the short-term pathway (3-6 months; average 4 ± 1 months; n=101), enrolled at discharge from hospitalization, or in the long-term pathway (6-12 months; mean 10 ± 3 months; n=100) for frail/chronic patients already followed in home care', 'patients with heart failure', 'enrolled, from November 2014 to February 2016, 201 patients in integrated home care (""usual care"" [UC] in our study) to TM (n=100) or UC (n=101', 'patients with chronic diseases and specifically with heart failure (HF', 'patients with chronic non-communicable diseases (CNCD) through home telemonitoring (TM) and promoting self-management and patient empowerment', 'Inclusion criteria were age >50 years, at least 1 CNCD (HF, chronic obstructive pulmonary disease, or diabetes) and 1 missing BADL', 'patients with chronic diseases (mainly HF']",['Telemedicine'],"['chronic obstructive pulmonary disease', 'number of home accesses and telephone contacts', 'days of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0237015,"The days of hospitalization were significantly reduced only in the TM arm of the post-acute pathway (20 days of hospitalization avoided for 10 patient-months of follow-up, p=0.03) and the effect was mainly evident in patients with HF (p=0.02).","[{'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Radini', 'Affiliation': 'S.C. Cardiovascolare e Medicina dello Sport, Ospedale Maggiore di Trieste, Azienda Sanitaria Universitaria Giuliano Isontina.'}, {'ForeName': 'Gianmatteo', 'Initials': 'G', 'LastName': 'Apuzzo', 'Affiliation': 'S.C. Cardiovascolare e Medicina dello Sport, Ospedale Maggiore di Trieste, Azienda Sanitaria Universitaria Giuliano Isontina.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Pellizzari', 'Affiliation': 'S.C. Servizio Infermieristico, Azienda Sanitaria Universitaria Friuli Centrale.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Canciani', 'Affiliation': 'Distretto Sanitario di Udine, Azienda Sanitaria Universitaria Friuli Centrale.'}, {'ForeName': 'Ofelia', 'Initials': 'O', 'LastName': 'Altomare', 'Affiliation': 'Distretto Sanitario n. 3 Trieste, Azienda Sanitaria Universitaria Giuliano Isontina.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gabrielli', 'Affiliation': 'Dipartimento di Assistenza Primaria Aziendale, Azienda Sanitaria Friuli Occidentale.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Stellato', 'Affiliation': 'S.C. Cardiovascolare e Medicina dello Sport, Ospedale Maggiore di Trieste, Azienda Sanitaria Universitaria Giuliano Isontina.'}, {'ForeName': 'Maila', 'Initials': 'M', 'LastName': 'Mislej', 'Affiliation': 'Già Direttore della Direzione Infermieristica, Azienda Sanitaria Universitaria Integrata di Trieste.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Maggiore', 'Affiliation': 'Direttore Sanitario, Azienda Sanitaria Universitaria Giuliano Isontina.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Delli Quadri', 'Affiliation': 'Già Direttore Generale, Azienda Sanitaria Universitaria Integrata di Trieste.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Marcolongo', 'Affiliation': ""Direttore Generale, Azienda Ospedaliero-Universitaria Sant'Andrea, Roma.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Di Lenarda', 'Affiliation': 'S.C. Cardiovascolare e Medicina dello Sport, Ospedale Maggiore di Trieste, Azienda Sanitaria Universitaria Giuliano Isontina.'}]",Giornale italiano di cardiologia (2006),['10.1714/3557.35342']
1829,33687370,"[The AFFIRM-AHF trial: results, impact of COVID-19 and clinical implications].",,2021,,[],[],[],[],[],[],,0.0395849,,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Di Tano', 'Affiliation': 'U.O. Cardiologia, Ospedale, ASST di Cremona.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Navazio', 'Affiliation': 'U.O. Cardiologia Ospedaliera, Presidio Ospedaliero ASMN, Azienda USL di Reggio Emilia - IRCCS.'}]",Giornale italiano di cardiologia (2006),['10.1714/3557.35337']
1830,33687336,Development of a Web-Based Intervention Course to Promote Students' Well-Being and Studying in Universities: Protocol for an Experimental Study Design.,"BACKGROUND


The decline in the well-being among university students well as increasing dropouts has become a serious issue in universities around the world. Thus, effective ways to support students' well-being and their ability to study are highly needed.
OBJECTIVE


The purpose of this study was to build an intervention course for university students, which promotes both students' well-being as well as their learning and study skills, and to describe the experimental study design that explores the effects of this intervention course.
METHODS


Research has shown that psychological flexibility has a great effect on the well-being as well as the study skills of students pursuing higher education. The basis of our intervention course was to promote psychological flexibility and students' study skills with the help of peer support and reflection.
RESULTS


This course was offered as a voluntary course to all the students at the University of Helsinki twice during the academic year 2020-2021. The first course was from October to December and the second course was from January to March. This course was advertised in fall 2020 through social media and by different student organizations and program leaders at different faculties of the University of Helsinki. As of October 2020, we enrolled 566 students comprising 310 students for the course in fall 2020 and 256 students for the course in spring 2021. Of the 256 students who enrolled in the second course, 170 students voluntarily participated in this study and they answered the questionnaires, including all the measures, simultaneously with the participants in the first group and thus served as the control group. The effect of this course will be measured with multiple data, including questionnaire data, reflective journals, and physiological data of well-being with a longitudinal experimental design. This research very strictly follows the ethical guidelines drawn up by the Finnish National Board on Research Integrity. We expect to publish the results of this study in fall 2021 at the latest.
CONCLUSIONS


We argue that a web-based, 8-week intervention course, which promotes both student well-being and their study skills, is a good way to support students pursuing higher education, and both aspects should be considered when supporting university students.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/23613.",2021,"We argue that a web-based, 8-week intervention course, which promotes both student well-being and their study skills, is a good way to support students pursuing higher education, and both aspects should be considered when supporting university students.
","['fall 2020 through social media and by different student organizations and program leaders at different faculties of the University of Helsinki', 'university students', '256 students who enrolled in the second course, 170 students voluntarily participated in this study and they answered the questionnaires, including all the measures, simultaneously with the participants in the first group and thus served as the control group', 'students at the University of Helsinki twice during the academic year 2020-2021', 'As of October 2020, we enrolled 566 students comprising 310 students for the course in fall 2020 and 256 students for the course in spring 2021', 'students pursuing higher education']",[],[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0424933', 'cui_str': 'Higher education'}]",[],[],566.0,0.013776,"We argue that a web-based, 8-week intervention course, which promotes both student well-being and their study skills, is a good way to support students pursuing higher education, and both aspects should be considered when supporting university students.
","[{'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Asikainen', 'Affiliation': 'Faculty of Educational Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Katajavuori', 'Affiliation': 'Faculty of Educational Sciences, University of Helsinki, Helsinki, Finland.'}]",JMIR research protocols,['10.2196/23613']
1831,33687323,Perceived benefits of a brief acupuncture for sleep disturbances in post-deployment military service members.,"STUDY OBJECTIVES


The purpose of this study was to describe the perceived benefits of a manual standardized stress acupuncture (MSSA) for sleep disturbances (SD) in service members with deployment exposure.
METHODS


This qualitative study was imbedded in a two-arm randomized controlled trial, mixed-methods research that evaluated the effect of weekly MSSA for four weeks as an adjunct treatment with an abbreviated cognitive behavioral therapy for insomnia (CBTi) for SD in service members. Participants were randomized to either the experimental group (CBTi and MSSA) and control group (CBTi only). CBTi consisted of one group psychotherapy for 60 minutes, a follow-up telephone therapy for 30 minutes, and additional four 30-minute follow-up sessions via telephone. Participants provided written journal entries by answering five open-ended questions about their treatment experiences at week five during the posttreatment assessment. Journal log entries were transcribed verbatim in the Dedoose software. A thematic content analysis method was used to code emerging themes.
RESULTS


Three overarching categories were found from the qualitative data: personal challenges in implementing the CBTi sleep strategies, no perception of improvement from treatment, and perceived benefits of treatment. The CBTi/MSSA group reported greater benefits in sleep and in other life areas including mental, physical, and social functioning using thematic content analysis.
CONCLUSIONS


Findings of this study showed greater improvements in participants' sleep, mood, physical health, and occupational and social functioning after receiving the combination of CBTi and MSSA. Future research that investigates the long-term effects of CBTi and MSSA may be beneficial among post-deployment service members.
CLINICAL TRIAL REGISTRATION


Our study was conducted as part of a mixed-methods study registered with clinicaltrials.gov identifier: NCT04031365.",2021,Participants were randomized to either the experimental group (CBTi and MSSA) and control group (CBTi only).,"['insomnia (CBTi) for SD in service members', 'sleep disturbances (SD) in service members with deployment exposure', 'post-deployment military service members']","['acupuncture', 'abbreviated cognitive behavioral therapy', 'manual standardized stress acupuncture (MSSA', 'MSSA', 'experimental group (CBTi and MSSA) and control group (CBTi only', 'CBTi and MSSA']","[""participants' sleep, mood, physical health, and occupational and social functioning"", 'mental, physical, and social functioning', 'written journal entries', 'sleep disturbances']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",,0.0990039,Participants were randomized to either the experimental group (CBTi and MSSA) and control group (CBTi only).,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Abanes', 'Affiliation': 'U.S. Naval Hospital, Okinawa, Japan.'}, {'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'Vanderbilt University School of Nursing, Nashville, Tennessee.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Rhoten', 'Affiliation': 'Vanderbilt University School of Nursing, Nashville, Tennessee.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9222']
1832,33687321,Interrater reliability between in-person and telemedicine evaluations in obstructive sleep apnea.,"STUDY OBJECTIVES


We examined how telemedicine evaluation compares to face-to-face evaluation in identifying risk for sleep disordered breathing.
METHODS


This was a randomized interrater reliability study of 90 participants referred to a university sleep center. Participants were evaluated by a clinician investigator seeing the patient in-person, and then randomized to a second clinician investigator who performed a patient evaluation online via audio-video conferencing. The primary comparator was pretest probability for obstructive sleep apnea.
RESULTS


The primary outcome comparing pretest probability for obstructive sleep apnea showed a weighted kappa value of 0.414 (SE 0.090, p=0.002), suggesting moderate agreement between the two raters. Kappa values of our secondary outcomes varied widely, but the kappa values were lower for physical exam findings as compared to historical elements.
CONCLUSIONS


Evaluation for pretest probability for OSA via telemedicine has a moderate interrater correlation with in-person assessment. A low degree of interrater reliability for physical exam elements suggests telemedicine assessment for OSA could be hampered by a suboptimal physical exam. Employing standardized scales for obstructive sleep apnea when performing telemedicine evaluations may help with risk-stratification, and ultimately lead to more tailored clinical management.",2021,"The primary outcome comparing pretest probability for obstructive sleep apnea showed a weighted kappa value of 0.414 (SE 0.090, p=0.002), suggesting moderate agreement between the two raters.","['90 participants referred to a university sleep center', 'obstructive sleep apnea']",['patient evaluation online via audio-video conferencing'],"['Interrater reliability', 'pretest probability for obstructive sleep apnea']","[{'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",90.0,0.038973,"The primary outcome comparing pretest probability for obstructive sleep apnea showed a weighted kappa value of 0.414 (SE 0.090, p=0.002), suggesting moderate agreement between the two raters.","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Yurcheshen', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Pigeon', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Carolina Z', 'Initials': 'CZ', 'LastName': 'Marcus', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Marcus', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Messing', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Nguyen', 'Affiliation': 'Saddleback Medical Center, Laguna Hills, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Marsella', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9220']
1833,33687161,The Effect of Vitamin D Deficiency on Overgrowth of Uterine Fibroids: A Blinded Randomized Clinical Trial.,"Background


To evaluate the effects of vitamin D (vitD) supplement on uterine fibroid growth.
Materials and Methods


A randomized blinded clinical trial was conducted at a tertiary university-based hospital from August 2017 to September 2018. Totally, 204 women were enrolled into the study. They had at least one uterine fibroid >10 mm on transvaginal ultrasound and their vitD level was insufficient (i.e. 20-30 ng/ml). The intervention group was treated with vitD 50000 U supplements for two months. After 2 months, ultrasound screening and vitD level measurement was done in both groups.
Results


At first, the mean serum vitD levels in intervention and control group were 23.62 and 23.20 ng/ml, respectively. After 8 weeks, the mean serum vitD levels in the control and intervention group were 22.72 and 28.56 ng/ml respectively (P<0.05). Also, mean fibroma diameter in the intervention group before and after 8 weeks of vitD supplementation was 43 ± 4.68 and 42.6 ± 1.31 mm, respectively. Mean uterine fibroid diameter in the control group which did not receive vitD supplements, before and after 8 weeks was 41.98 ± 5.25 and 47.81 ± 3.42 mm, respectively. The variation in the mean size of the uterine fibroid between the control and intervention group which was respectively about 5.83 mm increase and 0.48 mm decrease, was significant (P<0.001).
Conclusion


Our results showed that vitD supplementation prevents fibroid growth. It seems that vitD supplement is a simple, safe and inexpensive modality for leiomyoma growth prevention (Registration number: IRCT201703122576N15).",2021,"The variation in the mean size of the uterine fibroid between the control and intervention group which was respectively about 5.83 mm increase and 0.48 mm decrease, was significant (P<0.001).
","['tertiary university-based hospital from August 2017 to September 2018', '204 women were enrolled into the study']","['Vitamin D Deficiency', 'vitD supplementation', 'vitamin D (vitD) supplement']","['ultrasound screening and vitD level measurement', 'Overgrowth of Uterine Fibroids', 'mean serum vitD levels', 'mean fibroma diameter', 'Mean uterine fibroid diameter', 'fibroid growth', 'mean size of the uterine fibroid']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0016045', 'cui_str': 'Fibroma'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",204.0,0.291299,"The variation in the mean size of the uterine fibroid between the control and intervention group which was respectively about 5.83 mm increase and 0.48 mm decrease, was significant (P<0.001).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Davari Tanha', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Endocrinology, Vali- asr Health Research Center, Vali- asr Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Feizabad', 'Affiliation': 'Department of Obstetrics and Gynecology, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran. Email: elhamfeizabad@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Vasheghani Farahani', 'Affiliation': 'Department of Obstetrics and Gynecology, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hoora', 'Initials': 'H', 'LastName': 'Amuzegar', 'Affiliation': 'Department of Obstetrics and Gynecology, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Moradi', 'Affiliation': 'Department of Radiology, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saghar', 'Initials': 'S', 'LastName': 'Samimi Sadeh', 'Affiliation': 'Department of Anesthesiology, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of fertility & sterility,['10.22074/IJFS.2020.134567']
1834,33687136,Long-term relapse rates after cognitive behaviour therapy for anxiety and depressive disorders among older adults: A follow-up study during COVID-19.,"OBJECTIVE


This study assessed the long-term symptom relapse rates among older adults previously treated with cognitive behaviour therapy (CBT) for anxiety and/or depression during COVID-19.
METHOD


Participants were 37 older adults (M = 75 years, SD = 5; 65% female) previously treated with CBT for anxiety and/or unipolar depression who were re-assessed an average of 5.6 years later, during the first Australian COVID-19 lockdown.
RESULTS


On average, there was no significant group-level change in anxiety, depression or quality of life. When assessing change in symptoms based on clinical cut-off points on self-report measures, results suggest only 17%-22% showed a relapse of symptoms by the COVID-19 pandemic.
CONCLUSIONS


Findings suggest that CBT may be protective in coping with life stressors many years after treatment ends. However, results warrant replication to attribute continued symptom improvement to CBT given the lack of control group.",2021,"On average, there was no significant group-level change in anxiety, depression or quality of life.","['Participants were 37 older adults (M\xa0=\xa075 years, SD\xa0=\xa05; 65% female) previously treated with CBT for anxiety and/or unipolar depression who were re-assessed an average of 5.6\xa0years later, during the first Australian COVID-19 lockdown', 'older adults', 'older adults previously treated with']","['cognitive behaviour therapy (CBT', 'cognitive behaviour therapy', 'CBT']","['anxiety, depression or quality of life', 'anxiety and depressive disorders', 'relapse of symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",37.0,0.026823,"On average, there was no significant group-level change in anxiety, depression or quality of life.","[{'ForeName': 'Carly J', 'Initials': 'CJ', 'LastName': 'Johnco', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Jessamine T H', 'Initials': 'JTH', 'LastName': 'Chen', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Muir', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Strutt', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Piers', 'Initials': 'P', 'LastName': 'Dawes', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Siette', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Cintia Botelha', 'Initials': 'CB', 'LastName': 'Dias', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hillebrandt', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Maurice', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Viviana M', 'Initials': 'VM', 'LastName': 'Wuthrich', 'Affiliation': 'Centre for Ageing, Cognition and Wellbeing, Macquarie University, Sydney, NSW, Australia.'}]",Australasian journal on ageing,['10.1111/ajag.12928']
1835,33687130,Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma.,"BACKGROUND


Hepatic arterial infusion chemotherapy (HAIC) with cisplatin is beneficial to patients with advanced HCC treated with sorafenib. This study aimed to examine the effect of HAIC with cisplatin before radiofrequency ablation (RFA) in patients with HCC.
METHODS


This was a multicenter, single blinded, randomized controlled study (UMIN000007267). Early-stage HCC patients were randomly assigned (1:1) to receive HAIC with cisplatin before RFA therapy (HAIC group) or RFA monotherapy (non-HAIC group). The primary endpoint was recurrence-free survival. Efficacy analysis and safety analysis followed the intention-to-treat principle.
RESULTS


Between August 2012 and July 2016, 74 patients were recruited. Seventy eligible patients were randomly assigned to the HAIC group (n = 35) and non-HAIC group (n = 35). Recurrence-free survival rates at 1 (3) year in the HAIC group and non-HAIC group were 82.9% (54.3%) and 74.3% (34.3%), respectively [hazard ratio (HR), 0.597; 95% CI, 0.320-1.091; p = 0.094]. Subgroup analysis revealed that the beneficial effect of HAIC was observed in patients with a single nodule and Child-Pugh 5. Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022). Adverse events were observed only in two patients in the HAIC group (6%), grade 2 cholecystitis, and grade 2 hyperkalemia.
CONCLUSIONS


HAIC with cisplatin before RFA did not significantly decrease recurrence in patients with early-stage HCC. However, it might be effective in preventing intrahepatic distant recurrence. This article is protected by copyright. All rights reserved.",2021,"Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022).","['Early-stage HCC patients', 'patients with early-stage HCC', 'patients with HCC', '74 patients were recruited', 'Seventy eligible patients', 'patients with a single nodule and Child', 'patients with advanced HCC treated with', 'hepatocellular carcinoma', 'Between August 2012 and July 2016']","['HAIC with cisplatin before RFA therapy (HAIC group) or RFA monotherapy', 'HAIC with cisplatin before radiofrequency ablation (RFA', 'hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation', 'cisplatin', 'HAIC', 'sorafenib']","['recurrence', 'intrahepatic distant recurrence', 'grade 2 cholecystitis, and grade 2 hyperkalemia', 'recurrence-free survival', 'Recurrence-free survival rates', 'Adverse events', 'beneficial effect of HAIC', 'Intrahepatic distant recurrence-free survival rate']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C4304118', 'cui_str': 'Hepatic arterial infusion chemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0008325', 'cui_str': 'Cholecystitis'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4304118', 'cui_str': 'Hepatic arterial infusion chemotherapy'}]",74.0,0.157278,"Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022).","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Oyama', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nouso', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Medical Center for Clinical and Translational Research, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Morimoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Onishi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Takaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Shouta', 'Initials': 'S', 'LastName': 'Iwadou', 'Affiliation': 'Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-city, Hiroshima, 730-8518, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kariyama', 'Affiliation': 'Okayama City Hospital, 3-20-1 Kitanagase-omotemachi, Kita-ku, Okayama-city, Okayama, 700-8557, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kuwaki', 'Affiliation': 'Fukuyama City Hospital, 5-23-1 Zao-cho, Fukuyama-city, Hiroshima, 721-8511, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Yabushita', 'Affiliation': 'Fukuyama City Hospital, 5-23-1 Zao-cho, Fukuyama-city, Hiroshima, 721-8511, Japan.'}, {'ForeName': 'Kosaku', 'Initials': 'K', 'LastName': 'Sakaguchi', 'Affiliation': 'Fukuyama City Hospital, 5-23-1 Zao-cho, Fukuyama-city, Hiroshima, 721-8511, Japan.'}, {'ForeName': 'Jyunichi', 'Initials': 'J', 'LastName': 'Toshimori', 'Affiliation': 'Japanese Red Cross Okayama Hospital, 2-1-1 Aoe, Kita-ku, Okayama, 700-8607, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Kobashi', 'Affiliation': 'Japanese Red Cross Okayama Hospital, 2-1-1 Aoe, Kita-ku, Okayama, 700-8607, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Moriya', 'Affiliation': 'Mitoyo General Hospital, 708 Himehama, Toyohama-cho, Kannonji-City, Kagawa, 769-1695, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Mitoyo General Hospital, 708 Himehama, Toyohama-cho, Kannonji-City, Kagawa, 769-1695, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hepatology research : the official journal of the Japan Society of Hepatology,['10.1111/hepr.13633']
1836,31887321,Short-term exposure to blue light emitted by electronic devices does not worsen melasma.,,2020,,[],[],[],[],[],[],,0.0131027,,"[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Duteil', 'Affiliation': 'Centre de Pharmacologie Cutanée Appliqué à la Dermatologie (CPCAD), Nice, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Queille-Roussel', 'Affiliation': 'Centre de Pharmacologie Cutanée Appliqué à la Dermatologie (CPCAD), Nice, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Department of Dermatology, CHU Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Montaudié', 'Affiliation': ""Department of Dermatology, CHU Nice, Université Côte d'Azur, Nice, France; INSERM U1065, C3M, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Department of Dermatology, CHU Nice, Université Côte d'Azur, Nice, France; INSERM U1065, C3M, Université Côte d'Azur, Nice, France. Electronic address: passeron@unice.fr.""}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.12.047']
1837,32916128,Nivolumab Plus Ipilimumab for Metastatic Castration-Resistant Prostate Cancer: Preliminary Analysis of Patients in the CheckMate 650 Trial.,"Metastatic castration-resistant prostate cancer (mCRPC) is immunologically ""cold"" and predominantly resistant to immune checkpoint therapy due to few tumor-infiltrating T cells. Ipilimumab (anti-CTLA-4) or anti-PD-1/PD-L1 monotherapy failed to show a significant benefit. Although the PD-1/PD-L1 pathway is minimally expressed in prostate tumors, we previously demonstrated that PD-1/PD-L1 expression increases as a compensatory inhibitory pathway in parallel with an ipilimumab-induced increase in tumor-infiltrating T cells. Here, we report the largest trial to date in mCRPC with anti-CTLA-4 plus anti-PD-1 (nivolumab 1 mg/kg plus ipilimumab 3 mg/kg; CheckMate 650, NCT02985957). With median follow-ups of 11.9 and 13.5 months in cohorts 1 (pre-chemotherapy; n = 45) and 2 (post-chemotherapy; n = 45), objective response rate was 25% and 10%, and median overall survival was 19.0 and 15.2 months, respectively. Four patients, two in each cohort, had complete responses. Exploratory studies identify potential biomarkers of response. Grade 3-4 treatment-related adverse events have occurred in ∼42%-53% of patients, with four treatment-related deaths. Therefore, dose/schedule modifications have been implemented.",2020,"Grade 3-4 treatment-related adverse events have occurred in ∼42%-53% of patients, with four treatment-related deaths.",['Metastatic Castration-Resistant Prostate Cancer'],"['mCRPC with anti-CTLA-4 plus anti-PD-1 (nivolumab 1\xa0mg/kg plus ipilimumab', 'Ipilimumab (anti-CTLA-4) or anti-PD-1/PD-L1 monotherapy', 'Nivolumab Plus Ipilimumab', 'Metastatic castration-resistant prostate cancer (mCRPC']","['median overall survival', 'objective response rate', 'adverse events']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0747439,"Grade 3-4 treatment-related adverse events have occurred in ∼42%-53% of patients, with four treatment-related deaths.","[{'ForeName': 'Padmanee', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, University of Texas, Unit 1374, 1155 Pressler Street, Houston, TX 77030, USA. Electronic address: padsharma@mdanderson.org.'}, {'ForeName': 'Russell K', 'Initials': 'RK', 'LastName': 'Pachynski', 'Affiliation': 'Division of Oncology, Washington University School of Medicine, St. Louis, MO 63110, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Narayan', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Fléchon', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, 69008 Lyon, France.'}, {'ForeName': 'Gwenaelle', 'Initials': 'G', 'LastName': 'Gravis', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes Aix-Marseille Université, 13009 Marseille, France.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Mahammedi', 'Affiliation': 'Department of Medical Oncology, Centre Jean Perrin, 63011 Clermont-Ferrand, France.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Patnaik', 'Affiliation': 'Department of Medical Oncology, The University of Chicago Medicine, Chicago, IL 60637, USA.'}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Subudhi', 'Affiliation': 'Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, University of Texas, Unit 1374, 1155 Pressler Street, Houston, TX 77030, USA.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Ciprotti', 'Affiliation': 'Bristol Myers Squibb, Uxbridge UB8 1DH, UK.'}, {'ForeName': 'Burcin', 'Initials': 'B', 'LastName': 'Simsek', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Saci', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'G Celine', 'Initials': 'GC', 'LastName': 'Han', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, University of Paris Saclay, 94800 Villejuif, France.'}]",Cancer cell,['10.1016/j.ccell.2020.08.007']
1838,33246104,Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study.,"OBJECTIVES


This study was done to identify the effect of pilates exercises on the symptoms of premenstrual syndrome.
DESIGN


A quasi experimental was conducted on university student with premenstrual syndrome.
METHODS


Population of the study included midwifery students with premenstrual syndrome at Istanbul University Faculty of Health Sciences (N = 286) and 50 of them became the sample (25 in experimental group and 25 in control group). Non-probablistic sampling method was used. While the students in experimental group were asked to practice the pilates exercises for three months, the students in control group were told to maintain their routine habits. At the end of the three months, premenstrual syndrome problem of experimental and control group was diagnosed and the effect of pilates on premenstrual syndrome was evaluated. Premenstrual Syndrome symptoms were evaluated through Premenstrual Syndrome Scale (PMSS). The high score received from PMSS shows that the symptoms are intensive.
RESULTS


It was seen that the students in the experimental and control group were similar in terms of their aspects which were individual, health and could affect premenstrual syndrome (p > 005). A statistical significant difference was not found between total scores and sub-dimension scores of PMSS in experimental and control group (p < 0.05). It was seen that PMSS total score of experimental group was significantly lower than that of control group (p < 0.001). When in-group comparisons were examined, it was identified that PMSS scores of control group did not change at the beginning and end of exercise, but PMSS score of experimental group at the end of exercise was lower than their score received at the beginning of exercise and, the difference was statistically significant to the highest degree (p < 0.001).
CONCLUSION


It was seen that the pilates exercises, which were practiced in this research, decreased the PMS symptoms considerably. In this regard, the pilates exercises have an important role in healing the PMS symptoms.",2020,A statistical significant difference was not found between total scores and sub-dimension scores of PMSS in experimental and control group (p < 0.05).,"['university student with premenstrual syndrome', 'Population of the study included midwifery students with premenstrual syndrome at Istanbul University Faculty of Health Sciences']",['pilates exercises'],"['Premenstrual Syndrome symptoms', 'total scores and sub-dimension scores of PMSS', 'PMSS scores', 'PMSS score', 'premenstrual syndrome', 'Premenstrual Syndrome Scale (PMSS', 'PMSS total score']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C1321049', 'cui_str': 'Pilates exercise'}]","[{'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0160664,A statistical significant difference was not found between total scores and sub-dimension scores of PMSS in experimental and control group (p < 0.05).,"[{'ForeName': 'Elif Tuğçe', 'Initials': 'ET', 'LastName': 'Çitil', 'Affiliation': 'Department of Midwifery, Health Science Faculty, Kütahya Health Science University, in Kütahya, Turkey. Electronic address: eliftugce.citil@ksbu.edu.tr.'}, {'ForeName': 'Nurten', 'Initials': 'N', 'LastName': 'Kaya', 'Affiliation': 'Department of Midwifery, Health Science Faculty, İstanbul University-Cerrahpaşa in İstanbul, Turkey. Electronic address: nurka@istanbul.edu.tr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102623']
1839,33245618,"Your Path to Transplant: A randomized controlled trial of a tailored expert system intervention to increase knowledge, attitudes, and pursuit of kidney transplant.","Individually tailoring education over time may help more patients, especially racial/ethnic minorities, get waitlisted and pursue deceased and living donor kidney transplant (DDKT and LDKT, respectively). We enrolled 802 patients pursuing transplant evaluation at the University of California, Los Angeles Transplant Program into a randomized education trial. We compared the effectiveness of Your Path to Transplant (YPT), an individually tailored coaching and education program delivered at 4 time points, with standard of care (SOC) education on improving readiness to pursue DDKT and LDKT, transplant knowledge, taking 15 small transplant-related actions, and pursuing transplant (waitlisting or LDKT rates) over 8 months. Survey outcomes were collected prior to evaluation and at 4 and 8 months. Time to waitlisting or LDKT was assessed with at least 18 months of follow-up. At 8 months, compared to SOC, the YPT group demonstrated increased LDKT readiness (47% vs 33%, P = .003) and transplant knowledge (effect size [ES] = 0.41, P < .001). Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002). A focused, coordinated education effort can improve transplant-seeking behaviors and waitlisting rates. ClinicalTrials.gov registration: NCT02181114.",2021,"Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002).","['802 patients pursuing transplant evaluation at the University of California, Los Angeles Transplant Program into a randomized education trial', 'Your Path to Transplant']","['YPT', 'tailored expert system intervention', 'Your Path to Transplant (YPT), an individually tailored coaching and education program delivered at 4 time points, with standard of care (SOC) education on improving readiness to pursue DDKT and LDKT, transplant knowledge, taking 15 small transplant-related actions, and pursuing transplant (waitlisting or LDKT rates']","['LDKT readiness', 'transplant knowledge', 'transplant-seeking behaviors and waitlisting rates', 'knowledge, attitudes, and pursuit of kidney transplant', 'Time to waitlisting or LDKT', 'Transplant pursuit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1141889', 'cui_str': 'Transplant evaluation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0015324', 'cui_str': 'Expert Systems'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",802.0,0.0353113,"Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002).","[{'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Waterman', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Peipert', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Terasaki Institute of Biomedical Innovation, Los Angeles, California, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Beaumont', 'Affiliation': 'Terasaki Institute of Biomedical Innovation, Los Angeles, California, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paiva', 'Affiliation': 'Department of Psychology, The University of Rhode Island, Kingston, Rhode Island, USA.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Lipsey', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Robbins', 'Affiliation': 'Department of Psychology, The University of Rhode Island, Kingston, Rhode Island, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16262']
1840,33247306,"A high-protein total diet replacement increases energy expenditure and leads to negative fat balance in healthy, normal-weight adults.","BACKGROUND


High-protein diets and total diet replacements are becoming increasingly popular for weight loss; however, further research is needed to elucidate their impact on the mechanisms involved in weight regulation.
OBJECTIVE


The aim of this inpatient metabolic balance study was to compare the impact of a high-protein total diet replacement (HP-TDR) versus a control diet (CON) on select components of energy metabolism in healthy adults of both sexes.
METHODS


The acute intervention was a randomized, controlled, crossover design with participants allocated to 2 isocaloric arms: 1) HP-TDR: 35% carbohydrate, 40% protein, and 25% fat achieved through a nutritional supplement; 2) CON: 55% carbohydrate, 15% protein, and 30% fat. Participants received the prescribed diets for 32 h while inside a whole-body calorimetry unit (WBCU). The first dietary intervention randomly offered in the WBCU was designed to maintain energy balance and the second matched what was offered during the first stay. Energy expenditure, macronutrient oxidation rates and balances, and metabolic blood markers were assessed. Body composition was measured at baseline using DXA.
RESULTS


Forty-three healthy, normal-weight adults (19 females and 24 males) were included. Compared with the CON diet, the HP-TDR produced higher total energy expenditure [(EE) 81 ± 82 kcal/d, P <0.001], protein and fat oxidation rates (38 ± 34 g/d, P <0.001; 8 ± 20 g/d, P = 0.013, respectively), and a lower carbohydrate oxidation rate (-38 ± 43 g/d, P <0.001). Moreover, a HP-TDR led to decreased energy (-112 ± 85 kcal/d; P <0.001), fat (-22 ± 20 g/d; P <0.001), and carbohydrate balances (-69 ± 44 g/d; P <0.001), and increased protein balance (90 ± 32 g/d; P <0.001).
CONCLUSIONS


Our primary findings were that a HP-TDR led to higher total EE, increased fat oxidation, and negative fat balance. These results suggest that a HP-TDR may promote fat loss compared with a conventional isocaloric diet. These trials were registered at clinicaltrials.gov as NCT02811276 and NCT03565510.",2021,"Moreover, a HP-TDR led to decreased energy (-112 ± 85 kcal/d; P <0.001), fat (-22 ± ","['Forty-three healthy, normal-weight adults (19 females and 24 males', 'healthy adults of both sexes', 'healthy, normal-weight adults']","['HP-TDR', 'control diet (CON', 'high-protein total diet replacement (HP-TDR', 'HP-TDR: 35% carbohydrate, 40% protein, and 25% fat achieved through a nutritional supplement; 2) CON: 55% carbohydrate, 15% protein, and 30% fat']","['total EE, increased fat oxidation, and negative fat balance', 'protein balance', 'protein and fat oxidation rates', 'Body composition', 'carbohydrate balances (-69\xa0±', 'Energy expenditure, macronutrient oxidation rates and balances, and metabolic blood markers', 'total energy expenditure', 'lower carbohydrate oxidation rate']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0855758', 'cui_str': 'Protein total increased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.038436,"Moreover, a HP-TDR led to decreased energy (-112 ± 85 kcal/d; P <0.001), fat (-22 ± ","[{'ForeName': 'Camila L P', 'Initials': 'CLP', 'LastName': 'Oliveira', 'Affiliation': 'Human Nutrition Research Unit, Department of Agricultural, Food, & Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Normand G', 'Initials': 'NG', 'LastName': 'Boulé', 'Affiliation': 'Alberta Diabetes Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Arya M', 'Initials': 'AM', 'LastName': 'Sharma', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Elliott', 'Affiliation': 'Human Nutrition Research Unit, Department of Agricultural, Food, & Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': 'School of Life Sciences, Division of Physiology, Pharmacology and Neuroscience, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Department of Medical Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Aloys', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Prado', 'Affiliation': 'Human Nutrition Research Unit, Department of Agricultural, Food, & Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa283']
1841,31772117,Ottawa Statement does not impede randomised evaluation of government health programmes.,"In this issue of  JME , Watson  et al  call for research evaluation of government health programmes and identify ethical guidance, including the Ottawa Statement on the ethical design and conduct of cluster randomised trials, as a hindrance. While cluster randomised trials of health programmes as a whole should be evaluated by research ethics committees (RECs), Watson  et al  argue that the health programme per se is not within the researcher's control or responsibility and, thus, is out of scope for ethics review. We argue that this view is wrong. The scope of research ethics review is not defined by researcher control or responsibility, but rather by the protection of research participants. And the randomised evaluation of health programmes impacts the liberty and welfare interests of participants insofar as they may be exposed to a harmful programme or denied access to a beneficial one. Further, Watson  et al 's claim that 'study programmes … would occur whether or not there were any … research activities' is incorrect in the case of cluster randomised designs. In a cluster randomised trial, the government does not implement a programme as usual. Rather, researchers collaborate with the government to randomise clusters to intervention or control conditions in order to rigorously evaluate the programme. As a result, equipoise issues are triggered that must be addressed by the REC.",2020,"The scope of research ethics review is not defined by researcher control or responsibility, but rather by the protection of research participants.",[],[],[],[],[],[],,0.0888451,"The scope of research ethics review is not defined by researcher control or responsibility, but rather by the protection of research participants.","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Weijer', 'Affiliation': 'Rotman Institute of Philosophy, Western University, London, Ontario, Canada cweijer@uwo.ca.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}]",Journal of medical ethics,['10.1136/medethics-2019-105938']
1842,31843269,"Safety and immunogenicity of a single dose of a tetravalent dengue vaccine with two different serotype-2 potencies in adults in Singapore: A phase 2, double-blind, randomised, controlled trial.","BACKGROUND


Early formulations of Takeda's tetravalent dengue vaccine candidate (TAK-003) have demonstrated notably higher neutralizing antibody responses against serotype 2 than other serotypes. Here, we assessed the immunogenicity and tolerability in adults living in Singapore of two TAK-003 formulations: an early formulation, referred to as HD-TDV, and a new formulation with 10-fold lower serotype 2 potency, referred to as TDV (NCT02425098).
METHODS


Subjects aged 21-45 years were stratified by baseline dengue serostatus and randomised 1:1 to receive a single dose of either HD-TDV or TDV. Immunogenicity was evaluated at Days 15, 30, 90, 180, and 365 post-vaccination as geometric mean titres (GMTs) of neutralising antibodies and seropositivity rates. Viremia was assessed per vaccine strain. Solicited and unsolicited adverse events (AEs) were assessed by severity and causality.
RESULTS


Of 351 subjects randomised, 176 received HD-TDV and 175 received TDV. Peak GMTs against all serotypes were observed at Day 30, with highest GMTs against DENV-2 in both groups. In subjects seronegative at baseline, the response to DENV-2 was less dominant with TDV (Day 30 GMTs: 813 for TDV, 10,966 for HD-TDV). In these subjects, DENV-4 seropositivity rates and GMTs were higher with TDV (Day 30 GMTs: 58 for TDV, 21 for HD-TDV; seropositivity rates: 76% for TDV, 60% for HD-TDV). Viremia mainly occurred for TDV-2 in both vaccine groups, with a lower incidence in TDV recipients, and mostly resolved by Day 30. Both vaccine formulations showed an acceptable safety profile with similar overall rates of solicited and unsolicited AEs across vaccine groups.
CONCLUSIONS


These results suggest a more balanced immune response with the new formulation TDV compared with the early formulation HD-TDV, particularly in subjects who were seronegative prior to vaccination, and support the choice of the new formulation for the phase 3 efficacy assessment.",2020,"Both vaccine formulations showed an acceptable safety profile with similar overall rates of solicited and unsolicited AEs across vaccine groups.
","['351 subjects randomised, 176 received HD-TDV and 175 received', 'adults living in Singapore of two TAK-003 formulations', 'Subjects aged 21-45\xa0years', 'adults in Singapore']","['HD-TDV or TDV', 'TDV']","['geometric mean titres (GMTs) of neutralising antibodies and seropositivity rates', 'Safety and immunogenicity', 'Viremia', 'immunogenicity and tolerability', 'Immunogenicity', 'DENV-4 seropositivity rates and GMTs']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}]",351.0,0.168021,"Both vaccine formulations showed an acceptable safety profile with similar overall rates of solicited and unsolicited AEs across vaccine groups.
","[{'ForeName': 'Vianney', 'Initials': 'V', 'LastName': 'Tricou', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland. Electronic address: Vianney.tricou@takeda.com.'}, {'ForeName': 'Jenny G', 'Initials': 'JG', 'LastName': 'Low', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Oh', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Yee-Sin', 'Initials': 'YS', 'LastName': 'Leo', 'Affiliation': 'National Centre for Infectious Disease NCID, Singapore; Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Kalimuddin', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wijaya', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Junxiong', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': 'Tan Tock Seng Hospital, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Li Min', 'Initials': 'LM', 'LastName': 'Ling', 'Affiliation': 'Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Tau Hong', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Brose', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Yanee', 'Initials': 'Y', 'LastName': 'Hutagalung', 'Affiliation': 'Takeda Vaccines Pte Ltd, Singapore.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rauscher', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.11.061']
1843,33252690,"Effect of a Low-Fat Vegan Diet on Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels in Overweight Adults: A Randomized Clinical Trial.","Importance


Excess body weight and insulin resistance lead to type 2 diabetes and other major health problems. There is an urgent need for dietary interventions to address these conditions.
Objective


To measure the effects of a low-fat vegan diet on body weight, insulin resistance, postprandial metabolism, and intramyocellular and hepatocellular lipid levels in overweight adults.
Design, Setting, and Participants


This 16-week randomized clinical trial was conducted between January 2017 and February 2019 in Washington, DC. Of 3115 people who responded to flyers in medical offices and newspaper and radio advertisements, 244 met the participation criteria (age 25 to 75 years; body mass index of 28 to 40) after having been screened by telephone.
Interventions


Participants were randomized in a 1:1 ratio. The intervention group (n = 122) was asked to follow a low-fat vegan diet and the control group (n = 122) to make no diet changes for 16 weeks.
Main Outcomes and Measures


At weeks 0 and 16, body weight was assessed using a calibrated scale. Body composition and visceral fat were measured by dual x-ray absorptiometry. Insulin resistance was assessed with the homeostasis model assessment index and the predicted insulin sensitivity index (PREDIM). Thermic effect of food was measured by indirect calorimetry over 3 hours after a standard liquid breakfast (720 kcal). In a subset of participants (n = 44), hepatocellular and intramyocellular lipids were quantified by proton magnetic resonance spectroscopy. Repeated measure analysis of variance was used for statistical analysis.
Results


Among the 244 participants in the study, 211 (87%) were female, 117 (48%) were White, and the mean (SD) age was 54.4 (11.6) years. Over the 16 weeks, body weight decreased in the intervention group by 5.9 kg (95% CI, 5.0-6.7 kg; P < .001). Thermic effect of food increased in the intervention group by 14.1% (95% CI, 6.5-20.4; P < .001). The homeostasis model assessment index decreased (-1.3; 95% CI, -2.2 to -0.3; P < .001) and PREDIM increased (0.9; 95% CI, 0.5-1.2; P < .001) in the intervention group. Hepatocellular lipid levels decreased in the intervention group by 34.4%, from a mean (SD) of 3.2% (2.9%) to 2.4% (2.2%) (P = .002), and intramyocellular lipid levels decreased by 10.4%, from a mean (SD) of 1.6 (1.1) to 1.5 (1.0) (P = .03). None of these variables changed significantly in the control group over the 16 weeks. The change in PREDIM correlated negatively with the change in body weight (r = -0.43; P < .001). Changes in hepatocellular and intramyocellular lipid levels correlated with changes in insulin resistance (both r = 0.51; P = .01).
Conclusions and Relevance


A low-fat plant-based dietary intervention reduces body weight by reducing energy intake and increasing postprandial metabolism. The changes are associated with reductions in hepatocellular and intramyocellular fat and increased insulin sensitivity.
Trial Registration


ClinicalTrials.gov Identifier: NCT02939638.",2020,"Thermic effect of food increased in the intervention group by 14.1% (95% CI, 6.5-20.4; P < .001).","['Overweight Adults', '244 participants in the study, 211 (87%) were female, 117 (48%) were White, and the mean (SD) age was 54.4 (11.6) years', 'overweight adults', 'January 2017 and February 2019 in Washington, DC', '3115 people who responded to flyers in medical offices and newspaper and radio advertisements, 244 met the participation criteria (age 25 to 75 years; body mass index of 28 to 40) after having been screened by telephone']","['low-fat vegan diet', 'low-fat vegan diet and the control group (n\u2009=\u2009122) to make no diet changes for 16 weeks', 'Low-Fat Vegan Diet']","['hepatocellular and intramyocellular lipids', 'insulin resistance', 'Body composition and visceral fat', 'body weight', 'Changes in hepatocellular and intramyocellular lipid levels', 'homeostasis model assessment index', 'homeostasis model assessment index and the predicted insulin sensitivity index (PREDIM', 'Hepatocellular lipid levels', 'hepatocellular and intramyocellular fat and increased insulin sensitivity', 'intramyocellular lipid levels', 'Thermic effect of food', 'Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels', 'Insulin resistance', 'body weight, insulin resistance, postprandial metabolism, and intramyocellular and hepatocellular lipid levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0881457,"Thermic effect of food increased in the intervention group by 14.1% (95% CI, 6.5-20.4; P < .001).","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Kahleova', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC.'}, {'ForeName': 'Kitt Falk', 'Initials': 'KF', 'LastName': 'Petersen', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gerald I', 'Initials': 'GI', 'LastName': 'Shulman', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Alwarith', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rembert', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Padua, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Institute of Endocrinology, Prague, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Barnard', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.25454']
1844,33252489,Depressive symptoms and use of HIV care and medication-assisted treatment among people with HIV who inject drugs.,"OBJECTIVE


Vietnam, Indonesia, and Ukraine have major burdens of IDU and HIV. We estimated the prevalence of depressive symptoms at baseline among people living with HIV who inject drugs, evaluated associations between depression at baseline and 12-month HIV care outcomes and medication-assisted treatment (MAT), and evaluated the study intervention effect by baseline depression subgroups.
DESIGN


HPTN 074 was a randomized study. The study intervention included psychosocial counseling, systems navigation, and antiretroviral treatment (ART) at any CD4+ cell count.
METHODS


Moderate-to-severe depression was defined as a Patient Health Questionnaire-9 score of 10 or above. ART and MAT were self-reported. Eligibility criteria were: 18-60 years of age, active IDU, and viral load of at least 1000 copies/ml. Adjusted probability differences (aPD) were estimated using inverse-probability weighting.
RESULTS


A total of 502 participants enrolled from April 2015 to June 2016. Median age was 35 years; 85% identified as men. Prevalence of baseline moderate-to-severe depression was 14% in Vietnam, 14% in Indonesia, and 56% in Ukraine. No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up. The study intervention improved the proportions of people who inject drugs achieving 12-month viral suppression in both the depressed [intervention 44%; standard of care 24%; estimated aPD = 25% (95% confidence interval: 4.0%, 45%)] and nondepressed subgroups [intervention 38%; standard of care 24%; aPD = 13% (95% confidence interval: 2.0%, 25%)].
CONCLUSION


High levels of depressive symptoms were common among people living with HIV who inject drugs in Ukraine but were less common in Vietnam and Indonesia. The study intervention was effective among participants with or without baseline depression symptoms.",2021,"No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up.","['people living with HIV (PLWH) who inject drugs, evaluated associations between depression at baseline and 12-month HIV care outcomes and medication-assisted treatment (MAT), and evaluated the study intervention effect by baseline depression subgroups', 'participants with or without baseline depression symptoms', 'Median age was 35 years; 85% identified as men', 'Moderate-to-severe depression was defined as a Patient Health Questionnaire (PHQ-9) score of 10 or above', '502 participants enrolled from April 2015-June 2016', 'people living with HIV who inject drugs']","['psychosocial counseling, systems navigation, and antiretroviral treatment (ART) at any CD4 count', 'HIV care and medication-assisted treatment']","['Depressive symptoms', 'proportions of PWID achieving 12-month viral suppression', 'baseline depression and ART, viral suppression, or MAT', 'depressive symptoms', 'Prevalence of baseline moderate-to-severe depression']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0841579', 'cui_str': 'Psychosocial counseling'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",502.0,0.166131,"No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up.","[{'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Zeziulin', 'Affiliation': 'Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.'}, {'ForeName': 'Katie R', 'Initials': 'KR', 'LastName': 'Mollan', 'Affiliation': 'School of Medicine.'}, {'ForeName': 'Bonnie E', 'Initials': 'BE', 'LastName': 'Shook-Sa', 'Affiliation': 'Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Hanscom', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Kostyantyn', 'Initials': 'K', 'LastName': 'Dumchev', 'Affiliation': 'Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Viet A', 'Initials': 'VA', 'LastName': 'Chu', 'Affiliation': 'UNC Vietnam, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Kiriazova', 'Affiliation': 'Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.'}, {'ForeName': 'Zulvia', 'Initials': 'Z', 'LastName': 'Syarif', 'Affiliation': 'Abhipraya Foundation & Department Psychiatry Faculty of Medicine, University of Indonesia, Depok, Indonesia.'}, {'ForeName': 'Sergii', 'Initials': 'S', 'LastName': 'Dvoryak', 'Affiliation': 'Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Reifeis', 'Affiliation': 'Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Family Health International (FHI 360), Durham, North Carolina, USA.'}, {'ForeName': 'Riza', 'Initials': 'R', 'LastName': 'Sarasvita', 'Affiliation': 'Indonesia National Narcotics Board & Abhipraya Foundation, East Jakarta, Indonesia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Family Health International (FHI 360), Durham, North Carolina, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Clarke', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Metzger', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Irving F', 'Initials': 'IF', 'LastName': 'Hoffman', 'Affiliation': 'School of Medicine.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Miller', 'Affiliation': 'College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002774']
1845,33252482,Optimizing respondent-driven sampling to find undiagnosed HIV-infected people who inject drugs.,"OBJECTIVE


We evaluated whether identification of undiagnosed HIV-infected people who inject drugs (PWID) via respondent-driven sampling (RDS) can be enhanced through a precision RDS (pRDS) approach.
DESIGN/METHODS


First, using prior RDS data from PWID in India, we built a prediction algorithm for recruiting undiagnosed HIV-infected PWID. pRDS was tested in Morinda, Punjab where participants were randomly assigned to standard or pRDS. In the standard RDS approach, all participants received two recruitment coupons. For pRDS, the algorithm determined an individual's probability of recruiting an undiagnosed PWID, and individuals received either two (low probability) or five (high probability) coupons. Efficiency in identifying undiagnosed HIV-infected PWID for the RDS approaches was evaluated in two ways: the number needed to recruit (NNR) and identification rate/week.
RESULTS


Predictors of recruiting undiagnosed PWID included HIV/HCV infection, network size, syringe services utilization, and injection environment. 1631 PWID were recruited in Morinda. From the standard RDS approach, 615 were recruited, including 39 undiagnosed; from pRDS, 1012 were recruited, including 77 undiagnosed. In pRDS, those with higher predicted probability were more likely to recruit others with HIV/HCV co-infection, undiagnosed and viremic HIV, and who utilized services. pRDS had a significantly higher identification rate of undiagnosed PWID (1.5/week) compared with the standard (0.8/week). The NNR for pRDS (13.1) was not significantly lower than the standard approach (15.8).
CONCLUSION


pRDS identified twice as many undiagnosed and viremic PWID significantly faster than the standard approach. Leveraging RDS or similar network-based strategies should be considered alongside other strategies to ensure meeting UNAIDS targets.",2021,"The NNR for pRDS (13.1) was not significantly lower than the standard approach (15.8).
","['undiagnosed HIV-infected people who inject drugs', '1631 PWID were recruited in Morinda', '615 were recruited, including 39 undiagnosed; from pRDS, 1012 were recruited, including 77 undiagnosed', 'undiagnosed HIV-infected people who inject drugs (PWID) via respondent-driven sampling (RDS']","['standard or pRDS', 'pRDS']","['identification rate of undiagnosed PWID', 'HIV/HCV infection, network size, syringe services utilization, and injection environment']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1010821', 'cui_str': 'Morinda'}, {'cui': 'C5192273', 'cui_str': '615'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",1631.0,0.0633873,"The NNR for pRDS (13.1) was not significantly lower than the standard approach (15.8).
","[{'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'McFall', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Mayland, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Mayland, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Mayland, USA.'}, {'ForeName': 'Aylur K', 'Initials': 'AK', 'LastName': 'Srikrishnan', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Santhanam', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Canjeevaram K', 'Initials': 'CK', 'LastName': 'Vasudevan', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Shruti H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Mayland, USA.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Solomon', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002763']
1846,33259001,Relationships between pathological factors and long-term outcomes in patients enrolled in two prospective randomized controlled trials comparing the efficacy of oral tegafur-uracil with CMF (N·SAS-BC 01 trial and CUBC trial).,"PURPOSE


To evaluate the efficacies of cyclophosphamide, methotrexate, and fluorouracil (CMF) and tegafur-uracil (UFT) as adjuvant therapy in patients with resected stage I-IIIA breast cancer by immunohistochemistry (IHC)-based subtype and to determine the relationships between clinicopathological factors and long-term outcomes.
METHODS


A pooled analysis of the randomized controlled N·SAS-BC 01 and CUBC studies was conducted. Expression of hormone receptors (HRs; estrogen and progesterone receptors), human epidermal growth factor receptor 2 (HER2), and Ki67were assessed by IHC. Tumor-infiltrating lymphocytes (TILs) and nuclear/histological grades were determined by hematoxylin and eosin staining. Relapse-free survival (RFS) and overall survival (OS) were estimated by Kaplan-Meier analysis and hazard ratios were determined by Cox model adjusted for baseline tumor size and nodal status.
RESULTS


A total of 689 patients (342 CMF and 347 UFT) were included in the analyses with a median follow-up of 11.1 years. There was no significant difference in RFS or OS between the two cohorts (RFS: 0.96 [95% confidence interval: 0.71-1.30], log-rank test p = 0.80; OS: 0.93 [0.64-1.35], p = 0.70). There was no difference in RFS or OS between the two cohorts for HR+/HER2- and HR+/HER2+ subtypes. RFS was significantly longer in patients treated with UFT compared with CMF in patients with HR-/HER2+ subtype (0.30 [0.10-0.88], p = 0.03). A high TILs level was associated with a better OS compared with low TILs level (p = 0.02).
CONCLUSIONS


This long-term follow-up study showed that RFS and OS were similar in patients with luminal-type breast cancer treated with CMF and UFT.",2021,"RFS was significantly longer in patients treated with UFT compared with CMF in patients with HR-/HER2+ subtype (0.30 [0.10-0.88], p = 0.03).","['patients with luminal-type breast cancer treated with', 'patients with resected stage I-IIIA breast cancer by immunohistochemistry (IHC)-based subtype', '689 patients (342 CMF and 347 UFT) were included in the analyses with a median follow-up of 11.1\xa0years']","['CMF and UFT', 'CMF', 'oral tegafur-uracil with CMF (N·SAS-BC', 'cyclophosphamide, methotrexate, and fluorouracil (CMF) and tegafur-uracil (UFT', 'UFT']","['Relapse-free survival (RFS) and overall survival (OS', 'Tumor-infiltrating lymphocytes (TILs) and nuclear/histological grades', 'RFS or OS', 'RFS', 'RFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0456201', 'cui_str': 'Histological grades'}]",689.0,0.214985,"RFS was significantly longer in patients treated with UFT compared with CMF in patients with HR-/HER2+ subtype (0.30 [0.10-0.88], p = 0.03).","[{'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. shinji.ohno@jfcr.or.jp.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Tsuda', 'Affiliation': 'National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Akiyama', 'Affiliation': 'Cancer Institute of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kurosumi', 'Affiliation': 'Kameda Medical Center, Chiba, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Shimomura', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Takao', 'Affiliation': 'Hyogo Cancer Center, Hyogo, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Ohsumi', 'Affiliation': 'NHO Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Tokuda', 'Affiliation': 'Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Inaji', 'Affiliation': 'Kaizuka City Hospital, Osaka, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Hamamatsu Oncology Center, Shizuoka, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Chuo University, Tokyo, Japan.'}]",Breast cancer research and treatment,['10.1007/s10549-020-06018-1']
1847,33249244,"Arthroscopic Bankart Repair With and Without Curettage of the Glenoid Edge: A Prospective, Randomized, Controlled Study.","PURPOSE


To determine whether curettage of the cartilage on the glenoid edge in arthroscopic Bankart repair reduces the postoperative recurrence rate compared with noncuretted glenoid.
METHODS


Between January 2010 and December 2013, 134 patients underwent arthroscopy and stabilization for recurrent anterior dislocation of shoulder; 42 patients were excluded. Alternate glenoid edge was curetted in 92 patients undergoing arthroscopic Bankart repair. Twelve patients were lost to follow-up. The remaining 80 patients were divided into 2 groups of 40 patients each, curettage and noncurettage. In both groups, the Bankart lesion was repaired using ≥3 bioanchors loaded with nonabsorbable braided sutures. Postoperative rehabilitation was the same for the 2 groups. We recorded recurrence of instability, pain, and Constant and Rowe shoulder scores. Statistical analysis of data was performed using unpaired t test (significance level P < .05).
RESULTS


The 2 groups were comparable in terms of age, number of dislocations, and bone loss. The average follow-up was 7 years and 9 months (range 6 to 10 years). Of the total 40 patients in the curettage group, 6 (15%) had recurrence of dislocation and none had subluxations, whereas in the noncurettage group, 13 (32.5%) had recurrence of dislocation and 3 (7.5%) had subluxations. The difference in postoperative recurrence of instability was statistically significant (P = .012). The average (standard deviation) Rowe score was 83.75 (23.28) in the curettage group and 70.13 (31.29) in the noncurettage group (P = .030).
CONCLUSIONS


During arthroscopic Bankart repair, curettage of the cartilage on the anterior glenoid edge reduces the incidence of postoperative recurrence of instability.
LEVEL OF EVIDENCE


II, therapeutic; prospective, randomized, controlled study.",2021,The difference in postoperative recurrence of instability was statistically significant (p = 0.012).,"['ninety-two patients undergoing arthroscopic Bankart repair', 'Total 42 patients were excluded', 'Between January 2010 and December 2013, 134 patients underwent arthroscopy and stabilization for recurrent anterior dislocation of shoulder', '80 patients which were divided in two groups, curettage & non-curettage, of 40 patients each']",['Arthroscopic Bankart repair with and without curettage of the glenoid edge'],"['recurrence of dislocation', 'postoperative recurrence of instability', 'recurrence of instability, pain, Constant and Rowe shoulder scores', 'postoperative recurrence rate', 'Postoperative rehabilitation']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0409411', 'cui_str': 'Recurrent anterior dislocation of shoulder'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}]","[{'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]",92.0,0.042146,The difference in postoperative recurrence of instability was statistically significant (p = 0.012).,"[{'ForeName': 'Sanjay S', 'Initials': 'SS', 'LastName': 'Desai', 'Affiliation': 'Bhatia Hospital, Mumbai, India. Electronic address: krisorthodoc@gmail.com.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Bhatia Hospital, Mumbai, India.'}, {'ForeName': 'Hari Krishna', 'Initials': 'HK', 'LastName': 'Mata', 'Affiliation': 'Bhatia Hospital, Mumbai, India.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.11.042']
1848,31310839,How to improve the clinical experience for dermatology patients requiring a genital examination: A randomized trial of deodorizing wipes versus standard of care.,,2020,,['Dermatology Patients Requiring a Genital Examination'],['Deodorizing Wipes versus Standard of Care'],[],"[{'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}]",[],,0.02847,,"[{'ForeName': 'Susruthi', 'Initials': 'S', 'LastName': 'Rajanala', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts.'}, {'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Burdine', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts.'}, {'ForeName': 'Mayra B C', 'Initials': 'MBC', 'LastName': 'Maymone', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts.'}, {'ForeName': 'Neelam A', 'Initials': 'NA', 'LastName': 'Vashi', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts; US Department of Veterans Affairs, Boston Health Care System, Boston, Massachusetts. Electronic address: nvashi@bu.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.026']
1849,22124610,Effectiveness of two new types of sealants: retention after 2 years.,"The hypotheses tested were: survival rate of fully and partially retained glass-carbomer sealants is higher than those of high-viscosity glass-ionomer, with and without energy supplied, and that of resin composite; survival rate of fully and partially retained sealants of high-viscosity glass-ionomer with energy supplied is higher than those without energy supplied. The randomized clinical trial covered 407 children, with a mean age of 8 years. The evaluation took place after 0.5, 1 and 2 years. Survival of sealant material in occlusal and in smooth surfaces, using the traditional categorization (fully and partially retained versus completely lost sealants) and the modified categorization (fully and more than 2/3 of the sealant retained versus completely lost sealants), were dependent variables. The Kaplan-Meier survival method was used. According to both categorizations of partially retained sealants, the survival of completely and partially retained resin composite sealants in occlusal and in smooth tooth surfaces was statistically significantly higher, and those of glass-carbomer sealants lower, than those of sealants of the other three groups. There was no statistically significant difference in the survival rates of completely and partially retained high-viscosity glass-ionomer sealants with and without energy supplied in occlusal and in smooth surfaces. After 2 years, glass-carbomer sealant retention was the poorest, adding energy to high-viscosity glass-ionomer sealant did not increase the retention rate and resin composite sealants were retained the longest. We suggest the use of the modified categorization of partially retained sealants in future studies. It seems not necessary to cure high-viscosity glass-ionomer sealants. The use of glass-carbomer sealants cannot be recommended yet.",2012,There was no statistically significant difference in the survival rates of completely and partially retained high-viscosity glass-ionomer sealants with and without energy supplied in occlusal and in smooth surfaces.,"['407 children, with a mean age of 8\xa0years']",[],"['retention rate and resin composite sealants', 'survival rate', 'survival rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1261530', 'cui_str': 'Sealant (substance)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",407.0,0.109708,There was no statistically significant difference in the survival rates of completely and partially retained high-viscosity glass-ionomer sealants with and without energy supplied in occlusal and in smooth surfaces.,"[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Preventive Department, Key Laboratory for Oral Biomedical Engineering, School and Hospital of Stomatology, Wuhan University, Luoyu Road 237, 430079 Wuhan, Hubei, People's Republic of China.""}, {'ForeName': 'Minquan', 'Initials': 'M', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Mingwen', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mulder', 'Affiliation': ''}, {'ForeName': 'Marie-Charlotte', 'Initials': 'MC', 'LastName': 'Huysmans', 'Affiliation': ''}, {'ForeName': 'Jo E', 'Initials': 'JE', 'LastName': 'Frencken', 'Affiliation': ''}]",Clinical oral investigations,['10.1007/s00784-011-0633-9']
1850,31809394,"Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter Study.","BACKGROUND


Bone-graft substitutes are commonly used for the augmentation of traumatic bone defects in tibial plateau fractures. However, their clinical performance compared with that of autologous bone-grafting, the gold standard in bone defect reconstruction, still remains under debate. This study investigates the differences in quality of life, pain, and radiographic outcomes in the treatment of tibial plateau fracture-associated bone defects with either autologous bone grafts or a bioresorbable hydroxyapatite and calcium sulfate cement (CERAMENT BONE VOID FILLER [CBVF]; BONESUPPORT).
METHODS


In this study, 135 patients with acute depression and split-depression fractures of the proximal part of the tibia (OTA/AO types 41-B2 and 41-B3) were enrolled in a prospective, controlled, randomized, multicenter trial including 20 hospitals in Germany. Patients were randomized to receive either autologous iliac bone graft or CBVF for reconstruction of the bone defect. The primary outcome measures were the Short Form (SF)-12 version 2 Physical Component Summary (PCS) score at week 26 (the study was designed to show noninferiority of the CBVF with regard to the PCS with a prespecified margin of -5 points) and the pain level at 26 weeks postoperatively measured by a visual analog scale (VAS). The secondary outcomes were the SF-12 version 2 Mental Component Summary (MCS) and SF-12 PCS scores at weeks 1, 6, and 12 and bone-healing on radiographs.
RESULTS


Age, sex, fixation methods, and fracture pattern were comparable in both groups. There were no significant differences (p > 0.05) in the SF-12 PCS or VAS scores at postoperative week 26. There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group. The rates of fracture-healing, defect remodeling, and articular subsidence were not significantly different (p > 0.05) in both groups.
CONCLUSIONS


Bioresorbable CBVF was noninferior to autologous bone graft with regard to both patient-reported and radiographic outcomes in tibial plateau fractures of OTA/AO types 41-B2 and 41-B3.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group.,"['tibial plateau fractures', '135 patients with acute depression and split-depression fractures of the proximal part of the tibia (OTA/AO types 41-B2 and 41-B3', '20 hospitals in Germany', 'Tibial Plateau Fractures']","['Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement', 'autologous bone-grafting', 'autologous iliac bone graft or CBVF', 'autologous bone grafts or a bioresorbable hydroxyapatite and calcium sulfate cement (CERAMENT BONE VOID FILLER [CBVF]; BONESUPPORT']","['rates of fracture-healing, defect remodeling, and articular subsidence', 'SF-12 PCS or VAS scores', 'Bone Defects', 'pain level', 'quality of life, pain, and radiographic outcomes', 'Short Form (SF)-12 version 2 Physical Component Summary (PCS) score', 'SF-12 version 2 Mental Component Summary (MCS) and SF-12 PCS scores at weeks 1, 6, and 12 and bone-healing on radiographs', 'visual analog scale (VAS', 'blood loss', 'pain levels']","[{'cui': 'C0584640', 'cui_str': 'Tibial plateau structure (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1386135', 'cui_str': 'Acute depression'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C3658778', 'cui_str': 'cerament'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}]","[{'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",135.0,0.067637,There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hofmann', 'Affiliation': 'Department of Traumatology and Orthopaedics 1, Academic Teaching Hospital of the Universities Mainz and Heidelberg, Westpfalz-Clinics, Kaiserslautern, Germany.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Gorbulev', 'Affiliation': 'Interdisciplinary Center for Clinical Trials (IZKS), University Medical Center, Mainz, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Guehring', 'Affiliation': 'Department for Traumatology and Orthopaedic Surgery, BG Traumacenter Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Arndt Peter', 'Initials': 'AP', 'LastName': 'Schulz', 'Affiliation': 'Department of Traumatology, Orthopaedics and Sports Traumatology, BG Trauma Hospital, Hamburg, Germany.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Schupfner', 'Affiliation': 'Department of Trauma Surgery, Clinical Center Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Raschke', 'Affiliation': 'Department of Trauma Surgery, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Huber-Wagner', 'Affiliation': 'Department of Trauma Surgery, University of Munich, Munich, Germany.'}, {'ForeName': 'Pol Maria', 'Initials': 'PM', 'LastName': 'Rommens', 'Affiliation': 'Department of Orthopedics and Traumatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00680']
1851,30227731,Comparison of efficacy of oral paracetamol versus ibuprofen for PDA closure in preterms - a prospective randomized clinical trial.,"Background:  Currently nonselective cyclooxygenase (COX) inhibitors, ibuprofen and indomethacin, are approved drugs for closure of patent ductus arteriosus but have potential toxicities. There are reports of the effectiveness of paracetamol in ductal closure. However, there is paucity of data comparing paracetamol to ibuprofen or indomethacin in relation to the efficacy and safety profile. Methods:  This randomized clinical trial was done in our tertiary care neonatal unit from October 2014 to January 2016 after clearance from ethical committee. It was registered with clinical trial registry of India (CTRI/2016/09/007261) and drug controller general of India (CT/Drugs/56/2014). Preterm neonates with clinical suspicion of hemodynamically significant PDA after echo confirmation were included in the study. Randomization was done by stratified randomization through sealed opaque envelopes. A sample size of 150 was estimated with an expected difference in success of closure as 20% between the treatment groups at level of 5% significance and 80% power. The echocardiography was done 24 hours after completion of treatment by a cardiologist blinded to treatment. Results:  The baseline parameters were comparable between two groups. One hundred and forty-six babies had hs-PDA, out of which 110 babies were randomized. No significant difference was found between the two groups with respect to PDA closure (RR 0.97, 95%CI 0.78-1.20,  p  = 1), mortality or cardio-respiratory morbidity. The babies who received ibuprofen had a higher occurrence of acute kidney injury (RR 0.33, 95%CI 0.13-0.85,  p  = 0.024). Conclusions:  Paracetamol is as effective as ibuprofen for PDA closure in preterm neonates. Ibuprofen used for PDA closure in preterms poses an increased risk for acute kidney injury compared to paracetamol.",2020,"The babies who received ibuprofen had a higher occurrence of acute kidney injury (RR 0.33, 95%CI 0.13-0.85, p = 0.024).
","['preterm neonates', 'One hundred and forty-six babies had hs-PDA, out of which 110 babies', 'Preterm neonates with clinical suspicion of hemodynamically significant PDA after echo confirmation were included in the study', 'our tertiary care neonatal unit from October 2014 to January 2016 after clearance from ethical committee']","['ibuprofen', 'nonselective cyclooxygenase (COX) inhibitors, ibuprofen and indomethacin', 'Paracetamol', 'paracetamol', 'indomethacin', 'Ibuprofen', 'oral paracetamol']","['acute kidney injury', 'efficacy and safety profile', 'PDA closure', 'success of closure', 'mortality or cardio-respiratory morbidity']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0085387', 'cui_str': 'Prostaglandin Endoperoxide Synthase Inhibitors'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}]",110.0,0.276427,"The babies who received ibuprofen had a higher occurrence of acute kidney injury (RR 0.33, 95%CI 0.13-0.85, p = 0.024).
","[{'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Balachander', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry, India.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Mondal', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry, India.'}, {'ForeName': 'Vishnu', 'Initials': 'V', 'LastName': 'Bhat', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry, India.'}, {'ForeName': 'Bethou', 'Initials': 'B', 'LastName': 'Adhisivam', 'Affiliation': 'Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry, India.'}, {'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Satheesh', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry, India.'}, {'ForeName': 'Mahalakshmi', 'Initials': 'M', 'LastName': 'Thulasingam', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry, India.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1525354']
1852,31764068,Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities.,"OBJECTIVE


We aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer) was associated with the development of cervical cytology abnormalities.
DESIGN


Secondary analysis comparing cervical cytology results between two randomized controlled microbicide trials (MTN-020/ASPIRE and MTN-003/VOICE).
METHODS


Data from ASPIRE, a phase III, placebo-controlled trial of the dapivirine vaginal ring, were used in this analysis. Cervical cytology smears were evaluated at baseline and at the final visit with product use. We compared cytology results between women randomized to dapivirine versus placebo vaginal ring. We further assessed for the effect of the vaginal ring device on cervical cytology by comparing results with data from the oral placebo arm of VOICE, a prior HIV-1 prevention trial conducted in a similar population.
RESULTS


Cervical cytology results for 2394 women from ASPIRE (1197 per study arm) were used in this analysis; median time between baseline and final visit with product use was 22.1 months. Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6 versus 91.5%, ASC-US//LSIL: 7.8 versus 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7 versus 1.1%, P = 0.44. Cytology data from VOICE had findings (normal: 87.8%, ASC-US/LSIL: 9.8%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 2.4%) comparable with that of both dapivirine (P = 0.93) and placebo vaginal ring arms (P = 0.24).
CONCLUSION


These findings indicate that neither use of the dapivirine vaginal ring nor the vaginal ring device alone, over a period of 2 years, is associated with development of cervical cytology abnormalities that could lead to precancerous or cancerous lesions.",2020,"Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6% vs. 91.5%, ASC-US//LSIL: 7.8% vs. 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7% vs. 1.1%, p = 0.44.",['2394 women from ASPIRE (1197 per study arm'],"['dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer', 'vaginal ring device', 'dapivirine vaginal ring', 'placebo', 'placebo vaginal ring', 'dapivirine']","['Cytology smear findings', 'Cervical cytology smears', 'cervical cytology abnormalities']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0856201', 'cui_str': 'Cervical cytology'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",2394.0,0.16241,"Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6% vs. 91.5%, ASC-US//LSIL: 7.8% vs. 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7% vs. 1.1%, p = 0.44.","[{'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, School of Clinical Medicine, Johannesburg, South Africa.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center, Seattle.'}, {'ForeName': 'Nitesha', 'Initials': 'N', 'LastName': 'Jeenarain', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban.'}, {'ForeName': 'Logashvari', 'Initials': 'L', 'LastName': 'Naidoo', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Siva', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gonasagrie', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Bonus', 'Initials': 'B', 'LastName': 'Makanani', 'Affiliation': 'College of Medicine-Johns Hopkins University Research Project Queen Elizabeth Central Hospital, Blantyre.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'UNC Project, Lilongwe, Malawi.'}, {'ForeName': 'Nyaradzo', 'Initials': 'N', 'LastName': 'Mgodi', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Zvavahera', 'Initials': 'Z', 'LastName': 'Chirenje', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Flavia Matovu', 'Initials': 'FM', 'LastName': 'Kiweewa', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Marrazzo', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, Alabama.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bunge', 'Affiliation': 'University of Pittsburg.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jeanna', 'Initials': 'J', 'LastName': 'Piper', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, School of Clinical Medicine, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002451']
1853,31744452,"Intravenous Tranexamic Acid for Brain Contusion with Intraparenchymal Hemorrhage: Randomized, Double-Blind, Placebo-Controlled Trial.","INTRODUCTION


Controlling of secondary traumatic brain injuries (TBI) is necessary due to its salient effect on the improvement of patients with TBI and the final outcomes within early hours of trauma onset. This study aims to investigate the effect of intravenous tranexamic acid (TAX) administration on decreased hemorrhage during surgery.
METHODS


This double-blind, randomized, and placebo-controlled trial was conducted on patients referring to the emergency department (ED) with IPH due to brain contusion within 8 h of injury onset. The patients were evaluated by receiving TXA and 0.9% normal saline as a placebo. The following evaluation and estimations were performed: intracranial hemorrhage volume after surgery using brain CT-scan; hemoglobin (Hb) volume before, immediately after, and six hours after surgery; and the severity of TBI based on Glasgow Coma Score (GCS).
RESULTS


40 patients with 55.02 ± 18.64 years old diagnosed with a contusion and intraparenchymal hemorrhage. Although the (Mean ± SD) hemorrhage during surgery in patients receiving TXA (784.21 ± 304.162) was lower than the placebo group (805.26 ± 300.876), no significant difference was observed between two groups (P=0.83). The (Mean ± SD) Hb volume reduction immediately during surgery (0.07 ± 0.001 and 0.23 ± 0.02) and six hours after surgery (0.04 ± 0.008 and 0.12 ± 0.006) was also lower in TXA group but had no significant difference (P = 0.89 and P = 0.97, respectively).
CONCLUSION


Using TXA may reduce the hemorrhage in patients with TBI, but this effect, as in this study, was not statistically significant and it is suggested that a clinical trial with a larger population is employed for further investigation.",2020,"Hb volume reduction immediately during surgery (0.07±0.001 and 0.23±0.02) and six hours after surgery (0.04±0.008 and 0.12±0.006) was also lower in TXA group but had no significant difference (P = 0.89 and P = 0.97 respectively).
","['patients referring to emergency department (ED) with IPH due to brain contusion within 8 h of injury onset', 'Brain Contusion with Intraparenchymal Hemorrhage', '40 patients with 55.02 ± 18.64 years old diagnosed with contusion and intraparenchymal hemorrhage', 'patients with TBI']","['Placebo', 'tranexamic acid (TAX', 'Intravenous Tranexamic Acid', 'placebo', 'TXA', 'TXA and 0.9% normal saline as placebo']","['severity of TBI based on Glasgow Coma Score (GCC', 'hemorrhage', 'Mean ± SD', 'intracranial hemorrhage volume', 'SD) hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0663679', 'cui_str': '(123I)-IPH'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0149844', 'cui_str': 'Brain Contusion'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009938', 'cui_str': 'Bruise'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0039371', 'cui_str': 'Taxes'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score finding'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",40.0,0.498786,"Hb volume reduction immediately during surgery (0.07±0.001 and 0.23±0.02) and six hours after surgery (0.04±0.008 and 0.12±0.006) was also lower in TXA group but had no significant difference (P = 0.89 and P = 0.97 respectively).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mousavinejad', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Mozafari', 'Affiliation': 'Department of Emergency Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Reza Bahrami', 'Initials': 'RB', 'LastName': 'Ilkhchi', 'Affiliation': 'Department of Neurosurgery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Ghasem', 'Initials': 'MG', 'LastName': 'Hanafi', 'Affiliation': 'Department of Radiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Ebrahimi', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Reviews on recent clinical trials,['10.2174/1574887114666191118111826']
1854,32050214,Prospective Randomized Comparative Trial: Visual Performance Comparison Of Two Enhanced Depth Of Focus IOLs - Symfony and IC-8.,"PURPOSE


To compare the visual acuity and satisfaction outcomes of two different concepts of enhanced depth of focus intraocular lenses (EDOF IOLs).
SETTING


University Eye Hospital Bochum, Germany DESIGN:: Prospective randomized comparative clinical trial METHODS:: This study included a sample of 76 eyes of 38 patients undergoing cataract surgery with the implantation of two different EDOF concepts. In the first group (IC-8 group) a monofocal 1-piece Tecnis Z B00 IOL (Johnson & Johnson Vision) was implanted in the dominant eye and an IC-8 IOL (AcuFocus) was implanted in the non-dominant eye. In the second group (Symfony group) a Tecnis Symfony IOL (Johnson & Johnson Vision) was implanted in both eyes. The target refraction of the dominat eye was emmetropia and slight myopia (mini-monovision; -0.75 D) in the non-dominant eye. Visual and refractive outcomes and patient satisfaction rates were evaluated 3 months after surgery.
RESULTS


In both groups no intra- or postoperative complications occurred. The target refraction was reached in both groups without statistical significant differences. The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02 (photopic); IC-8 group 0.12 ± 0.09, Symfony group 0.22 ± 0.1, p-value <0.01 (mesopic)). Binocular uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA) were also good in both groups without significant differences (UIVA IC-8 group 0.01 ± 0.07, Symfony group -0.01 ± 0.08, p-value 0.35; UNVA IC-8 group 0.14 ± 0.11, Symfony group 0.09 ± 0.08, p-value 0.14). Subjective satisfaction was high in both groups.
CONCLUSION


Both EDOF IOLs provided a very good UDVA with superior results in the IC-8 group, good UIVA and UNVA under photopic light conditions. Subjective patient satisfaction was higher in the IC-8 group.",2020,"The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02","['sample of 76 eyes of 38 patients undergoing cataract surgery with the implantation of two different EDOF concepts', 'University Eye Hospital Bochum, Germany DESIGN']","['enhanced depth of focus intraocular lenses (EDOF IOLs', 'Two Enhanced Depth Of Focus IOLs - Symfony and IC-8', 'Tecnis Symfony IOL (Johnson & Johnson Vision']","['target refraction', 'uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions', 'visual acuity and satisfaction outcomes', 'postoperative complications', 'Visual and refractive outcomes and patient satisfaction rates', 'Binocular uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA', 'Subjective patient satisfaction', 'Subjective satisfaction']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0042789', 'cui_str': 'Vision'}]","[{'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",38.0,0.0530222,"The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02","[{'ForeName': 'Merita', 'Initials': 'M', 'LastName': 'Schojai', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Tim Schultz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Corinna Jerke', 'Affiliation': ''}, {'ForeName': 'Dipl Ing', 'Initials': 'DI', 'LastName': 'Jörg Böcker', 'Affiliation': ''}, {'ForeName': 'H Burkhard', 'Initials': 'HB', 'LastName': 'Dick', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000068']
1855,32048083,"Re-establishment of efficacy of tofacitinib, an oral JAK inhibitor, after temporary discontinuation in patients with rheumatoid arthritis.","INTRODUCTION/OBJECTIVE


Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This post-hoc analysis evaluated the effect of temporary discontinuation and reinitiation of tofacitinib on disease control in patients with RA in the vaccine sub-study of the long-term extension (LTE) study ORAL Sequel (NCT00413699).
METHODS


The sub-study of ORAL Sequel was a randomized, parallel-group, open-label study. Patients who received tofacitinib 10 mg twice daily for ≥ 3 months in ORAL Sequel were randomized to receive continuous (tofacitinib monotherapy/with methotrexate) or interrupted (tofacitinib withdrawn for 2 weeks post-randomization then reinitiated as monotherapy/with methotrexate) treatment. Efficacy assessments included ACR20/50/70 response rates, change from baseline (∆) in C-reactive protein (CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4 [ESR]), Clinical Disease Activity Index (CDAI), Patient Global Assessment of arthritis (PtGA), Pain (Visual Analog Scale [VAS]), and Physician Global Assessment of arthritis (PGA). Safety was assessed throughout.
RESULTS


The sub-study included 99 patients each in the continuous and interrupted treatment groups. ACR20/50 response rates, ∆CRP, ∆HAQ-DI (day 15), ∆DAS28-4 (ESR), ∆CDAI, ∆PtGA, ∆Pain (VAS), and ∆PGA were significantly worse in interrupted vs continuous patients during dose interruption, but were generally similar to pre-interruption/continuous treatment levels 28 days post-reinitiation. A numerically higher proportion of interrupted patients reported adverse events (49.5%) vs continuous patients (35.4%).
CONCLUSIONS


Tofacitinib efficacy can be re-established after temporary withdrawal and reinitiation. The safety profile of patients who temporarily discontinued tofacitinib in the sub-study was consistent with previous tofacitinib LTE studies over 9 years.
CLINICAL TRIAL REGISTRATION NUMBER


NCT00413699 Key Points • In this sub-study of the long-term extension (LTE) study, ORAL Sequel, the efficacy of tofacitinib was re-established after temporary withdrawal (2 weeks) and reinitation of treatment in patients with RA. • Patients with RA who temporarily discontinued tofacitinib had similar safety events to those reported in previous LTE studies. • The results of this sub-study were consistent with a post-hoc analysis of pooled data from two LTE studies, ORAL Sequel and A3921041, which assessed the efficacy of tofacitinib following a treatment discontinuation period of 14-30 days.",2020,"A numerically higher proportion of interrupted patients reported adverse events (49.5%) vs continuous patients (35.4%).
","['patients with rheumatoid arthritis', 'patients with RA in the vaccine sub-study of the long-term extension (LTE) study ORAL Sequel (NCT00413699', '3\xa0months in ORAL Sequel', 'patients with RA', 'patients who temporarily discontinued tofacitinib in the sub-study was consistent with previous tofacitinib LTE studies over 9\xa0years', '99 patients each in the continuous and interrupted treatment groups', 'rheumatoid arthritis (RA']","['tofacitinib', 'tofacitinib 10\xa0mg twice daily for ≥', 'continuous (tofacitinib monotherapy/with methotrexate) or interrupted (tofacitinib withdrawn for 2 weeks post-randomization then reinitiated as monotherapy/with methotrexate']","['safety events', 'ACR20/50 response rates, ∆CRP, ∆HAQ-DI (day 15), ∆DAS28-4 (ESR), ∆CDAI, ∆PtGA, ∆Pain (VAS), and ∆PGA', 'ACR20/50/70 response rates, change from baseline (∆) in C-reactive protein (CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4 [ESR]), Clinical Disease Activity Index (CDAI), Patient Global Assessment of arthritis (PtGA), Pain (Visual Analog Scale [VAS]), and Physician Global Assessment of arthritis (PGA', 'adverse events', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243089', 'cui_str': 'sequels'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C4704009', 'cui_str': 'tofacitinib 10 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",99.0,0.278829,"A numerically higher proportion of interrupted patients reported adverse events (49.5%) vs continuous patients (35.4%).
","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kaine', 'Affiliation': 'Independent Healthcare Associates Inc, Cullowhee, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tesser', 'Affiliation': 'Arizona Arthritis & Rheumatology Associates, Glendale, AZ, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Takiya', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA. Liza.Takiya@pfizer.com.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'DeMasi', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Lisy', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Snyder', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Koshika', 'Initials': 'K', 'LastName': 'Soma', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Haiyun', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Vara', 'Initials': 'V', 'LastName': 'Bandi', 'Affiliation': 'Eliassen Group Inc, New London, CT, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Wollenhaupt', 'Affiliation': 'Rheumatology im Struenseehaus, Hamburg, Germany.'}]",Clinical rheumatology,['10.1007/s10067-020-04956-1']
1856,31843270,"Safety and immunogenicity of a 30-valent M protein-based group a streptococcal vaccine in healthy adult volunteers: A randomized, controlled phase I study.","BACKGROUND


Streptococcus pyogenes (group A Streptococcus, Strep A) is a widespread pathogen that continues to pose a significant threat to human health. The development of a Strep A vaccine remains an unmet global health need. One of the major vaccine strategies is the use of M protein, which is a primary virulence determinant and protective antigen. Multivalent recombinant M protein vaccines are being developed with N-terminal M peptides that contain opsonic epitopes but do not contain human tissue cross-reactive epitopes.
METHODS


We completed a Phase I trial of a recombinant 30-valent M protein-based Strep A vaccine (Strep A vaccine, StreptAnova™) comprised of four recombinant proteins containing N-terminal peptides from 30 M proteins of common pharyngitis and invasive and/or rheumatogenic serotypes, adjuvanted with aluminum hydroxide. The trial was observer-blinded and randomized in a 2:1 ratio for intramuscular administration of Strep A vaccine or an alum-based comparator in healthy adult volunteers, at 0, 30 and 180 days. Primary outcome measures were assessments of safety, including assays for antibodies that cross-reacted with host tissues, and immunogenicity assessed by ELISA with the individual vaccine peptides and by opsonophagocytic killing (OPK) assays in human blood.
RESULTS


Twenty-three Strep A-vaccinated participants and 13 controls completed the study. The Strep A vaccine was well-tolerated and there was no clinical evidence of autoimmunity and no laboratory evidence of tissue cross-reactive antibodies. The vaccine was immunogenic and elicited significant increases in geometric mean antibody levels to 24 of the 30 component M antigens by ELISA. Vaccine-induced OPK activity was observed against selected M types of Strep A in vaccinated participants that seroconverted to specific M peptides.
CONCLUSION


The Strep A vaccine was well tolerated and immunogenic in healthy adults, providing strong support for further clinical development. [ClinicalTrials.gov NCT02564237].",2020,The vaccine was immunogenic and elicited significant increases in geometric mean antibody levels to 24 of the 30 component M antigens by ELISA.,"['healthy adults', 'healthy adult volunteers, at 0, 30 and 180\xa0days', 'healthy adult volunteers', 'Twenty-three Strep A-vaccinated participants and 13 controls completed the study']","['recombinant 30-valent M protein-based Strep A vaccine (Strep A vaccine, StreptAnova™) comprised of four recombinant proteins containing N-terminal peptides', 'Strep A vaccine', '30-valent M protein-based group a streptococcal vaccine', 'aluminum hydroxide', 'Multivalent recombinant M protein vaccines']","['Safety and immunogenicity', 'safety, including assays for antibodies that cross-reacted with host tissues, and immunogenicity assessed by ELISA with the individual vaccine peptides and by opsonophagocytic killing (OPK) assays in human blood', 'geometric mean antibody levels', 'tolerated and immunogenic', 'OPK activity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0034861', 'cui_str': 'Biosynthetic Proteins'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0887906', 'cui_str': 'Streptococcal Vaccines'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0162388', 'cui_str': 'Killing'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005768'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.207819,The vaccine was immunogenic and elicited significant increases in geometric mean antibody levels to 24 of the 30 component M antigens by ELISA.,"[{'ForeName': 'Élodie', 'Initials': 'É', 'LastName': 'Pastural', 'Affiliation': 'Pan-Provincial Vaccine Enterprise Inc. (PREVENT), Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Division of Infectious Diseases, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: Shelly.McNeil@nshealth.ca.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'MacKinnon-Cameron', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Langley', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Division of Infectious Diseases, Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Martin', 'Affiliation': 'Pan-Provincial Vaccine Enterprise Inc. (PREVENT), Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Hurley', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Salehi', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Penfound', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Halperin', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Division of Infectious Diseases, Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Dale', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.12.005']
1857,32107337,"Response-adapted therapy with infusional EPOCH chemotherapy plus rituximab in HIV-associated, B-cell non-Hodgkin's lymphoma.","Four cycles of rituximab plus CHOP chemotherapy is as effective as 6 cycles in low-risk diffuse large B-cell lymphoma (DLBCL). Here we report a post-hoc analysis of a prospective clinical trial in patients with HIV-associated DLBCL and high-grade lymphoma treated with 4-6 cycles of EPOCH plus rituximab based a response-adapted treatment strategy. 106 evaluable patients with HIV-associated DLBCL or high-grade CD20-positive non-Hodgkin's lymphoma were randomized to receive rituximab (375 mg/m2) given either concurrently prior to each infusional EPOCH cycle, or sequentially (weekly for 6 weeks) following completion of EPOCH. EPOCH consisted of a 96-hour IV infusion of etoposide, doxorubicin, and vincristine plus oral prednisone followed by IV bolus cyclophosphamide every 21 days for 4 to 6 cycles. Patients received 2 additional cycles of therapy after documentation of a complete response (CR) by computerized tomography after cycles 2 and 4. 64 of 106 evaluable patients (60%, 95% CI 50%, 70%) had a CR in both treatment arms. The 2-year event-free survival (EFS) rates were similar in the 24 patients with CR who received 4 or fewer EPOCH cycles (78%, 95% confidence intervals [55%, 90%]) due to achieving a CR after 2 cycles, compared with those who received 5-6 cycles of EPOCH (85%, 95% CI 70%, 93%) because a CR was first documented after cycle 4. A response-adapted strategy may permit a shorter treatment duration without compromising therapeutic efficacy in patients with HIV-associated lymphoma treated with EPOCH plus rituximab, which merits further evaluation in additional prospective trials. Clinical Trials.gov identifier NCT00049036.",2021,"The 2-year event-free survival (EFS) rates were similar in the 24 patients with CR who received 4 or fewer EPOCH cycles (78%,","[""HIV- associated, B-cell non-Hodgkin's lymphoma"", 'patients with HIV-associated lymphoma treated with', ""106 evaluable patients with HIV-associated DLBCL or high-grade CD20-positive non-Hodgkin's lymphoma"", 'patients with HIV-associated DLBCL and high-grade lymphoma treated with 4-6 cycles of EPOCH plus rituximab based a response-adapted treatment strategy']","['rituximab', 'cyclophosphamide', 'EPOCH plus rituximab', 'infusional EPOCH chemotherapy plus rituximab', 'rituximab plus CHOP chemotherapy', 'etoposide, doxorubicin, and vincristine plus oral prednisone']",['2-year event-free survival (EFS) rates'],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",106.0,0.145786,"The 2-year event-free survival (EFS) rates were similar in the 24 patients with CR who received 4 or fewer EPOCH cycles (78%,","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore-Einstein Cancer Center, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Jeannette Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Ramos', 'Affiliation': 'University of Miami, Sylvester Comprehensive Cancer Center, Miami, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ambinder', 'Affiliation': 'Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wachsman', 'Affiliation': 'Moores University of California, San Diego Cancer Center, La Jolla, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aboulafia', 'Affiliation': 'Virginia Mason Cancer Institute, Seattle, WA, USA.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Noy', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Henry', 'Affiliation': 'University of Pennsylvania, Pennsylvania Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ratner', 'Affiliation': 'Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Cesarman', 'Affiliation': 'Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mitsuyasu', 'Affiliation': 'University of California, Los Angeles Medical Center, Los Angeles, CA, USA.'}]",Haematologica,['10.3324/haematol.2019.243386']
1858,32049283,Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial.,"AIMS


Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV).
METHODS AND RESULTS


SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference -2.39 (90% confidence interval, CI -9.45 to 4.66); Pequivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference -0.93 (90% CI -4.78 to 2.92); Pequivalence < 0.001], stroke 0.5% vs. 4.7% [rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003], moderate/severe paravalvular leak 3.4% vs. 1.5% [rate difference -1.89 (90% CI -5.86 to 2.08); Pequivalence = 0.0001], and permanent pacemaker implantation 23.0% vs. 19.2% [rate difference -3.85 (90% CI -10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06].
CONCLUSION


In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.",2020,Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3%,"['patients with symptomatic aortic stenosis', '447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA', 'transcatheter aortic valve implantation', 'patients with aortic stenosis undergoing']","['Transcatheter aortic valve implantation (TAVI', 'transfemoral TAVI', 'generation self-expandable vs. balloon-expandable valves']","['moderate/severe paravalvular leak', 'cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}, {'cui': 'C0458216', 'cui_str': 'Sev (substance)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1709508', 'cui_str': 'Paravalvular leak'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0336548', 'cui_str': 'Prosthetic valve'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",447.0,0.108761,Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3%,"[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kurz', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stachel', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hartung', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Marquetand', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Nef', 'Affiliation': 'Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Klinikstr. 33, D-35392 Gießen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Doerr', 'Affiliation': 'Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Klinikstr. 33, D-35392 Gießen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holzhey', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borger', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Ince', 'Affiliation': 'Medizinische Klinik I im Zentrum für Innere Medizin (ZIM), Universitätsklinikum Rostock, Ernst-Heydemann-Str. 6, D-18057 Rostock, Germany.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Öner', 'Affiliation': 'Medizinische Klinik I im Zentrum für Innere Medizin (ZIM), Universitätsklinikum Rostock, Ernst-Heydemann-Str. 6, D-18057 Rostock, Germany.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'Wienbergen', 'Affiliation': 'Klinikum Links der Weser, Herzzentrum Bremen, Senator-Wessling-Str. 1, D-28277 Bremen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fach', 'Affiliation': 'Klinikum Links der Weser, Herzzentrum Bremen, Senator-Wessling-Str. 1, D-28277 Bremen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Frey', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Inke R', 'Initials': 'IR', 'LastName': 'König', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Vonthein', 'Affiliation': 'Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, D-23562 Lübeck, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Rückert', 'Affiliation': 'Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany.'}, {'ForeName': 'Anne-Kathrin', 'Initials': 'AK', 'LastName': 'Funkat', 'Affiliation': 'Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}]",European heart journal,['10.1093/eurheartj/ehaa036']
1859,32152335,Melinjo seed extract increases adiponectin multimerization in physiological and pathological conditions.,"Melinjo seed extract (MSE) contains large amounts of polyphenols, including dimers of trans-resveratrol (e.g. gnetin C, L, gnemonoside A, B and D), and has been shown to potentially improve obesity. However, there is no clinical evidence regarding the anti-obesity effects of MSE, and its mechanisms are also unclear. We investigated the hypothesis that MSE supplementation increases the adiponectin (APN) multimerization via the up-regulation of disulfide bond A oxidoreductase-like protein (DsbA-L) under either or both physiological and obese conditions. To investigate the effect of MSE on the physiological condition, 42 healthy young volunteers were enrolled in a randomized, double-blind placebo-controlled clinical trial for 14 days. The participants were randomly assigned to the MSE 150 mg/day, MSE 300 mg/day or placebo groups. Furthermore, in order to investigate the effect of MSE on APN levels under obese conditions, we administered MSE powder (500 or 1000 mg/kg/day) to control-diet- or high-fat-diet (HFD)-fed C57BL/6 mice for 4 weeks. All participants completed the clinical trial. The administration of MSE 300 mg/day was associated with an increase in the ratio of HMW/total APN in relation to the genes regulating APN multimerization, including DsbA-L. Furthermore, this effect of MSE was more pronounced in carriers of the DsbA-L rs191776 G/T or T/T genotype than in others. In addition, the administration of MSE to HFD mice suppressed their metabolic abnormalities (i.e. weight gain, increased blood glucose level and fat mass accumulation) and increased the levels of total and HMW APN in serum and the mRNA levels of ADIPOQ and DsbA-L in adipose tissue. The present study suggests that MSE may exert beneficial effects via APN multimerization in relation to the induction of DsbA-L under both physiological and obese conditions.",2020,"The administration of MSE 300 mg/day was associated with an increase in the ratio of HMW/total APN in relation to the genes regulating APN multimerization, including DsbA-L.",['42 healthy young volunteers'],"['Melinjo seed extract', 'Melinjo seed extract (MSE', 'placebo', 'MSE', 'MSE supplementation', 'MSE 150\u2009mg/day, MSE 300\u2009mg/day or placebo', 'MSE powder']","['adiponectin (APN) multimerization', 'levels of total and HMW APN in serum and the mRNA levels of ADIPOQ and DsbA-L in adipose tissue', 'metabolic abnormalities (i.e. weight gain, increased blood glucose level and fat mass accumulation', 'ratio of HMW/total APN']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",42.0,0.193401,"The administration of MSE 300 mg/day was associated with an increase in the ratio of HMW/total APN in relation to the genes regulating APN multimerization, including DsbA-L.","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Oniki', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan. oniken@kumamoto-u.ac.jp.'}, {'ForeName': 'Taisei', 'Initials': 'T', 'LastName': 'Kawakami', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Azusa', 'Initials': 'A', 'LastName': 'Nakashima', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Department of Molecular Genetics, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Takehisa', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Departments of Gastroenterology and Hepatology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Fujikawa', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Nakashima', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Aoi', 'Initials': 'A', 'LastName': 'Nasu', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Eto', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Noriki', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Nohara', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Suico', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Kotani', 'Affiliation': 'Department of Organic Chemistry, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Obata', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Seguchi', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Saruwatari', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Imafuku', 'Affiliation': 'Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Maruyama', 'Affiliation': 'Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kai', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Shuto', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}]",Scientific reports,['10.1038/s41598-020-61148-2']
1860,32069463,Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy for Insomnia in General Practice: Results from a Pragmatic Randomized Clinical Trial.,"INTRODUCTION


Guidelines recommend cognitive behavioral therapy for insomnia (CBT-I) as the first line of treatment for insomnia in general practice, but CBT-I is rarely available. Nurse-guided Internet-delivered CBT-I might be a solution to improve access to care.
OBJECTIVE


We aimed to determine the effectiveness of nurse-guided Internet-delivered CBT-I (I-CBT-I) on insomnia severity experienced by patients in general practice.
METHODS


Nurse-guided I-CBT-I (""i-Sleep"") was compared to care-as-usual (and I-CBT-I after 6 months) in 15 participating general practices among 134 patients (≥18 years old) with clinical insomnia symptoms. Assessments took place at 8, 26 and 52 weeks. Primary outcome was self-reported insomnia severity (Insomnia Severity Index) at 8 weeks. Secondary outcomes were sleep diary indices, depression and anxiety symptoms (Hospital Anxiety and Depression Scale), fatigue, daytime consequences of insomnia, sleep medication and adverse events.
RESULTS


Two thirds of the 69 intervention patients (n = 47; 68%) completed the whole intervention. At the posttest examination, there were large significant effects for insomnia severity (Cohen's d =1.66), several sleep diary variables (wake after sleep onset, number of awakenings, terminal wakefulness, sleep efficiency, sleep quality) and depression. At 26 weeks there were still significant effects on insomnia severity (d = 1.02) and on total sleep time and sleep efficiency. No significant effects were observed for anxiety, fatigue, daily functioning or sleep medication. No adverse events were reported.
CONCLUSIONS


Nurse-guided I-CBT-I effectively reduces insomnia severity among general practice patients. I-CBT-I enables general practitioners to offer effective insomnia care in accordance with the clinical guidelines.",2020,At 26 weeks there were still significant effects on insomnia severity (d = 1.02) and on total sleep time and sleep efficiency.,"['15 participating general practices among 134 patients (≥18 years old) with clinical insomnia symptoms', 'general practice patients', 'Two thirds of the 69 intervention patients (n = 47; 68%) completed the whole intervention', 'insomnia severity experienced by patients in general practice']","['Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy', 'nurse-guided Internet-delivered CBT-I (I-CBT-I', 'cognitive behavioral therapy', 'Nurse-guided I-CBT-I (""i-Sleep']","['total sleep time and sleep efficiency', 'several sleep diary variables (wake after sleep onset, number of awakenings, terminal wakefulness, sleep efficiency, sleep quality) and depression', 'self-reported insomnia severity (Insomnia Severity Index', 'adverse events', 'sleep diary indices, depression and anxiety symptoms (Hospital Anxiety and Depression Scale), fatigue, daytime consequences of insomnia, sleep medication and adverse events', 'anxiety, fatigue, daily functioning or sleep medication', 'insomnia severity']","[{'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0459295,At 26 weeks there were still significant effects on insomnia severity (d = 1.02) and on total sleep time and sleep efficiency.,"[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Van der Zweerde', 'Affiliation': 'Department of Clinical Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, The Netherlands, t.vander.zweerde@vu.nl.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Lancee', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Slottje', 'Affiliation': 'Department of General Practice and Elderly Care, Academic Network of General Practice (ANH), Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Eus J W', 'Initials': 'EJW', 'LastName': 'Van Someren', 'Affiliation': 'Department of Sleep and Cognition, Netherlands Institute for Neuroscience, an Institute of the Royal Netherlands Academy of Arts and Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, The Netherlands.'}]",Psychotherapy and psychosomatics,['10.1159/000505600']
1861,31359800,Does radiopaque cement conceal periprosthetic bone loss around femoral stems?,"BACKGROUND


Periprosthetic bone remodelling may increase fracture risk and deplete bone stock around hip implants. These changes are in part caused by implant design, advocating an early evaluation of bone remodelling properties of new implants. This can be done by repeated dual-energy x-ray absorptiometry (DXA) measurements. We know that radiopaque cement falsely elevates bone mineral density (BMD) in single measurements, however, its impact on repeated measurements, i.e. BMD changes is unexplored. We have therefore investigated whether the presence of radiopaque cement affect repeated BMD measurements.
METHODS


33 patients eligible for total hip replacement were randomly assigned to either radiopaque or radiolucent cement. BMD changes up to 12 months were measured by DXA, in addition to Harris Hip Score, plain radiographs and radiostereometric analysis (RSA).
RESULTS


Periprosthetic BMD declined during the first 3-6 months in all zones in both groups. The greatest reduction (14%) was seen in the proximal Gruen zones (1 and 7). We found a significant difference in Gruen zones 1 and 2, where the measured bone loss was higher in the radiolucent cement group.
CONCLUSIONS


The presence of radiopaque agents in bone cement may influence DXA measurements of bone remodelling.ClinicalTrials.gov identifier NCT00473421.",2020,"We found a significant difference in Gruen zones 1 and 2, where the measured bone loss was higher in the radiolucent cement group.
",['33 patients eligible for total hip replacement'],['radiopaque or radiolucent cement'],"['Periprosthetic BMD', 'BMD changes', 'bone mineral density (BMD', 'bone loss', 'Harris Hip Score, plain radiographs and radiostereometric analysis (RSA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}]","[{'cui': 'C0443285', 'cui_str': 'Radiolucent (qualifier value)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C3178874', 'cui_str': 'Radiostereometry'}]",33.0,0.0760213,"We found a significant difference in Gruen zones 1 and 2, where the measured bone loss was higher in the radiolucent cement group.
","[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Flatøy', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dahl', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Stephan Maximilian', 'Initials': 'SM', 'LastName': 'Röhrl', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nordsletten', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019863352']
1862,32036375,Efficacy of a Specialized Group Intervention for Compulsive Exercise in Inpatients with Anorexia Nervosa: A Randomized Controlled Trial.,"INTRODUCTION


Treatment of compulsive exercise is recognized as a key unmet challenge in the treatment of anorexia nervosa (AN). To address this challenge, we developed the manualized group intervention ""healthy exercise behavior"" (HEB). This study evaluates the efficacy of HEB for the reduction of compulsive exercise as add-on to routine inpatient treatment (treatment as usual [TAU]) in a randomized controlled trial.
METHODS


Two hundred and seven adolescent and adult female inpatients with (atypical) AN were randomly allocated to TAU or to additional participation in HEB (TAU + HEB). HEB integrates elements of exercise-based therapy into a cognitive-behavioral approach. Assessments took place at admission, pre-intervention, post-intervention, discharge, and 6 months follow-up. Primary outcome was the severity of compulsive exercise assessed by the Commitment to Exercise Scale between pre- and post-intervention; secondary outcomes were additional aspects of compulsive exercise, assessed by the Compulsive Exercise Test, weight gain, eating disorder and general psychopathology, and emotion regulation.
RESULTS


In intention-to-treat analysis for the primary outcome, the TAU + HEB group showed significantly stronger reductions in the severity of compulsive exercise compared to the TAU group (z = -2.81; p = 0.005; effect size [ES] = -0.3). We also found significantly stronger reductions from admission to discharge (z= 2.62; p = 0.009; ES = -0.43), and from admission to follow-up (z = 2.1; p = 0.035; ES = -0.39). Regarding secondary outcomes, we found significant group differences between pre- and post-intervention in additional aspects of compulsive exercise (z = -2.55; p = 0.011; ES = -0.27). We did not find significant differences regarding weight gain, eating disorder and general psychopathology, and emotion regulation.
CONCLUSIONS


Our intervention proved efficacious in reducing compulsive exercise in inpatients with (atypical) AN.",2020,"Regarding secondary outcomes, we found significant group differences between pre- and post-intervention in additional aspects of compulsive exercise (z = -2.55; p = 0.011; ES = -0.27).","['Inpatients with Anorexia Nervosa', 'Two hundred and seven adolescent and adult female inpatients with (atypical', 'inpatients with (atypical) AN']","['TAU + HEB', 'manualized group intervention ""healthy exercise behavior"" (HEB', 'HEB', 'Compulsive Exercise', 'TAU or to additional participation in HEB (TAU + HEB', 'Specialized Group Intervention', 'compulsive exercise']","['effect size [ES', 'weight gain, eating disorder and general psychopathology, and emotion regulation', 'severity of compulsive exercise', 'additional aspects of compulsive exercise', 'severity of compulsive exercise assessed by the Commitment to Exercise Scale between pre- and post-intervention; secondary outcomes were additional aspects of compulsive exercise, assessed by the Compulsive Exercise Test, weight gain, eating disorder and general psychopathology, and emotion regulation', 'compulsive exercise']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}]",207.0,0.103307,"Regarding secondary outcomes, we found significant group differences between pre- and post-intervention in additional aspects of compulsive exercise (z = -2.55; p = 0.011; ES = -0.27).","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Dittmer', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany, NDittmer@schoen-klinik.de.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Voderholzer', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mönch', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Cuntz', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Jacobi', 'Affiliation': 'Department of Clinical Psychology and E-Mental-Health, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schlegl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Munich (LMU), Munich, Germany.'}]",Psychotherapy and psychosomatics,['10.1159/000504583']
1863,31879124,Augmented immune responses to a booster dose of oral cholera vaccine in Bangladeshi children less than 5 years of age: Revaccination after an interval of over three years of primary vaccination with a single dose of vaccine.,"We have earlier reported that a single dose of oral cholera vaccine (OCV) is protective in adults and children ≥5 years of age and sustained for 2 years. We enrolled participants (n = 240) from this study, between March-September 2017, over 3 years after receiving a primary single dose. Immune responses were measured in placebo group (Primary Immunization group: PI) and compared with those who received a single dose (Booster Immunization group: BI). The children were 4 to <5 years, 5 to <18 years and adults >18 years. Blood was collected at day 0 (before vaccination) and after receiving 1st and 2nd doses of OCV. Overall, the BI and PI groups showed vibriocidal antibody response after 1st and 2nd dose of vaccination in all age groups to V. cholerae O1 and O139. Young children in the BI group showed significantly higher vibriocidal antibody response two weeks after receiving the first dose as compared to PI group to LPS. Elevated plasma IgA responses to LPS after the first dose were observed among the BI group compared to the PI group among the young children. Mucosal antibody responses measured in fecal extracts showed similar increases as that of vibriocidal and LPS responses in the BI group. These results suggest a single boosting dose of OCV generated immune response in primed population >5 years of age who had earlier received OCV. However, young children who had received OCV earlier, boosting after a single dose, resulted in increased immune responses compared to the PI group. Further studies are needed to assess protection obtained from different strategies, especially for young children and to determine the numbers of primary and booster doses needed. In addition, more information is needed regarding the optimum interval between primary and booster doses to plan future interventions for cholera control. ClinicalTrials.gov Identifier: NCT02027207.",2020,Mucosal antibody responses measured in fecal extracts showed similar increases as that of vibriocidal and LPS responses in the BI group.,"['children were 4 to <5\xa0years, 5 to <18\xa0years and adults >18\xa0years', 'adults and children ≥5\xa0years of age and sustained for 2\xa0years', 'Bangladeshi children less than 5\xa0years of age', 'enrolled participants (n\xa0=\xa0240) from this study, between March-September 2017, over 3\xa0years after receiving a primary single dose', 'young children', 'Young children']","['placebo', 'oral cholera vaccine', 'oral cholera vaccine (OCV', 'vaccine']","['Elevated plasma IgA responses', 'vibriocidal antibody response', 'immune responses', 'Immune responses', 'Mucosal antibody responses', 'vibriocidal and LPS responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}]",,0.0583191,Mucosal antibody responses measured in fecal extracts showed similar increases as that of vibriocidal and LPS responses in the BI group.,"[{'ForeName': 'Fahima', 'Initials': 'F', 'LastName': 'Chowdhury', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Taufiqur Rahman', 'Initials': 'TR', 'LastName': 'Bhuiyan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Afroza', 'Initials': 'A', 'LastName': 'Akter', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Saruar', 'Initials': 'MS', 'LastName': 'Bhuiyan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ashraful Islam', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Imam', 'Initials': 'I', 'LastName': 'Tauheed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Tasnuva', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Jannatul', 'Initials': 'J', 'LastName': 'Ferdous', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Pinki', 'Initials': 'P', 'LastName': 'Dash', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Salima Raiyan', 'Initials': 'SR', 'LastName': 'Basher', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Hakim', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'International Vaccine Institute (IVI), Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute (IVI), Seoul, Republic of Korea.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'International Vaccine Institute (IVI), Seoul, Republic of Korea.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute (IVI), Seoul, Republic of Korea.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh; UCLA Fielding School of Public Health, Los Angeles, CA, USA; Korea University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh. Electronic address: fqadri@icddrb.org.'}]",Vaccine,['10.1016/j.vaccine.2019.12.034']
1864,31812464,"A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1).","BACKGROUND


A global shortfall of vaccines for avian influenza A(H5N1) would occur, especially in low- and-middle income countries, if a pandemic were to occur. To address this issue, development of a pre-pandemic influenza vaccine was initiated in 2012, leveraging a recently established influenza vaccine manufacturing capacity in Vietnam.
METHODS


This was a Phase 2/3, double-blinded, randomized, placebo-controlled study to test the safety and immunogenicity of IVACFLU-A/H5N1 vaccine in healthy adults. Phase 2 was a dose selection study, in which 300 participants were randomized to one of the three groups (15 mcg, 30 mcg, or placebo). Safety and immunogenicity were assessed in all participants. In Phase 3, 630 participants were randomized to receive the IVACFLU-A/H5N1 vaccine dose selected in Phase 2 (15 mcg, n = 525) or placebo (n = 105). Safety was assessed in all Phase 3 participants and immunogenicity was measured in a subset of participants.
RESULTS


The vaccine was well tolerated and most of the adverse events were mild and of short duration. Mild pain at the injection site was the most common adverse event seen in 60 percent of participants in the vaccine group in Phase 3. In Phase 2, both 15 mcg and 30 mcg doses were immunogenic, so the lower dose was selected for further testing in Phase 3. In Phase 3 overall seroconversion rates were 68 percent for hemagglutination inhibition (HI), 51 percent for microneutralization (MN) and 56 percent for single radial hemolysis (SRH). The seroprotection rates were 44 percent for HI, 41 percent for MN and 55 percent for SRH. The GMT ratio was 5.31 and 3.7 for HI and MN respectively; GMA was 4.75 for the SRH.
CONCLUSION


The IVACFLU A/H5N1 was safe and immunogenic. Development of this pandemic avian influenza vaccine is a welcome addition to the limited global pool of these vaccines. ClinicalTrials.gov register NCT02612909.",2020,"In Phase 3 overall seroconversion rates were 68 percent for hemagglutination inhibition (HI), 51 percent for microneutralization (MN) and 56 percent for single radial hemolysis (SRH).","['healthy adults', '2012, leveraging a recently established influenza vaccine manufacturing capacity in Vietnam', '630 participants', 'healthy adult participants in Vietnam', '300 participants']","['IVACFLU', 'placebo', 'IVACFLU-A/H5N1 vaccine', 'inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1']","['overall seroconversion rates', 'seroprotection rates', 'Safety and immunogenicity', 'GMT ratio', 'Mild pain', 'Safety']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0137988', 'cui_str': 'alum'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}]",300.0,0.538309,"In Phase 3 overall seroconversion rates were 68 percent for hemagglutination inhibition (HI), 51 percent for microneutralization (MN) and 56 percent for single radial hemolysis (SRH).","[{'ForeName': 'Tran Nhu', 'Initials': 'TN', 'LastName': 'Duong', 'Affiliation': 'National Institute of Hygiene and Epidemiology, Hanoi, Viet Nam.'}, {'ForeName': 'Vu Dinh', 'Initials': 'VD', 'LastName': 'Thiem', 'Affiliation': 'National Institute of Hygiene and Epidemiology, Hanoi, Viet Nam.'}, {'ForeName': 'Dang Duc', 'Initials': 'DD', 'LastName': 'Anh', 'Affiliation': 'National Institute of Hygiene and Epidemiology, Hanoi, Viet Nam.'}, {'ForeName': 'Nguyen Phu', 'Initials': 'NP', 'LastName': 'Cuong', 'Affiliation': 'PATH, Hanoi, Viet Nam.'}, {'ForeName': 'Tran Cong', 'Initials': 'TC', 'LastName': 'Thang', 'Affiliation': 'PATH, Hanoi, Viet Nam.'}, {'ForeName': 'Vu Minh', 'Initials': 'VM', 'LastName': 'Huong', 'Affiliation': 'PATH, Hanoi, Viet Nam.'}, {'ForeName': 'Vien Chinh', 'Initials': 'VC', 'LastName': 'Chien', 'Affiliation': 'Institute of Vaccines and Medical Biologicals, Nha Trang, Viet Nam.'}, {'ForeName': 'Nguyen Thi Lan', 'Initials': 'NTL', 'LastName': 'Phuong', 'Affiliation': 'Institute of Vaccines and Medical Biologicals, Nha Trang, Viet Nam.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Montomoli', 'Affiliation': 'Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy; VisMederi srl, Siena, Italy.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Holt', 'Affiliation': 'PATH, Seattle, USA.'}, {'ForeName': 'Francesco Berlanda', 'Initials': 'FB', 'LastName': 'Scorza', 'Affiliation': 'PATH, Seattle, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, Seattle, USA.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Tewari', 'Affiliation': 'PATH, Seattle, USA. Electronic address: ttewari@path.org.'}]",Vaccine,['10.1016/j.vaccine.2019.11.059']
1865,32152377,Implications of early diagnosis of autosomal dominant polycystic kidney disease: A post hoc analysis of the TEMPO 3:4 trial.,"It is unknown whether early diagnosis of autosomal dominant polycystic kidney disease (ADPKD) can enable earlier management and improve outcomes. We conducted a post hoc analysis of data from the TEMPO 3:4 trial. Subjects were stratified by ADPKD diagnosis at age ≤18 (childhood diagnosis [CD]) or>18 (adulthood diagnosis [AD]). Groups were compared for baseline characteristics and total kidney volume (TKV) growth and estimated glomerular filtration rate (eGFR) decline over 3 years. 294 CD and 1148 AD subjects were analyzed. At inclusion, CD subjects were younger (mean age 34.2 versus 39.8 years; p < 0.0001) and had better eGFR (mean ± SD 87.4 ± 23.9 versus 80.1 ± 20.7 mL/min/1.73 m 2 ; p < 0.0001), while CD had more severe Mayo risk classification (p < 0.0001) and more PKD1 mutations (p = 0.003). No statistical differences were found in TKV or eGFR change. At study end, placebo-treated CD subjects had better eGFR than projected by a prediction equation (mean difference ±SD for observed versus predicted eGFR: 2.18 ± 10.7 mL/min/1.73 m 2 ; p = 0.0475). However, these results are not confirmed when excluding stage 1 CKD. Whether CD subjects, despite their risk profile, have a slower disease course than predicted remains inconclusive. Future studies are needed to confirm that early diagnosis and management can alter the disease course of ADPKD.",2020,"At inclusion, CD subjects were younger (mean age 34.2 versus 39.8 years; p < 0.0001) and had better eGFR (mean ± SD 87.4 ± 23.9 versus 80.1 ± 20.7 mL/min/1.73 m 2 ; p < 0.0001), while CD had more severe Mayo risk classification (p < 0.0001) and more PKD1 mutations (p = 0.003).","['294 CD and 1148 AD subjects', 'Subjects were stratified by ADPKD diagnosis at age ≤18 (childhood diagnosis [CD]) or>18 (adulthood diagnosis [AD', 'autosomal dominant polycystic kidney disease']",['placebo-treated CD'],"['severe Mayo risk classification', 'TKV or eGFR change', 'total kidney volume (TKV) growth and estimated glomerular filtration rate (eGFR) decline', 'PKD1 mutations']","[{'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0085413', 'cui_str': 'ADPKD'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C3811844'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",,0.0952539,"At inclusion, CD subjects were younger (mean age 34.2 versus 39.8 years; p < 0.0001) and had better eGFR (mean ± SD 87.4 ± 23.9 versus 80.1 ± 20.7 mL/min/1.73 m 2 ; p < 0.0001), while CD had more severe Mayo risk classification (p < 0.0001) and more PKD1 mutations (p = 0.003).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Janssens', 'Affiliation': 'PKD Research Group, Laboratory of Pediatrics, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jouret', 'Affiliation': 'Division of Nephrology, University of Liège Hospital (ULiège CHU), Liège, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Bammens', 'Affiliation': 'Department of Microbiology & Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Max C', 'Initials': 'MC', 'LastName': 'Liebau', 'Affiliation': 'Department of Pediatrics and Center for Molecular Medicine, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Schaefer', 'Affiliation': ""Division of Pediatric Nephrology, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Dandurand', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Perrone', 'Affiliation': 'Division of Nephrology, Tufts Medical Center and Tufts University School of Medicine, Boston, USA.'}, {'ForeName': 'Roman-Ulrich', 'Initials': 'RU', 'LastName': 'Müller', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Pao', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Djalila', 'Initials': 'D', 'LastName': 'Mekahli', 'Affiliation': 'PKD Research Group, Laboratory of Pediatrics, University Hospitals Leuven, Leuven, Belgium. djalila.mekahli@uzleuven.be.'}]",Scientific reports,['10.1038/s41598-020-61303-9']
1866,32165251,"A randomized, placebo-controlled, phase II study of obeticholic acid for primary sclerosing cholangitis.","BACKGROUND & AIMS


Primary sclerosing cholangitis (PSC) is a rare, cholestatic liver disease with no currently approved therapies. Obeticholic acid (OCA) is a potent farnesoid X receptor (FXR) agonist approved for the treatment of primary biliary cholangitis. We investigated the efficacy and safety of OCA in patients with PSC.
METHODS


AESOP was a phase II, randomized, double-blind, placebo-controlled, dose-finding study. Eligible patients were 18 to 75 years of age with a diagnosis of PSC and serum alkaline phosphatase (ALP) ≥2× the upper limit of normal (ULN) and total bilirubin <2.5× ULN. Patients were randomized 1:1:1 to receive placebo, OCA 1.5-3.0 mg, or OCA 5-10 mg once daily for a 24-week, double-blind phase followed by a 2-year, long-term safety extension (LTSE). Primary endpoints were change in ALP from baseline to week 24, and safety.
RESULTS


The intent-to-treat population comprised 76 patients randomized to placebo (n = 25), OCA 1.5-3.0 mg (n = 25), and OCA 5-10 mg (n = 26). At week 24, serum ALP was significantly reduced with OCA 5-10 mg vs. placebo (least-square [LS] mean difference = -83.4 [SE = 40.3] U/L; 95% CI -164.28 to -2.57; p = 0.043). Serum ALP was not significantly reduced with OCA 1.5-3.0 mg vs. placebo at week 24 (LS mean [SE] difference = -78.29 [41.81] U/L; 95% CI -162.08 to 5.50; p = 0.067). Total bilirubin remained comparable to baseline in all groups. The most common treatment-emergent adverse event was dose-related pruritus (placebo 46%; OCA 1.5-3.0 mg 60%; OCA 5-10 mg 67%). Reductions in ALP were maintained during the LTSE, and no new safety signals emerged.
CONCLUSIONS


Treatment with OCA 5-10 mg reduced serum ALP in patients with PSC. Mild to moderate dose-related pruritus was the most common adverse event.
REGISTRATION


ClinicalTrials.gov: NCT02177136; EudraCT: 2014-002205-38.
LAY SUMMARY


Primary sclerosing cholangitis (PSC) is a long-term disease that damages the bile ducts in the liver over time. In the AESOP clinical study in patients with PSC, obeticholic acid reduced serum alkaline phosphatase (a potential marker of disease severity) during an initial 24-week treatment period. The result was sustained during the 2-year, long-term extension of the study. The most common side effect of obeticholic acid in the study was itchy skin, which is consistent with earlier clinical studies.",2020,"At week 24, serum ALP was significantly reduced with OCA 5-10 mg vs. placebo: least-square (LS) mean difference = ‒83.4","['primary biliary cholangitis', 'primary sclerosing cholangitis', 'Eligible patients were 18 to 75 years of age with a diagnosis of PSC and serum alkaline phosphatase (ALP', 'patients with PSC']","['Obeticholic acid (OCA', 'OCA 1.5-3 mg (n=25), and OCA', 'obeticholic acid', 'placebo, OCA 1.5-3 mg, or OCA 5-10 mg once daily for a 24-week double-blind phase followed by a 2-year, long-term safety extension (LTSE', 'placebo', 'OCA']","['Serum ALP', 'serum ALP', 'efficacy and safety', 'change in ALP from baseline to week 24, and safety', 'Reductions in ALP', 'Total bilirubin']","[{'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}]",,0.685916,"At week 24, serum ALP was significantly reduced with OCA 5-10 mg vs. placebo: least-square (LS) mean difference = ‒83.4","[{'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Institute Northwest, Seattle, WA, USA. Electronic address: kkowdley@liverinstitutenw.org.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Vuppalanchi', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Division of Hepatology, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Annarosa', 'Initials': 'A', 'LastName': 'Floreani', 'Affiliation': 'Università di Padova, Padova, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Andreone', 'Affiliation': 'SMECHIMAI Department, Università di Modena e Reggio-Emilia, Modena, Italy.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Shrestha', 'Affiliation': 'Department of Transplantation, Piedmont Transplant Institute, Atlanta, GA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Trotter', 'Affiliation': 'Division of Transplant Hepatology, Baylor University, Dallas, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldberg', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rushbrook', 'Affiliation': 'Faculty of Medicine and Health Sciences, Norwich Medical School, Norwich, UK.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'Toronto Centre for Liver Disease, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schiano', 'Affiliation': 'Recanati/Miller Transplantation Institute/Division of Liver Diseases, The Mount Sinai Medical Center, New York, NY, USA.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pencek', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hepatology,['10.1016/j.jhep.2020.02.033']
1867,31784354,Machine Learning Identifies Large-Scale Reward-Related Activity Modulated by Dopaminergic Enhancement in Major Depression.,"BACKGROUND


Theoretical models have emphasized systems-level abnormalities in major depressive disorder (MDD). For unbiased yet rigorous evaluations of pathophysiological mechanisms underlying MDD, it is critically important to develop data-driven approaches that harness whole-brain data to classify MDD and evaluate possible normalizing effects of targeted interventions. Here, using an experimental therapeutics approach coupled with machine learning, we investigated the effect of a pharmacological challenge aiming to enhance dopaminergic signaling on whole-brain response to reward-related stimuli in MDD.
METHODS


Using a double-blind, placebo-controlled design, we analyzed functional magnetic resonance imaging data from 31 unmedicated MDD participants receiving a single dose of 50 mg amisulpride (MDD Amisulpride ), 26 MDD participants receiving placebo (MDD Placebo ), and 28 healthy control subjects receiving placebo (HC Placebo ) recruited through two independent studies. An importance-guided machine learning technique for model selection was used on whole-brain functional magnetic resonance imaging data probing reward anticipation and consumption to identify features linked to MDD (MDD Placebo  vs. HC Placebo ) and dopaminergic enhancement (MDD Amisulpride  vs. MDD Placebo ).
RESULTS


Highly predictive classification models emerged that distinguished MDD Placebo  from HC Placebo  (area under the curve = 0.87) and MDD Placebo  from MDD Amisulpride  (area under the curve = 0.89). Although reward-related striatal activation and connectivity were among the most predictive features, the best truncated models based on whole-brain features were significantly better relative to models trained using striatal features only.
CONCLUSIONS


Results indicate that in MDD, enhanced dopaminergic signaling restores abnormal activation and connectivity in a widespread network of regions. These findings provide new insights into the pathophysiology of MDD and pharmacological mechanism of antidepressants at the system level in addressing reward processing deficits among depressed individuals.",2020,"RESULTS


Highly predictive classification models emerged that distinguished MDD Placebo  from HC Placebo  (area under the curve = 0.87) and MDD Placebo  from MDD Amisulpride  (area under the curve = 0.89).","['31 unmedicated MDD participants receiving a single dose of 50 mg', '28 healthy control subjects receiving', '26 MDD participants receiving']","['amisulpride (MDD Amisulpride ', 'placebo (HC Placebo ', 'HC Placebo', 'placebo', 'dopaminergic enhancement (MDD Amisulpride  vs. MDD Placebo ', 'placebo (MDD Placebo ', 'Machine Learning Identifies', 'MDD (MDD Placebo  vs. HC Placebo ']",[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]",[],26.0,0.291919,"RESULTS


Highly predictive classification models emerged that distinguished MDD Placebo  from HC Placebo  (area under the curve = 0.87) and MDD Placebo  from MDD Amisulpride  (area under the curve = 0.89).","[{'ForeName': 'Yuelu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'BlackThorn Therapeutics, San Francisco, California.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Admon', 'Affiliation': 'Department of Psychology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Monika S', 'Initials': 'MS', 'LastName': 'Mellem', 'Affiliation': 'BlackThorn Therapeutics, San Francisco, California.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Belleau', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Roselinde H', 'Initials': 'RH', 'LastName': 'Kaiser', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Clegg', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Beltzer', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Goer', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Vitaliano', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Parvez', 'Initials': 'P', 'LastName': 'Ahammad', 'Affiliation': 'BlackThorn Therapeutics, San Francisco, California.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts. Electronic address: dap@mclean.harvard.edu.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2019.10.002']
1868,32108545,Interrater Reliability of Dynamic Muscle Testing After Breast Cancer Surgery in Women at High Risk of Lymphedema: To Improve Quality in Clinical Practice.,"Background:  The purpose of this study is to determine the interrater reliability of dynamic muscle tests in the early rehabilitation phase in women after breast cancer surgery with axillary lymph node dissection (ALND) based on the ""preventive intervention against lymphedema after breast cancer"" (LYCA) randomised controlled trial.  Methods:  Fifteen women treated with breast cancer surgery including ALND were recruited from participants in the LYCA trial. In this interrater reliability study, women were tested in 4 dynamic muscle tests by 2 physiotherapists at a Capital Hospital in Denmark. Intraclass correlation coefficients (ICCs) with 95% confidence intervals (CIs) was used to assess the relative reliability between raters. A Bland-Altman plot and limits of agreement were calculated to describe the absolute reliability.  Results:  All 6 subtests displayed high interrater reliability. ICC values were: leg press 0.96 (95% CI = 0.87-0.99), elbow flexion (contralateral) 0.94 (0.83-0.98), elbow flexion (affected arm) 0.93 (0.80-0.98), elbow extension 0.80 (0.41-0.93), shoulder abduction (contralateral) 0.89 (0.68-0.96), and shoulder abduction (affected arm) 0.91 (0.74-0.97). Cumulated interrater reliability for the test battery was very high (ICC = 0.99, 95% CI = 0.990-1.0). The absolute reliability of this study was considered high, and the absence of large shifts between mean and the line of 0 difference suggest no systematic bias that could influence clinical interpretation.  Conclusions:  The dynamic muscle tests evaluated in this study had high interrater reliability and can be used reliably in women in the postoperative phase after breast cancer surgery with ALND.",2020,"ICC values were: leg press 0.96 (95% CI = 0.87-0.99), elbow flexion (contralateral) 0.94 (0.83-0.98), elbow flexion (affected arm) 0.93 (0.80-0.98), elbow extension 0.80 (0.41-0.93), shoulder abduction (contralateral) 0.89 (0.68-0.96), and shoulder abduction (affected arm)","['women after breast cancer surgery with axillary lymph node dissection (ALND) based on the ""preventive intervention against lymphedema after breast cancer"" (LYCA', 'women in the postoperative phase after breast cancer surgery with ALND', 'Fifteen women treated with breast cancer surgery including ALND were recruited from participants in the LYCA trial', 'Women at High Risk of Lymphedema', 'women were tested in 4 dynamic muscle tests by 2 physiotherapists at a Capital Hospital in Denmark']",['Dynamic Muscle Testing'],"['shoulder abduction', 'Intraclass correlation coefficients (ICCs', 'Cumulated interrater reliability', 'elbow flexion', 'ICC values']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0905105,"ICC values were: leg press 0.96 (95% CI = 0.87-0.99), elbow flexion (contralateral) 0.94 (0.83-0.98), elbow flexion (affected arm) 0.93 (0.80-0.98), elbow extension 0.80 (0.41-0.93), shoulder abduction (contralateral) 0.89 (0.68-0.96), and shoulder abduction (affected arm)","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Korsholm-Rosfort', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, University College Copenhagen, Denmark.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Larsen', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, University College Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Aagaard', 'Affiliation': 'Department of Physio- and Occupational Therapy, Holbaek Hospital, Denmark.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Ammitzbøll', 'Affiliation': 'Danish Research Center for Equality in Cancer (COMPAS), Zealand University Hospital, Naestved, Denmark.'}, {'ForeName': 'Susanne O', 'Initials': 'SO', 'LastName': 'Dalton', 'Affiliation': 'Danish Research Center for Equality in Cancer (COMPAS), Zealand University Hospital, Naestved, Denmark.'}]",Integrative cancer therapies,['10.1177/1534735420903801']
1869,31972249,Molecular and Cellular Responses to the TYK2/JAK1 Inhibitor PF-06700841 Reveal Reduction of Skin Inflammation in Plaque Psoriasis.,"The IL-23/T helper type 17 cell axis is a target for psoriasis. The TYK2/Janus kinase 1 inhibitor PF-06700841 will directly suppress TYK2-dependent IL-12 and IL-23 signaling and Janus kinase 1-dependent signaling in cells expressing these signaling molecules, including T cells and keratinocytes. This clinical study sought to define the inflammatory gene and cellular pathways through which PF-06700841 improves the clinical manifestations of psoriasis. Patients (n = 30) with moderate-to-severe psoriasis were randomized to once-daily 30 mg (n = 14) or 100 mg (n = 7) PF-06700841 or placebo (n = 9) for 28 days. Biopsies were taken from nonlesional and lesional skin at baseline and weeks 2 and 4. Changes in the psoriasis transcriptome and genes induced by IL-17 in keratinocytes were evaluated with microarray profiling and reverse transcriptase-PCR. Reductions in IL-17A, IL-17F, and IL-12B mRNA were observed as early as 2 weeks and approximately 70% normalization of lesional gene expression after 4 weeks. Immunohistochemistry showed significant decreases in markers of keratinocyte activation, epidermal thickness, KRT16 and Ki-67 expression, and immune cell infiltrates CD3 + /CD8 +  (T cells) and CD11c (dendritic cells) after 2 weeks of treatment, corresponding with improvement in histologic score. PF-06700841 improves clinical symptoms of chronic plaque psoriasis by inhibition of proinflammatory cytokines that require TYK2 and Janus kinase 1 for signal transduction.",2020,"Immunohistochemistry showed significant decreases in markers of keratinocyte activation, epidermal thickness, KRT16 and Ki-67 expression, and immune cell infiltrates CD3+/CD8+ (T cells) and CD11c (dendritic cells) after 2 weeks of treatment, corresponding with improvement in histologic score.",['Patients (n=30) with moderate-to-severe psoriasis'],"['interleukin (IL)-23/T-helper type 17 cell axis', 'placebo']","['markers of keratinocyte activation, epidermal thickness, KRT16 and Ki-67 expression, and immune cell infiltrates CD3+/CD8+ (T cells) and CD11c (dendritic cells', 'lesional gene expression', 'histologic score', 'IL-17A, IL-17F, and IL-12B mRNA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022567', 'cui_str': 'Keratinocyte (cell)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C1705097', 'cui_str': 'Interleukin-17F'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}]",,0.0954999,"Immunohistochemistry showed significant decreases in markers of keratinocyte activation, epidermal thickness, KRT16 and Ki-67 expression, and immune cell infiltrates CD3+/CD8+ (T cells) and CD11c (dendritic cells) after 2 weeks of treatment, corresponding with improvement in histologic score.","[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Page', 'Affiliation': 'Pfizer, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Suarez-Farinas', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Suprun', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Pfizer, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Garcet', 'Affiliation': 'Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Judilyn', 'Initials': 'J', 'LastName': 'Fuentes-Duculan', 'Affiliation': 'Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Scaramozza', 'Affiliation': 'Pfizer, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kieras', 'Affiliation': 'Pfizer, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Pfizer, Cambridge, Massachusetts, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Clark', 'Affiliation': 'Pfizer, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fensome', 'Affiliation': 'Pfizer, Cambridge, Massachusetts, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': 'Pfizer, Cambridge, Massachusetts, USA. Electronic address: Elena.Peeva@pfizer.com.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.11.027']
1870,32150017,Can Benign Paroxysmal Positional Vertigo Be Treated in a One Session?,"OBJECTIVE


To determine the reliability and safety of posterior canal BPPV (pc-BPPV) treatment with subsequent assessment of the effectiveness of the maneuver in a single session, compared to the classic weekly procedure.
METHOD


A prospective study of two randomized groups of unilateral pc-BPPV was performed: a weekly management group (27 patients) and single-session treatment group (26 patients). The number of maneuvers required to clear pc-BPPV, incidence of side effects (re-entries and canal conversions), and recurrence rates were compared.
RESULTS


There were no statistically significant differences in the number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate between the two groups. Two re-entries were diagnosed in the single-session group, and both were easily and successfully treated. Three early recurrences were found in the single-session group and one spontaneous recovery was encountered in the weekly group. Time required to discharge patients to follow-up was significantly reduced in the single-session group.
CONCLUSION


Managing pc-BPPV in one session is safe and reliable, resulting in fewer visits to outpatient clinics and optimization of treatment strategies.",2020,"There were no statistically significant differences in the number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate between the two groups.",[],"['unilateral pc-BPPV', 'posterior canal BPPV (pc-BPPV']","['number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate', 'number of maneuvers required to clear pc-BPPV, incidence of side effects (re-entries and canal conversions), and recurrence rates', 'Time required to discharge patients to follow-up', 'spontaneous recovery']",[],"[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]",,0.0413024,"There were no statistically significant differences in the number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate between the two groups.","[{'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Pérez-Guillén', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario La Fe, Valencia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Franco-Gutiérrez', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario Marqués de Valdecilla, Santander.'}, {'ForeName': 'Maria Teresa Gil-', 'Initials': 'MTG', 'LastName': 'Aguilar', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario Marqués de Valdecilla, Santander.'}, {'ForeName': 'Enrique García-', 'Initials': 'EG', 'LastName': 'Zamora', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario La Fe, Valencia.'}, {'ForeName': 'Paz', 'Initials': 'P', 'LastName': 'Pérez-Vázquez', 'Affiliation': 'ENT Department, Hospital Universitario de Cabueñes, Gijón, Spain.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002621']
1871,21049267,Tolerance and cross-tolerance to neurocognitive effects of THC and alcohol in heavy cannabis users.,"INTRODUCTION


Previous research has shown that heavy cannabis users develop tolerance to the impairing effects of Δ9-tetrahydrocannabinol (THC) on neurocognitive functions. Animal studies suggest that chronic cannabis consumption may also produce cross-tolerance for the impairing effects of alcohol, but supportive data in humans is scarce.
PURPOSE


The present study was designed to assess tolerance and cross-tolerance to the neurocognitive effects of THC and alcohol in heavy cannabis users.
METHODS


Twenty-one heavy cannabis users participated in a double-blind, placebo-controlled, three-way study. Subjects underwent three alcohol-dosing conditions that were designed to achieve a steady blood alcohol concentration of about 0, 0.5, and 0.7 mg/ml during a 5-h time window. In addition, subjects smoked a THC cigarette (400 μg/kg) at 3 h post-onset of alcohol dosing during every alcohol condition. Performance tests were conducted repeatedly between 0 and 7 h after onset of drinking and included measures of perceptual motor control (critical tracking task), dual task processing (divided-attention task), motor inhibition (stop-signal task), and cognition (Tower of London).
RESULTS


Alcohol significantly impaired critical tracking, divided attention, and stop-signal performance. THC generally did not affect task performance. However, combined effects of THC and alcohol on divided attention were bigger than those by alcohol alone.
CONCLUSION


In conclusion, the present study generally confirms that heavy cannabis users develop tolerance to the impairing effects of THC on neurocognitive task performance. Yet, heavy cannabis users did not develop cross-tolerance to the impairing effects of alcohol, and the presence of the latter even selectively potentiated THC effects on measures of divided attention.",2011,"RESULTS


Alcohol significantly impaired critical tracking, divided attention, and stop-signal performance.","['Twenty-one heavy cannabis users participated in a double-blind', 'subjects smoked a THC cigarette (400 μg/kg) at 3 h post-onset of alcohol dosing during every alcohol condition', 'heavy cannabis users']","['THC', 'Δ9-tetrahydrocannabinol (THC', 'THC and alcohol', 'placebo']","['steady blood alcohol concentration', 'perceptual motor control (critical tracking task), dual task processing (divided-attention task), motor inhibition (stop-signal task), and cognition (Tower of London', 'critical tracking, divided attention, and stop-signal performance', 'neurocognitive task performance']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0589101', 'cui_str': 'Divided attention, function (observable entity)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.0529886,"RESULTS


Alcohol significantly impaired critical tracking, divided attention, and stop-signal performance.","[{'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands. j.ramaekers@maastrichtuniversity.nl'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': ''}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'de Brouwer', 'Affiliation': ''}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': ''}, {'ForeName': 'Manfred R', 'Initials': 'MR', 'LastName': 'Moeller', 'Affiliation': ''}, {'ForeName': 'Gerhold', 'Initials': 'G', 'LastName': 'Kauert', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-2042-1']
1872,31248307,"The effects of zinc supplementation on clinical response and metabolic profiles in pregnant women at risk for intrauterine growth restriction: a randomized, double-blind, placebo-controlled trial.","OBJECTIVE


This investigation was conducted to assess the effects of zinc supplementation on clinical response and metabolic status among pregnant women at risk for intrauterine growth restriction (IUGR).
METHODS


This randomized, double-blind, placebo-controlled, clinical trial was conducted among 52 women at risk for IUGR according to abnormal uterine artery Doppler waveform. Participants were randomly assigned to take either 233 mg zinc gluconate (containing 30 mg zinc) supplements ( n  = 26) or placebo ( n  = 26) for 10 weeks from 17 to 27 weeks of gestation. Fasting blood samples were taken at baseline and after the 10-week treatment to quantify related variables.
RESULTS


After the 10-week intervention, taking zinc led to a significant reduction in serum high-sensitivity C-reactive protein (hs-CRP) ( β  ‒1.17 mg/L; 95% CI, -1.77, -0.57;  p  < .001) and plasma malondialdehyde (MDA) levels ( β  -0.23 µmol/L; 95% CI, -0.45, -0.02;  p  = .03); also a significant rise in total antioxidant capacity (TAC) ( β  59.22 mmol/L; 95% CI, 25.07, 93.36;  p  = .001) was observed in comparison to placebo. In addition, zinc supplementation significantly reduced serum insulin ( β  -1.33 µIU/mL; 95% CI, -2.00, -0.67;  p  < .001) and insulin resistance ( β  -0.30; 95% CI, -0.44, -0.15;  p  < .001), and significantly increased insulin sensitivity ( β  0.008; 95% CI, 0.003, 0.01;  p  < .001) compared with the placebo. Zinc supplementation did not influence pulsatility index (PI) and other metabolic parameters.
CONCLUSIONS


Overall, zinc supplementation in pregnant women at risk for IUGR had beneficial effects on TAC, MDA, hs-CRP, and insulin metabolism, but did not affect PI and other metabolic profiles.",2021,"After the 10-week intervention, taking zinc led to a significant reduction in serum high-sensitivity C-reactive protein (hs-CRP) ( β  ‒1.17 ","['52 women at risk for IUGR according to abnormal uterine artery Doppler waveform', 'pregnant women at risk for IUGR', 'pregnant women at risk for intrauterine growth restriction', 'pregnant women at risk for intrauterine growth restriction (IUGR']","['Zinc supplementation', 'zinc supplementation', '233\u2009mg zinc gluconate (containing 30\u2009mg zinc) supplements', 'placebo']","['clinical response and metabolic profiles', 'insulin sensitivity', 'serum high-sensitivity C-reactive protein (hs-CRP', 'TAC, MDA, hs-CRP, and insulin metabolism', 'plasma malondialdehyde (MDA) levels', 'insulin resistance', 'Fasting blood samples', 'total antioxidant capacity (TAC', 'serum insulin ', 'clinical response and metabolic status', 'pulsatility index (PI) and other metabolic parameters']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0450448', 'cui_str': 'Waveforms (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",52.0,0.81381,"After the 10-week intervention, taking zinc led to a significant reduction in serum high-sensitivity C-reactive protein (hs-CRP) ( β  ‒1.17 ","[{'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Mesdaghinia', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Naderi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Chamani', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Addiction Studies, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1637847']
1873,32060166,Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors.,"INTRODUCTION


Many breast cancer survivors report an inability to fully participate in activities of daily living after completing cancer treatment. Reduced activity participation is linked to negative consequences for individuals (eg, depression, reduced quality of life) and society (reduced workforce participation). There is currently a lack of evidence-based interventions that directly foster cancer survivors' optimal participation in life roles and activities. Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors.
METHODS AND ANALYSIS


This protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors' activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1-3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later.
ETHICS AND DISSEMINATION


Study procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03915548; Pre-results.",2020,"Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors.
","['Many breast cancer survivors', 'breast cancer survivors', 'Human Subjects at Dartmouth College', 'female breast cancer survivors', '300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1-3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham']","['rehabilitation intervention', 'nine-session BA and PST-informed rehabilitation intervention (BA/PS', 'rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST']",[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],300.0,0.0960632,"Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors.
","[{'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Hegel', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Marie Anne', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Bruce', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pisu', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Chamberlin', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Keene', 'Affiliation': 'Radiation Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Rocque', 'Affiliation': 'Medicine, Divisions of Hematology and Oncology, and Geriatrics, Gerontology, and Palliative Care, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Ellis', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Gilbert', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Jamme L', 'Initials': 'JL', 'LastName': 'Morency', 'Affiliation': 'Physical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Newman', 'Affiliation': 'Occupational Therapy, Boston University College of Health and Rehabilitation Sciences Sargent College, Boston, Massachusetts, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Codini', 'Affiliation': 'Physical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Thorp', 'Affiliation': 'Physical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Dos Anjos', 'Affiliation': 'Occupational Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Danielle Z', 'Initials': 'DZ', 'LastName': 'Cloyd', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Echols', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Milford', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Ingram', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Kathleen Doyle', 'Initials': 'KD', 'LastName': 'Lyons', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA kathleen.d.lyons@dartmouth.edu.'}]",BMJ open,['10.1136/bmjopen-2020-036864']
1874,31281558,Effect of Deep Slow Breathing on Pain-Related Variables in Osteoarthritis.,"This study evaluated the effect of a six-week deep slow breathing (DSB) program on pain, physical function, and heart rate variability (HRV) in subjects with lower extremity joint pain. Twenty subjects were assigned into training ( n  = 10) and control ( n  = 10) groups. The training group participated in a six-week DSB program consisting of weekly training sessions and at-home breathing exercises. DSB exercises focused on prolonging the exhalation and the pause following exhalation. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to assess pain and physical function, and HRV data were obtained before and after intervention. Results revealed no significant interactions between group and time for any of the variables. There was no significant main effect for group, but there was a significant main effect ( p  < 0.025) and a large effect size for time on both pain ( η   p   2  = 0.454) and physical function ( η   p   2  = 0.506). There were no significant main effects ( p  > 0.017) for group and time on LF power (group  η   p   2  = 0.039, time  η   p   2  = 0.061), HF power (group  η   p   2  = 0.039, time  η   p   2  = 0.039), and LF/HF ratio (group  η   p   2  = 0.036, time  η   p   2  = 0.169). Results indicated that the six-week DSB program was not sufficient to alleviate pain or improve physical function in subjects with lower extremity joint pain. Although the pain was not alleviated, other beneficial effects such as better coping with the pain were reported in the majority of training subjects. As this is the first study to examine the use of DSB for lower extremity joint pain and dysfunction, further research is needed to investigate the efficacy and applicability of DSB.",2019,"There were no significant main effects ( p  > 0.017) for group and time on LF power (group  η   p   2  = 0.039, time  η   p   2  = 0.061), HF power (group  η   p   2  = 0.039, time  η   p   2  = 0.039), and LF/HF ratio (group  η   ","['subjects with lower extremity joint pain', 'Twenty subjects', 'Osteoarthritis']","['Deep Slow Breathing', 'DSB program consisting of weekly training sessions and at-home breathing exercises', 'six-week deep slow breathing (DSB) program', 'DSB exercises', 'DSB']","['physical function', 'large effect size for time on both pain', 'HF power', 'pain, physical function, and heart rate variability (HRV', 'pain and physical function, and HRV data', 'time on LF power']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration (finding)'}, {'cui': 'C0603200', 'cui_str': 'DSB'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",20.0,0.0146163,"There were no significant main effects ( p  > 0.017) for group and time on LF power (group  η   p   2  = 0.039, time  η   p   2  = 0.061), HF power (group  η   p   2  = 0.039, time  η   p   2  = 0.039), and LF/HF ratio (group  η   ","[{'ForeName': 'Kalee L', 'Initials': 'KL', 'LastName': 'Larsen', 'Affiliation': 'Health and Human Development Department, Western Washington University, Bellingham, WA 98225, USA.'}, {'ForeName': 'Lorrie R', 'Initials': 'LR', 'LastName': 'Brilla', 'Affiliation': 'Health and Human Development Department, Western Washington University, Bellingham, WA 98225, USA.'}, {'ForeName': 'Wren L', 'Initials': 'WL', 'LastName': 'McLaughlin', 'Affiliation': 'Health and Human Development Department, Western Washington University, Bellingham, WA 98225, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Health and Human Development Department, Western Washington University, Bellingham, WA 98225, USA.'}]",Pain research & management,['10.1155/2019/5487050']